Johnson & Johnson

Substantial rise in blood pressure to 205/110. This was recorded 20 minutes after injection. The dizziness associated with the high blood pressure started within 5 minutes of the injection.

Patient is a 60 y.o. male who received the Janssen COVID 19 Vaccine lot #1805020 on 3/12/2021. The patient experienced the following reaction(s) during the immediate of observation: 9:05am Patient c/o dizziness during observation period. Patient evaluated in treatment area. Reports PMH of HTN, depression, and anxiety. Patient was treated/managed as follows: 9:05am VS BP 150/92, HR 56, RR 18, 96% on room air. Patient states symptoms are same. 9:15am VS BP 146/86, HR 60, RR 20, O2 sat 97% on room air. Patient reports feeling better. Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance.

Fever,headache,cold/hot sweats,bad muscle aches,no appetite,dizzy ,stiff neck ,stinky major sweat , uncomfortable no sleep felt like i had the Corona virus...

For 24 hours had fatigue, fever, nausea, diarrhea, lost of appetite, soreness in shot arm, and dizziness

THURSDAY MARCH 11TH VACCINE SHOT ADMINISTERED. FRIDAY MARCH 12TH DEVELOPED SWOLLEN RIGHT ANKLE AT WORK AROUND 10:30 AM. SWOLLEN ANKLE MADE MOBILITY DIFFICULT. MARCH 18TH ANKLE STILL SWOLLEN ACCOMPANIED FOR THE FIRST TIME WITH PAINFUL RED RASH AND FEVER. AS A RESULT, UNABLE TO PUT ANY WEIGHT ON RIGHT ANKLE FROM MARCH 18TH TO DAY OF WRITING THIS REPORT, MARCH 22. RIGHT ANKLE IS IN EXTREME PAIN. PATIENT HAS NEVER FELT PAIN SO SEVERE IN HIS LIFE. PATIENT CONTINUES TO FELL UNWELL.

Day of vaccine: No symptoms. Next day: Slightly achy, occasional mild nausea, occasional mild light-headedness. Day 2: Headache, muscle aches, bone aches, more prevalent nausea. Feel "feverish", though no elevated temperature present.

I was dizzy, lightheaded, and sweaty. I felt like I was about to pass out. The doctor gave me a cold pack, had me to lay down and checked my vitals--all were normal. I sat there for about 20 minutes until I was feeling better. I still have some soreness and lingering headaches.

rash. Generalized body rash x 10 days with stiff joints developing 2-3 days ago, after receiving J&J vaccine on 15MAR21; states seen in ED 4-5 days ago and Rx Famotidine and Benadryl with no relief. 60 yo M w/ no known chronic medical conditions, presents w/ 10 days papular, flesh-colored rash to extremities; started 8 days after receiving J&J vaccine. Most prominent on the extensor surfaces of his MCPs, PIPs, elbows, but also extends up both of his arms. 2 days joint stiffness. No facial rash, mucosal involvement, systemic sx, weight changes. No personal or family h/o autoimmune dz. VS w/o acute abn. Well-appearing, NAD. Papular rash as described above. No desquamating rash, mucosal involvement. I spoke to Dr.

BODY ACHE; DIZZY; CHILLS; HEADACHE; TEMPERATURE GOT AS HIGH AS 101.8; This spontaneous report received from a consumer concerned a 60 year old male. The patient's weight was not reported and height was 170.18 centimeters. The patient's concurrent conditions included alcohol user, non-smoker, and type 2 diabetes mellitus, and other pre-existing medical conditions included the patient had no known allergies to vaccine, drug and food. the patient had no history of drug abuse, no illness at the time of vaccination, no past history of similar events, no adverse event after any previous vaccination, no pre-existing acute illness 30 days prior to vaccination, no history of hospitalization in last 30 days and no family history of any disease (relevant to vaccination) or allergy.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 the right arm, on 08-MAR-2021 06:07 for prophylactic vaccination. Concomitant medications included empagliflozin for type 2 diabetes mellitus, and metformin for type 2 diabetes mellitus. On 08-MAR-2021, the subject experienced body ache. On 08-MAR-2021, the subject experienced dizzy. On 08-MAR-2021, the subject experienced chills. On 08-MAR-2021, the subject experienced headache. On 08-MAR-2021, the subject experienced temperature got as high as 101.8. Laboratory data included: Body temperature (NR: not provided) 101.8 deg. On 09-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99.5 deg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, chills, headache, and temperature got as high as 101.8 on 09-MAR-2021, and had not recovered from dizzy. This report was non-serious.

60yr old male (documented allergies: erythromycin (diarrhea) and penicillin (rash)) with unknown PMH presented for COVID-19 vaccine on 4/7/21. Of note, patient reported previously lightheadedness/dizziness after blood draw or injection. Patient declined to be reclined for administration. RN administered JANSSEN COVID19 VACC (LOT # 043A21A, exp 6/21/21) IM in patient's left deltoid at 1425. Shortly after, patient reported feeling lightheaded and requested to be reclined. Patient alert and oriented, other symptoms denied including hives, shortness of breath, or throat swelling. BP 152/76, MAP 102, HR 85, 92% RA (of note, patient hypertensive at baseline). After resting in reclined position for ~5min, patient r BP 152/76, MAP 102, HR 85, 92% RA (of note, patient hypertensive at baseline). After resting in reclined position for ~5min, patient reported feeling better. BP upon sitting was 161/92, MAP 115, HR 85, 97% RA. Patient endorsed being back at baseline. Patient discharged in stable condition with no other issues.

Too weak to lift himself out of bed into the wheelchair or from wheelchair onto toilet. Fell twice on two consecutive days when trying to get from the bed into his wheelchair. 911 was called each time to help him get off the floor and into his chair.

muscle tightness, Onset: 3 weeks ago. The problem has worsened. The frequency of pain is constant. Location of pain is bilateral anterior neck, bilateral lateral neck and right shoulder. Associated symptoms include difficulty sleeping and muscle spasm. Pertinent negatives include numbness. Additional information: Pt here alone. Pt reports that 3-4 weeks ago he awoke with neck, right shoulder and arm pain. States he can't turn his head, raise his right arm due to pain. Taking 800mg of ibuprofen and it is not helping. States "it just dawned on me, I had the J/J vaccine 3days prior" Per pt and it was given in. right arm. Not sleeping well. Feels it is triggering his reflex sympathetic dystrophy.

Dizziness, imbalance, vertigo like symptoms - when changing position from sitting to standing or bending. Symptoms were intense on 4/15/2021 - one week after receiving the vaccination. Since then the symptoms have become milder and infrequent.

Tues 4/13/21- Headache and dizziness started about 4p. Wed 4/14/21- Could not go to work because of headache and dizziness. Made appt for 4/15 at 6:45a with Dr Thur 4.15/21- Awoke with intense headache and dizziness. Ready to go to appt but emergency room called at 6:37 to switch to a Virtual appt. I never received a call so I walked to the office. They told me they would not see me as I had Covid 19 symptoms. Went to airport and received a Negative Covid test. Went o Clinic and was diagnosed with fluid in the ears and a sinus infection. Went to work and only stayed 2 hours. Drove myself to the emergency room with weakness, shortness of breath and intense pain under the sternum. Diagnosed with a blood clot in the right ventricle. The cardiac cath lab removed it. Was in intensive care Thur-Sat.

DIZZINESS; SORENESS AT INJECTION SITE; HEADACHE; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient has no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: 21-JUN-2021) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced dizziness. On 03-APR-2021, the subject experienced soreness at injection site. On 03-APR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and had not recovered from soreness at injection site, and dizziness. This report was non-serious.

WEAKNESS; TIREDNESS; FEVER; NAUSEA; HEART RACING; DIZZINESS AND LIGHTHEADEDNESS; 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: Unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported On 06-APR-2021, the subject experienced heart racing. On 06-APR-2021, the subject experienced dizziness and lightheadedness. On 06-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced weakness. On 07-APR-2021, the subject experienced tiredness. On 07-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart racing, dizziness and lightheadedness, weakness, tiredness, nausea, and fever on APR-2021. This report was non-serious.

Immediately got hyper dehydrated. Then felt like I was going to passout soon. I ate a banana and drank pint of water. That helped 36 hours later my throught 1/2 of it, got very sore, like pins sticking inti it like a tonselitious maybe. Same time my mid/right side back started to hurt. Thought it might be gastral. Continious to this day and wordened up until today. Maybe Kidneys? or?? I was thinking again was gastral, but now I know it is not. Same pain when pressure put on it by bending, sitting in my truck against seats etc... Now I am worried. NEVEER had something like this other than a Gal Blagger which was removed.

LETHARGIC; FLUSHED; FEELS WORSE EVERY DAY; WOOZY AND UNSTEADY; A BIT TIGHT IN THE BOTTOM OF HIS CHEST; NO ENERGY; PAIN IN ALL MAJOR MUSCLES, HURTS EVERYWHERE; NAUSEA; LOW GRADE FEVER UNDER 99F; SPLITTING HEADACHE; TIRED; RESTLESS SLEEP; This spontaneous report received from a patient concerned a 60 year old male. The patient's weight was 350 pounds, and height was 75 inches. The patient's concurrent conditions included high blood pressure, chronic lyme disease, seasonal allergies, arthritis, hives allergy, non smoker, and alcohol user. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Concomitant medications included ibuprofen for arthritis, naproxen sodium for arthritis pain, lisinopril for high blood pressure, and fexofenadine hydrochloride for seasonal allergies. On 11-APR-2021, the subject experienced flushed. On 11-APR-2021, the subject experienced feels worse every day. On 11-APR-2021, the subject experienced woozy and unsteady. On 11-APR-2021, the subject experienced a bit tight in the bottom of his chest. On 11-APR-2021, the subject experienced no energy. On 11-APR-2021, the subject experienced pain in all major muscles, hurts everywhere. On 11-APR-2021, the subject experienced nausea. On 11-APR-2021, the subject experienced low grade fever under 99 F. On 11-APR-2021, the subject experienced splitting headache. Treatment medications included: paracetamol. On 12-APR-2021, treatment medications included: acetylsalicylic acid/caffeine/paracetamol/salicylamide. On 13-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 had not recovered from tired, restless sleep, splitting headache, pain in all major muscles, hurts everywhere, no energy, lethargic, nausea, low grade fever under 99 F, flushed, feels worse every day, woozy and unsteady, and a bit tight in the bottom of his chest. 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

Guillain Barre syndrome. Severe progressive motor impairment upper and lower extremities. Respiratory distress severe widespread edema, hypertension increase,

In the beginning a very strong pain arms whole body after the stomach started the back and everything got worse for 4 days going to and from the emergency room and then still hospitalized all due to problems after the vaccine in the last exam the variant was positive for guillen barrer before discovering this he lost his sight for two hours he cannot walk he lost the strength of his limbs and his pressure shot up he has dysphacia and is still hospitalized with physical therapy

Got up on Friday morning and almost fell over and had to be careful not to fall while walking to bathroom to get a shower. That night I was dizzy and could not lay down and especially could not lay on side so I propped up pillows and slept upright. Same thing Saturday night but less. Some thing on Sunday night but much less. Just a little spaced out on Monday and slight headache. CAlled doctor, no call back yet but I did not want to go to ER. So far it is going in the right direction. Had minor headache initially, night 2, but tylenol worked to relieve.

Moderate headache, joint stiffness, muscle aches and skin sensitivity began 8 hours after injection and lasted 36 hours.

Presented to emergency department on 5/12/21 with productive cough what onset a week and half prior to presentation. Also had complaints of diarrhea, nausea, dizziness, and shortness of breath when standing. Patient had cardiac stent placed approximately 5 weeks earlier. Was found to be COVID-19 positive and was admitted for further management. He was admitted for 2 days.

Patient had sweating , snoring, dizziness, shaking , throwing up .we called 911, before the paramedic came in, he started to talk and be more aware about everything around. they checked his blood sugar was 152, blood pressure was above the normal. the paramedic kept talking to him and he was responding good. Patient refused to go to the hospital

About 5 min after getting immunization the patient started to stand to tell an associate that he was having a reaction. He got light headed and started to pass out. A pharmacy technician was able to get to him in time and guide him to the ground. He was unresponsive for 10-30 seconds. Before we could take further action he regain consciousness. After a couple minutes he wanted to go back to chair. Within a minute he lost color and passed back out. This time he came back sooner and stayed on the ground till EMSA arrived. Only BP we got was several minutes into the event 124/82 HR 54. Paramedics did not transport the pt.

Client received the Janssen COVID vaccine lot #205A21A and expiration date 6/23/21 at approximately 3:01PM. Client arrives to the vaccine observation room and within 10 minutes reports feeling lightheaded and having tunnel vision to EMTs. EMT takes vitals: blood pressure 170/92, heart rate 80 and oxygen sat: 94%. PHNs arrive to assess client. Client is upright in chair alert and oriented x 4. Client denies any shortness of breath. PHNs observe sweating and rashes on left and right arms. Client reports his oxygen is normal for him since he has COPD. Client reports having a history of severe anaphylaxis allergy to penicillin, client reports taking morphine, lexapro, tizanidine, lyrica, and remeron. At 1:15pm client reports feeling "clammy and cold". Clients face is flushed and rash is spreading to neck, upper chest, lower left leg. PHN offers client Benadryl and he accepts. PHN starts calling 911 at 1315. PHN administered 50 mg of IM Benadryl at 1:17pm. At 1:17pm, vitals by EMT: heart rate:88 and oxygen: 94%. Client reports he "feels something in his throat" at 1:18PM. At 1:20pm client reports feeling in his throat is improving. At 1:20pm paramedics arrive and assume care. Client left facility wheeled out on a gurney at 1:27pm. Client will get transported to hospital. PHN alert security that a car left here overnight might belong to client being transported.

Covid vaccine received on 5/20/2021. Patient went to another state over weekend and reported spending most of Sunday, June 13, 2021 in a vehicle. Patient presented to cardiology outpatient appointment with dyspnea on 6/16/2021. Later that same day was loading hay in very hot weather (around 100 degrees Fahrenheit) and became dizzy. Later, that same day the dizziness remained and new symptoms of chest pain and shortness of breath. Patient presented to ER that evening, and was admitted to the hospital for bilateral pulmonary emboli extending into all lobes of the lungs.

The evening of the vaccine my neck began hurting. When I awoke the following morning I couldn?t move my head. I had to move my head with my hands. The pain was excruciating. This cycle continued for four days. On the fifth day the symptoms began to subside.. After about ten days the symptoms were gone. I did not contact the doctor about it. That was my mistake.

AE: Dizziness, extreme fatigue, inability to stand or walk immediately after administration of vaccine. Treatment: Vitals taken; stable. Blood glucose taken; not hypoglycemic. Gave Pt water to sip on. Pt assessed by PCP and cleared to go home.

I had no symptoms up until May 3rd. I had high blood pressure - it was through the roof. - It was 193/101. I was experiencing dizziness and wobbly - not sure on my feet. ER. Changed dosage to - higher dosage - Lisinopril and Amlodipine. Primary care doctor decided to give me Prednisone - I did the series of it and I no longer take it. Blood pressure is still high and racing with the heart issues and working with the doctor to still get it under control and taking the meds. They did issue me Meclizine - in case I have a vertigo feeling. May 26th - I told her I am not going to use her services anymore and so I'm seeing Dr. now. Remicade infusion every 8 weeks. I still go to work right now.

I am experiencing numbness in my left leg and food. When walking my left food feels heavy and I can't control my step, i.e., my foot hit the ground with a thud and I can't control it. It makes waking at a normal pace more difficult and I don't have control nor dexterity that I have in my right leg and foot.

61 y.o. right handed male who the Program is consulted for possible stroke. Patient reports that he got his COVID vaccination (Johnson & Johnson) today (3/11/2021) at about 10:30 AM. While waiting after the vaccination, at about 11 AM he became dizzy and felt like he was "loaded" ("stoned from smoking weed") and the started shaking "as though he has a fever but without a fever." and left side sensory loss which is non-disabling. He was taking to a CT scan which was negative for stroke and was discharged home.

I was achy and became weak and dizzy about 1pm. By 2pm , I developed Ortho static hypotension which caused my blood pressure to drop and travel to ER via ambulance .

Approximately 4:30 pm I started feeling leg/calf pain. I was driving at the time. Got home about 6:30pm, got out of the car and felt immediately sore all over. I took our trash can to the street and started feeling very cold and intense body cramps and shaking, also feverish, hot flash. It felt difficult to walk. I went immediately to lay down. Now I felt very cold. I slept on/off until 10pm. Woke a few times with intense leg/hip pain, Woke up around 10pm, vitals 115/77 107 temp 101.5 Took a long hot shower, feel better, but still feel some hip and leg pain, slight fever. I took one Acetaminophen 325mg.

After receiving vaccination, patient proceeded to observation area. He passed out briefly, then regained consciousness, but was sweaty, disoriented, dizzy and drowsy. EMS was called, he asked to lie down and was helped to ground into a recovery position. EMS arrived and took him for further evaluation.

Patient reported at 1112. Self reported as feeling woozy, "i think it's anxiety, it started as soon as they gave me a shot". 0 CP, 0 SOB, 0 throat tightness. 0 PMH. Allergies to pollen. VS 98%, P 50, BP 144/100, R 16. patient provided water and snack. Patient feeling better and repeated BP at 149/86. Patient had a driver to drive home.

started getting numbness in hands-fingers and lips and then numbness to feet and fell to ground with inability to walk - no strength in legs knees or arms. left facial drooping and slurring of speech and severe weakness -paralyzed

14 days after receiving the vaccine, I started getting dizzy/vertigo. When i lay down on my back, or when i tilt my head back or when i turn my head to the left and right. The room that I am in, starts to spin. I have to stop and stand still for several seconds before I am ok. I am 61 years old and never had any dizzines/vertigo in my life before I received the vaccine. I exercise 3 times week, dont smoke, drink very little alcohol consumption. I am 5 feet 9 inches tall and weigh 165 pounds. My blood pressure is 130/80. I have been going to a chiropractor about 2 times a month for the past 20 years for regular spinal adjustments. I am an active person with no health issues. .

After patient received the covid -19 vaccine, he reported: anxious, and does not feel good. We observed him for 15mins, after 15mins, patient reported he wants to pass out, developed cough and then he developed wheezing, his breathing is heavily, I gave him a dose of Epipen and called 911.

The injection itself was high on my arm and was very painful as it was administered (much more so than a typical vaccination in the arm). The pain has been persistent, and has gotten worse over time. No fever, no inflammation at the injection site other than a red dot that resolved over about one week. On advice of my physician (nurse practitioner) I've been icing the shoulder three times a day and taking ibuprofen 800 mg q 6h - this has not led to any improvement - to the contrary the pain is getting worse and the shoulder is losing substantial mobility. Something seems to have been done wrong - and am wondering if the injection itself was given in the shoulder or tendon rather than intramuscularly.

Soon after shot felt sweaty - dizzy - that is all he remembers. States he was very nervous on arrival and does not like needles. Patient observers states they noticed patient coughing and then he passed out.

HOT FLUSHES IN THE FACE; A LITTLE DIZZINESS; A LITTLE KIDNEY PAIN ON HIS RIGHT SIDE; This spontaneous report received from a consumer concerned a 61 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included back fusion, rheumatoid arthritis, and mild high blood pressure. 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, administered on 06-MAR-2021 on left arm for prophylactic vaccination. Concomitant medications included etanercept for rheumatoid arthritis. On 06-MAR-2021, the subject experienced hot flushes in the face. On 06-MAR-2021, the subject experienced a little dizziness. On 06-MAR-2021, the subject experienced a little kidney pain on his right side. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hot flushes in the face, and a little dizziness on 06-MAR-2021, and a little kidney pain on his right side on 12-MAR-2021. This report was non-serious.

Dizziness and light headedness beginning approximately four (4) hours after injection. Currently (04/10/2021) experiencing mild light headedness and impaired ability to mentally concentrate and focus. Mild pain with palpation at injection site.

The patient called today to inform us he has adverse events on Saturday evening, 40 minutes after getting the Covid Vaccine, he had a sensation of floating, and 4 hours later sharp chest pain which occurred every 3 minutes , lasting 10-15 seconds for a duration of 3 hours, he could not move. then at 2am Sunday morning, he woke up gasping for air, he drank some water and tried drinking coffee which he spilled and blacked out, by Sunday afternoon he felt better, and today he is feeling a lot better

Pt was immunized at 1:30pm on monday 4/12/21, He presented today 4/15/21 and stated he had woke up Tuesday 4/13/21 with a knot on his left leg that was very painful and had difficulty walking

Pt reports that 36 hours after he received his vaccine he developed vertigo and went into a cardiac arrhythmia. He took an ambulance to the ER, he was given IV fluids and had lab work done. He reports he is now starting to feel better (5 days later)

Feeling unwell. "Burning" head to toe, shakes, near syncope, sweats, tiredness, dizziness, lightheaded. Onset of symptoms less than 1 hour. Patient denied symptoms of chest pain, (L) arm pain, or SOB. Patient sent by EMS to local emergency department.

BODY ACHES; LIGHT HEADEDNESS; STOMACH ACHE; CHILLS; LOW GRADE FEVER; This spontaneous report received from a consumer concerned a 61 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no medication allergy. 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 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, light headedness, stomach ache, chills, and low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the low grade fever, chills, body aches, light headedness and stomach ache was not reported. This report was non-serious.

CHEST TIGHTNESS; LEG HEAVINESS; LEG TIGHTNESS; TIREDNESS; THROAT CLOSING UP ON HIM; SWEATING; DIZZY; This spontaneous report received from a patient concerned a 61 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high cholesterol, pollen allergy, asthma, chronic obstructive pulmonary disease, colon disorder, non smoker, and non alcoholic, and other pre-existing medical conditions included no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with cefalexin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: 25-MAY-2021) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, Laboratory data included: Blood test (NR: not provided) high cholesterol. On 06-APR-2021, the subject experienced throat closing up on him. On 06-APR-2021, the subject experienced sweating. On 06-APR-2021, the subject experienced dizzy. On 07-APR-2021, the subject experienced tiredness. On 13-APR-2021, the subject experienced chest tightness. On 13-APR-2021, the subject experienced leg heaviness. On 13-APR-2021, the subject experienced leg tightness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, and dizzy on 06-APR-2021, and had not recovered from throat closing up on him, tiredness, chest tightness, leg heaviness, and leg tightness. This report was non-serious.

The patient states that on March 20 he was vaccinated with the Johnson and Johnson COVID-19 vaccine. He states that over the past several days he has developed erythema of the palms and a change of appearance of the palms that ?looks like they aged 3 years.? He states that he has developed new onset pain of the thigh, which has made ambulation difficult. He states that these symptoms were not present prior to obtaining the vaccine.

since getting the COVID 19 vaccine on April 7, I had at least 6 times "heart beat stopped" feeling, two times I almost passed out. I never had that kind of feeling before.

Dizzy spells (room spinning, nausea) for first 2 weeks. Now only having light headed and nausea spells no dizziness. Does seem to be getting less severe as time goes by but still having spells. Had an MRI done on 04/26/2021 of my head and everything came back normal.

At 1238 pt stood up c/o dizziness. Pt. refused to sit down for 3-5 min. After pt sat down, CFD took @1243 BP 99/65, HR 95. Pt drinking Gatorade, states he was diabetic and hadn't eaten today. At 1247 BP 97/60, HR 94. At 1249 HR 94, BP 103/68, BS 147 Pt states he was feeling better and wanted to go home. Pt left @ 1252. BS 147, BP 103/68

HE CALLED ME ON MAY 6, 2021 REPORTED THAT HE IS HAVING SEVERE NAUSEA, MUSCLE ACHES, THROWING UP. NO DIZZINESS. BECUASE OF MUSCLE ACHES I ASKED HIM TO STOP TAKING ATORVASTATIN NEED TO CONTACT MD ABOUT THE FURTHER CHECKUP AND EVALUATION.

Five minutes after receiving the Janssen vaccine, this patient was observed to be diaphoretic sitting in the post vaccination observation area by this nurse. Patient was alert and oriented x 3. Patient reported that he felt nauseous and felt like "passing out". Vital signs were assessed by this nurse and paramedic. Patient's vital signs were normal. Symptoms resolved shortly after vital sign assessment and 5 minutes after first reported. Diaphoresis resolved. Nausea resolved. Patient denied "feeling like passing out". Family escorted and drove patient home after he completed his 30 minute observation. Patient encouraged to call 911 or his PCP if symptoms reoccur.

Patient fainted and fell on the floor, as soon as he left the room to wait in the observation area for 15 minutes. He was conscious and oriented, We called 911, they took care of him and got him out of the store. He didn't go to the hospital, and said that he felt much better as soon as they gave him water.

For the first two weeks, there was only mild headache and fatigue. But on day 12 (or 13) following the shot, my husband had severe abdominal pain and black, tarry poop. He passed out on the toilet in the middle of the night and hit his head, woke up in a puddle of blood (from hitting his head) . He was severely lightheaded, short of breath, could not walk. He had to crawl back to bed. He continued to have severe lightheadedness, shortness of breath, muscle aches, abdominal pain, and also ringing in his ears. He called me early Saturday morning and told me what happened and that he called out from work. (We do not live together. He is 280 miles away because of his job.) That man has called out sick only one time since I've met him in 1998; so when he told me he did not go to work, I knew it had to be really bad. I drove up there ASAP the same day, and I took the pulse oximeter with me. His oxygen levels were all over the place. They were usually better (like high 70s to low 80s) while he was lying down. When he would sit up or stand up, the number would plummet, reading so low I thought he was going to die. One time his finger was so cold that it took me 4 tries to get a reading. It read at 55, but I realize that might be because his finger was too cold.

The day after the vaccine I was working and later in the day I started to feel dizzy. Within an hour and a half I could not stand up and I was very dizzy. My coworkers said my eyes rolled back in my head. The ambulance transported me to the ER and my Blood Pressure was at 80 Systolic. I was given fluids and I was discharged after five hours. I still couldn't work the next day and I was still really tired for the rest of the week. It seemed to take a couple of weeks to feel normal but the fatigue was extreme for the first week after the episode of dizziness. I have two autoimmune diseases and a history of blood clots so I might not have gotten the Janssen vaccine if the risk was known. The blood thinner I was taking at the time might have helped but my blood pressure on discharge was still only 110/60.

muscle pain in my left leg for the last three days unable to sit or use my leg to stand up pain meds do not work

Almost immediately after patient sat down in observation chair after vaccine administration, he stated he was feeling extremely dizzy and light-headed. He also became extremely sweaty and cold/clammy to the touch. Took his blood pressure and it was 80/56 mmHg. HR was 49 bpm. Grabbed him some cool cloths to apply to his face/head/neck. He stated he was extremely anxious about the vaccine as he has an extremely phobia of needles & thought this may have contributed to the event, but was not sure. After a few minutes, he began to feel better. He stopped sweating, skin warmed up and he was no longer dizzy or light headed. By the time his 15 minutes were up, he was back to normal again.

Wasn?t able to stand up at all... nausea fainting dizziness etc... had to take rescue twice within 5 days... was in the ICCU unit at one point.. diagnosed with orthostatic hypotension

Pt became nauseated, lightheaded, and dizzy about 3 minutes post vaccination (Janssen). Pt was laid down on the floor and feet propped up on chair. BP 112/74. Vomited x3. Symptoms began improving after vomiting. Repeat BP 116/80. Pt sat up and was observed for 15 minutes. Pt has history of similar reactions post blood draws. Pt left after 15-minute observation period with symptoms resolved.

Patient began sweating and feeling lightheaded shortly after vaccination at approximately 1125. Patient then fainted in his chair and was initially non-responsive to the nurse. At this time I called 911. The nurse administered a single epi pen in patient's quad and he woke up. The nurse then took patient's vitals at 1138: BP - 109/73; P-84; SPO2-99%; T-97.4; R-16. Patient stating he was still feeling dizzy and fatigued. The paramedics arrived and took patient to hospital for continued evaluation. I called patient later in the afternoon and he had already been discharged and was at home resting and feeling better.

The afternoon after receiving the vaccine I had a job interview at 1:00PM EST and I wasn't certain I could make it because I felt a little off. I drank a bottle of water that was offered and I started feeling lightheaded and worse. As soon as I stood up, I thought I was going to fall so I sat back down. I waited around for about an hour before leaving. I stood up and felt a little better, but still a little off. I felt okay enough to drive and went to my interview. Once I got to the building, I had no clue how I got there. I completed my interview and remember leaving the building and sat in my car for a long time. I don't remember how I got home. I walked into my apartment and I lay on my bed and didn't wake up until the next morning. In the morning I went to my kitchen and grabbed more water. My ears started hurting, my head starting hurting and I felt off. I called and made an appointment with Dr. and informed her that I did not feel right. She wasn't sure if my feeling was from the vaccine or if it was a sinus infection. She gave me vancomycin 160mg capsule and tobramycin 20mg capsule. I feel that the shot is what messed me up. I felt like someone stuck a pencil in my ears. I felt like I wanted to sleep all the time. I also had chills in 65 degree weather. I had to have the heat on in my house. I'm still feeling a bit of pain around the injection site.

Patient denied history of fainting. Patient received Janssen vaccine at 11:49. Immediately after receiving vaccination patient was complaining of arm pain. Patient was asked by charge RN to stay seated at table instead of moving to observation area. Patient started complaining of feeling dizzy at 11:53 am. RN asked patient to lie down. Patient wanted to remain seated. Patient asked if he was diabetic. Patient confirmed he had type 2 diabetes and was unsure of last time he ate and blood sugar. Snack and cold water was obtained for patient. Patient became diaphoretic and was breathing fast. Blood presssure obtained and read 195/177. Blood glucose was obtained and read 132. RN asked for assistance lowering patient to ground. Patient's eyes rolled back while lowering patient. Patient was unconscious for approximately 60 seconds. EMS was called by bystander. Patient came back to consciousness and was alert and oriented. Patient's Blood pressure was obtained adnd read 156/80. HR was 58. EMS arrived and obtained vitals. Patient refused further treatment by EMS. Patient had ride pick him up at 12: 40. Patient was alert and oriented and no other symptoms upon leaving vaccination site.

Fatique, joint pain, tunnel vision, memory fog. Bad tunnel vision (4 by 4 range) Severe memory fog (called doctor) Bad word recall, poor eye hand cordnation, poor cordnation, balance. 6/23/2021 went back to work, had trouble walk and stacking crates. Very tired, severe joint point. Had to leave work. Felt disoriented

Arthralgia in both knees. No visible swelling. Symptoms became progressively worse. Pain and difficulty walking peaked 5 days after administration. On the sixth day the symptoms stopped completely. No longer in pain. Walking returned to normal. I participated in the Pfizer m-RNA clinical study. Received my second m-RNA dose in October 2021. After the second m-RNA dose I made a VAERS report of pain in joints. I should not have made the decision to take the booster dose. I made this decision on my own.

5/23 chills,headache, sore throat, diarheah, vomiting, cough, low energy 5/24 Seen doctor given steriod and antibiotic injections, prescribed prednisone and antibiotics. Condition improved for a few days but never went away. Then condition started to worsen as energy and breathining became worse. condition continued to decline as breathing becomes more labored and energy level dropped more. had to stop working as condition worsend. couldnt walk 20 feet without having to stop and rest. i was out of breath and struggling. decided to see doctor again. 6/17 seen doctor and given steriod and antibiotic injections again. given new scripts for prednisone and antibiootics. condition did not improve. more to add

sat-ok, sun sore arm weak sleep all day,mon tired weak left arm restricted tues tired left arm weak bad headace wed seem better left arm weak, sharp pain in center chest slightly labored breating, thur severe pain still in center chest like something is stuck. the pain subsided , fri sore area center chest , tired. seem better sat tired weak. have been slow and weak since. through july . otherwise ok but tired and sleeping alot.

Sudden onset of severe headache, chest pain, difficulty breathing, fatigue and nausea, ~72 hours post vaccination. After 16 hours of bad symptoms that got worse, I took my husband to the ER, as he was having difficulty breathing and moving. (He is normally very fit, active and healthy). In hospital, they ran a battery of tests and found signs of inflammation in chest and lymph nodes. They gave him fluids, and intravenous pain meds (acetaminophen, Toradol), which helped slightly. Symptoms diminished slowly over next 24 hours, and he was feeling 90% better by Saturday afternoon.

blood pressue 96/42. patient sweating. feeling dizzie like he was about to pass out. provided food/water and constant monitoring until symptoms resolved

Double vision about 25 minutes after treatment. Driving home and had to pull off side if road. Lasted 2 to 3 minutes. Continued then on to home.

Day 1: 11 hours after injection - severe fatigue, dizziness, diminished ability to mentally focus, severe weakness in legs and diminished ability to control legs. Legs intermittently felt numb and at time with "pins and needles" tingling. Knee joints felt as if in danger of flexing backwards. Arms were similarly affected but not as drastically as legs. Arms had better function and control than legs but with marked weakness. Day 2: Some improvement. Able to go to work but still have fatigue and leg weakness persist. It takes additional mental and physical effort to walk. Walking does not feel automatic or safe like it was before. Still have high level of fatigue. Symptoms improve some later in the afternoon. Days 3

Janssen COVID-19 Vaccine EUA 2 1/2 days of severe flu symptoms. Nausea, Fever, Chills, weakness,no sleep. The next days nausea and light headedness Day 7 (today 3/20/2021) nausea, weakness, and fainting spells. Fainting spells include vision impairment (everything looks fuzzy like a bad tv reception).

Patient experienced perspiration, dizziness, and fainting with no loss of consciousness. Patient was talking and answering questions appropriately. B/P 120/80, FSBS 131 @ 1:52PM. EMS was notified and Patient was transported to local hospital. I spoke with the patient today and he states he was discharged from hospital and everything was fine. He states he is doing good today.

Patient started feeling warm and dizzy around the last few minutes of waiting for the vaccine 15 minute window. About 13 minutes after the vaccine was administered. We provided the patient with water and informed him to sit and wait a few more minutes.

High fever, dizziness, weakness, sore joints, headache, diarrhea. Started approx. 8 hours after injection, worsened over the night, lasted into the next day.

I have been experiencing severe pain in my joints, my shoulders and lower back are the worse. It's bad enough I can't sleep very well or even walk right.

Patient fell to right side while sitting in chair hitting back of head on wall and floor. Unresponsive , diaphoretic and pale. Pt was unresponsive for approximately 30 seconds. He said "the last thing I remember was feeling like I needed to take my mask off, then I saw yall stating over me." Pt denies "passing out" in the past. EMS was called and patient was taken to ambulance on a stretcher. He declined to go to the hospital.

Patient fell to right side while sitting in chair hitting back of head on wall and floor. Unresponsive, diaphoretic and pale . Patient was unresponsive for approximately 30 seconds. He said "the last thing I remember is feeling like I needed to take my mask off, then I saw yall standing over me." Pt denied "passing out" in the past. EMS called and the patient was taken out on a stretcher by EMS but refused to be taken to the hospital.

After 10 minutes of vaccination, patient was sweating and dizzy. Ambulance team arrived check the vital signs which were stable. Patient was alert and conscious at the movement. He indicated that he wanted water. The ambulance team allowed him to drink about 1 sip (10-15 ml) of water. Then he had tachycardia. Then ambulance took him to the hospital. His wife was with him.

Janssen COVID-19 Vaccine Woke middle of the night very cold under heavy covers, Hard to walk the next day, had some of the same symptoms I had when I had covid in November. I can't find the lingering side effect mentioned and why I am sending this: A month later my legs feel like they are in ice water, everything else went away after 3 days. At the touch they feel normal, this is all day everyday.

Warm feeling followed by fainting and slight convulsions. Nausea, gas, feeling faint, and usability to drive a vehicke for approximately 75 minutes. Slept for several hours, faint feelings subsided after 15 hours.

On 04/12/21 I had just eaten and sat down at the computer. I started feeling disoriented, light headed and my vision started to become affected. I could not focus my vision and tried to vomit also also but immediately went to bed. Throughout the day/night when i got up I was unable to walk/see as normal and required my hand on the wall for balance. I also felt nauseated and could not eat anything during this time. I was able to sleep mostly and as of this submittal(04/13/21 7:51 pm CT) i have been symptom free for several hours. No medical treatment was sought due to no health insurance. All symptoms indicate stroke .

About 10 minutes after getting the shot, while waiting in the Doctor's waiting room, I began to feel dizzy and began sweating. They moved me into an exam room, and which time I passed out. I was awoken by the doctor standing over me, rubbing my chest. I was subsequently transferred to the ER.

Severe lower bottom left of the abdomen on March 26 at around 7am. Difficulty in walking. Pain around hip and middle and upper back.

First 72 hrs....Extreme joint stiffness, cramping, lower extremities ( both legs to feet) felt extremely hot, chills, , disoriented, weakness in legs while standing, and extreme fatigue. The fatigue and weakness has continued and now experiencing headaches and blurred vision with brain fog since the vaccine.

Headache, dizziness starting several hours after vaccine administration and persisting for the past week.

Patient received the Janssen vaccine on 3/17/21 at 4:42 pm. Beginning at 2:30 am on 3/18/21 the patient began to experience dizziness, vertigo, shaking, tremors, nausea, and vomiting. The shaking and tremors occurs all over but is most significant in the hands and arms leaving the patient unable to do simple daily tasks or return to work. These symptoms began 3/17 and have persisted every day since in varying severity. Sometimes the tremors last for more than 20 minutes straight. The patient was seen in the emergency department on 3/26/21 but the hospital notes are unavailable to the pharmacy at this time. Per patient, he had an MRI and no other tests and was given a prescription for ondansetron for nausea and discharged. The patient believes he was not adequately assessed and is still suffering from symptoms. He has a follow up with a primary physician 5/28/21 which is the soonest he was able to be referred.

DIZZINESS WITH MOVEMENT; MUSCLE ACHES ALL OVER; SLIGHT NAUSEA; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, overweight, and dental numbing, and other pre-existing medical conditions included the patient had no known allergies. The patient experienced drug allergy when treated with epinephrine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025, and batch number: 1805025 expiry: UNKNOWN) .5 ml, administered on 08-MAR-2021 09:00 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021 16:00, the subject experienced dizziness with movement. On 08-MAR-2021 16:00, the subject experienced muscle aches all over. On 08-MAR-2021 16:00, the subject experienced slight nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle aches all over, dizziness with movement, and slight nausea. This report was non-serious.

Pt. Vaccination was March 5,2021, became immediately dizzy and light headed onsite paramedic walked with him around the site for observation and evaluation. Allowed to leave was fatigue and nap and when he awoke had the within 24 hrs . Tenetus increase dramatically in high pitch and intensity that was constant. Had disruptive sleep since the vaccine because of the ringing in ear. Average 4.5 and 5. Never straight sleep it is disruptive sleep. Three telehealth appt. March 26, 2021 because of anxiety because of the ringing.

Patient states he received J&J vaccine on 4/1; on 4/10 he had nonradiating persistent low back pain. A few days after that (on 4/13) he felt numbness and pain in his legs, in addition to ?decreased sensation in his inner thighs. These sensations were migratory and intermittent. Also noted in his upper extremities as well. He also had issues with temperature sensation in his lower extremities. On 4/14 he had slight haziness in vision while driving which resolved after 30-60min and has not recurred. He also had slight difficulty walking. On 4/15 he had an appointment with his PMD; had L-spine XR which revealed moderate lower lumbar facet arthritis, and was thought that change in sensation was likely d/t radiculopathy - was prescribed ibuprofen, muscle relaxant, oxycodone (took oxy x1, ibuprofen for a few days). Since then he has also had intermittent stabbing pains in various parts of his body which resolved spontaneously. On 4/17-4/18 his back pain resolved. On 4/18 at 4:30am he woke up with R-sided facial weakness. He has not had focal weakness aside from the face. Was seen in ED that morning for this R-sided facial droop involving the forehead, diagnosed with Bell's palsy and given prednisone/valacyclovir. Yesterday 4/19 around mid-day he started having L-sided facial weakness and slurred speech. This has progressed since yesterday. Reports ability to swallow, though a little difficult d/t cheek weakness. Low back pain has returned as well. Does report constipation and possible poor bladder emptying for the last few days. He was seen by a Doctor and referred to ED to rule out AIDP and other diseases after J&J vaccine.

BURNING; SLEEPY; THROMBOSIS AND BURNING WENT AWAY; SORE ARM; FELT TIRED; WARM BANDANA LIKE HEADACHE; DIZZINESS; BLEEDING BY ANKLE; This spontaneous report received from a patient concerned a 62 year old white and not Hispanic or Latino male. The patient's height, and weight were not reported. The patient's past medical history included thrombosis, burning on inner thighs and concurrent conditions included thick varicose vein. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 043A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 05-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in APR-2021, the patient experienced bleeding by ankle. On 05-APR-2021, the patient experienced dizziness, sore arm, felt tired and warm bandana like headache. On 05-APR-2021, after getting a shot the patient noticed thrombosis and burning went away. On 06-APR-2021, the patient experienced sleepy. On 16-APR-2021, the patient experienced burning The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning on APR-2021, dizziness, sleepy, felt tired, and warm bandana like headache on 06-APR-2021, and sore arm on 07-APR-2021, and the outcome of bleeding by ankle and thrombosis and burning went away was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0; 20210436178-covid-19 vaccine ad26.cov2. s-Bleeding by ankle. 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 events than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE

He received the vaccine, had very painful going in and tingling going down his left arm and to the elbow which was numb, and the left little finger was numb, and a dizzy spell afterward which was typical for him. He then on the 9th day had extreme intercostal pain in the ribs on the right side and his right shoulder extremely painful, low grade fever, chills, fatigue and inability to draw a full breath. He called the doctor and they were on the way to the clinic they told him to go to the ER based on his symptoms. He went to the ER and they admitted him and did blood work, and then did a chest x-ray, then a chest CT scan and it was positive for pulmonary embolism. He was treated with an anti-inflammatory through the IV and a blood thinner to the stomach. He was hospitalized for 1 full day, and discharged home with Eliquis double dose for 14 days and then a single dose until further notice. He is still having fatigue and aches on the right side of his brain and aches in his feet, but is to see a pulmonologist for his lungs, as it will take up to 6 months for it to resolve. He also has damage to the right side of the heart and lung. Is waiting to get a CT of the brain.

COLD; CHILLS; FATIGUE; SORENESS AT THE SITE OF INJECTION; DIZZINESS; UNABLE TO STAND UP; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's past medical history included sinus infection, and problems in ear, and concurrent conditions included acid reflux, motion sickness, and dizziness.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 09-APR-2021 for prophylactic vaccination. Concomitant medications included meclozine for motion sickness. On APR-2021, the subject experienced dizziness. On APR-2021, the subject experienced unable to stand up. On APR-2021, the subject experienced fatigue. On APR-2021, the subject experienced soreness at the site of injection. On 10-APR-2021, the subject experienced cold. On 10-APR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizziness, soreness at the site of injection, fatigue, chills, cold and unable to stand up was not reported. This report was non-serious.

Site: Pain at Injection Site-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Tingling was only located in fingers and hands. Patients Blood Pressure after event was recorded at 106/58. Patient states he naturally runs lower blood pressure and heart rate. Also mentioned that he has a fear of needles.. Patient is now responsive and feeling better.

Seven days after the vaccine I got up from dinner and I had sharp pains in both wrists on the inside. I could not rotate my thumbs and I could hear clicking. I called my doctor and she confirmed Dequervains Syndrome. It was bilateral. I don't have any history or other symptoms of Rheumatoid Arthritis. I couldn't pick anything up for ten days and I still have to stretch my wrists to have any strength or motion. I have full motion but I still get pain when I rotate my arm.

Abrupt onset of widespread joint pain, stiffness, significantly limited range of motion within a few days of receiving his covid vaccine -- > PMR like symptoms -- > elevated CRP

Light-headed, vertigo, fast pulse, high blood pressure over 2 days. EKG was negative. Holter heard monitor results pending

He came into the pharmacy and was complaining that he had gone to the doctor and was told to report to the pharmacy so that they could report the pharmacy. He received his vaccine, and he wrote down to the pharmacy that he had a numb arm, no nerve conduction in the upper arm, he cannot raise his elbow outward, and he's still having bicep movement. He informed the pharmacist that it was not any better, his doctor did not give him anything for it and that it would be better over time.

Right after receiving the vaccination I immediately became drowsy. I became very dizzy could not keep any food down including water. The duration was about 24 hours. I also experienced Vertigo and could not stand up. My head also was spinning like a merry go round.

RIGHT HAND CRAMPING AND PULSATING PRETTY GOOD; RIGHT HAND SWOLLEN; UNABLE TO CLOSE HAND COMPLETELY; This spontaneous report received from a patient concerned an adult male. The patient's weight was 240 pounds, and height was 73 inches. The patient's past medical history included ablation, and stents, and concurrent conditions included heart issue, non-alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies and no drug abuse or illicit drug usage.The patient received covid-19 vaccine (suspension for injection, route of admin not reported batch number: 1808986 expiry: 04-JUL-2021) dose was not reported, administered on 24-MAY-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced right hand swollen. On MAY-2021, the subject experienced unable to close hand completely. On 25-MAY-2021, the subject experienced right hand cramping and pulsating pretty good. The action taken with covid-19 vaccine was not applicable. The patient was recovering from right hand cramping and pulsating pretty good, right hand swollen, and unable to close hand completely. This report was non-serious.

LIGHTHEADED; DIZZY; FELT LIKE LOSS OF BALANCE WHEN STANDING UP; This spontaneous report received from a consumer concerned a 62 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included squamous cell cancer on right arm. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-MAY-2021, the subject experienced lightheaded. On 27-MAY-2021, the subject experienced dizzy. On 27-MAY-2021, the subject experienced felt like loss of balance when standing up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lightheaded, dizzy, and felt like loss of balance when standing up. This report was non-serious.

BRUISING ON BACK OF LEFT KNEE; SEVERE PAIN ON LEFT LEG BEHIND KNEE; HEADACHE; DIZZINESS; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and did not had drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A, expiry: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced dizziness. On 13-APR-2021, the subject experienced headache. On 26-APR-2021, the subject experienced bruising on back of left knee. On 26-APR-2021, the subject experienced severe pain on left leg behind knee. On 10-MAY-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, and headache on 20-APR-2021, and had not recovered from severe pain on left leg behind knee, and bruising on back of left knee. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.

Patient has had intermittent weakness since covid vaccine in April. Admitted on May 11 for weakness, stroke was ruled out. Noted to have bilateral upper and lower extremity paresthesia thought secondary to diabetes. Readmitted on May 17, began to have frequent falls with bilateral lower extremity weakness, when he stood up his legs could not hold him. MRI ruled out ischemic infarction. Diagnosed with Guillain-Barre disease and ambulatory weakness. Followed up with neurologist.

I had severe dizziness and difficulty breathing where i just could not catch my breath, and something was going on with my heart where my heart was doing flip flops, I took benadryl for the breathing issue and caffeine for the chest issue. the symptoms lasted two days and were very severe.

Client received dose of COVID vaccine (Janssen Lot#205A21A expiration date: 08/07/2021). Client received vaccine at 1050 am and walked away with steady gait to next tent to sign in for clinic appointment. At 1100 PHN went up to client to check on client. Clt reported "feel dizzy" while standing next to clinic check in table. PHN walked client to sit in nearest chair. 1105 vitals taken: BP 110/78, RR14, 75 bpm. PHN gave juice to client to drink. Clt denies itchiness and nausea. Clt non diaphoretic, color appropriate to Ethinicty. Client has history of environmental allergies, and allergic reaction to penicillin (unknown route ) of hives and itchiness when taken as a child. Client Ax0 x4, freely conversing with PHN. 1110 am client states "feeling better" and "not dizzy anymore." 1112 PHN stood client up. Client denied dizziness or nausea. Vitals: 130/80, RR 16, 80 bpm. Client states staying in a shelter, waiting for transportation from outreach to go to SSI appointment. PHN educated when to see PMD. Client plans to go today. 1120 Client walked off with a steady gait and got into car for transport.

In May patient noticed progressive painful lower extremity edema (left greater than right). On June 11, patient came to the hospital with sudden onset dyspnea, palpitations, lightheadedness and dizziness while refereeing a basketball game. Ultrasound of lower extremities found non-occlusive thrombus in the left common and profunda femoral veins/occlusive thrombus throughout the left femoral vein/popliteal vein, and tibioperoneal trunk. Patient started on heparin drip and admitted to stepdown unit for concern of submassive PE given elevated BNP, DVTs, and dyspnea, and confirmed via VQ scan. Patient was transitioned to oral anticoagulation (apixaban). Swelling of legs greatly improved, and dyspnea improved though cough persistent by the time of discharge. Of note, patient also has a history of elevated PSA (to 80s), but patient has not seen urology for follow-up for possible malignancy. Patient also found to have UTI (klebsiella) secondary to his chronic urinary retention.

Four hour after injection I started to shiver almost uncontrollably. My temperature around midnight spiked to 103 and my heart rate was constant at 150. I was dizzy. Very little sleep. Temperature broke at 4:00AM

Injection site soreness for 6 days. Mental and physical lethargy for 7 days with a mild headache and odd taste in throat for the first couple. Workout reduction of capability of 20% slowly edging back up to 95% on day 6.

I experienced acute vertigo and nausea three days after vaccine. I was treated at the ER at Hospital on Wed. 3/17/21, and discharged on 3/19/21. The diagnosis was Unilateral Vestibular Hypofunction; it was the same side I got the shot on (left). I was treated with meclizine and given outpatient eye-hand exercises to do. The symptoms have faded, but not disappeared as of today, 3/20/21.

Patient presented with vitals 160/79. Patient approached by clinical observer as a check-in and patient mentioned feeling dizzy. Patient walked to tent and stated dizziness did not worsen. After resting in chair for a few minutes, pt states he is feeling fine and "this usually happens when I get my flu shots too". Repeated blood pressure and went to 146/77 and is feeling better. patient denied dizziness, left at 1107.

Within about 30 mins of getting the vaccine I felt a little dizzy/disoriented. This feeling passed within an hour. That night, 3/27 around 9 PM I began to feel cold as if I was running a fever and started having body aches. I did not take my temperature to see if I actually did have a fever. The symptoms lasted most of the night. The next day, 3/28 I had the flu-like symptoms again at night.

Hot flashes and excessive sweating, dizziness and nausea, fatigue and achiness. Started at approximately 3:30 am Sunday, March 28th. Symptoms greatly subsided by that evening. Mild nausea Monday morning.

Started feeling ill a few hours after vaccination. Became increasingly ill over the next few days with nausea and vomiting, severe diarrhea, leg cramps that progressed to where he was not able to ambulate, flushed, confused.

PATIENT WAS ADVISED TO WAIT FOR 15 MINUTES. THE PATIENT AFTER LEAVING THE PHARMACY FELL ON THE GROUND REPORTED BY ANOTHER PERSON WHO CAME TO THE PHARMACY. HE SAID HE GOT DIZZY AND FELL AND SUFFERED A WOUND ON HIS HEAD. PARAMEDICS CAME AND THE BLOOD PRESSURE WAS FOUND TO BE LOW. PATIENT WAS BROUGHT TO THE HOSPITAL

POSSIBLE SYNCOPE-PT FELT DIZZY PULSE WAS 51, BP WAS 133/91. FRONT ASSOCIATE CALLED 911 AND AMBULANCE CAME AND REFUSED TO GO AND WAS ABLE TO GET UP AND WALK OUT

After vaccination, pt sitting in observation area. Patient fell to right side out of chair and hit his head on concrete wall while falling. Pt was unresponsive, diaphoretic, and pale after fall. Unresponsive for approximately 30 seconds. ?The last thing the patient remembered was feeling like he needed to take his mask off. Next thing I knew, everyone was standing over me.? Patient denied history of passing out. Patient was transported via stretcher to outside ambulance where he was evaluated. Pt refused to be transported to hospital. Follow up call to patient 4/7/2021 at 6pm ? Pt states bp elevated, but hx of hypertension. Patient calling PCP to discuss medication. Pt adivised if problems arise, call 911 or go to ER.

morning after, woke up to dizziness and unstable on my feet, so dizzy at times I think I will pass out, 04/10/2021 symtoms are still going strong have missed 2 weeks of work

around 3 AM patient got dizzy and passed out. When I talked to patient at 6:30 AM, he stated to me that he was dizzy and fell during the night, his voice was very slurred and I could hardly understand him, he was also very disoriented. Took him to hospital ER around 7 AM

Janssen COVID-19 Vaccine EUA 6 Hours after injection I became violently ill. Severe Sweats Severe Vomiting Severe Headache Severe Dizziness (could not stand with out falling) Severe Diarrhea

63 year old male with progressive weakness at bilateral faces and extremities, LEs > UEs, absent DTRs throughout x 2 weeks. Received J&J vaccine at 3 weeks ago. His current neurological examination and clinical history is suggestive of GBS NEUROLOGICAL EXAM: MSE: A+Ox 3 Language: no aphasia CRANIAL NERVES: 2nd CN: bilateral pupils are equal round and reaction to light, visual field-full 3rd,4th and 6th CN: EOM-I 5th CN: no sensory deficite 7th CN: face: symmetric, not able to smile or blowing air or holding water 8th CN: hearing loss: no 9, 10th CN: no dysarthria, palate movement:normal 11th CN: no neck weakness 12th CN: tongue: middle, no atrophy MOTOR EXAM: Tone: normal Strength: 4+/5 at bilateral UEs, 4 Pt symptoms started very early. Narrative from family below: "Day 1 (The day he took the vaccine): My father was complaining of very heavy chest pressure (said he felt like his chest was being pushed down with force.) He felt really tired and had a nasty headache. Day 2 He began to feel tingles in his legs and arms. Said he felt sore and had mild pain around his back, feet, legs, hands, and arms. The headache came in and out. Day 3 He began feeling more severe pains in both legs + headache. More tingling around his face, lips, and jaw. Day 4 Severe pain continued around his entire body. Had an episode where he lost vision from 1 eye (he described it as blurry vision) felt like he was going blind from one eye. Day 5 Could barely stand on his two feet and could no longer go to work. He stayed in bed and then hospital visits began. My mom took him to emergency for the first time. I was able to get details of the location where he was vaccinated and onsite contact information. The info is below:

Pain in right leg that lasted for 2 days, that started 2 weeks after injection. Also had 5 minutes of dizziness the morning after the injection. I?m going to report this info to my personal physician today.

Feeling tired, muscle aches, nausea, vomiting, difficulty breathing, dizziness, weakness, heartburn Medications given: NaCl 0.9 %, ondansetron (ZOFRAN) Rx for ZOFRAN ODT

Developed BAD vertigo (not normal for med) At aprox 9 PM day after shot. From 11PM- next day noon it moderated somewhat, but I still had to touch the wall without falling. This is not normal for me. Been ok since around noon last week Sunday. My doctor is aware of the situation. He didn't feel it was serious. We corresponded by telehealth; NOT visit.

Client left message on immunization nurses line 04/13/2021 stating he received J&J vaccine on Friday, and is having a severe reaction, can't eat, drink, breathing problems, hasn't been able to pee for 4-5 days, throwing up and severe diarrhea, and he can't stand. I returned his call and he verbalized all issues above and also said his legs, arms and hands were cramping up and having ringing in the ears. I recommended him to go to the ER now, he said he had called his PCP and was told the same thing. He stated he is single and lives alone and does not drive. I told him to call 911 and he verbalized he is too embarrassed to do that and states he will wait for his daughter to call him. I offered to call his daughter for him and he declined. Addendum: Created by RN. 04/16/2021 02:01 PM 04/16/2021 Client called reporting the same symptoms as in 4/13 message -- I told him to go to the ER immediately. He stated he could not drive due to muscle spasms and feet and leg pain. Asked if he would please call 911 and stated that was not necessary. He verbalized he understood my directions and stated he would go to urgent Care. Called Sheriff office to make a well person check.

I experienced extreme vertigo on the in the middle of the first night after the shot. When rolling over in bed from flat on my back to my left side my body felt like it kept moving when I had in fact stopped. It feels like I am rolling out of a hammock. Right side has the same sensation. Also happens if I bend over when standing. It is not always accompanied with dizziness. Severity increased over a few days, then gradually decreased over the next 5 days or so and is now increasing again. I HAVE NEVER HAD THESE SYMPTOMS IN MY ENTIRE LIFE. My pre existing tinnitus has grown very much louder. I have had occasional low pain / pressure deep in my sinuses.

Feel winded, short of breath, with moderate physical exertion . ex briskly walking up a long flight of stairs a couple of time wearing a mask caused me to breath every hard. Seems more than normal....I had to keep the mask on Typically, with heavy physical exertion I would feel this way. Also, The first time this happened I did feel a little light headed and noticed a higher than normal heart rate.

SHAKES; COULD NOT SLEEP; HOT AND COLD CHILLS; COUGHING WAS DRY TODAY BUT PRODUCTIVE YESTERDAY (STUFF WAS COMING OUT); LUNGS WITH BURNING SENSATION LIKE BRONCHITIS; SORE LUNGS; COULD NOT STAND UP; STOMACH ACHE; BURNING ARM FROM SHOT; PAINFUL /SORE ARM; NAUSEA; FEVER; This spontaneous report received from a patient concerned a 63 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported. batch number: 203A21A expiry: 23/JUN/2021) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced shakes. On 06-APR-2021, the subject experienced could not sleep. On 06-APR-2021, the subject experienced hot and cold chills. On 06-APR-2021, the subject experienced coughing was dry today but productive yesterday (stuff was coming out). On 06-APR-2021, the subject experienced lungs with burning sensation like bronchitis. On 06-APR-2021, the subject experienced sore lungs. On 06-APR-2021, the subject experienced could not stand up. On 06-APR-2021, the subject experienced stomach ache. On 06-APR-2021, the subject experienced burning arm from shot. On 06-APR-2021, the subject experienced painful /sore arm. On 06-APR-2021, the subject experienced nausea. On 06-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not sleep on 07-APR-2021, and lungs with burning sensation like bronchitis, stomach ache, and burning arm from shot on 11-APR-2021, was recovering from painful /sore arm, had not recovered from hot and cold chills, shakes, nausea, fever, and coughing was dry today but productive yesterday (stuff was coming out), and the outcome of sore lungs and could not stand up 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.

BLOOD PRESSURE INCREASED 147/60; TACHYCARDIA; ACHINESS; FATIGUE; SEVERE LEG PAIN; UNABLE TO WALK LONG DISTANCES; SORENESS IN ARM; This spontaneous report received from a consumer concerned a 63 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total dose administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the patient experienced soreness in arm. On APR-2021, the patient experienced unable to walk long distances. On APR-2021, the patient experienced severe leg pain. On 01-APR-2021, the patient experienced fatigue. On 05-APR-2021, the patient experienced achiness. On an unspecified date, the patient experienced blood pressure increased 147/60, and tachycardia and his EKG came back clear on a suspected heart attack. His blood pressure was normally low. On 19-APR-2021, the patient was hospitalized. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 147/60 mmHg, 110/60 mmHg. Treatment medications (dates unspecified) included: sodium chloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood pressure increased 147/60147/60, had not recovered from soreness in arm, unable to walk long distances, fatigue, achiness, and severe leg pain, and the outcome of tachycardia was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0 20210440548-COVID-19 VACCINE AD26.COV2.S-Blood pressure increased, Tachycardia, Unable to walk long distances and Achiness. This event(s) are considered unassessable. The event(s) 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(s). V0 20210440548-COVID-19 VACCINE AD26.COV2.S-Soreness in arm, Severe leg pain, Fatigue. This event(s) are labeled per RSI and are therefore considered potentially related.

The patient described severe left arm weakness with inability to lift his arm in order to bring a cup to his lips. He has some sort of upper respiratory complaints at after he got the vaccine and received treatment from his PCP.

Within a minute I had a hot flash that started in my calf and went through my body. In less than a minute I was lightheaded and almost passed out (or fell asleep). I beeped my horn and the nurse came right over. They took my blood pressure and it was 150 over 120. (I've never had high blood pressure before. The second reading was 140 over 110. In about 5 minutes my BP was normal 120 over 80.

One week after vaccination, I had to all 911 and was put in the hospital, I had a stroke, I had a blood clot in my brain, and severe abdominal pain, and terrible headache where the clot was, I couldn't see, my legs weren't working right. My head was sensitive on the right side, like a tingling and sore to touch, then the headache started in the center of my head. I stayed in the hospital for 3 weeks. I'm home but have slurred speech and I use a walker now.

I started feeling kind of puny and sat down for supper - no taste or smell. After that I felt cold symptoms - and I had no energy whatsoever. I talked to the Dr online and he told me take Zinc Sulfate and Hydroxychloroquine; nebulized a medication but I can't remember what it was. I got pretty sick for about three days. I got to the point that I was so weak I could hardly move. I went to ER and was there for 1/2 day. They gave me IV fluids. They said that my lungs still sounded good The illness ran it's course of about 10 days. I still feel winded two months later. I have a little nagging cough yet. I can still go to work though.

Severe vomiting, severe diarrhea, weakness, spasms in legs. Could barely get out of bed for 36 hours.

Patient has severe phobia of needles. About 10 minutes following administration of Janssen vaccine, patient began turning pale and said that he felt dizzy. Moments after, patient fainted and was out for about 30 seconds. During this time, 911 was called and then patient came to but was still very pale and lips were blue. EMTs came minutes later and took patient to ambulance to be checked out. Patient was feeling better by then and did not leave in ambulance.

I didn't have anything for two weeks. But then a lot of pain in arm. from a sound sleep. I took ibuprofen. Over the next few hours, the pain radiated down my left arm. Wave would come and go (of pain). The pain came on to my chest - and I decided to go get check. Had very low energy for about four days - after that. My left arm, I lost the strength in it - I could barely lift 10 lbs over my head. Swimming - I couldn't pull my arm with my elbow high - I could barely skim the top of the water. This is still happening. I had a doctor appt - yesterday but that was for arthritis pain that is in my knees, wrists etc - he gave me arthritis medication and I noticed the positive affects of it already. But it didn't address the arm that I can't pull up over my head. It seems like my immune system is attacking me- a couple of years ago this happened when I had a virus and it took me almost a year to get that muscle to start working again.

Yesterday felt dizziness and queasy and deep pain in the venter of my chest, about 1am it was exacerbated and felt it was symptoms of a heart attack and I took a baby aspirin.

High levels of pain and stiffness in joints, tendon anchorages and muscles. Initially concentrated in hips; migrating to shoulders joints, deltoids, trapezoid, front of pelvis, buttocks.

HEADACHES, SOMETIMES BLURRED VISION, AND SLITHG PAIN IN THE STOMACH, ALONG WITH SOMETIMES LIGHTHEADED (DIZZINESS) C.HEST PAINS

Seven minutes after being injected, pt reported feeling lightheaded and thought he might pass out. Myself and other helped lower patient to the floor. He began to shake for 2-3 seconds. instantly snapped out of it. Applied cold ice packs and gave patient water. elevated pt legs. BP taken. After drinking fluids and rest, pt reported he began to feel better. Kept him for a total of 35 minutes. Initial BP was 90/47 with a HR of 50 At time of discharge pt BP was 113/77 with a HR of 76.

Severe muscle weakness, joint pain in shoulders hips, groin area. worse in morning , or long seated period. Can't stand up from kneeling position

Eight minutes after receiving the J&J vaccine the patient began sweating profusely, was very hot, had a tingling feeling all over his body and was lightheaded. He was breathing fine and talking the entire time. Used ice packs to cool patient down. Called 911, paramedics took him to the hospital ER where he was discharged to home doing well.

Woke up in the early morning and was real dizzy, a little later in the morning in went away. Itchy around the eyes for a day and a half. Seems to of gone away this morning.

Site: Bruising at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Mild, Additional Details: Paramedics and Firefighters came out. Gave him 1 liter of normal saline. His heart rate was in the 30's. They stablizied the patient and took him to hospital.

10 minutes after receiving the vaccine, the patient claimed he was feeling light headed and needed to lay down. After speaking, his eyes then went closed, and he clenched his fists and he started coughing up liquid. He was not responsive. He was moved to the ground and turned on his side. He became alert about 3 minutes after becoming unresponsive. He claimed this happens to him when he is at doctor's offices or receiving vaccines/procedures. He claimed it was "normal." He said he felt fine/normal, and this has happened in the past, though he did not mention this to the pharmacist prior to administration. 911 was called and examined him. He was allowed to go home on his own, did not go to the hospital.

Injection on Mar. 13, around 10:40 am. Slight chills starting around 7 pm, approx 8 hours after injection. Later that night around 10 pm had severe chills, teeth chattering that lasted till approx. 3 am the next morning. Chills so bad I had a hard time walking to the bathroom. Mar. 14, low-grade fever, 99.4, aches, tired, flu-like symptoms all day, took Tylenol. Mar. 15 feeling much better, flu-like symptoms gone, still a little tired, left arm finally sore. Wifes's arm hurt for 2 days.

Janssen COVID-19 Vaccine EUA , Accelerated Heart Rate of 115 / 120, Acclerated Respirations, Fever with temp of 101.6 lasting for 23 hrs, Extreme body aches, headache, feeling very tired, minor dizziness, minor nausea

Light-headedness, high blood pressure, high blood sugar. Approx. 8 hours after injection, blood pressure reading was 163/89. It is going down slightly each day. Blood sugars have been higher than normal, ranging from 140 to 223.

Patient complained he was feeling dizzy about 5 minutes after vaccination. He was laid on the floor and legs elevated. Patient reported feeling better after several minutes. He also states he generally have this type of episode when it comes to needles. Patient left pharmacy with wife and expressed he was feeling fine.

I received the shot and waited there about 15-20 minutes after before returning home. No issues at that time. About an hour after the vaccination, I began to lose my mental function. My brain/mind were not functioning properly - to the point that I could hardly remember my name, let alone do anything on the computer that I was attempting to do. At about that same time, I had a feeling of near complete exhaustion come over me, to the point of thinking I might faint at any moment. I went to my bedroom and laid down. I fell asleep shortly there after and woke up approx 2.5 hours later. After waking, I felt normal again. I was able to process my thoughts and did not feel faint or exhausted any more. It has been 1 month today since having the shot. I have not felt any additional adverse affects to this point, other than the several hours after the shot. On a side note, I had not been sick prior to the shot or in the several months leading up to the shot. I have also not been sick since the shot. It was only the several hours on the day of the shot.

Patient vaccinated on 3/7/21, on 4/2 presented pain in left leg and some redness, on 4/3 some dizziness, lightheadedness, difficulty with vision in right eye, some slurred speech; on 4/5 his health agravated and EMS was called and taken to hospital; spouse informed that patient had a blood clot in stem of brain; on 4/6 patient died. No autopsy performed

Patient received his J&J vaccine for COVID-19 on 03/10/2021. On 3/17, he was at the grocery store when he felt a sting on his left lateral ankle. When he pulled up his pant leg, he saw the small little red spots that were exquisitely tender. He went immediately to his primary care physician's office, where he was prescribed Bactrim for suspected cellulitis. The rash steadily worsened with extension up his left leg and onto his right leg and blistering of some of the lesions most markedly in his groin. Pain associated with the rash increased and remained most severe on the lateral aspect of the left ankle. He presented back to his primary care physician's office on 3/19, where he was given methylprednisolone 80 milligrams IV, discharged with a prescription for prednisone 60 milligrams daily for the next few days. Pain worsened the morning of 3/20/21 to the point that he was unable to bear much weight on the left leg prompting his presentation to the emergency department.

It started from the chest and went abnormal serve pain couldn?t walked. Went to the emergency room and gave me pain.

About an hour after I received the vaccination, my left leg fell asleep. That never has happened before. on 4/7/2021, at approximately 1:00 pm, I stood up, got light headed and blacked out for a few seconds. I took my blood pressure and it was in the normal range. I didn't think much of this until the recent reports on the Johnson and Johnson vaccine started circulating. I've had no other issues.

symptoms of shortness of breath, dizziness and weakness 5-6 days after vaccination. complete heart block

Patient was found on the floor next to his chair facing forward in observation area. When we attended patient alert, awake and oriented x3. Denied any resp distress. No HA. No n/v. Patient has h/o dvt on coumadin. No h/o DM. recommended further evaluation in ER due to patient had syncope, on coumadin, hit his head to ground. But pt declined and signed AMA. patient reported that he will seek emergency if he feels any worsening symptoms.

DIZZINESS; VERTIGO; SPINNING AND FALLING SENSATION; FELT OFF; This spontaneous report received from a patient concerned a 64 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had not known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 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 vertigo. On 19-MAR-2021, the subject experienced spinning and falling sensation. On 19-MAR-2021, the subject experienced felt off. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from dizziness, vertigo, spinning and falling sensation, and felt off. This report was non-serious.

PATIENT WAS GIVEN THE JANSSEN COVID VACCINE. ABOUT 5-10 MINS LATER, PATIENT REPORTED HAVING SOME DIZZINESS WITH SOME CHEST PAIN. BENADRYL WAS PROMPTLY GIVEN @1202PM. THEN AT 1209PM, PATIENT BP WAS TAKING, IT WAS HIGH AT 160s/90s. PATIENT STATED THAT HE DOES HAVE HBP IN WHICH HE DOES TAKE MEDICINE FOR. HE ALSO STATED THAT, AT THAT PRESSURE, IT WAS NORMAL FOR HIM. PATIENT WAS MONITORED TILL AROUND 1245PM, HE STATED THAT HE WAS FEELING BETTER AND HIS WIFE HAS TAKEN HIM HOME. A FOLLOW UP PHONE CALL WAS CALLED AROUND 105PM. AT THAT TIME PATIENT WAS A HOME AND SAID THAT HIS SYMPTOMS HAS SUBSIDE BUT JUST FEELS SLEEPNESS FROM THE BENADRYL.

I felt dizzy and had problems with breathing right away after the injection. A doctor from that site who checked my vitals wanted to call an ambulance to take me to a hospital. I couldn't let this happen as I was 120 miles away from my apartment, where two dogs were left unattended. I decided to come back home and monitor my vital signs. Since that time, I had almost every other day a chest pain and high blood pressure and low level of O2 but was too busy at work to care of myself. On 04.30.2021 around 3am I decided to drive into ER at where I was admitted and had CABG surgery on Tuesday 05/04/2021.

Within 48 hours began to ache at major joints, experience lethargy. Following weeks joint pain ebbs and flows but remains constantly higher than before the vaccine. It isn't debilitating, but it does interfere with the quality of life and activity. I reported the issue to my pain management provider, and we are monitoring it at this time to see if it will subside.

April 20, 2021. PT needed to use the restroom. We stopped, he walked to the restroom, I went to the gift shop. Upon returning, I saw PT sitting on a bench. He was leaning to his left, could not see out of his left eye, very unstable when sitting. We missed lunch, so we thought it was his sugar dropping. I started to feed him jam and a chocolate bar. After 2 hours, his vision returned & he seemed better. He drove us back to the rental cabin. He rested the next 2 days. Then on Friday, we packed up our vehicle and Pt drove us back home. After arriving home, Pt's condition got worse. We went to the Dr, explained the events of the previous week & she came to the same conclusion, Diabetes spell. His condition continued to worsen, we went back to Dr several times, the ER 2 times and finally we got into see a Neurologist. That appointment, the doctor said he thought stroke. Dr scheduled a MRI for June 1, 2021. Results of that MRI was a definite stroke. Now he has started outpatient rehab with no promise he will ever regain full mobility. He can no longer drive, mow grass, walk without a cane and help, etc. Life has changed dramatically for both of us.

FALLEN SEVERAL TIMES; BARELY MOBILE; DIFFICULTY SPEAKING; SHORTNESS OF BREATH; BARELY ABLE TO SLEEP; HEADACHES; FEVER; This spontaneous report received from a patient concerned a 64 year old male other race and unspecified ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 in total administered to right deltoid on 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 patient experienced fever, headaches and shortness of breath. He stated that he was barely mobile (severe discomfort, feels like a handicapped, needs assistance to do anything) after receiving vaccination about 2 months ago. He felt like a handicapped person who needs assistance to do anything. He was barely able to sleep and found it difficult to speak. He stated he had fallen several times after receiving the vaccine. On an unspecified date, he had been hospitalized at 2 different hospitals and both instances did not help with his symptoms. He stated his HCP was aware and he could not help. He sounded to be in severe discomfort and as stated several times to fix it. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from barely mobile, fever, difficulty speaking, shortness of breath, headaches, fallen several times, and barely able to sleep. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: - fallen several times, barely mobile, difficulty speaking, shortness of breath, barely able to sleep. 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). - headaches, fever. This event(s) is labeled per RSI and is therefore considered potentially related.

Approximately 2 weeks after being vaccinated, I started having joint pain and stiffness throughout my body. It continues to bother me. It is especially noticeable in the morning after rising from bed, or after sitting for a long period of time. After pushing through the pain into normal activities, the pain lessens, but afterwards, the pain returns. I especially notice numbness and stiffness in my calves and feet after waking in the morning. I do not feel pain while not moving. Only when I attempt to move. My range of motion has been decreased because of the pain. I am normally an active person.Taking Ibuprofen seems to relieve the symptoms, but pain returns after the medication wears off.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium

Knee pain - left knee. Went to the doctor - it's believed to be a torn Meniscus. I'm going to have an MRI done. MRI scheduled for June 29th, 2021. No treatment. The pain comes and goes - it's not constant. It occasionally is painful enough that I limp.

2 days after receiving shot i experienced weakness in my left leg, difficulty walking, abnormal movement in my leg like continuous movement in my legs when standing still or setting. These events are still ocurring daily after 3 weeks

Vertigo or dizziness. Symptoms are mild. They became evident 30 hours after inoculation. I will remain home for the day and see how I feel tomorrow.

Slight dizziness and mild nausea occurring the day following the immunization (3/5) and continuing through present. No treatment as of yet has been administered.

Headache, achy and dizzy on evening of March 26 (about 6 hours after). This continued morning of March 27. Then suddenly mid-day (about 24 hours after the vaccine) fever (over 100), chills, shaking, dizzy, nausea set in (could not function) and lasted for 14 hours. March 28, still achy, dizzy and feeling of light headedness and exhaustion.

Patient reported sore arm that lasted almost 3 weeks. Soreness has been improving but still present when he reported. Pt also reported episodes of dizziness and flu like symptoms after the shots. Patient was advised to continue monitoring if symptoms did not improve, pt would call MD.

Serious increase in tinnitus since vaccination. Can?t sleep. Tinnitus started when contracting COVID in December. Had that with vertigo. Vertigo has passed. Tinnitus is a 4out of 5 and is debilitating.

we administer Janssen Covid-19 Vaccine , 5 to 10 minutes later the patient fainted in the waiting area. the associate who is watching our patient notified me that the patient is dizzy. I went outside and I noticed that the patient is leaning on the table and he fainted i put him down on the floor and lifted his feet up. he woke up in few seconds we also called 911 and they took the patient to the ER

Intense Lymphadenopathy, left neck below the ear, hard, warm, fever, headache, swollen, painful. Am onset impaired neck movement but no challenge to swallowing or breathing.

Fever 101.9 degrees, dizziness, Elevated pulse 105 bpm. (Normal pulse rate ranges between 75-78.) Elevated BP 175/100. (Normal BP in the 125/78 range. Nausea. Severe headache. Fever, headache and nausea subsided after 5 days. Heart rate and BP still elevated, Pulse will "race." I contacted my family physician . He suggested I keep close check on BP and go to ER if major symptoms persist after 4 days.

Extreme dizziness to the point of falling down even when attempted to just sit up, lasting around18 hours. Extreme headache with mild fever and other flu like symptoms. The reason why I am reporting this is that in my entire live I have have been so dizzy and unbalanced. I literally could not even sit up, I was super foggy and achey. By 3 days all the symptoms cleared.

Shopping, climbed a single level stairway, became winded, nauseous, got bad heartburn feeling, felt flush and started getting dizzy. Took Tums, no help went to Emergency Room and was told that there was an enzyme in my blood which showed I had a heart attack

PAIN IN BACK; PAIN IN LEFT HIP AND SHOULDER; DRAGGING FOOT; This spontaneous report received from a patient concerned a 65 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: not reported) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced dragging foot. On 28-MAR-2021, the subject experienced pain in left hip and shoulder. On 28-MAR-2021, the subject experienced pain in back. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in back, and pain in left hip and shoulder, and the outcome of dragging foot was not reported. This report was non-serious.

Muscle in shoulder is still very painful. Hard to lift arm over my head. Hard to take off a shirt and make certain motions.

I'm dizzy a lot. It comes and goes through out the day. Sometimes I'm dizzy all day long. Sometimes I'm not dizzy at all. But it's more often than not. This started a few days after the vaccine and I'm still experiencing it. It's kind of a floaty, unstable feeling. I didn't put two and two together at first. I've been to my doctor two times.

On April 16 patient came home fatigue, pale and legs hurting. The next day complained of right knee pain, Fatigue and looked pale. He woke up in the middle of the night complaining of right calf tightness and pain. On Sunday 18th he started to limp and when we looked at his calf it was double in size, warm to touch, and redness. We then went to the ER and had an ultrasound and CT scan . We were told he has multiple blood clots in the right leg and clots in both lungs. He was then transported to a hospital and given blood thinner shots in stomach. He was released from the hospital 4/20 and given blood thinners and assigned a hematologist. He?ll be on blood thinners 6-12 months, out of work a month and tested regularly to check platelets.

DIFFICULTY BREATHING; CANNOT FINISH EXERCISES; WEAKNESS; SWEATING; NAUSEA (FELT LIKE VOMITING); FEVER; This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. The patient's past medical history included stage 3 colon cancer, and concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and had no history of drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced sweating. On 10-APR-2021, the subject experienced nausea (felt like vomiting). On 13-APR-2021, the subject experienced difficulty breathing. On 13-APR-2021, the subject experienced cannot finish exercises. On 13-APR-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, difficulty breathing, weakness, sweating, nausea (felt like vomiting), and cannot finish exercises. 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.

1.stiffness in joints, 2. achy 3. coughing 4.runny nose 5. feeling tired 6. nauseous 7. blurred vision

On Saturday April 24, 2021, I began experiencing severe headaches, eyeball pain, light-headiness, weakness and lack of energy, pain at the injection site and flu like symptoms.

2 weeks ago on April 17th, I woke up feeling very dizzy and nauseous. The room was spinning. My left ear was ringing, My balance was off. Every time I bent over it was worse. I vomited after I ate. Spent the day and the next day in bed. On Monday I called my doctors office and explained how I was feeling and a tele visit was scheduled later in the day. During the tele visit, the doctor diagnosed my symptoms as vertigo. I never had vertigo in the past. She couldn't tell me if it was from the vaccine or not. She did mention she had patients complaining of vertigo after getting the covid vaccine. Medication and exercises were given to me. A few days later, my big toe on my right foot was aching terribly. Each day it seems to be worse and I am at the point where I can barely walk. Today I did some research online and saw that it could be gout. I never had gout n the past. I read vaccines can cause gout. So here I am 2 weeks since my symptoms began and I am still dizzy and have the toe pain. Exercises and medication is not helping.

Lightheaded, extreme fatique, red dots on skin and in mouth, bruising, low blood platelets, low hemoglobin

PATEINT RECEIVED THE VACCINATION ON 5/21/2021 AT 1330 HOURS. BY 5/22/2021 HE HAS REPORTED THAT HE HAS DEVELOPED PERIPHERAL NEUROPATHY IN BOTH OF HIS HANDS THAT HAS PROGRESSIVELY GOTTEN WORSE OVER THE LAST 6 DAYS. TODAY HIS HANDS HURT SO BAD THAT HE CAN HARDLE ZIP UP HIS PANTS AND CANNOT LIFT MOST OPTIONS. ANYTHING THAT PUTS ANY PRESSURE ON HIS FINGERS OR HANDS CAUSES PAIN. AT THIS TIME, I AM GOING TO CONTACT HIS PHYSICIAN TO SEE IF INCREASING HIS GABAPENTIN WILL BE OF ANY BENEFIT AND IN THE MEANTIME WE ARE STARTING SCHEDULED APAP 1000 MG QID AND NAPROXEN 440 PO BID-TID UNTIL A PHYSICIAN CONSULT CAN BE MADE. CONDITION DOES NOT APPEAR TO BE LIFE THREATENING AT THIS TIME, HOWEVER THE PATIENT IS EXTREMELY DISABLED AT THIS POIN AS USE OF EITHER HAND FOR COMPLETION OF DAILY ACTIVITES IS EXTEREMLY LIMITED.

Pain at injection site followed by Angina, Heart palpitation, Tightness in chest, lowered pulsox, dizziness. Followed by admission to emergency room with diagnosis of ABNORMAL ECG, lowered pulsox, Atelectisis (Chest Xray) Followed by referral to Cardiologist Symptoms are persistent Undergoing further treatments and further tests scheduled as of the date of this report.

Started experiencing fatigue, muscle weakness. After light cardio exercise, energy depleted and would have to lie down and then would fall asleep. I didn't feel sleepy, just extremely weak. Most pronounced in the arms and legs, but sometimes felt like whole body. Saw doctor on 5/12. Later on 6/5 had a complete CBC, physical workup. Some values were slightly out of range, but nothing significant. Went to urgent care about a week or so later because symptoms seemed to be getting worse. They repeated the complete CBC and also ran a lactic acid test. Again results were insignificant. Echo completed on 7/1 showing only mild diastolic disfunction. I'm afraid to exercise. I wake up in the morning with a mild tingling in hands and legs. As the morning progresses, the tingling, weakness, fatigue get worse. I can have some fairly good days, but most are not good. I have experienced some fatigue in the past, but this time has absolutely been the worse. Even as I am writing this, I feel the tingling, weakness in my hands. Earlier my legs felt achy, Legs feel ok at this time.

Had lower blood pressure since day 6. No treatment. dizziness some times. PS: day 1: blood pressure was <120/<80, day 6 to present: blood preesure was 89-112/60-81 PS: blood pressure monitor: Omron (model# BP7100) from pharmacy

Severe vertigo started on 15 Mar 2021. Symptoms include: vomiting; dizziness; unable to walk without falling; etc.

DIZZY; NAUSEA; HEADACHE; FEELING HOT; COLD FINGERS; DRY LIPS; This spontaneous report received from a patient concerned a 66 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043a21a, expiry: not reported) dose was not reported, administered on 04-APR-2021 16:30 to left arm for prophylactic vaccination. No concomitant medications were reported. On 04-APR-2021, the subject experienced feeling hot. On 04-APR-2021, the subject experienced cold fingers. On 04-APR-2021, the subject experienced dry lips. On 04-APR-2021 23:00, the subject experienced dizzy. On 04-APR-2021 23:00, the subject experienced nausea. On 04-APR-2021 23:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, nausea, feeling hot, cold fingers, and dizzy, and the outcome of dry lips was not reported. This report was non-serious.

Substantial lower back pain making mobility difficult. No prior hx of back issues or injuries. Started 2nd day after vaccination.

7 days after receiving J&J COVID19 vaccine, patient developed left ear pain, left sided facial numbness/droop, vertigo. Pt was seen in clinic and physician diagnosed pt with Left Bells Palsy. Prescribed 12 day prednisone course. Pt on Day 3 of steroid course today and slowly feeling better.

2 days after shot, fatigued, minor muscle ache, dizziness, blurry weak vision. Some nausea in a.m., then today, 7 a.m. nausea and weakness, chilly and extreme fatigue, in bed all day so far. Feeling like not enough air all week since shot.

Client fell while waiting in line to enter the POD. Client states that he got hot while waiting in line a long time. Client states that he does not think he lost consciousness but may have hit his head. 911 was called, EMS evaluated client and found him medically stable and client declined to go to the hospital. Client received Johnson and Johnson vaccine and left on his own after 30 minutes waiting time after vaccine.

SHORTNESS OF BREATH; BODY ACHES; DECREASED MOBILITY; EXTREME FATIGUE; PAIN AT INJECTION SITE/LEFT ARM SORE TO TOUCH; This spontaneous report received from a patient concerned a 66 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient allergic to triple antibiotic ointment.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Concomitant medications included omeprazole for drug used for unknown indication. On 06-APR-2021, the subject experienced pain at injection site/left arm sore to touch. On 07-APR-2021, the subject experienced shortness of breath. On 07-APR-2021, the subject experienced body aches. On 07-APR-2021, the subject experienced decreased mobility. On 07-APR-2021, the subject experienced extreme fatigue. On 17-APR-2021, Laboratory data included: Blood test (NR: not provided) within normal limits, and EKG (NR: not provided) within normal limits. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain at injection site/left arm sore to touch, and had not recovered from shortness of breath, extreme fatigue, body aches, and decreased mobility. This report was non-serious.

Within within 2-3 hours was dizzy and fatigued, since that day progressive feelings of exhaustion and little balance.

Patient was administered the Johnson and Johnson Janssen COVID-19 vaccine. Shortly after, a few seconds, the patient stated he felt flushed and head started to fall back. Staff member cradled his head and called another staff member over. Staff member called 9-1-1. Patient went unconscious and his eyes rolled back for approximately 30 seconds. When aware, we (staff members) transferred patient from the chair to the floor where staff member supported his back and fanned him due to his profuse sweating. Staff member continued talking to him when he became unconscious again, this time gasping for air and turning pale. We kept saying his name until he came to again and was somewhat aware of his surroundings. He fainted one last time. After this time, he sat up on his own and seemed to be very coherent. The EMS arrived shortly after and took over. They said they would take him out to check him out but he seemed to be doing better. An EMS personnel let us know the patient did tell him that he has fainted from vaccines before. However, he did not disclose this to us on the PQCF form or when asked verbally.

Patient experienced dizziness about 40 minutes after dose. Then significant arm swelling at injection site, patient described as "a deltoid on top of his deltoid" started by the same evening. Pain subsequently occurred described as severe that radiated into shoulder and all the way down the patient's arm that also felt like burning. The patient is still experiencing this 15 days later, although admitting it is finally starting to improve. Patient admitted to not being able to do much for the first 1-2 weeks and requiring opioid pain medication relieve the pain enough to sleep at all. Patient contacted primary care as well as drug manufacturer, Janssen.

DECREASE MOBILITY IN SHOULDER; UNABLE TO WORK; DEPRESSED; SEVERE SHOULDER PAIN; This spontaneous report received from a consumer concerned a 66 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient was in good health. patient had undergo physical therapy. 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 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced decrease mobility in shoulder. On 2021, the subject experienced unable to work. On 2021, the subject experienced depressed. On 2021, the subject experienced severe shoulder pain. Treatment medications (dates unspecified) included: ibuprofen, paracetamol, cortisone, prednisone, and hydrocodone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe shoulder pain, decrease mobility in shoulder, unable to work and depressed was not reported. This report was non-serious.

PAIN IN LEFT SHOULDER RADIATING ALL THE WAY DOWN FOREARM INTO DIGITS AND EXTENDS INTO THE SHOULDER; SUSPECTED INAPPROPRIATE ROUTE OF VACCINATION; DIZZY; SWELLING AT INJECTION SITE; INTENSE PAIN AT THE INJECTION SITE THAT SEEMS TO HAVE GOTTEN WORSE; UNABLE TO SLEEP AT NIGHT DUE TO PAIN; LARGE HEMATOMA AT INJECTION SITE; UNUSUAL AMOUNT OF BLOOD IN ARM AFTER INJECTION; This spontaneous report received from a patient concerned a 66 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug usage. The patient was treated with covid-19 vaccine (intramuscular, and 205AZ1A, serial number, model number, UDI number, and expiration were not reported) therapy dates not reported for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the patient experienced large hematoma at injection site, unusual amount of blood in arm after injection, unable to sleep at night due to pain, swelling at injection site, and intense pain at the injection site that seems to have gotten worse. Laboratory data included: Pain scale (NR: not provided) 7/10. On 08-MAY-2021, the patient experienced pain in left shoulder radiating all the way down forearm into digits and extends into the shoulder, suspected inappropriate route of vaccination, and dizzy. Treatment medications (dates unspecified) included: hydrocodone, and ibuprofen. The action taken with covid-19 vaccine was not applicable. The patient recovered from pain in left shoulder radiating all the way down forearm into digits and extends into the shoulder on MAY-2021, and dizzy on 08-MAY-2021, had not recovered from intense pain at the injection site that seems to have gotten worse, large hematoma at injection site, and swelling at injection site, and the outcome of unusual amount of blood in arm after injection, unable to sleep at night due to pain and suspected inappropriate route of vaccination was not reported. This report was non-serious. This case is a duplicate of 20210544916.; Sender's Comments: V0-Medical assessment comment is not required as per standard procedures, as the case was assessed as non-serious.

Received the J&J vaccine on May 11th, on May 17th I began having a migraine headache. On May 19th I began having vertigo symptoms, loss of balance, spinning room if I turned my head and when rolling over in bed. I needed to hold onto a countertop to avoid falling over. The headache subsided after six days, the vertigo (spinning room) continued to June 1st. I am still having balance issues when bending forward. I was seen by a Nurse Practitioner on May 18 at a Clinic. I told the NP I was conerned that I was experiencing headaches and vertigo with one week of receiving the J&J vaccine. I was told to review a video on Eply exercises for the vertigo. I do not know if a report was made by clinic regarding my adverse reactions.

extreme pain in location of shot - upper left arm. Substantial loss of mobility in left arm. Cortizon shot, prescription pain pills, physical therapy, but pain and mobility problems continue

That day, light headed ness and heart palpitations. Heart palpitations for short time only but felt periodically over the next few days. June 11, lower left led swelled and painful and shortness of breath. June 14, went to ER. They found multiple blood clots in upper thigh, behind knee and lower left leg. They also found approximately 20 clots in the lungs and administered Heparin drip and I was impatient. They put me on Eliquis and released me the next day. Now convalescing at my daughter?s house. Diagnosis. Acute Deep Vein Thromboses and Pulmonary Embolism bilateral.

My shoulders began hurting. I could not flex my left arm for a couple of days. That was now over 2 months ago, and I still have pain and stiffness, in both shoulders, that I never had before the vaccination.

Moderate to severe radiating right leg pain since late May, 2021, w/ no known cause. Recent swelling and stiffness in right knee. OTC meds for pain and cyclobenzaprine. Physical Therapy.

Pain well after injection of shoulder/arm injection was given in. From shoulder to elbow, rarely to wrist. Not joint pain but feels like muscles/nerve Can not lay on that side, limited comfortable positions. limited motion during the day because of varying amounts of pain.

Headaches and dizziness starting roughly 1 week after vaccination, and continued until eventual hospitalization. Experienced first time ever seizure (tonic-clonic) at midnight, March 29th. 2nd seizure approximately 12 hours later. 3rd seizure on May 2nd, at approx. 5 am. Patient is currently taking 500 mg levetiracetam (Keppra) twice daily. Doctors are still yet to identify the cause of seizures.

Pt called today 7/21/21 around 12:10 pm to inform us that he experience electrical shocks on his arm where he got his vaccine, severe pain on his arm, unable to lift his arm and shoulder, and had phlegm/cough about 3 days after getting the shot. These symptoms continue until now per pt. He said he informed his MD Dr. about it a week ago after he read/heard about the side effects of Janssen vaccine. He was upset at first because he said we didn't inform him about the side effects but I told him as a protocol, we usually inform pts about the side effects before getting the vaccine, provide the EUA fact sheet and advise pt to register on vsafe. The paralysis or nerve side effects were not known yet that time he received the vaccine. Informed pt that we will report this incident to VAERS and for him to also register to vsafe. Advised pt to coordinate with his PCP so they can run necessary test to evaluate his condition.

COULD NOT MOVE LEGS, ARMS AND UPPER BODY; LOSS OF APPETITE; CHILLS; This spontaneous report received from a consumer concerned a 66 year old male. The patient's height, and weight were not reported. The patient's past medical history included aneurysm in 2012 (rupture killed the nerve with one leg), the aneurysm changed the way he was walking and problems walking and concurrent conditions included ex-alcohol user (Stopped drinking 2 years ago), non-smoker, rheumatoid arthritis, and blood thinner. The patient had no known allergies. The patient had no history of drug abuse or illicit drug use. The patient was previously treated with prednisone. 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, 1 total, administered on 03-MAR-2021 in left deltoid for prophylactic vaccination. Concomitant medications included infliximab for rheumatoid arthritis. The last dose of infliximab was in FEB-2021. The patient did not discuss getting the vaccine with rheumatoid arthritis doctor. On 05-MAY-2021, the patient had more limited movement until could not move legs and was not walking good. It went up from legs to arms, upper body (coded as could not move legs, arms and upper body). The patient went to emergency room at hospital and stayed in hospital for 1 week. The patient went to rehabilitation one week after for physical therapy. The patient was about ninety percentage back to where he was before the vaccine. The patient also experienced chills and loss of appetite. The symptoms lasted 3 weeks and went away. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of appetite, and chills, and was recovering from could not move legs, arms and upper body. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210730947-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Could not move legs, arms and upper body. 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.

(3) syncopal episodes following vaccination, one of which resulted in a fall with direct injury to the base of neck, head, and right flank. Pt reported chest pain prior to syncope.

About 7pm I started feeling terrible chills and headache. by 10pm I had extreme body aches, bones , muscles, etc. Headache was very intense,eyeballs ached ,face etc. I was dizzy, jaw was stiff but mostly terrible pain. had some wheezing by it went away when I coughed up mucus. Had a 101.5 degree temperature all night which went down to 100 in the morning and back up to 101.2 later on the 14th. I had nausea and extreme pain all over my body and restlessness. it got a little better the next day but still feels like I have the flu. I had covid back in march of 2020 and was tested for the antibodies at the end of August. There is a horrific dearth of research on people who have had covid and whether they should get the vaccines. It is disgraceful, and the next time I will listen to my gut which told me NOT to get vaccinated!

One day after the vaccine I had extreme muscle and join pain all over body, general malaise, fever. This lasted for about 3 days. About 10 days post vaccine, the symptoms returned with a ferocious energy. The pain in my muscles and joints is so severe that I can't roll over in bed, have difficulty walking, and getting on and off the toilet. It interrupts my sleep so that I play musical bed-chair-couch throughout the night. Needless to say, it exacerbates the level of pain and fatigue I'm already experiencing. It is life debilitating as I cannot participate in my usual daily activities of walking, hiking, gardening, biking, etc. As a result of joint and muscle stiffness, I am also now experiencing headaches. These extreme conditions have persisted from March 23- April 9...and I don't see relief in the future.

Since March 7 (the day I got the J&J shot coincidentally), I have been experiencing dizziness (lightheadedness), weakness, racing heart from time to time (very badly after I did a work out on the day of the vaccination), tingling in my feet, jitters (like having too much caffeine), fatigue, and being cold (more than usual). Things have gotten progressively worse as I now cannot walk up a flight of stairs without a racing heart and heavy breathing and extreme exhaustion. (FYI, before this I was running 4-5 miles 4-5 times a week). In addition, my doctor tells me that I have no Covid-19 protection based on blood tests.

Increasing chest pain and colon discomfort. I went to hospital on Friday April 9th because of this. Troponin levels were normal. Symptoms have been coming and going and are still present. At times I feel like I am going to black out. I feel generally unwell and the chest pain is concerning.

LIGHTHEADED; FELT STRANGE; BRAIN FOG; SORE ARM/ARM FEELS PUNCHED; FELT UNWELL; TIREDNESS; LOCAL REACTION / REDNESS; This spontaneous report received from a patient concerned a 67 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid19 infection, and concurrent conditions included high blood pressure, and white coat syndrome. 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 10-APR-2021 for prophylactic vaccination. The batch number was not reported the company is unable to perform follow up to request batch/lot number. No concomitant medications were reported. On NOV-2020, Laboratory data included: SARS-CoV-2 test (NR: not provided) Positive. On APR-2021, Laboratory data included: Blood pressure (NR: not provided) Elevated. On 10-APR-2021, the subject experienced lightheaded. On 10-APR-2021, the subject felt strange. On 10-APR-2021, the subject experienced brain fog. On 10-APR-2021, the subject experienced sore arm/arm feels punched. On 10-APR-2021, the subject felt unwell. On 10-APR-2021, the subject experienced tiredness. On 10-APR-2021, the subject experienced local reaction / redness. Laboratory data included: Blood pressure (NR: not provided) Low grade 100. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lightheaded, felt strange, brain fog, and felt unwell on 10-APR-2021, and was recovering from tiredness, sore arm/arm feels punched, and local reaction / redness. This report was non-serious.

Per history, patient experienced a ground-level fall early 4/16, and was noted to have weakness on his left side. Patient was brought to the ER 4/18 with concern for CVA, found to have acute pulmonary embolism.

DIZZINESS; FEELING HIGH; WEAKNESS; This spontaneous report received from a patient concerned a 67 year old male. The patient's weight was 167 pounds, and height was not reported. The patient's past medical history included blood clots, and concurrent conditions included flu shot and weed smoker. 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 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 feeling high. On 09-APR-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, and weakness, and the outcome of feeling high was not reported. This report was non-serious.

The Headache/Pressure is there in the morning, and I feel fatigued, like I really didn't get any rest in the night., And the headache/pressure stays with me all day., But I don't believe it wakes me in the night, I did developed blurry vision, but only in one eye (right)., I went to Eye doctor, and they said it appeared a cataract had developed since the last visit. but the blurry vision has somewhat improved with reduction of the blood pressure., as far a dizziness., I would not feel comfortable going out and flying a plane since the covid vaccine shot, so I'd say I am a little unstable on my feet right now.....

Nauseous, vomiting, headache, light headed, disorientation, vision changes, jaw pain, lymph node inflammation, lethargy, mental confusion, sense of hopelessness, 15 days taper Prednisone, ibuprofen, acetaminophen, still currently experiencing symptoms today

Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Medium, Systemic: Nausea-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Severe

Patient received COVID vaccine (Janssen) on Saturday, March 6th at the Fairgrounds, patient called Health Department on 5/12/21 with the following report. Approximately the week of April 6th patient begin experiencing weakness in both thighs. Patient describes the weakness feeling like 'a twisted tendon', reports difficulty standing from a seated position, and reports pain when walking. Patient saw physician, on May 7th who prescribed a muscle relaxer and recommended PT. Advised patient to return if symptoms persist for an ultrasound.

Had a heart transplant 5 years ago. After vaccination, my calf muscles ached and I had to walk on the balls of my feet. I didn?t feel well and was achy, but all of that resolved after about 4 or 5 days. About 25 days after the vaccine, I woke up and my legs were hurting, swollen and lumpy. I went into the house and elevated my feet. I was sore from my calf to my ankles. I called the doctor and he told me to go the ER. After a 3 hour wait, one of the patients waiting almost threw up me, so I told them I was going home. Later, I went in to see the doctor about what was going on. After rubbing my calf vigorously, some of the lumps started to go away. The only thing my doctors came up with was that I was retaining water. I felt like I had gained some weight. I couldn?t stand long before my legs swelled. They prescribed a strong diuretic called Torsemide and I lost about 10 lbs. I currently wear compression socks every day, which helps with the swelling and my ankles hurt all of the time. I only take the meds as needed because it?s hard on my kidneys, which are already compromised due to my transplant meds.

Increased fatigue, lightheadedness, nausea, intermittent left arm pain and underarm pain and swelling. Left sided chest discomfort - pain worse with breathing and coughing non productive cough

BLEEDING IN BRAIN; COULD NOT SEE WITH HIS EYES; COULD NOT WALK; PAIN IN LEGS; SHARP PAINS THROUGH HEAD; BLEEDING FROM HIS EYES; BLEEDING FROM HIS EARS; SICK; This spontaneous report received from a consumer (patient's sister) concerned a 67-year-old, White, not Hispanic or Latino male patient. The patient's height, and weight were not reported. The patient's past medical history included covid-19. His concurrent conditions included inability to see after he got something sprayed into one of his eyes in jail and wheelchair user. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on 31-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. Since the day of the shot, the patient had been sick. On 02-JUN-2021 (about 2-3 days after the vaccination), the patient experienced side effects. He had bleeding in his brain due to which he could see with his eye, could not walk, had so much pain in legs, and sharp pains through his head. The patient was getting worse. On an unspecified date in JUN-2021, the patient had bleeding from his eyes and ears. The patient could not walk at the time of reporting. He had one good eye (not the eye with which he could not see due to bleeding in brain) but could not see from it too as he got something sprayed into it previously. Hence, he lost both eyes and could not see at all at the time of report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bleeding in brain, could not walk, could not see with his eyes, pain in legs, and sharp pains through head, and the outcome of bleeding from his ears, bleeding from his eyes and sick was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 - 20210632304 - Covid-19 vaccine ad26.cov2.s - BLEEDING IN BRAIN , COULD NOT SEE WITH HIS EYES , BLEEDING FROM HIS EYES . 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).

HEADACHE; DIZZINESS; This spontaneous report received from a patient concerned a 67 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 103AZ1A expiry: UNKNOWN) dose was not reported, administered on 29-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced dizziness. On an unspecified date, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, and the outcome of headache was not reported. This report was non-serious. This case, from the same reporter is linked to 20210702102 and 20210701921.

Headache, dizziness, vomiting over 3x in a 7 hour time period, pressure in neck up to the back of head, tightness in the back of head, faint feeling.

april 20th his foot started to hurt, April 21st his legs felt slightly weak, April23 & 24th felt sick had a hard time getting out of bed and dressing. April25th felt numb mid body and legs really weak had a hard time standing took him to the ER had a MRI on Back and Bloodwork done. April 26th saw his doctor ordered another MRI for head and neck. April 27th had MRI for head and neck. April 28th rushed to hospital symptoms got worse and was admitted also had a CAT scan and an MRI again. April 29th another MRI was diagnosed with GILLIAN-BARRE syndrome. Had six doses of IGG transfusions May 6th moved to rehab. was in Therapy till June 10th and Back to the hospital for 5 more treatments because his legs quit working again. WAs in the hospital for a week and then insurance denied therapy so had to find skilled nursing, found one moved him . He was at his new place maybe 8 hours then rushed back to the Hospital because a fever and may had an infection had medician to help get rid of that lost his facility he came from and then took a week to find another place he was there 3 weeks and had a EMG and the nerves in is legs are Damaged in and out so he will take a long time to heal and walk again and he is also very depressed because the whole situation.

Cough. Body aches Sharp pain shoulders, neck, torax. Could not move his head, could not move his arms. Fever, chills. Short breath Sharp pain right wrisk (fractured long ago and healed) - X-Rays showed arthritis. He did not complain before or it did not bothered before. A sharp pain in a specific point of his head (Right - front - up side). Not being able to laid down. Moving hurts.

Chills, headache, sinus congestion began 7/18/2021 Chest congestion and cough began 7/19/2021 Chest congestion, productive cough with thick mucus and hard white chunks began 7/21/2021 Difficulty breathing , wheezing, and continued cough 7/22/2021 First Emergency Room visit on 7/24/2021 for worsening Congestion, cough, and decreased 02 saturation. Second Emergency Room visit on 7/25/2021 for same complaint Third Emergency Room visit on 7/26/2021 for above complaints and fall from LOC

Fever of 100° began @ 10 pm 3/23/21and ended @ 8am on 3/24/21. Minor achy shoulders, back and injection site. Due to MS, fever raises inflammation in quadriceps making walking very difficult. Treated with Tylenol, cool compress and rest. General feeling of fatigue 3/24/2021. All symptoms completely resolved 3/25/2021

Patient had received his vaccination and was waiting for 15 minutes. Patient was shopping in pharmacy area and began to feel warm, flush, and light headed. Patient laid himself down and this was noticed by an associate. Code white was announced and 911 called. Pt was responsive and pharmacist applied cold compress to pt. EMS arrived and took over. Pt seemed fine after a few minutes of EMS arriving. Pt did state during the event that this has happened to him before in the past.

Initial complaints were of a headache and dizziness, follow by unsteady gait, confusion and eventually was unresponsive.

Woke up with swelling in both hands. Right more pronounced. Slight nerve tingling in left hand and wrist. Pronounced tingling in right hand and wrist. Over the next two days the left stayed the same while the right continued to worsen to include pain and tingling from the elbow to the hand particularly in the three central fingers. Hand difficulty holding item in my right hand. I then decided to seek medical attention the next day. The next morning swelling and pain were lessened so I did not contact medical attention. Each day since symptoms have improved except for discomfort in my right middle finger which is noticeable upon touch. Most noticeable when using eating utensils. The right middle finger has remained the same for days.

Had vaccine 7-March at 4:15 PM. One week later, 14-March, woke up at 8:15 AM with severe BPPV. Went to doctor and had Epley Maneuver performed a few days later. Then on 23-March woke up at 4:15 AM with another BPPV event. Again, returned to doctor for Epley Maneuver. Then on 2-April went to ENT Doctor to have ears checked. She performed the Epley Maneuver and everything was fine; there was no nystagmus. Then she laid me down on my back and tilted my head off the table and I had the worse dizziness ever, but no nystagmus. She sat me up. My BP jumped to 190/100; pulse 100. I couldn't stop being dizzy. Paramedics took me to emergency room. After 2 hours the doctor performed the Epley Maneuver, but there was no nystagmus so it wasn't BPPV. Had CT scan and MRI and everything was clear. What changed and what may have caused all this was that I had the J&J vaccine prior to all the dizziness.

Facial pain or headache becomes more severe, drowsiness or confusion , swelling of the forehead or eyelids, vision problems including blurred and double vision, seizure, dry mounth nausea tiredness constipation, double vision Diplopia, one aye is affected, vertigo, speech or walking

BP-200/120 BP-190/200 (ASYMPTOMATIC) P-80 BASLINE: LIGHTHEADEDNESS. RECENTLY RESTARTED ON HTN MEDS BY PCP. VERBAL ORDER: INCREASE AMLODIPINE TO 10 MG + LINOPRIL TO 40 MG. FLU (SDA) SXHEDULED WITH PROVIDER FPR 3/22

Patient's body was found on May 1st. Since the shot , he was complaining of tinnitus, sore legs, dizziness (passed our several times), loss of bowel control, and unable to maintain a stream of thought, which are stroke symptoms. He has had surgery for blood clots in the past. He seemed to get worse in the weeks following the Jansen shot.

day after vaccination had violent headache. chills, extreme muscular, joint pain, nausea., eyes glossed over, disorientation, dizziness . had weakness in left arm [site of vaccination and left leg .didn't take anything. only ate 2 dry english muffins. day 2. same with marginal relief. day 3 woke up at 4 am with sweats. clothes soaked with sweat. violent diarrhea . at 9 am. still have some disorientation, glossy eyes. afraid to eat because of diarrhea. had 2 , 2 liters of room temperature coke for previous 2 days. now 6 hours later somewhat better feeling.

On 03/14 I woke at 8:15 am and I was having a really bad dizzy spell and I had something like this before it was called bppv ( bengen paroxysmal positional vertigo) but i never had it as intense as it was when i woke up it was beyond anything that i have had in the past and I thought it was that I went on Friday 3/19 to another doctor that specialized in the Epley maneuver and that helped so much but then I had it again on 03/23 and I went back and they did the same thing Epley maneuver 04/02 I went to go see an ent and go to get my ears check she also did Epley maneuver an and nothing happen she turned my head and I had a bad episode of vertigo. and it was worse then it was the first time My blood pressure went up to 190/100 my pulse was at 100 broke out in a cold sweat she called 911 they took me to general hosptial. They did the and nothing came from it. They gave me volume but I only took one pill and it didn't do much for me. They sent me home I called Dr and they person on duty said that they can do a cat scan i said not they told me to go to emergency room right now I had a cat scan nothing came up they put in a ambulance and took me to another hospital so that i could an MRI which 10:30am, everything came back normal from that. So then my regular doctor told me to see my cardiologist to make sure it was not a heart problem last Tuesday i had a nuclear stress and echo cardiogram that came back to show that the dizziness is not from the heart or a blood flow problem

Arm was so sore could not use for about 10 days. Improving but 3 weeks later my bicep is still very sore

4/15/2021: Severe headache, hip/joint pains, Nausea & vomiting. Mobility & balance issues, unable to walk or stand, tinnitus & extreme fatigue, change is mental status. *tinnitus, fatigue, nauseous feeling and balance problem & sudden depressed feeling continuous for weeks. 5/20/2021: severe neck pain and neck stiffness. Fatigue, nausea, tinnitus, confusion & mood changes

diffuse severe myalgias, arthralgias, starting 2 days after vaccine administration, and progressive through current day. Patient evaluated today in clinic, and symptoms are increasing. No fevers, chills, but diffuse muscle tenderness and guarding with range motion shoulders and hips

The day after shot Covid like symptoms. The nest morning Stroke like symptoms required hospitalization for two weeks. I was wobbly and could not drink water without asperating. Symptoms still persist today..Extensive testing showed no stroke occured. Prior to shot, I was tested for antibodies from a Covid infection 7 months ago. The antibodies where still very strong. I gave in to peer pressure and got the shot with my doctors approval.

The night after getting the vaccine I laid down and it felt like the whole room was spinning around, it lasted about ten seconds. It hadn't happened again until the 11th of June, and the same thing happened. Also happens when I get up to fast. It seems like they are increasing in frequency. I went yesterday to my PCP and they performed some scans and tests. They get scheduled me for CAT scan on Monday.

Pt felt like he was going to pass out - seemed to go in and out of consciousness for a few minutes but then was fine

PT had no reactions post administration. About 36 hours after administration, the patient had a CVA. Pt experienced numbness in his left arm and shortly after proceed to have slurred speech and loss of balance and gait. Patient take to Emergency Room where he received the diagnosis. the patient was hospitalized. After several days, patient was discharge and was recovering.

- The following message was transmitted to my PCP on Sunday, 04/11/2021, about 11 PM. - Hello, yesterday, Saturday, April 10th, 2021, I received the Janssen (O42A21A) single-dose vaccine around 10 AM. About an hour after arriving home, i started having some of the most common symptoms reported, as in the following: Low-grade fever 99.3', Marked fatigue, mild muscle aches, some dizziness and generalized weakness. Took one 800mg Ibuprofen and rested. Last night, at around 10 PM, I had one episode of hematuria with some visible small-to-medium sized red clots, with no pain or discomfort on urination. Today, in the AM, I took another 800m Additional information for Item 18: 800mg Ibuprofen tablet, and by 12 noon, there was less fatigue and weakness, as I moved on in the day, the other symptoms improved or sub-sided, Except, for some, small clots, in a otherwise normal-appearing colored urine, around 1 PM. My B/P was 148/78, pulse 70, which is normal range for me. Additional information for Item 18: On Monday, 04/12/2021, during the day-time, I again experienced severe-to-moderate fatigue, and some dizziness, and then, last night, at around 7 PM, and 10 PM, I had two separate episode's of hematuria with some visible small-to-medium sized, Dark red clots this time, with no pain or discomfort on urination.

Onset severe headache that went away, dizziness that diminished when he lay down, two previous nights of stomach cramps

on March 18, 2021 ( the day following my J&J vaccination ), While on my way back from a 2 mile run , I experienced left-sided listing and lack of control of my left leg and arm. I was dizzy and saw black spots. My wife and son took me to emergency room. My symptoms abated while at the hospital. Hospital staff conducted many tests and I was kept overnight and discharged the next day around 5:00 p.m. with possible TIA as diagnosis.

I received the vaccine on March 8th, and got dizzy and was taken to Hospital by Ambulance. Diagnosed with Pulmonary Embolism, and was operated on the next day and put on Blood thinner, Eliquos. Happened 20 days after THE VACCINE WAS GIVEN, and I almost died.

Patient's daughter called phamacy today 4/13/21 to report that her father suffered a fall at his home on 4/4/21, the following day after patient received Janssen covid vaccine at pharmacy. Patient's daughter stated on phone that she took her father to hospital after she learned that he fell on 4/7/21 to be examined. Patient's daughter stated that he was diagnosed at hospital with having a stroke and discharged to return home on 4/8/21.

SHORTNESS OF BREATH WITH EXERCISE; LIGHTHEADEDNESS; This spontaneous report received from a patient concerned a 69 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced shortness of breath with exercise. On 10-MAR-2021, the subject experienced lightheadedness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath with exercise, and lightheadedness on 10-MAR-2021. This report was non-serious.

Started 1 week after injection. Swelling in lower legs, felt like balloons. Feeling of swelling in lips. Headache started in left temple area of head; after a couple of days went across forehead and on back of head with intensity increasing but not extreme pain. Slight nausea; no vomiting. Some abdominal pain that would come and go. Periods of shortness of breath; tightness feeling in upper chest. Loss of energy and some light headed feeling.

Patient describes frequent bouts of diarrhea with associated weakness and lightheadedness, symptoms started 05/08/21, he had received the Jand J vaccine 05/05/21

DIZZINESS; LACK OF ENERGY; This spontaneous report received from a patient 69-year-old male white not Hispanic or white patient. The patient's height, and weight were not reported. The patient's concurrent conditions included abstains from alcohol, nonsmoker, coronary artery disease (takes blood pressure meds, cholesterol meds, and OTC glucosamine/supplements), penicillin allergy, scallops allergy, and contrast media allergy. The patient had no known drug allergies and no drug abuse/illicit drug use. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: 21-JUN-2021) dose 1 total administered on 20-MAY-2021 for prophylactic vaccination. Concomitant medications included glucosamine for coronary artery disease. On 29-MAY-2021, he woke up with dizziness, light-headedness, and low energy. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from dizziness, and lack of energy. 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.

In about 2-3 weeks after the vaccine, I had just real achy and soreness all over. And I got very stiff muscles and was hardly mobile - not unlike my usual flares for Rheumatoid Arthritis event. My joints hurt. I hurt all over. I told my doctor I was having an ongoing flare that wouldn't stop. I had suggested that maybe it had something to do with the vaccination as I couldn't pinpoint anything else that would have caused it. He prescribed Prednisone - for seven days - I felt good during that time. As soon as it wore off, it went back to flare. He is treating me again with Prednisone for a whole month to try to calm the inflammation down. It also could mean that one of my meds is no longer working for me. The prednisone seems to be working this time, as well. He took me off my Celebrex, too, for this period of time and so the first few days were kind of rough but the prednisone is starting to build, I think, and I'm feeling better.

DIZZINESS; MUSCLE ACHES; SWELLING IN THE NECK AND SHOULDER AREA; UNUSUAL TASTE IN THE MOUTH; UPSET STOMACH; This spontaneous report received from a patient concerned a 69 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the subject experienced swelling in the neck and shoulder area. On 22-MAR-2021, the subject experienced unusual taste in the mouth. On 22-MAR-2021, the subject experienced upset stomach. On 22-MAR-2021, the subject experienced muscle aches. On 24-MAR-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling in the neck and shoulder area, muscle aches, unusual taste in the mouth, upset stomach, and dizziness. This report was non-serious.

I experienced 3 strokes consecutively. First one came when I was sitting in the couch and they took me to the hospital. They took me in and we stayed there for about 2-3 days (Can't focus) and then they dispatched me. I was pretty messed up. Then I spent like the next 2 weeks with micro strokes. I didn't know what was going on and went back to the hospital only for them to send me back home. Shortly after that, I saw Dr. and told him that I wasn't feeling well and went home. At about 4 o'clock I took a shower and didn't feel well. My wife drove me to the hospital and when I went I couldn't do anything. I got shots for strokes and took me to a bed. That is where I stayed and saw Dr. who told me that I got a stroke. I stayed there for 3 days and they sent me home. By now, I have lost my eyes, speech and it is really hard to focus or remember everything. I was going to a speech therapist and walk funny. I was stumbling at home.

After vaccinating, light headed and a little swelling in throat but says it happens out of the blue to him at times. Took Claritin and was fine. O2 sat 98%.

Muscle cramps in hands and legs, severe pain, unable to walk, unable to move around. Went to doctor. Doctor has scheduled test, but currently no test have been done.

Patient got up from chair to pick up his phone and collapsed, diaphoretic. There was no loss of consciousness. Initial BP = 80/60 and HR =84. He had no symptoms other than sweating and dizzyness. He stated he felt dizzy after the vaccine but had not eaten since the night before. He also said sometimes gets dizzy after shots. Repeat BP was 110/60 EKG by EMS demonstrated ST wave changes and patient was sent to Medical Center by EMS.

Patient started to experience dizziness a couple seconds after the shot. Provided patient with water and he waited another 30-45 minutes and he started to experience nausea and chest pain that was rated a 3/10. 911 was called and his blood pressure was measured at 210/110 (previous blood pressure was 190's/110. Nitroglycerin was given but it did not help with his chest pain and he began to have a headache. He was taken to the hospital. He stated that he was not feeling good a couple days before today. He felt better today and received his J&J vaccine. Fired his cardiologist and was looking for a new one.

Patient brought to Emergency Department due to knee pain after sustaining a fall 2 days prior to arrival- patient tripped over bump on sidewalk. No loss of conciseness. XR showed right patella fracture, received surgical intervention- ORIF.

Per my aunt (uncle's wife), my uncle complained of severe headache especially on the right temple area, nausea, and dizziness at around 6am on 4/11/2021. Soon afterward, she noted my uncle has left side weakness and drooling when drinking.

The patient received the Janssen vaccine lot # 1808980 in his left deltoid muscle at 1250pm on the side of the road from our mobile foot team. He was seated on the sidewalk during vaccination and remained seated for his observation period. At 1301 the patient said he felt "fuzzy," and "light headed" but said "I do not feel like I'm going to pass out." The patient refused to lay down. He was offered a mat or the back of the car to lie down on. He was also given water by RNs and a snack by the police. He drank a few sips of water and refused the snack. His BP was 150/100, HR 76 and regular per palpation, RR 16 and unlabored. No signs of respiratory distress. The patients skin was dry and color was appropriate for ethnicity. At 1306 the patient said " I feel the same, a little light headed." RNs and asked him to describe what he meant by light headed as he still denied feeling like he was going to pass out. He said "I feel dizzy." RNs asked patient if he felt like he was spinning but he said no. BP 158/90, RR 18 and unlabored, HR 74 and regular per palpation. Pt still declined to lay down. At 1311 the patient still felt the same. RNs asked the patient to lie down again. The patient agreed to lay down in the back of the car. The patient stood up and said he felt short of breath upon standing. He has a Hx of COPD and said that he often feels SOB when he first stands. He took his own Ventolin Inhaler before laying down in the back of the car with the air conditioning on. It was 1316 when he laid down and vitals were taken again. BP 130/90, HR 70 and regular per palpation, RR 18 and unlabored. At 1321 the patient said "I feel a little better but still light headed and my head is throbbing but I get headaches every day." Vitals: 138/90, HR 70, Spo298%. At 1326 the patient tried to sit up but became flushed and said he felt "weird." Vitals were 144/90, HR 75, RR 18, Spo2 97%. RNs assisted the patient to lay back down. At 1328 RN asked the police to call 911 while RN placed a call to our lead RN. Vitals were taken again at 1331 BP 150/90, RR 18 and unlabored, HR 81, Spo2 98%. At 1337 the paramedics arrived with the ambulance and resumed care. The patient was transported to Hospital.

om 5/8/21 at 9:00 PM, felt light headed, stepped outside for air, returned to closest chair, calling to significant other, I feel dizzy. Sat in chair, staring blankly, not responding to calling, or physical touch. breathing shallow, facial and lip color pale, pasty white gray. weak pulse. 911 called, and responded 8-9 minutes later. By the time they arrived, patient had aroused and aware of his surroundings,. Although color was slow on returning to normal. EMS arrived, BP 120/80. Patient refused to go to ER . On 5/10/21 at 2:00am, patient woke up and had a nosebleed lasting 2 hours, pouring from nose. 911 called and transported to medical center for cauterization, nasal packing and observation. 5/11/21 developed a reddened rash on right hand, lasted 5 days. Nasal packing removed on 5/13/21. No further complaints at this time.

Patient's wife reports 1-1&1/2 weeks after vaccine patient has been experiencing shortness of breath, shoulder pain/movement problems, & tingling in the right hand. He had severe hot sweats that have subsided.

On Thursday, March 18, I had some slight dizziness during the day. After going to bed that night I woke up and the night light in the smoke alarm on the ceiling appeared to be spinning. I sat, then stood, grabbling walls for support and attempted to reach my recliner. At that point I was severely dizzy, completely lost any sense of balance and collapsed into the chair. I could not stand or walk. After 20 minutes, I asked my wife to call an ambulance. I did not think she would be able to get me into our car. The paramedics ran an EKG and tested me for a stroke. Both were normal. I was transported to the ER. The doctor gave me Meclizine. Had a CT scan of my brain, and blood work. All results normal. Dizziness resolved. They tested my balance and then released me at 3:30 a.m. on March 19. I was tired that day, but did not need further medication. During that night, as I turned over in bed, the vertigo returned. I took a Meclizine and went to the recliner for the remainder of the night. I am feeling somewhat fuzzy today, March 20. Not sure how long this will continue, or if it is related to my Covid vaccination. However, I am reporting it in the event that others may be experiencing this problem as well.

3/22/21 Admission HPI: 71 y.o. male with a history of poorly controlled diabetes mellitus and COPD. He presented to my office today acutely with a several day history of increasing shortness of breath. He has increased his prednisone at home recently and been increasing the frequency of his DuoNebs. Despite this, he states that his oxygen saturations have been staying in the low 80s. He has a hard time walking due to the shortness of breath. He states previous to about a week ago he was doing very well. He denies any fever. He denies any known exposure to coronavirus (COVID-19). In the office today his oxygen saturations were 88% on 4 L. Because of his failure of outpatient therapy, he will be admitted to the hospital for further evaluation and treatment. This patient has a history of severe respiratory decompensation that happens very quickly. Therefore, it is medically urgent we get him into the hospital. 3/25/21 Admission HPI71 y.o. male with a known history of severe COPD and type 2 diabetes mellitus. He came to my office with a several day history of increasing shortness of breath. He had increased his oral steroids and breathing treatments at home and despite this was still having oxygen saturations in the low to mid 80s on 2-4 L of supplemental oxygen. In my office he was extremely diminished and had basically failed outpatient therapy. Therefore he was admitted to inpatient status for acute treatment of a severe COPD exacerbation requiring IV antibiotics and IV steroids. He was admitted and treated with IV treatments. He did recover nicely. However, he was found to be extremely physically deconditioned. Because of this he was thought to be an excellent candidate for swing bed and is being transitioned to swing bed. 4/5/21 ER Practitioner Note: Upon arrival to ED trauma room I found patient to be in cardiac arrest, CPR in progress. History is that EMS was called to the scene for a patient with chest pain. Shortly after arrival at his home patient developed a cardiac arrest. They followed standard ACLS protocol and the patient was intubated. Blood sugar normal. As CPR was given, medications were administered consisting of epinephrine and 1 mg in 2 different doses along with 1 amp of bicarb. IV access via an IO. Patient was then transported to the emergency department. Upon arrival, CPR was continued and oxygen supplied via endotracheal tube with good tube placement verified by auscultation and good sat readings. Monitor was placed and patient demonstrated initially a sinus rhythm but there was no pulse. Therefore, diagnosis was PEA and no reversible causes were identified. ACLS protocol was followed with epinephrine 1 mg IV every 5 min. He received a total that including EMS, 5 mg of epinephrine and 1 amp of bicarb. Monitor at this point revealed the rhythm changed to an agonal rhythm. When CPR was given, there was good results from the CPR. However, CPR discontinued and there is no pulse and patient had an agonal rhythm for several minutes, pupils were fixed but not dilated year. Lungs demonstrating clear bilateral breath sounds when he was bagged via the endotracheal tube. No external signs of any trauma noted. The patient's sister is here and she is a registered nurse. We had discussed management at this point with her and all were in agreement that the code be terminated. At 1015, patient was pronounced deceased.. ACLS protocol was followed. See nursing record for medication and vital sign details. Code outcome: Deceased CC time 20 minutes.

Janssen COVID-19 Vaccine EUA Itching on left shoulder of back Dizziness when first getting up from sleeping or reclining

got up out of his chair to leave from his 15 minute wait and fell face down on the floor. He did not put his hands out and received a cut on his left cheek below eye from glasses. He was assisted onto his feet and back onto his chair. Vital signs were BP-117/64, Pulse 85, RR 18, O2 sat 98% (WNL). Water provided to patient. Had him take several deep breaths. Band Aid applied to cut on cheek. Patient did not complain of any symptoms. Denies dizziness. Refused to seek further medical attention or go to ER. He was then assisted back to his car by staff after the incident.

10 days after receiving the Janssen vaccine, patient experienced extreme / debilitating fatigue, muscle soreness, stiff joints that lasted 72 hours. At the same time as the fatigue onset, a severe rash with inflamed welts and blood-filled blisters covering torso and abdomen - front and back also appeared. The rash was severe for 3 days and slowly subsided; scars still visible today - red dots.

5 minutes after administration of vaccine patient became very hot/body temp very high, sweating, felt like he was going to faint. RPH gave him water, put an ice pack on the back of his neck and sat with him for 15 minutes. His body temp came back to normal after 15 minutes and he left.

DIZZINESS; This spontaneous report received from a patient concerned a 71 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, alcohol use, non-smoker, heart diseases, cholesterol, and blood pressure, and other pre-existing medical conditions included the patient was taking medications for heart diseases, cholesterol and blood pressure. The patient experienced drug allergy when treated with codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204821A, expiry: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-MAY-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. This case, from the same reporter is linked to 20210537307.

Four days after injection developed symptoms of labyrinthitus - slight nausea, light headedness, dizziness and vertigo. Started acutely then got better but continue now for 31 days. Took flu injection 14 days before the Covid-19 injection. Previous viral labyrinthitus years before with lingering symptoms for months. On receiving Covid injection healthy. More info on injection EVDS vac number VP4WNUAHLAJ9 Symptoms may be related or nonrelated to Covid injection. Symptoms getting better but still present. Use antihistamnine on occasion without real effect.

Right after the vaccine, I experienced no symptoms. I had stomach problems and I felt very woozy and had diarrhea, and I also fainted. I hit my head but not bad at all. I went to the ER. I was dehydrated and they gave me IV. They told me drink liquids and Gatorade. It did help with symptoms. They said that it could have been a virus that was going around or it was food poisoning, one or the other.

Patient's wife states that he was not the same the evening after receiving the vaccine. She stated that he was unable to hold objects and his eyes were bulging from his head. He was going to a nursing facility after vaccination and later died on 7/4/21.

72-year-old male history multiple medical problems including coronary artery disease with stents Barrett's esophagus asthma enlarged prostate hypertension presents from the infusion center secondary to being found to have hypotension after receiving his immunoglobulin infusion today for COVID. Patient states he has been feeling ill for the past few days due to COVID he has been eating and drinking much. Patient states that he felt no different during his infusion or after but the blood pressure being low specially felt lightheaded when he stood up he was sent down to the ER for further evaluation. Patient denies any chest pain associated with this no palpitations he is awake alert and not diaphoretic in no significant distress on my evaluation. Patient denies any recent blood in stools. Note is the patient did receive the COVID vaccine Johnson and Johnson approximately 10 days ago. He was diagnosed with COVID infection 4 days after that.

Presented to ED for paresthesia in bilateral palms and plantar aspect of feet, muscle weakness, fall, numbness in arms starting on 04/21 and went to ED on 04/25/2021 after worsening and losing balance.

fever, chills, chest pain/dizziness for 4 days starting 48 hours after vaccine - dizziness - SOB since

Shortly after vaccine, upper respiratory issue started. Fatigue, falling, soiling bed sheets and pants regularly. Then went to hospital on june 7th with abdominal pain. Low bloid pressure and hight white blood count. Had blood clot. Urinary Infection Possible sepsis. Still in hospital.

On May 20th he came down with a cough and not feeling well. Went to hospital on May 22 and was diagnosed with pneumonia. Gave iv antibiotics and fluids. Sent home. On may 24 went back because he was worse. Temperature and high blood pressure and a headache. They admitted him to the hospital then checked him for covid. He was positive. They gave him a shot on may 24 and May 25th in the stomach for blood clots. On may 25th they sent him home. He started feeling better may 28. Then on June 17th he fell out of his chair complaining of severe dizziness. Called 911 and they transported him to hospital. Did a procedure to see if there were any blood clots. It was determined that he had a blood clot in his artery in the neck. They gave him tPA to break up the clot right away. Then transported him to the hospital to the icu. It was determined that the blood clot caused the stroke. Still having severe dizziness. Released him to rehab on 6/18 @ 4:30 pm

SEVERE DIARRHEA (8-10 EPISODES PER DAY); FATIGUE (MEDIUM TO HIGH SEVERITY); LOW GRADE FEVER; DISORIENTED (MEDIUM TO HIGH SEVERITY); SHUFFLING FEET AND UNSTEADY (NEEDED TO HOLD ON TO STUFF TO PREVENT FALLING); This spontaneous report received from a consumer concerned a 72 year old male. The patient's weight was 180 pounds, and height was 72 inches. The patient's concurrent conditions included alcohol use, non smoker, and penicillin allergy, and other pre-existing medical conditions included no drug abuse or illicit drug usage. the patient was healthy as a horse. patient did not had diagnostic data available'. The patient experienced reaction to a flu vaccine when 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: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2008, the subject experienced reaction to a flu vaccine. On MAY-2021, Laboratory data included: Body temperature (NR: not provided) 101 F. On 01-MAY-2021, the subject experienced disoriented (medium to high severity). On 01-MAY-2021, the subject experienced shuffling feet and unsteady (needed to hold on to stuff to prevent falling). On 01-MAY-2021, the subject experienced low grade fever. On 02-MAY-2021, the subject experienced severe diarrhea (8-10 episodes per day). On 02-MAY-2021, the subject experienced fatigue (medium to high severity). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe diarrhea (8-10 episodes per day) on 10-MAY-2021, disoriented (medium to high severity), and shuffling feet and unsteady (needed to hold on to stuff to prevent falling) on 03-MAY-2021, fatigue (medium to high severity) on 15-MAY-2021, and low grade fever on 08-MAY-2021. This report was non-serious.

"Pt c/o flushing/sweating and dizziness 3mins after vaccination. Vitals significant for bradycardia. @13:08 BP 100/58, HR 39, RR 12, SPO2 99% -- > @ 13:12 83/40, 41, 100% -- > @13:22 87/43, 50, 100% -- > @13:23 107/67, 61, 100%. 911 Called at 13:15 and paramedics arrived 13:20. At 15:15 pt elected to leave vaccination site . form signed. Pt driven home. Unknown PMH or current medications."

Thursday, March 11, 2021 (approximately 8:30 am) Patient experienced blurred vision, unbalance, and slurred speech and had an irregular heartbeat. March 11, 2021 (approximately 11:30 am) Patient was admitted to Hospital administered CT scan, MRI and multiple blood tests. Diagnosis - Ischemic Stroke

HEAD SPINNING/WORLD SPINNING/ VERTIGO; SLIGHT DIZZY; This spontaneous report received from a patient concerned a 73 year old male. The patient's weight was 165 pounds, and height was 175.26 centimeters. The patient's past medical history included drug allergy, and concurrent conditions included okra allergy, alcohol use, nonsmoker, essential hypertension, and seasonal allergic asthama, and other pre-existing medical conditions included the patient had no history of drug abuse. The patient experienced drug allergy when treated with hydrochlorothiazide. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. The batch was not reported and has been requested. Concomitant medications included amlodipine besilate for hypertension, and losartan for hypertension. On MAR-2021, the subject experienced slight dizzy. On 24-MAR-2021, the subject experienced head spinning/world spinning/ vertigo. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from head spinning/world spinning/ vertigo on 24-MAR-2021, and the outcome of slight dizzy was not reported. This report was non-serious.

INCREASED BLOOD PRESSURE; BONE PAIN IN LEFT ARM; DIZZY; This spontaneous report received from a patient concerned a 73-year-old male. The patient's height, and weight were not reported. The patient's past medical history included heart stent for heart attack. The patient was non-alcohol user, and non-smoker. 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: unknown) dose was not reported, 1 total, administered on 10-MAR-2021 at right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-MAR-2021, the patient experienced significant increase in blood pressure (200/110)/headache and bone pain in left arm (vaccine was administered on right arm). On the same day, he also experienced headache and felt dizzy. Laboratory data included: Blood pressure (NR: not provided) 200/110 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy on 10-MAR-2021, and had not recovered from increased blood pressure, and bone pain in left arm. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210430234-COVID-19 VACCINE AD26.COV2.S- Increased 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: MEDICAL HISTORY.

Patient felt L sided weakness and couldn't stand up, had some slurred speech-admitted to PHC 4/26/21 At hospital-EKG- within normal limits, PTT elevated not a TPA candidate, CT of head unremarkable, no acute intercranial findings, unremarkable Circle of Willis and MRI of brain -pending.

6 days after injection woke with soreness in all joints, stiffness, fatigue. Now on day 10, the S/S are getting worst. Fingers are swollen,. I can't grasp or pinch things. I must use both hands to hold a glass or cup. Very weak, sleeping 16-18 hours a day. At times I get very chilled and start to shiver. Never have had a fever, loss of taste, or smell. I tested NEG for the virus on day 3 (10 days after receiving the vaccine). Soreness is turned into pain. Feels like full-blown RA and if I was black I would be thinking sickle-cell because of the general pain.

73 year old male with PMHx of AFib, CAD, and HTN who presents with c/o dyspnea that started 4/6/21. Patient states it got to the point where he could not walk in his house without severe dyspnea. States he was diagnosed with COVID-19 one week prior. Per chart review he was in our ER 4/3/21 and diagnosed with COVID-19. At the time he was 95% on room air. His only other symptom has been diarrhea. He states he received the Johnson and Johnson vaccine one month ago. He denies any dizziness, chest pain, abdominal pain, n/v, weakness, or numbness. In ER patient was hypoxic and improved only with BiPAP. Per chart review patient had cardiac arrest on 11/2020 for 17 minutes. He has a significant cardiac history consisting of stemi, fem-pop bypass surgery, PVD, CABG x4, AFib post ablation 2017, V-tach. He was started on therapy with steroids, anticoagulation, and Remdesivir. He failed to improve and had increasing oxygen requirements. He was eventually intubated. Due to failure to improve patient was made DNR and eventually expired.

Violent chills 9 hours after injection; very difficult to stand; shaking almost continuous for 60 minutes, followed by fatigue for 10 hours and fever for about 90 minutes. Tried to laugh it off as a natural reaction, but I did not find chills listed as a common side-effect.

blurred vision, hallucinations, rash around his eyes, HA, running nose, off balance patient refused going to emergency room, is waiting to consult with provider

My father received his shot on March 13, 2021. He drove to move home and on March 28th started having his right arm go numb but did not tell us. He asked to go the ER March 29th at 6:45am saying his chest hurt and was having a hard time breathing, this has happened before since having Covid in September. I called 911 after he became dizzy and could not walk. While at the ER suffered a massive stroke that paralyzed him from his nose down over a course of 3 days. His brain stem was affected and he lost the ability to swallow. After being on a ventilator for 72 hours he was removed from it and died less then 30 mins later from drowning in his own saliva on April 1, 2021.

Patient noticed blotches on both legs approximately 6 to 7 days after vaccine was administered. On 03/30/2021, patient fell to ground, unable to get up. Patient was taken by ambulance to Hospital emergency room. Scans revealed patient had multiple blood clots and was operated on. Later in the stay, patient developed widespread hematomas in groin, stomach, rear, and both legs. Patient was released from hospital on 4/8/2021.

I felt dizzy and very unsteady on my feet when walking. When I went to lie down, I had a sensation of slight spinning. These events were ongoing, with the worst day being Sunday April 4 2021. The symptoms subsided at the end of Monday, April 5th and were completely gone by the following day. I called my doctor, however, by the time I had an appointment, the symptoms were gone.

I am submitting this report because of symptom onset relative to vaccination date, and because I have not experienced this cluster of symptoms before. My wife and I received the same lot number of the J&J vaccine on Saturday, March 13. We both had slight fatigue that evening and into the following day and she has had no further symptoms. On Tuesday, March 16, I had a mild ache around injection site with no further symptoms until Saturday, March 27 when I experienced a brief episode of lightheadedness. (CONTINUED BELOW)

Had mild symptoms of headache, fatigue, nausea, light headedness for starting about 3 hrs. after shot given and lasting into evening of next nigh; No fever or shortness of breath experienced. Except for fatigue was generally OK for next 6 days. Then eyes started blurring down my vision, and started seeing double/triple vision... symptoms are intermittent; worse in evening when eyes are fatigued. Called medical center for info and course of action and was advised to report to medical center emergency Room. Will see what eyes are like in morning

Patient received vaccine on 5/24/21. He called pharmacy on 6/14 complaining that his arm had been sore for about a week since getting the vaccine. he stated that his arm did not bother him after he got the vaccine but started "aching" on 6/7/21 and has been aching on and off every since. patient states that he does not have problem moving his arm or raising arm above his head, but was concerned that the pain did not start until approximately 2 weeks after receving vaccine. he states that there is no redness or swelling or heat around the injection site, has not developed rash or any other reactions, etc. I told patient to continue taking tylenol since that was helping with his muscle soreness and to contact his doctor if aching sensation continued.

Mild fever (100.7), chills, body aches, dizziness, mild sore throat all beginning 12 hours after vaccination and continuing until the following morning

Extreme vertigo, weakness, unable to walk, extremely unbalanced when attempting to stand up, severe Headaches, blurred vision.. Also with sinus type drainage. Extreme nausea and fatigue. Literally couldnt even hold his head up. All sypmtoms started within 48 hours of injection and came on with a vengance. He was so unsteady and unstable he fell with attempts to get up. Prior to the vaccine he was great! Strong and healthy for all of his underlying medical condtions. Completely Independant, driving , working around the house ect. Unfortunaley this is still going on. He is very weak, and still unsteady when he is up. Nausea continues. He is doing Vestibular therapy for the balance issues. Took a round of seroids.

It started with a familiar reaction and that was I had tingling and pain in my feet it started with both feet and it was significant, like when the feet goes to sleep and it is coming back and you feel the pins and needles feeling, and it was exactly what I get with CIDP. It moved from both feet up to both hands and I was not really afraid because that is what happens with CIDP when your auto immune system is stimulated. I get numbness on my feet and in my hands. I thought that the vaccine stimulated my immune system. The CIDP has been in remission and maybe the shot has stimulated my nervous system. The other day I noticed that when taking the hot plate from the microwave it was hot but I did not feel it at all. I thought the food has not heated up, when my wife touched the plate she said it was very hot and I did not feel the plate hot at all. I also felt pain in my left foot to a point that I am not ambulatory. The pain is so extreme in my left foot if I try to stand up. I have been in my bed for the last 2 days. I am not sure if it is the CIDP or GOUT that is attacking my foot but it has been triggered by the vaccine. I also have severe pain in my left leg. I called my cardiologist and I have a phone consultation with him today to check for clot formation. The pain has subsided a bit today, but yesterday the pain in my leg was very intense. I also had pain at the injection site and felt a little feverish since yesterday around 3PM and it went to 101F and this morning I am fine again. I did not take anything for it and this morning I woke up and I felt well (in regards to the fever). I did not have fever before then.

About 4 weeks from vaccination I started having increased muscle and joint stiffness and soreness. Symptoms have not abated as of this report.

3/24/2021 headache, congestion, weakness, loss of balance 5-7-2021 shortness of breath, shaky, weak

pt says a couple of days after taking the vax he woke up feeling woozy. He says his head hurt and he couldn't think straight. He felt like he was coming unglued. He had some confusion and trouble with his memory. He had burning in his stomach. On 3/12/21 he contacted his PCP for a tele-visit. He couldn't remember what the doctor told him after speaking with him because of his confusion. He was prescribed Raglan. He said the food going in his stomach does not come out. He saw his gastro Dr. regarding his stomach pain. He had a scope procedure and had bile pumped out of his stomach. He was prescribed famotidine, tenatoprazole, Amitiza, and Sucralfate. He is not taking the Amitiza or Sucralfate. It is 2 months later and he still has these symptoms and still doesn?t feel normal.

extreme soreness in muscles head to toe, especially neck, shoulder, arms, hands, legs. One night my neck locked up in pain and I couldn't move, called ambulance which took me to hospital where they put me on cyclobenzaprine muscle relaxer, prednisone and hydrocodon for pain.