Johnson & Johnson

Extreme fatigue from 3/11/21 to3/19/21; Severe headache from 3/12/21 to 3/18/21; light-headed sensation 3/12/21 to 3/20/21; fainted 3/17/21; gastrointestinal issues and severe cramping the evening of 3/15/21 to 3/17/21; gastrointestinal issues (constipation followed with diarrhea without cramping).Colo

Patient reported having dizziness and lightheaded ness and nervousness Provided water and seen by medical team Patient refused medical transport and signed AMA form, Symptoms resolved Patient will be driven home by spouse

Patient reported feeling dizzy, nauseated and lightheaded Patient provided with water and seen by medical team Patient stated symptoms resolved, refused medical transport and signed AMA form Patient?s family drove him back home

"Janssen COVID-19 Vaccine EUA" Dizziness, ringing in ears, nausea (used Sea Bands for nausea, situation was resolved in 12 hours.

6:30p Post vaccination reports feeling dizzy and light headed Medical monitoring w/ vital assessment: BP 160/90 P 98 RR16; rest w/ symptom resolve, BP 140/84 P71 RR18 Released from facility w/self

Patient received the vaccine on 4-9-2021, on 4-10-21 patient felt "blah," on 4-11-21 patient got up and around and was ok, on 4-13-21 patient was not feeling real great, but was tolerable, on 4-14-21, patient was feeling worse with blurred vision, throwing up, aches, doesn't want to eat, dizziness. Recommended that patient contact their primary care doctor for further treatment. On 4-13-21 pt went to ER and was admitted for one night, on 4-14-21 pt was dismissed from hospital, and is feeling improved.

WENT LIMP; DIZZINESS; CAN'T SLEEP; FEELING OF WARMTH; FELL DOWN; STOMACH UPSET; FELT LIKE FLU(HEADACHE, BODY TIREDNESS, SORE THROAT); WEAK IN KNEES; NAUSEA; This spontaneous report received from a patient concerned a 76 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced went limp. On 06-APR-2021, the subject experienced dizziness. On 06-APR-2021, the subject experienced can't sleep. On 06-APR-2021, the subject experienced feeling of warmth. On 06-APR-2021, the subject experienced fell down. On 06-APR-2021, the subject experienced stomach upset. On 06-APR-2021, the subject experienced felt like flu (headache, body tiredness, sore throat). On 06-APR-2021, the subject experienced weak in knees. On 06-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from feeling of warmth, had not recovered from nausea, dizziness, can't sleep, weak in knees, stomach upset, and felt like flu(headache, body tiredness, sore throat), and the outcome of fell down and went limp was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.

The patient is a 76 y.o. female who presents to the Emergency Department with three days of left ankle pain and swelling status post mechanical GLF. Patient reports that she fell onto her left side three days ago. She is not anticoagulated and denies striking her head or any LOC. Since then she has had constant dull left ankle pain which is acutely worsened with ROM and weight bearing. Patient reports a history of fracture to this ankle. Patient notes that she is able to shuffle when wearing her compression stocking, but this elicits pain. She has pain radiating up her LLE, into her buttocks, and up her back "all the way to my neck." Patient has not taken any pain medications symptomatically. Patient reports feeling chills last night.

This spontaneous report received from a patient concerned a 76 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced cramps. On 08-MAR-2021, the subject experienced aches. On 08-MAR-2021, the subject experienced dizzy. On 08-MAR-2021, the subject experienced sore arm. On 08-MAR-2021, the subject experienced headache. On 09-MAR-2021, the subject experienced diarrhea. On 09-MAR-2021, the subject experienced stomach cramps. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cramps, aches, dizzy, and headache on 09-MAR-2021, and sore arm on 12-MAR-2021, and had not recovered from diarrhea, and stomach cramps. This report was non-serious.

LOSS OF FINE MOTOR CONTROL IN RIGHT ARM; HEADACHE; This spontaneous report received from a patient concerned a 76 year old female. The patient's weight was 130 pounds, and height was 65 inches. The patient's past medical history included pacemaker for nerve block (4-5 years ago), appendectomy (10 years ago), cataract surgery, and concurrent conditions included alcohol user (occasional, not often), and ex-smoker (used to smoke for 30 years (half pack a day), but quit 10 years ago) and bladder cancer growth (7 years ago). The patient experienced drug allergy with opioids (deathly ill, sick to stomach and passes out). The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: 25-MAY-2021) dose was not reported, 1 total, administered on right arm on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the patient experienced headache. On 21-MAR-2021, the patient lost fine motor control in right arm, and was hospitalized for 2 days. It was reported that, the patient had 2 computerized tomography scans showed no evidence of clot however according to the patient's physician, the patient might have had small clot that dissolved. The patient had no high blood pressure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of fine motor control in right arm on 21-MAR-2021, and headache on 2021. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0 This report concerns a 76-year-old female patient who experienced headache and loss fine motor control in right arm, 8 and 12 days after receiving Jansen COVID-19 vaccine respectively. Patient's medical history included pacemaker insertion, ex-smoker, bladder cancer, and drug allergy with opioids. Eight days after vaccination, the patient had headache. Four days later, the patient lost fine motor control in right arm and was hospitalized for one and a half days. Two CT scans showed no evidence of clot. The patient's physician commented that the patient might have had small clot that dissolved. The treatment was not reported, and patient was recovered from the events. Based on the reported information, the causality is considered possible to vaccine for headache and unassessable for the event of loss fine motor control in right arm.

Chills (no fever) within 24 hours of the Janssen vaccination, lethargic, no appetite. Very dizzy and lightheaded on day 5 and day 6 after the Janssen vaccination with continued lethargy and loss of appetite for approximately 3 weeks. Heavy nosebleed in left side of nostril with large blood clots for 1.5 hours approximately 3 weeks after the Janssen vaccination

5:15pm: Light headedness and soreness along right forearm down to right hand. 5:30pm: BP 184/110. Pt sitting on ground. Alert and talking/laughing/normal breathing. Was told by EMS to not give pt water/food in case of exacerbation. 5:40pm: EMS arrived 6:30pm: Pt discharged, reported BP down to 140/??

the day after the vaccine I got a headache that became a terrible Migraine that lasted for 4 day, subsided and then returned. It was bad and I did call and spoke to the nurse and doctor. I vomited for 4 days. I am a little better but this is day 6 and I am still dizzy and have a slight headache

Had PVC's, feeling like I was going to pass out...4 days after getting the vaccine. Lightheadedness was off and on for about a month.

03/05/21 - 6 p.m. - severe throbbing headache lasting all night, cold (no fever) 03/06/21 - 8 a.m. - weakness , sense that blackout very possible 03/06/21 - 9 a.m. - severe lower back pain lasting entire day and into evening, difficultly moving

Pt began experiencing aches, dizziness while walking, chills, and headache on 03/11/2021 at bedtime. Pt began experiencing nausea on 03/12/2021 morning. Pt took Tylenol for symptoms, but received mild relief. Pt was advised to continue taking Tylenol as directed, and if the symptoms worsen or do not resolve in 1-2 days to seek medical care. SPI was consulted and Dr. was notified.

Janssen COVID-19 Vaccine EUA: Adverse effects were nausea, vertigo, headache, body aches, chills, cold sweats for 6 days total. Took Bonine for Vertigo and Nauzene for Nausea.

Patient fainted after the covid shot, she was feeling hot and fell off the chair onto the floor. She hit her left eye and left temple resulting in a bump and a bruise. Patient opened her eyes when I called her name and she was not aware of were she was. Her blood pressure was 95/64 65 bpm laying down and 70/54 114 bpm when sitting. We laid her back down because she was feeling dizzy and the Ambulance arrives 45 mins after called. Because of her bump and her low BP she was taken to the hospital.

Fell two weeks after immunization. Developed blood clot after procedure. Husband concerned immunization is cause of clot and not the surgery or down-time after the procedure. Transfered to new hospital from previous hospital and had significant stroke due to clot

UNABLE TO EAT OR DRINK; PAIN IN THE BODY (NECK & RIGHT ARM/SHOULDER); DIZZINESS; SICK; FEELING LOUSY; DIDN'T WANT TO GET OUT OF BED; WANTED TO SLEEP; FEVER; NAUSEA; FELT WEAK; This spontaneous report received from a patient concerned a 77 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 10:30 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: Body temperature (NR: not provided) 99 F. On 07-APR-2021, the subject experienced unable to eat or drink. On 07-APR-2021, the subject experienced pain in the body (neck & right arm/shoulder). On 07-APR-2021, the subject experienced dizziness. On 07-APR-2021, the subject experienced sick. On 07-APR-2021, the subject experienced lousy. On 07-APR-2021, the subject experienced didn't want to get out of bed. On 07-APR-2021, the subject experienced wanted to sleep. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced felt weak. On 08-APR-2021 18:50, Laboratory data included: Body temperature (NR: not provided) 101.5 F. On 09-APR-2021, Laboratory data included: Body temperature (NR: not provided) 100.6 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in the body (neck & right arm/shoulder), fever, nausea, dizziness, sick, lousy, felt weak, didn't want to get out of bed, unable to eat or drink and wanted to sleep was not reported. This report was non-serious.

SWELLING OF BOTH EYELIDS- UPPER AND CORNER; SWELLING OF LEFT SIDE OF FACE; HEADACHE BEHIND EYES; DIZZINESS; This spontaneous report received from a patient concerned a 77 year old female. The patient's height, and weight were not reported. The patient's past medical history included hysterectomy, and concurrent conditions included dust allergy, allergy to cats, antibiotic allergy (hives), diverticulitis, alcohol intolerance, and drug intolerance. The patient was previously treated with calcium for hives. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802025, and batch number: 1802025 expiry: 25-MAY-2021) .5 ml, administered on 08-MAR-2021 09:30 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced swelling of both eyelids- upper and corner. On 09-MAR-2021, the subject experienced swelling of left side of face. On 09-MAR-2021, the subject experienced headache behind eyes. On 09-MAR-2021, the subject experienced dizziness. Treatment medications included: achillea millefolium/aconitum napellus/arnica montana root/atropa belladonna/baptisia tinctoria/bellis perennis/calendula officinalis/echinacea spp./hamamelis virginiana/hypericum perforatum/matricaria recutita/ruta graveolens/symphytum officinale. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness on 09-MAR-2021, was recovering from swelling of both eyelids- upper and corner, and headache behind eyes, and had not recovered from swelling of left side of face. This report was non-serious.

severe headache 2 weeks later, dizzy spells for about a week. Had a CT scan and found out it was a stroke.

Patient has severe arm pain and still cannot raise her arm above shoulder level without experiencing severe pain.

Patient arrived at the pharmacy 7-19-21 reporting she began to experience left arm weakness between the shoulder and elbow on 7/3/21 .She was unable to move or use the arm for 3 days, at which time it resolved. She also reports a sharp, bone pain just above the injection site-she experiences the pain only when she touches the area, (began 7/3/21). She continues to experience this pain as of the time of this report. She also reports a feeling of compression/numbness on the on the outside of her lower left leg between the ankle and the knee, this started 7/3/21 it has improved but has not completely resolved. Patient states she has not reported this to her health care provider

3/11/21- pt was feeling fine. She stood up got dizzy and seamed to have a seizure. when she came to she did not know that it had happened. about 5 hours later she stood up again got dizzy and seamed to have had another seizure. her husband called 911. EMTs took her vitals but did not detect anything to be wrong at the time and was advised to see PCP. Next day 3/12/21 she went to her PCP. She had blood work which showed high enzymes for heart failure so was sent to hospital to be admitted. Pt had blood work, chest xray which showed blood clots in both lungs. She was administered blood thinner. MRI of head was clear. Echocardiogram was clear. Pt stayed about 4 days. Enzymes for heart failure was clearing up. Pt was released and had a FU appt w/ PCP on 3/22/21. Pt found out that she also had bilateral deep vein thrombosis in both legs while she was in the hospital. Pt is improving and is almost back to normal.

Woke a bit dizzy which lasted all day. Going to bed I coughed and searing pain flashed thru my body. After the initial pains my right hand felt like it'd been crushed by heavy object. It's not as bad this morning but I'm using hemp creme to sooth the soreness.

78 year old woman admitted with severe back pain, inability to ambulate and leukocytosis on 3/31/21. History of hypertension, CHF, obesity, chronic kidney disease, and back pain. Work up included multiple consults. The patient was placed on SQ heparin for VTE prophylaxis. Acute L5 fracture was found along with emphysematous changes. Neurosurgical evaluation- no surgery was necessary. During the first 24 hours (before receiving the vaccine), the patient's Hg dropped 9.3 to 6.8 and platelets dropped 130K to 61 K with no apparent bleeding source. PRBC transfusion was given. GI consult was obtained the patient was scheduled to have EGD the following morning (day 3). Cardiology was obtained for elevated troponin and hypoxia. An echo obtained on day 2 showed moderate elevated pulmonary artery pressure, mild to moderate tricuspid regurgitation, and normal sized right atrium and ventricle. The patient received the Janssen vaccine upon request the morning of hospital day 2 (4.1.21 at 11:02). At 11:37PM on 4/1/21 the patient received 5mg IV metoprolol for elevated HR of 132 (BP 129/67). At 0128 on 4/2/21 the patient's heart rate dropped into the 60's and then declined further requiring cardiac resuscitation. The attempt was unsuccessful and the patient expired at 01:43 on 4/2/21. An autopsy was conducted (results available on 4/13/21) showed a 4 cm clot in the patient's right atrium and a mural thrombus in her femoral artery.

Started having muscle pain; I didn't have chills. I was very fatigued - in bed all day. I had a headache and the muscle pains went into my left side and into my left lung and every time I breathed I would get a sharp pain. It went into both of my breasts but worse on left side of breast. This lasted about three or four days. I went to the doctor on Thursday, the 15th. But now everything is cleared up and I feel good. Yesterday, the 22nd I started feeling myself again. Except, I have a tremor that won't go away - I had a slight tremor before the vaccine but now after the tremor it is much worse.

UNABLE TO RISE UP ARM; KNOB LEFT ARM; LEFT SHOULDER PAIN; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's past medical history included vitiligo, and pruritus, and concurrent conditions included diabetes mellitus, hypertension, severed leg cramps, osteoarthritis, venous reflux, sulfonamide allergy, iodine allergy, shellfish / lobster allergy, shrimp/ lemon/ pepper allergy, no alcoholic user, and non smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808980, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 12:45 for prophylactic vaccination. No concomitant medications were reported. On 27-APR-2021, the subject experienced unable to rise up arm. On 27-APR-2021, the subject experienced knob left arm. On 27-APR-2021, the subject experienced left shoulder pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left shoulder pain on 28-APR-2021, and had not recovered from knob left arm, and unable to rise up arm. This report was non-serious.

Patient was discharged from the hospital after massive PE. She went to the hospital at 2am last Saturday. Patient described unbelievable pain from shoulder neck and arms. She could hardly walk to her car. Went to ER. There they ran tests and found many blood clots in lungs. Blood clots had stopped the blood in that area. They were not definitive but said it sounded like that. Got a breathing apparatus after because it's been hard to breathe and she has been shaky. Her shot was administered 04/12 during chemo. Hospital April 24. She was discharged and given a blood thinner and pain medication - Oxycodone & Eliquis.

NOT CLEAR VISION; SENSATION IN RIGHT SIDE OF THROAT; SENSATION ON TOP OF HEAD; DIZZY SPELLS; SORENESS UP SPINE; SORENESS IN JOINTS (HIPS, PELVIC, AND LEGS DOWN TO KNEES); This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's past medical history included half thyroid removed.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 43AZIA expiry: 21-JUN-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced soreness up spine. On APR-2021, the subject experienced soreness in joints (hips, pelvic, and legs down to knees). Treatment medications included: paracetamol. On 10-APR-2021, the subject experienced sensation in right side of throat. On 10-APR-2021, the subject experienced sensation on top of head. On 10-APR-2021, the subject experienced dizzy spells. On MAY-2021, the subject experienced not clear vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sensation in right side of throat, sensation on top of head, and dizzy spells on APR-2021, and the outcome of soreness in joints (hips, pelvic, and legs down to knees), soreness up spine and not clear vision was not reported. This report was non-serious.

4-10 and 4-11-2021 Complained of headache; 4-12-2021 Sister-in-law stopped by around 5pm and noticed facial drooping on left side. My brother took her to a stand alone ER, She was given a CT Scan and nothing was seen on the CT Scan. Asked her to do various actions and was diagnosed with Bell's Palsy. It was recommended for her to go to a hospital ER or follow up with primary doctor for an MRI. 4-13-2021 Early AM lost her balance and fell down. Complained of legs cramping. Lost strength on leftside of body especially hand and legs. Appointment with primary doctor made for next day. 4-14-2021 Had 11 am appointment with primary care doctor who scheduled an MRI for 1:20pm. Sent to hospital ER following a positive result for an ischemic stroke in frontal lobe. Evaluated at hospital ER around 3:15pm. Admitted into hospital ER at 7:33pm.

Pt found down on 5/7 for unknown period of time. Prodromal dizziness reported, but no additional history or witnesses until pt found down. At ER presentation, noted CHI with subdural hematoma and intracranial hemorrhage. Also noted left cortical vein thrombosis. Follow-up imaging after 24 hours demonstrated persistence of above findings. Pt had concomitant humerus fracture and medical instability after being found down. Now stable but below baseline in rehab facility.

Tiredness, pain in right side of the body stopped at knee, dizziness, unbalance, loss of appetite, symptoms continued about a week, pain in back, burning effect, takes Tylenol every 8 hours

1 day after vaccination, patient experienced pain in both arms from shoulder to elbows, headache, and overall felt sick causing patient to lay in bed for several days. Majority of symptoms resolved on 7/21/21. Patient does complain of lingering headache still today (7/22/21). Patient did not take any medications to treat symptoms

(07/20/2021) sharp pain in right heel, usually walks 5 miles/day without pain. Experienced sharp pain (10), during walking. After icing the foot, got it down to a 5 on the pain scale.

AFTER GIVING THE SHOT PT REPORTED SEVERE HEADACHE, DIZZINESS AND SHAKY CALLED 911 ,PT REQUESTED TO LIE DOWN ON THE FLOOR , PT WAS BREATHING AND CONSCIOUS ALL THE TIME TILL AMBULANCE WAS HERE AND CHECKED BY THE EMERGENCY STAFF CREW, TOOK HER TO THE HOSPITAL

2 days after vaccination, patient started having vertigo, nausea and headaches. That day she tried to notify her doctor unsuccessfully. 2 days after that patient's headache became extreme and she lost her vision in one eye. Family doctor prescribed migraine medication and referred her to her eye doctor for the next day. The eye doctor told her he believes she had a stroke after a full exam. Stroke confirmed with MRI per family doctor. The stroke was in the occipital area. Referred to neurologist at present time. Vision loss persists. Patient is starting physical therapy and following up with neurologist, eye doctor and cardiologist.

recurrent acute embolic stroke noted on MRI brain. Received vaccine on 4/10. Seen in ER 4/11 with confusion. CT head negative and discharged home. Admitted 4/13 with worsening L weakness and fall at night. Acute stroke noted on MRI imaging.

EXTREME DIZZINESS; HIGH BLOOD PRESSURE; VOMITED 3 TIMES; FOUR BOWEL MOVEMENTS; HYPERGLYCEMIA; NAUSEA; This spontaneous report received from a patient concerned a 79 year old female. The patient's weight was 65.5 kilograms, and height was 157.48 centimeters. The patient's concurrent conditions included high blood pressure, elevated cholesterol, non-smoker, alcohol user, hyperlipidemia, and hypertension, and other pre-existing medical conditions included patient had no drug abuse. The patient was previously treated with codeine, and acetylsalicylic acid. 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-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included nebivolol hydrochloride for high blood pressure. On 13-MAR-2021, the subject experienced extreme dizziness. On 13-MAR-2021, the subject experienced high blood pressure. On 13-MAR-2021, the subject experienced vomited 3 times. On 13-MAR-2021, the subject experienced four bowel movements. On 13-MAR-2021, the subject experienced hyperglycemia. On 13-MAR-2021, the subject experienced nausea. Laboratory data included: Alanine aminotransferase (NR: not provided) 52 IU/L, Alkaline phosphatase (NR: not provided) 80 IU/L, Aspartate aminotransferase (NR: not provided) 42 IU/L, Bilirubin total (NR: not provided) 1.2 mg/dL, Blood test (NR: not provided) Normal, Body temperature (NR: not provided) 34.4 F, Brain natriuretic peptide (NR: not provided) 34 pg/mL, Chest X-ray (NR: not provided) Normal, Diastolic blood pressure (NR: not provided) 99, 88, 68, 59, 43, 67, 57 mmHg, Heart rate (NR: not provided) 70bpm, 65 bpm, High sensitive troponin I (NR: not provided) <0.003 ng/mL, Oxygen saturation (NR: not provided) 92, 91, 93, 91 %, Respiratory rate (NR: not provided), Systolic blood pressure (NR: not provided) 250, 160, 130, 96, 103, 150, 130 mmHg, and Urinalysis (NR: not provided) Normal. On 13-MAR-2021 11:38, Laboratory data included: Pulse rate (NR: not provided) 62 pm. Treatment medications (dates unspecified) included: hydrochlorothiazide/triamterene, valsartan, omega-3 triglycerides, oyster shell, diclofenac, celecoxib, potassium chloride, ubidecarenone, xantofyl/zeaxanthin, simvastatin, and ascorbic acid/betacarotene/biotin/calcium/chlorine/chromium/copper/cyanocobalamin/dl-alpha tocopheryl acetate/folic acid/iodine/magnesium/manganese/molybdenum/nickel/nicotinamide/pantothenic acid/phosphorus/phytomenadione/potassium/pyridoxine hydrochloride/retinol/riboflavin/selenium/silicon/thiamine/vanadium/vitamin d nos/xantofyl/zinc. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extreme dizziness, high blood pressure, vomited 3 times, and nausea on 16-MAR-2021, and the outcome of four bowel movements and hyperglycemia was not reported. This report was non-serious.

Upon approaching her 30 minutes observation time, patient stood up and felt dizzy. Patient assisted back to chair with legs elevated. EMS evaluated. Vital signs obtained. Glucose checked by EMS. Drink provided to patient. Patient eager to go home and eat as she has not eaten since breakfast. Patient reports no longer feeling dizzy. Patient assisted back to car via wheelchair.

30 min after vaccination patient felt nausea and started vomiting, chest tightness, trouble breathing, "funky" feeling at chest, sudden movements cause dizziness . pt notified us on 05/11 and symptoms have resolved, pt instructed to monitor for continue symptoms especially related to chest symptoms tightness, SOB, etc and to go to ER if symptoms arose again

Eleven days after getting the shot, my mother in law was experiencing severe back pain and was not able to get comfortable or sleep at night. Before we could take her to see a doctor, she fell while trying to get out of bed at 7am the next morning. She had trouble getting up and exerted a lot of energy trying on her own. She called for my husband and I to help her get up. I grabbed her around the waist and my husband held her walker for her as support. Upon rising (mostly of her own ability) she was so exhausted that we had her sit on her walker and rest a moment. My husband went to check on her twice over the next 15-20 minutes, but when he returned again she was showing classic stroke signs and EMS was called. They arrived quickly and agreed. She was taken immediately to the ER, where they also agreed that it looked like a stroke. She was admitted as they continued to run tests, but she continued to decline more and more each day at the hospital losing motor skills and ability to speak. She was not able to move her right side at all and the left side was fidgety and had uncontrollably flailing that left her bruises on her arm and leg. She was also excessively sleepy. After loads of testings and images, the MRIs finally showed that the brain stem was extremely inflamed and it was an auto-immune response. By this time, she was already a vegetable in the ICU ward under incubation, IVs and a feeding tube. They continued to run more tests and brought in infectious diseases, but they ultimately said her body was fighting an infection that she did not have. They attempted a hemoglobin treatment with an oncologist to shut down her immune system but never consulted with her renal doctor, even through they were very concerned about renal failure. She could not complete the treatment and only received 4 out of the 5 doses they wanted to give her because of her kidney counts. They said that the auto-immune attack was very aggressive and they could not shut it down. In the early morning of 4/28/21, they finally contacted her kidney doctor and she was put on dialysis as a last effort to try to save her, but it was too late and all her organs were failing. She passed at 1:56 pm. Patient was homebound during the pandemic and did not leave the house unless she was visiting her doctor's office. My husband and I have limited contact at our jobs, as we work in small offices, and our children (that also lived with her) were being schooled virtually. There is nothing that I know that could have caused her immune system to go into overdrive, except for the vaccine that was administered less than 2 weeks (which is considered the time frame for vaccine immunity) prior to her symptoms.

I received the Johnson & Johnson Covid19 vaccine at 3:30 PM on June 30, 2021. At 5:30 PM I experienced muscle pain in my right lower thigh muscles right below my hip replacement scar that continued throughout the night. The next day the muscle pain was so sever I could not walk on my right leg and had to get down my walker from my surgery. The following day the pain was less severe. It has been 12 days now since the vaccination and my right thigh muscles are still sore but I can walk OK.

HYPERTENSIVE CRISIS (HIGH BLOOD PRESSURE); DIVERTICULITIS; BOWEL IMPACTION; DIZZINESS; FEELING FATIGUE; BLOOD PRESSURE FALLS TOO LOW AT TIMES; SOME HEADACHES; SHORTNESS OF BREATH; SOME LEFT NECK PAIN; This spontaneous report received from a consumer (reported as daughter) concerned a 79 year old White and Not Hispanic or Latino female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included that she had no known allergies. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, and expiry: unknown) dose was not reported, frequency time was 1 total administered on right arm on 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-APR-2021 (reported as right away after vaccination), the patient started feeling bad which was further elaborated as feeling fatigue, shortness of breath, and had some left neck pain. On an unspecified date in MAY-2021 (reported as on or about 10-MAY-2021), the patient started experiencing some headaches. The patient went to see her doctor on 17- MAY-2021 for routine checkup and got to know that everything was fine, and her blood pressure was fine at this time. On 06-JUNE-2021, the patient was hospitalized with hypertensive crisis, diverticulitis, bowel impaction, dizziness, and fatigue. The patient was discharged from hospital on 11-JUNE-2021. On 28-JUNE-2021, the patient was hospitalized again for second time for high blood pressure, and she was put on 2 different blood pressure medications (unspecified) including a diuretic (reporter was unsure of the medication names/dosages). It was also reported that the patient feels fatigued at times now when her blood pressure falls too low (date unspecified). The results, units and normal ranges for blood pressure was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from some left neck pain, some headaches, and bowel impaction, and had not recovered from hypertensive crisis (high blood pressure), diverticulitis, shortness of breath, blood pressure falls too low at times, dizziness, and feeling fatigue. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210743176 - Covid-19 vaccine ad26.cov2.s - Hypertensive crisis, Diverticulitis, Bowel impaction, Dizziness. 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). 20210743176-Covid-19 vaccine ad26.cov2.s - Fatigue. This event(s) is labeled per RSI and is therefore considered potentially related.

Pt became SOB and dizzy. Vital signs stable. She was put on O2 and given po benadryl 25 mg; sent to er for persistent sob and later discharged home

Patient at clinic to receive Johnson & Johnson vaccine. Patient started complaining of being lightheaded. BP was 112/65, pulse 82, Temp 98.5, O2 sat 99. Patient began having tremors and weakness when standing. Physician evaluated patient. Patient became short of breath when talking. Physician ordered 50 mg Benadryl IM and advised staff to call ER. Patient taken to hospital emergency. A message was left for family to inform them. Member was discharged home same day.

Patient noticed swelling in neck (lymphadenopathy) around 10:30 PM (4-5-21). She said there was no pain or discomfort in left arm, but noticed a "small amount of swelling" at the injection site (left deltoid). She went to bed shortly after. Woke up following morning (4-6-21) at 7:15 AM & had generalized aching at the following body sites: back of head, neck, both legs, & both feet. She compared the aches to a case of "bad flu." Also reports malaise (tiredness, lethargy) and spent the entire day "laying around." On 4-7-21, the aches had resolved but she still felt tired & lethargic. On 4-8-21, all symptoms resolved & patient "felt fine." She did contact her primary care provider, & on 4-8-21 she filled a prescription for celecoxib 100 mg: 1 cap once a day, #30 capsules, which she began later that day.

DIZZINESS; ALL OVER BODY ACHE; SORE ARM; HEADACHE; This spontaneous report received from a patient concerned an 80 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included unspecified health issues, and other pre-existing medical conditions included the patient had no health history that would relate to the vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, batch number: 1805022, and 1005022 expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 in right arm for prophylactic vaccination. No concomitant medications were reported. On 2020, Laboratory data included: COVID-19 virus test negative (NR: not provided) negative. On 16-MAR-2021, the subject experienced dizziness. On 16-MAR-2021, the subject experienced all over body ache. On 16-MAR-2021, the subject experienced sore arm. On 16-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, all over body ache, and headache on 17-MAR-2021, and had not recovered from sore arm. This report was non-serious.

COULD NOT MOVE AND WAS PARALYZED FOR 3 DAYS; HEART RACING; FOGGY; CHILLS; WEAKNESS/NOT HAVING THE STRENGTH; HIGH FEVER(NOT SPECIFIED); FATIGUE; This spontaneous report received from a consumer concerned an 80 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included ovarian cancer 4 years ago., hay fever, non alcohol user, and non-smoker, and other pre-existing medical conditions included patient did not have drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1865020, and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced could not move and was paralyzed for 3 days. On 19-MAR-2021, the subject experienced heart racing. On 19-MAR-2021, the subject experienced foggy. On 19-MAR-2021, the subject experienced chills. On 19-MAR-2021, the subject experienced weakness/not having the strength. On 19-MAR-2021, the subject experienced high fever (not specified). On 19-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not move and was paralyzed for 3 days on 22-MAR-2021, had not recovered from fatigue, foggy, high fever(not specified), and heart racing, and the outcome of chills and weakness/not having the strength was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.

Right hip pain causing difficulty walking which is new onset immediately following vaccination. Woke with symptoms next morning. Started with generalized weakness midnight after the vaccine.

LEG CRAMPS; HARD TO WALK; ACHY HIPS; ACHY LEGS; This spontaneous report received from a patient concerned an 81 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1805031, expiry: 26-MAY-2021) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced leg cramps. On 26-MAR-2021, the subject experienced hard to walk. On 26-MAR-2021, the subject experienced achy hips. On 26-MAR-2021, the subject experienced achy legs. Laboratory data (dates unspecified) included: Scan (NR: not provided) No blood clots, and X-ray (NR: not provided) No blood clots. The action taken with covid-19 vaccine was not applicable. The patient was recovering from hard to walk, and had not recovered from achy legs, achy hips, and leg cramps. This report was non-serious.

HEAD "FEELS LIKE IT IS SWIMMING"; WEAKNESS; FATIGUE; FEELING LIKE PASSED-OUT; ACCELERATION OF BREATHING DURING WALKING OR MOVING; UNSTEADY; This spontaneous report received from a patient concerned an 80 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included type ii diabetic, and hiatal hernia, and other pre-existing medical conditions included patient had no known allergies. patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. Concomitant medications included darunavir/cobicistat non-company. On 10-MAY-2021, the subject experienced feeling like passed-out. On 10-MAY-2021, the subject experienced acceleration of breathing during walking or moving. On 10-MAY-2021, the subject experienced unsteady. On 10-MAY-2021, the subject experienced weakness. On 10-MAY-2021, the subject experienced fatigue. On an unspecified date, the subject experienced head "feels like it is swimming". The action taken with covid-19 vaccine was not applicable. The patient had not recovered from weakness, fatigue, feeling like passed-out, acceleration of breathing during walking or moving, and unsteady, and the outcome of head "feels like it is swimming" was not reported. This report was non-serious.

DIZZINESS; This spontaneous report received from a patient concerned an 80 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known allergies and has not had covid or been tested positive for covid. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAY-2021, the subject experienced dizziness. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient was recovering from dizziness. This report was non-serious.

pt says she felt very strange like she was having some type of reaction and like something was wrong with her. She wants to sleep all the time and stay asleep. She says she has never been so tired and she is scared to even drive. She reported this to her pharmacist. She cant keep her balance and has never been so tired in her entire life, saying she could sleep night and day if she could and has felt bad since the day she took the vax. She also has some brain fog. She had to put her husband in a Rehab because he needs her care and she was not able to take care of him since she was so sick. (she wanted me to take note of these numbers)

Reported to me by patients niece, who developed similar symptoms around the same time: Patient developed cough aches, fartigue and shortness of breath about 8 days after receiving COVID vaccine. After another 10 days of illness was taken to hospital by ambulance as too weak to stand., and died in hospital about 5 days later, on or about 5/22/21

Patient stated that she was very week. Patient stated that she could hardly walk. Patient stated that she felt like she had the flu. She kept her self hydrated. Patient stated she gets tired easily and can not continue her everyday lifestyle.

DYSSTASIA; COVID-19; SARS-COV-2 TEST POSITIVE; ASTHENIA; FATIGUE; DYSPNOEA; COUGH; PAIN; ILLNESS; DEATH; This spontaneous report received from a health care professional concerned an 80 year old female of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, and hypertension. The patient experienced drug allergy in past when treated with ACE (angiotensin-converting-enzyme) inhibitors for an unknown indication. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 205A21A, and expiry: unknown) dose was not reported, frequency time was 1 total administered on left arm on 30-APR-2021 for prophylactic vaccination. Concomitant medications included Amlodipine, Atorvastatin, Bupropion, Escitalopram, Furosemide, Lantus (insulin glargine), Levothyroxine, Metoprolol, Mirtazapine and Pantoprazole for an unknown indication. On an unspecified date in MAY-2021 (reported as about 8 days after vaccination), the patient developed cough, aches, fatigue, and shortness of breath. After another 10 days of illness, the patient was taken to the hospital by ambulance as she was too weak to stand. On 22-MAY-2021, the patient experienced Covid-19, dysstasia and she had her SARS-COV-2 (severe acute respiratory syndrome coronavirus 2) test positive. On an unspecified date in MAY-2021 (reported as on or about 22-MAY-2021), the patient died from unknown cause of death in hospital about 5 days later. It was unspecified if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on MAY-2021, and had not recovered from asthenia, cough, covid-19, dyspnoea, dysstasia, fatigue, illness, pain, and sars-cov-2 test positive. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender's Comments: -covid-19 vaccine ad26.cov2.s. Death, cough, covid-19, dyspnea, dysstasia, illness, pain, and sars-cov-2 test positive. This events are considered unassessable. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the covid-19 vaccine ad26.cov2.s. Asthenia , fatigue, This events are labeled per RSI and is therefore considered potentially related.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH

DIZZINESS; LOOSE STOOL; WEAKNESS; CHILLS; FEVER; This spontaneous report received from a patient concerned an 81 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 01-APR-2021 11:00 at left deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-APR-2021, the subject experienced dizziness. On 02-APR-2021, the subject experienced loose stool. On 02-APR-2021, the subject experienced weakness. On 02-APR-2021, the subject experienced chills. On 02-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, loose stool, weakness, chills, and fever on 03-APR-2021. This report was non-serious.

Within 4 days of the vaccine she became weak, nauseous, body pain and developed a fever. She was unable to get out of bed at all. One week after vaccine she suffered a stroke.

Pt received vaccine in her home state, unable to get details of vaccine administration such as date, site, lot #, etc. Per ED MD note : 81-year-old female with reported history of atrial fibrillation found down at hotel room. Patient states she has been on the ground in the room for 3 days, she was found covered in feces. Alert and oriented x4 however intermittently appears confused and has varying history. She does not know how she got on the ground, however denies fall or syncope. No significant current complaints. Slightly tachycardic and febrile, slightly hypertensive, exam without any significant acute findings, no obvious skin source of ulcer or infection, no focal neurological deficits, no pain. Initiated aggressive fluid hydration and sepsis work-up. EKG appears normal with no signs of ischemia or arrhythmia. Labs show slightly elevated troponin, low magnesium, metabolic/lactic acidosis. VBG relatively normal. Urine negative for infection chest x-ray without evidence of pneumonia, no clinical signs or symptoms to identify source of infection. Nothing to suggest meningitis at this time. CT head is negative. Unclear source of fever however empirically treated with antibiotics and fluids. Patient remains hemodynamically stable with no hypotension. She did arrive slightly hypoxic and with increased respiratory rate however clear lung sounds and no indications of heart failure, COPD/asthma. CT chest without evidence of pulmonary embolism, focal pneumonia, or fluid overload. Respiratory status possibly related to compensation for metabolic acidosis that is likely due to lack of fluid intake due to being on the ground. CK is normal and kidney function is normal. Consulted medicine for admission for further evaluation and treatment. Cardiology was also consulted for NSTEMI, agrees with current plan. per H&P 4/28/21: Altered mental status (R41.82): Etiology is not clear. Patient states she had J&J Covid vaccine about 3 weeks ago. Need to rule out cerebral venous sinus thrombosis. Get a CT scan of the brain with contrast. If negative will get CT venogram or MRV and MRI of the head. Neuro checks. Request PT OT and speech therapy evaluation. Check urine drug screen. Check blood alcohol level. Non-STEMI (non-ST elevated myocardial infarction) (I21.4): Start argatroban drip until cerebral vein sinus thrombosis is excluded then we can switch to heparin drip. Start aspirin and statin. Check fasting lipid panel. Monitor on telemetry. Trend troponin. Request echocardiogram. Cardiology to consult. Dr. was consulted from the ER. » Beta-Blocker Ordered: Beta-Blocker Ordered » Aspirin Ordered: Aspirin Ordered » Statin Ordered: Statin Ordered Fall (W19.XXXA): Plan as documented above. Rhabdomyolysis (M62.82): Hydrate and recheck CPK. Elevated liver enzymes (R74.8): Check hepatitis panel. Monitor levels. Fever (R50.9): No clear source of infection. Follow up on blood cultures. CT chest negative for infectious process. Check CT of the abdomen and pelvis.Start empiric antibiotics: Vancomycin and Zosyn. Hypomagnesemia (E83.42): Administer magnesium sulfate. Repeat level in the morning. Diabetes (E11.9): Start sliding scale insulin. Monitor fingersticks. Hypoglycemic protocol. Check hemoglobin A1c. Hypertension (I10): Fortunately patient is hemodynamically stable. We will cautiously start metoprolol. Adjust antihypertensives to optimal blood pressure control. Acidosis, lactic (E87.2): Likely due to profound volume depletion. Rule out sepsis. Hydrate and trend level. VTE: Argatroban. » VTE Prophylaxis Assessment: Risk Level documented as Low Risk Discharge Planning: » Discharge Planning: » Discharge To, Anticipated: Home independently Per Intensivist note 4/30/21: . Another consideration was TTP, however, patient has normal renal function with no significant evidence of microangiopathic hemolytic anemia (no schistocytes on smear). Also does not seem consistent with ITP. Suspect more a result from sepsis given bacteremia Per attending note 4/30/21: Altered mental status (R41.82): Likely septic encephalopathy due to sepsis. No cerebral venous sinus thrombosis. MRI negative for stroke. AMS has resolved. Continue antibiotics. Per attending note 5/2/21: Addendum by MD, on May 02, 2021 09:58:55 (Verified) Discussed with cardiologist, Dr. . Possible need for TEE with regards to persistent bacteremia. We will keep n.p.o. overnight for TEE tomorrow. Repeat blood culture from 4/30/2021 just came back positive for Enterococcus. Suspect endocarditis due to TAVR. ? need for TEE to evaluate the valves (TAVR) more closely. Duration of antibiotics depends on bacterial clearance: To be determined. Get another set of cultures. On Zosyn. per attending note 5/4/21: Enterococcal bacteremia (R78.81): Etiology not entirely clear but suspect GI source or endocarditis. Repeat blood culture from 4/30/2021 is positive for Enterococcus. PCP he is accepting to follow-up for IV antibiotics management: Will arrange home IV infusion through care . Antibiotics end date to be determined: Pending bacterial clearance. Repeat blood cultures pending. Infectious disease specialist following: Patient is currently on Unasyn. Will need 4 weeks of IV antibiotics.

At the time of the vaccine, the patient reported she felt an "explosion" when the needle was inserted into the left arm. She had left arm soreness over the subsequent days. After a week or two symptoms got worse with increased pain noted on 4/20/21. Supportive care with analgesia was recommended by her primary care doctor. The pain in the left arm continued and the patient noted impaired range of motion of the left shoulder with sensation of swelling in the arm on 4/30/21. She was advised on shoulder exercises. There continued to be worsening pain and decreased range of motion of the left shoulder with notably impaired function. The patient also complained of ongoing tiredness and impaired sleep due to shoulder and arm pain. She was assessed on 5/3/21 by her primary care doctor where exam showed swelling of the anterior left shoulder without erythema. There was severely impaired range of motion. She was diagnosed with frozen shoulder on the left. She was referred to orthopedic specialist and was seen on 5/4/21 where the diagnosis was confirmed along with impingement syndrome of the left shoulder. She received an intra-articular injection of steroid and was referred to physical therapy. An MRI was recommended.

TROUBLE BREATHING; CAN'T STAND; CAN'T WALK; BRAIN FOG; STRONG ODOR IN THE URINE; CHEMICAL SMELL IN NOSE AND MOUTH; CHEMICAL TASTE IN NOSE AND MOUTH; BODY ACHE; SORE THROAT; LOOSING MEMORY; WEAKNESS; HEADACHE; This spontaneous report received from a patient concerned an 81 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced trouble breathing. On 10-APR-2021, the subject experienced can't stand. On 10-APR-2021, the subject experienced can't walk. On 10-APR-2021, the subject experienced brain fog. On 10-APR-2021, the subject experienced strong odor in the urine. On 10-APR-2021, the subject experienced chemical smell in nose and mouth. On 10-APR-2021, the subject experienced chemical taste in nose and mouth. On 10-APR-2021, the subject experienced body ache. On 10-APR-2021, the subject experienced sore throat. On 10-APR-2021, the subject experienced loosing memory. On 10-APR-2021, the subject experienced weakness. On 10-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine was not applicable. The patient recovered from trouble breathing, can't stand, can't walk, brain fog, strong odor in the urine, chemical smell in nose and mouth, chemical taste in nose and mouth, body ache, sore throat, loosing memory, and headache on MAY-2021, and had not recovered from weakness. This report was non-serious.

My mom had a stroke on 6/17/2021 and was hospitalized. A week or so before the stroke, my mom lost feeling in the fingers of her right hand and didn?t feel well...but she didn?t feel sick, just not her normal self. The stroke spidered out over both sides of her brain. Mom is off balance, her mouth droops on the right and that side of her face is numb. The doctors in hospital could see what happened to my mom but were puzzled why because she?s so healthy with no prior issues which would cause a stroke. We saw mom?s primary care doctor after release from hospital. She was very surprised that mom had a stroke as nothing in blood work, her health or family history would indicate that this would happen. Doctor said it was probably the COVID-19 vaccine.

3/24/21 eval of dizziness . States sx started this morning . Was in hospital and transferred approx. 1 week ago for dehydration and a-fib. Denies nausea or vomiting.

She received the vaccine, no problems initially, no real arm soreness. The next morning when she woke up she could not walk, had to hold onto something to walk, and has a lot of pain, and has not improved even with taking pain medications. There has been no improvement from the pain. There are times that she feels just a little better, but then returns back to where it was. She went to the ER on 3/17/21, they said that she had arthritis which she had but she has not had this type of pain until the vaccination. They gave her some pain medicine which did not help at all. She again is taking some pain medication now but the pain is still there. She can stand on her leg and it doesn't hurt, but when she moves her leg is when it hurts. She is now using a walker which she did not have to use before the vaccine.

Janssen -Covid 19-EUA Incident # 2021-00019561 The patient was standing in observation and complained to me that she was dizzy. I sat her down and Paramedic assessed the patient and recommended she be transported to the hospital. The patient refused tranport and signed out. See Paramedic PCR for further details. The patient stated she felt dizzy after her flu vaccine also.

Janssen -Covid 19-EUA The patient was standing in observation and complained to me that she was dizzy. I sat her down and Paramedic assessed the patient and recommended she be transported to the hospital. The patient refused tranport and signed out AMA. See Paramedic PCR for further details. The patient stated she felt dizzy after her flu vaccine also.

Pt was observed post vaccination complaining of dizziness & light headedness, pt brought to triage and attended by the doctor. Ekg was normal, pt sitting on gurney with pt's husband at bedside, EMS was also at bedside, pt was initially hypertensive, the rest of the vitals were normal, pt was give orange and apple juice, tolerated, observed further, vitals improved, pt denies any complaints and discharged. Pt wheeled off unit by nurse.

Awoke 3rd day after vaccination with severe positional vertigo or similar disorder - felt when I simply turned my head on pillow. It was as if I was falling in space, especially my head. Could not sit up without feeling terrible. Lessened somewhat during day but could not move head without feeling vertigo/dizziness. Unable to eat without nausea and vomiting. That was 04/09/21. On 04/10 and 04/11 it was difficult to arise from bed without feeling very dizzy. But after getting up very slowly without moving head, I could move slowly to use bathroom, get a little food, etc. Today, 04/12, still had to arise from bed very slowly, trying not to move head to avoid weird dizzy type feeling. Have been able to eat, get dressed and leave the house carefully. Try not to move head too much and move rather slowly.

Janssen COVID-19 Vaccine EUA Patient received J&J COVID Vaccine on 3/15/2021 per vaccine card. Patient had an ED Visit on 3/17/2021 for a chief complaint of lightheadedness and was diagnosed with Pneumonia with Chest X-ray showing small bilateral pleural effusions with underlying atelectasis or consolidation. On 4/12/2021, Patient presented to ED as instructed by outside physician for finding of blood clot on CT the morning of 4/12/2021 (Pulmonary emboli at the left upper lobe). The patient had CT scheduled during an office appointment on 4/5/2021. Patient admitted for treatment of pulmonary embolism.

Paraphrase from provider discharge to swing bed note: 83 y/o female brought to ED for fall and left shoulder pain. Baseline dementia, poor historian, early onset Parkinson's Disease. Fully vaccinated for COVID-19, showing no obvious symptoms of COVID. Cough, no dyspnea per review of systems. Problem list includes: Anterior shoulder dislocation, reduction. COVID-19. Essential Hypertension, Acute confusion, baseline dementia, urine + for nitrite and bacteria, started on macrobid. Depression. Unable to enter required fields for Q.#21, Hospitalization. Currently Hospitalized

stroke-like symptoms; left side extreme weakness; gran mal seizure with loss of cognitive function; gran mal seizure with cognitive awareness; loss of depth perception and dizziness. Treatment: increase in lamotrogine from 200mg/150mg to 200mg/200mg

around 7pm I had had a cup of coffee and a brownie and I suddenly felt tight in the chest and abdomen. tums did not help but didnt resolve. the next day I still had issues and was light headed. It did go away eventually. I have a history of indigestion/gas issues.

ARRHYTHMIA; COMPLEX MIGRAINE; BP BOUNCING HIGH AND LOW; TROUBLE MOVING LEGS AND NO STRENGTH; TIRED; EXTREMELY WEAK; TEMPERATURE ELEVATED; ELEVATED BLOOD PRESSURE; TROUBLE WITH ARM HARDLY USE ARM; GROIN PAIN; MUSCLE ACHE; COULDN'T SLEEP; UNABLE TO WALK; This spontaneous report received from a patient concerned an 83 year old female. The patient's height, and weight were not reported. The patient's past medical history included bulbar polio diagnosed at age 15, and concurrent conditions included seasonal allergy, non-smoker, and high blood pressure. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination at right arm. No concomitant medications were reported. On 12-MAR-2021, Laboratory data included: SARS-CoV-2 rapid diagnostic test (NR: not provided) NEGATIVE. On 13-MAR-2021, the patient experienced temperature elevated. On 14-MAR-2021 (Sunday) and 15-MAR-2021 (Monday), she felt bad and had elevated blood pressure (BP) and temperature. On 16-MAR-2021 (Tuesday), she felt lot better but by afternoon, she experienced loss of sight in right saw round circle with black triangle and her BP was 130/111 (77- heart rate (HR)). She developed arrhythmias. Her daughter and husband took her to the hospital. The hospital staff was concern about stroke. Her magnetic resonance imaging (MRI) and two computerized axial tomography (CAT) scans, one with iodine was performed and confirmed that she did not had stroke. Her BP was bouncing around high and low. She had trouble in moving legs were not working no strength. At one point her heavy muscle couldn't move. She reported that her BP was erratic, she was conscious but not mentally functioning, which was hard to explain. She was sent back to do scan with iodine, as health care professional was concern with blockage. Later, her MRI was performed. She started getting better and on the same day she was released from hospital after about 7 -8 hours. After coming home, she felt tired. She was diagnosed with complex migraine. On 26-MAR-2021, she started having trouble with arm and leg and she could not sleep. On 27-MAR-2021, her last muscle ache. Her BP elevated again and can hardly use her right arm. On 28-MAR-2021, her left leg was not in shape, trouble using right arm, groin area muscle is giving out with sharp pains. Treatment medications (dates unspecified) included: amlodipine, acetylsalicylic acid, and metoprolol. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arrhythmia on 16-MAR-2021, and temperature elevated, and unable to walk, had not recovered from elevated blood pressure, trouble moving legs and no strength, complex migraine, muscle ache, groin pain, and BP bouncing high and low, and the outcome of extremely weak, trouble with arm hardly use arm, tired and couldn't sleep was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210353871-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Arrhythmia, Complex migraine, Temperature elevated, Trouble moving legs and no strength, Tired. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). V0: 20210353871-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Elevated Blood pressure, BP bouncing high and low. 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 of High blood pressure. V0: 20210353871-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Extremely Weak. This event(s) is labeled and is therefore considered potentially related.

I received Botox on 2/19/21 In the right arm for post stroke treatment of muscle spasticity. Then I received the COVID-19 shot in the right arm on 3/12/21. Coincidentally within the following week, I developed extreme weakness in the right leg. It is severe enough that I'm still having trouble walking at all even with help. So I'm wondering if there was an interaction between the vaccine and the Botox that caused this. I've had adverse interactions between medications before.

Immediately got headache and that headache has been present for weeks (waxes and wanes in pain and intensity). Also dizziness which has gotten worse. Two days ago, she felt so dizzy and faint, she fell onto her husband in the kitchen, bruising herself. She saw her MD for a checkup last week and did not mention the symptoms to him.

I was walking in the airport and I just fell for no reason. I went down slow. I was able to get up on my own, but I have no idea what made me fall. I went to my daughter's house and I was trying to climb the stairs to get to her place, but I couldn't even bring my leg up to step on the first step. I had to physically pull myself up the stairs by my arms. I felt like I lost my strength. I lost control of my bladder. I went to the doctor to have a urinalysis done and there was not an infection. I also lost my balance and would often have chills. Anytime I would start walking it would feel like I was drunk with how I couldn't walk straight. I felt fatigued during this time as well. During time that I would try to speak, I would say something in a sentence that had nothing to do with the topic of conversation. I was thinking I may have had a stroke, but when I went to the doctor and had a CT scan, a brain MRI and blood work done, everything came back normal. All of this lasted three weeks and then just all went away. My doctor diagnosed me with post COVID viral illness, but I never had COVID. She said it's similar to a viral meningitis.

On the morning of admission, patient had another episode. She was sitting at the kitchen table and then slumped forward unconscious. She has no memory of the episode. Daughter is unsure how long she was unconscious for. She was taken to the ER via ambulance. Head CT in the ER showed only age-related changes. Chest x-ray showed an increase in infiltrate. Influenza test negative. Rapid COVID-19 test negative. Urinalysis only had 2+ leukocyte esterase. White count of 3.3. Cardiac enzymes negative. BNP normal. remains hospitalized at Hospital - inpatient

Patient received Moderna COVID vaccine at a health dept clinic in February and experienced blurred vision and 3 weeks of fever afterward. CDC consulted and the recommendation was to use Janssen COVID vaccine as second dose with monitoring for 30 minutes. Allergist agreed. After Janssen vaccine, patient was fine for first 28 minutes, then experienced blurred vision, light-headedness. At 10:10 patient became palor and lost consciousness. EpiPen given and patient immediately responded. EMS called and 50 mg IM diphenhydramine given. No SOB, wheezing, or CP. Positive for palpitations

SHOULDER SWELLING; SHOULDER PAIN; SHOT WAS EXTREMELY PAINFUL; FLUSHED FEELING; DIFFICULTY LIFTING THE ARM; This spontaneous report received from a patient concerned an 84 year old female. The patient's weight was 100 pounds, and height was 157.48 centimeters. The patient's concurrent conditions included arthritis in left shoulder and mammals allergy. The patient had no illness at the time of vaccination. The patient had no past history of similar event. the patient had no adverse event after any previous vaccination(s). The patient had no pre-existing acute illness 30 days prior to vaccination. The patient had no history of hospitalization or acute illness in last 30 days, with cause. The patient had no family history of any disease (relevant to vaccination) or allergy. The patient had no other suspected causes including co-administered vaccine(s)/risk factors. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for left deltoid prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the patient experienced flushed feeling. On MAR-2021, the patientexperienced difficulty lifting the arm. On 15-MAR-2021, the patient experienced shot was extremely painful. On 19-MAR-2021, the patient experienced shoulder swelling. On 19-MAR-2021, the patient experienced shoulder pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shoulder pain, and shoulder swelling, and the outcome of flushed feeling, difficulty lifting the arm and shot was extremely painful was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.

BLURRY VISION; UNCONTROLLABLE SHAKING; JAW PAIN; PAIN ON LEFT SIDE NEAR KIDNEY; FELT BODY HOT/BODY BURNING HOT; DIZZY; PAIN IN BONES ALL OVER BODY; FREEZING COLD; CHILLS; PAIN IN LEFT ARM WHERE INJECTED; HEADACHE; FEVER; This spontaneous report received from a patient concerned an 84 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included type 1 diabetes, and hypothyroidism, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 12:15 for prophylactic vaccination. Concomitant medications included levothyroxine sodium for hypothyroidism, and insulin for type 1 diabetes. On 11-APR-2021, the subject experienced blurry vision. On 11-APR-2021, the subject experienced uncontrollable shaking. On 11-APR-2021, the subject experienced jaw pain. On 11-APR-2021, the subject experienced pain on left side near kidney. On 11-APR-2021, the subject experienced felt body hot/body burning hot. On 11-APR-2021, the subject experienced dizzy. On 11-APR-2021, the subject experienced pain in bones all over body. On 11-APR-2021, the subject experienced freezing cold. On 11-APR-2021, the subject experienced chills. On 11-APR-2021, the subject experienced pain in left arm where injected. On 11-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from uncontrollable shaking, and chills on 11-APR-2021, jaw pain on 12-APR-2021, and felt body hot/body burning hot, freezing cold, pain in left arm where injected, headache, and fever on 13-APR-2021, was recovering from blurry vision, and pain on left side near kidney, and the outcome of dizzy and pain in bones all over body was not reported. This report was non-serious.

My Mom received the J&J Vaccine. Apprx 10 days later fell, fractured hip, Surgery April 3rd - On April 5th doctor at medical center said she has a blood clot and low platelets. Was in Hospital from April 2 to April 12th

Patient complained of not being able to read 1 week after vaccine. 1 week and one day, became very disoriented. Taken to ER on 1 week and 2 days after the shot and diagnosed with a stroke in the left occipital lobe of brain. Also diagnosed with atrial fibrillation same day. (for first time.). Patient had no history of blood clotting disorders nor heart problems. This stroke rendered patient with restricted vision. She is now unable to drive, and still quite foggy, though she is likely to recover almost fully.

CAT SCAN HEAD - SOMETHING IN HEAD; FEELING LIKE A BLOOD CLOT ON INNER UPPER THIGH OF RIGHT LEG; DIFFICULTY BREATHING; CALCIFICATION OF LUNGS; NUMBNESS IN BOTH FEET AND TOES; DIZZINESS; OFF BALANCE; RIGHT LEG TINGLING/FEELS LIKE WATER RUSHING; FELT LIKE BUGS RUNNING IN HEAD; ELECTRICAL SHOCK LIKE BUGS IN HAIR; SQUEEZING IN FACE; WHOLE BLOOD WAS DROPPING OUT OF BODY; This spontaneous report received from a patient concerned an 84 year old female. The patient's weight was 230 pounds, and height was 66 inches. The patient's past medical history included stroke, and concurrent conditions included atrial fibrillation, allergy to medications, non-smoker, and non-alcohol user. The patient was not pregnant at the time of reporting and the patient had no drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: 05-AUG-2021) dose was not reported, 1 total, administered on 04-APR-2021 to right arm for prophylactic vaccination. Concomitant medications included diltiazem hydrochloride for atrial fibrillation, and warfarin sodium for stroke. On 01-MAR-2021, the patient's laboratory data included Doppler scan and results were normal. On 04-APR-2021, the patient got dizzy right after the vaccination and off balance which exasperated everything. On the same day, the patient experienced tingling in right leg, felt like water rushing, both feet toes were numb, on right side felt like a blood clot on inner right thigh, difficulty breathing, calcification of lungs, felt like bugs running in her head, electrical shock, like bugs in her hair and squeezing in her face. The patient felt like her whole blood was dropping out of her body. The patient described everything comes and goes and one day it was there and another day it was not, then it came back. It was reported that, the patient visited her physician for the tenderness in her leg for possible blood clot issue and she did not know the results. On 29-JUN-2021, the patient's laboratory data included computerised tomogram (CAT scan) of brain and lungs which was abnormal, showed calcification on the lungs and that something was in her head. The patient had visited an ear, nose, throat (ENT) physician, internist, pulmonary physician, and cardiologist and it was made aware that all the side effects were from the vaccination. The patient had scheduled upcoming appointment with gastroenterologist physician. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness on 04-APR-2021, had not recovered from right leg tingling/feels like water rushing, numbness in both feet and toes, feeling like a blood clot on inner upper thigh of right leg, difficulty breathing, calcification of lungs, felt like bugs running in head, squeezing in face, electrical shock like bugs in hair, and whole blood was dropping out of body, and the outcome of off balance and CAT scan head - something in head was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210728298-covid-19 vaccine ad26.cov2.s -this case concerns a 84 year old female-feeling like a blood clot on inner upper thigh of right leg. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Patient was vaccinated in her home (COVID J&J) on 3/8. Vaccinator obtained consent and confirmed throughout the process that patient as at baseline since patient was nonverbal and bedbound. Later that same day she experienced an emergency and was take to the hospital and subsequently admitted to ICU. She died on 3/10, family present, on comfort care. Per HPI, "Patient is a 85 y.o. female with advanced dementia (non verbal, wheelchair bound at baseline), chronic aspiration, recurrent UTIs, voiding dysfunction currently self-straight cathing, has suspicious bladder and gallbladder masses (being worked up), has right sided hydronephrosis, BIBEMS for acute hypoxemia, difficult to bag en route, ED had difficulty intubating and so performed cricothroidotomy. Patient had brief PEA arrest due to hypoxia. ED provider noted "excessive pulmonary edema in airway, unfavorable anatomy, and airway swelling." Suspected insult stemming from J&J COVID vaccination reaction.

Friday 3/19 Confusion, did not know her granddaughter, which grandchild she was kept confusing family names. That was very unusual for her. Saturday 3/20 didn't feel good that day, Sunday 3/21 around 3am got up to go to the restroom got very light headed and fell/fainted hitting her head on the night stand and falling to the floor. When EMS arrived she was in A-fib. That had never happened before. No known heart problems.

Extremely off-balance for a few days (3) after the shot; she could barely walk on her own without falling over. Also had aches and pains everywhere, and especially in both arms, for several days (5) after receiving the shot. Has not felt well since receiving the shot and still feels weaker than normal.

A week following my mothers vaccination, she became increasing fatigued. On day 10 following her vaccination she went to bed and had to be helped to her room, this was unusual. She remained in bed for 19-20 hours a day for three days. I called all of her doctors, all of whom she had just been seen by, routine CT scans performed, blood work done, and visit with her neurologist. Her oncologist suggested we seek a hospice evaluation, even though her CT scans showed that her cancer had only slight growth, nothing to be concerned about. Her primary care office ordered the hospice evaluation and it was performed on Thursday, 3/18. They said ?she may just be having a bad week following her vaccination? and ?lets revisit this the following week?. her condition continued to deteriorate significantly over the next few days, so much that she began sleeping 21?23 hours a day. On the following Tuesday, 3/23, she was admitted into the hospice system. Now, four weeks later, we are in the final weeks of her life. She refuses food and water now, and her nurse says that it won?t be much longer. She went from a relatively healthily, senior woman, with underlying health issues, none of which presented her imminent demise, to dying at home within weeks of receiving her J&J vaccine. I have no idea if he demise is in anyway related to her vaccine, but thought it was important to report her symptoms.

April 9- mild headache and 2 dizzy spells 2 to 3 minutes each April 21- severe dizzy spell, 10 minutes long April 21- Dr. examination followed by blood work and brain CAT scan. All tests came back normal. April 23- severe migraine, feeling very sick, no appetite April 24- present- lite headed dizziness, unsteadiness

Pt has long hx of allergic (mild - moderate, rash and flushing) with different food preservatives and medication. Was cleared by doctor to get J&J but told to wait 30 minutes before discharge. Several minutes after getting vaccine, pt reported facial flushing and lightheadedness. Pt instructed to sit in reclined position in exam room and given bottled water (which she did not drink due to allergies to preservatives). Physical Exam. BP 167/95, T 96.6, RR 22, O2 95%. Lungs CTAB. Airway clear and non-edematous. After 30 minutes, pt felt well enough to go home on own. Pt given clear ER or PCP clinic return precautions.

Lethargic 4 days; headache, weak legs (knees buckled), odd pains various locations, tingling in hands and wrists, dizzyness, weakness, sore throat two weeks,

Patient called - received J&J Covid Vaccine 3/12/21 - has had sharp burning pain in her right arm ever since. Has seen primary care physician several times for it. He advised her to report to us. She can barely use her arm.

I RECEIVED THE JENSEN VACCINE ON JUNE 21ST. HAD NO REACTION FOR TWO DAYS. WHEN I WOKE UP ON THE THIRD DAY MY LOW BACK, BOTH HIPS, BOTH THIGHS, KNEES AND FEET HURT SO BAD I COULDN'T STAND ON THEM. I SPENT 3 DAYS IN BED AND SLOWLY BEGAN TO MOVE ABOUT. TODAY JULY 24TH I AM STILL HURTING WITH THE SAME PROBLEMS I DESCRIBED. MY DR. IS SEMI RETIRED AND LEFT NO ONE IN CHARGE OF HIS PATIENTS. HE HAS NOT BEEN INFORMED OF MY PAIN.

Patient reported right side of face red, hot and swollen beginning evening of 03/11/21. Ear aching. Pain and aching all over the body. Fatigue, nausea, dizziness and loss of appetite.

PATIENT WOKE UP AT 12 AM THROWING UP BLOOD AND FEELINGS OF PASSING OUT, 911 WAS CALLED AND AMBULANCE TOOK HER TO HOSPITAL, WHERE THEY DETERMINED IT WAS A STROKE AND MOVED HER TO ANOTHER HOSPITAL, WHERE CURRENTLEY BEING TREATED DETERMINED BLOOD CLOT IN BRAIN. MOST LIKELEY DUE TO VACCINE SHOT.

Pt reports fever; BLE edema; H/A - on & off with dizziness; Abdominal cramping; looses stools w/ offensive odor; fatigue started on 4/6/21

FEVER; NIGHTMARE; DIZZINESS; DROWSINESS; NIGHT SWEATS; FATIGUE; This spontaneous report received from a patient concerned an 86 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 04-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-MAR-2021, the subject experienced nightmare. On 06-MAR-2021, the subject experienced dizziness. On 06-MAR-2021, the subject experienced drowsiness. On 06-MAR-2021, the subject experienced night sweats. On 06-MAR-2021, the subject experienced fatigue. On APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nightmare, dizziness, drowsiness, and night sweats on 20-MAR-2021, and fever on APR-2021, and was recovering from fatigue. This report was non-serious.

Became dizzy when she bent into the freezer and remains with "vertigo". Unable to walk without a cane or walker.

SINUS ACTING UP; HOT FLASHES; LEG CRAMPS; LOOSE BOWELS; DIFFICULTY IN REMEMBERING; SWELLING INSIDE THROAT; ACHINESS ON SIDES OF NECK; DIZZINESS; NOSE BLEED; ACHINESS ON INSIDE OF LEFT ELBOW AND RIGHT KNEE; NAUSEA; TIREDNESS; MUSCLE ACHES; BLOOD PRESENT ON UNDERWEAR NEAR THE GROIN AREA; SHORTNES OF BREATH; FEELING OF BLOOD RUSHING TO HEAD; This spontaneous report received from a patient concerned an 86 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to sulfonamide derivatives, non-steroidal anti-inflammatory drugs (NSAIDs), sulfa antibiotics, penicillin, and cephalexin, asthma, and dry eyes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, 1 total dose administered on 06-APR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On 06-APR-2021, the patient felt rush of blood to her head almost causing her to pass out. On 07-Apr-2021 (in morning), she developed muscle aches, shortness of breath, a nosebleed one and hot flashes. She experienced trouble while remembering which was never a problem before. She developed leg cramps, loose bowels (for 1 week), swelling in her throat, achiness on both sides of her neck, dizziness, nausea if she ate something that did not agree with her, tiredness and an unusual blood stain in her underwear near the groin area (but not the private parts). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood present on underwear near the groin area, nose bleed, and achiness on inside of left elbow and right knee on 07-APR-2021, feeling of blood rushing to head, sinus acting up, leg cramps, swelling inside throat, and achiness on sides of neck, loose bowels on 14-APR-2021, dizziness on 11-APR-2021, and nausea on 09-APR-2021, was recovering from muscle aches, and had not recovered from shortness of breath, hot flashes, difficulty in remembering, and tiredness. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 :-covid-19 vaccine ad26.cov2.s-BLOOD PRESENT ON UNDERWEAR NEAR THE GROIN AREA. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

During the middle of the night she fell out of bed for no reason and hit the floor causing a blood clot to the brain. Taken to hospital by ambulance and then transferred to another hospital. After 18 days was transferred to a Rehabilitation facility. As of this date, she still a patient.

Hallucination, shortness of breath, dizziness, weakness, leg edema and low oxygen level. Patient sent to hospital for evaluation and treatment.

Systemic: Chills-Mild, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Nausea-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Visual Changes/Disturbances-Severe, Systemic: Vomiting-Mild, Systemic: Weakness-Severe, Additional Details: shot 4:23pm, pt complained of seeing stars, being nausous, weak, was going in and out of concsiousness for 30 -45 seconds. Had patient elevate legs a while seated and took bp at 4:30pm was115/36 pulse 52. pt tried to vomit but nothing came up.Took 2nd bp at 4:44pm 137/91 pulse 75. Moved patient inside pharmacy had her lay down flat with legs elevated for 8 minutes. complained of tingliness in both arms up to elbows. 3rd bp at 4:50pm was 127/80 pulse 65, 4th bp 125/82 pulse 77, left at 5pm

CONSTANT DIZZINESS; WEAKNESS TO THE POINT OF CONCERN; This spontaneous report received from a patient concerned an 87 year old female. The patient's height, and weight were not reported. The patient's past medical history included cardiac arrest, and concurrent conditions included chronic obstructive pulmonary disease, diabetes, high blood pressure, and henoch-schonlein purpura. 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, administered on 04-MAY-2021 19:00:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-MAY-2021, the subject experienced dizziness. On 07-MAY-2021, the subject experienced weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, and weak. This report was non-serious.

Fasting Blood sugar increased from 100 to 150 and stayed elevated for 2 weeks. Felt weak and lost balance.

4/12 3pm patient went to get up from recliner, body was very stiff and had severe muscle spasms and cramps from back, stomach, pelvis, thighs and legs down to feet. Legs swollen (enlarged veins) patient said. Patient slumped over and went down to floor. crawled to bathroom and applied Hemp Vana every few hours until some relief. 4/13 moring took 2 tylenol -muscles from hips down burning, stinging and sore. Called doctors. 4/14 patient continued applying Hemp Vana but then switch to Arnicare pain relief. Patient mentioned diarrhea and nausea with headache(she did not mention before) seemed little better(on and off) 4/16 up at 8am diarrhea and throwing up -muscles very sore -spent day exhausted and resting 4/17 patient used warm wet towels and arnicare. 4/18 diarrhea and nausea stopped 4/19 muscles beginning to relax. leg and thigh swelling going down 4/20 Saw dermatologist for other issue. He lower back and thighs and recommended patient to see ultrasound vascular surgeon for pelvic ingestion syndrome and recommended doctor.

BLE EDMEA/PAIN, GAIT DISTURBANCE, GENERALIZED WEAKNESS PRESENTED TO ER ON 5/1/2021 SYMPTOMS STARTED ON 4/30/2021. SHE WAS FOUND TO HAVE BLE DVT. NO EVIDENCE OF CT PE. REPORTED HAD J&J COVID VACCINE ON 4/6/2021. RECENT HOSPITAL ADMIT FROM 4/28/2021 TO 4/30/2021 WITH ACUTE RENAL FAILURE AND ACUTE CYSTITIS. PT ADMITTED TO MED SURG FLOOR. CALL REC'D FROM PROVIDER NOTIFIING OF RECENT COVID VACCINE AND NEEDED VAERS REPORT COMPLETED.

Patient presented to the ED 5/18/21 with voice slurring, headache, leg swelling. Patient with symptoms starting on Friday 5/14/21. Patient with profound weakness of her lower extremities, unable to ambulate around the house which is new. Patient also reporting she feels "different/wrong." While here in the Emergency department, patient fell onto her rear while at ultrasound, did not hit her head. Unable to stand on her own after. Patient was found to have an acute left lower extremity DVT on 5/17/21: Acute deep venous thrombosis throughout the left lower extremity with most proximal extension of thrombus into the common femoral vein noting that the external iliac vein could not be visualized

As per Daughter of PT, PT is in the hospital. Daughter of PT states that that on 04-07-2021 after receiving the J&J vaccine her mother developed severe right leg pain and is hard for her to mover leg, her right leg gets stiff and has difficulty to ambulate. Daughter of PT also states that her mother?s memory started to be off since receiving the J&J vaccine and that her doctors at the hospital placed her on Parkinson?s medication because the doctors think she displays symptoms of Parkinson?s disease. Daughter is at the hospital due to a fall injury and should be coming home soon. Due to the fall injury she has had lab work, x-rays, CT scan and lab work. Daughter of PT since the J&J vaccine she has had more frequent headaches on a daily basis than before.

Janssen COVID-19 Vaccine EUA Patient was found on the ground in home and admitted for observation on 6/24/21, reported frequent fals. Patient was provided J&J COVID Vaccine on 6/25/2021. On 6/26/2021 at 8:14 pm patient was noted to have left sided facial droop. Pt alert, confused. Can lift arms and legs for full 10 seconds. No weakness noted. Pt unable to tell when touching her left arm with her eyes closed x 3 attempts. Denies tingling/numbness in this arm. Not present in face/left cheek or left leg. 14 MRI brain showed small right MCA infarction on the background of considerable chronic microvascular changes. MRA head and neck showed diffuse intracranial and atherosclerosis without significant. stenoses or occlusion.