Johnson & Johnson

Pt found to have bilateral subsegmental pulmonary emboli. No right heart strain. Otherwise determined to be low-risk PE but will require anticoagulation.

Pulmonary Embolism and Lung Infarction. Signs began 5/1, to E.R. 5/3. Obviously, doctors unsure if from vaccine.

Patient looked normal and relaxed before and during vaccination. About 5-10 minutes after vaccination, patient passed out (fainted) while sitting down in a chair. Moved patient on to floor lying down flat and observed him for a few seconds. Patient was un responsive and appeared to struggle to breath. Asked my staff to call 911 for emergency services, and to bring an Epipen just in case, and started to perform CPR on the patient. The patient gained consciousness in about 15 chest compassions and became responsive. He answered the questions like his name, where he lives etc. As the patient became conscious, responsive and appeared to breath normally, I did NOT administer Epipen. Kept patient in observation and kept him engaged in talking until EMS personnel have arrived. They checked his vitals and blood glucose. In the conversation with EMS personnel, they said he is hypertensive and hyperglycemic. Ems took him to the ambulance by walking him (stretcher wasn't necessary)

Complained of Right lower leg pain, sent to radiology at local hospital for Ultrasound. Ultraspund was positive for DVT. Went from Radiology to Emergency room. Started on blood thinner medication and returned

Pt. was in his dorm, stood up and stated he could breathe, then went unresponsive. A medical response was called and staff arrived to the dorm within 2 minutes. Pt. took a couple of agonal breaths and stopped breathing, no pulse was found and CPR was initiated. Staff and EMTs administered 45 minutes of CPR, narcan and cardiac medications. He was pronounced dead by EMT at 10:45 am.

06/10/2021 Pt, per EMS report pt had his second covid vaccine shot, started having bad reaction, ems on scene, pt GCS 10, spo2 92% RA, hypotensive. at home pt having bad reaction, vomiting, defecated. Pt on gurney moaning, shaking answering questioning. Per MD, CT results show multiple Pulmonary emboli

Developed atrial fibrillation two days after vaccine - heart pounding and some chest discomfort.. Presented to ED the following day and was admitted and cardiologist consulted.

I ended up having a stroke after having blood clots Dr could not find cause of blood clots and this is only thing different I introduced into my body

PASSED AWAY; This spontaneous report received from a consumer via a company representative via social media concerned a 5 decade 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: not reported, expiry date: unknown) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient passed away due to vaccination. The cause of death was unknown. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20210732113-COVID-19 VACCINE AD26.COV2.S-Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH

COULD NOT BARELY MOVE OUT OF BED; BARELY WALK; BLOOD CLOTS IN BOTH LEGS; This spontaneous report received from a patient concerned a 40-year-old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, smoker (vapor about 10 -15 times a day), and non-alcohol user, and the patient had no known allergies. He did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: 07-AUG-2021) dose was not reported, 1 total, administered on left arm on 25-JUN-2021 for prophylactic vaccination. Concomitant medications included metoprolol succinate tablet for high blood pressure. On 30-Jun-2021 (5-6 days after receiving the vaccine), the patient started feeling pain in both legs. He had no other symptoms no fever, no aches. He climbs in a machine at his job, but he knew he didn't twist it. On 16-JUL-2021, he visited his physician because the pain lasted for 3 weeks. His physician ordered X-rays and Ultrasound. On 19-JUL-2021, he was notified that he had blood clots in both legs. He stated that it was worse and he could not barely move out of bed and barely walk. Physician prescribed him Eliquis (apixaban) for blood clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clots in both legs, and the outcome of could not barely move out of bed and barely walk was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210743268- Covid-19 vaccine ad26.cov2.s- Blood clots in both legs. 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

The vaccine was administered and within a few hours the patient was noted to be tachypneic and tachycardia RR 30s-40s; HR 130s. ABG done revealing hypoxemia to 57.6, blowing of pCO2 25.6. Lactate 6.6. EKG done revealing sinus tachycardia S1Q3T3; D-dimer 3000s; CTA done revealing a large embolus in the right mainstem pulmonary artery area crossing across midline into the left main pulmonary artery compatible with a saddle embolus. New saddle pulmonary embolism with hemodynamic instability Patient started on levophed to manage hypotension. Started tPA,and transferred to the ICU.

PATIENT REPORTS COUGHING UP BLOOD CLOTS FOR THE PAST 3 DAYS AND SENT PICTURE OF 1 THAT WAS COUGHED UP

On March 20th I received the J&J covid-19 vaccine shot. Starting on March 21st I begin to experience symptom such as fever, chills and body aches. That lasted for about 2 weeks. The week of April 5th- I been to experience struggling the ability to breathe. I was having serious pain in my left side of my chest and in the lower left side in my back. It was so severe, I went to the hospital on April 8th and at the hospital the Doctors discovered I had blood clots in my lung. I was in the hospital for 2 days. Iam currently on blood thinners inhaler and and oxygen.

the night after vaccine, patient had severe ocular migraine not relieved by his migraine meds, went to the local ED where he was dx with a R frontal SAH, transferred to medical center. No intervention done, SAH resolved spontaneously. Evolving Lancunar infarct seen on medical center serial imaging (CT/CTA brain). At the time of incident, patient was not taking meds for HTN .

I was vaccinated with J and J for COVID-19 I developed Pneumonia, Blood Clot on right calf (hospital diagnosis- acute deep vein thrombosis (DVT) of lower extremity), lower back pain

A 40 year old man with no apparent risk factors for current disease presents with an anterior myocardial infarction. At acute in far related angioplasty is LAD is found to be completely included by fresh red clot that was removed using an instruction catheter. Imaging of the interior endothelial surface of the left anterior descending which was occluded by clot did not reveal any ruptured plaque or abnormality in the endothelium. He experience extensive anterior myocardial infarction and now has a left ventricular ejection fraction between 35 and 40%. This was an and usual presentation in a young man who appears to be fit with no family history of cardiac disease. A non-smoker. Normal lipid profile. The nature the invite itself was unusual in that no abnormality of the vessel that was occluded by fresh thrombus could be detected

STROKE; LITTLE BIT OF JOINT PAIN ON LEGS; This spontaneous report received from a patient concerned a 41 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included ulcerative colitis, and psoriasis. The patient received guselkumab (solution for injection, subcutaneous, batch number was not reported) 100 mg, 1 time every 8 weeks, strength 100 milligram per milliliter from 2020 for psoriasis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included vedolizumab for ulcerative colitis. On an unspecified date, (13 days after vaccination), the patient had stroke. In APR-2021 (recent to this report), the patient had a little bit of joint pain on legs especially after exercising. The action taken with covid-19 vaccine ad26.cov2.s, and guselkumab was not applicable. The outcome of the stroke and little bit of joint pain on legs was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210438989-covid-19 vaccine ad26.cov2.s-stroke. 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). 20210438989-guselkumab-stroke. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

12 hours after injection, experienced normal side effects (e.g., muscle aches, chills, headache, fatigue) Within 1 week of receiving the vaccine, I began to experience blurriness in my left eye. After conferring with my primary care facility, it was recommended that I see an ophthalmologist. Confirmed that I had a Branch Retinal Vein Occlusion (BRVO) and recommended I meet with a retinal specialist. Dr. confirmed the BRVO was caused by a blood clot and commenced treatment via eye injection. I then met with my primary physician to discuss the situation. He recommend further tests to determine whether I had other clotting. In addition to blood work, he order MRIs of my brain, head and neck region and also recommended that I meet with a thrombosis specialist. I met with a Dr. who ordered additional blood work for additional testing. All tests performed to determine if I had additional clotting have come back negative.

Patient is 41 year old who presented with right sided upper and lower extremities weakness with facial drip , call as code stroke level 1 -CTbrain, CTA showed right basilar ganglia hemorrhage with small volume subarachnoid hemorrhage, left middle cerebral artery thrombosis with left basilar ganglia infarct and right basilar ganglia infarcts. TEE was negative for LV thrombus /vegetation .

5/21/21 10:00pm shortness breath, chest pain, shoulder pain, jaw pain, metallic taste, fatigue ?mini heart attack? symptoms 5/26-5/27 trouble breathing, fatigue, light headed 5/29 pain in left arm 5/30 night - second ?mini heart attack? symptoms General fatigue, hard to breath, overall feeling bad 6/2 - bruise on arm and lump Extreme headache, fatigue, chest pain, arm pain Emergency room visit = blood clots

Background:41-year-old male reported that he awakened with right lower leg pain intermittently since approx. May 10 2021. Woke on June 10 with increased pain and swelling to RLE. He tried to "run it out" but the pain worsened. In the ER he was noted to have elevated D-Dimer- 1980, ESR of 27, labs otherwise normal. Ultrasound showed DVT. He was started on hydrocodone-APAP and Xarelto. Returned on 11 June with SOB. PE was confirmed. Admitted to ICU Note today states continued swelling and pain to RLE. Considering transfer to hospital for vascular consultation and further management.

Within minutes of receiving vaccination, pt stated he was hot and thirsty, became unrepsonsive to verbal stimuli. Pt proceeded to have tonic-clonic seizure lasting 25 seconds. Pt lowered to the ground by staff, monitored VS. No incontinence, no biting of tongue. pt regained consciousness, and oriented x3. VSS. pt reported he felt light-headed. When attempted to place in chair, symptoms returned, and pt was placed back in supine position. EMS arrived, and after VS established, EKG indicated sinus rhythm, placed in chair. Pt stated he did not feel good, and similar symptoms began with eyes rolling back and contractures. Pt taken to hospital.

Flu like symptoms, joint pain, lungs heavy, pain in lungs, headaches - went to ED and PE was found - admitted to ICU - DC'd 5 days later

on the 2nd i had the shot in the left upper arm .. two days later i woke up to violently upchucking pure water after that i when to hospital and was admited i was told after a ekg that i was haveing a heart attack after that have no recolectiom of anything i wake up to a doc telling ,e it was a bad heart attack and had delovped about 5 blod clots in left lung and microcaditis i have been trying since then for a doc to talk to me but so far i been avoided

Right side tingling past 10 days. Reports tingling to right face and right arm feels like intermittent pins and needles. Received Janssen COVID vaccine on 4/12/21 at an outside facility. Diagnostic workup revealed Cerebral Vascular Accident (CVA).

Complain of headache to right back side of head and reports its moving to front of head. Reports its started on Monday. Was using ice packs and heating pads. Reports 10/10 on pain scale. Reports his head is tender to touch in the back. Denies any head injuries recently.

BLOOD CLOT; This spontaneous report received from a company representative concerned a 42 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 and expiry were unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, between three to ten days later after vaccination the patient died due to blood clots. It was unknown, whether autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0;20210510772-covid-19 vaccine ad26.cov2.s-Thrombosis. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: BLOOD CLOT

STEMI with 100% blockage in LAD with clot. Emergency cath lab with stents. Symptoms started at 330am on 3-29-21. Came to ED shortly after. Initial testing and labs were negative. Began to have severe symptoms shortly after. Multiple doses of nitro and morphine given for chest pain with no relief. Taken for emergency heart cath by 7am.

Could not get air into lungs, made sugar get out of control, had a seizure and turned purple, passing out , ambulance had to come get me from vehicle and take me to emergency room in the hospital, kept me there for about 6 hours then released me to go home, went to my Doctor next day and he immediately sent me to hospital. I was checked for Blood Cloth due to the signs being there along with other tests I am home however I still do not feel well.

11 days following the single shot I developed severe pain in my right calf muscle that felt like a charlie horse and on my leg from knee to my ankle felt a squeezing sensation like I was wearing a very tight sock that I couldn't take off. After a few days the pain subsided and the similar pain began in my left leg however not as severe. The pain would seemingly move around and come and go. Some days it was so bad I couldn't walk or balance. I believed I had a muscular issue. I then began having swelling on the top of my left foot and around the ankle of my left foot. After about a week, my right leg began to swell from the knee to ankle fairly significantly. New veins appeared on the front of my right leg and other veins on the back of my right leg began to bulge. Pain on both legs started to subside on the evening of 5/23, however swelling continued. On the evening of 5/25 I was experiencing severe squeezing sensation and bulging veins in my right leg.

Patient vaccinated on 5/19/2021 with the J&J vaccine. Patient came into hospital on 6/3 as stroke alert. Patient given alteplase and was positive for an acute cortical and subcortical infarct lateral right frontal lobe. Patient with no prior history to coming into the hospital.

Presented to ER with subacute malaise and worsening bruising area receiving Johnson & Johnson COVID vaccine 11 days ago, found to have microangiopathic hemolytic anemia and thrombocytopenia, concerning for TTP. He was transferred to Hospital as a direct admit to initiate plasmapheresis. Patient outcome tentative.

Current ongoing symptoms in order of severity include: lethargy/brain fog (daily since), thick mucus buildup (nose and back of throat throughout the day), regular headaches, depression, loose stool, eye redness, and tonsil stones (couched up daily). Events/symptoms after vaccine: tonic-clonic seizure (twice admitted to Hospital last event on 5/31/2021), petite-mal seizure (not admitted to hospital but noted by others in household), severe pounding headache (on and off in middle and back of cranium)

Patient was admitted for Multi drug resistant UTI (for which he has been admitted many times before). Was hospitalized for 3 days while awaiting cultures, hemodynamically stable, with no lab abnormalities. On the day of discharge (sensitivities to UTI came back, pt to be discharged on cefepime, had PICC line) pt got up from bed, sat on the edge of the bed and was being given belongings by the nurse, alert and oriented and in a pleasant mood, when suddenly pt grabbed at his chest and stated "I can't breathe" and became combative and altered when O2 was attempted to be placed on pt's face; then pt had PEA arrest x3 and unable to achieve ROSC.

Patient reports receiving Johnson and Johnson COVID vaccine on 3/19/21. He was hospitalized on 4/6/21 for an acute pulmonary embolism.

Experienced severe leg pain for several days. Ultrasound in ER revealed right calf DVT. Prescribed 21 day regimen of Xarelto starting yesterday.

Received vaccine on 5-6-21. On 5-8-21, complained of headache, bloating, fever, and constipation. Last seen alive at 9 PM on 5-8. Found dead at home at 7 PM on 5-9.

Patient was given the vaccine without incident at or near 0924a. He previously was diagnosed, through PCR test to have COVID-19 back in December 2019. Outside of supportive therapy at home, he was not treated and was not hospitalized and he recovered within a few weeks. At or near 930-10p, on April 9th, approximately 12 hours after the vaccine was given, while out at a restaurant with family, the patient experienced a medical event, (what appears to be an acute coronary event) and died.

Dizziness, Shortness of breath, Irregular Heartbeat Diagnosed with Atrial Fibrillation on 4/13/21 by primary healthcare physician

PATIENT SEEN FOR SOB X 2-3 WEEKS IN ED, CT SCAN SHOWED MULTIPLE PULMONARY EMBOLI. HEMODYNAMICALLY STABLE WITH NO EVIDENCE OF HEART STRAIN, D/C HOME ON XARELTO

Got COVID (Janssen) vaccine shot on April 6th at noon. Felt fine Tuesday and went to bed as normal. Woke up April 7th at 7AM with sharp pains in my left shoulder (same side as shot) and slight shortness of breath, and slight chest pain in the left quadrant of my torso (same side as shot). Proceeded to take Advil and seemed to help a bit. Minor aches/pains and shortness of breath throughout the day until about 8PM. At this time shoulder chest pain became more severe, and breathing became very strained, short, and painful. Pain and breathing kept getting worse and at midnight on Wednesday night thought I was having a heart attack due to extreme chest pain, couldn't breath, lightheaded, dizzy, tingly extremities. My wife drove me to ER at 12:30 AM Thursday.

Blood Clot and bruising on lower backside of leg, I noticed leg Pain (just uncomfortable) in the right leg at the location of clot. A time frame in relationship to the time of shot is unkown. Estimated within 24 hours. Bruising appeared morning of 04/14/21, PCP recommended in person visit. I went to urgent care, they had me drive to emergency Room at local hospital. Evaluation, blood testing and imaging concluded a blood clot in the lower right leg. Blod thinners was prescribed Eliquia 5 mg, discharged same day. It may be possible the hospital had submitted this form on my behalf.

The patient claims to have received the J and J vaccine on 3/30. He also claims it was his "second shot". He says he has felt ill since this shot, had an admission to the hospital and discharge for CHF. On 4/15, admitted again with Bilateral pulmonary emboli. He says the only thing he has done differently is vaccine.

Patient reported to medical clinic 24 hours after COVID 19 injection (03/19/2021) with symptoms of visual hallucinations, myalgia, rigors, headache, nausea, vomiting and dehydration. At the time of arrival to the medical clinic, he had refractory nausea and vomiting after receiving Zofran earlier in the day at another clinical site. Medical treatment consisted of IV Fluid bolus with maintenance fluids, IV Phenergan for the nausea and vomiting, and IV Ketorolac for headache pain. His symptoms resolved and he started to feel better so a clinical decision was made to discharge him home in the care of a close friend. He declined any other treatment modalities or medications at the time of the discharge. The patient returned on 03/28/2021 with a right arm DVT proven on U/S. He was then started on anticoagulation therapy after specialist phone consult and will be closely followed.

CHEST PAIN (WHOLE CHEST HAD LOT OF PAIN)/THOUGHT THAT HE HAD HEART ATTACK; SHORTNESS OF BREATH/COULD NOT BREATH; SEVERE CRAMPING IN LEFT SHOULDER AND UPPER BODY; DIFFICULTY IN STANDING; SINUS; THOUGHT THAT HE WAS ABOUT TO PASS OUT; BUNCH OF CLOTS IN THE BOTTOM SIDES OF BOTH LUNGS AND ON THE TOP OF ONE OF THE SIDES; BEGINNING STAGES OF PNEUMONIA ON BOTH LOBES OF THE LUNGS (COLLAPSED); CRAMPING IN CHEST; This spontaneous report received from a patient concerned a 44 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) frequency 1 total, dose was not reported, administered to left arm on 06-APR-2021 at 12 noon for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 6-APR-2021 at 12 noon, patient got vaccinated and was fine that day . Next morning on 07-APR-2021, patient woke up with sever cramping in same shoulder which he got the shot in, most pain was in the upper left quarter of his torso to down half way to chest up to the shoulder till the neck . By the end of the day it spread to his whole chest and upper body. Also he had shortness of breath ,could not breath .The cramping and shortness of breath came at same time. He took Advil and went along with his day . He took 3 tablet of Advil 200mg every 4-5 hours all day ( total of 3 dose that day) . By night time the case was progressively worse as the whole chest had a lot of pain . He thought that he had heart attack . He thought that he was about to pass out . He could not stand on his own . So his wife took him to emergency room at mid night at 12:30 am on 08-APR-2021. He stayed there for 5 hours and they did bunch of tests , EKG which rolled out the heart attack .They did Chest X-ray which found things then did D-dimer which its level was very high . They found bunch of clots in the bottom sides of both lungs and on the top of one of the sides. They did ultra sound on the legs which had no evidence of blood clots . They discharged him from the emergency room as they felt that he was ok to be out . After couple of hours after discharge , patient's health care professional wrote for him Eliquis, antibiotic and pain reliver. He was given antibiotic because he had beginning stages of pneumonia on both lobes of the lungs (collapsed) . It was found air sacs in lung with signs of pneumonia in both lobes . He came home and started to monitor his blood oxygen . He stayed in the same position till recovery . He was better each day since last week but still had sinus and cramping in the chest ( very minor but was still there). The lung capacity was very limited to take some steps. Patient stated that he needed a specialist to understand his condition. He had no medical history before that incidence . He was wondering regarding which type of blood thinner was good for this type of blood clots because he read that the regular blood thinners are not good for that type of blood clot which his HCP gave (regular blood thinner). Laboratory data included: Total lung capacity decreased (NR: not provided) lung capacity is very limited. On 08-APR-2021, Laboratory data included: Chest X-ray (NR: not provided) found things, EKG (NR: not provided) rolled out heart attack, Fibrin D dimer (NR: not provided) level was very high, and Ultrasound scan (NR: not provided) no evidence of blood clots. Treatment medications (dates unspecified) included: apixaban, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe cramping in left shoulder and upper body, chest pain (whole chest had lot of pain)/thought that he had heart attack, shortness of breath/could not breath, thought that he was about to pass out, difficulty in standing, bunch of clots in the bottom sides of both lungs and on the top of one of the sides, beginning stages of pneumonia on both lobes of the lungs (collapsed), cramping in chest and sinus was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: This 44-year-old male patient reported blood clots of both lungs 2 days after receiving COVID-19 VACCINE AD26.COV2.S for the prevention of symptomatic SARS-CoV-2 virus infection. The patient denies any medical history/condition prior to vaccination. The symptoms reported were severe cramping of arm that spread to his whole chest and upper body and shortness of breath; the patient thought he had a heart attack, about to pass out and could not stand because of the progression of pain. EKG done at the emergency room ruled out heat attack, D-Dimer was reported to be very high, clots were found in the bottom sides of both lungs and on the top of one of the sides, x-ray showed beginning stages of pneumonia on both lobes of the lungs (collapsed). The patient was prescribed with Eliquis, an unspecified antibiotic and pain reliever. Outcome of the events were not reported. Based on the information that is available, the event is assessed as plausible with the causal association to immunization, per WHO causality classification of adverse events following immunization based on a lack of a definitive plausible biological mechanism. However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded. Additional information was requested.

Initial reaction day after vaccination - 4/1/2021 site reaction with swelling, erythema, and warmth; generalized reaction - flu-like symptoms - all resolved within a few days. 6/6/2021 - uncertain if related to vaccine - patient reported chest pain as thought he thought he was having a heart attack. Went to hospital. Dx with pulmonary emboli and DVTs. Transferred from (Name) Hospital to (Name) Hospital to ICU. As of 6/7/2021, patient reports he has been moved from the ICU to a regular room, no on oral anticoagulants. Patient has not yet been discharged at the time of report submission.

Cardiac Arrhythmia AFib beginning 13 days post vaccination at night, progressing 2 weeks later to daytime AFib lasting up to 20 minutes per episode.

Pt. received the vaccine at approximately 2:44pm. Before I could hand him his card, his hands began trembling and he looked pale. I asked how he was feeling. He reported feeling shaky, dizzy, and very hot. I asked him if he was having any difficulty breathing, had tightness in his throat/airways, or even felt a tingle. He said no. Noting the time, I asked if he had eaten lunch. I asked if he has ever felt this way before. He said he had when he gets a "hypoglycemic attack." While not diabetic nor on any medications, he said he will occasionally get very low blood sugar. He said he had not eaten since early that morning. Another employee brought some juice I requested. I again asked him about symptoms related to anaphylaxis, to which was not an indication of an anaphylactic reaction. I gave him the juice to sip. I asked him again about symptoms. Because he was still dizzy, I took his blood pressure/heart rate. His BP was 160/119 and heart rate 96bpm. His color became more gray over the next several minutes. He was still too dizzy to stand, felt hot, shaky, and now nauseous. He handed over the juice and was given a receptacle if he vomited. We suspected a vasovagal response, but was still symptomatic after 10 minutes. Meanwhile, the other pharmacist tried to call his doctor's office. We learned his doctor had moved away and he had not yet come in nor selected a new provider. We asked him if he felt he needed to be seen by a doctor. He said he did and agreed to us calling an ambulance. The ambulance arrived around 3:10. The EMTs took his BP. It had come down, but he could not stand up without his knees buckling. The EMTs got him on the stretcher and took him to the hospital.

Complaints of diarrhea, sweating, weakness suffered sudden cardiac arrest. CPR, AED, Lucas device applied ACLS protocol initiated by EMS. Efforts terminated. Patient pronounced deceased at 1003am.

I had a stroke three weeks after the vaccine. I didn't think they were related, but I figured I should report it based on the recent news. TEE determined PFO. Heart monitor was placed to check for arrhythmia. High cholesterol was noted and medication for that was given. I was also given blood thinners and aspirin.

On March 13, I received the Johnson & Johnson vaccine at the clinic The pharmacist monitored me for symptoms but there were none right away. I did have a fever and some body aches in the two or three days that followed but those were short-lived. While driving on March 16, I started experiencing some irregular breathing and periods of shortness of breath about three hours after leaving home. I stopped at the emergency room at the Health Center where Dr diagnosed me with an acute pulmonary embolism after discovering a small blood clot in one of my lungs. He prescribed me with Eliquis, which I am still taking today. Their phone number is provided if you have questions. I haven't had too many shortness of breath episodes lately but do not know if the blood clot is still there. I am scheduled to see my hematologist on April 27 to get further updates on this. My hematologist Dr is located in clinic number provided While it has not yet been proven that the vaccine caused the blood clot in my lung, I feel the need to report this in the wake of recent news about the Johnson & Johnson vaccine. My hematologist and primary care physician are both aware that I have received the vaccine but I have not received any further communication from them.

Patient was doing paperwork when he experienced the worst headache of his life on 4/17 with associated emesis. Patient found to have a Hunt Hess 3 Fisher Grade 3 Subarachnoid Hemorrhage with hydrocephalus s/p EVD, s/p cerebral angiogram on 4/18 negative for aneurysm/AVM. On the evening of 4/20, patient became acutely hypoxic with wheezing for which he required oxygen via 10L oxymask. During 4/21, his oxygen requirements continued to increase with increased work of breathing requiring high flow nasal cannula (HFNC) at 50L/60% + pulmonary congestion on imaging and he was treated with diuresis. On 4/22, oxygen needs increased requiring 70L/100% with worsening imaging. He was then started on steroids, antibiotics were broadened, epoprostenal started in addition to diuresis. On 4/23, patient reports improved breathing and is on non-rebreather. Antibiotics, steroids, and epoprostenal were discontinued as patient showed improvement of oxygenation without clear signs of infection. Of note, patient reports vaping in the past 2-3 months. Patient has also been intermittently febrile. Wife was concerned that these symptoms were possibly related to him getting the J&J vaccine on 4/11. Patient is currently still in hospital on day 6 of admission at this time.

Ten days after vaccination I had an allergic shellfish reaction to a frozen lobster product. Never happened before and I've had other Lobster on the east coast before. I also ate shrimp a few days prior to vaccination with no reaction. I have eaten other Lobster all my life with no reaction. My sinuses and throat closed up making it very difficult to breathe. I didn't know what was happening so I took decongestants and antihistamines then went to the doctor and got injected with a steroid immune suppressor. I now have epinephrine just in case it happens again.

Patient started to have left leg pain. Presented to facility on 4/26/21. Ultrasound examination showed DVT

Acute saddle pulmonary embolus with acute cor pulmonale diagnosed 4/14/2021. Treated with anticoagulation, now on Eliquis for 6 months.

Complained of right lower leg pain and swelling, shortness of breath, sent to hospital for Ultrasound of right lower leg, Ultra sound was positive for a DVT. Was then sent to the Emergency room for evaluation and treat for DVT. Complained of Shortness of breath. CT Scan Angiogram completed and found to have bilateral Pulmonary Embolism

Patient presented to ED on 6/14/21 with 4 day history of cough, malaise and 1 day history of right flank/pleuritic pain. He was found to have a left leg DVT and bilateral pulmonary emboli. He was started on a heparin drip which he tolerated well. He was transitioned from heparin to Eliquis. He has no family or personal history nor other risk factors for DVT or PE; no long travel, no surgery, no immobilization. Hypercoag workup was initiated. He continued to have right sided pleuritic chest pain which improved during his stay. There was some question of possible community-acquired pneumonia, which he was empirically treated with CTX and azithromycin. He had normal WBC, low procalcitonin, and no fever. Patient was discharged home on 6/15/21 on Eliquis with follow up scheduled with primary care provider.

pt received Janssen vaccine around 10:28a. Patient was sitting in the post vaccination area. Around 3-5mins, he fainted, hit the floor. I ran out once this was brought to my attention. I found him on floor, blood on the floor and he was shaking and then stop. I don't know how long he was shaking but it stop. I checked the pt and he regained conciousness. I asked if he is ok. He ask what happened because he does not remember. He speaks another language and an associate was there to translate. We asked if he wants us to call 911, he refused. The firefighter/paramedics suggested they will come over anyway to make sure he is ok, he does not have to go with them to go to the hospital. Pt did not want to go to hospital because he does not have insurance. He was checked by a medic who also speaks his language. He checked pt's vital signs, asked questions like allergies, medical conditions, asked what day is today and what is his name (which were the same questions I asked before medic arrived). Medic informed patient the importance of seeing to a dr, the sooner the better. Pt still does not want to be taken to the hospital. Patient signed a refusal form. Nephew picked up the pt

Superficial thrombophlebitis in left medial lower calf, along with edema in foot and ankle on same leg and pain in calf, foot, and ankle. No explicit treatment prescribed. Symptoms are ongoing as of 6/25/2021, but have reduced in intensity. The was the first blood clot I've ever experienced.

On vacation in, just got to hotel and fell asleep. Wife said I lifted my head with a strange look on my face, laid back down. Then one minute later had a grand mal seizure. Called 911 and was sent to ER via Ambulance. ER conducted EKG, CAT Scan and other tests to determine the root cause. Found, no tumors or other explanations for the seizure. No prior history of neurological problems. Interestingly both of my parents are also now suffering neurolgical side effects after taking the Pfizer Covid vaccine.

Chest pain began 6/28 and thought to be muscular in etiology but increased on 7/3 and was seen in ER and found to have elevated d dimer and CT showed multiple R sided PE.

immediately felt tingling in left arm (like ben gay), then after about 10 min felt go into neck and and cheek. A little light headed. At 15 minutes asked nurse if normal. Then started sweating. left hand turned purple. Dont really remember anything else. Went unconscious. Remember them yelling Code something and Cardiac arrest. Taken to ER. Think they may have said anaphalatic shock. I think they gave me epinepherine. Had paralysis in left hand when i woke up for a few minutes. Blood work and EKG were normal. Went home within a couple of hours. Light-headed two days later still. Saw doctor two days after. Blood pressure is high. Little bit of fatigue and brain fog.

Heart attack after J&J vaccine - My husband, complained of on and off chest/lung discomfort after two days getting the vaccine. This continued for about 3-3.5 weeks. On the night of Apr 16, he went to bed early not feeling well. Next morning he complained of heaviness in the chest area. We immediately consulted Dr., and mentioned that he got the vaccine. Dr. advised us to immediately go to an Emergency Room. Patient was found to be having a heart attack. His right artery was 100% blocked. The 3 left arteries had no blockage at all. Angioplasty was done and he had a stent placed in right artery. The clot was removed as part of angioplasty. He now needs to be on blood thinners for life.

After receiving the J&J vaccine on Sunday afternoon, when my husband got up on Monday morning he passed out in the bathroom and was unresponsive. The EMTs arrived and were able to revive him in the ambulance. When they reached the hospital he was put on life support. After he coded again in the Emergency room they told me he was without oxygen for too long and was taken off the respirator. He passed away at 4:10 PM.

Patient suffered massive heart attack with 100% blockage of Left Main Coronary requiring CPR, shocking, Cardiac Cath and stent placement.

This is a hospitalized in-patient that received the vaccine on 4/12/21 and aspirated on 4/16/21. Unclear of causality.

Janssen COVID-19 Vaccine EUA: two weeks after vaccination patient reported to an urgent care with right leg swelling and headache. Two days later patient presented an emergency department, diagnosed with left lower extremity deep vein thrombosis (DVT) and bilateral pulmonary emboli (PE). Transferred to current hosptial for management including anticoagulation with a direct thrombin inhibitor, intravenous immune globulin (IVIG), and additional laboratory testing.

HIGH BLOOD PRESSURE; BRAIN FOG; FATIGUE; ANAPHYLACTIC SHOCK; PARALYSIS IN LEFT HAND; LIGHTHEADED; This spontaneous report received from a patient concerned a 46 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included pre-diabetic, and other pre-existing medical conditions included the patient had no known drug or non-drug allergies. The patient had no illness 30 days prior to vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) 1 total dose was administered at left arm on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021 at 14:35, the patient immediately felt tingling in left arm (like ben gay) after vaccination, 10 minutes later he felt tingling in neck and cheek. His left hand turned purple. He became unconscious (he did not remember anything). He had cardiac arrest (patient remembers yelling code). He was taken to emergency room. He thought people in emergency room said anaphylactic shock and gave him epinephrine (patient was not sure). He had paralysis in left hand when he woke up for a few minutes. His blood test and Electrocardiogram were normal. He went home in couple of hours (on 31-MAR-2021). On 02-APR-2021 (two days later) he was light-headed, he went to his doctor. His blood pressure was high, he felt little bit of fatigue and brain fog. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lightheaded, anaphylactic shock, paralysis in left hand, high Blood pressure, fatigue, and brain fog. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210443005-covid-19 vaccine ad26.cov2.s- anaphylactic shock, paralysis in left hand. 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).

Site: Pain at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: patient was unresponsive for few seconds less than a min and came back 911 paramedics evaluated him and took to emergency for further evaluation

Patient received their J&J vaccination on 4/7/2021. The patient's wife tested positive on 4/12/2021. The patient tested positive on 4/23/2021. The patient presented to the ER with a severe progressive cough (starting one week prior), worsening shortness of breath, a high fever, chills, myalgias, and malaise. The patient was diagnosed with COVID pneumonia and ARDS with hypoxia and given Lovenox, remdesivir, and dexamethasone, tessalon, and Brovana. The patient was admitted on the 23rd and continued to decline until their eventual passing on 4/28/2021.

BLOOD CLOT; STROKE; This spontaneous report received from a patient concerned a 46 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 and batch number: 202A21A expiry: 23-JUN-2021) dose was not reported, 1 total administered on 07-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-May-2021, the patient begun to experiencing confusion and could not think straight. On 23-MAY-2021, the symptoms progressed when the patient went to the hospital. The patient was diagnosed with blood clot and had stroke. The patient was hospitalized on 23-MAY-2021 and was discharged on 26-MAY-2021. The patient was hospitalized for 3 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot and stroke was not reported. This report was serious (Hospitalization Caused/Prolonged).; Sender's Comments: V0: 20210554839-covid-19 vaccine ad26.cov2.s-blood clot and stroke. 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 is a COVID-19 vaccine breakthrough case who is deceased. Patient was admitted to the hospital on 4/5/2021. He was then admitted to the ICU and placed on a ventilator before passing.

Shortness of breath chest pain severe headache. Multiple blood clots stent placed in one and taking medication now to help with the other blockages.

4/28/2021- Patient presented to ED for evaluation after a syncopal episode with fall and head injury, severe headache; loss of consciousness; bradycardia with early repolarization without acute ischemia. 6/3/2021- continued confusion, disorientation; Brain MRI shows early chronic infarct 6/14/2021- Patient presented with continued syncopal episodes, significant confusion ongoing for weeks, diagnosed with large left MCA stroke.

Patient was a healthy 46 y/o male with no significant medical history. He was taking no medications. He received the J&J vaccine on 04/06/2021. On 04/28/2021 he had a fall from probable syncope. He sustained a laceration to his forehead. He was sent to Hospital for evaluation. He had CTs of head and neck, which were unremarkable. A drug screen was negative. Both before and after his return he was having issues with his speech. He seemed to understand words but when he tried to respond, his speech was garbled . He was observed in the infirmary. There was slight improvement in speech. He returned to his block. Because of persistent issues with speech he had an MRI of his brain on 06/03/2021. This showed a left middle cerebral infarct which appeared as a late subacute/early chronic infarct. While an outpatient workup was being scheduled, he had another episode of witnessed syncope. This was on 06/14/2021. An MRI at hospital showed a larger infarct than seen on 06/03/2021. He was hospitalized for 3 days. No cause for the CVA was found during this hospitalization. He has continued with speech symptoms and is starting speech therapy in the near future. In summary, this I/M was in a normal state of health with no risk factors for vascular disease. Two weeks after receiving the J&J vaccine, he had a CVA which may have extended on 06/14/2021. After multiple tests, no reason was found for the CVA to occur. It is certainly possible that the CVA was related to his COVID-19 J&J vaccine.

Transferred from Hospital on 4/1/21 for fever and altered mental status, suspecting adverse reaction from Janssen COVID vaccine given 3/30/21, symptom onset 3/31/21 morning. Sepsis with unknown source of infection: This is evidenced by leukopenia, tachycardia and fever. Acute metabolic encephalopathy, likely secondary to possible sepsis versus effects of COVID vaccine. Encephalitis and meningitis ruled out. Acute nontraumatic rhabdomyolysis: evidenced by elevated CK levels 1700 on admission, likely secondary to sepsis. Acute renal failure, hypothyroidism, transaminitis, elevated troponin likely associated with rhabdo. On sepsis protocol (vancomycin, meropenem and acyclovir) Disc

2 days after receiving the vaccine I have been diagnosed with Deep vein thrombosis and pulmonary embolisms.

Pt. had (what we think) a small seizure on Thursday, March 18th and then again on Saturday, March 20th. On Sunday, March 21st, 911 had to be called as his seizure did not end. He had a grand male. He was seizing for several hours. At the time this was all occurring he has been on anti seizure meds for a few years Divalproex 1000 mg am and 1000 mgs pm daily). He passed 1 week later, March 28 at approx 6:45pm at the Clinic. I am unable to get any information on his medical report for that week. Statement from his Nurologists is on second page. Additional information for Item 18: Statement: 47 year old gentleman who passed away on March 28 from aspiration pneumonia secondary to status epilepticus and on a history of multiple sclerosis / additional leukoencephalopathy of unknown etiology (both treated with rituximab), prior seizures (on valproic acid) and pulmonary embolism (on apixaban). The key reason for reaching out is in light of the announcement about the side effects of the Johnson & Johnson vaccine specifically cerebral venous sinus thrombosis. While he had a known history of seizures, he had no clear trigger for these seizures; including that his valproic acid level was therapeutic (83.0 mcg/mL) at time of presentation. He had, however, received the Johnson & Johnson vaccine on March 12 before having what in hindsight appeared to be repeated seizures between March 18-21; he had a more significant one on March 21 that hospitalized him. This time frame appears consistent with the reported cases of central venous sinus thrombosis associated with the Johnson & Johnson vaccine. Equally, he was taking apixaban at that point in time and his PLT (173) / INR (1.1) / PTT (36.6) at time of presentation were all normal and stable. He did have an elevated ProBNP (552.0) at presentation; nasopharyngeal swab was negative for COVID / Influenza A/B / RSV and non-contrast head CT did not show any clear new abnormalities. His only D-dimer was obtained on March 23 and was 226. He did not have a CT angiogram or venogram. Overall the link between the vaccine and pt. seizures is not definite. At the same time, the similarity with the reported cases has led to me wanting to report it in case of the possible link. If you require further information then please don't hesitate to email me Pt. med list at the time of this incident Modifinil - 100 mg/1per day/AM Sertraline - 100 mg/1per day/AM Vitamin D3 - 50 mg/1per day/AM Divalproex - 500 mg/2per day/AM Eliquis - 5 mg/1per day/AM Furoseminde - 20 mg/1per day/AM Metroprolol - 100 mg/1per day/AM Lisinopril - 10 mg/1per day/AM Divalproex - 500 mg/2per day/PM Eliquis - 5 mg/1per day/PM Metroprolol - 100 mg/1per day/PM Melatonin - 5 mg/1per day/PM Quetiapine - 50 mg/3per day/PM

Chief complaint of worsening lower leg pain. Initially the patient though that he had pulled a muscle however he had complaints of claudication upon ambulation. Patient reports having J&J COVID vaccination approx 2.5 weeks prior. Patient reported his friend informed him that he might potentially have a blood clot and that he should come to the emergency department. Imaging consistent with acute DVT and patient taken to IR for tPA direct catheter infusion.

Pt experienced pain/cramping in his right leg on or about 4-15-21. Thought this was due to new work shoes. Pain continued through the weekend and on Monday 19th visited his PCP where a scan was preformed confirming a clot in his right leg between his thigh and ankle. Pt started on therapy and has a follow up with his physician on Friday 23rd. Pt doing well and in good spirits.

Pt had vaccine on April 6, 2021 and was in the ER on April 15, 2021 with a right popliteal blood clot

Pulmonary embolism diagnosed 1-2 weeks after vaccine, now on Eliquis. No right heart strain on echo. Uncertain if vaccine is cause. PE being treated as unprovoked.

Increased pain and swelling in left arm - started within 12 hours and continued for 2 weeks Fever over 100 - started within 12 hours and continued for 1 month (fever between 100 and 102) Nausea - within 12 hours (continued for 1 month) Vomiting - within 24 hours (continued for 3 days) / then again 2 weeks out for 3 days) Migraine Headache - started within 12 hours and continued for 6 weeks (and on-going) Labored breathing - started within 12 hours and continued for 5 weeks (and on-going) Low oxygen - started within 36 hours and continued for 1 month) General muscle and body aches and pains (started within 24 hours and continued for 6 weeks (and on-going) Extreme exhaustion and lethargy (started within 6 hours and continued for 6 weeks (and on-going)

Patient developed a nose bleed lasting from 7:10pm to 7:40pm on the evening that he received his vaccine. He coughed up a silver dollar sized blood clot around 7:35pm. He was feeling fine the following day, but had another nose bleed that started at bedtime the night after his vaccine. Patient's wife called on call doctor and was told to pinch his nose, which they'd been doing for 35 minutes and to go to ER if needed. Patient saw doctor, who told him to stop using Flonase for a few days.

Patient fainted 10 minutes after getting the vaccine, he felt light headed and had seizure like symptoms, and his body was rigid and shaking . He wasn't able to breathe, patient was put on his back and CPR was performed for 20 seconds, and 911 was called. Patient was able to breathe again and felt okay. Patient stated that he didn't eat or drink anything prior, he was given a sports drink and sat back in a chair for 20 minutes after. EMTs showed up and took his vital signs, patient refused to go to the hospital.

I had Atrial Fibrillation on the morning of Apr 12th. I have never had any Afib before this event. My heart was in AFIB for about 3 hours when it returned to normal by itself. I had to go to the emergency room where they took my EKG and was diagnosed as AFIB by my cardiologist (contacts above)

Blood clot which was diagnosed via ultrasound on my top left calf on 06/07/21. I began to experience swelling and pain on 06/03/21

AFIB, chills, fever, elevated heart rate phone heart app registered my heart rate increate from 75 to 95 bpm at 8:17pm while laying down. at 9:47 heart rate was at 108 and remained above 100 until 4am From 9pm 3/19/20 until falling asleep at 4am. I experience cold chills and fever. iphone heart app shows BPM slowly reducing from 106 at 4am to 74 at 9:35am 3/20/20 woke up at 9:45 and heart rate was now at 115 laying down in bed At 10:05 am i registered a BPM of 163 and was in AFIB At 10:15 I took my daily Eliquis and Metropolo At 10:45 I took 3 x Flecainide 100mg tablet for AFIB. I remained in AFIB with heart rate between 165 and 104 until 1:19pm 3/20/20 At 1:20 pm I was out of AFIB

Patient received the J&J vaccine on 3/10. On 3/13 he developed slurred speech, unilateral lower facial droop, weakness of extremities, generalized fatigue. On 3/15 he sought medical attention and was sent to ER -- > diagnosed w/ TIA. Pt sent back to jail where simvastatin -- > atorvastatin, pt started lisinopril, ASA. Pt denies deficits today

On April 7th in the morning, I woke with sharp pain in right calf. It was not swollen, discolored, or hot. I had not participated in any activity recently that I felt caused an injury. I took Advil and Tylenol and rested for a few days, but the pain got worse. On April 14th, after reading reports on some adverse affects from the J&J vaccine, I made an appointment to see my primary physician. After blood work and an ultrasound, I was diagnosed with a DVT in my right calf. I have a started a 90-day cycle of Xarelto to treatment the DVT.

DVT diagnosed 7 days after vaccine. Pt does have hx of DVT in past and was dx'd with COVID by NAAT at same time. Otherwise no risk factors.

Patient evaluated in ED 04/26 for bilateral leg cramping, swelling that started just over a week prior. Reviewed records from that visit. Work up was significant for bilateral lower extremity DVTs and thrombocytopenia. Patient was started on Xarelto at that time. Patient does not have any significant risk factors for blood clots. He is not obese, denies tobacco use, recent procedures, recent travel, prolonged immobility, family history of bleeding or clotting disease, etc. He is up to date on cancer screenings based on age/family hx. He did receive the Johnson and Johnson vaccine on 04/07.

48yoM (h/o childhood asthma, GERD, lipomas, preDM, obesity BMI 30) who had Covid J&J vaccine 3/12/21, then 4/4/21 had dizziness and a little SOB, seen in ER with neg brain MRI/MRA and trop/EKG neg. and labs. Later had DDIMER 560 on 4/15/21 due to h/o J&J vaccine and CTA lung 4/29/2021 shows Right lower lobe pulmonary emboli. Patient is clinically much better. No more SOB. Dizziness a little residual but significantly better. Never had hypoxia/tachycardia and BP always reassuring. Pt read about some blood thinner making clot worse and doesn't want to to start a blood thinner without checking with hematology first. I've prescribed rivaroxaban so that pharmacy can start authorization and ensure coverage, but patient strongly states that he will not take it yet until hearing from hematology.

DIZZINESS; SHORTNESS OF BREATH; PULMONARY EMBOLISM; This spontaneous report received from a physician concerned a 48 year old male. The patients 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 administered on 12-MAR-2021 for prophylactic vaccination. Vaccination site was not reported. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the patient experienced pulmonary embolism. Laboratory data included: Computerized tomogram thorax (NR: not provided) positive, Ear, nose and throat examination (NR: not provided) negative and Platelet count (NR: not provided) 197. On 04-APR-2021, the patient experienced dizziness and shortness of breath. Full neuro, cardiac, Ear, nose and throat workup and evaluation was negative in Erectile dysfunction and follow up clinics. Patient had a Wells Criteria of zero, and was hemodynamically stable, platelet was 197. Patient started with DDIMER which was 560 and later chest Computerized tomogram thorax was positive for right lower lobe Pulmonary embolus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizziness, shortness of breath and pulmonary embolism was not reported. This report was serious (Other Medically Important Condition). Sender's Comments: V0: -Covid-19 vaccine ad26.cov2.s-Pulmonary embolism. 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 is now hospitalized with the following: VITT, bilateral PE with left lateral lower lob infarct, left superficial femoral vein occlusive deep vein thrombosis, and thrombosis of the posterior tibial vein according to hematologist.

Shortness of breath due to heart failure. Hospitalized on 5/18 heart functioning at 25% being monitored by cardiologist.

Pt presented with 1 week of progressive fatigue, dry cough, chest pain, nocturnal fevers. Presented to ER on 5/30/2021, hs troponins were 71 twice. Discharged with advice for symptom management with antipyretics. Symptoms worsened and pt returned to ER, worsening CP and fevers up to 100+F. Repeat troponins 1100 to 1200+, elevated LFTs, diffuse 1mm J point elevation on EKG Cardiac MRI 6/1/2021: IMPRESSION: 1. Patchy subepicardial left ventricular delayed enhancement, greatest in the basal inferolateral wall, compatible with myocarditis. Normal left ventricular size and systolic function. LVEF = 52%. 2. Patchy consolidation in the right lower lobe consistent with pneumonia. Small right pleural effusion. 3. Mild splenomegaly. CT chest RLL consolidation, splenomegaly

BILATERAL LOWER EXTREMITY PAIN; MULTIPLE ACUTE BILATERAL PULMONARY EMBOLI; PLATELET COUNT DECREASED; DEEP VEIN THROMBOSIS; VACCINE INDUCED THROMBOTIC THROMBOCYTOPENIA; ULTRASOUND DOPPLER ABNORMAL; FULL BLOOD COUNT; METABOLIC FUNCTION TESTS; MUSCLE SPAMS; SWELLING; MILD HEADACHE; This spontaneous report was received from a health care professional via a Regulatory Authority and from literature: Vaccine-induced thrombotic thrombocytopenia following Ad26.COV2.S vaccine in a man presenting as acute venous thromboembolism. 2021 Jun 03;1-4., and concerned a 48 year old white male (not Hispanic or Latino). The patient's height, and weight were not reported. The patient's concurrent conditions included exercise induced asthma, and no tobacco use (both current and historically), and other pre-existing medical conditions included the patient had no known allergies. The patient was not obese, denied recent procedures, prolonged immobility, family history of bleeding or clotting disease, etc. The patient was up to date on cancer screenings based on age/family history. He was reported as being an unusually physically active and fit 48 year-old male who has enjoyed good health and exercised regularly. In 2019, his platelet count was 177 10*9/L. The patient reported flying out of town and back on 30-MAR-2021 and 04-APR-2021 respectively with the longest continuous flight lasting around 4 hours. The patient at age 48, received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 07-APR-2021 for prophylactic vaccination. Concomitant medications included finasteride, and salbutamol. On an unspecified date in APR-2021, the patient experienced mild headache. On 18-APR-2021, 11 days after receiving the vaccine, the patient experienced deep vein thrombosis, vaccine induced thrombotic thrombocytopenia; new pain in his big toe, bilateral leg cramping (muscle spasm), bilateral lower extremity pain, and swelling. The patient attributed soreness in the large muscle groups of his thighs to Peloton riding and exercise. The patient travelled again via airplane to an unspecified location 22-APR-2021 and 25-APR-2021 (both1 hr long flights). The patient administered Advil for the leg pain when he returned on an unspecified date. On an unspecified date he felt a leg vessel that "didn't seem right." On 26-APR-2021 the patient went to emergency department for evaluation presenting with leg pain and chest discomfort. He had normal vital signs and oxygen saturation. Additional laboratory results: Platelet count (NR 140-440 K/uL) 74; fibrinogen (NR 150-430 mg/dL) of 254; D-dimer (NR 0-499 ng/mL FEU) 15,109 ng/mL FEU; activated partial thromboplastin time (aPTT) (NR 25.1-36.5 s) 31.8. Venous duplex ultrasound of the lower extremities revealed non-occlusive DVT in the bilateral popliteal veins extending to the gastrocnemius veins, an occlusive DVT of the left posterior tibial vein, as well as occlusive superficial venous thrombosis in the bilateral saphenous veins. The patient was discharged from the emergency room on rivaroxaban 15 mg twice daily with two-day follow-up with his primary care physician. He had no known exposure to heparin before the onset of symptoms and no exposure during his emergency room visit. On 28-APR-2021 (also reported as the next day), the patient complained of a new onset of chest pain (pleuritic) and presented again to the emergency room. Chest CT showed presence of acute pulmonary embolism, with emboli present in segmental and more proximal arteries. He had already taken his rivaroxaban for the night (1800). The patient was hospitalized for further evaluation and work up. A peripheral smear showed thrombocytopenia without schistocytes. The hematology service was consulted, and a presumptive diagnosis of VITT (vaccine induced thrombotic thrombocytopenia) was made. His anti-PF4 enzyme-linked immunosorbent assay (ELISA) (LIFECODES PF4 IgG), performed on a sample collected prior to initiating IVIG therapy, demonstrated a strongly positive result of 3.323 optical density (OD) units (reference interval < 0.399), consistent with a diagnosis of VITT. The patient was immediately treated with 1 g/kg of intravenous immunoglobulins (IVIG) for 2 days, 1 mg/kg of prednisone, and switched from rivaroxaban to an intravenous argatroban infusion drip, during which he achieved therapeutic aPTT levels between 44 - 50 sec. The patient was also treated with apixaban. Other studies included: Magnetic resonance venography (MRV) and angiography (MRA) of the brain, performed due to symptoms of mild headaches, were unremarkable. Platelet factor 4 (NR: not provided) strong positive at 2.9 OD; Prothrombin mutation G20210A not detected, Red blood cell count (NR: 3.98 - 5.98) 5.07 M/ microliter, Red blood cell sedimentation rate (NR: not provided) Normal, SARS-CoV-2 test was negative, Serotonin release assay was positive, and WBC (NR: 3.2 - 10.6) 5.8 K/microliter. Anticardiolipin antibodies (NR: not provided) 5 GPL, Beta-2 glycoprotein 1 antibodies (NR: 0 - 20) 0 SGU, 5 SMU, Blood homocysteine (NR: not provided) 13.4 nml (normal), C-reactive protein (NR: not provided) 2.6, Cardiolipin immunoglobulin G (NR: 0 - 12) 6 MPL, Cell marker increased was positive, EKG (NR: not provided) Normal, Hematocrit (NR: 36.9 - 52.1) 42.2 %, Hemoglobin (NR: 2.5 - 18.0) 15.0 g/dL, Lupus anticoagulant (NR: not provided) not detected, MCHC (NR: 33.4 - 35.3) 35.5 g/dL, MCV (NR: 80.6 - 97.6) 83.2 fL. On an unspecified date the serotonin release assay was no longer positive. Within a week post-discharge, the patient developed recurrent thrombocytopenia, with a platelet count that down trended to 107 10*9/L His thrombocytopenia appeared to somewhat correlate with prednisone dose adjustments, suggesting an autoimmune-driven process, although it did not respond to repeat IVIG administration. Due to the normalized D-Dimer levels and negative SRA, it was assumed that there was no further ongoing platelet activation. The authors stated the patient had no prior risk factors for thrombosis other than the 2 recent 4-hour flights. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bilateral lower extremity pain, was recovering from deep vein thrombosis, vaccine induced thrombotic thrombocytopenia, platelet count decreased, swelling, full blood count, metabolic function tests, muscle spasms, ultrasound doppler abnormal, and multiple acute bilateral pulmonary emboli, and the outcome of mild headache was not reported. This report was serious (Hospitalization Caused / Prolonged). This case is a duplicate of 20210642952. Additional information was received from literature article on 19-JUN-2021. The following information was updated and incorporated into the case narrative: literature reference information, additional reporters, laboratory data, updated events. It has been determined that Manufacture Report Number 20210514958 is a duplicate of deleted case 20210642952. All relevant information from Manufacture Report Number 20210642952 will be reported in this case 20210514958.; Sender's Comments: V2: Follow up consisted of a literature citation, presenting this case as a case report. This does not change the previous assessment. This case obtained via VAERS (ID 1264060) concerns a 48-year-old White male who developed symptoms of bilateral lower extremity deep vein thromboses (DVT) and thrombocytopenia 11 days after receiving Janssen Covid-19 vaccine. Concurrent conditions included exercise induced asthma. Patient was not obese, did not smoke, denied recent procedures, family history of bleeding/clotting disease & was physically active. He was up to date on cancer screenings based on age/family history. He had taken two 1-hour long flights 15 days and 18 days post-vaccination. Concomitant medications included finasteride & salbutamol. After 1 week of bilateral leg cramping & swelling which began 11 days post-vaccination, he presented to emergency department (ED) where complete blood count showed platelets 74 k/uL, peripheral smear with giant platelets, and d-Dimer 15K. Venous duplex ultrasound showed nonocclusive DVT in the bilateral popliteal veins extending to the gastrocnemius veins, occlusive superficial vein thrombosis in the bilateral saphenous veins, and occlusive DVT of the left posterior tibial vein. He was started on rivaroxaban & was not hospitalized. Two days later, he developed new chest pain & returned to ED, where CT chest showed numerous bilateral pulmonary emboli. He was hospitalized; empiric treatment for vaccine-induced immune thrombotic thrombocytopenia was started: IVIG, steroids, & argatroban. Anti-PF4 resulted as OD=2.9 and 3.323 (strong positive), confirming diagnosis. The patient was recovering from the events. Based on evolving knowledge of Thrombosis with Thrombocytopenia Syndrome (TTS, per definition from Brighton Collaboration), low platelet count & temporal relationship to vaccination, the events are assessed to have a plausible relationship with vaccination.

I am dealing with a blood clot in my left atrial appendage. I am also experiencing A. Fib. I was hospitalized from 4/5 to 4/11 2021. I have been exhausted since vaccination date.

About a month after receiving the J&J vaccine, I noticed a bump in the top of my left calf, which caused some discomfort and also noticed slight numbness in left foot / toes. Primary, Dr., sent me for ultrasound, which showed I had several blood clots in my leg. I have never had any blood clots before. Dr. referred me to Hematologist, Dr. She ran extensive blood tests and found no genetic predisposition for clots. She stated it was likely the vaccine that caused me to develop blood clots. I am now on blood thinners to try to dissolve them and may have to take them for life if the clots don't go away in the new few months. Follow up ultrasound scheduled 9/7/21.

Day 1 after vaccine patient short of breath. Went to ER. Admitted to Hospital. Was in CHF, sustained MI. Eventually tranferred and underwent 4 vessel CABG and wears Defibrillator vest.

Janssen COVID-19 Vaccine EUA: patient presents to emergency department with altered mental status and confusion three days after being discharged from a different hospital for COVID-19 infection. In emergency department diagnosed with stroke, left ventricular thrombus, subacute anterior myocardial inferction with totally occluded mid LAD, and COVID-19 infection. Underwent cardiac catheterization and transferred to current facility for higher level of care and testing- currently remains hospitalized on anticoagulation and oxygen.

1 week post vaccination - patient, not responding to albuterol HFA, called 911, he passed out, was unresponsive, pronounced dead.

received Janssen J &J shot 9:15 am on April 7th approx, 24 hours later had to leave work for home because I became incredibly weak, tired and without energy. struggled at driving home had to repeatedly slap my face to stay awake. checked my temp. when arrived home, had a low fever (100.1) went to bed slept for 4 hours, checked temp (100.1) went back to sleep. woke 9 am on 4/9/2021 checked temp. (normal) fever broke on 4/9/2021 used restroom at 11:01 am 4/9/2021 large amount of bleeding from rectum LARGE AMOUNTS of blood clots in stool (shaped like Candy) Contacted medical provider. Spoke to a triage nurse, explained my concerns about bleeding from rectum and blood clots in stool... she dismissed that my restroom issues were related to the vaccine,

Pulmonary embolism symptoms felt April 12, 13. Pulmonary infarction felt night of April 15th forward. Blood test was positive for possible clots done April 16th. CT/CTA chest scan done at hospital (also April 16th) confirmed the above embolism and infarction. Blood thinner via shots, then via tablet (Xarelto) until discharge on April 17th. Continuing on Xarelto.

Patient seen at medical facility 4/6/2021 with headache, fatigue, lower extremity petechial rash, unexplained bruising, small amount of blood in stool. CBC ordered 4/6/2021 and obtained on 4/8/2021. Platelet count was 4 x 10^9/L. Patient admitted to hospital. Hematology/Oncology consult obtained. Patient diagnosed with Immune Thrombocytopenia Purpura (ITP). 4/9/2021 Given 1g/kg IVIG and 125mg IV methylprednisolone. Platelets increased to 15 x 10^9/L. 4/10/2021 Given 1g/kg IVIG and 125mg IV methylprednisolone, platelets increased to 81 x 10^9/L. Patient discharged on oral prednisone with Hematology/Oncology outpatient follow-up. Patient advised to stop Goodies Powder for Headache. 4/13/2021 patient returned to hospital emergency department with generalized weakness. His platelets were rechecked and were 277 x 10^9/L. D-Dimer was undetectable at <0.27. Patient was discharged home from the emergency department.

I received the J&J vaccine on 3/16/2021 and then flew to watch over my dads house while he went through cancer treatment. I began to have pain in my chest that was getting progressively worse, yesterday I had a very sharp pain when taking a shallow breath. I went to the hospital they thought I had pneumonia, but then saw a blood clot in right upper side, I've had a prior event but that was attached to an injury in 2012. I've not had any other issues.

DEEP VEIN THROMBOSIS; This spontaneous report received from a consumer concerned a 49 year old male. The patient's weight was 80.3 kilograms, and height was 182.9 centimeters. The patient's past medical history included post-operative deep vein thrombosis (more than 30 years ago), depression, heart murmur, and back surgery, and his concurrent conditions included non-smoker, no alcohol use, and marijuana abuse. The patient had no history of known allergies. The patient's mother had a history of aneurysm. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, and expiry date: unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included fexofenadine hydrochloride (Allegra) for allergy, rivaroxaban (Xarelto) for venous thromboembolism, and omeprazole (Prilosec) for unknown indication. About one and half weeks after vaccination, on 21-APR-2021, the patient was taken to the emergency department and was admitted with the complaints of leg pain since 2 days with suspected blood clot in leg. Over the last days, patient's left leg looked swollen compared to the right leg. The patient also had pain, initially started in groin area and radiated down across the anterior portion of the leg, then to posterior leg, and into toes. The patient also had some intermittent tingling in toes. The patient denied of weakness, numbness or persistent paresthesia. The patient was concerned regarding the pain as it felt similar to the post-operative deep vein thrombosis he had in the past. The patient had been anxious since vaccination when hearing about the development of blood clots. The patient also denied of fevers, chills, chest pain, shortness of breath abdominal pain, nausea, vomiting, diarrhea, and difficulty walking. On 21-APR-2021 16:25, the patient's laboratory data included: Blood pressure (148/66 mmHg), Body mass index (24), Body temperature (98.8 F), Oxygen saturation (100 %) Pulse rate (88), and Respiratory rate (16). On 21-APR-2021 16:32, laboratory data included: Blood pressure (148/66 mmHg), Body temperature (97.8 F), Oxygen saturation (100 %), Pulse rate (91), and Respiratory rate (15). Other general physical examinations included: General: Well-developed well-nourished in no acute distress. HEENT (Head, Eye, Ear, Nose, Throat) examination: normocephalic atraumatic extra ocular motions are intact. Neck examination: Supple without jugular vein distention or meningismus. Lung examination: Clear auscultation bilaterally without wheezes rales or rhonchi. Heart examination: Regular rate and rhythm without murmurs rubs or gallops. Abdomen examination: Soft no tender non-distended without rebound or guarding. Extremities: Without clubbing cyanosis edema, no lacerations or abrasions or ecchymosis noted, no appreciable size difference in the left leg compared to the right, the patient had some tenderness throughout palpation of the medial thigh on the left with radiation up into the left inguinal region, no calf tenderness or swelling, no erythema, palpable posterior tibialis pulse. Skin examination: Warm and dry and well perfused. Psych examination: Appropriate mood and affect. Neuro examination: Cranial nerves 2-12 are grossly intact, strength is 5/5 in upper and lower extremities, full distal sensation in the left lower extremity, full plantar and dorsiflexion of the left foot including the left great toe, sensation is grossly intact, awake, alert and oriented x3. On ultrasound Doppler venous lower extremity test, identified sub occlusive thrombus in the left superficial femoral veins, likely related to organizing/chronic thrombus, however no prior imaging was available at the institution for comparison, no evidence of occlusive deep vein thrombosis. The final diagnosis was made as Deep Vein Thrombosis (DVT). At no time the patient had ever endorsed any chest pain/pleuritic pain, shortness of breath or exertional dyspnea. Due to the nature of this clot, a course of anticoagulation was planned. Patient was prescribed with Xarelto at twice daily starting doses, with transition to 20 mg doses. During the initiation of treatment, the patient should be followed up by his primary care physician for further evaluation. The patient stated that he would call the primary care physician in the following morning for follow-up appointment. The patient was discharged from the hospital on APR-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of deep vein thrombosis was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210457179-Covid-19 vaccine ad26.cov2.s-deep vein thrombosis. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY

STROKE; This spontaneous report received from a patient concerned a 49 year old male. The patient's weight was 250 pounds, and height was 70 inches. The patient's past medical history included back pain, and concurrent conditions included pre-diabetic. The patient had no known allergies. The patient had no history of headache for several years. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, 1 total, administered on 07-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 02-MAY-2021, the patient developed a headache. Heath care professional (HCP) told him that he probably had been experiencing stroke symptoms from 02 to 04-MAY-2021. On 04-MAY-2021, the patient went to the hospital and was diagnosed with a stroke. He was hospitalized for 7 days. He experienced cognitive issues, like taking time to get his thoughts together, but no paralysis. He has been out of work. HCP has started him on aspirin (acetylsalicylic acid), but he could not remember what medications he was taking. He stated that until getting the vaccination, had no problems with his health. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stroke. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210548992-covid-19 vaccine ad26.cov2.s-stroke. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

initially no symptoms until on day 8 after vaccine (1 Jun 2021), rapid onset progressive severe muscular pains in calves, thighs, buttocks and then upper arms. Within 24 hours unable to walk easily. No other symptoms and no physical signs of infection. Urine became dark brown at 24 hours and clinically has myositis with suspected rhabdomyolysis - was admitted for iv fluids and analgesia and is improving clinically but gait still disturbed. No demonstrable weakness and no neuro deficit or symptoms. no other obvious cause for acute myositis so consider ?vaccine related.

Patient presented with symptoms of DVT on 05/15 at Urgent Care. Was admitted to ER on 05/17 to treat DVT

PNEUMONIA; MULTISYMPTOM INFLAMMATION SYNDROME; This spontaneous report received from a consumer concerned a 49 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included patient had no known drug allergies and not aware of previous medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, one total administered on 07-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. Consumer called to report patient developed multi-symptom inflammation syndrome after received the Janssen Covid-19 Vaccine and experienced pneumonia. Reporter was looked to get information regarding compensation for medical expenses after hospitalization. The patient was hospitalized on 23-May-2021 and discharged on 08-Jun-2021. The patient was hospitalized for 17 days. Laboratory data included: COVID-19 PCR test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pneumonia, and the outcome of multi symptom inflammation syndrome was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210621953-covid-19 vaccine ad26.cov2.s - Pneumonia, Multi symptom inflammation syndrome. 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 presents to the ER with 2 to 3 month history of cough which started 2 weeks after vaccination. diagnosed with bilateral pulmonary emboli - no other precipitating cause identified

49M with PMH significant for anxiety and depression; unmedicated due to lack of health insurance presenting with vasovagal syncope 15 minutes after Janssen vaccine administration in left arm. Pt reported feeling nervous prior to vaccine administration with remote history of fainting one time due to needle phobia, pt was offered to prophylactically lie down in a cot to receive the vaccine, he refused. Pt stated that he began feeling flushed and sweaty when he lost consciousness falling from a seated position, hitting his face and head. Pt was lying in prone position unconscious for 10-15 seconds, EMS was notified and pt was turned using C-spine precautions and transferred to stretcher. Pt was placed in trendelenberg,

On March 11 at5pm, after shooting basketball for 50 minutes, I had no medical issues. On March 24 at 6:40pm, after shooting basketball for 30 minutes, I had a heart attack with a coronary artery LAD 100% blockage and was treated with a stent procedure right after a visit to the ER.

Systemic: Visual Changes/Disturbances-Severe, Additional Details: patients wife called to say that around 1 week after vaccine pt experienced vision issues. dr say he had a blood clot in eye which lead to partial blindess in one eye.

Patient felt ok the day of the shot, next day got very sick. Said he felt terrible, felt like the vaccine was going to "do him in." He complained of weakness and shortness of breath. He was dehydrated and worried about his kidney function. Said he had a hard time going to the bathroom with stomach pains. On Mar 31, 2021, said he had fever, but didn't go to doctor. Was taken by ambulance April 3 to ER, admitted that night, transferred to ICU on April 4, on ventilator, proceeded to experience multiple organ failure and died on April 11, 2021

About 3 weeks after the vaccine I started having severe chest and belly aches on the right side. CT scan showed a blood clot on my lungs and pneumonia

A week and a half after taking the Janssen COVID shot I had a knot and pain come up in my lower back. After going to the chiropractor two times the knot and pain ended up in my right leg. I then went to Urgent Care where they diagnosed me with a large blood clot. They sent me to imaging and after scanning the area confirmed that there was a blood clot in my right leg. Urgent Care then set me up with a specialist.

6 days after the injection I suffered a massive heart attack of the Left Anterior Descending Artery with no prior heart history, less than a month earlier I had a physical with bloodwork and all cholesterol levels were normal, the doctors have not been able to give a real reason as to why this happen except I had a blockage but no explanation of why as my cholesterol levels are normal.

Soreness & lump in left lower thigh size of tic tac Swollen and sore left foot Diagnosed with ultrasound as superficial blood clot Heat applied and aspirin Still swollen

It was reported that patient had been experiencing difficulty breathing, walking and delusions as per his fiancé . Fiance notified Manger that they sought medical attention earlier in the morning on 1-Apr-21 at the Clinic and they refused to evaluate patient beyond performing a PCR swab test so, they went back to their apartment. An SMS notification was sent on 1-Apr-21 indicating that patient was COVID-19 positive which was not seen by patient or fiance who reported the result to Mgmt. on 6-Apr-21. He was contacted by patient's friend and advised him the patient was sick, not able to walk, and having difficulty.

starting have shortness of breath/difficulty breathing and back and chest pain. light headed, pain unbearable. Saturday April 23rd Went to er was treated for kidney stones but they could only find one small one, Was sent home with pain medication. Shortness of breath persisted as did bloody cough and pain in chest and all over. Went back to the er on 4/28 as pain was unbearable (chest pain) once given a cat scan and diagnosed with blood clots in my lungs and then an ultra sound and found a blood clot in my leg (just above knee). It is thought that I was mis-diagnosed on the original trip to the er with kidney stones. I have been put on blood thinners and pain medication and will be following up with my doctor.

BLOOD CLOT IN LEG; SHORTNESS OF BREATH; HEART RATE INCREASED; GANGRENE IN TOE; RIGHT LEG SWOLLEN; RIGHT FOOT SWOLLEN; CHILLS; RUNNY NOSE; FEELING HOT; This spontaneous report received from a patient concerned a 50 year old male. The patient's height and weight were not reported. The patient's concurrent conditions included high blood pressure and diabetes. The patient received COVID-19 vaccine Ad26.CoV2.S (suspension for injection, route of administration not reported, batch number 1802070, expiry date unknown), dose not reported, 1 total administered on 19-APR-2021 for prophylactic vaccination on left arm. Concomitant medications included amlodipine besilate for drug used for unknown indication, empagliflozin for drug used for unknown indication, fenofibrate for drug used for unknown indication, insulin aspart for drug used for unknown indication, insulin glargine for drug used for unknown indication, losartan for drug used for unknown indication, and pioglitazone hydrochloride for drug used for unknown indication. On an unspecified date (reported as 22-MAR-2021; 28 days prior to vaccination), the patient experienced shortness of breath, heart rate increased, runny nose, chills and was hospitalized (date unspecified). He reported that on this past Saturday, 17-APR-2021 (2 days prior to vaccination), he went to the emergency room. He reported that his toenails were coming off, the skin on his toes was coming off, and he had swelling in his right foot and up his leg. He says there was no circulation going to his toe and he was diagnosed with having a blood clot in his right leg. He says he had surgery to open up the arteries in his leg, and also reported gangrene in his toe. The subject was discharged on 21-APR-2021. On 23-APR-2021, the patient experienced feeling hot. He also reported that he may need to have his right pinky (fifth) toe amputated because it has gangrene. He reported that he is going to go back to the hospital, to which he would seek medical attention if he was having issues. Treatment medications (dates unspecified) included paracetamol. When called back due to his vaccination dates being after event start dates, the patient said that his memory is not too good, so he 'had to take his time to remember the correct dates'. The action taken with COVID-19 vaccine Ad26.CoV2.S was not applicable. The patient was recovering from blood clot in leg, and had not recovered from runny nose, shortness of breath, heart rate increased, chills, feeling hot, gangrene in toe, right leg swollen, and right foot swollen. This report was serious (caused hospitalization).; Sender's Comments: V0: This 50-year-old hypertensive and diabetic male patient reported that he was feeling hot and may need to have his fifth toe amputated because it has gangrene 4 days after receiving COVID-19 VACCINE AD26.COV2.S for the prevention of symptomatic SARS-CoV-2 virus infection and 2 days after discharge form the hospital. The patient was hospitalized for shortness of breath, heart rate increased, runny nose, and chills 28 days prior to vaccination. The patient went to the emergency room 2 days prior to vaccination because his toenails/skin on his toes were coming off, swelling in his right foot and up his leg, gangrene in his toe; he reported that there was no circulation going to his toe and was diagnosed with having a blood clot in his right leg; the patient reported he had surgery to "open up" the arteries in his leg. Four days after vaccination, the patient felt hot and reported reported that he may need to have his right pinky (fifth) toe amputated because it has gangrene. The patient is taking paracetamol as treatment. No other details was reported. Based on the lack of temporal association, the causality is considered not related for the events blood clot in leg, shortness of breath, heart rate increased, right leg swelling, right foot swelling, chills, and runny nose. The information available regarding event gangrent of fifth toe and feeling hot precludes a complete and meaningful assessment. However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded. Additional information was requested.

MYOCARDIAL INFARCTION; CORONARY ARTERY OCCLUSION; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's past medical history included sinus infection, fever, and left anterior descending artery blockage, and concurrent conditions included increased triglyceride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 08-MAR-2021 at 13:00 to left arm for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. Concomitant medications included eicosapentaenoic acid ethyl ester used for unknown indication. On 24-MAR-2021 19:10, the patient experienced myocardial infarction, and was hospitalized (date unspecified). On 24-MAR-2021 19:10, the patient experienced coronary artery occlusion. It was reported that on 11-MAR-2021 at 17:00, the patient played basketball for 50 minutes and he had no medical issues. On 25-MAR-2021 at 19:10 the patient played basketball for 30 minutes and he had heart attack with a coronary artery LAD 100% blockage and was treated with a stent procedure right after a visit to the emergency room. Laboratory data (dates unspecified) included: Triglycerides (NR: not provided) Increased (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from myocardial infarction, and coronary artery occlusion. This report was serious (Hospitalization Caused / Prolonged, Other Medically Important Condition, and Disability Or Permanent Damage).; Sender's Comments: V0- covid-19 vaccine ad26.cov2.s-Myocardial infarction, coronary artery occlusion. 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

Pt developed calf pain ~ 1-2 week after COVID vaccine. Diagnosed with DVT/PE on 5/6 with platelet count decreased from baseline at 92,000.

Pt was admitted to the hospital on 3/31/21 and diagnosed with stroke. Pt states that doctors told him it looked like the stroke may have occurred about one week prior to hospital admission. Pt started experiencing daily headaches after receiving the vaccine, then a couple of days later started experiencing chest tightness, panicky feelings, feeling like he was going to pass out, and some tingling sensation in his hands. Pt states that although he has been released from the hospital, he is still feeling like he is going to pass out multiple times a day and still experiencing tingling in his hands. Pt states that he is still having minor headaches.

Acute onset of dyspnea, predominantly with exertion over 1-2 days. Diagnosed with unprovoked pulmonary embolism diagnosed 2 months after vaccine. No family or personal history, no tobacco use. Up to date on cancer screenings.

Pt was vaccinated with the Johnson and Johnson Vaccine on 5/3/21. he presented to the emergency room with a stroke on 5/15/2021. 50-year-old male presents emergency department with difficulty finding words and difficulty getting his hands to do what he wants. Last known normal was 1030 the previous night when he went to bed. He has a past medical hx sign for controlled HTN, seasonal allergies and obesity with a bmi of 48. Family members noticed him having difficulty finding words the morning of admission and it got slightly worse throughout the day. According to his wife he was holding the phone and could not dial the right numbers. His hands were working but they could not follow instructions from what his brain wanted to do. On evaluation the patient felt as though he was stuttering and could not get the right words. No numbness or tingling. No weakness on one side or the other. wife and pt reported no prior problems with word finding or memory in the past and other than obesity and controlled HTN he was healthy. He does not smoke. he had no prior hx of atrial fibrillation. telemetry monitoring showed no atrial fibrillation. His LDL was 109, chol 167,trig 119, hdl 34. No prior hx of covid 19 infection. echo with normal EF, no thrombus. He received Physicial therapy and Occupational therapy and speech therapy. He was discharged home on 5/17 on an aspirin. He was called on 5/22 and is still experiencing expressive aphasia and word finding difficulty. He previously worked full time as a machinist and has not been able to go back to work. He is also complaining of fatigue still.

He was admitted to Hospital unresponsive as Ventricular Fibrillation cardiac arrest. Found to be COVID-19 positive upon testing on 5/31/2021. No prior positive tests on record.

I WOKE UP SATURDAY MORNING WITH FLU LIKE SYMPTOMS (FREEZING ONE MOMENT THEN BURNING UP THE NEXT). THAT WENT ON UNTIL MONDAY AFTERNOON. SATURDAY MORNING I ALSO NOTICED MY LEFT LEG WAS SWOLLEN AND HAD A BLUEISH/REDDISH COLOR AND WAS THROBBING. FROM TIME TO TIME i WOULD EXPERIENCE A SHARP PAIN BEHIND MY KNEE AND THIGH. AFTER A WEEK THE SYMPTOMS DID NOT GO AWAY SO I WENT TO THE DOCTOR. HE ORDERED AN ULTRASOUND ON MY LEG. THAT SAME DAY I HAD THE ULTRASOUND WHERE THEY FOUND MULTIPLE BLOOD CLOTS IN MY LEFT LEG. DOCTOR IMMEDIATELY PUT ME ON ELIQUIS. THE DOSE FOR THE FIRST 2 WEEKS WAS 10MG TWICE A DAY (10 MG MORNING AROUND 8AM AND 10 MG AROUND 8 PM). AFTER 14 DAYS HE REDUCED MY DOSE TO 5 MG AM AND 5 MG PM.

On June 29, 2021 I got poked by a plant on my left hand, my vaccine was on my left arm, and the reaction was anaphylaxis. I have been poked by this plant before, and I never had a reaction. I had the ambulance and the whole bit come out. I was taken to the hospital and was put on 4 different IVs. I was in the hospital for like 4 or 6 hours. I haven't been hospital again but it happened again 7/06/2021, I had the anaphylaxis again, it was triggered on it's own. No thorns or anything. I took 2 doses of Benadryl. The second dose stopped it. I'm on over on medication, Benadryl, Prednisone, Pepcid, Meclizine (takes care of any dizziness), to keep the anaphylaxis shock from coming back. As soon as I stop taking the medication it probably would come back. I have one more week of medication left.

migraines, vision issues within 12 hrs. On 4-29 I had a TIA (complete loss of right side and couldnt speak for 10 min). I went to hospital and had CT, ekg, blood work, all were ok. Cardiologist determined I did have a TIA and after an Echocardiogram discovered a Patent Ovale Foramen (hole in heart) and recommended immediate closure. Surgeon also said to get the procedure but as of now my insurance has not approved payment. I have been having numbness and pain in hands and feet (mostly left side) along with vision issues, dizzyness, problem finding words and concentration, fatigue. I went to Hospital again on 6-27 due to pain and numbness in left hand and foot and doctor said he could admit me but I did'nt stay. I have gone from a healthy person who is very active to someone who is always tired and is constantly worried about having another TIA.

Patient reportedly passed away on 3-24-21 on the day after the vaccine was given. We have no further information at our facility regarding the event.

Patient had a large pulmonary embolism 3 weeks after receiving the vaccine. Unclear if vaccination was the cause, but giving the timing we are reporting it. The health care proxy also noted some palpable masses on distal L extremity, unclear if related to vaccine or what these are.

Developed DVT. Complains of calf pain and swelling starting evening of 4/8/2021, worsening over weekend. To walk in care on 4/13/2021. Dx DVT in left lower extremity. Ultrasound shows DVT in the proximal femoral vein through the portal vein. Physician notes indicate patient seen for "left leg soreness, tender to touch, protruding veins, redness, cramping in calf, radiating up to posterior thigh"

Patient presented on 4/21 with 2 weeks of generalized fatigue, abdominal pain, and weight loss with multiple lab derangements concerning for acute liver failure. Patient on 4/22 is tachycardic and change in mental status. Acute liver failure likely due alcoholic hepatitis. Cholestatic etiologies will be considered. Acetaminophen toxicity treated with acetylcysteine. Started on methylprednisolone 32 mg daily. RUQ: biliary sludge within gallbladder. No sonographic evidence of acute cholecystitis. Acute respiratory failure secondary to COVID pneumonia. Chest pain and elevated troponins. Alcohol withdrawal on treatment protocol. Sepsis and Community acquired pneumonia. Thrombocytopenia and elevated INR. Macrocytic anemia and AKI.

R sided paresthesias started at 8pm on 4/24/21 and worsened to entire R side of body on 4/25/21 am. He was evaluated and admitted to the hospital 4/25/21 and found to have left thalamic stroke. No weakness in arm noted but some R hand dysmetria along with decreased sensation.

ultrasound the left lower extremity shows extensive occlusive lower extremity DVT involving multiple veins. Labs otherwise unremarkable, patient appears well, denies chest pain or shortness of breath. He had the J+J vaccine less than 3 weeks ago.

Onset of severe headache , slurred speech on 4/17/2021. Became aphasic with motor deficits, was not a tpa candidate at hospital due to time of symptom onset. Dx with L MCA ischemic CVA

R41.82 - Altered mental status R53.1 - Left-sided weakness R47.9 - Speech difficult to understand I63.9 - Cerebral infarction, unspecified

Exactly 11 days after receiving the J&J vaccine my husband developed leg pain in his right lower inner leg, he was taken to the hospital on 04/20/2021 which a ultrasound was completed but resulted no blood clots, no other labs or treatment was performed that day, the next day he developed severe diarrhea and flu like symptoms with continued leg pain and difficulty breathing, He was then rushed to the hospital by ambulance where he was suffering from very low BP 41/31 was the lowest, a line was placed and he was put on pressors to increase his BP. He was transferred to the hospital where he was diagnosed with a flesh eating bacteria in the right leg where the pain was at and Sepsis. He was taken to surgery to debride the right leg and was started on CVVHD because his new kidney was now failing, he eventually was started back on Hemodialysis and taken to surgery 2 more times where he cardiac arrested on the table in surgery and died. A private autopsy is being performed but the preliminary results shows he had multi-system organ failure, including his liver which was NEVER a problem in the past.

4/10/2021 vaccination 4/11 or 4/12 at the latest, I started feeling a pain in my R calf. It was constant pain for a week and decided to go to the walk in clinic. Blood work which was high and they referred me to the ER and administered a sonogram. *positive for blood clot Eloquence for 30 day starter pack. PCM is going to extend till July in which he will administer another sonogram. *COVID +; 01/2021

Patient presented to hospital on 4/23 after experiencing stroke-like symptoms the evening of 4/22. Symptoms included slurred speech, confusion, and repetitive grasping of his L hand. Patient was diagnosed with DM2 and HTN during his hospital admit, but had not previously received treatment.

Patient was admitted to the hospital on 4/5/2021 for severe AKI with hyperkalemia. Patient had a prolonged hospital course due to kidney failure and AIDS. The patient developed acute respiratory failure on 5/1/21 and was transferred to the ICU, where he was found to be in septic shock. Patient passed away on 5/4/21 at 9:59am

Patient received their vaccine on 6/17 and had no complaints of adverse effects. The patient was found unconscious at some point between 6/17-6/18. They appeared jaundice and had low BP. They were airlifted to the hospital and died on 6/18/21.

patient with chronic pain to bilateral lower extremities and is followed by wound care. During visit, 6/24/21 an ultrasound of bilateral lower extremities was ordered due to the pain and wounds to both heels. The ultrasound indicated acute occlusive DVT left mid femoral vein segment.

Nausea, vomiting, difficulty walking, unable to eat or drink; unable to clear secretions, difficulty breathing

Approximately three weeks after receiving Johnson & Johnson vaccine, I began to get pains in legs. Calves were aching and throbbing. Didn't think anything of it at first....just thought achy muscles and such. The day before Easter (April 3rd 2021) decided since the pain was continuing and the internet will scare you to death - I went to a local Emergency Room in advance, I had an ultrasound on my left leg and it was noted I had DVT. (blood clot in left calf) To briefly explain: I had an achilles issue back in Nov. 2020 (slight micro tear - achilles tendonitis) I thought maybe this was related to that, as I had not been to the doctor to get it checked until early March 2021. and it bothered me off and on for a few months. I thought the calf pain may have been related to that? I explained to the emergency room doctor about my achilles and thought it was an issue related to that. They decided to perform an ultrasound on my left leg. Which noted the DVT/Blood Clot. They put me on a starter pack of Xarelto and I am to follow up with my normal doctor on April 22, 2021.

Woke up Sunday the day after and couldn't walk. Waited to see if it would wear off the next day was admitted into emergency with a minor stroke caused by a blood clot

Per pt report: Pt started having body aches within a couple hours of vaccine, developed severe 9/10 pain over the next several days. L shoulder pain radiating to ribs and neck w/ muscle spasms, causing HA, R hip and sacral pain, flank pain radiating down R leg. Pt reports that vision in L eye is blurry, R eye vision intact, numbness to L arm and hand, able to move. Pt reports 1in x 0.5 in blood clot when blowing nose Thursday morning, small clot subsequently about 1/2 the size, smaller clots later.

Patient with extensive PMH- rectal adenocarcinoma with colostomy, sacral ulcers, cardiomyopathy, from Nursing Home. Sent from nursing home due to persistent hypotension for 2 days which did not respond to IV fluids, sepsis since patient was tachycardic and hypotensive. Urinalysis positive, sepsis possibly due to urinary tract infection, patient also with bacteremia- gram-negative. Patient still hospitalized on antibiotics.

We were vaccinated on April 2 in the morning. On April 12, 2021 we came home from work in the morning and he complained of numbness in his left. We thought it was related to the weather getting warm and we work the night shift, so he rested and increased his water intake. He was able to go to work on Monday night and return home and continued to rest on Tuesday. On Tuesday, there was no numbness, but there was weakness in both his legs. On Wednesday, he felt weakness throughout his body, especially in his legs. On Thursday, he collapsed. He did not lose consciences but his legs gave out under him and he was not able to get up up. He was taken to the hospital. He was diagnosed with a stroke, increased sugars (diabetes he has never had before), acute kidney injury, and uncontrolled increased blood pressure. He was hospitalized and discharged April 19, 2021. He was readmitted 04/24/2021 for another stroke.

DVT POST COVID INJECTION; This spontaneous report received from a patient concerned a 52 year (also reported as 53 year) old male. The patient's height, and weight were not reported. The patient's past medical history included provoked DVT (deep vein thrombosis) 10 years ago, and concurrent conditions included hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 12-APR-2021 into left deltoid for prophylactic vaccination. The product was properly stored from receipt to administration. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. Patient received J&J vaccine at place of employment. After 24 hours on an unspecified date in APR-2021, the patient developed lower leg DVT (deep vein thrombosis) post COVID injection. It was confirmed by positive d-dimer (coded as Fibrin D dimer) and US (ultrasound scan). Exact results and date of the tests were not provided. The patient was started on rivaroxaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of DVT post COVID injection was not reported (captured as unknown). This report was serious (Other Medically Important Condition).; Sender's Comments: This 52/53-year-old hypertensive male patient of unspecified ethnicity developed lower leg deep vein thrombosis (DVT) after 24 hours of receiving COVID-19 VACCINE AD26.COV2.S for the prevention of symptomatic SARS-CoV-2 virus infection. The was prior history of "provoked" DVT 10 years ago. No concomitant merdications reported. The patient reported that D-Dimer was positive and ultrasound showed DVT. The patient was started on rivaroxaban. No other details reported. The information available precludes a complete and meaningful assessment. However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded. Additional information was requested.

Immediately after the injection patient felt a pressure like and felt a ball on the back of his head left side that resolved within a day. Within a week from vaccine patient started having a headache on and off with feeling of like his brain is swelling on the left side. Within another week patient experienced abdominal pain and chest pressure. went to a hospital CT abdomen was negative. On 4/28 patient had a severe headache followed by numbness to left face and left facial droop. 911 was called patient was code stroke in ED.

Symptoms started 4/27 in patient - presented to the ED on 4/30 for sinus pain and headache. Confirmed venous sinus thrombosis on CT scan on 4/30/21 during emergency department visit. Platelets were with normal limits.

Three days after receiving the vaccine, he developed a headache which was intermittent with pain score of 5-8 out of 10. Headache became consistent around 4/11/21. Pain is in the occipital region and occasionally radiates behind the eyes. Also complains of dizziness, nausea, vomiting, and tingling in his hands bilaterally - worse in the mornings and goes away after waking up. He presented to Medical Center on 4/28/21 and transferred to Medical Center for treatment of vaccine induced thrombocytopenia and nonocclusive straight sinus thrombus. He was started on bivalirudin infusion 4/29 @ 0142 via continuous infusion. Still receiving treatment at the time of this report.

Pt presented to ED w/SOB, cough, tachycardic, febrile, and headaches. Pt resides in independent apt w/roommate who tested positive for COVID 04/07/21. Pt developed symptoms on 04/08/21 but was tested negative at the time. Progression of cough resulted in ED visit. Pt received Janssen vaccine on 3/25/21 w/no complications. Was admitted for additional management of acute respiratory failure w/hypoxia due to COVID-19 infection and pneumonia requiring bipap, dexamethasone & tocilizumab. Rapidly escalating O2 requirements required intubation (4/16) and trach/PEG insertion (5/1). On 4/23- developed MSSA pneumonia in which 10 days of cefazolin was given. Pt currently still in ICU.

Started getting achy and feverish. Diarrhea, vomiting. Told me, I'm as sick as I've ever been in my life. Died. Just want to know if he died from Covid or an adverse reaction from Johnson and Johnson vaccine he received in jail. No one wants to test his blood. He's at the mortuary awaiting cremation, and I thought it best if some government entity drew some blood to determine if he's a Covid or vaccine reaction fatality. Before they cremate his body.

Arm sore for a day - and that was it. A month later, April 10, 2021. Heart Attack - they put in a stent (two stents) - two of my coronary arteries had collapsed.

abdominal pain. The pain was so severe that my knees would buckle and several times if I was holding anything, it caused me to drop it. After about a week, I had an appointment at 4:30 and was scheduled for the next morning at 8:30 to meet with a back and spine doctor for xrays. Xrays were negative. I was then schedule with a neck and hand specialist a few days later. This appointment could not provide a diagnosis. Back and abdominal pain increase and soreness had spread to the stomach and groin. After the news broke of the cerebral blood clots in 6 women. See attached Continuation Page.

I felt shortness and restriction of breath, fever 101, body aches and headache. I have had issues with micro clotting, heart rate is even more irregular, and I was diagnosed as having a TMI. I rode in the ambulance on Mother's day was hospitalized

24 hours later, patient and wife had plans and patient stated that he was not feeling well, generally. Wife then states that he did complain of leg pain since they had been driving in the car. 05/30/2021 Patient presented to ED and was found to have DVT and extensive PEs

shock - hemoperitoneum - splenic rupture, also with portal vein thrombosis, PE, also had platelet count 11 on admission

In March I had a pain in my left calf muscle that I could not identify with getting hit or injuring it in any way. I called Urgent care because i read and heard about problem with the J&J vaccine that it was giving people blood clots. Urgent care said there was no need to come in that there was very little reason to believe that it was a blood clot. Then in June I woke up to very severe pain in my left leg from my foot all the way to my thigh. It was hot, swollen and I could barely bend my knee. I went to Urgent Care and they sent me across the street to the Hospital for an ultra sound on my leg. Here are the result from the ultra sound. Real time color Doppler imaging and spectral analysis were performed during ultrasound evaluation of the left lower extremity is performed. There is persistent occlusive deep venous thrombosis within the mid to distal superficial femoral vein extending nonocclusive bleed to involve the popliteal vein and exclusively within the proximal popliteal and peroneal veins of the calf. The doctor put me on 3 week of taking a blood thinner twice a day and then will go down to taking one blood thinner once a day for 6 months. I also saw MD. Here are his notes from my Drs appt. Patient is seen today, 6/14/2021, to discuss management of left leg DVT. Patient presented to urgent care on 5/20/2021. He had noticed soreness in his left leg for a couple of days and then he awoke that day and the leg was swollen. The duplex scan showed that he had occlusive clot involving left superficial femoral vein extending through popliteal vein down to peroneal vein in the left calf. He was started on rivaroxaban 15 mg twice daily. He transitions to 20 mg rivaroxaban daily tomorrow. The leg soreness has eased slightly but the swelling has not improved. He did have a repeat duplex scan on 6/7/2021 which was unchanged. Thrombus persisted but was not worse. He has not had chest pain or breathing issues or dyspnea. He does recall that about 4 weeks earlier he had a muscle spasm sensation in the left calf. He had received a Johnson & Johnson Covid immunization in late February, 2021. He was aware of the public information about venous clotting in women who had received the J&J vaccine and was also aware that it involved cerebral veins. He called his provider and was asked questions about the leg and otherwise the answers were negative. So imaging was not obtained. The muscle spasm sensation did not recur. His family history is negative for clots in his personal history for clots is otherwise negative. He is a maintenance manager. He has not had lengthy travel recently. He also denies any trauma to the legs. He has a history of GERD from which she had developed iron deficiency anemia in June 2020. He had undergone EGD has a result. He also had a colonoscopy when he turned 50 years of age and had polyps removed and then had repeat colonoscopy 6 months later. This evaluation occurred with Dr. of gastroenterology. His colonoscopy was on 12/20/2018. One of the polyps was a hyperplastic polyp. The second was a tubulovillous adenoma with high-grade dysplasia/intramucosal adenocarcinoma, 2 cm size. Polyps were excised. Had repeat endoscopy on 7/10/2019 he had a hyperplastic polyp in his rectum. Also he had a PSA checked in summer 2020. It was 0.5. He is a smoker only of very infrequent cigars, perhaps every 6 to 8 months. PAST MEDICAL HISTORY: GERD Sigmoid colon polyps, resected December 2018 and June 2019 Left leg DVT, May 2021 Sleep apnea Iron deficiency anemia related to gastritis. Diagnosed June 2020, treated with oral iron ADHD History of depression MEDICATIONS: has a current medication list which includes the following prescription(s): amlodipine, escitalopram, esomeprazole, multivit-iron-fa-calcium-mins, prednisone, rivaroxaban, unknown home medication, and tadalafil. ALLERGIES: Patient has no known allergies. PAST SURGICAL HISTORY: Vasectomy 2 colonoscopies, first in December 2018 and second in July 2019 EGD on 2 occasions, first in March 2019 and second in June 2020 FAMILY HISTORY: Father died age 66. He had a pacemaker and was on blood thinners Mother died of a throat cancer. She was a heavy smoker. Died at age 60 1 brother and 1 sister are healthy SOCIAL HISTORY: Smokes cigars, perhaps twice a year. Never smoked cigarettes Alcohol use maybe 4 beers on the weekend Previously married and divorced 3 children, 2 daughters and 1 son ranging in age from 17 through 21 REVIEW OF SYSTEMS: Significant for persistent soreness in his left leg albeit easing over the last 3 days and persistent swelling in his left leg including dorsum of his foot General: Denies weight loss, no issues with energy, denies night sweats HEENT: No mouth or throat soreness, no issues with hearing, no tinnitus, no issues with taste No epistaxis Resp: Denies cough, exertional dyspnea, sputum production. Heart: No palpitations, no exertional chest pain, no lightheadeness or dizziness when standing Gi: No dysphagia. No heartburn, Denies nausea or vomitting. Bowels are regular, no diarrhea or constipation. Denies melena or hematochezia GU Denies hematuria. No dysuria. No incontinuence. Skin: No rash, no petechiae, no dryness. No itching or burning. Musculoskeletal: No bone pains, no joint pains or swelling. No localized weakness Neurologic: Denies headaches, no double vision, no weakness, no change in sensation Psychiatric: Good spirits, sleeping well, no anxiety, normal mood Endocrine: Denies heat or cold intolerance. Heme: No easy bruising PHYSICAL EXAMINATION: BP (!) 142/99 | Pulse 95 | Temp 97.6 °F (36.4 °C) | Resp 18 | Ht 6' 3" (1.905 m) | Wt 295 lb (133.8 kg) | SpO2 96% | BMI 36.87 kg/m² Appears alert, oriented, not in distress. Well developed Psychiatric: Patient is alert oriented ×4, good spirits, interacts appropriately He has swelling in his left leg DATA: CBC: .5/20/2021: WBC 7.49 X10^3/uL; Hemoglobin 14.8 g/dL; Hematocrit (calc.) 43.4 %; Neutrophil (%) 75.4 %; MCV 98.4 fL; Platelet 141 X10^3/uL* CMP: 4/22/2021: Bicarbonate (TCO2) 25 mmol/L; BUN/Creatinine 16; Calcium, total 9.0 mg/dL; AST (SGOT) 41 IU/L*; ALT (SGPT) 38 IU/L; Alkaline Phosphatase 62 IU/L; Bilirubin, Total 0.4 mg/dL; Protein, total 6.9 g/dL; Albumin 4.3 g/dL; Albumin / Globulin 1.7 5/20/2021: Sodium 142 mEq/L; Potassium 4.6 mEq/L; Chloride 103 mEq/L; BUN 13 mg/dL; Creatinine 1.2 mg/dL; Glucose 110 mg/dL*; Calcium, Ionized 1.17 mmol/L ASSESSMENT: 1. Left lower extremity DVT. Etiology unclear. No definite provocation. He did receive a Johnson & Johnson Covid vaccine in late February, 2021. He first noticed a muscle spasm sensation in left calf in mid April, 2021 and then had onset of soreness 2 days before his visit with swelling onset the day of his urgent care visit, 5/20/2021. Currently on rivaroxaban. Transitioning now to the 20 mg daily dose. Family history negative for DVT as is his personal history. PSA was unremarkable and summer 2020. Has had prior colonoscopy in December 2018 and June 2019. Did have finding of sigmoid colon polyps with atypia in 1 and possible noninvasive adenocarcinoma. Repeat scope showed hyperplastic polyp but no additional polyps. Has also had EGDs in March 2019 and June 2020 because of GERD and iron lack anemia. Non-smoker. I discussed with patient that we would usually treat him for 6 months with anticoagulation and then reassess to determine whether it is safe to discontinue therapy. But if he has ongoing swelling and soreness in his leg it would be difficult to stop treatment because we would lose one of our early indicators of recurrence of DVT. I also suggested that we should do a lab panel to assure that he does not have any underlying inherited or acquired abnormality that predispose to this clot, since we do not have any clear-cut causative etiology. (We discussed that the Covid immunization may have been his predisposition, but that existing data suggest that this is a risk factor in females and that most of the episodes were central nervous system venous clots.) PLAN: 1. So we will draw lab panel assessing acquired and inherited predispositions for hypercoagulability. And we will plan to see him back in a couple of months to reassess his status.

Patient was immobile, not able to move when he was found and once transported to hospital they concluded patient had a stroke. He has been hospitalized since 4-25-21.

Pt. states 04/09/2021 @ 8:30am started experiencing symptoms from injection site (paralysis), numbness in the face (Left) droop 30mins-45mins, 05/18/2021 numbness in the face/difficulty speaking 2-3hrs, 06/12/2021 again numbness in the face05/20/2021 diagnosed with male Breast Cancer. Breast tissue removed. 06/27/2021 severe facial droop, whole numbness left-side of body, Admitted for observation. 06/28/2021 discharged TIA. Currently experiencing numbness.

5/15: Two days after vaccine: feelings of paranoia, unable to complete work, up all night, had to miss two days work. 6/18: Feelings of numbness on right side (hand, foot) while going through security at Airport. Weakness in right leg. 6/23: Went to urgent care facility. Was told it sounded like a stroke, sent to hospital for treatment. After imaging at hospital patient was told he had a minor stroke.

7/18/2021 Patent presemted to ED with a chief complaint of chest pain for the last 3 days associated with shortness of breath. Refers has been using ibuprofen achieving minimal relief. Received COVID 19 vaccinate in April (Johnson & Johnson). Upon initial evaluation on ED VS: stable. Laboratories revealed elevated creatinine and COVID 19 TEST Positive. EKG: Sinus rhythm, T wave abnormalities. A chest x ray: IMPRESSION: Left lower lung airspace disease. CT angio showed Acute pulmonary embolism, left lower lobe, nonocclusive. COVID-19 infection considered asymptomatic and no treatment required for this. Discharged home on 7/19/21.

Systemic: Fainting / Unresponsive-Mild, Systemic: Patient passed out and recovery after 40 seconds of chest compression-Mild, Additional Details: Patient was seen rocking back and forth in his chair according to 3 observers in the room, then fell back hit his head after observed his face turned pale. 3 Observers rushed over to him, patient was not breathing, unconscious and not responsive, eye ball stiff, sweating but cold. Eyelid peeled back and the eye is responsive to light. Started chest compression immediately and after 40 seconds of chest compression at third round, patient came back. no hx of preexisting condition or allergies note

CARDIAC ARREST; This spontaneous report received from a consumer concerned a 53 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included type 2 diabetes, picc line, and diabetic foot ulcer. The patient had no known allergies. The patient had no previous history of heart conditions. The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. Concomitant medications included Ceftriaxone for diabetic foot ulcer, and Heparin for picc line prophylaxis. On Saturday, 20-MAR-2021, the patient reported that his chest felt funny but he wasn't sure about the cause. On Monday, 22-MAR-2021 morning; the patient had collapsed when he got out of the shower and yelled for help. The patient was gasping for breath and reading on pulse oximeter dropped into the 70's and also reported that he felt light headed. It was unknown weather the patient died in ambulance or at hospital. It was unspecified if an autopsy was performed. Laboratory data included: Oxygen saturation decreased (NR: not provided) Dropped to 70's. On 22-MAR-2021, the subject died from cardiac arrest. The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. This report was serious (Death).; Sender's Comments: V0: 20210342361 -COVID-19 VACCINE AD26.COV2.S- Cardiac Arrest. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY.; Reported Cause(s) of Death: CARDIAC ARREST

PE; DVT; This spontaneous report received from a physician via a company representative concerned a 53 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included family history of DVT, and family history of PE. 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 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On unspecified date in 2021, the patient experienced PE (pulmonary embolism) and DVT (deep vein thrombosis). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the PE and DVT was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210332653-Covid-19 Vaccine AD26.COV2.S-PE and DVT. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY

Headache Shortness of breath Smart watch indicated Atrial Fibrillation (112 BPM average) on 4/12 at 3:04pm

My uncle unexpectedly passed away during the early morning hours of April 13. He had reported to my aunt that he was having shortness of breath, headaches, and in general not feeling well. She found him sitting up with a clear liquid pouring out of his nose and then he fell over dead.

Deep Vein Thrombosis- occlusive and non-occlusive in R axial and R brachial veins at level of PICC line. Pt admitted to hospital on 4/18/21 with acute basal ganglia hemorrhagic CVA, with PICC line placement on admission. DVTs identified on 4/21 via ultrasound. Pt currently admitted to Hospital

Blood clot in each lung. Started in legs, spread through heart and settled in lungs. This occured about 3 weeks AFTER J&J/Jansen vaccine. Immediate symptoms were painful leg cramps on both sides back pain, fever sweating, nausea, clammy skin, headache, neck pain.

Received the vaccine on 4/4/2021. On 4/8/2021 started having pain in lower left leg. Pain off and on for two weeks. Pain intensified on 4/23/2021. I went to the emergency room where they performed on ultra sound examination of my left leg. Confirmed that I have a deep vain thrombosis (DVT) behind my left knee. Prescribed Eliquis. Saw Dr. today. He could not confirm that DVT was caused by vaccine, but I thought I should report it. I am to stay on Eliquis for six months at which time I will be evaluated for a blood clot disorder.

POSSIBLE THROMBOCYTOPENIA; RASH FROM KNEE TO FEET /SPOTTY RED DOTS ON LEG; SLEEPINESS; NECK ACHE; TIREDNESS; MUSCLE ACHE; HEADACHE; This spontaneous self-report concerned a 53 year old male 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: 1805029 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the patient received the vaccine, waited at facility for 15 minutes, and everything was okay. On 17-APR-2021, the patient experienced neck ache, muscle ache and felt a sense of tiredness, headache, sleepiness, which he treated with Aleve (naproxen sodium). He also noticed his feet had a rash from his knee to feet, and according to his sister (who is a healthcare professional) it looked like small micro-embolisms (thrombocytopenia). The patient went to his physician who said the spotty red dots could be petechiae caused by thrombocytopenia. As recommended by his primary care physician, the patient has an appointment for lab work, including platelet counts, on 20-APR-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, tiredness, neck ache, rash from knee to feet (red dots), muscle ache, and possible thrombocytopenia, and the outcome of sleepiness was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This 53-year-old male patient was found to have petechiae-like rash on his knees to feet, that according to attending physician could be caused by thrombocytopenia, 2 days after receiving Janssen COVID-19 vaccine for the prevention of symptomatic SARS-CoV-2 virus infection. The patient underwent laboratory procedure including platelet count (results not reported). The patient complained of neck ache, muscle ache and felt a sense of tiredness, headache, sleepiness that he treated with Aleve (naproxen sodium) on the day the petechiae-like rash appeared. No other details reported. The information available precludes a complete and meaningful assessment. However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded. Additional information as requested.

As pt's PCP office, we became aware that pt was admitted to hospital on 5/3/21 with dx of pulmonary embolism. Per admission note, pt reporting increased shortness of breath x 4 days prior to his admission date. Also noted to have received J&J vaccine on 4/29/21. Pt still currently admitted to the hospital and undergoing treatment for PE.

Left side stroke;severe headache;blindness;treatment was TPA;no significant finds in any test;currently being treated as a cardiac patient

Had a stroke on May 12, 2021. Found unresponsive while at work, while at work and sent to ER at Hospital. Hospital sent him to Hospital, due to Stroke on the same day. On 5-15-21 sent to Acute Rehabilitation. Still in Rehab doing PT, OT and speech therapy. Many test completed and unknown to how stroke happened. Health prior to vaccine was healthy with no concerns.

5 days after COVID-19 vaccine, patient had a sudden unexpected cardiac arrest and died at his home after long resuscitation attempts by EMS.

Patient complained of exhaustion and malaise within 24 hours of receiving the dose. This never resolved. Three weeks later he complained of the same exhaustion and malaise. Jaw pain was reported on 5/23/2021. Patient found deceased 5/24/2021 at age of 53.

on 5/17/2021 pt developed a fever, pain in the left side of his ribs and had SOB. He was brought to Hospital ER. Pt had Chest x-ray, blood work, Doppler on both legs, and CT. His DX was pneumonia, blood clot in left lung and bilateral blood clot in legs. He was admitted and stayed for 5 days.

2 days after applying the vaccine I felt body pain, then a week later I began to have pressure in my chest that reached my throat so I was for a full week the third week I decided to go to the hospital and they discovered that I had blood clots in an artery in my heart. Then they installed 2 stents in my heart 2 days later they sent me home and 1 week later I had to return to the hospital after the studies they detected that I had blood clots in both legs, I had no problem before the vaccine and I'm almost 100 percent sure this is what caused these problems.

I went to Pharmacy on Aril 10 2021, after the vaccine I got fever for three days in a row, then four days with pain in my left leg. On the 19 I was not able to move my left leg with a lot of pain and a little discomfort on my right leg. Rush to the hospital and right away the found blood clots on my left leg, The ER did not check my right leg and two weeks later they found clots on the bottom part of my right leg. They gave me blood thinner and now Im taking Eliquis twice a day. Symptoms continue, I have the same pain, I dont see any improvent. I did went to work yesterday and I realize that I can do any lifting or be sitting down for at least one hour.

Patient experienced dyspnea on exertion and lightheadedness shortly after receiving vaccine. He continued with these symptoms until presenting to ER on 6/6/2021 and found to have extensive bilateral pulmonary emboli.

shortly after (few weeks) receiving the vaccine, I experienced a large amount of pain in my right forearm which resulted in a painful lump later identified as a thrombosis which had to be removed. It was removed on 5/27/21.

pt presented to ER 0230 3-17-21 pt c/o right sided weakness and numbness, tried to get out of bed and use bathroom and couldn't bear weight or move his right leg. NIH stroke scale score-2, Glasgow coma score =15 183/105, HR 103, RR 18, 02 saturation 95% RA 98.7 oral temp 0/10 pain. clonidine po tablet 0.1mg. EKG=tachycardia 106 normal P waves, normal PRI, normal QRS complex, normal ST and T waves. labs=SARSCoV2 RNA negative, CT head WO=no acute intracranial abnormality by CT criteria. UA=negative, glucose 359

Shortly after receiving the vaccination I started to experience chronic exhaustion, leg cramping and pain in my lower back right side, upper right thigh, behind my right knee and down into my right calf. I figured that the pain would go away but the pain increased and my leg started swelling and the pain increased making it very difficult for me to put my leg down on the ground and put pressure on my right leg.

I suffered two heart attacks. First heart attack was on the 6th day after the vaccine, second heart attack was on the 9th day of vaccine. Both heart attacks woke me up from sleep. I went to the emergency room and was hospitalized each time. I suffered chest pain prior to each heart attack but have never suffered chest pain before. I am continuing to suffer from periods of chest pain at rest.

DIAGNOSIS: 1. Superficial thrombophlebitis MEDICAL DECISION MAKING/DIFFERENTIAL DX: Differential diagnosis includes DVT, superficial thrombophlebitis, muscle strain, tendinitis. The patient presented to the emergency department with atraumatic left leg pain. An ultrasound reveals a fairly large blood clot in the greater saphenous vein. Although this is a superficial clot, given its extent, I think it warrants anticoagulation. Per the trial, the patient would benefit from 45 days of 10 mg Xarelto treatment. The patient was given good precautions regarding bleeding risk while on a blood thinner. He will schedule follow-up appoint with his primary care doctor. He will also use Tylenol and warm packs to help with the discomfort from the superficial thrombophlebitis. He was discharged in satisfactory condition.

Acute severe headaches and blurred vision after vaccine and acute ischemic stroke with resulting right hemianopsia

Patient presented to ED on 4/22/2021 with non-productive cough, mild shortness of breath x 10 days. Acute onset chest pain x 1 day. Chronic bilateral leg swelling, but worsening leg pain. Hx of DVT and PE, not on anti-coagulation.

Multiple pulmonary embolisms in bilateral lungs with lung infart, superficial blood clot in the right groin area, significant right abdominal pain, shortness of breath, low oxygen saturation levels admitted 3 days in the hospital. 36 hours of Lovanox injections followed by transition to Eliquis 10 mg twice per day, respiratory exercises, oxycodone given for pain Pain has diminished in lower right lung area, clotting appears to be under control

Patient had new acute areas of infarction involving the anterior periinsular cortex and left posterior temporal-parietal cortex.

I was admitted to the ER on 4/12/21 with dizziness, lightheadedness, vertigo, some auditory issues, shortness of breath, swelling/puffiness of legs and feet, unusual coldness in extremities, and some minor pain in chest. CT-Scan revealed DVT in left leg and PEs in both lungs. Was given two shots of heparin over a 24-hour period and then Xarelto 15mg (oral) the following day.

CHEST PAIN; TWO HEART ATTACKS; This spontaneous report received from a patient via the VAERS (Vaccine Adverse Event Reporting System; VAERS ID 1202551] concerned a 54 year old white not Hispanic or Latino male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient did not had allergies to medications, food, or other products, did not had other illnesses at the time of vaccination, up to one month prior and did not had spleen. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 12:00 for prophylactic vaccination on right arm. Concomitant medications included lisinopril for drug used for unknown indication. On MAR-2021, the patient experienced two heart attacks, first attack was on day of vaccine and another was the day after the vaccine and was hospitalized (date unspecified). On 16-MAR-2021 04:00, the patient experienced chest pain prior to each heart attack but had never suffered chest pain before. He further reported that he was continuing to suffer from periods of chest pain at rest. Laboratory data (dates unspecified) included: Cardiac catheterization (NR: not provided) 20 to 30 percentage blockage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from two heart attacks. This report was serious (Hospitalization Caused / Prolonged, Life Threatening, and Disability Or Permanent Damage).; Sender's Comments: V0. 20210439984-covid-19 vaccine ad26.cov2.s -Two heart attacks, Chest pain- 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).

death. Patient had inactive cirrhosis from successfully treated Hepatitis C. He had chroinically low platelet from cirrhosis and was also a clotter as evidenced several year ago with portal vein thrombosis travelling down to his mesenteric veins causing a similar lower GI bleed by clotting his colonic veins. He required several months of anticoagulants with blood thinner at that time. One week prior to his COVID-19 vaccination there ia picture of deceased with evidence of bilateral suborbital bleeding. Patient told family that he felt poorly after injection. The day he was found there was evidence of significant GI bleeding. His corpse is currenly at medical examiner's office with no plans for autopsy.

STROKE; FELL DOWN; This spontaneous report received from a health care professional (patient's wife) concerned a 54 year old male of Hispanic or Latino other race. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, diabetes, and high cholesterol. The patient had no known allergies and was non smoker. 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 16-MAR-2021 at 16:00 to right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. After vaccination, later on that evening her husband mentioned that he did not feel too good. He took a Tylenol and then went to bed. At around 3:00 that evening his wife woke up to go to the bathroom and noticed her husband was awake. When she asked he responded that he thought he might have suffered a stroke. On unspecified date he experienced fell down and unable to move the right side of his body. On 17-MAR-2021 at around 5:00 that morning, she took him to the emergency room (ER). There the ER department performed a computerized tomography (CAT) scan and confirmed that he indeed had a stroke and decided to transfer him to another hospital. On 22-MAR-2021, he was then discharged. He was hospitalized for 5 days. A few days later on 24 or 25-MAR-2021 she took him to her Doctor Of Medicine (MD.) where they had him do rehab which consisted of daily walking. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stroke, and the outcome of fell down was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210515350-Covid-19 vaccine ad26.cov2.s- A 54- year- old male of Hispanic or Latino other race presents with Stroke. 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

FEELING HORRIBLE; BLOOD CLOT; BODY ACHES; JOINT PAIN; SPAMS ALL OVER BODY; TOE SWELLING; KNEE SWELLING/ ANKLE SWELLING; This spontaneous report received from a patient concerned a 54 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: 042A21A expiry: unknown) dose was not reported, 1 in total administered on 03-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. After getting the vaccine, the patient had immediate joint pain and body aches. He had spasms since day one. After two weeks, he developed swollen toe looked like a bunyon, then it moved up to the ankle then it moved up to the knee being swollen. The patient was sent to the imagining center. He had following imaging tests done, bilateral Lower extremity Doppler Exam. On 30-APR-2021, he was recommended to go to the emergency room (ER) and was admitted. He was diagnosed with blood clot and stayed overnight. He was prescribed on Xarelto (rivaroxaban) 15 mg twice a day (BID), titrating to 20 mg once a day. The patient was hospitalised for 2 days. He got another follow up on 14-MAY-2021, gave him another prescription for blood thinner to be on for two months. On 18-MAY-2021, he was given tramadol 7 pills for spams which had helped with his pain and currently patient was feeling horrible. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from joint pain, body aches, toe swelling, knee swelling/ ankle swelling, spams all over body, and blood clot, and the outcome of feeling horrible was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210540030- Covid-19 vaccine ad26.cov2.s- A 54 yearold male presents with Blood clot, Body aches, Toe swelling, Knee swellng /Ankle swelling, Spasms all over body, feeling horrible. 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). 20210540030- Covid-19 vaccine ad26.cov2.s-Joint pain. This event(s) is labeled per RSI and is therefore considered potentially related.

April 13 (I had been traveling before it and came back) and I was preparing for work and my foot hurt. I hobbled around that day and noticed my foot was swollen. The next morning, I went to Piedmont Hospital ER( on the 14th) - they gave me a starter dose of blood thinners and I was able to schedule appt with Dr. Shamm -my hematologist - Zeralto - was what she prescribed. Everything is "back to normal." But based on my health history - the doctor care will be ongoing and I'll continue to see this doctor for treatment.

DVT IN LEFT LEG; SORE ARM; This spontaneous report received from a consumer (wife) concerned a 54 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: unknown, expiry: unknown) dose was not reported, 1 total, administered on 25-APR-2021 to right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 25-APR-2021, the patient had sore arm. On 17-MAY-2021, the patient noticed that his left leg got bigger and ignored it, he measured his calf which was 2 inch wider and elevated his feet. On 24-MAY-2021, it was really big and then the doctor sent him to urgent care and it was confirmed a case of deep vein thrombosis (DVT) and he was treated with blood thinner. Still his calf, ankle and foot looks bigger. The patient's wife did not have the lot number. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 28-APR-2021, and had not recovered from DVT in left leg. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210556854 -Covid-19 vaccine ad26.cov2.s - DVT IN LEFT 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).

After receiving , approx. next day, patient noted shortness of breath which worsened over the course of a few weeks. Right leg began to swell with some chest pain approx. 2 days before admission. He presented to ER, CT Chest Protocol showed multiple pulmonary thromboemboli, distal left and right main pulmonary arteries and several segmental branches. and had right heart strain. Venous Doppler of right leg revealed complete occlusion of multiple veins. He was admitted to hospital for anti-coagulation.

congestive heart failure, left bundle branch blockage, left ventricle wont dialate, EF of 20%. water pills 160mg a day, beta blocker, 1/2 a day. muscle twitch while sleeping or rest.

Patient developed an extensive acute, occlusive thrombus in the external iliac, common femoral, popliteal, and gastrocnemius veins

severe lethargy, shortness of breathe and fatigue (potential blood clot), went to PCP and prescribed Eliquis and Prednisone; however, written documentation said that he had no prior history of clotting prior to the vaccine.

Patient died of a brain stem bleed on 4/11/21. It is unknown if the vaccine received on 3/8/21 is in any way related to his passing.

Janssen vaccine received by patient on 3/24/21, no immediate symptoms. As of 4/14/21 started having petechia and non-traumatic ecchymosis. PLT count of 2. Hospitalized for severe thrombocytopenia, thought to be ITP. Currently admitted as of 4/16/21, report made on day 1 of hospitalization.

Cerebellum Stroke 4/11/2021. Presented in the Emergency Room of both hospitals with dizziness, nausea, unable to walk. Treated 4/12-4/14 and then again 4/15-4/19.

Developed transient SOB on 4/16 that resolved on 4/18. Developed left leg pain and swelling on 4/19. LE ultrasound revealed extensive DVT. Does report a 4 hour plane ride 4 weeks ago.

Immediately after shot had fever and chills with flu symptoms for about 4-5 days after vaccination. On 3/22 went to urgent care for left elbow swelling which had never occured before in this joint visit deteremined was olecranon bursitis. The very next day began complaining about leg pain around 3/23 and by 3/26/2021 pain was unbearable in the leg and went to ER where patient was then admitted for DVT and pulmonary embolisms.

BLOOD CLOT IN LEFT LEG; DIFFICULTY SLEEPING; SOME LEG CRAMPS; SWELLING; This spontaneous report received from a patient concerned a 55 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, expiry date: unknown) dose, 1 total on an unknown date in APR-2021 (reported as about three weeks ago from the date of reporting) on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. Since an unknown date in APR-2021 (reported as about a week ago), the patient experienced swelling and some leg cramps. It was reported that nothing (swelling and leg cramps) was dramatic initially, however, they worsened. On 28-APR-2021 (reported as last night), the patient had difficulty in sleeping. On 29-APR-2021, the patient was diagnosed with blood clot in left leg by his doctor. At the time of report (reported as currently), the patient was in transport to a hospital for further evaluation. The patient further mentioned that he did not have possession of the vaccination card, but his wife had it and she would be arriving at hospital later. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot in left leg, swelling, and some leg cramps, and the outcome of difficulty sleeping was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: -COVID-19 VACCINE AD26.COV2.S-Blood Clot in leg. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

On March 28th, started noticing symptoms. There was pain in my entire right leg, shin swelling; calf- swelling and skin discoloration; and right foot - swelling. On 4/1, I went to Urgent Care where I was seen, evaluated and treated by Dr. She ordered blood tests and an ultrasound within 20 minutes. I had 4 blood clots in 3 veins in my right leg/DVT. My blood platelet value was 267 and the standard range is 130 to 400. They didn't consider it low, but it's still an issue. I was given an injection of Enoxaparin Sodium Injection--1 ml injection twice a day for 5 days, which was started in the ER. I then switched to Pradaxa 150mg pill twice a day. I took that until around the 6th of this month when I noticed my right leg had gotten worse. I was instructed to go back to the urgent care. Another ultrasound was ordered and it showed I still had the 4 blood clots in 3 veins that seems to have worsened, so the meds were not working. He consulted with a vascular surgeon and they put me back on the injection once a day, which I am currently still on. I was told to follow up with my PCP in two weeks and that appt is on Thursday with Dr.

Very strong headaches and high blood pressure for two weeks. Went to the hospital twice in that span of time. Monday May 10, he couldn?t see through his right eyes. He went to the ER and they found a blood clot in his artery(thrombosis) and that night had a stroke in the brain. Still at hospital.

SIGNIFICANT GI BLEED; DEATH; SUBORBITAL BLEEDING AROUND BILATERAL EYES; FATIGUE/ FEELING TIRED; This spontaneous report received from a consumer concerned a 55 year old male. The patient's weight was 240 pounds, and height was 60 inches. The patient's past medical history included thrombocytopenia, and concurrent conditions included cirrhosis of the liver, smoker, and non alcoholic, and other pre-existing medical conditions included patient had no known allergies and drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JAN-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 02-APR-2021, the patient experienced fatigue/ feeling tired. On 15-APR-2021, the patient experienced suborbital bleeding around bilateral eyes. On 03-MAY-2021, the patient experienced death. On an unspecified date, the patient experienced significant GI bleed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died, and outcome of significant GI bleed, suborbital bleeding around bilateral eyes was unknown and not recovered from fatigue/ feeling tired. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0: 20210516526-covid-19 vaccine ad26.cov2.s-death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210516526-covid-19 vaccine ad26.cov2.s-significant GI bleed, suborbital bleeding around bilateral eyes. 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

MULTIPLE PULMONARY EMBOLISM; MULTIPLE BLOOD CLOTS; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a health care professional concerned a 55 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, Expiry: Unknown) dose not reported, 1 total, 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 developed multiple pulmonary embolism included multiple blood clots. On 19-MAY-2021, after 4 week of vaccination, the patient was diagnosed with suspected covid-19 infection (suspected clinical vaccination failure) and was not doing well. The patient got hospitalized. Number of hospitalization days was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, suspected clinical vaccination failure, multiple pulmonary embolism and multiple blood clots was not reported. This report was serious (Hospitalization Caused / Prolonged and Life Threatening). This report was associated with product quality complaint number: 90000180239. The suspected product quality complaint has been confirmed to be not voided based on the PQC evaluation/investigation performed.; Sender's Comments: V0:20210539965-covid-19 vaccine ad26.cov2.s - multiple pulmonary embolism,multiple blood clots,suspected covid 19 infection. 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). V0:20210539965 covid-19 vaccine ad26.cov2.s - suspected clinical vaccination failure This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically:SPECIAL SITUATIONS

Flu like symptoms x 5-10 days, back/pleuritic pain the following 5 days, SOB x 3 days later, finally went to ER dx with DVT, and PE

Patient experienced acute pulmonary embolism approximately 8 days after administration of the J&J vaccine. He did not have low platelets. No clear cause of the PE was found. It was thought to be possibly related to superficial thrombosis of his upper extremity secondary to IV that was placed 2 days prior when he was briefly admitted for workup of heavy hematocheiza, at which time he was found to have a mild anemia and discharged. He was treated inpatient at Hospital. I am not sure of the where he obtained the vaccine or the exact date.

Johnson & Johnson COVID Vaccine EUA J&J Dose 4/9/21 NOT COVID POSITIVE 5/25/21: The patient is a 55-year-old male presents to the emergency department via EMS today after calling 911 with acute shortness of breath and being found unresponsive and pulseless at home, subsequently requiring cardiopulmonary resuscitation on route to the ED. the patient has a past medical history significant for gout, which he takes indomethacin as needed, and recently went to another state in March. His significant other reports that COVID-19 infection went throughout the house in December, although he did test negative, they believe he had it due to his symptoms. He did have that Johnson and Johnson COVID-19 vaccination at the beginning of April of this year. Apparently the patient was speaking with the 1st responder right up until for minutes prior to EMS arrival and when fire department arrived on the scene the patient was found unresponsive, pulseless, and apneic, and subsequently they performed 1 round of CPR administering epinephrine and Narcan, when the patient regained a pulse. The patient lost a pulse again, requiring subsequent CPR and airway tube was placed. The patient arrived in the ED at 10:02 a.m., epinephrine was administered x7 rounds, patient was intubated with a 7.5 ET tube, Lucas device on patient, at 1053 the patient was awake, opening his eyes, squeezing nursing staff hand. At 10:59 a.m., nursing staff reported patient trying to pull his ET tube out. The patient received at least 1 hour 15 minutes CPR including time on scene, on route to ED, and in ED. At 11:10 a.m. patient's O2 saturation decreased to 79%, patient became diaphoretic with decreased responsiveness. At 11:13 a.m., cardiology was at the bedside. The patient's laboratory studies were significant for platelets 44, INR 1.2, CO2 16, AGAP 24, glucose 475, BUN 17, CR 1.55, ALT 248, AST 274, ALP 123, mg 2.9, lactate 15, troponin negative, 1st ABG: PH 7.11, pCO2 39.4, base excess -17, PO2 46, HC03 12.6, O2 saturation 100%. EKG showed right bundle-branch block with ST elevation in lead 3, V1, V2, V3, and V4 leads with ST depression in 1, aVL, and lead II. Limited stat bedside echo showed akinetic septum and hypokinetic right ventricle. The patient was taken to the cath lab. Dr. completed a pulmonary arteriogram and found bilateral massive emboli subsequently undergoing thrombectomy. Patient was on epinephrine, norepinephrine, IV fluids, heparin, and propofol. The patient was seen postprocedure in the intensive care unit while mechanically ventilated and sedated. The patient's sedation was stopped and the patient woke up, moved all extremities, and followed some commands. The patient's significant other was at the bedside. He is currently on norepinephrine at 20mcg/min, epinephrine 20mcg/min, heparin per PE protocol after receiving bolus in CCL, propofol 25mcg/kg/min, and IV NS fluids. The patient's wife reports that he has a history of chewing tobacco, but quit over 20 years ago. She believes that he has a family history of blood clots in his sister's and maybe his dad, but she is not completely sure about that. 6/8/21: 56-year-old man who called EMS with complaints of acute onset shortness breath, was found unresponsive, apneic and without a pulse on arrival of EMS. ACLS protocol was initiated, he was brought to the emergency department where CPR was continued with Lucas device. He was intubated, required administration of 7 rounds of epinephrine, a total of 1 arm 15 minutes of resuscitation was required prior to return of spontaneous CT circulation. Cardiology was emergently consulted, he was taken to the cath had last cath lab with only mild nonobstructive CAD noted. He then underwent pulmonary angiography with the finding of saddle pulmonary embolism as well as bilateral main pulmonary artery thrombosis. He underwent mechanical thrombectomy of the right and left main pulmonary trunk, right upper middle old and lower lobe pulmonary artery, left lower lobe pulmonary artery. Therapeutic anticoagulation was initiated with IV heparin then transition to oral Eliquis. He was treated with empiric antibiotic therapy for presumed aspiration pneumonia. Tunneled hemodialysis catheter was placed secondary to legal Rhea and acute kidney injury, renal replacement therapy was initiated with CRRT. Clinical response was favorable, he was subsequently extubated and transitioned to intermittent hemodialysis. He was assessed by Physical and Occupational therapy and recommended for acute rehabilitation placement. His been discharged today in stable medical condition to continue hemodialysis as scheduled per Nephrology at the acute rehabilitation unit.

I started to suffer from a numbness in my left hand that radiated into a deep pain and increasingly became intense. That pain radiated up to my shoulder and into the left quadrant of my chest. I started experiencing shortness of breath and a hypersensitivity to the heat. I went to Hospital ER and they ran a bunch of tests. I was diagnosed with a blood clot in my arm. I was given Eliquis. I was on that medication for about 2 weeks and after my second week of being on Eliquis, I started to suffer from the same symptoms. I decided to go to the Hospital. When I went there they admitted me and ran through blood tests to check for a heart attack or stroke or anything relating to the pain I was experiencing. Now I am back home and I am still taking Eliquis. As of today, I am still experiencing the symptoms. The symptoms are mild, but it's still scary. I would like to add that I have had an increase in dietary intolerance.

June 17-swelling of hands and arms, pain, tingling, burning sensations in arms and legs. Dizziness and fatigue.

PAIN OF THE LEG AND ARMS; WEAKNESS OF LEGS AND ARMS; DIZZINESS/ FEELING LIGHT HEADEDNESS; TINGLING AND NUMBNESS OF THE LEG AND ARMS; BREATHING DIFFICULTY; TINGLING AND NUMBNESS OF THE LEG AND ARMS; REDNESS OF THE RIGHT HAND; DVT, BLOOD CLOT, IN THE LEFT LEG; SWELLING OF THE RIGHT HAND AND LOWER PART OF THE ARM/ LEFT ARM SWOLLEN; This spontaneous report received from a patient concerned a 55-year-old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 207A21A expiry: unknown) dose was not reported, one total administered on right arm on 09-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-JUN-2021, the patient woke up in morning and experienced swollen right hand and the lower part of his arm. On the same day in the evening, nurse (from country jail) gave antibiotic due to redness and swelling of the right hand. On 18-JUN-2021, the patient experienced feeling light headedness, dizziness, continue to feel worse, breathing difficulty, weakness of legs and arms and continue to feel worse throughout the weekend. On 21-Jun-2021 on the afternoon, he took the last dose of antibiotic and noticed swelling went down. On the same day in the evening, he was taken to the hospital emergency room (ER) from the jail due to continued pain and tingling of the arms and legs, swelling, and blood pressure spike. Lab work was done, unable to finish the computer tomography (CT) scan of the chest due to left arm intravenous (IV) line blew out and dye went to the left arm. He was discharged back to the jail and left arm was swollen but was fine the next morning (22-JUN-2021). On 22-JUN-2021, he again returned to the hospital ER to get a chest CT scan but unable to perform the chest CT scan due to unable to get an IV line started. Laboratory work done from the night before resulted elevation of the d-dimer. Ultrasound performed on both legs and deep vein thrombosis (DVT), blood clot, was found on the left leg and no blood clot on the right leg. ER health care professional (HCP) prescribed blood thinner Xarelto (rivaroxaban 15mg) the first 3 weeks and fourth week started 20mg. (He was on his nineteenth dose at the time of reporting). After discharged from the ER on 22-JUN-2021, he was discharged from the county jail due to the current medical conditions. On same day at 17.47, he went to the local ER near home due to same symptoms, swelling and tingling of the arms and legs. ER HCP reviewed the medical records from the prison and agreed with the diagnosis of DVT from the above hospital ER visits. On 25-JUN-2021, he went to see his primary physician. HCP reviewed the medical records and verified the DVT on his left leg. HCP ordered the chest CT scan, ultrasound of both arms, and more blood work. On 27-JUN-2021, CT scan of chest resulted negative finding. On 01-JUL-2021, ultrasound of the arms resulted negative as well. On 09-JUL-2021, follow-up visit with primary physician, confirmed DVT and requested him to continue Xarelto for 3 months. He ordered the spine x-ray due to the pain and tingling of the arms and legs to find out the cause. Primary HCP follow-up appointment scheduled for 17-SEP-2021, Comprehensive Metabolic Panel (CMP), D-dimer test, ultrasound of the left leg due to DVT, B-12 test for the numbness and tingling of the legs and arms ordered to be completed prior to the follow-up appointment on 17-SEP-2021. HCP ordered X-ray of the spine. Tingling and numbness of the arms and legs are still severe at the time of report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness/ feeling light headedness on 25-JUN-2021, was recovering from breathing difficulty, and had not recovered from DVT, blood clot, in the left leg, swelling of the right hand and lower part of the arm/ left arm swollen, weakness of legs and arms, tingling and numbness of the leg and arms, tingling and numbness of the leg and arms, redness of the right hand, and pain of the leg and arms. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210725185-covid-19 vaccine ad26.cov2.s-DVT, Blood clot, in the left 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).

On May 25, 2021, I experienced sudden onset of shortness of breath. 911 was called and resuscitated me then transported me to medical center where I experienced several episodes of cardiac arrest and resuscitation. I was taken to the cardiac cath lab where it was discovered I had significant blood clots in all of my lung lobes (expect the left upper lobe). The doctors were able to remove the clots. I spent a week in the ICU sedated on a ventilator then moved to a medical floor for about 5 days, then moved to Inpatient Rehabilitation for a week. I am continuing to recover at home.

Headaches, migraines, and tired after vaccine for 2 weeks. 14th day after vaccine noticed some red spots on leg that looked similar to a heat rash and over the next 24 hours entire legs were covered in red dots and feet were almost solid purple. On the morning of 16th day constant nose bleed and multiple blood blisters in mouth inside cheeks and all over tongue. Blood was coming from mouth. At that point legs were covered in dark red almost purple and spreading to chest, back, and arms.

Presented with 2-3 weeks of fatigue and acute on chronic leg swelling (h/o chronic venous disease, phlebitis) 13 April; treated for dehydration and prescribed ASA. Tachycardia on exam, resolved with resuscitation. Asymptomatic 4 hours later, and expired overnight in his sleep. Found unresponsive in the morning, time of death 09:57.

DVT right lower extremity and pulmonary embolism: was hospitalized for 2days with a Heparin Drip and discharged home with Eliquis 10mg twice a day. Home meds discontinued: all BP meds, Ibuprofen, Tylenol, and Torodol. Follow up appointments with Dr. oncologist. Also had to cancel upcoming ventral hernia repair after having to wait 3 years due to complications with bowel obstructions and had to lose weight before surgery due to high risk. Now will have to wait longer until cleared medically, primary physician instructed me that it would be 6months or more before being cleared.

Patient received his J&J vaccine on 3/19/21 at at outside location. Patient was admitted to the hospital for acute urinary retention on 4/7/21 and had a catheter placed via cystoscopy. He was discharged on 4/8/21. On 4/14/21 he presented to the ED with chest pressure/palpitations/dizziness. He stated that he has had chest pressure for 1 week prior to the this. CT revealed a saddle pulmonary embolism. he was admitted to the hospital for further work-up and treatment.

Patient received their COVID vaccine on 4/7/21. Recently admitted for COVID (3/24/21 - 4/2/21) discharged on room air, doing well. Returned 4/17/2021 with acute onset and persistent right sided chest pain.

Less than 1 mo following injection pt developed DVT RLE. He presented with rt foot/ankle pain 3/29. The pain improved then around 4/10 he developed significant pain/swelling to rt calf. Venous US confirmed DVT. Pt started on Eliquis. Pt has h/o superficial thrombosis, not h/o DVT.

Went to the hospital with chest pain. They performed a catheter to check for blockages and instead found an extremely rare blood clot that ultimately caused a mild heart attack.

Patient started having leg cramping on 4/13/2021, presented to the emergency department on 4/18/2021 with increasing shortness of breath and chest pain.

Vaccine- Induced Thrombotic Thrombocytopenia Portal and hepatic vein thromboses Diabetic Ketoacidosis

After receiving COVID vaccine, patient reported Shortness of Breath, dizziness, loss of appetite, headache and chest pain. On 05/19/2021, patient exhibited right sided extremity weakness. Upon ED evaluation, was found to have suffered a TIA.

RIGHT MIDDLE AND BASILAR SEGMENTAL PULMONARY EMBOLISM; CHRONIC PULMONARY ARTERIAL HYPERTENSION; DILATED PULMONARY ARTERY; SMALL LEFT PLEURAL EFFUSION; PHLEGM; This spontaneous report received from a physician concerned a 56 year old male The patient's weight was 125 kilograms, and height was 175.2 centimeters. The patient's concurrent conditions included alcohol user, smoker, obstructive sleep apnea, asthma, tobacco abuse, high blood pressure, morbid obesity, and general pain, The patient had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-APR-2021 vaccination to left arm for prophylactic vaccination. Concomitant medications included salbutamol for asthma, acetylsalicylic acid for general pain, and atenolol for high blood pressure. It was reported that about 2 weeks ago in MAY-2021, the patient started to experience shortness of breath at rest and on exertion, pain in the left side of his chest, cough, and phlegm. The patient saw his family care provider who referred him to an orthopedic physician. The patient visited physician's office for treatment of the events. On 18-MAY-2021, the patient was hospitalized with a diagnosis of pulmonary embolism. The remarkable laboratory testing results were: D-dimer of 1,716 ng/mL, chest Computed tomography (CT) angiogram showed right middle and basilar segmental pulmonary embolism without evidence of heart strain, troponin of 103 was normal, chest X-ray showed chronic pulmonary arterial hypertension, dilated pulmonary artery, and small left pleural effusion. The patient's heart was fine, had no evidence of heart failure. The patient remained hospitalized currently treated with heparin drip, Lasix, and methylprednisolone. As of 19-MAY-2021, the patient remained hospitalized and was improving since a day prior to this report. The pain and shortness of breath were better. The patient never had this problem in the past. The reporter stated that vaccination was only identifiable change in the patient's normal routine/therapy. The patient also underwent imaging CT and echocardiogram without mention of specific results. Laboratory data included: Computed tomography (CT) scan (NR: not provided) Not Provided, and Echocardiogram (NR: not provided) Not Provided. Laboratory data included: COVID-19 virus test (NR: not provided) Negative, Computed tomography (CT) angiography (NR: not provided) pulmonary embolism without evidence of heart strain, Chest X-ray (NR: not provided) chronic pulmonary arterial hypertension, Fibrin D dimer (NR: not provided) 1, 716 ng/mL, Stress test (NR: not provided) Normal, and Troponin (NR: not provided) 103 normal. Treatment medications included: heparin, methylprednisolone, and furosemide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from right middle and basilar segmental pulmonary embolism, and the outcome of dilated pulmonary artery, small left pleural effusion, chronic pulmonary arterial hypertension and phlegm was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210537813-covid-19 vaccine ad26.cov2.s-right middle and basilar segmental pulmonary embolism, chronic pulmonary arterial hypertension, dilated pulmonary artery, small left pleural effusion. 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).

Fevers started on Wednesday evening, April 14th. Over the next three to four days, the fevers and chills continuously got worse. Patient experienced fatigue, congestion, headaches, sore throat, body aches, neck pain. Conducted a televisit on Sunday, April 18th, and then went into the doctor on Monday, April 19th. The day of the doctor appointment, the patient could not get out of bed and could not stand for longer than 15 minutes at a time before extreme fatigue set in. Blood tests were taken at the doctor, a Z-pack was prescribed. The evening of the 19th, the doctor called after hour to send patient to emergency room to be admitted to hospital. Patient went immediately to Medical Center at which point, the patient was admitted for the next 19 days. The patient was released from the hospital on Saturday, May 8th. While in the hospital, the patient saw almost every "category" of doctor possible. Patient experienced fevers every night for 15 days straight, and after release from the hospital and "fever free for 4-5 days, experienced fevers again for the next week. Doctors were unable for the first two and a half weeks of hospitalization to draw a conclusion about what was the cause of the sepsis (systemic). Patient received daily blood tests, MRIs, CAT scans, spinal tap, bone marrow biopsy, echocardiogram, etc. Patient spent the first two and a half weeks on an antibiotic, antifungal, and antiviral. The "final" diagnosis, which is still not confirmed, as histoplasmosis, which per the doctor would not have placed the patient in the hospital. Determined the fevers were officially "fevers of unknown origin" with a diagnosis of MIS-A and a vaccine contributing factor. Medication put patient in kidney failure and did not address the fevers (patient had fevers of 103+ for 25+ days in a row). On May 27th, doctors are conducing new fungal tests and patient is discontinuing antifungal medication because of severe liver damage. Patient was not and is not in a situation where histoplasmosis is a logical conclusion based on the patient's daily activities.

I received my shot and two days after I felt weak and sick. I fine for a few weeks and then I went outside to cut grass and all of my joints started to ache really bad. I came back inside and checked my temperature. I laid on my couch for a couple hours while running a high temp of 100.7. My eyes started to get really hot. I woke up at 12:30am and it was 90.7. I was checking my blood pressure and it was 110/64. I went to the doctor and it was discovered that I have pneumonia.

4/13 awoken at 6am with a sharp severe headache on the right side of the head. I had blurry vision the entire day and a little the next day. Since 4/13 I have had almost daily light headaches and light to moderate nausea. I had several doctors appointments after that who treated me for migraine. Since the symptoms persisted into June I was sent for an MRI on 6/1. I received a call on 6/2 stating that I had suffered a stroke. I followed up with an MRA on 6/9. I met physician on 6/10 and stated that there were no issues reported in the MRA, however they confirmed that I had suffered a stroke. I After presenting the physician information that the symptoms described in Jansen vaccine were similar to mine they ordered an MRA scheduled for today and blood tests also today.

MILD STROKE; This spontaneous report received from a patient concerned a 56 year old white, Hispanic or Latino 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: 1808609, expiry: unknown) dose was not reported, one total administered on 06-APR-2021 for prophylactic vaccination. Patient could not remembered which arm received the vaccine and thought it was upper right arm. No concomitant medications were reported. On 13-APR-2021, patient waked up with a very sharp headache pain on the right side of brain and had a blurry vision for entire day and much of next day. Since then until now patient still had a low and mild headache that comes and go and very mild nausea that comes and goes. On 01-JUN-2021, patient had an Magnetic resonance imaging (MRI) which showed result that patient had a mild stroke. On 09-JUN-2021, patient had an Magnetic resonance angiography (MRA) that revealed no plaque. Patient Stated that he had another MRV scheduled on day of reporting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from mild stroke. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210626713-COVID-19 VACCINE AD26.COV2.S-Mild Stroke. 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).

Stroke. Treated with the prescribed dosage of TPA. Hospitalization of24 hrs. Loss of right-side vision in both eyes at the onset. Resolved to a partial loss of right-side vision in the right eye.

Numbness in extremities, paralysis full body. Pneumonia left lung. Now diagnosed with Guillain-Barre syndrome, due to reaction to covid-19 vaccine

Patient started complaining of extreme back pain and trouble walking within days after receiving the vaccine. His pain got increasingly worse. On the 23rd he had to be taken into the hospital in an ambulance. He said he felt as if his lower body was separated from his torso, and visible was having trouble walking. They prescribed him Valium, preformed an x-ray, and sent him home. On the 27th he was taken back to the hospital due to leg weakness, tingling in his hands and feet, and extreme pain. He was diagnosed with Guillain-Barre Syndrome. He passed away April 6, 2021 after spending 11 days in the hospital, and 6 days on a ventilator.

Patient reports: 3/20/21 began experiencing tingling feeling in all four limbs at different times 3/28/21 experienced slurred speech 3/30 experienced what he describes as near blindness-was driving down road and all of a sudden most of visual field went black and could only see the white line of the road. Was close to hospital and was able to see enough to get himself to the hospital. Patient reports he was hospitalized at Hospital from 3/30/21-4/1/21 and was diagnosed as having a stoke

Received vaccine on 3/9/21. Started experiencing facial numbness , difficulty with speech and swallowing on 3/16/21 around 11pm. Had facial drooping of the mouth and eye on my left side of face. Went to Hospital ER around 5:30 am on 3/17/21 as symptoms did not subside. I was later placed in stroke observation unit. I had 2 MRI's, CT scan and Echo tests ran. i was diagnosed with TIA. All test were negative for a cause. I sent a total of about 26 hours hospitalized.

the day after the shot, started feeling unwell (approx 24 hours post shot). Slurring words, stumbling around and general unwell feeling with a fluttery feeling in chest. No previous heart issues of any kind. After it continued for an hour or so, I took him to the ER and it was discovered that he was in AFIB. 2 rounds of meds and tests, but stayed in that rhythm. They ended up doing a cardio version and it went back into normal sinus rhythm. Follow up with dr, placed on Eliquis, EKG, stress test and sleep study have found no other contributing factors atthis point.

Became short of breath a few days later, diagnosed with bilateral pulmonary embolism on 3/10/21 at Medical Center

Patient had a CVA, no left side movement. Unknown date of occurrence, discharged from hospital 4/15/2021. Patient works for DOT who held a clinic at their site. DOT HR Director informed us of this event. Unable to share much information.

Diagnosed with COVID infection on 4/13/2021. in ICU on 4/18 with severe hypoxemic respiratory failure

I received the vaccine on 3-12-21 and woke up 3-15-21 with pain in the bottom of my left foot. I scheduled an apt with my PCP on 3-16-21. My PCP scheduled an ultrasound on 3-24-21 where the nurse discovered blood clots in my lower left leg. I started taking Eloquis later that afternoon. I then had an apt with a blood dr. on 4-9-21 where she drew blood for tests. I was experiencing my heart racing and she scheduled me an apt with a cardiologist on 4-13-21 where the cardiologist suspected that the clots had moved into my lungs. The cardiologist did an EKG on the same day. I have a heart echo scheduled for 5-7-21. I am experiencing side effects from Eloquis so 4-19-21 I switched to Xeralto.

Patient received the COVID 19 vaccine on 4/2, he developed symptoms of COVID on 4/10, he tested positive for COVID on 4/13. He was admitted to the hospital on 4/17 for acute respiratory failure. On 4/20, he was diagnosed with a pulmonary embolus.

Blood clots, heart attack, died, cpr 5 times survived Blood is very thick blood thinners unable to thin

Two blood clots in right leg below the knee, calf pain, swelling of lower leg and foot, painful to walk

patient was fine until a week later when started getting dizzy and throwing up. taken to ER, but didn't tell them had been vaccinated. Couldn't find anything wrong and was sent home after a few days. Went to ER again and this time wife told them he had been vaccinated week before symptoms started. Did brain MRI and found a blood clot. Pt currently in rehab.

SLURRED SPEECH; TINGLING FEELING IN ALL FOUR LIMBS; STROKE; VISION DECREASED; This spontaneous report received from a patient via the VAERS (Vaccine Adverse Event Reporting System;) a 57 year old male. The patient's height, and weight were not reported. The patient's past medical history included history of CABG (Coronary artery bypass grafting), and concurrent conditions included diabetes mellitus, congestive heart failure, and diabetic retinopathy, and other pre-existing medical conditions included the patient had no known allergies to medications, food, or other products and did not had other illnesses at the time of vaccination and up to one month prior. The patient did not have an adverse event following any previous vaccination. The patient, at age of 57 years, received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 to left arm for prophylactic vaccination. Concomitant medications included insulin and insulin lispro for drug used for unknown indication. On 20-APR-2021, the patient began experiencing tingling feeling in all four limbs at different times. On 28-MAR-2021, patient experienced slurred speech. The patient experienced what he described as near blindness. The patient was driving down road and all of the sudden most of visual field went black and could only see the white lines of the road. The patient was close to hospital and was able to see enough to get himself to the hospital and was diagnosed as having a stroke. The patient had CT, MRI, and ultrasound of heart (results unspecified). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tingling feeling in all four limbs, slurred speech, vision decreased and stroke was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: 20210440193-covid-19 vaccine ad26.cov2.s-Stroke, Vision decreased, Tingling sensation in all four limbs, Slurred speech. 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: history of CABG, UNDERLYING DISEASE: congestive heart failure, and diabetic retinopathy

The evening of the shot I woke up with pain in my legs near my hips which lasted for a day. On 04/12/2021 my left leg was swollen and painful. I was already taking blood thinner. I went to the Emergency Room the next day and they found a blood clot in my leg. The Thrombosis was behind my left knee. My leg was swollen from the knee down and my ankle was very swollen. My Eliquis dosage has been increased from 2.5mg to 5mg twice daily. I did not have a repeat sonogram but my leg is no longer swollen.

Extreme muscle weakness in lower extremities. Currently using a walker when previously never had a gait issue. Developed Bell?s palsy. Weakness and at times severe pain in shoulders and arms. Tingling sensations in hands. Decreased feeling in legs and feet. These weaknesses are bilateral. Started with general feeling ?off? approx April 1, progressed to severe back pain April 13, visit to ER April 16 diagnosed with pneumonia sent home with antibiotics. Back to ER April 21 with severe back pain and beginning to have difficulty walking and weakness. Sent home with naproxen and muscle relaxers. Back to ER on April 24 fearing a stroke due to face droop. Admitted. Several tests run to R/O stroke,myasthenia gravis, lymes disease. Diagnosed with Bell?s palsy. Sent home on April 28. Still extremely weak. Using a walker. Still in pain. Sent back to ER per physician for another brain MRI on may 4. Not done due to argument between ER staff and physician who sent him in.

DIED; This spontaneous report received from company representative (via social media) concerned a 57 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: 206A21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. In APR-2021 (7 days after vaccination), the patient died due to unknown cause. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: v0;20210518573-covid-19 vaccine ad26.cov2-Died due to unknown cause. 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.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH

History of Present Illness: Patient has a history of sinus problems. He was schedule for sinuplasty and had preoperative evaluation on 04/21/2021 with WBC 5.8, Hb 15.5, PLT 193,000. He had J&J covid vaccination on 04/27/2021. He underwent sinuplasty on 05/05/2021. Subsequent to his surgery he was having headache. He had some nasal discharge with blood. He took tramadol but had persistent pain. His symptoms were worsening up with some weakness of his right upper extremity. Was having generalized fatigue and weakness. He states he was getting short of breath with a flight of stairs. He had decreased appetite. He was given Vicodin for his headache with some improvement. He noted discoloration and bruising with pain pain in his left internal thigh area. Was noticing some changes in his vision but no loss of vision. He presented to the ED on 05/11/2021 and laboratory showed WBC 8.7 Hb15.2, PLT 6,000, segs 77%, lymphs 9%. He had no dark colored urine. INR 1.4 PTT 33, immature platelets 30.2. His bili was 2.1. He was treated with dexamethasone 40 mg. There is tiny focus of restricted diffusion in the both cerebellar hemispheres measuring up to 0.4 cm white matter left cerebellar hemisphere of left parietal junction measuring 0.5 cm compatible small lacunar infarcts. Chronic paranasal sinusitis. Patient described minimal blood with flushing his sinuses. Patient was ultimately transferred to Hospital after 3 days (on 5/11) for further acute care management given the multiple clots and bleeds associated with severe thrombocytopenia.

5 days after dose had pain in left calf. On May 8th went to the hospital with pain under my left rib cage. It was determined by testing that I had a blood clot in left leg and one in each lung. There was also heart arrhythmia. I was given blood thinners for the clots which I am still taking. I was also given medication to help with high blood pressure and to help with heart beat.

Five weeks (05/16/2021) after receiving the Johnson and Johnson vaccine, my left leg just started feeling numb. I went into my kitchen and all of a sudden I started feeling dizzy. I lost all strength in my legs and in my left arm. I really couldn't move my arms or my legs and I felt really light headed. I had to have my 5 year old boys get me some water to drink. My son noticed that my heart was beating really strong and really fast. I saw water boiling over in the pot on the stove and I couldn't even get out of a chair to turn it off. I couldn't stand up. I finally managed to go back by my bed from the chair and slowly moved around. I tried holding my phone and it dropped out of my hands a couple of times because I couldn't hold it. A couple hours later, I felt a little better, but I had to fight to get around. We fell asleep and when I woke up, I still felt bad. I took my children to school and told them that I was going to the hospital to get checked out. At the hospital they performed multiple tests and they back showing I had stroke. I was treated for suffering from a stroke.

MILD ATRIAL FIBRILLATION; NUMEROUS PREMATURE VENTRICULAR CONTRACTIONS (PVCS); MILD HEADACHE; This spontaneous report received from a patient concerned a 57 year old white and not Hispanic or Latino male. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfa allergy, and dried onions allergy. The patient experienced drug allergy when treated with ibuprofen. 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, 1 total administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. Next day after getting vaccination (on 07-MAR-2021), the patient got a mild headache. On the same day around 10:30 pm, while sitting in a reclined position, he experienced palpitations in the neck. He put on his wife watch and it showed atrial fibrillation. Upon arriving to Emergency room (ER), he had mild atrial fibrillation and numerous premature ventricular contractions (PVCs). He was hospitalized for a few days. Various testing indicated no problems and was all fine. He was on 30 day monitor by his cardiologist. During that time, he continued to have premature ventricular contractions (PVCs) and 1 episode of atrial fibrillation. As of now (at the time of this report) he felt okay. Patient was waiting for insurance to cover testing inflammation of the heart. Last time he felt anything out of rhythm was 03-APR-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild atrial fibrillation, numerous premature ventricular contractions (pvcs), and mild headache. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210703427-covid-19 vaccine ad26.cov2.s-mild atrial fibrillation, numerous premature ventricular contractions (PVCs). 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 admitted with worsening numbness and weakness 2 weeks after vaccination; Neurology consulted and patient diagnosed with acute inflammatory demyelinating polyradiculoneuropathic form of Guillain-Barré syndrome and underwent plasmapharesis. Patient continued with progressive weakness difficulty with swallowing and choking on food as well as progressive loss of voice. Patient subsequently developed acute respiratory failure, transferred to critical care and was intubated.

dx:large cerebellar hemorrhage treatment: craniotomy, EVD outcome: poor, withdrawls from pain, CHF with EF 25-30%, Hospice consulted

Approximately 2 months after the vaccine the patient began to have pain in his right calf. No treatment at that time. About 2 weeks later the pain came back, an ultrasound was done and blood clots were seen. Zorelto was started however patient had a reaction to that of( lips swelling and nausea). At that time Eliquis was started at 5mg BID until current.

ADVERSE EVENT: ACUTE MYOCARDIAL INFARCTION TREATMENT: LEFT HEART CATHETERIZATION, CORONARY ARTERIOGRAPHY, LEFT VENTRICULAR ANGIOGRAPHY, PLACEMENT DRUG-ELUTING STENT IN MID LEFT ANTERIOR DESCENDING ARTERY. OUTCOME: DISCHARGED HOME WITH FOLLOW UP APPOINTMENTS WITH CARDIOLOGY AND PCP.

Patients power of attorney called to let us know patient had received Janssen vaccine on 3/12/21 and on 3/26/21 was hospitalized due to a clot and stroke. Patient had history of strokes in past.

4/4/2021 - feeling off, somewhat run down /// 4/5/2021 - feeling more run down /// 4/6/2021 - exhibiting sore throat and swollen glands throughout the day then at 5:45 was eating cocktail shrimp when I lost function and control of my right arm as well as a slight problem with my gait. As soon as the event took place my sore throat and swollen glands stopped immediately. My wife took me to the hospital where I was entered into stroke protocol. I was subjected to a series of tests including: EKG, ECHO, Platelet Cnt, Lipid Panel w direst LDL reflex, Hemoglobin, MRI Brain w/o contrast, CTA Stroke Alert (head/neck), CT Stroke Alert Brain, ECG, Basic Metabolic Panel, CBC, Protime - INR, APTT, Troponin I, Covid19, Influenz Influenza A/B, RSV PCR, and POCT GLUCOSE. I was kept for observation and determined I had suffered a small stroke. Released from the hospital 4/7/2021.

SOB/wheezing began 7 days after Janssen Covid vaccine. Patient found to have a PE and COPD exacerbation.

Received shot on 3/12. Starting having pain in chest on 3/22. Was diagnosed with blood clots in the lungs on 3/26 via blood test and CT scan.

pt developed symptoms on 4/19/2021 after receiving shot on 4/7/2021. Patient was admitted to hospital and discovered to have a clot in left leg. Patient is receiving Lovenox.

3/26 office appointment: New onset right and left sided chest pain with associated shortness of breath, fatigue and intermittent lightheadedness. Labs drawn. CT scan showed Scattered small occlusive and nonocclusive emboli within small distal pulmonary artery branches bilaterally. Started on apixaban. Has appointment with Hematology on 4/29

Patient flew from city to city through another city on Tuesday 3/16/21. He had a reaction on the flight where he coughed for 1.5 hrs and was hot in the airplane. He could not go to work and was required to get Covid tested on 3/18. Still coughing and having trouble sleeping (laying down). Rapid Covid test negative on 3/18. PCR test results negative on 3/21 from hospital. He continued to grow weak and cough from 3/16-3/21. At 3am on 3/22 he called and said that his feet were 2X their size and having difficulty breathing. Taken to hospital via ambulance. When transfered to ER bed, Dr said that he lost pulse. They intubated and got his pulse back. Died at 5:15am. Autopsy said cardiac arrest. Dr said that they could not maintain a heart beat. He asked me if the patient had a history of blood clots? No he did not ever has a blood clot that I know of. He had a chest xray post mortem showing fluid in his lungs from low circulation of blood.

BLOOD CLOT IN UPPER THIGH; NO PULSE FROM KNEE DOWN ON RIGHT LEG; RINGING AND BUZZING IN EARS; PURPLE TOE; COULD NOT MOVE; FEELING CRAPPY; TIRED; NAUSEOUS; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included Barrett's esophagus, and controlled high blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular batch number: 1805031, and expiry: unknown) dose was not reported, 1 total administered in left arm on 24-MAR-2021 for prophylactic vaccination. Concomitant medications included Nexium (esomeprazole sodium) for Barrett's esophagus, and lisinopril for high blood pressure. On 25-MAR-2021, the day after the vaccination, patient felt crappy and could not move, had tiredness and nauseous. After 10 to 12 days of vaccination on an unspecified date in APR-2021, the patient had ringing and buzzing in ears, pain in the bottom of feet on walking, and purple discoloration to front of the right toe. The patient had visited health care professional (HCP). The patient had undergone some tests and HCP identified no pulse from the knee down on his right leg and a blood clot in upper thigh. The patient had experienced pins and needles and buzzing on his leg. He has also has a ringing and a buzzing in his ears and the bottom of his feet hurt when he walked on them. The patient was scheduled for an appointment with cardiovascular surgeon on 28-APR-2021, prior to the visit the patient has to tested negative for COVID. The patient went to take test on 23-APR-2021 and results not yet received. Laboratory data included: Peripheral pulse absent (NR: not provided) no pulse from the knee down on right leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling crappy, tired, nauseous, no pulse from knee down on right leg, blood clot in upper thigh, ringing and buzzing in ears and could not move was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to.This spontaneous report received from a patient concerned a 58 year old male.; Sender's Comments: V0: This 58-year-old male patient was found to have blood clot in upper thigh with no pulse from the knee down 10 to 12 days after receiving COVID-19 VACCINE AD26.COV2.S for the prevention of symptomatic SARS-CoV-2 virus infection. Concurrent conditions include Barret's esophagus and "controlled" high blood pressure; concomitant medications includes Nexium and lisinopril. The symptoms reported were ringing and buzzing in ears, pain in the bottom of feet on walking, pins and needles and buzzing on his leg, and purple discoloration to front of the right toe that prompted consult with HCP, who advised the patient that there was no pulse from the knee down on his right leg and a blood clot in upper thigh. Prior COVID test was negative. No other details reported. The information available precludes a complete and meaningful assessment. However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded. Additional information was requested.

BLOOD CLOTS IN LUNGS; NUMBNESS IN HANDS AND FEET; SWELLING IN HANDS AND FEET; This spontaneous report received from a patient concerned a 58 year old white male. Initial information was processed along with the additional information received on 11-MAY-2021 The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no history of blood clots. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 207A21A expiry: UNKNOWN) dose was not reported, 1 total administered to right deltoid on 09-APR-2021 around 13:00 for prophylactic vaccination. No concomitant medications were reported. After receiving the vaccination on 09-APR-2021, the patient went home and slept for 6 hours. One week after vaccination, on 12-APR-2021 the patient experienced swelling in hands and feet. Two weeks after, on 19-APR-2021 the patient experienced numbness in hands and feet. On 21-APR-2021, the patient went to the emergency room (ER) and was given the tests, laboratory data included: Blood test (NR: not provided) unknown, CAT scan (NR: not provided) blood clots in lungs, and EKG (NR: not provided) unknown. The patient experienced blood clots in lungs and was hospitalized. On 22-APR-2021, laboratory data included: Sonogram (NR: not provided) results awaiting and will get records on wednesday. As of 22-APR-2021 the patient was started on blood thinner. Treatment medications included: apixaban (Eliquis) 2 a day. On an unspecified date in APR-2021 while in the hospital the patient was on oxygen (unspecified indication). The patient was discharged on 22-APR-2021 and the duration of hospitalization was 1 day. The patient was released with a prescription of Eliquis for 3 months. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling in hands and feet, numbness in hands and feet, and blood clots in lungs. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210518013 -COVID-19 VACCINE AD26.COV2.S- Blood Clots in lungs . 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 admitted to hospital on 05/13/2021 with bilateral pulmonary emboli with cor pulmonale. He received the Johnson and Johnson Covid 19 vaccination on 04/09/2021 thirty four days earlier.

Johnson and Johnson Vaccine, shortness of breath, elevated blood pressure, elevated temperature, increased heart rate, decreased kidney functions, blood clots in both arms and jugular vein, slurred speech, severe pain in right side, fluid in right lung and around heart. Admitted to MICU from emergency room. Intubated for 12 days. Chest tubes both sides, central line, Hickman Catheter. Discharged and admitted to hospital. Currently home receiving outpatient therapy.

Since covid vaccination I developed A-Fib. My family practice Dr as well as the cardiologist I recently saw both believe that there could be a link between the Johnson & Johnson vaccine and possible inflammation that could be causing me to be having A-Fib.

BLOOD CLOT IN LUNG; BILATERAL FEET AND HAND NUMB; BILATERAL HANDS AND LEGS SWOLLEN; SLEPT FOR 6 HOURS AFTER SHOT; TIRED; This spontaneous report received from a patient concerned a 58 year old male. The patient's weight was 285 pounds, and height was 56 inches. The patient's concurrent conditions included high blood pressure, depression, diabetes, flea bites allergy, peanut allergy, alcohol consumer, non smoker, heart disorder, nerve pain, mood disorder, fluid retention and pain. He had no known drug allergies. He did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 23-JUN-2021) dose was not reported, 1 in total administered to right deltoid on 09-APR-2021 for prophylactic vaccination. Concomitant medications included hydralazine 25mg BID (twice a day) for blood pressure, metformin hydrochloride 500mg BID for diabetes, Baby Aspirin (acetylsalicylic acid) EC (enteric coated) for heart disorder, escitalopram 10mg daily for mood disorder, gabapentin 100mg TID for nerve pain, and celecoxib 200mg 1 tablet a day as needed for pain. olmesartan medoxomil 40mg daily for blood pressure, amlodipine besilate 10mg daily for blood pressure, furosemide 40mg daily for fluid retention, potassium chloride ER (extended release) 20 Meq TID (thrice a day) and metoprolol succinate ER 50mg daily for an unknown indication. On the same day vaccination, the patient slept for 6 hours after shot and was tired. On 16-APR-2021, the patient experienced bilateral hands and legs swollen. On 19-APR-2021, the patient had bilateral feet and hands numb. On 21-APR-2021, he went to the emergency room (ER) and was hospitalized. He had following test done. Covid-19 test and EKG (electrocardiogram) results not provided, sonagram of legs showed no blood clots, computerized tomography (CAT) scan found blood clots in lungs. He was put on IV fluids and oxygen. He had blood clots in lungs, he could not specify if both lungs had it. He was discharged the next day without oxygen. He was put on Eliquis (apixaban) 5mg BID for 3 months. He was hospitalized for a day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slept for 6 hours after shot, and tired on 09-APR-2021, had not recovered from bilateral hands and legs swollen, and bilateral feet and hand numb, and the outcome of blood clot in lung was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210554313- COVID-19 VACCINE AD26.COV2.S- blood clot in lung, bilateral hands and legs swollen and bilateral feet and hand numb. 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).

My husband died of ?heart Attack? on April 17, 2021 Had an enlarge hearth and rupture in the Aortic Artery

Injection recieved 4/10/21, a-fib started 5/16/21. Admitted to hospital 6/19/21 with sepsis syndrome in the mechanical cardiac valve, leukipenia, thrombocytopenia, encephalopaty, acute kidney injury, respiratory failure, tachycardia, new onset afib. Patient is currently still hospitalized and declining in status- on ventalator

Stroke, treated at hospital with blood thinners. Outcomes - 85% within a year. Patient has memory and speech issues. Facial paralysis on right side.

(4/19) Began experiencing discomfort in right side (bottom of rib cage) when getting in/out of bed; no other symptoms. (4/30) Rapid fever onset with chills from 98.6 to 102.7 within four (4) hours; increased pain in right side; . Seen at urgent care: blood pressure normal; elevated heart rate (130); sub-normal SpO2; urinalysis negative; chest x-ray negative; COVID test negative. Referred to ER. (4/30) ER: increased pain; no coughing or symptoms beyond extreme chills/fever; two additional COVID tests negative; extremely high white cell count (25K), CT showed small pneumonia on right side. Treated with multiple antibiotics and released. (5/1-5/7) Continued elevated (99-100F) fever; occassional lethargy; no coughing or other symptoms. (5/8) Temperature normal; occassional lethargy; no coughing; increased pain on right side at night. ( through 7/10) increasing pain on right side; present constantly but worse at night; radiates front to back on right side below rib cage; no other symptoms. (5/12,6/23,7/1) Follow-up visits with PCP; additional chest x-ray negative; CT scheduled for 7/14.

"Chills and aches" the day and evening of the shot. After a couple of weeks, Pt began to experience various pains at different points of his body. He developed severe indigestion resulting in him visiting his physician on April 19th where he was put on a 7-day steroid regimen. One week later, early on Monday morning, April 26, 2021, Pt collapsed in his bathroom at home, was unresponsive, and pronounced dead by the paramedics who responded.

Bells Palsey 02May2021 Low grade fever and fatigue 12May2021 Breathing issues started 14May2021 Covid 19 Positive Test 15May2021 Covid related pneumonia 19May21 Hospital admitted 19May2021 to 24May2021 Tingling in fingers and toes started 30Jun2021 to present.

Leg pain 24 hours later, fever pneumonia, congestive cardiac failure, dialysis access dysfunction, post vaccine fever, hyperkalemia, anemia, vomiting, weakness, hypoxia, hypervolemia; Pt rcvd J & J and next day seen in ER with leg pain, N, V, diarrhea and shortness of breath. Mult stool antigens neg. Lactic acid and WBC elevated. Initial fever resolved as did hyperkalemia and hypervolemia state after urgent dialysis.

COVID-19 RELATED PNEUMONIA; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; ASTHMA AGITATED; BURNING SENSATION IN FINGERS; TINGLING OF FINGERS AND TOES; BELL'S PALSY; This spontaneous report received from a 58-year-old male patient. The patient's height and weight were not reported. The patient's concurrent conditions included high cholesterol, high triglycerides, mold allergy, alcohol use (6 to 8 beers in the weekend) and asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: 07-AUG-2021) dose was not reported, 1 total, administered on 08-APR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On 02-MAY-2021, the patient started experiencing bell's palsy. His mouth was dropping on the left side and he didn't have any feeling or nerve feeling on that area of mouth. His eyes and rest of the body was fine. He visited the physician. On an unspecified date in MAY-2021, Laboratory data included: CT scan result was Negative and Blood test was Negative. Patient was given a Steroid shot as treatment and it resolved. On 12-MAY-2021, he experienced low grade fever, fatigue and kind of illness. On 15-May-2021, he visited hospital with breathing problem and coughing. In the hospital patient was tested positive for covid-19 (suspected clinical vaccination failure). The chest X-ray showed that the lungs were clear. On 19-MAY-2021, he again had trouble breathing and was unable to breathe despite trying hard and was hospitalized for 5 days. Patient had another X-ray and was diagnosed with a COVID-19 related Pneumonia. He was put on Remdesivir and oxygen as treatment. Laboratory data included: Oxygen saturation was around 80. After 3 and half days, he was able to breathe on his own and was taken off oxygen. On an unspecified date in MAY-2021, while at hospital, patient experienced asthma agitated and was prescribed prednisone also. On 24-MAY-2021, he was discharged from hospital for 5 days. Non-company suspect drugs included: tyrosine (form of admin, route of admin, and batch number were not reported) dose and frequency were not reported from JUN-2021 for mental alertness. Since 29-JUN-2021, he experienced tingling in his fingers and toes. He reported that the physician had put him on D-Tyrosine for last one month and has experienced the event since then. On 08-JUL-2021, he stopped the supplement as the physician had asked him to stop but still have the event and symptoms were getting worse. On JUL-2021, he experienced burning sensation in fingers. He stated that it was not all the finger and toes in general but noticed more issue on the left side than the right side. The left side was worse for the toes but for the fingers issue progressed from right index to his left hand. At the time of reporting, He had tingling and burning sensation in both hands and was continuing and not getting any better. Physician was aware but did not prescribe him any medication. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bell's palsy, suspected covid-19 infection, covid-19 related pneumonia and asthma agitated, had not recovered from tingling of fingers and toes, and burning sensation in fingers, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This case is associated with product quality complaint (PQC) number 90000185884. The suspected product quality complaint had been confirmed to be not voided.; Sender's Comments: V0: 20210727746-covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure.. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS V0: 20210727746-covid-19 vaccine ad26.cov2.s-Bell's palsy, Covid 19 pneumonia. 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: 20210727746-covid-19 vaccine ad26.cov2.s-Asthma aggravated. 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

Pt received dose of J&J vaccine (Janssen) on 3/13/2021. Symptoms began around 3/27 similar to COVID-19. Pt presented to ED at another local hospital 3/29/2021, tested positive for COVID-19 and was transferred to be admitted to our hospital for treatment of COVID-19. Notes from hospital admission H&P: Patient is a 59 y.o. male with history DM, Who presented to Urgent care then hospital ER with covid positive, PNA, Fever and a cough. Real tachycardic there to 117, temp to 103, confused, moving slow. Altered mental status (slow cognition), 94% on 2L"

PATIENT CALLED Hospital 04-13-21 AND REPORTED HE HAD A STROKE 2 DAYS AFTER VACCINATION AND WENT TO another HOSPITAL. HE VERBALLY STATES IS HAVING PHYSICAL THERAPY FOR THIS STROKE. ENCOURGAED PATIENT TO SELF REPORT THIS EVENT. PATIETN WAS CALLING Due to THE TV NEWS NOTIFICATION OF THE J&J VACCINE PLACED ON HOLD DUE to IT CAUSING STROKES AND BLOOD CLOTS. PATIENT NOR DID HOSPITAL NOTIFY original HOSPITAL ON THIS PATIENT STROKE EVENT.

Mother called health department today, 4/14/21, to report reactions son experienced after receiving vaccine 3/4/21. She stated that on 3/6/21 he started having headaches, weakness and leg cramps. He went to the hospital two times with complaints. On 3/15/21 he was unable to walk/drive because headaches were severe. On 3/30/21 he passed out, squad was called. He was not responsive and was put on a vent at the hospital. A "scan" showed blood clots in brain and heart. This individual passed away on 4/4/21.

Patient presented 5 days after vaccine administration with a lacunar stroke. He had numbness in his right face and right hand which he woke up with on day 5.

Patient received J & J vaccine on 3/12/21. PCP states patient was admitted 4/21/21 with Pulmonary Embolism

10 days after the vaccine my perfectly healthy husband began developing terrible back pain and abdominal numbness, went to the ER, had a brain bleed and was daignosed with Guillain-Barre Syndrome. He has been in the hospital for a week. He is not being released yet.

o 2-Apr-21, developed fever, chills, nausea, and diarrhea which he was managing at home. o 5-Apr-21 performed a PCR swab at Hospital and received positive results on 6-Apr-21. o 8-Apr-21 developed difficulty breathing and notified his Mgmt. who called for an ambulance. He was transported to Hospital and later to Hospital. o SOB on exertion. Receiving vitamins, P and antibiotics. O2 via face mask. Stable condition was the report provided to his wife from Hospital. o 14-Apr-21 condition deteriorated and he was intubated and placed on the ventilator o 15-Apr-21 was transferred to Hospital

This is a 59 year old male that presented to the emergency department at approximately 1447 on 04/27/2021 with sudden onset of left upper and lower extremity weakness and left-sided numbness of his face. The patient stated he may have had some weakness the previous night (04/26/2021), but mostly noticed it when he woke up around 0900 on 04/27/2021. The patient stated he may have also had some transient speech changes which he felt were improved upon emergency department presentation. The patient stated he took an 81 mg aspirin prior to hospital arrival. The patient was overall hemodynamically stable in the emergency department. Past medical history is only significant for benign prostatic hyperplasia. This patient has no history of previous CVA or TIA, no smoking history, no history of clotting disorders, no recent trauma or other injury. CT head revealed a small right frontal subarachnoid hemorrhage with no midline shift and concern for clot. CTA head and neck perfusion study was significant for ?perfusion abnormality involving the right frontal lobe in the region of known subarachnoid hemorrhage, likely related to dural venous sinus thrombosis involving the posterior aspect of the superior sagittal sinus, left greater than right transverse sinus, and left sigmoid sinus.? This patient is noted to have recently received his Johnson and Johnson vaccine on 03/20/2021. The patient was admitted to the intensive care unit. Neurology and hematology were consulted.

Pt. called his daughter on Sunday April 18 and told her was not feeling well and said it was from the effects of the (one shot) COVID-19 vaccine. You would have to contact her directly for more information. He was found dead in his room by the manager around 5 pm on April 22nd. Manager told me his body was cold to the touch so she thought he may have passed the previus day on April 21st. Daughter todl me earlier today that a doctor is running some tests to try to determine the cause of death. You would need to contact her for the doctors name. My own inpression is that the emphysema was not severe enough to have d=caused his death as he could walk up to half a mile.

a severe pain in my left leg inside thigh. A bright red dot was there. My arch of my foot was burning and then the burning moved up my shin. Pain is not continuous, but moves to my calf and back to my thigh. I had a ultra sound done, my doctor told me I have a blood clot and put me on Eliquise on 4-21-21.

No symptoms other than just a mild injection site pain. Didn't last long. On 5th of April I began to get: I had rigors (shaking, chills), sweats at night 3 or 4 times of night changes of bedding, acute Prostatitis and pain upon urination and pain from prostrate itself. fever spike as high as 102.2 and my blood cultures were positive for Staphauereus in my blood stream. Sepsis diagnosis. I was admitted to hospital on 7th April of Hospital I had a fever of 102. My prostate was enlarged to 131 grams and I was having difficulty urinating. The infection was Staphaureus Staphlicottis. I was initially treated at a walk-in clinic and they did a direct admit to the hospital for UT .and I stayed there for 7 days. They installed a PICC line for IV upper arm to vena cava up into my heart. I still have that in - for intravenous home infusions of antibiotic. Peripheral Inserted central Catheter. Up until Sunday, May 16, of this past week, I had extreme fatigue to the point of not being able to walk a normal amount for me - maybe 1/3 of the amount. I haven't been able to get back to my regular exercise. I was having headaches and brain fog and a lot of aches and pains throughout the body up until Sunday. Since then I have felt quite a bit better.

Client was seen by his doctor on April 13th related to severe headaches . He stated that he had headaches prevaccine and was given Tropromax for it which he only took for 2 days as it caused him dizziness. He had CT scan of Head and MRIs on April 13 and 14th and then again on April 27th. The scan on April 27th showd a blood clot with 80% blockage in carotid artery and was dxd with a blood clot via CT scan. . He was told to get to Hospital where he was admitted to ICU for 4 days Client was also dxd with Factor5 Leiden at that time. Per client he ha a stroke and is recovering. Per client still unable to work r/t poor balance and dizziness

patient seen in clinic 5/26 for severe head ache, chest pain, diaphoresis, subjective fever and chills, SOB. Transferred to ER elevated troponin, transferred to other Hospital where he underwent cardiac cath and diagnosed with NSTEMI.

Patients wife stated he was found dead on floor the morning of 6/1/21 and exact time of death was unknown. It sounded like cause was unknown.