Johnson & Johnson

c/o headache- IDDM- ate breakfast 0930 other and nothing since. Denies any of adverse symptoms. does self report. high anxiety R/T being here, getting vaccine & "emtional" as has not seen spouse who underwent liver transplant 2 months ago & contracted meningitis. 173/94- 72 given water & banana. Rested & relaxed w/ fresh air flow x 15 additional mins. w/ resolution of symptoms.

Patient is a 61 y.o. female who received the Janssen Covid vaccine Lot# 1805020 on 3/12/2021. The patient experienced the following reaction(s) during the immediate of observation: "Feeling funny" "Cold feet" Patient was treated/managed as follows: Vital Signs: 1240pm -BP: 140/76 HR: 94 RR:18 1250pm-BP: 133/88 HR: 82 RR: 18 Pt reports feeling better Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. Pt escorted out to car by Site Lead

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.

Awakened by itchy, red hives at about 4am or 5am every morning since administration of the vaccine. Most of the hives are on the torso, more severe on the front and some on the back. A few have been on my arms. After going back to sleep, the hives are gone when get up for the day. No hives during the day. Then awakened by hives again at 4am or 5am. Prior to receiving the one-dose Janseen COVID-19 vaccine, had only experienced hives three times in my life, several years apart. Now it has occurred early every morning seven times in a row and expect it will happen again, since the ones this morning were worse than the previous few times.

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.

Arm was a little sore after injection but exploded into searing stabbing pain at the 2 week mark. The pinpoint soreness was vague and lingering until the middle of the night last night when the intense pain woke me from my sleep. It isn't bursa pain it is deltoid pain more intense than I ever imagined it could be especially at the two week mark post vaccine!! It is pretty terrible.

Around 13 hours later 7AM didn't sleep well. Woke up with dull headache and back of neck muscle aches. This lasted all day and evening. Today 3/26/21 I woke up feeling much better, dull headache pretty much gone. That was all that I had for side affects.

Sensitivity started within four hours of dose. Autistic sensitivities to maximum. Scrambling of all senses including proprioception to the point of not being able to move from standing or sitting. By hour seven, all sensory inputs were too overwhelming to do anything but shut down and sleep. 911 was not an option because they don't let you sleep, and ERs are overwhelming already, before maximizing all inputs. 7.5 mg hydrocodone for overwhelming pain and sensitivity, allowed sleep. On waking, sensitivity was lessened, but the pain started, 18 hours after the vaccination. Emotional lability for three days. Average aching of arm and injection site were not above expected levels. "Brain fog" and lack of ability to articulate (another autism symptom) started within that first seven hours, and diminished over next ten days. Not yet gone as of today Dry mouth; overproduction of thick 'chunky' mucus that wouldn't cough out, treated with guaifenesin, lasted three days. Shortness of breath and cough associated with that mucus also diminished after three days. Not completely gone ten days later. Excessive thirst, onset two hours after vaccine, lasted two days. Hyperalert (can't sleep without drugs), hyperactive despite weakness, and hypervigilant (extreme startle reflexes) lasted three days as well. Sleep was achieved with hydrocodone and THC. All over body pain, feelings of immune mobilization (coming down with) for two days were not above expected levels. No fainting or other collapse at time of injection, or later. Knowing that severe over-stimulation is exacerbated in a medical setting, it was decided not to seek medical support for three days of systemic symptoms that would have easily merited hospitalization.

Shot immediately started stinging. My upper arm swelled with a hard ridge about 3 inches long and 1 inch wide. Extremely painful. Could barely raise my arm and could not sleep on that side or tolerate even soft touch of my entire upper arm. No other reaction that seemed like an allergic response. I did get very sick for 2 days with severe flu symptoms and strange shooting pains in random parts of my body. Enough pain to wake me from a sound sleep. Bad chills, but no fever. I did. I give my legs seemed swollen for about 3 days. I got the J&J vaccine on 3-6-21 and my arm is still swollen with a slightly smaller hard and painful ridge at the injection site and it sometimes throbs and itches severely. Today is 4-2-21. Starting to wonder if it will ever go away. I still cannot sleep on that side. The pain overall is less, but it still throbs and itches periodically throughout the day.

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.

On 3/22 started exp swelling on eyelashes left eye. I woke up on 3/23 entire left eye was red, swollen and pain. I called went into see Opthamologist said it was cellulitis referred me to ER. I went to ER had CT scan done ruled out cellulitis stated it was upper eyelid swelling sent home do hot compresses. On 3/24 seen, said it was stye and discharge apply heat, prescribe Tobramycin to eye rest of the week. I seen my Opthamologist on 3/29 said it was stye continue hot compresses wear no makeup. I called back on 3/30 symptoms worsened my eye appeared droopy. The work I do selling jewelry on live caused me to exp issues on the computer. I started seeing flashes causing me to get off computer. As of 4/7 still exp droopy on left eye and got darker tint added to my shades so people wouldn't notice.

1. Soreness at injection side immediately after administration, duration around 6 hours 2. Significant headache presented in front and sides of head (near temples), beginning day 1 after injection, with duration of 4 days. 3. Fatigue presented on day 1 after injection, duration of 4 days. 4. Mental health symptoms after day 1, with duration of 5 days, presenting as feelings of sadness and depressive ideation. The last symptom (#4) is difficult for me to correlate specifically to the vaccination, as I am a 60 year-old and in my first year in a rigorous doctoral program at a hospital. The negative physical symptoms experienced by the injection could have added an extra layer to the sadness that I reported from the daily app check-ins. I already operate (since fall 2020) in an overwhelmed state (while beginning a difficult academic program via Zoom). Could the physical fatigue and headaches from the vaccine lead to the feelings of sadness? Or were the feelings of sadness a third symptom of the vaccine? I cannot answer, and therefore cannot provide this correlation link with any reliability. I did speak to my therapist via Zoom, and reached out via email to my general physician (who recommended OTC meds.

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).

Chills and low grade fever, then within another hour felt light-headed and my body hurt all over - skin was sensitive to even my clothes. Headache started in the front of my forehead by late evening, and I literally couldn't even walk up to my bed. Restless sleeping with all the sweating and chills. Woke up with headache remaining and feeling very "wiped out" and still light-headed. No more chills or sweats the next day, but I was weak for about 48 hours. Honestly - I'm very healthy and getting Covid directly from another person couldn't have been worse than getting the vaccine. :( And I am even saying that as a 35 year professional Research Scientist. Thank you

Felt hot within a few minutes after the vaccine, then passed out. The NP on site said she was unable to find a pulse so did 10 chest compressions before I woke up. Called the rescue squad who did an EKG on route to Hospital and once I was in the ER another EKG was performed along with blood work and chest X-ray. Entry was noted as allergic reaction but diagnosis was noted as Vasovagal Syncope, Adult. EKG?s performed along with labs were normal. I have pulled muscles, tendons and ligaments from the chest compressions which were questionable but since that day have experienced tingling in upper body and arms and have felt bad. Went back to my Primary Care Doctor for follow up on March 29 for another EKG. Have had panic attacks from the situation and per Doctor will take 2 months for my chest, muscles, tendons and ligaments to heal. Hard to determine if the way I have felt is from the vaccine or what transacted when I fainted. Today which is April 9, I still feel weak, normally I am very energetic. Just wanted to report as when I saw the news that others had some situations thought best to let you know.

-Within first day through 1 week: dry mouth, excessive thirst, thick mucus, skin sensitivity, dizziness, hyperactivity, hypervigilance, insomnia, irritability, -Persistent even 4 weeks after vaccine: confusion, increase in autism symptoms of sensitivity, "scrambled propioception sensory symptoms", "mismatch of emotions"

Was doing CDC TEXT tracing first week after injection, but new reactions started after tracking completed. Had mild reactions originally. Pain in arm, and fever next day that rose to 100.9. No chills, no major problems, no rash. A couple nose bleeds on second day which were not typical for me. Returned to work on third day. Now on day 10 I'm convinced I'm having a delayed reaction. Still mild but present. Low temp 99.5, headache, fatigue, feeling of not being normal. Not allowed to work today. Reason for report of such mild symptoms is my surprise of this delayed reaction 10 days later. There is a bruise on my injection arm now, opposite side of arm, that also is puzzling, but not really worrisome. Know to monitor for platelet issues.

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

Headache, fatigue, chills, intermittent shooting nerve pain at the left angle of my mandible. I went to work on Tuesday because my work was short staffed but was allowed to go home 3 1/2 hours early. I took Advil every 4-6 hours on Tuesday and half of Wednesday. I came straight home and slept until dinner, ate and then went back to bed and slept until midnight, took more Advil and drank a full glass of water, and slept the rest of the night. Wednesday I felt a bit better, headache not as bad and jaw pain not as frequent, still pretty tired. I went to bed straight after dinner and then felt great on Thursday.

I got an itchy rash on my right leg within the first 15 minutes, staff at the site tried to get me to belief it was from anxiety. The redness subsided though bumps remained when they let me go home. I also felt a bit "detached" on the drive home and really had to concentrate on my driving. Once home, I still felt odd but went about my day. About four hours later, I realized I was scratching my stomach and chest while watching TV. Upon raising my shirt, I saw a bright red rash on the top part of my belly that extended underneath both breasts and to the area directly over my heart, and up my left side into my left armpit. All of these areas were very itchy. I put Hydrocortisone cream on them, which helped reduce the itching quite quickly. I then took half a Benadryl tablet. When I awoke the next morning, the areas that had been bright red now had dark red dots but did not itch. However, I had lines of a bright red, itchy rash on both thighs near my groin. I again applied Hydrocortisone cream and took Benadryl, which helped abate the symptoms. Lymph nodes in my left armpit were quite sore as well, so I took ibuprofen.

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.

The second day after the shot I was really tired. I also had a strange sensation on my face. A couple of weeks after I started to have insomnia. I kept waking up scared. I started to have a flare up of my Arthritis. I still have feelings of tiredness, headaches and my back has been really flared up. I have a disability with my spine being crooked. The pain has been a lot worse than normal. I have been visiting the Chiropractor frequently three weeks after my shot. I did not have as much back pain before the vaccine.

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.

1ST DAY=Heachache, Dizzines, High blood pressure, Inflamation of hands. 2ND DAY= High blood pressure, headache, chills 3RD Day: Headache, kidney pain 4th Day: Headache, body ache. 5th day: Heachache, leg pain, can't sleep.

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.

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.

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.

elevated blood pressure, slurred speech, expressive aphasia, blurred vision,headache,shortness of breath confusion.

I felt very jittery felt as if I drank about 16 cups of coffee! Felt a little bit pressure in my heart. Could not sleep on Saturday night extreme anxiety feeling. Extreme hyper active feeling!!! Felt like if I had a surge of energy. Very restless, legs felt jittery! Left lymph node in my neck was swollen and slight headache.

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

On 4/16/21, patient reported that following vaccination on 4/8/21 around 9:45 am: ..."The feeling of being light headed began around 10:30 am while I was sitting at my computer. Six days after the vaccine, I actually went to bed with severe cold chills which lasted several hours. I am still experiencing intermittent periods of "brain fog" or at times feeling a little light headed. Last Saturday was the only day that I haven't experienced feeling this way. Again, it does not happen all of the time but it is bothersome. I am hopeful that after this Thursday (2 weeks will have passed since the vaccine) that symptoms will disappear. If not, I will follow up with my family practitioner. Thank you!"

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.

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.

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.

Day one post vaccination - dull headache, leg pain, abdominal pain, back pain - these symptoms continued for a few days, I started to feel a bit better, did not take any pain reliever medications because I didn't want to mask symptoms. On 4/14/21, 7 days post vaccination, my leg pain in both legs worsened including numbness and a burning sensation in both feet. Back pain continued, arm pain started in both arms with numbness in both hands however the pain on my left side with legs and arms is worse. I've had intermittent shooting pains in my left ear, left jaw, left temple and across the left side of my face. I've also experienced shoulder and neck pain. The abdominal pain is intermittent and mild. On 4/15 - 4/18 the pain in my legs was so bad that it was waking me up at night and my arm pain was occurring more frequently. I decided to go to the ER on 4/18, day 11 post vaccination, due to my concern of a possible DVT or other type of blood clot. The ER physician's assistant did not look at my legs but did several blood tests and other tests.

AT 2:00 A.M.HAD THE SWEATS BURNING UP NEEDED TO TAKE SHOWER TO COOL DOWN THAN HAD CHILLS AND BODY ACHES, AND HEADACHE STARTED, HAD A HARD TIME FUNCTIONING. THIS WENT ON FOR TWO DAYS THEN HEADACHE FOR A WEEK AND LEGS WERE PAINFUL TO WALK STILL ARE HEADACHE GONE BUT PAIN IN LEGS, STILL TAKING ADVIL ITS BEEN TWO WEEKS SINCE THE SHOT.

SINUS INFECTION; CHILLS; FOGGY FEELING IN HEAD/ DID NOT FEEL LIKE HERSELF; DIZZINESS; 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 high blood pressure, anxiety, seasonal allergies, and drug intolerance. 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-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 foggy feeling in head/ did not feel like herself. On APR-2021, the subject experienced dizziness. On 02-APR-2021, the subject experienced chills. On 05-APR-2021, the subject experienced sinus infection. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 03-APR-2021, had not recovered from foggy feeling in head/ did not feel like herself, and dizziness, and the outcome of sinus infection was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious

DIFFICULT TO SLEEP; SHORTNESS OF BREATH; FLU-LIKE SYMPTOMS; This spontaneous report received from a consumer 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: 207A21A 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 shortness of breath. On 09-APR-2021, the subject experienced flu-like symptoms. On an unspecified date, the subject experienced difficult to sleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu-like symptoms, and shortness of breath, and the outcome of difficult to sleep was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard operating procedures, as the case was assessed as non-serious.

CHEST PAIN; SHORTNESS OF BREATH; TROUBLE FALLING ASLEEP; HOT FLASH; EXTREME FATIGUE; HEADACHE; 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: Unk) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included progesterone for prevent breast cancer, and estradiol for prevent osteoporosis. On 18-APR-2021, the subject experienced chest pain. On 18-APR-2021, the subject experienced shortness of breath. On 18-APR-2021, the subject experienced trouble falling asleep. On 18-APR-2021, the subject experienced hot flash. On 18-APR-2021, the subject experienced extreme fatigue. On 18-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 headache, chest pain, and shortness of breath, and the outcome of extreme fatigue, trouble falling asleep and hot flash was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not needed as per standard procedure since case is assessed as non-serious.

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.

Adverse event started the same night. Extreme body aches, low grade fever, extreme anxiety, fatigue and headaches. Fever subsided with 24 hours but the body aches, anxiety, fatigue, and headaches continue to date. Just not feeling well since I received the vaccine. I am going on 4 weeks post vaccine.

As the 2nd week came I started feeling slightly tired/weak, but going into the 3rd week I felt that my inhaler was filed with pepper spray. On wed going home had bad cough. Then Thursday , left work early, had to go home. On the way there was like a circle of fire going around my heart to include that part of lungs. Had to bed rest till Monday. Dr. at Emergency gave a prescription of Antibiotics and a cough prescription, my son had to pick it up for me. Then a bout a week later I had finished dinner, taking my plate to the kitchen, body/brain completely quit. No time to get dizzy, speak out or say anything. JUST QUIT. My husband said I was in/out for about 10 minutes as he was trying to help me up. Right side of nose/head still has problems.

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.

I woke up Wednesday and I felt like I was hit by a train. I felt like a wet dish rag hanging on the sink. Everything hurt, even taking a step, I just felt bad, tired like the flu but no respiratory issues. By the 14th I started getting short of breath, couldn't walk without SOB, my legs started to swell, joints were sore, I felt tired. Went to the doctor and my blood pressure was high, I was prescribed medication for my blood pressure and fluid pills. It hurt just to brush against the skin on my calf. An ultrasound revealed 4 blood clots in my left calf. Went to the ER at . Hospital in and sent to hematologist Dr. and there were no findings.

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.

2 hours after shot I felt weak for 2 hours I started to get an itchy rash the same night and my left arm swelled. The shot location in my left arm itched a lot. I scratched it, it bled. It became a large hole. 3 days later approximately, I start feeling very very tired. It got progressively worse . I then developed " brain fog". I have barely been able to work since then.. I believe I started to recover yesterday but not completely sure yet. I also developed a painful tumor in my right arm pit that lasted for a few days. It has since gone away. It was approximately 3/4 " in size. It developed overnight.

Substantial body aches, unrelenting headache, fatigue, negative thinking, general malaise. Had to close my shop and lose business (would only do that if it knocked me off my feet)!

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.

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.

Normal side effects at first. 72 hours after shot extreme pain in joints. Pain resolved everywhere but forearms, wrists, and hands. Currently, blood pooling in thumb joints, tenderness in wrists and fingers, stiffness in hands wrists, and forearms. Heat and sense of hardness in veins. Veins sticking out in forearms and thumbs. 13 weeks since vaccination. Primary Care physician unresponsive. Limited use of hands. Psychological despair setting in.

FAINTING; BLURRED VISION; SHORTNESS OF BREATH; CHEST PAIN; HEART POUNDING/PALPITATIONS; FASTER HEART RATE; DIZZINESS; CANNOT SLEEP; FEELING SICK; SEVERE ALLERGIC REACTION; SEVERE PERSISTENT HEADACHE; 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 non alcohol user, and non-smoker. The patient had no known allergies and no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808978 expiry: 28-JUL-2021) dose was not reported, 1 total administered on 02-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the patient experienced severe allergic reaction and had visited the doctor first who then had sent the patient to the emergency room. Laboratory data included: Blood tests (NR: not provided) not reported, Head scan (computerized tomogram head) (NR: not provided) not reported, Heart scan (cardiac imaging procedure) (NR: not provided) not reported, and chest magnetic resonance imaging (NR: not provided) not reported. The patient was released after two hours. The patient felt sick, severe persistent headache, and blurred vision for which she had visited the ophthalmologist and had not found anything wrong. The patient also experienced fainting, shortness of breath, dizziness, chest pain, pounding heart and palpitations all the time especially at night. The patient also had faster heart rate of about 112 beats per minute and was unable to sleep. The reporter stated that the patient would wake up three or four times at night and to distract her, she would eat something to settle her down just a little bit and then the heart rate would go to 90 or 85 beats per minute. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling sick, severe persistent headache, blurred vision, shortness of breath, dizziness, heart pounding/palpitations, faster heart rate, cannot sleep, severe allergic reaction, fainting, and chest pain. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210664089-covid-19 vaccine ad26.cov2.s-fainting. 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).

4 months of new arm, shoulder and hand pain following vaccination with swelling and redness for 1month. Entire shoulder girdle burns and aches. Strong inflammatory reaction started on first night with many varied reaction symptoms for 10 days. Arm and shoulder pain remained and got worse daily for months, I now have nerve damage, weakness and loss of function. MRI showed damage, tendonitis, tears and much more, pain was severe for first 7 weeks, then I lost my job, I could no longer type for 10 hours a day. The pain progressed to pronounced weakness and poor coordination. Difficult to sleep for 4 months now. A steroid injection given for chemical bursitis by an orthopedic doctor did not help. Physical therapy, acupuncture and a home TENS unit have helped, progress of injury healing and nerve enervation is very slow. High medical costs. Symptoms are similar to Parsonage Turner syndrome, but two doctors said shot was given incorrectly, low and too deep, so possible SIRVA, or both. I progressively worsened for 4 months, now I am in slow recovery but I fear it will go on for years. This has affected all areas of my life. It has been difficult to get medical care and to care for myself. I live alone, there are so many things I can no longer do. I was self-employed, now I have no income and have lost full use of my left arm.

Strong headache and neck paon after two weeks of vaccination. Burning eyes. Leg pain. Difficulty to focus. Mind foggy. Tested for antibodoes for covid and vaccone resulted negatives after one month of vacconation and then again after 3 monthz. However had high autoinmune response. Headache and neck pain continued. Had N mri and neurologiat evaliation but nothing founf. Headaxhe continued and leg pain and stiffness also. Now also continuous ringing in my ears abd hot ears. Veins in my arm are unusually darker abd more visiblw.

The injection was given into the shoulder joint rather than the deltoid muscle. This has resulted in an inflammatory process that has caused pain and injury to my left shoulder (e.g., tendons, ligaments, bursae, nerves). I now have persistent shoulder and upper arm pain, weakness, and limited range of motion that has worsened in the two weeks following the injection. I am dealing with chronic shoulder and upper arm pain, and am unable to carry out daily activities that were not an issue prior to vaccination. When the symptoms did not subside, I sought medical treatment from my primary care provider on July 15, 2021.

LEFT EYE COVERED WITH VASELINE MUCOUS; DOUBLE VISION; FOGGY VISION/ EYE GLASSES DON'T WORK AS WELL FOR LEFT EYE; MUSCLE SPASMS; WATER RETENTION; DISCOMFORT; CRACKLES IN LUNG; SLEEP FOR LONGER THAN 2 TO 3 HOURS; WEIGHT GAIN; RIGHT FORE ARM BRUISE; BACK PAIN AND PRESSURE; BACK FREEZING UP; PAIN AT THE DIAPHRAGM; FELT SLEEPY; FELT REALLY HOT IN NECK; HEART BEATING REALLY FAST; FELT REALLY WEIRD; SWOLLEN AND RED FACE/ PUFFING UP LITTLE BIT; TROUBLE BREATHING; UNWELL FEELING (GROSS AND CRAPPY); ALLERGIC REACTION; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight was 150 pounds, and height was 64 inches. The patient's concurrent conditions included alcohol user, and non-smoker, and other pre-existing medical conditions included caller stated that she does not have any chronic medical conditions. she takes 2-2.5 mg ativan daily, she stated this is half of the dose she was on 1 year ago. Patient had no any drug abuse/ illicit drug use. The patient experienced drug allergy when treated with medroxyprogesterone acetate. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022, and expiry: UNKNOWN) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. Concomitant medications included diazepam, ketorolac tromethamine, and paracetamol. On 27-MAY-2021, the subject experienced felt sleepy. On 27-MAY-2021, the subject experienced felt really hot in neck. On 27-MAY-2021, the subject experienced heart beating really fast. On 27-MAY-2021, the subject experienced felt really weird. On 27-MAY-2021, the subject experienced swollen and red face/ puffing up little bit. On 27-MAY-2021, the subject experienced trouble breathing. On 27-MAY-2021, the subject experienced unwell feeling (gross and crappy). On 27-MAY-2021, the subject experienced allergic reaction. On 10-JUN-2021, the subject experienced back pain and pressure. On 10-JUN-2021, the subject experienced back freezing up. On 10-JUN-2021, the subject experienced pain at the diaphragm. Laboratory data included: CT scan (NR: not provided) Normal, Chest X-ray (NR: not provided) Normal, Laboratory test abnormal (NR: not provided) unknown, and Pain scale (NR: not provided) 9/10. On 08-JUL-2021, the subject experienced right fore arm bruise. On 09-JUL-2021, Laboratory data included: Spine X-ray (NR: not provided) could not find anything in the series. On an unspecified date, the subject experienced left eye covered with vaseline mucous, double vision, foggy vision/ eye glasses don't work as well for left eye, muscle spasms, water retention, discomfort, crackles in lung, sleep for longer than 2 to 3 hours, and weight gain. Laboratory data (dates unspecified) included: Pain scale (NR: not provided) 8-10/10, and Water retention (NR: not provided) gained 25 pounds. Treatment medications (dates unspecified) included: lorazepam, succinate sodium, methylprednisolone, methocarbamol, naproxen sodium, and methylprednisolone sodium succinate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen and red face/ puffing up little bit, and trouble breathing on 27-MAY-2021, and left eye covered with vaseline mucous, double vision, and foggy vision/ eye glasses don't work as well for left eye, had not recovered from back pain and pressure, back freezing up, pain at the diaphragm, right fore arm bruise, water retention, and weight gain, and the outcome of felt sleepy, felt really hot in neck, heart beating really fast, felt really weird, unwell feeling (gross and crappy), crackles in lung, sleep for longer than 2 to 3 hours, allergic reaction, muscle spasms and discomfort was not reported. This report was non-serious.

CHEST X-RAY; ELECTROCARDIOGRAM; NUMBNESS IN RIGHT ARM; TINGLING IN RIGHT ARM; COMPUTERISED TOMOGRAM; ULTRASOUND SCAN ABNORMAL; HYPERTENSION; SKIN SENSITISATION; ARTHRALGIA; PAIN; FATIGUE; PERIPHERAL SWELLING; DEEP VEIN THROMBOSIS; PULMONARY EMBOLISM; GAIT DISTURBANCE; FEELING ABNORMAL; DYSPNOEA; INFLUENZA LIKE ILLNESS; MALAISE; This spontaneous report received from a patient via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (ID: 1331063) concerned a 60-year-old female. The patient's height, and weight were not reported. The patient's past medical history included degenerative disc disease (neck surgery (four discs repaired), and knee replacement, and concurrent conditions included fibromyalgia, and arthritis. The patient had no known allergy and current illness at the time of vaccination. The patient received covid-19 vaccine ad26.cov2. s (suspension for injection, route of admin not reported, batch number: 1802072, and expiry: UNKNOWN) dose was not reported, 1 total administered on 08-MAR-2021 15:00 at right arm for prophylactic vaccination. Concomitant medications included diclofenac, ibuprofen, oxycodone hydrochloride/paracetamol. The patient woke up and felt like she was hit by a train (feeling abnormal) and felt crappy for next 3-5 days, everything was hurting (malaise), even taking a step. She experienced gait disturbance, patient felt bad, tired like the flu (influenza like illness) but does not had respiratory issues. On 12-MAR-2021, she had dyspnea. Patient started symptoms shortness of breath, could not walk without SOB (Shortness of Breath), her legs started to swell (Peripheral swelling/edema), joints were sore/pain (arthralgia), she felt tired (fatigue). On 23-MAR-2021, she visited doctor with high blood pressure (hypertension) and edema, she was prescribed medication for blood pressure and fluid pills (unspecified). Four days later, her legs were swollen bigger, and the PCP switched the medication. It hurt to brush against the skin on her calf (skin sensitization). The patient was diagnosed 4 blood clots (thrombosis) in left calf by ultrasound scan. She ended up in the emergency room the following day, and Computerized tomogram scans were performed and they found pulmonary embolisms in the lower lobes of both lungs. The patient was also diagnosed with electrocardiogram, computerized tomogram, Blood test and chest x-ray. Laboratory data included: Computerized tomogram (NR: not provided) pulmonary embolisms in the lower lobes of both lungs, and Ultrasound scan (NR: not provided) 4 clot on left calf (abnormal). She has been taking Xarelto ever since. In JUN-2021, she said that she began feeling tingling numbness in her right arm, from her elbow to her fingertips. It tingles most of the day and wakes her up at night. Patient was on blood thinners. Laboratory data (dates unspecified) included: Blood test (NR: not provided) unspecified, Chest X-ray (NR: not provided) Not reported, and Electrocardiogram (NR: not provided) not reported. Treatment medications (dates unspecified) included: rivaroxaban. The action taken with covid-19 vaccine ad26.cov2. s was not applicable. The patient recovered from feeling abnormal, had not recovered from deep vein thrombosis, skin sensitization, peripheral swelling, pain, malaise, influenza like illness, hypertension, gait disturbance, fatigue, dyspnea, arthralgia, chest x-ray, computerized tomogram, electrocardiogram, and ultrasound scan abnormal, and the outcome of pulmonary embolism, numbness in right arm and tingling in right arm was not reported. This report was serious (Other Medically Important Condition). This case is a duplicate of 20210538232. Additional information was received from patient on 13-JUL-2021. The following information was updated and incorporated into the case narrative: reporter details (first and last name, address, city, zip code, office, email address), Updated disease start date (degenerative disc disease and knee replacement), Events added (pulmonary embolism, numbness in right arm and tingling in right arm), updated event (thrombosis to deep vein thrombosis), Updated event onset date (deep vein thrombosis, ultrasound scan and computerized tomogram) updated lab dates(ultrasound scan and computerized tomogram), updated lab result(computerized tomogram), Added vaccination time and treatment drug(Xarelto) and vaccine facility details (vaccine facility name, city and military information) Upon review following information was amended: Removed partial date (2021) of event Electrocardiogram and lab test (chest x-ray, electrocardiogram and blood test). Additional information was received from patient on 13-JUL-2021. It was determined that (20210538232) was a duplicate of this case. All relevant information regarding this case will be submitted under (20210556305); Sender's Comments: V1-20210556305-Covid-19 vaccine ad26.cov2.s-PULMONARY EMBOLISM and DEEP VEIN THROMBOSIS. Follow-up received regarding Other Information: reporter details, disease start date, Events added, updated event (thrombosis to deep vein thrombosis), event onset date ,lab dates,lab result, vaccination time , treatment drug and vaccine facility details . 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). 20210556305-covid-19 vaccine ad26.cov2.s-Thrombosis, ultrasound scan abnormal. This events are considered unassessable. The events has a compatible/suggestive temporal relationship, are unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.

Sore upper left arm the day of vaccination. 20-26 hr after vaccination pain in left arm spread down to the elbow and unable to lift using that arm. trouble sleeping the evening of 7/21/21 due to pain in arm. Extreme fatigue beginning 3pm day after vaccination. Unable to do any physical activity for more than about 5 min. then had to rest. So tired had to go to bed for the day at 8pm when normal bed time is 10-11pm

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.

I start to have muscle pain all over the body. it has been on going till now. It is hard for me to e even perform everyday activities.

4 pm injection 10 pm mind racing unable to sleep 10 pm body ache 2 (scale 0=none 10=worst pain) 11 pm body ache shine bone pain 4 2 am body pain 7 2 am chills 7 3 am uncontrollable leg twitching 10 4 am body pain, fever now twitching 10 7 am body pain, fever, twitching 10 (Still no sleep) 10 am body pain, fever 10 10 am leg twitching 7 12 (Noon) body pain, fever 8 12 leg twitching 4 3 pm body pain, fever 5 3 pm leg twitching 0 6 pm body pain, fever 2 10 pm body pain 1, fever 0

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

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.

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

Started feeling "woozy" Sunday night (vaccinated in the am), woke up in the middle of the night with a pounding headache, 101.4 temperature (taken orally), chills, body aches. Fever would break, sweats, then teeth chattering chills. This would cycle until Tuesday afternoon. The "woozy" feeling persists, although not as intense.

61 y/o female received Janssen vaccine @ 2:08 pm, while in the recovery area, @ 2:15 began to c/o feeling flushed and rapid heart rate. 2:15 pm vitals: 128/87, 115, O2 Sats 99% on RA, expressed feeling very anxious stating, "I have a hx of panic attacks". Patient instructed on deep breathing, and posturing to relax from very tensed positioning. 2:20 vitals: 120/103, 130, sats unchanged. Recovery Nurse worked w/patient to continue relaxed breathing, began to calm , HR down to 99 @ 2:25. Remained in recovery until 2:45 pm, last vital check, 112/84, 80 sats 99% RA, feeling more at ease, no further c/o rapid heart rate or feeling flushed, dc from recovery w/Son In Law who drive patient to appoint.

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.

About 4 hours after the injection I developed terrible rigors. I had a fever up to 102 degrees, but I was also under blankets at the time. I continued to have a low grade fever for much of the next day and generally felt bad with headache and malaise. On the second day after my vaccination, 3/28/2021, I felt fine.

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.

Severe - Chills for 12 hours, horrible neck/back pain, hallucinated, whole body ached & felt like I couldn't move, extremely tired, shortness of breath for 1/2 day, no energy, rash, runny nose & sore throat, tingly sensation on extremities (still occurring), ringing/piercing sound in my ears, headaches. It has been over 3 weeks and I still don't feel energetic & like myself.

Started after falling asleep. Was woken up by profuse sweating and then sleeplessness. Went to work and felt muscle aches and weakness all over. Then major exhaustion with a bad headache.

Chills started about 10 hours after vaccine but minimal. Extreme chills started about 11 hours after vaccine and lasted about 1 hour or so. Layered with clothes and blankets to get under control. I have had many vaccines over the years and never experienced any adverse affect. Next day a bit cloudy and headache but subsided after about 27 hours after vaccine

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.

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.

began feeling tired and slightly light headed a few hours after the vaccine. Developed a headache by evening same day(Day 1). Arm very sore. Day 2- still tired with light head and headache, arm very sore. Day 3- tired, light headed, headache, arm very sore. Day 4- tired, light headed, headache, sore arm. Day 5- pounding, splitting, incapacitating headache that required 800mg Motrin to start and 400mg every 5-6 hours, fatigue, light headed, sore arm, felt horrible.. Day 6- Woke up back to normal.

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.

CHEST REDNESS; EYE ACHE; ELEVATED PULSE; DIZZINESS; DRY SKIN; EXCESSIVE THIRST; ITCHY RASH; HEADACHE; FACE FLUSH/ FACE WAS RED AND BUMPY; TOO HOT OR COLD/ INTERMITTENT FEELING EXTRA COLD(HEAD FEELS HOT AND REST OF BODY FEELS COLD); TINGLY FINGER; FELT LOUSY; BLOOD PRESSURE FLUCTUATION; 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: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced blood pressure fluctuation. On 12-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 150/84 mmHg. On 15-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 125/85 mmHg. On 16-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 137/91 mmHg, 156/90 mmHg, 142/92 mmHg. On 17-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 137/88 mmHg, 140/92 mmHg. On 18-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 143/89 mmHg. On 23-MAR-2021, the subject experienced felt lousy. On 24-MAR-2021, the subject experienced tingly finger. On 27-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 156/96 mmHg. On an unspecified date, the subject experienced chest redness, eye ache, elevated pulse, dizziness, dry skin, excessive thirst, itchy rash, headache, face flush/ face was red and bumpy, and too hot or cold/ intermittent feeling extra cold (head feels hot and rest of body feels cold). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood pressure fluctuation, and the outcome of headache, chest redness, eye ache, elevated pulse, dizziness, dry skin, excessive thirst, itchy rash, face flush/ face was red and bumpy, too hot or cold/ intermittent feeling extra cold(head feels hot and rest of body feels cold), felt lousy and tingly finger was not reported. This report was non-serious. This case, from the same reporter is linked to 20210408073.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.

Burning immediately when the needle entered her arm before the vaccine was injected; difficulty raising her arm and opening the dishwasher since- loss of range of motion and weakness 1 week out.

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 .

Janssen COVID-19 Vaccine EUA About 1-1/2 hours after injection I became very light headed. I sat down for a couple of hours and it went away. That night I could not sleep. I only had about 3 hours of on-and-off sleep through the night. One time I woke up with severe chills The following day (Saturday) I had a lack of energy and in the afternoon I was running a low grade fever (99.8). Went to bed around 8:30 Saturday night, slept all night and felt fine Sunday morning.

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.

Traveled and reported to family that she was disoriented and having some confusion. Was evaluated at ED, had some electrolyte imbalance and UTI. Once resolved, she continued to have neurological symptoms and was diagnosed with a stroke, including early onset dementia per telephone interview with daughter.

Nothing very serious. Cold chills, mild headache, some back and muscle pain, fogginess. All side effects were completely gone within 30 hours after onset.

On 4/6/21 morning, standing helping sick Dad to shower, I experienced dizzy spell and felt like I was leaning to the left side. Slow to regain balance. Lightheaded after for an hour or so. On 4/9/21 evening, while sitting, I felt my head fog up, my left eye spinning in the bottom, my left arm went numb and fingers tingled, left leg numb (1st episode). Lasted several minutes. Shortly after, I experienced another like the first, Tried to walk to the other room, felt like I was dragging my left leg and left arm. Lasted several minutes. Took baby asprin, Within the hour I had 2 more milder episodes. Reported to my doctor on Sunday. She is scheduling tests for me today.

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.

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.

Patient states that she developed altered mental status approximately 4 days after receiving the vaccine as witnessed by family and friends. Her mental status continued to decline over 2 week period, at which time she was brought to the hospital on April 13th. At that time, it was determined the patient had suffered an age-indeterminant ischemic stroke with hemorrhagic conversion. No neurosurgical interventions were done at this time as patients symptoms have appeared to improve after observation.

Began having chills about 7 hours after the injection. On the early afternoon of 4/8. Developed excruciating headache (very similar to when I had Covid previously in Sept. 2020), all over body aches, ringing in my ears and temp. 101. Unable to sleep during the night and excessively thirsty. Was essentially bedridden for 36 hours when headaches and body aches subsided on Saturday morning (4/10) Have only had a few brief headaches and some exhaustion since Sat. Morning. Of note, I have been donating convalescent plasma and platelets since my illness in September, 2020. On March 28 (approaching 7 months after my illness) I was still positive for Covid Antibodies prior to the vaccine.

My arm was very sore and 3 weeks later my left arm is STILL very tender at injection site. I was very tired for about a week w ? brain fog? very scattered pertaining to staying on task. I see a neurologist in for headaches and administers Botox for that. I am concerned if I get a headache from the vaccine the Botox will mask it. I did have a bad headache yesterday which is unusual given I get Botox for headaches

Intermittent 102° fever with normal temperature of 97.7° three days in a row, cold sore on mouth, migraine, body aches, chills, insomnia.

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.

Symptoms occurred 12 hours after shot - approx 2 am. Chills all over body - hands freezing, body aches- whole body, heart racing. After approx 6 hours - developed additional symptoms of a headache - location was back of head and severe teeth and jaw pain on right side of face. Unable to sleep all night. At noon - got up and read vaccine literature to see if I could take anything for the pain. Took Extra Strength Tylenol - 2 00 mg gel caps . Stayed awake for a 1/2 - pain in teeth, jaw and head got got better. Went back to bed for 4 hours. When work up later in the afternoon - felt okay.

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.

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.

Presented as a TIA (mini stroke) Had vision issues, difficulty speaking, vertigo, could not walk, passed out and taken to hospital by ambulance . Began at around 10am. Felt like I was dying. Placed on Stroke Unit. Scans and tests all negative for stroke and Drs. thought could be panic attack or TIA. Since then my lingering effects point to TIA, Seemed to clear up around 2pm with gradual improvement through the day. Still experiencing some side effects including tinnitus, memory and word retrieval issues, fatigue, anxiety. DO NOT HAVE PANIC ATTACKS. The only time I have had a panic attack was at 26 after the death of my mother.

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.

Transient global amnesia - had 24 hours of short and long term memory loss, admitted to hospital, symptoms resolved without intervention

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.

Patient discribed mild headache immediately after. Patient experienced sore arm for about 10 days. Patient started experiencing pain all over a week after the injection. she describes it as a burning sensation though her nervous system and joint pain. Patient also experienced a brain fog a week after her injection. She states that she has trouble putting her thoughts to words. She still feel this reactions on your 17th day.

INTENSE HEADACHES; CLICKING IN THE LEFT EAR; PRETTY STRONG SENSATION; NO SENSATION IN BIG TOE AND TOE NEXT TO IT; COULD HARDLY SLEEP; COULD HARDLY SEE; COULD HARDLY HEAR (INAUDIBLE); CHILLS; FEVER; EXTREME 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 viral meningitis, nausea, and headache, and concurrent conditions included clotting. 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 21-MAR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for clotting. On 2021, the subject experienced clicking in the left ear. On 2021, the subject experienced pretty strong sensation. On 2021, the subject experienced no sensation in big toe and toe next to it. On 2021, the subject experienced could hardly sleep. On 2021, the subject experienced could hardly see. On 2021, the subject experienced could hardly hear (inaudible). On 2021, the subject experienced chills. On 2021, the subject experienced fever. On 2021, the subject experienced extreme fatigue. Treatment medications included: paracetamol. On MAR-2021, the subject experienced intense headaches. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 deg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the clicking in the left ear, pretty strong sensation, chills, intense headaches, extreme fatigue, no sensation in big toe and toe next to it, fever, could hardly sleep, could hardly see and could hardly hear (inaudible) was not reported. This report was non-serious.

CHEST PAIN IN THE MIDDLE OF CHEST; FELT TERRIBLE; ACHES ALL OVER; EXTREMELY TIRED; TERRIBLE HEADACHE; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight was not reported and height was 63 inches. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting and had no known drug allergies. 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 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced felt terrible. On 11-MAR-2021, the subject experienced aches all over. On 11-MAR-2021, the subject experienced extremely tired. On 11-MAR-2021, the subject experienced terrible headache. On 12-MAR-2021, the subject experienced chest pain in the middle of chest. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from terrible headache on 12-MAR-2021, was recovering from extremely tired, and felt terrible, had not recovered from chest pain in the middle of chest, and the outcome of aches all over was not reported. This report was non-serious.

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.

My knee was swollen, body ache and fatigue for 3 day couldn't go to work. Since I heard the vaccination was stopped on 4/12 I was concerned. I went to doctor was advised to take Tylenol.

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.

J&J on 4/12/2021- other details unknown Fatigue, significant, prevents daily activity Headache, Arthralgia

She received her vaccine, and on 4/9/21 she developed a severe ringing in her right ear really loud. It then just kept getting worse and worse and then went to the other ear. Then there was a buzzing at night inside her head. She started getting head tremors inside of her head, and it has not stopped as of 4/29/21. She called her doctor and talked to him and he gave her Zyrtec, however, she is very very sensitive to medications so she could not take a lot of it. It didn't help the right ear which is the worst one. The left ear just started to subside a little bit. It has now been on and off, but still pretty severe in the right ear. The head tremors feel like shaking inside of her head which are not apparent from the outside, and the buzzing. She had another phone APT again and she is scheduled to see a specialist an ENT on 5/3/21 as the condition is debilitating. She is not able to sleep, eat or function due to this condition.

3/18/21, Day after Vaccine, drowzy in the morning, around 12:00 p.m. I had a brief period of incoherent speach and a few moments of having trouble putting sentences together. Around 2:00 a moment of temporary blindness in my left eye. 03/19/21 -03/20/21, extreme fatigue, stayed in bed. 03/21/21, fatigue, light-headed, slightly dizzy 03/22/21, right side leg and arm became numb as if asleep. Went to Hospital Emergency. I had a stroke, had a Carotid Endarterectomy at medical center, was in the Hospital for 5 days, two weeks after surgery became seriously enemic and d_Dimers are still elevated THE CONTINUATION PAGE IS INOPT. AND WOULD HAVE LIKED TO EXPLAIN IN FURTHER DETAIL.

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.

3/20/2021 @ 1:00 vaccination I sat in a chair for 5 minutes. After, I felt warm, I was flushed. Fifteen minutes later I walked out, driving down road with friend and I said 'something is wrong'; really bad 'metal taste' in mouth, blurred vision, grabbed her arm and said I am going to throw up, I was so dizzy and I said I can't think. My face was drooping, I couldn't say my A,B,C's, and by the time I got to the ER they got me on an IV. I couldn't talk, think, and had the metal taste for a few hours. The dr. said we are going to give you fluids, my BP was elevated for 6 hours 198/130, no clots. BP went down to 178/98, taste started to go down, I was drinking fluids, I was able to talk a little bit. I felt like in a 'bubble', I couldn't think. When I was discharged I had no temp, my BP was normal. *my body reacted to the vaccination. *6 hours my body reacted *body had felt like I was recovering from the flu for 2 weeks *Never ran a temperature

A few minutes after the patient received dose 1 of the Janssen Covid-19 vaccine, the patient started having trouble breathing, her throat felt "swollen and thick", was shaky, had itchy hands, and her lip was swelling. Her blood pressure was 174/86 and her pulse was fluctuating in the mid-high 80s. I administered 1 tablet of diphenhydramine (25mg) and 1 dose of the 0.3mg epi-pen. After about 7-10 minutes, she said her symptoms started to level out and were no longer getting worse. Her lip swelling started going down by the time EMS arrived. I continuously checked her blood pressure, heart rate, and heart rhythm while waiting for EMS to arrive and take over her care. They took her to the closest emergency room for continued monitoring.

Insomnia, muscle aches and weakness. Back pain, severe headaches, fatigue. Abnormal D-Dimer levels. Shortness of breathe and chest pain.

Insomnia, muscle aches and weakness. back pain, severe headaches, fatigue. Abnormal D-Dimer levels. Shortness of breath and chest pain.

I have no memory of the day of the vaccine and barely memory for the day after. I still can't remember anything from the two days., so I believe this is permanent memory loss. I could not fine the Johnson & Johnson vaccine on the drop down.

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.

My gums were inflamed they felt like they were pulling away from my teeth. My gums were discolored. I had cavities and it made the pain unbearable. All my teeth felt loose like they were going to fall out. I went to a dentist but no dentist could prescribe me any medication. It hurt from my ear all the way to center of the jaw. I got some antibiotics from my doctor but soon as I finished the pain would come right back. I did three rounds of antibiotics back-to-back. I went to an oral surgeon and he said the antibiotics were not working and he had to pull two of my teeth. The pain was has been unbearable, it feels like nerve pain. I did have some bloodwork sometime during this but I don't remember when.

Weird feeling no my left neck. Stiff? Like something is pulling on it. The nurse practioner told me to wait a month, but it has not completely gone away yet.

on April 11, 2021 I experienced confusion and unable to read or say a few words correctly. I ended up calling my Dr who insisted I go to the ER. I was admitted to the hospital and after 2 days and many tests it was determined I had a small stroke.

I couldn't sleep, I was very tired but I couldn't sleep. My head was throbbing , felt like it would burst. My blood pressure went up to 170/93. Ached all over rest of body.

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.

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)

Whole body pain; sweaty, feverish feeling but never registered a fever when checked. Extreme fatigue and brain fog, headache

Patient received covid-19 vaccine at off-site clinic. As she was walking up to the post vaccination waiting area after receiving the vaccine, she suffered what appeared to be an anxiety attack and fainted. She awoke quickly and was monitored by pharmacy staff. She maintained good blood pressure and was fine afterwards.

My wife got the J&J shot last Wednesday and had the typical sore arm and a little fatigue. On the following Saturday she had a very severe episode of anger at the members of our household and wanted to leave our marriage, sell the house, and said she could not live like this anymore. She slammed doors, yelled and screamed, insulted everyone around her, and would not listen to reason. 3 days later she is calming down somewhat but still has a lot of anger. I have lived with the woman for over 30 years and have never seen anything like this before. She does have her moments and has had mood swings in the past but this episode was exceptional. I think she will be OK in a few more days but I wanted to report this to possibly prevent something similar from happening to others. It is possible this episode was unrelated to the vaccine. It is also possible this is related to her heavy use of Neurontin with Prozac. Let me know if you have questions.

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.

Pt states approx 10 min after injection started with a headache and dizziness. Pt ate something around 0900. Patient was given a granola bar and water. at 1405 BP 171/90, HR 83, SP02 98%, RR 16. Pt states heart is "fluttery", pulse regular. 1416 pt states headache is better. pt denies chest pain or SOB. After sitting up from laying position pt states she was dizzier, repeated BP at 1427, no improvement. Gave pt juice b/c she felt shaky and thinks it's because she hasn't eaten. Had pt rest for 10-20 mins more and then obtained orthostatic vitals, no concern for orthostatic HTN, pt states she no longer has headache or is dizzy. Per pt's visitor her color had returned to normal, pt still feels a little shaky. Pt rested another 5 mins, repeated vitals and pts BP was elevated. Discussed with pt and visitor that due to her hx of HTN and her already being on BP meds, pt should be seen in ER and EMS called. Explained that she should have an EKG done b/c of flutters and HTN along with headache. Educated pt on importance of being seen in ED. Gave pt and visitor time to discuss suggestion, when returning pt states, "Talked to niece who is EMT and said I should be fine if I just went home, rested, ate, and checked BP and took another BP pill (1/2) like suggested with doc before getting ahold of physician. All they'll do in ED is continue to check BP". Advised pt that ED would do more than that. Pt refused EMS and wished to go home. Pt visitor stated that they would watch patient and if anything changed take to ED. Patient left clinic in wheelchair and assisted to vehicle. Pt denies any symptoms that she initially presented with but states she just feeling weak.

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

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.

8 pm- fatigue, beginning of headache. 11 pm chills and fever 1 pm body ached and crushing headache. did not sleep. fever went away after 3-4 hours, body aches dissipated over 2nd day, headache lasted until 3rd morning. woke up Sunday feeling tired but headache all but gone. now 3 days later, still have fatigue and a little fogginess. much like when I get over the flu- just weak and tired.

Client received the COVID vaccine (Janssen, Lot# 1808980) at 11:30. EMT observed the client sitting with her head in her hands and alerted RN, then all responded at 1140. The client complained of shortness of breath and dizziness. Upon assessment, the client was pale, diaphoretic, and clammy, and her skin was cool and dry. The client stated that she is anxious about needles and vaccinations, and that her mask was making her feel "claustrophobic." The client was encouraged to practice deep breathing and her vital signs were obtained: blood pressure of 96/76, respiratory rate of 12. The client stated that she did eat breakfast that morning at 0930 and was offered some water to drink. . Per the client, she has a medical history of hypothyroidism and the only medication she takes is levothyroxine. The client also stated that she tends to have lower blood pressure and "110/60 is normal" for her. The client was alert and oriented. At 1145, the repeat vital blood pressure for the client was 97/63. She stated at this time that she felt like she was going to pass out, and was transferred to the reclining chair. At 1150, the repeat vital signs were as follows: blood pressure of 118/80, heart rate of 78, respiratory rate of 16, and pulse O2 reading of 95%. At 1155, repeat vital signs were as follows: blood pressure of 112/74, heart rate of 78, respiratory rate of 14, pulse oximeter reading of 96%. At this time, the client's color returned to normal and they were no longer clammy. At 1207, the client's blood pressure was 110/72, their heart rate was 73, their respiratory rate was 8, and their pulse oximeter reading was 97%. The client stated they "feel great" and left the facility at 1210, ambulating with a steady gait to their car, where they were driven home by an acquaintance.

Fatigue that worsened over 3 week period, weakness in legs, arms that progressed over that time, dizzy foggy brain that progressed, chest tightness/heaviness that became more frequent over time, ending in inability to stay active for normal activities, fever on & off - thought MS exacerbation - symptoms completely subsided by 4/7/21

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.

Began to feel light headed around 11:45 pm followed shortly by achiness that was mild at first and within an hour became very significant. Then, headache started and was quickly very severe. Accompanied by fever and chills. Slept for 24 hours, woke up for five minutes and slept for another six hours. Though I felt better within 36 hours, I would not call the side effects mild. Still feel lightheaded and having difficulty sleeping.

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.

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

After the shot i had slight swelling in my neck glands, not too bothersome. Severe insomia up from 10 pm to 5 am , really bad headache, pain pressure in my ears, { Couldl feel my heart beating in my ears } Took acetamiphen and cold compress to the head and eyes, seemed to help. Awake at 10 with no further symtoms so far.

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.

"loopy" - counting backwards on a game board; using wrong words at time in sentences; sleep for one day

Feeling glooomy snd a little foggy in the head since day one. Tightness in my leggs thighs. Feeling warm not fever. Not as much on day 7

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 received the Janssen COVID-19 Vaccine EUA on Thursday morning. April 8, . Six hours later I had chills and a low grade fever for two hours. Then, thoughout the night, I experienced jaw pain making it difficult to sleep, but in the morning I applied ice and the pain went away. By Sunday, I felt 100% better.

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

I called a message that patient had experienced a stroke recently and had also rececived the Jansson vaccine. I called patient, who had reported that it happened on 4/2. She had woke up and couldn't put her robe on. Her left arm was not working right. She also noted that she had drooled. She kept thinking that she was find and got ready and went to work. During work she was typing and found that her left hand was not working still, but still went throughout her day and typed with her right hand. Later that evening when she got home, her husband took her to the ER. There, she reports that her blood pressure was through the roof. She had a CT scan and MRI and labs done and was diagnosed with a TIA. She was started on Plavix, baby aspirin, and was started on a statin drug (couldn't remember the name as that information was at home and she was at work at time of call). She is on a heart monitor for 4 weeks and has follow ups with her outside PCP and cardiologist. Today she states that she is feeling back to normal and has regained function on her left side. She reports that she had a headache at time that had lasted for a while. She also reports that she feels like she was having issues weeks before because her brain felt foggy and just was not thinking right.

On Tuesday, April 6, 2021, about 11:45 am, I felt a sudden sharp pain in the right temple area just above eye level and about 2 inches posterior. I also felt some dizziness and wondered if I was having a stroke or some type of arterial inflammation. At the time I was treating a patient and wondered if I was going to have to leave to go home. I did get through the rest of my workday but had difficulty concentrating. I had recurring waves of pain in the same area several times that day and into the evening, was considering alerting my adult daughter that I might need to go to a hospital. Fortunately, resting and increased fluids seemed to resolve the pain and it was mostly gone by the next day.

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.

colonic necrosis 62 yo woman history of prior L occipital CVA and DVT on Xarelto presented to Hospital on April 6 with mental status changes. Patient was noted to be in severe metabolic acidosis, renal failure and shock. Chest x-ray showed interstitial infiltrates and she tested positive for SARS-CoV2. She required intubation and mechanical ventilation. CT brain showed encephalomalacia and atrophy, no new changes. She was transferred on April 8. She was given IV bicarb for persistent metabolic acidosis. Initially she was only treated with steroids, then antibiotics were added for fever and persistent hypotension. She started to spike fevers up to 40. Abdominal CXR ordered prior to MRI, showed possible pneumatosis. A follow up CT April 13 abdomen/pelvis was done which shows colonic pneumatosis, with air in the SMV, portal vein, air in the liver. No thrombocytopenia; platelets on April 13 were 310k, as low as 260 on April 8.

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.

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.

Frontal lobe headache to start within a few hrs of vaccine. Back of the head to lower neck headache 8 hrs after. Every tooth in my mouth started throbbing at around 11 hrs and continued for about 5 more hours. Also during that time, waves of nausea but no vomiting, also uncontrollable shivering but I wasn't cold and I wasn't hot but weird shivering. I did not take my temperature as I didn't feel like I had a fever. Around 13 hrs after a stabbing pain in front of thighs like hot pokers started and around 14 hrs thigh pain was still present but then the calves on both legs started to get the same stabbing pain. At around 24 hrs after - headache remained, pulsating teeth stopped, thigh pain stopped but calf pain remained. Headache remained off and on for several days. General brain fog also lasted for about 1 week. The calf pain comes and goes even after 2 weeks. Arm where shot was administered was very tender to the touch for the last 2 weeks. Lastly, I wouldn't say I had shortness of breath but at times I just felt like I needed to stop and force myself to take a very deep breath.

4-9-21 vaccination Later that evening, I basically feeling 'outside of myself' like my 'spirit left my body'. Took me a week to feel like myself. I had the headaches, felt sluggish, lethargic for a week. I was unable to do normal daily activities. I went to see my PCM on 4-12-21. He did some medical tests / labs. Results were negative for clots. They said I have a cyst on the back of my leg. Waiting on results of my MRI. *HA are ongoing.

SPEECH PROBLEM/SLUTTER; LACK OF MEMORY (FORGET THINGS); WEIGHT LOSS; HIGH BLOOD PRESSURE 172/95 SOMETIMES 180; RASH ON HER FACE; CHILLS; PAIN IN RIGHT ARM AND RIGHT LEG; 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: 1805020 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced speech problem/slutter, lack of memory (forget things), weight loss, high blood pressure 172/95 sometimes 180, rash on her face, chills, and pain in right arm and right leg. Laboratory data (dates unspecified) included: Blood pressure high (NR: not provided) BLOOD PRESSURE 172/95 SOMETIMES 180. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in right arm and right leg, weight loss, chills, lack of memory (forget things), speech problem/slutter, rash on her face, and high blood pressure 172/95 sometimes 180. 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.

SWEATING; INCREASED BLOOD PRESSURE; EXTREME THIRST; SHAKINESS; CONFUSION; MILD HEADACHE; DRY MOUTH; CLAMMINESS; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 100 pounds, and height was not reported. The patient's pre-existing medical conditions included normally had low blood pressure was at 170/92. 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 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced dry mouth. On APR-2021, the subject experienced clamminess. Laboratory data included: Blood pressure (NR: not provided) stabilized. On 18-APR-2021, the subject experienced extreme thirst. On 18-APR-2021, the subject experienced shakiness. On 18-APR-2021, the subject experienced confusion. On 18-APR-2021, the subject experienced mild headache. On 19-APR-2021, the subject experienced sweating. On 19-APR-2021, the subject experienced increased blood pressure. Laboratory data included: Blood pressure (NR: not provided) 170/92 mmHg. Treatment medications (dates unspecified) included: atenolol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from increased blood pressure, and the outcome of extreme thirst, shakiness, confusion, mild headache, sweating, dry mouth and clamminess was not reported. This report was non-serious.

RECURRENT NOSE BLEEDS; WEIRD SENSATION IN HEAD; 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: Unknown) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced recurrent nose bleeds. On 2021, the subject experienced weird sensation in head. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from recurrent nose bleeds, and weird sensation in head. This report was non-serious.; Sender's Comments: V0: Medical assessment comment was not required as per standard procedure as case assessed as non-serious.

MIND FOGGY; SHORTNESS OF BREATH; HEART RACING; UNABLE TO MOVE AROUND; CHILL; FATIGUE; FEVER; MUSCLE PAIN; VERY RED VEINS ON RIGHT LEG LOWER PART/RED VEINS ON LEFT ARM LOWER PART BETWEEN WRIST AND ELBOW; 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, and other pre-existing medical conditions included patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced very red veins on right leg lower part/red veins on left arm lower part between wrist and elbow. On 06-APR-2021, the subject experienced shortness of breath. On 06-APR-2021, the subject experienced heart racing. On 06-APR-2021, the subject experienced unable to move around. On 06-APR-2021, the subject experienced chill. On 06-APR-2021, the subject experienced fatigue. On 06-APR-2021, the subject experienced fever. On 06-APR-2021, the subject experienced muscle pain. Laboratory data included: Pulse rate (NR: not provided) 92 /min. On 16-APR-2021, the subject experienced mind foggy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chill, fatigue, fever, and muscle pain on 08-APR-2021, was recovering from shortness of breath, and unable to move around, and had not recovered from heart racing, mind foggy, and very red veins on right leg lower part/red veins on left arm lower part between wrist and elbow. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard operating procedures, as the case was assessed as non-serious.

Day vaccine was administered to patient the only effective on that date was Tired and drowsiness were experienced. in the late afternoon this condition was only intensified . The next business day was difficult due to a Migraine that was in full force on that Friday. Patient was unable to perform any actions including Work from home. Patient slept for the next 20 hours. Other than sleep no other actions were committed. On that date 3/19/2021 it was noticed that her eyes were sensitive to Light and were also very puffy.. On the Sunday there was little and or no change still sensitive to light and the puffiness was still felt but the eyes were so swollen that it was almost impossible to open them. The Urgent care patient went to on the Sunday was the initial with Healthcare facility

Exhaustion, weak balance, foggy brain within 24 hrs. of vaccination. Neck pain (right side) within 1st week.

BOTTOM EYELIDS ROLLING INWARDS TOWARDS EYES; LIGHT SENSITIVITY TO EYE; EYE RED; ENTROPION IN EYE; PAIN EYE; MIGRAINE HEADACHE; FOGGY FEELING IN HEAD; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 140 pounds, and height was 67 inches. The patient's concurrent conditions included codeine allergy, alcohol consumption, and cigarette smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included amoxicillin for allergic reaction, and for allergic reaction. On 18-MAR-2021, the subject experienced foggy feeling in head. On 19-MAR-2021, the subject experienced migraine headache. On 20-MAR-2021, the subject experienced pain eye. On 20-MAR-2021, the subject experienced light sensitivity to eye. On 20-MAR-2021, the subject experienced eye red. On 20-MAR-2021, the subject experienced entropion in eye. On 21-MAR-2021, the subject experienced bottom eyelids rolling inwards towards eyes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from foggy feeling in head on 18-MAR-2021, had not recovered from pain eye, light sensitivity to eye, entropion in eye, and bottom eyelids rolling inwards towards eyes, and the outcome of migraine headache and eye red 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.

Extreme muscle aches and joint pain throughout the entire body which started in the evening. I did not sleep well with the pain with not being able to lay on my sides as my arms would go numb and I hurt terribly the next day until the afternoon when I took two Advils.

Patient was walking in the store, said she started feeling anxious and light headed and began to feel like she was going to pass out. The manager came and got me and we went to her. She was seated and I gave her water. After about 10 minutes she said she felt better and said she wanted to leave. I walked her to her car, helped her load her groceries in the car and she left with her sister. An incident report was written by store management

The soreness experienced continued for a week to the day of the shot and on the 8th day until the present became increasingly unbearable. I'm unable to dress myself because the pain in my left arm is excruciating. I can't raise my arm for more than a foot from my side. I've taken ibuprofen and am using ice compresses, but it doesn't help enough. So far I've missed 3 days of work. I cannot dress myself, so I know I can't drive. Please advise. I also massage the sore area to keep my arm from stiffening up.

I came in from outside and sat down and all of a sudden I couldn't tell what year it was. My husband suggested that I check my blood pressure and it was elevated. I went to the ER and had a CT scan and a chest x-ray, no damage was seen. I was sent home because they assumed it was a TIA. I saw my doctor the next day for observation.

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.

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

severe right arm pain over bicep and tricep, limits ROM, sharp shooting pain down arm, wakes her from sleep, no localized reaction, pulses and circulation are normal, pain does not improving with tylenol or ibuprofen.

My heart started feeling funny. I walk a lot and we usually walk four miles 4 or 5 days a week. I told her my chest felt funny. It didn't funny. It felt like heart was pounding. I waited about a month before I went to doctor - never had it in my life this kind of thing. It beats out of whack ( my heart) - I feel it mostly at rest. If I lie down I can hear heart beating in my ear. It is still occurring. The next step would maybe be to take beta blockers but haven't tried that yet. My doctor can hear it. It's constant - it is always is doing it. When I stop and slow down, I hear that it's beating irregular.

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

In the evening I started to feel aches in my eyes and joints. I was having trouble falling asleep. I woke up every 2 hours. My heart bpm went up to 102 in the middle of the night. I know this because my fit bit was vibrating and encouraging me to keep exercising and I was just laying in bed trying to sleep. I finally got up around 2:30 in the morning and took 1 Aleve. I also took my temperature with a forehead type and it was 98.5, so no high fever. I took another Aleve around 7:00 in the morning. Now I am feeling fine. It's now 8:22 a.m. and I am working from home. I just wanted to report that the aches in joints and 102 bpm and unable to fall asleep were my side effects. I feel fine now. I will continue to take Aleve as needed. I have never been tested for Covid. I have never had any symptoms to warrant testing for covid. Since March 13, 2020 I have been fortunate to work for a company that has us all working from home. We are still working from home. i am 63 years old. I shop around 6 a.m. in the morning for groceries to avoid people. I do not go out. I have been very careful.

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

Patient state she felt light headed and dizziness and "weird". Patient was sitting at the time and I had the patient lay on the ground to prevent any injury in the event she were to pass out. Due to her stating she felt so hot and "bad" 911 was called and dispatched. Upon arrival the patient was seated. and stated she felt weird to the EMS. She stated she did not want to go to the hospital but was unsure if she could stand without passing out. Vaccine was given around 11:40 am and around 11:50 to 11:54am patient started complaining of not feeling well. EMS arrived within 10 minutes of calling 911. Patient stated she did not want to go to the hospital but would go to the ambulance to be evaluated. EMS stated they could exam her in the ambulance and decide from there if she wanted to go to the hospital.

Eight hours after the vaccine, I awoke with moderate chills and tremors. Eleven hours after the vaccine, i awoke with all-over body aches and a mild headache. I slept 3 more hours and woke up with all of the previous symptoms at once. I felt moderate malaise and these symptoms for 24 hours. I had a sore arm for 4 days.

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.

Could not sleep for 6 days and nights. The first night I did not sleep at all, the next 5 days and nights I could sleep a few hours at a time but it was quite fitful sleep.

Janssen COVID-19 Vaccine EUA Based on the paperwork I received at my vaccination, I am reporting my side effects for your records. I received the dose (1805029) on 3/12/2021 (Friday) at 4:30 in the afternoon. At around 10:30 p.m. I began to feel unwell with chills, shaking/tremors of my hands/arms, and overall aches. I had trouble sleeping through the night due to these symptoms in addition to night sweats (fever). These conditions persisted through the next day (Saturday) and evening (24 hours). I managed to sleep 8 hours and had only a headache the following morning (Sunday). I treated my symptoms by taking Tylenol which was helpful. Hope this helps with your research/records.

Felt feverish and achy with chills and extreme fatigue beginning at 10:30 pm on 3/12 and lasting all day Saturday 3/13. Treated by alternating ibuprofen/aspirin every 3-4 hours. Fever was gone by Sunday morning, although extreme fatigue and head fog lasted the entire day. Felt completely fine by Monday morning - 3/15.

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.

Immediately after receiving the vaccine, stood up and felt dizzy and could feel headache moving to my scalp. At bedtime, around 10:30 pm, I could not fall asleep, was freezing, achy, in and out of sleep. Took temperature at around 2:00 AM. My temp was 102 deg. F, my pulse was at 125 bpm. I could feel my heart rate beating rapidly. Was still dizzy. At around 6:30 AM, my temp was 101.9 deg. F. Stayed home from work. Got out of bed around 2:00 PM. As I went to the restroom during the morning, early afternoon, my temp gradually decreased, my heart rate gradually decreased. Still had headache. Was very fatigued. The next day, my temp was normal, had mild headache and was still fatigued.

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.

Saturday after shot: felt fine afterwards; no soreness in arm, no other effects. Sunday after shot: started feeling lightheaded/dizzy in the evening; headache Monday -- Friday: fatigue, muscle ache, lots of congestion (nose/lungs) and deep bronchial cough, intermittent headache, intermittent low grade fever -- unable to work. Saturday-today after shot: still fatigue but better; congestion better as well--still congested but cough is relieved (saline nasal rinse helped a lot); no headache; no fever

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.

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".

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.

Pt developed throat discomfort. Was given benadryl 25 mg po x1. BP 153/69, HR 65, O2sat 100%. Respirations appeared normal. Also reported arm pain radiating up to left side of face and tight chest pressure. Was given 2 puffs of albuterol inhaler. Pt stated throat felt better at this time. Repeat BP 135/59, HR 64, O2sat 99%. Pt felt shaky and cold, possibly from albuterol. Pt stated chest tightness subsided but still continued to have weird sensation in her arm up to her jaw area and throat was still feeling funny. Repeat VS 123/61, HR 61, O2sat 100%. Was taken to ER via W/C. Pt c/o being dizzy and throat was tightening up again on the way to ER. Was given solumedrol in ER. Discharged home. Feels better but still has some left throat swelling, improved with steroids, antihistamine. Airway unaffected. Chest tightness/pressure resolved.

Head pounding My entire body muscles felt like I had been beat up. Blankets were difficult move stretching/ spasms were strong and long. Took two pain killers my low back felt so bad I wasn?t sure if I could walk to bed. Rough night still have a bad headache low back ~ hips hurts to bend over.

Started with extreme tiredness around 8 pm same day as vaccine. Woke up with fever and some confusion the next morning. Fever persisted with analgesics on board and hydration efforts for almost 15 hrs.

Worst headache of my 63 years, starting in the night, still bad (though controlled by Tylenol Extra Strength) until about noon later that day, then faint headache for another day AND fog-brain, strange forgetfulness, almost dementia-like (both parents have dementia). Other symptoms earlier than the headache were joint/bone aches like with the flu and lethargy. Brain fog still a worry 3 days later.

pt says that later in the evening after taking the vax she had a weird feeling moving from the left arm to the left shoulder then to the base of her neck. This was very uncomfortable for the first couple of weeks, especially around the base of her neck. The pain seemed to be worse when she is laying down. On 4/13/2021 over a month later she still has some soreness but is getting better. She has been taking ibuprofen for the pain.

I had a fever that evening and thru the night into the following morning. I have had ongoing EXTREME exhaustion and have been unable to return to work since Thur. April , 2021.

Severe headache unable to go to work for one day Still not up to my normal abilities two weeks later. More fatigue than usual. Right and left leg pain and right arm pain. Possible DVT but not tested have had in the past so feels that way

vertigo 8 a.m. I was so dizzy I could not dress myself or drive; stayed in bed the whole day was less dizzy the second day but did not go to work I feel small repercussions of slight dizziness since then

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.

Patient called clinic 4/13 to report having been seen by PCP and in ER twice since vaccination. She reported onset of headache and fatigue day of vaccine. She reported later feeling short of breath and having a decreased tolerance of activity. She stated she had an elevated heartrate and "neurological symptoms", but did not specify. She reports still feeling off at this time 4/13 and having appointments scheduled with a Vascular surgeon and neurologist in the near future. I am doing the reporting as the vaccine was given by Public Health staff, but this is the first notification we have received of the her potential adverse reaction.

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.

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.

She presents to ED on 04/14/2021 with complaints of altered mental status and rash. Patient states that she went to work on Saturday, she is a food server, she started to feel not herself and felt like she ?snapped?. She states that on the way home in her car she was nearly struck by the train crossing barriers. She states that she went home and sat in her recliner on Saturday and did not get up until Wednesday at around lunchtime. She states that she did not get up to eat or drink. She used incontinence pads and depends. She did not get up to use the restroom. She did continue to take her medications. Patient states that she was motivated to get up today because her friends were concerned for her and 1 of her friends came over to take her out for lunch. Elevated D Dimer History of DVT - mild leg pain, no swelling or erythema. No chest pain, cough or SOB. Low suspicion for PE - full dose lovenox - BLE duplex in the morning

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.

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.

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.

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.

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: 203A217 expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 14:15 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced neck pain. On 08-APR-2021, the subject experienced flu symptoms. On 08-APR-2021, the subject experienced bad night. On 09-APR-2021, treatment medications included: ibuprofen. On 10-APR-2021, the subject experienced dizzy/ light headed. On 10-APR-2021, the subject experienced sweaty. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from neck pain on 10-APR-2021, and bad night on 09-APR-2021, and had not recovered from dizzy/ light headed, sweaty, and flu symptoms. This report was non-serious.

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.

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.

After receiving J&J vaccine on Friday, 3 days later I developed severe lower back ache that spread across and covered my entire lower back and hip area also. The muscle pain was so severe I had trouble sleeping and sitting but could stand pain free. This lasted about 3 days. I took Tylenol to help with the pain and used a heating pad also. After day 3 it was all over and I've been fine ever since!

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.

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.

Patient describes fatigue starting 4/2, improving but not resolving. States she is participating in ADLS but is needing to take breaks in between, which is unusual for her.

Heart palpitations. Left arm numb where received vaccine numb and still is over 2 weeks later. Left forearm and finger pain. Insomnia for two weeks and still have it.

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.

ANXIETY; HEART RACING; STRANGE FEELING IN LEGS; RESTLESS LEG SYNDROME; NUMBNESS AND TINGLING IN LEFT ARM; 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: 206A21A and 205A221A expiry: 01-JUN-2023) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced strange feeling in legs. On 07-APR-2021, the subject experienced restless leg syndrome. On 07-APR-2021, the subject experienced numbness and tingling in left arm. On 13-APR-2021, the subject experienced anxiety. On 13-APR-2021, the subject experienced heart racing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from strange feeling in legs, restless leg syndrome, numbness and tingling in left arm, anxiety, and heart racing. This report was non-serious.

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.

1) Severe headache and delirious sleep and overall muscle achiness. Lasted for 36 hours approx. 2) Approx ten days later on April 19th, 2021, I awoke at night with severe left shoulder pain/deep ache. It came and went over the next week, but became more constant and severe. I couldn't sleep most nights without sleep meds, and even then it was for a few hours, and on my back. I couldn't sleep on either the good and especially not the bad shoulder. Via a phone call, my PCP suggested I begin treatment with Ibuprofen, 3-4 times per day. I took 2-3 Ibuprofen at a time. As of today, May 12, 2021, I am still taking Ibuprofen 3 times a day as I still cannot sleep on my bad (left) side. I didn't think this was related to the vaccine shot until my husband said that he also was having shoulder pain on the same side as the injection. His was milder and lasted about a week, but began about the same time as mine did.

SOME DAYS SHE DID NOT USE HER LEFT ARM; LEFT ARM WEAK; JOINT PAIN; CHILLS; FATIGUE / TIRED; HEADACHE; FEVER 101F; MUSCLE PAIN; SHORTNESS OF BREATH; DRY COUGH; BRAIN FOG; ALL SHE DID WAS SLEEP FOR 2 WEEKS; RACING HEART RATE; DIZZINESS; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight was 150 pounds, and height was 175.26 centimeters. The patient's past medical history included covid-19 infection, and concurrent conditions included non-smoker, alcohol use, sulfonamide allergy, high blood lead level, and neurological problems, and other pre-existing medical conditions included the patient had no known allergies and no food allergy. the patient did not have any drug abuse/illicit drug use. The patient experienced drug allergy when treated with ciprofloxacin, clindamycin, erythromycin, and nortriptyline. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and 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 racing heart rate. On 06-MAR-2021, the subject experienced dizziness. On 09-MAR-2021, the subject experienced shortness of breath. On 09-MAR-2021, the subject experienced dry cough. On 09-MAR-2021, the subject experienced brain fog. On 09-MAR-2021, the subject experienced all she did was sleep for 2 weeks. On 09-MAR-2021, the subject experienced left arm weak. On 09-MAR-2021, the subject experienced joint pain. On 09-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced fatigue / tired. On 09-MAR-2021, the subject experienced headache. On 09-MAR-2021, the subject experienced fever 101f. On 09-MAR-2021, the subject experienced muscle pain. Laboratory data included: Body temperature (NR: not provided) 101 F. On an unspecified date, the subject experienced some days she did not use her left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from racing heart rate on 17-MAR-2021, dizziness on 04-APR-2021, and joint pain, chills, and fever 101 F on MAR-2021, was recovering from dry cough, fatigue / tired, headache, brain fog, left arm weak, and muscle pain, had not recovered from shortness of breath, and the outcome of all she did was sleep for 2 weeks and some days she did not use her left arm 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.

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.

About 15 mins after injection my legs started itching, and I felt slightly disoriented, dizzy. I did feel like it wouldn't be smart to drive so my husband drove me home. I had a slight fever that night and next day, I felt super tired. I scheduled an ultrasound for 1 week following the shot, My ears kind of freaked out after the ultrasound and was itching and burning, I also got a rash around my neck after ultrasound. The rash felt like fire. Allegra helped with the itching. Faint rash traveled down my arms. The Dr. put me on prednisone the rash spread to my back and upper legs. Benadryl was not helpful. It lasted approximately 2 weeks.

FELT WOBBLY; MILDLY SORE ARM; TEARY FOR NO REASON OR SOBBING (OVER EVERYTHING SEVERAL TIMES A DAY); EVERYTHING HURT HER FEELING; 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 doesn't metabolize alcohol, and menopause, and other pre-existing medical conditions included patient had nothing wrong and had no ongoing medical issues, patient was not on medication of any kind and had not taken any medication after shot. the patient had pms (premenstrual syndrome) (wanted to cry over everything, no anger though). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022, and expiry: UNKNOWN) dose was not reported, administered on 09-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced teary for no reason or sobbing (over everything several times a day). On MAY-2021, the subject experienced everything hurt her feeling. On 09-MAY-2021, the subject experienced felt wobbly. On 09-MAY-2021, the subject experienced mildly sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from teary for no reason or sobbing (over everything several times a day), everything hurt her feeling, and mildly sore arm on MAY-2021, and had not recovered from felt wobbly. This report was non-serious.

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.

FLU-LIKE SYMPTOMS; UTERINE BLEEDING; SEVERE BRUISING; TIGHTNESS IN CHEST; STRANGE FEELING IN HEAD; 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 anemic, menopausal since 2006, asthma, and irritable bowel syndrome. The patient was not pregnant at the time of reporting. The patient had a history of steroid shots in shoulders, knees and back. The patient had never experienced any uterine bleeding or bruising after receiving the Kenalog (triamcinolone) in the past. The patient never had any of these symptoms in the past. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, 1 total, administered on left deltoid on 26-MAR-2021 for prophylactic vaccination. Non-company suspect drugs included: triamcinolone acetonide (form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported. On 26-MAR-2021, the patient experienced severe bruising and uterine bleeding after receiving the Janssen COVID-19 vaccine. The bruising and bleeding started after she received a Kenalog (triamcinolone) shot. The patient experienced tightness in the chest the same day she received the vaccine and her head felt very strange like it was not part of her body. On 27-MAR-2021, the patient felt fatigue, flu-like symptoms and fever. The fever lasted for 5 days. The patient also had a headache for 2 weeks. The patient recently observed the bruising which had continued to increase. She reported this to her HCP who did some testing. The patient received a Computerised tomogram head scan which showed no blood clots. She used her Albuterol (salbutamol) inhaler and nebulizer to help with chest tightness which resolved. The patient would receive the test results sometime next week. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with triamcinolone acetonide was not reported. The patient recovered from tightness in chest, had not recovered from severe bruising, and the outcome of uterine bleeding, strange feeling in head and flu-like symptoms was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210702690-covid-19 vaccine ad26.cov2.s-uterine bleeding. 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: CONMEDS-OTHER SUSPECT DRUGS

Right after the vaccine - Really bad sore arm for at least a week. I did have chills and aches for maybe a day. My usual joint pain that I experience wasn't worse that usual but I had just gotten cortisone shots a month earlier (March) so it was possible that it was keeping it all under control. But now I've been experiencing pain in joints. My thumb joints are in a lot of pain, very difficult to do almost anything; my lower back is really inflamed - the bones there. Other joints - knees and other joints hurt too but mostly those joints. Had chiropractic care - sometimes that increase inflammation because I'm moving the joints and but also have gotten 7 laser treatments on those joints - which has helped. Another number to call regarding my joint pain history medical records- haven't seen him since March, though -Doctor - who did - - he's not listed as my doctor but he did the cortisone shot and was my doctor before.

It began with being light-headed and difficulty walking on March 25th. On April 14 I had my first "seizure like" event as I was going to teach school. I had Upper arm tremors and difficulty speaking and walking. Sent by ambulance to the emergency room. Released later that day and given meds for UTI which was later deemed a misdiagnosis by Dr. Didn't go to work as I continued to have difficulty walking and had headaches and overall weakness. Saw Dr. on April 20th. Had to use wheelchair to attend the office visit and was given blood tests to see what was causing my condition. Had high blood pressure. She also advised me to see a neurologist and heart doctor. ON April 20th had to go back to ER as I had the smae seizure like event!On April 22nd I visited Dr. office (heart doctor). Blood pressure was off on this day as well and I stayed at clinic until it was better. Was given a heart monitor to wear for 24 hours. Heart was fine after wearing the monitor. Visited Neurologist and was given EEG and CT CTA tests. All came back fine.

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.

Continued pain in upper left arm where given the shot. Never had pain there before until given the shot. Pain sometimes wakes me up at night. No pain in right arm. Is difficult to get dressed in the morning and loss of strength in the upper arm. Pain started day after the shot in upper arm and has not gone away. Is tender to the touch at the location the shot was given in the arm.

brain fog vision problems, extreme exhaustion weight gain all scar tissue from surgerys is swollen and painful blown up and very visible, ( face is distorted) tingling in hands and feet

During a conversation, I was told I began smacking my lips then proceeded to completely ?zoneout? for 5-7 minutes. My arm was touched and I was asked a couple of questions to which I did not respond. After a few minutes, I became alert and continued conversation where I left off. I was unaware any of this was happening. I was pretty much wiped out for about 5 days. I have never had a seizure before.

Face flushing within 1/2 hour that then subsided within another 1/2 hour. 6 1/2 hours after inoculation, at 7pm, I began to feel unwell. I felt a burning all over my body (especially my back), and body aches, and began a fever which grew from 97.3 (my normal) to a high of 100.1 (+2.8 degrees) within 2.5 more hours (by 9:30pm). Very bad chills and fever. By 9:30 took 1 500mg Tylenol. Little sleep that night. Felt very unwell next day (3/9) including headache. At noon I could get up and get some food. By 1pm fever subsided completely, but temporarily. Fever came back by 4pm, but only to 98.6 (+1.3 above normal). Took another 500mg Tylenol. Night 2 slept well. Woke up 3/10 no fever, headache gone, but balance still peculiar. I noticed the first night that my sense of balance was off.

One week after vaccination, patient awoke with intense generalized itching (she described as a "internal burning itchiness" that was "all over"). She saw no rash or hives. Continued for remainder of night, difficult to sleep. Next day her husband found what he described as a few "faint, non raised patches of very light hives" on the patient's back. She looked more carefully and found a few small similar patches on both arms and legs. Treated with OTC lotion, CeraVe Itch Relief Lotion from store. Patient says 12 hours after onset that the "insane burning/ itching has subsided for now." Patient reports no new foods, clothing, washing machine detergent, illnesses, or other exposures. I am a physician, and the patient called me (her brother) to ask me whether this was a known side effect of the Janssen COVID vaccine. I did not see this described in the FDA advisory committee data package, but just a general reference that urticaria would be an expected side effect to a vaccine.

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.

Within 12 hours I became to have severe muscle aches and joint aches. All my joint felt hot, it was bad enough I wasn't able to sleep. I took Ibuprofen to help sleep. I slept most of Friday I has extreme fatigue. On Saturday I has muscle weakness and tingly in my hands, the muscle aches have gone away. I couldn't knit ot fine motor skills, It bothered me. I woke up on Sunday where I had extremes muscle weakness in both my legs. I called my PCP, they were surprised by how the reaction was delayed. They wanted me to get a test for the strength in my legs and sent me to the ER. I wen to the Er they tested for stroke, blood work, scans, they were worried about Guillain Barre Syndrome. I stayed there about 5 hours. Yesterday afternoon the tingly went away from my hands but my legs are still kinda goofy. The muscle in my forearm and thigh feel like my muscle are really sore, like they have been tense

Work up with headache and chills, felt "fuzzy" - not necessarily adverse event but side effect I guess you could call it.

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.

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.

Patient became lightheaded and woozy approx. 5 min after injection. Pt has a hx of low BP, denies diabetes. Patient began to feel better but states if she turns her head she feels "weird". Vitals taken: 164/72, HR 74, SP02 98% at 0936. Patient laid down and was given water and a granola bar. Repeated vital signs and were improved at 0951: 129/74, HR 66. Patient states that the repeat BP was closer to baseline. Pt observed until 10am. Patient stated feeling better and back to normal.

Resident had an Anxiety attack, passed out approx 5 minutes after administration. Vital signs were taken, blood pressure & pulse elevated, temperature & oxygen levels okay. Patient was sweating. Approx 2 minutes later, patient became alert & oriented x4. Patient stated that she has a fear of needles. Patient relayed having similar symptoms in the past. Patient has hx of hypertension. No further care given. 911 was called at the time the patient became unconscious. EMS arrived approx the same time as the patient becoming conscious. EMS ran vitals. EMS did not transport. Patient is stable and walking. Patient left location after 30 minutes of monitoring.

Bad headache, muscle pain over entire body, chills ,then hot, 101.7 fever. I just slept a lot ,drank lots of water, everything but the muscle ache is gone

30 minutes after receiving the vaccine- -- hot flashes that lasted 8 hours. Right away after receiving the vaccine-- stiff neck on the left side which after a night's sleep, moved to my right side of neck. No big deal. Tired & 'drunk' after the vaccine which lasted until mid-afternoon the next day. No big deal. The worst of all happened at 3 1/2 days, a rash started in the evening, went to bed, woke up the next day with rash almost everywhere. Red, swollen, & itching like crazy. The next day- Sunday, along with Monday & Tues. was horrid. I am covered from my scalp to the tops of my feet, my crotch hurts, as do my breasts. Used Benadryl cream, aloe vera to no avail.

Patient reported feeling heart palpitations and fatigue and anxiety Patient provided with water and seen by medical team Patient stated symptoms have resolved and refused medical transport and signed Medical form

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.

NO medical intervention required. For reporting purposes ONLY. Within about five minutes, throat swelled but not to the point of concern. Don't remember reactions to previous vaccines but not surprised considering allergies. Left side of face felt strange but didn't look any different when a selfie was taken. Sometime during the afternoon/evening, experienced a headache of short duration. Approximately six hours after shot, experienced chills and low grade fever. Simply went to sleep. Better the following morning, though very tired. Probably unelated rough itchy patch on RIGHT arm the day following vaccine. Went away with no treatment.

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????

6-1/2 hours later: Symptoms came on quickly. Hands and feet felt frozen, chills, severe shoulder joint and muscle pain. Immediately had to lay down and took Advil/Tylenol. Could feel the movement of joint pain from shoulders to elbow, hips to knees. Headache. Couldn't navigate stairs safely. In bed or on the couch for 24 hours until 6pm Friday 4/9/2021. Three of us from the same company had the Janssen Vac within a day of each other and all 3 of us had the same adverse reaction. To me, that is not mild symptoms when it debilitated me and kept me from going to work. Most family members have had Pfizer with two shots and had NO side effects.

I wasn't sure how to indicate which dose I'm reporting on. It's my second dose of a vaccine but my first of Johnson & Johnson. My first shot for Covid-19 was a Moderna shot, to which I had a bad reaction (immediate and prolonged lightheadedness reported already on this site). My doctor advised me that my second dose should be a Johnson & Johnson vaccine, as per information he had received from the CDC. So, 28 days after the first shot I had the Johnson & Johnson vaccine. I experienced the expected side effects of body aches, chills, headache--no big deal on day 2, but on day 3, I started some lightheadedness, as did my daughter who had the shot the same day. Her lightheaded subsided the next day, but mine continued into day 4 and got worse when it became accompanied by pressure in my head/ears, and it felt like I was talking in a tunnel with echoing. I couldn't function the rest of the day. Today, the head pressure is not there, but the lightheadedness and shakiness are still there. I hope I fully recover from these shots, but I don't have a lot of hope.

Patient reports check tightness, anxiety. Patient was treated by EMS and nurses on site. Patients symptoms resolved and patient left site via personal vehicle.

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.

Arm really hurt for about 15 min., then went away. Intense cold, couldn't get warm with multiple layers of clothes and blankets. Fever. Restless sleep ~ hot, then cold. Sunday am woke with a headache that lingered and felt like I was in a fog ~ dizzy if I turned my head quickly, and then really tired. About 7pm I felt fine.

Awakened earl y morning 12:00 am of April 9th with horrible pain in left calf of leg. Pain continued throughout the night, until I finally got up and just walked around house to try to get some relief then laid down and try elevating leg on pillows. The pain continued so got u p and walked around more and pain finally subsided enough to get some rest. Then felt like just had a bruise in that area of the leg for a day.

UNABLE TO LIFT WITH LEFT ARM; BODY ACHES; MUSCLE SPASM; DIFFICULTY CONCENTRATING; SEVERE LEFT ARM PAIN; CHILLS; HEADACHE; FEVER; 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 ptsd, and concurrent conditions included osteoporosis, gluten allergy, non-smoker, and abstains from alcohol, and other pre-existing medical conditions included no drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029, and expiry: 25/MAY/2021) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: cannabidiol, and paracetamol. On 17-MAR-2021, the subject experienced unable to lift with left arm. On 17-MAR-2021, the subject experienced body aches. On 17-MAR-2021, the subject experienced muscle spasm. On 17-MAR-2021, the subject experienced difficulty concentrating. On 17-MAR-2021, the subject experienced severe left arm pain. On 17-MAR-2021, the subject experienced chills. On 17-MAR-2021, the subject experienced headache. On 17-MAR-2021, the subject experienced fever. Laboratory data included: Pain scale (NR: not provided) Described pain 12/10. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 22-MAR-2021, and headache on 26-MAR-2021, was recovering from body aches, muscle spasm, and difficulty concentrating, had not recovered from severe left arm pain, and the outcome of unable to lift with left arm 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

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.

reported feeling of warmth over her right after injection and tingling sensation in arm & "anxious & nervous". TX: mask removal ; opened car windows x 4 for air flow; emotional support for anxiety.

HEART RACING; SLIGHTLY DIZZY/LIGHTHEADED; ANXIETY; 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 pre-existing medical conditions included the patient had no known 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: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 16:00 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced heart racing. On 09-APR-2021, the subject experienced slightly dizzy/lightheaded. On 09-APR-2021, the subject experienced anxiety. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heart racing, slightly dizzy/lightheaded, and anxiety. This report was non-serious.

PULSE RACING; BLOOD PRESSURE WAS UP; FELT ANXIOUS; 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: 1808609, expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced felt anxious. On 27-MAR-2021, the subject experienced pulse racing. On 27-MAR-2021, the subject experienced blood pressure was up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pulse racing on 2021, and had not recovered from blood pressure was up, and felt anxious. This report was non-serious.

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.

Note this is in reference to initial report filed 03/31/2021 - Received Janssen vaccine for COVI-19 in mid-March 2021. Over the next couple of days, became very ill, spent five days experiencing severe headache, disorientation, confusion, neck, shoulder, and back pain together with generalized arthralgias and myalgias. Around the 2nd week post-vaccination began to experience ?numbness and tingling? initially, affecting all fingers and toes; symptoms gradually evolved into ascending paresthesia affecting the upper and lower extremities. (worse in the upper extremities). Neurological symptoms are accompanied by painful electrical-like impulses running along my spine and elicited by flexing my neck (Lhermitte neurological phenomenon). Neurological signs and symptoms prompted me to go to the emergency room. Currently, I am under the care of a neurologist and undergoing extensive diagnostic workup. Present treatment: Glucocorticoids (tapering) and Gabapentin. Among the initial rule out diagnosis, were transverse myelitis, and Guillain Barre. Present preliminary r/o diagnosis: Post-vaccine immune reaction ? No definitive diagnosis yet.

Exactly a week after receiving the J&J vaccine, I was out on my morning walk when my head became very fuzzy and my vision was altered (seeing jagged zigzags-fuzzy ones with my left eye). The vision issue persisted when I closed my eyes. The fuzzy head issue continued during a very difficult walk home and when I arrived and things didn't clear, my husband ended up taking me to the emergency room. I got in quickly because the symptoms I described sounded to them like a stroke. But, I didn't have a stroke. They did a CT scan. It was fine. The vision thing they thought sounded like the effect of a migraine. But, I've never experienced migraines. (Note: this incident occurred the day before the news of the J&J blood clots became public). Anyway, after a couple of hours in the emergency room, I was fine and went home. So, I don't know what happened and it probably didn't have anything to do with the vaccine. I'm not prone to being alarmist and I would only consent to go to the emergency room if I thought I were in a serious situation. The blood work indicated my platelets were in the normal range. And, I'm too old to be in the category of the six women who experienced blood clots. However, I just thought I should report this in case anyone else experiences something similar.

A little over a week after the vaccine I begin feeling so tired because my back started feeling so weard and fatigued feeling. It was like my back was tired and the muscles were really tensed. Moving helped but while sitting is when the issue back hurt worse. I reached out to your Chiropractor on 3/31 who performed a few settings on my back to help with the tension but the pain went up and down during that time and seems as if the pain went away on it on.

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.

April 2 -3 felt tired and achey and chills April 8 - 10 tingeling of face, left eye hurt. April 11 no energy, left eye watering, lips swelling April 13 more swelling of face - Night of 13 wanted to rip my face off!!! April 14 swelling of eyes, lips, cheeks, hives on face and eyes. Felt miserable Zoom call with Doctor put on Medrol dose pack, Allegra, AM Zyrtec,PM Pepcid AC, purchased Epinephrine, Benadryl during day April April 19 more hives on chest

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.

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.

TINNITUS; UNABLE TO EAT; UNABLE TO SLEEP; 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: 042A01A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 08:15 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced tinnitus. On 08-APR-2021, the subject experienced unable to eat. On 08-APR-2021, the subject experienced unable to sleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tinnitus, unable to eat, and unable to sleep. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not needed as per standard procedure since case is assessed as non serious.

SORE ARM, AT FIRST ATTRIBUTED TO muscle ache, but later realized it was very specific to injection site, and very intense pain. I was unable to sleep more than a few short spurts the entire night as the pain was so intense. I read online that Benadryl was to be used for the pain, as well as ice. Originally I had used heat, before finding the information online. Nothing seems to help at this point.

patient stated that around 12 hours after vaccine administration she developed extreme fatigue and around 48 hours after receiving vaccine she developed a headache severe enough for her to miss work. The fatigue is still present and forces patient to nap for 2 hours which is unusual for her and she still gets headaches on and off which is unusual for her.

At 1:00 AM, I started to have dizzy, the whole ceiling was spinning . I waited until 8:00 AM that Urgent Care opened, My husband drove me to Urgent Care at 8:00, got medicine for stopping dizziness. I slept almost for two days. On 4/26, my dizziness started again. I went to my family doctor and ENT. Since I still have very light dizziness. It has been for a month.

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.

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.

I received the vaccine on March 13, 2021. I did not have an immediate reaction, but began breaking out in hives all over my body 24 hours later. I was lethargic, wanted to sleep all the time, and had no energy. This is gradually getting better, but still occurs. I periodically have headaches. After two full months I continue to have regular eruptions of hives on my arms. Prior to taking the vaccine I had no health issues, ran daily, and worked out regularly. I have just recently started walking, but have not been able to run.

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.

Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Anxiety-Medium, Systemic: Hypertension-Medium, Systemic: Shakiness-Mild, Additional Details: Patient experienced high levels of apprehension and anxiety pre-administration. After 15 minute observation period, pt was visibly anxious and reported a "weird" feeling on her left side, local to administration and radiating from left shoulder. Pt BP was read as 173/109 and 5 minutes later 168/95. Pharmacist advised pt leave site due to perceived anxiety/worry, measure again in an hour, and report to ER/Urgent care if BP still above 120/80. RPh will follow up with pt following day.

I had about 20 min of being fuzzy headed. I couldn't remember the names of people I've known all of my life, including my best friend and boss. I couldn't think of a town I had vacationed to. My daughter could tell by looking at me that something was wrong. My nephew took me to the ER. They CT Scan, EKG, COVID test, blood work and took my vitals. My BP was 196/84. They gave me IV meds to decrease my BP. They needed to do an MRI, so I was sent by ambulance. They didn't find anything new and my BP had gone down by that time. I was sent home around 4:30am. I was told to follow up with cardiologist and neurologist. I see the cardiologist on 6/14, but I can't get in with the neurologist until August. I was also instructed to rest and I'm still pretty fatigued, so that's what I've been doing.

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.

She got her vaccine, and a couple of weeks after getting it she woke up and she was off. She wasn't dizzy but wasn't herself, felt off. Then she got petechia in both legs and she took it easy, drank a lot of water. She took it easy, but ever since then her energy is not there, she is "zapped". She has changed her whole routine, she is pretty active and now she cannot do much due to the fatigue. She is now really concerned as it is lasting. She feels like she is mentally confused. She could not tell me her address without looking it up first. It has started to subside some the feeling of being off. She feels like that she has no blood in her. She feels like she's out of iron, and zapped of energy. She has not called her doctor.

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.

EXTREME FATIGUE; EXTREME MUSCLE PAIN; JOINT PAIN; PAIN IN SHOULDER; SWELLING IS WORSE IN RIGHT ARM; PAIN ALL OVER BODY MORE IN HANDS AND ELBOWS; NOT BEEN ABLE TO SLEEP; PAIN IS WORSE IN RIGHT ARM; This spontaneous report received from a patient concerned a 64 year old female. The patient's weight was 220 pounds, and height was 62 inches. The patient's concurrent conditions included fibromyalgia, bipolar polar i, hypothyroidism, reactive hypoglycemia, abstains from alcohol, non smoker, and preexisting hand pain, and other pre-existing medical conditions included the patient had known allergies antidepressant drug had agitation allergy and narcotics drug had itching allergy. the patient did not have any drug abuse/illicit drug use. the patient is taking eye drops for unknown indication. The patient was previously treated with risperidone for bipolar disorder; and experienced vomiting when treated with dexamethasone for drug used for unknown indication, and drug allergy when treated with erythromycin 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 26-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included acarbose non-company for drug used for unknown indication, calcium citrate for drug used for unknown indication, colecalciferol for drug used for unknown indication, colestyramine for drug used for unknown indication, duloxetine hydrochloride for drug used for unknown indication, fluticasone furoate/vilanterol trifenatate for drug used for unknown indication, iron for drug used for unknown indication, lamotrigine for drug used for unknown indication, levothyroxine sodium for drug used for unknown indication, lithium non-company for drug used for unknown indication, melatonin for drug used for unknown indication, nortriptyline for drug used for unknown indication, pancreatin for drug used for unknown indication, phenytoin for drug used for unknown indication, tegretol non-company for drug used for unknown indication, vitamin b12 nos for drug used for unknown indication, vitamin c for drug used for unknown indication, oxycodone/paracetamol for pain, and vitamins nos. On JUN-2021, the subject experienced pain all over body more in hands and elbows. On JUN-2021, the subject experienced not been able to sleep. On JUN-2021, the subject experienced pain in shoulder. On JUN-2021, the subject experienced swelling is worse in right arm. On JUN-2021, the subject experienced pain is worse in right arm. On 10-JUN-2021, the subject experienced joint pain. On 10-JUN-2021, the subject experienced extreme muscle pain. Laboratory data included: Pain scale (NR: not provided) 7-8/10. On an unspecified date, the subject experienced extreme fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extreme fatigue, had not recovered from extreme muscle pain, swelling is worse in right arm, pain is worse in right arm, pain all over body more in hands and elbows, and joint pain, and the outcome of pain in shoulder and not been able to sleep was not reported. This report was non-serious.

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.

J and J vaccine: 40 min. after shot, my lower lip began to tingle, then went numb, next my upper lip, next nose felt funny. chest felt tight, no wheezing. Was still at Clinic so I went to Urgent care. I used my albuterol inhaler, chest tightness resolved. Treated in UC with solumedrol, famoditine, 1 liter NaCl. My allergist had me on 2 Zytec, and 2 famoditine the day of shot. Went to urgent care 7/5 for neuropathy. Saw neurologist on 7/8/21. Today is 12 days after the vaccination. My peripheral neuropathy is so bad I can't work. I have constant pain in my shoulder girdle, lower back thighs, calves, feet, hands, and visceral. My PCP won't give my any pain meds, my pain is 8/10.

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.

LITTLE BRUISES TO LEFT HAND AND ARM UNDER THE SKIN; TINGLING UP LEG TO THE KNEE LIKE PINS AND NEEDLES/TINGLING ALL UP AND DOWN LEFT LEG; HURTS AFTER A MINUTE OR TWO OF WALKING OR STANDING/IT ONLY HURT WHEN PUT PRESSURE ON LEG; HARD TO SLEEP AT NIGHT; PAIN IS BELOW KNEE ABOUT 3/4 OF WAY DOWN TO THE ANKLE, NOT QUITE ABLE TO PINPOINT EXACT LOCATION; PAIN IN LEFT THIGH; LOWER LEFT LEG PAIN; NERVE PAIN IN LEG ALL ON LEFT SIDE; LEFT HIP BECAME SORE; CYST IN LEFT ARMPIT; 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 pre-existing medical conditions included the patient had no related medical history. patient feels normal, super good and fine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and batch number: 201A21A expiry: 07-AUG-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced cyst in left armpit. On MAY-2021, the subject experienced left hip became sore. On 25-MAY-2021, the subject experienced nerve pain in leg all on left side. On 25-MAY-2021, the subject experienced lower left leg pain. On an unspecified date, the subject experienced little bruises to left hand and arm under the skin, tingling up leg to the knee like pins and needles/tingling all up and down left leg, hurts after a minute or two of walking or standing/it only hurt when put pressure on leg, hard to sleep at night, pain is below knee about 3/4 of way down to the ankle, not quite able to pinpoint exact location, and pain in left thigh. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cyst in left armpit on 14-APR-2021, and little bruises to left hand and arm under the skin, pain in left thigh, and left hip became sore, had not recovered from nerve pain in leg all on left side, and lower left leg pain, and the outcome of hard to sleep at night, tingling up leg to the knee like pins and needles/tingling all up and down left leg, hurts after a minute or two of walking or standing/it only hurt when put pressure on leg and pain is below knee about 3/4 of way down to the ankle, not quite able to pinpoint exact location 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 considered non serious.

Following immunization patient had a fever overnight and feeling of being "hit by a mack truck" which caused fatigue and she had slept it off. Patient had lump that developed behind left knee two weeks after vaccination. She described the feeling of losing the ability to move her left leg and a feeling of a rip when getting out of her boat. She called her chiropractor who told her to get to the ED and stated she likely had a clot. She was seen in the clinic and was taken by ambulance to the hospital and had a surgery to remove a clot she was told was from her left ankle to her left knee. She had a Boston Scientific Wallstent placed (lot number 25506141) and was hospitalized for a week duration. Patient taking Lasix, blood thinner, aspirin, and antibiotic. She was taken off of work for a month duration.

Feeling flu like symptoms until next day but daily fatigue that I have that I did not have previous to vaccine. I get through my daily activities with a feeling of fatigue. Have to take a break to manage.

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.

Starting about 5 hours after injection, fatigue, followed by extreme headache, followed by chills and aches. Lasting about 24 hours, treated with extra strength tylenol. I couldn't sleep due to the chills, and muscle aches during the night so I slept most of the next day until late afternoon. Kept taking Tylenol through the day and evening. Felt ok the following day.

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.

WITHIN 2-3 MINUTES OF ADMINISTRATION PATIENT BEGAN TO FEEL WEAK, LIGHTHEADED AND WAS SWEATING. PATIENT WAS EXAMINED AND ALL VITAL SIGNS WERE STABLE. WE SUPPLIED WET CLOTH AND COOL AIR. PATIENT THEN SAID HE THROAT FELT HEAVY AND LIKE SHE COULDNT SWALLOW. PT WAS ADMINISTERED EPI 0.3ML IM INTO R DELTOID. MONITORED PATIENT FOR ANOTHER 15 MINUTES AND TOLD TO GO TO ER FOR FUTHER WORKUP. PATIENT WAS STABLE AT THE TIME OF DICHARGE.

Client received the Janssen covid vaccine to right deltoid and became very anxious following. Patient does have a history of Anxiety per her husband and responds this way to most events concerning her health. Client stated this is "Normal" for me . Client alert and oriented with blood pressure at 200/85 and pulse at 130 initially. Client stated "I am fine" She reported not taking any medications for her blood pressure prior. Second blood pressure 192/86 . Client monitored by EMS and finally transported to hospital. Attendees nurse and doctor.

Shingles- on head, scalp, face - treatment valacyclovir, lost of 10 teaching days, Atrial fibrillation - irregular heart beat, 4 EKG ?s, 1 physicians care facility, 1 emergency room visit, 1 urgent care facility, 1 phone call to family doctor, 1 visit to Dr. cardiologist , suppose schedule of a cardiac stimulus procedure ; treatment apixaban and metoprolol

At around 3:30 am patient or my mum sorry having chills shivering muscle aches her temperature was 102.5 took Tylenol and fell asleep around noon that day very confused swore she took Tylenol but didn?t bell and couldn?t get off the floor again very confused lethargic MS was called temperature noted to be 106 Greece Fahrenheit was taken to the hospital given three bags of fluids was given Tylenol even though patient was argumentative and said she took Tylenol continue to be confused and lethargic throughout the stay at the hospital upon leaving hospital at 8 pm temperature was 100.7 patient was able to walk

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

Felt cold, and chilled after going to bed, and feverish. took temperature and it was 101.8. couldn't sleep tossed and turned most of the night until I took Tylenol PM

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.

Night of shot experienced fever of 101, nightmares and slurred speech. The following day experienced fatigue. By the second day post vaccination memory impairemt. By the third day post vaccination has gait unsteadiness and fell six times. The 4th day post vaccination left arm weakness and could not use arm. accompanied by slurred speech.

^ hours after injection my arm was aching. Then Head ache set in by 7pm. pain with neck and head and fever progressed quickly. by 9pm it was 103.7 By 11:00pm my fever was 105.4. By midnight it was 105.9 I took Vicks NyQuil because it was the only pain med that had Tylenol in it. Fever reduced to 105.4 by 2:30 am fever was at 104.5 and I felt safe to try and sleep and not die. A nurse friend was telling me to go to the emergency room. I applied and Ice pack to my splitting headache and eyeballs felt like they were going to pop out. also Icepack to neck. ate a popsicle. I hydrated emencely before the shot and All day with the shot. I kept moving my arm and it was fine after a few hours. THE FEVER SITUATION WAS QUITE FEARFUL AND STRESSFULL. My throat felt a "little" tightening. I swallowed every few minutes to make sure it did not progress. I had Benadryl on hand just in case. I slept from 3:00am until 9:30 am. My morning fever was between 103.7 and 104.5 It was 102.4 at 3:00pm it is 8:45 pm and my temp is 202.2 now. head ache is at 50% of yesterday.

When I was receiving the shot on 4-6-21 it was very painful I could feel it all the way to my elbow and About 2 AM on 4-7-21 I tarted feeling very very cold and trembling and delusional I could not recognize my home I had muscle spams on both legs and fever finally got up and took some Advil put on extra PJ's and socks and turn on the heater finally fell asleep about 4 AM about 8 AM on 4-7-21 woke up with a headache and very very tired lot of pain on my left arm so stayed home from work and rested on 4-8-21 came to work at 7 AM and was seeing everything blurry as the day progressed it got worse finally went home about 3 PM took more Advil and rested some more my left arm hurt me for 6 days and I felt very tired and a bit confused I did not call my doctor or any one at Health Department I just took care of myself

Approximately two weeks following her vaccine, my mother suffered from a bout of transient global amnesia, as eventually diagnosed by her family doctor. All of a sudden one evening, she lost any and all orientation to time. My father and I rushed her to the hospital for fear she was suffering from a stroke. She could not remember what day it was, what she had done that day, conversations we had the day before and she kept repeating herself in 3-minute loops. About 6 hours after the initial onset and while still in the ER, she regained all orientation however she does not remember what happened to her or what she did or said during this period of time.

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.

SHINGLES-lesions developed on the left side of my forehead w/ nerve pain to my head and ear. Itchiness to my scalp with left top pf head very warm to touch. Flush feeling to entire face. Woke up with this the Saturday morning after the injection and lacey rash over entire body w/ rash gone Sunday morning with lesions to my left forehead still visible. Lesions began to weep on Monday morning.

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!

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.

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.

At the time, I had very mild injection site pain and warmth on the site. For a couple of days. On Monday, the 15th, I had the worst flare-up of sciatica that I have ever had in my life. Left leg - it had a tremendous swelling. It was crippling. I am still using a pain. I cried because the pain was so horrific. I was able to get into the doctor early on Tuesday - prescribed Prednisone; hydrocodone; muscle relaxer. None of which touched the pain. I was unable to sleep for three days. I slept upright in a chair. I used an office chair as a wheel chair. I wasn't able to lay down. I've improved but I still can't walk to the mailbox - could walk down there - two houses down but couldn't get back. I am using a cane still. I have to elevate leg on a recliner to sleep so it will help with the continued swelling. There was nothing I did that triggered it.

4/19/2021: Woke up in the middle of the night with an achy arm. Had this for a week. Went to chiropractor as she thought it was neck trouble. Chiropractor states arm is swollen and see MD. MD sent patient for ultrasound and blood clot confirmed in right arm pit. Patient started on eliquis.

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.

FELT LIKE LEGS WILL BUCKLE UNDER HER WHEN GOING TO RESTROOM; HIVES; ITCHING; INSOMNIA; DOES NOT FEEL HERSELF; ANXIETY; DRY MOUTH DESPITE DRINKING A LOT OF WATER AS DIRECTED; WEAKNESS; 24 HOUR FLU; 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 reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207a21a, and expiry: UNKNOWN) dose was not reported, administered on 05-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-MAY-2021, the subject experienced 24 hour flu. On 06-MAY-2021, the subject experienced dry mouth despite drinking a lot of water as directed. On 06-MAY-2021, the subject experienced weakness. On 07-MAY-2021, the subject experienced itching. On 07-MAY-2021, the subject experienced insomnia. On 07-MAY-2021, the subject experienced does not feel herself. On 07-MAY-2021, the subject experienced anxiety. On 07-MAY-2021, the subject experienced hives. On 08-MAY-2021, the subject experienced felt like legs will buckle under her when going to restroom. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from 24 hour flu on 08-MAY-2021, and insomnia, was recovering from hives, and felt like legs will buckle under her when going to restroom, and had not recovered from itching, anxiety, does not feel herself, dry mouth despite drinking a lot of water as directed, and weakness. This report was non-serious.

No problems the remainder of day of injection. Next morning upon awakening, I was very groggy and unable to stay awake. I slept 4 hours past my normal time for getting up. I had no balance and would stagger when standing. My entire body was in muscle and nerve pain. Even my skin hurt. I took 300 mg of Gabapentine which eased my pain. I continued to be off balance the remainder of the day, however, by the end of the day I was much better. I took several 1 hour naps throughout the day.

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.

PATIENT FELT ODD AFTER APPROX 10 MINS. HER EYES GLAZED OVER AND IT SEEMED AS IF SHE PASSED OUT FOR A FEW MOMENTS. WE DETERMINED SHE WAS DIABETIC AND HAS HTN. WE ALSO DETERMINED SHE DID NOT TAKE HER MEDS IN THE MORNING PRIOR TO VACCINATION. EMTs WERE CALLED

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

Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Mild, Additional Details: LOSS OF URINARY CONTROL

Little brown, purple, and red spots (lots of red spots) allover the body. Little blood vessels broke. Pt has not been feeling good since receiving the shot. Pt did not hit her legs but had a very painful legs and when she looked down she had blood vessels broking. Has red blood vessels on face and legs only. Pt has been feeling tired and no energy and was not able to work some days.

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

Adverse reaction to a J & J vaccine. Reaction was described as an anxiety attack, happened 5 min later after a vaccine. Had chest tightness, felt like throat was closing for ~1 min, took vitals, gave water, left with friend, walking on her own.

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

Re-occurrence of Lyme symptoms that had been in remission - double vision, memory problems especially short-term memory, headache, back and neck pain, insomnia,

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.

June 14, I had the vaccine. June 25, I started having muscle aches, severe headache and sore throat. This continued through the next week along with being extremely tired. July 5, I went to the ER due to severe chest pains (I have NEVER had chest pains before). They sent me home that same day. By July 7th, I felt like my heart was seizing and went back to the ER this time also with shortness of breath and a fever. I was admitted on July 7th and discharge on July 9th, with diagnosis of Pericarditis--a SIDE EFFECT OF THE VACCINE. I am now currently on sick leave as I cannot work. I was told by medical staff to report this so that is what I am doing.

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

Chills, body aches 6 hours after vaccine. Treated with ibuprofen regularly that day/night. The following day, continued with ibuprofen all day. No chills or body aches, just tiredness and foggy head. Second day post vaccine, I felt fine.

Pt felt swelling on the right side of her neck(has went down) felt soar head hurt when turning but also going away, a little on left side very slight, brain fog on Friday night still very slight, and fatigued (still occurring), headache on first night no longer occurring

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

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.

WEAKNESS, FATIGUE. SHAKY, DIZZY. HYPERTENSIVE 190/80. REQUESTED TO GO TO THE ER. DISCHARGED HOME AFTER EVAL IN THE ER

The patient reported feeling tired and "spacey" 2 hours after the immunization. She also reported the following day, bumps (possible oozing, she indicated they feel wet but cannot see it) that itch on her back; right of her spine about an inch below her bra strap. She was unable to see the reaction site but said they feel like her shingle flare ups. She believes this to be another flare, possibly triggered by the immunization.

BOTH EYES WERE IRRITATED; BOTH EYES WERE RED; DIZZINESS; FELL AGAINST SINK; FEELING VERY BAD; HEADACHE RADIATING TO SHOULDER AND NECK; TEMPERATURE 101.4 F; MUSCLE ACHES TO BILATERAL BUTTOCKS AND BILATERAL THIGHS; LEFT ARM PAIN ALL THE WAY TO THE BACK OF THE SHOULDER; VERY BAD HEADACHE; NOSE SWELLING; LIP SWELLING; LEFT EYE SWELLING; FEELS NASAL PASSAGE CLOSED; LEFT EYE NOT OPENING COMPLETELY; LEFT EYE TEARING; This spontaneous report received from a patient concerned a 66 year old female. The patient's weight was 218 pounds, and height was 62 inches. The patient's past medical history included anaphylaxis (closed throat) to sulfa, and concurrent conditions included asthma, sulfa allergy, corn allergy, non-alcoholic, smoker, hypothyroidism, seasonal allergies, and allergy to pcn, and other pre-existing medical conditions included the patient have allergy to caines. the patient did not have any drug abuse/illicit drug use. The patient was previously treated with epinephrine for anaphylaxis (closed throat) to sulfa. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1805018 and expiry: unknown) dose was not reported, administered on left arm on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced left arm pain all the way to the back of the shoulder. On 24-MAR-2021, the subject experienced very bad headache. On 24-MAR-2021, the subject experienced nose swelling. On 24-MAR-2021, the subject experienced lip swelling. On 24-MAR-2021, the subject experienced left eye swelling. On 24-MAR-2021, the subject experienced left eye not opening completely. On 24-MAR-2021, the subject experienced left eye tearing. On 24-MAR-2021, the subject experienced feels nasal passage closed. On 25-MAR-2021, the subject experienced both eyes were irritated. On 25-MAR-2021, the subject experienced both eyes were red. On 25-MAR-2021, the subject experienced dizziness. On 25-MAR-2021, the subject experienced feeling very bad. On 25-MAR-2021, the subject experienced temperature 101.4 f. On 25-MAR-2021, the subject experienced muscle aches to bilateral buttocks and bilateral thighs. On 25-MAR-2021, the subject experienced fell against sink. On 25-MAR-2021, the subject experienced headache radiating to shoulder and neck. Laboratory data included: Body temperature (NR: not provided) 101.4 F. The action taken with covid-19 vaccine was not applicable. The patient was recovering from dizziness, had not recovered from nose swelling, lip swelling, temperature 101.4 f, left arm pain all the way to the back of the shoulder, very bad headache, left eye swelling, both eyes were irritated, left eye tearing, muscle aches to bilateral buttocks and bilateral thighs, both eyes were red, and left eye not opening completely, and the outcome of feeling very bad, feels nasal passage closed, fell against sink and headache radiating to shoulder and neck 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.

Immediate pain at injection site as expected , as well as fever, headache, chills, fatigue. Towards evening these symptoms worsened. (not adverse). I hardly slept. (all these not worrisome to me) I'm so glad my vaccine provider warned me that with underlying conditions, the vaccine could make them flare up. Which they did. In the morning I had widespread pain all over. Severe headache, and shortness of breath. Because I already have near emphysema hypoxemia oxygen levels, I checked my Oximeter and my blood oxygen was in the dangerously low 70's. It stayed there until I put my oxygen concentrator on. Monitoring oxygen levels all day, I was able to keep it in the 80's to 90's, which helped. 40 hrs after injection , symptoms already fading away. All my adverse events were related to underlying conditions responding to the inflammation of the immune response. I feel protected, glad I had the oxygen handy, and I feel great about the J & J vaccine!

The shot was painful but that wasn?t unexpected. I immediately felt woozy after the shot but thankfully I had brought a cold full sugar ginger ale and started drinking it. My sensation was kind of like a low blood sugar event where a soda can help. I was not surprised to feel this way and felt somewhat reluctant to report this as I didn?t really think it was unusual. and I didn?t report it at the time. The shot was at a drive up event at a University.. After chugging the ginger ale I felt a bit better and was given the ok to leave after 15 minutes. Back at work, I felt better but still just a bit ? off?. But this passed in an hour and I was good the rest of the day. For a few days afterwards I had a mild headache but no other real symptoms. My usual blood pressure under medications is 116/72. It could be possible that the shot caused some lower blood pressure immediately or within the hour after the shot? Or perhaps the effect was low blood sugar for which the ginger ale helped.

About 7 hours after vaccine delivered had severe chills that lasted for 3 hrs. Difficulty sleeping that night. Next day tired but overall feeling fine. A slight bruise at the injection site but not very painful. No other adverse conditions after the initial ones.

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.

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.

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.

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.

Reports of having symptoms of severe bilateral leg pain at night. Started Sunday 4/11/21 at 11:00 pm and reports pain was so severe it kept her awake for 4-5 hours on night of 4/11-4/12 and had the same leg cramps 4/12 night and 4/13 night, noting the last two episodes did not last as long. Currently report of having swelling to left knee, tenderness to bilateral knees and bilateral calves.

Woke up at 6 a.m., Friday April 2, feeling buzzing feeling in right arm, right leg, and feeling of swelling on right side of throat, rapid heart rate. Duration of feelings lasted for approx. 1 1/2 hours. In general felt strange. On April 13, developed bothersome headache, had to take tylenol to alleviate. On April 14, developed bothersone headache, had to take tylenol to alleviate. On April 15, developed bothersome headache, had to take tylenol to alleviate.

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).

CHILLS; TIRED; INJECTION SITE PAIN; HEADACHE; FEVER; PAIN; FELT MISERABLE; BACK HURTING; LIGHTHEADED; 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 acid reflux, pollen allergy, alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug use and was healthy individual 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: 1808982 expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 09:00:00 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced pain. On 08-APR-2021, the subject experienced felt miserable. On 08-APR-2021, the subject experienced back hurting. On 08-APR-2021, the subject experienced lightheaded. On 08-APR-2021, the subject experienced tired. On 08-APR-2021, the subject experienced injection site pain. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.8 F. On 08-APR-2021 18:00, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lightheaded, chills, and headache on 08-APR-2021, and fever on 09-APR-2021, was recovering from felt miserable, and back hurting, and had not recovered from pain, tired, and injection site pain. This report was non-serious.

SLEPT THROUGH OUT THE DAY AND NIGHT; VERY TIRED AFTER WALKS; 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, and batch number were not reported) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, the subject experienced slept through out the day and night. On 08-APR-2021, the subject experienced very tired after walks. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from very tired after walks, and slept through out the day and night. This report was non-serious.

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

Headache after I drink a small amount of alcohol. I drink 6 ounces of wine at night and wake up in middle of night with headache almost every time. This has never happened before and I never ever had headaches and I have been very healthy. I have to take 2 extra strength Tylenol and headache doesn?t always go away for Awhile.

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.

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.

HARD TIME BREATHING; SUSPECTED SINUS INFECTION; FELT BAD AND MISERABLE; LEFT ARM HURTS WHILE PRESSING INJECTION SITE; DIFFICULTY LIFTING LEFT ARM; MUSCLE ACHE; SEVERE INFLAMMATION ALL OVER THE BODY; PAIN EVERYWHERE; JOINT ACHE; TENDON ACHE; SLEPT FOR 6 HOURS THROUGHOUT THE DAY/SLEEPINESS; DRY COUGH; INJECTION SITE WAS RED; 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 allergies, and other pre-existing medical conditions included patient has type-a blood group. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: 25/MAY/2021) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced injection site was red. On 07-MAR-2021, the subject experienced severe inflammation all over the body. On 07-MAR-2021, the subject experienced pain everywhere. On 07-MAR-2021, the subject experienced tendon ache. On 07-MAR-2021, the subject experienced slept for 6 hours throughout the day/sleepiness. On 07-MAR-2021, the subject experienced dry cough. On 07-MAR-2021, the subject experienced joint ache. On 07-MAR-2021, the subject experienced muscle ache. On 07-APR-2021, the subject experienced difficulty lifting left arm. On 07-APR-2021, the subject experienced left arm hurts while pressing injection site. On an unspecified date, the subject experienced hard time breathing, suspected sinus infection, and felt bad and miserable. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Unknown, EKG (NR: not provided) Normal, Erythrocyte sedimentation rate (NR: not provided) indicated inflammation, and Fibrin D dimer (NR: not provided) indicated inflammation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slept for 6 hours throughout the day/sleepiness on 07-MAR-2021, had not recovered from severe inflammation all over the body, pain everywhere, joint ache, left arm hurts while pressing injection site, hard time breathing, dry cough, muscle ache, and tendon ache, and the outcome of difficulty lifting left arm, injection site was red, suspected sinus infection and felt bad and miserable 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.

BODY ACHES; INSOMNIA; ENLARGED LYMPH NODE IN LEFT UNDERARM; TINGLING IN ARM; CHILLS; HEADACHE; FEVER; FATIGUE; MUSCLE SPASM; PAIN IN ARM; 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 pre existing arthritis. The patient experienced drug allergy when treated with hydrochlorothiazide/methyldopa, cefalexin, and diazepam. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced muscle spasm. On APR-2021, the subject experienced pain in arm. Laboratory data included: CAT scan (NR: not provided) Pre-existing arthritis, and X-ray (NR: not provided) Pre-existing arthritis. On 01-APR-2021, the subject experienced body aches. On 01-APR-2021, the subject experienced insomnia. On 01-APR-2021, the subject experienced enlarged lymph node in left underarm. On 01-APR-2021, the subject experienced tingling in arm. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced headache. On 01-APR-2021, the subject experienced fever. On 01-APR-2021, the subject experienced fatigue. On 14-APR-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) No problem in lymph node. Treatment medications (dates unspecified) included: paracetamol, and oxycodone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from insomnia on 13-APR-2021, chills, and headache, and fever on 06-APR-2021, was recovering from fatigue, had not recovered from body aches, and enlarged lymph node in left underarm, and the outcome of pain in arm, tingling in arm and muscle spasm was not reported. This report was non-serious.

TIRED; LETHARGY; SLEEPY ALL THE DAY; This spontaneous report received from a patient concerned a 66 year old female. The patient's weight was not reported and height was 62 inches. The patient's concurrent conditions included smoker, and non alcohol user, and other pre-existing medical conditions included patient was not pregnant at the time of reporting and patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced lethargy. On 10-MAR-2021, the subject experienced sleepy all the day. On an unspecified date, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lethargy, and sleepy all the day, and the outcome of tired was not reported. This report was non-serious.

Waited 30 minutes after shot at clinic, just sore in upper arm. About 45 min after vaccine in car, shooting pain in upper arm that went down my forearm, and up neck, stopped and then started up again... - lasted for about 10 min. thought I was having a heart attack, but it all subsided. My husband felt it was anxiety - Happened again when we got home on and off, we thought sore muscle - subsided. Wakes me up at night sometimes, happens occasionally during day, happens when golfing - asked a PA friend in heart department at hospital and she said it may take time to heal from vaccine bruising. Past 3 days got another cold virus and yesterday my vaccine site and forearm was killing me all day off and on, a couple of times up same side neck. Got me concerned enough today to call Tri-county who scheduled vaccine to see if anyone else had similar symptoms - told me to fill this form out. I was concerned it was a blood clot. Better today- dull pain off and on.

That next day, the injection site pain was with me for over a month. I couldn't move my arm; felt like someone was jabbing me. I can finally touch my arm now without feeling pain. The brain fog - it feels like - in the front of my forehead right above my eyebrows - like there's something the size of orange that is just sitting there. It stops my thoughts and word processing. I was fine the day before the vaccine. That has not gone away. The doctor does not know what to do about the brain fog. I was having horrific full body muscle pain - especially in my legs. Like someone had put 20 lbs weight on each of my ankles. That is sort of resolved. But the fatigue - hasn't resolved. I always have a little bit of low level fatigue but this is worse - I have to have two naps a day now. Brain fog is the most troubling to me - hard to function - it's like instant Alzheimer's - my words are stuck in my mouth and I feel like I'm trying to think through a veil or fog.

Significant muscle and joint pain, particularly in legs, mostly in right but varies. Feelings of cramping right calf. Went to ER, ultrasound negative, bloodwork unremarkable, MD visit later, was told to reduce inflammation via diet and moderation of activity. Symptoms have continued until present and have affected ADLs

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.

The signs started with light headiness, fatigue, unbalanced after walking a block. Felt like I was going to pass out. Next it was headaches and they got worst and felt like some one was pounding something in my head. Ear pressure with headaches and the next to unbearable is the feeling like my body is moving and I am not moving. A wave sensation that comes and goes almost like I am not in control of what's going on in my brain. My blood pressure started to dropped for a week down to 105/68 daily. I went to emergency room because of pain in left arm. At times I feel things in my brain like moving around. I don't know how to explain it but it's scary. I have been to a previous Dr for help but lots of test no results. I am not seeing Dr, had a balanced test done it came back very good. I will see a Neurologist on 7/13 to see if she can help. Please help me!!

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.

Okay so it started on the June 23rd 2021, I remember vividly because it was the day before I was supposed to take my sister out for her birthday and I could not. I first experienced a sore throat and aches throughout my body. Then on the 24th of June I continued developing the aches and checking my temperature, it got worse throughout the day. I canceled my plans on the 24th of June, the illness invaded me quite quickly. On the 25th of June I had the fever, was coughing up phlegm and was just not feeling well. I took my own cough syrup and such for the day and then it still continued, a lot of chills and headaches and even my neck was swelling a lot, my temperature got to about 101. I got a bit concerned because my neck was very swollen and under my neck I could feel my glands were very inflamed so I made an appointment to see my primary DR on June 30th 2021. He examined me and he said it seemed as though I had a cold, he put me on antibiotics, levofloxacin, and told me to rest and hydrate. He told me to alert him if anything got worse. I got better, but the neck inflammation and headaches are still present. I just wonder about the continued swelling and headaches so that keeps me concerned. I have a virtual appointment with my DR soon.

COULD NOT THINK; BRAIN FOG; CAN'T FOCUS; FORGETTING WORDS; AFFECTING BEHIND EYES; BRAIN FATIGUE; VERY TIRED AND PHYSICAL FATIGUE; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient had no prior health issues and patient did not take any medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: 07-AUG-2021) dose was not reported, 1 total administered in left arm on 08-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-JUL-2021, the patient experienced brain fog, forgetting words, affecting behind eyes, brain fatigue, very tired and physical fatigue and patient couldn't focus. Patient was ok for few days. Symptoms started three days later of vaccination and it is progressing worse and worse. Patient stated that Friday was really bad and Saturday was horrible. On Saturday 17-JUL-2021 patient came home and slept for five hours because she could not think. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from brain fog, very tired and physical fatigue, can't focus, forgetting words, affecting behind eyes, and brain fatigue, and the outcome of could not think was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210755714-Covid-19 vaccine ad26.cov2.s-Could not think . 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).

Slight chill started about 7:15 p.m. and within minutes my entire body was shaking uncontrollably. After about 1 and 1/2 hours extreme shaking stopped. Felt very wiped out the following day with slight headache and legs hurting.

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.

Vaccine was painful but then pain partially subsided, then came home and had chills, temp 96F. Went to bed and had muscle aches, pains and headache. Next morning felt flu like symptoms, malaise especially. Tried to work and could only work 3 hours. Arm remained sore. 14 days later still experiencing soreness in injection site (does not appear swollen), tender to the touch. If arm is lifted up then feels like it is "pulling on something."

I got the shot they had to clean up my arm because I was cleaning and put pressure on the arm. I sat for 30 mins. My chest felt a little funny. about 9am my face was really red, I got my BP checked 188/85 Oxygen was good and Dr said to take benadryl and took two right away and I took 2 more after 6 hours, symptoms subsided that evening. My BP stayed high and I felt not good, I had pressure in my chest and some pressure on the left and right side of my breast, BP was 177 at 4pm. I went home to bed I woke up with pressure again in my chest. I went to the Dr and he said come back in two weeks and see how you are, I went in this last monday and he put me on medication for high blood pressure

Right after I got it I had a metal taste in my mouth. About 45 minutes later I started seeing little light like Christmas lights, it lasted for about a half hour. The next morning I woke up, I felt like I got hit by a truck, I felt so bad, no chest and body hurt. I got up and did a breathing treatment. I went to the Dr. because it sacred me, she gave me antibiotics , cough medicine with codeine- I couldn't stop coughing. I asked her to change my nebulizer treatment because it wasn't working. The Dr. suspected that this would happen.

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.

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.

Extreme body and mind agitation, thought psychosos (first night after shot) Chest pains in left side (first night after shot) Pain spot inside of left elbow for 9 days Shortness of breath for first 2 days with intermittent recurrences for next 7 days Achy, dizzy, headache, fever, & fatigue starting evening after shot, lasting 2 days with intermittent recurrences for next 11+ days

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.

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.

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.

Patient with racing heart, trembling within 15 minutes. Blood pressure checked and result was 131/61. Patient complained of dry mouth and Benadryl administered. Patient continued to be monitored and within 5 minutes following Benadryl, heart continues to race, chest heaviness, trembling hands, tongue numbness, tongue swelling, slowness of speech and thought. EpiPen administered to Left thigh. Within 30 seconds, tongue numbness and swelling resolved. 911 was called and responded to check patient. Vitals and EKG were monitored. BP somewhat elevated due to epinephrine. EKG WNL. Patient did not go to hospital.

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.

I began having chills and shakiness at about 7 PM. I could not warm up. Took a hot bath still could not get warm. Turned up my electric blank in bed and still could not warm up. Finally about 1 Am I got up and took an oral dose of Thera Warming Flu. It knocked out the chills immediately and I was finally able to sleep. I had no arm pain.

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

My sister suffered a massive stroke with blood clots. Totally paralyzed on right side and limited speech. Unable to function on her own, receiving care at a Nursing Home

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

SORE THROAT; SHORTNESS OF BREATH; MYALGIA; FATIGUE; HORRIFIC HEADACHE; HORRIBLE PAIN IN CHEST LIKE HEART ATTACK; BONE WRACKING DRY COUGH; METALLIC TASTE IN MOUTH; FELT DIZZY; FELT LIKE HIT BY DUMP TRUCK; BODYACHE; NOT FEELING WELL; AGITATED; URINATING A LOT; BILATERAL EARACHE; WAS TOO SICK; HEART RATE WENT UP TO MORE THAN 80 BPM; This spontaneous report received from a patient concerned a 67 year old female. The patient's weight was 66.7 kilograms, and height was not reported. The patient's past medical history included tachycardia, atrial fibrillation, left periorbital ecchymosis, dry eyes, trouble focusing, headache, nausea on right side of chest, felt like gas bubble and emesis, possible post concussion symptoms, voice hoarse/raspy voice, chronic laryngitis, flare up of hemorrhoid, constipated over a weekend, increased heart rate, nontoxic uninodular thyroid goiter, atherosclerosis of aorta, fatigue, papillary thyroid cancer, right thyroid lobectomy, deep vein thrombosis, gerd, melanoma of skin, dyspnea, deep vein thrombosis, sinus pain, tooth pain, treatment non compliance, pharyngitis, stroke, vertigo, and influenza like illness, and concurrent conditions included non-smoker, no alcohol use, asthma, cerebral palsy, qt prolonged, chest pain when tired, diabetes mellitus, chronic kidney disease stage 3, hypertension, congenital nystagmus, hearing loss, hypothyroidism, and diabetes, and other pre-existing medical conditions included the patient had no history of abuse or illicit drug usage. The patient was previously treated with phenoxymethylpenicillin, guaifenesin for sore throat, calcium carbonate, famotidine, simeticone, promethazine, cefalexin, diphtheria vaccine toxoid/pertussis vaccine acellular/tetanus vaccine toxoid for prophylactic vaccination, salbutamol, ciclesonide, and polymyxin for red eyes; and experienced drug allergy when treated with atenolol, ciprofloxacin, and erythromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: 21-JUN-2021) dose was not reported, administered on 04-APR-2021 11:15 for prophylactic vaccination. Concomitant medications included disopyramide phosphate. On 10-MAR-2014, Laboratory data included: Factor V Leiden mutation (NR: not provided) negative, and Prothrombin mutation G20210A (NR: not provided) HET Abnormal, coagulation. On APR-2021, the subject experienced heart rate went up to more than 80 bpm. On APR-2021, the subject experienced agitated. On APR-2021, the subject experienced urinating a lot. On APR-2021, the subject experienced bilateral earache. On APR-2021, the subject experienced was too sick. On APR-2021, the subject experienced bodyache. On APR-2021, the subject experienced not feeling well. On 04-APR-2021, the subject experienced metallic taste in mouth. On 04-APR-2021, the subject experienced felt dizzy. On 04-APR-2021, the subject experienced felt like hit by dump truck. On 05-APR-2021, the subject experienced horrible pain in chest like heart attack. On 05-APR-2021, the subject experienced bone wracking dry cough. On 05-APR-2021, the subject experienced horrific headache. On 09-APR-2021, the subject experienced fatigue. On 13-APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 20-APR-2021, the subject experienced sore throat. On 20-APR-2021, the subject experienced shortness of breath. On 20-APR-2021, the subject experienced myalgia. Laboratory data included: Anion gap (NR: not provided) 10 mEq/L, B-type natriuretic peptide (NR: not provided) 64 pg/dL, BUN (NR: not provided) 26 mg/dL, Blood pressure (NR: not provided) 214/91 mm Hg, Body temperature (NR: not provided) 97.8 F, CO2 (NR: not provided) 26 mEq/L, Chloride (NR: not provided) 102 mEq/L, Creatinine (NR: not provided) 0.92 mg/dL, Differential white blood cell count (NR: not provided) Normal, Glomerular filtration rate (NR: not provided) more than 60 mL/min, Glucose (NR: not provided) 328 mg/dL, Hematocrit (NR: not provided) 42.9 %, Hemoglobin (NR: not provided) 14.9 g/dL, Lab test (NR: not provided) Normal (no blood clots/thrombocytopenia), MCV (NR: not provided) 91 fL, Nucleated red cells (NR: not provided) 0 kilo per microliter, Oxygen saturation (NR: not provided) 98 %, Pain scale (NR: not provided) 1 (units unspecified), Platelet count (NR: not provided) 190 kilo per microliter, Potassium (NR: not provided) 4 mEq/L, Pulse rate (NR: not provided) 81 beats per minute, RBC count (NR: not provided) 4.73 million per microliter, Respiratory rate (NR: not provided) 18 (units unspecified), Sodium (NR: not provided) 138 mEq/L, Troponin I (NR: not provided) more than 0.02 ng/dL, WBC count (NR: not provided) 7.3 kilo per microliter, and X-ray (NR: not provided) Aortic atherosclerosis. Treatment medications included: hydralazine. On 20-APR-2021 17:34, Laboratory data included: Blood pressure (NR: not provided) 190/100 mm Hg, Body temperature (NR: not provided) 36.6 degree celsius, Glasgow coma scale (NR: not provided) Eye opening:4, Verbal response:5, Motor Response: 6, Total Coma Score:15, Oxygen saturation (NR: not provided) 97 %, Pulse rate (NR: not provided) 74 bpm, and Respiratory rate (NR: not provided) 16 (units unspecified). On 28-APR-2021, treatment medications included: prednisone. Additional treatment medications (dates unspecified) included: estradiol, levothyroxine, paracetamol, verapamil hydrochloride, salbutamol, diphenhydramine hydrochloride/lidocaine/nystatin, budesonide/formoterol, guaifenesin, benzonatate, chlorhexidine gluconate, ipratropium, aciclovir, fluticasone, montelukast, hydralazine hydrochloride, fluticasone propionate/salmeterol xinafoate, and famotidine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from metallic taste in mouth on 05-APR-2021, felt dizzy on 20-APR-2021, felt like hit by dump truck on 16-APR-2021, was too sick, and shortness of breath, and horrific headache on 19-APR-2021, had not recovered from bone wracking dry cough, horrible pain in chest like heart attack, sore throat, and bilateral earache, and the outcome of heart rate went up to more than 80 bpm, myalgia, not feeling well, fatigue, urinating a lot, agitated and bodyache was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non serious

4 hours after the vaccine, a dull headache; restless sleep/insomnia throughout the night. 24 hours after the vaccine two rashes appeared (upper back behind left shoulder; and on the underside of left breast); they are suspected as herpes zoster. Rx is 800mg acylovire 5x/day for 7 days with advil or tylenol for pain, caladryl for itching and ice. Pain is localized and severe. No fever.

April 22, about 7 pm, vision was way off, blurry and even lost to the far left in my left eye. Woke up on the 23rd confused, I had a maintenance coming to the house and when they called, I had no idea who they were....thank the Lord they called 911. EMT's came and took me to the hospital where I stayed for 5-days. Diagnosis: Hypertension; Embolic stroke

PAIN AT SITE OF INJECTION; SLEPT THROUGHOUT THE DAY; FATIGUE; FELT LIKE NEEDLE HIT THE BONE; CHILLS; FEVER; This spontaneous report received from a patient concerned a 67 year old female. The patient's weight was 109 pounds, and height was 61 inches. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 205A201A, expiry: UNKNOWN) dose was not reported, administered on 22-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-MAY-2021, the subject experienced felt like needle hit the bone. On 22-MAY-2021, the subject experienced chills. On 22-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99 F. On 23-MAY-2021, the subject experienced slept throughout the day. On 23-MAY-2021, the subject experienced fatigue. On 24-MAY-2021, the subject experienced pain at site of injection. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 97 F. The action taken with covid-19 vaccine was not applicable. The patient recovered from chills, and fatigue on MAY-2021, pain at site of injection on 24-MAY-2021, and fever on 23-MAY-2021, and the outcome of felt like needle hit the bone and slept throughout the day was not reported. This report was non-serious.

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.

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.

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

TEETH WERE BLUE THAT HAD FILLINGS; HAIR LOSS; FATIGUE; DIFFICULTY FUNCTIONING; RACING HEART; BLURRED VISION; SHORTNESS OF BREATH; SLICK FINGERS; LACEY RASH TO ARMS, HANDS, LEGS, AND CHEST; SEVERE HEADACHES; CHILLS; RIGHT ARM PAIN; 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 breast surgery, tonsillectomy, pulled chest wall muscle, rib separation, and eye surgery, and concurrent conditions included penicillin allergy, environmental allergies, and atrial fibrillation. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced right arm pain. On 08-APR-2021, the subject experienced chills. On 11-APR-2021, the subject experienced severe headaches. On 15-APR-2021, the subject experienced lacey rash to arms, hands, legs, and chest. On 18-APR-2021, the subject experienced blurred vision. On 18-APR-2021, the subject experienced shortness of breath. On 18-APR-2021, the subject experienced slick fingers. On 20-APR-2021, the subject experienced racing heart. On 25-APR-2021, the subject experienced difficulty functioning. On 25-APR-2021, the subject experienced fatigue. On 01-MAY-2021, the subject experienced hair loss. On 10-MAY-2021, Laboratory data included: C-reactive protein (NR: not provided) Elevated, and Sonogram (NR: not provided) normal. On 24-MAY-2021, Laboratory data included: Blood test (NR: not provided) Normal, and Thyroid function test (NR: not provided) Normal. On 03-JUN-2021, the subject experienced teeth were blue that had fillings. On 08-JUN-2021, Laboratory data included: C-reactive protein (NR: not provided) Normal, and Complete blood count (NR: not provided) Normal. On 09-JUN-2021, Laboratory data included: Panoramic dental X-ray (NR: not provided) Not reported. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blurred vision, difficulty functioning, and shortness of breath, right arm pain on 04-APR-2021, chills on 11-APR-2021, and severe headaches on 14-APR-2021, was recovering from lacey rash to arms, hands, legs, and chest, and fatigue, had not recovered from hair loss, teeth were blue that had fillings, and slick fingers, and the outcome of racing heart was not reported. This report was non-serious.

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.

From the April 4, 5, 6 I felt very dizzy and out of it. When I got home on the 4th of April I had a metallic taste in my mouth and I started to feel pain in my chest. On my right side, center of my chest and the left side of my chest is where I felt pain. It was the worst pain I felt in my life, I took Tylenol. I called my doctor the next day 4/5/21 and she told me take off for 2 days per protocol for J&J vaccines. I did have a fever on 4/5/21On the 7th of April I had to stop working because my headaches were so bad. The doctor ordered new nebulizer kits for me, I was just using those. My doctor told me not take anything else except for Tylenol. I was having trouble breathing so I went to ER on the 20th of April, they ran tests (xray, blood). Since the ER visit, I have not been able to work full time. I have been feeling very unwell, breathing issues and a bad cough. I have been sick again since 6/2/21, I was given antibiotics and I have also been prescribed prednisone. The prednisone has made a huge difference, I was able to start working more. Once off the prednisone, I started to feel bad again. Since getting my COVID 19 vaccine, I have not been able to work a full work week.

I started experiencing a type of anxiety feeling that rushed through me that lasted for a minute or so at least 4 - 6 times a day which started the day after my injection and had lasted for a couple of weeks. It is not a hot flash but as I explained a type of anxiety feeling which I have never had in my entire life. I?ve always been a healthy non sick person. I still experience these effects a few times a week. Actually I was very hesitant about any of these vaccines and now I am sorry I got. I have not sought medical attention because the symptoms did subside and I will be having my once a year physical in the coming months. Have there been any other symptoms reported similar to mine? Thank you for your time

Within 2 minutes of receiving vaccine funny sensation in my mouth Very mild Only lasted few minutes never reported. Within 1 hour of receiving the vaccine numbness tip of my tongue. At around 0630 started with restlessness, sob, coughing which kept getting worse, stated losing my voice. Went to urgent care and given injection of solumedrol, and back to back doses of duo neb treatments Released. At 0400 next day started again with SOB, coughing, Resolved with duoneb treatment 4 to 5 hours later started again with SOB and coughing Resolved with duoneb treatment. No further episodes

Still have Pain in upper arm where vaccine was given now more than 4 months later. Difficult to sleep on my left side. Hurts. PCP did ultrasound and asked a lot of questions. PCP did an ultra sound at about 2 months to be sure there were no blood clots. There were not. PCP wants to see me again next week specifically to address pain in arm at site of injection. PCP is considering putting me on prednisone to see if that helps. NOTE — this is unresolved so difficult to answer question 21 — hopefully this is not disability or permanent damage.

Pt received vaccine and was directed to mandatory waiting area by pharmacist, shortly after pt started having lightheadedness due to anxiety. This only lasted 5 minutes in length and after the 15 minutes, pt was back to normal mental status.

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

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.

Problems began one day after the vaccine, at first with sort of tolerable fatigue, headache, dizziness, and fatigue. Symptoms increased on 3rd day's evening post-vaccine. Pronounced hypersomnia, with up to 16 hours sleep and periods of rest/sitting in between, which lasted up to 12 days. Fatigue above my normal level continues, but not now as severe, and sleep back to close to normal (about 10 hours). Severe headache with marked dizziness for first 3-5 days, with these symptoms continuing at rather low level off and on now. Elevated body temperature around 3-4am at night for first 3-4 days, with vivid dreams. About 80% recovered.

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)

Johnson Johnson one dose vaccine..I awoke at approximately 2am with burning sensation in both shoulder and hip joints..it subsided within 30 minutes, however it was enough to startle me and wake me up.

I slept 12-14 hours/day for nine days following the injection and was very groggy when awake. This is likely a mast cell activation flare, but I am reporting it as an adverse reaction just in case). People with MCAD receive no information about potential flares, whether one dose vaccines are safer, the excipients in the injection (which can cause flares), etc. There are enough of us that you may want to track this. I received no information about excipients....

Approximately an hour after receiving the J&J vaccine, I noticed a loud constant ringing in my ears (tinnitus) which has continued. I still heard the ringing in my ears on April 8. The ringing was so loud on April 9, that it woke me up during my sleep. The morning of Saturday, April 10, I called insurance company Advice Nurse and was advised to go to an Urgent Care to discuss my symptoms. with a doctor who checked my ears and blood pressure--both look normal. He also recommended going to an ENT, for which I have set up a future appointment. Last night, I slept better, but still hear the ringing in my ears this morning. I am very concerned about this ongoing side-effect.

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.

On 3/21, 10 days post vaccine, I experienced ocular migraine with severe vertigo. Felt like I was going to pass out. Called 911 as I was alone at the time. BP was elevated..likely general anxiety. The vertigo subsided as did the ocular migraine but had slight headache the rest of the day. Notified my PCP.

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.

BONE PAIN; HARD TO SLEEP; BAD FLU; BOTH SIDES OF THE BACK HURT; SHAKING; HARD TO BREATH IN MIDDLE OF THE NIGHT; BOWL MOVEMENT WAS VERY GROSS AND SMELLY; PAIN IN HIP; MUSCLE SORENESS; SLIGHT HEADACHE; FEVER; 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 blood thinner, and stroke, and concurrent conditions included grass allergy, tree allergy, and yellow paint allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and batch number: 043A21A 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 fever. On 08-APR-2021, the subject experienced bone pain. On 08-APR-2021, the subject experienced hard to sleep. On 08-APR-2021, the subject experienced bad flu. On 08-APR-2021, the subject experienced both sides of the back hurt. On 08-APR-2021, the subject experienced shaking. On 08-APR-2021, the subject experienced hard to breath in middle of the night. On 08-APR-2021, the subject experienced bowl movement was very gross and smelly. On 08-APR-2021, the subject experienced pain in hip. On 08-APR-2021, the subject experienced muscle soreness. On 08-APR-2021, the subject experienced slight headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight headache on 09-APR-2021, and fever, was recovering from muscle soreness, bone pain, bad flu, both sides of the back hurt, pain in hip, and hard to breath in middle of the night, had not recovered from shaking, and bowl movement was very gross and smelly, and the outcome of hard to sleep was not reported. This report was non-serious.

shoulder and neck tightness and soreness, tiredness lasting to the present date, weak arms, tingling in hands, poorer short term memory and speech, pain below directly below lower sternum

Pain at injection site, 16 days. Dizziness. Fever. Chills. Muscle ache 72 hours. Depression. Suicidal Ideation. 4 days. Excessive Fatigue 15 days.

ZOMBIE LIKE; NO ENERGY; 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 concurrent conditions included dykinesia with parkinson's disease, covid-19, diverticulosis of intestine, opioid dependence, repeated fall, ventricular tachycardia, continuous positive airway pressure, and flopping like a fish. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included amantadine hydrochloride for dykinesia with parkinson's disease, carbidopa/entacapone/levodopa for dykinesia with parkinson's disease, carbidopa/levodopa for dykinesia with parkinson's disease, rotigotine for dykinesia with parkinson's disease, levodopa for dykinesia with parkinson's disease, and flopping like a fish, calcium, carvedilol, celecoxib, colecalciferol, entacapone, estradiol, ezetimibe, fluoxetine, gabapentin, hydrocodone, loratadine, mirabegron, nortriptyline, ramipril, tapentadol hydrochloride, and vitamin e nos. On 16-MAR-2021, the subject experienced zombie like. On 16-MAR-2021, the subject experienced no energy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from zombie like, and no energy on 20-MAR-2021. 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.

Injection site felt like a heavy material was injected. Started feeling ill shortly after. Slept fitfully with fever chills, next day body aches. 16 days later still have a constant headache, and stiffness in my neck.

LOSING SLEEP; 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 not reported) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced losing sleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from losing sleep. This report was non-serious.

EXTREME BREAK OUT OF COLD SWEAT; BEE STING-LIKE PAIN; NERVE PAIN; LOW BLOOD PRESSURE; IRRITABLE; RASH TROUGHOUT BODY; CHILLS; SWELLING AT SITE OF INJECTION; FEVER; NO STRENGTH TO STAND UP; ITCHING; BODY ACHES; 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 sepsis, and concurrent conditions included no alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 12:30, in the left arm, for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced itching. On MAR-2021, the subject experienced no strength to stand up. On 18-MAR-2021, the subject experienced extreme break out of cold sweat. On 18-MAR-2021, the subject experienced bee sting-like pain. On 18-MAR-2021, the subject experienced nerve pain. On 18-MAR-2021, the subject experienced low blood pressure. On 18-MAR-2021, the subject experienced irritable. On 18-MAR-2021, the subject experienced rash throughout body. On 18-MAR-2021, the subject experienced chills. On 18-MAR-2021, the subject experienced swelling at site of injection. On 18-MAR-2021, the subject experienced fever. Laboratory data included: Blood pressure (NR: not provided) Low. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 19-MAR-2021, had not recovered from extreme break out of cold sweat, chills, low blood pressure, swelling at site of injection, rash throughout body, bee sting-like pain, nerve pain, and irritable, and the outcome of itching, no strength to stand up and body aches was not reported. This report was non-serious.

DID NOT SLEEP; CHILLS LIKE IN FLU; 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 breast cancer survivor, and concurrent conditions included heart disease, copd, back and nerve damage, and iodine dye allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025) dose was not reported, once a total administered vaccinated on right deltoid on 17-MAR-2021 09:20 for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021 21:00, the subject experienced did not sleep. On 17-MAR-2021 21:00, the subject experienced chills like in flu. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills like in flu on 19-MAR-2021, and was recovering from did not sleep. This report was non-serious.

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.

TINGLING ALL OVER; WEIRD FEELING LIKE NUMBNESS; JERKY LEGS; FEET FEELING LIKE CRAMPING UP WITH CHARLIE HORSE; WEIRD FEELING IN HANDS AND FEET; This spontaneous report received from a patient concerned a 68 year old female. The patient's weight was 113 pounds, and height was not reported. The patient's concurrent conditions included penicillin allergy, and sulfonamide allergy, 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: 1808982, expiry: 23-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced weird feeling in hands and feet. On 12-APR-2021, the subject experienced not quite pins and needles. On 12-APR-2021, the subject experienced tingling all over. On 12-APR-2021, the subject experienced weird feeling like numbness. On 12-APR-2021, the subject experienced jerky legs. On 12-APR-2021, the subject experienced feet feeling like cramping up with charlie horse. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling all over, weird feeling like numbness, jerky legs, feet feeling like cramping up with charlie horse, weird feeling in hands and feet, and not quite pins and needles. This report was non-serious. This case, from the same reporter.

4/13/21 - 7pm Developed confusion and amnesia noted by husband. Taken to local ER where tests showed small acute stroke left temporal lobe and previous (3-4 weeks prior) small stroke right temporal lobe. Hospitalized for 2 days. No neurological deficits. No previous signs or symptoms of stroke prior to 4/13. Wt. 137 lbs, ht 5"7; normal sinus rhythm.

I have a major history of blood clots Muscle Aches Im never real chill was unable to get warm Rash on half my body Tired When I ate I felt a flushing feeling I felt like a pile of crap But it has lighten up Still dealing with core temperature problem, still cold

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.

FALL/SHE FELL OVER AGAIN; UPON DISCHARGE WENT HOME WITH WALKER/SENT HER HOME WITH A WALKER; HAVING TROUBLE WITH HER DAILY LIFE; RED POLKADOTS ON HANDS; DRY SKIN; SOMETHING IN THROAT/RASPY THROAT; LEGS COLLAPSED; HER LEGS TURNED TO RUBBER; SAT DOWN HARD ON HER RIGHT ASS; HIT HEAD ON THE PAVEMENT; IT HURT; GOT UP DURING THE NIGHT; This spontaneous report received from a patient concerned a 68 year old other race female. The patient's height, and weight were not reported. The patient's past medical history included has broken 3 bones in the top of the foot, stroke, and shattered her shoulders and arm, and concurrent conditions included seizure, hydrochlorothiazide allergy, and penicillin allergy. The patient taking blood pressure pills and pills for seizures (unspecified). The patient received Covid-19 (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) 1 total dose, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the patient hurts. Then the patient went home; and went to store for picked up some groceries. On the way back to car the patient's legs turned to rubber and she sat down. Her legs collapsed and sat on ass hit head on the pavement. On 25-MAR-2021 the patient got up during the night and same things happened again and she fell over again and spent the night on the floor and admitted to hospital (dates unspecified) for 4 days and the patient received blood thinner shots (unspecified) in her stomach. The patient discharged from hospital (dates unspecified) with walker. On an unspecified dates the patient had all kinds of tests and all came back normal. On an unknown date the patient having trouble with her daily life. The patient had a physical therapy and occupational therapy for a month. On 30-MAR-2021, the patient experienced dry skin and something in throat/raspy throat. On an unknown date the patient had red polkadots on hands. The action taken with covid-19 vaccine was not applicable. On an unknown date the patient was recovered from fall/she fell over again, and not recovered from dry skin, and something in throat/raspy throat and the outcome for and the outcome of red polkadots on hands, her legs turned to rubber, sat down hard on her right ass, legs collapsed, hit head on the pavement, got up during the night, it hurt, upon discharge went home with walker/sent her home with a walker and having trouble with her daily life was not reported This report was serious (Hospitalization Caused / Prolonged). FALL/SHE FELL OVER AGAIN. 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).

12 hours later after I had the shot my heart was pounding so hard it woke me up. Tried to look up information and couldn't find information about a speeding heart rate. The more I moved around the higher my heart beat got. I ended up calling 911 and they suggested I go to hospital, admitted into the ER. They did a chest x-ray, ran some EKGs and blood work and then was admitted into the cardiac unit. They sent me home and told me to check up with my doctor. Did some more blood work later and a thyroid checkup and everything came back fine.

Initially on vaccine evening 3/19/21 mild sore arm, mild brain fog, following day03/20/2021 headache, tired, second day post vaccine 03/21/2021 no noticeable symptoms . 03/17/2021 first notation of headache,, 03/18/2021 headache continued all day ,03/19,2021 notation of headache setting in early evening , 03/20/2021 notation of tiredness all day accompanied by headache and achy everywhere-joints-muscles. Days following had notation of mild headache/body aches. 04/01/2021-8:30am Extremely Dizzy upon getting out of bed, Strong Panic attack-symptoms subsided with am medications, and reappeared about 11:00am. Strong Panic attack, very dizzy, neck stiff,muscle tightness in shoulders, sysmptoms continued off and on

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.

Patient is a 69 year old female who was admitted on 5/27/2021 for CEREBRAL VENOUS SINUS THROMBOSIS. Patient is a 69 year old female "who lives at home with husband. Patient with a h/o DM2, hyperlipidemia, epilepsy followed by Dr. neurology outpatient, hypertension. Patient on keppra and tegretol with some episodes of partial seizures, sensitive to being off medications. Patient was in usual state of health until today. Daughter noticed around 6 PM patient was confused, altered, dizzy, not able to walk, and had left arm weakness. The patient's sister had a stroke in the past and they were concerned for this and so brought her in for evaluation when she didn't improve. Daughter thinks patient might have started having symptoms around 1 PM. Daughter reports patient was not taking her aspirin, and they never picked up the lisinopril that was prescribed for blood pressure in the past. She did have the J&J covid vaccine 6 weeks ago.

Heart pounded heavily starting at 10PM preventing sleep. Continued until 3AM (April 29, when medics arrived). Right side of face flushed. Front of thighs very flushed. Called 911. Medics measured blood pressure at 182/81. BP had always been normal (120/60 or less). Pulse = 84. BP lowered to c. 164/?? while medics were with patient. Patient saw her doctor a few days later. Metoprolol prescribed; started May 12 @25 mg with dosage increased to 100mg over three weeks. BLOOD PRESSURE REMAINS ELEVATED DESPITE MEDICATION 100mg daily. BP ranges erratically 184/81 to 134/66 on medication. BP HAS NOT RETURNED TO NORMAL.

Blurred vision, muscle & bone aches in most of the body, fogging brain, fatigue, & headache = 5/11/21 sick with very intense symptoms These same symptoms, much milder, continuing most days, all day long since 5/11/21 and still present today 6/19/21

FOGGY FEELING, FEELING LIKE TAKEN AN HALLUCINOGENIC; LETHARGIC; 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 penicillin allergy. 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, administered on 14-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-JUN-2021, the subject experienced foggy feeling, feeling like taken an hallucinogenic. On 15-JUN-2021, the subject experienced lethargic. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from foggy feeling, feeling like taken an hallucinogenic, and lethargic. This report was non-serious. This case, from the same reporter is linked to 20210651147.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.

Since receiving the vaccination, I have lost work due to flu symptoms a few days a month. On 20 June I began a slught Shingles outbreak. I was prescribed Valcyclovere. On 2 July, I experienced what felt like a sinus infection accompanied by cough and fever. I was prescribed Amoxicillin and prednisone. The discomfort in my sinus area, accompanied by headache, runny nose and fatigue, has not gone away. I reported these symptoms on the wellness check-in and was contacted by phone. Unfortunately, I was unable to properly understand the message and phone number to return the call.

(1) Swelling behind left knee- approximately 1 month after vaccine (2) Pain inside left thigh and leg area - recurring since taking vaccine, nothing done, just noted (3) Wake up with stiffness in left side of neck approximately 2 times per week- recurring approximately 1 month after taking vaccine (4) Developed a dry cough - present and recurring everyday, approximately 1 month after vaccine (5) Severe insomnia noted after taking vaccine - developed approximately 2 months following vaccine (5) Severe lack of energy and body tiredness

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.

Johnson and Johnson Janssen COVID-19 EUA vaccine At the time of the injection, the vaccine burned as it entered my arm. (I have never felt that burning sensation with any other vaccination that I have had in the past. Twenty minutes after the vaccination, I became lightheaded and dizzy. I could walk but I was wobbly. At one hour after the vaccination, I felt a sharp stabbing pain in the left side of my tongue and then the left side and only the left side of my tongue began to go numb. Within a couple of minutes, I realized that my left jaw was going numb, too. The numbness slowly but surely began to move up the left side of my face all the way to the top of my head. I had a sharp but brief headache on the left side of my head that subsided quickly but the numbness remained. I went home and talked to two people on the phone for several hours because they wanted to be sure that I was OK. At two hours after the vaccination, my face was still numb but I could think and talk clearly, but I was clearing my throat and coughing a lot. At that point, I also realized that my whole left arm was a little numb and my fingers on my left hand were tingling. That numbness lasted about 20 minutes and then subsided. The facial numbness lasted for hours. I wasn't scared and I wasn't in pain but it was very strange. It felt a little bit like the after affects of dental anesthesia but it wasn't just in my mouth it was the whole left side of my face. I believe that this must have been an allergic reaction to one of the chemicals in the vaccine but I don't know which one. If you can tell me which chemical it might have been, I will avoid it in the future.

Pt came in for appointment for COVID vaccine, pt was instructed to have a seat in the waiting area. Only a few moments after, pt started to experience 8-10 minutes of nausea and light-headedness. RPH came over to provide care, asked more about past experiences - pt admitted that a long time ago she experienced nervousness and has had this feeling before. She states she has not had such a reaction since she was a child and was also embarrassed for the incident occurring in front of others.

Client complained of feeling dizzy with chest discomfort following vaccine. She also complained of a lump in her throat with swelling. and a headache. Client was able to talk without gasping. She was monitored by EMS and Dr.who administered an Epi pen 0.3ml at 17.20 pm At 17.33 pm blood pressure was 136/77 with heart rate of 93. Client was transported to EMS observation van and monitored by DR. . Dr administered several medication intravenously following IV insertion by EMS. Solumedrol 125mg, Benadryl 50mg and pepcid 20mg. Client was transported to Hospital. Her husband was advised that client needed to receive further vaccines in the office of an Allergist for observation

Extreme racing of heart for 2 hours starting about 45 minutes after injection. Slight asthmatic cough for one week. Brain fog for one day. Heart irregularities still occurring two weeks later.

Tinnitus starting approximately 10 days, two weeks after vaccine.This is very intrusive, and the lingering adverse affect I am reporting in this form. Initial adverse reaction starting +/- two days after vaccine; sore arm at injection site, lasting 10 days, still somewhat sore.. took Tylenol extreme tiredness. Low appetite. Feeling ?buzzed? ?high? , ( not lightheaded.) these reactions lasted for 10 days.

Excessive gas, diarrhea, and belching to the point that I could not sleep and resulted in my chest being sore for a couple days. I did not take anything except some baking soda and water on Thursday (the day after my shot). The symptoms eased up on Thursday night and I was able to sleep.

Patient became diaphoretic, pale, and began crying. Slow to respond to verbal commands. Paramedic and NP onsite assisted patient to cot and elevated legs. after 15 minutes, patient walked to observation area and was monitored for 30 minutes without event. VS 116/64, 80 HR, 98%

NECK WAS PAINFUL; EARS WERE PAINFUL; BAD CASE OF THE FLU; DIFFICULT TO SLEEP; FEELS AWFUL; BODY ACHE; LETHARGIC; SEVERE CHILLS; PAINFUL JOINTS; HEAD WAS PAINFUL; PAINFUL MUSCLE; NAUSEA; FATIGUE; LOW GRADE FEVER; This spontaneous report received from a patient concerned a 69 year old female. The patient's weight was 140 (pound), and height was 167.64 (centimeter). The patient's concurrent conditions included shellfish allergy, alcohlic, artheriosclerosis, cholesterol, non smoker, and contrast dye allergy, and other pre-existing medical conditions included the patient did not have any history of drug abuse. The patient experienced mild adverse events when treated with influenza vaccine for prophylactic vaccination. 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, 1 total, administered on 10-MAR-2021 10:00 on right arm for prophylactic vaccination. Batch number was not reported and has been requested. Concomitant medications included rosuvastatin for cholesterol, ascorbic acid, colecalciferol, fish oil, magnesium, sambucus nigra, and zinc. On 10-MAR-2021, the subject experienced neck was painful. On 10-MAR-2021, the subject experienced ears were painful. On 10-MAR-2021, the subject experienced bad case of the flu. On 10-MAR-2021, the subject experienced difficult to sleep. On 10-MAR-2021, the subject experienced feels awful. On 10-MAR-2021, the subject experienced body ache. On 10-MAR-2021, the subject experienced lethargic. On 10-MAR-2021, the subject experienced severe chills. On 10-MAR-2021, the subject experienced painful joints. On 10-MAR-2021, the subject experienced head was painful. On 10-MAR-2021, the subject experienced painful muscle. On 10-MAR-2021, the subject experienced nausea. On 10-MAR-2021, the subject experienced fatigue. On 10-MAR-2021, the subject experienced low grade fever. On 11-MAR-2021, Laboratory data included: Body temperature (NR: not provided) low grade fever of 100. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ears were painful, bad case of the flu, feels awful, body ache, head was painful, nausea, and low grade fever on 13-MAR-2021, and severe chills, and fatigue on MAR-2021, had not recovered from lethargic, and the outcome of neck was painful, painful joints, painful muscle and difficult to sleep was not reported. This report was non-serious.

I experienced two days later, nausea and fatigue and headaches in the frontal lobe and around and behind the eyes. On day 3-4; racing pulse ad felt breathless. I also felt fatigued, with shooting pain to my right arm. This pain comes and goes. I also have brain fog. My leg pain comes and goes. I have migraine headaches with fatigue, cough, nausea and sputum. I went to an acupuncturist which has helped a lot and will be going tomorrow for another session.

EYES WENT CROSSED; PERSPIREING; FELT LIKE SHE WAS GOING TO PASS OUT; VISION BECAME BLURRY/COULD NOT SEE; STOMACH WAS WOOZY; FELT A LITTLE OFF; This spontaneous report received from a patient concerned a 69 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 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced vision became blurry/could not see. On APR-2021, the subject experienced stomach was woozy. On APR-2021, the subject experienced felt a little off. On APR-2021, the subject experienced felt like she was going to pass out. On 02-APR-2021, the subject experienced eyes went crossed. On 02-APR-2021, the subject experienced perspireing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from perspireing, and the outcome of eyes went crossed, vision became blurry/could not see, stomach was woozy, felt a little off and felt like she was going to pass out was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.

Night of vaccine, patient experienced weekness, dizziness, nausea/vomiting, felt "odd". prolonged symptoms, tinnitis, continues to get dizzy and fall. One fall resulted in hitting head leading to ER visit. continued vertigo to this day, new onset of headaches. has reported this to pcp.

pt says on the 6th day she woke up w/ a headache and nauseated. She started vomiting and took Medizine which seem to help. On 4/11/21 she started having cramps in her stomachs like a spasm and SOB. She went to hospital ER. They did blood work and Chest X-Ray which came back negative results. She was told she did not have the same blood disorder as the other people who have had blood clots after taking the vax. She was told she had blood in her urine but had no infection. She will FU w/ PCP in June. Pt says her only symptoms now are some nausea and still does not feel normal.

FOGGY FEELING IN HEAD; BURNING IN THE HEART MUSCLE; EVERY BONE WAS HURT; HEADACHE; CHILLS; FEVER; SWOLLEN HEART MUSCLE; CHEST PAIN; URINE COLORING YELLOW ORANGE; BODY ACHE; VOICE WAS HOARSE; This spontaneous report received from a patient concerned a 69 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: UNKNOWN) dose was not reported, administered on 06-APR-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced voice was hoarse. On APR-2021, the subject experienced body ache. On 07-APR-2021, the subject experienced swollen heart muscle. On 07-APR-2021, the subject experienced chest pain. On 07-APR-2021, the subject experienced urine coloring yellow orange. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced foggy feeling in head. On 08-APR-2021, the subject experienced burning in the heart muscle. On 08-APR-2021, the subject experienced every bone was hurt. On 08-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain, foggy feeling in head, voice was hoarse, fever, chills, and headache on 11-APR-2021, burning in the heart muscle, and every bone was hurt on 09-APR-2021, urine coloring yellow orange on 10-APR-2021, and body ache on APR-2021, and was recovering from swollen heart muscle. 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.

Developed intense tinnitus on April 6th, partially debilitating accompanied with headaches, difficulty sleeping, aches in ear and occasional shooting pain. On April 7th I had a NEGATIVE Covid test to rule out the disease. Ear Nose and Throat exam ruled out causes other than vaccine induced ototoxic impact to the ear nerve. audiology exam for hearing loss scheduled. It is now a month with no improvement and no proven treatment available.

The nest morning when I woke up I felt like I had been hit by a truck. Every part of my body ached. Took monumental effort to get out of bed. Had a headache, felt just terrible. Stayed in bed for the day. It got better over the next several days so I could function. The joint pain got a little better but never really went away. Many of my joints still ache, wrists, fingers, ankles, not hurting enough to keep me in bed. But enough to feel different from before I had the shot. Was afraid to go to the doctor because there was a high rate of COVID in her immediate area so I was concerned about going to a hospital or something.

The weekend after the shot, I noticed deep purple coloring at the top of my thighs, pubic area, arm pits. There are also welts on the top of my thighs, where coloration is more blotchy. After a couple days I realized I was having small episodes of near-fainting. I would have the sensation that I was was going to faint, and it went away without any fainting or dizziness. It was a warning sensation. This occurred 10-15 times a day. It would grab my attention & be gone just as quickly. The same weekend I started with the rash, my anxiety level rose very high. I felt a motor in my chest all the time. Sleeping was very difficult. This anxiety & motor are indicative of a thyroid rage, which I have experienced p

Intense UTI and urgency to urinate, no control of it. Fatigue/sleeping, brain confusion, aches, headaches everyday, old injuries became active again i.e. my broken hand 7 years ago began hurting and couldn't use it, my knee would not hold me up to stand and kept going out on me (from 2010 broken tibia and torn knee ligaments). Began a sinus infection, cough and eye pain with awful bouts of constant sneezing. Third round of antibiotics for the UTI and my bladder is still not right with leakage and urgency. Liver enzymes are high chart.

pressure on center of chest...fever....muscle aches....sweating....lack of appetite....fatigue.....sleep problems lasted 4 nights and days

Intense UTI and urgency to urinate, no control of it. Fatigue/sleeping, brain confusion, aches, headaches everyday, old injuries became active again i.e. my broken hand 7 years ago began hurting and couldn't use it, my knee would not hold me up to stand and kept going out on me (from 2010 broken tibia and torn knee ligaments). Began a sinus infection, cough and eye pain with awful bouts of constant sneezing. Third round of antibiotics for the UTI and my bladder is still not right with leakage and urgency. Liver enzymes are high chart.

Onset was 10 days after vaccination with a pressure-like headache and dizziness associated with constant loud tinnitus bilaterally. She noted these symptoms for over 5 weeks, plus some right ear ache with occasional throbbing, amplification of some sounds, and some shooting pains in the head, plus insomnia. Symptoms seemed to subside on about 5/21, perhaps helped by her avoidance of caffeine and alcohol. There was a brief flare up the week of 5/19 after a meal of spicy food. That same week she notice some shuffling of the left foot and apparent left leg weakness, without injury.

2 different events: 1) 20-30 minutes after the shot, I felt dizzy and disoriented, similar to car-sickness, but I wasn't in a moving vehicle; It appeared that the center of the field of vision for my left eye had become blurred. Subsequently, I had a bad headache and body aches, which lasted most of that day and the next day. My vision is still blurred. A visit to my optician on 13 April 2021 confirmed an epi-retinal membrane, which was not present at my previous eye exam. 2) about two weeks after the shot, I experienced severe pain and raised blood vessels in different areas of both my fore arms, hands and fingers, and my lower left leg and left foot. These lasted a few minutes and then subsided. They were severe enough to wake me up multiple times every night. I finally went to my doctor's office on April 26, saw the nurse practitioner who actually watched one of these episodes. She consulted Dr., they were only concerned about my left leg being a potential blood clot; said the other areas were unlikely to cause significant problems, sent me for an ultrasound examination of my left leg on April 27th, which showed no blood clot. The intermittent raised veins and pain continued for another week or so then subsided.

SEVERE ABDOMINAL PAIN, BLOOD CLOT IN RIGHT LEG, CONFUSION (CURRENTLY STILL IN THE HOSPTIAL FOR THESE ISSUES)

Began feeling tired on way home at 3 pm, rested in chair until 9 pm, in bed was so cold and shivering even with two heavy blankets. Headache developed, heart was pounding (97 pulse rate), headache was the worst ever. Could not sleep, then got up all night until 4 am , finally got back into bed, slept a little, then got extremely hot and sweaty. Finally slept until 9:45 am, still have headache but not as bad. Heart more normal, pulse 75. My temperature stayed a little below normal, 96.6 degrees.

On the morning of 3/11/2021 Patient experienced periods of confusion. slight loss of memory (couldn't remember where to turn to get to destination). The episode lasted approximately 6-8 hours. The remainder of the evening did not experience any symptoms previously described.

Got extremely cold and shivering starting around 6:30 pm on Friday 3/12/21. Could not get warm. Took my temperature and it was 97.1 (my temp is usually in the mid 97's). Weak and tired. Took Tylenol about 7:30 pm - it helped a little but still felt freezing cold. Went to bed and next morning felt better but wrung out.

Patient lost consciousness and was unresponsive for few minutes. She came to and began to vomit. 911 was called immediately and the area was secured with privacy screens. In the meantime, patient was moved to the ground to lie down on her side. She continued to feel nauseas and out of it. The EMTs arrived promptly and took over, once they arrived.

I awoke at 2:45 am feeling unwell and almost immediately starting feeling terrible. I remained lying down in bed, but struggled to stay conscious. I woke my husband and asked him to take my temperature - I had no fever. I then asked him to call 911 to ask if my symptom was typical of the vaccine. They sent paramedics to my house and before they arrived I started feeling better so there was no treatment performed. The whole bad episode lasted 10-15 minutes and I felt like I was going to die. It was not repeated.

HALLUCINATION; FLU LIKE SYMPTOMS, HEADACHE, MUSCLE ACHES AND FATIGUE; This spontaneous report received from a patient concerned a 70 year old white 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 not reported, batch number: 1805018, expiry: 20/MAY/2021) dose was not reported, administered on 06-MAR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the patient experienced hallucination, headache, muscle aches, flu like symptoms and fatigue. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hallucination on 07-MAR-2021, and remaining flu like symptoms like fatigue were much better, not completely back to normal but better than a week before and close to normal. The reporter considered the causality between Covid-19 vaccine ad26.cov2.s and hallucination as related. This report was serious (Other Medically Important Condition). As per follow-up information received on 16-Mar-2021: Added and updated: The outcome of flu like symptoms was updated to recovering/resolving and narrative.; Sender's Comments: V.1: The follow up information in this version updates outcome of flu like symptoms. This updated information does not alter the causality of previously reported event . 20210320317- Covid-19 vaccine ad26.cov2.s-Hallucination. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

Severe muscle pain throughout body, legs and arms weak to the point of not being able to walk or get to the bathroom, chest pain, severe head/face pain, dizziness/vertigo, chills, fever, vomiting. Was so bad that I thought about calling 911. 15 hours later - muscle pain remains, head exploding pain, dizzy.

Head ache, ringing in the ears, Arthritis in the hands, Numbness in right finger, stiffness in body, feeling cold and feeling agitated.

04/04/2021 - Significant shortness of breath when I went for outdoor walk around lake; 04/09/2021 - Awoke in cold sweat with blinding headache - checked in with work saying I was out for day at 04:12 am, took Aleve, and slept for the rest of the day. Slept for most of weekend

SLEEPINESS 30 MINUTES AFTER VACCINATION; INJECTION SITE TENDERNESS; SLIGHT HEADACHE; STONED FEELING; DECREASED RINGING IN RIGHT EAR (UNEXPECTED THERAPEUTIC BENEFIT); This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included ringing in right ear only from approximately 15 years. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025, expiry: UNKNOWN) .5 ml, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced sleepiness 30 minutes after vaccination. On 09-MAR-2021, the subject experienced injection site tenderness. On 09-MAR-2021, the subject experienced slight headache. On 09-MAR-2021, the subject experienced stoned feeling. On 09-MAR-2021, the subject experienced decreased ringing in right ear (unexpected therapeutic benefit). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sleepiness 30 minutes after vaccination, stoned feeling, and slight headache, had not recovered from injection site tenderness, and the outcome of decreased ringing in right ear (unexpected therapeutic benefit) was not reported. This report was non-serious.

Five minutes after getting injection, I noticed a tightening and tingling in my throat, mouth, trachea; sharp sudden onset headache; racing pulse 100 beats per minute; blood pressure 154/100. Because of the headache, I had the pharmacist take my BP. Upper palate was scratchy and irritated. Took 25 milligram tablet of Benedryl. Throat getting tighter but no shortness of breath. At 4:00 BP was 164/104, pulse still 100. At 4:00 took another 25 mg of Benedryl. BP remained high. Stayed for an hour. Turned down epi-pen because her breathing was fine. 5:15 BP still 164/104. Left site and started feeling itchy-- eyelids, lip, scalp. 7:00 BP had come down. 148/94, pulse 88; headache persisted. Took 650 mg of aspirin. 9:00 headache had lessened and BP was 138/80, pulse was 84. By 10:00, moderate headache. Slept. Woke up at 12:00 am with muscle pain in right leg. 3:30 am woke with bad headache, chilled, slight fever (99.6), rash on right trunk and upper abdomen. Took two more aspirin for headache. 8:00 am 130/76, normal temp, hives.

I experienced the day after my vaccine my right breast hurt so bad that I could not sleep. I also had a total breast reconstruction January 2012. My symptoms lasted a couple of days then they resolved.

STARTING AROUND 4/3 she started to experience dizziness, nausea and memory loss. On 04/06 She passed out while sitting in her chair, woke up and began throwing up. Had extreme short term memory loss and low blood pressure. On 04/08 while at her primary care Dr, he suggested a hospital visit with suspicion of possible stroke. Was admitted and released the following day. Dr advised possible mini strokes but could also be dehydration. CBC with differential showed other results than dehydration. Starting around 04/20 she started having chest pains and thought it was heart burn, after medication and another visit to her pcp she was admitted to the hospital again on 04/23. Her troponin levels indicated a possible heart attack. She had a heart catherization and was found to have a healthy heart. Again, her blood pressure has been decreased since, her hgb and hct has also been low with a history of it being high. A high WBC since all of this has started among other unexplained blood results.

feeling bad & nauseous in morning during physical therapy. Asthma flared up. Used rescue inhaler AM, used again in 3 hours, then in two more hours used nebulizer. Eventually falling asleep for about an hour. Woke up and still needed rescue inhaler when trying to perform any tasks.

severe chills, fever, fatigue, urinary tract infection (no symptoms before 5/02, more memory problems than previous ( normal aging, not dementia).

It seems I experienced every listed side effect, save for fatigue. That included fever, muscle aches, brain fog, nausea, gastrointestinal distress

ANXIOUS; EXPERIENCING GROGGINESS; FEELING TIRED; FELT HORRIBLE; CHILLS; HEADACHE; NAUSEA; FELT ILL; FEEL ALMOST PARALYZED; MUSCLE STIFFNESS AND ACHINESS / BACK STIFF AND ACHY; SLIGHT TINGLING IN BOTH LEGS; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection, and night sweats, and concurrent conditions included asthma (severe eosinophilia asthma), nasal polyps, high blood pressure, non smoker, and abstains form alcohol. The patient experienced drug allergy when treated with acetylsalicylic acid for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: 23-JUN-2021) dose was not reported, administered on 18-MAY-2021 16:00 for prophylactic vaccination. Concomitant medications included fluticasone propionate for asthma, zileuton for asthma, beclometasone dipropionate for drug used for unknown indication, fish oil for drug used for unknown indication, lisinopril for hypertension, and mometasone furoate for nasal polyps. On 2021, Laboratory data included: Body temperature (NR: not provided) 99.7 F. On JAN-2021, Laboratory data included: COVID-19 virus test positive (NR: not provided) Positive. On 18-MAY-2021, the subject experienced feel almost paralyzed. On 18-MAY-2021, the subject experienced muscle stiffness and achiness / back stiff and achy. On 18-MAY-2021, the subject experienced slight tingling in both legs. On 18-MAY-2021, the subject experienced felt ill. On 19-MAY-2021, the subject experienced felt horrible. On 19-MAY-2021, the subject experienced chills. On 19-MAY-2021, the subject experienced headache. On 19-MAY-2021, the subject experienced nausea. On 21-MAY-2021, the subject experienced experiencing grogginess. On 21-MAY-2021, the subject experienced feeling tired. On an unspecified date, the subject experienced anxious. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feel almost paralyzed, muscle stiffness and achiness / back stiff and achy, slight tingling in both legs, felt horrible, chills, headache, and nausea on 20-MAY-2021, had not recovered from feeling tired, and experiencing grogginess, and the outcome of felt ill and anxious was not reported. This report was non-serious.This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection, and night sweats, and concurrent conditions included asthma (severe eosinophilia asthma), nasal polyps, high blood pressure, non smoker, and abstains form alcohol. The patient experienced drug allergy when treated with acetylsalicylic acid for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, and batch number: 206A21A expiry: 23-JUN-2021) dose was not reported, administered on 18-MAY-2021 16:00 for prophylactic vaccination. Concomitant medications included fluticasone propionate for asthma, zileuton for asthma, beclometasone dipropionate for drug used for unknown indication, fish oil for drug used for unknown indication, lisinopril for hypertension, and mometasone furoate for nasal polyps. On 2021, Laboratory data included: Body temperature (NR: not provided) 99.7 F. On JAN-2021, Laboratory data included: COVID-19 virus test positive (NR: not provided) Positive. On 18-MAY-2021, the subject experienced feel almost paralyzed. On 18-MAY-2021, the subject experienced muscle stiffness and achiness / back stiff and achy. On 18-MAY-2021, the subject experienced slight tingling in both legs. On 18-MAY-2021, the subject experienced felt ill. On 19-MAY-2021, the subject experienced felt horrible. On 19-MAY-2021, the subject experienced chills. On 19-MAY-2021, the subject experienced headache. On 19-MAY-2021, the subject experienced nausea. On 21-MAY-2021, the subject experienced experiencing grogginess. On 21-MAY-2021, the subject experienced feeling tired. On an unspecified date, the subject experienced anxious. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feel almost paralyzed, muscle stiffness and achiness / back stiff and achy, slight tingling in both legs, felt horrible, chills, headache, and nausea on 20-MAY-2021, had not recovered from feeling tired, and experiencing grogginess, and the outcome of felt ill and anxious was not reported. This report was non-serious.

Pain down left arm, severe pain, to hand and hand was numb, up all night could not sleep. Went to ER because she thought it might be her heart, it wasn't. Diarrhea was uncontrollable, messed herself a few times, never had time to run to restroom. Had to take a leave from work. Has been out of work a month because of the diarrhea. Had a colonoscopy, endoscopy, has to go back for another endoscopy, was in the hospital. Had blood in stool. Never experienced diarrhea or pain like that before. Afraid to go back to work or leave her house because the diarrhea continues and starts without warning.

I was fine up until the 5/21. As I was leaving work, I got a horrible headache. I had a fever, coughing, congestion, wheezing, irritated throat--it felt like I had COVID. My lasted from 5/21-5/23. It never got over 100, but I never get fevers. I had a tele-med visit on 5/24 and she had me take antibiotics for a week, but they didn't work. On the 5/28, I spoke with her again and she wanted to see me again in a week. On 6/1, she had me take another round of antibiotics that helped a little, so I was able to return to work part-time. I got a Rocephen injection on 6/7 and that finally helped. I was then able to return to work full time. Currently, I am still experiencing some throat irritation and coughing, but I'm much better. I'm taking some cough medicine that she prescribed as needed.

Woke up at 4AM on 03/05/2021 with shaking chills, feeling very cold, couldn't get warm. Shaking so bad I couldn't get whole sentences out. Body aches and stiffness, affected my walking. Did not take temperature at that time. Got back into bed with 2 blankets and a comforter and still couldn't sleep. Got up a 7AM - temp 102.2, shaking less but still feeling cold, body was hot to touch. I had a bad headache and body aches and stiffness were still there. I noticed at that time that I had a bright red flush on both cheeks and my nose that was hot to the touch. Took 600mg of Ibuprofen. Went back to bed feeling terrible. At 12 noon I got back up and temp was down to 99.7. Headache, body aches, stiffness, and "red flush" still on cheeks and nose. Went back to bed. Took more Ibuprofen at 7pm - temp was down to 98.7. Headache was better, body aches improved. Flushed hot face was still present. Went to sleep at 11:30PM and slept for 10 hours. Today, 03/06/21, all symptoms improved, no fever, redness of face is still present but less.

Pt describes feeling severe chills, fever of 101.4, inability to walk overnight, and delirium yesterday afternoon and overnight last night. She reports chills causing contortions, inability to walk, she stool up and fell down immediately, and hallucinations. She describes thinking she was using a computer when she was not.

pt reports waking up the next morning with "amnesia" "didn't know where I was, forgetful, " numbness radiating down her vaccinated arm, neck soreness

pt states that after she took the vax upon leaving the clinic she started getting woozy and could feel the medicine going through her body all of the way down to her feet. She felt like her heart rate was up. She sat down to relax before driving home. Pt started taking ibuprofen immediately. The next day her right arm was sore, some fatigue and slight fever. All of her symptoms have subsided at this time.

Cool feeling, dizziness, anxiety, Increased BP. H2O, snack, cool rag, breathing techniques to calm anxiety. Date: 3/22/2021 Problem: J&J Post-Vac Notes: Time: 1114 Pt c/o dizziness, coldness, and anxiety. BP: 207/130, HR 77, SpO2 98%, temp 97.2F. Offered pt water and crackers. Applied cool raag to pt neck. Coached pt through therapeutic breathing. Pt encouraged to wait 30 minutes. Time: 1147 Pt reports feeling better. Ambulated to restroom independently. Pt has no s/s of distress. BP 152/93, HR 68, SpO2 98%, temp 97.4F. pt teaching on s/s of allergic reactions. Pt ambulated out of building independently.

WARM AT SITE; WOKE HER UP; HURTS TO RAISE LEFT ARM; ACHY AT SITE; SPACY; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included exercise induced asthma, not treated, codeine allergy, alcohol use, and non smoker, and other pre-existing medical conditions included no drug abuse or illicit drug use. patient consumes 1-2 glasses of wine per week.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 08-MAR-2021 for prophylactic vaccinatio on left arm.. Concomitant medications included ascorbic acid, and . On 08-MAR-2021, the subject experienced spacy. On 23-MAR-2021, the subject experienced achy at site. On 25-MAR-2021, the subject experienced hurts to raise left arm. On 26-MAR-2021, the subject experienced woke her up. On an unspecified date, the subject experienced warm at site. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from spacy on 08-MAR-2021, had not recovered from achy at site, and warm at site, and the outcome of woke her up and hurts to raise left arm was not reported. This report was non-serious.

Noon the day after the vaccine I was suddenly overcome with nausea, and dizziness that sent me stumbling to bed and vomiting into a bucket next to me. Vomiting lasted for one session, but dizziness and nausea stayed for about 3 hours, and then nausea, fatigue and general sick feeling kept me in bed until the next day. April 9 I woke up still feeling out of sorts, but not as bad. Note: 28 minutes after having the vaccine, once I started driving home, the vision in my left eye suddenly went blurry, and I nearly lost vision in that eye. I tried to find a safe place to pull over but couldn't. After 5-8 minutes the vision came back but stayed a bit blurry for a couple hours. Never had any such thing happen before.

Tues. eve., after the vaccine, I got the CHILLS that lasted all night long! I woke up (Wed.) with NAUSEA and took the "anti-nausea" pills that I had left over from when I had COVID (11 - 2020). My upper arm was now very sore, especially when I tried to lift it. I took my temp. and I had a FEVER (101). On Thurs., my temp. went down to 99.5 and the nausea was gone. Today (Fri.), I woke up with pain on my shoulder (over the injection site). I took Advil and iced it and it is now much better (this eve.). The only side effect I have now is the pain in my arm (mostly when I lift it). I am eating better and sleeping better now.

First 24 hours: Fever of 99.9; chills, sweats, spasms of muscles throughout body, extreme pain with muscle spasm, and muscle weakness. I could not go up and down steps as my legs would not hold me. Headache. Week 2 to present. Fatigue, I have to nap every day and I sleep 8 hours or more at night. Diarrhea, despite taking OTC medications to control. Dehydration and dizziness. I am now 4 weeks since my shot on March 4th and I continue to have these symptoms. I went to see my doctor and all lab tests are normal. There is no other diagnose reason for my continued symptoms. I wish I waited to get either the Pfizer shot or Moderna as I have not heard of these extreme and prolonged side effects from those shots.

Starting at 2:00am on 4/9/2021, Patient reports cold sweat and headache. She attempted to go to work on 4/10/21 but felt weakness when walking so patient went home. She is still experiencing headache, weakness, and some diarrhea.

After vaccine I noticed I was having a horrible time sleeping, then I started having joint inflammation 10 days later. I was I excruciating down my legs, I had big knots on my as well. Days 12-14 the pain kept me up because it was bad. By day 15 I had extreme pain, water retention and I had to take something for pain. On 4/4 I had nausea and last Wednesday I was nauseated and started running a temperature and felt like the flu and chills. I went to get a covid test because of the way I was feeling and it came back negative.

taste has changed, starting from 1st day of shot and ongoing. Salt is hard to detect and flavors of all foods have decreased. No other expected side effects, just a slight 30 second wave of nausea 20 minutes after shot, and again the next day with a feeling of being a bit "off" for a day or two. Only the taste decrease seems to be ongoing and unexpected.

4/17/21 around 5 pm lost consciousness and did not knowingly awaken until a friend came to her home and said she was sitting on the bathroom floor and responding inappropriately. Pt has no memory of any events that occurred between Sat evening through Sunday morning . Feeling of being in a fog is slowly improving.

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, expiry: 25-MAY-2021) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: alprazolam. On 05-MAR-2021, the subject experienced numbness from the waist down for 4 hours. On 06-MAR-2021, the subject experienced body aches. On 06-MAR-2021, the subject experienced emotional fatigue. On 06-MAR-2021, the subject experienced physical fatigue/exhaustion. On 07-MAR-2021, the subject experienced depression. On 07-MAR-2021, the subject experienced anxiety. On 07-MAR-2021, the subject experienced short term memory loss. On 07-MAR-2021, the subject experienced right hand not work properly, she cant hold things properly. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numbness from the waist down for 4 hours, was recovering from depression, and anxiety, had not recovered from physical fatigue/exhaustion, emotional fatigue, right hand not work properly, she cant hold things properly, and short term memory loss, and the outcome of body aches was not reported. This report was non-serious.

FELT AWFUL LIKE SHE WAS GOING TO DIE; FELT CRAPPY; NAUSEA; FELT TIRED/EXHAUSTION/FATIGUE; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's past medical history included vaccination adverse reaction, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient was previously treated with influenza vaccine for prophylactic vaccination; and experienced drug allergy when treated with sulfamethoxazole/trimethoprim. 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 12-APR-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced felt crappy. On 13-APR-2021, the subject experienced nausea. On 13-APR-2021, the subject experienced felt tired/exhaustion/fatigue. On 14-APR-2021, treatment medications included: paracetamol. On 18-APR-2021, the subject experienced felt awful like she was going to die. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt crappy, and nausea on 15-APR-2021, and felt tired/exhaustion/fatigue on APR-2021, and had not recovered from felt awful like she was going to die. This report was non-serious.

Patient exhibited stress and anxiety about receiving vaccination. After administration, she said that the site hurt more than expected and said she was feeling dizzy. Cold wet paper towels were offered to her to place on her face. Next, reported feeling strange, shaky. Leaned forward with head low. Instant cold pack was placed on back of neck. Over next five to ten minutes patient's anxiety increased, as did shakiness. Blood pressure readings were taken and elevated, as was heartrate, but not at hypertensive crisis. Patient could breathe and speak. She contacted someone to assist her with leaving, but when the ETA seemed too long, she agreed to have us contact EMS. Her condition seemed to improve and decline several times before assistance arrived. She expressed concern about the elevated BP readings. A second cool pack was administered until she next reported feeling cold and chilly, with shakiness. She mentioned that her abdomen also felt cold, which was strange. EMS arrived and transported patient approximately 30 minutes post administration.

Extreme fatigue, dizzy, foggy brain, disoriented, nausea, congestion, joints aching, extreme neck and shoulder pain on the left side . Feels like the Cortizone shot that I normally get for my joints stopped working once I got the J&J shot Shoulder doctor said the shoulder pain was caused from the shot being given to high in my arm

pt says she had a few episodes of feeling dizzy before having a stroke. Pts right hand became numb, she had some confusion, she was nauseated and had a severe headache several days prior to going to the emergency room. On 3/28/21 her face was dropping on the right side so was brought ER. She was admitted and given CT and multiple test. She was treated for a Stroke and stayed for about 3 days. She was discharged to FU w/ Neurologist next week.

BLOOD CLOT INSIDE THE BUMP (INJECTION SITE); WHEEZING; HIVES ON NECK; BLADDER INFECTION/ABDOMINAL PAIN TO GROIN; BLADDER INFECTION/ ABDOMINAL PAIN TO GROIN; INJECTOR PULLED THE NEEDLE BACK AND PUT IT IN AGAIN; COULD HARDLY WALK; COULDN'T TOUCH THE ARM; REDNESS IS STILL AS BIG AS A BASEBALL; NAUSEA; VOMITING; HALLUCINATIONS; DIARRHEA; This spontaneous report received from a consumer concerned a 71 year old white (Hispanic/Latino) female. The patient's height, and weight were not reported. The patient's past medical history included bladder infection, and concurrent conditions included high blood pressure, high cholesterol, and asthma/ bronchitis/ get asthma attacks often. The patient's other pre-existing medical conditions included that she had no history of heart attack or pain. The patient's family history included that her mother had bladder infection and lady part infections. 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: 202A21A and expiry: 23-JUN-2021) dose was not reported, 1 total administered on 10-APR-2021 around 10;00 AM for prophylactic vaccination on right arm. No concomitant medications were reported. On 10-APR-2021, the patient almost passed out after she got the shot (vaccination), they (vaccine facility) had to take her out to the car, and she could hardly walk. The patient reported that injector pulled the needle back and put it in again (Wrong injection technique). It was reported that right after injection when she turns around her arm was big as baseball, mushy, swollen and it was painful (injection site). The mushiness was going down, but it was still mushy. The patient's arm was hard as a marble, redness was still as big as a baseball and she could not touch her arm. On 20-APR-2021, the patient had bladder infection/abdominal pain to groin and had infection from lady's problem and further stated it as bladder infection. The patient think that the bladder infection was not because of the Janssen vaccine. On 21-APR-2021, the patient experienced hives on the neck and she applied Benadryl cream on it. The patient went to her physician on 22-APR-2021 (Thursday) and Nurse looked at her arm and said that it was perfusion and there was blood clot inside the bump. The patient's physician told her to take Benadryl and put ice and heating pad on it. The patient reported that she was already putting ice packs 3-4 times a day and heating pads 3 times a day. The patient also showed her hives to her physician and she was told to keep putting Benadryl on it. The patient had a follow up with her physician on 03-MAY-2021 for her arm checkup. On an unknown date in APR-2021 (reported as first night), she could see penguins walking around, marching up the stairs on first night (Hallucinations) and then no more penguins after the first night. On the same first night, the patient experienced nausea, diarrhea, and vomiting. On an unknown date, the patient experienced wheezing and she thinks that her wheezing was not related to the Janssen Covid-19 vaccine. According to patient her wheezing is related to her asthma. The patient did not have any trouble sleeping since she was taking the Benadryl. The patient stated that she could move her arm up and down, but she was scared to do so. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hallucinations, bladder infection/abdominal pain to groin, diarrhea, vomiting, and nausea, and the outcome of almost passed out, hives on neck, couldn't touch the arm, blood clot inside the bump (injection site), wheezing, could hardly walk, injector pulled the needle back and put it in again and redness is still as big as a baseball was not reported. The reporter considered the causality between Covid-19 vaccine ad26.cov2.s and wheezing, and bladder infection as not related. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210452551-covid-19 vaccine ad26.cov2.s- blood clot inside the bump (injection site), hallucinations. 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).

STOMACH ACHES; GENERALIZED BODY PAIN; ATRIAL FIBRILLATION; HEARTBEAT SPED UP AND THEN SLOWED DOWN/IRREGULAR HEARTBEAT; BRAIN FOG; FEVER; HEADACHE; NAUSEA; This spontaneous report was received from a 71-year-old, White, not Hispanic or Latino female patient. The patient's height, and weight were not reported. The patient's concurrent conditions included Hashimoto thyroiditis, celiac disease, arthritis, autoimmune disease. The patient was diagnosed with atrial fibrillation (Afib) in JAN-2018 and seldom had an episode of Afib since then. The patient had no known allergies and was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (JANSSEN COVID-19 VACCINE) (suspension for injection, route of administration was not reported, batch number: 1808978 and expiry: unknown) dose was not reported, 1 total, administered on 30-MAR-2021 to right deltoid for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, following vaccination, the patient had an episode of atrial fibrillation almost every day unlike the time before vaccination and her heartbeat sped up and then slowed down (irregular heartbeat). On the same day, the patient experienced brain fog, fever (axillary temperature of up to 100 degrees) and headache. Since the vaccination, the patient's nausea worsened. On 31-MAR-2021, the patient experienced stomach aches and generalized body pain. Due to the ongoing concern of reports of blood clots associated with the JANSSEN COVID-19 VACCINE, the patient's doctor put her on a blood thinner (unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach aches, and fever on 09-APR-2021, and headache on 04-MAY-2021, had not recovered from atrial fibrillation, generalized body pain, heartbeat sped up and then slowed down/irregular heartbeat, and brain fog, and the outcome of nausea was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210516760-COVID-19 VACCINE AD26.COV2.S- Atrial fibrillation. 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 am diabetic so symtoms are like low blood sugar..I PASS OUT, SWEAT, COLD, DIZZY, MUSCLE PAINS, CONFUSED, VERY SLEEPY, PAIN IN EUSTACHIAN TUBE , HEADACHE, TOE PAIN,

I had a headache that bothered me I mean it hurt. Then I got diarrhea, sick on the stomach and real weak and watery mouth. Just didn't feel right, feverish, real thirsty almost like the flu and my body would ache, like going up and down the hill. For a while I was really totally upset and said I shouldn't have gotten the shot. All I wanted to do was lay down and I got so weak. I don't think I would take another shot again if they come out with a booster.

The medication that was injected stung me. My arm just kept stinging, I kept ice packs on it all day. After 3 hours I started feeling very tired which lasted for days. The next day my left gland in my neck was swollen, arm was hot. I felt like I was getting a sinus headache. The gland kept swelling on and off for about a week. The tiredness lasted for about three weeks. Developed a rash on my chest and lower back area. The doctor gave me a cream to use on the rash.

Exactly 12 days after my vaccine I developed a mild case of depression/anxiety/stress that persists as of this writing There was no other precipitating event that could have triggered this. I have always been emotionally strong. I have never felt like this in my life. This anxiety/depression caused GI symptoms that I had evaluated.

periodic neck stiffness, leg cramps, some rapid heart rate,memory loss, continual itching on torso and head, not energy and sleepiness after a good nights sleep, low energy. I am afraid of long term results. Wish I had not received it

Many lasting for 2 weeks - pain, nausea, diarrhea, extreme weakness and fatigue, dizziness, fever and chills, cold sweats,, headache, brain fog, dyspnea on exertion, dry mouth. Medicated with Tylenol, bananas, oatmeal and herbal tea. Documented on pdf form, but unable to use "continuation page", so added sheet that unable to attach. Will try again to upload and send separately to this. NO forms given to me at pharmacy for reporting anything. I called several times and left messages, but no return call. Sent email, but response saying unable to help at this time. Very frustrating as I continued having severe symptoms and unable to get help. Finally feeling better enough today to send form.

Chills that kept me from sleeping, muscle aches and pains, lowgrade (100 degrees) fever, lack of energy, sleepiness

since being vaccinated for 4-5 weeks pt experienced on and off headaches, nausea, fogginess and fatigue. Denies any peripheral edema, bruising, petechiae, SOB, chest pain, vision changes, or abd pain.

DIZZINESS; BODY ACHE; CHILLS; HEADACHE; FEVER; PAIN RADIATED TO THE BACK; STINGING SENSATION; FELT TERRIBLE; This spontaneous report received from a patient concerned a female of unspecified age. 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, expiry: 25-MAY-2021) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced stinging sensation. On 17-MAR-2021, the subject experienced felt terrible. On 17-MAR-2021, the subject experienced pain radiated to the back. On 18-MAR-2021, the subject experienced dizziness. On 18-MAR-2021, the subject experienced body ache. On 18-MAR-2021, the subject experienced chills. On 18-MAR-2021, the subject experienced headache. On 18-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stinging sensation on 23-MAR-2021, and felt terrible, dizziness, body ache, pain radiated to the back, chills, headache, and fever. This report was non-serious.

No reaction until the 6th day, Sunday. Expected reactions on Day 6: temperature 100.4, tiredness behind eyes, slightly achy body. Massive headache by Monday and ringing in ears. Took Naproxin and Mucinex Monday morning before going to work. At the end of the day I took Naproxin and Mucinex in order to sleep. By Tuesday I had chest congestion which has gotten only worse along with needle-like pain in the chest upon coughing. I spit up yellow phlegm, tiredness behind eyes returned, sneezing, choking on phlegm, and constant runny nose and ringing in ears. This has made working difficult, but not impossible. Please ignore if these are normal reactions. I'm just not sure.

DIZZY; FELT COLD; DRY HEAVES; COUGHING; SEVERE CHILLS; TIREDNESS; FEVER; HEADACHE; QUEASY/NAUSEA; FELT LIKE IN FOG; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included 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: 202A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. Concomitant medications included furosemide for blood pressure, spironolactone for blood pressure, and metoprolol for drug used for unknown indication. On APR-2021, the subject experienced felt like in fog. On 07-APR-2021, the subject experienced dry heaves. On 07-APR-2021, the subject experienced coughing. On 07-APR-2021, the subject experienced severe chills. On 07-APR-2021, the subject experienced tiredness. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced queasy/nausea. Treatment medications included: ibuprofen. On 08-APR-2021, the subject experienced dizzy. On 08-APR-2021, the subject experienced felt cold. On 08-APR-2021, the subject experienced headache. On 13-APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from coughing, tiredness, and fever on 08-APR-2021, and headache on 11-APR-2021, had not recovered from severe chills, dizzy, queasy/nausea, and dry heaves, and the outcome of felt cold and felt like in fog was not reported. This report was non-serious.

PAIN NEAR THE EAR AND UNDER THE CHIN; CANNOT SLEEP; FEELS SWOLLEN; PAIN IN SHOULDER; This spontaneous report received from a patient concerned a 72 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: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced pain near the ear and under the chin. On 25-MAR-2021, the subject experienced cannot sleep. On 25-MAR-2021, the subject experienced feels swollen. On 25-MAR-2021, the subject experienced pain in shoulder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in shoulder, cannot sleep, pain near the ear and under the chin, and feels swollen. This report was non-serious.

At unspecified date the patient's nephew noticed acute onset change in the patient's mental status. Upon arrival to unspecified hospital by EMS she was aphasic with right facial droop, right gaze preference, right sided weakness. CT and CTA showed Intraparenchymal hemorrhage with 3mm midline shift as well as superior sagittal dural sinus thrombus in the anterior 3rd. Repeat NCHCT showed bilateral parenchymal hemorrhages.

Pt called the pharmacy on 4/26/2021 stating that since approximately 4/16/2021 (roughly 10 days after receiving the Janssen Vaccine) she began noticing that she felt tired and fatigued and that she didn't have the normal 'energy' that she was used to. After that time she has noticed a worsening of the fatigue and 'tiredness' to the point that she can no longer perform normal activities. She states that she is normally very active and enjoys activities like cutting the grass and other outdoor chores. But for the last 10 days or so she has been unable to do those things and finds herself falling back asleep during the day. She says this overwhelming feeling of tiredness seems to be getting worse. I suggested she visit her doctor for bloodwork and she said she would do so.

I got the shot on 4/6/21 and on 4/10/21, I experienced brain fog, dizziness and a rash on my left side, right below my left breast. Now, as of 5/8/21, I have developed ringing in both ears, which I never had before.

RED ITCHY SPOTS ON LEGS; NO APPETITE; FEELING ACHY; FEELING TOUCHY; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's past medical history included childhood asthma. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced feeling achy. On 12-APR-2021, the subject experienced feeling touchy. On 13-APR-2021, the subject experienced no appetite. Treatment medications included: diphenhydramine hydrochloride. On 14-APR-2021, treatment medications included: acetylsalicylic acid. On 20-APR-2021, the subject experienced red itchy spots on legs. On 28-APR-2021, treatment medications included: sulfamethoxazole/trimethoprim. Additional treatment medications (dates unspecified) included: triamcinolone, lidocaine, and ketoconazole. The action taken with covid-19 vaccine was not applicable. The patient recovered from feeling achy, and no appetite on 13-APR-2021, had not recovered from red itchy spots on legs, and the outcome of feeling touchy was not reported. This report was non-serious.

DYING FROM PAIN; FEVER 99-100.8 F AS IF GOT THE SHOT AGAIN; CHILLS AGAIN; SEVERE PAIN IN THE LEFT LEG FROM HIP TO KNEE, THE WHOLE LEFT SIDE; FUNCTIONABLE DURING THE DAY BUT NOT AT NIGHT; CAN NOT SLEEP AT NIGHT; BOTH LEGS HURT AT GROIN; CRIES FROM THE SEVER PAIN; INCREASE IN THE BLOOD PRESSURE; DEHYDRATION WHICH MADE HER VERY THIRSTY; FELT BURNING IN THE RIGHT ARM WHILE GETTING THE SHOT; SWOLLEN FACE; SEVER CHILLS; FELT EXHAUSTED; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's past medical history included hip implant. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: 09-JUN-2021) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: Blood pressure measurement (NR: not provided) increased, COVID-19 virus test (NR: not provided) negative, Hip X-ray (NR: not provided) normal, and Investigation (NR: not provided) Negative. On 31-MAR-2021, the subject experienced increase in the blood pressure. On 31-MAR-2021, the subject experienced dehydration which made her very thirsty. On 31-MAR-2021, the subject experienced felt burning in the right arm while getting the shot. On 31-MAR-2021, the subject experienced swollen face. On 31-MAR-2021, the subject experienced sever chills. On 31-MAR-2021, the subject experienced felt exhausted. On 14-APR-2021, the subject experienced functionable during the day but not at night. On 14-APR-2021, the subject experienced can not sleep at night. On 14-APR-2021, the subject experienced both legs hurt at groin. On 14-APR-2021, the subject experienced cries from the sever pain. On 14-APR-2021, the subject experienced severe pain in the left leg from hip to knee, the whole left side. On 16-MAY-2021, the subject experienced fever 99-100.8 f as if got the shot again. On 16-MAY-2021, the subject experienced chills again. On an unspecified date, the subject experienced dying from pain. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from increase in the blood pressure, and dehydration which made her very thirsty on 05-APR-2021, felt burning in the right arm while getting the shot on 2021, swollen face, sever chills, and felt exhausted on 14-APR-2021, and fever 99-100.8 f as if got the shot again, and chills again on 21-MAY-2021, had not recovered from severe pain in the left leg from hip to knee, the whole left side, functionable during the day but not at night, can not sleep at night, and cries from the sever pain, and the outcome of both legs hurt at groin and dying from pain was not reported. This report was non-serious.

INCREASED BLOOD PRESSURE; HOT FLASHES; SLEEPING ALL THE TIME; HIVES; CHILLS; FATIGUE/ EXTREMELY TIRED; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's past medical history included thyroid cancer, previous gallbladder surgery, and tumor removal surgery, and concurrent conditions included high blood pressure, and other pre-existing medical conditions included patient had allergy to steroids and zinc. The patient experienced drug allergy when treated with sulfamethoxazole/trimethoprim, cetirizine hydrochloride, pethidine hydrochloride, ibuprofen, morphine, and ketorolac tromethamine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: D42A21A, expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. Concomitant medications included hydrochlorothiazide, and losartan. On 2021, Laboratory data included: Blood pressure (NR: not provided) 150/90 (unit not reported). On 27-MAY-2021, the subject experienced increased blood pressure. On 27-MAY-2021, the subject experienced hot flashes. On 27-MAY-2021, the subject experienced sleeping all the time. On 27-MAY-2021, the subject experienced hives. On 27-MAY-2021, the subject experienced chills. On 27-MAY-2021, the subject experienced fatigue/ extremely tired. On 27-MAY-2021, the subject experienced headache. On 27-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) Highest temperature 101 and normal temperature 96.7. Treatment medications (dates unspecified) included: hydrocodone bitartrate/paracetamol, acetylsalicylic acid, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and fever on 2021, was recovering from chills, had not recovered from hives, and fatigue/ extremely tired, and the outcome of increased blood pressure, hot flashes and sleeping all the time was not reported. This report was non-serious.

Extreme tiredness; headache beginning around 4pm. Increasing fatigue and temperature into the evening. Stayed in bed. Temperature between 12 and 1 AM on that night/next morning rose to 102.7 F. Feeling of distress, headache, fever abated but continued. Felt barely able to move for several days. Extreme fatigue beyond normal has continued for many weeks. Occasional piercing headaches continue.

At 6 pm just 3 hours after the shot I felt totally ill, like I would die. I went to bed fir 15 hours to hopefully get better. I did not. I did not feel as totally ill but still did not feel normal. By the last week of May 23 and 26, I had been to the ER twice because I now was having a viral reaction in the form of rash and welts covering my body. And chest pains.

Anaphylactic reaction-flushing, lump throat, cough onset within 10 minutes. InER 2hrs home on medication solumedrol, benadryl,pepcid, IV fluids

3/6 vaccination. 6PM HA, neck pain, body aches, chills, fatigue; 12:AM woke up with increased HR. HR was too fast; up to 178-200. 911 called by husband. A fib with rapid pulse, convert with IV medicines. Low potassium and magnesium levels. Nitro administer by husband before EMS arrived; had gone down by time ambulance arrived by was irregular. Kept me in observation floor. *still not feeling 100%; fatigue, high HR

I received vaccine at 2:00 PM on 3/10//2021. I was tired afterwards. By 11:00 that same night I felt nauseous, has a headache and every joint and muscle in my body was painful. I could not sleep or get into a position where I was comfortable. The pain level was a 10. I took Tylenol in the middle of the night but it did not help. In the morning I was unable to contact my physician's nurse so I called the 24 hour Nurse Line. The nurse took all my information and told me that I could take Ibuprofen. I took 400 mg. and found a lot of relief from that. I still had some symptoms for the next few days. By 3/14/21 I felt fine. Now today I have a stuffy nose which could be an allergy to something else. I don't know yet.

Presented to the ED for evaluation of hallucinations. Received the Johnson & Johnson COVID vaccine on 3/8. She had been feeling fine following it, until early this morning. She awoke and went to the bathroom when she noticed a "paisley pattern" that was "all over everything", noting that it was even present when her eyes were closed. While she was in the bathroom, the pattern began to move, causing her to feel nauseated and eventually vomit. She has never had a similar episode to this. All of her symptoms completely resolved after droperidol. Observed in the ED and was ambulating independently and returned to her baseline. She had no recurrence of any of her symptoms. She was comfortable going home and discharged with her sister.

5 hours after injection I was shivering with fever and body aches and head ache. Next day same symptoms, no taste and slept a lot. Second day after I still Ache, brain is not as foggy as first onset, and not as high a fever. I had covid in September and this was exactly the same minus the vomiting and diarrhea I had with the virus.

DIARRHEA; FEELING OFF; NAUSEA; This spontaneous report received from a patient concerned a 73 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: 1802068, expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced feeling off. On 20-MAR-2021, the subject experienced nausea. On 21-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 21-MAR-2021, feeling off on 25-MAR-2021, and nausea on 24-MAR-2021. This report was non-serious.

Existing mild tinnitus became severe five days after vaccination on March 31, 2021. 24 hours per day--Ears pulsing. Ears hurt. Headache. Can't sleep due to EXTREMELY loud ringing in both ears. Difficulty performing everyday tasks. I know of no other adverse event that occurred at this time other than vaccination. Visited primary care physician on April 8, 2021. She could not say for certain why I have these sudden ear symptoms. She wants me to monitor for 2-3 weeks.

All my teeth began to ache and progressively get worse to the point I wanted to pull the out. At the same time it felt like my head (in notch immediately forward of middle of ear to ear) was in a tightening vise. Then I got hot and cold but not severely. Same for dizziness, very mild. I was nasusseous and not able to eat. I had random muscles pains , none lasting more than a few minutes in any one place. Odd thing was that I felt no discomfort at sight of injection. Next day I felt just as bad but at 8:30pm I felt like throwing up (after having 2 teaspons of vegetarian vegetable soup). However, I only had dry heaves. I live by myself and started to get scared. I called my daughter and took a Tylenol at 9pm. Within 10 minutes the feeling of a vise and my aching teeth felt significantly better. but stil very fatigued. Next day, today, I feel much better but still a little foggy headed. I can eat. I can function normally, thank heavens. If I had to take another shot now, I wouldn't. Not even sure I'll take a booster when it comes out . It was very scarey.

Myasthenic Crisis. Hospitalized. Immediately after shot got headache/still have it. Extreme tiredness day after shot which continued throughput. Got Short of Breath around day 9. Was sent to ER by ambulance from Urgent Care. Was close to being intubated.Was in SICU 7 days, then 2 days regular hospital room. Am still very tired and weak and short of breath with weak diaphragm and will ho back to ER if no improvement.

LOSS OF ENERGY; TIRED; HEADACHE; DIFFICULTY SLEEPING; PAIN IN THE ARM; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included mango allergy, and shellfish allergy. The patient experienced drug allergy when treated with cefaclor, and erythromycin. 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. Concomitant medications included levothyroxine. On 10-APR-2021, the subject experienced difficulty sleeping. On 10-APR-2021, the subject experienced pain in the arm. On 10-APR-2021, the subject experienced tired. On 10-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced loss of energy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from difficulty sleeping on 11-APR-2021, and was recovering from pain in the arm, loss of energy, tired, and headache. This report was non-serious.

This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included wasp sting, and non-smoker, and other pre-existing medical conditions included unknown. The patient was previously treated with varicella zoster vaccine rge (cho) for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) .5 ml, administered on AUG-2020 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2020, Laboratory data included: Antibody test (NR: not provided) antibodies present. On AUG-2020, the subject experienced flu. On AUG-2020, the subject experienced shivers. On AUG-2020, the subject experienced rib cage ache. On AUG-2020, the subject experienced felt lousy. On AUG-2020, the subject experienced muscle aches. On AUG-2020, the subject experienced stung at arm. On AUG-2020, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu, shivers, rib cage ache, felt lousy, muscle aches, and stung at arm on AUG-2020, and had not recovered from fatigue. Product Quality Complaint number:90000173522 This report was non-serious. The suspected product quality complaint has been confirmed to be voided (did not meet pqc criteria)- , this report does not contain any indication of a pqc but only mentions pure ae's which are outside of the scope of quality investigation. Based on the PQC evaluation/investigation performed.

PAIN/EXCRUCIATING; DID NOT SLEEP; SORE TO TOUCH; HARDLY MOVE ARM; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's past medical history included bad shoulder, and concurrent conditions included spinal stenosis, and psoriatic arthritis. 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-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced pain/excruciating. On APR-2021, the subject experienced did not sleep. On APR-2021, the subject experienced sore to touch. On APR-2021, the subject experienced hardly move arm. Treatment medications included: ibuprofen, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain/excruciating, sore to touch, and hardly move arm, and the outcome of did not sleep was not reported. This report was non-serious.

I started having headaches everyday that increased in intensity throughout the day and felt really sick. It hurt all over, but mainly in the back. I waited to call the doctor because I have seasonal allergies. My head would feel really tingling on the outside, I started experiencing a high pitched screaming sound in my ears and I felt foggy/off, along with memory issues. So after a month, I decided to call my doctor and we had a video call. She ordered an MRI, which hasn't been done yet. I had a CBC count done in the middle of April and it was normal. The headaches are getting better and I'm getting them about once a week versus daily. However, I did have a really bad headache yesterday that I would say was over a 10 on the pain scale, but it's better today.

pain in right arm. As the days past on the pain in arm became worse and could not raise arm or hold anything that was heavy. Extreme pain in right arm; was unable to sleep because of the pain. I am right handed and it is extremely difficult to do anything, it is very hard to eat, dress myself and do household chores because of the pain in the right arm,

Incoherent, forgetful, didnt want to eat or drink stayed in bed . went to doctor 5/6/21, was sent to hospital ER and admitted .

The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 09-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced tiredness. On JUN-2021, the subject experienced fatigue. On JUN-2021, the subject experienced lack of energy. On 12-JUN-2021, the subject experienced headache. On 12-JUN-2021, the subject experienced soreness in right arm at injection site. On 12-JUN-2021, the subject experienced pain in the muscle in upper arm. On 16-JUN-2021, the subject experienced dark red blood in left eye. On 20-JUN-2021, the subject experienced slight blurred vision in left eye. On 20-JUN-2021, the subject experienced sleeping more than usual. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, dark red blood in left eye, tiredness, slight blurred vision in left eye, fatigue, lack of energy, sleeping more than usual, soreness in right arm at injection site and pain in the muscle in upper arm was not reported. This report was non-serious.

SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; ANXIOUS; STRESS; This spontaneous report received from a physician concerned a 73 year old female. Initial information was processed along with the additional information received from central complaint vigilance on 01-JUL-2021 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) 1 total, 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. The patient's concomitant medications included unspecified medications for blood pressure. It was reported that, the patient's partner was not using mask and going out to multiple high risk areas and this was causing a lot of tension and stress for the patient. On an unspecified date, the patient was tested negative for SARS-CoV-2 IgG antibody test spike, Semi QN (SARS-CoV-2 IgG) antibody test, and regular antibodies SARS CoV 2 SEROLOGY (COVID19) AB (IgG, IgM) SARS-CoV-2 IgM (IA SARS CoV 2 AB) antibody test (suspected immunological vaccine failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the anxious, stress and suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000184427. The suspected product quality complaint has been confirmed to be voided (does not meet criteria) based on the evaluation/investigation performed.; Sender's Comments: V0: 20210665609- COVID-19 VACCINE AD26.COV2.S- Suspected immunological vaccine 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.

FELT KIND OF YUCKY; BURNED A LITTLE; MALAISE/DON'T FEEL GOOD; SORE ARM; FELT LIKE ALLERGIES; COLD; FATIGUE/TIRED/FEELING RUN DOWN; SHIVERING/CHILLS; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hip and knee pain arthritis, and other pre-existing medical conditions included consumer took an antidepressant and blood pressure medicine and centrum multivitamin when she could afford it. The patient was previously treated with pneumococcal vaccine, influenza vaccine, and varicella zoster vaccine rge (cho) for drug used for unknown indication. 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 29-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included naproxen for hip and left knee arthritis, and paracetamol for to prevent headaches. On 29-MAR-2021, the subject experienced shivering/chills. On 29-MAR-2021, the subject experienced fatigue/tired/feeling run down. On 30-MAR-2021, the subject experienced cold. On 30-MAR-2021, the subject experienced felt like allergies. On an unspecified date, the subject experienced felt kind of yucky, burned a little, malaise/don't feel good, and sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold, felt kind of yucky, malaise/don't feel good, sore arm, shivering/chills, felt like allergies, and fatigue/tired/feeling run down, and the outcome of burned a little was not reported. This report was non-serious.

ANXIETY ATTACK; NOT ABLE TO DO WALKING; TIRED/SORE FEELING ALL OVER BODY WHEN WALKS OR DO SOMETHING; PAIN AND SORENESS IN NECK/SHOULDER; BLOOD PRESSURE WAS 200/100; INFLAMMATION AROUND LUNGS; COULD NOT SLEEP; This spontaneous report received from a patient concerned a 73 year old female. The patient's weight was not reported and height was 65 inches. The patient's past medical history included neck surgery years ago, and multiple sclerosis diagnosed in 2003, and concurrent conditions included arthritic pain (has not had symptoms since 2010), diabetes type-II, non alcohol user, and non-smoker. The patient was not pregnant at the time of reporting and had no history of drug abuse or illicit drug use. The patient experienced drug allergy when treated with codeine, and influenza vaccine and she had stopped taking vaccines since vaccine made her sick. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, 1 total administered on 03-MAR-2021 to left arm for prophylactic vaccination. Concomitant medications included semaglutide for diabetes type-ii, and gabapentin. On 03-MAR-2021, at the night after vaccination she felt pain and soreness in her neck, shoulder, and chest and it escalated for several days. On an unspecified date in the same week of vaccination during a friday or saturday (MAR-2021), the patient could not sleep with hard time breathing. The patient went to emergency room and her blood pressure was 200/100 mmHg (millimeters of mercury). The patient was kept on emergency room and did a lot of unspecified tests and wanted the patient to put on a treatment to bring her blood pressure normal, but the patient did not feel like taking medicine and was hospitalized on an unknown date in MAR-2021. The patient also had a inflammation around her lungs and wanted to treat her. The patient was discharged on an unspecified date in MAR-2021 with a treatment medication of indomethacin 75 mg(milligram) 3 daily for 10 days. The patient felt better towards the end of the medicine. On an unspecified date, the patient had anxiety attack at the night and as a result her chest was hurt and had a hard time breathing. She went to primary care physician and was told to continue taking it. And also was told to call 911 or doctor's office if something happened. The patient's neurologist had ordered CT (computerized tomography) scan and MRI (Magnetic resonance imaging) and the results were not came at the time of this report. The primary care physician said it looked okay, but her neurologist said they needed time to talk to her about the results. The patient had residual effects of the vaccine which was dull pain sore in chest. She was walking and she was not able to do her walking without giving out, but was better with that. The residual pain in the chest was not as often. She was having coughing spells and her physician said there might still be some inflammation. The patient was on gabapentin which she only used it a few times, but at the time of this report she was taking it more. The patient also got tired and sore feeling all over her body when she walks or do something. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain and soreness in neck/shoulder, and not able to do walking, had not recovered from inflammation around lungs, and tired/sore feeling all over body when walks or do something, and the outcome of anxiety attack, could not sleep and blood pressure was 200/100 was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210733674-COVID-19 VACCINE AD26.COV2.S. Blood pressure was 200/100. 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.

pt developed shingles and increased blood pressure, anxiety. pt had tests done with dr to rule out other causes.

I received the shot at 440 pm on 3/17 At 11;00 pm the same day i started with extreme headache like migraine, nauseous, terrible joint pain, weakness with sweats. continuing through now 4/13 . When i take a shower so weak and shaky. am using a walker to get around the house. very sleepy. legs weak. I tried to work 4/10 driving for uber 5 hours by the time i got home every muscle and joint was hurting and the headache again . I have taken tylenol for the pain , I have not been able to work except that one day and i shouldn't have then i guess . i thought i was better/ I am in contact with my dr. The office does not know how long these symstoms will last

Patient contacted Public Health by phone call on 04/12/2021 to report the following information. Patient states approximately 15-20 minutes after leaving vaccination clinic her "tongue felt swollen, dizzy and staggering around, felt out of it, nausea, face was pale, felt drained". Patient also stated she still feels "out of it, tongue feels weird, doesn't feel 100%, trouble sleeping". Patient denies taking any medication such as an antihistamine and denies contacting her healthcare provider. Public Health advised patient to contact her healthcare provider now and seek emergency care if symptoms worsen, any shortness of breath, difficulty swallowing.

Patient woke up at 3am not feeling good and confused. Became increasingly confused and uncomfortable. Not very responsive to caregivers. Called an ambulance at 7:30am. ER ran tests that showed Sepsis with n o underlying infection. Patient had to be intubated. Admitted to ICU in hospital. Spent 3 days there and 4 days in regular room at hospital. Then transferred to a rehabilitation clinic where she is currently.

After getting shot I drove home. That night i felt fine and still feel fine. But while sleeping my dog tried to wake me up. I was having a bad nose bleed, while wearing my cpap. Also i had 2 more nose bleeds on the 14th. After that no more nose bleeds.I thought you should know.

She is a 74-year female with history of morbid obesity, OA on chronic opioids, T2DM, CKD 3, HTN, and hypothyroidism who presents with 10 days of worsening fatigue and trouble ambulating. She reports that she started feeling unwell about 10 days ago with a sore throat and pain radiated to her left ear. She had trouble swallowing due to the pain and was generally tired, thinking she had strep infection or ear infection. Her sore throat resolved as did her ear pain, however her fatigue worsened and had trouble walking due to weakness. Felt like she had trouble functioning at home, soshe presented to the ED. In the ED, she is hemodynamically stable, satting low 90s on room air. Labs are significant for mild hyponatremia 133 and bump in creatinine 1.84 (previously 1.44). Found to be Covid positive, and CXR with possible right lower lobe infiltrate. Currently, reports feeling tired with poor appetite and body aches though no shortness of breath, chest pain, nausea. She has been eating foods that taste good to her, not following diabetic diet and sugars have stayed appropriate. Denies any sick contacts or leaving the house. Of note had her Covid vaccine (J&J) 3/22 in her house, and does not know where she contracted Covid.

Pain in right and left leg. Pain started at hip and run down to toes. Pain was not shooting pain but was a constant pain. On a pain scale of 1-10, pt reports pain was around 20. Pain woke patient up from sleep and was strong enough that patient muscles locked up. Patient began trembling from the pain. Pain lasted about about 24 hours. Pain was so strong that patient could not think. Pain caused patient to become weak and lethargic.

Right arm had a large red and warm area where shot was given with itching. About ten days after shot this all began. There is a knot about the size of a large walnut at the injection site. This has been there since about 10 days after shot was given and it is still somewhat tender in spots and it feels like a bruise. I cannot lie on my right side comfortably. I have not had any serious pain with this reaction and can lift my arm without discomfort.

ACHY; VOMITING; DIARRHEA; FATIGUE/EXHAUSTION; HEADACHE; NIGHTMARES; ICED COLD CHILLS; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's past medical history included cold agglutinin (clumping) of red blood cells, and flu episode, and concurrent conditions included non smoker, occasional red wine user, and sulfa allergy. The patient experienced drug allergy when treated with codeine, erythromycin, morphine, and doxycycline hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: 21-JUN-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced iced cold chills. On 10-APR-2021, the subject experienced nightmares. On 10-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced achy. On 11-APR-2021, the subject experienced vomiting. On 11-APR-2021, the subject experienced diarrhea. On 11-APR-2021, the subject experienced fatigue/exhaustion. On 16-APR-2021, Laboratory data included: Cold agglutinins (NR: not provided) Not present. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nightmares, was recovering from headache, and had not recovered from fatigue/exhaustion, iced cold chills, achy, vomiting, and diarrhea. This report was non-serious.

Approx 1 wee after vaccination, I had a full body massage. Light non deep tissue. That evening my legs started to ache. The discomfort persisted and settled in my right knee. I could not bend it and barely walk. I had to miss work one day snd borrow a wheel chair got my remaining work days.

SHINGLES; ELEVATED BLOOD PRESSURE; NERVOUSNESS; ANXIOUNESS; INJECTION SITE ITCHINESS; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included thyroid disorder, and blood pressure disorder. 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 11-MAR-2021 for prophylactic vaccination to the right arm. No concomitant medications were reported. On 11-MAR-2021, the subject experienced injection site itchiness. On 13-MAR-2021, the subject experienced shingles. On 13-MAR-2021, the subject experienced elevated blood pressure. On 13-MAR-2021, the subject experienced nervousness. On 13-MAR-2021, the subject experienced anxiouness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shingles on 15-MAR-2021, and injection site itchiness, and had not recovered from elevated blood pressure, nervousness, and anxiouness. This report was non-serious.

weakness, fatigue, full body stiffness, joint and muscle pain and weakness, stiff neck, difficulty and pain when moving or walking, interrupted sleep due to pain, unable to lift out of a chair with legs only

Sore arm right away and then went to a sore muscle like normal the next day and was sore for three days. What happened next, I had gone to ENT for my ear (5th) and he put me on heavy dose of Prednisone (6th). Following Tuesday, I was on Prednisone for ear. I was already really achy by then. On the third day after the Prednisone I fatigue, headaches and neck pain but I didn't have any other pain. I still couldn't hear though. I was on this for almost 4 weeks and from them I started like I was having a hot flash and then I would get cold; sore throat; headaches heavy bones and achy muscles; earaches; fatigue; dizziness like you wouldn't believe. They were cyclical - I'd have them for a couple days and then for about a half a day I'd be a bit better and then it would start up again. The fatigues and dizziness didn't change when the other symptoms seemed to be a bit better. My hearing didn't start to clear until I went to see the 2nd ENT which was a couple of weeks down the road. I do not have the stamina I had before the vaccine - I'm not sleeping well at night and I'm always short of breath at any exertion. It is improving but it's slow. Again, the symptoms I experienced during cyclical times: Cold symptoms, runny nose, sore mouth, ringing in my ears was horrible; dizziness and short of breath - cyclical for three weeks. The Prednisone took away all my cramps and pain in my joints that I had before the vaccine. Currently: My heart feels like it's going 100 miles an hour at night in bed - chest discomfort at night. Legs blue in the shower. The week of the 28th, I was done with the Prednisone and then all the pain came back and more. I can't take an inflammatory - the pain is still there and my usual cramps came back.

Terrible pain affecting all joints; arms, back, shoulders, neck; collar bones, etc Out of breath; fatigue easily; difficulty getting out of chair; walking, doing yard work, interrupted sleep due to pain. this is arthritis , psoritic type with severe aching/pain. Have been referred to rheumatologist. Initial psoriasis flare=up 5 days after injection.

ELEVATED BP; "SPACEY"; MUSCLE CRAMPS; SORE ARM; EXTREME CHILLS; TIRED; This spontaneous report received from a patient concerned a 74-year-old white and not-Hispanic or Latino female. The patient's weight was 150 pounds, and height was 61 inches. The patient's concurrent conditions included high blood pressure, allergy to formaldehyde, paint, nail polish, raspberries and pepper. Patient was non-smoker, and non-alcohol user. Patient had breast cancer 15 years ago. Patient had allergy to new carpeting with fire protection coating. Patient did not have any drug abuse or illicit drug use. The patient experienced drug allergy when treated with Tylenol, sulfa drugs, ibuprofen, loratadine, and hydrochlorothiazide/losartan potassium for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on 28-MAY-2021 to Right Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 28-MAY-2021, couple hours later vaccination, patient was tired and spacey. At around 10:30 pm, she noted extreme chills and muscle spasms. She could not warm herself up, and kept getting colder and colder. She went ER (emergency room) at 1:30 am because her BP (blood pressure) was high (176/110 mmHg). She left the ER at 5 am it was 150/80 mmHg. At the hospital, they gave her Tylenol, which helped her within an hour. They noted to add some Advil with the Tylenol for relief, and to continue for another 48 hours. Her arm was little a sore. It sometimes cramps in the area about every 8 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from spacey, and tired on 28-MAY-2021, was recovering from extreme chills, elevated blood pressure, and sore arm, and the outcome of muscle cramps was not reported. This report was serious (Other Medically Important Condition); Sender's Comments: V0: 20210557834-COVID-19 VACCINE AD26.COV2.S-Elevated BP. 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: UNDERLYING DISEASE

Alot of soreness in upper left arm extending down to the middle of arm. Almost uncontrollable fits of crying, visions of past events felt very strongly, loss of concentration,strong loss of recent events, very strange dreams.

within about one hour after getting vaccine she started having severe nausea and vomiting and it would not stop. Daughter called me after 20 minutes after vomting started. I told her to take her mom to the emergency room. When there, the ER gave her IV fluids, zofran, and told her to take benadryl. She said she was a little confused as well. She said she does not know if they gave her anything else by IV. She was feeling much better about 7pm after I called her. I checked on her the next morning and she was doing good.

A LOT OF NEUROLOGICAL SYMPTOMS; ARM PAIN; DIZZINESS; FOGGINESS AND FELT REALLY BAD; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid symptoms, and concurrent conditions included fibromyalgia, and various genetic based immune diseases. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: 01-MAY-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced dizziness. On 08-APR-2021, the subject experienced fogginess and felt really bad. On 08-APR-2021, the subject experienced arm pain. On an unspecified date, the subject experienced a lot of neurological symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from arm pain, dizziness, fogginess and felt really bad, and a lot of neurological symptoms. This report was non-serious.

STIFFNESS IN BACK OF NECK OR STIFFNESS OF SHOULDER; PAIN IN NECK; WOKE ME UP; SHOULDERS PAIN; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, diabetic, non smoker, non alcohol user, and arthritis, and other pre-existing medical conditions included the patient had no known allergies, 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: 204N21A, expiry: UNKNOWN) dose was not reported, administered on 24-JUN-2021 for prophylactic vaccination. Concomitant medications included paracetamol for arthritis, metformin for diabetic, and lisinopril for high blood pressure. On 26-JUN-2021, the subject experienced stiffness in back of neck or stiffness of shoulder. On 26-JUN-2021, the subject experienced pain in neck. On 26-JUN-2021, the subject experienced woke me up. On 26-JUN-2021, the subject experienced shoulders pain. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stiffness in back of neck or stiffness of shoulder, pain in neck, woke me up, and shoulders pain on 26-JUN-2021. This report was non-serious.

June 2, 2021 found unconscious in home. Has lost 30+ pounds. Is in and out of conscience mental state since that date. Has been hospitalized 4 weeks since then. Is unable to maintain her own home or drive any longer. Is declining both mentally and physically on a daily basis. Neurologist is researching a Prion disease, which would be caused by the covid vaccine. More testing to come, but these diseases are verified post-mortem. This is devastating to her and our family.

Headache and sore throat and stiff neck. And I went to the doctor for these symptoms on the 17th of March because that is when I really started feeling bad for the symptoms. I'm feeling fine now. I still feel a little neck stiffness but almost gone.

Client received the Janssen dose lot # 1808980 and expiration date 6/20/21 at 11:01AM. At 11:16AM client had already waited their 15 minutes and reported to EMT that she was having shortness of breath and anxiety. Vitals were taken : Oxygen: 97%, Blood Pressure: 130/80, pulse=75. Client reports to EMT s that she has a history of bradycardia and anxiety. Client reports medications are amlodipine 5 mg, Irbesartan 50 mg, Aspirin 81 mg PO, inhaler for asthma. Client also reports that on January 8th of 2021 she tested positive for COVID-19. PHN was notified at 11:28AM of client's symptoms. PHN arrived to find client sitting upright and alert and oriented x 4. Since client had shortness of breath reported PHN offered 9-1-1 but client declined, stating she was already feeling better. PHN advised client to stay an extra 30 minutes since she had a reaction. Client reports she thinks it is because she forgot to take her inhaler dose this morning. Vitals were taken: respiration rate=20, Blood pressure 130/70 and oxygen 96% and pulse 55. Client then reports she also has a history of high blood pressure. Client reports that earlier she felt a little lightheaded but did not report to EMTs. At 11:31AM vitals were blood pressure: 146/80, oxygen:97%, pulse: 65 client reports she no longer had shortness of breath, no dizziness no headache, no blurred vision and no chest pain. Gave client water bottle. At 11:41AM vitals were pulse:70, blood pressure: 130/80, oxygen: 97%- client reports no shortness of breath and "feels great." PHN advised client of emergency precautions and to follow up with provider. At 11:46AM: blood pressure: 132/90, oxygen: 98%, pulse: 68. At 11:50AM client left facility with steady gait.

started day 2 , heavy sweats all over lasting now 2 days , day and night , periods of light headedness and spaced out feeling

Patient reported feeling dizzy and light headed the night after she received the vaccine. She reported that her head doesn't feel right and feels like she has a brain fog. She reported she started feeling better after few days . She reported that her blood pressure remained normal.

Client received her vaccine and immediately after injection she reported ?feeling weird and anxious?. VS: 1130 BP 192/82, 1134 138/79. She denied CP, SOB, dizziness or syncope. Her symptoms resolved within 15 minutes .

Severe left knee pain at onset 10 days after J+J vaccine; better since onset; affecting daily activities. associated signs and symptoms: edema; warmth; stiffness; limitation of movement; weakness; instability; limp; fatigue.

On Apr 17, 2021 I had COVID symptoms of cold like symptoms, then a night of chills and coughing, followed by aches then weeks of what I thought may be allergies, but not feeling good. I continued to cough, but thought it was attributed to GERD. I wasn't thinking it could be COVID because I had been vaccinated. By May 18, I was having trouble breathing as it was painful to inhale. I thought I might be having a heart attack so went into the emergency room at Hospital. I tested positive in ER. No heart problem. There were also at least 5 blood clots found in my lungs. It felt like what I imagine it would feel like if my ribs were broken and I was trying to take a deep breath. I continued to have difficulty inhaling because of the pain of doing so into the next day (19th) and part of the 20th. I was administered oxygen and pain meds for the first day. I was put on Eliquis, which I am ordered to take for 6 more months. I was released from ICU on the 20th, which appeared to be a quick turnaround. I still have no energy, lack of clarity of thought, and easily out of breath a month later. In the hospital, I had no fever. The only time I think I did was on April 19th when I had the chills and cough.

No Immediate effect. Not sure if events are related ! On March 24th 2021, patient received the one Janssen # 1805022 Covid vaccine, at home, from a at Home doctor. 1) On May 12th 2021, patient, at home on the vent, began getting tired, she threw up, could barely walk and eventually became totally lethargic. Her oxygen was low and the on hand nurse used the Ambu bag to get her oxygen up to 100, while I called the ENT?s. The ENT?s checked her vitals, and did an EKG. We spoke to the doctor, and although by that time she was acting somewhat ?normal?, the decision was made to take her to hospital. Her oxygen was stabilized and her CO2 at the hospital was 80. She remained in the hospital for four days. 2) On Sunday, July 4th, patient was at home on the ventilator. Approximately 1:30 pm she seemed to become somewhat tired and she dropped her coffee cup.A little later, while eating, she threw up, spilling food and drink on her top. She seemed more tired and needed help changing her top. She sat in her recliner for a while and then she had to go to the bathroom. I took her there in a wheelchair. By the time she was ready to leave the bathroom, she was comatose and I had to lift her, she was dead weight, and place her in the wheelchair. I rolled her to the recliner and lifted her into it. She was then completely unconscious, with a continuously running nose and bubbles and fluid coming from her mouth ! Note: This was exactly same experience we had with her on May 12th 2021, when she was taken to hospital. I increased her breath rate on the Vent from 16 to 20, hoping that would expel CO2. I also increased the oxygen setting on the floor concentrator to 9, her pulse oxy was stable at 90. With the help of my daughter in law and grandson, we repositioned her on the recliner to a more comfortable and accessible position, connected the AMBU bag to the oxygen and slowly applied oxygen through her trach connection. We had also called the emergency, requesting assistance. By slowly squeezing the AMBU bag, I got her oxygen up to 100 ! Note: This Is exactly what we did on May 12 th. The ENT?s arrived shortly and within a few minutes after they arrived, patient started to come out of her comatose condition. The ENT?s checked her vitals,(somewhat normal) did an EKG, and checked her CO2 (45).We spoke to the doctor, and by that time she was acting ?normal? ! The decision was made to keep her at home instead of going to the hospital and an at-home X-ray was ordered in case she aspirated and conducted the following day. This x-ray Did Not show any aspiration !

DIFFICULTY BREATHING; SWOLLEN ANKLES ON BOTH SIDES (MORE NOTICEABLY AFTER THE VACCINE); LEAKAGE/GOING TO THE BATHROOM CONSISTENTLY; HEADACHE; TIRED; HARDLY SLEPT; DEHYDRATED (THIRSTY/DRY MOUTH); DRY RIGHT DOWN IN THE THROAT; This spontaneous report received from a patient concerned a 75 year old female. The patient's height, and weight were not reported. The patient's past medical history included lung cancer, kidney infection, headache, swollen ankles, difficulty breathing, and leakage, and concurrent conditions included neuropathy, diabetic, and high blood pressure, and other pre-existing medical conditions included the patient was not pregnant at the time of vaccination. the patient's all medications were held at the time of vaccination. The patient was previously treated with oxygen for difficulty in breathing; and experienced drug allergy when treated with influenza vaccine for prophylactic vaccination, and drug allergy when treated with naproxen sodium, chlortalidone, carvedilol, lisinopril, losartan, morphine, prednisone, tiotropium bromide, and rashes when treated with cobalt. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 206A21A, expiry: 07-AUG-2021) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. Concomitant medications included paracetamol for headache. On MAY-2021, Laboratory data included: Allergy test (NR: not provided) Not reported. On 09-JUL-2021, the subject experienced dehydrated (thirsty/dry mouth). On 09-JUL-2021, the subject experienced dry right down in the throat. On 09-JUL-2021, the subject experienced hardly slept. On 10-JUL-2021, the subject experienced difficulty breathing. On 10-JUL-2021, the subject experienced swollen ankles on both sides (more noticeably after the vaccine). On 10-JUL-2021, the subject experienced leakage/going to the bathroom consistently. On 10-JUL-2021, the subject experienced headache. On 10-JUL-2021, the subject experienced tired. Laboratory data (dates unspecified) included: Oxygen saturation (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dehydrated (thirsty/dry mouth), swollen ankles on both sides (more noticeably after the vaccine), leakage/going to the bathroom consistently, difficulty breathing, hardly slept, headache, tired, and dry right down in the throat. This report was non-serious.

SUSPECTED CLINICAL VACCINATION FAILURE; PULMONARY THROMBOSIS; MENTAL IMPAIRMENT; COVID-19; COMPUTERISED TOMOGRAM THORAX ABNORMAL; COUGH; DYSPNOEA; NASOPHARYNGITIS; PAIN; PAINFUL RESPIRATION; ANTICOAGULANT THERAPY; ELECTROCARDIOGRAM; FIBRIN D DIMER; INTENSIVE CARE; SARS-COV-2 TEST POSITIVE; CHILLS; MALAISE; ASTHENIA; This spontaneous report received from a patient via a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) (VAERS ID: 1421473) concerned a 75 year old female of unknown race and ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included osteoarthritis, seasonal allergies, and hypothyroidism, and concurrent conditions included mild cold, and Gastroesophageal reflux disease (GERD). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number:1808078, and expiry: UNKNOWN) frequency 1 total, dose was not reported, administered on 03-APR-2021 to left arm for prophylactic vaccination. Concomitant medications included ascorbic acid, colecalciferol, compounded hormones, esomeprazole magnesium, fexofenadine hydrochloride, fluorometholone, fluticasone propionate, thyroid, vitamins nos, and zinc. On 17-APR-2021, patient had COVID symptoms of cold like symptoms, then a night of chills and coughing, followed by aches then weeks of what patient thought may be allergies, but patient was not feeling good. Patient continued to cough, but thought it was attributed to GERD. Patient wasn't thinking it could be COVID because patient had been vaccinated. Patient experienced pulmonary thrombosis, nasopharyngitis, and mental impairment and was hospitalized on unspecified day. By 18-MAY-2021, patient was having trouble breathing as it was painful to inhale. Patient thought patient might be having a heart attack so went into the emergency room at Hospital. Patient was tested positive in emergency room (ER). Patient had no heart problem. There were also at least 5 blood clots found in patient's lungs. Patient felt like what patient imagine it would feel like if patient's ribs were broken and patient was trying to take a deep breath. On 18-MAY-2021, patient experienced suspected clinical vaccination failure. Patient continued to have difficulty inhaling because of the pain of doing so into the next day 19-MAY-2021 and part of the 20-MAY-2021. Patient was administered oxygen and pain meds for the first day. Patient was put on Eliquis, which patient was ordered to take for 6 more months. Patient was released from ICU on the 20-MAY-2021. Patient still have no energy, lack of clarity of thought, and easily out of breath a month later. In the hospital, patient had no fever. Patient thought that the only time patient thought was on 19-APR-2021 when patient had the chills and cough. patient was hospitalized for 3 days. Laboratory data included: Computerised tomogram thorax abnormal (NR: not provided) Not Reported, Electrocardiogram (NR: not provided) Not reported, Fibrin D dimer (NR: not provided) Not reported. On 18-MAY-2021, laboratory test included, SARS-CoV-2 test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid-19, asthenia, chills, computerised tomogram thorax abnormal, cough, dyspnoea, malaise, mental impairment, nasopharyngitis, pain, painful respiration, pulmonary thrombosis, anticoagulant therapy, electrocardiogram, fibrin d dimer, intensive care, sars-cov-2 test positive and suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged and Life Threatening). This report was associated with product quality complaint: 90000185984. The suspected product quality complaint has been confirmed to be not voided. The reported allegation could not be confirmed, a manufacturing related root cause could not be identified, based on the PQC evaluation/investigation performed. Additional information was received from Consumer Complaint Vigilance Organization on 16-JUL-2021. The following information was updated and incorporated into the case narrative: Investigation result added.; Sender's Comments: V3: In this version following information was updated and incorporated into the case narrative: Investigation result. This updated information does not alter the causality of the previously assessed events. 20210705031-COVID-19 VACCINE AD26.COV2.S -19- Pulmonary Thrombosis, Mental Impairment, Covid-19, Asthenia, Chills, Cough, Dyspnoea, Malaise, Nasopharyngitis, Pain, Painful Respiration. 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). V0: 20210705031-COVID-19 VACCINE AD26.COV2.S -Suspected 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 20210705031-COVID-19 VACCINE AD26.COV2.S -19- Computerised Tomogram Thorax Abnormal, Anticoagulant Therapy, Electrocardiogram, Fibrin D Dimer, Intensive Care And Sars-Cov-2 Test Positive . 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).