Johnson & Johnson

Roughly a week following vaccination he cut his hand and was unable to stop the bleeding. 2 days later he developed mucosal lesions inside his mouth which began to bleed without resolution. He also cut himself shaving with prolonged bleeding. Following this event his rehabilitation center performed a CBC and he was found to be profoundly thrombocytopenic with platelets of 7. He presented to hospital where he was transfused with platelets which did not resolve his thrombocytopenia. He was transfused 2 more units with immediate CBC followup which did not improve his platelets; this was very suggestive of a consumptive process. Hematology was consulted and per their recommendations steroids were started. After initiation of systemic IV medrol platelet count began to rise. Per our hematology team, most likely culprit is the COVID vaccine. Patient had no medication changes, had been stable in his chronic conditions, and had never had any autoimmune or thrombocytopenic event before this time.

Deceased complained of abdominal pain and was taking aspirin for a headache. He died within less than a day of initial complaints.

Initial sore and very tired 03/31 then April 3 developed fever body ache Covid like symptoms fatigue body ache fever headache slight cough flu like symptoms extremely tired requiring sleep. Unable to go to work. Bed rest. April 5 went to urgent care for Covid test- negative chest xray referred to hospital for CT confirmed pneumonia My treatment is two different types of antibiotics. 1. Azithromycin for 5 day and Amoxicillin 3000mg per day for 10 days

3/31/2021: 6-7 HOURS S/P VACCINATION: HEADACHE, FEVER, COLD CHILLS, SWEATING, AND DRY HEAVES 3/31/2021-4/1/2021: UP AND DOWN ALL NIGHT, DIARRHEA, BODY ACHES, STOMACH ACHE, HEADACHE, DRY HEAVES 4/1/2021-4/4/2021: ABOVE SYMPTOMS CONTINUED . 4/4/2021: STARTED HAVING CHEST PAIN AND WENT TO MEDICAL CENTER - ER . WAS ADMITTED TO HOSPITAL FOR TREATMENT OF A-FIB. 4/8/2021: DEVELOPED A RASH ON BACK.

Patient began experiencing back pain on March 14 and on or around March 18 he started coughing up blood clots according to a coworker. Patient lived alone and was unable to be reached on Sunday March 21. I went over to his house and found him deceased in his bed. Patient had a trashcan beside his bed and it appeared to have some blood in it. Patient had thick mucus coming out of his mouth and blood coming out of his nose. According to paramedics he had passed a few hours before finding him. Unfortunately Patient has been cremated so there is no way to say that this was related to the Covid 19 shot from Johnson and Johnson, however there are new reports that blood clots have been a side effect. I would like to speak with someone from the Department of Health to discuss this further. I feel this could be related to the vaccination and I would to know how long the Health Department knew about this possible side effect. If patient would have known sooner that the blood clots were a side effect I feel he would have gone to the Emergency Room. Patient had no health insurance and he was trying to prevent getting Covid. This has caused our family so much heartache and we are all very apprehensive about getting the Covid Vaccine ourselves. Please contact me as soon as possible, I am also patient's executor so I am able to speak to you on behalf of patient and our family. Thank you.

60 year old male died unexpectedly at home, found 04/11/2021. Last known contact was by phone with his brother on 04/10/2021. Cause of death was determined to be MI due to ASCVD due to tobacco dependence, cigarettes. Autopsy was not requested. This medical examiner was later contacted by the daughter of the decedent to report that he had received the Johnson & Johnson COVID vaccine on 04/08/2021, 2-3 days prior to his death.

I have severe swelling in both legs from knee to my feet, severe itching and hives, legs have blistered and burst open. I also have a Blood clot in my lower left leg. Have tried 2 kinds of antibiotics, I am on Xarelto 10 mg tab for the blood clot

STROKE; This spontaneous report received from a consumer concerned a 60 year old white, Not Hispanic or Latino male. The patient's height, and weight were not reported. The patient's past medical history included epileptic seizures when seeing flashing lights, he had no prior history of stroke or any surgery, and concurrent conditions included high blood pressure, and type 2 diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) dose was not reported, administered, on 16-MAR-2021 around 10:30 in the morning for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 25-MAR-2021, the patient had stroke. The reporter did not know what kind of stroke the patient had. He was not found immediately when he had the stroke and when patient arrived at the hospital he was paralyzed on the left side and was put on the feeding tube and ventilator and moved to hospice after 8 days. On 09-APR-2021, the patient died from stroke. 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, Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210428085-COVID-19 VACCINE AD26.COV2.S -Stroke. 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, UNDERLYING DISEASE.; Reported Cause(s) of Death: Stroke

I'm reporting just in case others had a mini stroke after receiving this Johnson and Johnson shot, doctors at hospital say they have seen it causing Big strokes but not mini strokes but if J&J shots causes big strokes it can also cause mini strokes I believe, A stroke is a stroke. My husband is a healthy 60 year old with no real heath issues. all his test in hospital showed no reason for his stroke and they did them all...?..but test did show he had a stroke His arm and leg went numb at about 8 pm Friday at home so I took him to hospital and test showed he had a spot on his brain saying it was a stroke, they kept him 2 days running test and they found no reason he had a stroke but he did and I believe it was caused by the COVID-19 vaccine shot from Johnson and Jonson

PULMONARY EMBOLISM; CHEST PAIN; This spontaneous report received from a patient via a company representative via the local news, concerned a 60 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) at an unspecified dose on 06-MAR-2021 for prophylactic vaccination. The anatomical vaccination site was not reported. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On 01-APR-2021, 26 days after vaccination, the patient went to hospital due to chest pain. On 08-APR-2021, 33 days after vaccination, the patient was diagnosed with pulmonary embolism, and was hospitalized. The patient reported he suffered a blood clot after receiving the vaccine and was diagnosed with a pulmonary emboli. On 11-APR-2021, the patient was discharged. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pulmonary embolism and chest pain was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: A 60-year-old man experienced chest pain 26 days after vaccine and was hospitalized with pulmonary emboli 33 days after vaccine. Medical history and concomitant medications were not reported. The latency of greater than 3 weeks makes this unlikely related to vaccine. There is insufficient information to make a meaningful medical assessment. Additional information has been requested, including contacting the news station that reported the event.

The patient developed thrombotic thrombocytopenic purpura (TTP), a week after the Janssen vaccine (Started having symptoms on March 15, 2021- speech difficulty, petechiae, fatigue, and easy bruising). TTP was confirmed by ADAMTS13 level < 5% and the presence of inhibitor on March 19, 2021. In addition, he had schistocytes, thrombocytopenia, and elevated lactate dehydrogenase. He was treated with PLEX, steroids, and Rituximab. He is currently closely monitored at Clinic.

Medical team dispatched to the residence of the the name person on April 10, 2021 at 2327. Pt assessed by medic on scene and determine patient with obvious death. Pt found halfway on the couch and to be pulseless, apneic, and with rigor mortis. Unknown down time and when further assessed, patient death determine by EMS. pt had fixed and dilated pupils, non-responsive to painful stimuli, absent breath sounds, no heart sounds auscultated. Pt was also placed on the monitor and found to be in asystole in 2 contiguous leads. CPR with held and no resuscitative measures performed.

HEART ATTACK; This spontaneous report (social media) received from a patient via a company representative concerned a 60 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: not reported batch number: Unknown) dose was not reported, 1 total administered, 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 took vaccine and at night patient experienced heart attack and died due to heart attack. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to; Sender's Comments: V0-Covid-19 vaccine ad26.cov2.s -Heart attack. 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: HEART ATTACK

on April 2nd patient woke up at around 4:30 am and complained of pain in his back. I rubbed his back and he wondered if it was just something he ate. He then tried to calm down and got back into bed . He was holding my hand when suddenly his hand felt cold. I turned on the light to find his eyes rolled back and he was gasping his last breath . This was about 5:20 AM . Patient was a healthy active man.

60 yo male with BMI 30 and vodka x 2-3 bottles per day. In hospital 4/9-14 for obstructive uropathy of undetermined origin. In hospital on 4/12 and got J & J there. 4/13 with no prior history developed a DVT. D/C'd on 4/14 on Eliquis. Found unresponsive 4/19. At autopsy, found pulmonary thromboemboli

5/4 : Resident with PICC line following course of IV ABX for osteomylitis. Resident was administered Jassen vaccine at 1100am. Resident had PICC line and PIV removed at aprox 1700. He was followed up by nursing staff at 2000 at which time he complained of swelling, redness, and heat to the PICC site. On-call provider was notified and ordered transportation to Emergency Department for evaluation. Facility was notified of passing at 0200 on 5/5

Three weeks after the vaccine my ankles were swelled up. I gained 30 pounds over the course of fourteen days. I was having trouble breathing. I was admitted to the hospital and diagnosed with Atrial Fibrillation and Congestive Heart Failure. I also had water in my lungs. I have not had any heart symptoms before that. I tested positive for Covid-19 antibodies in June of 2020. I had multiple tests on every organ. There were no clogged arteries and no heart problems except for AFIB. My blood pressure is fine but I am taking half a blood pressure pill. I am trying to lose weight. I am scheduled to see a cardiologist on 05/25/2021

Patient had SOB, upper chest and back pain, diagnosed with small pulmonary embolism in right upper lung

Patient had a stroke on June 4. Developed unusual headache evening of June 3. Went to see doctor on June 4 . Bp remained elevated even after taking bp medicine . Doctors office sent him to ER. First it was said he had a aneurysm in heart which was ruled out . Then it was advised to us he had a brain stem stroke . Patient still in icu. Still in hospital as of today .06/16/2021. Patient will be going to pt therapy snd of therapy . Has dysphagia unable to eat and left side weakness . Peg tube inserted . Want to establish if Johnson and Johnson vaccination was linked to him having stroke . Patient current illness was maintained and under control until this event happened suddenly .

Began feeling like trying to catch a cold. Tired, tight chest, muscles sore. Symptoms continued for a couple weeks then a deep pain in side started. Could not stand the side pain and went to ER. Scan showed enlarged cardiac silhouette. Further tests showed fluid completely surrounding heart with inflammation in duodenum. Was taking into surgery to have fluid from heart sac drained then a drain put in.

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

My brother died 8 days after the vaccine due to a blood clot in his heart. Death Certificate indicates blood clot in heart.

COVID 19 Death - 7/17/2021 - Admitted to ICU from ED with symptoms of shortness of breath, productive cough, diarrhea, and chills. Started 1 week ago. COVID19 PCR positive while in ED. Diagnosed with COVID19 Pneumonia. Expired later on same day 7/17/2021.

Developed 3 small blood clots in his left lower leg on Saturday, 3/10/2021 - swelling and slight redness along with pain

Patient arrived at vaccine clinic SOB and acutely decompensated around the time of vaccination. He was found to be in acute respiratory distress with a pulse of 62%. EMS called and pt was transported to the hospital. He has found to be in acute CHF and hypertensive urgency. Initial BP 249/138 He was given IV lasix, IV lopressor and started on oxygen. He was admitted to the Facility on BIPAP. Over the course of the next 2 days he had good diuresis and able to be weaned off oxygen.

Immunization was administered at 1pm, and patient started to go into anaphylaxis at 10:00pm. He swelled up, and had trouble breathing. He received epinephrine, steroids and breathing treatments in the ER.

Janssen COVID-19 Vaccine EUA. One day after vaccine, patient reports onset right sided weakness (face, upper and lower extremities). Found to have stroke on brain imaging: L inferior M2 branch occlusion.

Patient was admitted on 4/9 to hospital with left facial, upper and lower extremity numbness that last 5 min and resolved. In ED had similar symptoms. CT head, MRI brain, MRA head and neck unremarkable. Hgb 6.6 and Plt 13. Transferred to Medical Center on 4/10 for more care. Diagnosed with TIA and possible TTP (ADAMTS13 pending, meets other criteria). Started on high dose methylprednisolone 1000 mg IV x 3 doses on 4/11, plasmapheresis on 4/11, and weekly rituximab on 4/11. Status/outcomes pending

PT STATED HE WENT TO THE CLINIC AND THEN THE ER WITH A BUMP ON THE BACK OF HIS LEG. PT WAS TOLD IT WAS A BLOOD CLOT.

shortness of breath, foot swelling, chills, body aches, dry mouth, fatigue, wheezing, eye burning sensation, joint pain, Blood clots in lungs, prescribed Xarelto

Swelling in right leg following workout. Became painful as day went on. Swelling, pain continued. After three days, visited doctor.

Within 24 hours pain in left side of left chest, in 48 hours pain on full left side of chest, within 72 hours pain through entire chest. Hospitalized within 72 hours, chest pains, catheterized within 120 hours, had a blood clotting issue, put into medically induced coma for three and a half days, followed by a pulmonary embolism and four (4) clogs, two (2) in either leg, within two weeks. Hospitalized twice, currently on three blood thinners, a beta blocker, pepcid, a statin, and one other. Expected to be on three blood thinners for at least three (3), most likely six (6) months. Start cardiac rehab on 5/19/21. Have chronic cough and chest discomfort. Expected recovery time: six (6) months.

Patient was vaccinated on 3/31/21. Noted to be positive for Covid on 4/19/21 and passed away on 5/8/21. Per the lab report, this is the information for the ordering provider: He had an emergency contact but no number. Phone number for patient is no longer operational.

Patient had onset of right calf pain and swelling several hours after receiving vaccine. Was seen on 5/10 and diagnosed with right lower extremity DVT.

pt received Johnson and Johnson vaccine on 5/21/2021, PT had been complaining of shortness of breath since getting the vaccine yesterday and today, pt collapsed at home, wife started CPR, EMS continued compessions and ACLS protocol when they arrived to ED he was in Vfib, After multiple shocks, Epinephrine, bicarb, lidocaine and multiple other life saving medications were administered to no avail, pt expired on 5/21/2021 at 1729

MINI STROKE IN LEFT ARM, HAS LEFT ARM WITHOUT STRENGTH, NO MUSCLE CONTROL OF 3 LEFT HAND/LEFT SIDE FINGERS. ARM/WRIST JERK UNCONTROLLABLY. DR. VISIT 8 DAYS AFTER STROKE. LAB TESTS DONE. PRESCRIBED atorvastatin 40 MG 1 PILL AT NIGHT. URGENT CARE VISIT 5/18/21 LEFT HAND AND FINGERS UNCONTROLLABLE, HAND HAD SEVERE SWELLING. PREDNISONE PRESCRIBED

Patient presented in the office on 5/12 complaining of edema. The edema involves the left lower extremity. Onset was gradual 2 month(s) ago. Onset followed starting a new medication (around J and J vaccine). The symptoms occur intermittently. The patient describes this as unchanged. Symptoms are exacerbated by prolonged standing. Symptoms are relieved by leg elevation. Associated symptoms include calf pain (in upper thigh) and calf swelling, while associated symptoms do not include dyspnea, decreased urinary output, ascites, diarrhea, localized redness, localized warmth or fever. No chest pain

Patient received vaccine on Thursday evening. He began to feel very tired Monday and Tuesday. Wednesday he woke up in alot of abdominal pain. We went to healthcare facility at 4:30pm. He was diagnosed with Acute Pancreatitis. He was sent home at 10:30pm We went back to ED at 1:30 am Thursday. He was admitted during the day. In the early morning of Friday May 28th his blood pressure tanked and he became unresponsive. His heart stopped and they did compressions for 8-9 minutes. He was put into ICU. By 3am we were told he may not survive. By 5 am we were told his organs were shutting down. He passed around 7:45am. In researching the vaccine we discovered the SARS virus used in vaccine can attack the pancreas. We believe he died as a result of the reaction to the vaccine and his body and organs could not fight.

Admitted with c/o generalized weakness and significant pain to BLE s/p J and J vaccination. Neurology diagnosed pt with Guillain-Barre syndrome and is s/p IVIG and steroids'. Pt improved with IVIG and steroids'. Of note pt. states he has been to the hospital multiple times with these symptoms and told he had rhabdomyolysis 2/2 statin use therefore it was d/c on prior evaluations and he was d/c home. Further evaluation showed pt has Guillain-Barre syndrome.

Death 5/21/2021 Causes of death listed on death certificate 1) COVID-19 2) ARDS Other: Lung Transplant for cystic fibrosis

Flu symptoms 12 hours after the vaccination that lasted for another 12 hours. Fatigue the rest of the week. Intermittent fatigue for the next few weeks. On 5-11-2021 another bout of flu like symptoms that lasted 2 days. Started having severe back spasms randomly for the next 2 1/2 weeks. On 5-30-2021 the back spasms became so severe and painful I was rushed to the ER. The first diagnosis I received was a Plural Effusion caused by a bacterial infection that later turned into Pneumonia, requiring a chest tube in my right lung, and a 10 day hospital stay. Before I was hospitalized I had no fever, no cough, no shortness of breath.

Respiratory Failure related to positive covid test. PCR positive on 07/01/2021 and PCR positive 07/07/2021. Patient placed on BIPAP due to hypoxia in ER and admitted. Remdesivir and decadron administed as inpatient. unknown exposure date admitted 07/07/2021

Patient received J&J COVID-19 vaccine on 3/26/21. Due to breakthrough infection, he was hospitalized from 7/9 to 7/12/21. Patient with sepsis presumed from COVID-19 infection. Blood culture negative at time of admission. Patient was weaned off O2 and did not receive steroids. Received empiric vancomycin and cefepime.

Six days after receiving Janssen vaccine at approximately 4:00 pm, left hand experienced numbness. As the evening wore on, weakness spread through the left side of body and speech began slurring. The next day, after no improvement, went to hospital to find from CT scan that he had suffered a stroke. He had no precursors that would lead to being prone to strokes.

Appx 3 hours post-injection, developed Acute STEMI, Proximal LAD lesion, and had aspiration thrombectomy and drug eluding stent placement.

Pt reported to Urgent Care with paralysis and numbness on his left side. Left-sided neck pain radiating into the top of the shoulder.

The patient had a ventricular fibrillation cardiac arrest on 4/12/21. He has new complete heart block requiring transvenous pacing and myoclonic jerks. The latter are likely a result of hypoxic brain injury.

Per patient's sister, Patient was administered the Janssen/Johnson & Johnson COVID-19 vaccination on 3/23/21, then on 4/3/21 he was hospitalized for a brain bleed and has been hospitalized in the ICU ever since.

Patient was diagnosed with a DVT. Also had symptoms of nausea and vomiting which preceded the vaccine.

PATIENT CALLED AND STATED THAT HE HAD A HEART ATTACK ON 3/14/21. (TEN DAYS AFTER THE VACCINATION) HE STATES THAT HE CALLED THE DEPARTMENT OF HEALTH AND WAS TOLD TO CONTACT THE LOCATION WHERE HE RECEIVED THE VACCINATION.

Patient presented with with on going shortness of breath. Patient was swabbed and diagnosed with COVID-19. CT of the chest shows that the patient had bilateral pulmonary emboli. Patient is currently being treated at our hospital for COVID-19 and PE

Experienced a TIA (Transient Ischemic Attack - mini stroke) approximately 40 hours after receiving vaccination.

Patient started with Left lower leg pain and redness on 4.1.21. Went to Emergency dept on 4.4.21 and diagnosis of Left leg cellulitis and prescribed Doxycycline. Patient came to PCP office on 4.6.21 with worsening left lower leg pain and swelling. Order L lower leg doppler. Diagnosis of L lower leg deep vein thrombosis of tibial vein on 4.7.21 and prescribed Apixaban 5mg 2 BID x 7 days on 4.7.21

Received the vaccine approximately 12:22 PM on Saturday, April 10, 2021. At approximately 6:55 pm that same day (Saturday, April 10, 2021) my husband collapsed in our living room. I called 911 and the operator talked me through how to do chest compression CPR on my husband until the paramedics arrived. My husband was then taken by ambulance to hospital where doctor performed an emergency procedure wherein he removed the blood clot in one of my husband's stints (he has three) that he had put in in 2017. Doctor was able to eventually stabilize my husband's heart. My husband spent 5 days in the hospital as a result of this.

Left leg pain started about 4/16/21. Reports evaluated by nurse practitioner at the medical office of primary care provider on 4/23/21. Ultrasound ordered a hospital and diagnosed with a blood clot in the left leg on 4/23/2021. Placed on a "blood thinner" to take orally BID for one month then once daily for undetermined duration. States MD is not considering the vaccination as the reason for the blood clot because of the duration of time between when the vaccine was given and the onset of the blood clot. When asked, pt reports a platelet count was done.

Johnson and Johnson COVID Vaccine use for COVID-19 under Emergency Use Authorization (EUA): Patient admitted to hospital for myocardial infarction one week following the J & J COVID-19 Vaccination. required emergent PCI with drug-eluting stent for occluded left anterior descending coronary artery. Patient subsequently developed congestive heart failure and a left ventricular thrombus requiring long term anticoagulation therapy.

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

Flu-like symptoms chills fever up and down shortness of breath itchy skin dry cough shaky hands restless urinating frequently urination blood clotting in calves

His brother reporting that he got the vaccine, the following day he was coughing. The coughing caused him not to be able to sleep and was weak due to that. He could feel his throat closing and he was having a hard time breathing and he called his brother who told him to call 9-1-1. He was taken to Medical Center 4/17/2021, diagnosed with possibly COVID. He was admitted to the COVID ward and he died on 4/26/2021. The doctor that pronounced him was . Cause of death diagnosis. Hypoxic respiratory arrest, COVID 19

Janssen COVID-19 Vaccine EUA. Severe headache in the night of Vaccine followed by vomiting. Sleepiness and disorientation the next two days. Hospital ER and discovery of bleeding in the brain and admission to the NICU

Temporary partial blindness in the left eye. Event lasted 1 minute. One quarter of the top portion of sight in my left eye was blocked by what appeared to be a dark curtain, this went away after 1 minute. Had an exam by eye doctor the same day , no eye problems were found. Had an exam by cardiologist the following day. He prescribed a imaging order for a head scan and prescribed Clopidogrel 75 mg and to monitor a fib for 30n days with Apple Watch.

I started to get a weird feeling in my chest a week after the vaccine. It was a burning sensation and I thought it was vaping at first. It started to get worse and worse. A week later I went to the ER and they ran some tests. After testing it was confirmed that I was having a heart attack. I had blot clot in my OM1discovered on 04/07/2021. I had had an angiogram in 2019 and there were no problems then. I was hospitalized for four days and I was given a Stent which ended up getting a blood clot. The original Stent was removed and a larger one was put in. I am now taking some blood thinners, Aspirin, Atorvastatin, Carvedilol 6mg, Prasugrel 10mg, and I am scheduled to see a cardiologist because I still a have a little chest pain.

CARDIAC ARREST (SEVER CHEST PAIN); CLOGGED VEIN; LEFT ARM GOES TO SLEEP; This spontaneous report received from a patient concerned a 62 year old white male. The patient's past medical history included blood clot, heart attack, lump in leg, and stents in main arteries, and concurrent conditions included heavy smoker, and heart issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808025, expiry: UNKNOWN) dose was not reported, 1 total administered on 12-MAR-2021 to left arm as prophylactic vaccination. The patient was previously treated with clopidogrel bisulfate for blood clot. On an unspecified date in 2021, Laboratory data included: Echocardiogram (NR: not provided) unknown, and Lab test (full workup)(NR: not provided) unknown. On an unspecified date in Mar-2021, a week later vaccination, the patient experienced that left arm went to sleep which felt worse next day, on 25-APR-2021, patient experienced severe pain in chest, called ambulance and was taken to hospital. On same day patient was hospitalized. Patient went to full cardiac arrest twice same day. It was stated that vein that was 60 percent good earlier was 100 percent clogged (clogged vein) in one month after getting the vaccine. They tried to put stent in, clear vein out, and put piece of metal and expanded it, to make alley way for blood flow. Patient stated that patient would not take Plavix this time. According to patient, stent was reacting with Plavix, and decided to take something different. They did same job twice. It was stated that patient was discharged on 05-May-2021 from hospital. On 12-MAY-2021, patient went to consult the health care professional to make sure everything was okay. The patient gave lot number 1808025, then stated that, patient thinks it is 180, and then either 5 or 8, and next it was either D or 0, and then after the space it is 25. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cardiac arrest (sever chest pain), left arm goes to sleep and clogged vein was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210523134-COVID-19 VACCINE AD26.COV2.S-CARDIAC ARREST (SEVERE CHEST PAIN), CLOGGED VEIN. 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

The patient received the vaccine, but uses the other pharmacy in town for his medications. The pharmacist called me to relay the info he got from the patient's family. He said that the patient had a headache and body aches on Saturday 05/22/2021 and went to bed but did not wake up the next morning.

Excruciating Inflammation, blood clots, pains in joints and muscles, and burning nerve sensations in legs/feet and slight numbing in hands.

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

Death - coroner's report received on 7/15/2021. Coroner Dr performed an autopsy and determined the cause of death as brochopneumonia. Heart disease and drug use also contributed to his death. The manner of death is natural.

pt was at his normal baseline of health the Monday of vaccine. Per sister, he had a fever of 104F, chills and myalgias hte following Saturday. he was not heard from on Sunday therefore on Monday his sister did a forced entry and found him on the ground.

Janssen shot on Mar 12, 2021. On Mar 25,2021 at 10 AM, I woke up with a headache, sore joints, nausea. Also blurry vision and inability to read words on a page. Sensing something wrong, my sister drove me to emergency room at Hospital where I was admitted. I was later told I suffered a stroke. I was in the hospital for 5 days, receiving various tests. (Hospital has all info on record). I am awaiting surgery to remove blockage from carotid artery. Doctor has all my information and should be reporting the event also to VAERS.

started coughing on 03/27/2021 and was taking to hospital on 03/30/2021. There he was treated for blood clots with anticoagulants and a filter placed in the vena cava.

He had his vaccine in different state while visiting his daughter. Returned home and was found to have a blood clot behind his left knee. Also, he called the doctor last week and told him that he believes he has another one above the left ankle. He has an appointment on Thursday to see him again. He had two venous ablation procedure in both legs in late November/December of 2020. He was taken off of the baby aspirin and then put on Xarelto. The 2nd possible blood clot appeared about 10 days ago above the left ankle.

Patient reports that several hours after receiving the vaccine that he became short of breath, he was taken to the hospital via ems, Diagnosed with blood clots at hospital. Reports he is now on blood thinners. I spoke with the patient and told him I would be reporting this information and that he may be contacted.

5 hours after had mild stroke like effects to include blurred vision followed by headache. 5 days after had muscle and joint aches in the night which are continuing.

PATIENT DEVELOPED RIGHT POPLITEAL DVT IN LEG AFTER JANSSEN/JOHNSON AND JOHNSON VACCINATION. PRESENTED TO MEDICAL GROUP 2 WEEKS AFTER VACCINATION WITH A 2 WEEK HISTORY OF LEG PAIN AND WAS DIAGNOSED AT THAT TIME. HE RECEIVED JOHNSON AND JOHNSON VACCINE AT MEDICAL CENTER.

Patient had severe pain in one leg since 03/14/2021 Went to the emergency room on 03/21/2021 where he was notified that he had a clot in his lung. It caused a bilateral pulmonary embolism.

Found seizing approximately 48 hours after vaccine. It was confirmed that he had a stroke on 3/12/21.

Patient presented to the ER with chest pain, non radiating, heavy weight. Patient was found to have acute DVT.

AE = PE/DVT. Difficult to say if vaccine played an ancillary role (very short time course). Treatment = anticoagulation with apixaban. Outcome = patient discharged from hospital in good condition after 2 days.

Employee developed a fever and chills on 01-Apr-21 which he managed with Tylenol. Symptoms resolved as per patient who contributed the symptoms as a result of the J&J vaccine. On 10-Apr-21 he developed a cough and requested a day to rest. On 11-Apr-21, he went to Hospital to be evaluated by the physician who ordered some labs which were normal. He was then advised to complete PCR swab and was notified on 12-Apri-21 that his test is positive. As per the protocol, all COVID-19 positive individuals must report to the Health Center within 24 hours of notification and complete 10 days home isolation. During isolation, on 17-Apr-21, patient developed hemoptysis and difficulty breathing a breathing and notified his supervisor who called 112 for an ambulance. He was transferred to Hospital. Evaluated and started treatment for pneumonia and was transferred to Hospital on 18-Apr-21. His condition started declining on 21-Apr-21 as he became hypoxic and tachypneic and was subsequently sedated and intubated. As he became HD unstable, Levophed and Vasopressin were started and reached maxed doses. On 25-Apr-21 Dr. from the hospital called and stated that patient expired at 0830.

On Jan. 26, 2021, I had an accident at home an suffered broken ankle, tibia and fibula broken from tarsus. I was rushed to hospital and had ORIF surgery. I later found out the surgeons failed to order blood thinners and about a month later, I was rushed to the hospital with 5 blood clots, one in each lobe or each lung and one forming in the calf muscle on the left leg. I have been taking Eliquis since late February and will be on it through May. I have had an echocardiogram which was normal but the doppler I had on my legs may have indicated the problem is still on-going. I don't know yet. I did contract JCCT to ask if I should get checked out due to recent clotting incidents and was told I did not. I decided I should report it anyway and my clotting situation probably has nothing to do with vaccine but I just want to make sure.

Patient received Johnson Johnson COVID vaccination on March 5th (Its not listed as an option for me to choose - Hence Janssen). Two weeks later patient and wife described symptoms of significant abdominal pain and headache, which improved after 24 hours, since then, abdominal pain on and off with worsening, nausea vomiting and diarrhea. Presented to Hospital with sepsis, negative evaluation, possibly GI etiology, given symptoms. MRI of the abdomen shows left portal vein thrombosis/which is an unusual site. Patient has no liver cirrhosis or metastatic cancer. Is being investigated for idiopathic or acquired thrombophilia

UNKNOWN CAUSE OF DEATH; ELEVATED HEART RATE; HYPER RESPIRATIONS; FLU LIKE SYMPTOMS; MENTAL CONFUSION; WEAKNESS WORSENED; This spontaneous report received from a consumer concerned a 63 year old male. The patient's height and weight were not reported. The patient's pre-existing medical conditions included the patient did not had medical and underlying condition and was healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 041A21A, expiry: Unknown) frequency one total, dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The patient was not taking any concomitant medications. On 03-APR-2021, the patient experienced elevated heart rate, hyper respiration, flu like symptoms including chills, weakness, fatigue, cough; the patient also had mental confusion and nausea. He was called in urgent care centre and they treated him with over the counter medications, Tylenol (paracetamol). On 16-APR-2021, the patient died due unknown cause. The daughter stated that she was taking him to emergency room the day he passed away. It was unknown if the autopsy was performed. The cause of death was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of unknown cause on 16-APR-2021, had not recovered from mental confusion, and the outcome of weakness worsened, elevated heart rate, hyper respirations and flu like symptoms was not reported. This report was serious (Death).; Sender's Comments: 20210439259-COVID-19 VACCINE AD26.COV2.S -Unknown Cause Of Death. 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

Developed Covid 19 infection 28 days after Johnson and Johnson vaccination. This was further complicated by bilateral pulmonary embolism requiring mechanical thrombectomy and ICU admission.

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

LOC with cardiac arrest within 15 minutes of injection. CPR started and patient did recover on his own. EMS transported to ED.

Combine a status asthmatic event lasting with a serious sinus and chest cold as well as occasional racing heart. That is how I felt. It felt like sudden pneumonia and chronic bronchitis onset. The second day was very serious in the third day and the fourth day I started to regain strength. I received an antibiotic on day 2 after my vaccine. I went from my normal daily activities to bedrest for 3 1/2 days straight. I called out sick from work because of it. I'm glad I was well versed with my chronic illnesses because it helped me handle the adverse event that started after receiving my vaccine. I feel that if I was a normal person I would have gone to the hospital.

Patient reported back to the pharmacy 1 week after his covid vaccination to inform us that he suffered a stroke shortly after receiving the vaccine. He is currently released but still recovering.

Please see ER physician note below. Patient later expired at 1337 on June 12th. One day after receiving the COVID vaccine. ER physician note: Patient presents completely unresponsive, CPR in progress Patient's wife reports that this afternoon, they were lying in bed and he leaned over to her and said "help me". He then became unresponsive. She reports that she believed he may have aspirated because he has an issue with his esophagus where he is unable to adequately swallow food sometimes. The family began CPR at home, and reports that EMS arrived approximately 10 minutes later. Patient arrived here at the ED around 1250. CPR continued. Patient given multiple rounds of epi and bicarb. Patient intubated with an 8 at 21 cm with some cold liquid around the tube. He was intubated at arrival.

Patient's wife stated he has been suffering from blood clots and is currently being treated with anticoagulants.

Patient had autoimmune appearing reaction with rash, iridocyclitis, DVT right femoral vein, thrombocytopenia, lymphadenopathy, aphthous ulcers, pharynigitis rheaumatology consultation, anticoagulation, ophthalmology care, hematology consultation, ENT consultation

Patient received vaccine on 3/13, initially had fatigue and myalgia the day after, which resolved, but also on 3/14 began having mild intermittent coughing, nonproductive, occurring every two hours or less. Patient began having some blood in his sputum since this morning at 4AM, and that occurred twice more with intervals of a few hours, both continuously improving and less blood. No other symptoms. No history of TB, no exposure to sick contacts, no recent travel. Unlikely a pulmonary embolus given normal vital signs and no risk factors. Patient was doing outdoor work in his yard for the past few days before the symptom onset and was working on mulch and compost. Although unlikely to have fungal infection currently, may be bacterial pneumonia

I was being treated for severe mitral stenosis prior to vaccination. The day of vaccination my condition significantly worsened and I was readmitted to hospital. Diagnosed with AFib. I had been AFib negative since a valve replacement two years prior in conjunction with MAZE procedure.

Symptoms: numbness/tingling and cold skin all over body (both sides of body), headache, facial droop, blurry vision. Stoke, CVA.

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

Blood clots in both lungs. Admitted to the hospital with severe pain in chest, trouble breathing, within 5 days of vaccination. Put on blood thinners to help get rid of the clots. Extreme fatigue before admittance to the hospital as well as ongoing extreme fatigue.

HOSPITAL COURSE: Patient is a 64 y.o. man admitted on 4/8/2021 with hx of HTN, HLD, tobacco use, Hypothyroidism, and OSA who presented with acute right facial droop in setting of 8 days of headaches and paresthesias, found to have acute ischemic stroke. New slurred speech and worsening of facial droop 4/9 AM, but no new findings on repeat MRI. .

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

Patient's wife notified our corporate office on 4/15/21 that her husband received a J&J COVID vaccine from our pharmacy on 3/23/2021 and that he passed away one week later, 3/30/2021, in their yard after having a heart attack. Phone number provided is the wife's.

03/24/21, patient hotel , patient fainted , tried to revive by family , ems was called , patient underwent surgery , patient did not survive surgery , death certificate was for acute infarction and dyslipidemia , patient passed

Patient awoke 04/09/2021 with visual disturbance and limited field of vision. Went to eye center and was evaluated. MD at eye center sent him to ER and told patient that it appeared he was having a stroke. Admitted to medical center 04/09/2021. Patient reports he was diagnosed with a stroke affecting the occipital region that affects his vision. Patient was discharged from the hospital 04/11/2021.

tested covid-19 positive on 4/3/21 resulting in bilateral pneumonia. patient was discharged home after improvement

6 days after receiving the Covid19 J&J vaccine I had sustained arrhythmia of 142bpm for 2 hours & received emergency intervention at the Hospital and 1 night observation. They were able to cardiovert me with abimondiron drip. 17 days later my heart started racing again & I received 2 consecutive shocks from my internal defibrillator and was transported to the hospital and stayed 1 night for observation. 22 days after receiving the above vaccine, I again developed a ventricular tachycardia rhythm & received 2 consecutive shocks and was transported to the hospital and stayed 2 nights. I do have a history of v-tach but prior to being vaccinated it had been two years without any incident of VTach or therapy.

Patient developed life threatening thromboembolism ( PEs) which potentially could have been caused by the Janssen vaccine

4/8/21 pt had brain fog like he was in a haze and felt strange being very relaxed like he had taken a tranquillizer he felt better next day. pt seemed to be fine at this point. 4/22/21 pt seemed to be fine and went to the store where he went shopping. He put shopping bags in car. He was found in his car after and hour and 20 minutes by a couple of bystanders unresponsive. 911 was called and he transported to ER. He was intubated but patient died. Unknown is any test were performed.

Patient received Janssen vaccine on 4/12 and developed left arm pain a few days later. Presented to the ED with left arm swelling 10 days after vaccination and was found to have a left upper extremity DVT.

4/25/2021 - He was apparently well until 2 days prior to admission when he developed spontaneous left calf pain and swelling. He denies any associated trauma, recent travel and immobility. He is not taking any new prescription, including steroids. One day prior to admission, he started experiencing left-sided pleuritic chest pain up to 9/10 in intensity and exertional shortness of breath. He denies any fevers, hemoptysis, sputum production, diaphoresis, nausea, vomiting, abdominal pain, dizziness or lightheadedness. The pain was persistent throughout the day. Today, his chest pain persisted and his shortness of breath had progressed. He also noted left arm swelling with mild discomfort. He felt that his left leg swelling and pain had improved today. Nevertheless, given persistent symptoms, he decided to come to the emergency room for further evaluation management. In the emergency room, his initial blood pressure was 218/104 with mild tachycardia of 99, normal oxygen saturation and no fevers. CBC showed a white count of 12.35, hematocrit of 50.4 and normal platelet count 198. INR was normal at 1.06. BMP showed mild hyperglycemia at 148. Troponin was 5 and BNP was 8. Imaging studies show extensive left upper extremity DVTs that involved the left subclavian vein, left lower extremity DVTs and bilateral lower lobe pulmonary emboli. 4/30/2021 Presumed unprovoked extensive DVT of the left upper extremity and left lower extremity. However, he did recently receive Johnson & Johnson Covid vaccine. Now status post catheter directed thrombolysis to the left upper extremity.

On 4/26/21 The patient presents to our clinic with concerns for back pain, fever, shortness of breath, fatigue and coughing. We performed a covid19 antigen test which resulted positive. Based on this and his history and examination we recommended he go straight to the hospital for further evaluation and treatment. He was admitted to medical center where a PCR was performed and confirmed positive. He was discharged on 4/29. Per his wife, they felt he was discharged too soon and he went to another hospital. He passed away 5/10/2021. This report is being made in regards to the claim by the CDC that "no one that has been infected with covid19 4 weeks after having the janssen vaccine has been hospitalized." This patient was not only hospitalized but passed away.

BLOOD CLOTS BOTH LEGS; POSSIBLE HEARTBURN; SWELLING AT INJECTION SITE; This spontaneous report received from a patient concerned a 64 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: 1805022, and expiry: UNKNOWN) dose was not reported, frequency 1 total, administered on 16-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the patient experienced swelling at injection site. On 19-APR-2021, patient had blood clots (1 in each leg), Hematologist put him on xarelto 10mg, in hospital for few days for blood clots. Patient initially went to hospital ER on 19-APR-2021 because he thought having chest pains or heartburn. Emergency Room ran tests and heart was normal, but found blood clots in his both legs. Lab test (NR: not provided) Heart normal. Treatment medications (dates unspecified) included: rivaroxaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from thought having chest pains/heartburn on 22-APR-2021, had not recovered from blood clots both legs, and the outcome of swelling at injection site was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210504455-COVID-19 VACCINE AD26.COV2.S-Blood clot both legs. 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).

Patient developed acute coronary syndrome, ST-elevation myocardial infarction, and ventricular fibrillation cardiac arrest on April 9, 2021. He had no prior history of coronary artery disease.

Patient admitted to hospital 5/15/2021 with acute toxic encephalopathy due to disseminated varicella zoster virus and acute hypercapneic respiratory failure. Patient remains hospitalized as of date of this report. Encephalopathy is resolving and patient has been extubated but remains on 4 liters of oxygen via nasal canula.

He received vaccine on 3/10 and on 3/12 was admitted to hospital with a brain bleed. his INR was 10 However he had INR done 3/2/21 and it was 2.5. Dr not sure if related to vaccine or not He underwent surgery on 3/13 and was in hospital 43 days

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

Patient had Janssen COVID-19 vaccine on 5/8/21. Developed calf tightness, pain, and swelling 5/13/21. Sought medical care 5/20/21. Diagnosed with DVT 5/20/21

On 6/7/21 I noticed my right lower leg was swollen. On 6/9/21 I went to my PCP and she sent me to get an ultrasound. The Ultrasound showed a large DVT and I was sent to emergency room. In emergency room a Cat scan of my chest was completed and showed several pulmonary embolism. I was admitted overnight and started on Eliquis. I was told to follow up with my PCP.

15 min. after receiving vaccine in left arm, felt tingling in left hand. Two weeks later left arm went completely numb, temporary loss of fine motor control, ok after a couple days. About a week later arm went numb with an icy cold prickly feeling. Lasted about a week, with a little residual numbness still present. About May 1st, also noticed swelling of left ankle. During the month of June had pain behind knee and continual pain and stiffness in left leg. End of June left leg became noticeable swollen. Went to Urgent Care on June 30, 2021. Sent for ultrasound, found four blood clots (DVT's) in left leg (3 upper thigh and one behind left knee). Sent to ER, started on Eliquis, will follow-up with primary care next week. No history of blood clots before, and I am quite active.

patient developed right lower extremity DVT diagnosed ultrasound 7/20/21. He started with acute pain right leg Saturday 7/17 and woke up on Sunday 7/18/21 with swelling right upper thigh and bruising and swelling of right foot. His swelling and pain increased and was seen urgent care where he was referred to emergency room for evaluation DVT.

patient reported having joint pains about 3 or so weeks after the vaccine then was found to have DVT 4 months later.

HEAVY FEELING ON HIS BOTH ARMS; CONFIRMED CLINICAL VACCINATION FAILURE; SUSPECTED COVID 19 (TEST UNSPECIFIED); This spontaneous report received from a consumer concerned a 64 year old male. The patient's height, and weight were not reported. The patient's past medical history included heart valve replacement last year, and concurrent conditions included allergic reaction to anesthesia, non-alcohol user, and non-smoker, and other pre-existing medical conditions included patient did not have drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: 21-JUN-2021) dose was not reported, 1 total administered to left arm (deltoid) on 21-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-JUL-2021 (last Sunday) patient started to develop dry cough towards the end of the day. On 19-JUL-2021 (Monday) patient started to experience weakness, heavy feeling on his both arms, fever with a temperature between 99-100 degree Fahrenheit, achiness all over the body, chills, headache and nausea. Patient decided to visit to the hospital. Patient undergone a series of blood test, flu test, pneumonia and Covid-19 test. On 23-JUL-2021, patient clinically tested positive of COVID-19 [Suspected covid-19 (test unspecified) and confirmed clinical vaccination failure]. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid 19 (test unspecified), and heavy feeling on his both arms, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000187127.; Sender's Comments: V0: 20210753055:Covid-19 Vaccine Ad26.Cov2.S: Confirmed 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

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

On Tuesday March 16 started having difficulty breathing went to ER. Blood Clots in both lungs. Was admitted and was treated in hospital until Friday March 19.

I spoke to patient by phone on Saturday morning around 9:20am. He was concerned about the fatigue, nausea, headache, chills, and muscle aches he had the night before. He felt better when I spoke to him. He wanted to know when those side effects would go away finally. Since I had the Moderna vaccine I said 24 to 36 hours. But I didn't know about the J&J vaccine. We disconnect the call at 9:40am Saturday morning. After the call at some point he fixed lunch or dinner and stopped eating before finishing his meal. He had left the food on the table and in the pans he fixed it in. Very unusual for him. The patient then went to his room where is was found Monday 3/22/21 around noon in his bed laying on his chest (he hated to lie on his chest) by the police and the HR officer from his work. The HR officer had called my other brother around 11:15am on 3/22 /21 to ask if we had heard from the patient because he had not reported to work or phoned in. He has passed sometime between noon on Saturday till Sunday evening alone at his residence. He had towels and a trash can beside his bed when he was found. The coroner call it death by natural causes and would not do an autopsy when even asked by his PCP.

Patient presented to clinic 9 days after vaccination in acute distress, shivering, tachypneic and having difficulty with speech. Heart rate at 130 beats per minute, Spo2 91% on room air, temp 99.9f oral. Initial difficulty obtaining blood pressure due to shaking. Patient was treated with 500mL NS and 2L O2 via nasal cannula, which immediately improved symptoms. Due to elevated glucose and minimal austere conditions, patient was evacuated from camp to hospital. There, patient diagnosed with COVID-19 infection, bilateral basilar and right apical pneumonia, diabetes and sepsis.

I started having migraine headaches on 3-19-2021 , this lasted for 3 days. On 3-23 started coughing up blood , that progressively became worse. Went to emergency room and was admitted CAT scan of lungs showed that I had 3 blood clots.

Emergency Department Note (Verified) Visit Date: 04/13/2021 CHIEF COMPLAINT: Shortness of breath. HISTORY OF PRESENT ILLNESS: The patient is a 65-year-old male with a history of hypertension and congestive heart failure, presents with shortness of breath that started on Friday and worsened significantly this morning. He does have some chest discomfort with this. No fevers, chills, or other complaints. Discharge Diagnoses 1. Hypertensive emergency, 04/13/2021 2. Chest discomfort, 04/14/2021 3. Heart failure, systolic, 04/13/2021 Assessment and Plan 65M w/ HTN and HFrEF p/w hypoxic respiratory failure i/s/o a hypertensive emergency. BP and respiratory status much improved, admitted to CCU for acute BP management and medication titration. #HTN Emergency Likely precipitated by lack of medication non-adherence since 04/11, when he ran out of his medications. SBP approx 220 at time of presentation, good response to enalapril and nitro gtt. Decreased work of breathing with Bi-pap. MAP 130-140 on presentation, will attempt to lower by 20-25% in first 2-6hrs w/ MAP goal of approx 100, while aiming towards normotensive in next 24-48 hrs while transitioning from IV to PO meds. -TTE ordered -cont incremental BP mgmt: -goal MAP < 110 -prn hydralazine -gradual goal towards normotensive over next 24-48hrs thereafter -cardiac monitor -will ensure that patient has anti-hypertensives prior to DC -q4hr neuro checks #Acute Hypoxic and Hypercapnic respiratory failure Decreased work of breathing with Bi-pap. Likely related to HTN emergency as above in addition to moderate-severe volume overload as seen on CXR. VBG in am of 4/13 showed pH 7.17, pCO2 64, pO2 58, bicarb 24. -cont Bi-pap, will wean as tolerable -repeat VBG this am for resp acidosis #HFrEF w/ acute exacerbation Last echo 04/14/2017, LVEF 38%, cxr on admission shows moderate-severe volume overload. -TTE ordered on 4/13 -may consider additional diuresis, given furosemide in ED on presentation, mindful of BP -goal net negative 1-2L/24hrs as pressures permit -daily standing weights -fluid and sodium restriction when off Bi-Pap #NSTEMI Likely type II given HTN emergency, did have chest pain on presentation which was relieved with BP control. -trend trops until flat, next at 08:00 #type II DM Hgb A1c 7.5% on 4/13, mild hyperglycemia on presentation -SSI #polycythemia Could be indicative of undiagnosed OSA vs manifestation of heart failure. Additionally, hemoconcentration from CHF i/s/o HTN emergency is another possibility. -TTE as above -ctm w/ am labs #lymphocytosis Afebrile, no urinary symptoms. Hypoxic on presentation, likely related to edema i/s/o HTN emergency as above. No suspicion for infectious etiology at this time, no white count. -ctm w/ am labs #HLD -cont statin #QTC prolongation 561 on 4/13/2021 -avoid QTc prolonging medications

Patient right leg became very swollen from knee down and was very painful to walk. Patient went to Urgent Care and was told that he would need to have ultrasound done to see what was going on. Patient went to Imaging and was told that he had several blood clots through out his right leg. They advised him to go to emergency room evaluation. Patient went to Medical Center and it was confirmed that patient had blood clots and was put on Xarelto for treatment.

My father had a massive stroke 3 days after taking his shot. He is now currently paralyzed on his right side and not speaking

Big blood clots following Prostate Surgery 3 days after Vaccine applied Please see attached explanation and pictures

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

pt had severe vomiting with red color and an order it. He had massive pain in his leg. Patient had loss of appetite, nausea, and headaches. His eyes were rolling in the back of his head, which this symptom would come and go. He would have hallucinations. On unspecified date Pt woke up screaming the house was on fire and there was a dog by the bed and a person in the closet, talking out of his head. An ambulance came and brought him to ER. Pt coded in the ambulance and brought back. Pt was coherent upon arriving to the ER. He had to be intubated and bagged and died about 15 minutes later. Pt had blood work which was totally out of whack. Family was told they did not understand what had happened to him. The only thing the family could think of that was different was he had recently been vaccinated.

HEART ATTACK; COVID-19 PNEUMONIA; SUSPECTED CLINICAL VACCINATION FAILURE; ELEVATED CREATININE; This spontaneous report received from a consumer concerned a 65 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included congestive heart failure. He was sick two weeks prior to hospitalization due to congestive heart failure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) dose, 1 total, administered in the beginning of MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included blood pressure and cholesterol medications. On 07-APR-2021, the patient went to the emergency room (ER) and was admitted to the hospital and was diagnosed with COVID-19 pneumonia and heart attack. He had suspected clinical vaccination failure. She reported of a positive COVID-19 test that was taken in the hospital and lab values showed everything as elevated. The reporter (daughter) also stated that her father had no issues with kidneys before but during hospitalization, he had elevated creatinine. During hospitalization, the patient received remdesevir, dexamethasone and was on heparin drip for first 4 days and was on bilevel positive airway pressure (BiPAP) machine and oxygen. He was stable and was going to be discharged from hospital later this afternoon on 13-APR-2021. He was hospitalized for 7 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from heart attack, and covid-19 pneumonia, and the outcome of elevated creatinine and suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused).; Sender's Comments: 20210424651-covid-19 vaccine ad26.cov2.s-Heart attack. 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 20210424651-covid-19 vaccine ad26.cov2.s- Covid19 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). 20210424651-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

Stoke occurred, including symptoms of: severe headache, shortness of breath, trouble speaking, plus leg pain

On April 7, my husband received the J&J COVID vaccination. On April 17, he started to feel ill and developed severe abdomen and back pain, which were not normal symptoms of his other health conditions. He ate very little on that date (and that was the last food he had). At 3:30 a.m. on Monday, April 19, I took him to the ER because of severe pain. They gave him multiple tests, including CT scan, labs, EKG, ultrasound, and others. He was admitted to the hospital, and multiple other tests were performed during his stay. During his stay, his sodium and other electrolyte levels dropped to dangerously low levels, he experienced major swelling, his pain persisted, his swallowing ability diminished, he didn't eat, and his heart consistently ran at a high rate. He was transferred home (with comfort care/hospice) on Tuesday, April 27, and died on Wednesday, April 28, at about 9:30 p.m.

Day after shot patient was tired, he was not feeling well, & he never fully recovered. He went to work on Monday, May 10th & worked until 6:00pm. Returned home eat a little & went to bed. Tuesday, May 11th he worked at home, Wednesday, May 12th we had coffee, laughed & joked around & he went back to work at home. I went to check on him about five minutes later & he was sitting up sleeping. He would usually wake up & say I took a power nap but he was not breathing. I started mouth 2 mouth but he did not respond. My sister told my nephew to call 911 & they told us to lay him on the floor & start CPR until the paramedics arrived. Once they arrived & took over they tried to get him to breathe & restart his heart. The paramedics worked on him for a long time giving us updates on what they were trying to do. Patient never regained consciousness. They indicated probably a heart attack.

Dont know if related or not-- around vaccine date noticed I was "dribbling" when drinking out of water bottle about 4-20-21-, mentioned to Doctor have been dribbling last week or 2 - look at me- told me right side of mouth not moving- thought I had stroke and told to go to e.r where they confirmed there was a stroke and I also had 30 % blockage in right carotid artery. Could also be related to ADD med( Vyvanse have been taking for last 10 years)- as med causes spike- high blood pressure.

Acute Ischemic Multifocal Posterior Circulation strokes resulting in L sided weakness, L facial droop and dysphagia. Hospital course complicated by respiratory failure. Patient had placement of tracheostomy en g-tube given failure to wean off the ventilator and prolonged dysphagia with poor mental status to aid in swallowing

COVID-19 symptom onset 4/23, hospital admission date 4/30, died 5/14. Primary cause of death COVID-19 viral pneumonia

Right leg swollen, went to ER on July 17, 2021and was diagnosed with Deep Vein Thrombosis (right leg - blood clot). Currently taking Xarelto 15 mg 2x a day for 3 weeks, then Xarelto 20 mg for 6 months.

the day following vaccine patient had episode of afib. they had never previously had a diagnosis of afib.

The decedent had significant medical conditions. The wife stated, the appointment for the vaccine shot was made on-line. Dept. of Health visited their home on 3/16. The shot was administered into the decedent's left arm at 0930hrs. The decedent expressed no health complaints and had no visible indications of adverse affects. The decedent was found not breathing supine in bed at 2347hrs 3/16 (same day as vaccine shot).

Brought to the ER as a code blue, 50 minutes down. CBC, CMP, and HIV screen completed. Deceased despite attempts of revival. Wife reports patient reported not feeling well, c/o feeling short of breath, started having foaming at the mouth, loss consciousness. He had pink sputum on arrival.

Massive Pulmonary embolism with evidence of right heart strain, acute hypoxic respiratory failure, Axute DVT of right lower extremity. No obvious known provoking factors

On 4/16 at around 10:24AM, patient presented to emergency department via EMS status post a witnessed cardiac arrest. After the witnessed cardiac arrest, EMS was called and reported that the patient was unresponsive. Per EMS, patient was immediately intubated and chest compressions started. EMS reports an initial cardiac rhythm of VFib and shocked patient once. Patient was given 3 epinephrine and brought into the ED. After prolonged CPR and resuscitation for more than hour and a half, the patient was made DNR/DNI and was pronounced dead at 11:45AM.

Started feeling bad two=three days after shot, became fatigued, lost 15 pounds and could not go to work. On morning of 4/21 was found unresponsive and rushed to hospital where he died 2 hours later

March 25 - loss of taste - March 30 - shortness of breath - resp failure - March 31 - transferred to ER - intubated for three days. Transferred to hospital - March 5 - transferred to Rehab - 4/15; released to home 4/24.

DIARRHEA; LETHARGIC; GENERALISED ACHING; HEADACHE; SWELLING AT INJECTION SITE; REDNESS AT INJECTION SITE; BLOOD CLOT FROM THIGH TO CALF; This spontaneous report received from a consumer concerned a 66 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included paralyzed on left side from a previous injury and not very active. 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 1 total administered on 06-APR-2021 on right arm for prophylactic vaccination. The batch number was not reported and it has been requested. No concomitant medications were reported. On 07-APR-2021, the patient had blow-out diarrhea, lethargic, body aches, headache. On APR-2021, the patient experienced leg pain (started week ago), swelling at injection site and redness at injection site. His left foot was swollen, and called physician to check for blood clot or break. The doctor said that the test showed a blood clot from his thigh all the way down to his calf that was a medical emergency. Reporter thinks there was a possibility that they were already exposed to COVID. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot from thigh to calf, diarrhea, lethargic, generalised aching, headache, swelling at injection site and redness at injection site was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210450241- COVID-19 VACCINE Ad26.COV2. S -Blood clot. 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).

HARDLY EATING; SKIN IS PALE; PNEUMONIA; BACK HURTING REAL BAD; LOST 30 LBS; This spontaneous report received from a consumer concerned a 66 year old white, Not Hispanic or Latino male. The patient's height, and weight were not reported. The patient's concurrent conditions included patient might have a touch of emphysema, alcohol use (used to drink beer, about 12 pack once weekly), and non smoker, and other pre-existing medical conditions included patient had no known allergy, the patient had no history of drug abuse/illicit drug use. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered, 1 total to right arm on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The patient was diagnosed with pneumonia and had lungs hurting on deep breath on 14-MAR-2021. Lung specialist which patient consulted did not know whether patient had covid-19 or not. The patients's pneumonia had got worse which resulted in weight loss of 30 lbs (pound). The patient had underwent CT (computerized tomography) scan by regular physician to determine pneumonia. The patient was put on prednisone and Doxycycline. The patient had subsequently went to lung specialist and was prescribed with Trelegy and 30 days of generic Augmentin. on 14-MAR-2021 patient had his back hurting very bad, was put on Flexeril for back pain, Flonase, Montelukast 10 mg and Tessalon. Subsequently patient was put on dexamethasone (unsure), 6 mg (milligram) once daily and was feeling better, but condition started going back. On 30-APR-2021, the patient experienced skin as pale. The patient still had shortness of breath, not coughing much at the time of reporting. Laboratory data included: CT scan for diagnosing pneumonia and Weight (NR: not provided) lost 30 lbs.. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from back hurting real bad, and had not recovered from pneumonia, lost 30 lbs (pound), skin is pale, hardly eating. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210518214-COVID-19 VACCINE AD26.COV2.S-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).

Next day - Patient had onset of shortness of breath, CXR and CTA chest were negative. EKG showed possible old MI, no acute findings. Cardiology referral was made. He wasn't seen. He came in on 5/6/2021 and ended up being admitted with non STEMI and new CHF.

Vaccine was given on 4/3/21. Pt. presented to this facility with chest pain, pneumonia, hypotension on dehydration on 5/28/21

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

Pt w/multiple comorbidities p/w 2-day duration of SOB, coughs and fevers. COVID test was positive despite receiving Janssen vaccine on 3/31/21. Was admitted given his risks for treatment of acute hypoxemic respiratory failure secondary to COVID PNA per CXR. Received dexamethasone with improved O2 sats. Pt did not meet criteria for remdesivir or tocilizumab and was eventually discharged home following home O2 evaluation.

PAROXYSMAL ATRIAL FIBRILLATION; FEELING OR SENSATION OF DRAINAGE IN LEFT NOSTRIL; OCCASIONAL PRESSURE IN BOTH EARS; SLIGHT BURNING SENSATION IN JUST LOWER LIP WITH SMALL, TINY PROTRUSIONS; LOCALIZED BACK PAIN BILATERALLY INFERIOR TO THE POSTERIOR RIB CAGE BUT MOSTLY ON LEFT SIDE; SLIGHTLY HIGH PITCH SOUND IN LEFT EAR; HEADACHE; FATIGUE; SMALL AMOUNT BLOOD IN STOOL; NODULE IN CUBITAL FOSSA AREA ON MEDIAL SIDE OF ARM; SMALL AMOUNTS OF BLOOD IN PHLEGM; IRREGULAR, LESS FREQUENT AND MORE SOLID BOWEL MOVEMENTS; INCREASED URINATION LASTED 2-3 WEEKS; OCCASIONAL LOCALIZED PRESSURE AND HEADACHES IN OCCIPITAL, FRONTAL, AND TEMPORAL AREAS; This spontaneous report received from a patient concerned a 66 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19 (experienced all the typical symptoms, but waited 13 days to get tested) and concurrent conditions included paroxysmal atrial fibrillation (last time he had an episode until after he received the vaccine). He did not have any recent episodes of atrial fibrillation The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 29-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 29-MAR-2021, the patient experienced occasional localized pressure and headaches in occipital, frontal, and temporal areas which were intermittent and pulsating in nature. On APR-2021, the patient experienced small amount of blood in stool and had irregular, less frequent and more solid bowel movements about 2-3 weeks post vaccination. He mentioned around the same time he was urinating more (increased urination lasted 2-3 weeks), and then his bowel movements and urinations became regular again. He also experienced a nodule that appeared in the cubital fossa area on medial side of his arm two weeks after the vaccination and then gradually resolved over 2.5 weeks after it appeared and small amounts of blood in his phlegm which appeared 1.5 weeks post vaccination and he continued to experience this on week 2, week5 post-vaccination and then resolved. On 14-APR-2021, Laboratory data included: Antibody test (NR: not provided) Negative, Complete blood count (NR: not provided) unknown, and Platelet count (NR: not provided) Normal. He reported experiencing 5 episodes of atrial fibrillation within the 7 weeks after vaccination, a diagnosis of paroxysmal atrial fibrillation was confirmed by his cardiologist. He also experienced fatigue about 5-6 weeks after vaccination. He had intermittent waves had fatigue throughout the day which lasts for an hour and then came back later in the day, with no consistency and stated this was still unresolved. (Later on he stated he had no fatigue spells lately and considered this resolved). On an unspecified date, he experienced feeling or sensation of drainage in left nostril, (even though had no excess blood or fluid) which started a few weeks after received the vaccine and then lasted for several months but now resolved and occasional pressure in both ears (opening and closing his mouth did not relieve the pressure) and slight high pitched sound in the his left ear. His ear side effects came and gone and considered them to be resolving but not fully resolved. He noticed a few weeks after vaccination he had slight burning sensation in just his lower lip with small, tiny protrusions (He initially said this was unresolved, but then later said this was resolved). He also experienced localized back pain bilaterally inferior to the posterior rib cage but mostly on the left side. He mentioned he have a checkup next week and will discuss his concerns since this side effect was still unresolved and headache. The patient stated he did not experience any of these side effects before receiving the vaccine. He was generally healthy and tried not to take medication if possible. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from paroxysmal atrial fibrillation, nodule in cubital fossa area on medial side of arm, feeling or sensation of drainage in left nostril, slight burning sensation in just lower lip with small, tiny protrusions, and fatigue, and small amount blood in stool, small amounts of blood in phlegm, irregular, less frequent and more solid bowel movements, and increased urination lasted 2-3 weeks on APR-2021, was recovering from occasional pressure in both ears, and slightly high pitch sound in left ear, and had not recovered from headache, localized back pain bilaterally inferior to the posterior rib cage but mostly on left side, and occasional localized pressure and headaches in occipital, frontal, and temporal areas. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210667239-COVID-19 VACCINE AD26.COV2.S. Paroxysmal atrial fibrillation. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: UNDERLYING DISEASE 20210667239-COVID-19 VACCINE AD26.COV2.S. Small amount blood in stool. 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.

ANGIOEDEMA AND ANAPHYLAXIS. 4/6/202021- SWELLING OF LEFT EYE- WENT AWAY IN 2 DAYS. 4-9-21 SWELLING OF ENTIRE FACE TOOK TO URGENT CARE AND GIVEN SHOT OF SOLUMEDROL AND A PREDNISONE PACK. 4-16-21 SWEELING OF EYES AND FOREHEAD GIVEN PREDNISONE PACK. 4-23-21 ANAPHYLAXIS ON A VENTILATOR FOR 43 HOURS AND ICU

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

Death on 3/23/2021 at 9 AM. Home Health Nurse who gave immunization on 3/19/21 verbalized pt was fine after injection, stayed in home for 1 hour after injection was given. Wife verbalized pt was very tired the following day and through out the weekend. Pt stopped eating one day prior to death. Respirations changed on the morning of 3/23/2021 and wife called EMS, pt died at home.

Suspected pneumonitis. Patient presented on day following vaccination as shortness of breath, nausea, and diarrhea were not abating with home management. They had started later in the day after the vaccination. At ER admission - SpO2 = 80% room air. Nasal cannula was applied and SpO2 recovered quickly. BNP was elevated so acute exacerbation of heart failure was suspected and treated. However, patient did not improve with diuresis. Viral workup and bacterial cause workup negative. No acute cardiac events discovered. Patient continued to decline. Transferred to ICU on 3-19-21 to use BiPAP with 65% FiO2 and able to take breaks to 15L nasal cannula. Borderline blood pressures at this time. Infectious disease, pulmonology, cardiology, nephrology, and critical care anesthesia services evaluated and ruled out multiple possible diagnoses and patient continued to decline. Diagnostic bronchoscopy on 3-22-21 with BAL lead to patient ventilator dependent with profound hypotension. Aggressive ICU management ensued. Bronchoscopy very clean with no real secretions - in line with CT evidence of pneumonitis. Despite aggressive care and maximized pressor support, patient expired on 3-29-21 when family chose to withdraw care as blood pressure declined again.

This patient was under hospice care at home with Nursing Service and Hospice. He received the J&J vaccination at noon by local public health nurse on Mon 4/12/21. The patient's wife, reported to hospice team that he had been sleepy during the day and had received a dose of Ativan earlier that morning (PRN medication at 0750). The primary hospice nurse reported wife noted he became more lethargic throughout the day after vaccination with his condition worsening at 1720; at that time his blood sugar levels were noted to be low at "47" but patient was alert enough to drink orange juice, eat ice cream. The patient continued to deteriorate so MD was consulted and he was transported to the ED where he later expired at 1930.

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

Patient admitted with DVT, acute occlusive venous thrombosis in the left posterior tibial and peroneal veins.

On 5/2/21 patient presented to Emergency Room with Rt upper chest pain that is worse after meals and associated with vague nausea and some sob. Reported that pain was constant and burning in nature. Pt was admitted to hospital with mildly elevated troponin. D-dimer was greater than 20. Pt had a VQ lung scan which confirmed the diagnosis of pulmonary emobolus. Pt was given Enoxaparin 100 mg subcutaneously every 12 hours from 5/2-5/7. Then patient was started on Apixaban 10 mg po bid x 7 days which will transition to 5 mg po bid. Pt improved and will be discharged today 5/7/21.

Brief HPI and Hospital Course: 67 year old male with unknown past medical history was brought in by EMS as post-cardiac arrest. Patient was found on unresponsive on sidewalk, possible collapse. ACLS started by EMS, approx 10-15 minutes. Initial rhythm was junctional PEA. Was given 2 epi and intubated by EMS and had ROSC, Initial ROSC rhythm was SVT which slowed to 90s on its own. On arrival to ED, left femoral central line placed. Tox screen was positive for cocaine and ETOH. Was placed on ACS protocol for possible NSTEMI. Tested positive for COVID19 on admission. Patient required pressor support on admission. Hypothermia protocol was initiated. Patient was rewarmed per protocol, normothermic as of 5/5. Brief Narrative of Events leading to Patient's Death: Patient remained normothermic with persistent septic shock, multi organ failure, ARDS secondary to COVID19. Multiple attempts to reach family members made by ICU team and palliative care team daily without answer. Patient made DNR by two-physician consent. Patient's BP low despite maximum levophed support.

Developed LLE DVT and R sided PE. Unclear time correlation with vaccination. Symptoms worsened about 3 weeks ago.

To ED via ambulance for chest pain and shortness of breath. Decompensated during transport, hypoxic, cyanotic, hypotensive. Intubated in ED. CTA of chest positive for saddle embolism. 1/2 TPA/heparin given. Admitted to ICU. Change in mental status, CT of head showed intracranial hemorrhage. Patient had reportedly been sick about a week or 2 earlier, covid positive PCR on admission to hospital.

patient died. right side of patients face (eye, nose, mouth) were drooped, right hand was drawled up.

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

I didn't have pain in the arm, after an hour I had a slight headache. The headache lasted about a day. After the 3-4 day I had serve diarrhea and stopped taking my supplements. It stopped for a couple days then came back for a day. I had no headache or pain, just 3 bad episodes of diarrhea. On March 24th I went into the Hospital with severe pain in my lower left back side. I thought I was passing a kidney side, with the pain I was having. When I got there they did a CT scan and blood work and it wasn't kidney stone but I had a blood clot on the lower left side of lung and the right side as well. They immediate put me on blood thinners. I was there for a day and a night. They released and put me on medication. I've had minor pain but nothing like the pain I had before. I have since followed up with a Pomologist and PCP. Pulmonologist said I had blood clots but couldn't give me a cause. My PCP said she thought I had or have Covid. I asked to have my blood drawn and she said it was too late for that because I had taken the vaccine already.

About 24 hours after the vaccine administration, he became unresponsive at the nursing home. He was sent to the hospital where he is now on a heparin drip due to bilateral Pulmonary Embolisms and multiple DVTs.

DVT (LEFT CALF); PULMONARY EMBOLISM (BOTH LUNGS); ATRIAL FIBRILLATION; BLOOD CLOT IN RIGHT VENTRICLE; This spontaneous report was received from a consumer (patient's wife) and concerned a 68 year old male. The patient's weight was 250 pounds and was obese (body mass index 40) and sedentary. His height was not provided. The patient's concurrent conditions included high blood pressure, and 2 gout attacks in the last 8 months. The last gout attack was 2 weeks ago in the left foot. There was no history of clots or atrial fibrillation. He had a strong family history of thrombosis: his father had 2 episodes of deep vein thrombosis and his mother had a pulmonary embolism. No testing to identify any familial clotting issues have been performed. The patient developed a cough starting 29-MAR-2021 and, prior to vaccination, took a COVID-19 test on 31-MAR-2021 which was negative. On 02-APR-2021 a rapid COVID-19 test also came back negative. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) on 02-APR-2021 at approximately 19:00 in the left arm for prophylactic vaccination. Concomitant medications included amlodipine, hydrochlorothiazide, and losartan for high blood pressure. On 03-APR-2021, the patient's cough persisted but had not worsened and he developed pain in the ribs on the right. His wife checked his pulse, which seemed fast and irregular. His respiratory rate was 22 breaths per minute and his oxygen saturation with a home pulse oximeter was in the 70s. He was not in distress at the time. The patient called his physician and the doctor suggested to go to Emergency room. The patient went to Emergency room at approximately 10:00. An echocardiogram revealed a number of clots in the right ventricle which were "bouncing all around". He was also found to be in atrial fibrillation which the doctors said was secondary to the ventricular clots. Unspecified tests revealed a saddle pulmonary embolus and a deep vein thrombosis on the left. He was diagnosed with deep vein thrombosis (left calf), pulmonary embolism (both lungs), blood clots in right ventricle and atrial fibrillation. Platelet count was not known by the reporter; it is unknown if D-dimer and fibrinogen levels were performed. He underwent emergency surgery at 19:00, during which most of the ventricular clots and the pulmonary embolism were removed. He was placed on heparin after the surgery. He spent 5 days in the Intensive Care Unit (ICU) and 2 additional days in the hospital. The patient was discharged from the hospital after 1 week and had recovered from the events of deep vein thrombosis (left calf), pulmonary embolism (both lungs), atrial fibrillation, and blood clots in right ventricle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The reporter did not believe that the covid-19 vaccine ad26.cov2.s had caused deep vein thrombosis (left calf), pulmonary embolism (both lungs), atrial fibrillation, and blood clot in right ventricle This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: a 68-year-old male experienced left deep vein thrombosis, saddle pulmonary embolism, right ventricular thrombosis, and atrial fibrillation, approximately 15 hours after receiving the Janssen COVID-19 vaccine for prevention of COVID-19 infection. The patient has a history of hypertension, is obese (BMI 40) and has a strong family history of blood clots. He tested negative for COVID 2 days before and the day of vaccine administration. He developed a cough 4 days prior to vaccination. The morning after vaccination, he developed right rib pain; his heart rate was rapid and irregular, and oxygen saturation with home pulse oximeter was in the 70s. Upon arrival in the emergency room, he was found to have clots in the right cardiac ventricle, a saddle pulmonary embolus, left deep vein thrombosis and new-onset atrial fibrillation. He underwent surgery for removal of the ventricular clots and pulmonary embolism. No laboratory details were provided. Given the symptoms which pre-dated vaccine administration, the short latency between the vaccine administration and the event, and multiple risk factors for embolism and thrombosis (family history, obesity, sedentary nature), the events are assessed as inconsistent with the causal association to immunization, per the WHO causality classification for adverse events following immunization. Therefore, company causality is considered not related to the Janssen COVID-19 vaccine.

On March 1st, I had a sonogram of the veins in both of my legs and nothing was found, on March 5th I received the COVID-19 vaccine after standing in line for 2&1/2 hours. By March 8th the swelling and pain in my left leg was so bad I made an appointment with Dr. for March 11th. He ordered another sonogram and found 2 DVTs in my left leg, and prescribed anti-coagulants whyich I am still on. At the time the Doctor said that this was most likly a result of having stood in line for 2&1/2 hours.

Came to ED on 4/15 with c/o anginal symptoms, found to be in rapid afib. EKG showed ST elevation in later precordial leads, went for emergent left heart catheterization. Went into V-fib arrest requiring defibrillation (x2) in addition to CPR in cath lab. Angio showed acute thrombotic occlusions of LM, LAD and RI, underwent mechanical thrombectomy of LM and LAD with balloon angio of RI (recent cardiac cath in March 2020 showed clearly patent stents). Placed on Impella bypass. Currently in CVICU care, intubated with Impella.

ITP with platelet count of 2K. Presented with subdural hematoma. Platelets recovered with dexamethasone 40mg PO daily and IVIG 400mg/m2 daily x 4 days. No further brain bleed.

The following evening after the shot, he had severe pains in his back and shoulders, headache, nausea (vomited). 2 days later, felt severe pain in his stomach, along with pain in his shoulders and back, with a headache, also vomited.

"Janssen COVID-19 Vaccine EUA" 3/18 twitching of foot...severe leg pain 7:45 PM 3/19 involved in a motor vehicle accident with cardiac arrest and a dissecting aortic aneurysm 12;45 PM

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

had redness and tightening of the legs, went to ER, found very small blood clot in right calf. Gave rx blood thinner eloquis along with current plavix and asa

Extremely large amounts of bleeding into bladder during the release of kidney stone. Taken to OR for insertion of urethra tube. Follow-up Fragmentation procedure on 6/7/2021 caused large amounts of blood loss and blood clots the size of quarters into the urine. Blood loss and excessive clotting lasted for 5+ days.

3/12/21 Sudden cardiac arrest at home; unable to be resuscitated at scene (Brother) Caller is a family friend who was asked by family to call and report incident. If f/u is needed, please contact him first. Current Medical History: unknown by caller Current Medications: unknown by caller

Patient developed symptomatic COVID infection with symptoms starting 3/13, was admitted to the hospital for respiratory failure on 3/16 and expired on 3/18/21

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

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

PATIENT SUFFERED AN ISCHEMIC OCCIPITAL LOBE STROKE, CONFIRMED BY CT SCAN, ON 4/2/2021. PATIENT WAS TRANSFERRED TO AND ADDMITTED TO HOSPITAL. PATIENT WAS NOT ADMITTED TO THE ICU PER HIS WIFE. PATIENT WAS RECENTLY TRANSFERED TO REHAB WHERE IS HE IS CURRENTLY AS OF 4/13/2021. PATIENT LOST VISION IN LEFT EYE AS WELL AS FUNCTION IN HIS LEFT ARM PER THE PATIENTS WIFE. PATIENT IS REGAINING SIGHT AND STRENGTH IN BOTH HIS LEFT EYE AND ARM BUT PROGRESS IS SLOW, PER HIS WIFE.

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

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

PATIENT PRESENTED TO CLINIC FOR ANNUAL WELLNESS VISIT ON 4/12/2021 AND RECEIVED THE JANSSEN COVID-19 VACCINE FOLLOWING HIS VISIT. ON 4/14/2021 PATIENT CALLED EMS FOR C/O CHEST TIGHTNESS. DISCOMFORT HAD RESOLVED BY THE TIME EMS ARRIVED. PATIENT WAS TAKEN TO ER FOR FURTHER EVALUATION. PATIENT REMIANED FREE OF CHEST TIGHTNESS/DISCOMFORT THROUGHOUT THE VISIT AND CARDIAC WORK-UP AT THE ER WAS ESSENTIALLY NORMAL. PATIENT WAS DISCHARGED HOME WITH F/U INSTRUCTIONS. ON 4/15/21 RN RECEIVED A CALL FROM THE COUNTY MEDICAL EXAMINER STATING THAT PATIENT WAS FOUND DECEASED IN HIS DRIVEWAY THIS MORNING AT AROUND 09:41 AM. THERE WERE NO SIGNS OF FOUL PLAY AT THE SCENE. PATIENT'S RECENT PHYSICAL AND LAB WORK WITH HIS PROVIDER ON 4/12/2021 SHOWED NO FINDINGS OF CONCERN. PATIENT HAD NO CHRONIC ILLNESSES, WAS ACTIVE, AND OFFERED NO MEDICAL CONCERNS AT HIS VISIT ON 4/12/2021.

PATIENT'S SISTER CALLED THIS AFTERNOON STATING HE HAD RECEIVED THE JANSSEN COVID VACCINE 4/05 AND THEY FOUND HIM DEAD THIS MORNING. THEY ARE NOT CERTAIN IF IT WAS FROM VACCINE. THEY CLAIM HE HAS NO OTHER HEALTH ISSUES AND IS NOT ON ANY OTHER MEDICATIONS. THEY HAVE NOT PERFORMED AUTOPSY. SHE WAS MORE RELAYING INFORMATION RATHER THAN BLAMING THE DEATH ON THE VACCINE. SHE REQUESTED WE SUBMIT REPORT TO VAERS; SHE HAS NO WAY TO AND DOES NOT KNOW HOW.

Patient reported no adverse reactions after and the days after receiving JJ Covid vaccine. Fast forward, as he was talking to me on 4/16/21, he revealed that he did have one event that occurred the morning after he received the vaccine which was 3/9/21. He said that he had reservations reporting it to me at the time. He did contact his primary doctor about it and had a check up. On the morning for 4/9/21, he walked into his shower then looked down at his feet, he notice blood on the floor of the shower. At this time, the water was not on yet. He described the blood as pink. He said he thought he lost about 1-2 ounces of blood. He only had one incident and none other.

On 4/9/2021 started with left sided pleuritic CP and went to ED and found to have bilateral pulmonary emboli. On Eliquis 5mg BID No underlying chronic conditions for increased risk of PE Extensive work up without a direct cause found, no underlying malignancy noted

patient developed severe chest pain, ambulance was called and patient was taken to ER. Patient was transferred to higher level facility and was told he had a heart attack and that it was caused by a "blood clot"

initially had mild headache and diarrhea but this resolved after a few days. Then around 4/25, developed atraumatic bruising and swelling and pain to the left biceps region (opposite side from vaccine). denied current headache/visual symptoms/abdominal pain or other bleeding/bruising.

Patient found to have pulmonary embolism 22 days after receiving vaccine. Onset of symptoms occurred 18-19 days after receiving vaccination, however, very likely PE related to patient hx of small cell lung cancer. He is currently hospitalized for respiratory distress as of 4/30/21

DEEP VEIN THROMBOSIS IN RIGHT LEG (PAIN AND SWELLING); This spontaneous report received from a physician concerned a 69 year old White and not Hispanic or Latino male. The patient's height, and weight were not reported. The patient's concurrent conditions included arterial fibrillation, and sedentary lifestyle. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 207A21A expiry: 23-JUN-2021) dose was not reported, frequency 1 total, administered on 11-APR-2021 at left arm for prophylactic vaccination. Concomitant medications included apixaban for chronic atrial fibrillation. It was stated by internist that, on 26-APR-2021, the patient experienced deep vein thrombosis in right leg with symptoms pain and swelling, and was hospitalized on unspecified date. On unspecified date doctor was screening patient for covid-19 infection. On 27-APR-2021, Laboratory data included: Platelet count (NR: not provided) 167000. Laboratory data (dates unspecified) included: Duplex ultrasound (NR: not provided) definite clot in right leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of deep vein thrombosis in right leg (pain and swelling) was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210455157-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Deep vein thrombosis. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE.

On March 30th the patient had loss of appetite and headache. On March 31st the patient collapsed and was taken to the ER, the patient's oxygen was low. Patient's blood pressure had dropped and you could not wake him up all afternoon. The Ambulance took him to the hospital on April 1st where he had shortness of breath and blood clots in lungs. On April 1-2 the patient was leaking blood but the hospital staff could not find where so they gave him 3 units of blood. Patient also received 3 antibiotics for a rare pneumonia.

Pt received Covid-19 vaccine on 3/19 then presented to ED with fever and shortness of breath on 3/23 admitted to the hospital found to be COVID 19+ and requiring 2L oxygen via NC. Treated with dexamethasone, remdesivir and empiric antibiotics. Following admission, O2 requirement increased, received tocilizumab then required transfer to the ICU on 3/29. On 3/31 developed right leg ischemia, underwent thrombectomy and heparin infusion then on 4/1 patient intubated due to increased need for respiratory support and had bilateral chest tubes placed, post-intubation course complicated by shock with AKI requiring pressor support, prolonged encephalolpathy. On 4/24 with worsening shock, hypoxemic resp failure, AKI requiring pressors and CRRT with broad spectrum antibiotics and resumption of stress dose steroids, the family was transitioned to comfort measures and passed away on 4/29.

Blindness in left eye, blood clot in left eye- no treatment available. Permanently blind in left eye now.

"Janssen COVID-19 Vaccine EUA" This patient's wife called me on 06/14/21 after the patient being in a hospital all weekend in another state. She stated the patient had a blood clot in his lung and had passed out due to lack of oxygen. Patient is improving now but their MD at the hospital told patient to report this to me, vaccine provider, since this blood clot occurred within 6 months of receiving the covid vaccine on April 1, 2021.

HEART INFLAMMATION LEADING TO MILD HEART ATTACK AND PNEUMONIA. 6 DAYS IN HOSPITAL, 3 STENTS IN ARTERIES, 6 WEEKS OF CARDIAC REHAB NEEDED.

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

6.29: Patient recently seen on 6.29.21 at hospital ER and was diagnosed with COVID-19. He was sent home and told to return if symptoms worsened. 7.5.21: patient presents with shortness of breath and cough that have become increasingly worse. Hospitalization due to COVID-19 infection. diagnosed with community acquired pneumonia secondary to COVID-19, acute hypoxic respiratory failure. Patinet has history of receiving the J&J COVID-19 vaccine in April 2021. 7.16: as of the date of this report submission, the patient is still admitted.

Wife reports that patient went to see his cardiologist on 6/7/21 for a follow up to the aortic valve replacement on 10/1/20. He received a good report from the cardiologist and was going to be taken off Warfarin the following week. On the way home he complained of a headache and felt like it was sinus headache. When he got home he went to bed as the headache had worsened. His wife assisted him up to the bathroom and back to bed and he went to sleep. She could hear him breathing from the other room. Later in the evening she became aware that she could not hear him breathing and upon checking on him she found him unresponsive, not breathing and he was blue in the face. She call 911 and they attempted to resuscitate him without success. Wife also reported that after the aortic valve replacement in 10/20, her husband went to the hospital with a fever and was diagnosed with covid and sepsis on 12/14/20. He was admitted and started on IV antibiotics and was hospitalized for 5 days. He had home health care coming into his home for 6 weeks of IV antibiotic therapy. He made a good recovery and was followed by an infectious disease doctor who put him on Amoxicillin po tid until the end of May. She states that he was doing very well physically and was playing golf, walking and felt better than he had in a long time.

Patient had cardiac arrest secondary to MI less than 24 hours from receiving the vaccine. Now on 3 pressors. Although due to the patient's health condition, this may not have been attributed to the vaccine.

PATIENT SUFFERED ANAPHYLAXIS 40 MINUTES POST DOSE. WAS FINE AFTER 30 MINUTES, THEN LEFT FOR THE BUS STOP AND FELT HIS THROAT CLOSING UP. HE HAD AN EPI-PEN ON HIM DUE TO HIS DRUG ALLERGIES, AND WAS ABLE TO ADMINISTER AND THEN GO STRAIGHT TO MD OFFICE.

Flank chest pain (pain under right rib cage) and Dyspnea on exertion; woke pt up at 0300 on 4/9/21 Chest pain with deep breathing., fever, and nausea upon presentation to ED Pt denied recent travel or prolonged immobilization Patient diagnosed with bilateral pulmonary embolism per CTA

pulmonary embolism with chest pain symptoms on 4/9, improved with anticoagulation. Patient also had laparoscopic paraesophageal hernia repair on 3/25 and so could also have been a provoked pulmonary embolism.

Left upper extremity DVT in brachial vein. Left upper extremity SVT in basilic vein. Started on xarelto, plan for 3 month course. Sepsis - no source

I experienced a mini-stroke (TIA) in which my speech was affected and which resulted in me being hospitalized. For about 5 minutes, I was unable to find words and properly communicate. I went to the ER and was admitted and had a battery of tests, kept overnight, and discharged the following day My statin dose was increased, and I was put on a baby aspirin, in addition to Pradaxa blood thinner. i believe that I may have had a vascular thrombi related to the effect of the medicine/spike protein.

Heart went into Atrial fibrillation causing blood clotting. He has no prior heart condition. A blood clot traveled to his brain causing a Posterior Cerebral Artery Stroke. He has been in ICU since 04/22/2021.

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

Patient developed cough, fever, shortness of breath on 4/22/21. Tested positive for COVID-19 and was found to have a pulmonary emoblus in the ER on 4/27/21. She is currently admitted at Hospital, under my care. I'm also her primary care physician.

Presented to emergency department at ancillary facility on 3/19/21 with shortness of breath and was admitted at that time. He was transferred to regional medical facility on 3/23/21 for further management due to increasing oxygen requirements and worsening congestion. Patient was discharged on 4/2/21 to rehab facility. Patient presented to emergency department on 4/12/21 from rehab facility for worsening hypoxia and respiratory failure. Chest xray showed new infiltrates and he was started on antibiotics for pneumonia. He was discharged on 4/20/21 to a skilled nursing facility.

Right lower leg sudden onset severe swelling, pain, redness. Went to urgent care doctor who then performed assessment, blood work and ultrasound. Placed on Xarelto 15mg twice daily for 21 days.

Veteran scheduled for CT scan for screening for malignancy due to unintentional weight loss. Incidental finding of Tiny linear pulmonary embolus in lower lobe pulmonary arteries on the right that is nonocclusive. Follow-up MRI negative for malignancy. CT scan was completed 4/14/21. Patient was asymptomatic in terms of PE symptoms

CARDIAC ARREST DURING ANESTHESIA FOR A SCHEDULED HEART SURGERY; ATRIAL FIBRILLATION; This spontaneous report received from a patient concerned a 70 year old White and Hispanic or Latino male. The patient's height, and weight were not reported. The patient's past medical history included general anesthesia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: not reported) dose 1 total, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the patient experienced atrial fibrillation. On 02-APR-2021,the patient went to the hospital for ablation of atrial fibrillation and experienced cardiac arrest during anesthesia for a scheduled heart surgery. Patient heart was stopped suddenly but cardiologist were able to revive patient .Patient had tested for Catheterization of heart ,CAT scan and stress test for heart prior 2-3 weeks before heart surgery. All the test were normal .On 02-APR-2021,After an event ,Patient was hospitalized for 5 days. The surgery for heart was pending. On MAR-2021, Laboratory data included: CAT scan (NR: not provided) normal, Cardiac catheterization (NR: not provided) normal, and Stress test (NR: not provided) normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cardiac arrest during anesthesia for a scheduled heart surgery on APR-2021, and the outcome of atrial fibrillation was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0. 20210512607-COVID-19 VACCINE AD26.COV2.S-Cardiac arrest, Atrial fibrillation. 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)

BLOOD CLOT IN LEG; SWEATING; This spontaneous report received from a consumer concerned a 70 year old male of unspecified ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in 2021, the patient experienced sweating which lasted about one day. It was stated that patient received vaccine around 18-APR-2021. It was also reported that actual date of vaccination may have been prior to 18-APR-2021 but definitely in April. On 17-MAY-2021, patient visited hospital and got diagnosed with blood clot in leg. The patient was on unspecified medications to dissolve clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating on 2021, and had not recovered from blood clot in leg. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20210534558-Covid 19 Vaccine- This case concerns a 70 yr old male. Blood clot in leg, Sweating. 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).

MAJOR HEART ATTACK, GOT PLACED WITH A STENT; This spontaneous report received from a patient concerned a 70-year-old male. The patient's weight, height, and medical history were not reported. Prior to the vaccination, patient was never on any medication. Patient had no pre-existing conditions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: not reported) dose was not reported, 1 total administered on 04-MAY-2021 at 15:00 to left arm as prophylactic vaccination. No concomitant medications were reported. On 08-MAY-2021, four days after vaccination, the patient experienced major heart attack due to which he went in an ambulance (his spouse called 911) and was hospitalized on the same day. Patient was placed in ICU (intensive care unit) and got step down. On 10-MAY-2021, patient was discharged and he went home with a life vest. Patient was hospitalized for 3 days. No other side effects were reported. Patient got placed with a stent. Patient was discharged with Treatment medications (dates unspecified): lipitor 80 mg, losartan potassium 25 mg, plavix 75 mg, metoprolol succinate extended release 50mg, and baby aspirin 81 mg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from major heart attack on 17-MAY-2021. This report was serious (Hospitalization).; Sender's Comments: V0; 20210535227 -covid-19 vaccine ad26.cov2. s major heart attack. 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.

I had a incident of atrial fib, which required me to be cardioverted to correct it. I went to my cardiologist.

RIGHT LEG DEEP VEIN THROMBOSIS; RIGHT ARM PAIN; PULMONARY EMBOLISM; This spontaneous report received from a patient concerned a 70 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, alcohol user, non smoker, tree allergy, onion allergy, topical iodine cleanser allergy, and weeds allergy, and patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070 and expiry: UNKNOWN) dose was not reported, 1 total administered on 19-MAR-2021 on left arm for prophylactic vaccination. Concomitant medications included amlodipine, atorvastatin, cetirizine, fluticasone, levothyroxine and omeprazole used for unknown indication. On 05-APR-2021, the patient experienced chest pain, shortness of breath, extreme shortness on upper back, right arm pain, right rib cage pain. On 19-APR-2011 patient was travelling, took a bus, when patient arrived, symptoms were so severe that patient could not pick up the luggage. Patient arrived around 5:30pm to his destination and was taken to the ER (emergency room). Patient had x-rays and an MRI done, and was admitted to hospital. Patient was discharged on 24-APR-2021 (hospitalized for 5 days) with diagnosis of acute pulmonary embolism, Shortness of breath, right leg deep vein thrombosis, pain in chest, elevated troponins. Patient was prescribed Eliquis during this admission and patient was currently taking it. On 11-JUN-2021 Patient went to the hospital out of town and was admitted. Patient had chest pain and right arm pain, and right side rib pain. Patient was discharged on 12-JUN-2021 and diagnosed with pulmonary embolism. Patient stated that the chest has improved since starting to take Eliquis, but still feels pressure on the right side of rib cage and felt has not fully recovered yet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from right arm pain, and had not recovered from pulmonary embolism, and right leg deep vein thrombosis. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210629366-COVID-19 VACCINE AD26.COV2.S- Pulmonary embolism, right leg deep vein thrombosis, right arm pain. 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. 20210629366-COVID-19 VACCINE AD26.COV2.S- right arm pain. This event is labeled per RSI and is therefore considered potentially related.

BLOOD CLOTS (RIGHT HAND AND LEFT LOWER LEG); BLOOD CLOT IN THE LUNGS; This spontaneous report received from a patient concerned a 70 year old male. The patient's height, and weight were not reported. The patient's past medical history included lung cancer, tumor removal surgery, four chemotherapy sessions, and surgery to remove the blood clots, and concurrent conditions included non-smoker, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: unknown) dose was not reported, 1 total administered on 11-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAY-2021, the patient developed blood clot in the lungs was reported. On 14-MAY-2021, (three days after) the patient experienced shortness of breath was reported. On 20-MAY-2021 went to Emergency room (ER) and was subsequently admitted to Intensive Care Unit (ICU). On 21-MAY-2021, the patient underwent through surgery to remove the blood clots on the lungs along with this on same day patient developed swelling of left leg and right arm was reported. On 22-MAY-2021, the patient developed blood clot right hand and left lower leg. On 29-JUN-2021, patient underwent through laboratory test included: Computed tomography (CAT) scan revealed negative for blood clots. It was also stated that patient was on Eliquis (apixaban) for anticoagulation due to blood clots. Treatment medications (dates unspecified) included: apixaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood clot in the lungs on 21-MAY-2021, and had not recovered from blood clots (right hand and left lower leg). This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20210702546-Covid 19 Vaccine ad26.cov2.s- Blood clots in the lungs, Blood clot (right hand and left lower leg). 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

Stroke on 07/192021 at ~05:30am of unknown cause. Rushed by ambulance to hospital () Was in hospital for 3 days and was administered many tests. Please contact Hospital for detailed records

Occipital stroke involving vision on 3/14/21, was seen at ophthalmologist and sent to Hospital and stroke confirmed on MRI.

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

Two weeks after the shot, he noticed bloody noses, hematuria, ecchymoses all over his abdomen, bruises on the top of his mouth. Fatigue

Patient admitted 4/14/2021 to the ICU from ED. Patient was experiencing hand weakness. Patient given TPA as treatment for a potential stroke. Patient with known stroke on CT imaging, unable to further verify with MRI imaging. Upon further investigation/discussion with the patient, he reports receiving the Johnson & Johnson Vaccine 10 days prior to admission. Patient with known comorbidities which increase his risk of an embolitic stroke however with recent findings from the CDC, unsure if this needs to be further investigated. Patient had 2 head CT scans, showing no intracranial abnormalities and MRI was unable to be completed due to patient's size. Neurology states high probability of stroke within their consult note. Patient's risk factors for stroke include: uncontrolled hyperlipidemia (LDL 132 on Crestor 40 mg daily PTA), hypertension (as high as 182/92 mmHg in ED), physical inactivity (BMI 76 kg/m^2), and male. Low suspicion of CVST based on patient's platelet count of 212 on admission and no abnormality on head CT. MRI would have been beneficial in potentially diagnosing CVST, as well. Our recommendation is to submit this information to the VAERS database as a possible ADR from the vaccine. The patient fits the timing of an ADR, within 6-13 days of vaccine administration, and CDC recommends watching for neurological symptoms based on their most recent press release.

Developed COVID symptoms for a "few" days. Called his physician who referred him to the local hospital for suspected COVID. Tested positive for COVID at the hospital and blood clots in the lungs were discovered by CT scan. Patient was admitted to ICU for treatment. Details reported to VAERS by hospital and the Health District

On 5/3/2021 was found to be unresponsive with low BP and slow heart rate. 911 was initiated and CPR started. Resident was admitted to Hospital with diagnosis of respiratory failure

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

Pt received COVID19 shot on 3/12/2021. Pt passed away on 3/15/2021. Dr called us to inform us that our patient had passed away but he did not believe it was caused by the vaccination at this time.

Patient developed progressive weakness and was diagnosed with Guillain-Barre Syndrome based on physical exam findings (ascending muscular weakness), lumbar puncture, and MRI findings. Disease course complicated by acute hypoxic respiratory failure which required endotracheal intubation and mechanical ventilation. He was treated with intravenous immunoglobulin x4 days.

6 days after vaccine patient had ICH/IVH or (R) spontaneous aneurysmal hemorrhage. On April 8th while in acute rehab he had (L) brainstem infarct.

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

Patient presented to the ED on 6/7/21 with abdominal pain that had started earlier that day. CT abdomen, CXR, and urinalysis were done and all came back negative. Patient denied any respiratory symptoms. On physical exam, he was found to have severe swelling, erythema, and ecchymosis on his left leg extending into the upper thigh and knee. A lower extremity doppler was done and found extensive occlusive thrombosis within the left lower extremity beginning in the external iliac vein and extending into the common femoral, femoral, profunda, popliteal and visualized deep calf veins. No evidence of PE or DVT in the RLE was found. Vascular Surgery was consulted, who did not recommend any procedures, but patient was started on a heparin drip. Hematology later saw the patient and changed the heparin drip to rivaroxaban on 6/9/21. Infectious Diseases was also consulted for possible sepsis.

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

swelling began in feet and moved up legs to abdomen; 25 lb weight gain in two weeks between routine doctor exam and emergency visit leading to hospital admission for 6 days where an atrial flutter was detected that was not present in May 19th exam. Diuretics in the week since admission have pulled off over 35 lbs and vastly reduced swelling but heart damage remains.

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

My husband is still in hospital trying to recover. He had bad headaches that then led to seizures and confusion ,blood clots, and has been hospitalized since. He's literally fighting for his life and tomorrow Wednesday April 14 th he will be transferred to a rehabilitation center.

Patient developed chest pain and shortness of breath 4/15 Presented to hospital emergency department 4/17 found to have a pulmonary embolism without heart strain, however with pulmonary infarction of left lower lobe with associated right lower extremity DVT Patient admitted to the hospital, initiated on therapeutic anticoagulation with Lovenox, started on oxygen therapy for acute hypoxic respiratory failure Discharged home 4/20 on therapeutic anticoagulation with Xarelto and home oxygen as needed

Intermediate Risk PE-diagnosed due to symptoms of pre-syncope, palpitations. Clinical history includes long car ride

73 y.o. male former smoker with PMH significant for coronary artery disease with history of CABG in 12/22/2020, hypertension, hyperlipidemia, type 2 diabetes mellitus, GERD, hypertension, non proliferative diabetic retinopathy, sleep apnea presents to emergency room complaining of generalized fatigue and body aches ongoing for 2 weeks. Patient received Johnson and Johnson COVID-19 vaccine 2 weeks ago. Patient denies any fever or chills. Denies any chest pain or shortness of breath. No nausea or vomiting. Poor appetite. Patient had is the cardiac catheterization rehab post CABG, last session was 1 week ago. Denies any sick contacts. ED vitals stable, afebrile. Patient on room air. Labs remarkable for lymphocytes 15.3, monocytes 10.9, glucose 190, BUN 21, creatinine 1.3, sodium 133, potassium 5.3, chloride 97. Lactate normal at 1.6, troponin 14, Last A1c 6.7 from 12/19/2020. EKG no acute ST wave changes EKG changes. CTA chest no pulmonary embolism seen. Patchy airspace disease of the lungs suspicious for mild to moderate bronchopneumonia. Ultrasound Dopplers of the lower extremity right negative for DVT. COVID-19 positive. Patient received Rocephin, Zithromax in ED, ER asked to admit patient the hospital for observation due to ongoing fatigue and body aches from COVID-19 pneumonia.

HOSPITAL COURSE: The patient was admitted to the hospital with acute respiratory failure secondary to COVID pneumonia

Patient experience rapid heart rate / tachycardia 36 hours after receiving vaccine. Next day, Cardiologist diagnosed atrial fibrillation. Patient now taking digoxin. No improvement. 10 days following vaccine, at follow up appointment with doctor, doctor recommends cardioversion. Patient continues to experience dyspnea and atrial fibrillation.

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

No adverse event reported during home visit provided by RN on 5/26/2021 from 11:15am to 11:45am. VIS information given to patient prior to vaccination. Patient went to ER on 5/27/2021-5/28/2021 and reported that not feeling well. Patient discharged home from ER. Family found him dead in his apartment on 6/3/2021.

Coughing started about May 5, 2021, confusion started on about May 8, 2021, put on oxygen in Emergency room on May 9, 2021. Admitted to hospital where he stayed until his death on June 18, 2021.

73 year old male, vaccinated with the Janssen Covid-19 vaccine at the time of hospital admission (5/31/21) for a type 3 odontoid fracture; C2 vertebral body fracture extending into bilateral transverse foramina and nasal bone fracture from a fall from standing. Admitted to the trauma service for pain control. Noted to be somnolent throughout admission. On 6/2, developed AKI, likely related to dehydration vs. contrast nephropathy. On the early morning of 6/3, found unresponsive. Given naloxone 0.02 mg x 3 with no documented response. Transferred to the ICU, intubated and had PEA arrest on induction for intubation. CPR was initiated and he received epi x 1 with ROSC within 3 minutes. Remained intubated and sedated in the ICU with labile pressures on 2 pressors throughout the day on 6/3. The patient expired following compassionate extubation 6/3 2211.

Father received vaccine on May 13, 2021. Complained of migraine headaches, feeling tired, and generally unwell. Migraines became more persistent. Father died on June 16, 2021 at home. Coughed up blood and vomited around time of death.

Pt was in his usual state of health. He received the J and J Covid 19 vaccine on 4/29/2021. By Mid May pt c/o sudden decline c/o sudden abdominal pain and poor appetite and lost 9 lbs by the end of may. In June the pain and poor appetite worsened and he saw his primary care provider who recommended an abdominal u/s and then a ct scan which showed liver masses/lung metastasis and lymphadenopathy . She scheduled a PET Scan and biopsy but the cancer progressed so rapidly a full work up including a biopsy and PET scan could not be done and he expired the afternoon of 7/16/21. Comparing the 2 CT scans he had on 6/30/21 and 7/13/21 show that the cancer rapidly progressed from 6.5 x 8.4cm lesion in the right lobe of the liver with no adenopathy seen and pulmonary nodules suggestive of metastatic disease to in 13 days the lesion encompassing the entire R lobe of the liver and then measuring 14 cm with no rapid progression of diffuse adenopathy and possible lymphatic obstruction. He was not a smoker (quit over 30 yrs ago per family and only smoked while in the military) and did not drink alcohol. His family denies any history of toxin exposure and He worked as a prison guard and then as a teacher. He was active prior and actively golfed, worked in the garden and was active in the gun club. He had no hx of hepatitis C. He had a past history of Melanoma s/p local incision 2008 with no history of recurrence. He was compliant with annual dermatology follow ups with no signs or symptoms of recurrence.

Following the vaccination, individual ate lunch and then returned home. Later found deceased in chair in home ~8 hours after vaccine. No known symptoms. However no one was at home with individual for prolonged period of time during this time frame.

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

Hospice patient received Janssen vaccine on Friday and passed away peacefully on Monday. We don't think the death is related to the vaccine but reporting it since it happened less than a week after receiving vaccine

Massive heart attack due to blood clot. Heart Cath putting in a stint with over night stay in hospital

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

Patient was already in hospital for severe COPD. While there, he was given J&J Covid-19 vaccination. Approximately 11 days after vaccination, patient developed vomiting that could not be controlled. He later developed abdominal pain that worsened and also could not be controlled. Intravenous pain killers eventually hastened his passing.

13th of April. I had a blood clot in my hand. My index finger on my left hand was numb and black and blue all around the knuckle area and into my hand area. I went to my primary care - I went to the acute center there. She said the hand was cold and could see the black and blue. They put me on Plavix for 30 days and I haven't had any reoccurrence of that. I think it was the 21st, I couldn't sleep all night, I had a kidney stone - the pain was so bad I got nauseous - around my back and side and in my front. I didn't have a fever. I went to the doctor office and they checked urine - and said there was blood in the urine. I was prescribed - Tamsulosin HCL. They thought I had passed most of it by the time I got there.

Patient received covid-19 vaccine in left arm on March 9th. He alerted health care provider of left arm swelling on April 19th that started 4-5 days prior. There was no redness or warmth, reported as non pitting left arm swelling. Venous duplex revealed Left upper extremity DVT predominately effecting subclavian and axillary vein.

Patient developed shortness of breath with bilateral pulmonary emboli. He was hospitalized on 6/3/21 to 6/4/21 and was discharged home on blood-thinning medication.

Patient developed a lower extremity DVT approximately 2 weeks after receiving the J&J COVID-19 Vaccine. Patient was treated and discharged from our facility on apixaban.

Blood Clot leg/broke off went to lung Blood thinner Very weak tired cough Emergency room 4/72021 hospital two days 372021-3/9/2021

Initial Complaint of Constipation, admitted for altered mental status, respiratory failure, HTN, hypothyroidism. Information pulled from Report

He complained Fever and after that shortness of breath, and when I tried to see a Doctor he suddenly collapse and died

Patient seen in clinic on 04/07/21 reporting 2 weeks of right leg swelling and calf pain. Vascular ultrasound on 04/07/21 showed blood clots in legs. Lovenox injections started 04/07/21. Warfarin started 04/08/21.

4/7/21 patient presents to ED with severe left arm pain and neck pain, dopplar shows occlusive thrombus in left cephalic vein 4/9/21 patient goes in to cardiac arrest; found to have an INR>10 and concern for life-threatening bleed that required treatment with KCentra; intubated and sedated; liver shock, heart failure with reduced ejections fraction; troponin elevation 4/13/21: patient extubated; patient's wife informs Dr. that patient was vaccinated on 3/31 with Jansen product after seeing news reports regarding adverse events 4/16/21 patient expected to be moved out of CCU to medical floor

Not feeling well, malaise, fatigue, intermittent upper stomach pain (sharp) beginning day after vaccine administration lasting 8 days resulting in death on 4/10/21

patient had massive intracerebral hemorrhage 3 days after vaccination. family claims patient was doing well until vaccination. there is a suspicion that patient might have had sinus venous thrombosis that lead to the the ICH.

Deep Vein Thrombosis right leg. Five days after being vaccinated I began to notice swelling in my right leg from my knee through my ankle-foot area. There was an associated increase in pain in the knee. I tried to shake it off hoping that the swelling and pain would go away, but I finally relented to the concerns of my family and sought care on the 6th of April at the emergency room because my doctor refused an in-person appointment. The emergency room physician prescribed Eliquis which I have been taking. The swelling seems to have leveled off, but my right leg still appears to be twice the size of my left leg

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

Patient received 1 dose of Janssen vaccine at pharmacy on 5/25/21. Patient visited hospital emergency department on 5/28/21 after experiencing new a syncopal episode with abdominal pain and vomiting, then acute left-sided chest and arm pain after with new atrial fibrillation diagnosis which was managed. Patient revisited same ED later on 6/1/21 for significant fatigue/weakness and diagnosed with STEMI.