Johnson & Johnson

March 5,2021 at 3:30 am approximately I woke up trembling severely ( entire body ) and intense internal spasms :, high fever : could not grab or hold bottle of water ; tried to get up and and could not stand trembling so bad : I covered up and it lasted till 7:30 am. Now bad headache and back ache

Experienced light headedness and felt shaky few minutes after receiving the vaccine. BP 142/70 O2 sat - 100%

Severe headache, very tired, muscle aches,fever, short periods of dizziness, several hours of the feeling of pressure on my chest which then was replaced by significant burning sensation, bottoms of both feet were very painful and a wrist that i broke a couple of years ago and a knee which has caused pain in the past were very, very painful.

9 hours after injection, woke up with chills, body aches, head ache, and extremely dizzy. Lasted 8 hours then all symptoms were gone except the continued dizziness I still have whenever sitting up or rolling over when I'm laying down. Been 7 days now and hasn't subsided.

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

Arm soreness at site of injection lasting for several days. A tension headache developed by 2pm the day of the shot. Not debilitating, but obvious. It lasted until late the first night, leaving a feeling of lightheadedness afterwards that was gone by late morning the next day. Some tiredness, but not extreme.

Patient was sitting in chair when she alerted Medic she was feeing dizzy and lightheaded. Patient had syncope episode lasting approximately 45 seconds. Patient did not strike her head and was placed in recovery position on the floor by two medics. EMS was called to facility. EMS cleared patient to return home with spouse.

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

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

Shortness of breath, fatigue, dizzy, aches. 1 week out and still have listed symptoms. May be improving slightly but not gone

Patient had completed her 15 minutes in recovery area and upon rising to exit the area, became dizzy, unsteady and needed to sit back down. Patient informed the recovery Nurse, had not eaten anything yet today. Initial VS check, 1330: B/P 158/100, HR: 71, O2 Sat 96%, recheck at 1349: 142/82, HR: 68, O2 Sat 98%, provided with simple snacks, maintained in recovery area for add'l 15 minutes, stable, 911 not activated, dc from recovery area, stable, AAOx4, left recovery area ambulating freely.

Patient developed Severe INflammatory response syndrome . Was hospitalized as her cbc was abnormal and no infection could be found, could not walk or take care of herself

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

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

Fever and chills began around 3 am following vaccination at 6:45 PM. Upon arising around 7 am, fainted in bathroom and was dizzy when upright for about thirty minutes. Bruised ribs secondary to falling.

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.

Chills and fatigue for 3 days,fatigue and lightheadedness x10 days. Seen at the walkin 3/15/21 sent to ER for two units of blood. Acute anemia-seen at Hospital 3/15-3/16/2021. 3/24/2021 stool tested and no blood found. Next test is on 4/22/21-endoscopy

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.

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

Lightheaded, dizziness. vitals: B/P-130/86 P-91, SPO2-95%, R-24 Fluids, offered snacks, offered to lay down. Pt refused snack and to lay down. Patient waited an additional 15 minutes. Pt stood up and was feelin improvement in symptoms, Walked out of waiting area with spouse present within normal limits

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

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

fever of 101, achy, tired, dizzy, lightheaded. Took two naps and slept 10 hours that night. Felt a bit better the next day.

pt start feeling lightheaded and dizzy ,she lie down on floor and could stay up , no difficulty of breathing we contact 911 and paramedic took her to hospital for observation.

-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"

Pt reported feeling dizzy, blurry vision, chest pain directly after vaccine administration, while sitting in chair, 911 called, , ambulance arrived, pt refused ER transfer. Pt reported feeling better and went home with husband.

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

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.

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

Day 1 40min in... intense, in-tense....fiery, pain radiates from-injection. Up neck, across shoulders and down back. In.tense. Fiery. Pain. Just over 1hr very intense bone ache. Not muscle. Bone. Ache. Stop for lunch and find extreme bone ache across collarbone. Intense pain. Like i thought I broke collarbone. On walking in, to order lunch, dizzy and blurred vision. Had to sit awhile to dissipate. 1.5 hrs in Finish eating and spend time breathing thru pain. Vision clear, on my way back to work. Intense pain continues adding, now, itchy across shoulders. Through afternoon increased fatigue and itch. Little better at 4hrs. Day 2 utter fatigue. Want to. S.l.e.e.p. Pain now replaces the burn. Every. Where; ache. Ache. Ache. Day3 fatigue on waking. Pain is now in all joints. Knees hips excruciating. Manage 3hrs household tasks before the fatigue sets in to stop. Awake but still pain in joints. Not ache; pain. Hard to move. Spend afternoon cooking and resting. Soooo exhausted. Day 4-2wks arm still sore and swollen and warm to touch. cannot bear weight in left arm. Cannot use arm to drive. swelling down day 15 still cannot bear weight in left arm. pain continues along pathway of injected drug. burn sensation. now day 17 still cannot bear weight in left arm. If I do I get sudden weakness in arm and pain in back of shoulder.

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.

Headache, neck soreness, Itchy all over, fever, and dizziness. Patient stated the headache started around 1:00pm on 4/12/21 and the itchy all over started about 4:00pm. All other symptoms started later that afternoon. Patient called to report this issue and stated he fever is now gone and so is it itchy all over feeling but the sore neck and dizziness are still present.

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.

One week after shot experienced left sided chest pain2/10 progressed to burning in left axils. Fatigue heaviness in bilateral arms and legs. Cold feet. Persistent dull left temporal headache. Felt dizzy and lightheaded in addition on 4/7 went to ER

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

FEELING WOOZY OR DIZZINESS; HEART RACING; FEELING VERY TIRED; HEADACHE; MUSCLE ACHE; ACHY ARM; 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: 201A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced achy arm. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced muscle ache. On 10-APR-2021, the subject experienced feeling very tired. On 11-APR-2021, the subject experienced heart racing. On 12-APR-2021, the subject experienced feeling woozy or dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achy arm, and muscle ache on 11-APR-2021, and feeling very tired on 12-APR-2021, and had not recovered from heart racing, feeling woozy or dizziness, and headache. This report was non-serious.

4/8/21- unable to walk with normal stride 4/9/21 severe pain in right hip making it difficult to walk or go up stairs 4/10/21 morning - unable to walk at all. Called my doctor, who after discussion, prescribed 5 days of prednisone for severe inflammatory response 4/11/21 able to walk again and complete course of steroid. 4/16/21 some inflammation in joints and hip persists.

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!"

3/16 vaccination 4/4 extreme HA, tired, High BP, dizzy. 4/6 went to the ER. Shot for headache. Tramadol for HA if got worse. I took Tylenol. I saw PCM on Friday Meloxicam 7.5 1 per day. Will go to 2 tablets per day if continues. Not consistent HA as of yet. Scheduled echocardiogram on 4/29/2021 *Usual BP runs 115-120 range. Never had issue with BP. Knee replacement sx 12/1/2020 and no issues with BP then. Since vaccine my BP has been in the 150's. My BP has been consistently high since vaccine. Lowest has been 141 on 4/12/2021. I feel like I am out of breathe.

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.

BLURRINESS; RASH; DIZZINESS; DRY MOUTH; COUGHING; HEADACHE; TIREDNESS; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight was not reported. The patient's concurrent conditions included allergic to many medications including flu vaccination. The patient was previously treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A22A expiry: UNKNOWN) dose was not reported, administered 1 total on 09-APR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. It was reported that few minutes after administration she started feeling dizzy, dryness in mouth, coughing, felt like there is a cotton ball in mouth, slight rash all over and blurriness. Then she was transferred to the emergency room where they used intravenous (IV) Benadryl and Epipen and they monitored her. Ever since then she still has headaches and tiredness. Treatment medications (dates unspecified) included: Benadryl (diphenhydramine hydrochloride), and Epipen (epinephrine) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and tiredness, and the outcome of rash, dizziness, dry mouth, coughing and blurriness was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:-Covid-19 vaccine ad26.cov2.s-Blurring, Coughing, dizziness, dryness of mouth. These events are considered unassessable. The events has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events. V0:-Covid-19 vaccine ad26.cov2.s-Rash. This events is labeled per RSI and is therefore considered potentially related.

DIZZINESS; FATIGUE; NOT FEELING WELL; ELEVATED PLATELETS; LOW CLOTTING TIME; ELEVATED EOSINOPHILS; LEFT SIDE PAIN STARTING FROM THE LEFT BREAST DOWN TO THE HIP; LEFT FACIAL SWELLING; FACIAL NUMBNESS; LEFT EYE TWITCHING; IMPAIRED VISION IN LEFT EYE; LEFT LEG NUMBNESS; LEFT ARM 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 concurrent conditions included blood pressure, and other pre-existing medical conditions included the patient was not diabetic, not on blood thinners prior to going to the hospital, and does not take thyroid medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered to the left arm, on 27-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-MAR-2021, the subject experienced left side pain starting from the left breast down to the hip. On 27-MAR-2021, the subject experienced left facial swelling. On 27-MAR-2021, the subject experienced facial numbness. On 27-MAR-2021, the subject experienced left eye twitching. On 27-MAR-2021, the subject experienced impaired vision in left eye. On 27-MAR-2021, the subject experienced left leg numbness. On 27-MAR-2021, the subject experienced left arm pain. On 29-MAR-2021, the subject experienced elevated platelets. On 29-MAR-2021, the subject experienced low clotting time. On 29-MAR-2021, the subject experienced elevated eosinophils. On 29-MAR-2021, the subject experienced not feeling well. Laboratory data included: CT scan (NR: not provided) unknown, Clotting time (NR: not provided) LOW, Eosinophil count high (NR: not provided) UNKNOWN, MRI (NR: not provided) unknown, Mean platelet volume (NR: not provided) LOW, and Platelets increased (NR: not provided) 10 times above normal. On 30-MAR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced 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 left side pain starting from the left breast down to the hip, facial numbness, left eye twitching, impaired vision in left eye, left arm pain, and fatigue on 2021, and dizziness on APR-2021, was recovering from left facial swelling, and not feeling well, had not recovered from left leg numbness, and the outcome of elevated platelets, elevated eosinophils and low clotting time 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

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

HIGHER LEVEL OF PAIN (EXTREME PAIN) IN THE SHOULDER AND IN UPPER ARM; LACK OF MOBILITY IN THE SHOULDER AND THE UPPER ARM OF THE INJECTED SITE; FROZEN SHOULDER; HIGHER LEVEL OF PAIN (EXTREME PAIN) AT THE LOCATION OF INJECTION; SORE ARM; LITTLE FATIGUE; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included immune thrombocytopenic purpura, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, 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 sore arm. On 01-APR-2021, the subject experienced little fatigue. On 24-APR-2021, the subject experienced higher level of pain (extreme pain) in the shoulder and in upper arm. On 24-APR-2021, the subject experienced lack of mobility in the shoulder and the upper arm of the injected site. On 24-APR-2021, the subject experienced frozen shoulder. On 24-APR-2021, the subject experienced higher level of pain (extreme pain) at the location of injection. Laboratory data (dates unspecified) included: Platelet count (NR: not provided) Platelet count before the vaccination was 40. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little fatigue on 03-APR-2021, and had not recovered from sore arm, higher level of pain (extreme pain) at the location of injection, lack of mobility in the shoulder and the upper arm of the injected site, higher level of pain (extreme pain) in the shoulder and in upper arm, and frozen shoulder. This report was non-serious.

On and off symptoms include: light headedness, light weakness/tingle on the underside of my left arm, on and off achey weakness in right hand too. It started on day 12, 13, 15 (up to two weeks after vaccination). Symptoms went away and returned at night on April 27 and throughout the day on April 28, 2021. I was borne with mitral valve prolapse (no work/life restrictions) and wondered if the vaccine has any connection to the mitral valve prolapse.

LEG SWOLLEN; CANNOT PUT PRESSURE ON FOOT, WALKS ON TIP TOES; TENDERNESS ON OUTSIDE OF LEFT LEG; PAINFUL KNEE/LEG; 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 blood pressure abnormal, knee disorder, and hand arthritis. 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 30-MAR-2021 for prophylactic vaccination. Concomitant medications included methotrexate for hand arthritis, and acetylsalicylic acid. On 10-APR-2021, the subject experienced leg swollen. On 10-APR-2021, the subject experienced cannot put pressure on foot, walks on tip toes. On 10-APR-2021, the subject experienced tenderness on outside of left leg. On 10-APR-2021, the subject experienced painful knee/leg. On 14-APR-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) No blood clots. On 20-APR-2021, Laboratory data included: Blood test (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tenderness on outside of left leg, painful knee/leg, leg swollen, and cannot put pressure on foot, walks on tip toes. This report was non-serious.

DULL HEADACHE; INJECTION SITE ARM PAIN; FATIGUE; ACHY; DIZZY; 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 (suspension for injection, route of admin not reported, batch number: 042A21A expiry: 21-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 achy. On 09-APR-2021, the subject experienced dizzy. On 09-APR-2021, the subject experienced injection site arm pain. On 09-APR-2021, the subject experienced felt fatigued. On an unspecified date, the subject experienced dull headache. Treatment medications (dates unspecified) included: naproxen sodium. The action taken with covid-19 vaccine was not applicable. The patient recovered from achy, dizzy, injection site arm pain, and felt fatigued on APR-2021, and had not recovered from dull headache. This report was non-serious.

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

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

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

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 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.

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.

HEART RACING; EXTREME DIZZINESS; 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 experienced drug allergy when treated with hydrocodone. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced heart racing. On 17-MAR-2021, the subject experienced extreme dizziness. On 19-MAY-2021, Laboratory data included: Blood test (NR: not provided) Not reported, and Electrocardiogram (NR: not provided) Not reported. The action taken with covid-19 vaccine was not applicable. The patient was recovering from heart racing, and had not recovered from extreme dizziness. This report was non-serious.

POSSIBLE SMALL STROKE; POSSIBLE TRANSIENT ISCHAEMIC ATTACK (TIA); SUPER DIZZY; THROWING UP; COULD NOT OPEN EYES; WIERDLY AND EXCEEDINGLY THIRSTY; COULD NOT WALK; NUMBNESS IN LEFT ARM; COULD NOT STAND; HEAVINESS IN LEFT ARM; NAUSEOUS; HEADACHE; FELT LIKE HAD CHILLS LIKE ONE GETS FROM THE FLU; This spontaneous report received from a patient concerned a 60 year old White, Not Hispanic or Latino female. The patient's weight was 175 pounds, and height was 65 inches. The patient's concurrent conditions included slightly elevated blood pressure, alcohol user socially and on weekends, non smoker, and penicillin allergy since childhood. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, expiry: UNKNOWN) dose was not reported, 1 total, administered on 08-MAR-2021 for prophylactic vaccination. Concomitant medications included valsartan for elevated blood pressure, acetylsalicylic acid, and furosemide. On 10-MAR-2021, the patient felt like having chills like getting from the flu, for couple of hours might be, a headache for several days, might be for 3 days. For that the patient took some Advil 200 mg every 6 hours for the first couple of days. Then that passed and felt fine. On 24-APR-2021, around 04:00 in the morning the patient woke up and felt weirdly thirsty, exceedingly thirsty and super dizzy, nauseous thought was having a heart attack and heaviness and numbness in left arm but could still move the arm, however could not walk and could not open eyes until was in hospital. As a treatment Aspirin was given to the patient by husband. The patient was throwing up, could not stand. About 05:30 went to the hospital and ran many tests. Ruled out brain bleed, heart attack, anything cardiac did a CAT scan; bloodwork found that the patient was low in potassium and it was determined that the patient either had a small stroke or a TIA that dissipated on its own. The patient saw her cardiologist and wore a Holter monitor for 10 days. The patient also has an appointment with a neurologist coming up in June and having another CAT scan. Also seeing a vascular neurologist. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from possible small stroke, possible transient ischaemic attack (TIA), super dizzy, could not open eyes, wierdly and exceedingly thirsty, could not walk, throwing up, numbness in left arm, could not stand, heaviness in left arm, and nauseous on 2021, felt like had chills like one gets from the flu on 10-MAR-2021, and headache on MAR-2021. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: covid-19 vaccine ad26.cov2.s-Possible small stroke, Possible transient ischaemic attack , super dizzy, could not open eyes, wierdly and exceedingly thirsty, could not walk, throwing up, numbness in left arm, could not stand, heaviness in left arm. These events are considered unassessable. The events has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events. covid-19 vaccine ad26.cov2.s-Nauseous. This event is labeled per RSI and is therefore considered potentially related.

I just really got dizzy to point I felt like my head was swimming. I could not lay on my back, that also cause dizziness. I also broke out in sweats in the middle of the night.

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.

I had leg pain, lymph nodes were swollen on the left side, pain down the right arm and tingling in my fingers, dizzy spells, back and head pain.

Patient became dizzy upon standing and experience left sided weakness. Ambulance was called and patient transported to hospital. Upon exam it was determined the patient had a bleed on the ride side of the brain. After 4 or 5 days she was transferred to Rehab. She was then sent back to hospital after complications. Patient began having kidney problems and was undergoing dialysis. 06/16/2021 patient began having bad headaches, CT scan showed multiple previous strokes(clots). Patient currently still in hospital.

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.

Redness at the injection site and has swelled and became large over time, about the size of a quarter. Fatigue and dizziness. Severe pain under rib.

Patient states that arm has been sore to use since receiving the vaccine; NO redness, rash, warmth to touch or lump or swelling; she states it is sore upon waking in the morning and the stiffness lesses slightly as the day progresses but is sore all day sometimes she has issues gripping & moving arm front to back but not as much soreness raising arm upwards; she was advised by her prescriber to have pharmacy report

Sore throat and headache. Runny nose, sneezing and Productive cough next. And Had a fever once and 02 went down to 95 and then to 92 and then back up. I got Tylenol (took it around the clock - until the week after the hospital due to headaches); Vit D; and I took herbal teas Ginger/Turmeric and water. I had Telehealth visit the whole time. I went to ER when 02 went to 92 and I couldn't smell. I couldn't lay down - had to sit up due to not being able to breathe. I couldn't bend down without being out of bed. I still was short of breath for about three weeks after. Fatigue lasted that long, too. They gave me some (Received Oxygen for breathing at ER). My sense of smell has now returned - not sure when. I'm back to going to gym now - I can walk around and not get out of breath.

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.

My head hurt really bad shortly after injection and continued for at least 2 weeks, trouble with body shakes, also had trouble when taking walks with urinary isues, and exusted climbing stairs, caused pressure in my chest which is still there. Finally did Ultrasound of heart because of the pressure in chest, it came back ok. Having alot of junk in throat daily, constantly trying to clear it, I have to use fexofenadine daily instead of ocasional with Asthma flair ups., with shortness of breath it almost fells like emphysema, very sensetive to all smells worse then before.

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.

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.

Could NOT breathe, Afib increased, could not walk 15 feet without stopping, gasping for air at night when trying to lay down, major edema in legs and feet - this lasted approximately 2 weeks. Then returned on 6/17 & 6/18.

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

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

I felt no immediate side effects of the shot, but 2 hours later, while sitting calmly, my heart rate suddenly elevated and I began to feel light headed. My home blood pressure monitoring kit provided a reading of 149/99 and a resting heart rate of 108. Normally, my blood pressure is very well maintained with my meds and hovers in the 118/75 range. My resting heart rate is usually below 70. I was going to dial 911 but within 5 minutes, my heart rate began to slow down and I felt better. When I rechecked my numbers at 8 pm, BP was down to 118/80 and resting heart rate was 70.

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: Dizziness Patient was treated/managed as follows: Given Gatorade and VS taken: 12:16pm: BP-180/90 HR: 71 RR:18 O2: 98% 12:26pm: BP: 180/90 HR: 73 RR: 18 O2: 97% Pt states she has not taken BP meds this morning. Pt reports feeling better Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. Pt escorted to car by Site Lead

Patient reported prior to administration of vaccine significant history of syncope episodes with previous vaccine injections. Placed in wheelchair prior to administration of vaccine. After vaccine given patient experienced lightheadedness and feeling hot within 1 to 2 minutes placed on cot no respiratory distress or anaphylaxis occurred symptoms persisted EMS on site now feeling better EMS recalled back to site and transported to local hospital.

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

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

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

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

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

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

30 minutes post vaccine injection I stood up and felt lightheaded, paramedic on site took my blood pressure was 167/85, minutes later was 163/82. Ekg normal, blood sugar by finger stick 109, oxygen 98%. After 15 minutes BP improved to 137/73. While driving home I felt weak again unable to finish conversation. Walking from car mildly lightheaded, rested in bed. At 2:33 pm BP 105/58 heart rate 78, tired.

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.

Woke up around midnight with fever of 102.8 and chills. My normal temp is 97.4. Felt slightly dizzy when standing up. Took Tylenol and started feeling better after about 2-1/2 hours. The next morning, the 25th, felt like I had a mild case of the flu but, again, Tylenol seemed to help. No soreness in arm or other symptoms.

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

covid-19 janssen shot given and seated in observation area. pt in observation area appeared faint and eyes rolled back. RPH, EMT, and store management all called to scene. Pt was monitored and clear to drive home.

HIGH BLOOD PRESSURE; CHEST TIGHTNESS; DIZZINESS; STAGGERING FROM WALKING; This spontaneous report received from a patient concerned 61 year old female patient. The patient's weight was 183 pounds, and height was 167.64 centimeters. The patient's concurrent conditions included high blood pressure, COPD (Chronic Obstructive Pulmonary Disease), thyroid problem, severe arthritis, non-alcoholic user, non-smoker, allergic to ginger (throat closes), drug allergy to sulfur, drug allergy to antihistamines and steroid rash. The patient did not had drug abuse or illicit drug usage. 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: 1805018, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 in the left arm for prophylactic vaccination. The patient's concomitant medications included two unspecified BP (blood pressure) medications. On 12-MAR-2021, the patient received covid-19 vaccine and she experienced high blood pressure (180/120 mm hg), her chest got tight, she was dizzy and had staggering from walking. On 12-MAR-2021, the patient took BP medicine directly after receiving vaccine to get BP down. Laboratory data included: Blood pressure (NR: not provided) 180/120 mmHg. On 13-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 152/106 mmHg. On 22-MAR-2021, her BP was still elevated and her other symptoms had resolved. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest tightness, dizziness, and staggering from walking, and had not recovered from high blood pressure. This report was serious (Other Medically Important Condition). Additional information received from consumer on 22-MAR-2021.The following information was updated and incorporated into the case narrative: patient demographics (age, weight, height), concurrent conditions (drug allergy to sulfur and antihistamine and steroid rash) event outcome updated (recovered/ resolved for events chest tightness, dizziness and staggering from walking).; Sender's Comments: V1: The follow up information in this version updates patient demographics, concurrent conditions (drug allergy to sulfur and antihistamine and steroid rash) event outcome updated (recovered/ resolved for events chest tightness, dizziness and staggering from walking) and narrative updated. This updated information does not alter the prior causality assessment for the reported event 20210325494- Covid-19 Vaccine Ad26.Cov2.S - Blood pressure high. 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.

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.

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

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

FEVER; DIZZINESS; 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 levofloxacin allergy, midazolam allergy, amoxicillin allergy, and aleve allergy, and concurrent conditions included myelodysplasia, recurrent bladder infection, and sulfa allergy. The patient was previously treated with levofloxacin, midazolam, amoxicillin, and naproxen sodium. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 16:00 for prophylactic vaccination. Concomitant medications included aciclovir for myelodysplasia, and recurrent bladder infections, calcium carbonate for myelodysplasia, and recurrent bladder infections, colecalciferol for myelodysplasia, and recurrent bladder infections, docusate sodium for recurrent bladder infections, and myelodysplasia, fluconazole for recurrent bladder infections, and myelodysplasia, iron for recurrent bladder infections, and myelodysplasia, and nitrofurantoin for recurrent bladder infections, and myelodysplasia. On 18-MAR-2021, the subject experienced dizziness. On 19-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness on 18-MAR-2021, and fever on 25-MAR-2021. This report was non-serious.

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

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.

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.

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

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

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.

At 4 AM the following day I woke up with a severe headache and fever. I attempted to take 2 extra strength Tylenol which seemed to trigger cyclic vomiting every 15-20 minutes for approximately 4 hours. After this, I vomited once an hour for another 4 hours. I was finally able to sip water and sleep after this. I also took my first temperature once feeling better and it was 99.9F. My normal temp is in the 97s and I?m sure it was much higher during the vomiting. My fever broke approximately 12 hours after the first symptoms. Headache lasted approximately 36 hours and resolved the next day, although a milder one did come back off and on for a couple more days. I did not have much pain in the arm I received the injection in.

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.

Pt stated she felt dizzy. B/P normal range, pulse rate lowered to 47. Pt was monitored until pulse reate increased to 65. Pt. was discharged home.

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

HURT; COULDN'T FOCUS; COULDN'T LIFT A STEP; SHUFFLING; THROAT CLEARING; SINUSES; CHILLS; EXHAUSTED; NAUSEA; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight, height, and medical history were not reported.he patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced hurt, couldn't focus, couldn't lift a step, shuffling, throat clearing, sinuses, chills, exhausted, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, exhausted, nausea, hurt, couldn't focus, shuffling, throat clearing, couldn't lift a step and sinuses was not reported. This report was non-serious.

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.

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

Had injection on March 31, 2021. Very sore arm with soreness and stiffness in the neck for a few days. On April 8th woke up very dizzy, had to lay back down for a little bit. On April 10th woke up not being able to take a deep breath without a very bad pain in my back (it felt like my right lung) same issue the 11th, and 12th. This pain was not severe unless I took a deep breath. I was able to go about my daily activities. Today April 13th still a little tight in my lung but do not have the pain in my back that I had the last few days.

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.

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.

Felt crippled unable to walk excruciating pain (bone next to tailbone on left side) Shortness of breath Couldn't hold urine Felt perfectly fine until the morning of 3/20/21 (lasted 2 weeks-until I begged DR. to provide anti-inflammatory, 5% lidocaine patch to treat this, and I did not want continue to take my Percocet (from previous facture event) that the Dr. recommended.

It has been a month since getting the vaccine and my arm is still painful to the point of limited movement. The first few days after the shot, I was not concerned about the soreness, I knew it was a normal side affect. But at this point I am more concerned and do feel it is an issue to be reported. This may keep me from getting the vaccine in the future.

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

3/29/21 6 pm - Severe pain lower right leg, ankle, and foot, unable to weight bear on right leg About an hour later I was able to walk a little. Stayed off my feet. Right foot became very cold. 3/30/21 Saw my primary care physician at med center. She sent me for an ultrasound at medical arts. From there I was sent to the emergency room at hospital. I asked the attending physician assistant about a correlation between the blood clot and the Covid vaccine because I had read about it being a concern in other countries. He stated that was a bunch of baloney. Was told to have a repeat ultrasound in a few days and was prescribed a 30 day starter pack of Xarelto and released. 3/30 repeat penis ultrasound of right leg showed the same results. 4/1 appointment with hematologist. Prescribe Xarelto for three months and ordered a repeat ultrasound in three months and bloodwork at that time.

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.

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.

Headache since shot with fluctuating intensity Extreme fatigue since 4/1/21 Cough since 4/5/21 (asthma) Dizziness since 4/11

BODY ACHE; DIZZINESS; HEADACHE; This spontaneous report received from a consumer concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal pollen allergy, non alcoholic, and non smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 19:30 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced body ache. On 07-APR-2021, the subject experienced dizziness. On 07-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, body ache, and dizziness. This report was non-serious.

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.

FEELING COLD; DIZZINESS; BODY ACHES; TIREDNESS; HEADACHES; 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 pre-existing medical conditions included the patient did not have any allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced feeling cold. On 09-APR-2021, the subject experienced dizziness. On 09-APR-2021, the subject experienced body aches. On 09-APR-2021, the subject experienced tiredness. On 09-APR-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from feeling cold, and dizziness, and had not recovered from body aches, tiredness, and headaches. This report was non-serious.

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

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.

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

"Pressure on the chest/ pinching feeling up to my back. My left arm goes numb on and off with a little pain. Headache and dizziness. Vaccine given in the right arm."

On 3/21/2021 I woke up with sudden bad left lower back pain that radiated down the lateral left thigh. It continued to get worse as the week wore on. I could not bend over, lie down or sit for very long without severe discomfort. I ended up seeing a chiropractor within the week who has been treating the problem over this past month. X rays were taken. I have been treating it with ice, ibuprofen, and aspirin.

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

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.

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

LIGHT HEADEDNESS (HER HEAD DOES NOT FEEL CONNECTED TO HER BODY); LIGHT SENSITIVITY; FLU-LIKE SYMPTOMS; CHILLS; HEADACHE; NAUSEA; TIREDNESS; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight was 106 pounds, and height was not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A-21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced flu-like symptoms. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced tiredness. On 11-APR-2021, the subject experienced light sensitivity. On 12-APR-2021, the subject experienced light headedness (her head does not feel connected to her body). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms, chills, headache, and nausea on 11-APR-2021, and light sensitivity on 13-APR-2021, and was recovering from tiredness, and light headedness (her head does not feel connected to her body). This report was non-serious.

DIZZINESS; HEADACHE ON LEFT SIDE OF FACE; 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 expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced dizziness. On 19-MAR-2021, the subject experienced headache on left side of face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, and headache on left side of face. This report was non-serious.

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

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

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

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

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.

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

Immediately after my J&J vaccine, I experienced soreness to my left arm, fatigue , dizziness and a bad headache. In the middle of the night my headache kept getting worse, my eyes started to hurt really bad and I also broke out in hives. About 6 hours later my headache felt like it wanted to explode. I saw a doctor through Tele-health by who prescribed a 6pk of steroids. Then on Day 6, my headaches came back along with the hives and I felt really tired and the hives broke out all over my body including my crotch and ear canal. He prescribed a 6pk of steroids and I started to feel and get better. On Day9, all of my symptoms were resolved except for the fatigue. To this day I still continue to have fatigue.

patient started to feel faint/dizzy-placed cold pack on back of her neck and she asked for a sip of water. We stayed with her for duration of time she was at our pharmacy to make sure she was ok. Patient was feeling good when left.

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

VERTIGO; RUNNY NOSE; FEELING SICK; This spontaneous report received from a patient concerned a 61 year old not Hispanic or Latino, African American female. The patient's height, and weight were not reported. The patient's concurrent conditions included blood pressure, cholesterol, depression, and non smoker, and 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: 1805025, expiry: unknown) frequency 1 total, dose was not reported, administered on 31-MAR-2021 to right arm for prophylactic vaccination. Concomitant medications included blood pressure pill, cholesterol pill and anti-depressant. One week after vaccination, on 07-APR-2021, the patient was feeling sick and dizzy. She said that the ambulance picked her up that day she felt really dizzy and took her to the hospital. There they performed tests on her and kept her overnight. Doctor of Medicine (MD) diagnosed her with vertigo and told her to take some over the counter medications for it. She reported that her runny nose and sick feeling went away after about a day. One to two weeks after that emergency room (ER) visit, she again went to the ER. This occurred at around 1-2:30 AM she went to the ER and MD said she had vertigo but she just stayed until the morning. MD prescribed her medicine for the vertigo, but the vertigo had not gone away. The MD there, did tests for blood clots but did not find anything but told her to take Aspirin (acetylsalicylic acid). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from runny nose, and feeling sick on 08-APR-2021, and had not recovered from vertigo. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210544583-covid-19 vaccine ad26.cov2-Vertigo, Runny nose. 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). V0:20210544583-covid-19 vaccine ad26.cov2-Feeling sick. This event(s) is labeled per RSI and is therefore considered potentially related.

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

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

About two weeks afterwards I start having Vertigo. I had it before but it has been about 11 years since I last had it. Still having some light headiness and dizziness.

5/07/2021 I had the shot and immediately I got dizzy when I stood up. That night I encountered fatigue, fever, muscle ache and sore throat. Fever lasted 2 days and fever lasted for 5 days. 5/10 the arm was sore and there was a 6x6? huge rash. 5/24- 5/26 I had a rash that I kept under control with Benadryl. 5/29 my saliva glands began to swell and that?s why I went to the Doctor. The Dr sent me to an ENT and Rheumatologist.

Bleeding from belly button - extreme headache within an hour of the shot - very sore and tired - felt like an extreme hangover headache while still drunk - my balance was gone - could barely walk for two days.

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

04-23-21 - Woke up super dizzy & was unable to get out of bed for about 30 mins after that I had to VERY carefully move around slowly for weeks after that (until mid June) I also had ringing in my ears for most of that time pretty severe at first & still present but better that when I was dizzy. I had not had this before & it is quite unnerving. I have been doing PT for the dizziness & it has pretty much subsided. I have also had pain (no rash or lymph discomfort or swelling) just muscular pain in my upper right arm. This started about a month after the vaccination. It is in the arm muscle NOT the bursa. It happens when I have not moved the arm for awhile & I reach for something, etc.. the pain is not severe but obvious (0 to 10 it is about a 4) & goes down to about a 1 after I move the arm around for 30 seconds or so. I have also had pain & a bit of weakness in my legs & a sharp pain in my left beast (not my chest - the upper left quadrant about 1" below my armpit & 3 inches in the breast tissue. It is a single sharp pain (0 to 10 = 7) and only stays for a few minutes.

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

after 5-6 minutes post vaccination while sitting in waiting / monitoring area, patient got very dizzy and fell off her chair on to the ground. she immediately got up with help from staff and sat back on the chair. paramedics were called on her request and after monitoring and running diagnostics patient asked to be taken to emergency room to be further monitored because she felt dizzy and had bumped her head when she fell off the chair. she returned a few hours later on her own after getting discharged from the hospital to get her vaccination card.

At 1615 client informed EMT she "felt dizzy and her blood pressure was high". PHN arrived at 1618, client sitting upright in chair, alert and oriented x4. Per client has history of hypertension and pre-diabetes. Current medication Losartan and client stated she took medication this morning. Allergies to flu vaccine and cats. Vitals at 1818 by EMT: blood pressure 220/110, pulse 71, oxygen sat 99%. Client denies chest pain, shortness of breath, blurry vision, headache, or nausea. PHN retook blood pressure at 1824: 180/90. Per client feeling palpitations. Dizziness same, denies chest pain or shortness of breath. Vitals at 1826: blood pressure 180/90, pulse 71. Per client palpitations same. RN called 911 at 1830. At 1833 client stated new onset of "feeling sleepy" and "eye heaviness". PHN continued to speak with client, client alert and oriented x4. PHN advised to follow up with provider. Fire Dept and Paramedics arrived at 1839 and assumed care. Client transported to Hospital at 1845.

SYNCOPE/COLLAPSED; FELL DOWN; TREMBLING; HYPERVENTILATED; BLOOD PRESSURE WAS VERY DOWN; COULD NOT TALK; HIT HEAD; HIT HAND; HIT ELBOW; BUMP ON HEAD, ELBOW, AND HAND; HEADACHE; This spontaneous report received from a patient concerned a 61 year old Hispanic or Latino female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 2076A21A, and expiry: unknown) dose was not reported, frequency 1 total, administered on 07-JUL-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On 07-JUL-2021, after receiving vaccine, the patient felt dizzy and could not talk. The patient fell down and hit her head, hand, and elbow. Paramedics were called to help the patient and she was taken to emergency room (ER). The patient was informed that her blood pressure was very down, she was hyperventilated and was trembling. On the same day, the patient felt fine and experienced headache after going home and noted bump on her head, hand, and elbow because of the fall. The patient was diagnosed with syncope/collapsed. Laboratory data included: Blood pressure (NR: not provided) Decreased, and Laboratory test (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from syncope/collapsed, trembling, hyperventilated, blood pressure was very down, and could not talk, and the outcome of fell down, hit head, hit hand, hit elbow, headache and bump on head, elbow, and hand was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:- 20210718537- covid-19 vaccine ad26.cov2.s-syncope/collapsed. 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).

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

CAN'T WALK AT TIMES; VERY UNSTEADY WHEN WALKING; STANDING ON ONE LEG IMPOSSIBLE; MUSCLE CONTRACTED AND WON'T LET GO; MUSCLE WEAKNESS; MUSCLE PAIN; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included arthritis in knees.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-APR-2021, the subject experienced can't walk at times. On 25-APR-2021, the subject experienced very unsteady when walking. On 25-APR-2021, the subject experienced standing on one leg impossible. On 25-APR-2021, the subject experienced muscle contracted and won't let go. On 25-APR-2021, the subject experienced muscle weakness. On 25-APR-2021, the subject experienced muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from can't walk at times, very unsteady when walking, standing on one leg impossible, muscle pain, muscle contracted and won't let go, and muscle weakness. This report was non-serious.

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

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

Patient arrived to the outpatient vaccine clinic for her scheduled appointment. Immediately after receiving the vaccine, the patient felt chest pain, dizziness, and passed out. She had swelling of the tongue, lips, eyes, and throat. Patient was admitted to the hospital and treated for anaphylaxis with epinephrine, benadryl, famotidine, methylprednisolone, Duoneb and tylenol. Patient is currently still in the hospital but her condition is stable.

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)

Mild headache, mild muscle aches, light headedness. Regular aspirin taken about 11 hrs after onset were effective for the aches. Mild light headedness continued for about 12 more hrs.

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

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

I started running a fever and aching very bad Saturday morning. By Saturday afternoon my fever was up to 103.5. I did not want to go to the hospital, but I came very close to calling. I decided to try ice packs on my forehead, neck and chest. I have never had a fever this high, or ached this bad. I don't know how long it took for my fever to come down, but finally came down to 102.5, where it stayed throughout the rest of the day and into Sunday. I continued to use the ice packs throughout Sunday. I drank a lot of water and took Tylenol for fever and pain. I had a fever for three days. Today, Tuesday, 3/17/2021, I am very light headed. I was diagnosed with covid-19 on Dec 29th 2020.

Janssen COVID-19 Vaccine EUA I received the single dose at 10:40. In approximately 11 minutes I started to experience shortness of breath. I thought it was my N95 mask so decided to head to the car after my 15 minute wait period was completed. After sitting down in the car I started the following symptoms: shortness of breath, rapid heart rate, swelling of face, dizziness, weakness. I sit in the car for approximately 15 minutes then headed home. I had a driver (thank goodness). I continued to have symptoms and what felt like elevated blood pressure (I did not have access to a pressure cuff). After resting at my driver's house for about 5 hours I felt better and headed home. The next morning the symptoms were less but still present. In addition I had a slight rash on my stomach that wrapped around my back. After approximately 48 hours all of the symptoms subsided. My blood pressure had returned to normal also. All swelling went down.

Patient C/O dizziness approximately 10 minutes in the observation BP at 10:45 122/88, 80 HR, 95.7 temp. 11:05 am BP 120/82, 78 HR, 95.7 temp.

Patient experienced lightheadedness, spots in vision, and shakiness approximately 30 mins after receiving the vaccine. Was monitored for 25 mins with no resolution in symptoms and was sent to the emergency room for additional evaluation.

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.

Patient received vaccine and immediately began to feel sweaty and light-headed. She did not faint or lose consciousness. Patient received an ice pack and some cold water and began to feel better. Her blood pressure was normal and after about 10 minutes she began to feel like herself again. There was no sign of anaphylaxis or further respiratory distress.

INAPPROPRIATE ROUTE OF VACCINE ADMINISTRATION; OFF LABEL USE; SHAKING; BODY ACHES; SERIOUS DIZZINESS; CHILLS; TIREDNESS; HEADACHE; .This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 110 kilograms, and height was 162.56 centimeters. The patient's concurrent conditions included non-alcoholic user, and non-smoker, and other pre-existing medical conditions included the patient had no known drug allergy. the patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intravenous, batch number: UNKNOWN) dose was not reported, administered on 07-MAR-2021 at left arm for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included vitamins nos. On MAR-2021, the subject experienced headache. On 07-MAR-2021, the subject experienced inappropriate route of vaccine administration. On 07-MAR-2021, the subject experienced off label use. On 07-MAR-2021, the subject experienced shaking. On 07-MAR-2021, the subject experienced body aches. On 07-MAR-2021, the subject experienced serious dizziness. On 07-MAR-2021, the subject experienced chills. On 07-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking, body aches, serious dizziness, chills, and tiredness on 14-MAR-2021, and the outcome of headache, inappropriate route of vaccine administration and off label use was not reported. This report was non-serious.; Sender's Comments: V2: Medical assessment comment not required as per the standard operating procedure as the case is assessed as non-serious.

Fatique, Neck tightness, Chills, Fever 102.3, bone pain fingers/hands, shaking legs, unstable walking.

I started experiencing dizziness when my head turned in a specific position. This began about one week after the vaccination. At the next VSAFE check I reported that I was having some dizziness and tiredness. However, I saw a doctor on April 2 and he diagnosed me with Benign Paroxysmal Positional Vertigo and treated me in his office using the Epley Maneuver. The dizziness was cured and I am not experiencing it any longer. I do not believe it was associated with the vaccination but had not seen my doctor when I completed the report on VSAFE.

UNABLE TO USE ARM AS SHE DID IN THE PAST; ACHING RIGHT DELTOID MUSCLE/ACHING ARM AT THE SITE OF THE INJECTION; 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: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, 1 total, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced unable to use arm as she did in the past. On 06-MAR-2021, the subject experienced aching right deltoid muscle/aching arm at the site of the injection. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from aching right deltoid muscle/aching arm at the site of the injection, and unable to use arm as she did in the past. This report was non-serious.

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

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.

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.

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.

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

migraine Headache BP 235/110 was getting dizzy, tongue became numb she went to nurse 911 called. she was uncomfortable taking vaccination, For 30 minutes she was ok- tongue numb lips swollen still has migraine TMJ pains Did not get epinephrine. BP is on the "high normal side" 140/90, did not check pulse Oxygen level No rash

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

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

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

A few hours after receiving the "Janssen COVID-19 Vaccine EUA" I started to experience the following side-effects: headache, fever, muscle aches, tired and weakness. I also felt a little dizzie. I monitored my temperature thoughout the night; I recorded at 7:54pm 99.7; 9:23pm 99.2; 10:45pm 99.8; and at 6:00 am on 4/9 my temperature was back to normal at 97.5. The muscle ache were gone and the headache was mild. I do still feel a little dizzie and weak.

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

8 hrs after vaccine had fever if 104 and pulse of 125. Very weak and dizzy. This continued until the next morning.Took 1300 MG acetaminophen. Had no effect. Used ice bags, had no effect.

A couple minutes after receiving the vaccine, patient started feeling dizzy and described it as her head feeling heavy, and some weakness. She was offered water and was brought in to the clinic for further monitoring. BP- 164/78. PR- 71. Symptoms did not worsen and it improved after 1 hour, but not totally resolved. BP recheck was 143/62. PR- 76. Patient said she felt better and volunteered to go home. Instructed to go to ER if her symptoms persist and worsen; patient verbalized understanding. Discharged to home after an hour of monitoring.

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

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

BAD Dizziness, Rash & Bruising at injection site, (hot to the touch & Burning sensation .) Headache, spots in left eye, I fell due to dizziness ..

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).

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

Very lightheaded while vaccine was injected into my arm. It has never happened with other vaccines. Once needle was pulled out of arm, was not lightheaded anymore. Also muscle in my arm is sore 1 month later and not getting better yet.

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

The day after having been vaccinated with Johnson & Johnson/Janssen COVID19 vaccine (04/11/2021), my mother started to feel intense pain, swelling, tenderness and cramping in her legs, especially her right leg, to the point that she couldn't walk. By the fourth day after the vaccine her right leg was completely swollen, twice as big as its normal size, the pain was unbearable and she experienced fatigue and shortness of breath. I took her to the ER on 04/14/2021

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

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.

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.

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.

Received the vaccine friday then monday has numbness to the tongue , near syncope, dizziness, ems called taken to ER and admitted to hospital for TIA. CT of neck, head, abd done, chest xray, full blood work, echo, results sent to primary care said all test ok

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

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

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

DIZZINESS; HEADACHE; FEVER; TIREDNESS; SHAKING; GENERALISED ACHING; CHILLS; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid 19, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 17:20 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced generalised aching. On 11-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced shaking. On 12-APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced tiredness. On 13-APR-2021, the subject experienced headache. On 14-APR-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 14-APR-2021, and was recovering from generalised aching, chills, fever, shaking, tiredness, and dizziness. This report was non-serious.

PT CALLED C/O NUMBNESS/TINGLING LEFT ARM FROM FINGERS TO SHOULDER 2 DAYS AFTER SHOT; HAD DIZZINESS FOR ABOUT 3 DAYS; FATIGUE; HAS HX OF HEART FLUTTERS BUT GREATLY INCREASED AND CONTINUES NOW; KNOT IN ARM JUST RESOLVED YESTERDAY

My wife has been sick for a few days with a slight fever, chills, weakness and cough. We figured she may have caught the Flu. Today she woke up and had no balance with the other symptoms listed. They went over her symptoms with her and gave her a rapid COVID test , according to their test she was found to be POSITIVE for COVID-19. Just can't understand this as she received her vaccination on the 7th.

FEVER; HEADACHE; NAUSEA; LIVER PAIN; TIPSY; LIGHT HEADEDNESS; COLD CHILLS; LEFT LEG PAIN; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's past medical history included hepatitis c, and concurrent conditions included controlled epileptic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Concomitant medications included silybum marianum for hepatitis c, bifidobacterium bifidum/bifidobacterium lactis/fructooligosaccharides/lactobacillus acidophilus/lactobacillus casei for immune system, and ascorbic acid/ergocalciferol/folic acid/nicotinamide/panthenol/retinol/riboflavin/thiamine hydrochloride for nutritional supplement. On APR-2021, the subject experienced cold chills. On APR-2021, the subject experienced left leg pain. Laboratory data included: Pain scale (NR: not provided) pain score 2 or 3. On 09-APR-2021, the subject experienced liver pain. On 09-APR-2021, the subject experienced tipsy. On 09-APR-2021, the subject experienced light headedness. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the liver pain, left leg pain, light headedness, tipsy, headache, nausea, fever and cold chills was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious

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.

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

After injection I too seat to wait 15-20 minutes. Immediately I started to lose peripheral vision and then my hearing....I called for help. They took me in a room to lay down and said my blood pressure had dropped vary low. After an out of doing better I just needed t get home. So another hour passes and I get home, go directly to bed and what seems like a bad flu begins. That night my temperature continues to climb, the aches and headache are horrible. I continue fevers for 3 nights. Feel a little better and then with 2 days it relapse and all starts again. I am in bed for 1 and 1/2 weeks, then stay home due to continued headache, dizziness. After 3 weeks the dizziness continues and I then start getting an aching pain in the back of my left leg. Seeing my doctor on May 11th and hope to discuss.

My both hips started hurting approximately 24-48 hrs after vaccine. I have had pain , sharp and dull, in both my hips when I walk, and they feel stiff too. I have had to take Motrin ever since. I started taking glucosamine with joint shield ever since with some relief.

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.

DIZZINESS; FEEL LIKE LEGS WERE GOING TO COLLAPSE; This spontaneous report received from a consumer 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 had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and batch number: 205A21A expiry: 23-JUNE-2021) dose was not reported, administered on 04-MAY-2021 12:00 for prophylactic vaccination. No concomitant medications were reported. On 05-MAY-2021, the subject experienced dizziness. On 05-MAY-2021, the subject experienced feel like legs were going to collapse. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feel like legs were going to collapse, and dizziness. This report was non-serious.

Patient felt dizzy and fainting 2-3 minutes after vaccine. Her breathing was normal. Pharmacist gave her 5 ml of benadryl ( 12.5mg/5ml). Patient start responding within 1 min, Mean while pharmacy call 911. Paramedics arrived and check all symptoms ,BP and ECG. BP was little elevated and ECG came normal.

VERY LOW TEMPERATURE; VERY LIGHT-HEADED; LIPS WERE COLD; MUSCLE SORENESS; CHILLS; HEADACHE; BODY ACHES /LITTLE SORE; FEELING WORSE; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 170 pounds, and height was not reported. The patient's concurrent conditions included depression. 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 06-MAY-2021 13:00 for prophylactic vaccination. Concomitant medications included bupropion hydrochloride for depression. On MAY-2021, the subject experienced body aches /little sore. On MAY-2021, the subject experienced feeling worse. On 06-MAY-2021, the subject experienced headache. On 07-MAY-2021, the subject experienced chills. On 07-MAY-2021, the subject experienced muscle soreness. On 08-MAY-2021, the subject experienced very low temperature. On 08-MAY-2021, the subject experienced very light-headed. On 08-MAY-2021, the subject experienced lips were cold. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 94 F. Treatment medications (dates unspecified) included: naproxen sodium, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, chills, muscle soreness, body aches /little sore, lips were cold, very low temperature, very light-headed and feeling worse was not reported. This report was non-serious.

I have MS and I was having some stomach issues and they said it wouldn't be a problem but I ended up in the hospital for 5 days then in rehab. I woke up about 2am after vaccine and when trying to go to bathroom my legs gave out and I hit the floor, we called EMS to get me up and I was really weak. My legs were gone the rest of the night and I couldn't stand my husband had to help me . On the 24th, we called the EMS to take me to the hospital and they sent me to rehab and I got out of there on the 28th to home but I do not have my strength back.

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

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

Old injuries are flaring up again. In 2010, I dropped a 45-pound Olympic weightlifting bar from overhead onto my foot and fractured 3 bones. That was treated and healed (cast and flexible cam walker). In 2013 I had surgery on my left wrist for Derkervains. That healed up just fine also. All of the sudden, both past injuries have flared up again. I had foot pain so bad that I couldn't walk for a day. An Xray shows no damage. Yesterday, my wrist has flared up and is very painful. I have not seen a doctor about that. My foot is improving. I think it will bounce back. I now suspect that my wrist will also improve. My hypothesis is that the vaccine has challenged my immune system enough that old injuries are flaring up and then calming back down again. It's very odd. I don't know if it's significant, but thought I should report it, in case my experience matters.

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.

fever, dizzy, headache, severe pain throughout body for 24 hours, screaming pain could feel vaccine going through entire body tiredness hoarseness, heavy breathing 6 weeks after vaccine

Patient reported full body joint aching stating that she could barely move the night of her vaccination. The aching is slowly resolving.

The patient stated that she felt dizzy and lightheaded. The staff attended to her. They took her vitals. She stated that she felt ok after a few minutes. The patient stayed at the center eating and speaking to the director of the center after her observation time was up.

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

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

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.

Patient reported feeling shakiness and lightheaded after initial vaccine, following 20 minute observation period patient reported feeling more normal, and left. Patient reported this is the first vaccine she has had since childhood.

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

I am 7 years post-menopausal, and 6 weeks after the vaccine I had a week-long, full-fledged menstrual period. Then for the next five or six weeks, I had 4 or 5 hot flashes every day (I never had any in my 7 years of being post-menopausal). I also had a migraine mid morning every day after the menstrual period. They have lessened now (tapered and mostly stopped by end of June 2021). I also have slight balance problems now, that are still ongoing.

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

Fast heartbeat and moderate to severe dizziness began at 3:30 PM on March 6. Fast heartbeat slowed considerably after 10:30 pm. Dizziness is mild to moderate as of 5:00 pm March 7. I am reporting this simply because it said we should make you aware of adverse events with the vaccine.

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.

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

Pt felt lightheaded/dizzy after receiving the vaccine. She stated that she usually felt that way after receiving all kinds of vaccines. She stated that after consuming some sugary drinks, she felt better. She had the symptoms for about 15 minutes

Patient felt light-headed and dizzy 15 minutes after receiving the vaccine. She also felt like her hand was shaking. Her forehead and cheeks appeared to be red and flushed. Her symptoms did not improve, she was evaluated by the ID physician and was transferred to the ER.

At the time of injection I felt a pressure pain radiating diagonally downward toward my armpit. Where she injected me was very high up on my arm almost close to the top. The pain at injection site was quite sore for the first few days and then went away for the most part for a day or two but has now come back much worse. It hurts to lift my arm or move it and feels like I've lost strength to raise my arm. I am in constant pain now and my arm around the injection site is painful when I press down especially on the bony area.

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

Patient came in complaining that she was having weakness and dizziness. She was having trouble standing up from seated position. She was also having trouble walking in a straight line. Her husband was with her and drove her to the ER after leaving the pharmacy.

Patient came in to the pharmacy complaining of dizziness and weakness. She was having trouble standing up from seated position and walking in a straight line. Her husband was going to take her to the emergency room after leaving here. I had her smile and it was even. She said that she was ok the day before, but developed these symptoms 2 days after vaccination.

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.

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

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

Less than two minutes after J & J vaccine I was unconscious and unable to move my entire body. I could not move my eyelids, mouth, arms, legs...entire body . Upon becoming mentally alert it was more than two hours until I could move all of my body. I was taken by ambulance to an emergency room. IV fluids, potassium, and released 3 hours later.

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

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

vaccine received April 1 in left arm. On April 2, after sitting normally while watching TV, I experienced severe pain in my left wrist joint, heaviness, along with limited range of motion due to pain. Massaging relieved some of the pain.

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".

Patient was getting light headed and fainted but did not lose conscienceness. Patient fell at around 2 feet but was conscience, we had patient lay down and called 9-1-1. I called patient afterward to follow up, as she denied going to hospital, she reports being fine, just a little sore on the head. She most likey had her vasosyncopy

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.

DIZZINESS; FACE SWELLED; THROAT CLOSING; CHEST TIGHTNESS; ITCH IN EAR; HEART BEAT RACING; WHEEZING; 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 concurrent conditions included non-smoker, non alcoholic, penicillin allergy, and sulfonamide allergy, and other pre-existing medical conditions included the patient had anaphylaxis with tetanus booster shot 4 years ago. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: unknown) dose was not reported, administered on 31-MAR-2021 at 12:18 p.m. vaccinated on left arm for prophylactic vaccination. Concomitant medications included cetirizine hydrochloride for allergy, and fluticasone propionate for allergy. On 31-MAR-2021, the subject experienced dizziness. On 31-MAR-2021, the subject experienced face swelled. On 31-MAR-2021, the subject experienced throat closing. On 31-MAR-2021, the subject experienced chest tightness. On 31-MAR-2021, the subject experienced itch in ear. On 31-MAR-2021, the subject experienced heart beat racing. On 31-MAR-2021, the subject experienced wheezing. On 31-MAR-2021, the subject experienced weakness. Laboratory data included: Blood pressure (NR: not provided) Unknown. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, face swelled, throat closing, chest tightness, heart beat racing, wheezing, and weakness on 31-MAR-2021, and had not recovered from itch in ear. 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

Janssen COVID-19 Vaccine EUA: 18 hours after getting the vaccine i began to feel dizzy, then got chills and body aches. There was no fever. Very uncomfortable though shivering under blankets in 72 degree weather. I expect the symptoms to lessen, have taken tylenol at 7:30pm and feel a little better now.

Patient received Janssen Covid 19 shot. Waited appropriate 15 minutes, had no reactions, and continued shopping. An hour and a half later, patient returned stating she felt dizzy. She sat at the pharmacy for 15 more minutes with a cold pack. She then felt better and went home.

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.

Patient is found with secondary provider reporting the patient had an episode of syncope and hypotension. Patient reports that she is hot, diaphoreticand dizzy after receiving J&J Vaccine. A 12 lead ECG is completed as noted in chart. Patient's vitals are taken as noted in chart. Patient reports that she is beginning to feel better, patient continues to be monitored by EMS. Patient is found A&O x4, flushed warm and diaphoretic. Patient has no noted neurological deficits, pupils are PERRL. No trauma is noted to patient's face. Airway is patent, respirations are as noted. No JVD is noted, trachea is midline. Patient has equal chest rise/fall, lung sounds are equal bi-laterally. Patient denies chest pain, shortness of breath. Abdomen is soft/non tender. Patient denies abdominal pain, no GI/GU Symptoms are noted. Patient has no deficits noted to extremities, pulses are strong. Patient denies covid 19 concerns, other injuries or illness. 12 lead ECG is taken showing sinus rhythm as noted in chart

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

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

Light-headiness, chest pain on evening of injection, along with high blood pressure (155/88). High blood pressure lasted through the evening of the injection plus 2 days, with readings decreasing each day. This morning (4/11) was my first (almost) normal blood pressure reading.

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

Slight chills and headache on the day following the vaccination. My two adult children were vaccinated at the same time and had hard lumps and more pain at the injection site than I did. My daughter's arm stayed that way for more than a week and then looked bruised. My son has complained of mental fogginess while my daughter and I have suffered frequent light-headedness, chills and fatigue. My lightheadedness seems to be becoming worse by the day.

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

Developed right facial droop in the hospital, lead to a new diagnosis of Bell's Palsy (MRI no evidence for stroke, CT no acute abnormality) She has Johnson and Johnson Vaccine and she is currently hospitalized after a fall at home

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

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

BAD PAIN ON RIGHT SIDE (TOWARDS THE BACK); SWOLLEN NOSTRILS (INSIDE); Shaking; HARD TO WALK; Fever; Nausea; Chills; JOINT PAIN (KNEES, ELBOWS, SHOULDERS, HIPS, FINGERS, ANKLES); HEADACHE THAT FELT LIKE A SLEDGE HAMMER; SORENESS AT INJECTION SITE; EXTREME THIRST; Loss of taste; LOSS OF APPETITE; SWOLLEN HANDS; Runny nose; EYES CRUST AROUND THE EDGES; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 09:00 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced extreme thirst. On 03-APR-2021, the subject experienced loss of taste. On 03-APR-2021, the subject experienced loss of appetite. On 03-APR-2021, the subject experienced swollen hands. On 03-APR-2021, the subject experienced runny nose. On 03-APR-2021, the subject experienced eyes crust around the edges. On 03-APR-2021, the subject experienced joint pain (knees, elbows, shoulders, hips, fingers, ankles). On 03-APR-2021, the subject experienced headache that felt like a sledge hammer. On 03-APR-2021, the subject experienced soreness at injection site. On 03-APR-2021 22:00, the subject experienced shaking. On 03-APR-2021 22:00, the subject experienced hard to walk. On 03-APR-2021 22:00, the subject experienced chills. On 03-APR-2021 22:00, the subject experienced fever. On 03-APR-2021 22:00, the subject experienced nausea. On 05-APR-2021, the subject experienced swollen nostrils (inside). On 05-APR-2021 14:00, the subject experienced bad pain on right side (towards the back). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from runny nose on 05-APR-2021, and bad pain on right side (towards the back) on 05-APR-2021 21:00, was recovering from hard to walk, joint pain (knees, elbows, shoulders, hips, fingers, ankles), and swollen hands, had not recovered from swollen nostrils (inside), and the outcome of shaking, chills, fever, nausea, extreme thirst, loss of taste, loss of appetite, headache that felt like a sledge hammer, soreness at injection site and eyes crust around the edges was not reported. This report was non-serious.

Hello, I received my J&J vaccine on 3/31/2021. 11:00a.m. Here is my results: 3/31/21 Day1: Waited 30 mins at site due to the history of Penicillin and Sulfa issues in the past. I had a little itching at the shot site. That went away in about 15 mins. Late afternoon I had a slight headache. 4/1/21 Day 2: Morning was normal. Afternoon I started feeling a little sluggish. I had a little headache. 4/2/21 Day 3: Morning was slow. I noticed that I was tired. Headache was stronger. I took Ibuprofen 400mg. By mid day, I was on the couch the rest of the day. My body was telling me to rest. So I did.

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

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.

I have had various infections since the vaccine, sinus infection, upper respiratory infection, even a small cut became infected, coughing, severe headache lasting about 8 days, dizziness, fatigue

Patient states that on 4-10-21 she developed a severe pain in her right knee. Patient states that the pain radiates from her thigh to her knee and sometimes down her leg. Feels a tightness in her leg and knee, No noted swelling of discoloration of the area.

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.

RAISED AROUND THE INJECTION; WARM TO TOUCH AROUND THE INJECTION; HURTS TO LIFT LEFT ARM; LEFT ARM SORENESS; REDNESS AT THE INJECTION SITE; 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 hypothyroidism, high cholesterol, outside weeds allergy, eczema, and hives. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 203A21A expiry: 19-JUL-2021) dose was not reported, administered on 08-APR-2021 16:00 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for thrombolytic event. On 28-DEC-2020, Laboratory data included: Coronavirus test (NR: not provided) Positive. On 08-APR-2021, the subject experienced raised around the injection. On 08-APR-2021, the subject experienced warm to touch around the injection. On 08-APR-2021, the subject experienced hurts to lift left arm. On 08-APR-2021, the subject experienced left arm soreness. On 08-APR-2021, the subject experienced redness at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from redness at the injection site, raised around the injection, warm to touch around the injection, left arm soreness, and hurts to lift left arm. This report was non-serious.

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

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

DIZZINESS; VERTIGO; 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: 042az1a, and batch number: 042AZ1A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced dizziness. On 11-APR-2021, the subject experienced vertigo. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, and vertigo. This report was non-serious.

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

1st effect was migraine with left side numbness, woke up at 4 am and was unable to walk correctly. Went to ER 1 and was transferred due to lack of CT Scan, hospital then admitted for stroke. Can also still feel injection site

VERTIGO EXPERIENCED AT DAY 3 AND DAY 4; LIGHTHEADEDNESS; 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 breast cancer, right knee replacement, and skin cancers, and concurrent conditions included lymphedema, type 2 diabetes mellitus, asthma, worse pollen allergy, severe allergies, meniere's disease, mold mildew allergy, naproxen dust allergy, non alcoholic, non smoker, and migraine, and other pre-existing medical conditions included the patient had no history of drug abuse/ illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808982, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Concomitant medications included fremanezumab for migraine. On 06-APR-2021, the subject experienced lightheadedness. On 10-APR-2021 02:30, the subject experienced vertigo experienced at day 3 and day 4. Treatment medications (dates unspecified) included: dimenhydrinate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lightheadedness on 06-APR-2021, and was recovering from vertigo experienced at day 3 and day 4. 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.

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

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.

UNABLE TO WALK; GENERALISED PAIN; VASCULITIS; 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: UNKNOWN) dose was not reported, administered on 13-MAR-2021on right deltoid arm for prophylactic vaccination . The batch was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced vasculitis. Laboratory data included: Pain scale (NR: not provided) 2/10. On 13-MAR-2021, the subject experienced generalised pain. Treatment medications included: paracetamol. On 19-MAR-2021, the subject experienced unable to walk. Laboratory data included: Pain scale (NR: not provided) 10/10. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from unable to walk on 24-MAR-2021, and generalised pain on 13-MAR-2021, and the outcome of vasculitis was not reported. This report was non-serious.; Sender's Comments: Report not required as per standard procedure as case was assessed as non-serious.

Throbbing pain at injection site and entire arm. Unable to move up without assistance. Pain grew more and more intense. Went to urgent care on unspecified date. NP examined me and discovered a lump in my arm. Both the lump and the vaccination site hurt when she pressed on them. She prescribed presdone and gave me a work order for a vascular ultrasound to be performed on my left arm. I went on unspecified date for the scan. It was discovered that a DVT blood clot had formed in my brachial vein in the left arm. I was then prescribed eliquis, 20 mg a day for 7 days and told not to take the predesone. NP called my pcp, his office immediately called me and asked me to come in as they are concerned about the high dosage of the eliquis.

Nervous system impairment severe dizziness syncope no balance 12 days as impatient, received solumedrol antivert and 5 doses of IVIG

DIFFICULTY BREATHING; DIZZINESS; SEVERE HEADACHES; This spontaneous report received from a consumer concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included enlarged heart, and poor lung function. 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 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 difficulty breathing. On APR-2021, the subject experienced dizziness. On APR-2021, the subject experienced severe headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe headaches, dizziness and difficulty breathing was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure since case is assessed as non-serious.

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

ACHES; FLU-LIKE SYMPTOMS; HARD TO WALK; This spontaneous report received from a consumer 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: 205A21A expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 10:15 for prophylactic vaccination. No concomitant medications were reported. On 03-MAY-2021, the subject experienced aches. On 03-MAY-2021, the subject experienced flu-like symptoms. On 03-MAY-2021, the subject experienced hard to walk. Laboratory data included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from aches, flu-like symptoms, and hard to walk. This report was non-serious.

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.

Patient was vaccinated on 4/10/2021, with the Johnson & Johnson (Janssen) Covid-19 Vaccine. On 4/14/2021, patient had a stoke and collapsed, falling on her head & face at approiximately 3pm. No signs/symptoms prior to stroke & collapsing. Patient became hospitalized with internal bleeding in her brain and is still unresponsive. ‘Unresponsive' in this case is defined as but not limited to: unable to be mobile / stationary in a reclined bed postion since the incident / no movement of upper & lower extremities / minimal reactionary response in eyes / unable to ingest food by mouth

SHORTNESS OF BREATH (WORSE UPON EXERTION); ELEVATED HEART RATE; DIZZINESS; CHEST PAIN; WEAKNESS; FEVER; MUSCLE ACHES; HEADACHE; FATIGUE; 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 penicillin allergy, allergy to plavix, and compazine allergy. The patient was previously treated with for drug used for unknown indication; and experienced drug allergy when treated with amlodipine 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: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAY-2021, the subject experienced shortness of breath (worse upon exertion). On 13-MAY-2021, the subject experienced elevated heart rate. On 13-MAY-2021, the subject experienced dizziness. On 13-MAY-2021, the subject experienced chest pain. On 13-MAY-2021, the subject experienced weakness. On 13-MAY-2021, the subject experienced fever. On 13-MAY-2021, the subject experienced muscle aches. On 13-MAY-2021, the subject experienced headache. On 13-MAY-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, muscle aches, and headache, and had not recovered from shortness of breath (worse upon exertion), elevated heart rate, dizziness, weakness, fatigue, and chest pain. This report was non-serious.

I experienced usual side effects, fever and chills but the entire reason is that I have swelling and edema in both feet and ankles enough so to concern doctors. I went to clinic on 03-26-2021 for evaluation. They put me on 3 day steroids. I went back to First med which they put me on a 6 day course of medication of steroids. I then went to my podiatrist, of my right ankle, I was scanned for blood clots but no blood clots were found. My exams only identify swelling and edema. I can only take NSAID'S. I have to get up wait a few hours to move. My ankle swelling and edema nerve decreases and my feet hurt so bad when I apply pressure. I had an MRI done as well and I am very upset that they cant find why I can not walk without pain and swelling. My doctors at this point do not what to do for me and I would like some answers. To this day, I am still having swelling and edema to both of my feet and ankles.

Less than 15 minutes after vaccine I experienced frontal sensations in my brain. I also felt very dizzy and have ringing in left ear. A day after I experienced a dull headache for almost a month.

The injection did hurt quite a bit more than other injections I have had in the past but it began to feel better and I sat in a chair and was on my phone to send a message, spoke to a stranger who was looking for where to go, and was ok until the feeling of fainting began 10 minutes after the shot. I put my head between my knees but it did not help so I called for help and eventually was helped onto the floor to lie down which began to help. I had vision trouble and hearing trouble and could not speak. I was told my neck became bright red as my face grew white and my hands twitched and my eyes rolled around. I found out later that I had also peed my pants. I have fainted only once before in 1989, and found this reaction pretty frightening although I do not believe it happened as a result of anxiety or fear, the adverse effect itself was frightening and unexpected- not listed on any paperwork I received and was not aware it could occur.

Severe leg swelling a couple of days after the Janssen vaccine. Can not walk very well now and does not drive so no access to a doctor or clinic. The vaccine was administered at her house by the fire department.

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.

As the lady jabbed me and started putting the vaccine in my arm, it started burning. It hurt so bad that I wanted to scream. I felt lightheaded and needed to sit for awhile after the shot. The next night I started getting pain in my right arm and I couldn't move it. My nerve endings in my arm, shoulder, and clavicle felt like they were on fire. The lymph nodes under my right arm and neck were swollen. I had three swollen lymph nodes in my neck, but one went down, and I still have two swollen nodes in my neck. My quality of life has suffered because the pain in my arm is so bad.

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

I had COVID like symptoms again. After that I was doing good for about two weeks, but I still had a stiff neck. I have had a stiff neck for about 6 weeks now. I have had steroid medication provide for me and I felt better this lasted for about two weeks. After this I have went back to the hospital because I have not been able to stand, or barely make a fist.

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

LOUD TINNITUS IN BOTH EARS; LIGHTHEADEDNESS; 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 tinnitus episodes, and concurrent conditions included penicillin allergy, and hear aid user. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 2051A211A expiry: UNKNOWN) dose was not reported, administered on 05-JUN-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On 05-JUN-2021, the subject experienced loud tinnitus in both ears. On 05-JUN-2021, the subject experienced lightheadedness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from loud tinnitus in both ears, and lightheadedness. This report was non-serious.

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.

Vaccine administered @ approximately 1613 and @ 1615 patient began complaining of dizziness. Documenter presented to patient for evaluation and treatment. Upon meeting the patient, patient was awake, alert and oriented x4 in no acute distress, breathing equal and non labored, color appropriate for ethnicity. Pt denied shortness of breath, chest pain, palpitations, tachycardia, rash, swelling, difficulty swallowing, drooling, itchy throat, nausea, diarrhea, abdominal pain, and other signs of anaphylaxis. Pt given Gatorade and salty snack. EMS arrived and began patient assessment; vital signs and blood glucose assessed. After 15 minutes patient reported feeling better, patient asked to wait another 15 minutes to ensure complete resolution of symptoms and/or need to advance care and send to emergency department. After completing a 30 minute wait, patient reports she was better and had a complete resolution of symptoms and felt safe to drive. Patient remained awake, alert and oriented x4. Pt self-transported home.

pt says she started having pain all over her body. The pain from her knees down to her feet was horrible. The left arm hurts and has tingling numb feeling in the hand. She gets episodes of being light headed and SOB. She gets sharp pains in her head like something is pinching her on the inside of the brain and is a very strange feeling. She went to see her PCP about 10 days after taking vaccine and was referred to a Neurologist Dr. She was told it looked like nerve inflammation and was prescribed Neurontin. The medicine helps but has side effects and makes her feel bad. She has a FU appt next week.

Pain and have limited range of motion in left arm shoulder. Findings supraspinatus and infraspinatus tendinosis and sub deltoid burial fluid.

patient reported she was fatigued after receiving the vaccine. She then began to have joint pain and she reports she was barely able to walk. She has an appt. with her MD Wednesday (joint specialist). She has been taking Advil 325mg PRN.

Patient complained of burning sensation immediately after receiving vaccine and progressively worsening arm pain over the course of a few day after vaccine administration. Patient states arm pain did not resolve and was seen at provider's office 6/17/21 stating she has decreased range of motion to left arm and continues with left deltoid pain. X-ray of left shoulder and humerus were ordered along with physical therapy.

PATIENT BECAME VERY LIGHTHEADED MOMENTS AFTER GETTING VACCINATED. SHE HAD A HARD FALL OUT OF A CHAIR IN THE WAITING AREA. SHE WAS OFFERED COLD WATER AND COLD COMPRESS FOR NECK AND FORHEAD IN WHICH SHE DENIED THE COLD COMPRESS. SHE ALSO DENIED LAYING FLAT ON BACK ON A BENCH IN THE WAITING AREA AS WELL. I ALSO CHECKED BLOOD PRESSURE AND PULSE VALUES WHICH WERE LOW. SHE SAT IN THE WAITING AREA FOR APPROX 45 MINS. A STORE MANAGER WAS CALLED PER PROTOCOL AS WELL

About 5 days after the shot, I was still having a lot of fatigue, but I developed severe headaches, like someone was sticking a knife in my head, and I was having bouts of light headedness. I am a person who never has headaches. Because the issue of the blood clots came about with the J&J, I ended up, because of the severe headeaches had to have a brain MRI to rule out the blood clots. I did not have any. But the headaches were very much a problem and the light headedness. I had to leave area for the summer, and now came to another area. I still was not feeling right. The bad headaches subsided, but I was till getting the lightheadedness with a slight headache after almost every day. II also had a full blood panel done on April 8. It is showing my thyroid is low and now have to be on Thyroid medication. I just had full blood work done in March, and all my blood work was normal. I also have noticed that my arthritis in my hands is exacerbated. And sometimes my feet go numb when I am riding my horse. And in the morning, my arms and legs ache. My BP was a little elevated as well. I never have had high blood pressure. I am 63 years old and have always had great health. Since I had the covid shot, I have had nothing but problems. If I had to do it over again, I WOULD NOT have gotten the shot. I only got it because my daughter was having a baby and insisted even though I had the virus back in October.

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.

Numbness , Tingling in my feet, severe leg cramps and now i can't walk came to the ER on June 22 2021 still here in rehab July 13th 2021

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.

Symptoms from improperly administered vaccinations - known as SIRVA, for "shoulder injury related to vaccine administration'' - include chronic pain, limited range of motion, nerve damage, frozen shoulder (the inability to move the shoulder) . I received a COVID-19 vaccination (2nd dose as part of the Janssen study ).. When the nurse injected the needle into my arm it HURT. I started to leap off the table but she told be to stop and 2 nurses stepped forward to steady me. I told her it hurt extremely bad but she didn't withdraw the needle. Another nurse handed me a tissue to wipe the tears from my eyes. The injection hurt, more so than the usual injection. In the days that followed, the pain in my right shoulder worsened. Initially, I dismissed it as typical post-shot soreness. But it didn?t go away. Months later, it still hurts. The sports medicine doctor says I have excess fluid buildup in the bursa. He withdrew the fluid. I'm still going for physical therapy 3 times a week to get back range of motion and strength in my arm. I?m convinced this occurred because the nurse injected the vaccine too high on my arm. I had no symptoms before the shot, and pain has persisted since.

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.

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

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

at injection, arm was not opperable, too weak to pick up coat or purse. After about 15 minutes the full use of arm was back. The muscle is still affected and strained after 6 days. I waited a half hour at the site and got into my car at 3:45. On the drive home within 30 minutes my face started to itch and turn red, then my mouth inside started to itch, then my eyes started to itch. After that my throat started to feel gravely, so I took 75 mgs of gel cap benedryl. This is what I feel and take upon getting stung by a bee. I also took my albuterol inhaller two puffs which I also always have on me because of my asthma. I was sleepy but had dinner and went to be. I did not feel that I had to take more benedryl during the night.

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

I experienced fever, chills, tiredness, and headache approximately five hours after administration of the vaccine on 3-10-21. Symptoms became severe within 30 minutes thereafter, at which time I experienced difficulty standing. After five hours with no improvement, I used my home blood pressure monitor to check my BP and HR; BP was high for me, 120/90 sustained, and HR varied between 135 and 150, with 143 being the most consistent value after multiple readings. I seemed to be experiencing a "severe allergic reaction" per the instructions I was given and called 9-1-1. I was transported to Hospital, treated in ER, and then admitted to the intermediate care unit. I was discharged to home on 3-12-21.

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

At 1003, RRT was activated at the end of client?s post-vaccine 15-minute monitoring period. 64 y/o F complaining of head ?heaviness? in the back of her head, dizziness, and mouth dryness. Head-to-toe assessment completed and WNL. BP: 118/60, HR: 68, breathing even and unlabored on RA. Client in no acute distress. Throughout response time, client?s condition improved. Recommendation to client to be monitored for an extra 15 minutes by post-vaccination nurses. At 1030, client felt much better and left facility ambulatory, in not acute distress, breathing even and unlabored.

Limited range of motion in left arm. Extreme pain with some movements. Started physical therapy 3/25/21

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.

Immediately after the shot, I felt dizzy and started to sweat throughout my body including my hands. I waited more than 40 minutes to see if improved but it was exactly the same. Didn't get better or worse. I did not report it immediately because it was not alarming and I did not feel bad. It was just my head that was spinning a little bit and sweating. After waiting more than 45 minutes I decided to drive home because the dizziness was not that strong. I would say it was like a 45% dizzyness if I have to calculate how I felt. The sweating passed after 4 hours and at soon as I arrived home I went to bed and relax. It is now 6:08 pm and the dizziness has improved considerably. I would calculate now about 10% of that vertigo feeling. It is getting better and better. I just wanted to point out that in no time I was feeling bad. Everything was just in my hearing labyrinth internal with balance. I also felt 20 minutes of echoing in my ears about 2 hours ago.

Patient reported feeling dizzy Patient provided with water and seen by medical team Patient refused medical transport and signed AMA form Patient stated her symptoms resolved

Patient reported feeling dizzy and provided with water Patient seen by medical team, refused medical transport. And signed AMA form Patient stated symptoms resolved

Experienced light-headedness, heart palpitations March 31st, 6 days post receiving the Covid 19 (Janssen) vaccine. Pulse rate in the 170 range for around 3 hours. Blood pressure elevated with the systolic in the 150's to to 170 range. Tachycardia noted during Emergency room stay. Labs taken as well as EKG.. All within normal range. Felt some mild tremors to head all the way down to my left foot. This was intermittent and lasted around 20 minutes. Had cardiac monitor applied for 24 hours and saw Cardiologist on April 8th. EKG at this time was within normal range and vital signs all within normal limits. No other symptoms noted since the one and only event on March 31st.

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????

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 received J&J COVID Vaccine 4/12/21 around 12:05 pm. Patient waited in waiting area and complained to her husband about feeling dizzy and might faint. Pharmacists went to aid the patient and lay her down gently, monitored her blood pressure which was high at the time, once patient sat up her BP decreased, it fluctuated the whole time, EMT was called and once they arrived and monitored her, they said the cause of her fainting was due to her blood pressure. Patient was alert and responsive the whole time. Patient was unsure if she took her BP medicine this morning.

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.

Vax received Saturday. Entire leg very sore on Sunday. Monday morning woke early with pain in the knee that was replaced. I was unable to straighten leg when lying in bed. I managed to stand up and walk it off, but with pain as severe as in January when knee was replaced. Leg continued to be sore, then Monday night I didn't have the same issue w/bending, but I did wake early with horrible stabbing pains in knee. I treated with Tylenol, Alprozalan & Ice.

2 weeks post inoculation developed burning sensation/tingling /pain from armpit to thumb; some tingling in thumb - sensation more like nerve pain vs muscle pain. After two days gradually improved. Muscle strength not affected, but movement in most directions elicited sharp pain coursing down arm. Gradually improving to pain over the deltoid near injection site; as of 19 days since initial pain motility much improved but still periodically throbs and sensitive to pressure and certain movements. No treatment except restricting use of arm and time. 10 hrs post inoculation developed chills, myalgia and headache. Chills and myalgia resolved in a few hours; an aspirin the next day resolved the headache. This reaction was not unexpected. Did not have pain at injection site until 2 weeks post injection.

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.

DIZZINESS; 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 penicillin allergy, and other pre-existing medical conditions included patient had on beta blocker. The patient experienced drug allergy when treated with acetylsalicylic acid. 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 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-APR-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness. This report was non-serious.

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

4/8/21: "Six and a half hours after my J&J vaccine I had started shaking with severe chills. By 8 hours after my vaccine I had impaired coordination, extreme fatigue, and it was laborious to walk. Muscle aches and a blinding headache overnight added to my misery. This morning the headache was painful not blinding and the muscle aches not as intense. Had to return to bed right after eating soup, due to weakness. Chills abated by this morning. Speech slowed this morning while talking on the phone. Have spent the day in bed resting" 4/9/21: "Voice was back to normal by 8:30 pm last night. Slept well overnight - no chills or headache. Feeling stronger this morning - no headache!!! Arm still aches, but that is nothing c

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

I was standing in the hallway at the copy machine at work, talking to someone else making copies and waiting for his job to finish. I became so dizzy that I put my hand out to brace myself against the wall. The dizziness passed quickly and has not returned. But at that moment it was so bad I thought I would faint. But I didn?t.

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.

3/30/2021: lost consciousness for hours at a time for 36 hours extreme pain in lower back and side 4/10/2021 extreme pain in lower back, down left leg, shin, top of left foot. Could not stand or walk or lift anything without enormous difficulty. Restricted movement. Pain in all joints throughout body. Ongoing.

Patient was vaccinated on 4/6/2021 and reports that on 4/16/2021, she started to experience joint pains and muscle pain in her arms and legs, feeling fatigued and could barely stand. She reported these on 4/19/21. I advised her to contact her PCP to get evaluated for the signs/symptoms that she is experiencing to rule out anything severe. She did not seem to understand and asked to speak with the manufacturer. She said that she would contact the manufacturer and walked away. When I attempted to contact her again today on 4/20/21, the phone number she provided to us has been disconnected and we have no means of reaching her at this point in time. I am hoping she heeded my advice and contacted her PCP to get evaluated.

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.

LIGHT HEADEDNESS; SWELLING IN FACE; SWELLING IN THE THROAT AREA; THYROID PROBLEMS; BALANCE PROBLEMS; BODY ACHES; CHILLS; 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 colon cancer, sinus problems, neck injury, jaw virus, and hashimoto disease and concurrent conditions included allergy to hay fever, allergy to cleaners, allergy to rubber gloves, steroids allergy, and allergy to some chemotherapy medications, 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: 202A21A 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 fever. On an unspecified date, the subject experienced light headedness, swelling in face, swelling in the throat area, thyroid problems, balance problems, body aches, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the thyroid problems, light headedness, swelling in face, fever, chills, balance problems, body aches and swelling in the throat area was not reported. This report was non-serious.

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

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

Patient was driving on 3/24 when her vision became blurry in her left eye. She saw her eye doctor on 4/21 and was sent to a specialist. On 4/23 she was diagnosed with a blood clot in her left eye. She is to begin eye injections for treatment.

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

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

DIZZINESS WHEN SUPINE; KNEE PAIN; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's past medical history included left knee surgery - complete knee replacement, and concurrent conditions included penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On OCT-2020, Laboratory data included: CAT scan (NR: not provided) unknown. On 12-APR-2021, the subject experienced knee pain. On 19-APR-2021, the subject experienced dizziness when supine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from knee pain on 28-APR-2021, and had not recovered from dizziness when supine. 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.

DIZZY; TIRED; PRODUCT STORED AT INAPPROPRIATE STORAGE CONDITION; 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 past medical history included covid-19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 27-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-APR-2021, the subject experienced dizzy. On 27-APR-2021, the subject experienced tired. On 27-APR-2021, the subject experienced product stored at inappropriate storage condition. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy on 27-APR-2021, and tired on 28-APR-2021, and the outcome of product stored at inappropriate storage condition was not reported. This report was non-serious.

Taken to directly to the ER from the site SOB Headache Chills Chest pain Dry hives Faintness Aching legs Heavy feeling in chest Vertigo following day Increase HR-as though heart was pounding in my chest

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.

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

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

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.

LIGHT HEADED; FELT COLD; 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 full hysterectomy, and concurrent conditions included no alcohol use, and cigarette smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 19-MAY-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 19-MAY-2021, the subject experienced light headed. On 19-MAY-2021, the subject experienced felt cold. On 19-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.1 F, 100.9 F, 101.5 F. The action taken with covid-19 vaccine was not applicable. The patient was recovering from fever, light headed, and felt cold. This report was non-serious.

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.

Complaint of cramping in legs on April 26. 2021. Resolved for a short period of time. Earlier in May 2021 Complaint of Left Flank pain with Radiating pain to Left Thigh. Appointment with Orthopod cancelled due to inability to drive with pain. On May 15, 2021 complaint of continued Left Flank Pain Radiating to to Left thigh with burning and discoloration. Unresponsive on May 16, 2021. Pronounced Dead at 1:52pm by County Coroner. Cause of death noted as CV. Nature of death :Natural This is being reported in case another patient complains of these same symptoms. There may or may not be a Correlation with this Death and The Jassen Covid-19 Vaccine

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

I had symptoms of fatigue for a week. My arm hurt a lot where the injection was. I was given an anti-inflammatory medication 10mg for fourteen days. My arm and shoulder are still sore and its hard to cross over. I have limited range of motion. I had double hip replacement ten years ago but after getting the vaccine, pain started to arise in that area where I had the surgery. I have to go to physical therapy now because of this.

SWOLLEN LYMPH NODES IN THE BACK OF NECK; STIFF KNEES; JOINT PAIN/KNEE WAS SORE; This spontaneous report received from a patient via (other manufacturer- Abbvie ) concerned a 64 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose was not reported, 1 time every 1 week, therapy dates were not reported for moderate to severe chronic plaque psoriasis, and moderate to severe rheumatoid arthritis. Concomitant medications included methotrexate for drug used for unknown indication. On 2021, the subject experienced stiff knees. On 2021, the subject experienced joint pain/knee was sore. On 16-MAR-2021, the subject experienced swollen lymph nodes in the back of neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen lymph nodes in the back of neck on 2021, was recovering from joint pain/knee was sore, and the outcome of stiff knees was not reported. This report was non-serious.

35 minutes after injection experienced dizziness, shortness of breath, tingling of lips, tongue, fingers and toes. Went to nearest Emergency room, 8 minutes away. Treated with IV Solumedrol, Benedryl, and Pepsid. Stabilized and discharged after 2 hours. Minor symptoms for 2-3 more days. Back to normal now.

COUGHING ALL DAY WITH DRY COUGH; FEELING DIZZY; FATIGUE; FEVER; NAUSEAOUS; SHARP PAIN IN THE UPPER RIGHT SHOULDER NEAR INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and gall bladder taken out, and concurrent conditions included long covid hauler.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-JUN-2021, the subject experienced sharp pain in the upper right shoulder near injection site pain. On 03-JUN-2021, the subject experienced coughing all day with dry cough. On 03-JUN-2021, the subject experienced feeling dizzy. On 03-JUN-2021, the subject experienced fatigue. On 03-JUN-2021, the subject experienced fever. On 03-JUN-2021, the subject experienced nauseaous. Laboratory data included: Body temperature (NR: not provided) 101 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, was recovering from coughing all day with dry cough, and had not recovered from fatigue, nauseaous, feeling dizzy, and sharp pain in the upper right shoulder near injection site pain. This report was non-serious.

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

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.

Patient had complaints of dizziness and swollen throat. Patient stated that after she received the flu vaccine she passed out and has passed out before after the administration of previous vaccinations. BP: 110/76, HR: 87, O2: 95%, temp: 97.9 The healthcare team remained with the patient during this time. Patient remained alert and oriented with no breathing or swallowing difficulties. After 10 minutes the patient stated that the swelling feeling of her throat resolved. Vital signs taken again, BP: 110/80, HR: 80, O2: 95%, Temp: 97.9 Patient asked if she could stand up, no dizziness per patient. She remained with us an additional 15 minutes and then was walked to her vehicle in which she performed with no difficultly.

On the same day I got the vaccine and the next day, I had fever, body aches, and malaise; I was in bed for 2 days. I had a lack of energy that was worse than it had been before the vaccine. On or about 4/14/2021, I woke up at about 2:00AM with chest pain, pain in the left shoulder and in the left side of the neck. The symptoms subsided after some time. I had low oxygen saturation levels; I knew this, because I used a pulse oximeter that had been used by my late husband. The low oxygen saturation levels have been ongoing ever since, and I have had periods of rapid heart rate and oxygen levels that are even lower than the low levels I have experienced since the vaccine. I have also had periods of chest pains at times, so my PCP referred me to both a pulmonologist and a cardiologist.

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.

Janssen COVID-19 Vaccine EUA Per POD First Aid provider syncope episode, complaint of tingling to lips and difficulty breathing, patient experienced a syncopedic reaction when returning from bathroom, was unconscious for 1 minute, complained of dizziness, odd taste in her mouth and difficulty breathing. 12:15 PM B/P 150/82 Pulse 68 Respirations 16 Pulse ox 98% 12:20 PM B/P 122/72 Pulse 64 Pulse ox 100% Benadryl administered @ 12:20 PM, patient transported to A Medical Center for evaluation.

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.

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.

Patient received Janseen COVID vaccine. The first 1/2 of the vaccine was given easily IM to the left deltoid and then the patient complained of severe arm pain, tensed her muscles, and the last 0.25ml was difficult to inject. Then the patient became hypotensive 90/45, dizzy, and felt like she was going to pass out. She was laid in the supine position, given a cool cloth for her forehead and monitored for approx. 45 minutes. Her blood pressure remained 90/60, 96/56 at discharge. Her heart rate ranged from 55-65, regular. Her son came to take her home as we did not feel comfortable with the patient driving. The patient was continuously monitored by the NPs and APCT. She ambulated without difficulty and was discharged home. She was given information for V-safe to report her reaction and advised to follow up in the ER for any SOB, difficulty breathing, difficulty swallowing, syncope, CP, etc.

Shot at 2:00 pm. Chills at 7:00 pm. Violent shaking from the chills that hurt my back & chest. Headache sore throat, dizzy

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

Pt got very diaphoretic and felt lightheaded. BP 173/84 with HR of 55 and O2sats 96%. Pt observed by RN until returned to baseline.

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

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.

3-13 developed dizzyness with room spinning, cleared after 1 hour of additional sleep. 3-14 repeat of dizzyness with room spinning, did not clear. Diastolic B/P elevated from 87 to 107 mmHg; Systolic from 143 to 166 mmHg; Tilt Test Positive. Symptoms onset around 0715 hrs and lasted until 1600 hrs when EMS called and taken to Hospital

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

Woke up during the night ( 2 am) and was unable to stand due to dizziness. Had to crawl to the bathroom; then realized I had lost bladder control when trying to stand up while I was still in the bedroom. No previous history of urinary incontinence. I also experienced significant chills prior to going to bed; about 10 pm but I don't consider it an adverse reaction.

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

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.

Within minutes of the vaccine shot, began to sweat and was dizzy. Immediate attention by health care professionals at site. Blood pressure dropped severely. Laid on cot to recover. Left after approximately 50 minutes. Driving home, some tongue swelling, went directly to Hospital ER, where they proscribed fluids, Benedryl and observation. Arrived home around 2:30. 24 hours later, still having dizziness and some tongue swelling, headache and weakness.

Within minutes of getting the injection, became faint with a severe drop in blood pressure. Under observation at the site by Health professionals for 50 minutes. On leaving the facility, on the 15 minute drive home, had some tongue swelling and other indications of anaphlyaxsis, so drove directly Hospital ER. They suggested fluids and prescribed Benedryl and waiting nearby. When symptoms did not worsen, left and arrived at home around 2 p.m. Now 24 hours later, still some swelling of tongue and tinnitus, along with site soreness and dizziness.

BLOOD PRESSURE SLIGHTLY HIGHER THAN NORMAL; DIZZY AND LIGHT HEADEDNESS; SWOLLEN ARM; REDNESS; 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: 1805031 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 at 12:20 to right arm for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced dizzy and light headedness. On 31-MAR-2021, the subject experienced swollen arm. On 31-MAR-2021, the subject experienced redness. On 02-APR-2021, the subject experienced blood pressure slightly higher than normal. Laboratory data included: Blood pressure (NR: not provided) 157/72. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swollen arm, and redness, and had not recovered from dizzy and light headedness, and blood pressure slightly higher than normal. 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.

Fever 101.3 chills, splitting headache, wekness, sore throat, dizziness, slight swelling of throat and tongue. Took two benadryls and four ibuprofens.

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

TERRIBLE HEADACHE; DIZZINESS AND LIGHTHEADEDNESS; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's past medical history included colonoscopy, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 to left arm for prophylactic vaccination. Concomitant medications included apixaban for blood thinner. On OCT-2020, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 2021, the subject experienced dizziness and lightheadedness. On MAR-2021, the subject experienced terrible headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness and lightheadedness, and terrible headache on 2021. This report was non-serious.

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

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

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

On 4/10/21 to Urgent Care. Found blood clots in my lungs and Pneumonia, Clots removed at Hospital on 4/11/21. Hospitalized until 4/13/21. Treatment - blood thinners (enoxaparin, heprin and steroids), azithromycin, Advair disk, albuterol, Spiriva, Symbicort Outcome: Still trouble breathing, slow moving and sore from the incesion.

3/28/2021 at 6:00 a.m. patient reported chest pain to a family member. He arrived at her home at 6:15 and found her slumped to the right in her chair, unresponsive. Patient was taken to our facility via EMS. On arrival, patient could open her eyes but could not talk or move her extremities. She was treated with alteplase 100 mg and flown to a trauma center. She was released on 4/2 and is currently receiving rehabilitation services in our facility; she is expected to return home in 4-5 days.

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

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

Janssen Covid-19 Vaccine EUA. Left arm muscle continues to be sore- not able to use arm for functionality- It has continued to be very sore- when I use the arm - it gets worse. I rely on ibuprofen but still pain is there.

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.

On March 20, I started with flu symtoms: sneezing, running nose, headache , pain in my body this was the first day. I stayed on bed,. The second day I had headache, and my body felt Ok. but no my head so I stay on bed. The third day I felt Ok. but since ever when I get up in the morning I felt dizziness, I would like to know if this is normal and for how long is going to be. 40% of the day I am with headache not so strong.

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

4 days after vaccine couldn't grasp with hands, numbness, tingle throughout arms and hands, loss of balance, now uses a walker, can not sit up alone. Had to have emergency surgery ACDF of C4/5 and C5/6

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.

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.

Very dizzy so I sat down and have felt totally off balance ever since. The room does not spin and I am not nauseous but I am very unsteady on my feet. Then there are times when I feel fine. But off balance on a daily basis.

Extreme dizziness- ongoing since injection. Weakness, fatigue, blood results show increase in calcium levels and albumin levels. Urgent Referral to ENT in process.

Heart palpitations, could not stand taken by ambulance to ER; discharged home after 3 hours with prescription for metoprolol, advised to see PCP. Patient went to PCP who referred to cardiologist, scheduled for halter monitor on 05/17/2021, stress test and echocardiogram on 05/24/2021.

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.

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

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

She started itching, got hot, said her tongue felt funny. I sat with her asked her if was ok breAThing short of breath, she said no. I ASKED IF SHE WANTED A BENADRYL AND SHE SAID NO. MY TECH WAS AN EMT AND CAME OUT WHILE I WENT TO GET BLOOD PRESSURE CUFF, WE WATCHED HER AND SHE STARTED GETTING ITCHIER BUT BLOOD PRESSURE WAS FINE. WE CALLED EMS . SHE WAS RESPONSIVE, DIZZY, AND ALERT WHEN SHE LEFT WITH EMS.

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

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

SUBACUTE PULMONARY EMBOLISM IN LEFT AND RIGHT LUNG; DVT IN LEFT CALF; UNABLE TO DRIVE; EXTREME EXHAUSTION; HEADACHE; SHARP SHOOTING PAIN IN RIGHT LEG; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known previous medical conditions and had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: 21-JUN-2021) dose was not reported, once total administered on 06-APR-2021 15:00 in Left Arm for prophylactic vaccination. Concomitant medications included amlodipine, hydrochlorothiazide and losartan for which indication was not provided. On 06-APR-2021, the patient experienced headache while driving back to home and was not sure if it was due to vaccine or traffic conditions. At 18:30, patient got up to walk across the room and felt a strong sharp pain in her right and left leg described as incredible cramping type of pain which her husband had to help sit down to a chair. Patient states that although the pain was in both legs, the left leg felt as though someone had took a knife to her thigh, the pain lasted approximately 15 minutes. On 07-Apr-2021, patient states that she went for a routine doctors visit to her family care physician who wrote her a prescription for routine blood work. On 14-Apr-2021, patient went to get the blood work done and states at this time, she felt extremely exhausted and that due to a bloodwork mix up which required her to drive back to the lab, she was not able to drive back so her husband had to drive her. Around 17-Apr-2021 to 18-Apr-2021 patient had to chase the dog and found that she couldn't catch her breath and that she started coughing. Her daughter who happened to be there asked her why she was coughing and thought that it was not normal and that she should contact her doctor.On 19-Apr-2021, patient called the doctor. On 21-Apr-2021 patient saw the doctor and during examination, patient was instructed to run a D-Dimer test to rule out blood clots. On 22-Apr-2021, doctor stated patient to go to the Emergency Room as the result for the D-Dimer test came positive. The patient was immediately hospitalized where Doppler and CT scan was performed on her and was diagnosed with Deep Vein Thrombosis and Pulmonary Embolism on both the lungs. Patient mentioned that she was treated with Heparin drip from 22-Apr-2021 to 24-Apr-2021 and then she was given Xarelto. On 25-Apr-2021, the patient was discharged from the hospital after 4 days of hospitalization. Patient reports that she was still experiencing extreme exhaustion and that the pulmonologist states that this is the normal course of blood clots and it could take anywhere from 60-90 days for the body to clear up the blood clots. She states she still has bouts of shortness of breath but showing signs of improvement. Patient stated that she was scheduled for another Doppler on 19-Jun-2021 which was recommended by her primary care physician. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sharp shooting pain in right leg on 06-APR-2021 ,had not recovered from extreme exhaustion, and the outcome of pulmonary embolism in left and right lung, dvt in left calf, headache and unable to drive was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210550248-COVID-19 VACCINE AD26.COV2.S, The case concerns with a Caucasian female. Subacute pulmonary embolism in left and right lung, deep vein thrombosis in left calf. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

Upon receiving the vaccine I felt light headed immediately. I was observed for 30 minutes, I was given some juice. Within a few hours after arriving home I had terrible flu symptoms. These lasted 5 days and included severs body aches, fever and chills, terrible headache, coughing , just not feeling well at all. I received no medical treatment After 5 days I was fine

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

Taking a shower and starting having severe shortness of breath, got real weak and it lasted about 45 mins. Could barely walk. Went to the ER got admitted and they couldn't find anything. She had to walk with a walker, body and joint aches. Walks very slow now, balance is off and she get lightheaded

OUT OF BREATH, SHORTNESS OF BREATH; HEADACHES; FELT DIZZY,FELT LIKE SHE WAS GOING TO PASS OUT; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's past medical history included sinus infection, temporomandibular joint disorder, deviated septum, and jaw pain, and concurrent conditions included low blood pressure (110/50), tooth problems, penicillin allergy, celery and avocado allergy, and allergy to animal products. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-APR-2021, the subject experienced felt dizzy, felt like she was going to pass out. On 06-APR-2021, the subject experienced out of breath, shortness of breath. On 06-APR-2021, the subject experienced headaches. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 110/50 (low). Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headaches on 30-JUN-2021, was recovering from felt dizzy, felt like she was going to pass out, and had not recovered from out of breath, shortness of breath. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required per standard procedure as the case is assessed as non-serious.

Approximately 5-7days after Johnson/Johnson COVID 19 Vaccine, mild pain has appeared to my left arm, and now it?s been 2mo., that pain much much worse, and unable to move in certain position. I?m very high tolerance to pain and hope it will go away but now at times its extremely unbearable. NOT sure, this left arm pain is due to vaccine, but this pain did appeared 5-7 days after JJ injection. At first, I thought it maybe sympathy pain since the injection was received on my right arm.

Janssen COVID-19 Vaccine EUA Approximately six hours after administration of the vaccine, patient experienced sever chills and dizziness. Unable to stop shaking, patient took temperature which registered at 95.4F and then 95.1F at 15 minutes. Patient donned flannel pants, thermal shirt, and oversized hooded sweatshirt and got in bed under flannel sheets, two doubled-over blankets, a bedspread, and quilt. A down-filled king-size pillow was placed on top of patient's torso and a space heater was turned on to highest setting. Patient reports heart seemed to be racing, but did not take BP. Unable to quell the chills, the patient continued to shake, developing very stiff shoulders, neck and back as a result. This continued until approximately 2 am. The next morning, patient's temperature was registering at 99.4F and pulse was 96, but patient did not report chills. General muscle aches and mild headache were noted. At time of this report, patient's temperature and pulse are normal (97.6F and 76 pulse).

Janssen eua Very slight dizziness afterwards, and then very heavy feeling in chest, hard to breathe about 45 minutes later, and then hives about an hour later. Next day very slight feeling in the injection area, muscle aches, still have heavy chest and breathing issues, but not as bad as yesterday. I took a Zyrtec tablet around 6:00 p.m. on 3/9/21. Also used CPAP during the night. Oops, forgot to add CPAP and Zyrtec to medication list, I use CPAP nightly and Zyrtec 1xd at night time. I also had a resting pulse of 111 with fast heartbeat. My blood pressure was 136/84, my oxygen was down to 93.

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

Symptoms began little after ten hours of receiving vaccine. Symptoms included flu like symptoms of aches , joint pain and fatigue with fever up to 101 lasting 3 1/2 days. Fever broke SUnday night 14th, approx 9:00pm. Awoke Monday the 15th light headed and fatigued but aches and fever gone. Then approximately 5 pm on Monday the 15th started having chest pain, upper right side. By midnight I was being transferred to ER for the chest pains. Released Monday morning the 16th from ER Dx. Possible chest wall inflammation; Followed up with primary care office (not my regular Dr. but with Dr. Have been experiencing internal jittering; agitated cough, upper respiratory issues (but lungs are clear.) ever since I originally had Covid.

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

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

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

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

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.

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

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.

Pt was feeling hot and was on verge of fainting. Had pt lie down in supine position and applied ice pack to foreheard and pt felt better

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.

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

About 30 minutes after the vaccination (on the way home), I felt very faint and almost passed out. At the same time, my injection arm started burning. Also, I started experience a mild headache while on the way home which became VERY bad about an hour after the vaccination (at home). My head, neck and shoulders hurt so badly that I could not move and my vision was blurry; it was a searing type of pain. Then, I developed a fever which, at its highest temperature, was 101.6° along with overall achiness, malaise and severe fatigue,

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

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

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.

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

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

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.

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

Patient received J&J Covid Vaccine at 1:46 pm. At approx. 2:05 pm she stated she had an increased HR (wears wrist monitor) and was light headed. Spoke to patient about if she had previously felt this way after a vaccine and she stated she felt this after her "first covid vaccine". After questioning, she stated that she had received a Pfized Covid Vaccine in February which was not noted in her consent form. She also did not note that she had been hospitalized post-vaccination for a burning sensation and flushing that would not cease. She received the J&J vaccine at the advice of her primary care physician but had not advised pharmacy staff. After discussing it with the patient, it was determine that EMS would be called. EMS came to evaluate patient.

Patient received Johnson&Johnson CV-19 1805018 5/21 on March 9, 2021. Patient began experiencing chest pains and abnormal sensations in chest area beginning April 26, 2021. Patient began experiencing electrical-like abnormalities in both hands and feet that cause severe dysfunction beginning May 7, 2021. Patient developed blood clot behind the retina of right eye as examined by ophthalmologist during clinical visit on May 25, 2021 at 8:15am appointment.

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

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.

STRANGE FORMATION ON THE INNER UNDERSIDE OF ARM WHERE VACCINE WAS ADMINISTERED LEFT ARM THAT TURNED YELLOW; DIZZINESS; FOOT ACHE; MUSCLE ACHES UNDERNEATH LEFT ARM; NOT FEELING WELL SINCE RECEIVING THE VACCINE; FALL; FEELING WOBBLY; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced feeling wobbly. On MAY-2021, the subject experienced fall. On 14-MAY-2021, the subject experienced not feeling well since receiving the vaccine. On an unspecified date, the subject experienced strange formation on the inner underside of arm where vaccine was administered left arm that turned yellow, dizziness, foot ache, and muscle aches underneath left arm. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from strange formation on the inner underside of arm where vaccine was administered left arm that turned yellow, feeling wobbly, not feeling well since receiving the vaccine, and muscle aches underneath left arm, and the outcome of dizziness, foot ache and fall was not reported. This report was non-serious.

First 5 days-fever, pain joints muscles lightheaded Since to date- racing heart and pulse. Severe dizzy spells. Intense pain and tingling I n legs.

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.

Painful injection site right away And within 20 min very painful left side-shoulder blade, shoulder, then pain went into neck, then jaw, then ear- felt blocked up and numb, then to eye- vision off, light headed. Pharmacist observed for 30 minutes and suggested I go to urgent care. I thought I was ok but on way home, jaw and cheek area went numb and sharp pain at left base of skull to top of head with chest and underarm muscles sharp pains. Went to urgent care. BP, temp & oxygen ok. While observing me for 45 min, also had left leg cramps, and profuse sweating Gave me 2 prednisone tabs 20 mg. Watched for another 45 minutes. Went home. 7 hours after injection still had these symptoms. Next morning 7/16/21, cheeks flushed, moderate jaw pain, cheek numbness and ear/ hearing not right. As day went on, numbness became intermittent but jaw pain remained.

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

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

Around 10 minutes after vaccine patient reported feeling dizzy, tired and weak. Patient was still responsive, stated she had eaten breakfast. She then was given water. She then became unresponsive, eyes closed, snoring with head slumped down while sitting. After we realized patient could not be awoken, property manager called 911. While ambulance was on thier way, patient "woke up" but was drowsy and could barely communicate. No epinephrine or diphenhydramine was administered. BP was 130/100. After EMS arrived, patient's partner came in from the car and reported this has happened multiple times at doctor appointments/procedures. Patient was unconscious for around 5minutes. Patient reported she went to the ED but was discharged after a short visit.

15-20 minutes after the injection, I started feeling a tightness in back of my throat; I broke out in cold sweat. I started getting dizzy and very whoozy. I felt my vision starting to close in. I thought I was going to pass out. I got the attention of the person across me to get an attendant and they brought me a chair with wheels. Two people got me up (and I'm not a big person) - they were worried I was going down and I was taken to exam room. They said I was white as a sheet. She checked my eyes and throat a few times and checked my blood pressure. It was lower than normal but she didn't seem really concerned about it - 104 over 60 something which is low for me. She gave me water to sip. She gave me very cold compresses to put on my forehead. They watched me pretty good. She had the epi-pen ready. She watched me and I sat in there and nurse came in a quite a few times to check me for about an hour. About an hour later the tightness went away and I started feeling myself again. We went home. I went to sleep. I woke up at night to go to bathroom and I was still a little woozy but I didn't fall. Next day, I just didn't feel well. My left arm was starting to hurt - was no swelling; it was a little red at injection site. It hurt just a little. I was woozy. My eyes couldn't focus as well. I felt out of it. I drank a lot of water and took a nap. Yesterday, I felt pretty decent but still woozy somewhat. I tried to run errands with my husband - just wasn't quite right. Today, much better but I'm not quite myself yet. Just a little wooziness - weird feeling. Yesterday, I did feel a soreness in the back of my right calf muscle. It wasn't warm to the touch or swollen. I don't have it anymore, it went away. It could have been a muscle thing from the first day of the vaccine when I got home and I got up and almost fell down. I do still have some achiness in joints. Especially in my knees - which isn't normal because they are replaced.

I woke up on 3/16/21 feeling my heart beating rapidly. I was slight dizzy upon standing from bed. I took my blood pressure at 6:06 -- readings were 112/84 and 120BPM. My usual BPM is between 60 and 75. I meditated and took my readings again at 7:44 a.m.. They were 105/78 and 95 BPM. I verified this on an oximeter.

Fever, chills, sweats, huge red and swollen arm at injection site, headaches, can?t hardly move that arm! For, 3 days +

Paramedic assessed patient. Pt stated head felt heavy, light-headed. Vitals, HR 89, BP 142/93, respiratory 18. Patient monitored and was stable to leave upon expired observation timeframe.

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.

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

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

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

HEART PALPITATIONS; DIZZINESS; SHOULDER PAIN; HEADACHE; BODY ACHES; BACK PAIN; This spontaneous report received from a patient concerned a 67 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: 1808978 or 1808928 (unsure), and expiry: UNKNOWN) dose was not reported, administered on left arm on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced body aches. On 01-APR-2021, the subject experienced back pain. On 01-APR-2021, the subject experienced shoulder pain. On 01-APR-2021, the subject experienced headache. On 02-APR-2021, the subject experienced heart palpitations. On 02-APR-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, back pain, and shoulder pain, and had not recovered from headache, heart palpitations, and dizziness. This report was non-serious.

About one week after my injection, I had severe cramping in left leg. On April 5th started with a couple of days with severe pain in tendons of right shoulder. The pain referred into the right neck and base of occiput. On April 7, 2021, I felt off then developed a severe, stabbing headache over my right eye referring back into the occiput. Was not steady on my feet. Did not eat dinner, went to bed. Felt tingling around my mouth, and my neck and shoulders were very tight. I debated about going to the hospital, but decided against it. Still have tightness on the right side of my neck into the occiput and right shoulder.

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

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

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.

2 weeks 8 days after vaccine, patient suffered which sent pt to emergency room. Husband states she had a "blood clot" to brain with skull fracture and traumatic brain injury. Transferred to Medical Center, then to long term facility. Has not recovered to date. Husband states unable to speak or move.

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

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.

WHOLE BODY SHAKES; DIZZINESS; TROUBLE WALKING AND HAND TO WALK REAL SLOW; FEELING SICK; CHILLS/SHIVERS; TIREDNESS; HEADACHE; 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 pace maker, and concurrent conditions included arthritis, herniating disk in the lower back, and dyslexia.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 08-APR-2021 10:15 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021 15:00, the subject experienced whole body shakes. On 08-APR-2021 15:00, the subject experienced dizziness. On 08-APR-2021 15:00, the subject experienced trouble walking and hand to walk real slow. On 08-APR-2021 15:00, the subject experienced feeling sick. On 08-APR-2021 15:00, the subject experienced chills/shivers. On 08-APR-2021 15:00, the subject experienced tiredness. On 08-APR-2021 15:00, the subject experienced headache. Treatment medications (dates unspecified) included: lorazepam, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from whole body shakes, feeling sick, and headache, recovered with sequelae from chills/shivers, had not recovered from dizziness, and tiredness, and the outcome of trouble walking and hand to walk real slow was not reported. This report was non-serious.

LOSS OF BALANCE; BLURRY CLOUDY VISION; DIZZINESS; This spontaneous report received from a patient concerned a 67 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: 203A21A, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced dizziness. On 13-APR-2021, the subject experienced blurry cloudy vision. On 15-APR-2021, the subject experienced loss of balance. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blurry cloudy vision, dizziness and loss of balance was not reported. This report was non-serious.

Injection site sore for about 5 days - then 5 days later shoulder became very sore and achy. Arm now aches continuously and is very weak. Mobility without pain is limited. Have not contacted my doctor yet - but will do so soon. No doctor visit planned yet. (Suspecting this is SIRVA????)

DIZZY; RUN DOWN; FEVERISH; HEADACHE; WEAK; TIRED; SORE ARM; BRUISED ARM AT INJECTION SITE; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sinus issues.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 14:30 for prophylactic vaccination. Concomitant medications included fexofenadine hydrochloride for sinuses. On 07-APR-2021, the subject experienced bruised arm at injection site. On 07-APR-2021, the subject experienced sore arm. On 08-APR-2021, the subject experienced weak. On 08-APR-2021, the subject experienced tired. On 01-MAY-2021, the subject experienced dizzy. On 01-MAY-2021, the subject experienced run down. On 01-MAY-2021, the subject experienced feverish. On 01-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine was not applicable. The patient recovered from bruised arm at injection site, and sore arm on 09-APR-2021, and had not recovered from tired, feverish, dizzy, headache, run down, and weak. This report was non-serious. This case, from the same reporter is linked to.

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

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

LEFT SIDED WEAKNESS; HEART PALPITATIONS; DIZZINESS AND FEELING FAINT; UNABLE TO LIFT LEGS TO GO UPSTAIRS; FATIGUE; WEAKNESS; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on left deltoid 08-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAY-2021, the patient experienced dizziness, heart palpitations during weeding outside, had fatigue and was feeling faint. On 08-MAY-2021, the patient was also unable to lift legs to go upstairs. On 12-MAY-2021, the patient experienced left sided weakness. On 20-MAY-2021, the patient visited the emergency room or department for treatment of the events and this was the second time of weakness. On 20-MAY-2021, Laboratory data included: Blood test (NR: not provided) Not reported, computed tomography scan (NR: not provided) No stroke and no blood clot, Chest X-ray (NR: not provided) Not reported, electrocardiogram 12 lead (ECG) (NR: not provided) Not reported, Investigation (NR: not provided) Not reported, and Magnetic resonance imaging (NR: not provided) No stroke and no blood clot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fatigue, and had not recovered from left sided weakness, heart palpitations, dizziness and feeling faint, unable to lift legs to go upstairs, and weakness. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000180437.; Sender's Comments: V0:20210544480-Covid-19 vaccine ad26.cov2.s-Left sided weakness. 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.

was at work inside in air conditioning on 5/25/2021 when she noticed she had blurry vision and felt dizzy. called PHN who referred her to call her doctor or go to the emergency room as these could be signs of a blood clot. PHN spoke with on 5/26/2021 and informed PHN that she went home yesterday from work and declined to go to an emergency room or doctor's office, as she has not seen a doctor in the last 10 years. was offered rides from friends and coworkers to a hospital or clinic, but declined. She went home and drank a lot of water, ate some bananas and sat still. She felt better after and that and has not had any reoccurring symptoms. See CONTINUATION PAGE. PHN expressed continued concern for her and recommended considering going to an emergency room or contacting a doctor. PHN reiterated that if she has another episode like that she should go to the hospital or clinic to be checked out.

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.

Immediately after the shot I got a little dizzy. Four to five hours after vaccine I experienced extreme Vertigo when I tried to stand up. I ended up falling when I tried to reach my walker. I am normally a little unstable, but I was unprepared to be so unsteady and I wish I was warned that this might happen. I was still a little dizzy the next day with some flu like symptoms. The Vertigo has happened again since then more than usual, but it is not as bad.

RIGHT FOOT SWELLING; CAN'T PUT WEIGHT ON IT WITHOUT PAIN/FEEL LIKE CAN'T PUT WEIGHT ON FOOT; LUMP ON TOP OF RIGHT FOOT, SLIGHTLY TO THE SIDE; CAN'T WALK; RIGHT FOOT PAIN; FEVER; 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 pre-existing medical conditions included patient did not seek medical attention. 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 20-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 20-JUN-2021, the subject experienced fever. On 22-JUN-2021, the subject experienced right foot swelling. On 22-JUN-2021, the subject experienced can't put weight on it without pain/feel like can't put weight on foot. On 22-JUN-2021, the subject experienced lump on top of right foot, slightly to the side. On 22-JUN-2021, the subject experienced can't walk. On 22-JUN-2021, the subject experienced right foot pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 21-JUN-2021, and had not recovered from right foot pain, right foot swelling, can't put weight on it without pain/feel like can't put weight on foot, lump on top of right foot, slightly to the side, and can't walk. 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.

Patient states she had unexplained swelling in her knees and legs. She was concerned about a possible clot so she went to the orthopedic doctor to be examined. They couldn't determine cause of swelling asked if she wanted a CAT scan she declined. Also stated sever pain at injection site that doesn't go away, tender to touch, limits mobility. I suggested she return to providers office and let them know she received Janssen COVID-19 vaccine and that additional test may be warranted.

Patient received vaccine on 6/19/21. She came into the pharmacy on 7/10/21 to ask about side effects she had been experiencing from the vaccine. She stated having severe pain in her arm at the injection site. I asked questions to determine the type of pain and when it occurred. She stated it started a week or two after the injection, there was localized swelling, tenderness, and difficulty with mobility. As I asked more questions she also mentioned swelling in her knee and leg and that she had gone to her orthopedic doctor to be checked out and they couldnt determine the cause. They asked if she wanted a scan done because she was concerned about a clot she declined. I asked if she told the provider she had recently recieved the J&J COVID-19 vaccine she said no. I suggested she return to the doctors office and let them know that as they may be more apt to do more thorough testing and examination to rule out possible clots.

LEFT ELBOW STIFFNESS; JOINT PAIN; LEFT ARM SORENESS AT INJECTION SITE; LEFT ELBOW MUSCLE PAIN; SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a 67 year old female. The patient's weight was 200.4 pounds, and height was 67.5 inches. The patient's concurrent conditions included asthma-like attacks, palpitations, anaphylaxis-like reactions, formaldehyde allergy, and cat dander allergy, and other pre-existing medical conditions included patient had a 98 squares test on her back & breathing test. Pin sticks on arm to check for other allergies. The patient experienced drug allergy when treated with nickel, and fluoxetine hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A, expiry: 07-AUG-2021) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. Concomitant medications included salbutamol for asthma-like attacks, epinephrine for palpitations, metoprolol for palpitations, and loratadine. On 21-JUN-2021, Laboratory data included: Imaging procedure (NR: not provided) Normal. On 09-JUL-2021, the subject experienced shortness of breath. On 11-JUL-2021, the subject experienced left elbow stiffness. On 11-JUL-2021, the subject experienced joint pain. On 11-JUL-2021, the subject experienced left arm soreness at injection site. On 11-JUL-2021, the subject experienced left elbow muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath on 09-JUL-2021, and left arm soreness at injection site on 12-JUL-2021, and had not recovered from left elbow stiffness, left elbow muscle pain, and joint pain. This report was non-serious.

CHEST POUNDING, HEART RATE SPIKING TO 206 WHILE RESTING ON 3 SEPARATE OCCASIONS, BLOOD PRESSURE AT 160, LIGHT HEADED, EXHAUSTION. DIAGNOSES WAS ATRIAL FIBRILLATION. TREATMENT WAS INJECTIONS TO LOWER HEART RATE AND BLOOD THINNER. PRESCRIBED PRADAXA 150MG X2/DAY AND DILTIAZEM 180MG X2/DAY.

Within minutes of receiving the Janssen vaccine, patient c/o dizziness, difficulty breathing, and feeling like her throat was closing. Her breathing was labored, shallow and fast RR high 30s, 93% RA, HR 120s. Lungs sounds with poor air entry, no wheezing. No rash, injection site unremarkable. Pt disclosed extensive history of allergies and h/o anaphylaxis needing Epi. States that current symptoms feel like previous anaphylaxis events. Called Code. Administered Epinephrine IM L thigh and within 2 minutes patient felt better, vital signs improved to HR 121, 99% RA, 170/86 speaking in full sentences. Allergy fellow and ED team arrived and patient was transported to ED alert and responsive in NAD.

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.

Lightheadedness and tachycardia noted 20 minutes after administration of Covid Vaccine. Emergency drugs available. Airway assessment done, vital signs obtained, cold, damp cloth placed on patient's head and neck. Husband requested EMS to transport patient to ER for further evaluation. Patient stable when EMS arrived.

Each day, from 3/7/21 through 3/13/21 felt lightheaded for a few seconds, less than a minute. The last on on the 13th lasted the longest and may have been over a minute. This did not cause any problems. It was very noticeable, caught my attention each time, like there was nothing I could do but pay attention to how I was feeling and then it was gone.

Pt. states feeling light headed. pt. has a Hx of hypotension. vitals BP 122/82, HR 50, SPO2 97; Pt. stable able to drive home.

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.

Pulmonary embolism with acute Cor Pulmonale/hypoxia I had shortness of breath, dizziness, coughing. I had Covid test on 3/12/21 that was negative. Went to Urgent Care on 3/12/21. Gave me an albuterol inhaler which was not effective in relieving symptoms. I wasn't improving, so went to emergency room at the hospital on 03/18/2021. I was admitted to hospital and placed on oxygen and kept overnight. I was also given Xarelto. I am at home and on Xarelto.

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.

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

Seven hours after the shot (8:00 p.m.), I experienced chills. By 9:00 p.m. I felt weak and light headed. Later in the evening, at approximately 11:00 p.m. I had a fever of 103.3. The fever lasted for about three hours or so. I took acetaminophen at 11:45 p.m. I also kept cold compresses on my forehead. I woke up at approximately 8:00 a.m. and felt much better. I had a mild headache and took more acetaminophen. By 11:00 a.m. I was back to normal.

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

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

5 minutes after vaccine I felt a sharp pain in the middle of my head like a headache and thought it would go away and i got dizzier and dizzier for about 25 minutes, I started getting hoarse in my voice, and my heart rate went up.

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.

Within first 12 hours, felt very tired, leg, back and shoulder muscles ached. Experienced on and off chills, low grade fever. Bad headache, dizziness and light headedness. All symptoms lasted 4 days. I handled this at home without medical intervention.

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

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.

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

PULMONARY EMBOLISM; THROMBOSIS; COR PULMONALE ACUTE/ DYSPNOEA; HYPOXIA; DIZZINESS; COUGHING; This spontaneous report received from a patient via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAER reference number 1120494) concerned a 68 year old female unknown ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 14:15 for prophylactic vaccination. Concomitant medications included amitriptyline for sleep, and zolmitriptan for migraine. On 07-MAR-2021 08:30, the subject experienced pulmonary embolism, thrombosis, cor pulmonale acute/ dyspnoea, hypoxia, dizziness, coughing, and was hospitalized (date unspecified). On 12-MAR-2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) Negative. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) normal, Blood test (NR: not provided) normal, CT scan (NR: not provided) Pulmonary Embolism, Chest X-ray (NR: not provided) normal, Diagnostic ultrasound (NR: not provided) No blood clots or vein thrombosis, Echocardiography (NR: not provided) Increased pressure on the right side of heart due to blood clots, and Heart rate (NR: not provided) elevated. Treatment medications (dates unspecified) included: oxygen, salbutamol, and rivaroxaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pulmonary embolism, thrombosis, cor pulmonale acute/ dyspnoea, hypoxia, dizziness, coughing was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition); Sender's Comments: V2:Additional version created for MAC update. This updated information does not alter the causality of previously reported events. 20210441745-Covid-19 vaccine ad26.cov2.s-Thrombosis, pulmonary embolism ,Cor pulmonale acute, Hypoxia, dizziness, cough. These events are considered unassessable. These events has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.

Leg Cramps/ Numbed/ Unable to walk Headaches Antibodies blood test yielded negative/low antibodies Ultra sound results pending

(1) Approximately one month after vaccine, swelling in the muscle behind my left leg. I went to my Primary Care doctor, he examined my leg and immediately sent me to hospital ER because he was concerned that it might be a blood clot. They performed an ultrasound, but the results were negative and showed no signs of any blood clots. (2) Approximately three weeks after vaccine, I developed stiffness on the left side of my body in my arm, thigh and hip area. The stiffness was intense, uncomfortable and bothersome enough for me to take Tylenol for the pain the next 5 days and it lasted for about a week.

Pt said that on the day following the vaccine she felt very dizzy and kept blacking out. Her husband said that she was also mumbling nonsensical things, and started drooling. Today when she called, she had trouble with speaking and she is still drooling. Client suspects that she might have had a stroke or a blood clot, but she have not gone to the doctor because she does not have health insurance.

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).

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

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.

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

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

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

Pt. states after receiving J&J started feeling dizzy, vision turned white. She sit down to avoid falling, lasting about 5mins at a time. Attempted to get to her feet but shortly after standing repeated vision blurring and dizziness. Decided to just lay down for awhile. Spoke with Physician regarding symptoms with no explanation, still continuing to experience symptoms. Fear of passing out while driving.

DIZZINESS; HEADACHE; This spontaneous report received from a consumer concerned a 68 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 29-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced dizziness, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and the outcome of dizziness was not reported. This report was non-serious. This case, from the same reporter is linked to 20210701429 and 20210701921.

The patient had her vaccine on 6/10 and then on 6/11 began to experience tingling throughout her legs and feet. She also complained of swelling in the feet in the mornings and shuffling gait. She also noticed joint pain and cramping in the legs. She still has these symptoms at this time.

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

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.

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

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.

After vaccine later I felt very dizzy and exhausted, a bad headache, I fell asleep in the kitchen standing up. I laid down.

Slight pain at injection site. Moderate headache. Severe chills with chattering teeth and body shaking. Severe fatigue. Moderate muscle aches. Nausea. Racing, pounding heart. Rate measured at 100 bpm. Continued for approximately 12 hours. Overall weakness. Slight dizziness at height of symptoms.

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

Janssen Covid 19 Vaccine EUA Patient experienced sudden onset Dizziness and Nausea following her vaccination. Vitals recorded and the patient was placed in a supine position. Facility contacted and they responded to the location and patient was placed in the ambulance and a 12 lead was completed. At this point the patient felt improved, Hypotension had resolved and the 12 lead was negative. Patient decided to AMA and healthcare facility was contacted for the AMA. Patient was taken home by her husband

Side effects started evening of 4/3/2021 with extreme fatigue, nausea, heart palpitations, slight fever, coughing, chills, stomach cramping, dizziness. Side effects still in progress at this writing.

On the night of the 3/9 at 10PM I had shakes/tremors in both my hands for 24 hours. I was freezing, terrible head aches, and nauseated till , could not get out of bed and was very tired. I could not move till sunday night; 6 days later i started feeling better. I called my pcp on the 16,and the 23 complaining that i had pain in my ccchest anad heart, She said that it was allergies. I called her on the 3/23 again telling her that i still had pain in my chest/heart, She told me that it was allergies and that it was a side affect of the shot.On March 26 a neighbor came over that was a nurse took my pulse and said that i had an irregular heart beat.Called pcps office spoke to Nurse told to come in on3/30. PCP checked my lungs/heart.said nothing wrong. I told her to take an EKG-showed PAC

Slight light headed ness, but major flushing and the beginnings of hives. I got myself up and ate 2 Benadryl. Made it home, fell asleep for 3 hours, seems okay now.

headaches, body aching pretty much all over, high fever,chills,shivering,cold,nausea,, loss of appetite,diarrhea,very week,disn?t care about anything, could barely move, uncontrollable loud with moaning fast heavy breathing all onset approzimately 7.75 hrs after the injection and sum lasted for very approximately five hours, some lasted very approximately 14.75 hours abd some lasted very approximately 18.75 hours

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.

Very Sudden onset nausea and diarrhea with chills for about 2 hours. Slowly subsided. Also dizzy spell a few days later, lasted a couple of hours.

She fell twice. The second time was due to a blood clot on the brain that led to multiple bleeds under dura and the brain. She needed an emergency craniotomy and is now undergoing acute rehab for speech, PT and OT.

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.

DIZZINESS; ARM PAIN; CHILLS; FEVER; NAUSEA; HEADACHE; 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, and batch number: 99205A21A 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 dizziness. On 12-APR-2021, the subject experienced arm pain. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced nausea. On 12-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, chills, fever, and nausea, and was recovering from arm pain, and headache. This report was non-serious.

CONSTANTLY CLEARED THE THROAT; FELT KIND OF SWOLLEN THROAT; A LOT OF COUGHING; NUMBNESS IN LEFT ARM; TINGLING IN LEFT FINGERS; SHARP HEADACHE; TWINGE OF PAIN IN LEFT SIDE OF TONGUE; LIGHT HEADEDNESS; BURNING SENSATION AT ADMINISTRATION SITE/ TENDERNESS AT INJECTION SITE; LEFT-SIDED NUMBNESS THAT SPREAD FROM HER JAW, FACE TO TOP OF HEAD; LEFT SIDED FACIAL NUMBNESS LASTED FOR AT LEAST 5 HOURS DESCRIBED IT AS WAS SIMILAR TO DENTAL ANESTHESIA, BUT MORE EXTENSIVE; ALLERGIC REACTION; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid infection, and concurrent conditions included seasonal allergy, vision damaged, and sensitivity to alcohol, and other pre-existing medical conditions included azithromycin allergy (headache, rash, hives, swollen lips, tongue and throat , breathing problems, chest pains, raises blood pressure), sulfadiazine allergy (headache, rash, hives, swollen lips, tongue and throat), omnicef allergy (headache, rash, hives, upset stomach), cefdinir, clonidine allergy (headache, rash, hives, upset stomach), cipro allergy (headache, rash, hives, upset stomach), aspirin allergy (upset stomach), cortisone allergy (feels like shards of glass), lisinopril allergy (cough), amlodipine allergy (swelling of legs &feet), hydrochlorothiazide allergy (headache, upset stomach). The patient experienced drug allergy when treated with amlodipine, acetylsalicylic acid, azithromycin, cefdinir, ciprofloxacin, clonidine, cortisone, hydrochlorothiazide, lisinopril, cefotaxime sodium, and sulfadiazine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 14:05 to left arm for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2020, Laboratory data included: COVID-19 antibody test (NR: not provided) Positive (units unspecified). On 06-MAR-2021, the subject experienced left-sided numbness that spread from her jaw, face to top of head. On 06-MAR-2021, the subject experienced left sided facial numbness lasted for at least 5 hours described it as was similar to dental anesthesia, but more extensive. On 06-MAR-2021, the subject experienced allergic reaction. On 06-MAR-2021 14:25, the subject experienced light headedness. On 06-MAR-2021 14:25, the subject experienced burning sensation at administration site/ tenderness at injection site. On 06-MAR-2021 15:05, the subject experienced twinge of pain in left side of tongue. On 06-MAR-2021 15:15, the subject experienced sharp headache. On 06-MAR-2021 16:00, the subject experienced constantly cleared the throat. On 06-MAR-2021 16:00, the subject experienced felt kind of swollen throat. On 06-MAR-2021 16:00, the subject experienced and had a lot of coughing. On 06-MAR-2021 16:00, the subject experienced numbness in left arm. On 06-MAR-2021 16:00, the subject experienced tingling in left fingers. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from constantly cleared the throat on MAR-2021, and and had a lot of coughing, numbness in left arm, burning sensation at administration site/ tenderness at injection site, and sharp headache on 06-MAR-2021, had not recovered from light headedness, left sided facial numbness lasted for at least 5 hours described it as was similar to dental anesthesia, but more extensive, left-sided numbness that spread from her jaw, face to top of head, tingling in left fingers, and twinge of pain in left side of tongue, and the outcome of felt kind of swollen throat and allergic reaction was not reported. This report was non-serious.

LIGHTHEADED AN HOUR AFTER THE VACCINATION; SHOOTING PAIN THAT WAS SO INTENSE THAT CAUSED HARD TIME TO SLEEP; 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: UNKNOWN expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 24-MAR-2021, the subject experienced lightheaded an hour after the vaccination. On 24-MAR-2021, the subject experienced shooting pain that was so intense that caused hard time to sleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lightheaded an hour after the vaccination on 25-MAR-2021, and had not recovered from shooting pain that was so intense that caused hard time to sleep. This report was non-serious.

April 15- late morning. Numbness right arm and hand and left arm. Loss of feeling in arm and hand. Difficult to raise arms, heaviness. Lasted less than 30 minutes. April 16- late morning. Left leg/foot very heavy, couldn?t walk. Lasted less than 15 minutes. 4:00 pm. Numbness again in left leg. Lasted less than 15 minutes. 5:00pm. Numbness in left arm and thumb and first finger. Lasted less than 15 minutes.

10 min. post inject Lt upper arm started swelling. No pain. 5min. later intense pressure/pain/surge to nose & sinus's. Couldn't breathe thru nose. Within 15 sec sinus/nose rush went to entire head with dizziness & passing out intensity. Did not loose consciousness. RN on scene. 10min later made comeback. Beads of sweet on forehead. Lt. upper arm swelling gone. Felt fine for 3 days. On 3rd day rt & lt knees to ankles began off & on sporadic (static electricity like) shocks concentrated to one area at a time. Coming & going in daytime, not at night. Continuing for 10 days. On 9th shocks lessening but then started experiencing pressure in lt. leg calf. Went to ER & had lt leg doppler. Neg. for clots. Now 4wks. later shocks gone but pressure in rt. & lt. calves continue off & on.

The patient got her single shot Johnson and Johnson vaccine on 3/6/2021. Then, on or about 4/22/2021, she began to complaint of dizziness and left-sided weakness. She presented to emergency room on 4/29/2021 and was found to have a stroke via CT and MRI.

First 2 weeks no symptoms at all. After about 2 weeks I noticed 4 small bruises on my L forearm. About a week later I noticed a huge black bruise on my L hip with a knot in the middle of it - it is still there but much lighter. Some days later I noticed a bruise on my R knee. Today I noticed a bruise on my R forearm. I do take a low does aspirin every day. I did get a little dizzy a couple of times and when I look up I get vertigo - not sure if that is related.

passed out in car. felt weak and fell over (according to spouse) syncope. Evaluated by EMS- Transported to Emergency room/department or urgent care.

TIGHTNESS IN HAMSTRINGS; BUTT PAIN; PAIN IN THIGHS AND CALVES AND ARM; GREAT DIFFICULTY IN MOVING; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's past medical history included polio, and concurrent conditions included arthritis in the arms, and other pre-existing medical conditions included the patient had no known allergies. The patient was previously treated with abaloparatide. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced great difficulty in moving. On 15-MAR-2021, the subject experienced tightness in hamstrings. On 15-MAR-2021, the subject experienced butt pain. On 15-MAR-2021, the subject experienced pain in thighs and calves and arm. Laboratory data (dates unspecified) included: Diagnostic ultrasound (NR: not provided) no blood clots, not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tightness in hamstrings, pain in thighs and calves and arm, and butt pain, and the outcome of great difficulty in moving was not reported. This report was non-serious. This case, from the same reporter is linked to 20210509287.

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.

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.

6/5/21 NO SYMPTOMS RIGHT AFTER SHOT, NO SORENESS. 6/13/21 SHE STARTED TO FEEL MUSCLE ACHE ON RIGHT FOOT, COULDN'T WALK. DR AWARE OF THIS SYMPTOMS AND DR THINKS IT MAY HAVE BEEN CAUSED BY HER MEDICATIONS. DR STOPPED FENOFIBRATE AND LOWERED DOSE ON ATORVASTATIN. ALSO DOING LAB TESTS

Cramping began in right leg off & on over 6wk period. Not thinking much of it just older I guessed. Then on June 6th my calf locked up & could barely walk. Later in evening my toes & foot went numb & cold & no feeling. Called Ambulance to take me to Hospital. 6 days of treatment. Many injections & needles.

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.

Within 1 week of receiving Covid Vaccine, patient developed extreme lethargy, severe shortness of breath, lightheadedness at times, oral sores and swollen gums, dysphagia. At 3 months out now, all symptoms have continued with no signs of improvement.

High fever, headache, muscle pain, neck pain, dizziness, tremors starting with in 7 hours of injection lasting all night and next day

Today I started to have a bad stomach ache and thought I was having indigestion. Thean I had loose bowels. This continued and got worse. This started around 11 a.m. Around 3 p.m. I felt dizzy and faint and nearly passed out. I was very weak. I had to lie down. I still feel weak and dizzy and it is now 4 pm but I feel a little better. My stomach is still gurgling

Fever of 102F, Derma, between 11:30 PM to 2:30 AM, Chills at same frame, Sore Throat, Headache, pounding continuing from 11:30, 03/23/21 until 9:45 03/24/21, Several hours of weakness and dizziness, Injection site, Left arm, continues to be sore.

About 10 hours after receiving vaccine, I suddenly began shaking, so hard I could barely walk. At the same time, my fever shot up to 101.8, and mucus began running from my nose like never before. Shaking subsided after an hour or so, fever broke during the night, and cold symptoms lasted about 3 days.

JANSSEN COVID-19 EUA. ADMINISTERED VACCINE TO PATIENT AT APPROXIMATELY 10:30 AM. PATIENT WALKED OUT TO THE WAITING AREA AND WAS SITTING WHEN REPORTED THAT SHE WAS FEELING DIZZY AT ABOUT 10:45 AM. OFFERED PATIENT AN ICE PACK AND WATER - SHE DECLINED; SHE DRANK SOME TEA SHE HAD. BY 11:00 AM HER SYMPTOMS WERE RESOLVED AND PATIENT LEFT OF HER OWN ACCORD.

after Midnight on the night of the 7th, it started with body aches. During the night I needed to go to the bathroom and could not get out of bed, needed assistance. On the morning of the 8th, I experienced chills and headache. Took Advil that morning and 4 hours after. Did start to feel better. Experienced Dizziness at times. Today, the 9th just chills throughout the day.

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.

severe lower abdominal pain more on the right hand side, somewhere around the ovary area It was like having had abdominal surgery, again, which I had years ago, couldn't move easily, hard time getting in and out of bed which lasted about three days decreasing in severity with each day Headaches, still, that are unusual and I find it hard to wear a straw hat this week! Which is also unusual as I am a gardener and wear one all summer. More than usual fatigue, still happening. Dry heaves and felt like I had a hang over for two days too! I have never had a problem with my gall bladder or liver which I know are on the right had side also.

Patient states that on the night of 4/9/2021 around 10PM she was laying down and felt paralyzed and could not move for 6 hours. Patient states that she was unable to call 911 because she could not move.

LITTLE DIZZY; This spontaneous report received from a patient concerned a 70 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: 1808978, expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced little dizzy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little dizzy on 31-MAR-2021. This report was non-serious.

FEET AND ANKLE SWELLING; DIZZY; 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 chemotherapy treatment. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 08-APR-2021 10:30 for prophylactic vaccination. Concomitant medications included potassium for swelling. On 08-APR-2021, the subject experienced dizzy. On 11-APR-2021, the subject experienced feet and ankle swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy on 09-APR-2021, and had not recovered from feet and ankle swelling. This report was non-serious.

I felt dizzy 45 mins after having my vaccine and i had a headache for 7 days straight and now it comes and goes. i have had fatigue and my blood pressure shot up and my cholesterol went up after having vaccine and now I am having to be on meds to control it

2 weeks after vaccine had mild headache. 4 weeks after vaccine had cramping in R hamstring. 4-6 weeks after vaccine started having balance issues, difficulty swallowing, weakness. LP as below which showed albuminocytologic dissociation. Clinical picture was concerning for Guillain-Barre syndrome. Patient started on IVIG.

First, the injection was far more painful than anticipated (and it bled down my arm). My arm immediately ached intensely. Approximately 10 minutes after injection, I began to sweat profusely, followed by intensifying extreme lightheadedness. I could not stand, or lift my head, as I would have definitely passed out. My shoulders and neck became extremely painful, as if ?frozen?, also preventing me from lifting my head. After about 35 minutes I very gradually began to recover. It was about an hour before I began to move around normally. Pharmacy and store staff debated calling the paramedics, but I refused. FYI, I had not been especially anxious about the vaccine, and I have never experienced such a reaction to anything in my life. It was a traumatic experience I would not wish to repeat.

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.

Headache - I had some neck pain. I don't remember - I might have some dizziness - I put them on the v-safe check-ins. I had to be taken by ambulance to the hospital on 4/17/2021 - I thought I was having a stroke. They said that I had developed bells palsy on the right side of my face. They gave me medication to use for one week. The symptoms that I was having went away less than two weeks later. They told me that Bells Palsy symptoms could last two weeks to six months. It's gone right now - I don't see any symptoms of it. I did have a virtual appt appt with my doctor -

4/30/21: This patient comes in complaining of worsening low back pain. She has a history of severe degenerative disease in his had surgery. She was scheduled to see her neurosurgeon last year however it got canceled due to the COVID-19. Patient states she saw her neurologist on Tuesday and was given injections which significantly helped. She states that her pain has returned however. She has had no trauma. No footdrop. No difficulty with her bowel or bladder. Patient states she only uses Tylenol arthritis at home. 5/1/21:The patient is a 70-year-old female presenting to the emergency department for back pain. She has a history of chronic back pain and states that has been worsening. She was recently seen here for the same complaint. She currently rates her pain 10/10 intensity. She reports that she has chronic numbness and tingling of her bilateral arms/hands and legs/feet. She states that this is also worsening. She denies any changes in bowel or bladder function or perineal numbness. She states that she has been using a walker at home and that she has tried to make an appointment with her neurosurgeon who previously operated on her but that she has been unable to get through to their office. She reports that she only called 1 time on a Friday. She is taking Tylenol at home for her pain and reports minimal relief. She denies any fevers or associated concerns at this time. 5/2/21: This is actually her 3rd visit in less than a week with this complaint. She was seen 2 other times at a outside facility. She states that she had back surgery about 10 years ago at Beaumont. She states she was supposed to see her neurosurgeon last year but this did not occur secondary to COVID-19. Her primary care physician had referred her to a neurologist did some injections ahead some relief of her back pain for a week or 2 but this is since worsened. She states that over last several days she has had increasing numbness and tingling in her feet as well as increasing weakness of her lower extremities as well as some now some new incontinence of urine when she stands up. She today she also complains some chest pain she attributes more from just amount of pain he has from her back. She rates her back pain as a 10/10 intensity. She did have 1 episode of a week or 2 ago where she slipped down and fell on her knee but did not hit her back directly. She did not hit her head. She describes the chest discomfort in her upper abdomen lower chest area. She is nauseated but not vomiting here. She denies any exertional dyspnea or orthopnea prior to this. She has had no recent fever chills. 5/11/21: The patient is an 70 y old female admitted on 5/4/2021. The patient was originally seen by Neurology on 05/07/2021 when she presented with diffuse weakness. She has a history of hyperlipidemia, hypertension and diabetes. The patient at that time described the acute onset of weakness ascending from the feet, then involving the legs and arms also associated with sensory symptoms that started about 2 weeks prior to her presentation. She also had persistent neck and back pain radiating to her arm and legs limiting her ability to walk. On neurologic examination at that time the patient had absent deep tendon reflexes in the lower extremities and trace reflexes at the biceps. She had significant weakness in the lower extremities and mild weakness in the upper extremities. She also had a dysarthric speech. Given the patient's CSF analysis showing protein elevation to 266 with no pleocytosis, wbc's were only for, there was support for a clinical diagnosis of acute inflammatory demyelinating poly radicular neuropathy or such variant. The patient was started on plasmapheresis and has received her 2nd session of plasmapheresis on 05/09/2021. She will have a total of 5 sections, one every other day. The patient also has hyponatremia, this can be seen in about 5% of patients with Guillain-Barre syndrome, we also do see pseudohyponatremia but this is in patients that have received IVIG.

I got my vaccine twelve weeks ago and I still have problems with my left arm. I have lost a lot of the range of motion and I get shooting pains when I try to do regular activities. At first I noticed pain when I reached back. It will not work if I try to reach for something and I get a shooting pain. I have tried taking Ibuprofen and icing it and it did not help. I also tried massage which helps a little for a short period of time.

A day after the vaccination, I experience loud ringing in my ears. I have not had this condition before. I could also hear a pulse in my ears. The tinnitus has still not resolved 10 weeks after the vaccine. Also, I was lightheaded and dizzy and that has only subsided somewhat. 3 days after the vaccine, I had very strong veryeffects when I took Snythroid, my thyroid medication which I have taken for many years. This issue has persisted even though we have lowered my dose. This was not an issue prior to the vaccine.

At 1543, patient reported slight dizziness and general weakness to EMT. Patient given water and offered anti-gravity chair. Patient drank water and denied anti-gravity chair. At 1544, Paramedic assessed patient vitals: blood pressure 110/70 mmHg, pulse 66 beats/minute, and 93% SpO2. Patient reported history of fainting with prior vaccinations and a heart murmur. At 1600, Paramedic assessed patient vitals: 115/70 mmHg, pulse 73 beats/minute, and 93% SpO2. At 1610, Paramedic reassessed patient vitals: 115/70 mmHg, pulse 66 beats/minute, and SpO2 92%. Patient reported she wanted to leave. Patient reported feeling less dizzy and weak. Lead nurse educated patient on signs/symptoms of when to seek emergency care, to sign u on website and to follow up with primary care provider. At 1613, patient left facility with steady gait and unlabored respirations, accompanied by husband and Paramedic.

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.

about two hours after injection, I experienced headache, then mild dizziness, then extreme dizziness, then sudden overwhelming fatigue, then swollen eyes and eyelids, then chills and elevated heart rate, with pounding. I had to cancel the class I was supposed to teach, because I would not have been safe to drive to campus. I slept from approximately 2:30 pm on March 8 until 8:30 am today, March 9, all symptoms continuing, with bathroom breaks, a couple of short reports to family members who were watching out for me, and one 2-hour window during which I ate a small meal, went back to bed, and read part of a book. During bathroom breaks I took more antronex, some milk thistle, and some glutathione, which seemed to at least temporarily reduce dizziness and eye/eyelid swelling. At one point I took some hawthorne tincture because I was concerned about the heart pounding. Today I woke up feeling symptom-free, but by 2 pm I was compelled by sudden fatigue to take a two-hour nap. After that I felt better, and I think I am now fine, at 7:45 pm on 3/9/21. I am happy to have gotten the Janssen vaccine, because it is one and done!

Dizziness, passed out and fell backwards onto tile floor. (FIRST TIME EVER) Stopped bleeding from cut on back of head. Severe headache for 3 days. Occasional nausea and lightheadedness.

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.

8:30 pm started - very cold/ then very bad body aches and slight headache; then dizziness and 4 hours later started vomiting for about 15 hours; slept all of next day and night/ waves of nausea; dizziness gradually faded after 24 hours, nausea faded after 26 hours

I became dizzy, nauseous, sweaty, and rapid breathing about 10 minutes after receiving the vaccine. I was given an EpiPen injection and taken by ambulance to a local ER

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.

0910 patient recieved vaccine. 0920 client described feeling woozy & like she had run fast. (hearting racing) Patient alert, talkative, denies swelling of mouth or tongue, no rash, no difficulty breathing. POX 98%, HR 120, BP 194/110. 0926 BP 200/120, Hr137. Called EMS. 0942 EMS brought her to Hospital. 1240 husband of patient called me to say "we are going home. She is doing better. The doctor said he did not think it was an allergic reaction to the vaccine."

Day 1: no sx, Day 2: extreme fatigue . Dizzy lightheaded Day 3: profound lethargy + dizzy & lightheaded . bedridden Day 4: profound lethargy dizzy + lightheaded bedridden Day 5: visit to urgent care. rx for keflex for injection site sub cutaeneous lump. c/o right arm swollen, petechia, right torso petechia. dizzy lightheaded. Patient reports she is blood type AB negative Day 6: visit to PCP

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.

I had ligament repair surgery on my right ankle on 01/06/2021. My recovery was going well. I was walking well without pain and was gaining balance and strength with physical therapy. I had almost no discomfort at the site of my surgery. Three days after having my J&J vaccination I woke up to a lot of discomfort in my right ankle, making it difficult for me to walk as I had been able to walk. I have struggled over the last six days to get back to the mobility I had prior to getting my J&J vaccination. I spoke with representative from my orthopedic surgeon?s office this morning who confirmed that I am most likely suffering from the side effects of the J&J vaccination, and she suggested that my lack of normal mobility will most likely last another week.

pt states after about 4 hours after taking vax she developed a headache. She says the headache keeps getting worse and worse. She took Tylenol and went to bed. the next day the headache was so severe the next day that she could hardly function. she tried to flush out the vax by drinking lots of water and not eating any food. She took Tylenol and slept most of the next 36 hours. After 3 days she still has a headache but started eating again. Today she is feeling drained and still has a headache.

LIGHT HEADED MOSTLY WHEN STAND UP; LOOSE BOWELS; 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 blood pressure issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 in the left deltoid for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced light headed mostly when stand up. On MAR-2021, the subject experienced loose bowels. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the light headed mostly when stand up and loose bowels was not reported. This report was non-serious.

STIFF KNEES; DIFFICULTY IN STANDING; SICK TO HER STOMACH; This spontaneous report received from a patient concerned a 71 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 expiry: UNKNOWN) dose was not reported, administered to left arm on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced sick to her stomach. On 27-MAR-2021, the subject experienced stiff knees. On 27-MAR-2021, the subject experienced difficulty in standing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sick to her stomach on 25-MAR-2021, and had not recovered from stiff knees, and difficulty in standing. 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

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.

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.

SORENESS IN ELBOW, WRIST AND KNUCKLES; SORENESS IN ARM, HAND AND FINGERS; INJECTION SITE SORENESS; DIFFICULTY USING HAND; SWOLLEN SHOULDER; INJECTION SITE BRUISING; This spontaneous report received from a patient concerned a 71 year old female. The patient's weight, height, and medical history were not reported. The patient received Tylenol unspecified (form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: 20-JUN-2021) dose was not reported, administered on 31-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 2021, the patient experienced injection site bruising. On 02-APR-2021, the patient experienced difficulty using hand. On 02-APR-2021, the patient experienced swollen shoulder. On 02-APR-2021, the patient experienced injection site soreness. On 03-APR-2021, the patient experienced soreness in arm, hand and fingers. On 04-APR-2021, the patient experienced soreness in elbow, wrist and knuckles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with Tylenol unspecified was not reported. The patient had not recovered from injection site soreness, difficulty using hand, swollen shoulder, injection site bruising, soreness in elbow, wrist and knuckles, and soreness in arm, hand and fingers. This report was non-serious.

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.

From 04/04/21 until now: Bad headache, elevated blood pressure, numbness in face and extremities, dizziness.

Taste in mouth. Could feel in lungs. Eyes watering. Teeth chattering. Could not walk at first. When could walk needed help of two person to sit in observation area. After about 40 minuets was able to walk. Felt like my heart was bouncing at times. Legs were very weak. Headache the next day and nausea. My legs and balance are still off but I?m much better. Notified md office on April 12, and 13th by phone and was told if not better by next Monday to call back then by the nurse that I did not need to be seen at this time.

As I was driving, I noticed that my vision was becoming blurred. I was ready to pull the car over to the side, when it cleared up. Total time of blurred vision was probably one to two minutes.

COULD NOT WALK FAR WITHOUT FEELING TIRED; HAD BEEN TIRED; This spontaneous report received from a patient concerned a 71 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 administration, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced could not walk far without feeling tired. On MAR-2021, the subject experienced had been tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not walk far without feeling tired, and had been tired on MAR-2021. This report was non-serious. This case, involving the same patient.

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).

PATIENT GOT DIZZY WITHIN 5 MINUTES OF RECEIVING VACCINE-BECAME UNRESPONSIVE FOR ABOUT 30 SECONDS. SHE CONTINUED TO BE DIZZY/FAINT AND HAD A COLD SWEAT. PT WAS NOT INJURED WITH LOSS OF CONSIOUSNESS. CALLED 911, EMS ARRIVED AND TOOK PATIENT TO THE HOSPITAL. WHILE WAITING FOR EMS BLOOD PRESSURE AND HR CHECKS WERE PERFORMED WHILE PATIENT WAS IN LAYING DOWN POSITION.

Nausea, chills, fatigue, body aches with unusual and extreme upper back pain. Took Aleve. Too tired and hurting too much to move.

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,

First 2 days after shot both knees ached, could hardly walk, third day pain gone, then on 18th all heck broke loose at 1:10 am, I had uncontrollable diarreah with velocity vomiting at EXACT same time. I was chilled to the bone with temp that ran between 95.4 to 96, The chills quit on the 20th. Diarreah has been on going since the 18th, haven't held food or water for 6 days, goes right through me. I went to ER today, my blood pressure going in was 179/99 and after 2 bags of IV Fluid blood pressure was 122/68

Patient's daughter, called and states she is her mom's POA and she stated that she was with her mom when she got the vaccine in the parking lot. About 3 weeks ago her mom started dragging her foot and fell twice, she went to a facility and then was sent to hospital and was hospitalized for about 3 weeks, she has had two mini strokes, she is currently at nursing home. She also provided the name of her mom's PCP.

DIARRHEA/MUSHY POOP; CRAMPING IN STOMACH WHEN EATS; DIDN'T EAT; SORE ARM; FEELS DIZZY; FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 71 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-MAY-2021, the subject experienced feels dizzy. On 28-MAY-2021, the subject experienced flu like symptoms. On 28-MAY-2021, the subject experienced sore arm. On 29-MAY-2021, the subject experienced diarrhea/mushy poop. On 29-MAY-2021, the subject experienced cramping in stomach when eats. On 29-MAY-2021, the subject experienced didn't eat. The action taken with covid-19 vaccine was not applicable. The patient was recovering from diarrhea/mushy poop, cramping in stomach when eats, and sore arm, had not recovered from feels dizzy, and flu like symptoms, and the outcome of didn't eat was not reported. This report was non-serious.

GOT UP LIMPING A LITTLE BIT SORE TO THE TOUCH; RIGHT HIP BOTHERING/ SORENESS; LEFT LEG SWELLING,PARTICULARLY AROUND AND ABOVE THE ANKLE BY 4 INCHES; 3-4 EPISODES OF DIARRHEA PER DAY/ LOOSE STOOL THAT HAS BEEN BOTH LIQUID AND SEMI FORMED/ STOOLS ARE NORMAL COLOR; 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 leg injury, and darker skin discoloration, and concurrent conditions included asthma allergies, kiwi allergy, and reflux, and other 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: 2028A21A expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. Concomitant medications included bismuth subsalicylate. On 27-MAY-2021, the subject experienced 3-4 episodes of diarrhea per day/ loose stool that has been both liquid and semi formed/ stools are normal color. On 29-MAY-2021, the subject experienced left leg swelling, particularly around and above the ankle by 4 inches. On 30-MAY-2021, the subject experienced got up limping a little bit sore to the touch. On 30-MAY-2021, the subject experienced right hip bothering/ soreness. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from left leg swelling,particularly around and above the ankle by 4 inches, right hip bothering/ soreness, and 3-4 episodes of diarrhea per day/ loose stool that has been both liquid and semi formed/ stools are normal color, and the outcome of got up limping a little bit sore to the touch was not reported. This report was non-serious.

Patient is a 72 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: Dizziness Patient was treated/managed as follows: Pt given gatorade and VS taken 0948: BP: 106/82 HR 76 O2: 96% 0958: BP: 122/82 HR: 78 O2: 97% Pt reports feeling better Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. Pt escorted to car by RN.

Vomiting, fever, dizziness started at 2am following vaccination at approximately 10:45am. In the morning of 3/12/21 reported vomiting black. Sent to ER.

Patient complained of shortness of breath, general weakness, dizziness, chest pain which she specifically described as ?angina.? Patient stated symptoms lasted for about 30 minutes then resolved. No medications administered in response to event.

Very severe muscle aches, headache, and shivering within hrs after receiving vaccine. Lasted all night into today. Dizzy and needed help walking. Seemed very extreme for a vaccine reaction. Starting to feel a little better but I am loaded up with Tylenol and Advil.

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.

I had several episodes of Meniere's Disease with severe vertigo. I had not had any such episodes since 2013

Patient stated that she was light headed immediately after receiving the vaccine. She responded well to a cold compress.

Around 5:30 pm on Friday night, I started feeling really cold; couldn't get warm for 2 hours. Then I started getting a fast heart rate; checked this around 7 pm; BP was 181/80 and heart rate was 135. I was starting to feel warm along with being cold. I had a gradually increasing temperature; checked it around 8:30 pm; was 102.1; took 2 tylenol and temperature slowly started going down. My heart would not slow down; I sat in my recliner and kept deep breathing and had calming herbal tea; was afraid to go to the ER due to Covid. After more than 4 hours with a racing heart, I felt exhausted and laid down around 12:30 a.m. and fell asleep. I woke around 3 am with nausea and soaking wet pajamas from sweating. I fell asleep again and woke around 7 am; I felt very tired, woozy and my heart hurt. I felt a bit more normal after a few days. I still feel a bit dizzy and light headed. I was concerned when I later heard some J&J vaccines were contaminated; on 4/2/21, I called the pharmacy because the number they wrote on my card, 1805D18 wasn't clear; they told me this # was incorrect and should be 037A21B and couldn't explain why this was so. They were going to check into this and call me; I called them again on 4/5/21 and was told the correct # was 043A21A and that the vaccine was from the Netherlands. They couldn't offer any more information or explain why the initial # was incorrect. I find this concerning and have been unable to find an answer.

HEADACHE; PAIN IN THE HEEL; FEVER; PAIN AT INJECTION SITE; FELLING UNCOORDINATED; PAIN RADIATING TO THE NECK; DIZZY; SHOOTING PAIN IN EAR; PAIN IN THE ANKLE; MUSCLE PAIN; 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 osteo-arthritis, fibromyalgia, kidney stone, penicillin allergy, ibuprofen allergy, corticosteroid allergy and erythromycin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 14:00 at left arm for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced dizzy. On 2021, the subject experienced shooting pain in ear. On 2021, the subject experienced pain in the ankle. On 2021, the subject experienced muscle pain. Treatment medications included: acetylsalicylic acid. On 25-MAR-2021, the subject experienced felling uncoordinated. On 25-MAR-2021, the subject experienced pain radiating to the neck. On 25-MAR-2021, the subject experienced pain at injection site. On 25-MAR-2021 20:00, the subject experienced fever. On 31-MAR-2021, the subject experienced pain in the heel. On 02-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy, felling uncoordinated, and fever, had not recovered from headache, and the outcome of pain at injection site, pain in the heel, pain in the ankle, muscle pain, shooting pain in ear and pain radiating to the neck was not reported. This report was non-serious.

Patient felt dizzy when she got ready to stand up after waiting for 15 minutes after her immunization. The technician told me and I went and talked to the lady. She said she was feeling better but I asked her to wait another 15 minutes. I checked on her again and she said she was feeling fine and was ready to leave. I told her that if she wasn't sure to wait longer but she insisted she was ok and left.

SEIZURE; JOINTS LOCKED UP/WHOLE BODY LOCKED UP; NO APPETITE; SWEATING; BARELY BEEN OUT OF BED/HOME BOUND; CHILLS; WEAKNESS; 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 had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: 25-MAY-2021) dose was not reported, 1 total, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021, after 23:00 the patient began shaking and had seizure, her mouth was drawn up. On the same day, the patient experienced fever, chills, sweating, weakness, no appetite and her whole body locked up and her joints locked up. According to the patient, she had barely been out of bed and had been home bound since vaccine was administered. The patient visited doctor/healthcare professional's office for events seizures, shaking, mouth drawn and fever. It was reported that, on 02-APR-2021, a nurse came to the patient's home and tried to encourage her to go to the hospital but she declined. On the day of this report, the patient had an appointment via phone video for her pulmonologist and with her primary care physician. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from joints locked up/whole body locked up on 28-MAR-2021, was recovering from fever, chills, and sweating, had not recovered from seizure, no appetite, and barely been out of bed/home bound, and the outcome of weakness was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: covid-19 vaccine ad26.cov2.s-seizure. 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)

This is a spouse. Medical Center do not have this patient's medical record and is reporting the reaction on her behalf based on available information. Patient reported she was having brunch 4/11/21 am and started feeling very dizzy (was dining outside) and her son informed her that she was very pale. Her stomach started to rumble and threw up. Son called the ambulance due to "low pulse" and "loss of consciousness". She was treated at ER with iv fluids and anti-nausea medicine and was discharged that day (4/11/21) around 1pm with diagnosis of "Vagal Response". She recalled being in the ambulance around 4/11@11:10am.

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.

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.

pt reported feeling hot and lightheaded - 3-5 minutes later, she became unresponsive - I administered one dose of epinephrine, she came to about 3 seconds later, and stayed stable until the EMTs arrived.

Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypertension-Medium, Additional Details: I have been observing patient for 30+ minutes. Patient is feeling better after drinking a bottle of apple juice. It has been about 40 minutes now and patient said she is feeling back to normal 99%. She said she wants to go home herself. I had the nurse from the minute clinic check her blood pressure and systolic was 158. Patient does have hypertension and takes 2 blood pressure medications. Patient does not have pain at injection site, the system made me select something

Mild nausea ongoing, migraine, exhaustion ongoing, off balance mentally and physically, mild vertigo intermittent, low back pain intermittent, both mild and severe,

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.

SWOLLEN KNEES; LOOSE JOINTS; CHARLEY HORSE; HIGH FEVER (3 DEGREES OVER NORMAL); SEVERE FATIGUE; MUSCLE SPASMS; SEVERE MUSCLE CRAMPS; DIFFICULTY WALKING/BARELY MOBILE; 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 pre-existing medical conditions included the patient has no medical history. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 180898L (or a 2 for last digit)) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced muscle spasms. On 06-APR-2021, the subject experienced severe muscle cramps. On 06-APR-2021, the subject experienced difficulty walking/barely mobile. On 06-APR-2021, the subject experienced charley horse. On 06-APR-2021, the subject experienced high fever (3 degrees over normal). On 06-APR-2021, the subject experienced severe fatigue. On 12-MAY-2021, the subject experienced swollen knees. On 12-MAY-2021, the subject experienced loose joints. On 04-JUN-2021, Laboratory data included: Blood test (NR: not provided) No blood clots detected., and X-ray (NR: not provided) No diagnosis. The action taken with covid-19 vaccine was not applicable. The patient recovered from high fever (3 degrees over normal), and severe fatigue on 14-APR-2021, and had not recovered from muscle spasms, severe muscle cramps, difficulty walking/barely mobile, swollen knees, loose joints, and charley horse. 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.

BLOOD PRESSURE HIGH; CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; DIZZINESS; HEADACHES; NAUSEA; WEAKNESS; This spontaneous report received from a patient concerned a 72 year old female. Initial information was processed along with additional information received on 04-JUL-2021, 08-JUL-2021 and 09-JUL-2021. The patient's weight was 64.86 kilograms, and height was 165 centimeters. 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: 1802072 and expiry: unknown) dose was not reported, 1 total administered to upper left arm on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, (5 days after vaccination) the patient had a strong reaction to the vaccine and experienced headaches, dizziness, nausea, and weakness which persisted for several weeks. On an unspecified date, the patient experienced high blood pressure and started using losartan, and metoprolol from 30-MAR-2021 as treatment. On 22-JUN-2021, the patient's physician got tested her for the spike protein immunoglobulin G (IgG Antibody) test and its results came negative (confirmed immunological vaccine failure). The patient wanted to know whether it was okay to get another vaccine as a booster dose to boost her immunity because she felt if she did not do that, she would be at risk of catching a virus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, headaches, nausea, and weakness, had not recovered from blood pressure high, and the outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000185416. The suspected product quality complaint has been confirmed to be not voided (meet pqc criteria) based on the PQC evaluation/investigation performed.; Sender's Comments: V0 - 20210710887-COVID-19 VACCINE AD26.COV2.S -Confirmed Immunological Failure. 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: SPECIAL SITUATIONS

Pt noticed increased weakness in legs after receiving COVID vaccine. Had been walking steadily. Now unsteady with walking, feeling like legs will buckle. Pt referred for home PT.

fever 100 degrees, lethargy, aches, cold symptoms, tiredness , dizziness Janssen COVID-19 Vaccine EUA

Shot administered 3/9/2021; side effects started 3/11/2021. Patient states she had chills, muscle pain/spasms. Mostly in her legs. Her feet still hurt and she states her walking ability has declined. 3/14/2021 she states she has had improvement consistently, but is still feeling her walking ability is back to where it was.

Stated that 45 min after vaccine when walking to car, began having SOB, felt like she was breathing through cotton and then sand. Increased her prednisone to 20 mg per day. Day 3-4 became dizzy, weak, developed a rash with itching. SOB continued Day 8 SOB is getting better and weaning down to 8 mg prednisone

2-3 days after vaccine patient experienced lightheadedness 18 days after the vaccine patient experienced muscle aches 19 days after patient experienced neuropathy of hands and feet

My arm started hurting about a week and a half after shot and has not stopped. It is not quite as excruciating as it first was but , it still hurts and I have limited movement without pain . Has been like this for 2 weeks now.

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.

Patient got the Jansen covid 19 vaccine today. She waited 30 minutes (since she stated she got a rash as a kid from a vaccine and hadn't received a vaccine since then). She was fine after 30 minutes and handed us the timer and walked away. She came back and said she thought she is just hungry since she hadn't eaten and felt funny. She said she was going to get some food. We had associate walk her over. They came back. She sat down and ate her food. We checked on her but now she stated she had vertigo and needed meclizine and thought she'd be ok if she went home and laid down. I offered her ice for her neck or head and she refused. I also offered to lay her on the floor and elevate her feet, but she refused. She said her neck gives her problems so didn't want ice or to lower her neck. She was sitting this whole time and said she felt in slow motion. She said she wanted to go to the restroom but I didn't want her going alone. She called her son in law that was shopping in the store and we asked him to come over. He was going to drive her home but she said no one was home. I asked if they'd like an ambulance and they both said yes. We called 911 and stayed with the patient until EMS arrived. She was feeling somewhat better but they took her to get checked out to be safe.

Patient had the vaccine on March 26, 2021, she started having reactions on March 28th. She states started out with chills and fever and progressed into allergy like symptoms and gradually got worse. She has pain from her neck to her toes. Loss of appetite and generalized weakness causing it hard for her to ambulate.

DIARRHEA; NO APPETITE; CHILLS; JOINT HURTING; FEVER; ACHES; FLU LIKE SYMPTOMS; SHORTNESS OF BREATH; DIZZINESS; 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 chronic obstructive pulmonary disease, severe bronchitis, arthritis, bad back, and drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808978 expiry: 13-JUN-2021) dose was not reported, administered on 06-APR-2021 11:30 for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 104 F. On 07-APR-2021, the subject experienced aches. On 07-APR-2021, the subject experienced flu like symptoms. On 07-APR-2021, the subject experienced shortness of breath. On 07-APR-2021, the subject experienced dizziness. On 07-APR-2021, the subject experienced no appetite. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced joint hurting. On 07-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced diarrhea. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches, shortness of breath, diarrhea, no appetite, and joint hurting on 12-APR-2021, flu like symptoms, dizziness, and chills on 11-APR-2021, and fever on 10-APR-2021. This report was non-serious.

HYPERACUSIS; DIZZINESS; SORENESS IN ARM; TIREDNESS; 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 hypothyroidism, tinnitus, nonsmoker, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, expiry: UNKNOWN) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the subject experienced hyperacusis. On 07-MAR-2021, the subject experienced dizziness. On 07-MAR-2021, the subject experienced soreness in arm. On 07-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hyperacusis, and dizziness on 07-MAR-2021, soreness in arm on 08-MAR-2021 17:00, and tiredness on 08-MAR-2021. This report was non-serious.

April 20 2021: suffered a fainting/blackout episode where I collapsed onto my apartment building's outside entry stair. I hit the deck causing contusions to my knees and upper back. I regained consciousness after _about 10 seconds, was helped up another flight of stairs by a friend and neighbor where I - again - blacked out falling to the hallway floor. I regained consciousness in another 10 seconds.

I started feeling faintly, experienced headaches, flashing blackness in my eyes and head. I also had blurry vision , extreme fatigue, nausea and diarrhea. I sat down for 10 minutes to be monitored and then I went home. To this day I still have headaches that come and go and I have no energy whatso ever and still have nausea that comes and goes.

PASSED AWAY; HIGH BLOOD PRESSURE; DIZZINESS; THROWING UP; HEADACHE; This spontaneous report received from a consumer concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: unknown) dose was not reported, 1 total administered on 16-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. It was reported that the patient received covid-19 vaccine ad26.cov2.s on 16-MAR-2021. On 17-MAR-2021, the patient's only complaint was that she experienced headache. On 14-APR-2021, she complained about dizziness and throwing up that was getting worse and high blood pressure on same day the reporter called the patient's doctor's office at 14:30 p.m. and doctor saw the patient's blood pressure was returned to normal and she underwent laboratory data included: systolic blood pressure (NR: not provided) 113 mmHg, 170 mmHg, 190 mmHg. After few hours, 7 or 10 hours she passed away in her sleep, no pain at the time of death between 12:00 a.m. or 15:00 p.m. on 15-APR-2021. It was unspecified if an autopsy was performed. The reporter was unsure about the true time of death. The reporter did not complaint for a lawsuit as the doctor of the patient did not know if the death was correlated with the vaccine. The patient did not had no other disease, except high blood pressure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient passed away on 15-APR-2021, recovered from high blood pressure on 14-APR-2021, and headache on an unspecified date in 2021, and the outcome of dizziness and throwing up was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: - covid-19 vaccine ad26.cov2.s-Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). covid-19 vaccine ad26.cov2.s-High Blood pressure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: UNDERLYING DISEASE; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH

LEFT SHOULDER PAIN; FELT TIRED; PAIN IN BOTH OF LEGS AND CALF; PAIN AT INJECTION SITE; BRUISE ON HIP; FELL OVER A BOX; 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 shoulder surgery, and concurrent conditions included type ii diabetes, lupus, and cholesterol issues. 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 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced bruise on hip. On APR-2021, the subject experienced fell over a box. On 05-APR-2021, the subject experienced pain in both of legs and calf. On 05-APR-2021, the subject experienced pain at injection site. On 06-APR-2021, the subject experienced left shoulder pain. On 06-APR-2021, the subject experienced felt tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain at injection site on 06-APR-2021, and felt tired on 07-APR-2021, had not recovered from left shoulder pain, pain in both of legs and calf, and bruise on hip, and the outcome of fell over a box was not reported. This report was non-serious.

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.

Thursday late night started have pain in both feet. Friday pain getting worse. Saturday could hardly walk. Saturday night was getting unbearable. Temperature went from 97.6 to 100.3, then 100.8 and had chills and fever. Extremely rare for me to have chills, etc. Sunday could not walk on feet. Used wheelchair to get to bathroom, etc. Sunday night, I called the urgent care who recommended me to ER. 03/14 admitted to ER. ER did xray of foot to eliminate break. Concluded POSSIBLE cellulitis. Treated with antibiotics. kept overnight for observation. Monday 03/15 pain was severe but could walk to bathroom. Released Monday 03/15 at @ 5:00 pm. Pain subsided after 4 days.

All over body stiffness, muscle aches,hard to walk, couldn't raise arms up, weakness and fatigue. First we tried nsaids, then steroids, took various tests including Covid test. I was negative. All this took about 2 months. May 4 was last steroid pill. Nsaids had no good effect. Steroids helped quite a bit, but not totally. The day after the last steroid pill, all the aches, pains, everything came back.

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,

Patient's arm was sore and continued to hurt to the extent it was difficult to raise above her head. On 6/7/21, she experienced high blood pressure of >200 systolic and sought care at the ED since she was also having left arm pain. EKG, bloodwork and heart monitoring all indicated no cardiac issues. ED provider recommended acetaminophen for the pain. Blood pressure continued to stay somewhat elevated on 6/8/21 but had returned to baseline by 6/9/21 and patient was feeling better.

UNEXPLAINED SEVERE, CUTTING, HOT, DEEP, INTERNAL-TORNADO LIKE PAIN TO LEFT SHOULDER; EXTREME FATIGUE AND UNABLE TO CARE FOR MYSELF/3 VERY STRANGE EPISODES WHICH LEFT HER VERY DRAINED; FEEL WEAK; DIZZY/OFF BALANCE; HURT ALL OVER/INCREASE IN NECK AND BACK PAIN; TEETH CHATTERING; This spontaneous report received from a patient concerned a 73 year old female. The patient's weight was 220 pounds, and height was 67 inches. The patient's past medical history included right shoulder arthroscopy, and weakness, and concurrent conditions included chronic pain homebound patient with scoliosis, bone spurs, spine curvature /abnormalities, abnormal muscles, degenerative disc disease, penicillin allergy, non alcoholic, non smoker, and sick w/ scoliosis at age 16, and other pre-existing medical conditions included the patient had allergies and no drug abuse or illicit drug usage.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-JUN-2021 for prophylactic vaccination. Concomitant medications included hydromorphone hydrochloride, and oxycodone. On 11-JUN-2021, the subject experienced dizzy/off balance. On 11-JUN-2021, the subject experienced hurt all over/increase in neck and back pain. On 11-JUN-2021, the subject experienced teeth chattering. On 11-JUN-2021, the subject experienced feel weak. On 13-JUN-2021, the subject experienced unexplained severe, cutting, hot, deep, internal-tornado like pain to left shoulder. On 13-JUN-2021, the subject experienced extreme fatigue and unable to care for myself/3 very strange episodes which left her very drained. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from feel weak, teeth chattering, dizzy/off balance, hurt all over/increase in neck and back pain, unexplained severe, cutting, hot, deep, internal-tornado like pain to left shoulder, and extreme fatigue and unable to care for myself/3 very strange episodes which left her very drained. This report was non-serious.

Had normal sore arm after a few days but a month later couldn't get up out the bed without help. Have no use of her hands she can barely write. Both shoulders are not working so her grandkids have to come pull her up. Hurt all over.

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.

Janssen COVID-19 Vaccine EUA 19 hours after injection chills, headache, heaviness on chest and dizzy did not feel better until 10 hours later. symptoms gone but still very tired.

3/8/21: Immediate dizziness lasting all day. Headache, fatigue/lethargy all day. Intermittent chest pain/tightness, throat tightness, gas, fever, chills. 3/9/21: Gas, loose bowls, tired, but otherwise pretty good. 3/10/21: Still tired and mildly dizzy all day. In afternoon, chest pain/pressure with any exertion, even climbing the stairs in my home, Chest discomfort stopped when I stopped the activity. 3/11/21: Chest discomfort, mild dizziness and tiredness continued this day. 3/12/21: Chest pain gone. Sore throat started in evening. 3/13/21: Sore throat all day. Runny nose for about 10 minutes. 3/14/21: mild tiredness in afternoon.

She got the vaccine, was feeling fine, went to church and did her normal things for the rest of the day, and approximately 24 hours after the vaccine around 12:30 to 1:00 and started getting chills. She wrapped up in a blanket and took a nap. Then approximately 1:30 PM she had blurry vision, couldn't see clear, and she felt very, very faint like she was going to faint and was sitting in a chair and continued to sit there for a few minutes. Then she was weak after that, and then a while later she was okay.

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.

Mom started feeling ill on Tuesday, April13 with extreme fatigue and a headache. Then on Wednesday, April 14 she experienced: Headache Dizziness Swelling: Left side of face Swelling: Neck Swelling: Knees and legs (unusual swelling) Chest pain Right arm pain shooting up shoulder left arm pain back pain (unusual/more intense) We went to the ER and they treated her with: pain relief 4 aspirin IV Benadryl

For 2 nights following the immunization, starting the night of the shot, bleeding from the injection site occurred, overnight. In the morning, her entire arm was covered in blood and her sheets wet. Her husband cleaned her up, and the next day, she did not have any bleeding. But then the second night, again overnight, she bled heavily and woke up with her arm covered in blood and sheets wet with blood. She also experienced leg pain so bad that she couldn't walk. This happened after she had done some leg exercises in which she used a tension band.

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.

Immediately felt dizziness and dry mouth. Then within 2 hours felt extremely nauseated and fatigued. For two days I felt shortness of breath and fatigue for 4-5 days. The nausea lasted for over a week and then by the 4th day, diarrhea set in, which is now finally resolving after two weeks in.

On the night of my vaccine, 04-06-2021, I experienced chills all night long. I also had a terrible headaches, SOB, chest pain. I also experienced light headiness which lasted one week. I went to see a doctor on 04-13-2021, who performed x-rays of the chest, did lab work and did an EKG which the tests came back normal. To this day I still have light headiness, nausea and light-headiness.

Day 1 chills Day 2 4am morning Dizziness and Vomiting --- contiues and still she feels dizzy. She was admitted on day 13 to ER for observation.

Vaccine was given at 10:30am and patient waited for 30 min after receiving vaccine. Patient c/o dizziness when walking and when sitting, along with nausea. 11:05am: BP 154/96, pulse 102, O2 sat 98$ on RA. 11:20am: BP 144/100, pulse 100, O2 sat at 98% on RA. Evaluated by Fire Department and paramedic. Patient to go home with husband. Will contact physician or call 911 if symptoms get worse.

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.

NOSE BLEED; BODY ACHES; HEADACHE; FATIGUE; NAUSEA; DIZZINESS; WARM FEELING IN THE VEINS OF THE PALMS AND FEET; SEVERE CHILLS; This spontaneous report received from the patient concerned a 74 year old mixed race female. The patient's height and weight were not reported. The patient's concurrent conditions included penicillin allergy. The patient took no concomitant medications. The patient received COVID-19 vaccine Ad26.CoV2.S (suspension for injection, route of admin not reported, batch number: 1805020 expiry: 25-MAY-2021) dose was not reported,1 total, administered on 09-MAR-2021 to left arm for prophylactic vaccination. On 09-MAR-2021, the patient experienced severe chills at around 21:00, 5 hours post vaccination. On 10-MAR-2021 around 04:30, the patient woke up with a pounding headache, chills, body aches. During day the patient also felt fatigue, nausea, dizziness and a feeling of warmth in the veins of her palms and feet. It was reported that the symptoms disappeared on the morning of 11-MAR-2021, which was 2 days post vaccination. It was reported that about 30 minutes prior to call on reporting day of 25-APR-2021, the patient blew her nose and she said a little bloody clot came out, followed by a nose bleed lasting about 30 minutes. The patient reported that she never got nose bleeds and she had no fever, shortness of breath or chest pain. The action taken with COVID-19 vaccine Ad26.CoV2.S was not applicable. The patient recovered from dizziness, warm feeling in the veins of the palms and feet, body aches, severe chills, fatigue, nausea, and headache on 11-MAR-2021, and nose bleed on 25-APR-2021. 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

DIZZINESS; PAIN AT THE INJECTION SITE; STOMACH ACHES; This spontaneous report received from a consumer concerned a 74 year old female. The patient's height, and weight were not reported. The patient's past medical history included brain cancer, and concurrent conditions included seizures, dementia/Alzheimer, and vertigo. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 29-APR-2021 15:00 for prophylactic vaccination. Concomitant medications included levetiracetam for seizures. On 29-APR-2021, the subject experienced stomach aches. On 29-APR-2021, the subject experienced pain at the injection site. On 06-MAY-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach aches on 29-APR-2021, and pain at the injection site on 30-APR-2021, and had not recovered from dizziness. This report was non-serious.

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.

About 15 minutes after immunization during observation, patient complained of feeling hot all over and somewhat lightheaded. denied chest or other pain, shortness of breath, nausea . initial blood pressure was 210/ >100. Patient assisted to a cot to lay flat. further hx: no prior vaccination problems, but reports only few vaccines in her lifetime. Reports recent change in thyroid supplement few weeks prior . No TSH level since change. Has not been checking BP, but has cuff at home. No known hx hypertension or cardiac disease. hx "white coat HTN" remotely. repeated BP every 5 minutes; 184/92, 72. 172/84, 78. By 30 minutes after vaccine, patient was feeling normal. Was asymptomatic sitting up and then standing . She was discharged with instructions to continue checking her blood pressure at home and if persistently > 140/90, she is to f/u with her medical provider. It was also suggested that she speak with her provider about TSH check 6 weeks after starting her new supplement dose.

The evening of 5/13/21 pt experienced light headedness, tired, hot/cold flashes; headache, nausea and vomitted once which continued until the evening of 5/15/2021. Has been ok since.

5 min after shot was given: warmth, nausea, dizzy, feeling of passing out, throat closing up, pins and needles in face and fingers/hands/forearms, red face and chest, and weakness. Second day, nausea, stomach cramps, dizziness.

After getting the vaccine I came home and I fell asleep for a couple hours and I woke up very sick to my stomach and vertigo really bad. I was coughing a lot and I could not breathe and it was terrible. I was also tired and my muscles were sore. I made a doctor's appointment and I was waiting on the car and I tried eating some chips and I could not taste them. Then they let me in the hospital and I had a Covid test done and it was positive. That happened in 04/09/2021. They gave me a medicine for vertigo and an inhaler, Ibuterol and a medicine to control wheezing in my lungs

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.

Flu like symptoms on March 13 & 14. Dizzy, fatigue, lightheaded started March 15. I went to the Emergency Room on March 15 and told them I was having a reaction to the vaccine. I waited for over an hour and no one helped me but they helped everyone else who came after me, and with Covid so I left. I called Dr and went to his office that day. I had a hyperbaric oxygen chamber treatment and he put me on glutathione, multiple vitamin, zinc, Vitamin C, minerals. I continued seeing Dr and continued with the oxygen chamber treatments until I left New York to return home to Cape May, NJ. on May 3. I then rented a Hyperbaric Oxygen Chamber on May 4 that I continue to use daily to this day, as I continue with fatigue, dizziness, lightheadedness , although it is lessening.

Experienced pain within minutes in right kidney area and the right and left sides of her head. She then had a low blood sugar attack. For the following 3 days, she suffered from chills and many low blood sugar attacks. Also upset stomach and diarrhea for a few days, as well as headache and body aches. April 12th, left side of face was puffy and more headaches; continued into April 13th; also some sinus pressure/overall stuffiness June 4th- Vertigo attack; had another back in May Continues to have chills, body aches, and headaches, and tired with low energy

Patient reported that she started feeling complications the same day. She went to the store and felt dizzy and fell out in the parking lot. The following Wednesday everything she ate she threw it up. She blacked out again. Neighbor called 911. She passed out and awaken in the hospital. She had a server condition of diarrheia. She was hospitalized from the 14th of April to the 27th. They found out that she had blood clots in her arm after the scan. Hard to raise arm up and could hardly walk. Was put on blood thinner to dissolve the blood clot and was dropping blood pressure. Passed out in the shower. Almost hit head. If she is doing any kind of walking her blood pressure drops. Patient stats that she did not have any of these medical problems since she has taken the vaccine. Patient also states that she has lost weight.

Pt lost use of limbs, had to drag herself to living room where she passed out and Neighbor was able to awaken her. Patient refused to go to hospital due to just coming home from there earlier. Was able to recoup at home. Mobility has not fully recovered.

3.5 months of prolonged fatigue, headaches, malaise, night sweats, balance issues since Covid vaccine and not improving.

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.

Severe pain in right back, right groin, hip and upper leg. Blood clot in right lung. Placed on heparin (IV medication) by healthcare provider. Transferred to a rehabilitation hospital after being hospitalized for 5 days. Currently has home help by nurse, provided blood thinner. Unable to walk.

Headache- Thursday 3-11-21-- took tylenol Feeling listless 3-12-21 Severe Dizziness in the middle of the night 3-14-21 All adverse symptoms went away on there own.

severe abdominal cramping; high fever (102.9); chills; severe body aches; headache; dizziness; body aches

When I woke the next morning I had a moderate headache, sore muscles all over which intensified throughout the day, intense pain in the spine between shoulder blades and when I tried to walk, my limbs would not do as I wanted. They moved in wide circles- arms and legs. This lasted through the day and next day it was sliightly better. Balance was poor. Had to hold onto things to walk. Also I had fatigue.

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 some dizziness within 30 minutes of receiving the vaccine which went away prior to leaving the clinic, she experienced mild feeling of swelling in the cheeks, nose, and jaw after leaving the clinic

Sudden onset of very rapid heartrate lasting 15 minutes or more and including shortness of breath and dizziness and feeling of being light headed. In the 4 days following I had several subsequent similar episodes multiple times per day, but not lasting as long as the first one. Perhaps lasting a few minutes to about 5 minutes. Sometimes I also had a low grade headache.

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.

HEADACHE; DIZZINESS; NAUSEA; This spontaneous report received from a patient concerned a 75 year old female. The patient's weight was 89 pounds, and height was not reported. The patient's past medical history included covid 19 infection, and concurrent conditions included migraine.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 05-MAR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021 15:00, the subject experienced dizziness. On 06-MAR-2021 15:00, the subject experienced nausea. On an unspecified date, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, and nausea on 06-MAR-2021 19:00, and the outcome of headache was not reported. This report was non-serious.

FELT LITTLE TIRED; DIZZINESS; VERTIGO; MILD HEADACHE; chills; This spontaneous report received from a patient concerned a 75 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 13-MAR-2021 10:30 for prophylactic vaccination. Batch number was not reported and has been requested, No concomitant medications were reported. On 13-MAR-2021, the subject experienced dizziness. On 13-MAR-2021, the subject experienced vertigo. On 13-MAR-2021, the subject experienced mild headache. On 13-MAR-2021, the subject experienced chills. On 14-MAR-2021, the subject experienced felt little tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vertigo, and mild headache on 13-MAR-2021, was recovering from dizziness, and the outcome of chills and felt little tired was not reported. This report was non-serious.

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.

DIZZINESS; PALPITATIONS; DIFFICULTY BREATHING; JOINT PAIN IN BILATERAL SHOLDERS; MUSCLE ACHES; WEAKNESS; TIREDNESS; HEADACHE; This spontaneous report received from a patient concerned a 75 year old female. The patient's weight was 123 pounds, and height was 67 inches. The patient's past medical history included laminectomy of l4 & l5, urinary mesh insertion, and removal of urinary mesh, and concurrent conditions included chronic obstructive pulmonary disease, thyroid problems, urinary incontinence, mold allergy, alcohol, and occasional smoking, and other pre-existing medical conditions included the patient has allergy of different plants and prilosec (difficulty breathing & swallowing). The patient had correction of urinary mesh in 2009 and 2010 and did not have history of drug abuse or illicit drug. The patient experienced difficulty breathing and swallowing when treated with omeprazole. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 27-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2020, Laboratory data included: BUN (NR: not provided) UNKNOWN, CBC (NR: not provided) UNKNOWN, Thyroid function test (NR: not provided) UNKNOWN, and WBC (NR: not provided) Elevated. On 29-APR-2021, the subject experienced dizziness. On 29-APR-2021, the subject experienced palpitations. On 29-APR-2021, the subject experienced difficulty breathing. On 29-APR-2021, the subject experienced joint pain in bilateral sholders. On 29-APR-2021, the subject experienced muscle aches. On 29-APR-2021, the subject experienced weakness. On 29-APR-2021, the subject experienced tiredness. On 29-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizziness, palpitations, muscle aches, weakness, tiredness, headache, difficulty breathing and joint pain in bilateral sholders was not reported. This report was non-serious.

Weakness in my lower legs- between my knees and my feet. All of a sudden the calves in my legs get so weak that I have fallen twice. My legs go out from under me. This just happens randomly. I can walk completely normal some days and some days it's not. The severest times is when it's hot outside. Today, I just about fell on my way into a building. I sat down for a few minutes and then it was okay. I have gout in my feet and in my knees but I have never had this weakness attributed with gout. I noticed that both arms - were like a flu-like ache from shoulders to the palms of my hands -that has happened just a couple of time. I see my doctor tomorrow. I go for blood tests and work up in the morning before seeing. him.

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 !