Johnson & Johnson

Eight hours after the shot, I quickly became very chilled with total body aches and pains and extremely tired. My mouth became very dry. This lasted most of the night. The next morning approaching 24 hours after the shot, the initial side effects were gone but I then had a headache and a bit of nausea. Again was extremely tired and pretty much rested all day. All side effects were gone the next day. I felt no need to call my healthcare provider and did not take any over the counter pain medication.

headache started at approx 3pm, debilitating chills with uncontrolled shaking started at 4pm with low grade fever that began to climb. Fever peaked at 104.8 and stayed there for approx 6 hours. Vomiting started around 7pm. Rapid hear rate for approx 4 hours. Pulse was over 120 beats for approx 2 hours with chest pain.

Horrendous headache starting 13 1/2 hrs later. Then nausea, and I passed out. Came to and had extreme chills. After the 24 hr mark, just tired and had to stay in bed. Today 3/9, all good.

Nothing serious but the roof of my mouth and back of my throat felt numb for about an hour and then was tingly. This happened about 30 minutes after the shot. I also was very nauseous the next morning.

The vaccine injection was given at 1:15PM. Symptoms started 8 hours later at 9:00PM. After the first bout of vomiting on night #1, symptoms diminished in intensity but continued into the next day until 10:00PM (when the fever finally broke) for a total of 25 hours. Took 200mg Advil/ibuprofen x 1 dose for relief/sleep on night #1. The symptoms included the following: 1. Chills w/ intense body shivering 2. All over body aches 3. Nausea 4. Violent vomiting 5. Fever 100.3F at the onset 6. Fever 99.9F the following day 7. Headache 8. Extreme tiredness (eyelids felt like lead weights) 9. Dizziness 10. Minimal to no pain at the injection site (very mild if pressing on the skin below the site)

Fever for 40 hours, chills, uncontrollable shaking for more than 3 hours, severe nausea for 36 hours, nausea continues now but at a much less severe amount, swollen glands around head and in right arm pit for more than 40 hours, pain in right eye started within 10 minutes of shot and continues now, pain in ankles started about 8 hours after shot and continues now but is becoming much more bearable, joints of toes and joints of a few fingers were painful for about 24 hours, sore arm started about 3 hours after shot and continues now, overall muscle aches started about 8 hours after shot - became much worse within 12-14 hours after shot and became less severe after 30 hours. Overall I felt as if I had a terrible case of the flu. It was very intense. I was unable to sleep the first night due to the severity of symptoms. The second night I sweated a tremendous amount and my fever broke. I am still not over all of my symptoms but I am feeling better.

At 9pm I started to feel tired and went to bed. At 3am I woke up with nausea, headache, and arm very sore at site of injection. I was also a bit dizzy when I got up. By 10am, I just had a bit of a heachache and fatigue.

Approximately 6 hours after receiving the injection, chills began. Then headache, low grade fever, neck ache. Then nausea and vomiting. I couldn't keep anything down. About 24 hours after the side effects began, I started to feel better.

The vaccine injection was given at 1:15PM. Symptoms started 8 hours later at 9:00PM. After the first bout of vomiting on night #1, symptoms diminished in intensity but continued into the next day until 10:00PM (when the fever finally broke) for a total of 25 hours. Took 200mg Advil/ibuprofen x 1 dose for relief/sleep on night #1. The symptoms included the following: 1. Chills w/ intense body shivering 2. All over body aches 3. Nausea 4. Violent vomiting 5. Fever 100.3F at the onset 6. Fever 99.9F the following day 7. Headache 8. Extreme tiredness (eyelids felt like lead weights) 9. Dizziness 10. Frequent runny stools 11. Minimal to no pain at the injection site (very mild if pressing on the skin below the site)

March 13, 2021 - Upset stomach; headache; fever & body aches March 14, 2021 - Fever; headache and tired March 15, 2021 - Tired & slight cough March 16, 2021 - Slight cough & minor rise in body temperature

Chills, fever ranging up and down between 100 and 105. 105 @ midnight 12 hours after vaccine. The rest of the time during first 24 hours temp fluctuated between 102 and 104 along with chills, body aches, severe headache and nausea. Hours 24-48 were similar but with slightly lower temps finally ending about 3rd days post vaccine. Nausea and diareah 3rd and 4th day post vaccine

Felt great and then all of a sudden diarrhea started around 11 pm. Went to bed and became extremely cold - teeth chattering, chills and fever at 11:30pm - approx. 8 1/2 hours after injection. After that vomiting, soreness, headache body aches, fever of 100 degrees. When awaking the next morning, still had fever of 99.8, chills, nausea, headache. Finally felt like myself by 3pm on Tuesday, March 16. I am not a chronic complainer. After receiving my flu shots every year for many years, this was the first reaction I've ever had to any immunization - ever.

Six hours after vaccine, extreme muscle aches; splitting, nauseating headache across the forehead. All symptoms resolved 30-36 hours post vaccine

severe chills, exhaustion, nausea, constipation, urinary discomfort, odor in urine - most symptoms lasted until Tuesday 3/16. However, that evening I developed a red bumpy itchy rash on both my legs (front only from knee to upper thigh). I took a Benedryl and it was gone this morning. The discomfort while urinating has returned this morning 3/17 and my primary doctor is sending me for lab work.

6 pm chills 10 pm tired, needed to sleep 2 am awoke with extreme headache, nausea, fever, chills. lasting 2 hours, husband wanted to call 911, thought I was going to die, was able to take 2 Advil then sleep in 30 minutes, slept till 11 am

fever to 100.4, headache, neck pain for 10 hrs then 3 days later developed fever 100.6 and abd pain, diarrhea,

Almost received an instant headache within minute's Extreme fatigue the following day. Got vaccine on a Friday and on Sunday started to experience pretty tense stomach pain and nausea. Now its Monday and still tired, with headache and stomach pains and nausea I wanted to report but not sure if this is due to the vaccine or not?

It hurt momentarily and I stayed for 15 min as required. I went to work at 2pm. At around 8:30pm, I started feeling like I ran a marathon. I felt like I hit a wall. My body just ached. I took some Ibuprofen and continued my shift. I woke up the next day with a headache so bad that I couldn't lift my head off of the pillow. I took Tylenol and that continued the entire day. I stayed in bed all day. The next night, I woke up in the middle of the night with chills, but no temperature. The following Monday, I still had the chills along with nausea. By Tuesday, I felt normal again.

Dizziness, vertigo, nausea3 days post vaccine 24 hour after vaccine chills shoulder pain on side of injection

Within a minute of receiving the vaccine, pt reported itchy/tingly sensation in her mouth and throat. Initially stated she could breathe/swallow just fine but very quickly stated the swallowing was getting more difficult. 911 was called followed by 0.3 mg EpiPen in her right outer thigh and 50mg of oral Benadryl. Her BP was then taken around 4:45 and it was 162/93 at which point EMT arrived and took over.

8 hours after the vaccination, patient felt cold/chills along with ascending body temperature. Then, patient felt hot. Dizziness and fever persisted for almost 12 hours. Patient waking up in the morning felt lose of appetite due to nausea.

Worst headache ever - intense pain when walking or moving head, nausea. Dr told me to take 4 ibuprofen 3 times per day. I took 2 3 times per day. The headache and nausea lasted 4 days. Headache is milder but still present, especially with head movements. Ringing in ears, moderate tinnitus from the day I got the shot and it still remains.

Approximately, 11 hours after the shot Severe cold chills, so severe my teeth would not stop chattering. I was shaking so hard my body ached from shaking. Goosebumps, a crazy headache. I thought i was having an anurysm. Not a normal headache. Cold sweats so bad you could just about wring out my sheets and clothes. Nausea, some vomiting. On a scale of 1-10 of these symptoms is was an 11-12. These symptoms changed as the days went on. In the moring of the first night. I was ok. Woke up with a bad headache, still nauseas and still cold but not like at night tollerable. About 5PM day 2 it started all over again, just as severe. Next moring ok. This pattern kept reapeating for 4 days. Food now getting repulsive. No way I could eat anything. On day 5 the symptoms continue now throug the day, however the teeth chattering not happeing and the cold chills a bit less severe. I would say by day 5 on the scale of 1-10 i am now about a 9. This was so horrible for so long. Every single night i would wake up soaked in my own sweat. This is still happening 11 days later. I am still experiencing headaches. I never have headaches. I did not go to a Doctor because i figured what are they going to do, i have to ride this out. Also a strange thing is took my temparture daily and seveal times. Zero temprature. by day 5 I could not get out of bed for 3 days. Day 8 things getting better, still cold chills and headaches but not as bad. Day 9 way better, now getting hungry. Daytime cold chills now gone mostly less headaches. Oddly headaches and cold chills start about 4-5pm and continue through the night. In the morning i wake up with a headache still today.

Started 6 hours after injection and lasted 24 hours that included - Chills, Nausea, Muscle & Joint aches, Severe headache, Fatigue. I didn't take any course of action other than rest and sleep.

Got really tired at 10pm, 11 hrs after shot, but couldn't sleep until 4:30. Was slightly nauseous. Vomiting then started around 7:30 am and continued. Last vomit was around noon today, April 4, but am still nauseous and not sure I'm done vomiting. Been in bed since 10 pm on April 2. Fever today is 99.0. Also have been experiencing a lot of nasal congestion off and on.

Patient reported dizziness and nausea following the administration of vaccine. Patient reported dizziness, lightheadedness, nausea, and exhibited hypertension throughout monitoring period. Patient monitored for a total of 1hr and 30 minutes. Patient received apple juice, water, and crackers during monitoring period. Patient remained alert and oriented during monitoring period. Patient reported feelings of anxiety prior to vaccination. Patient exhibited various blood pressure reading see the following, 121/80 HR 79, 130/87 HR 79, 129/81 HR 82, 140/86 HR 79, 150/86 HR 77, 136/86 HR 76, 170/102 HR 86. Patient final blood pressure reading prior to leaving the facility was 175/102 HR 82. Patient requested transfer to emergency room due to increased nausea, dizziness/ lightheadedness, and hypertension. Patient denied shortness of breath or difficulty breathing throughout monitoring period and prior to transfer.

Approximately 10 minutes after receiving the vaccine, the patient's husband said she was feeling faint. I checked her blood pressure, which registered as 80/60. I offered to call 911, due to hypotension, but when I checked it on her other arm, it was 177/87, which she confirmed was closer to her baseline. Additionally, she complained of nausea and vomited. I then offered to call 911 again, but she said that she was feeling better. I continued to monitor her, and offered to call an ambulance again, She did not complain of any difficulty breathing or chest tightness/pain. I continued to monitor her for twenty minutes, and then she said that she wanted to go home. I offered to call an ambulance again, but she assured me that she felt better and wanted to go home.

7 hours from vaccine, my heart started palpitating and I started feeling sick. I got in my car to go home from a friends house and started severe chills and called Doctor for fear of heart attack. They told me to go to ER. I continued driving home. Chills got worse. I got in shower with heater on and chills persisted. Drank coconut water and heart palpitations resided. Got in bed and fever spiked to 102 and every bone was inflamed in pain. Nyquil did nothing. After a few hours of severe and unbearable pain I called ER. Headed over to ER at 3:00 a.m. and sat in parking lot. Fever broke at 3:00 a.m. which was hour 14 after vaccine. Other than severe nausea, pain calmed down. Drove home with Tylenol. Took 1,000 mg and finally rested at 4:00 a.m. Woke up at 8:00 a.m. with nausea but pain gone. 24 hours from vaccine, most of the reaction gone. 48 hours out body normal but pain in injection site.

FAINTED; QUALITY OF SLEEP WAS LOW/DID NOT SLEEP WELL; FELT VERY RESTLESS; CHILLS; FEVER (UNKNOWN TEMPERATURE); EXTREME NAUSEA; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight, height, and medical history included the patient had several comorbidities. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978) dose was not reported, frequency 1 total, administered on 03-APR-2021 at left Arm for prophylactic vaccination. No concomitant medications were reported. It was reported that, On 04-APR-2021 at approximately 04:00 a.m. in the morning, the patient experienced chills, extreme nausea, fever (unknown temperature, felt like she had a fever, hot) and she fainted. She also stated that when she went to sleep her quality of sleep was low and poor as she felt very restless. She stated that before fainting she called out to her husband who then carried her back to her bed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the quality of sleep was low/ did not sleep well, chills, fever (unknown temperature), fainted, extreme nausea and felt very restless was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210408190-Covid-19 Vaccine ad26. cov2.s-Fainted. 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).

Sunday 04/04/2021 started itching on right side next to breast, no redness or rash. itch got more severe over nigh. 04/05/2021 morning lips dry and burni,g throat and back tongue scratchy. 04/06/2021 severe itching from head to toe still no rash or redness. took benedryl called fam. doctor, told me to continue benedryl till itch subsides. evening severe pain in upper stomach near breast, felt like big bubble /knot, started vomiting and diarhea all night . 04/07/2021 entire body rash and hives, went to ER. said it was severe alergic reaction. gave me prednisone shot, and told me to contact allergist. taking prednisone for 4 days also pepcid and benedryl. it is now 04/09/2021 still itching all over , and diarhea

Chills, Nausea, Headache, Body Ache, Skin Hurt, Left hand pain base of middle finger back of hand Lasted about 5 hours, Headache remained into the next morning. Took Benadryl and Ibuprofen

extreme fatigue mild headache muscle pains nausea and vomiting chills taste confusion loss of appetite eye focus issues dizziness brain fog low grade fever sores on tongue lip blisters (Important to note: still experiencing severe blisters on my lips) low energy and fatigue continues day to day

Woke up with body aches, headache, low grade temperature. Stayed in bed most of day(thu) That evening finally took a couple tylenol because the aching was preventing me from sleeping. Fri I felt better maybe a little tired. Friday evening I started vomiting, and had diarrhea. Fever was at 202 at highest. Brain fog. Had severe chills for a couple hours. Fever hung around 100 most of Saturday. Have slight tightness in upper chest. Occassional dry cough. Occassional diarrhea. Weak. Sunday. Still have occassional diarrhea. Temp has been around 99.5. Weak. But a little more energy. Still have tightness in chest.

Within 5 minutes of receiving the shot, I had stomach cramps and felt extremely nauseous. I had periods of nausea and dizzy spells for the following week. I had an extreme migrane the night of the shot and chills throughout the next week. I did not report the symptoms to anyone because I had not heard that these were reactions to this vaccine. After I heard that others were experiencing similar symptoms, I felt I should report my experience.

Within first hour: pain at vaccination site, headache and left neck/shoulder ache, worser headache, numbness and tingling on left side of face and jaw (sort of like novocaine?) spreading down left arm, increasing severity of headache, nausea, tiredness. Throughout pm: chills, body aches, decreasing numbness on left side face/arm, increased fatigue. Took 2 acetamenaphen extra strength Throughout night: severe chills, headache, body and muscular pain. Day 2: frequent and severe chills; mild fever (100.8); severe headache, severe joint, muscle, and body aches (like flu), nausea, severe fatigue. Day 3(today): much fewer chills, decreased nausea, some fatigue, increased pain in back along spine and down legs, cont tylenol xs

Extreme chills where my body would not stop shaking, sweats, muscle aches, nausea, bad headache, tired. Took 2 Tylenol every 4-6 hours to help the headache. It lasted until Sunday morning. My nose felt stuffy when I woke up Sunday morning at which time there was blood in my nose. The rest of the day it was clear but a small amount appeared Monday morning as well. Both sides of my temples are sore to the touch as if they were bruised. Other than that and being weak the other symptoms are gone.

I woke up at 2AM on the 03/29/2021 with a severe headache, nausea and chills. I went to get a RAPID test at CVS which was a NEG result.

Extreme chills & shaking. Blood pressure hyper (160/90]and hypotensive (90/65), erratic pulse, fever (102.4), headache, nausea.

The patient had burning sensations and increased urination symptoms consistent with a possible urinary tract infection prior to the vaccination that took place on 2 April 2021. A urinary culture was negative on 31 March 2021. A few days after the vaccination, the burning pain and urgency subsided but was replaced by increasing lower abdominal pressure and pain. The patient will see a doctor on 14 April 2021. Other effects observed following the vaccination on 2 April 2021 include: headaches, muscle pain, injection site arm pain, sore throat. These effects resolved within 24 hours after the vaccination with exception of the sore throat which is ongoing.

Severe to moderate headache, fever (unknown first night and feverish feeling since), large joint and abdominal pain, very fatigued, thirsty, increasingly redness and tenderness at 8njection site and surrounding area over the past 2 days.

Approx 31 hours after the vaccine, I ran a 99.9 temp. Ran than for about 30 hrs. I also got diareah within 30 hours after shot. That lasted about 24 hrs. I had a slight headache for about 24 hrs

Chills, lasting approximately 4 hours. Low grade fever (range 99 to 101), fatigue, lasting approximately 22 hours. Nausea and vomiting for approximately 2 hours--cumulatively. The day after inoculation at about 10:00 pm, everything back to "normal".

3/22/21: Vaccine administered 4:45 pm. Burning sensation on arms and legs began about 2 hrs later. Achy and feeling cold about 2 hrs after that. Then headache, shaking, muscles quivering, fever, weakness, some itchy spots, increased urination throughout next several hours. Fitbit showed elevated heart rate for several hours. 3/23/21: Nausea and vomiting. Could not keep water down. Very weak/shaky. That night, went to ED. Treated for dehydration and allergic reaction. 3/24/21: Able to tolerate clear liquids. Still weak. 3/26/21: Woke up with rash on both legs (small bumps, not itchy). Added bread to diet. Still weak. 3/29/21: Low grade fever, strong pain in right side of lower back.

Shortly after the vaccine I fainted which came on quite quickly and upon waking within a minute I felt sick and vomited.

April 13: Diarrhea, nausea in morning. Fever of 100 at 4 pm, muscle aches. Fever morning of April 14 with Diarrhea, fever gone by 3 pm.

Approximately 24 hours after the administration of the vaccine the patient experienced a fever of 110.6, and left work and remained out for 24 hours. The patient proceeded to experience GI symptoms which presented as diarrhea for 10 days post vaccination. The fever resolved after 24 hours. The patient experienced pain in joints, this has continue and not yet resolved, the patient has made an appoint with their primary physician to address the matter. The patient is currently taking ibuprofen to treat the pain.

At time of injection:Burning and pain at injection site 11 hours later:Fever of 101, nausea, stomach pain, chills and other flu-like symptoms Appx. 8-10 days later: terrible deep /aching cramp-like pain in upper left arm. Limited range of motion due to pain. Sporadic head aches-unusual for me as i do not hget headaches unless it's sinus which this isn't.

Starting the 10th, patient has had bad headache, severe muscle pains more than usual, SOB more than normal and severe fatigue. She thought it would go away but the symptoms got worse with each day. No fever. She had been taking Ibuprofen and Tylenol around the clock. Symptoms had not improved Also had been nauseated since Monday 4-12-21. The site was sore and her arm felt heavy and she could hardly lift it.

Developed heart palpitations approximately 10 hours after receiving vaccine. Also insomnia making it impossible to sleep. Palpitations seemed to get better by 11 am the next morning but my heart rate was still elevated ( pulse 106-112). Shortly after that ( around 11:45 am) I became extremely light headed and dizzy and felt like I was going to pass out. I also started to feel nauseous and sweaty. I rested lying down for two hours before hearing back from my doctor's office. I was able to control the lightheadedness and dizziness by lying down. The feeling of passing out / nearly fainting went away. I continued to feel nauseous and my heartrate was still elected. I started to get a headache as well. On the advise of a nurse at my doctor's office, my husband took me to the ER. My EKG was normal . My heartrate was elevated. Due to the overcrowding at the ER that day I was made to wait at least an hour and half for further evaluation. I continued to feel light headed and slightly dizzy. My nausea and headache got much worse . I was finally taken back to a treatment room and received IV fluids, Zofran and Tylenol. My heartrate went back to normal and my headache and nausea improved with treatment and I was discharged around 7pm. I continued to feel very tired and slightly lightheaded that evening. The next morning I was much more nauseous again and still very weak feeling and slightly lightheaded. I have continued to feel weak, very fatigued , unwell and nauseous on and off until today, April 14, which is 6 days after I was vaccinated.

Report she got the vaccine on 4/10/21 and started having achiness, fatigue shortly after. 3 days later pt developed diarrhea (watery), cough, SOB. Reports SOB worse with exertion, talking.

All symptoms for up to 10 days after vaccination: pain at injection site; muscle aches around neck/shoulders; chills; malaise; stuffy nose/sinus problems; blood while blowing nose; all over body aches; excessive sneezing; watery eyes; brain fog; tongue/gum swelling; shortness of breath; throat tightening; acne; fleeting stomach pain; sore sternum.

DELIRIUM; FLUSHED TO FACE; UNCONTROLLED SHAKING; VOMITING; CHILLS; FEVER; This spontaneous report received from a patient concerned a female of 60 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to latex (adhesives band aids leave a welt on skin), non-alcohol use, and nonsmoker, and other pre-existing medical conditions included patient did not have any history of drug abuse or illicit drug. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 05-APR-2021 at 13:00 on left arm for prophylactic vaccination. No concomitant medications were reported. The patient was not pregnant at the time of report. On 05-APR-2021 at 21:00, the patient experienced delirium, flushed to face, uncontrolled shaking, vomiting, fever and chills. Body temperature (NR: not provided) at 103.5 F. The patient has received paracetamol for fever. The patient consulted a physician at emergency room and physician suggested her to use alternate paracetamol, and ibuprofen to manage symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, uncontrolled shaking, flushed to face, vomiting, chills, and delirium. This report was serious (Other Medically Important Condition).; Sender's Comments: v0;20210417227-covid-19 vaccine ad26.cov2. s-Delirium. 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

constantly nauseous,stomach feels bloated,hurts,red dots on arm and neck, hot sweats, all to present date 04/21/21.On 04/08/21 got fever 99.5, body aches & pain,then all of the above stuff to date.

This spontaneous report received from a patient concerned a 60 year old female. The patient's weight was 143 kilograms, and height was 65 inches. The patient's past medical history included shingles vaccine, and concurrent conditions included alcoholic, and non smoker, and other pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-202113:30 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced heart thumping hard in chest. On 06-APR-2021, the subject experienced foggy feeling in head. On 06-APR-2021, the subject experienced shallow breathing. On 06-APR-2021, the subject experienced violent chills. On 06-APR-2021, the subject experienced fever. On 06-APR-2021, the subject experienced excruciating headache. On 06-APR-2021, the subject experienced fatigue. On 06-APR-2021, the subject experienced body ache. On 06-APR-2021, the subject experienced nausea. Treatment medications included: paracetamol. On an unspecified date, the subject experienced eye running d/t the pain, couldn't stand the light and sound, pure misery, burning up, and full body shaking/came on like a train wreck. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103.6 F, 100.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart thumping hard in chest, and violent chills on 07-APR-2021, shallow breathing, fever, and excruciating headache on 08-APR-2021, and body ache on 09-APR-2021, had not recovered from fatigue, and foggy feeling in head, and the outcome of nausea, full body shaking/came on like a train wreck, eye running d/t the pain, couldn't stand the light and sound, burning up and pure misery was not reported. This report was non-serious.

BODY ACHES; HEADACHE; LOSS OF APPETITE; CHILLS; FEVER; EXTREME FATIGUE; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced extreme fatigue. On 11-APR-2021, the subject experienced loss of appetite. On 11-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced body aches. On 12-APR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, loss of appetite, extreme fatigue, chills, body aches, and headache. This report was non-serious.

FOGGY FEELING IN HEAD; FATIGUE; NAUSEA; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfonamide allergy, non smoker, and alcohol user, and other pre-existing medical conditions included the patient did not have any drug abuse or illicit drug usage. The patient experienced drug allergy when treated with clindamycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201a21a, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced foggy feeling in head. On 09-APR-2021, the subject experienced fatigue. On 09-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, nausea, and foggy feeling in head. This report was non-serious.

Rapid heartbeat 24 hours severe stomach pain two weeks muscle and joint pain two weeks extreme high blood pressure two weeks. Extreme fatigue two weeks. The vaccine triggered an auto immune response. It triggered a flareup in my body and I was very ill for several weeks. Because of my severe stomach pain and blood pressure soaring my doctor ordered a CAT scan and blood work up. I am now three weeks post vaccine and my body seems to be calming down my blood pressure has returned to normal and the stomach pain has stopped. The extreme fatigue muscle and joint pain is still present but much better.

Headaches, fever, loss of appetite, diarrhea, fatigue for 24 hours then daily headaches x?s 4 weeks. Taking Aleve for headaches, discussed symptoms with the provider

SWELLING ON THE SIDE OF LEFT NECK; DIFFICULTY SWALLOWING; HANDS AND FEET FREEZING FOR A LONG TIME; CHILLS AND SHIVERING; SUSPECTED FEVER; HEADACHE; NAUSEA DRY HEAVES; DEHYDRATED; THIRSTY; QUATER SIZE KNOT IN LYMPH GLAND AND SWELLING; FAST HEART BEAT; THROAT TIGHTNESS; ACHYNESS JOINT PAIN; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight was 190 pounds, and height was 155.44 centimeters. The patient's past medical history included covid-19 infection, and concurrent conditions included alcohol use, non smoker, allergy to animal, dust allergy, ragweed allergy, mold allergy, asthma, copd, joint pain, joint swelling, fibromyalgia, osteoarthritis, and drug allergy to tenormin somac metrogel amoxicillin, and other pre-existing medical conditions included the patient had no illness at time of vaccination. the patient had no past history of similar events. the patient had no pre-existing acute illness in 30 days prior to vaccination. the patient had no hospitalization in last 30 days prior to vaccination. the patient had no family history of any disease or allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072 expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. Concomitant medications included ascorbic acid/ergocalciferol/folic acid/nicotinamide/panthenol/retinol/riboflavin/thiamine hydrochloride for drug used for unknown indication, budesonide/formoterol fumarate for drug used for unknown indication, and for drug used for unknown indication. On 30-DEC-2020, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On MAR-2021, the subject experienced dehydrated. On MAR-2021, the subject experienced thirsty. On MAR-2021, the subject experienced quarter size knot in lymph gland and swelling. On MAR-2021, the subject experienced fast heart beat. On MAR-2021, the subject experienced throat tightness. On MAR-2021, the subject experienced achyness joint pain. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced nausea dry heaves. On 17-MAR-2021, the subject experienced suspected fever. Laboratory data included: Body temperature (NR: not provided) 99.4 deg. On an unspecified date, the subject experienced swelling on the side of left neck, difficulty swallowing, hands and feet freezing for a long time, and chills and shivering. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills and shivering, headache, nausea dry heaves, dehydrated, thirsty, achyness joint pain, fast heart beat, and throat tightness, had not recovered from quater size knot in lymph gland and swelling, and the outcome of swelling on the side of left neck, difficulty swallowing, hands and feet freezing for a long time and suspected fever was not reported. This report was non-serious. Additional information was received from patient on 16- APR-2021. The following information was updated and incorporated into the case narrative: Patient age group, medical history(alcohol use, non smoker, allergy to animal, dust allergy, ragweed allergy, mold allergy, asthma, COPD, joint pain, joint swelling, fibromyalgia, osteoarthritis, and drug allergy to tenormin somac metrogel amoxicillin), events( chills and shivering, headache, nausea dry heaves, dehydrated, thirsty, achyness joint pain, fast heart beat, and throat tightness, quarter size knot in lymph gland and swelling), outcome updated, causality; Sender's Comments: This case was non serious

SWOLLEN LYMPH NODE; BODY ACHES; HEADACHE; FATIGUE; NAUSEA; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced swollen lymph node. On 09-APR-2021, the subject experienced body aches. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced fatigue. On 09-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, body aches, fatigue, nausea, and swollen lymph node. This report was non-serious.

DIARRHEA; VOMITING; HEADACHE; This spontaneous report received from a consumer concerned a 7 decade old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced diarrhea. On 26-MAR-2021, the subject experienced vomiting. On 26-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, vomiting, and headache on 27-MAR-2021. This report was non-serious.

While I had nausea and fatigue Saturday morning after the vaccine, this report is about my nasty shingles outbreak. Rash started on left hand and calf and spread up my leg. Started with itching, not so much pain as in my prior outbreak which when I was 19 was local on my left arm. This is a bigger rash are, blistered red swollen, oozing, burning...the usual.

ABDOMINAL PAIN; BRUISES ON LEG AND RIGHT ARM; CRAMPING ON LEG; This spontaneous report received from a consumer concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included Lyme disease, shellfish allergy, allergy to an unknown antibiotic, non alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced abdominal pain. On 12-APR-2021, the subject experienced bruises on leg and right arm. On 12-APR-2021, the subject experienced cramping on leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from abdominal pain, bruises on leg and right arm, and cramping on leg. This report was non-serious.; Sender's Comments: v0-Medical assessment comment is not required as the case is assessed as non-serious.

weak, loss of Appetite called 911 transported to Hospital 4/21-patient still having issues with eating , patient was dehydrated . went to hospital , got out now

Patient with development of nausea and non bloody emesis x1, Patient observed for 30 min post emesis without return of symptoms . ER precautions given .Patient without symptoms at time of discharge.

Itching, rubbing, nausea, dry heave, stridor, heavy breathing, cough, swelling of uvula Given Benedryl - Patient declined EpiPen, EMS and ER. Remained tired and itchy for the rest of the day.

Janssen COVID-19 Vaccine EUA Sloughing of skin of roof of mouth - has pealed off 3 times in 2.5 weeks white bumps on tongue - as if some taste buds have died Sensitivity of inner lips to acidic foods and mouthwash

Janssen COVID-19 Vaccine EUA 24 hours of SEVERE pain in every muscle and especially neck, eyes, head, face, jaw. Also fever, nausea, vomiting, inability to sleep, intense tiredness. After 24 hours, all symptoms continued but were milder for 2 more days. Couldn't eat at all for 3-4 days.

Patient experienced nausea, vomiting, diarrhea, headache and fever (101 F) from 10:00 pm 03/18/21 to 12:00 pm 03/19/21.

Patient reports potential side effects for 2 weeks post dose. She has been having diarrhea, chills, body aches, and fatigue. She stated that the symptoms started the day after the vaccine and continue still 2 weeks later.

BOTH LEGS HURT (HAD SHOOTING PAIN/ ON RIGHT LEG) AND BELOW THE KNEE AREA; SWEATING; MIGRAINE WHICH LEAD TO NOT TO SLEEP; ACHINESS ALL OVER THE BODY; CHILLS; NAUSEA FELT LIKE HAD FLU; HEADACHE; BURNING SENSATION; INFLAMMATION OF BOTH LEGS; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient did not do well with drugs generally. The patient experienced drug allergy when treated with morphine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 12:15 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced inflammation of both legs. Treatment medications included: ibuprofen. On 12-APR-2021, the subject experienced burning sensation. On 12-APR-2021, the subject experienced migraine which lead to not to sleep. On 12-APR-2021, the subject experienced achiness all over the body. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced nausea felt like had flu. On 12-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) sub normal 97.5. On 12-APR-2021 02:00, the subject experienced sweating. On 28-APR-2021, the subject experienced both legs hurt (had shooting pain/ on right leg) and below the knee area. Laboratory data included: Blood test (NR: not provided) normal. On 29-APR-2021, treatment medications included: methylprednisolone, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning sensation, and sweating on 13-APR-2021, migraine which lead to not to sleep on 19-APR-2021, chills on 14-APR-2021, and headache on APR-2021, and was recovering from nausea felt like had flu, achiness all over the body, both legs hurt (had shooting pain/ on right leg) and below the knee area, and inflammation of both legs. This report was non-serious.

4/11/21 (evening) - Headache. Called doctor on Monday. Took 1 aspirin with doctor's approval and was fine. 5/4/21 (approximately 1 a.m.) Awoke feeling nauseous. Went to bathroom and proceeded to vomit four times over the next 90 minutes. Last episode was just vomiting water that I'd sipped and could not hold down. No sore throat, fever, chills or diarrhea. Just vomiting. Able to handle crackers, ginger tea & ginger beer. Plan to try soup today. Still more tired than normal (though 16-18 hour workdays don't help here), and stomach still feels a little unsettled. 5/4/21 - Present - Headache. Afraid to take aspirin as it might upset stomach that has already had a tough time. NOTE: Regarding question on next page about adverse reactions to vaccines, I haven't had a vaccine since childhood. My parents, who were typically never sick, became terribly ill for months after receiving their first and only flu vaccine. One of my sister's had a similar reaction. For that reason, my other sister and I have never opted for vaccines in adulthood, until now. I just took it now because I don't want to die, my employer is pushing for us to return to campus, and I know my high school students will not vaccinate or wear masks if they can avoid it.

I felt fine after the vaccine and I took a walk. Three hours later I got a massive headache. I was nauseous with vomiting and diarrhea. I felt like had bubbles going up my spine when I was lying down about a week after the vaccine. The nausea and vomiting went on for ten hours. After five weeks my arm is still a little slow I still have headaches intermittently, and sometimes daily.

Pain at Injection Site-Medium, Redness at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Severe, Systemic: Nausea-Mild, Systemic: Visual Changes/Disturbances-Severe, Additional Details: recieved shot at 3:10pm, patient reported severe arm pain, nausea, blurred vision. 1st bp: 96/66 pulse 64 at 3:34pm, 2nd bp:102/68 pulse 62 at 3:50pm, 3rd bp 122/76 pulse 68 at 4:04pm. advised pt not to drive and left pharmacy around 4:10pm, observed patient for over 30mins due to use of epipen for cipr allergy in past

AFTER REVIEWING PRE-VACCINATION CHECK LIST, DISCUSSED WITH PATIENT ALLERGY TO PENICILLIN AND INQUIRED INTO DETAILS OF FLU VACCINE REACTION. PATIENT DISCUSSED BOTH "ALLERGY/REACTIONS" WITH PHYSICIAN AND HE ADVISED PATIENT TO GO AHEAD WITH VACCINE. PATIENT NOTIFIED OF 30 MINUTE WAIT TIME. THE JANSSEN COVID VACCINE WAS ADMINISTERED IM AT 2:05 PM. 5 MINUTES LATER WHILE DISCUSSING SIDE EFFECTS THE PATIENT EXPERIENCED LIGHT HEADNESS, FOLLOWED BY DIZZINESS, THEN NAUSEA. PATIENT PLACED HEAD DOWN TO KNEES BUT UPON RAISING HER HEAD THE SYMPTOMS RETURNED, ALONG WITH SWEATING AND A HEADACHE. PATIENT ASKED TO LAY DOWN ON CARPETED FLOOR AND , 911 WAS CALLED. A PHYSICIAN IN OUR MEDICAL BUILDING NOTICED AND ASSISTED BY CHECKING BLOOD PRESSURE (122/77) AND PULSE WHICH WAS STRONG AND REGULAR.. HE REMAINED AT HER SIDE UNTIL THE FIRESTATION MEDICS ARRIVED FOLLOWED BY EMS. BY THIS TIME . PATIENT SAID THIS TYPE OF REACTION HAS OCCURRED BEFORE AND LASTS 30 MINUTES WITH A FULL RECOVERY. PATIENT WAS PUT INTO A CHAIR TO SIT UPRIGHT, THEN ALLOWED TO WALK AROUND UNASSISTED. EMS GAVE PATIENT OPTIONS OF GOING TO THE ED TO BE EXAMINED, OR RELEASED TO HER HUSBAND. SHE CHOSE THE LATTER OPTION AND LEFT VIA CAR. AT 3:45 PM

Patient described intractable vomiting, dehydration, blood sugar over 800. Patient went to hospital and was admitted to ICU for approximately 4 days. Patient has been discharged from the hospital.

4/6/2021 vaccination. Within an hour, I had hives .5", and spread to smaller all over body. I had a hard time breathing. I was fine for the first 15 minutes. I started to get itchy, neck started to hurt. My head was all broken out. All down my legs. An hour or 2 later is when it started to itch really bad. Burning going down my arm. I went to work and worked rest of the day, hard time breathing. I had major stomach ache. I couldn't eat. The HA kicked in and had asthma attack. Fever started; 102. Stomach cramps. HA was severe for quite a while. Seven days later, I called my doctor. 4/13/2021 Saw PCM; Pneumonia and sinus infection. Put on upper respiratory medication; Sefedna. *Migraine for 12 days, became a HA for almost a whole month. 102 FEVER lasted 7 days vomiting for 2.5 weeks body aches, chills, teeth chattering; first 2 days extreme fatigue 4/12 or 4/19 (?); COVID + *still experiencing muscle and joint pain *felt like breathing bleach whole time

I experienced acute onset of dizziness with chest pain, shaking chills, muscle spasms in my legs, headaches and nausea. I went to hospital where they did lab work, 1280 EKG, gave me fluids, and gave me Zofran medication. They also gave me a prescription for meclizine. They also did a Covid test which was negative. I saw my PCP on 04-11-2021 who ordered a chest x-ray and lab work. I also saw my PCP 05-11-2021, because I had a TIA on Sunday 05-09-2021. I still being worked up on lab work, TIA and an MRI has been ordered for next Monday 05-17-2021.

Janssen COVOD-19 Vaccine EUA. I had a fever, terrible headache, muscle aches, tired, chills, soreness in upper abdomen and not being able to take a very deep breath. These lasted for a little over 24 hours, but I still have some tenderness in upper abdomen and cannot take a deep breath.

LIGHTHEADED; HEADACHE THAT GOES FROM NECK AROUND THE SKULL, AROUND FACE AND HAIR AREA; NAUSEA; FATIGUE; DOESN'T FEEL LIKE HERSELF; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 12-MAY-2021 14:45 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced doesn't feel like herself. On 13-MAY-2021, the subject experienced lightheaded. On 13-MAY-2021, the subject experienced headache that goes from neck around the skull, around face and hair area. On 13-MAY-2021, the subject experienced nausea. On 13-MAY-2021, the subject experienced fatigue. Treatment medications included: paracetamol. Additional treatment medications (dates unspecified) included: dimenhydrinate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from nausea, and lightheaded, had not recovered from headache that goes from neck around the skull, around face and hair area, and fatigue, and the outcome of doesn't feel like herself was not reported. This report was non-serious.

Fatigue, HA and migraine, neck pain, body aches, diarrhea that have lasted 4 days. Pt has taken Tylenol, Meloxicam, and Sumatriptan with mild improvement after medication but HA returns later. Diarrhea has improved. No improvement in body aches or fatigue

I woke up at 5am and when I sat up, I slumped over. I sat up again, stayed for 30 sec, went to the bathroom and when I came back, I experienced severe dizziness. For the next 4 hours, I couldn't move my head and would get a zing right up the back of my neck. When I tried to sit up again, I got really sick to my stomach. After 8 hours, I started feeling better and was able to sleep on either side, but not on my back. When I was on my back everything would start spinning again. By the afternoon of the next day, I was feeling better, but was afraid to move my head too much because I didn't want everything to start up again, so I went to the doctor. My BP was high, so he had me lay on the table. He turned my head and set it off again, so I was miserable again for the next 10 hours. After that, I felt better and was able to get up and function.

I am filling out this report today because I received a follow up call from the website because I had reported loss work, loss of job, loss of activity and visits to doctors. I received the vaccine on March 12, 2021, I started having arm and shoulders symptoms the day after getting the vaccine but did not feel well that first night while trying to sleep. The symptoms worsened every day, I am in week 11 post vaccination. I have had 22 medical appointments with 3 to PCP, 13 to Physical Therapy who diagnosed left bicep tendinitis and shoulder impingement many weeks ago, 4 to acupuncture, and 1 to xray. This Thursday I finally get an MRI. I lost my job on week 7 after the vaccine, I can barely use my left arm, I live alone, I am exhausted and spend much time chasing a diagnosis or help in resolving this issue. I reported to website every time the link was sent to me. I called the Pharmacy on Day 3 and called Janssen hotline on Day 3 to report a reaction. I wrote to my doctor on Day 5 to say something was not right. By the next day I had an injection site reaction, very hard swelling in my arm, a dark red jagged surface reaction at the injection site now there is a divot there. Feeling very unwell, aches and pains, no fever. I had bad abdominal cramps that night after the injection, diarrhea for days, arm pain with swelling, joint pain in shoulder, knee, and fingers, and a rash across my back, I had to continue to work, typing fast 9 to 10 hours a day, I am a self-employed contractor doing tax technical support and the pain in my arm grew worse daily, I was in tears trying to work. Sitting to type, to read, to drive is the worse. I can dictate into my devices but not rapidly enough for the level of my work. The worse pain in my arm and shoulder is less by avoiding typing and driving but the injury is still there. The pain is constant even without movement.

POSSIBLE SMALL STROKE; POSSIBLE TRANSIENT ISCHAEMIC ATTACK (TIA); SUPER DIZZY; THROWING UP; COULD NOT OPEN EYES; WIERDLY AND EXCEEDINGLY THIRSTY; COULD NOT WALK; NUMBNESS IN LEFT ARM; COULD NOT STAND; HEAVINESS IN LEFT ARM; NAUSEOUS; HEADACHE; FELT LIKE HAD CHILLS LIKE ONE GETS FROM THE FLU; This spontaneous report received from a patient concerned a 60 year old White, Not Hispanic or Latino female. The patient's weight was 175 pounds, and height was 65 inches. The patient's concurrent conditions included slightly elevated blood pressure, alcohol user socially and on weekends, non smoker, and penicillin allergy since childhood. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, expiry: UNKNOWN) dose was not reported, 1 total, administered on 08-MAR-2021 for prophylactic vaccination. Concomitant medications included valsartan for elevated blood pressure, acetylsalicylic acid, and furosemide. On 10-MAR-2021, the patient felt like having chills like getting from the flu, for couple of hours might be, a headache for several days, might be for 3 days. For that the patient took some Advil 200 mg every 6 hours for the first couple of days. Then that passed and felt fine. On 24-APR-2021, around 04:00 in the morning the patient woke up and felt weirdly thirsty, exceedingly thirsty and super dizzy, nauseous thought was having a heart attack and heaviness and numbness in left arm but could still move the arm, however could not walk and could not open eyes until was in hospital. As a treatment Aspirin was given to the patient by husband. The patient was throwing up, could not stand. About 05:30 went to the hospital and ran many tests. Ruled out brain bleed, heart attack, anything cardiac did a CAT scan; bloodwork found that the patient was low in potassium and it was determined that the patient either had a small stroke or a TIA that dissipated on its own. The patient saw her cardiologist and wore a Holter monitor for 10 days. The patient also has an appointment with a neurologist coming up in June and having another CAT scan. Also seeing a vascular neurologist. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from possible small stroke, possible transient ischaemic attack (TIA), super dizzy, could not open eyes, wierdly and exceedingly thirsty, could not walk, throwing up, numbness in left arm, could not stand, heaviness in left arm, and nauseous on 2021, felt like had chills like one gets from the flu on 10-MAR-2021, and headache on MAR-2021. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: covid-19 vaccine ad26.cov2.s-Possible small stroke, Possible transient ischaemic attack , super dizzy, could not open eyes, wierdly and exceedingly thirsty, could not walk, throwing up, numbness in left arm, could not stand, heaviness in left arm. These events are considered unassessable. The events 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 events. covid-19 vaccine ad26.cov2.s-Nauseous. This event is labeled per RSI and is therefore considered potentially related.

Heart rate seemed much higher than normal. I felt pressure on my chest, especially on the upper right side of my chest, all day. Breathing was also more difficult than normal. These symptoms lasted all day and were very concerning, but they seemed to have subsided by the next day (Monday May 17th), so I did not seek medical attention. On Monday May 17th, I had a headache from the time I awoke and for hours thereafter. But that went away shortly after I took an aspirin. This is my third reaction event to this vaccine. The first was a headache 3 days after the vaccine. The second was severe vomiting 3.5 weeks after the vaccine. This increased heart rate, chest pressure, difficulty breathing, and headache is the third event.

After my first dose I experienced- body aches, left arm soreness and stomach pain which lasted a couple of days.

I have had a low-grade fever for 4-6 weeks, always between 99.4 and 100. I am also experiencing aches and stomach issues. I had some type of a lung issue/bronchitis starting about May 1st or so, which has not resolved. In treating that, I tested negative for COVID, had a normal CBC and had a normal chest x-ray.

I noticed a large lump, it started as a rush that was itchy and painful. I had some joint and muscle pain. The lump is still there and painful. I did have diarreha and fatigue.

Patient was nervous about receiving the vaccine and felt nauseous almost immediately after receiving the vaccine. She felt faint as she walked away and wanted to sit down. After a minute or two she fainted while sitting in the chair. Her husband who had been with her the whole time was able to arouse her after about 20 seconds. She felt as though she needed to vomit but was did not. After a few minutes the patient laid down on the floor. Had a fan positioned at them and had the lights off in our pharmacy's counseling room. After about 30 minutes she was feeling a little better and sat up on the floor and was able to drink a little ice water. After a few more minutes she progressed to sitting up in a chair. At no time did she have any rash, hives, or breathing issues. she said she felt very nervous. About an hour after the immunization the patient felt like things were better and was able to stand up and walk out on her own. she held on to her husband's arm as a back up in case she felt faint again.

ABDOMINAL CRAMPING; EXTREME CHILLS; SHOULDER PAIN IN BOTH SHOULDERS; REALLY BAD HEADACHE; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 042A21A 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 abdominal cramping. On 02-JUN-2021, the subject experienced extreme chills. On 02-JUN-2021, the subject experienced shoulder pain in both shoulders. On 02-JUN-2021, the subject experienced really bad headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from abdominal cramping, and had not recovered from extreme chills, really bad headache, and shoulder pain in both shoulders. This report was non-serious.

As soon as the vaccine was given, I was lightheaded ,dizzy and difficulty walking. My left hand went numb and I felt the vaccine travel through my system. I had to be helped to the 15 minute waiting area where I grew nauseous and continued to feel dizzy and light headed. The paramedics were called but my vital signs were normal. I came home and slept for 12 hours. By Saturday ( 4 days ) after the vaccine, I felt like I was in a fog, couldn't think straight, and my speech become slow. Once I got to the ER, I was having delusions and was convinced my deceased dog was sitting on my lap.

LIGHTHEADEDNESS/DIZZINESS; MUSCLE CRAMPS/CRAMPING IN ARMS AND LEGS; ABDOMINAL PAIN (DESCRIBED AS LABOUR PAIN)/ STOMACH MUSCLES SORENESS; FELT WARM WITH NO FEVER; BURPING; DIFFICULTY IN SLEEPING; CHILLS; SORE ARM PAIN; BACK PAIN; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's past medical history included bronchitis, and concurrent conditions included diabetes, and bipolar disorder. The patient experienced drug allergy-rash when treated with sulfamethoxazole/trimethoprim. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: FC 202A21A expiry: 07-AUG-2021) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-JUN-2021, the subject experienced back pain. On 07-JUN-2021, the subject experienced sore arm pain. On 16-JUN-2021, the subject experienced muscle cramps/cramping in arms and legs. On 16-JUN-2021, the subject experienced abdominal pain (described as labour pain) / stomach muscles soreness. On 16-JUN-2021, the subject experienced felt warm with no fever. On 16-JUN-2021, the subject experienced burping. On 16-JUN-2021, the subject experienced difficulty in sleeping. On 16-JUN-2021, the subject experienced chills. On 17-JUN-2021, the subject experienced lightheadedness/dizziness. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle cramps/cramping in arms and legs, abdominal pain (described as labour pain)/ stomach muscles soreness, and difficulty in sleeping on 16-JUN-2021, and back pain, burping, chills, and sore arm pain on 17-JUN-2021, and had not recovered from lightheadedness/dizziness, and felt warm with no fever. This report was non-serious.

The evening after the vaccination, it triggered my asthma. I consulted my doctor and started breathing treatments (levoalbuterol) twice a day. At 5 days post vaccine, the asthma improved but I came down with a very sore throat and also noticed a enlarged lymph node. It was so painful I could not talk or eat. I was tested for strep and was negative. I was prescribed budesonide to calm down the inflammation and I took cough drops. I am still suffering from sore throat but it getting better. Right below my jaw line, I have an enlarged lymph node that is sore to the touch. I am having difficulty swallowing, talking and eating. I am still having these symptoms.

BLOODY STOOL; INFLAMED BURSA OF LEFT HIP, RADIATING TOWARDS SPINE; ARTHRALGIA; MYALGIA; SLIGHTLY LOW KIDNEY FUNCTION; FATIGUE; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroidism. The patient had no known allergies. The patient was previously treated with cortisone in shoulder joint. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, 1 total, administered on 16-MAR-2021 on right arm for prophylactic vaccination. Concomitant medications included ascorbic acid, calcium, chondroitin sulfate/glucosamine hydrochloride, colecalciferol, levothyroxine sodium, and magnesium. In the morning of 17-MAR-2021, the patient felt some fatigue, stayed in bed until noon and fatigue disappeared in the afternoon. On 07-APR-2021, the patient started experiencing pain and soreness in hamstring, behind knees and in hips. The pain and soreness gradually progressed upwards towards spine. The symptoms were worse in the morning and evening, with the period between noon and 8 PM saw some improvement. Since pain and soreness started, the patient had been taking painkillers like candy, Tylenol (paracetamol), Advil (ibuprofen) and Aleve (naproxen sodium) and had no effect on symptoms. On 21-APR-2021, the patient had some bloody stool and saw primary care physician that week. The blood tests, bone density and thyroid function were done. Only finding of note was slightly low kidney function and diagnosis of myalgia and arthralgia. The patient was told to discontinue painkiller use. On 12-JUN-2021, the patient saw orthopedist, was diagnosed with inflamed bursa on the left hip, radiating towards spine and was prescribed a 5 days tapering course of prednisone. The symptoms disappeared starting on the second day of prednisone. The symptoms reappeared with same severity 2 days after stopping prednisone (19-JUN-2021). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bloody stool on 21-APR-2021, and fatigue on 17-MAR-2021, had not recovered from inflamed bursa of left hip, radiating towards spine, myalgia, and arthralgia, and the outcome of slightly low kidney function was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210660357-covid-19 vaccine ad26.cov2.s- bloody stool, slightly low kidney function. 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).

Initially pain in arm severe and last a few weeks 06/19/2021 got sick with diarrhea, sore throat, earache, nausea felt like had the flu for several days was on a liquid diet of broth no medicines. 07/07/2021 started feel better with still scratchy though, no nausea or diarrhea.

VOMITING (WHEN SHE VOMITS, NOTHING COMES OUT); HAND SORENESS; FEVER; NAUSEA; HEADACHE (FEELS SHE CAN SCREAM); WEAKNESS; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: unknown) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUL-2021, the subject experienced vomiting ( nothing comes out). On 09-JUL-2021, the subject experienced hand soreness. On 09-JUL-2021, the subject experienced fever. On 09-JUL-2021, the subject experienced nausea. On 09-JUL-2021, the subject experienced headache (feels she can scream). On 09-JUL-2021, the subject experienced weakness. Treatment medications included: oxycodone/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, nausea, vomiting (nothing comes out), headache (feels she can scream), weakness and hand soreness was not reported. This report was non-serious.

Night 1-severe chills Days 2-3-4 -flu like symptoms-diarrhea Chronic diarrhea has continued to this day

PAIN IN THE LEFT LEG; IMPROVEMENT FROM FIBROMYALGIA PAIN, MUSCLE ACHES AND PAIN WITH 80 TO 90% RELIEF; SOAPY TASTE IN THE MOUTH; MILD NAUSEA WITH ON AND OFF; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's past medical history included blood clot in the left leg at the age of 18, and concurrent conditions included asthma, fibromyalgia pain, muscle aches, and pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 05-AUG-2021) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced soapy taste in the mouth. On 02-APR-2021, the subject experienced mild nausea with on and off. On 05-APR-2021, the subject experienced improvement from fibromyalgia pain, muscle aches and pain with 80 to 90% relief. On 06-APR-2021, the subject experienced pain in the left leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in the left leg on JUN-2021, and mild nausea with on and off, had not recovered from soapy taste in the mouth, and the outcome of improvement from fibromyalgia pain, muscle aches and pain with 80 to 90% relief was not reported. This report was non-serious.

2 days later nausea, vomiting, diarrhea, palpitions, tachycardia, fatigue, general malaise. Still have occassional palpitations.

First 3 days - headache, nausea, body pain, chills, sweats,fatigue. About 3 weeks to present. Memory loss, brain ?fog? Using the wrong word when speaking. ( not the word I was thinking ? , doing stupid things that I wouldn?t normally do , not thinking clearly. Forgetting where I?m going and what I?m doing with a long effort to recall where I am / what I?m doing.

day 1 severe hot and cold flashes bad headache and severe arm pain today could not stand up sat down felt Like I was going to pass out sat on floor bad cold sweats feeling nauseous bad diarrhea

Within 4 hours: extreme fatigue, headache, loose stools continued until 8am 3/7/2021. Itching all over body, without hives, from 2pm 3/7/2021 until 6:45pm 3/7/2021 - unsure itching is over.

Work up at 12:30 a.m. very hot and nauseous. When I tried to stand up I fainted. When I came to I crawled to the bathroom and vomited several times. Continued to run fever for about an hour or so. Then headache began. As of 7:00 I still feel nauseous and have a slight headache.

Severe headache pain in the eyes a lot of pain in the body breast pain the arm swollen and red nausea

24 hours after receiving the vaccine I began experiencing adverse side effects that have continued to last (Tuesday-Friday). I've experienced constant migraines, nausea, fatigue, diarrhea since Monday, all of which have caused difficulty with eating and sleeping.

Nausea first for 2 hours then fever that reached 101.9 at 12 hours after injection. Fever and aches and shaking all night. Fever broke at 5:30 am-19.5 hours after injection. It?s 24 hours after injection and fever has broke but nausea has returned. Comes in waves. Extra tired and sick feeling just like the flu.

Patient was observed to be sitting in her chair with head down on knees in 15 minute waiting area after receiving Johnson and Johnson Vaccine. Patient reported light headiness and nausea. Patient was AOX4 and vital signs laying at 11:24 am: HR: 79, O2: 96% RA and Temp: 98.1 F, BP not reading. BP retaken at 11:34 am laying down: BP: 50/29 with thready pulse. Patient denies any chest pain, trouble breathing, itchiness, pain. BP retaken laying down at 11:40 am BP: 95/59 and Heart Rate 71. BP retaken sitting at 11:49 am. BP: 83/49. Blood pressure retaken sitting at 12:06 pm : BP 92/57 , HR: 65. Patient reported she normally runs a low blood pressure. Per Patient stated she feels better, had a snack. As precaution called friend to pick her up.

3/13/21 03:00 am, chills, shakes 3/13/21 04:00 am, fever 102, threw up 3/13/21 07:00 am, dizziness, cold sweats, nausea

Janssen COVID-19 Vaccine EUA 3/11/2021 - 8pm very sore lymph nodes under armpits, sore chest muscles - sore all the way around my torse from one armpit to the other. Start getting the chills. Went to bed at 10pm. 3/12/2021 - 12am woke up with VERY Intense headache (forehead area and temples) - never had a headache this bad in my entire life, back of neck very sore, couldn't sleep, relax or focus. 3/12/2021 - 3am Diarrhea and nausea started, mouth very dry, tried to drink water but couldn't due to nausea, Headache still intense, haven't slept since midnight and couldn't relax or focus. In and out of bed, up and down stairs just didn't know what to do. 3/12/2021 - 7am diarrhea and nausea ended but still very intense headache. No sleep since midnight and just kept pacing , trying to sit, tried breathing learned in childbirth, but nothing was relieving the headache or letting me relax and sleep. Husband thought I looked like death. 3/12/2021 - 9:30am I finally broke down and took 2 Tylenol and was able to sleep for 2 hrs. 3/12/2021 - 11:30am body still ached and headache was now tolerable. Able to finally focus and relax. Symptoms were now tolerable as compared to 12am-9:30am, prior to taking Tylenol. 3/12/2021 - 5:00 pm beginning to feel better and eat a regular dinner. 3/13/2021 - 8:00 am woke up and felt 100% normal injection site was never sore or red, didn't have a fever

Fatigue, tired, dizziness, palpitations, shallow breathing, lack of energy, diarrhea on 5th day after the vaccine shot

Janssen COVID-19 Vaccine EUA I developed severe chills (no fever) 8 hours after receiving the vaccine. Taking Aleve helped to ease the chills. For the next 6 days, I had a headache, flu-like symptoms, light-headedness and nausea. Four days after receiving the vaccine, I had a nose bleed, which is a very rare occurrence for me.

weakness, nausea, dry heaving, abdominal cramping and headache for a 2 day duration. Abdominal CT showed 5 cm left adrenal mass consistent with acute adrenal hemorrhage. Platelets were 32,000 on admission. On the evening, the patient had a change in mental status; head CT revealed acute subarachnoid hemorrhage and small intraparenchymal hemorrhage.

Extremely tired, headache for 24 hours, loss of appetite & fever for 8 hours ....Highest fever went was 100.1 ....Would do it again !!!! Worth it to be protected from a deadly infection of Covid 19 !!!!

Janssen COVID-19 Vaccine EUA; at 4:15 a.m. I took a tylenol for the headache I'd had since around 8 pm; ate a few crackers with it; then as I was going back to bed I immediately felt weak/dizzy and then I passed out on the floor. My life partner started calling my name and check my pulse (which he said was strong) ; then I came to but was really dizzy; I was nauseous and vomited for a few minutes; extremely hot/sweating; and after I stopped vomiting, then had a bowel movement (He had to aid me in getting to the bathroom). About 20 - 25 minutes later I felt much better; everything calmed down. I was ultimately able to fall back to sleep.

DOSE AT 12:50 PM, ABOUT 5 PM GOT VERY NAUSEAND LAID DOWN IN BED ABOUT 8:00 PM, WITHIN MINUTES BECAME VERY VERY COLD. WAS VIOLENTLY SHAKING FROM CHILLS, THEN VIOLENT SHAKING WITH MUSCLE TENSION FOR SEVERAL SECONDS THEN RELAXED FOR A FEW MINUTES THEN MORE TENSION. ALL OF THIS ALONG WITH THE CHILLS.I DO NOT KNOW HOW LONG THIS HAPPENED BEFORE I FELL ASLEEP. NEXT DAY WAS VERY TIRED, AND ACHED ALL OVER AND WAS WEAK.

Chills, 103 fever, nausea, dizziness,aches, headache, fatigue. Came and went within 24 hours. Red face. On and off since vaccine Elevated blood pressure. Ongoing Tinnitus. Noticed last night, getting worse.

Severe chills/fever/body aches/nausea/headache/fatigue/closed eye hallucinations/sweating/mediciney aftertaste/sweat smelled like medicine/dizzy. All were severe and lasted for 3 days and I was unable to even function for 2.5 days. Dizziness has lasted longer.

Elevated blood pressure 230/170 for over 24 hours. Dry mouth, Feeling of unease. Chilled, Insomnia. Loss of appetite. Joint pain, Headache for 6 days.

Received vaccine on Wednesday 3/17/21 @ 1250pm, pretty painful going in my R deltoid. Started feeling very tired on Thursday 3/18/21 around 7pm. Woke on Friday 3/19/21 with fatigue and diarrhea with body aches. Woke Saturday 3/20/21 with fever 101.7. (During this duration to include today I have taken Tylenol rotating with Motrin every 2 hours, this never broke my fevers). Fever continues on and off with body aches, nausea, the worst headache I have ever experienced and pain in the base back of my neck L side. These symptoms have continued since Saturday. It is now Friday, 3/26/21. I will say that during waking hours 8am - 10pm on Wednesday 3/24/21 and Thursday 3/25/21 I had no symptoms except absolute fatigue. The fever returned on those two nights at around midnight with it breaking about 4 am, waking up in a pile of sweat.

teeth-chattering chills, excruciating headache, 101 fever, muscle aches, vertigo, diarrhea, fatigue, achy chest with tingly cough, brain fog

Four days after vaccine, muscles at injection site started getting sore. No symptoms prior to day 4. Continues to worsen day 5. Day 5 very tired despite adequate sleep. Mild diarrhea. Symptoms not bad enough to keep me home from work, but I thought it odd symptoms didn't begin to appear until 4 days after vaccine.

On 03-25-2021, at 7pm, I started to feel flu like symptoms with body aches but no congestion. In the morning it seemed getting better but then my symptoms got worse. I took two Ibuprofen which helped. I still continued to feel tired. After my vaccine, I also got a weird taste in my mouth. I was very tired over the weekend. My armpit itched and so I scratched it and I felt raised bumps under my armpit, under the pit of my arms on both sides, right greater than left. My left arm was the one vaccinated. I also had bad diarrhea on 03-29-2021. Today I still continue with the rash under my armpits and still feel very tired and fatigued.

Eight hours after vac: Body aches, followed by low grade temp, headache, fatigue, resolved after 36 hours, then followed by moderate diarrhea.

RIB PAIN; VOMITING; HEADACHE; NAUSEA; INJECTION SITE PAIN; NIGHTMARES/VIVID DREAMS; FEELING COLD; FEELS AWFUL; INAPPROPRIATE ROUTE OF VACCINE ADMINISTRATION; OFF LABEL USE; ARM PAIN; CHILLS; FEVER; FATIGUE; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight was 175 pounds, and height was 161.29 centimeters. The patient's concurrent conditions included stroke, alcohol use 1-2 glasses per week, non smoker, depression, and sleeping problem. The patient experienced drug allergy when treated with povidone-iodine, and codeine for drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intravenous, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 09:30 in left arm for prophylactic vaccination. Concomitant medications included fluoxetine for depression, zolpidem for occasion sleeping problems, acetylsalicylic acid for stroke, and atorvastatin for stroke. On 12-MAR-2021, the subject experienced inappropriate route of vaccine administration. On 12-MAR-2021, the subject experienced off label use. On 12-MAR-2021, the subject experienced arm pain. On 12-MAR-2021, the subject experienced chills. On 12-MAR-2021, the subject experienced fever. On 12-MAR-2021, the subject experienced fatigue. On 12-MAR-2021 18:30, the subject experienced feels awful. On 12-MAR-2021 19:00, the subject experienced feeling cold. On 13-MAR-2021, the subject experienced nightmares/vivid dreams. On 13-MAR-2021, the subject experienced vomiting. On 13-MAR-2021, the subject experienced headache. On 13-MAR-2021, the subject experienced nausea. On 13-MAR-2021, the subject experienced injection site pain. On 14-MAR-2021, the subject experienced rib pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nightmares/vivid dreams, rib pain, vomiting, feels awful, feeling cold, arm pain, chills, fever, headache, nausea, injection site pain, and fatigue on 15-MAR-2021, and the outcome of off label use and inappropriate route of vaccine administration was not reported. This report was non-serious. Additional follow up information received on 26-Mar-2021.The following information was updated and incorporated into the case: age, medical history, demographics, concomitant medication, route of administration for suspect product, events (inappropriate route of vaccine administration and off label use) concomitant medications and outcome was updated.; Sender's Comments: V1: Medical assessment comment not required as per the standard procedure as the case is assessed as non-serious.

By 6pm, I started feeling feverish, with chills, nausea, chest pains and abdominal pain. I also experienced headaches and my fever got up to 102.5. I went to the ER and they gave me fluids. I was told it was a reaction to the vaccine, but my paperwork said upper respiratory infection. My cough started out dry, I had SOB, weakness, fatigue, diarrhea and joint pain. My PCP put me on a steroid and an antibiotic Keflex (500mg, 3 times a day). I get lightheaded just walking around the house. I'm still experiencing SOB, fatigue and the cough. Today is the first day that I could get up an move around. I'm fine when I first wake up, but I eventually feel depleted.

Extreme dizziness, nausea for several days, now it's intermittent. Couldn't stand up without help for 5 days - spinning and dizzy.

I was fine at first but after 11 hours, I began to get a bad headache within 30 minutes I also had nausea and severe pain all over my body to the point I did not want to move at all. Ibuprofen did not help. I was so tired, I could not move. It lasted through the night and would wake me up. I slept most of the next day until about 1:00pm. I finally began to feel better about 12 hours after it began and within 24 hours I was back to normal other that the sore shoulder.

Patient received the vaccine on 3/23/21 and developed symptoms of COVID on 4/5/21 (abdominal discomfort, heartburn, shortness of breath, and cough). On 4/8/21 she was admitted to hospital with COVID and is currently on supplemental oxygen.

The next morning, 09:00 am, I had mild flu symptoms which was full body aches and feeling feverish and unwell. I didn't register a fever on the thermometer. I was very tired; no appetite. I stayed resting all day. Slept a lot. It was easy for me to sleep - very unusual. By 9:00 pm that all lifted and I was feeling back to normal. The morning of March 28, I woke up with a very sore throat. And on 3/29, I had really continued sore throat on and off and Tuesday it got much worse. There was a really strange sensation of being extremely thirsty - I had never had experienced that before. Swollen gland on the right side of my throat - between the jaw and ear area. I had a little bit of an earache on the right side. I drove by the drive-in testing area. I am working in person each day so I get the drive by testing - I think Tuesday, the 30th. Called the dr and did the Telehealth visit - Wednesday - the 31st. I had in and out of laryngitis - raspy voice and headache. I looked in my throat with flashlight and could see a definitive red spot in back of throat and some white spots. They said it could be a blocked salivary gland and told me to eat something very sour to activate it. Over 6 to 8 hours it did clear the issue somewhat - thirst went away. I still had a sore throat. They told me that by the weekend, I could maybe start antibiotic. Saturday night I took first dose of Zpack - two tablets at first dose and then one tablet a day after that. By late evening Sunday (Easter) I felt some relief of symptoms. This week I still have a little bit of raspy voice and post nasal drip and clearing my throat at this point. I am recovering but not fully recovered.

Within 2 hours of the shot, I felt nauseous, somewhat dizzy, and very tired. I experienced this for over 24 hours. I still don't feel quite well. Also, my arm is still sore where the shot was administered, 3 days later.

Janssen COVID-19 Vaccine 6 hours after injection, my temperature was 101.4, my head was pounding and every inch of my body hurt and felt nauseated. Now that it has been just over 24 hours, temperature 99.2, I still have body aches (not as severe) and feel nauseated.

Very strong chills during the night, the next day weakness. Inappetence, excessive sleepiness, headache. place of the vaccine inflamed with pain and itching it is been five days and it's still swollen and painful, from day 4 throat swelling with pain, place of the vaccine inflamed and pain. I have taken antiallergy, ibuprofen, cortisone cream in the place of the vaccine, and cold and hot

DIZZY; TEMPERATURE 99; LETHARGIC; DID NOT FEEL LIKE EATING; VACCINE WAS AMBER TO LIGHT BROWN IN COLOR; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced dizzy. On 25-MAR-2021, the subject experienced temperature 99. On 25-MAR-2021, the subject experienced did not feel like eating. On 25-MAR-2021, the subject experienced vaccine was amber to light brown in color. On 25-MAR-2021, the subject experienced lethargic. Laboratory data included: Body temperature (NR: not provided) 99 Not provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizzy, lethargic, temperature 99, did not feel like eating and vaccine was amber to light brown in color was not reported. This report was non-serious. This report was associated with product quality complaint:90000175219.

Mild tingling in tongue, felt "funny allover", itching, mild shortness of breath, difficult shallowing, hives, swelling in arm (right administered 75mg of Diphenhydramine oral 10 minutes apart, symptoms leveled out until assisting to restroom, needed assistance ambulating to and from toilet felt dizzy and weak, itching in arm became unbearable, itching all over became severe, administered patient's epipen, called EMS, patient was responsive when sent in ambulance to ER.

Forty minutes after the shot, my mouth, lips, neck, gums, and tongue became numb and I had difficulty swallowing. This came on immediately. I started having shortness of breath and chest tightness. I acknowledge that the shortness of breath could have been due to panic, but the allergic reaction came first and was most definitely real. I also have muscle twitching on my left hand, which started after the shot. I've had it now for 28 hours. I got the shot on my left arm.

Immediate pain at injection, stinging sensation. Lasted for another 20 to 30 minutes off and on. Tingling and numbness of right arm for short periods after shot off and on for about first 15-20 minutes. Slight dizziness for first 15 -20 minutes lasting short periods. Nausea, briefly twice in first 20 minutes. Light-headed for the duration of 30 minute wait-and-watch period. This was the most noticeable for me, besides the intense stinging sensation in my arm. After 30 minutes of being watched in common area, I stood up to leave with my adult children and my legs were wobbly. The nurses made me sit and stay a while longer and brought me a snack. I drank my water I had brought with me. Left after an additional 15 minutes.

VOMITING; FEELS HOT; FEVER; DIARRHEA; COULDNT SLEEP; CHILLS; MUSCLE ACHES; NAUSEA; This spontaneous report received from a consumer concerned a 61 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced diarrhea. On 31-MAR-2021, the subject experienced could not sleep. On 31-MAR-2021, the subject experienced chills. On 31-MAR-2021, the subject experienced muscle aches. On 31-MAR-2021, the subject experienced nausea. On APR-2021, Laboratory data included: Body temperature (NR: not provided) under 100. On 01-APR-2021, the subject experienced vomiting. On 01-APR-2021, the subject experienced feels hot. On 01-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from vomiting, and nausea, had not recovered from muscle aches, chills, feels hot, and fever, and the outcome of diarrhea and could not sleep was not reported. This report was non-serious. Version created to amend previously reported information on 01-Apr-2021. Upon review the following information was amended: Event ranking updated and reporter type changed to consumer/ non health care professional from contact.

Pt had postmenopausal bleeding starting on 3/30-4/3. Workup with u/s was negative. Pt had burning with bowel movement on 3/29, felt like a "habenero pepper." Also had itching and rash of chest wall, right breast, back. Received her shot in the left arm.

extreme pain on left side of face, throat, and neck. swelling in throat that caused fair amount of difficulty in breathing, talking and swallowing received epipen at urgent care on 04/09/2021 as the doctor felt I was having an allergic reaction to the covid vaccine and was told to go to the emergency room. was given IV of benedryl and pepcid. had a CT with contrast do to feeling of having something lodged in my throat. sent home with perscriptions for steroids and pepcid. still having symptoms though they are less severe

I received the J & J covid vaccine this morning at 8:30 a.m. At approximately 4:30 p.m a dull headache, nausea and aches in my joints began. About 1/2 hour later I had a brief bout of chills then a fever set in. At 6 p.m. the fever was 100.0.

mild headache, dizziness, nausea, and lack of energy six days after shot... Let's hope this won't last long.

HURT; COULDN'T FOCUS; COULDN'T LIFT A STEP; SHUFFLING; THROAT CLEARING; SINUSES; CHILLS; EXHAUSTED; NAUSEA; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight, height, and medical history were not reported.he patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose, start therapy date were not reported 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 an unspecified date, the subject experienced hurt, couldn't focus, couldn't lift a step, shuffling, throat clearing, sinuses, chills, exhausted, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, exhausted, nausea, hurt, couldn't focus, shuffling, throat clearing, couldn't lift a step and sinuses was not reported. This report was non-serious.

Shortness of breath, stomach issues, muscle aches and pain, headaches, rapid heart rate, nausea, vision problems.

Onset next day Chills. Fever, body aches, joint pain, abdominal pain, left breast swelled to double the size

Chills, muscle aches, fever of 102 for 6 hours from 2AM 3/9/2021-, fever of 101 and headache/ muscle aches afterwards to 2AM 3/10/21 -fever broke. Fatigue, muscle aches continued for 3 days. (maybe not associated with vaccine... but hip/leg pain flared and continues as well as sudden fainting and flare of diverticulitis (ER-CTscan 3/28/21)

Chills, severe headache, fatigue, dizziness, lack of appetite, nausea, anxiety. On 4/9/2021, I started to feel a pulsating feeling on my upper head and felt anxiety. It felt like I could not reduce my stress by taking deep breaths and letting it out slowly which was unusual because this usually works.

Approx 5 Minutes post vaccination : Severe Headache lasting approx 10 minutes, slight throat tightening, acceleration of heart rate that lasted about 15 minutes but continued intermittently for the first day post vaccination. Leg pain (aching) that lasted for 4 days. I struggled to think...as though I was in a fog ...for example it took me along time to think of an answer to a question I was asked. This lasted for 2 days. Severe tiredness 6 hours post vaccination, I slept for 2 hours then insomnia the first evening. Nausea beginning 6 hours post vaccination then rolling nausea that continued 6 days .

Beginning approximately 10 PM (about 8 hours post-injection), I started to have chills (feet were freezing) and was exhausted. Went to bed, and slept most of the night, only waking once to urinate and to drink a small amount (approx 2 oz) of Coca Cola -- I was very nauseous and thought it would help settle my stomach. During the night I sweated profusely. At 8 AM, I woke again and went to urinate. At that time I felt very nauseous, dizzy, and light headed. When I walked about 2 -3 feet to my bedroom, I collapsed on the floor - unconscious. My partner called EMS, they arrived minutes later. By then I was conscious. They transported me to Medical Center Emergency Room, where I remained for several hours. They indicated that my SYNCOPE was a result of dehydration. TODAY, 4/13, news of BLOOD CLOTS has compelled me to report my adverse reaction.

Nausea, chest pain, diarrhea, headache, body aches, and fatigue. Symptoms start the next morning and lasted for 5 days. As of this writing, no symptoms persistent at this time.

FEVER, ACHES, VOMITING, DIARRHEA, STARTING THURSDAY AT 10 PM UNTIL WOKE UP MONDAY MORNING AT 6 AM AND ALL SYMPTOMS GONE

Swelling, tenderness at site. Headache within 5 hours. Muscle aches. Abdominal cramping and back pain all within 5 days (3/10-3/14 )of vaccine.Passed out on 4/10/21 while walking, noted fatigue on 4/8 until 4/13.

Right after shot, did not feel anything that morning till around 5pm I started to feel feverish, headache, tired. My arm never got sore or swollen. AFter 5pm till, the feverish feeling and hot cold got worse as time went by and I started shaking uncontrollably - pretty severe. I took Tylenol early hoping to stop the achy feverish and shaking but did not seem to help. THis went to till about 1am or 2am when I could finally lay down and try to sleep. The shaking had stopped. I did take more Tylenol and drank some herbal chamole type of hot tea. I could not sleep that night. Next day I was exhausted, body aches and still had some feverish feeling. By the way, took my temperature and it was normal. Then on Wednesday, I believe is when I had a huge episode of diarrhea (came on sudden). I kept calling and talking virtually to the doctor telling him all of what was going on. The next day I the feverish feeling and body aches and being tired kept happening - adding headache getting worse. I kept taking Tylenol. Seem to help some but did not take the pain away. EAch night , I could not sleep due to the headache. I started to feel better but then on the weekend, I had that headache and tired feeling. The headache was getting stronger and it circled my whole head and both shoulder and around my neck. It scared me because I felt at times that my throat was getting smaller. I could still swallow but it was so strange. I kept putting heat packs and ice packs and taking Tyelnol. I know that on Thursday or Friday the week, the doctor told me if I wanted to to go get tested for Covid and I did. I was tested negative on both the quick test and the other test that takes longer. I had that headache, sinus tension pressure for quite a few more days. Overall it took 7 days. I had to take off most of the week from my telework job because I could not function. I also did not eat much and drank lots of water during this time. It seem to go away and then about a week later, I got this painful diarrhea out of the blue and went to see an urgent care doctor. They tested me for blood, urine, and stool and they were negative. I was also having pain on my left side. Then it seem to go away after I was on the BRAT diet for a few more days. Then the diarrhea happened again the next week or so. This week, as of yesterday, I got a very strange throbbing pain in my left hand and not sure where that came from. It can be extreme at times. I tool Tyleonol but the pain is still there. Also, during this time and before the shot, I got a trigger finger issue on my right index finger. I don't think that has anything to do with the vaccine. Please note I have been told my doctors and I know this for a fact, my body is super sensitive to food, meds. I don't usually get the flu shot because of that. Today I am experiencing the left hand pain and now metal tasting in my mouth. I am about 5 weeks out from the vaccine. I wish I had never taken it. I pray nothing more will happen in my body If I have left anything off it is because I did not write this down when was happening. I really thought I was going to die one night because of the pressure I was having in my head, neck and shoulders. I have a little bit of a headache now and told my PT doctor that if I needed to know, I could get a brain or some kind of scan to see if I am hainvg any issues. I am going to bring this up to my virtual call today.

Whether the adverse events were caused by the vaccine is to be determined. We are available to discuss more details if this information can be used to help others from experiencing these reactions. The morning after getting the vaccine, patient discovered that she could not swallow. As her condition worsened, she was taken to the emergency room. Over the past month, patient went to the emergency room 4 times. The last time resulted in extended hospitalization that continues to this day. In addition to the swallowing problem, two other major adverse events need to highlighted. First, on 27 March, while in the hospital, vaginal bleeding started. On 29 March, her doctor, performed a hysteriscopy/DNC finding " "an unexplained blood clot (hematoma)." The second major event was when patient demonstrated significant confusion and lack of memory. On 7 April, she was diagnosed with Metabolic Encephalopathy. Neurologists at the hospital suspected that her MS was reacting to her UTI and once the infection is eliminated her memory should come back. But as of 10 April, she was still having issues including hallucinations. Although she is eating some as of 13 April, she is still very weak and will likely by moved from the Hospital to a rehab facility. She still does not remember much of the last 37 days.

101 fever for 12 hours. Chronic headache that has not resolved to date, ongoing chills since vaccination, unresolved insomnia, intestinal discomfort, and intermittent shortness of breath.

Stroke- hearing loss in right ear, extreme headache left temple lobe, nausea, dizziness, diarrhea, inability to move legs. Hospitalized for 5 days Continued weakness left side of the body

Patient experience flu like symptoms and body aches the same evening after receiving vaccine. On 4/1/21 the patient experienced nausea, high blood pressure, and a headache. Around 7:00 pm that night the patient threw up and became unresponsive. The patient was then transported to the hospital by ambulance. A CT scan showed a brain bleed and the patient was intubated and transferred to another hospital.

Symptoms started as a dull headache , chills and myalgia that progressed to an ocular migraine the next morning and continued for the next 5 days. on the third day of the migraine I saw my PCP and was give Toradol IM and Zofran for the nausea. this dulled the HA but it returned the next day and remained for 2 more days before decreasing to a dull HA again. I have had a dull HA off and on since then, not a constant HA as initially.

vaccine reaction-passed out. c/o worsening headache and feels tire. states broke out sweat, stomach pain, HA, leg cramping and passed out (for about 30sec according to husband) on Mon. took Advil several days. last Advil 0600. J&J vaccine on 5 Apr. 61 yo f w/spouse c/o ongoing headache w/concerns for single episode of 'passing out' approx 48hrs pta approx 30-45 sec per spouse at bedside; Pt states nighttime episode w/preceding leg crampings, sweating, dizziness, sat on footstool and per spouse passed out but caught by spouse and avoided injury; spontaneous recovery w/o further issue from that episode, spouse denies any post-syncope seizure-like activity/urinary incontinence/tongue biting; Pt and spouse concerned. for cerebral venous thrombosis; Pt has sig hx of prior neurosurgery for posterior/occipital schwannoma around 2017, successfully removed, w/o further findings or complications on f/u (last DEC 2020) to include repeat imaging at that time Pt states has been taking advil OTC for ha but no sig relief at this time; Pt defers need for medications at time of provider evaluation; Pt denies any fevers/ns/chills, cp, sob, palpitations, dyspnea, abd pain/cramping, current nvd, prior syncope, fam hx of MI/SCD/dysrhythmias.

Chills, body aches, nausea, headache, tired beginning 7 hours after the vaccination and last 30 hours. I did not seek treatment. After 30 hours the symptoms had largely subsided other than a minor headache. Within 48 hours the headache was also gone.

Progress Notes - Clinical MD at 4/15/2021 1:30 PM HPI: 61 year old female with IBS presents with concerns about adverse reactions to vaccine which she got on 3/19/21. Patient reports that she felt lightheaded after the vaccine when she was leaving. She got home and felt better but then that night woke up in a delirium which passed by the morning. She had some weakness in her extremities, brain fog, cold feeling, funny GI feeling and fatigue for 3 days and then was fine. Two weeks ago she started to feel that the circulation in her lower legs was cut off with sensation of blood pooling in her legs with associated numbness and tingling. She describes it as what you feel when a tourniquet is applied to your arm. No visible lower extremity swelling, redness and no pain. One week ago she felt like her right hand was not working well and then left hand too. She then felt pooling in her arms like the sensation in her legs.No swelling, redness or pain. She reports she did a hand stand and afterward felt pooling sensation in her lower abdomen which has since resolved but continues to have a prickling sensation that comes and goes. Last night while lying on her back she felt the pooling sensation in her chest and this morning throbbing in head and chest and neck. That is when she decided to come in and be seen. Patient denies severe headache, backache, abdominal pain, shortness of breath, bruises, unusual bleeding or rashes. Patient has not had a physical exam with blood work since 11/9/17.

SHAKING TO THE BONE; RADIATING MUSCLE PAIN; LOW GRADE FEVER; ARM BRUISED FROM INSIDE; DISCOMFORT UNPTO THE SHOULDER; STOMACH PAIN; ARM HURTS ALL THE TIME; LOSS OF ENERGY; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 22-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced arm bruised from inside. On MAR-2021, the subject experienced discomfort up to the shoulder. On MAR-2021, the subject experienced stomach pain. On MAR-2021, the subject experienced arm hurts all the time. On MAR-2021, the subject experienced loss of energy. On 23-MAR-2021, the subject experienced shaking to the bone. On 23-MAR-2021, the subject experienced radiating muscle pain. On 23-MAR-2021, the subject experienced low grade fever. The patient recovered from arm bruised from inside, discomfort up to the shoulder, shaking to the bone, stomach pain, loss of energy, and low grade fever on MAR-2021, and had not recovered from arm hurts all the time, and radiating muscle pain. This report was non-serious.

NECK SORE TO TOUCH; EXCRUCIATING BACK PAIN; COULD NOT LIE ON BACK AND ON SIDE; MILD BODY ACHES; BACK PAIN RADIATING TO ABDOMEN; CHILLS BECAME WORSE; HEADACHE; MILD TEMPERATURE; CAHRLIE HORSE IN NECK, SHOULDERS. AND LEGS; DIARRHEA; SLEEPY; STOMACH PAIN; LOSS OF APPETITE; FELT TIRED; DRY COUGH; COULD BARELY WALK; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included type 2 diabetes, non-alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and did not have drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced could barely walk. On 2021, the subject experienced dry cough. On 28-MAR-2021, the subject experienced loss of appetite. On 28-MAR-2021, the subject experienced felt tired. On 29-MAR-2021, the subject experienced stomach pain. On 30-MAR-2021, the subject experienced sleepy. On 31-MAR-2021, the subject experienced diarrhea. On 31-MAR-2021, the subject experienced cahrlie horse in neck, shoulders; and legs. On APR-2021, the subject experienced mild body aches. On APR-2021, the subject experienced back pain radiating to abdomen. On APR-2021, the subject experienced chills became worse. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced mild temperature. On 01-APR-2021, the subject experienced excruciating back pain. On 01-APR-2021, the subject experienced could not lie on back and on side. On 02-APR-2021, the subject experienced neck sore to touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from excruciating back pain, and could not lie on back and on side on 08-APR-2021, and cahrlie horse in neck, shoulders. and legs on 01-APR-2021, was recovering from diarrhea, loss of appetite, neck sore to touch, and mild temperature, had not recovered from felt tired, sleepy, headache, mild body aches, stomach pain, and chills became worse, and the outcome of dry cough, back pain radiating to abdomen and could barely walk was not reported. This report was non-serious.

WEIGHT LOSS; HEADACHE; PAIN AT INJECTION SITE; FATIGUE; NAUSEA; LACK OF APPETITE; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's past medical history included brain aneurysm. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid, and calcium carbonate. On 06-APR-2021, the subject experienced lack of appetite. On 06-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced pain at injection site. On 06-APR-2021, the subject experienced fatigue. On 06-APR-2021, the subject experienced nausea. On 12-APR-2021, the subject experienced weight loss. Laboratory data included: Weight (NR: not provided) lost 4 pounds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from weight loss on 13-APR-2021, and headache on 12-APR-2021, was recovering from fatigue, nausea, and lack of appetite, and had not recovered from pain at injection site. This report was non-serious.

Severe headache starting with 2 hours post injection lasting 6 days, severe nausea 6 days, diarrhea day 3 only. Red circular spot on hand, toes, shoulder area, day 2-4.

CHILLS; LOSS OF APPETITE; DIZZINESS; TIREDNESS; MUSCLE ACHE; WEAKNESS; PAIN IN ARM; VOMITING; NAUSEA; FEVER; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the patient experienced nausea, fever. On 10-APR-2021 the patient experienced tiredness, weakness, muscle ache, vomiting, dizziness, pain in arm. On 11-APR-2021, the patient experienced loss of appetite and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting on 10-APR-2021, and dizziness on 11-APR-2021, was recovering from nausea, and pain in arm, and had not recovered from fever, weakness, muscle ache, loss of appetite, chills, and tiredness. This report was non-serious.

My sister, received the J & J vaccine on March 5th. I now know that she was not feeling well for a few days afterwards. She then felt better until day nine after the vaccine. On the evening of the ninth day, she began having abdominal pain, vomiting & diarrhea, headache. This was Sunday evening. Unfortunately I wasn?t aware of how she was feeling and she didn?t go to the emergency rm. until Tuesday morning. Tests determined her platelet level was low and abdominal CT showed bleeding from her adrenal glands. She was given platelets, pain meds and admitted into the hospital. Later that night staff felt she wasn?t responsive and a head CT was performed. It was determined she had a brain hemorrhage and emergency surgery was performed. It is my understanding that there was brain damage at that point. During the early morning hours of the 10th day, post surgery, a repeat CT scan was done showing more hemorrhaging and blood clots. She also developed a DVT and PE and was kept on a respirator until the 13th day post vaccine to allow family to say their goodbyes. On the morning of the 13th day patient was removed from life support and she passed.

Starting around midnight, my joints were extremely achy. I went to bed, but tossed and turned, even though I was very tired, but so sore. I got chills and fever, but didn't take my temperature. The next morning, took my temperature and it was 101. Ate a piece of coffee cake with some tea. Was very tired, so went back to bed. Was also a bit queasy, and not hungry for lunch, and had a mild headache. Slept most of the day, had chills and fever off and on, and joints very sore. I did eat dinner. The next day I was much better, but still had some soreness in my joints, one or two episodes of mild chills, was somewhat tired and lethargic. The next day I was more or less back to normal. I did take Tylenol at some point, but I can't remember if it was the afternoon of the first day of fever, or not until the next afternoon. I know I did take it again the next morning. All in all, it felt like a full-blown case of the flu, but was of short duration.

headache, light headedness, nausea, muscle aches, joint aches, lymph node swelling, fatigue, swelling at the injection site. All symptoms lasted about 48hrs. The swelling and bump at the injection sited lasted 1 week.

DRY MOUTH; TINGLING IN HANDS; HEADACHE; NAUSEA; INCREASED FATIGUE; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's past medical history included thyroidectomy, and concurrent conditions included breast carcinoma, and teeth problems. The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced dry mouth. On 17-MAR-2021, the subject experienced tingling in hands. On 17-MAR-2021, the subject experienced headache. On 17-MAR-2021, the subject experienced nausea. On 17-MAR-2021, the subject experienced increased fatigue. Laboratory data (dates unspecified) included: Chest X-ray (NR: not provided) normal (units unspecified), and electrocardiogram (NR: not provided) normal (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, nausea, tingling in hands, increased fatigue, and dry mouth. This report was non-serious.

Headache started 4/11/2021 approx 10:30 - ice packs to top of head, over eyes and back of neck, ended 4/11/2021 approx 1600; Nausea started 4/11/2021 approx 10:30 ended 4/11/2021 1600; Malaise started 4/11/2021 approx 10:30 ended 4/11/2021 ended 1600 sips of water throughout day and nibbled on saltines; photosensitivity (lights brighter than usual) started 4/11/2021 approx 10:30 ending 4/11/2021 1630; Bilateral eye pain started 4/11/2021 10:30 ending 4/11/2021 16:30 pain scale 7 (0 no pain, 10 extreme pain); Hot flashes started 4/11/2021 0800 ending 4/20/2021 0800

I have severe dizziness when I am laying down/sleeping. Each time I wake up 1-2 times per night) my head is spinning. When I am awake and standing I don't have the spinning, but I do have a faint headache/fog and with that, nausea.

LEFT GROIN PAIN RADIATING TO THE LEFT LEG/ HARD TO WALK; MUSCLE ACHES; NAUSEA; FATIGUE; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Concomitant medications included tramadol hydrochloride. On 10-APR-2021, the subject experienced left groin pain radiating to the left leg/ hard to walk. On 10-APR-2021, the subject experienced muscle aches. On 10-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle aches, nausea, and fatigue on 11-APR-2021, and had not recovered from left groin pain radiating to the left leg/ hard to walk. 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.

LIGHT HEADEDNESS (HER HEAD DOES NOT FEEL CONNECTED TO HER BODY); LIGHT SENSITIVITY; FLU-LIKE SYMPTOMS; CHILLS; HEADACHE; NAUSEA; TIREDNESS; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight was 106 pounds, and height was 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: 201A-21A, 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 flu-like symptoms. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced tiredness. On 11-APR-2021, the subject experienced light sensitivity. On 12-APR-2021, the subject experienced light headedness (her head does not feel connected to her body). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms, chills, headache, and nausea on 11-APR-2021, and light sensitivity on 13-APR-2021, and was recovering from tiredness, and light headedness (her head does not feel connected to her body). This report was non-serious.

No immediate side effects except for a slightly sore arm. Extreme fatigue began 4 days from date of injection and lasted to day 16. Dizziness and nausea began about 10 days from date of injection but were intermittent. Nausea and dizziness finally resolved around day 16. No lasting side effects to-date.

PATIENT PRESENTED TO OUR EMERGENCY ROOM WITH COMPLAINTS OF DIZZINESS, VERTIGO, AND VOMITING WHICH ONSET WAS ONE DAY. PATIENT REPORTS RECEIVING JOHNSON & JOHNSON COVID VACCINE 2 WEEKS AGO . CTA OF HEAD SHOW POSSIBLE TRANSVERSE VENOUS SINUS THROMBOSIS ABOUT 7MM, PATIENT IS ADMITTED TO ICU FOR FURTHER WORK UP .

Admitted with high blood glucose, intermittent nausea, decreased appetite. Subsequently found to be COVID1-9 positive. >14 days post vaccine completion.

DIARRHEA; VOMITING; BODY ACHES; CHILLS; TIREDNESS; HEADACHE; FLU LIKE SYMPTOMS; This spontaneous report received from a consumer concerned multiple patients. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and non-smoker. 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 APR-2021, the subject experienced flu like symptoms. On 09-APR-2021, the subject experienced vomiting. On 09-APR-2021, the subject experienced body aches. 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 13-APR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, tiredness, and headache on 10-APR-2021, was recovering from vomiting, and diarrhea, and the outcome of flu like symptoms was not reported. This report was non-serious. This case, from the same reporter is linked to 20210424370.

LOSS OF APETITE; TINNITUS RINGING IN EARS; HEADACHE; LEG PAIN; HEAVINESS; LOSS OF ENERGY; CHILLS; FEVER; TIRED; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced leg pain. On 06-MAR-2021, the subject experienced heaviness. On 06-MAR-2021, the subject experienced loss of energy. On 06-MAR-2021, the subject experienced chills. On 06-MAR-2021, the subject experienced fever. On 06-MAR-2021, the subject experienced tired. On 07-MAR-2021, the subject experienced tinnitus ringing in ears. On 07-MAR-2021, the subject experienced loss of apetite. On 07-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from leg pain, heaviness, and chills on 07-MAR-2021, and fever, and headache on 09-MAR-2021, was recovering from tinnitus ringing in ears, and had not recovered from tired, loss of apetite, and loss of energy. This report was non-serious.

LOSS OF APPETITE; MALAISE; CHILLS; TIRED; NAUSEA; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, penicillin allergy, alcohol use, and nonsmoker, and other pre-existing medical conditions included patients was not pregnant at the time of reporting. patient had no history of illicit drug use or drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022 expiry: UNKNWON) dose was not reported, administered on 10-MAR-2021 to right arm for prophylactic vaccination. Concomitant medications included metoprolol for hypertension. On 10-MAR-2021, the subject experienced headache. On 11-MAR-2021, the subject experienced loss of appetite. On 11-MAR-2021, the subject experienced malaise. On 11-MAR-2021, the subject experienced chills. On 11-MAR-2021, the subject experienced tired. On 11-MAR-2021, the subject experienced nausea. On 11-MAR-2021, the subject experienced fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of appetite on 16-MAR-2021, malaise, chills, nausea, fever, and headache on 12-MAR-2021, and tired on 15-MAR-2021. This report was non-serious.

April 12, 2021-Mild face swelling and light dizziness began about one hour after injection and lasted for about 2 hours. I took a Zyrtec-D the morning of the injection so I think that helped keep the swelling under control. April 15, 2021-around 6:00 pm I became very nauseous and dizzy. The nausea subsided by the next morning but the dizziness has continued to this day. Had to stay in bed all day April 17 and 18 due to dizziness.

TINNITUS; INSOMNIA; CHILLS; ACHINESS DOWN LEFT LEG; NAUSEA; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's past medical history included degenerative disc, and concurrent conditions included osteoarthritis, non alcoholic, and non-smoker, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with ceclor. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025, expiry: 25-MAY-2021) dose was not reported, administered on 10-MAR-2021 19:20 to left arm for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced chills. On 11-MAR-2021, the subject experienced achiness down left leg. On 11-MAR-2021, the subject experienced nausea. On 11-MAR-2021, the subject experienced headache. On 11-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.1 F. On 12-MAR-2021, the subject experienced tinnitus. On 12-MAR-2021, the subject experienced insomnia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, achiness down left leg, nausea, and fever on 11-MAR-2021, and had not recovered from tinnitus, headache, and insomnia. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.

Super Dizzy (2 days), nausea (4 days), tingling throughout body (5 days), fatigue (10 days), Severe body aches. Felt like every bone in my body was broken (4 days)

UPPER SPINE WAS VERY TENDER; COLD SWEAT; COULD NOT STAND UP FROM FLOOR; SEVERE DIARRHEA; FELT LIKE SOMETHING HAPPENED; ARM PAIN; BURNING HEAT OFF BODY; BRUISING AT UPPER SPINE/YELLOW BRUISING DOWN LOWER LEFT LEG; SEVERE PAIN UP NECK AND DOWN BACK; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sensitive to antibiotics, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068 and expiry: UNKNOWN) dose was not reported, administered on 04-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-MAR-2021, the subject experienced bruising at upper spine/yellow bruising down lower left leg. On 04-MAR-2021, the subject experienced severe pain up neck and down back. On 04-MAR-2021 14:00, the subject experienced burning heat off body. On 05-MAR-2021, the subject experienced arm pain. On 07-MAR-2021, the subject experienced cold sweat. On 07-MAR-2021, the subject experienced could not stand up from floor. On 07-MAR-2021, the subject experienced severe diarrhea. On 07-MAR-2021, the subject experienced felt like something happened. On 19-MAR-2021, the subject experienced upper spine was very tender. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from upper spine was very tender, bruising at upper spine/yellow bruising down lower left leg, and severe pain up neck and down back on 07-APR-2021, burning heat off body on 04-MAR-2021, and cold sweat, could not stand up from floor, and severe diarrhea on 07-MAR-2021, and the outcome of arm pain and felt like something happened was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.

FIBROMYALGIA EXACERBATION; SORE GLANDS AT JAW LINE; FEELING LIKE CENTRAL NERVOUS SYSTEM ON FIRE; SPINAL CORD PAIN; VERTIGO; SORE ARM; NAUSEOUS; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included fibromyalgia, atrial fibrillation, and anxiety. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: (6 or 0)43A(2or Z)(Ior1)A) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced fibromyalgia exacerbation. On APR-2021, the subject experienced sore glands at jaw line. On APR-2021, the subject experienced feeling like central nervous system on fire. On APR-2021, the subject experienced spinal cord pain. On APR-2021, the subject experienced vertigo. On APR-2021, the subject experienced sore arm. On APR-2021, the subject experienced nauseous. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vertigo, sore arm, sore glands at jaw line, feeling like central nervous system on fire, spinal cord pain, fibromyalgia exacerbation and nauseous was not reported. This report was non-serious. The Product Complaint Number was 90000177550 The suspected product quality complaint has been confirmed to be confirmed no PQC was identified within the reported complaint reported. complaint is approved for void. based on the PQC evaluation/investigation performed.

UNBEARABLE HEAD POUNDING; NAUSEA; VOMITING; LOW FEVER; FATIGUE; This spontaneous report received from a patient concerned a 61 year old adult female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805022 expiry: unknown) dose was not reported, administered on 23-MAR-2021 14:37:00 for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced fatigue. On 27-MAR-2021, the subject experienced low fever. 100 F. On 02-APR-2021, the patient woke up at 3am with unbearable head pounding for which the patient took 2 acetaminophen even after 15 min there was no relief so she took small amount of codeine around (1/3 of a 15mg tab) after 5-10 min the patient threw both meds and experienced nausea for which she took anti-nausea tab under her tongue but that did not released her nausea. The Patient could not take her medication due to nausea and vomiting. At 10:30 am one of her family member took her to Hospital in and performed CT (computerized tomography) scan and PET (positron emission tomography) scan which are normal The Patient was hospitalized for 5 hours and received IV of a steroid (unspecified), Benadryl, anti-nausea (unspecified) and (unspecified) pain medication as a treatment CT scan and PET scan was normal based on which Doctor concluded that the side effects are due to J and J vaccine. Treatment medications included: codeine, diphenhydramine hydrochloride, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from unbearable head pounding, nausea, and vomiting on 02-APR-2021, fatigue on 26-MAR-2021, and low fever on 27-MAR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210452159-COVID-19 VACCINE AD26.COV2.S-headache. This event(s) is labeled per RSI and is therefore considered potentially related. 20210452159-COVID-19 VACCINE AD26.COV2.S-vomiting. This event(s) is considered not related. The event(s) has an unknown/unclear 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: CONMEDS-OTHER SUSPECT DRUGS

9 hours later began feeling a general "ick" like when coming down with something, then moderate headache and body aches, especially my back. This lasted less than 2 days. Other things, mostly starting 5 or 6 days later and some cropping up as late as 4/11. Random itchy red rashes on each shoulder and back of upper arm that would go away within an hour or 2. Itching and possibly bumps on buttocks and thighs. Intensely itching palms for a little while on 2 or 3 different days. Sudden appearance of a 4 x 4 inch patch of 15-20 bumps of various sizes in the crook of my left elbow (injection arm) with bright red skin. These looked similar to mosquito bites or blisters but didn't itch. It completely disappeared without a trace within an hour. Tingling tongue followed by tongue swelling on 4/6/21. I had eaten my bran flakes with some rice pudding a little bit before this, both of which I'd eaten every day for the past week or so and had had several times in the past. On the advice of my doctor's nurse, my husband drove me to an urgent care center. By the time we got there, probably 1.5 hours after this started, the swelling was some better. The nurse practitioner that I saw prescribed an antihistamine and 3 days of one 20 mg prednisone pill a day. I've never had a tingling or swelling tongue before in my life. I took only a half of one prednisone on 4/6, no Allegra. On 4/7 the random itchy red rashes mostly on arms/shoulders happened once or twice and disappeared fairly quickly, but my upper lip swelled. I could feel it happening as I sat in my recliner in the morning. I hadn't had anything to eat yet. The doctor advised I take my Allegra and prednisone I received at urgent care on 4/6, so I did. The lip swelling gradually went down over a few days, but it still feels irritated on the inside of the lip as of 4/11. Diarrhea beginning around 1:30 a.m. 4/8. Lasted about 3 days. I only very very rarely have diarrhea. Mild sore throat starting Friday 4/10. Better by Saturday. Sore throats are so rare for me that I can't remember the last one, possibly several years ago.

About 10 hours after receiving the vaccine I became nauseous and weak. I sat down on a kitchen chair and then passed out, falling to my right onto the floor.

That night, no chills or fever but uncontrollable shaking - 10 pm - 4 am in morning. Starting at 10, as well, body aches - run over by a truck type. My chest was burning like it was on fire - lungs felt like they were on fire. I woke up the next morning, with a little bit of body aches - I slept the entire next day pretty much (the 7th). On the 7th, I noticed that my heart was beating - fluttering- skipping- beating. My left left also swelled up and was red. I had PVCs with pulmonary embolism on that left leg in1996 - when I was doing the chemo. My left leg ached, burned and got red on the 7th. I was going to see the PCP the following week and I was still having issues with the heart but the leg was getting better. It can still swell, burn and get red quite a bit of night because I stand on my legs all day - but the amount of pain and swelling did go down over that week while I was waiting to see the doctor. I had an ultrasound on my leg. And a heart halter to monitor my heart for 24 hours. I do have PVCs. Stress from vaccine caused Herpes Outbreak - that was on the left inner thigh right next to genitals - bumps within four days of vaccine. Created more pain. Took Benadryl for pain - helps with the nerve pain - two days with. I took 3000 mg a day of Tylenol for three days after the vaccine. Have not recovered from the calf and heart symptoms.

Was fine after receiving the shot at 11 AM . Then at about 8 o?clock at night I had violently severe chills fever nausea weakness and tiredness. Was unable to perform daily to asks the whole next day.

That day when I woke up, I had a headache, my eyes felt hot, I was 99.3 temp, had diarrhea , lessoned Sunday and Monday and then on Tuesday , I had diarrhea and a headache again, I called my doctor and tele-med visit. Two weeks after that, the inside of my mouth felt irritated, faded away after four days and then it came back. I contacted my allergist, they ran test. She did not have an allergy to anything she has eaten. Then my tongue was raw.

Fever 102.2 lasting about 18 hours; Severe headache lasting about 24 hours; Nausea with vomiting lasting about 10 hours; Ringing in ears still occurring; Tiredness lasting 24 hours

Two weeks after the vaccine, that night my stomach was upset by the time I took the TUMS my stomach was upset and I was throwing up and it was coming from both ends, by the morning I could not get out of the bed and had to call ER. Went to the ER and was told I had stomach flu and received morphine, pepcid, zofran and felt much better

Headache and dizziness started that day. Headaches got increasingly worse during the first week along with dizziness and loss of balance. Mid second week, headaches went from moderate to very severe. The nausea and back and forth between diarrhea and constipation began. Horrible headaches. PCP put me on zolfram 1 pill 1x a day. That did not help. I was then put on zolfram 2x a day. I was also put on pepcid AC 2x a day. I also stayed on tramadol for pain. It seemed to help. It delayed my nucala. At the end of week 3, I went in for my Nucala for my asthma. Within hours of receiving that shot, the side effects came back. With the medication, I was beginning to feel better but the Nucala shot brought them all rushing back. Week 4 was even more miserable. I was put on 10mg dextramethazone. My last dose was yesterday morning and today I woke up dizzy again with a massive headache and a sour stomach. I am still taking pepcid AC. My dr. office is working on a plan.

When I got home, I had a headache. I felt tired. I took a nap. When I woke up, I was sick. I was nauseated, my stomach and body hurt all over. The headache was three days long. I felt achy and sore the next day as well. I felt like I had a flu. There were huge blood clot looking blisters, and red dots on both my arms. My left arm was worse than my right arm. I called the doctor and she asked me to come in, but I had to take pictures first of my arms before coming in. Then when I was able to go to the office, I took blood tests and the MRI. Everything came back okay.

I start of feeling sick in the stomach, headache, muscle aches, feverish. By that night I had chills and the really bad nausea, that I had to sleep on the bathroom. The next day, I barely made it to the bed. I am very weak, still having a headache, body aches and feeling fatigue. The ringing in my ear has gotten worst than it was before.

Janssen COVID-19 Vaccine 13 days after receiving her Covid vaccine, the patient stated ?I have been experiencing bad headaches that makes the right side of my face numb and/or painful to the touch. Although I have had headaches in the past, these feel different.? Patient stated that she started noticing these headaches late in the week that followed that administration of the vaccine (beginning on or around 6/4/21) Patient also stated that she began developing stomach aches approximately one week following the vaccine administration (beginning on or around 6/6/21)

Whole left side pain from head to calf. Temp at 104 for 16hrs. Headache, ears ringing, stomach pain, strong pain left leg left side of thigh. Felt like a bus hit my left side. Severe fatigue. Congestion.

Non-stop dry cough since day after vaccine, persistent headache since day after vaccine, vomiting 3 times on day after vaccine only.

When I first had the shot, I got very sick afterward with a fever and sore throat, although I was expecting that. However, it's possible that the vaccine has damaged my immune system because I suffered the effects of lactose intolerance yesterday (digestive problems), but, totally unlike other times that I had such response to lactose, I also had a fever and a bit of sore throat, which has nothing to do with lactose intolerance. Is the vaccine causing a reaction to lactose as though it is an invader? Please contact me right away. I am quite sick.

Severe Chills and shaking repeated nightly for 5 nights Body aches, vertigo, nausea, headache , muscle cramp at injection site resolved slowly over 3 weeks

Within an hour headache ,stomach ache, cough, exhaustion . After 10 days went in for Covid test per Dr.s orders. Came back neg. But had small bruise on arm below injection site that night. All symptoms resolved with in 2 weeks except bruising. Keep getting small bruises on arms and legs. Most are only about the size of a pea but now have one on forearm size of half dollar with 2 smaller ones just below it.

25 June 11 pm: Entire body aching -- Up multiple times during the night, general muscle aching and fatigue, some confusion; migraine developed overnight. 26 June, 7 am: Out of bed, short walk, general myalgia, fatigue, migraine, had to lie down. 8:30 am: Slightly longer walk, felt slightly better, able to eat small amount after this. 9:30: Felt nauseated, migraine, fatigue, and myalgia worse. Noon: Brief walk outside, lay back down due to nausea, fatigue, myalgia. 2:30 pm: Nausea a bit better, ate apple, lay back down due to symptoms above. 5 pm: Migraine and nausea slightly better, fatigue and myalgia persist. 6:30 pm: Ate plain lettuce, extreme nausea, and tinnitus; vomited entire quantity; nausea improved. Remained prone rest of evening. 7:30 pm: Mild nausea persists, migraine improving, may be slight decrease in myalgia. 9 pm: To bed, slept well, definite improvement through night, some myalgia persists and occasional tinnitus. Able to drink water throughout.

Abdominal pain/cramping/diarrhea 2-3 days Some joint achiness off & on for several weeks. Severe right groin pain around May 12. Saw PCP. Xray showed chondrocalcinosis which I've never had before. Aleve, Volteran. Still achy but not severe. Muscle weakness, fatigue, double vision waxed & waned for several weeks & then just got worse. Saw neurologist May 21. (Doing so well I hadn't seen him for 3 years) Blood tests & brain MRI. Only abnormal was a seropositive AchR which I've always been seronegative. Doubled MTX & wants to do IVIg but insurance is denying at this time.

Extremely painful when vaccine was injected into my arm! The pain radiated up and into my left jaw. I could taste the vaccine. Before the injection I discussed the fact that I have many allergies and my concern that the form didn?t ask which vaccines I had had anaphlaxic reactions to. My tongue immediately became slightly swollen. By the time I arrived home an hour later, I could barely left my left arm, I was sick to my stomach and almost started to dry heave; it passed in about 10 minutes. My tongue remained swollen until 7:00 pm 6/30/2021. My arm remained extremely sore until 7/01/2021; the injection site still hurts a little as of 07/05/2021.. on 07/02/2021 I had chills until approximately 5:30 pm. I carry Epi-pens should I need to self administer.

So on Friday at 10:30PM On the Friday 25th of June, I had GI issues and a lot of stomach pain. I also had cramping and pain in the back of my legs as well. I went to the DR and she put me on antibiotics, Cipro and something else I cannot remember. I went to the DR on Wednesday the 30th of June. The GI problems have been happening for about 2 weeks. I also saw my cardiologist on 4/8/2021 and he saw I was ok, the pulmonary DR also said my lungs looked fine on 4/26/2021.

My stomach pain started a couple weeks after the vaccine. On May 8, I went to the ER because I had left side abdominal pain. I was prescribe antibiotics and given an IV of antibiotics. On the 12th, I called my doctor again and I was admitted me to the hospital. I still feel weak and have abdominal pain on and off. I am scheduled for a colonoscopy on July 23, 2021.

I went to bed feeling fine but experienced chills, achy joints and headache until the next afternoon. That was fine, expected that. On about the 4 or 5th day. I thought I had full blown Covid. Had all the symptoms. As this progressed my fatigue was overwhelming. I lost my appetite, had a bad headache, joints and muscles ached, etc. No fever at this time though and breathing was ok. Texted Dr. and was told it was my immune system overreacting and he prescribed oral steroid to calm it down. My fatigue lasted for a good 3 weeks. This was as sick as I have ever been.

On 15th of June I began throwing up, couldn't keep food down, major cramping in my stomach, wouldn't go away, chills that lasted until 6/24, I took peptol bispol, tums, ginger, but still cramped and threw up, couldn't eat, slept a lot because of pain. I did stop taking the metrondasel antibotic given for my swallon jawl, kept taking Pennicillin because I'm not allergic. I was very weak, on vacation when this started, couldn't be out in the side much at all, felt like I was going to pass out. Later in week begin having tingling in my feet like they were going to sleep and in my upper legs/hips. I do have stents in my legs that are doing well, so it kind of worried me that they were tingling. On 24th of June, went to my doctor, she gave me Hyoscyamine for pain/discomfort in my stomach and back, also PureGG 25B for probiotic. It's been working ok, but still having stomach episodes of pain and goes to my back like sharp object. Also I've never had heartburn until this sickness, have to have tums and something for pain every once in a while, should've been over all of this by now, but have called the new doctor because I'm not sure what's going on. I'm not a sickly person.

Patient said that she is experiencing extreme fatigue and chronic pain in her hip back neck. she can hardly walk. She stated that she falls asleep any where. She has a strange feeling in her chest. She is experiencing breathing complications. She has a hard time drinking water without choking. She stated that she has a high tolerance for pain, but this pain is unboreable. She stated that she was taking walks and now she can barely walk to her car without loosing her breathe.

2 Straight Days Headaches 7/20/21-7/21/21 I Don?t Get Headaches 7/22/21 cramps in stomach light blood through 7/23/21 heavy dark blood with light clotting. 7/25/21-7/26/21 large blood clots until 7/28/21. 0n 7/28/21 called Primary Physician for a Consultation it?s scheduled for Friday. I have enormous swelling in my Right leg in rear upper thigh. I have decided to go to Emergency Room. I have a slight headache and after Blood completely stop I am now seeing very light blood. I?m 61 I had stop having periods at 58!started back when I first took John & Johnson shot. I reported here before.

8 hours after getting the vaccine I started feeling very cold. It came on me all of a sudden. Shaking, shivering, teeth chattering ensued along with generally feeling very unwell. (Similar to how I felt years ago after having surgery) This progressed during the night to fever, chills, extreme body aches, stabbing pains in the head, heart racing, dizziness and nausea. After 12 hours I started to feeling improvement. At the 16 hour mark I am really tired and nauseous but feel like I'm coming back. Probably the worst I've ever felt. We considered going to the ER in the night.

Fever, chills, dry sore throat, headache, body and joint pain, nausea starting 5 hours after vaccination and lasting at least 12 hours

Janssen COVID-19 Vaccine EUA. Gradual headache late afternoon, followed by neck ache, then muscle aches, Horrible chills and shakes, nausea and throwing up. Muscle aches continued throughout the night and into the morning. Left with some muscle aches, stuffy head today. Tylenol did not help in the evening, so switched to Advil at midnight and that started to help.

While waiting the 15 required minutes after the shot was administered..I experianced a headache and left jaw discomfort. Minor arm pain the first day, I expected that. Did my regular errands and was fine, a little tired. The next day, (Sunday)...I went to church, had a headache, arms aching like mad, arthritic symptoms , legs cramping, joint pain in elbows especially, were off the chain! I returned home and took immediately to the couch, where I had a low grade fever and stayed all day. I had no appetite, no energy to get up except to go to the bathroom.

8 hours after vaccination I got headache, fever (101), fatigue and body aches. Woke up in the middle of the night with headache and slight nausea. The next morning and through the day/ night had some joint pain and extremely tired.

This was a Johnson & Johnson vaccine. No option was given on the website for this. Nausea no vomiting for about 10 hours Fever of about 102 20 hours post shot. She experienced a long bout of a fibrillation along with this fever. She?s experienced an abnormal level of confusion with her Alzheimer?s. This morning about 32 hours post shot her temperature is 95°. At 48 hours there were still redness and swelling at the injection site. However all the other symptoms had abated.

Chills Fever of 101.8 Nausea Muscle Aches Fatigue Trouble Breathing Dizziness Symptoms gradually subsided over 24 hours. Used a rescue inhaler for the breathing troubles, took extra strength tylenol for the fever. Slept for 18 solid hours from 9pm on March 7th till 3 pm on March 8th - had been napping most of the day before 9pm.Fever and fatigue were the last symptoms to resolve.

Headache, chills, nausea, body aches starting about 7 hours after the vaccination. The side effects lasted about 36 hours and improved with ibuprofen.

Mild Headache -15 mins. after injection Nausea- evening 3/9/21 Tummy ache- 3/10/21 @11 am Low grade fever-3/10/21 @ 5 pm Chills-3/10/21

started vomiting at 1:30 and I felt really dizzy and confused. My roommate found me on the floor passed out. I am not sure how long I was passed out. I woke up and I was talking gibberish. I was aware that nothing I said was making sense. I went to bed and slept almost 24 hours. I woke up feeling wiped out but I wasn't confused and I was talking normal again. Right arm hurt and is numb. ( right side of my body typically is kind of numb but the right arm seemed more so numb after the vaccine)

The actual injection itself was so painful that I almost passed out. It hurts so badly while the needle was in my arm and when she took it out it was worse. I was in such pain that I began to sweat profusely and apparently I turned white and began dry heaving. This was all within a minute or so. I really thought I was going to pass out. A woman with a tag that said pharmacist came rushing over. She got a reclining chair with wheels, they help me into it and then took me to a recovery room. After a few more minutes of sweating and dry heaving I began feeling better. The pharmacist got me some paper towels so I could dry myself off as I was drenched in sweat. I asked her for a bottle of water. I waited the 15 minutes and came home. They never checked my vital signs. Once I got home, I laid down and slept for 15 hours. I was fine the next day and my arm was never sore. Could the shot have hit a nerve? I?ve never felt such acute pain.

Patient complained of nausea after receiving vaccine . symptoms resolved and no further issues at this time.

3p received infection. 8:15 severe chills, vomiting until 2am. From 2am through the next day fever ( 100c) with it breaking through the night. Mild flu the next day with general Malaise. The chills were so intense that I was constricted for much of the time with little relieve. I would call them violent chills with a tetany kind of full body involvement. Never have I experienced chills like I have described. I?ve never had a reaction to vaccines and tend have a high tolerance. I did not contact my physician but spoke to colleagues who suggested report the experience.

Patient went to the ER the morning after receiving the vaccine because she reports she was experiencing a severe migraine with ear and eye pain, nausea, vomiting, diarrhea, pain in hands and feet, and muscle spasms that last for 4 days.

Body aches, fever 100.8, chills, loss of appetite, lasted about 24 hrs only. Nausea lasted about 1 hr Sore swollen arm at injection site sore for 6 days. They side affects put me to bed for the 24 hrs...slept through it.

1st day: chills, pale skin, vomiting, loose stool, body aches,, fatigue; 2nd day fatigue, fever not exceeding 100.3, body aches. 3rd day: fatigue. 4th day felt 100% back to normal.

Flu-like symptoms lasting 3+ days, including lethargy, body aches, light sensitivity/headache, nausea, chest pain

Intense and strong vomiting and mild diarrhea for 5 hours and unable to keep water down during that time.

first 2 days slight headache and body aches, third day through 10th day, nausea, vomiting on the days 9 and 10, stomach pain, hives. I went to the ER on March 19 for nausea and vomitting, was dehydrated and received IV fluids. I also had hives which I was prescribed Steroids for. The next day, March 20, I went to urgent care for severe hives and was given a steroid shot and epinephrine shot. I don't know if these symptoms are a result of the vaccine, but I did not have them prior to the vaccine so I thought they should be reported. Thanks

About a week after the vaccine, I came down with pain in my lower back which progressed to the front lower abdomen and two red spots showed up on my right lower back side.

Nausea then vomiting for 24 hours. Also had general aches, headaches, chills, fatigue. The nausea and vomiting required call to Dr or nausea medication prescription the next day.. Nausea and inability to eat much persisted for more than a week and required visit to CNP for additional nausea medication.

Extreme tiredness starting at about 3 hours after the vaccination. Then about 8 hours after the vaccination got really cold, freezing, unlike another coldness I've felt. Feet and toes were especially cold to the touch. Shivering, heart palpitations too. Bloating and stomach ache and nausea. Tiredness continues the day after (today)

Starting midday Sunday ( one day after vaccine) I started feeling nauseous and about 2:00 I started throwing up. I threw up until about midnight for a total of 7 times. The night before I had difficulty sleeping. The next morning I felt nauseous again and threw up about 10:00 a.m. I started having diarrhea which has lasted through today (Thursday) and I had lost over 5 pounds in just 3 days and my weight is still over 5 pounds less today because it is difficult to eat much. Sunday I was feeling pain around my lest breast where I had had my mastectomy in June of 2006. That eased up the next day. Feeling stressed because I have bad tinnitus and was worried about a reaction.

Systemic: tooth sensitivity, could not eat or chew-Severe, Systemic: Joint Pain-Medium, Additional Details: 3/19/21: after work, patient came home and noticed itchy rashes on both ankles\r\n3/20/21: Overnight, patient experienced tooth sensitivity, uncomfortable and painful to chew/eat. 1 top and 1 bottom teeth affected more than the others. Experienced joint pain in hips, hands, and ankles. Patient had history of arthritis\r\n3/21/21: Joint pain continued. Rash on R ankle had a few tiny blisters\r\n3/22/21: Dentist appt where one tooth was extracted. amox & pain med started, rash and pain went away

Fever 101 for 2 days Headache ongoing (currently day 5) Nausea ongoing Insomnia ongoing Fatigue ongoing

First noticed as driving away my tinnitus was triggered. More serious adverse events started about 6-7 hrs after injection about 10:30pm with achy body and nausea. Progressed to Chills, achy body, sore muscles, nausea. Took Tylenol but persisted. By 10:00am next day (12 hours after began) symptoms lessened, but still persisting nearly 24 hours after injection.

Confusion, anxiety, 4 to 5 days. Went back in time with things that happened years ago, brain fog. Abdominal gut pain , diarrhea. Exhaustion lasting 2 weeks.

Janssen COVID-19 Vaccine EUA Started at 6:30 pm and Fever of 102 by 9:00 pm, Chills, Diarrhea, Ibuprofen brought down fever,

TINGLY ON THE RIGHT UPPER LIP; MILDEST ACHY JOINTS; NOT FEELING HUNGRY; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included latent TB, and concurrent conditions included diabetes, obese, and skin eczema, and other pre-existing medical conditions included patient had allergies to MRI dye. The patient was previously treated with immunoglobulin g human; and experienced allergy when treated with metronidazole. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown expiry date: unknown) dose was not reported, administered on 26-MAR-2021 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced not feeling hungry. On 27-MAR-2021, the subject experienced mildest achy joints. On 28-MAR-2021, the subject experienced tingly on the right upper lip. Laboratory data (dates unspecified) included: Lab test (NR: not provided) negative, 7 times tested. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingly on the right upper lip, and had not recovered from mildest achy joints, and not feeling hungry. This report was non-serious. T

SORENESS AT INJECTION POINT (SHOULDER); NAUSEA; FATIGUE; This spontaneous report received from a patient via a company representative concerned a 62 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose, 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 number. No concomitant medications were reported. On an unspecified date, the subject experienced soreness at injection point (shoulder), nausea, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness at injection point (shoulder), nausea, and fatigue. This report was non-serious.

Chest palpitations vomiting fever breathlessness rash on neck and face thickening of tongue palate lips blood pressure 174/106 spike tiredness headaches aches since Friday I had called nine times to this number

Patient reported feeling pain in the base of the head, difficulty swallowing, jaw pain, and dizziness Patient seen by medical team and ambulance was called Patient stated symptoms improved a little Patient refused medical transport because ?it?s too expensive? and signed AMA form Patient stated she will be driven by husband to ER

Fever chills tired and aches for 2 days. Starting day 3 had lightheaded feeling with nausea and intestinal cramps. Had diarrhea for 2 days which resolved but lightheaded and nausea remained for 2 weeks. After 2 weeks had some relief but lightheaded feeling returns on occasion. Can remain functional but don?t feel right some days.

Extreme headache for 2 days. Worse than any migraine I?ve ever had. Severe pain in neck, shoulders and spine. My heart heart. Extreme nausea, vomiting and diarrhea. Extreme fatigue. Couldn?t move or eat for 2 days. Didn?t think I was going to recover. 3rd day feeling light headed and tired but feeling better.

4/1 at 10PM started aching. Took tylenol and went to bed. by midnight she was feeling worse. She had chills and achiness and shivering. By midnight she had chills and aching and shivering. By 4/2 0600 she took ibuprofen but had a fever, aching and chills that were getting worse. By 4/3 she had vomiting and diarrhea. She finally felt better 4/5 but remained very tired. She finally felt back to normal on 4/9/2021.

Fever 103.2 for 24 hours; Fever 102.1 for next 24 hours; chills for 6 hours; heart racing for 6 hours ; fatigue 1 week; diarrhea 3 days; headache on going; severe bruising to injection site about 1.5 weeks after the injection

Four days after I received the vaccine (this week Tuesday), I suddenly felt very dizzy and faintish. I sat down until the dizzy spell passed. I felt very cold and clammy and nauseous. My hands were very shaky. I felt very weak and very tired so I slept the whole day. Today I woke up and felt the same dizziness, very cold hands and nauseous. Both times I had diarrhea. I have never had dizzy spells before so I know this has to be vaccine related.

Really bad headache, nausea, dizziness, fever, achy all over, arm swollen even in arm pit and really sore,diarrhea

Nausea, headache, stiff neck six hours later. Muscle pain, elevated blood pressure, severe ringing in ears occurred 15 hours (3am) after injection. Saw PCP on 3/25- prescribed blood pressure medication (never taken before) and referred to ENT. Saw ENT on 3/29 and 3/30. Prescribed high dose Prednisone for two weeks. Hearing test shows hearing loss in left ear. Received injection in left arm. Shrill high pitched ringing in both ears with no improvement. See Audiologist on 4/20 for hearing recheck to see if hearing has improved in left ear.

Shortness of breath, difficulty breathing, difficulty speaking, chills, violent shaking, left kidney pain , headache, Coughing body aches, fatigue, confusion, difficulty sleeping ,loss of appetite, weakness , burning in my lungs

03/08/2021 (Symptoms began 45 minutes after shot): sore arm down to fingers, stuffy nose, watery eyes, headache, light headed, slight balance issues, malaise, no appetite, slight nausea, tight chest, arm soreness down to fingers became worst & was accompanied by arm swelling which included the fingers, 2 hives, tingle around mouth & nose, asthma feeling progressed to shortness of breath upon exertion, slight face swelling, Temp 102, chills. 03/09/2021 same symptoms as 03/08/2021 but minus the hives & the addition of the following symptoms: Temp 101, shaking so bad from chills couldn't hold anything, runny nose & eyes, extreme fatigue, small chest pain, skin cold like had been in freezer, lips & fingers slightly purple. 03/10/2021 same symptoms as 03/08/2021 & 03/09/2021 but minus the hives, slight face swelling, servere chills, lips & fingers barely purple & the addition of the following symptoms: Temp 100. 03/11/2021 symptoms include: Temp 99.7, sore arm down to fingers, stuffy nose, watery eyes, headache, slight balance issues, malaise, no appetite, slight nausea, tight chest, shortness of breath upon exertion, runny nose & eyes, extreme fatigue, & small chest pain. 03/12/2021 symptoms include: Temp 98.7, sore arm down to fingers, slight headache, slight balance issues, malaise, no appetite, slight nausea, slight tight chest, shortness of breath upon exertion, runny nose & eyes, extreme fatigue. 03/13/2021 symptoms include: Temp 97.7 (my normal), sore arm down to fingers, malaise, no appetite, slight nausea, slight tight chest, slight shortness of breath upon exertion, runny nose & eyes, extreme fatigue. 03/14/2021 symptoms include: Temp 97.7 (my normal), sore arm down to fingers, malaise, slight appetite, slight nausea, slight tight chest, slight runny nose & eyes, extreme fatigue. 03/15/2021 symptoms include: Temp 97.7 (my normal), sore arm down to fingers, malaise, slight tight chest, slight runny nose & eyes, extreme fatigue. 03/15/2021- 04/10/2021 symptoms include: Temp 97.7 (my normal), fatigue & slight malaise at times.

Numbness on left side of face lasting from 3pm to after midnight on 3/8/21. It subsided on 3/9/21 during the day, but again felt numbness on left side of face at 10:00pm on 3/9/21. Continue to feel nausea, no appetite, and extreme fatigue.

This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included rheumatoid arthritis, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042a21a, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced tiredness. On 01-APR-2021, the subject experienced subject could not lift things (strength loss). On 01-APR-2021, the subject experienced pain in arm. On 01-APR-2021, the subject experienced muscle ache. On 01-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on APR-2021, and had not recovered from muscle ache, pain in arm, patient could not lift things (strength loss), and tiredness. This report was non-serious.

almost two weeks later my arm is still very sore at injection site. the next morning after the vaccine when i was at work i had to leave my classroom because i felt sick. i felt nauseated, sweaty, light headed, short of breath and my heart was pounding like i had been running a marathon. i thought i was gonna have a heart attack. i HAD to go outside for fresh cool air and sit down. i was also applying a cold compress, drinking cool water and taking very deep breaths i was able to return to work in about 15 minutes. i continued to feel nauseated for the rest of that day and the next.

At time of the shot, bright red face, rash, skin warm to touch. In the early evening chills, dizzy, waves of nausea. In the morning: vomit, nausea, chills, headache, dizzy

Swollen lymph nodes in groin (1 day)and underarms and under jaw (2 days), headache(2 days), loss of appetite (2 days), muscle aches(1 day), feeling very tired(1.5 days) Treated with acetaminophen and rest. Symptoms mostly resolved by end of 2nd day

Day one: soreness at injection site, mild achiness and headache, brief episode of intense coughing/wheezing Day two: slight lightheadedness, episode of vertigo and nausea. All totally resolved by the end of day 2

Experienced all common symptoms as well as other I have not heard of. Mental fogginess began at 8 PM (8 hrs after shot) and lasted until late the next evening Chills began at 8:30 PM and continued until early Friday AM. There were also a few instances of hot flashes in between the chills. About 10 hours after the shot the following began: headache (I rarely get headaches), nausea, muscle aches - mostly my quadriceps, low back pain, pain in the back of my neck, general lethargic feeling. These all lasted into Thursday evening, except the low back pain, which lasted into Friday AM. I felt a dull pain in all my back teeth that lasted about a day and was intermittent. See page 2 for more.

Same night of the vaccine I had fevers & chills. They were gone after 12 hrs. On 3/18/2021 I stated having stomach problems. I had diarrhea & cramping this was going on & off. Around one week later I went to urgent care because of how much I was cramping. I followed up with my regular doctor & he did some la work. It kept going on & off but it started getting better & today on 4/12/2021 is the first day I started feeling like myself.

beginning the following morning: hot flash followed by chills followed by vomiting. Hot flashes, Chills, Nausea, Vomiting, Diarrhea continued for 48 hours

HORRIFFIC HEADACHE FOR 24 HRS. THE NEXT DAY FELT GREAT, THEN ON THE EVENING OF 4/10 HAD SEVERE STABBING ABDOMINAL PAINS THOUGHT THAT HAVING BOWEL MOVEMENR=T WOULD MAKE ME FEEL BETTER BUT UNABLE TO GO. A FEW HOURS LATER ABLE TO PASS SOLID STOOL THEN WENT TO MASSIVE UNFORMED STOOL IN LARGE AMOUNTS WITH VOMITING. CONTINUED STABBING PAIN BUT NOW FEELS LIKE MY INSIDES ARE BEING TWISTED., PAI HAS TRAVELED FROM LOWER ABDOMEN AND MOVED UP TO UPPER ABDOMEN. UNABLE TO EAT AND ONLY DRINKING WATER. . DAY 6 AND STILL HAVING PAIN

Experienced strong all-day headache. A number of days later I experienced strong abdominal pain on at least two separate occasions. There is no history of pregnancy.

Vaccine given April 5, 2021. On April 5, 2021 around Midnight/April 6, 2021 12:01am, I became very chilled and a very uncomfortable headache started; I remained cold for about 1 hour; headache lasted for 7 hours - subsided after I took one 200 mg Advil softgel; aches and pains in head, both sides of jaw, knees, and ankles from Midnight to 4:00am; very tired and didn't feel like walking or moving around much from Midnight to Noon (April 6, 2021); felt nausea on and off from 1am to 7am; perspired from 2am to 4am (didn't get up to take my temperature so don't know if I had one but pretty sure I did since I sweated for so long).

I have mild headaches daily due to seasonal allergies, but I was told to report even if I wasn?t sure if it was a reaction. Early Monday, 4/12/21, I woke up with a severe sinus headache. I took some sinus medicine by 7 am but it remained fairly strong for 2-3 hours. It eased up some so I went to work and by 11 am took another dose of sinus medicine. I felt nauseated so I ate a couple of Tums through the afternoon. I assumed it was related to the sinus medicine. After work, I went home and was very tired. I went to bed earlier than normal but woke up this morning feeling normal. (With a mild - as usual - headache)

Temperature between 99 and 100 for four days, one episode vomiting 54 hours after vaccine, headache 3 days after vaccine, body aches just the day after, patient took Tylenol but temperature not getting below 99.

Persistent rectal bleeding and passing blood and blood clots for 7 days since vaccination. Bleeding occurs with stool and throughout the day, requiring the use of pads.

Got shot a little after 3 pm March 11, 2021. At about 10 pm that evening, had about an hour of chills, no big deal. Then began to get headache with slight fever and the headache got progressively worse, with nausea and rapid heart rate. The headache was so bad I could not sleep at all - the worst headache I have ever had. I took one extra-strength Tylenol at about 10 or 11 am the next day, March 12, which took the edge off the headache. The headache diminished till it was gone by about 8 or 9 pm. The rapid heart rate, along with tiredness, low energy, and feeling jittery continued for several days, then stopped. About 3 or 4 weeks later...there's more BUT FORM WON'T LET ME GO TO CONTINUATION PAGE

Within 15 minutes of receiving vaccine, massive headache, slight nausea, flushing of face, rapid heart rate double the normal heart rate for myself (120 beats per minute, as opposed to 60 BPM), heat in right hand. Adverse effects lasted 20 hours after injection. Slight headache on and off from 4/11/2021 to 4/14/2021. Also noted jaw pain, felt like slight swelling around eustachian tubes of both ears.

received Jansen vaccine on 3/31/21 and the following day I had a headache,, achy and tired. I expected this, but a few days later I was still having what I describe as migraine type headaches and at one point I was sweating profusely, dizzy massive headache with not only nausea, but dry heaving so bad I could barely get to my medication and seriously thought it would never subside. I continued with headaches up until today April 14. This is the first day I have not had a headache. I contacted my vascular doctor as I had a blood clot several years ago and he has prescribed Eliquis twice a day for the next 2 weeks. Today marks 2 weeks and like I said, it's the first day I have not had a headache

Some minutes after the injection I started feeling a burning sensation under my bra (around my chest), and it was hard to breath and then I started feeling it in my throat and then my lips started tingling, I also had a headache that started. I alerted the person at the vaccination site saying something was not right and then they called the paramedics who took my vitals and said my heart rate and blood pressure was extremely high. They gave me a shot of Benadryl and oxygen because I was feeling shortness of breath. They kept me until about 11:35 in observation when I felt myself again. The headache, nausea and body aches stayed for about 2 weeks but all other symptoms subsided.

Sore arm at injection site and then a couple hours later started with fever, then red rash over top of body chest, arms rash felt like a burn, nausea, diarrhea, body aches all over, slight headache, tired- took tylenol ever four hours. Rash lasted until Sunday early evening, headache until Sunday morning, tired and aches lasted until Tuesday. Nausea and diarrhea on and off until Tuesday. Fever until Sunday afternoon. Pain in back rt side. About 1 hour after vaccine - chest tightness felt like asthma coming on, then it went away.

PT reports intermittent epigastric pain described as sharp x 04/09 after receiving JJ vaccine. reports nausea, denies vomiting and diarrhea.Patient is a 63 year old female who presents to ED with epigastric pain for 5 days, sharps, rated 9/10 associated with nausea. She denies any fever, no vomiting. She states the pain started one day after receiving the J&J vaccine. She has had some headache, denies any chest pain or shortness of breath. She was recently diagnosed with elevated cholesterol, has not had treatment for it yet. She had a colonoscopy with benign polyp removed, no other abdominal procedures.

10 minutes after shot i started to feel tingling and numbness in my chest which traveled to my neck and into face. Began having a dry cough, went to nurse to as if normal, she said no, she started monitoring me. Still had cough, then became light headed and nausea. She gave me 25 mg of Benadryl, coughing continued, breathing became rapid, then I was given shot of epi, I became dizzy again and couldn?t complete a sentence. Words were slurred, heart beat racing. EMT?s were called. Received another shot of Benadryl. It did not counteract anything. Received another shot of epi. Had uncontrollable shakes and hard to breathe or speak. Was difficult to get BP reading due to shaking. Finally got reading of 196/99. EMT listened to heart and lungs. Said all was good. Taken to ER for monitoring of heart, Lungs and BP. Was there for approximately 2 hours u til shakes and BP were good.

severe headache from 2:30 am until 4:00 pm took tylenol nauseau took 1/2 dose of meclizine gone by early afternoon hive in mouth when woke up with headache gone by late afternoon I am 87 pounds

Vaccine administered on right arm on 4/8/2021. Approximately, 12 hours later she began experiencing severe abdominal stomach pain, fever and general malaise (fever and malaise have generally resolved), numbness in her left arm, and elevated blood pressure. She continues to have abdominal pain 7 days after immunization. Advised to go to emergency room out of an abundance of precaution.

DIVERTICULITIS ATTACKS; FLU- LIKE SYMPTOMS; FREQUENT URINATION; NOT SLEEPING WELL; DIARRHEA; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 95.5 kilograms, and height was not reported. The patient's concurrent conditions included primary pulmonary hypertension. The patient received Selexipag (form of admin and route of admin were not reported, batch number: UNKNOWN expiry: UNKNOWN) dose, frequency, and therapy dates were not reported for drug used for unknown indication; and Macitentan (tablet, route of admin not reported, batch number: ZE019B0101 expiry: 31-JUL-2024) 10 mg, 1 time every 1 day, therapy dates were not reported for primary pulmonary hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in 2021, the patient had diarrhea, flu- like symptoms, body aches, nausea, fatigue, short of breath frequent urination and was not sleeping well. She was unsure if this was due to the vaccine or a combination of the Uptravi and the vaccine. The patient also had short of breath when she took her garbage out and that she had occasional diverticulitis attacks. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the diverticulitis attacks, diarrhea, flu- like symptoms, frequent urination and not sleeping well was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210414881-Covid-19 vaccine ad26.cov2.s-Diverticulitis . This event is considered unassessable. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. V0:20210414881-UPTRAVI-Diverticulitis. This event is considered unassessable. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. V0:20210414881-OPSUMIT-Diverticulitis. 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.

FEELS SPACEY; DIZZINESS; PAIN FROM HEAD TO TOE; NAUSEA; DRY THROAT; EYEBALLS WERE HURTING; FEELING HOT; FELT LIKE RUN OVER BY A MACK TRUCK; CHILLS; HEADACHE; HOT SWEATS; STOMACH ACHE / BELLY MUSCLE ACHE; INCREASED GAS; BURPING; SWOLLEN THROAT; THROAT IRRITATION; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced increased gas. On 07-APR-2021, the subject experienced burping. On 07-APR-2021, the subject experienced swollen throat. On 07-APR-2021, the subject experienced throat irritation. On 08-APR-2021, the subject experienced stomach ache / belly muscle ache. On 08-APR-2021, the subject experienced hot sweats. On 08-APR-2021, the subject experienced dry throat. On 08-APR-2021, the subject experienced eyeballs were hurting. On 08-APR-2021, the subject experienced feeling hot. On 08-APR-2021, the subject experienced felt like run over by a mack truck. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced headache. On 08-APR-2021 03:00, the subject experienced dizziness. On 08-APR-2021 03:00, the subject experienced pain from head to toe. On 08-APR-2021 03:00, the subject experienced nausea. On 09-APR-2021, the subject experienced feels spacey. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stomach ache / belly muscle ache, increased gas, burping, headache, swollen throat, dizziness, nausea, pain from head to toe, chills, hot sweats, feels spacey, throat irritation, dry throat, eyeballs were hurting, feeling hot, and felt like run over by a mack truck. This report was non-serious.

FLU LIKE SYMPTOMS; SWEATING; BODY ACHE; MIGRAINE/HEADACHE; FATIGUE; NAUSEA; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included stent in heart, and stent in leg, and concurrent conditions included migraine, high blood pressure, gastroesophageal reflux disease, and irritable bowel, and other pre-existing medical conditions included patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. Concomitant medications included esomeprazole magnesium for gastroesophageal reflux disease, and irritable bowel, hydrochlorothiazide for high blood pressure, lisinopril for high blood pressure, metoprolol succinate for high blood pressure, pantoprazole for irritable bowel, and gastroesophageal reflux disease, butalbital/caffeine/paracetamol for migraine, acetylsalicylic acid for stent placed in heart, and clopidogrel bisulfate for stent placed in heart, and stent in leg. On 05-APR-2021, the subject experienced flu like symptoms. On 05-APR-2021, the subject experienced sweating. On 05-APR-2021, the subject experienced body ache. On 05-APR-2021, the subject experienced migraine/headache. On 05-APR-2021, the subject experienced fatigue. On 05-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms, sweating, body ache, and migraine/headache on 09-APR-2021, and nausea on 07-APR-2021, and was recovering from fatigue. This report was non-serious.

Dizziness approx. 30 minutes after vaccination, spinning sensation 1hr after vaccination. Chills and shivering approx. 5 hrs after-- nausea-vomiting-102 fever, severe muscle, joint and headache. 5 1/2 hrs later. 36 hrs after shot side effects lessen. 72 hrs later weakness and fatigue. Day 4 these symptoms resolve. Five days after vaccine dizziness and muffled hearing in left ear which is unresolved.

Dizziness, nausea, leg pain(left), migraines, diarrhea (ongoing),chills, unable to regulate body temperature(ongoing), severe fatigue (also ongoing), difficulty working, inappetince... Spoke with doctor. No help. No treatments.

Sudden onset extreme dizziness/vertigo. So severe and sudden I called 911 because I felt I might lose consciousness. Followed by nausea and violent vomiting. (EMT Vitals were all normal and they didn't think it was an allergic reaction this long after vaccine so I declined hospital ER visit.) After several hours of severe dizziness I developed violent chills with heavy breathing that lasted 20 minutes then stopped. Much improved after 24 hours but two days later I still have considerable dizziness. Headaches occurred Earlier in the week but none with onset of dizziness. Otherwise I experienced the typical fatique and flulike vaccine side effects with no pain at injection site about 2 days after vaccination that lasted several days.

I received the Janssen COVAX on Monday morning, 5 Apr 2021. A week later, on Monday evening, 12 Apr 2021, I experienced extremely painful leg cramps and broke out in a sweat. I felt extremely nauseous, and weak, this was followed by a sever pain in my head that was so extreme that I passed out. After coming to, the pain in my head finally began to subside, along with the leg cramps. My husband indicated that I was unconscious for just under a minute. For the next two days, I had bouts of nausea, headaches, sweats, and was extremely tired. On Wednesday, 14 Apr, after learning of the issues related to the Janssen vaccine, and the symptoms described being what I experienced, I contacted the advice (cont'd)..Additional information for Item 18: Line and was told to go to Emergency Room at the hospital, which I did. I do not feel that they addressed my concerns or the symptoms that I was experiencing, and at no time did they try to determine if it was due to the vaccine. The discharge papers did not even address the "event" and the "symptoms" that I described. They did not take any information down related to the vaccine, lot number, etc., that I had received. They seemed to go through a set routine: blood pressure, blood work, temperature, EKG, and CAT scan. 21. (continued)...Visited Emergency Room, however, was requested by ER to go to Primary Care as follow-up, however, as a Employee we cannot be seen by Primary Care on THIS site. Instead , we have to go on the local clinic to receive care. The issue is that this was a vaccine that I was scheduled by my leadership to receive, with no choice in choosing which vaccine I could receive, and without follow-up care for adverse reactions. The hospital did not indicate to me that I should report this incident, however, I am concerned as a result of the "event" that I experienced, that it should be reported. Furthermore,we should have a choice as to which vaccine we want to receive, just as everyone does. Your form does not allow for input addresses Also, your form does not allow for a phone number. I am out of the country.

NAUSEA; HEADACHE; INJECTION SITE PAIN; BODY ACHE; ARM HURT; CHILLS; JOINT PAIN; MYALGIA; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 125 pounds, and height was 174 centimeters. The patient's concurrent conditions included no alcohol user, and non smoker. The patient experienced drug allergy when treated with tetracycline. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068 expiry: 25/MAY/2021) dose was not reported, administered on 10-MAR-2021 11:00 for prophylactic vaccination. Concomitant medications included ascorbic acid/calcium/minerals nos/retinol/tocopheryl acetate/vitamin b nos/vitamins nos/zinc for drug used for unknown indication, calcium carbonate/colecalciferol for drug used for unknown indication, vitamin c for drug used for unknown indication, alendronate sodium for osteoporosis, nebivolol hydrochloride for slow heart down, aloe vera, and chondroitin sulfate/collagen/glucosamine. On 10-MAR-2021, the subject experienced body ache. On 10-MAR-2021, the subject experienced arm hurt. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced joint pain. On 10-MAR-2021, the subject experienced myalgia. On 10-MAR-2021 15:00, the subject experienced nausea. On 10-MAR-2021 12:30, the subject experienced headache. On 10-MAR-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, arm hurt, chills, myalgia, nausea, joint pain, and injection site pain. and headache on 11-MAR-2021 This report was non-serious.

I was ill with diarrhea, sick to stomach, blood clots coming out of my rectum for 24 hrs., body aches.

STABBING PAIN IN STOMACH; NAUSEA; INJECTION SITE SORENESS; FEVER; LOSS OF 5-6 POUNDS; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, penicillin allergy, and keflex, tylenol and asprin allergy. The patient experienced difficulty in breathing when treated with hydrocodone bitartrate/paracetamol, and hives when treated with naproxen sodium, erythromycin, and swelling of the face when treated with magnesium sulfate. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: 21-JUN-2021) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced loss of 5-6 pounds. On 01-APR-2021, the subject experienced stabbing pain in stomach. On 01-APR-2021, the subject experienced nausea. On 01-APR-2021, the subject experienced injection site soreness. On 01-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site soreness, and fever on 03-APR-2021, had not recovered from nausea, and stabbing pain in stomach, and the outcome of loss of 5-6 pounds was not reported. This report was non-serious.

2 hours after receiving the vaccine, I grew exhausted and had to sleep into late evening and was chilled, had a fever of 101 and developed severe pain and inflammation on the top of my collar bone that was feverish and migrated toward my shoulder region on the same side as my vaccine. Ibuprofen would not help with the pain but helped with the fever. My mind told me that I had things to tend to the next day, but still was forced to sleep off and on for 2 more days. After a week and a half, not only did I have thirst, but also food didn't taste right and was metallic. This lasted for 2 days and finally my taste was restored. The exhaustion lasted off and on for 2 weeks and I just listened to my body. The pain and inflammation on my collar bone has subsided 4 days ago but still have pain in my shoulder when I sleep. On April 5 around 8:30 a.m. a nasty virus hit me out of the blue. I grew week and tired and had to go to bed. I slept all day until around 9:00 p.m. and woke to uncontrollable diarrhea and fainting spell while in the bathroom. I had abominable pain and nausea that last for a half hour and then I returned to bed. The next 2 days, I was week and exhausted but continued with my regular routine. My equilibrium is still affected from time to time.

DIARRHEA; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was not reported and height was 157.48 centimeters. The patient's past medical history included surgery, and concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included no known drug allergies and had no history of drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included sulfamethoxazole/trimethoprim for post surgery. On 12-MAR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 15-MAR-2021. This report was non-serious.

That evening I felt like my abdomen/GI was on fire, inside. I experienced residual feelings of the inflammation (? I am calling it a "fire" to approximate what it made my abdomen feel like) for the rest of the week. Since the perception of abdominal irritation/inflammation wasn't on my handout of possible adverse reactions I did not report. I had muscle ache and ache that I treated with advil. Those aches only lasted 2 days, but the abdominal symptoms continued until the weekend. I read last eve an article online and am reporting because I saw that abdominal pain was listed as an adverse effect that was to be reported.

DIARRHEA; DIZZINESS; FUNNY TASTE; PAIN IN LEFT ARM; HEADACHES; NAUSEA; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic back pain, preexisting degenerative joint disease, non smoker, and non-alcohol user, and other pre-existing medical conditions included the patient did not have any drug abuse/illicit drug use and had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced diarrhea. On 09-APR-2021, the subject experienced dizziness. On 09-APR-2021, the subject experienced funny taste. On 09-APR-2021, the subject experienced pain in left arm. On 09-APR-2021, the subject experienced headaches. On 09-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 11-APR-2021, dizziness, and nausea on 10-APR-2021, and funny taste on 09-APR-2021, and had not recovered from pain in left arm, and headaches. This report was non-serious.

On the day of the vaccination and for the next 3 days I felt tired, fatigued and on Saturday the 10th I noticed my gland under my jaw on that evening that it was swollen. Then on the 15th or 16th I noticed that the roof of my mouth was hurting, was sore. So I asked my husband to check it for me because I could not see it very well and he said there was a sore on the roof of my mouth. Yesterday I asked him to check again and he said it was even worse. I am going to see a doctor today, appointment today at 12:30PM. I also saw another Dr. also at the same clinic on 04/14/2021.

Fever, body aches, headache, chills, tired, vomited bile, weak, high blood pressure, visual changes.

SORE THROAT; TERRIBLE COUGH; NO APPETITE; RUNNY NOSE; DARK GREEN MUCOUS; AFFECTING VOCAL CHORDS; FEVER; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included stroke. The patient was previously treated with apixaban for stroke. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180502) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced fever. On APR-2021, the subject experienced sore throat. On APR-2021, the subject experienced cough. On APR-2021, the subject experienced no appetite. On APR-2021, the subject experienced runny nose. On APR-2021, the subject experienced dark green mucous. On APR-2021, the subject experienced affecting vocal chords. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and had not recovered from sore throat, cough, no appetite, runny nose, dark green mucous, and affecting vocal chords. This report was non-serious.

FLU LIKE SYMPTOMS; STOMACH DISCOMFORT; BODY ACHES; CHILLS; FEVER; NAUSEA; HEADACHE; TIRED; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980,expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced flu like symptoms. On 08-APR-2021, the subject experienced stomach discomfort. On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced tired. On 13-APR-2021, treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, nausea, flu like symptoms, headache, chills, stomach discomfort, and body aches, and the outcome of tired was not reported. This report was non-serious.

HIVES; CHILLS; NAUSEA; FEVER; ACHE; RAPID HEART RATE; RASH ACROSS CHEST; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, Laboratory data included: Antibody test (NR: not provided) negative. On 02-APR-2021, the subject experienced ache. On 02-APR-2021, the subject experienced rapid heart rate. On 02-APR-2021, the subject experienced rash across chest. On 02-APR-2021, the subject experienced chills. On 02-APR-2021, the subject experienced nausea. On 02-APR-2021, the subject experienced fever. On 14-APR-2021, the subject experienced hives. Laboratory data (dates unspecified) included: PCR (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ache, and chills on 04-APR-2021, and rapid heart rate, nausea, and fever on 06-APR-2021, was recovering from hives, and had not recovered from rash across chest. This report was non-serious.

HEADACHE/HEAD HURTING; FELT NAUSEA; FELT FATIGUE/TIRED; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included low blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid. On 08-APR-2021, the subject experienced headache/head hurting. On 08-APR-2021, the subject experienced felt nausea. On 08-APR-2021, the subject experienced felt fatigue/tired. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 120/62 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache/head hurting, felt nausea, and felt fatigue/tired. This report was non-serious.

HOT FLASH; NAUSEA; JOINT PAIN/JOINT BURNING; FOGGINESS; VOMITING; FACIAL REDNESS; METALLIC TASTE; APPETITE LOST; SWOLLEN TONGUE; PAIN TONGUE; PEELING TONGUE; ADVERSE REACTION; LOSS OF TASTE; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 04DDZ1D 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 hot flash. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced joint pain/joint burning. On APR-2021, the subject experienced fogginess. On APR-2021, the subject experienced vomiting. On APR-2021, the subject experienced facial redness. On APR-2021, the subject experienced metallic taste. On APR-2021, the subject experienced appetite lost. On APR-2021, the subject experienced swollen tongue. On APR-2021, the subject experienced pain tongue. On APR-2021, the subject experienced peeling tongue. On APR-2021, the subject experienced adverse reaction. On APR-2021, the subject experienced loss of taste. The dose of covid-19 vaccine ad26.cov2.s was increased. The outcome of the hot flash, nausea, joint pain/joint burning, fogginess, vomiting, facial redness, metallic taste, appetite lost, swollen tongue, pain tongue, peeling tongue, adverse reaction and loss of taste was not reported. This report was non-serious.

Patient called stating she began having severe nausea and pounding headaches 1 week post-vaccination. She said she went to urgent care due to nausea. They tested her BP and it was fine. Said she is still having the headaches now, 1 week after they started.

HEADACHE; SICK TO STOMACH; BODY HURT/COULD NOT MOVE/FELT LIKE A SEMI HIT 5 TIMES; START TO THROW UP; SICK FOR 2 DAYS; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced sick for 2 days. On 09-APR-2021, the subject experienced body hurt/could not move/felt like a semi hit 5 times. On 09-APR-2021, the subject experienced start to throw up. On 09-APR-2021, the subject experienced sick to stomach. On 10-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body hurt/could not move/felt like a semi hit 5 times, had not recovered from sick to stomach, and the outcome of headache, sick for 2 days and start to throw up was not reported. This report was non-serious.

FEVER; HEADACHE; NAUSEA; LIVER PAIN; TIPSY; LIGHT HEADEDNESS; COLD CHILLS; LEFT LEG PAIN; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's past medical history included hepatitis c, and concurrent conditions included controlled epileptic. 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 09-APR-2021 for prophylactic vaccination. Concomitant medications included silybum marianum for hepatitis c, bifidobacterium bifidum/bifidobacterium lactis/fructooligosaccharides/lactobacillus acidophilus/lactobacillus casei for immune system, and ascorbic acid/ergocalciferol/folic acid/nicotinamide/panthenol/retinol/riboflavin/thiamine hydrochloride for nutritional supplement. On APR-2021, the subject experienced cold chills. On APR-2021, the subject experienced left leg pain. Laboratory data included: Pain scale (NR: not provided) pain score 2 or 3. On 09-APR-2021, the subject experienced liver pain. On 09-APR-2021, the subject experienced tipsy. On 09-APR-2021, the subject experienced light headedness. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the liver pain, left leg pain, light headedness, tipsy, headache, nausea, fever and cold chills was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious

VOMITING; FEET AND LEG PAIN; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included aspirin allergy, and concurrent conditions included history of blood clot, and chronic inflammatory demyelinating polyneuropathy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included immunoglobulin human normal for chronic inflammatory demyelinating polyneuropathy. On 28-MAR-2021, the subject experienced vomiting. On 28-MAR-2021, the subject experienced feet and leg pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vomiting and feet and leg pain was not reported. This report was non-serious.

Janssen COVID-19 Vaccine EUA Extreme chills and quaking, despite 3 blankets and two heating pads, occasional jerks of my body -within 7 hours. Lasted 20 hours or more. Fatigue- unable to walk myself to bathroom within 8 hours, lasted two or more days. Very weak. VERY Severe Headache, including facial pain, neck pain, temple pain and eye sockets , stared 7 hrs, lasted two days Severe nausea, I actually thought of food poisoning (but it wasn't). Approx. onset 9 hours. Very painful body aches and muscle spasms throughout my body but especially my Back, underarms, legs, feet. Approx. onset 7 hours. lasted 48 to 60 hour Diabetic Ketoacidosis approx 30 hours after. Wasn't able to eat, blood sugar remained in the 150 to 180 area. Managed to eat 2 TBsp of applesauce to reduce ketones, (which worked) Fatigue unable to work until 5 days later.

Sudden rapid heart rate , sweat , nausea, light headed , almost passed out . Ems was called . vitals returned to normal while in ambulance . No further heart fluctuations. A month later tinnitus has begun . I?m currently being checked by an ENT to find out why . No previous tinnitus issues .

REALLY SICK; DIARRHEA; SUSPECTED COVID-19; HEMORRHOID PROBLEM; BOWEL MOVEMENTS ARE MORE FIRM; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 103.2 kilograms, and height was not reported. The patient's concurrent conditions included secondary pulmonary hypertension, diarrhea, and change in her bowel movements. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch number in this case. Non-company suspect drugs included: macitentan (oral, batch number: ZE019B0101 expiry: 31-JUL-2024, form of admin was not reported) 10 mg, 1 time every 1 day, therapy dates were not reported for an unspecified indication; and epoprostenol sodium (intravenous, batch number: MM254M0101 expiry: 31-JUL-2022, form of admin was not reported) 1.5 mg, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported. On 2021, the subject experienced suspected covid-19. On 2021, the subject experienced hemorrhoid problem. On 2021, the subject experienced bowel movements are more firm. On 2021, the subject experienced diarrhea. On 26-APR-2021, the subject experienced really sick. The action taken with covid-19 vaccine was not applicable; and dose of macitentan, and epoprostenol sodium was not changed. The patient recovered from really sick on 28-APR-2021, and the outcome of suspected covid-19, diarrhea, bowel movements are more firm and hemorrhoid problem was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious.

Immediate reaction = headache 4 hour reaction = increasing fatigue, headache 12 hour reaction = headache, joint aches, fatigue, fever 101.4 24 hour reaction = headache, fever gone, excessive fatigue and joint and muscle aches 24-72 hour reaction = headache, excessive fatigue, joint and muscle aches, bloating with intestinal discomfort Day 5 - 96 hour - symptoms improved, mild fatigue and joint aches, mild headache, able to do daily activities Day 5 - 10 pm = fatigue, headache, and joint aches increased Day 5- 11 = extreme excessive fatigue, joint and muscle aches, bloating and intestinal discomfort, mild headache - unable to work or perform daily activities Day 11- 17 symptoms improved slightly to allow some resumption of daily activities, intestinal symptoms include alternating diarrhea with constipation, joint and muscle aches prevent any return to walking and exercise, minimal work tasks completed Day 17-22 Symptoms the same as week before - becoming chronic - visit to MD on April 29th. Day 23-47 Treated with combination of Zyrtek, Pepcid, and Probiotic due to sensitivity to steroids. Symptoms gradually improved Day 48 (May 22nd) - first full day of ability to resume normal activities, including walking 2 miles (previous to vaccine was running 3-4 miles 3-4 times a week)

I am still experiencing pain at the injection site from when I received the vaccine. I have been experiencing heart palpitations that have been waking me up in the morning as well. I'm not sure if it's from the vaccine, or the nasal spray that I have had an allergic reaction to. My stomach still seems off. I'm not feeling right. I saw Dr. about my allergies and allergic reaction.

Loose BM's in the evening of the vaccine and the next morning, turned to Diarrhea. Subsequently during that time, it was intermittent diarrhea. It was either very soft or very watery. I noticed I was having more shortness of breath that usual. It's common for me to have some shortness of breath but this was more. That went on for a month or so. I happened to see Pulmonary Dr because of my normal appt.

I have had a cold and cough ache and headache and vomiting from coughing, since 05/01/2021 it started with a scratchy throat then went into a bad cold and cough, it appeared like it was starting to go away and then it started all over again with the scratchy throat and quickly back into the cold symptoms cough and headache and coughing so hard I vomit again. As of today after taking antibiotics, prednisone robitussin dm , fluticasone propionate nasal spray and benzonate capusules. I am not getting any better.

4/7/2021 patient had a normal cbc with differential. on 4/8/2021 she received the J&J vaccine. On 5/6 and 5/25 she was hospitalized with GIB secondary to AVMs. However, from a hematology perspective she has bicytopenia. Further workup as outpatient determines she has continued bleeding issues, clumped platelets, elevated platelet factor analysis. We are going to do a bone marrow biopsy.

6 days after vaccine after having no symptoms at all I suddenly felt nauseous about 9 p.m. Went to the bathroom and can't remember what happened next as I passed out. Fell hard and knocked shower out of track. Woke up throwing up massively. My husband ran in and helped me. I threw up a lot and had chills. After cleaning up, went to bed and piled on blankets. Woke up again sometime in the 11 to midnight range and threw up once more. Still chilled. About 3 a.m. I woke up and removed all the blankets as I felt okay again. I never found a place to report this in my daily reports as within 24 hours I felt normal again. I am 100% positive this was a reaction to the vaccine. I did not need to seek medical treatment as it passed within 6 hours or so.

Patient received J and J covid vaccine on 3/7/21. She did not feel well for the next few days and had the following symptoms: headache, fatigue, nausea, body aches, loss of taste. She recovered after a few days and was doing well until 6/11/21. She began having the following symptoms: migraine headache, nausea, dizziness, loss of appetite, blurred vision, weakness, loss of taste, muscle weakness and joint pain. She went to ER on 6/13/21. They did a cat scan and ekg, both came back normal. They did not do a covid test. She then went to her regular Dr. on 6/15/21 and he gave her topiramate. He did not do a covid test. She was off work for a week and returned to work on 6/18/21. She is feeling better now and has worked for the last two days. She came to pharmacy and told me what was happening and she thinks that her symptoms are from the original J and J covid vaccine on 3/7/21 and she is worried that she may have recurring symptoms for the vaccine

Pain and burning on L side (arm, shoulder, neck, face, ear, back), headaches, brain fog, anxiety, twitching, spasms, neuropathy in feet, low appetite, fatigue, weakness, tired eyes, blurry vision, heart palpitation when lying on either side at night, hypo thyroid

Chills. Headache. Nausea. After 6 hours of symptoms, I took Tylenol and felt normal 30 minutesl later.

Right after you received the vaccine on 03/31/2021, it was painful, but I thought it was just a shot pain, put I thought it was extremely painful. On my drive home it kept hurting. Finally on 04/17/2021, I was concerned because that was the time the media was mentioning blood clots from the vaccine. Because my arm, my shoulder hurt, and under my arm still continued to hurt I went into the ER. The doctor did not feel any abnormality in my arm. Till this day I still feel soreness in your arm and shoulder and under my arm. I can't extend my arm or use my arm. I use it cautiously, if I use it. I have had 3 or 4 visits with my doctor and she put me on methylpred 4 mg/ triage pack. It helped somewhat with the pain, but I still had soreness. So she prescribed Methocarban 500 mg. I just took it for 3 days. and it upset my stomach and gave me diarrhea . Now I have an MRI that is scheduled, but I don't know when at this point. I have to see if my insurance will cover it. I'm still pursuing to see why my soreness is persisting.

Headache started at 4:oopm on Friday, July 23, 2021 and then light headed feeling. Started sweating at 6pm. Started vomiting around 6:15pm and have continued vomiting through Sunday. Patient took excedrin on Friday, for headache. Patient tried to take pepto bismol on Saturday and ant acids on Saturday, but she has had trouble keeping them down. She hasn't been able to keep food or drink down successfully until only a small amount of water on Monday, July 26, 2021. She has been in the bed and is still very light headed as of 1:oopm Monday, July 26, 2021.

Itching and soreness at injection site 03/07/2021 Arthritis pain worse than usual 03/07/2021 Nausea 03/07/2021 Fatigue 03/07/2021

I noticed aching in my legs and 3 hours later I woke up and it was worse. I also had chills and shaking, a slight headache, and mild nausea. This continued into the next day (March 7, 2021). It was significantly better by mid-afternoon.

Severe chills, body ,muscle, joint aches, fever and sweats. Some stomach cramping . These all lasted 7 hours. Next day still body aches, headache and fatigue.

Half hour after injection my throat felt tight and my OPPOSITE arm hurt. About 1:00 am I got so chilled I couldn't get warm, I did not take my temperature because my thermometer goes under my tongue and I was afraid I would break it cause my teeth were chattering so bad. The next day I felt very weak and nauseous. Then I discovered I had a rash at the top of my legs. My left breast was very sore I felt like someone punched me. Today is Monday and I still have diarrhea.

Fever, chills, and vomiting the evening of the vaccine administration. Symptoms continued into the following evening. Fever broke early morning of 3/8/2021

My symptoms were muscle aches and pains, headache and nausea. it started about 10 hours after the injection and lasted about 36 hours. Thereafter I was just very tired for 24 hours. I took an Advil about 10 hours (around noon) after the headache set in, which lessened the headache.

Day 1 - received injectionwithin a fe minutes of administration I noticed a slight lightheadness and feeling "off" within half hour slight nausea began and headache began within hour muscles aches began with joint pain. Above symptoms progressively worsened by midnight was in pain and could not sleep. no fever. took tylenol and only had moderate relief. Day 2 -entire day severe muscle and joint pain - worst headache of my life, severe nausea and chills - no fever. double vision and dizzy Day 3 - same as day 2 - in evening - around 7 pm headache lessened so that it was tolerable with tylenol - muscle aches jopint pain the same Day 4 - headache tolerable, was able to eat. muscle pain better but joint pain still sharp Day 5 - headache sporadic and better - fatigue and muscle pain would come and go, joint pain not as sharp, extreme fatigue Day 6 - extreme fatigue - other symptoms much better

The patient reported to the pharmacist that she was feeling sweaty and nauseous after receiving the vaccine today. She stated she got sweaty immediately after administration and experienced nausea during her 15 minute observation period. The pharmacist requested patient to stay for observation for another 15 minutes which she did. At the end of that period, the patient stated she felt fine and was ready to go home and sweating and nausea had gone away.

approx. 15 minutes after vaccine, had left ear fullness, lip swelling and difficulty swallowing. Given EpiPen x1 IM right thigh with improvements in symptoms. 911 called and transferred to hospital.

woke up not feeling well, little dizzy & chills, diarrhea. Got worse the next day with nausea & headache.

The night I received the shot, I felt "achy" and took two Tylenol and went to bed. I woke up the next morning with a headache, chills, runny nose, fatigue, and nausea. I took an allergy medication and stayed in bed. This lasted all day. I woke up the next day feeling fine, except for the constant runny nose. Also, on that day, I started having "floaters" in my left eye that I never had before (probably unrelated but I want to let you know).

Body aches/quite severe, nausea, chills, headache beginning 4 hours post-injection and lasting 30 hours

Starting at 0100 on 03/11/2021. Awoke with symptoms of fever with chills, headache, neck and back pain (moderate to severe), pain in what seemed the bones of the skull and mandible (moderate to severe), nausea and vomiting, unable to take fluids, unable to sleep besides 60 mins. 24 hrs post vaccine. Vomiting lasting 12 hours and nausea continued without ability to take fluids. Dr. prescribed Zolfan and after the first dosage, fluids were tolerated. Fever lasting less than 48 hours, muscle soreness was mild by 48 hrs and continues as mild at this point, 78 hrs hrs post vaccine.

Janssen COVID-19 Vaccine EUA Severe pain developed about 6 hours following injection in central region of upper back, and at lowest ribs. Moderate pain developed in mid-abdomen. Duration of pain 8-12 hours. Unusual fatigue developed about 6 hours following injection, duration of fatigue about 5 days.

Stomachache, diarrhea. I went to my gastroenterologist he gave me diaphenoxlate-atropi and Dicylomine HCL. He sent me for blood work

@1247 once client?s 15 minutes of observation was completed, she stood up to leave and felt dizzy. LPN assisted client to sit down and notified site managers. Client than reported feeling nauseated and dry heaved. RN and Site Supervisor and EMT arrived to client area. @1248 vital signs: 174/100, 82, 97% RA. Client AAOX4. NAD. Skin WNL. HA. EMT called 911 @1250. Fire Department Engine #1 arrived @1258. EMS repeat vitals @1300: 98.2, 187/102, 73, 20, 99% RA. EMS assessed BP/HR while standing, 218/123, 77. Stroke assessment negative. LAC 20g PIV inserted by Fire Department. BGL 170. County Rescue# 425 arrived @1307. Client showed no signs of improvement and no changes from prior assessment. Client transported to ER via ambulance @1310 in stable condition.

Fatigue, aches, nausea, cotton mouth, headache, wheezing, loosing voice, and arms and legs feel heavy. Called doctor the next day (the 16th) for medical advise, was told to drink coffee and take tylenol due to aspirin allergy.

Janssen COVID-19 Vaccine EUA. extreme lethargy and headache began later in afternoon on day of vaccine. Headache became worse, and fever during the night. By morning dizziness, extreme fatigue, severe headache and stomach upset which continued throughout day and night of second day. By third day symptoms had subsided some but still incapacitating. By fourth day better but symptoms still there, kind of how a hangover feels. Each day since there has been a little more improvement. Received the shot Tues. morning. Now it is Sunday morning, and still some fatigue and dizziness, but headache is gone and stomach better. Only medication I used during severe symptoms was tylenol.

Approximately 3 hours after my injection I became very lethargic and my heart began to race. I had fever of 101 and became very weak and tired. I experienced nausea, pain in my upper back and my heart raced for approximately 10 hours. On Tuesday, March 16, 2021 I slept on and off for the entire day and continued to have a fever. My heart rate came down within 24 hours after my injection and the fever came down to normal 36 hours after the injection. I felt weakness for approximately 3 days after the injection. I am currently recovered from all symptoms as of March 22, 2021.

3/14/2021 Goosebumps, shivering, fever (101.8), headache, nausea, achy. Took Tylenol and it helped for about 3 hours. 03/15/2021 Woke up with symptoms again around 2:30 am and took Tylenol. Woke up around 8 am with slight headache and VERY tired. Kept a nagging headache and "brain fog" all of the day and tired. Took Tylenol and it helped some. I felt a bit foggy all day even with Tylenol. 3/16/2021 Still felt tired with a bit of a headache on and off. Took Tylenol and it helped. I don't take meds often so I just took 500 mg Tylenol, 1 tablet. I am healthy with no underlying conditions and do not have reactions to the flu shot. I expected the same with this shot.

Started with chills, fever ,Nausea aches and pains for 2 days went into full sinue infection, weal and its been 5 days,

The shot made my arm very sore for about an hour. When I went to sleep that night, I experienced feeling chilled all night long. It ended by morning. I had one bought of mild diahrea the next morning. Then all was fine.

Slight soreness in right arm. Headache (which lasted 2 days), nausea, muscles aches, fatigue (which lasted 12 hours or so).

I had my shot at 3:45 pm on friday, the 26th of March. at around 6:30 I started to feel nauseous and started to get body aches. Lot of congestion and a runny nose. I also got a stomach ache later in the evening. by the time I went to bed around 10 pm I hurt all over and was very sick to my stomach. I felt like if someone touched my skin my bones and muscles would all shattered. I did not sleep much that night and woke up on Saturday, the 27th with the same symptoms but not quite as bad. I still had nausea and a stomach ache and was very tired and drained. I did start to get diarrheic around 3:30, 4:00. I still hurt and have diarrheic and am very tired today, which is Tuesday, the 30th of March at 5:15 pm.

Severe chills, fever, headache, neck pain, bad taste in mouth, severe nausea, dry retching and abdominal pain. The severe nausea and abdominal pain continued for 1 1/2 days. I still have some nausea and intermittent abdominal pain.

LOSS OF CONSCIOUSNESS, FAINTED; HEART WAS RACING; DIZZY; VOMITING; CANKER SORE UNDER TONGUE; HEADACHE; NAUSEA; FATIGUE; INFLAMMATION ON LEFT EYE; FALL ON BED; SMALL HIVES UNDER EYE; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight, height, and medical history were not reported. The patient's concurrent conditions included seasonal allergies, and codeine allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 to left arm as prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, after vaccination, she felt fine all day and night. The next morning she woke up and felt sick. She had nausea, headache, hive under eye. She laid back down and tried to sleep. A few hours later, she woke up to use the bathroom. She was very nauseous and dizzy. She lost consciousness and fell trying to get to the bathroom. She fell on her bed and was uninjured. The paramedics took her to the hospital. She was given medication for nausea, headache, and IV fluids. She gave blood for lab tests and they came back normal. No COVID test was administered. When she felt better, she was released. A few days later, she discovered her tongue was sore and red. She called her primary care physician (PCP). PCP said the red and sore tongue was probably related to allergies. Two weeks later, her tongue was not sore, but still red. They advised her to get a second opinion with another HCP. She was going to visit her allergy specialist.. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of consciousness, fainted, heart was racing, dizzy, headache, nausea, fatigue, inflammation on left eye, and small hives under eye on MAR-2021, and vomiting on 07-MAR-2021, and had not recovered from canker sore under tongue, and the outcome of fall on bed was not reported. This report was serious (Hospitalization Caused / Prolonged). Additional information was received from the patient on 23-Mar-2021. The following information was updated and incorporated into case narrative: Patient's medical history added as seasonal allergies and codeine allergy, Vaccination site as left arm added; Additional events as small hives under eye, fall on bed; lab test of blood work added; Event outcome of loss of consciousness, fainted, heart was racing, dizzy, headache, nausea, and fatigue was updated to recovered/resolved.; Sender's Comments: v1: Follow up information received updates patient's medical history (seasonal allergies and codeine allergy), Vaccination site as left arm; Additional events (small hives under eye and fall on bed), laboratory test (Blood Work); Event outcome (loss of consciousness, fainted, heart was racing, dizzy, headache, nausea and fatigue was updated to recovered/resolved). This updated information does not alter prior causality assessment of reported events 20210323730-COVID-19 VACCINE AD26.COV2.S-headache, nausea and fatigue. These events are labeled and are therefore considered potentially related. 20210323730-COVID-19 VACCINE AD26.COV2.S-loss of consciousness, fainted, heart racing, dizzy, vomiting, canker sore under tongue. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There are no information on any other factors potentially associated with the events.

At 3 am when I woke to urinate, I was very loopy in the head as if I had not slept at all for 24 hours. Kind of dizzy feeling. The next morning I was very tired. As time progressed, I felt like I HAD to be horizontal. No energy at all. No appetite at all. Took my temperature and was shocked to see it at 101.4º. Pharmacist suggested I take aspirin, which I took one, and then another one several hours later. It did help and reduced the fever to 99º. The following day the temperature remained at 99º but under 100º. (I never took any other aspirin other than the two that I mentioned). The third day I was good to go!

next day felt very tired, was fine 2 days until Monday-Wed got headache-pressure in head, felt woozy, stomach was queasy, very low energy, croupy cough, nose runny, no stamina for long walks Was ok 2 days and then it started again off and on till 3/31. Sometimes stomach felt sick, couldn't eat much. Finally feeling better in stomach but still getting headaches. Still have little stamina and very low energy and headaches make it hard to think, runny nose, croupy cough comes and goes. Teleconference with Dr. on 3/23/2021 Saw family Dr. 4/2/2021. Saw no urgent needs, just noted side effects

March 4 - J&J Covid Vaccination March 5 - Woke up feeling terribly under the weather; sinus inflammation/chills/fatigue/pressure in ears/pain in teeth (upper back molars), swollen glands - just plain "ill" Week of March 8 - See above, the same March 9 - Appointment at Primary Care Clinic due to March 5th symptoms and a 1-day bout of diarrhea Diagnosis ?cold, sinus issues? - try Mucinex/Tylenol / Covid Test = Negative Mid-March: fever blister appears for a few days and ringing in my ears (noise) increases. Fever blister lasts about 4 days. Week of March 15 - Same Symptoms as March 5 plus another 1-day bout of diarrhea Sunday, March 21 - stomach cramps / diarrhea - chills/overwhelming fatigue - same sinus issues as March 5 Week of March 22nd - equilibrium is off and starts to become an issue - 3 nights of vertigo but not severe during that week. Last vertigo attack was in 2018. March 28th - sinus situation the same, diarrhea again, start Pepto Bismol regime based on past microscopic colitis issues Mucus is thin and clear, just started to discharge. March 31st - Schedule another appt at Primary Care Clinic due to ?status quo? - this doctor thinks inflammation and prescribes prednisone (2) 20 mg for 5 days - Covid Test / Strep Test / Influenza Tests = Negative March 31 - April 4 / Prednisone: Visibly more stuffed up. Tooth/nerve pain increased from a 3 to a 7; didn't take the final days dose. After stopping my head felt numb. Vertigo stopped; equilibrium still off. Increased tinnitus and increased pressure/burning under my eyes and around my cheekbones. April 5 - 6 - New symptom appeared approximately a week ago; tightness in throat, difficulty swallowing. Still experiencing tooth nerve pain (sinus cavities). Woke up soaked the last 2 nights. Noticed increased difficulty concentrating "brain fog".

Shortly after the vaccine my tongue begin feeling really thick and furry. Moments later my lips began tingling causing me to seek medical attention. My body got really shaky and I got really anxious but after about 45 minutes my body returned back to its normal state. Later that day and up into that Saturday I was very fatigued, nauseous and the body aches were severe.

She got the vaccine, had no reaction initially and then went home and was tired, slept for a couple of hours and felt good. When she went to bed had a fever under 101 degrees, and really bad headache and then muscle pain all the way down to her calves to the point that she was sick to her stomach. This continued throughout the night. This morning she is still having the chills, so believes she has a temperature, feels miserable. About 1:30 AM she took 2 Tylenol for her symptoms.

less than ten minutes after administration of JJ vaccine, patient started to complain of nausea, palpitations, and a "warm flush feeling", but the patient did not exhibit any signs of visible color change. All of the stated symptoms appeared with rapid onset together over a period of 1 to 2 minutes, then started to reside. Patient was given 25mg diphenhydramine and stabilized. Patient instructed to wait additional 30 minutes in pharmacy and had no additional symptoms and stated she felt ok prior to leaving. Follow up phone call 4/7/2021 and patient stated she experienced no additional or subsequent events/symptoms.

Patient's lips started to swell, itchy throat, back pain and stomachache, no fever, gave benadryl, called 911 after 30mins

RACING HEARTBEAT; DIZZY; CHILLS; WEAKNESS; HEADACHE; FEVER; MUSCLE ACHE; NAUSEA; FATIGUE; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-APR-2021, the subject experienced racing heartbeat. On 01-APR-2021, the subject experienced dizzy. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced weakness. On 01-APR-2021, the subject experienced headache. On 01-APR-2021, the subject experienced fever. On 01-APR-2021, the subject experienced muscle ache. On 01-APR-2021, the subject experienced nausea. On 01-APR-2021, the subject experienced fatigue. Laboratory data included: Heartbeats increased (NR: not provided) 144 /min. Laboratory data (dates unspecified) included: Body mass index (NR: not provided) 21 BMI. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from racing heartbeat, weakness, fever, muscle ache, and nausea on 02-APR-2021, and headache on 03-APR-2021, was recovering from chills, and had not recovered from fatigue, and dizzy. This report was non-serious.

That evening about 11:00 pm I became extremely cold, teeth chattering , complete body ache , nauseated and had a slight headache. The next morning about 6:30am I had a major headache I can only describe as a migraine times 10. All day and all night. Did not go away at all . The next day it was very very slight and by the evening the headache was gone.

very sore upper arm for about 1/2 hour after 5 hours quickly increasing fever and uncontrolable shivers for 1 hour after 8 hours fever topped at 101.7 continueing nausia and fatigue the next day with low fever and low appetite continuing nausia and fatigue the third day tinitus the third night lingering fatigue and low appetite the forth day (today)

Dizzy ,nausea ,complete loss of consciousness, catatonic, eyes rolled back , rigid total body ,extreme low blood pressure for over 1/2 hour Immediately at vaccine time ... 24 hours later chills , bad headache, nausea vomiting

woken up by a severe pain in my heart area. Bad Headache shortly after receiving the shot. My Left eye won't stop twitching. Rash on upper chest, nausea, upper chest/lungs area feel like they have a slight burning feeling. Chills, Fever. muscle pain my body feels like a truck hit it.

EXCESSIVE URINATION; VOMITING; INCREASED HEART RATE; CHILLS; NAUSEA; FATIGUE; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight was 134 pounds, and height was 176.78 centimeters. The patient's concurrent conditions included supraventricular tachycardia, high cholesterol, thinning bones, no alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no no allergies/no history of drug abuse/no past history of similar event/no adverse event after any previous vaccinations/ no history of allergy to vaccine, drug or food/ no history of hospitalization in last 30 days, with cause/no family history of any disease (relevant to vaccination) or allergy. the patient was not pregnant at the time of event. the patient was not currently breastfeeding.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 to the left deltoid, on 07-MAR-2021 16:30 for prophylactic vaccination. The batch number was not provided and has been requested. Concomitant medications included fish oil for heart health, pravastatin for high cholesterol, metoprolol succinate for supraventricular tachycardia, and calcium carbonate/colecalciferol for thinning bones. On 07-MAR-2021, the subject experienced excessive urination. On 07-MAR-2021, the subject experienced vomiting. On 07-MAR-2021, the subject experienced increased heart rate. On 07-MAR-2021, the subject experienced chills. On 07-MAR-2021, the subject experienced nausea. On 07-MAR-2021, the subject experienced fatigue. Laboratory data included: Heart rate (NR: not provided) increased. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from excessive urination, vomiting, increased heart rate, nausea, and fatigue on 08-MAR-2021, and chills on 07-MAR-2021. This report was non-serious.; Sender's Comments: V0 : Medical assessment comment is not required as per standard procedure as the case is non serious

Sign/Symptoms: vomiting, nausea, and diarrhea. Took one bite of sandwich and pickle from Wendy's prior to vaccine and she vomited prior to getting the vaccine.

SORE ARM; JOINT MUSCLE ACHE; HEADACHE; NAUSEA; DIARRHEA; DIZZINESS; This spontaneous report received from a patient concerned a 63-year-old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 at 10:10 in left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021 10:25, the subject experienced dizziness. On 07-APR-2021, the subject experienced diarrhea. On 07-APR-2021, the subject experienced sore arm. On 07-APR-2021, the subject experienced joint muscle ache. On 07-APR-2021, the subject experienced headache. On 07-APR-2021, the subject experienced nausea. Treatment medications (dates unspecified) included: bismuth subsalicylate/calcium carbonate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 07-APR-2021, and had not recovered from headache, joint muscle ache, nausea, dizziness, and sore arm. This report was non-serious.

At 24 hours post-vaccination, I experienced Dizziness. Nausea. Increased Appetite. Muscle aches/pain. Then Fainted and was out for a few minutes. Then woke up on my own. Still experiencing fatigue and some nausea/dizziness and mild diarrhea. Did not get transported to hospital or recieve medical care.

Received the shot at 11 am and had felt fine all day. Arm was sore a vaccine site but that's it Then around 10 pm I started to get chills. Within 10 minutes of this I felt violently ill. The chills amd shaking were intense. I began vometing and had severe intestinal issues. This attack came on fierce and lasted until 4 am. I was sweating and shaking at the same time and for at lease 6 hours. My body felt tired and drained. I never expected to be so sick. The following day my symptons had began to go away for the most part, headache and feeling drained continued for a few more hours.

Janssen COVID-19 Vaccine EUA At post injection time 6 hours, I began feeling ill with chills, but no fever. Then at 9 hours after injection, I began being nauseated and began vomiting. The vomiting continued about every hour for the next 11 hours, feeling very ill between, and unable to keep down even sips of water. Also had a mild headache, but still no fever. Just very extreme nausea. After 11 hours, the vomiting stopped. I felt tired and nauseated for about 2 more days, then improved.

I had fever, chills, headache, dizziness, loss of appetite and extreme fatigue for 24 hours. I was in bed from 5pm 3-27-2021 to 6 pm the next day 3-28-2021. The dizziness lasted for one more day and I had injection site pain for 3 days.

Dizziness, weakness, digestive system issues, loose stools, active bowels actively with gas. 5 minutes after injection I noted pain below both of my ears and visual disturbances. Nausea with the taste of bile in my mouth

BAD PAIN ON RIGHT SIDE (TOWARDS THE BACK); SWOLLEN NOSTRILS (INSIDE); Shaking; HARD TO WALK; Fever; Nausea; Chills; JOINT PAIN (KNEES, ELBOWS, SHOULDERS, HIPS, FINGERS, ANKLES); HEADACHE THAT FELT LIKE A SLEDGE HAMMER; SORENESS AT INJECTION SITE; EXTREME THIRST; Loss of taste; LOSS OF APPETITE; SWOLLEN HANDS; Runny nose; EYES CRUST AROUND THE EDGES; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection. 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 on 03-APR-2021 09:00 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced extreme thirst. On 03-APR-2021, the subject experienced loss of taste. On 03-APR-2021, the subject experienced loss of appetite. On 03-APR-2021, the subject experienced swollen hands. On 03-APR-2021, the subject experienced runny nose. On 03-APR-2021, the subject experienced eyes crust around the edges. On 03-APR-2021, the subject experienced joint pain (knees, elbows, shoulders, hips, fingers, ankles). On 03-APR-2021, the subject experienced headache that felt like a sledge hammer. On 03-APR-2021, the subject experienced soreness at injection site. On 03-APR-2021 22:00, the subject experienced shaking. On 03-APR-2021 22:00, the subject experienced hard to walk. On 03-APR-2021 22:00, the subject experienced chills. On 03-APR-2021 22:00, the subject experienced fever. On 03-APR-2021 22:00, the subject experienced nausea. On 05-APR-2021, the subject experienced swollen nostrils (inside). On 05-APR-2021 14:00, the subject experienced bad pain on right side (towards the back). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from runny nose on 05-APR-2021, and bad pain on right side (towards the back) on 05-APR-2021 21:00, was recovering from hard to walk, joint pain (knees, elbows, shoulders, hips, fingers, ankles), and swollen hands, had not recovered from swollen nostrils (inside), and the outcome of shaking, chills, fever, nausea, extreme thirst, loss of taste, loss of appetite, headache that felt like a sledge hammer, soreness at injection site and eyes crust around the edges was not reported. This report was non-serious.

After the injection I started to sweat profusely. I could feel the vaccine traveling through my body. I started to get sick to my stomach. I had to regulate my breathing by slowing it down. When I opened my eyes the light was so bright I had to keep them closed. I thought I was going to faint. I finally decided to put my head between my legs and then I started too pullout of it. Very scary feeling. This lasted for 10min.

Approximately 3 weeks after getting the shot, I had really bad lower back pain and a fever of 100.2. The fever lasted one day and the back pain for about a week until it started feeling better. I also had pain on the left side of my stomach area and a rash under my breasts. Rash and stomach pain gone.

On March 8th received the J&J shots, March 9, 10th & 11th was extremely nauseous in the morning. On the 12th had severe chest pains which I chalked up to a very bad case of heart burn. On March 24th, while driving I had two major (what I thought at the time) was panic attacks...body started shaking, heart was beating like crazy, couldn't catch my breath, felt like I was going to pass out or die. Had to pull over twice to calm myself down. (From what I read this could be a sign of a blood clot but I am not a doctor.) Had minor heart burn until April 5th....which ironically was the end of my 28 days until the vaccine fully kicked in. Just reporting what happen. I feel fine now.

mild abdominal pain starting one days after injection, then developed into stomach discomfort. On April 11-12 (4 days after injection), my stomach burped a lot.

Head rush and heart palpitations approximately 10 minutes after injection, and nausea. Assisted by EMTs to monitor heart rate, blood pressure , and blood oxygen level. Went into atrial fibrillation and blood pressure steadily rose. 165/99 was one reading I heard them call out.

Chills, shivering, short of breath, vomiting for 15 minutes, chills for an hour and sweating after that, headache. After vomiting I took a Benedryl and than extra strength Tylenol at night.

During the week of 3/29/21 (the week following my vaccine), I began to experience periodic lower abdominal pain (lower right and lower center) during movement (walking or going from sitting to standing. On Monday, 4/5/21 (13 days after my vaccine), I began experiencing severe abdominal pain upon getting out of bed at 7am. The pain was worse with movement of any kind (walking, turning, going from sitting to standing). I was convinced something was seriously wrong, and called my Dr's office . While waiting for the NP to call me, I decided that I should go to the hospital. My husband drove me, and even the car ride there was painful (bumps and turns). The pain upon standing was as if my bladder was going to fall out. The pain when walking was a stabbing type of pain in my lower right abdomen and a stretching sensation in my center/lower abdomen. The E.R. Dr diagnosed me with epiplogic appendagitis, and instructed me to rest, hydrate, and take tylenol. I followed the Drs advice. I took 4/5&6 off from work, spending most of that time in a reclining position in my livingroom and I drank plenty of water. I felt noticeable improvements daily. I saw my PCP for a follow-up visit on 4/8 for an abdominal exam, at which time I was experiencing pain primarily in bed (in a stretched out position) and periodically with movement (walking and going from sitting to standing or turning). I had my second follow-up today with my PCP (4/15). I continue to improve daily.

On 4/6/21 evening of the shot, I had a fever 100.5 and chills all night. Felt better the next day. On 4/12, 13, and14 , I started having lower abdominal pain off and on for 3 days, and started running a fever again for those days, 99.5 to 100.5. The 15th no pain or fever, so far.,

My symptoms started 03-18-2021 at 11am where I developed chills, was very sleepy that I slept 15 hours straight. I felt very fatigued and my eyes hurt so much and I could not keep them open. On 04-06-2021 I still was not feeling well. I started to have problems with my right side of my face, eyes and mouth which gradually got worse so I went to the hospital. At the hospital they checked me for stroke, performed lab work, did MRI and CT scans and the the doctors came back and said it was Bell's palsy. I again went to the hospital 04-11-2021 but this time due to GI issues with pain. On 04-14-2021 through 04-15-2021, I started to experience neck pain behind my right ear. At the hospital they had prescribed my prednisone 50mg, so I took half for my pain. I still have trouble sleeping and have lots of pain.

Day 2 - fever to 100.1, fatigue, aches, headache Day 3 - 5, no fever, fatigue, aches, headache, nausea (less each day) Day 6 - normal

Extreme Diarrhea, Fever 103 degrees, Chills, Sweating, Muscle Weakness, Fatigue, Muscle Pain, Nausea, Uncontrollable Diarrhea, Incontiness, headache, injection site welt, swelling, shoulder pain, unable to lift arm due to shoulder. Lasted 72 hrs for most extreme symptoms: headache, ongoing fever, extreme weakness (unable to walk without help). Did not return to regular strength until 8 days after administration of vaccine. Liquid Diet, Bedrest (4 days), Pain medication, Tylenol

Patient advises that she has been experiencing lower back pain, leg painful and swelling on her right foot, a fogginess that "feels like I'm on a conveyor belt", depression, diarrhea and fatigue since receiving the vaccine. Patient also advises that she used to be able to walk her dogs 4 miles a day and now can barely walk them 20 min. Patient also states that the foot that is painful is also a blueish gray in color.

fatigue and aching/chills mid afternoon the day of the injection, 101.6 degree fever that evening reduced to 99.2 degrees by next morning, headache developing during the evening and lasting through the night, nausea and sporadic stomach and abdominal pain occurring the following morning which recurred for several days, diarrhea and rectal bleeding culminating in clotting 3 days after immunization and scaring me enough to see my nurse practitioner the next day

4 1/2 hours of severe body tremors and spasms, accompanied by chills. Followed by severe migraine, bodyaches and fever. Vomiting and diarrhea began approximately 9:00 AM on April 2, and lasted six hours. Extreme exhaustion and weakness continued until approximately 12 o?clock noon on April 3.

Extreme soreness in right breast and throughout by entire body. Vomited after my shower and felt sick but this only lasted about an hour and a half. After that, I was wore out, which last a few days. Nothing serious other than the vomiting was tough.

I received the vaccine on a Saturday evening and by Sunday morning, I was sick as a dog with flu like symptoms - massive headache, terrible backache (like someone kicked me in the back), chills and fever. Sunday evening in the middle of the night, in bed, I was shaking so badly from chills that I was afraid to get up to get Tylenol. I finally did and I couldn't even focus my eyesight and control my hands as I went to open the bottle of pills that my hands were shaking so badly that I spilled them all over the place. Finally I woke my husband who heated up blankets in the dryer and brought me hot tea. My husband helped me to the bathroom where I vomited. I cannot remember when I was so sick. I missed work that day at my part-time job and the next day at my full time job as a teacher.

Lightheaded x 1 week, Fevers 101-101 x 1 week, lack of appetite x 3 days, fatigue x 10days, severe headache, diarrhea

72 hours later I was hit hard with severe chills, extreme nausea, some vomiting (foam) and diarrhea. Day after vaccine, I had mild symptoms - woke up with mild chills and was very tired - slept most of the day. Following night I had the worst night sweats ever - woke up drenched.

Within 4 hours and lasting at least 50 hours; Terrible headache, chills, vomiting, tightness in muscles of calves that moved also to shoulder and stomach, swollen fingers, chest tightness and heaviness, diarrhea. Constipation on 4th day lasting through today the 9th day. Fatigue lasted for 8 days. Chest tightness and heaviness lasted for 6 days. Finally feel somewhat normal on 9th day although tongue still heavily coated with white.

SOME AUTOIMMUNE EFFECTS; Tooth pain; Night sweats; STOMACH BURNING SENSATION; DIFFICULTY SWALLOWING; PRESSURE CHOKING; VERTIGO; Facial pain; SUSPECTED PRODUCT CONTAMINATION; FEVER BLISTER; Foggy feeling in head; DIARRHEA; SEVERE STOMACH CRAMPS; SINUS INFLAMMATION; Sensation of pressure in ear; Injection site lump; CHILLS; FELT ILL; INJECTION SITE PAIN; FATIGUE; This spontaneous report received from a patient. 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: 1805022 expiry: UNKNOWN) dose was not reported, 1 total administered on 04-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, upon vaccination the patient woke up and experienced sinus inflammation, sensation of pressure in ear. On 05-MAR-2021, the patient experienced injection site lump. On 05-MAR-2021, the patient experienced chills, felt ill, injection site pain and fatigue. On 11-MAR-2021, the patient experienced severe stomach cramps and diarrhea. On 22-MAR-2021, the patient experienced foggy feeling in head. On 23-MAR-2021, the patient "believes the vaccine is contaminated", fever blister and facial pain. On 24-MAR-2021, the patient experienced vertigo. On 28-MAR-2021, the patient experienced pressure choking and difficulty swallowing. The patient visited 2 clinics and an ear, nose and throat (ENT) specialist but they were unable to diagnose and they felt there was some autoimmune effects (onset date unspecified). The patient suspected that the vaccine was contaminated based on the news report. On 02-APR-2021, the patient experienced stomach burning sensation. On 04-APR-2021, the patient experienced night sweats. On 05-APR-2021, the patient experienced tooth pain. The patient has been visited two clinic Treatment medications (dates unspecified) included: famotidine for 14 days for pressure choking and difficulty swallowing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe stomach cramps, vertigo on 28-MAR-2021, night sweats on 06-APR-2021, stomach burning sensation on 05-APR-2021, and injection site lump, and injection site pain on 16-MAR-2021, had not recovered from felt ill, sinus inflammation, chills, fatigue, sensation of pressure in ear, tooth pain, foggy feeling in head, pressure choking, and difficulty swallowing, and the outcome of diarrhea, fever blister, facial pain, some autoimmune effects and suspected product contamination was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: v0 This report involves a patient who experienced sinus inflammation, sensation of pressure in ear, injection site lump, chills, felt ill, injection site pain and fatigue next day after receiving Janssen COVID-19 Vaccine Ad26.COV2.S for prophylactic vaccination. Approximately a week later, the patient experienced stomach cramps and diarrhea and 1.5 weeks later she had foggy feeling in head and "believes the vaccine is contaminated", had fever blister, facial pain and vertigo. Approximately 3.5 weeks after being vaccinated the patient experienced pressure choking and difficulty swallowing. A throat (ENT) specialist was unable to diagnose and they felt there was some autoimmune effects. A month after being vaccinated the patient experienced stomach burning sensation, night sweats and tooth pain. Given the close temporal relationship and the nature of the events, the events of sinus inflammation, sensation of pressure in ear, injection site lump, chills, felt ill, injection site pain and fatigue are considered related to the vaccination. The insufficient information precludes a meaningful medical assessment of the remaining events, including "autoimmune effects". The events will be assessed further when additional information is received.

1. severe headaches that are not going away 2. severe abdominal pain that is not going away 3. Swelling in legs & belly 4. nausea (but not throwing up) 5. Diarrhea (comes & goes) 6 100.3 temp (today) 7. body itching all over comes & goes

PROFUSE SWEATING; SHORTNESS OF BREATH; EYES SENSITIVE TO BRIGHT LIGHT; FEELS AWFUL; PHOTOSENSITIVITY; SICK TO STOMACH/NAUSEA; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: not reported) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-MAR-2021, the subject experienced profuse sweating. On 29-MAR-2021, the subject experienced shortness of breath. On 29-MAR-2021, the subject experienced eyes sensitive to bright light. On 29-MAR-2021, the subject experienced feels awful. On 29-MAR-2021, the subject experienced photosensitivity. On 29-MAR-2021, the subject experienced sick to stomach/nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from profuse sweating, shortness of breath, eyes sensitive to bright light, feels awful, photosensitivity, and sick to stomach/nausea on 29-MAR-2021. This report was non-serious.

4 hours after receiving vaccine I came down with overwhelming head pain that could not be lessened with pain medication. No pain meds worked at all - all I could do was sleep. I had nausea, muscle aches (bad-still suffering); While still undergoing symptoms I got my teeth cleaned at the dentist (BIG MISTAKE). I came down immediately with a severe periodontitis infection that needed treating with antibiotics. The dentist was dubious that the infection had anything to do with the teeth cleaning (I disagree- I believe the infection exacerbated the period of disease (2 weeks one day ) I am writing because I literally CRINGE each time I hear about the Janssen vaccine only effecting a handful of people!! I SAY CRAP TO THAT!! This is a bad vaccine. I have not been this ill for decades and it is doubtful to me whether or not it was worth getting this vaccine at all. I would NEVER take it had I know HOW BAD and HOW LONG the side effects lasted - Over 2 weeks. I highly recommend that this vaccine is permanently shelved. I would not wand ANYONE to undergo what I have gone through the past 2 weeks - obviously complicated to some degree with the oral infection and teeth cleaning, however, I have never in the past been affected by a vaccine or teeth cleaning in this way before - ever.

Later that evening I began having severe chills, nauseous, my body was achy and I was very tired. The skin of my upper body begin to itch and burn and got worse over the next couple day. It continued to get worse so I went back to the pharmacy on 15th but the pharmacist knew nothing regarding what I was experiencing and advised I used Aveno and swithch from Allegra to benedryl to help with the itching and if it didnt get any better to go to the dr. Within the next couple weeks I reached out to my PCP a couple times but all he could provide it that I continued to take the benedryl because topical ointments wouldnt work. Its still here but not as bad as it originally was. I have a dermatologist appt on May 6th. It had gotten better over the next few weeks but I am still experiencing the skin sensitivity.

On 4/20/2021 around 1 pm patient called the pharmacy and reported intermittent symptoms of severe headache, a feeling of tingling and pinching, and nausea. She stated the last symptom of HA 4 days before her call. She was instructed by the pharmacist to promptly call her primary care provider to report symptoms and receive instructions.

SWELLING RIGHT UPPER ARM; CHILLS; PAIN IN RIGHT AND LEFT LOWER LEGS KNEE TO ANKLES/PAIN IN RIGHT UPPER ARM; HEADACHES; EXTREME FATIGUE; SWEATING; LOSS OF APPETITE; BRAIN FOG; SEVERE STOMACH PAIN; DIARRHEA; COUGH; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included borderline diabetes, without medication, abstains from alcohol, and cigarette smoker, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUN-2020, Laboratory data included: PCR (NR: not provided) NEGATIVE. On 02-APR-2021, the subject experienced cough. On 05-APR-2021, the subject experienced sweating. On 05-APR-2021, the subject experienced loss of appetite. On 05-APR-2021, the subject experienced brain fog. On 05-APR-2021, the subject experienced severe stomach pain. On 05-APR-2021, the subject experienced diarrhea. On 05-APR-2021, the subject experienced chills. On 05-APR-2021, the subject experienced pain in right and left lower legs knee to ankles/pain in right upper arm. On 05-APR-2021, the subject experienced headaches. On 05-APR-2021, the subject experienced extreme fatigue. On 07-APR-2021, the subject experienced swelling right upper arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe stomach pain, and diarrhea on 05-APR-2021, had not recovered from cough, headaches, sweating, pain in right and left lower legs knee to ankles/pain in right upper arm, extreme fatigue, loss of appetite, brain fog, and swelling right upper arm, and the outcome of chills was not reported. This report was non-serious.

FAINTING; ABNORMAL HEART BEAT; DIZZINESS; BLADDER CONTROL LOST/URINATED ON HERSELF; COULDN'T STAND UP; NAUSEA; CHILLS; DIDN'T HAVE APPETITE; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included little asthma, cardiac resynchronization therapy (CRTS), and allergic to red tide. The patient was previously treated with gabapentin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 and expiry: unknown) dose was not reported, administered on 13-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in 2020, Laboratory data included: COVID-19 antigen test (NR: not provided) negative (units unspecified). On an unspecified date in MAR-2021, the subject didn't have appetite. On 13-MAR-2021, the patient experienced chills at night. On 14-MAR-2021, morning the patient experienced dizziness, nausea, she couldn't stand up and fainted (dead weight) and she reported that she was a dead weight and she didn't have control of bladder and urinated on herself (she was lying in a pool of urine. Also her heart rate went up to 84 b/p per min after she fainted and lasted for the whole day, next day it came down to 74 b/p. Her normal heart beat were 64 b/m. She was nauseous and dizzy for the past 3 weeks. Laboratory data included: Heart rate (NR: not provided) 84 (units unspecified). On 15-MAR-2021, Laboratory data included: Heart rate (NR: not provided) 72 (units unspecified). Laboratory data (dates unspecified) included: Heart rate (NR: not provided) 64 b/p. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from abnormal heart beat on MAR-2021, and bladder control lost/urinated on herself, chills, and nausea, and the outcome of dizziness, fainting, didn't have appetite and couldn't stand up was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210420179-COVID-19 VACCINE AD26.COV2.S-Fainted. 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.

FATIGUE; FELT HORRIBLE; SKIN BURNING AND HURTS TO TOUCH/SKIN ON FIRE/PAINFUL SKIN; NAUSEA; CHILLS; DIARRHEA; VOMITTING; LEG HEAVINESS; LEG PAIN/INTERMITTENT PAIN IN HIPS, BACK, DOWN TO MY KNEES; WEAKNESS; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid infection, double lung pneumonia, leg pain, and leg heaviness, and concurrent conditions included arthritis, and fatigue, and other pre-existing medical conditions included patient second shingles shot begins in february. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced leg heaviness. On 2021, the subject experienced leg pain/intermittent pain in hips, back, down to my knees. On 2021, the subject experienced weakness. On 19-MAR-2021, the subject experienced diarrhea. On 19-MAR-2021, the subject experienced vomitting. On 19-MAR-2021, the subject experienced chills. On 19-MAR-2021 16:00, the subject experienced nausea. On 19-MAR-2021 23:00, the subject experienced skin burning and hurts to touch/skin on fire/painful skin. On 20-MAR-2021, the subject experienced felt horrible. On 25-MAR-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) No clots found. On an unspecified date, the subject experienced fatigue. Treatment medications (dates unspecified) included: calcium chloride dihydrate/fructooligosaccharides/glucose/magnesium chloride hexahydrate/potassium chloride/sodium chloride/sodium lactate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomitting, and nausea on 20-MAR-2021, was recovering from diarrhea, had not recovered from chills, skin burning and hurts to touch/skin on fire/painful skin, leg pain/intermittent pain in hips, back, down to my knees, weakness, fatigue, and leg heaviness, and the outcome of felt horrible was not reported. This report was non-serious.; Sender's Comments: V1:Medical assessment comment not required as per standard procedure as case assessed as non-serious.

HEADACHES/PAIN AT THE BACK OF THE HEAD AND BASE OF THE SKULL 3 EPISODES; MILD NAUSEA EXPERIENCED IT 4 TIMES LAST WEEK AND LAST NIGHT; INCREASED SALIVA/MEDIUM AMOUNT OCCURS DURING NAUSEA EPISODE ONLY; SWEATINESS OCCURRED ONLY AT NIGHT, STATED THAT SHE WOKE UP WITH A WET T-SHIRT IN A COLD SWEAT; CHILLS OCCURRED ONLY AT NIGHT AT THE SAME TIME AS THE FEVER; RIGHT ARM SORENESS; FEVER/FELT HOT; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's past medical history included blood clot in leg, and concurrent conditions included hypertension, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. Concomitant medications included diazepam, and fluoxetine hydrochloride. On APR-2021, Laboratory data included: Pain scale (NR: not provided) 5-6/10. On 01-APR-2021, the subject experienced increased saliva/medium amount occurs during nausea episode only. On 01-APR-2021, the subject experienced sweatiness occurred only at night, stated that she woke up with a wet t-shirt in a cold sweat. On 01-APR-2021, the subject experienced chills occurred only at night at the same time as the fever. On 01-APR-2021, the subject experienced right arm soreness. On 01-APR-2021, the subject experienced fever/felt hot. On 01-APR-2021, the subject experienced mild nausea experienced it 4 times last week and last night. On 03-APR-2021, the subject experienced headaches/pain at the back of the head and base of the skull 3 episodes. Laboratory data included: Pain scale (NR: not provided) 8/10. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweatiness occurred only at night, stated that she woke up with a wet t-shirt in a cold sweat, chills occurred only at night at the same time as the fever, right arm soreness, and fever/felt hot on 03-APR-2021, had not recovered from mild nausea experienced it 4 times last week and last night, and increased saliva/medium amount occurs during nausea episode only, and the outcome of headaches/pain at the back of the head and base of the skull 3 episodes was not reported. This report was non-serious.

Fever 102.5 within 30 min SEVERE Chills at 3 am (4/2) Vomiting at 5 am Continued fever on 4/2 and 4/3 Slept 12 hours Severe diarrhea on 4/3 Fever broke at 3 pm on 4/3

HIGH BLOOD PRESSURE; HEAD AND NASAL CONGESTION; LOSS SENSE OF TASTE; SOFT STOOLS; BACK AND SIDES ARE HURTING; GOING TO THE BATHROOM 4-5 TIMES PER DAY; SOMETIMES NO STOOL; ACID BUILDUP; FELT WEAK OCCASIONALLY; PHELGM BUILDING UP IN THE LUNGS; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hyperacidity. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: 23-JUN-2021) dose was not reported, 1 total administered on 09-APR-2021 on right arm for prophylactic vaccination. Concomitant medications included calcium carbonate for acid buildup. It was reported that on 09-APR-2021 evening, the patient started to feel some lightheadedness and congestion. She noted that the lightheadedness happened here and there. She had head and nasal congestion and had snot coming out the nose. She felt like her head was about to explode. There was sort of a snap, crackle, and pop in the head. Her back and sides were hurting. She was going to the bathroom 4-5 times per day, sometimes with no stool, and other times with soft stool.She noted some phlegm building up in the lungs. Coughing was noticeable. She also felt weak occasionally. She had a loss sense of taste. She also had acid buildup and took Tums occasionally but did not take on 13-APR-2021. She had noted high blood pressure and heart rate, but they had gone down due to blood pressure medicine. She had exercised in an attempt to reduce her symptoms. She did not had a healthcare professional. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from high blood pressure, had not recovered from head and nasal congestion, weakness, loss sense of taste, going to the bathroom 4-5 times per day, and acid buildup, and the outcome of soft stools, back and sides are hurting, sometimes no stool and phelgm building up in the lungs was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210423813- Covid-19 vaccine ad26.cov2.s-Phelgm building up in lungs. 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 injection in automatic terrible taste in my mouth like I could taste the vaccine. Return For 20 days experienced severe diarrhea morning noon and night.

got it April 10th First day fine, second-day urine dark, third-day fog and disoriented sensation in my head and double vision, and periods of weakness in hands (now coming and going), lack of appetite, extreme thirst, no fever, no vomiting, pains in my thighs and stomach, middle back pain, Hips, pelvis, 9th day: calves so painful and tight I could not get out of bed, figures swelled up to the point that I could not put on my finds, 10th day my calves are very painful (like the soreness that is felt after someone punches you) Especially right calf. The batch number is 206a21a if I can read it from my card.

As soon as I got the shot, I immediately had a metallic taste in my mouth. I had a weird sensation in my nerves in my right arm and a little all over my body. I think the shot may have hit a nerve in my arm. Two weeks after the shot I was very pale, and my stomach was very upset. I had a headache and abdominal pain. I felt very ill so I didn't eat or drink much that day. The smell of food made me throw up and felt really bad for 24 hours. I did not eat much for three days and it helped my nausea and I recovered after four days I still had the unusual feeling all over my body. I got some IV therapy twice and it helped. It did start to fade over time and I finally started to feel normal after a month. I am fully recovered now.

Fatigue and malaise within 3 hours; chills, nausea and vomiting after 11 hours; headache, muscle aches, weakness and nausea/vomiting for 24 hours after the vaccine.

4/11 11:30 vaccination 11:40 I felt had a head rush and my heart started pounding like it never had before. I reported back to the EMTs on site. They monitored me. After another 10 minutes, I was not feeling better, nauseous. My BP rose and I went into a fibrillation. They transported me at that time to the ER. The Afib went away on its own. It was probably an hour at the mobile clinic and ER ride; by the time I had arrived my afib had resolved on its own. Discharged Heart palpitations over the next few weeks. The following Sunday, I started to feel like I was going back into Afib. By the time I got there, everything was ok. They sent me home with a heart monitor for 48 hours. I will get the information on 5/7/2021. *5/7/2021 follow up appointment with PCM to find results of HR monitor.

April 8, 2021- Vaccinated with the Johnson and Johnson vaccine. April 10, 2021 ? Fever, strong headache, unable to hold on, diarrheas, respiratory difficulty. April 14, 2021- She lost her balance and fall, hitting her face. Had a CT scan and no mass nor bleeding was found, only sinus. Discharged home. SARS-CoV-2 test ? Negative results April 18, 2021- Found dead in her sofa. No thromboembolism nor bleeding

NAUSEA; FEVER; SLIGHT ARM PAIN; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180890 expiry: UNKNOWN) dose was not reported, administered on 02-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, Laboratory data included: Body temperature (NR: not provided) 99.8. On 02-MAY-2021, the subject experienced slight arm pain. On 04-MAY-2021, the subject experienced nausea. On 04-MAY-2021, the subject experienced fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 97. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight arm pain on 02-MAY-2021, and had not recovered from nausea, and fever. This report was non-serious.

Fever night of getting the shot. Severe abdominal pain for weeks. GI Dr. visit on April 7, 2021 and the PA ordered an abdominal CT with contrast. CT exam on April 13, 2021 which showed total occlusion of the superior mesenteric artery (SMA) and a clot in the thoracic aorta. Went to emergency room on April 14, 2021. Doctor determined that a SMA embolectomy is needed via exploratory laparotomy. Post operation had an event and returned to the ER but was released with all normal blood and heart values.

that night, work from sleep with rapid heart beat, headache, sweating, nausea, took aspirin, drank more water, work just feeling off, slight headache and nausea, and left arm pain, concern of blood clots.

after her vaccination on 4/2/21, she was tired on 4/5/21. on 4/11, she was achy, had HA, sens to light, stomach, backache, nauseous, bilat sciatic pain, temp up to 102, fatigued, oxygen sat 92%. she had visual hallucinations. she went to ER on 4/15/21.

Fever (99.80), Nausea, Headache, Low back pain, Intestinal cramping x 36 hours; left arm pain around site of injection x 5 days.

04/25 I had an upset stomach and at that point I notice that my blood pressure was really high and I took my blood pressure and it was 190/110 I thought it would go down it didn't on 04/29 I went to urgent care and they did run test and the did prescribe me the L-Prill I started taking it right away and it did take my blood pressure down 50 point they told me to go visit my PD and I ended up going in on 5/3 and they ended up doing a full check up and full blood work. and we talked about some course of action, I talked to them about the allergy medication that I was taking and they told me to stop taking the allergy meds, I felt my blood pressure racing when I went to lay down ( also allergic to wheat ). I determined that when I get into bed there is no reason for my blood pressure to be this high and 10 years ago I had another reaction to allergies meds. so I stopped taking it on 5/03, I still have upset stomach but I think it something that I ate. Since I stopped taking the meds my blood pressure has been yester, yesterday it was 144/71. In general I feel good.

STOMACH PAIN; SWEAT; DIZZY; CHILLS; JOINT ACHES; FEVER; HEADACHES; MUSCLE ACHES; FATIGUE; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight was 140 pounds, and height was 60 inches. The patient's concurrent conditions included lupus, rheumatoid arthritis, diabetes, latex allergy, non alcoholic, and non smoker, and other pre-existing medical conditions included no drug abuse or illicit drug usage. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. Concomitant medications included hydromorphone for drug used for unknown indication. On 24-MAY-2021, the subject experienced sweat. On 24-MAY-2021, the subject experienced dizzy. On 24-MAY-2021, the subject experienced chills. On 24-MAY-2021, the subject experienced joint aches. On 24-MAY-2021, the subject experienced fever. On 24-MAY-2021, the subject experienced headaches. On 24-MAY-2021, the subject experienced muscle aches. On 24-MAY-2021, the subject experienced fatigue. On 25-MAY-2021, the subject experienced stomach pain. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) highest was101F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from fever, muscle aches, stomach pain, headaches, fatigue, chills, and sweat, and the outcome of joint aches and dizzy was not reported. This report was non-serious.

Fever Unable to hold down food. Vomiting immediately after eating or having a bowel movement after 3-4 hours.

Headache, dizziness, chills, fever, eye movement, nausea, chest pain, muscle weakness and pain, falls.

I had no regular symptoms, but a few days later I sat down in my chair and it felt like someone shot me in the stomach, I took oxycodone, it kept getting worse and I dealt with it for a week. I started getting pain in my kidney and went to the ER because of the pain and the pain level on a scale of 1-10 was a 8-9 at all times. I couldn't' breathe and was rushed to the hospital. I have portal vein thrombosis and have three blood clots in my stomach. I tried to figure out what to do to relieve the pain, I couldn't eat or during and was on IV's. I was in so much pain to even eat a cracker, they kept me at the hospital. While in the hospital they did a CAT scan to see if it was diverticulitis and found out that I had 3 blood clots, they also did the dye or contrast. I spent days in the hospital and was transferred to the hospitals skilled nursing facility so that they can watch me because of the clots. I was told that the blood clots could burst in the vein.

Began my yearly physical two days after the vaccine, as did my husband. Both of our urine tests showed blood in our urine. Had a second urine test a month later. Still had blood in urine. Also had 3 weeks of diarrhea. That was followed by a vaginal yeast infection. Given a prescription to clear that up. Then my breasts became swollen and painful. It has been ten weeks since the vaccination. Saw a urologist this week there is still blood in my urine. The amount of blood has decreased, but still showing up.

In November of 2019, my bloodwork was all normal. When I had bloodwork in April, it showed my red blood cells were clumping, but my anti-DSDNA was still normal. By mid-May, all the Lupus tests were double the high normal accepted and cold agglutinen tests were positive, although I am not anemic. I have had morning nausea ever since the shot and feel off balanced. I think it has triggered a lupus flare because of its affect on T-cells and antibodies. I am undergoing further testing and have an upcoming appointment with a rheumatologist.

The night of the vaccine I got hives on my chest which lasted for an hour. The first week after the vaccine I had severe flu like symptoms of fever, nausea and sweats for six days. The next week on 04/15/2021 I started to get pain over my left eyebrow and my Diverticulitis was flared up. My doctor sent me to get the headache checked out because it was very painful. The headaches were there all day every day and localized to the left side over my eyebrow. Migraine medicine made it worse Sumatriptan. The pain persisted but I was checked up for Glaucoma. My Neurologist advised that I take Indomethacin and it worked to relieve the pain. Regular pain killers did not work. It slowly improved over the course of two months. It had been twelve weeks and I am still getting headaches intermittently, It is more like a twinge.

At 04:00 pm, excessive fatigue. I was taking my mom shopping and I had to stop and take her home. Just excessive fatigue. 3/26/ 21- I woke up at 01:00 am with chills; freezing and infrequent tremors. I had a bad headache. Body aches. 04:00 am started feeling nausea. I contacted Dr to see what I could take. Got a reply email that recommended not to take anything. I toughed it out and I was in bed all day. I finally ate at 05:00 pm that day for the first time. The nausea and chills subsided with the mild food. But headache and achy body persisted. On 3/27, mild headache and mild body aches - I was a 2 out of 10 for pain. It continued to get better. I have joint pain in the winter when it is cold but I don't have any of that when it's warm. But I'm having joint point this summer. Which is weird and not usual. My joints have never hurt in summer time and spring before but have been this year. My left shoulder is frozen out of the blue at the injection site. It hurts. Have been having foot pain. Shooting pain in my right heal. Communications via email to Dr and Dr said to do heat and ice and sent me exercises to do with feet and shoulder. The shoulder still hurts but it is slowly getting better. I have been seeing Naturopath for hormone/menopause and I have been taking the hormonal supplements a month before the shot.

Rushed to emergency room with severe, severe pain left shoulder, arm, hand, underarm breast, upper back and midback (left side). Given morphine and nausea and sent home. Still in pain. Rushed back to emergency room exactly a week later with same symptoms plus blisters and rash (still left side). Treated for symptoms of shingles, but no "classic" signs of shingles. Saw primary care doctor on 06/02/2021. Continued the treatment for shingles. Extremely limited function in left hand (holding, etc.) Future doctor visits schedule for August.

Probably immediately, I was lightheaded and woozy. As soon as she put it in my arm I could taste it and I felt like I was going to vomit. She kept me there for 45 minutes to keep an eye on me. As a disclaimer, I am a vegan and very earthy, I do not take any drugs or anything like that. When I was driving home the lightheadedness got so bad that I had to pull over and sat for 15-20 minutes. I called my brother and he told me to get something to eat. I just had some steamed vegetables. I came home, ate and drank a lot of water to try and get the wooziness to pass. I did not have an unusual amount, no more than I would usually drink. Then after the last bottle of water I had, I started getting more queasy and started to feel dizzy. I then vomited all over my self from head to toe. That lasted for two or three hours and then after that I was dry heaving. That happened on Friday, on Saturday I was too afraid to eat anything I only had toast and a smoothie. On Sunday I was just so woozy and lightheaded and exhausted. I didn't feel chills or anything though. My brother brought me soup on Sunday and I did have some broth. I also started drinking a little bit more water. The water didn't taste good though - it tasted like the vaccine so I did not want to have it. I did not workout at all for that week, I was just so tired. I felt like I could sleep for a month and just not get up. I normally workout five days a week. I got an IV with fluids for hydration and a glutathione push on 7/2/2021. On the following Saturday 7/3/2021, I was still lightheaded. Now, I still am extremely tired and there are days that focusing takes more energy than it typically does. My mouth feels like I have cotton balls in it, the nausea and the lightheadedness is still present, but the tiredness is the worst. I normally run everyday but I cannot even do that at all, walking is hard enough. I just had another IV today 7/14/2021. When this started happening, I did contact my DR but I am unable to get in yet, I need to schedule for a full blood panel and see the DR.

On 4/14/21, patient awoke with a severe headache and nausea and vomiting. She does not have a history of headaches. Some photophobia. Patient is treated with diphenhydramine, prochlorperazine and IV fluids.

Severe Chills, headache from 4:00 pm until 10:00. After that sweating, I was in bed from 4 until midnight. Today 03/08/2021 I feel much better, just a slight headache and a little nauseous.

Janssen COVID-19 Vaccine EUA Uncontrollable Shakes, fever spiking between 100 and 104, throwing up, pounding headache, aches throughout body

Covid 19 Johnson and Johnson, first and only dose ( not found above) Fever, chills, muscle aches, headache and loose stool Symptoms onset approximately 12hrs after shot lasting 36 hours Treatment Acetaminophen No medical professional consulted

Janssen COVID-19 Vaccine EUA Injection site bruising, swelling, redness, burning General - headache, very very tired, bloating/puffiness, muscle aches, nausea, low grade fever, light dizziness Took ibuprofen and drank lots of water... cold compress on arm...rest when needed As of Wednesday morning, the reactions are lowering and slowing down. The site is still swollen some and bruised and red.

Bad headache, nausea - threw up numerous times until there was no more to throw up. These conditions lasted for about 30 hours, followed by body aches and weakness. Now feeling mostly better two days after receiving vaccine.

64 y.o. female who is consulted for possible stroke. Patient reports that she awoke this morning (3/10/2021) at about 4:30 PM with severe spinning dizziness. She reports associated nausea, diaphoresis, blurred vision and bilateral hand numbness and tingling. She denies speech or language problems or weakness. She reports she got a COVID vaccine (Johnson & Johnson) Sunday 93/7/2021) and felt a little "woozy" Monday (3/8/2021).

Severe headache everyday since injection, lightheaded, extreme fatigue, no appetite, vomiting, brain fog

I received the Janssen Covid-19 Vaccine EUA on 3-11/21 at 10:15 AM. Starting at 3:30 PM I began having mild body aches; by 5:30 PM the body aches were severe and accompanied by a fever of 100-101 degrees, headache, extreme fatigue and intermittent mild nausea. This lasted throughout the night with body aches severe such that I was awakened by them about once an hour. By the following morning, Friday, 3-12-21, symptoms were still present but less pronounced, and the headache had abated. Slept most of the day and by nightfall had only lasting fatigue, which was still present this morning, 3/13/21. By this afternoon all symptoms had abated.

Beginning around 3 pm on 3/10/2021 I experienced chills. The chills worsened, accompanied by bodily shaking. Around 6 pm I experienced body aches. By 9 pm my temperature was 100.4 and I had a mild headache. By 10 pm my temperature was 100.6. At that time I took two 200 mg ibuprofen. At 4:00 am on 3/11/2021 I began vomiting and felt like I would pass out. Vomiting continued until approximately 9:00 am on 3/11/2021. As the day progressed on 3/11/2021 I began to feel somewhat better. Since 3/12/2021 I have felt sporadic, brief periods of nausea and light-headedness. This continues at this time, 3/14/2021.

Janssen COVID vaccine was administered on 3/13/21- patient was screened twice and denied receiving any vaccines in the past 2 weeks. after administration it was noted today (3/15/21) that the patient received the Moderna COVID vaccine (one dose) on 3/4/21. I attempted to reach out to patient to discuss and noted that she is admitted to Hospital for a NSTEMI. Per chart notes patient reported symptoms of fever, nausea, malaise on 3/13/21 after vaccination. The next day 3/14/21 developed syncope and chest pain. Patient reported to emergency room and was admitted with NSTEMI

5 hours after receiving the vaccine, I began having chills, then fever, nausea, and I threw up once. The chills subsided after awhile, but the fever and nausea continued until about 10 a.m. the next day. The fever was not higher than 102.2, and in the morning hours, it was 99-100.(varied). Gone by the afternoon. I had fatigue throughout the day after the shot, and still have a little today. I didn't feel I needed to contact a doctor at this point.

Received vaccine 1:20 pm on 3/14/2021, That night experienced chills, headache, fever and nausea. Chills and headache throughout following day. Fever broke after taking Tylenol. Not allowed back to work for 48 hrs after shot due to adverse effects,

Chills and fever as high as 101 started at 10:30 pm along with skin sensitivity and then deep pain in muscles, joints, & tissue throughout my body & very bad headache. Had mild nausea. Took Aleve for pain, was unable to sleep through the night. Pain better by next morning, mild fever continued until approx 5 pm the following day. Some headache pain lasted about 20 hours.

3/8/2021 - 9 hours after vaccine had severe chills for 4 hours, headache, nausea - stayed in bed for 1 day and then seemed fine. 3/16/2021 - late afternoon - developed swelling in left foot along with rash on both legs from the knee down to toes. on 3/17, swelling on both feet with rash and swelling of left hand.

03/12 flu like symptoms, fever (99.3), headache, vomiting, diarrhea She stated her symptoms are getting better, I recommended she follow up with her doctor just to get a check up to make sure everything is ok

My blood sugar went to 364 and stayed there all day and then that night it was 267 and then it was the next morning 202 and then it went to normal in the low 100s. Hives in the crook of my right arm. Burning, itchy little red bumps. I couldn't swallow but I think that was from the high blood sugar as my mouth was very dry. I felt like I had a really bad cold, my head felt foggy.

I have a really bad sore throat that actually started the night of March 25th however it got worse tonight, March 26th around 7:30 pm. It hurts to swallow.

Headache, low grade fever, chills, vomiting, diarrhea. Started headache 3 hours after shot fever and chills 10 hours after shot then other issues started at 8pm-midnight.

Pain radiation from injection site down arm to elbow, extreme headache (migraine like), nausea staring 24 hours after injection, no solids only liquid.

Rosacea flare up within 10 minutes of injection. Face bright strawberry red. Entire body became hot and had to fan myself (not a hot flash) Approximately 45 minutes later left ear started tingling and then pain followed and only in left ear. An hour after the shot ( and back home) started feeling tingling in lips and face. Face swelled up and smoothed out wrinkles. Lasted about 2 hours and then subsided. Also metallic taste in mouth during swelling of the face. Metallic taste lasted as long as the face swelling which was about 2 hours. Loose stools and tummy upset which is still going on.

3/29/2021 metallic taste in mouth, 15 min after leaving the clinic. Tingling in lips and chin. 3/30/2021 hives, mouth sores on roof of mouth. went to ER received steroid and magic mouth wash. patient is at home recovering at this time.

Post vaccination reports feeling nauseous and sweaty, denies any additional symptoms / complaints. Medical monitoring x 30 min. w/ vital assessment: BP 120 / 68 P 74 RR16 O2 sat 95% RA. All symptoms resolve and released from facility w/daughter.

Shot taken with no issues at 9:54am, April 4, 2021. At 5:30pm, same day, became immediate flush, dizzy, barely made it to bathroom, violently vomiting all that was in my stomach. This was followed by severe chills, the shakes and a mild headache. Took (2) Tylenol at the time of the shot, drank many ounces of water all day but still had this issue. Took another (2) Tylenol after vomiting and more water. Went to bed at 8pm. Woke at midnight, 4/5/21, severe headache, now took (2) Advil and slept better until Mon. Morning, 4/5/2021. Experienced two sluggish, low energy days and still have no appetite. What the heck????

Within a few hours of receiving the vaccine, I started feeling nauseated. Since the day I took the vaccine, my appetite has been nonexistent. A day later, I felt very tired and confused. I received the vaccine on Monday and I woke up in a panic on Wednesday morning. My heart was racing, palms were sweaty, I felt like I couldn't breathe and it seemed like I was having a panic attack when I woke up. From that point forward, I fell into a deep depression. At first I didn't connect it with the vaccine, but I kept feeling nauseated and then wondered if it was connected. The depression became unbearable and I felt suicidal by the next week. I finally contacted my doctor's office and had a telemed visit where I explained that I had the J&J vaccine the week before and these symptoms presented themselves afterward. The doctor put me on Zoloft and I HAVE been treated for depression in years past with that; however, I had not taken depression medication for about 8-10 years until this. Likewise, because my doctor put me on an anti-depressant, she also wanted me to see a counselor--which I have done. The medication is helping somewhat but I still don't have an appetite. I don't know if the vaccine had anything to do with the depression, but I wanted to report it just in case others have had similar symptoms.

BRUISING AT THE SITE OF INJECTION; SORENESS AT THE SITE OF INJECTION; LETHARGIC; FATIGUED; SLEPT THROUGHOUT THE WHOLE WEEKEND; NAUSEA; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's past medical history included back surgery, and concurrent conditions included von willebrand disease.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 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced slept throughout the whole weekend. On 02-APR-2021, the subject experienced nausea. On 03-APR-2021, the subject experienced lethargic. On 03-APR-2021, the subject experienced fatigued. On 04-APR-2021, the subject experienced bruising at the site of injection. On 04-APR-2021, the subject experienced soreness at the site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on APR-2021, was recovering from lethargic, and fatigued, had not recovered from soreness at the site of injection, and bruising at the site of injection, and the outcome of slept throughout the whole weekend was not reported. This report was non-serious.

Sweating in the palms of hands, forehead, extreme out of body sense, diarrhea. EMS was contacted and patient had their vitals checked and then refused to go to be evaluated at hospital via ambulance 30 minutes later. A follow up call was made to patient 17 hours later for check up and patient reported she was a little tired but otherwise felt fine with no injection site pain to report. Pt did note she was experiencing discomfort in her collarbone no relation to immunization.

On March 7th, the day after receiving the vaccine, I woke up with a stomach ache. It lasted all day and was sometimes very uncomfortable. It felt like a bad case of constipation, but it was not. I still had it when I went to bed, but it was gone the next day.

patient came back 4/13/2021 the day the vaccine was paused due to thrombotic events concerned about her risk and health. She reported having body aches, sore throat, low grade fever, cough, and loss of appetite.

Patient received vaccine at another facility on 4/5/21. On 4/13/21 She came to our facility complaining of still having headache and nausea from her vaccination on 4/5/21. She wanted me to take her blood pressure and the machine would stop working after certain inflation. The machine was working fine because tested on another person. I tried the other arm and same thing happened so, I advised patient to go to urgent care since she said she does not have a primary care physician.

LETHARGIC; HEAVINESS OF HEAD; CRAMPS IN LEGS; ACHEY; GENERALLY FELT LIKE A CRAP; DRY MOUTH; NAUSEOUS; HEADACHE; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included heart defect. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered in Left Arm on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced lethargic. On 08-APR-2021, the subject experienced heaviness of head. On 08-APR-2021, the subject experienced cramps in legs. On 08-APR-2021, the subject experienced achey. On 08-APR-2021, the subject experienced feeling bad. On 08-APR-2021, the subject experienced dry mouth. On 08-APR-2021, the subject experienced nauseous. On 08-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lethargic, nauseous, headache, heaviness of head, cramps in legs, achey, feeling bad, and dry mouth. This report was non-serious.

Nausea, headache that increased to monstrous proportions throughout day and lasted 3 days; severe joint and muscle pain., incoherent thinking process, fatigue, some dizziness. Presently have shortness of breath. Surprisingly, injection site only hurt the first day.

During the night I felt like I had a fever, chills and body aches. And the next morning after I woke up needing to use the restroom, got up but started feeling dizzy and fainted for about 2minutes. EMT was called and once they arrived I began vomiting and my BP was super low. During the transport to the hospital I vomited again and was given antinausea meds. At the ER I was given IV fluids, chest xray, EKG and blood was drawn and I was released after a few hours of monitoring

Metallic taste in mouth 30 minutes after receiving vaccine. I have had a lot of stress (significant other diagnosed with Stage 4 inoperable NSCLC ) and had been attributing the often present headache to that, but they were also accompanied by a butterfly pattern red flush across my nose. Acid reflux which I was attributing to stress or alendronate. Woke in the night 4/12 to severe acid reflux, nausea, headache, flush, thought maybe I was having a heart attack (I have no cardiac/BP issues); then last night, 4/14 about 6 PM, weird numbness tingling in right arm from center of my chest passed in about 5 minutes. Significant Other said I had the pattern flush on face at time of attack which faded as I began to feel better. I have not consistently felt at 100% since vaccination, but I have a lot going on and attributed it to that.

Call rec'd from pt; she wants to report a reaction to the J & J vaccine which she got this past Saturday 4/10 at 10am; her symptoms began that night at 9pm , primarily nausea and vomiting. she could not keep anything down, finally she remembered a past txment from her childhood, pepto bismol and milk; ( she had IBS as a child); her sxs persisted for about 3 days, finally on Wednesday she felt better and has been tolerating a bland diet; she is better now; pt feels that there is a strong correlation between her diabetes and the vaccine; she is asking that this be reported via the VAERS system; pt did not experience anaphylaxis nor rashes/urticaria, nor any classic blood clot sxs; rn

RUNNY NOSE; DIARRHEA; SORE THROAT; LOSS OF TASTE; VOMITING; UP ALL NIGHT; CHILLS; FEVER 101; HEADACHE; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included lactose intolerant, seasonal allergies, non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had no drug abuse or illicit drug use. the patient was not pregnant at the time of reporting.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced runny nose. On 08-APR-2021, the subject experienced diarrhea. On 08-APR-2021, the subject experienced sore throat. On 08-APR-2021, the subject experienced loss of taste. On 08-APR-2021, the subject experienced vomiting. On 08-APR-2021, the subject experienced up all night. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced fever 101. On 08-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, vomiting, chills, and fever 101 on APR-2021, had not recovered from headache, sore throat, runny nose, and loss of taste, and the outcome of up all night was not reported. This report was non-serious.

Severe pain in lower right abdomen, a bursting sensation, and continued pain for about an hour on 4/10/21. No pain for a week, then moderate pain in same area on 4/17/21 beginning at about 3 pm and continuing at the time of completing this form. Moderate headache for the entire day on 4/16/20; took 2 Advil at 7 p.m. on 4/16 and it went away and has not returned.

Started morning after with terrible headache, pain in the eyes, nausea and sore arm. Few days later felt tightness in the chest, shortness of breath and a cough started. Feeling unwell. Continued and went to urgent care. Covid 19 test negative. continued to feel the worse and went back again to urgent care. Same symptoms with nausea and headache on and off. another covid test negative and chest xray. looked ok. Continued with the same symptoms and went to Primary Care Cough worse and pain in chest. Blood work done. Looked ok. Woke up with terrible headache at 3am. Went to the ER. IV ,Blood work ,ct scan, ekg. No real answersBP elevated. Still struggling but cough improving.

BODY ACHE FELT MOSTLY ON KNEES, PELVIS AND HIPS; NAUSEA; INJECTION SITE PAIN; FEELING VERY TIRED; This spontaneous report received from a patient concerned a female. The patient's height, and weight were not reported. The patient's past medical history included anxiety, and concurrent conditions included bactrim allergy, alcohol use, and non-smoker, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient was previously treated with lorazepam for anxiety. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043a21A or batch number: 043A21A, 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 body ache felt mostly on knees, pelvis and hips. On 10-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced injection site pain. On 10-APR-2021, the subject experienced feeling very tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea, and feeling very tired on APR-2021, and was recovering from body ache felt mostly on knees, pelvis and hips, and injection site pain. This report was non-serious.

Patient complained of headache, diarrhea, and left arm pain that is ongoing since 4/6/2021. She contacted the clinic on 4/19/2021 with her symptoms. The patient was advised to go the the ER.

Fever, Headache, Nauseous, Severe Pain All Over, Extreme Tiredness, Shortness Of Breath. Swelling Of Both Feet. Onset - 9 Days Out. Still Ongoing 12 Days Out.

VOMITING; WEAKNESS; CHILLS; HEADACHE; NAUSEA; This spontaneous report received from a consumer concerned a 64 year old female. The patient's height, and weight were not 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: 1808609, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. Concomitant medications included topiramate for migraine. On 13-APR-2021, the subject experienced vomiting. On 13-APR-2021, the subject experienced weakness. On 13-APR-2021, the subject experienced chills. On 13-APR-2021, the subject experienced headache. On 13-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, chills, vomiting, nausea, and weakness. This report was non-serious.

CRANKY; REDNESS OF EYE; HEADACHE; DIZZINESS; BOTH EYES ARE SWOLLEN AND RED; RIGHT EYE BURNS; VISIBILITY NOT GREAT DUE TO SWELLING OF EYE; CHEEK BONE SWELLING; DIARRHEA; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included poison oak, abstain from alcohol, and non-smoker, and other pre-existing medical conditions included no illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced diarrhea. On APR-2021, the subject experienced visibility not great due to swelling of eye. On APR-2021, the subject experienced cheek bone swelling. On 08-APR-2021, the subject experienced dizziness. On 08-APR-2021, the subject experienced both eyes are swollen and red. On 08-APR-2021, the subject experienced right eye burns. On 08-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced redness of eye. On an unspecified date, the subject experienced cranky. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, had not recovered from both eyes are swollen and red, right eye burns, and dizziness, and the outcome of cranky, diarrhea, cheek bone swelling, visibility not great due to swelling of eye and redness of eye was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.

Patient stating day after vaccine was administered began experiencing nausea and vomiting and body aches. 4/4/2021 patient states began to experience loss of appetite, fatigue and weakness. Described all food and beverage having an acidic taste. As of today, 4/21/2021 patient states symptoms are still persistent but seem to be subsiding.

APPETITE LOST; SORE THROAT; ACHING JOINTS; MUSCLE PAIN; HEADACHE; INJECTION SITE PAIN; UNABLE TO SLEEP; ITCHY RASH; FEVER; FATIGUE; This spontaneous report received from a patient concerned a 64 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 09-APR-2021 03:24 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced unable to sleep. On 09-APR-2021, the subject experienced itchy rash. On 09-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced fatigue. Laboratory data included: Fever (NR: not provided) 100 increase body temperature (units unspecified). On 10-APR-2021, the subject experienced sore throat. On 10-APR-2021, the subject experienced aching joints. On 10-APR-2021, the subject experienced muscle pain. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced injection site pain. On an unspecified date, the subject experienced appetite lost. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore throat, itchy rash, and fever, was recovering from muscle pain, headache, and injection site pain, had not recovered from fatigue, and the outcome of appetite lost, aching joints and unable to sleep was not reported. This report was non-serious.

VOMITING; RATTLING COUGH; NOT SLEEPING; TEMPERATURE-FEEL FOREHEAD WARM; NAUSEA; This spontaneous report received from a patient concerned a 64 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and batch number: 1808982 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 vomiting. On 10-APR-2021, the subject experienced rattling cough. On 10-APR-2021, the subject experienced not sleeping. On 10-APR-2021, the subject experienced temperature-feel forehead warm. On 10-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vomiting, rattling cough, not sleeping, nausea, and temperature-feel forehead warm. This report was non-serious.

PAIN IN RIGHT EYE COMING FROM BACK OF HEAD STOPS FOR A WHILE AND THEN REPEATS; EYE ITCHING; TIREDNESS; PAIN AT INJECTION SITE; STOMACH PAIN; This spontaneous report received from a patient concerned a 64 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch number. No concomitant medications were reported. On 05-APR-2021, the subject experienced stomach pain. On 05-APR-2021, the subject experienced tiredness. On 05-APR-2021, the subject experienced pain at injection site. On 15-APR-2021, the subject experienced pain in right eye coming from back of head stops for a while and then repeats. On 15-APR-2021, the subject experienced eye itching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach pain, and pain at injection site, and tiredness on 07-APR-2021, had not recovered from pain in right eye coming from back of head stops for a while and then repeats, and the outcome of eye itching was not reported. This report was non-serious.

Slight dizziness within 10 minutes after injection. Dizziness continues daily for brief periods with slight nausea. Low body temp - 95.8F average

Subarachnoid hemorrhage on 4/20/21. She began complaining of strong pain that caused vomiting, swelling, and hospital visits from about 3 weeks ago. We thought it was her blood pressure but it was consistently normal. She described it as the worst pain she has ever felt.

Department of Health received a call from her sister, in response to a call/letter/text sent out to all recipients of the Janssen vaccine. She stated that her sister received the J and J vaccine on 3/12/21 (confirmed in State vaccine system) at the hospital where she receives her oncology care. She reported the following: "She had a massive stroke on MARCH 27TH, 2021 leaving her paralyzed on the right side with the inability to speak, swallow, or see. She was initially diagnosed with Ovarian cancer approximately three and one half years ago. She was chosen for a study with Pharmaceuticals and her diagnosis was changed to a vary rare form of cancer called clear cell carcinoma which originates in the gynecological area. She did have a previous stroke approximately three years ago, (just after original diagnosis) but she was on a different course of treatment at that time...Oncologists have explained that this most recent stroke event would not be considered a side effect of her current treatment routine. She wanted to bring it to the attention of the health department in case it needs to be looked at more closely by the J&J research/scientific team. She passed away on 4/5/21. Her current treatment consisted of palliative chemo only. " Decedent was a resident but was vaccinated in another state. After the CVA she was brought to the hospital and subsequently transferred to the Medical Center where she died on 4/5/2021. Sister is willing to speak with any investigators if deemed necessary.

2021-04-23 Patient presents to the ED with right-sided mid-back pain and shortness of breath starting 2021-04-22 evening. Pain is sharp and worsens with coughing and deep inspiration; she feels that she is taking shallow breaths. On ED presentation, no shortness of breath, chest pain, dizziness, fevers, dysuria, or abdominal pain. She does have reproducible pain on her right mid-back area. There is some mild diffuse tenderness in her abdomen, but reports that she always has a tender abdomen due to Crohn's disease. No peritoneal signs. No recent travel. Patient was found to have pulmonary embolism. Hematology/Oncology specialist was consulted and recommended initiation of argatroban for treatment of pulmonary embolism. Patient was admitted to inpatient.

Extreme fatigue, fever, severe body aches, severe headache, diarrhea - lasting 48 hours. Reactions commenced 2 hours after vaccine. Stayed in bed for 48 hours. NOTE: I had Covid in November 2020. Tested positive for Covid antibodies March 1, 2021.

Woke up out of a sound sleep with severe headache ,nausea and vomiting. Location of headache:Frontal, top of head, behind eyes. Severe pain. Different than her usual migraines. Had a brain bleed in 2013 so is familiar with how that felt and this felt very different per patient. Tylenol was taken and did help but not much . Constant thing. Had severe headache for 1 week. Dissipated and continues with it today. When had headache she was in bed . Only up to do her husbands medication. Was told to contact her PCP on 04/13/2021. Never had pain like this prior. She took BP 04/14/21 and was 119/65. Waiting for MD call back.

Immediately post injection severe stinging occurred. Three days later night sweats bodyaches low-grade fever diarrhea intense headache which lasted three weeks. Headache and bodyaches continued with night sweats for an additional two weeks.

Admitted after 1 day of epigastric pain with associated nausea and vomiting, since resolved without recurrence, admitted with markedly elevated LFTs with AST 1701, ALT 2980, Alk phos 219, T bili 3.92, with mildly elevated INR to 1.2.

I started to get Migraines the day of the shot. I was nauseous and I did have seizure which only happens twice a year. My seizures are not always triggered by migraine. I have a history of hives and I get reactions to bites. I decided to get the Johnson & Johnson because it seemed to be a better option. Ten days after the vaccine I had a Migraine that was so bad I had to go to the doctor. When I got there my blood pressure was high. I was given some migraine medicine, but it did not help. The migraine was there for four weeks after the shot. I still got a numbing headache after the shot until five weeks after the shot.

FEET AND ARMS BURNING; EYES BURNING; SWEATING; COULD NOT EAT; CHILLS; HEAD FELT IT WILL EXPLODE; EXTREME NAUSEA; FEVER; This spontaneous report received from a consumer concerned a 64 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 05-MAY-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 05-MAY-2021, the subject experienced feet and arms burning. On 05-MAY-2021, the subject experienced eyes burning. On 05-MAY-2021, the subject experienced sweating. On 05-MAY-2021, the subject experienced could not eat. On 05-MAY-2021, the subject experienced chills. On 05-MAY-2021, the subject experienced head felt it will explode. On 05-MAY-2021, the subject experienced extreme nausea. On 05-MAY-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, feet and arms burning, head felt it will explode, sweating, extreme nausea, fever, eyes burning, and could not eat. This report was non-serious.

Same day of vaccine around 3:30pm I started to shiver I showed a fever of 99 by 4:00pm I had incontrollable shaking with a fever 104.2 fever and sever headache. I had muscle pain on my back and neck. I had violent vomiting multiple times. I felt asleep and about 2 hours later I woke up and I had an SVT episode where my heart rate was beating was up to 200 by then the fever had gone down to 99. I called the nurse line.. they told me to call an ambulance. I called the ambulance they took me in they immediately put fluids they monitored me for 7 hours and they sent me home afterwards. I slept for 24 hours. Then on 4/27/2021 I had another SVT episode where my heart rate went up to 176 beats per minute. This lasted for 2.5 hours but I did not have to go to the the ER.

BOTH LEG PAIN; HIVES / WORSENING HIVES; GASTROESOPHAGEAL REFLUX DISEASE; FELT LIKE HAVING HEART ATTACK; SLEEP INTERRUPTIONS; FLU-LIKE SYMPTOMS; ACHES; NAUSEA; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's past medical history included neuropathy. 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 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: Investigation (NR: not provided) blood clots which were negative. On 24-MAR-2021, the subject experienced flu-like symptoms. On 24-MAR-2021, the subject experienced aches. On 24-MAR-2021, the subject experienced sleep interruptions. On 24-MAR-2021, the subject experienced nausea. On 27-MAR-2021, the subject experienced felt like having heart attack. On 27-MAR-2021, the subject experienced gastroesophageal reflux disease. On 30-MAR-2021, the subject experienced hives / worsening hives. On 04-APR-2021, the subject experienced both leg pain. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, and famotidine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms, aches, felt like having heart attack, sleep interruptions, gastroesophageal reflux disease, hives / worsening hives, and nausea on 2021, and both leg pain on APR-2021. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.

Next morning awoke with severe Vertigo with nausea with vomiting and went to the doctor and he referred to the physical the Epley maneuver to assist with Vertigo . End of the day on 03/07/2021. 03/11/2021 husband performed the assistance. Physical therapist was able to perform the Epley maneuver and correct the vertigo. Hold Vertigo with about a week with Vertigo. In resolved occasional dizziness.

I had oral surgery four days before the vaccine with laughing gas and Novocain which lasted four hours. The morning after the vaccine I felt lightheaded and weird. I had heart palpitations and I was queasy. I started to walk back to my bedroom. The next thing I knew I woke up on the floor after passing out. After that I felt like my body was crumpled and I was disoriented. I could barely walk but I made it to the couch, and I had bumps in the front and back of my head near my ear. I was in a lot of pain and I think I was in shock. My foot was painful, and I saw a foot doctor. I had a doctor?s appointment and they did an EKG and they sent me to a Neurologist. It has been seven weeks I still have dizziness and nausea and it is hard to focus. I also have pain in my knee and my right arm.

Day 3 sudden severe onset of nausea, followed by vomiting and chills. Day 4 nausea and weakness Day5 back to normal- just sore from vomiting

Started with severe chills and shakes. Nausea and diarrhea. Severe headache, chills and fever (101.4). Arrived home about 7pm and fell asleep for 3 hours. Blood pressure was up to (159/82). Pulse (120). Unable/no desire to move. Called facility around 11pm with concern instructed to alternate Tylenol and Ibuprofen for fever. Started Tylenol and Ibuprofen around 1am (once I had some delivered). By morning only had a slight headache but was gone by late afternoon. Continue to have fatigue.

Janssen COVID-19 Vaccine EUA: patient presented to outside facility one day after vaccination reporting confusion, vomiting,and abdominal pain. Found to be hypotensive (blood pressure 70/40 mmHg) in DKA with electrolyte abnormalities and ventricular arrhythmias requiring shocks. Patient initiated on blood pressure support, airway protection, insulin, intravenous fluids, antimicrobials, electrolyte management and transferred to this facility for a higher level of care. Patient improved, DKA and shock resolved, electrolytes normalized, and was discharged five days later medically stable.

HEART BEATING FAST; HEART "SKIPPING BEATS"; ACHING JOINTS/JOINTS HURTING; NAUSEATED; HURTING ALL OVER; DIZZY; COULDN'T SLEEP; STOMACH FELT "BLOWN UP"; NO APPETITE; HURTING "DOWN REAL LOW" IN ABDOMEN; HAD TO URINATE ALOT; SHAKINESS; ITCHING ARM; FATIGUE; WEAKNESS/NO ENERGY; SORE ARM; DID NOT FEEL WELL; CHILLS; BREASTS SORE; SEVERE HEADACHE/SORE SPOTS ON HEAD; UNDER ARMS SORE; SUSPECTED COVID; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included dental surgery, and left arm broken. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A and expiry: 23-JUN-2021) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced suspected covid. On MAY-2021, the subject experienced breasts sore. On MAY-2021, the subject experienced chills. On MAY-2021, the subject experienced did not feel well. On MAY-2021, the subject experienced sore spots on head. On MAY-2021, the subject experienced under arms sore. On 11-MAY-2021, the subject experienced shakiness. On 11-MAY-2021, the subject experienced itching arm. On 11-MAY-2021, the subject experienced weakness/no energy. On 11-MAY-2021, the subject experienced sore arm. On 11-MAY-2021, the subject experienced fatigue. On 11-MAY-2021, the subject experienced severe headache. On 12-MAY-2021, the subject experienced hurting all over. On 12-MAY-2021, the subject experienced dizzy. On 12-MAY-2021, the subject experienced couldn't sleep. On 12-MAY-2021, the subject experienced stomach felt "blown up". On 12-MAY-2021, the subject experienced no appetite. On 12-MAY-2021, the subject experienced hurting "down real low" in abdomen. On 12-MAY-2021, the subject experienced had to urinate alot. On 12-MAY-2021, the subject experienced aching joints/joints hurting. On 12-MAY-2021, the subject experienced nauseated. On 18-MAY-2021, the subject experienced heart beating fast. On 18-MAY-2021, the subject experienced heart "skipping beats". Treatment medications (dates unspecified) included: ibuprofen, naproxen sodium, and amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate. The action taken with covid-19 vaccine was not applicable. The outcome of the severe headache, shakiness, weakness/no energy, fatigue, sore arm, itching arm, did not feel well, hurting all over, hurting "down real low" in abdomen, nauseated, dizzy, chills, couldn't sleep, stomach felt "blown up", no appetite, had to urinate alot, heart beating fast, heart "skipping beats", breasts sore, aching joints/joints hurting, sore spots on head and suspected covid was not reported. This report was non-serious.

Chills, pain behind eyes, fever, body aches, nausea, vomiting, diarrhea, chest restriction, bloating, fatigue

5/3/21 Pt presented to ED with a 3 day history of feer to 103.5, sore throat, SOB and N/V. She had a known exposure to a household member(s) with COVID. NP swab was positive for SARS-CoV-2, Otherwise her labs were unremarkable. CXR showed subtle streaky opacities in left lung base. She had no oxygen requirement and was discharged to home with a referral for monoclonal antibody. 5/6/21 Patient received infusion of BAM+E. During the infusion she was noted to be SOB and O2 sat was 90%. She was sent directly from the infusion center to the ED. HOSPITAL COURSE: patient is a 64 y.o. female with shortness of breath from infusion clinic after getting antibody for covid. Pt was found hypoxia. Pt has been treated with Remdesivir, decadron and supportive care. Pt recovered very well Pneumonia due to COVID-19 virus Acute hypoxic respite failure secondary to above. -Was admitted on May 6, SP remdesivir and IV diuretics -05/11 improving respiratory failure, current on 6 L NC, continue supportive care, ID continue following up -05/12 pt is on 3 L NC without shortness of breath. Pt's CRP trending down 18.3. Pt will be discharged home with home oxygen. She will continue taking 4 days of decadron. Follow up with primary care physician. Return to ER for worsening symptoms or other concerns.

I tested positive for Covid-19 with no severe symptoms in February of 2021. One week after the vaccine on 04/09/2021 I broke out in hives after eating a meal. The hives were mostly on the right side of my body but there were some on the left. I also had some numbness and tingling in my mouth. I used some anti itch cream, and the hives were mostly gone the next day. Twelve days after the vaccine I started to unusual vision symptoms which included wavy zig-zag lines in my vision. My doctor advised that they were Ocular Migraines. I had a headache at the same time, but I have never had Migraines before. I was also fatigued with a little dizzy and nauseous. The headache lasted for one day, but I still felt a little nauseous the next day. The feeling of fatigue and tired ness lasted for about six weeks. Two to three days after Ocular Migraines I started to notice a bright red rash on the right side of my back. It quickly spread around my side to the midline and then up my right side to my Bra line in front. I consulted my doctor on 04/19/2021 and he identified the rash as Shingles I was prescribed Acyclovir 800mg for 7 days and then an additional 5 days. I saw my Dermatologist on 05/06/2021 and he said that the Shingles were still active so I was Prescribed Valacyclovir. The Shingles lasted about six weeks total with some fatigue before I felt normal. I still have some visible signs of the rash on my back. Dr., PCP, 04/21/2021 Dr. Dermatology. 05/06/2021 for Shingles

COUGHING ALL DAY WITH DRY COUGH; FEELING DIZZY; FATIGUE; FEVER; NAUSEAOUS; SHARP PAIN IN THE UPPER RIGHT SHOULDER NEAR INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and gall bladder taken out, and concurrent conditions included long covid hauler.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-JUN-2021, the subject experienced sharp pain in the upper right shoulder near injection site pain. On 03-JUN-2021, the subject experienced coughing all day with dry cough. On 03-JUN-2021, the subject experienced feeling dizzy. On 03-JUN-2021, the subject experienced fatigue. On 03-JUN-2021, the subject experienced fever. On 03-JUN-2021, the subject experienced nauseaous. 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 fever, was recovering from coughing all day with dry cough, and had not recovered from fatigue, nauseaous, feeling dizzy, and sharp pain in the upper right shoulder near injection site pain. This report was non-serious.

Within 10 minutes after getting vaccine I was nausea and had major headaches.. After I got home I took drink some water and it was burning my throat . The next day it was hard to close my hands because the inflammation. I went to the Dr. and She prescribed me a steroid and it helped but I'm still having trouble with my left hand.

COULD NOT SWALLOW HER FOOD DUE TO NAUSEA; COULD NOT BREATHE VERY WELL; NIGHT SWEATS; RIGHT ARM AND LEG BEGAN TO HURT; CHILLS; HEADACHE; TIREDNESS OR FATIGUE WAS UNGODLY; NAUSEA; VERTIGO-LIKE FEELING; PASSED OUT ON FLOOR; CHEST PAINS HERE-AND-THERE NOT CONSTANT; This spontaneous report received from a patient concerned a 64 year old white and non Hispanic or Latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included colitis, non alcohol user, smoker (2 cigarettes per day), allergy to penicillin cause chest pains and swelling, allergy to sulfa cause chest pains and swelling, and medication sensitive. The patient had no drug abuse or illicit drug use. The patient experienced sick when treated with influenza vaccine (flu shot), chest pains and swelling when treated with codeine, and naproxen. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286 expiry: 23-JUL-2021) dose was not reported, 1 in total, administered at right arm on 13-MAY-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient could not swallow food due to nausea and could not breathe very well (difficulty in breathing) and fatigue was ungodly. On 13-MAY-2021, the patient had tiredness, headache, nausea, night sweats and chills after took the vaccine. The right arm and right leg began to hurt. Tiredness was not gone away and Lightheadedness here-and-there. The patient had chest pains here-and-there, that was not constant. The patient felt like she had vertigo and passed out on her floor twice last week in MAY-2021 and on 04-JUN-2021. The Lightheadedness and dizziness presented again on 04-JUN-2021. A chill was come-and-go. The right arm and leg pain have resolved on 04-JUN-2021. She was not reached out to her primary care provider for medical advice. Patient mentions that she was medication sensitive. The patient had tendency for low blood pressure, but her low blood pressure was fine at 120/80 mmHg. The patient took Norco for pain and occasionally took Zofran for nausea. The patient had history of colitis and these medications help her. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from night sweats, and right arm and leg began to hurt on 04-JUN-2021, had not recovered from tiredness or fatigue was ungodly, chills, vertigo-like feeling, headache, chest pains here-and-there not constant, passed out on floor, and nausea, and the outcome of could not breathe very well and could not swallow her food due to nausea was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210612160-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Passed out. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY.

Gagging, coughing, nausea, back neck and abdomen pains, aching, tiredness, headache and running fever

Six hours after the vaccine I got chills, headache, stomach upset and swelling in my lower face and throat. I had body aches all over my body but no fever or pain at the injection site. Those symptoms lasted for ten days. I went to ER. I was given medication for the nausea and pain. The chills were a little better by then. The medication helped with everything but the headache. The headache is constant at the back right of my head. I then get other head pain at the same time in my temples on the left. It is a sharp shooting pain. I get flashes of light in my eyes and my eyes start twitching at the sides. I also get pain at the top of my head on the left hand side on occasionally which comes after the temple pain. I sometimes get head pain on the right side with deep concentration. I have recently started to get tremors in my right hand. Sometimes the headache wakes me up at night. I wake up every day with a headache and it has been thirteen weeks. I can not drive or concentrate. I have seen a neurologist but I am still having trouble scheduling scans. I have tried some prescription pain medication and it did not work. I have taken two courses of steroids.

June 2, 2021 became confused, nauseated and dizzy. Kept asking the same questions over and over. Diagnosed with most likely TIA secondary TGA with J and J vac most likely a contributing factor.

DOUBLE VISION; SLEPT THE WEEKEND AWAY; STUMBLING POST-VACCINATION; EXTREMELY TIRED/ TIREDNESS; SHAKINESS/UNSTEADINESS; LOSS OF APPETITE; DIZZY; This spontaneous report received from a patient concerned a 64 year old female. The patient's weight was 115 pounds, and height was 64 inches. The patient's past medical history included emphysema, and smoker, and concurrent conditions included non-alcohol user, 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, and batch number: 04A21A expiry: UNKNOWN) dose was not reported, administered on 08-JUL-2021 16:15 for prophylactic vaccination. No concomitant medications were reported. On 10-JUL-2021, the subject experienced shakiness/unsteadiness. On 10-JUL-2021, the subject experienced loss of appetite. On 10-JUL-2021, the subject experienced dizzy. On 10-JUL-2021, the subject experienced slept the weekend away. On 10-JUL-2021, the subject experienced stumbling post-vaccination. On 10-JUL-2021, the subject experienced extremely tired/ tiredness. On 13-JUL-2021, the subject experienced double vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from double vision, and had not recovered from extremely tired/ tiredness, shakiness/unsteadiness, loss of appetite, dizzy, slept the weekend away, and stumbling post-vaccination. This report was non-serious.

Day after vaccine: chills so hard I had charlie horses; bones ached; nauseous and diarrhea In May, Telemed visits to Dr. sneezing, sore throat followed by coughing. wheezing, tightness of chest, shortness of breath, tired, nauseous. All COVID tests came back negative. Blood test - no antibodies, no COVID, Seeing a heart Dr. for continued shortness of breath and pressure on my chest. Had stress test and echo test.

Initially dizzy and lightheaded after the injection, heart racing, lasted about 30 minutes. 24 hours later extremely tired, no energy, sore upper L arm, nausea, no appetite, talking, reading, writing/typing almost impossible. This lasted for 3 days. Developed a migraine headache(had migraines 30 years ago) that lasted for the following 10 days and then just a normal headache for 2 more days. I took Advil and Tylenol without any relief. Called the nurse at physicians office who told me to increase the dosage and to use only Advil. If it got worse to go to urgent care to get Tordal and/or steroid injection. I didn?t want anymore side effects of medication so I just toughed it out. The injection site became the size of a half of a tennis ball, was red and hot to touch. It is now 18 days later and there is still a small knot and tender to touch. Trouble sleeping through the night also started at the time of vaccine and finally stopped last night. I felt like I was in a dark hole for the first 3 days and was then in a fog for a week. I had blurry vision off and on for the first 3 days and then again on day 5.

On 3/7/2021 after I returned home, I ate broiled, skinless chicken, salad and small amount of corn at 5:00pm. I started having diarrhea about 5:30pm. Later in the evening around 8:30pm, I had more diarrhea. Around the same time I became very, very sleepy and had extreme fatigue. My right arm where I received the shot did not hurt and still does not hurt. Around 6:00pm, my left arm starting hurting in the same spot where I received the vaccine in the right arm. On the morning of 3/8/2021, I ate breakfast consisting of whole wheat bread and peanut butter and weak coffee (my usual breakfast) and had diarrhea again soon after eating. At 3:30pm, I ate broiled, skinless chicken, green beans and small amount of instant mashed potatoes. Around 5:00pm, I had diarrhea again. I have been drinking a great deal of water on both 3/7/2021 and 3/8/2021 as I normally do every day. At 6:30pm, I had more diarrhea. Soon after, I took two imodium gelcaps and hoping they will help the diarrhea. My left arm has become increasingly more sore and hurts in the muscle. No other symptoms.

Began with violent shakes and chills. Migraine type headache developed, followed by nausea feeling, all over sore muscles. This lasted about 12 hours, then slowly started to subside. By second day, nausea gone, headache gone, but very light-headed. On third day, still very light-headed.

started during dinner, 6pm, hands and feet cold, chills continued and increasingly worse, shaking, muscle spasms, headache, temp 103, vomited, ache muscles. Tylenol had no notable affect. Next day 3/8/21 chills subsided, groggy, headache #7 on pain scale with light sensitivity. Tylenol little affect. A metal taste in my mouth, food didn't taste right. Next day 3/9/21 felt much better. Please note I had hydrated well previous to getting the vaccine.

I woke up with severe case of vertigo. I vomited once. I laid down in bed all day with occasional need to use bathroom. I was able to keep down liquids during the day and was able to eat soup and 2 pieces of toast in early evening.

About 4hours after being vaccinated, I started to feel weak. I wen to sleep. Woke up an hour later (9PM) with fever (100.5), HUGE migraine and being nauseous. I threw up, tried to go back to sleep but couldn't because of the migraine and fever. Decided to take 2 Tylenol, but I vomited about 20 mins later. All night, I hardly could sleep at all, so sick I was feeling (and I'm never sick!). No reaction at all on the site of the vaccine, no redness, no swelling at all. All day today (day after the vaccine), I have felt really weak, slightly feverish (though less than last night), with a persistent headache.

Almost exactly 6 hours after receiving the vaccine I came down with severe chills, pretty severe headache, and nausea. I took 3 Advil which helped with the headache . All of these symptoms lasted for another 6 hours at which time I was able to fall asleep. I woke up 7 hours later and all of the symptoms were gone and I felt good!

On 3rd day after vaccination, pain began in left pectoral region on left side. Pain heals settled in intercostals of left rib cage. This has caused difficulty in taking a deep breath. No congestion, coughing, or vomiting. Just pain with inhalation. Pain can be palpated in ribs, level 6 and 7. Somewhat better today, March 17.

pt stated that after she took the covid vax her arm was red and hurting very badly. Later she felt nauseas, had muscle pain and headache. Temp was 100.4. She took 2 Tylenol and felt some better. By 3/17/2021 she began having more muscle pain in her arms and legs and her arm is still very sore. Pt states she will call her PCP for medical advice.

Chills, sweats, sick headache, vomiting (3 a.m. to 11 a.m.), diarrhea. Administered anti-nausea medicine by doctor. Stabilized within 30 hours after vaccine.

At 9:45 Patient complained of nausea after smelling Lysol being sprayed. Patient stepped outside to get fresh air and I stepped out also to observe her. V/SBP 153/89, 98 % O2 and HR 74. Gave patient water and had her sit for additional 30 minutes. Patient said no signs of difficulty breathing ans she felt better after breathing fresh air.

Adverse events experienced and are they still occurring now: Local Pain, Fever till march 10 and headache started 2100 and last at least 24 hours, nasal congestion started on Tuesday, diarrhea days later Friday or Saturday What happened as a result of the adverse event? (doctor visit, ED or urgent care visit, hospitalization, life threatening illness, disability/permanent damage, death, none of these): She is back to normal but mentioned that she was not feeling herself for 2 weeks after the vaccine.

Patient received vaccine on 3/16/21. At 24 hours, she started having flu-like symptoms, along with diarrhea and vomiting that persisted for 48 hours. She continued to feel nauseous, congested, fatigue and rigors. Labs were ordered when she was seen in clinic on 3/25/21. Her creatinine reported on 3/26/21 was 7.19. She was admitted to local hospital for acute kidney injury, "probably" due to acute tubular necrosis from ischemic ATN per nephrologist. She was treated with IVF and bicarb drip.

Has gotten diarrhea and because of fatigue, is sleeping harder and causing a sort of sleepwalking. Mistaking other objects as the toilet.

dizzy, nausea, loss of appetite, headache, diarrhea, unable to leave bed for 2.5 days, fever, chills, body aches, swollen gland on right side of neck

Patient reported previous nausea after receiving vaccines in the past as well as fainting. Monitored the patient for 30 minutes after her vaccination, and she vomited within 30 minutes. The patient reported she felt well after vomiting and denied needing any further attention or assistance

Scratchy throat within 2 hours of vaccine inoculation, a raging headache started within 3 hrs of Johnson & Jonson (Janssen) vaccine, massive muscle cramping starting at 1800 and continuing through the night - I drank a gallon of water between 6 PM and 9 PM on 04/06/2021 and then 3 more 1/2 liter bottles during the night. None of it came out in the usual manner -- I had cramping of my left side muscles across my rib cage between 4 PM and 6 PM on 04/06/2021 and then massive lower leg cramps starting at about 10 PM 04/06/2021 lasting until 0300 AM 04/07/2021

Extreme chills, fever (102), body aches, vomiting, diarrhea, extreme fatigue, strange taste in mouth, and headache. This lasted for 8 days and I'm still dealing with the fatigue and lack of energy. I took alternating doses of tylenol and motrin and drank lots of fluids. I had to miss 6 days of work because I was too sick to teach.

MILD STUFFY NOSE; DIARRHEA; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included primary pulmonary hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included sildenafil citrate for drug used for unknown indication. On 2021, the subject experienced mild stuffy nose. On 2021, the subject experienced diarrhea. Treatment medications (dates unspecified) included: fluticasone propionate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the diarrhea and mild stuffy nose was not reported. This report was non-serious. This case, involving the same patient is linked.

When needle came out I felt like my upper arm was filled with lead - very heavy feeling for about 8 minutes. About 2 hours later I felt very fatigued and slept for 2 hours. Woke up at 4:30 am next day (04/08/21) with a raging migraine, unbearable nausea and cold to the bone. Vomited 2 times in the day. After drinking some ginger beer at 3 pm the nausea was gone by 3:30 pm. Migraine gone by 7 pm and freezing cold feeling gone this morning (04/09/21).

Burning pain, waves of body Chills, left side neck pain, headache, slight nausea. Had a Blood Pressure check immediately and temperature check (97.1), waited for a longer period at facility to make sure I was OK. blood pressure was extremely high at first reading (I've never had such a high reading in my entire life); blood pressure was within normal limits on second check (127/85), and I was well enough to leave. The chills come in waves, with continued slight nausea.

3/18 vaccination 3/19 4am woke up I felt sick I had a HA, Nauseas, dizzy, hard to stand, hard to keep eyes open to even go to the bathroom. I tried to go back to sleep. When I woke up, I took it easy. I did get the chills and sweats thru the day; skin turns really red (MCAS). That symptoms still comes and goes. The chills, regulating body temperature, has flared back up after being dormant for years. 3/30 I saw MD. She wanted to defer for 4-6 weeks after vaccination to see if symptoms were still persisting or leveling out. I have since canceled every sort of appt since then as I don't have the energy. *I am on the very tail end of an opioid withdrawal; tramadol. I have taken for 6 years, 400 mg weened down to 100 mg this last year, down to 12.5.

groggy, almost comatose state for 36 hrs beginning evening of 3/9/21 until 3/11/21...Unable to walk...nauseau with some vomiting...slept mostly...no intake...then, 4 days of severe nausea, chills, severe headache, no appetite. felt better for 2 days, then another day of several chills on 3/16/21 followed by 2 days of diarrhea. Severe fatigue for 2-3 weeks.

Upon leaving the store, started to develop headache. Next morning, headache severe, neck pain, nauseated and very tired. Headache lessened by 2nd day, still very tired, neck pain and nauseated. Neck pain persists, very tired and still some nausea. Eating very little due to feeling of getting sick.

Vomitting, Wretching, Dry Heaving, Diahrrea, Mild Fever, Beet Red Face, Body Aches, Cough, Lethargy starting the evening of the vaccination 4/10/21 9PM. Continued until 4/11/21 Midday.

anaphylaxis, severe face swelling, throat closing, arm swelling, headaches, ongoing dizziness, equilibreum issues, aches, stomach issues, rash on face, neck, torso and both legs, nausea ongoing, tingling sensations. 8 benadryl in first 30 min. kept me there for one hour - almost two weeks out and still not fully resolved (very dizzy, severe headaches, some swelling remains)

Sever Stomach pain, went to ER, they gave pain meds, check gall bladder, Cat scan on stomach, blood work

INDIGESTION; GENERALIZED JOINT PAIN; FEVER; RAISED RASH ON RIGHT LEG; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included osteoporosis, mitral valve prolapse, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced raised rash on right leg. On 06-APR-2021, the subject experienced fever. On 06-APR-2021 15:00, the subject experienced generalized joint pain. On 06-APR-2021 19:00, the subject experienced indigestion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 06-APR-2021, and had not recovered from indigestion, generalized joint pain, and raised rash on right leg. This report was non-serious.

ITCHINESS; HIVES; FEVER; HOT; SWEATY; LIGHT HEADED; SHAKY; NAUSEA; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. the patient was not pregnant at the time of reporting.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced shaky. On 05-APR-2021, the subject experienced nausea. On 05-APR-2021 14:30, the subject experienced hot. On 05-APR-2021 14:30, the subject experienced sweaty. On 05-APR-2021 14:30, the subject experienced light headed. On 06-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.9 F. On 08-APR-2021, the subject experienced itchiness. On 08-APR-2021, the subject experienced hives. Treatment medications included: diphenhydramine hydrochloride, loratadine, and prednisone. The patient recovered from hot, sweaty, light headed, shaky, and nausea on 05-APR-2021, and fever on 06-APR-2021, and had not recovered from itchiness, and hives. This report was non-serious.

chills, body aches, nausea, extreme fatigue at exactly 24 hours after shot. I felt exactly like my worst covid days in December 2020. At exactly 48 hours it was like someone flipped a switch and I felt fine.

I had the Janssen vaccine at 2pm. on Friday afternoon. By 8:00 I was doubled over with stomach pain. All weekend had pain, diarrhea and vomiting horribly. By Monday March 8th I doubled over in stomach pain so bad I had to call an ambulance. Was admitted to hospital on Monday with Accute Pancreatitus. Was in the hospital until Friday March 12th. I am a TOTALLY HEALTHY person that is NEVER sick, very healthy, and I workout daily. I have no gallbladder, I NEVER drink ANYTHING, there was NO reason I should have been there except for the vaccine reaction. After having a Cat scan, MRI, Altrasound , and an Endoscopy, the my specialist concluded it was the vacinne.

Severe Joint and muscle aches, fever, chills, loss of appetite, night sweats, severe headache, extreme fatigue. Symptoms started 8 hours after injection and persisted for 3 days. Took Tylenol as needed for fever and pain. Extreme fatigue kept me immobilized for those 3 days.

Evening of Day 1, shaking chills, fever (100), headache. Went to bed at 9:00, woke at 3am with severe "swelling" I felt like my brain was too big for my skull, my entire face felt swollen. Joint aches, muscle aches, nausea. Nausea has been intermittent thru day 5. Headache continues but not as severe. I still wake up with it every day (this is now day 5). Diarrhea began on Day 3 (watery, every 1/2 hour for 4 hours). fever subsided and returned on Day 3 (100). no fever since but muscle aches, headache and joint aches continue.

Taken by ambulance from home to ER on Sunday, March 21, around 7:30 pm. Symptoms were severe head and leg pain, vomiting and diarrhea. X-rays and blood work taken. Given pain medication and fluids. Dr in ER said it could be a virus. Discharged at midnight Monday 22. Followed up with my primary.

Got shot at 10:15am. Felt tired mid-afternoon. Got chills early evening. Went to bed with low grade fever, which ramped up quickly. Fever-topped out at 101.4 by 3:00am, body aches, repeated vomiting, repeated massive diarrhea, severe headache -crushing, squeezing vise (in the top 10 worst of my life -including migraines!), bright pink/red fingers and toes, racing uneven heartbeat. Couldn't sleep. In tears from headache pain. In desperation took an 800mg Ibuprofen pill at 4:00am. Finally got to sleep. Woke up 5 hours later. Fever mostly gone. Other symptoms receding, except headache. Took 2 aspirin at noon. Still have minor headache. Yuck!

Suddenly blacked out and fell; mild concussion and soft issue injuries to right side of body; extreme fatigue and nausea.

BODY TWITCHING; HEADACHE; CHILLS; BODY ACHE; UPSET STOMACH; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no known drug or non drug allergy. the patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and 1805018 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 headache. On 12-MAR-2021, the subject experienced chills. On 12-MAR-2021, the subject experienced body ache. On 12-MAR-2021, the subject experienced upset stomach. On 13-MAR-2021, the subject experienced body twitching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and upset stomach on 13-MAR-2021, and had not recovered from headache, body ache, and body twitching. This report was non-serious.

Patient had slurred speech, headache, pain in the thigh muscles, bloody nose, lost strength in the arms, hands and legs, could not chew or swallow. She was diagnosed with Guillian Barre Syndrome and hospitalized from 04/04/2021-04/18/2021.

The patient presented to the emergency department with altered mental status, dry heaving, and body aches. She was found to have a partially occluding thrombus of the right cephalic vein consistent with venous thrombosis, as well as findings of thrombosis in the anterior segment branch of the right portal vein. She had a d-dimer of 25.77 increased to 35.2, and was thrombocytopenic with a platelet count of 92, which dropped to 36 the following morning. Platelets to present were: 92-36-32-23-19-28. The patient received the Johnson & Johnson COVID-19 vaccination two weeks prior to presentation.

Very High Fever followed by aches and pains with congestion then a severe headache like a migraine and ending with 3-4 days of diarrhea

Vomiting of blood, treatment was rehydration and supportive. Patient doesn't recall other treatment. Time course was 1 week from start. Patient has recovered.

Vomiting for 24 hours starting at noon 4/02/2021 and ending late 4/03/2021. Intestinal cramping yellow, watery diarrhea started 2:30PM 4/08/2021. Diarrhea continues, but getting better, more normal color. Injection burned. I did not experience any serious soreness, but my arm still burns if something touches it. No swelling, redness, rash.

Patient admitted 4/12/21 with fatigue and abdominal pain. Found to have UTI but no definite sepsis, and acute renal failure. Treated with iv antibiotics and iv fluids. Over next 48 hours developed worsening encephalopathy and thrombocytopenia. MRI/MRA/MRV showed no acute findings. Hyperammonemia noted, with no known Hx of cirrhosis; US did not show portal vein or hepatic vein thrombosis. Encephalopathy worsened, no clear etiology; EEG just showed generalized encephalopathy. Renal function worsened. Patient became obtunded and was intubated 4/16/19. Platelet nadir of 31k. Dialysis started. Left common femoral DVT developed. Patient had DIC type picture. Respiratory failure worsened, hypotension developed, patient passed away 4/20/21. No clear etiology of encephalopathy and thrombocytopenia identified, unclear if related to J&J vaccine received 2 weeks prior.

April 8 tired 2 days/ April 16 had 12 hours bad diarrhea non stop/ April 17 to now bad gas /no desire to eat/bloated/tired.

On Sunday night, 04/11/2021 around 7:00pm, patient stated she started getting sick to her stomach. She complained of headaches and fatigue. At midnight she vomited, couldn't lay down and symptoms lasted all night. She complained of back pain too. she noticed blood in her urine with a clot of blood in it and had shortness of breath. She vomited twice. In contact by phone with her daughter at the time. Patient refused to go the the emergency room or call her physician. She has a cardiologist who is her primary care physician.

I currently have swelling in my hands, pain in my vaccinated arm, bone pain, a bump in my hand like thrombi, burning sensation in my stomach, taste of blood in my throat, leg and joint pain. After I was vaccinated.

ACHY; ARM SORENESS; MINIMAL CALF PAIN; SPLIT SECOND FEELINGS OF NAUSEA; TIRED; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's past medical history included blood transfusion, and concurrent conditions included toxic shock syndrome, and neutropenia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1043A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced achy. On 09-APR-2021, the subject experienced arm soreness. On 09-APR-2021, the subject experienced minimal calf pain. On 09-APR-2021, the subject experienced split second feelings of nausea. On 09-APR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tired, and the outcome of arm soreness, split second feelings of nausea, achy and minimal calf pain was not reported. This report was non-serious.

MILD CONFUSION; CAN NOT GET A THOUGHT TO GO OUT; SEVERE HEADACHE; NAUSEA; FATIGUE; DIZZINESS; VOMITING; BRAIN FOG; This spontaneous report received from a patient concerned a 65 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced brain fog. On 27-MAR-2021, the subject experienced dizziness. On 27-MAR-2021, the subject experienced vomiting. On 27-MAR-2021, the subject experienced severe headache. On 27-MAR-2021, the subject experienced nausea. On 27-MAR-2021, the subject experienced fatigue. On 28-MAR-2021, the subject experienced mild confusion. On 28-MAR-2021, the subject experienced can not get a thought to go out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, vomiting, brain fog, mild confusion, can not get a thought to go out, severe headache, nausea, and fatigue on 2021. This report was non-serious.

DIARRHEA; THREW UP; NAUSEATED; HEADACHE; LUNG PAIN (FELT LIKE LUNGS GOING TO EXPLODE); LEFT ARM PAIN; FATIGUE AND FELT TIRED; LETHARGY; SICK; PAIN DOWN FROM LEFT BREAST TO ELBOW; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of this report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced pain down from left breast to elbow. On 07-APR-2021, the subject experienced lethargy. On 07-APR-2021, the subject experienced sick. On 07-APR-2021, the subject experienced left arm pain. On 07-APR-2021, the subject experienced fatigue and felt tired. On 08-APR-2021, the subject experienced lung pain (felt like lungs going to explode). On 08-APR-2021, the subject experienced nauseated. On 08-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced threw up. On 11-APR-2021, the subject experienced diarrhea. Treatment medications (dates unspecified) included: oxycodone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from threw up, and diarrhea, had not recovered from fatigue and felt tired, lung pain (felt like lungs going to explode), nauseated, left arm pain, lethargy, headache, and pain down from left breast to elbow, and the outcome of sick was not reported. This report was non-serious.; Sender's Comments: V0: MAC comment not required for non serious cases as per standard protocol

NUMBNESS IN HANDS, FINGERS AND FACE; CONGESTION; SORE THROAT; DIZZINESS; CHILLS; WEAKNESS; FEVER; FATIGUE; NAUSEA; HEADACHE; MUSCLE PAIN IN BACK; This spontaneous report received from a patient concerned a 65 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced numbness in hands, fingers and face. On 09-MAR-2021, the subject experienced congestion. On 09-MAR-2021, the subject experienced sore throat. On 09-MAR-2021, the subject experienced dizziness. On 09-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced weakness. On 09-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced fatigue. On 09-MAR-2021, the subject experienced nausea. On 09-MAR-2021, the subject experienced headache. On 09-MAR-2021, the subject experienced muscle pain in back. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, chills, weakness, fever, and headache on 10-MAR-2021, and had not recovered from fatigue, nausea, muscle pain in back, numbness in hands, fingers and face, congestion, and sore throat. This report was non-serious.

Very high fever for 3 weeks; Shivers; Extreme fatigue; Lethargy; GI problems; Increased level of traponin; Very dark and itchy red rash; Very high blood pressure

The patient was given Janssen vaccine @ 11:38am. She stated she had anaphylaxis reaction before after colonoscopy was not sure exactly what from. Made sure this vaccine didn't have PEG in it. Asked her to stay for 30 minutes after vaccine so I could monitor her. Around 12:10pm she said her mouth felt like anaphylaxis may happen. Asked her if she felt like she could swallow she said yes gave her (2) 25mg diphenhydramine. Had her sit and took her blood pressure which was BP 202/101 hr 70 I asked her if maybe she was anxious she said no she was very calm. Around 12:20pm she said felt throat was closing like before told partner to call 911. Got out Epi pen 0.3mg but she had her own administered 1 dose in right thigh. Shortly after EMS arrived and took over. The whole time she was awake and alert and responsive. Spoke to her around 4pm she was just leaving ER and said she was doing better.

About 4 and a half weeks after getting the J&J vaccine, I began to experience marked symptoms: dizziness and disorientation,, balance problems, bilateral numbness in hands, feet and tip of tongue, awareness of left side of brain, intermittent mild nausea (likely related to dizziness). These symptoms had a sudden onset. I am normally very healthy and active so these unusual symptoms without any illness were quite a departure from my normal health. They have, to date, persisted continually since onset over the past 3 weeks. They are very concerning. Last night I went to the ER to be seen since I could not get an appt. with a neurologist for several months and I am concerned about my sudden change in health status.

About three weeks after getting the J & J vaccine, I began getting headaches, mostly on the top of my head. They have lasted a month. Within a week I went to the ER and had a battery of tests; The only thing that showed up is that I was dehydrated after several hours of not drinking water. Normally, I drink about 64 oz. of water a day. The pain sometimes radiated to my neck. An x-ray showed arthritis. I have had occasional nausea.

The day after the vaccine I experienced extreme fatigue, Some nausea, slight headache and some flu-like muscle aches. On day 13 I have a toothache that switches between my lower right jaw and my upper right jaw. It comes and goes throughout the day and I have since experienced the same pain daily. I have had no treatment for the pain. I take Tylenol.

On the way home I had neurological symptoms, tongue and lip tingling, nauseated. The smell of Lysol spray made me not be able to breath. Made me dizzy and nauseous. It was like an LSD trip. It like being on a roller coaster, It continued all the way home. I could see all the timbers and bright green colors. Neck was stiff and it crawled up my head to my temples. It was like someone was holding my head. About 3 days later after vaccine my throat started to close and we headed to ER. I took turmeric and ginger to the ER as well as Benadryl. The symptoms subsided before we reached ER so I didn't seek care. I took vitamin E and fish oil 2X everyday after vaccine for 10 days following vaccine.

Right away, they were watching me because I felt like my throat was tightening up a little bit. My blood pressure sky rocketed. Then I was okay after awhile. They pharmacist said to take some Benadryl when I got home if I needed it. He knew I had taken Claritin D earlier. I was okay though. But the next morning, I was so exhausted I could barely get out of bed. The next day, I was still really tired. On Sunday morning, 10th, it hit me - I woke up at 04:00 in am. Nauseous; light-headed; gastro-intestinal issues; extremely ill. I called my brother in and was afraid to be by myself. I could barely move around to even get water or go to bathroom. I got through it somehow that day and on Monday I was just maybe a little but that isn't saying much - still severe. By Tuesday, I called the pharmacy - I was so light-headed I thought I was going to pass out and they told me to go to ER and someone took me and doctor said he was seeing a lot of this. Gave me IV fluids. It was difficult to stay hydrated - they gave me paperwork on what to drink to stay hydrated - Pedialyte - anything that had water in it. I drank Essentia Water, too. I couldn't stay hydrated and I was so light-headed (kept feeling like I was going to pass out) that I could have gone to ER again two days later. Doctor said take it easy - he said my body was busy making antibodies. That light-headedness for about a week - but I couldn't drive for two weeks because of it - was still so dehydrated. I had a strange sensation - like I was outside my body - I couldn't think straight. I was feeling pain in my back by my kidneys and went to my doctor.

After my J&J vaccine I experienced fatigue and was very tired. On 04-21-2021 I had incredible abdomen pain that caused me to become very nauseous. I went to see a doctor who prescribed anti nausea medication. I could not eat for about 10 days due to my nausea. Then after taking the anti nausea medications my symptoms started to go away.

-Severe abdominal pain, projectile vomiting, severe diarrhea that lasted for 3 days. - spasms and pain in legs

Systemic: syncope-Medium, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Additional Details: Patient sat down for more than 15mins after receiving vaccine then walk out side to wait for pick up. While waiting, she got syncope and fell down on the side walk, got a bump on the leftside of her forehead. Pt complained of nausea. She felt better after given some water. She refused to call 911. Patient came back inside and continue waiting for 45 mins when her pick up arrived, she stated feeling better and wanting to leave to go back to her hotel

Immediate extremely strong metallic taste in mouth. Tongue and lips a little puffy. Very inflamed lymph nodes in neck. Metallic taste went to gums, and I could feel the metal taste scallop across my teeth, from left to right. Felt a sweaty sensation on top of head, like I had a bowl on top of my head. Metallic taste started going down my throat. Soft palate swollen causing gagging due to uvula touching my tongue. Could feel the sensation on my head inching its way down my head. It stopped at the hairline above my ears, which made me think that I was getting in feeling in my hair follicles and not a sweaty sensation. Stayed 70 minutes at site. Metallic taste mostly gone. I was told to pick up some Benedryl. As soon as I took it I felt a strong pounding in my ears. When eating dinner I could feel a slight constriction while swallowing. The next morning the lymph nodes in my armpits were extremely sore. Neck lymph nodes stopped being sore Saturday, but are still a little swollen. Lymph nodes in arm pits were better on Sunday, but are still sore if pushed on.

feeling light headed, nausea, some coughing tightness in chest, some loose stool, lower back ache, weakness, lack of sleep the first night. ate chicken noodle soup, tylenol PM, slept, drank white tea with peppermint tea, sucked, on Ricola drops and EmergenC drops

1st 24 hours, the expected chills, fever, shakes, severe headache, muscle aches, N&V. After that, profound fatigue, disordered taste, nausea, for one week. After that, exhaustion continued, with any mild to moderate activity causing return of chills, nausea, and headache. This lasted over FOUR WEEKS and began to resolve only with naturopathic treatment.

CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; BRAIN FOG; EAR ACHE; SINUS CONGESTION; FEVER; NAUSEA; SINUS PAIN; BOWELS ARE "FLOATING"; HEADACHE; MALAISE; This spontaneous report received from a patient concerned a 65 year old female. The patient's weight was 146 pounds, and height was 63.5 inches. 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: 1808980, and expiry: 20-JUN-2021) dose was not reported, 1 total administered on 31-MAR-2021 around10:45 for prophylactic vaccination on left deltoid. No concomitant medications were reported. On 31-MAR-2021, 5 hours after vaccination patient got sick and did not reported this because it got better after couple of days. She experienced fever, malaise, nausea, headache, sinus pain and bowels movement were floating. Patient recovered in 3 days and was doing fine till 06-JUN-2021. On 06-JUN-2021 patient started really feeling bad. Patient's all joints, head and everything was hurting. On same day patient experienced fever, headache, chills, nausea, joint pain, brain fog, body aches, sore throat, ear ache, sinus pain, sinus congestion, productive cough (phlegm), and shortness of breath. Patient's shortness of breath was not severe enough to go to emergency room. Patient experienced shortness of breath while talking and walking up the stairs. ON 08-JUN-2021 Patient experienced sharp pain in random body places and loss of taste and smell. Patient got herself tested on 08-JUN-2021, with an antigen test (nasal swab), and it was positive(confirmed clinical vaccination failure). It was reported that turned positive quickly without waiting. On an unspecified date, the patient experienced breakthrough infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ear ache, and sinus pain on JUN-2021, fever, and nausea on 02-APR-2021, and malaise, and headache on 03-APR-2021, had not recovered from bowels are "floating", confirmed covid-19 infection, brain fog, and sinus congestion, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). The suspected product quality complaint has been confirmed to be not voided based on the evaluation/investigation performed.; Sender's Comments: V0: 20210627726- covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS

DISCOMFORT IN UNDERSIDE OF RIB; DISCOMFORT IN LEFT ARM; NAUSEA; HEADACHE; TINGLING DOWN TO FINGERNAILS; PULLED A MUSCLE IN BACK; DIZZINESS, LIGHTHEADEDNESS UPON STANDING; DRY MOUTH; ARM HURTS WHEN STRETCHED; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included narcolepsy, and cluster headache. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, expiry: UNKNOWN) dose was not reported, administered on 21-JUN-2021 for prophylactic vaccination. Concomitant medications included verapamil for cluster headache. On JUN-2021, the subject experienced tingling down to fingernails. On JUN-2021, the subject experienced pulled a muscle in back. On JUN-2021, the subject experienced dizziness, lightheadedness upon standing. On JUN-2021, the subject experienced dry mouth. On JUN-2021, the subject experienced arm hurts when stretched. On 21-JUN-2021, the subject experienced discomfort in underside of rib. On 21-JUN-2021, the subject experienced discomfort in left arm. On 21-JUN-2021, the subject experienced nausea. On 21-JUN-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the discomfort in left arm, dizziness, lightheadedness upon standing, dry mouth, nausea, headache, pulled a muscle in back, arm hurts when stretched, discomfort in underside of rib and tingling down to fingernails was not reported. This report was non-serious.

increased irritability I have an exceptionally good memory, and post-vaccine began to struggle a bit with it (memoryissues) impaired appetite/food tastes different

Started w/ nauseau and diarhea, shaking and chills (even in hot climate), take ibuprofen and peptobismalevery three hours, dreams, weird fever dreams, left leg burning, lower teeth pain, joint pain in left hand (unusual). After two weeks burning dissapeared, everything else lasted only 4 days

My temperature is usually 96 degrees, but I reached a fever of 98.8 on the morning of 4/10/2021. I felt foggy and very fatigued. Between 4/10 and 4/12, my fever reached 101.1. I had a dull headache and I had bone pain and joint pain; I felt like a walking skeleton. I felt like I could feel every joint connected to every bone. I was extremely sleepy and had no appetite. I was in a neurological fog. The days just went by, and I basically don't remember anything. I went to a cardiologist on 5/2/2021 and had a halter monitor put on; the results indicated an electrophysiological myopathy, second and third degree heart blockage, supraventricular tachycardia. The etiology to all of these is unknown. There was no afibrillation. I wore the monitor for 13 days.

HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: 07-AUG-2021) dose was not reported, administered on 10-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-JUL-2021, the subject experienced headache. On 11-JUL-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from nausea, and had not recovered from headache. This report was non-serious.

VOMITING (5 TIMES IN TOTAL SINCE THE ONSET); PERSISTENT CONSTANT/LIGHT NAGGING NAUSEA; This spontaneous report received from a patient concerned a 65 year old female. The patient's weight was 160 pounds, and height was 64 centimeters. The patient's concurrent conditions included diabetic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 03-JUL-2021 for prophylactic vaccination. Concomitant medications included insulin for diabetes. On 04-JUL-2021, the subject experienced vomiting (5 times in total since the onset). On 04-JUL-2021, the subject experienced persistent constant/light nagging nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from persistent constant/light nagging nausea, and vomiting (5 times in total since the onset). This report was non-serious.

Left arm was mildly sore, as expected. Around 10 pm Thursday, I started feeling chills. During the night I felt fevers and chills alternating. Around 3 am, I was nauseous and vomited, although there wasn't much actual vomit. I vomited again around 9 am the next morning, with even less vomit, since I hadn't eaten any breakfast. I rested most of Friday and ate sparingly. Today (Saturday) I feel better.

After roughly 4 hours I started to get chills and body aches. I went to bed but could not get warm and writhed in considerable distress for at least an hour. (This was the most uncomfortable I've been since induced labor before the anesthesiologist arrived for an Epidural 28+ years ago.) My temperature fell to 95 before I took acetaminophen and was able to fall asleep.. Now, at 7 hours it's 101.2 and I'm just getting the side effects I expected: weakness, a little nausea.

11 am March 8 onset of fatigue, body aches, "brain fog" which increase over course of afternoon and persist rest of day/evening Body temperature climbs to 99.5 in late afternoon Focused pain in hip joints, left side neck and jaw Unable to work/pursue normal daily activities entire day of March 8 Symptoms resolve as of March 9, when temp returns to normal, fatigue and aches abate

extreme feeling of being cold and moderate feeling of nausea for approximately 7 hours, followed by headache for about 6 hours (treated with ibuprofen), fatigue for about 24 hours.

6:30 p.m. chills, body aches, fever 99.9 8:30 p.m. nausea, fever 101.4 10:00 p.m. fever 101.9 1:00 a.m. headache 2:15 a.m. headache fever 99.7 - took 2 Advil

10 hours after vaccination I got very tired. Went to bed at 9:30. Had chills. and slight head ache. Woke up around 12:30 with rapid heart beat. My normal resting heart rate is 61(per activity tracker) It was 98 ish. and somewhat eractic. (but not a lot). Also had nausea and diarrhea. Finally got some sleep. Woke up at 7:00am and took 2 aspirin. Today I'm feeling fine. Maybe a little tired.

Violent shaking and chills, 100.1 fever, muscle aches, headache, dry mouth, pain in arm, nausea but no vomiting

66 y.o. female who presents with DIZZINESS LIKE ROOM IS SPINNING. PT STATES IMPROVES WITH CLOSING EYES AND LAYING STILL. PT STATES HAS HAD SEVERAL TIMES BEFORE AND LAST TIME WAS ONE WEEK AGO AND TOOK A MOTION SICKNESS OVER THE COUNTER PILL AND DIZZINESS WAS RELIEVED. TODAY PT WAS AT WORK WHEN BECAME DIZZY AND NAUSEOUS AND VOMITED. PT DENIES CHEST PAIN BUT HAS PAST HISTORY OF CAD WITH PACEMAKER PLACEMENT.

Initial headache and nausea and headache, slight fever. Felt generally lousy. Over weekend and continuing the headache has gotten worse and my fever has spiked to over 102.5

I have developed a metallic/salty taste in my mouth effecting the taste pf food and causing nausea at times.

The night of the day after the vaccine was given, client started feeling an upset stomach with nausea and cramps, felt very weak; didn't sleep that night, unable to eat d/t nausea and diarrhea started the following day. Felt better on day 3 and resolved by day 4.

loose green stools for 3 days, then slowly progressed to right upper quid pain after eating , nausea, navel pain, loose stool at times Have not resolved

Flu symptoms, weak, nerve twitching, swelling, fever, chills, nausea, pain, headache, very weak pulse, heart palpitations, malaise, rigor, a horrible experience lasted 36 hours.

Right Unilateral Cranial Nerve 7 Paralysis, 6 hours after administration of vaccine, associated symptoms included diarrhea, emesis Treatment included prednisone and valacylovir

At 2:00 am on the morning of March 6, 2021 I woke up with terrible chills, upset stomach and a very rapid heartbeat that continued until 5:30 am. The remainder of the day I had a horrible headache.

3-13-21 Shot, soreness in arm and knot nothing else notable except maybe mild headache 3-23 start with itchy rash mid back, arm still sore knot smaller 3-24 Rash continued to spread up back extremely itchy 3-25 Rash continue to spread to stomach area , major head ache, vomiting (one time) temperature 97.1 3-26 Rash continue to spreading to left breast headache, no appetite 3-27 Rash continued spreading to buttock cheeks, apatite improving 3-28 Rash continued to spread arms, Knott in arm getting small feeling itchy all over. 3-29 Rash continued to spread to lower limbs. knot in arm almost gone, visit to doctor . Prescribed steroids for 7 days follow up in one week.

03/28/2021 all day-upper left arm muscle very sore (no redness) 03/29/2021- 06:00am- 100.4 temp, nausea/projectile vomiting, fatigue, headache, chills, body aches 03/30/2021 - no symptoms

Extreme Vertigo with vomiting lasting an hour. Then several hours later, another episode exactly the same on Day 12, March 16, 2021 Mini episodes lasting a minute or so with and without vomiting since.

Day 2 post vaccination, swollen glands Day 3 post vaccination Chills, aches Day 4 post vaccination dizziness, vomiting, headache Day 5 post vaccination headache, dizziness, flu-like, sleepiness Day 6 post vaccination glands still swollen, headache, tiredness Day 7 post vaccination, glands still swollen but much improvement overall Day 8, continuing to improve

Began with tinnitus at both ears on the morning of March 31, 2021. On the morning of April 1, the left ear lost hearing and tinnitus appeared to better. In the afternoon around 12 noon felt nauseated, dizzy. At about 4:00p.m. vomited and felt the sky spinning with eyes open.

Janssen COVID-19 Vaccine EUA Immediate dizziness, vertigo with nausea, dry mouth, shortness of breath, headache and increased blood pressure. Later at night I had a low grade fever with achiness and headache. The flu like symptoms resolved by morning but I continue to have vertigo and intermittent nausea and my BP was still high in the morning around 9 am but came down by 12:45 to my normal range. Paramedics at the site did a BP, pulse ox, blood sugar, ECG . Everything was normal except my BP which was 180/90. This morning it was 167/98 and 168/97. No treatment. Saw my doctor's partner at 1:00 today and BP was back to my normal range but I still have mild vertigo and intermittent nausea. Doc gave me some exercises to do for the vertigo and did not seem to think that it was related to the shot, but since the paramedics said they had seen a LOT of the same reaction yesterday to the J&J shot and two sites in other cities shut down for the same reactions, nobody will convince me that it was anything but the shot. I expected the flu like side effects but never dreamed it would cause my BP to spike and the vertigo.

SWELLING IN ARM; SWELLING OF FACE; TINGLING OF BODY; THROAT STARTED TO CONSTRICT; LEGS ARE ITCHY; SHAKY FEELING ALL OVER; RASH ON TORSO; CHILLS; KILLER HEADACHE; LITTLE BIT OF NAUSEA; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination, vaccinated at the left arm at 12:00 PM. No concomitant medications were reported. On 01-APR-2021, the subject experienced swelling in arm. On 01-APR-2021, the subject experienced swelling of face. On 01-APR-2021, the subject experienced tingling on face. On 01-APR-2021, the subject experienced tingling of body. On 01-APR-2021, the subject experienced throat started to constrict. On 01-APR-2021, the subject experienced legs are itchy. On 01-APR-2021, the subject experienced shaky feeling all over. On 01-APR-2021, the subject experienced rash on torso. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced killer headache. On 01-APR-2021, the subject experienced little bit of nausea. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swelling of face, tingling on face, tingling of body, throat started to constrict, chills, shaky feeling all over, and little bit of nausea, and had not recovered from swelling in arm, rash on torso, legs are itchy, and killer headache. This report was non-serious.

went to bed at 10, and was cold but that's normal. about 12am was getting colder and back hurt. went to couch with heating pad, was so terribly tired, little nauseous, went to bathroom 8times. got up at 6am with husband and crawled into bed and slept, didnt hear anything happening in the house, just slept. got up to couch again and heating pad, then bed again. freezing and warm and sweating head. at 12 noon finally 'woke' up and got up and sat on couch but didn't feel need to sleep as much. ate a little at 1pm, now am sweating like a fever broke, not cold anymore. headache yet, stiff neck, arm sore

Profuse sweating 14 minutes after injection, dizziness and nausea. overwhelmed my body and limbs. lasted 35 minutes before I could leave the store to get in my car. felt fatigue for first 1 hours. Then at 10 hour mark severe fatigue low grade fever 99.1. At 22 hour mark sever headache, spine ache neck ache, loss of appetite, heartburn,/GRD, fatigue,muscle fatigue, fever 99.9 controlled with Tylenol brain fog, Severity of these symptoms still persisting as of 72 hours after injection.

My are has hurt since the shot, it hurts to lift my arm up and aches into the shoulder, have been nauscious and started vomiting on 4/11, have had a bad head ache. Body Ache all over. Feeling very weak.

sudden onset EXTREME chills about 3p.m. on the same day. followed by fever of 102.8 and nausea and vomiting x 2. The fever and vomiting were not present the next day, but dizziness, nausea and fatigue were very prevalent the first 10 days. The fatigue and periodic dizziness and nausea have persisted through now, though they have lessened.

I had abdominal pain for 2 to 3 days. I also was light headed, weak and had some dizziness for 2 to 3 days. I also had a headache the evening of 3-11-21 and the morning of 3-12-21

PAIN BELOW THE INJECTION SITE; LOSS OF APPETITE; SHAKY HANDS; FLU-LIKE SYMPTOMS; SLEPT ALL DAY; TERRIBLE CHILLS; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's past medical history included osteoporosis, high bad cholesterol, and varicose veins. The patient experienced drug allergy when treated with nitrofurantoin. 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, 1 total, administered on 06-APR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced loss of appetite. On APR-2021, the subject experienced shaky hands. On APR-2021, the subject experienced flu-like symptoms. On APR-2021, the subject experienced slept all day. On APR-2021, the subject experienced terrible chills. On 06-APR-2021, the subject experienced pain below the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms, and pain below the injection site on APR-2021, was recovering from loss of appetite, shaky hands, and terrible chills, and the outcome of slept all day was not reported. This report was non-serious.

Had shot in left arm no problem, a few hours later started getting a headache chills achs and pains nausea stomache pain hands and feet numb. still not feeling good.

My mom had called saying she's feeling nausea, dizziness, drowsiness and vomiting. We called the emergency services when they arrived she had collapsed. They broke the window and took her to the hospital, upon arrival we were informed that she has got a hemorrhage possible clotting due to high blood pressure. I now know the term is Cerebral Hemorrhage, she has been in ICU on a ventilation machine while they tried to drain the blood and clots. She's currently out of ICU however still complains about headache and back pain. We are informed that she has now developed some blood pressure and diabetes however it could be cleared in the short term. She's at the hospital and unknown how long she would have to stay there.

Got the vaccine on Apr 6 Fever and leg pain started on Apr 7 Sever headache, nausea occurred on Apr 11, called 911 immediately and sent to emergency room of hospital The diagnosis is large volume of subarachnoid hemorrhage in the brain. Surgery conducted on April 11 and the patient is still in ICU now

About three hours after the vaccination, after eating a light dinner of two pieces of pizza and drinking a beer (to celebrate, I thought) (an identical dinner to my husband, who was vaccinated minutes after me, and who suffered no adverse effects) I suddenly had extreme nausea and, immediately, projectile vomiting. My entire stomach emptied, but I continued to retch for the entire night and into the next day, weak and nauseated for about 72 hours. I became dehydrated but couldn't keep water down for 48 hours. That first night, I experienced body temperature swings, whole body pain (not muscle aches, and not localized) and most disturbingly, hallucinations. I awoke in the middle of the night convinced that my body had stretched in length and there were two of me. This was similar to the reaction I had to opiodes, but even worse (I didn't think anything could be worse).

SMELLY URINE; CLOUDY URINE; ABDOMINAL CRAMPS; DIZZINESS; HEART RACING; FEELING COLD; BRAIN FOG; NECK SORE; SOUND IN HEAD/HUMMING NOISE IN HEAD; DID NOT FEEL HUNGRY; FORGETFULLNESS; SHAKING WITH COLD/TEETH CHATTER/CHILLS; SEVERE HEADACHE; FEVER; NAUSEA; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's past medical history included cholesterol, and concurrent conditions included hypertension, non-smoker, non- alcoholic, and sensitive to medications, and other pre-existing medical conditions included the patient had no drug abuse/illicit drug use. the patient had no known drug allergies. The patient was previously treated with hydrochlorothiazide/lisinopril for hypertension, vitamins nos for drug used for unknown indication, and atorvastatin for cholesterol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On DEC-2020, Laboratory data included: Blood test (NR: not provided) not reported. On 12-MAR-2021, the subject experienced heart racing. On 12-MAR-2021, the subject experienced feeling cold. On 12-MAR-2021, the subject experienced brain fog. On 12-MAR-2021, the subject experienced neck sore. On 12-MAR-2021, the subject experienced sound in head/humming noise in head. On 12-MAR-2021, the subject experienced did not feel hungry. On 12-MAR-2021, the subject experienced forgetfullness. On 12-MAR-2021, the subject experienced shaking with cold/teeth chatter/chills. On 12-MAR-2021, the subject experienced severe headache. On 12-MAR-2021, the subject experienced fever. On 12-MAR-2021, the subject experienced nausea. On 14-MAR-2021, the subject experienced dizziness. On 02-APR-2021, the subject experienced smelly urine. On 02-APR-2021, the subject experienced cloudy urine. On 02-APR-2021, the subject experienced abdominal cramps. Laboratory data (dates unspecified) included: Chest X-ray (NR: not provided) NEGATIVE, Computerised tomogram head (NR: not provided) NEGATIVE, Fibrin D dimer (NR: not provided) ELEVATED, and Head MRI (NR: not provided) NEGATIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling cold, and fever on 12-MAR-2021, and smelly urine, cloudy urine, and abdominal cramps on APR-2021, was recovering from neck sore, and had not recovered from heart racing, shaking with cold/teeth chatter/chills, severe headache, nausea, did not feel hungry, brain fog, sound in head/humming noise in head, dizziness, and forgetfullness. 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

Dull headache for several days. Excruciating abdominal cramping off and on for almost a week. Arm soreness appeared about a week later severe enough to keep me from sleeping on that side of my body. Lasted about a week. At the same time, large bruises appeared on the "shot arm" from the shoulder down almost to my elbow. Soreness in my right calf developed after four weeks and still comes at times.

NO APPETITE; BAD FLU; JOINT ACHE; NAUSEA; This spontaneous report received from a patient concerned a 66 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 17:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced no appetite. On 08-APR-2021, the subject experienced bad flu. On 08-APR-2021, the subject experienced joint ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from no appetite, and joint ache on 09-APR-2021, and bad flu, and nausea on APR-2021. This report was non-serious.

SORE THROAT; MORE RUNNY DIARRHEA; This spontaneous report received from a patient concerned a 66 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 21-JUN-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced sore throat. On 08-APR-2021, the subject experienced more runny diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore throat on 08-APR-2021, and the outcome of more runny diarrhea was not reported. This report was non-serious.

FLU SYMPTOMS; UPSET STOMACH; HEADACHES; This spontaneous report received from a patient concerned a 66 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Vaccinated at the right arm. No concomitant medications were reported. On an unspecified date, the subject experienced flu symptoms, upset stomach, and headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu symptoms, headaches and upset stomach was not reported. This report was non-serious.

Transcribed from hard copy filled out by Pt who was unable to download to submit---- 4/08 3am: drenched in sweat: VIOLANT headache: SEVERE all-over body aches lasting 24hours. 9am: drenching sweats, nausea, hypersensitivity, hperacusis, overwhelming fatigue, mild nausea. 4/10 : seas, flushing , shaky, lightheaded. 4/11: body tremors, sweats, chills, nausea, diarrhea,. 7pm: tinnitus: severe body aches-diazepam. 4/12: Tinnitus resolved: flushing, profuse diarrhea,: Imodium. 4/313: diarrhea. Polyuria about every 2 hours the entire 6 days, even when taking little to no fluids. No fevers-i never run a fever. When body aches subsided, severe post-op spine and associated leg pain vanished, has not returned.

DIZZINESS; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known other medical condition and not on any medications.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: jj206a21a, and batch number: JJ206A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced dizziness. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on APR-2021, and had not recovered from dizziness, and nausea. This report was non-serious.

It started with flu like symptoms, upset stomach, not feeling well according to my husband who was present, fast onset of vomiting and continued to vomit for 24 hours many times, complete loss of memory for 24 hours, this started around 3:00 p.m. on 3/14/21, started to feel better about 24 hours later. Next event, 4/19/21, 7:30 a.m. had a very bad nose bleed with two large clots coming out of my nose. Nose bleed stopped after about 15 minutes.

My symptoms i had sever headache! Once April 1st Hit! Thats Was the day I Had a Heart stroke at store, i don?t remember anything and once i woke up i was at the hospital, and they told me that i had a heart stroke because i had lots of blood clots in my body. And they told me i vomit and peed myself durong the whole situation i went in store

about 6 days after taking vax she had nausea and vomiting. On 4/11/2021 she had SOB and cramping in her stomach. She went to ER. They did blood work, EKG and Chest-X-RAY. She was told that she did not have the blood disorder that people with the blood clots have after taking the vax. She was released and told to FU w PCP. She still has some nausea that comes and goes and does not feel back to normal.

DIZZINESS; APPETITE WAS POOR THAT THERE WAS DIFFICULTY IN FINISHING A MEAL; FEVER; COUGHING; WEAKNESS; This spontaneous report received from a patient concerned a 66 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: 25-MAY-2021) dose was not reported, administered administered to the right arm, on 29-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-MAR-2021, the subject experienced weakness. On 29-MAR-2021, the subject experienced coughing. On 29-MAR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced dizziness. On 11-APR-2021, the subject experienced appetite was poor that there was difficulty in finishing a meal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 08-APR-2021, and had not recovered from weakness, coughing, appetite was poor that there was difficulty in finishing a meal, and dizziness. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.

LETHARGY; OVERALL ACHES/SORENESS; NO ENERGY; NAUSEA; TIREDNESS; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's past medical history included anxiety/depression, and concurrent conditions included non alcohol user, non smoker, and dry cough, and other pre-existing medical conditions included patient had no known allergies and no drug abuse or illicit drug usage history. the patient was not pregnant at the time of reporting.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805051, and batch number: 1805051 expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021, the subject experienced lethargy. On 27-MAR-2021, the subject experienced overall aches/soreness. On 27-MAR-2021, the subject experienced no energy. On 27-MAR-2021, the subject experienced nausea. On 27-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lethargy, and nausea, and the outcome of overall aches/soreness, tiredness and no energy was not reported. This report was non-serious.

1-2 weeks after dose of vaccine, developed nausea, chills, diarrhea. Presented 1 month after vaccine to ED with embolic strokes and new renal failure.

The evening after the vaccine Developed severe abdominal pain and joint pains This lasted about a week Also developed mild rash and itch the day after the vaccine Had extreme fatigue for about a week The second morning developed what appeared to be swollen blood vessels in both forearms This lasted several hours and went away Went To dr and received fluids and vitamin iv

Diarrhea (persisting) Fatigue (persisting) Vomiting (resolved) Sore arm (resolved) Decreased stamina (persisting)

CHILLS; BLOATING; ITCHING TO LEFT LOWER ARM/LEFT UPPER; SWOLLEN AND TENDERNESS TO LEFT AXILLA TOWARDS BREAST; ACHING IN NECK; NECK SWELLING; MASSIVE HEART ACHE; NAUSEA; FEVER 100.6 F; MASSIVE HEADACHE TO FRONTAL AND TEMPORAL LOBES; RINGING TO LEFT EAR/RIGHT EAR; This spontaneous report received from a patient concerned a 66 year old female. The patient's weight was 117 pounds, and height was 61 inches. The patient's past medical history included pain to arm, inflammation, swollen neck, and fever 102 f, and concurrent conditions included non-smoker, and non-alcohol user, and other pre-existing medical conditions included the patient has no history of drug abuse or drug illicit use. She had a history of severe immune reaction to the Pneumovax (pneumococcal vaccine polysacch 23V) in 2019 which caused excruciating pain to arm and inflammation with swollen neck with 102 F and had to call 911. Paramedics stated stable and not taken to the hospital. The patient also experienced drug allergy when ibuprofen, neomycin, and magnesium sulfate/potassium sulfate/sodium sulfate. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered to the left arm, on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the patient experienced ringing to left ear and right ear. On 01-APR-2021, the patient experienced massive heart ache, massive headache to frontal and temporal lobes, rapid heart rate, pain near sternum that radiated downward, sensation of pressure at breast level, neck swelling, aching in neck, gastrointestinal upset, solar plexus, nausea and fever 100.6 F. On the same day, the patient went to urgent care and was given Zofran 4 mg sublingual. They took the lab at the urgent care. On 01-APR-2021, the patient's laboratory data included: Absolute lymphocyte count (NR: not provided) 0.7 (units not provided), Blood glucose (NR: not provided) 106 mg/dL, Body temperature (NR: not provided) 100.6 F, Chest X-ray (NR: not provided) normal, Complete blood count (NR: not provided) normal, Electrocardiogram (NR: not provided) normal, Heart rate (NR: not provided) Rapid, Lymphocyte count (NR: not provided) 11 % (low), Neutrophils (NR: not provided) 81 % (high), and Troponin I (NR: not provided) normal. On 02-APR-2021, the patient experienced swollen and tenderness to left axilla towards breast. On 05-APR-2021, the patient experienced itching to left lower and upper arm. On 08-APR-2021, the patient experienced bloating, pain from gas and increased changing of bowel habits. On 18-APR-2021, the patient's headache reappeared. On 19-APR-2021, the patient experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ringing to left ear/right ear on 06-APR-2021, aching in neck, neck swelling, and nausea on 01-APR-2021, swollen and tenderness to left axilla towards breast, and itching to left lower arm/left upper on 05-APR-2021, chills on 20-APR-2021, and fever 100.6 f on 02-APR-2021, was recovering from massive headache to frontal and temporal lobes, had not recovered from bloating, and the outcome of massive heart ache was not reported. This report was serious (Other Medically Important Condition). Initial information was received on 20-APR-2021, with additional information obtained via telephone follow up from a patient on 21-APR-2021, the following information was updated and incorporated into the case: events added (Ringing to left ear and right ear).; Sender's Comments: V0 : -covid-19 vaccine ad26.cov2.s -Massive heart ache. 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.

STOMACH HURTS; BODY ACHES; HIVES ON BOTH LEGS; BRUISE ON LEFT WRIST; This spontaneous report received from a patient concerned a 66 year old female. The patient's weight was 107 pounds, and height was 61 inches. The patient's past medical history included cyst on pancreas, and concurrent conditions included severe asthma, high blood pressure, non alcoholic, and smoker, and other pre-existing medical conditions included the patient had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207421A, and batch number: 207421A expiry: UNKNOWN) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. Concomitant medications included fluticasone propionate for drug used for unknown indication, omeprazole for drug used for unknown indication, ibuprofen for pain, budesonide/formoterol fumarate for severe asthma, and diltiazem. On 02-MAY-2021, the subject experienced bruise on left wrist. On 03-MAY-2021, the subject experienced hives on both legs. On 04-MAY-2021, the subject experienced stomach hurts. On 04-MAY-2021, the subject experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hives on both legs, bruise on left wrist, stomach hurts, and body aches. This report was non-serious.

After the vaccine I had a headache. With the headache I became nausea and had serve diarrhea. I was always hot or cold and ran a fever. and also experienced chills. I also did not have a appetite.

I had facial tingling which included the mouth and jaw, and my vision was blurred. I was also a little lightheaded which subsided but did not go away completely. The next day I was better, but I had soreness around the injection site. I also had diarrhea.

BODY ACHES; SORE THROAT; NAUSEA; This spontaneous report received from a patient concerned a 66 year old female. The patient's weight was 161 pounds, and height was not reported. The patient's past medical history included mood change, not sleeping, chest pain, frequent bowel movement, faeces discoloured more orange in color, pain between shoulder blades, faeces soft or sluggish, itching on front leg, unspecified sleep issues, and sweating, and concurrent conditions included acromegaly. The patient was previously treated with acetylsalicylic acid for chest pain; and experienced vulvovaginal swelling when treated with octreotide for acromegaly. 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 01-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included octreotide acetate for acromegaly, cyclobenzaprine hydrochloride, fenofibrate, ibuprofen, macrogol 3350, and tramadol. On JUN-2021, the subject experienced generalised aching. On JUN-2021, the subject experienced sore throat. On JUN-2021, the subject experienced nausea. Laboratory data (dates unspecified) included: Growth hormone stimulation test (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from generalised aching, nausea, and sore throat. This report was non-serious.

CONFIRMED COVID-19 INFECTION (LETHARGIC); CONFIRMED CLINICAL VACCINATION FAILURE; HEADACHE; FEELING WORN OUT; NAUSEA; This spontaneous report received from a patient concerned a 66 year old female of an unknown race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included chronic obstructive pulmonary disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A and expiry: unknown) dose was not reported, 1 total administered on 08-MAR-2021 for prophylactic vaccination. The patient could not recall the vaccination site. Concomitant medications were not reported. On 08-MAR-2021, after the vaccination, patient developed nausea, headache and felt really worn out for 3 days and then the symptoms went away. On 05-JUN-2021, the patient started to feel lethargic, wicked headache and the oxygen kept going low and the pulse rate was high. On 09-JUN-2021, the patient decided to get tested for COVID and the result went positive. The patient had confirmed clinical vaccination failure. Patient was hospitalised until 12-JUN-2021 and was probably to be discharged the next day. Patient stated that was taking a lot of medications including prednisone, antiviral and anti-bacterial drugs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, feeling worn out, and nausea on 11-MAR-2021, and the outcome of confirmed clinical vaccination failure and confirmed covid-19 infection (lethargic) was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000182633. The suspected product quality complaint has been confirmed to be not voided based on the PQC evaluation/investigation performed.; Sender's Comments: V0;20210626624-covid-19 vaccine ad26.cov2.s -confirmed clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS V0;20210626624-covid-19 vaccine ad26.cov2.s -confirmed covid-19 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

On May 27th, I had an episode of double vision and light headedness and my blood pressure was up. Not quite confusion but just strange. They thought it might be a mini stroke - so I had an MRI or MRA - showed vascular changes but showed no acute stroke and carotids were okay. Also did an EKG with some changes and a repeat EKG - and that one seemed like a normal EKG. I had an echocardiogram - on Tuesday; Coronary CT on Wednesday and radiologist called my primary care doctor and said there was a "broken glass" opaqueness (opacity) of left upper lobe. This Wednesday with the chest x-ray, I'm concerned - I have been short of breath and tired lately - just not feeling good. On May 28th, I started Lisinopril for blood pressure and also started aspirin. My blood pressure is still fluctuating. I'm waiting for a lung CT to be scheduled - Pulmonary function study to be schedule and that's a couple of weeks out. I haven't had another episode of double vision. Fatigue and short of breath and I have had some diarrhea. I had had some weird GI stuff all winter long but it restarted (diarrhea) 2 weeks ago. I hadn't had it for four months or so.

Instant headache and pain shooting down arm and side while being injected, sick feeling and light headed right as I was leaving the facility. Within 4 hours I was struggling to do anything. I was tired and felt and nauseated, light headed and felt like i was hit by a truck. The bottoms of my feet hurt and I had stabbing pains so bad in my knee joints I could barely walk without assistance. I felt very ill for about a week after the shot but the headaches continued constantly for over a month but aren't daily anymore even though I still have them, and the fatigue was getting worse and still is a problem to this day. Once I was feeling a bit better my right knee started to give out and my left knee was cracking. Since I got that vaccine on 3/6/21 I have had back to back problems. Below is a quick list of these things that have occurred by dates: 3/30/21 - Constant headaches since the vaccine and ear pain and throat issues. 4/16/21 - Right knee giving out on me that started shortly after vaccine and gotten worse. X-ray and physical therapy ordered. 4/22/21 - Shortness of breath, back pain, constant fatigue. Blood work that showed elevated D-dimer then chest x-ray and ct-scan ordered. 4/26/21 - Ultrasound for nodule found on ct-scan. 5/4/21 - Biopsy done of mediastinal mass. 5/11/21 - Physical done for surgery. 5/24/21 - Surgery to remove mediastinal mass, right side of thyroid, two parathyroids and lymph nodes. 6/1/21 - Follow-up for surgery. When I asked why this happened, the doctor said we may never know but the biopsy of the right thyroid nodule result showed thyroiditis, Autoimmune/Hashimoto's, and that my immune system attacked my thyroid. The doctor said she tested me for that in 9/20 and it was negative. 6/2/21 - Left knee pain. About 4 days after my surgery on 5/24 i turned towards the door and heard a loud pop in my left knee. It had been crackling since the vaccine but wasn't giving out like the right one. I couldn't walk on it at all and was using crutches. 6/9/21 - Mri on left knee showed medial and lateral meniscus tears. Referred to Ortho Dr. 6/28/21 - Test thyroid levels post op. TSH levels high. Referral to Endocrinologist. 6/30/21 - Left knee treatment, cortisone shot in knee for now to help with pain and inflammation so I can function and physical therapy. Since then my 4th toe on my right foot has been numb for almost two weeks. I am scheduled for numerous future physical therapy appointments and doctors appointments. Then to make matters worse I just heard 2 days ago that J&J is having more issues and mentioned autoimmune and wondered could that be what caused all of this? I regret getting that stupid J&J vaccine. I expected it to he the Pfizer because that is what was there 2 days before I got my shot. I told the person I didn't want it and she got someone in charge to talk me into it. I should have walked out of there and I am mad at myself for caving to this woman. If J&J says we need a booster I will refuse to take it. I don't know if the vaccine was what triggered all of this but I find it quite odd that all of this started almost immediately after I got that vaccine. Not only to me but also to my sister who got it at the same time. She fell within 30 minutes of getting that vaccine and 3 more times that day, and has had and is still having numerous problems that mimic mine, such as issues with her feet and legs. She struggles to walk and is having issues with her thyroid among other things that she wasn't having a problem with prior to the vaccine. This is just the short version of all I have been through. Any questions feel free to contact me.

Numbness of extremities, flu, loss of appetite, headache, sluggishness, joint pain, loss of coordination, and confusion.

BLOOD CLOT IN ABDOMEN AND EXTREMITIES; ANEURYSM CLOTS IN THE ABDOMEN; LOSS OF MOBILITY; LOSS OF APPETITE; HEADACHE; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. . The patient's past medical history included stent placed on lower extremities few years ago, and concurrent conditions included former smoker, cardiac issues, non-alcoholic and racing heart, and COPD (Chronic obstructive pulmonary disease) and other pre-existing medical conditions included no known allergies and patient does not abuse drug or illicit drug usage On 03-May-2021, the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: Unknown) frequency 1 total, dose was not reported, administered on right deltoid for prophylactic vaccination. Concomitant medications included rivaroxaban, and sildenafil. On 04-JUN-2021, the patient experienced blood clot in abdomen and extremities, aneurysm clots in the abdomen, loss of mobility, loss of appetite and headache. The patient though the pain was due to medicines she had for cardiac disorder. The pain worsened to the point she went to her gastro intestinal doctor, who did CT scan which showed aneurysm. Her Doctor called cardiologist who suggested referral to a vascular surgeon. The vascular surgeon discovered more blood clots in the abdomen. The CT scan with contrast and Doppler studies were performed. The patient was on blood thinners for 3-4 months. The medicines were started prior to vaccination. None of the doctors were aware that she has taken the Johnson vaccine. The patient stated that she had all the side effects. On 28-JUN-2021, Laboratory data included: Oxygen consumption (NR: not provided) increased. On 28-JUN-2021, Laboratory data included: CT scan (NR: not provided) CT scan with contrast showed clots in abdomen and extremities. On 30-Jun-2021, the patient experienced aneurysm clots in the abdomen. Laboratory data (dates unspecified) included: CT scan (NR: not provided) Not reported, and Ultrasound Doppler (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot in abdomen and extremities, headache, loss of appetite, and loss of mobility, and the outcome of aneurysm clots in the abdomen was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210716346-covid-19 vaccine ad26.cov2.s-Thrombosis. 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

Overnight on the 6th - muscle aches, chills, fever, headache, weakness. Starting on Sunday morning the 7th - bad nausea all day with vomiting for 12 hours. Barely able to have an ice chip.

At the time of the injection neck and arm were painful-fingers tingled. At about 60 minutes became dizzy, headache, About 2 hours after injection body aches, nausea, feeling very tired, teeth began to ache, all over joint pain About 9 hours after injection - low grade fever (~100* F.) and chills

Fever on the night of vaccination. Body aches that felt like every bone in my body hurt. Tylenol did not control the fever. Body aches lasted three weeks. Fever lasted about 4 days. No appetite, diarrhea. Sill lack of appetite and run down and nothing tastes good. The fatigue is lingering. The breathing and low oxygen levels are still causing problems since the first dose.

injection site becoming sore and tender. little headache, really tired. low energy, nausea. This is all very unusual for me.

Patient complained of feeling nausea and warm "flushed" apprx 15 mins post vaccine. VS HR 74, RR 17, O2 95, 100/60, wheeled patient outside for fresh air. Patient improved. Left walking to car with family members.

Severe pain in hips and lower back like passing a kidney stone, severe bone pain in chest area, could not sleep for 2 nights and then slept 12 straight hours, headache and blood pressure spike on 3/14 resulting in ER trip with bp at 204/100. Anxious and nervous with low appetite.

24 hours after vaccine, hard lump, swollen and pink, moderate chills. The next day, bigger lump, swollen, all just below injection and red, moderate chills, a bit itchy, nausea., and painful. Same on 3rd day but much bigger redness spreading down arm, 2 1/2 by 2 1/2' hard mass and red, itchy, painful, chills and nausea. Next morning called Dr. I am taking amoxicillin-clav 875-125ng tab. Three days later mass is turning from red to pink and retreating. Still hurts and now bruses show around the injection site, which I thought was strange. The vaccine actually hurt when given (I get injections every three months, so I know what they will feel like, but this hurt and went very deeply and then burned). I felt warm afterwards for about 10 minutes.

On day 11 post shot I started to feel mildly nauseated. Next day nausea increased, as did muscle aches and pain - by early evening I had repeated bouts of uncontrollable vomiting and uncontrollable diarrhea [no cramps, no warning] that lasted most of the night. I did have a fever briefly - got all red and felt like I was on fire - but that passed pretty quickly while the rest continued. I had to stay up all night, any attempt to lie down triggered more vomiting. By 3 in the morning I was ?on empty? and by 6 am could lie down. Nausea took three more days to leave completely. Muscle pain is resolving, almost gone. I am resuming my meds [everything that went down before came right back up]. The only tummy pain was after hours of vomiting [muscle strain]. Today is the 25th and I?m still tired and a bit foggy but otherwise feel better. I had a call with my doctor about this and she said I should report it so that?s what I?m doing.

Prior to vaccination, the patient stated that she was nervous, but seemed relieved and okay directly following the vaccination. Following vaccination, patient became restless during the 15 minute post-vaccination window about 2-5 minutes after receiving the vaccine. She initially presented with uncontrollable shaking/bouncing legs, palpitation, sweating, and shortness of breath (though this was very brief. Patient remained coherent and oriented to time/person/place. The shaking and palpitations subsided after a couple minutes and resumed towards the end of the 15 minute waiting period, accompanied by nausea. 25 minutes post-vaccination she appeared to have stabilized, and we assisted the patient to her room nearby at her request to allow her to lie down while being monitored. After returning to her room, she very quickly ran to her sink due to her nausea, then after a minute of attempting to vomit, she collapsed and appeared to have briefly lost consciousness. EMS was called and the patient was rolled onto her side to prevent choking in the event of emesis. Patient remained responsive, but was weak and clammy with a weak pulse and breathing. After the firefighters came, a search of the apartment found the previously listed medications. Additionally, the patient experienced a seizure-like episode lasting 15 seconds in duration. Once the EMT came, they assessed her and monitored her in the ambulance; they reported that her condition appeared stable, her vitals were strong, and transported her to Hospital for observation/testing.

Started with a runny nose next day, 3rd day had Severe migraine on the right side of the head with blurred vision and eye pain, light sensitivity and swelling of face, the base of the neck and at the site of injection and behind shoulderblade, Numbness of lips and burning mouth, Ongoing nausea, and upset gastrointestinal issues. Low-grade fever and chills, tremors in both arms and hands, upset stomach Still have nausea and headache, body pains,, tremors, and strong fatigue. issues

I got the vaccine at 11:30 a.m. About 8:30 p.m., I started to feel achy. At 9:30 p.m. I felt really achy. At 10:00 p.m. I had slight chills, and my hands felt colder than I had ever felt them before. At 10:30 p.m., I felt slightly nauseous. I went to bed then. When I woke up the next morning about 7:30 a.m., my body felt fine, but my brain was a bit foggy. This continued until about 12:00 p.m. After that, I was fine.

3/11/21: 11:05 AM - Pressure in chest lasting 8 hours; 9:00 PM- chest pressure gone, body chills began; 12:30 AM - fever of 101.3 F; loss of appetite 3/12/21: 8:30 AM - Fever reduced to 99.5 F (no treatment taken) ; attempted normal daily activities; loss of appetite; 6:30 PM- extreme fatigue and dizziness, no appetite, slept 12 hours with night sweats 3/13/21: 8:30 AM -Fever gone, sweats gone; extreme fatigue lasting 24 hours; no appetite 3/14/21: 8:30 AM - Appetite returning, still tired, but functioning some daily routines; slept 12 hours 3/15/21: 8:30 AM - Appetite returned, normal daily activities achieved

Heart rate increased within 5 minutes of having the shot, went from 72 to 114. My heart rate stayed at 109 or more until 10 PM the next night when its slowly went down to a normal heart rate. At 3 am (12 hours after the shot) i had a blinding debilitating headache that lasted until 9pm the next night. It also affected my vision. The headache was so bad i could not concentrate on the simplest task. I was unsure of what i could take for the headache. So, I did not take anything. When i woke up i was very tired and this lasted until the following day. 6am i had a fever of 102.3 this went down to 100.4 at 9:15 pm that night. I also had chills for several hours. 9:20 AM the nausea started followed by vomiting and dizziness. This only lasted for a few hours. I experienced very vivid dreams the night of the shot. I only drank some coconut water all day and could not eat any food. The next day Saturday March 27 i felt better but the fatigue did not go away until late in the evening. Sleeping seemed to help but i could only sleep for 2- 3 hours at the most.

After receiving vaccine, i started to feel headache then extreme nausea, body aches, dizzy, feeling like i'm going to pass out I went to ER at the Hospital the next day, so so sick

Dizziness, light-headed, nausea, sweating, pale skin. The patient was observed and given water and orange juice for 25-30 minutes. She felt well enough to leave the pharmacy on her own after 25-30 minutes. The patient had a prior history of anxiety prior to receiving vaccinations and was very nervous about getting the vaccination prior to administration. The patients daughter was with her and felt that her symptoms were due to anxiety about getting vaccinated, but later called the pharmacy asking to report the adverse events as being related to receiving the vaccine. It is not known weather or not the symptoms are directly related to the vaccine.

Woke with body aches,102.6 fever,horrible headache. Lasted the whole day after injection. Around 5:30 pm I started feeling whoozy and passed out. Neighbor couldn't bring me around. 911 was called. I started vomiting and very nauseous by 6:00 pm. All vitals were ok by medics. I went in my house,went to sleep and woke the next day fine. Wasn't sure about the passing out and vomiting, nor the fever for the day being normal.

About an hour after having the shot, I was nauseous, dizzy and light headed, I thought I was going to pass out. I had to lay down. My eyes swelled and they started to tear up, I felt weak all day and into the evening. I never had a bad reaction to a vaccine before, so this was surprising. I contacted the health department as they came to my house and gave me the shot, but I could not get through to anyone. I had to leave a message. After I was contacted back, I was told that someone would contact me that very same day, but no one ever did that day or any other day. .Because of that, I thought it must not have been a big deal, but after reading today that people in a specific had some of the same reactions I did, I thought I should report it.

NAUSEA, VOMITTING, HEADACHE. STARTED ABOUT 13 HOURS AFTER INJECTION. UNABLE TO HOLD ANY FOOD OR LIQUIDS FOR 24 HOURS, STILL NAUSEA AND TIRED, PLUS HEADACHE 36 HOURS POST INJECTION.

3/6/2021- received vaccination. 3/9/2021 didn?t feel good 3/12/2012 went to q clinic and got a Covid-19 test and flue test. Both negative and was sent home. 3/15/2021 Doctor sent me to get a x ray, diagnosis pneumonia. Symptoms: Fever, Headaches, rash under both breast, muscle aches, nausea, fatigue, loss of appetite As of 4/12 2021 I am still nauseated , and fatigued

Received the vaccine on the 9th of April. In the middle of the night started feeling badly. a bit of nausea, headache, body aches and a fever. Stayed in bed most of the day on Saturday and went to bed early on Saturday. Woke up Sunday completely soaked from head to tail. I have never broke a sweat like that before. Felt a bit better, but still not great all day Sunday. Monday I got up and felt better. Had lots of things to do and when I returned home I mowed the lawn. It totally wiped me out, which it never does. I was sweating bullets and extremely thirsty. Today I feel better.

BODY ACHES; LIGHT HEADEDNESS; DIARRHEA; FULL BLOWN FLU; CHILLS; HEADACHE; NAUSEA; FATIGUE; APPETITE LOST; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included cigarette smoker, and other pre-existing medical conditions included the patient has no known allergies. The patient was previously treated with escitalopram, atorvastatin calcium, and vitamins nos. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031,expiry:UNKNOWN) dose was not reported, administered on 11-MAR-2021 16:30 for prophylactic vaccination. Concomitant medications included alprazolam, and nicotine. On 11-MAR-2021, the subject experienced appetite lost. On 11-MAR-2021, the subject experienced fatigue. On 12-MAR-2021 02:30, the subject experienced body aches. On 12-MAR-2021 02:30, the subject experienced light headedness. On 12-MAR-2021 02:30, the subject experienced diarrhea. On 12-MAR-2021 02:30, the subject experienced full blown flu. On 12-MAR-2021 02:30, the subject experienced chills. On 12-MAR-2021 02:30, the subject experienced headache. On 12-MAR-2021 02:30, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, light headedness, diarrhea, full blown flu, appetite lost, chills, headache, and nausea on 18-MAR-2021, and had not recovered from fatigue. This report was non-serious.

March 8th: After inj., floaters in eyes, slight dizziness, felt warm. Water given, observation by staff approx 30min. Nurse escorted me out of building for extra precautions. April 9th: Stomach cramping, headache left side. 400mg IBU taken. April 10th bi-lateral edema , lower legs, right sided headache. 400mg IBU taken and elevated legs. April 11th: slight stomach cramping returned, with excessive flatulence. April 12th: Tingling in lower legs, edema diminished.

I experienced moderate pain in calves beginning evening of 3/18/21, & sporadically since then. I began having moderate lower abdominal pain on 3/19/21, lasting approximately 24 hrs.

Severe headaches, A little nausea, Upset stomach, Heart racing, and I think it made my diazepam and the stuff I take for my restless legs stop working. As my tremors from the withdrawals I have from Valium I?ve gotten worse, and my doctor switched me to another medication for restless legs. Cold all the time.

Strange odor a few minutes after injection, followed by bitter taste, then nausea and spaciness. Dizzyness, with vision looking 2D and flat by 15 minutes. Told Pharmacist, of spaciness who said stay as long as I wanted. Left at 30 minute point, still spacy and nauseous. Spaciness ended by an hour with nausea off and on. Chest pain - began around 7pm, continued to expand in area of chest, sharp stabbing pain later, pain from just above left elbow to hand and tingling of fingers, pain lower left leg and tingling of left foot. Irregular heart rate at different times. Checked into emergency room at 11:00. IV inserted, placed on continual heart and oxygen monitors, EKGs, chest X-rays (2), blood tests (3). Admitted to hospital sometime during the night. Given IV medications to counteract IV contrast allergy. These medications caused full body shakes, eyesight auras and extreme nausea with gagging. Heart CT taken with IV contrast. Discharged around 3:00 PM.

HARD KNOT AT INJECTION SITE; FLUSHING; DIZZINESS; RED SWELLING AT INJECTION SITE; NAUSEA; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included non smoker, and non alcohol user.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced hard knot at injection site. On APR-2021, the subject experienced flushing. On APR-2021, the subject experienced dizziness. On APR-2021, the subject experienced red swelling at injection site. On APR-2021, the subject experienced nausea. Laboratory data (dates unspecified) included: Chest 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 nausea, hard knot at injection site, flushing, dizziness, and red swelling at injection site. This report was non-serious.

HEADACHE; BODY ACHES; FEVER; SHAKINESS/TREMBLING; CHILLS; NAUSEA; TIRED; This spontaneous report received from a patient concerned a 67 year old female. The patient's weight was 58.96 kilograms, and height was 158.49 centimeters. The patient's concurrent conditions included non alcoholic, and nonsmoker, and other pre-existing medical conditions included the patient had no known drug allergies. the patient had no illicit drug usage. the patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 10:25 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: ibuprofen. On 10-MAR-2021, the subject experienced shakiness/trembling. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced nausea. On 10-MAR-2021, the subject experienced tired. Laboratory data included: Body temperature (NR: not provided) 101.7 F. On 10-MAR-2021 22:48, the subject experienced body aches. On 10-MAR-2021 22:48, the subject experienced fever. On an unspecified date, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shakiness/trembling, chills, fever, nausea, and tired on 12-MAR-2021, and the outcome of body aches and headache was not reported. This report was non-serious.

ROOF OF MOUTH ITCHED; FEELS LIKE FACE (JAW) HURTS; DIZZINESS WHEN GOT UP AT NIGHT; CHILLS; THROBBING HEADACHE; NAUSEA; FEVER; SHAKING FROM INSIDE; KEPT GETTING UP EVERY HOUR AT NIGHT; BURNED AT INJECTION SITE; HAVING DIFFICULTY FALLING BACK TO SLEEP WHEN WOKE UP AT NIGHT; This spontaneous report received from a patient. The patient's concurrent conditions included non hodgkin's lymphoma, non-smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no known allergies and did not had any drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced shaking from inside. On 19-MAR-2021, the subject experienced kept getting up every hour at night. On 19-MAR-2021, the subject experienced burned at injection site. On 19-MAR-2021, the subject experienced having difficulty falling back to sleep when woke up at night. On 19-MAR-2021, the subject experienced dizziness when got up at night. On 19-MAR-2021, the subject experienced chills. On 19-MAR-2021, the subject experienced throbbing headache. On 19-MAR-2021, the subject experienced nausea. On 19-MAR-2021, the subject experienced fever. On 19-MAR-2021 23:30, Laboratory data included: Body temperature (NR: not provided) 101.1 F. On 20-MAR-2021, the subject experienced feels like face (jaw) hurts. On 20-MAR-2021, the subject experienced roof of mouth itched. Laboratory data included: Body temperature (NR: not provided) 100.2 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking from inside on 21-MAR-2021, kept getting up every hour at night, having difficulty falling back to sleep when woke up at night, feels like face (jaw) hurts, dizziness when got up at night, roof of mouth itched, throbbing headache, nausea, and fever on 21-MAR-2021 09:00, and chills on 20-MAR-2021, and the outcome of burned at injection site was not reported. This report was non-serious.

FELT LIKE SHE WAS ON ACID TRIP/HER PHYSICAL BODY WAS FUNKY/WAS BIZARRE; CHILLS; FEVERISH; NAUSEA; HALLUCINATION; MORE SEVERE HEADACHE; This spontaneous report received from a consumer via company representative concerned a 67 year old female. The patient's height, and weight were not reported. The patient's past medical history included concussion. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, 1 total, start therapy date were not reported 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. It was reported that, after vaccination the patient experienced chills, feverish, headache, and nausea. On 10-APR-2021 (in the middle of the night), the patient started hallucinating with a more severe headache and she felt like she was on an acid trip and her physical body was funky. The patient felt like she wanted to stretch her muscles but felt like she did not have control. At the time of this report, the patient said it was bizarre. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from more severe headache, and hallucination, and the outcome of feverish, chills, nausea and felt like she was on acid trip/her physical body was funky/was bizarre was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: covid-19 vaccine ad26.cov2.s-Hallucination. 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

I got the J&J vaccine around noon on Wednesday, April 17. Shortly after noon on Thursday, April 18, I started having very severe abdominal pain that lasted well into the night. The only thing I can remotely compare it to is extremely severe gas pain. I did take simethicone in case it was gas -- but that did nothing & the pain lasted 10 hrs or so. The pain subsided by the following day but my abdomen was sore internally. This was NOT listed in the FACT SHEET that I was given after vaccination. The deep pink sheet listed: Injection site reactions, General side effects, Difficult breathing, Swelling of face & throat, etc.

RASH RESEMBLING A SUN BURN; DIARRHEA; BODY ACHE; CHILLS; FEVER; ASTHMA; RESTLESS LEG SYNDROME; MIGRANE; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy. The patient experienced drug allergy when treated with cortisone for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced asthma. On 08-MAR-2021, the subject experienced restless leg syndrome. On 08-MAR-2021, the subject experienced migrane. On 08-MAR-2021, the subject experienced chills. On 08-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced rash resembling a sun burn. On 09-MAR-2021, the subject experienced diarrhea. On 09-MAR-2021, the subject experienced body ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from asthma, and migrane on 08-MAR-2021, and restless leg syndrome, body ache, and fever on 09-MAR-2021, had not recovered from rash resembling a sun burn, and diarrhea, and the outcome of chills was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.

DISCOMFORT OF THE JAW; DISCOMFORT OF THE TEETH; ABDOMINAL PAIN; MODERATE HEADACHE; This spontaneous report received from a consumer concerned a 67 year old female. 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 any medical history 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: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, the subject experienced moderate headache. On 31-MAR-2021, the subject experienced abdominal pain. On 12-APR-2021, the subject experienced discomfort of the jaw. On 12-APR-2021, the subject experienced discomfort of the teeth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from abdominal pain, was recovering from moderate headache, and the outcome of discomfort of the jaw and discomfort of the teeth was not reported. This report was non-serious. This case, from the same reporter is linked to 20210445480.

101.2 fever for four days with weakness for two weeks - 14 days. Since then, I have had virus symptoms every four or five days, such as aching joints, lethargy, muscle pain, and nausea that lasts about 48 hours each time. Then it clears up and I feel better for a few days, then it comes back. I haven't felt well since the shot.

Cold chills the first day, then 2 weeks of explosive liquid diarrhea. Also, a very, very upset stomach.

DIARRHEA; BODY ACHES; HEADACHES; This spontaneous report received from a consumer concerned a 67 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1812072 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced diarrhea. On 13-MAR-2021, the subject experienced body aches. On 13-MAR-2021, the subject experienced headaches. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from headaches, diarrhea, and body aches. This report was non-serious.

12 hours after vaccine started to have congestion, hives/welts (50-cent piece size) on head, neck and chest, itching, difficulty breathing, "bronchial asthma-type symptoms", GI cramping, throat felt like it was closing. She is still having difficulty breathing, congestion, itching, and hives are still present.

48 hours of severe chills, rigors, fevers, severe headache, severe joint pains in all joints, full body muscle aches, nausea, loss of appetite, severe fatigue. Tylenol and Advil prn. (Note: I had monoclonal antibody IV 2/5/21, was told to wait 90 days which I did. These symptoms are exactly why I got those antibodies. I am a retired Nurse Practitioner in Internal Medicine. Why is the CDC and government official NO recognizing and giving credit for natural antibodies. I've had covid 19, monoclonal antibodies, there is herd immunity, and yet you want EVERYONE to get vaccinated. Very poor judgement for the cdc and government official. You wonder why people don't trust both of them? What if I had died or had resulting health conditions because of what I just went thru? I will never trust either again and will recommend others NOT get the vaccine. We don't even know what permanent disability or damage may come from this.

HIGH BLOOD PRESSURE; HEART PALPITATION; SEVERE DIARRHEA; HEADACHE/THROBBING IN THE TEMPLES; TIRED; INJECTION SITE PAIN; VOMITING/THROWING UP; SICK; FELL ASLEEP; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's past medical history included adverse reaction to beta blockers, and concurrent conditions included blood pressure, and hypersensitive to drugs, and other pre-existing medical conditions included the patient had adverse reaction to beta blockers. The patient had 15 medicinal allergies and reaction to drugs. 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, 1 in total administered at left arm on 03-APR-2021 for prophylactic vaccination. Non-company suspect drugs included: nebivolol hydrochloride (form of admin, route of admin, and batch number were not reported) 5 mg, frequency was not reported, from 2021, and 2.5 mg, frequency, and therapy dates were not reported for high blood pressure; and losartan (form of admin, route of admin, and batch number were not reported) 25 mg, 2 times every 1 day, from 2021 for high blood pressure. No concomitant medications were reported. On 03-APR-2021 (on the day of injection), the patient had injection site pain on the day of injection. On 05-APR-2021, the patient starred to getting tired. On 07-APR-2021 or 08-APR-2021, the patient woke up with heart palpitation, throbbing in the temples and diarrhea. Were on vacation, left and came home, still did not feel good, went to urgent care on 11-APR-2021 and blood pressure was 190/100 mmHg. The patient have had blood pressure before, but had been controlled for years until this. Went to cardiologist twice, gave her another medication (carvedilol) which did not bring it down. Carvedilol increased her blood pressure. She was taking 3.175 in morning and 3.175 at night. The patient was tried another medication Bystolic 5 mg that did not bring it down. Cardiologist said they could not do anything else for patient. Referred to a nephrologist that she was not seen yet. No tests from the nephrologist yet. Kidneys were working fine. Meanwhile went to her primary care 3 times, tried on 2 other medications but blood pressure didn't come down. primary care physician lowered the Bystolic to 2.5 mg because she was getting sick from it. Started Losartan 25 mg morning and 25 mg at night, started getting headache. Last night she started getting headaches and throwing up which she said were side effects of the losartan. She went to emergency room on 09-MAY-2021 blood pressure was 215/105 mmHg and kidney was fine, heart was fine, all tests were good (coded as unspecified lab test) and emergency room physician gave her clonidine 0.1 and blood pressure went really low to 129 mmHg over something and she got really sick. They gave her a prescription of clonidine. Family physician told her to take 1/2 of the clonidine if her blood pressure was over 190. On 15-MAY-2021, the patient went to emergency room again because the heart rate was higher (95 ) usually was 60 and blood pressure was 210 over 99 mmHg. She took 1/4 of clonidine and it did drop it down to 160/79 mmHg. She took 1/4 of Xanax and fell asleep. She woke up with severe diarrhea and threw up. Medications included 1/4 Losartan last night. 20 mg Enalapril (original medication) and Hydrochlorothiazide 25 mg and xanax and blood pressure didn't come down. She was taking a 3 course medication therapy all along. For 5 weeks she had been housebound, tryied different medications, throwing up, diarrhea, and xanax tried to bring it down blood pressure right now 188/ 86 mmHg. The patient had been taking the blood pressure medicine and diuretic and a quarter of the Xanax . Her usual BP was 130/140 over 70 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with nebivolol hydrochloride, and losartan was not reported. The patient was recovering from high blood pressure, and the outcome of injection site pain, headache/throbbing in the temples, heart palpitation, severe diarrhea, vomiting/throwing up, tired, sick and fell asleep was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210529638--High blood pressure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY

5-3-2021: at 11:54 am got J&J Covid-19 vaccine at Pharmacy. No anaphylaxis or other severe reactions within first four hours. By 8:00 pm began feeling fatigued and generally warm. No nausea or vomiting. By 11:00 pm developed diffuse soreness of left deltoid at injection site, mild chilling, muscle aches, T 98.8. Then developed severe shaking chills and profuse sweating, generalized, systemic burning sensation, nausea, light-headedness. This reaction lasted through the night, about 8 hrs. I spent 5-4-2021 in bed, and started feeling a bit better by 7:00 pm. By the next day felt very weak, light-headed and tired, and a little short of breath with movement. By 5-8-2021 felt pretty much back to normal, but tired. Arm soreness resolved. Reported reaction to my MD.

Bleeding from rectum, as though having a period, for about 5 to 10 minutes with spotting before and after then nothing

STOMACH CRAMPS; BODY FEELS LIKE BREAKING DOWN RAPIDLY WITHOUT THE MEDICINE; DIARRHOEA; PUS IN BODY; This spontaneous report received from a patient concerned a 67 year old female. The patient's weight was 195 pounds, and height was 164 centimeters. The patient's concurrent conditions included crohn's disease, non alcoholic, non smoker, diabetes, blood pressure, cholesterol, and vertigo, and other pre-existing medical conditions included the patient had no history of allergies and drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The patient received ustekinumab (solution for injection, intravenous, batch number: UNKNOWN expiry: UNKNOWN) 90 mg, 1 time every 10 months, therapy dates were not reported for drug used for unknown indication. No concomitant medications were reported. On an unspecified date, the subject experienced stomach cramps, body feels like breaking down rapidly without the medicine, diarrhoea, and pus in body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with ustekinumab was not reported. The outcome of the body feels like breaking down rapidly without the medicine, stomach cramps, diarrhoea and pus in body was not reported. This report was non-serious.; Sender's Comments: V1: Medical assessment comment not required as per standard procedure as case assessed as non serious.

Felt great @ post injection. 9pm took 2 Melatonin & drank small cup hot Sleepy Time tea.. Went to bed. At 11:30 pm still not asleep. Restless & uncomfortable. 1:40 am woke up with terrible whole body muscle aches, sore belly, flatulence, gas, migraine-like headache, C5 & C6 neck pain, occasional leg cramping. Felt like I had the flu. Got out of bed & sat in recliner with quilt over me. After a bit started feeling a little better. Went back to bed @ 3 am. Still had a rough time getting back to sleep. Very uncomfortable. Got up @ 5am. Still have intense total-body aches, neck pain, headache, fever 100.1 Drinking a lot of water. Took 2 / 500mg Acetaminophen

Janssen covid-19 vaccine EUA - side effects 1. head 'fog' 2. voracious hunger [i've NE:VER had a flu vaccine] 21 hours in i'm still starving . what's the cure? 15 hours later I woke up at 6 a.m. because I was starving I had to make myself eggs and toast. 17 hours " I had a bagel. 18 hours " I made meatballs I was eating them like candy. [albeit my meatballs are delish carmelized onions, roasted garlic, basil, pesto...yum] I feel drugged. [ it's like a trip from the 70s flashback]. I feel weird. closest thing is dizzy but not dizzy just weird, very weird. head/brain fuzzy . The munchies continue. I never heard of these side effects before we'll see how long they last. only a pale yellow bruise where the injection went in. minimal arm soreness if any , no rash. I got a 12-page booklet for taking the vaccine yesterday I'm going to report the symptoms to the CDC, Johnson & Johnson janssen and whoever else wants to hear about them there's a big long list in the pamphlet they gave me. Maybe there's a cure. I hope it doesn't last too long I'll run out of food. 6 hours later I've got the munchies I'm eating everything in sight for dinner I had soup, two salad,s a steak, dessert and pretzels. I've never eaten that much ever. 4 hours down I started getting super hungry but I thought it was cuz I barely ate breakfast and lunch cuz I didn't know how this was going to react. I still don't feel a thing in the arm. yay hope it sticks. I can't even see where they gave me the shot. I will admit the shot did hurt a little when it went in, I don't know if it's cuz she pushed the plunger fast, or if it was cold from the refrigerator or what but I definitely felt a little something with it going in but not since. I realized that when I went into the hospital out building to get the vaccine I was talking to the nurse for a while because they had to go get my vaccine and she was telling me that three of her family members got the Johnson & Johnson and they didn't feel a thing, no sore arm no fever no nothing so I'm hoping that subliminally I absorbed that and that's why I'm having such a favorable results cuz I think I was really expecting something or other. Even though I know someone who got the jnj & didn't have a problem. I did my own research and nobody under 50 has had a problem and even those people had medical conditions and we're taking prescription drugs and so on which is not my case we'll see. The first hour has passed no rash, no soreness of arm nothing I'm a little bit surprised happily.

inflamed psoriatic arthritis, Very sore muscles , chills, rash, fatigue, stomach upset since march 10, 2021

PROFUSE SWEATING; FELT LIKE I WANTED TO PASS OUT AND DIZZINESS; FEEL ICKY ALL OVER MY BODY AND FEELING CRAPPY; NO APPETITE; RACING HEART; DON'T FEEL WELL AND ILL ALL OVER; VERY WEAK; HEADACHES; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's past medical history included severe nausea, and heart race, and concurrent conditions included depression, penicillin allergy, non alcohol user, and non smoker. The patient experienced drug allergy when treated with ciprofloxacin, erythromycin, and sulfacetamide sodium/sulfadiazine/sulfadimidine/sulfamerazine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1821286 expiry: UNKNOWN) dose was not reported, administered on 06-JUN-2021 13:30 for prophylactic vaccination. Concomitant medications included citalopram for depression. On 06-JUN-2021, the subject experienced profuse sweating. On 06-JUN-2021, the subject experienced felt like i wanted to pass out and dizziness. On 06-JUN-2021, the subject experienced feel icky all over my body and feeling crappy. On 06-JUN-2021, the subject experienced no appetite. On 06-JUN-2021, the subject experienced racing heart. On 06-JUN-2021, the subject experienced don't feel well and ill all over. On 06-JUN-2021, the subject experienced very weak. On 06-JUN-2021, the subject experienced headaches. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from profuse sweating, felt like i wanted to pass out and dizziness, racing heart, and headaches, and had not recovered from don't feel well and ill all over, very weak, feel icky all over my body and feeling crappy, and no appetite. This report was non-serious.

6/20/21 Diarhea at 4 am. 6/11/21 Diarhea at 6 am. 6/12/21 Severe Diarhea, nausea, headache, extremely tired beginning at 6am. This lasted till 6/13/21 .

On 6/7/2021- UTI, had to get antibiotics On 6/10/2021- CT scan, diverticulitis, antibiotics again On 6/26/2021-throat and ear infection, antibiotics

feeling very tired (within 25 min), headache (within 3 hrs) worsened over the next several hours, muscle aches (within 8 hrs) worsened in time, fever (@100 dgs) with chills (within 8hrs), runny nose, watery eyes and dry mouth (within 8hrs), sinus pain (dry) and loss of appetite Called advice line @ 7am on 3/7/21 to see if I could take Ibuprophen (yes) and that helped. All side effects subsided in @ 36 hours.

Low-grade fever and fatigue, followed by increased fever and chills. Nausea & diarrhea. Severe headache. All symptoms continued throughout the night. Severe headache persisted until following day. Ibuprofen taken to relieve headache. All symptoms were diminished by that time.

Approximately 2 hours afterwards?intense sweating Later that evening?Nausea, body aches, fever, headache

Nausea then headache at 5:00 pm. Progressively worse all night unable to sleep with bossy aches chills and fever all the next day. It almost 9:00 hopefully this stops tomorrow

Excruciating headache, nausea, dry cough - entered emergency room around 11:00am driven by my husband treatment at nearest Emergency Room, Fluids given to me intraveniously mixed with pain meds and nausea meds mixed in with, vitals taken, blood taken, urine specimen - headache was a #10 on pain chart 4 hrs later around 4pm, headache was about a 3-4 pain chart, i left hospital given pain meds, nausea meds, cough meds, antibiotics

Repeated vomiting over a five or six-hour period, dizziness, aches, feeling unwell. The vomiting stopped by 7:00 AM Saturday, 19 Mar. 2021, but I felt quite sick for a few days. I don't yet feel my normal self.

0845 Vasovagal with strong retching - no emesis Initial VS: HR 50's O2 sat 85% Subsequent VS: 110/63-HR 60-RR 20- O2 sat - 98% CBG 150 PMHx: HTN, HLD S: patient felt nauseated, dizzy, "hot all over", anxious O: Awake but unable to answer due to retching. Pale, diaphoretic, cool to touch. Cards: radial pulse thready - apical pulse in 50's RRR, no murmur. Resp: clear to auscultation. No cough or evidence of aspiration. GI: strong retching but no emesis. A/P: 68 y/o female who just rec'd J&J Covid Vaccine was in monitoring lot and found to be diaphoretic and retching - semi conscious.   Vasovagal response - patient recovered VS within 5 min of start of event. Wanted to go to hospital for evaluation. She was alone in her car. Called her dtr to apprise of situation. Authority parked her car and returned her car keys to her prior to transport to hospital.

pt stated that she was good with just a little headache and some nausea that lasted about 30 hours. pt states that her symptoms have subsided.

DAY 1 DIZZINESS FOLLOWING THE VACCINE . AROUND 5PM ON THAT SAME DAY CHILLS AND FEVER STARTED AND LASTED UNTIL UNTIL MID MORNING OF DAY 2. AROUND MIDDAY OF DAY 2, DIZZINESS IS STILL BOTHERSOME WITH VOMMITING AND DIAHRREAH STARTING. CAN'T EAT OR DRINK MUCH DAY 3, BODY ACHES AND GENERAL LETHARGARY FOLLOWS. VOMITING CONTINUES, BUT NOW CONSTIPATION STARTS. DAY 4 , VISIT MY FAMILY DOCTOR

Severe headache. Severe fatigue, achy, Nausea diarrhea Stayed in bed for 3 days. Drank a lot of water. Missed 2 days of work. 3rd day was able to be up all day. Did not consult physician. Took aspirin

NAUSEA; TIREDNESS; HEADACHE; TEMPERATURE 99 DEGREES; BODY ACHES; INJECTION SITE REDNESS; SORE ARM; This spontaneous report received from a vaccine facility concerned a 68 year old female. The patient's weight was 195 pounds, and height was 173.73 centimeters. The patient's concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included no history of drug abuse. 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: 1805018, and batch number: 1805018 expiry: 25-MAY-2021) dose was not reported, administered on 07-MAR-2021 13:30 on left arm for prophylactic vaccination. Concomitant medications included atorvastatin for cholesterol, venlafaxine hydrochloride for hot flashes, colecalciferol for immune health, ascorbic acid/rosa canina/sodium ascorbate for immune support, and ascorbic acid/biotin/calcium pantothenate/choline bitartrate/colecalciferol/cyanocobalamin/dl-alpha tocopheryl acetate/folic acid/inositol/inulin/magnesium citrate/nicotinamide/pyridoxine hydrochloride/retinol palmitate/zinc citrate for overall health. On MAR-2021, the subject experienced sore arm. On 07-MAR-2021, the subject experienced injection site redness. On 08-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99 deg. On 08-MAR-2021 11:30, the subject experienced body aches. On 08-MAR-2021 11:30, the subject experienced nausea. On 08-MAR-2021 11:30, the subject experienced tiredness. On 08-MAR-2021 11:30, the subject experienced headache. On 08-MAR-2021 11:30, the subject experienced temperature 99 degrees. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, sore arm, injection site redness, nausea, tiredness, headache, and temperature 99 degrees on MAR-2021. This report was non-serious.

Dizzy, nausea, headache, very sore legs and hands, chills, fever., fatigue. The headache was the last to go, it lasted for 2 days.

pain in large intestines, bloating, diarrhea headaches fuzzy brain (confusion, hard to focus) dizziness (lingering 6daysafter inoculation) extreme fatigue (still tired 6 days after inoculation)

Pale, Sweating, Shaking Nausea gave water, cool compress and chocolate had patient stay seated for 3- minutes then remain in store until feeling better Patient felt better and left of her own accord

4/08/2021 @1200 - diarrhea, tired, weak. At 1700, extreme muscle achiness. At 2300, severe headache, temp 102° F, chills, sore mucous membranes in mouth, tachycardia (110-120/min), Respiratory expiratory wheezes. Took Tylenol extended release 650mg po. Drank grape juice & 7up. Diarrhea twice during night (4/09/2021) 0100 - 0600. Very sick. By 0700 on 4/09/2021 symptoms slightly better. Still had temp of 100 °F, O2 Saturation 94%, Took Tylenol every 6 hrs x 3 daily on 4/09/2021 thru 4/11/2021. Didn't feel better til 4/11/2021.

Headache and nausea started at 10 pm, 9 hours after injection. Over the next several hours, headache worsened, chills set in along with low-grade fever (100) and elevated heart rate. Took Tylenol 500 mg at 4:30 a.m. after not sleeping for hours. Continued taking Tylenol every 6 hours for the next 24 hours for the headache. Fatigue and slight 'brain fog' lasted for 5 days.

4/7 late night fever 100.5. Woke up around 3AM 4/8 feeling very dehydrated with migraine like headache pain which continued throughout that day with occasional bouts of vomiting. 4/9 headache and vomiting gone, just felt drained and tired. 4/7 and 4/8 in the early evening, I think around 7, also had odd waves of intense pain in left heel lasting 2-3 minutes.

About two weeks later developed cramping in Left leg. Also has varicose veins. Had the cramping before. No more cramping but feeling of tightness remains around the calf. Not hot, not red. but seems like the veins seemed red and now purple. Seem to have more spider veins. medial posterior part of calf below the knee. Didn't think anything about all this until heard about the news about the JnJ vaccine. Also had a different type of abdominal pain. Almost felt like she may be constipated but wasn't. Only lasted a few days. Has been unable to make an appointment with PCP until may 4th.

BODY ACHES; FLU LIKE SYMPTOMS; SLIGHT DIARRHEA BUT NOT BAD; FEELS LIKE SINUS INFECTION; FEELING BLAH; SORE ARM/MUSCLES; CHILLS THAT COME AND GO; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sarcoidosis autoimmune disease, arthritis, and arthritis pain. The patient experienced swelling around ankles when treated with felodipine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included paracetamol for arthritis pain. On 09-APR-2021, the subject experienced body aches. On 09-APR-2021, the subject experienced flu like symptoms. On 09-APR-2021, the subject experienced slight diarrhea but not bad. On 09-APR-2021, the subject experienced feels like sinus infection. On 09-APR-2021, the subject experienced feeling blah. On 09-APR-2021, the subject experienced sore arm/muscles. On 09-APR-2021, the subject experienced chills that come and go. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches, flu like symptoms, chills that come and go, slight diarrhea but not bad, and sore arm/muscles, and the outcome of feels like sinus infection and feeling blah was not reported. This report was non-serious.

SWOLLEN RIGHT PINKY FINGER; PAIN IN RIGHT ARM; SHIVERS; LOW GRADE HEADACHES; DARK DIARRHEA; SEVERE STOMACH PAIN; DIFFICULTY SLEEPING; SWOLLEN STOMACH OR BLOATEDEDNESS; LETHARGIC; This spontaneous report received from a patient concerned a 68 year old female. The patient's weight was not reported and height was 59 inches. The patient's concurrent conditions included irritable bowel syndrome, and migraine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A2A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medications included linaclotide for irritable bowel syndrome, macrogol 3350 for irritable bowel syndrome, senna alexandrina for irritable bowel syndrome, simeticone for irritable bowel syndrome, sodium phosphate dibasic/sodium phosphate monobasic for irritable bowel syndrome, and acetylsalicylic acid/caffeine/paracetamol/salicylamide for migraine. On 09-APR-2021, the subject experienced dark diarrhea. On 09-APR-2021, the subject experienced severe stomach pain. On 09-APR-2021, the subject experienced difficulty sleeping. On 09-APR-2021, the subject experienced swollen stomach or bloatededness. On 09-APR-2021, the subject experienced lethargic. On 09-APR-2021, the subject experienced shivers. On 09-APR-2021, the subject experienced low grade headaches. On 12-APR-2021, the subject experienced swollen right pinky finger. On 12-APR-2021, the subject experienced pain in right arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in right arm on 14-APR-2021, was recovering from dark diarrhea, and swollen stomach or bloatededness, had not recovered from swollen right pinky finger, severe stomach pain, and low grade headaches, and the outcome of difficulty sleeping, shivers and lethargic was not reported. This report was non-serious.

STUFFY NOSE; DIARRHEA; FAECES HAS REALLY BAD ODOUR; MIGRAINE-LIKE HEADACHE; CHILLS; INJECTION SITE PAIN; PRESSURE IN THE CHEST; RIGHT BREAST (FROM CENTER OF CHEST) UNDER THE ARMPIT STILL FEEL DISCOMFORT; HEART BEATING FASTER; FELT LIKE HEART WAS JUMPING OUT OF THE CHEST; STOMACH PAIN/SHARP PAIN; FELT THE URGE TO GO TO THE BATHROOM; REDNESS OF THE FACE; PAIN IN THE JAWS (BOTH SIDE); FELT LIKE HAVING A HEART ATTACK; PAIN SHOT UP TO RIGHT SIDE OF NECK TO SHOULDER AREA, THEN ELEVATED TO THE EARS; HARD TO BREATHE; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's past medical history included back surgery, and concurrent conditions included x-ray dye allergy, prednisone allergy, amoxicillin allergy, non alcoholic, non smoker, fibromyalgia, and lymphedema in the legs, and other pre-existing medical conditions included the patient had allergy to an unspecified pain medication. the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 11:15 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced pressure in the chest. On 10-APR-2021, the subject experienced right breast (from center of chest) under the armpit still feel discomfort. On 10-APR-2021, the subject experienced heart beating faster. On 10-APR-2021, the subject experienced felt like heart was jumping out of the chest. On 10-APR-2021, the subject experienced stomach pain/sharp pain. On 10-APR-2021, the subject experienced felt the urge to go to the bathroom. On 10-APR-2021, the subject experienced redness of the face. On 10-APR-2021, the subject experienced pain in the jaws (both side). On 10-APR-2021, the subject experienced felt like having a heart attack. On 10-APR-2021, the subject experienced pain shot up to right side of neck to shoulder area, then elevated to the ears. On 10-APR-2021, the subject experienced hard to breathe. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced injection site pain. On 10-APR-2021 13:00:00, the subject experienced migraine-like headache. On 13-APR-2021, the subject experienced stuffy nose. On 13-APR-2021, the subject experienced diarrhea. On 13-APR-2021, the subject experienced faeces has really bad odour. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart beating faster, and chills on APR-2021, redness of the face on 12-APR-2021, and pain in the jaws (both side) on 11-APR-2021, was recovering from migraine-like headache, pressure in the chest, and hard to breathe, had not recovered from stuffy nose, and diarrhea, and the outcome of stomach pain/sharp pain, injection site pain, felt like heart was jumping out of the chest, felt the urge to go to the bathroom, faeces has really bad odour, pain shot up to right side of neck to shoulder area, then elevated to the ears, felt like having a heart attack and right breast (from center of chest) under the armpit still feel discomfort was not reported. This report was non-serious.; Sender's Comments: V.0 Medical assessment comment not required as per standard procedure as case was assessed as non-serious.

VOMITING; DIARRHEA; NAUSEA; HEADACHES; TIREDNESS; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic obstructive pulmonary disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A 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 vomiting. On 09-APR-2021, the subject experienced diarrhea. On 09-APR-2021, the subject experienced nausea. On 09-APR-2021, the subject experienced headaches. On 09-APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headaches on 11-APR-2021, and tiredness on APR-2021, and had not recovered from nausea, vomiting, and diarrhea. This report was non-serious.

ON 4/25/21, PT STOPPED AT PHARMACY COMPLAINING OF ADVERSE REACTIONS SHE WAS HAVING DUE TO THE JOHNSON AND JOHNSON VACCINE SHE GOT. SHE C/O NAUSEA AND HANDS SHAKING. I TOLD HER I WOULD SUBMIT A REPORTAND FOR HER TO SEEK TREATMENT FROM HER PCP. I ASKED THAT SHE CONTACT ME WITH ANY CONCERNS OR SHARE COMMENTS THAT DR SHARES WITH HER.

IRRITABLE; HEAD PAIN; EXTREME FATIGUE; STABBING PAINS IN ABDOMEN; This spontaneous report received from a patient concerned a 68 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: 23-JUN-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced stabbing pains in abdomen. Treatment medications included: paracetamol. On 12-APR-2021, the subject experienced head pain. On 12-APR-2021, the subject experienced extreme fatigue. On 21-APR-2021, the subject experienced irritable. Laboratory data included: COVID-19 virus test (NR: not provided) Negative, and PCR (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stabbing pains in abdomen on 17-APR-2021, was recovering from extreme fatigue, and had not recovered from head pain, and irritable. This report was non-serious.

FEELING INTENSE DEBILITATING PAIN AROUND LOWER STOMACH AND GROIN AREA ON RIGHT SIDE; NEW TREMOR IN HANDS; THOUGHTS JUMBLING; INTERRUPT SLEEP; UNABLE TO EXERCISE; TERRIBLE HEADACHE; TERRIBLE VOMITING; COULD TAKE NO FOOD OR MEDICATION AT ALL; INTENSE VOMITING IT CAUSED TO LOSE CONTROL OF BLADDER; This spontaneous report received from a patient via a company representative concerned a 68 year old female. The patient's height, and weight were not reported. The patient's past medical history included dental implants, and concurrent conditions included malignant neoplasm of right kidney except renal pelvis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included axitinib, and ondansetron. On MAR-2021, the subject experienced intense vomiting it caused to lose control of bladder. On 10-MAR-2021, the subject experienced terrible vomiting. On 10-MAR-2021, the subject experienced could take no food or medication at all. On an unspecified date, the subject experienced feeling intense debilitating pain around lower stomach and groin area on right side, new tremor in hands, thoughts jumbling, interrupt sleep, unable to exercise, and terrible headache. Treatment medications (dates unspecified) included: naproxen, and codeine phosphate/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from terrible vomiting, could take no food or medication at all, and intense vomiting it caused to lose control of bladder on 2021, and the outcome of feeling intense debilitating pain around lower stomach and groin area on right side, new tremor in hands, terrible headache, thoughts jumbling, interrupt sleep and unable to exercise was not reported. This report was non-serious.

numbness in my right leg the night of the vaccine, a mineral or metallic taste in my mouth for a few hours after receiving the vaccine. Also severe diarrhea started around midnight the night of the vaccine and did not clear up until March13.

DIARRHEA; MUCOUS STOOLS; STOMACH TURNING; STOMACH GAS; STOMACH ACHE; FLU LIKE SYMPTOMS EXCEPT FEVER; This spontaneous report received from a patient concerned a 68 year old female. The patient's weight was 169 pounds, and height was 172 centimeters. The patient's concurrent conditions included lactose intolerant, sulfonamide allergy, abstains from alcohol, and non smoker, and other pre-existing medical conditions included no pertinent medical history. no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced flu like symptoms except fever. On 17-APR-2021, the subject experienced stomach gas. On 17-APR-2021, the subject experienced stomach ache. On 17-APR-2021, the subject experienced stomach turning. On 17-APR-2021 12:00, the subject experienced diarrhea. On 17-APR-2021 12:00, the subject experienced mucous stools. On 24-APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative, and Urine analysis (NR: not provided) Negative. Treatment medications (dates unspecified) included: omeprazole. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from diarrhea, flu like symptoms except fever, stomach ache, stomach gas, and mucous stools, and the outcome of stomach turning was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.

Dizziness, headache, nausea. Took meds all day for headache, nausea and dizziness. Finally slowly started to go away. Had it like 36 hours then was fine. This morning got up with it again and took meds all day again. Slowly going away but is just sickening to feel this way I can't do anything. I have never had this until got this shot.

Pt reported bloating that kept her up the night of the vaccination. The bloating had not resolved 9 days post vaccination. She has experienced this type of bloating in the past but not to this extent. She is seeking further information from the hospital to determine if they believe the polysorbate from the vaccination is the cause or an alternate cause.

fierce "flu like" symptoms onset approx 6-8 hours post-injection; too ill to rise from prone position for 8+ hours, insomnia and breathing difficulties throughout, violent vomiting ("dry" heaving). Slow restoration of strength, gastric upset for 60 hours (initial severe diarrhea, stomach upset). Since then (15 days) weakness, malaise, persistent minor headache.

Headaches began Monday after vaccine. Burning on outside of brain 2 days. Headaches became severe head pain which moved around. Several times ice pick like feeling in stomach. Felt like brain was shaking or vibrating. That lasted almost two weeks. At the end of that time electrical shocks firing randomly throughout my brain. Severe fatigue daily. Had to fall into bed and sleep for three hours daily during the severe symptoms. Now headaches daily but pain much less. Mostly on left side of head and behind left eye. Lesser fatigue but still there. Has affected quality of life.

FATIGUE; LOOSER STOOL THAN NORMAL; SORE ARM; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1816027, and batch number: 1816027 expiry: UNKNOWN) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAY-2021, the subject experienced looser stool than normal. On 25-MAY-2021, the subject experienced sore arm. On 27-MAY-2021, the subject experienced fatigue. The action taken with covid-19 vaccine was not applicable. The patient recovered from fatigue on 28-MAY-2021, and had not recovered from looser stool than normal, and sore arm. This report was non-serious.

Patient was waiting in waiting area after receiving Jenssen vaccine. After about 15 minutes, another patient who also received Jenssen came to inform me that her friend was having difficulty swallowing. Patient was not able to speak English so her fried translated to her. She was able to talk and responding to her friend's questions. I gave her Benadryl liquid to see if it resolves. After 5 minutes or so she complained of having chest tightness and having hard time breathing. I immediately gave her EpiPen 0.3mg injection in left thigh. After few minutes patient said he is feeling better with chest tightness but still having feeling of throat closing. at this time, I had one of my tech call 911 and provided another EpiPen injection (about 5 minutes after the first one). Police showed up in approximately 5 minutes. EMT showed up 10 minutes after them. Patient was conscious the entire time. When EMT took her, she was feeling better but still complaining of difficulty swallowing. Management was informed about the incident

after vaccination, patient felt dizzy and lightheaded. after some bottled water and a cold compress, she did not feel better. we elevated her feet, and she still did not feel good, said she felt like she wanted to throw up. Emergency personnel came and took her to the hospital

Had immediate severe pain in arm, head rush, hives, dizzy, sick to my stomach. Sick all week and missed 3 days of work.

I had an upper respiratory infection on 05-17-2021. I went to see my doctor who tested me for Covid and my test was negative on 05-19-2021. Post vaccine reaction I did have fatigue lasted longer than I thought I would. One week after my vaccine I had fatigue. On 04-11-2021, the fatigue was less than it had been, also had nausea. On 04-12-2021, I had dizziness during the night and I could not babysit the next morning because I was still feeling light headed. I also developed shingles after my upper respiratory infection and diagnosed on 05-31-2021, diagnosed on the 5th cranial nerve and had to go to the eye doctor to make sure my eye was not affected.

Developed cough 12 hours after shot. Developed severe indigestion, chills, fever, and exhaustion 24 hours after shot. Stomach problem continued and developed hives 3 weeks after.

At the time of vaccination I had a feeling of numbness in my lips and tongue. Woke up at 4am with severe vomiting and diarreha. The ER stated to follow up with my PCP. Follow up visit my heart rate was 120. I was put on a heart monitor which results came back inconclusive. Been referred to see a cardiologist. Awaiting appointment for a future date.

Before the shot I was fine. Once taken, a month later i began feelkng worse and needed to go the the hospital. Some of the symptoms are, Pins and needles feeling in face hands and feet, bloated stomach.

(Noted Auto-Immune Disease) Pt. states after receiving the dose of J&J vaccine 05/11/2021, started to experiencing symptoms 05/16/2021 a pulling pain in the right thigh, broken blood vessels through the leg (right), uncomfortable sensations going from groin to feet (both), pain beneath the fingernails, abdominal bloating, and chronic UTIs. Nerve sensations running through the facial area and (pinching) back of the head.

Dizziness, headache, nauseousness to the point of having to sit still. Home treatment with Ibuprofen reduced symptoms that lasted approximately 24 hours.

About 6 1/2 hours after receiving the vaccine, I began to feel really cold and began to have uncontrollable shivering and shaking for 4 hours straight. A heating pad helped but continued after removing it. I also had a slight stomach ache. The next day, I felt i had less energy than normal, lethargic.

pt states that afternoon after she got the covid vax that she developed fever, body aches, chills, loss of appetite, headache. Feels just like she did when she had the Covid Virus. Her urine is dark yellow and she is sweating profusely. Pt still has all of these symptoms and has a phone visit w/ her PCP today 3/10/2021.

Janssen COVID-19 Vaccine EAU I had a terrible headache for 2 days, chills for 2 days but slight chills for 3 days, terribly achy body, dizzy, nauseous, a little trouble focusing my eyes, diarrhea for 2 days the 3rd and 4th days, slightly sore arm.