Johnson & Johnson

Patient became hypoxic with chest pain. Wheezing noted throughout lung fields. SPO2 80% on room air. Tachycardic 115 with decreased level of consciousness. Admitted to hospital with diagnosis of COPD exacerbation with Hyperkalemia (6.2). Currently stabilized on O2 at 3l/m

fever, chills, myalgias, SOB, increase in baseline cough. Some symptoms improving after 24 hours of onset but SOB and increase in cough still present at 72 hours post-vaccination.

Felt poorly with myalgia, weakness and chills on first day after vaccine that did not resolve. Developed severe shortness of breath and chest pain on day 9 after vaccine and found to be in atrial flutter with rate of 160 on day 10 after vaccine. Has long ho diabetes, but no cardiac history.

COVID infection post vaccination 1 day following vaccination, patient experienced fatigue, myalgia and low grade fever. RA test positive. That evening, patient with increasing SOB and increasing oxygen requirement and was admitted for hypoxia + LE swelling. Although SNF where vaccination took place denied symptoms at time of vaccination, per H&P, increasing oxygen requirements were noted 3 days prior to vaccination. See H&P below He is currently residing in a rehab facility following a hospitalization detailed below, but essentially he noted some shortness of breath about 4-5 days ago. They checked his oxygen saturation and noted that he was hypoxic, so started him on oxygen (reportedly 4L NC?). He reports a worsened productive cough; sputum is dark but not bloody in color. He has been fatigued and chilled; he thinks he's been intermittently febrile. No nausea, vomiting, or constipation. He endorses twice daily diarrhea, but he associates this with his bowel regimen. He also has a fair amount of lower extremity swelling which is bothersome to him; he says this has been ongoing since his MVA in January.[KE.4] He was recently seen in Nephrology clinic, where he was started on lasix 40mg daily and started on a low sodium diet[KE.3]. He is unsure if the lasix is helping his swelling, but does have robust urine output after he takes it

"Client received Johnson & Johnson vaccine on 3/19/21 and started with symptoms on 3/21/21, he assumed it was a reaction to the vaccine." Client admitted to Hospital on 3/29/2021. Per hospital 3/30/2021: Presented to the ER with SOB and low oxygen saturations that started on 3/30. The patient did not have any complaints of shortness of breath up until that morning. He received the Johnson & Johnson vaccine on 19 March, then developed fevers, fatigue the Wednesday after his vaccine and tested positive for Covid on March 26. Patient does complain of fevers of 103 at home. He resides at home with his wife who is also sick with Covid. He was admitted with Covid pneumonia and new oxygen needs. Tested positive on 3/26.

Approximately five minutes after vaccination patient began to appear sleepy while in observation area. I walk over to the patient and by the time I got to him the patient was unresponsive. His body was rigid and breaths were erratic. He regained consciousness after about a minute or so and appeared to be alert. EMT's then arrived and took over.

Immediately after giving the vaccine, the patient started sweating profusely and stated he had trouble breathing. He proceeded to pass out. The patient woke up within 30 seconds without the administration of an Epipen and was fairly alert. He continued to sweat and when EMS arrived he was reported to have a pulse of 54. BP was not reported

6 hrs after neck stiffness, Throat swell a little (like trying to get a cold, slight headache, 8 hrs headache worse took tylenol, 10 Hrs after felt like a migrane , felt blood pressure elevated & took Ibuprofuen 800 mg, that calmed my haeadache down , went to bed woke up in a sweat/ slight headache, after eating took another Ibruprofuen 800mg & by 4pm headache was minimal, took tylenol after that no more headache after 9 pm, More tylenol before I went to bed , woke up fine really tired did not go to work on monday, tuesday went to work still tired , wednesday woke up no problems felt refreshed.

4/10/2021 - Arrived in ED with weakness reported in R arm and Bilateral legs, Admitted into facility. 4/11/2021 - Neurology consulted expressed concern for AIDP, various neurological tests performed (MRI Brain, CT head and Lumbar Puncture). CVC placed for plasma exchange treatment 1/5 4/12/2021 - CT no acute abnormality, L.P. high protein. 4/13/2021 - Continued ascending Paresis. Monitored closely for Respiratory distress plasma exchange treatment 2/5 4/14/2021 - Plasmapheresis 3/5 performed. decreasing GCS intubated.

Patient phoned and reported continued headache since vaccination, SOB, and continuous watering of unilateral eye.

Patient has had severe headache since vaccine - starting day after - "worst headache of his life". Now has loss of smell, shortness of breath and nasal drainage

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

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

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.

Shortness of breath with a crackle sound which became more pronounced when lying down. I sat upright for about 1.5 hrs and respiration returned to a normal rhythm at which time I was comfortable enough to return to bed. I did not seek medical attention but monitored closely during that time and was prepared to go to the ER if necessary. As I write this I am at 22 hrs post vaccination. Respiration is fine, I have some discomfort at the injection site, a slight headache and some aches and pains which is expected.

Pt presented to the ED with complaints of increased SOB. Pt was found to have COVID pneumonia post vaccination.

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

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

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

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.

Patient was taken to the ER by his wife, on 4/12/21 with shortness of breath. He was sent home on continuous O2, which was never needed prior to his vaccination. Wife denies any chronic health conditions and reports that pt has been to more that one specialist because of his continued need to be on O2. She reports his saturation drops with minimal exertion and that the client has not even been able to return to work. When asked what the doctors had said, she reported that they blamed it on his weight. She reports that his weight has been the same since well before the vaccination.

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.

DIARRHEA; SICK; FEVER; COULD NOT BREATH DEEPLY; LOSS OF TASTE; LOSS OF SMELL; SALIVA LIKE FOAM; DRY COUGH WITH NO SECRETIONS; LOSS OF APPETITE; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced loss of appetite. On 27-JUN-2021, the subject experienced loss of taste. On 27-JUN-2021, the subject experienced loss of smell. On 27-JUN-2021, the subject experienced saliva like foam. On 27-JUN-2021, the subject experienced dry cough with no secretions. On 27-JUN-2021, the subject experienced could not breath deeply. On 28-JUN-2021, the subject experienced sick. On 28-JUN-2021, the subject experienced fever. On 29-JUN-2021, the subject experienced diarrhea. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Twice Negative. Treatment medications (dates unspecified) included: dextromethorphan hydrobromide/guaifenesin/paracetamol/pseudoephedrine hydrochloride, and guaifenesin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of taste, loss of smell, saliva like foam, dry cough with no secretions, and fever, and the outcome of sick, could not breath deeply, loss of appetite and diarrhea was not reported. This report was non-serious.

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.

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

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

Patient's wife contacted office after husband was taken to hospital due to experiencing chest pain and difficulty breathing. Upon admissions, she stated he was tested for COVID and the test came back as positive. Wife upset due to the belief that the shot has caused her husbands condition and that we should be aware that hospitals are still testing for COVID and considering it positive even though her husband had been vaccinated. I tried to explain that he had not had the two full weeks since being vaccinated to have full immunity and that he could have been exposed early enough that he was still able to develop into actual illness.

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

Headache, body ache, flu like symptoms, shortness of breath All within an hour afterwards and remaining still. Taking aspirin with no relief

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

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

Saturday evening May 1 I met with nine friends (all vaccinated) and ate a lot of food, drank moderately, and then did not sleep well. Approximately noon the next afternoon (Sunday, May2) while driving I noticed a developing dry-cough, chest congestion, and general fatigue. While camping that night I had some chills, thought I might have a bit of a fever, and had little appetite. I arrived home Tuesday, May 4 coughing a lot and very fatigued. Wednesday morning I went in for a Covid test. My cough and fatigue continued to increase along with muscle pain and headache. Wednesday night my fever topped out near 104. It broke and I felt much better but for the next few days (until around May 11) it fluctuated between normal and around 100-102. The Covid test came back negative but I went back for another just in case. It too came back negative. My temperature has now stabilized, the cough and congestion are mostly gone. I'm still a bit tired but feeling much better. It seemed like a case of Covid without the Covid. I am glad I got vaccinated but that was rough.

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

Chills at 12 hours after shot. Abdominal aches around the rib cage and gut starting 48 hours after shot. Aches were severe for 14 days, moderate for 12 additional days, mild for 10 additional days. Treated abdominal pain with Advil. Shortness of breath after mild exertion - like walking the dogs around the block. Shortness of breath still persists today after 5 weeks. I am concerned the shortness of breath may be due to a PE blood clot.

About 10 days after the shot I could not breath. It came on over the course of a few hours to the point that my doctor told me to go to the ER. There they administered a nebulizer and a prescription for prednisone for 4 days which helped. 24 hours after the prednisone prescription was complete, the breathing difficulty resurfaced and I was back in the ER again. This time they gave me a longer course of prednisone (10 days) that reduced over that time. Once that course was complete the breathing difficulty started again, but not to the point of an ER visit. My GP then prescribed a smaller dose of Prednisone over 6 days combined with an inhaler. That has helped. I don't really know if this is related to the vaccine. My suspicion is that the vaccine may have revved up my immune system and because of my autoimmune disease it attached my airway. But that is just a guess.

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

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

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.

I had severe shortness of breathe, rapid heart rate, bruising on the arm of the vaccinated. I still experience them to this day.

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

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

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

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

Male patient received vaccine in the morning, then around lunch time started feeling symptoms of headache, runny nose and ringing in ears. He then got shortness of breath, which got exacerbated so Pharmacy called ambulance and because patient became hypertensive , it was recommended he go to the E.R. Patient is currently at the E.R. at time of this report

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

puffy hands and feet (inflammation) -- shortness of breath (1 night), Headaches (mild), lethargy (2 days)

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

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

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.

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

hx RA on Humira, HTN, IDDM, obesity, OSA untreated, essential tremor, TIA's, recent J&J covid vaccine on 4/8. He began developing symptoms of covid on about 4/14, testing positive on 4/16. Presented due to COVID 19 symptoms including dyspnea.

I experienced day after vaccine, really horrible chest pains. I went to ER after 8 hours, and had blood pressure 160/100 and pulse of 120. They did x-rays, treated like a heart attack and gave me medicine for an ulcer and some other type of injection placed in IV line. On Sunday I have breathing issues, wheezing and could not catch my breath.

ITCHY skin Pins and needles in arms and legs I get feeling like I am being pricked with a pin several times a day in various places on my skin, arms, legs, neck, feet tired and fatigued difficulty breathing snoring

the patient tested for COVID-19 on 6/21/2021 and the result came positive , two days before testing the patient have SOB

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

abdominal pain fatigue leg cramps and severe head pain and shortness of breath i now have full blown stage 4 lung cancer that has spead to neck and lymph nodes on left and right sides i was perfectly healthy before the vaccine i blame all of this on the vaccine

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.

The patient presented to the ER after having the vaccine several hours earlier in the day complaining of chills, shortness of breath, chest tightness, abnormal jaw movements and twitching of his eyelids with uncontrollable movements of his eyes as well.

COVID LIKE SYMPTOMS, RUNNY NOSE, LOSS OF TASE AND SMELL, SHORTNESS OF BREATH, NAUSEA/VOMITING, STOMACH HURTS

3/19/2021 - Chills, high fever, body aches, shortness of breath, coughing, and headaches. Symptoms have continued to present date ( 4/13/2021). Taking tylenol, and prescribed medicines. 4/9/2021 - Bright red splochy band around right calf, still having fever, body aches, shortness of breath, coughing, and headaches.

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.

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

Client presenting for assessment of new onset cough that occurred past 5 days, denies recent illness or known exposure, recently been started on lisinopril. COUGH This is a new problem. Episode onset: 5 days. The problem has been unchanged. The problem occurs constantly. The cough is non-productive. Pertinent negatives include no fever, myalgias, rhinorrhea, sore throat, shortness of breath or wheezing. Nothing aggravates the symptoms. He has tried nothing for the symptoms.

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

I started getting a headache about an hour along with pain in the back of my neck and a mild headache after my shot (maybe an hour or so). Around 1100 hours, about the time I got back from the Facility, I began to feel a tightness in my throat and got a little raspy. When I drank water and ate a little, it hurt similar a hangover as if dehydrated, but went away after a minute or so. About 1400 hours began to develop chills, causing me to get into bed, and then the chills, overall muscular pains, very tired, moderate headache and some nausea ensued as well along with an initial low grade fever. Fever went up to 102.1 degrees and had fever till about 2130 hours and broken only after I took two (1) Tylenols. Still had a very low grade fever till about 2300 hours or so (99-100), but finally went away. I awoke next day (13 APR) about 0800 feeling a bit better, but with a moderate headache and touch of diarrhea. Headache lasted all day. This prompted me to contact my treatment facility and a telecall was conducted giving them my symptoms. They recommended Rizatriptan should my headache continue and Tylenol not enough to relieve. I cannot take any analgesics due to my liver disease and Thrombocytopenia. Finally my headache went away (with a slight hint it might come back), but no more fever, chills etc. On 14 APR, no more headache but still felt a little tired. From 15 APR through today (16 APR), no further symptoms and feel great, but prepared to report anything that may develop laer.

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.

Reported "feels like unable to get enough oxygen while breathing normally and labored breathing upon exertion," onset 4/15/21.

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

SHAKES; COULD NOT SLEEP; HOT AND COLD CHILLS; COUGHING WAS DRY TODAY BUT PRODUCTIVE YESTERDAY (STUFF WAS COMING OUT); LUNGS WITH BURNING SENSATION LIKE BRONCHITIS; SORE LUNGS; COULD NOT STAND UP; STOMACH ACHE; BURNING ARM FROM SHOT; PAINFUL /SORE ARM; NAUSEA; FEVER; This spontaneous report received from a patient concerned a 63 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported. batch number: 203A21A expiry: 23/JUN/2021) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced shakes. On 06-APR-2021, the subject experienced could not sleep. On 06-APR-2021, the subject experienced hot and cold chills. On 06-APR-2021, the subject experienced coughing was dry today but productive yesterday (stuff was coming out). On 06-APR-2021, the subject experienced lungs with burning sensation like bronchitis. On 06-APR-2021, the subject experienced sore lungs. On 06-APR-2021, the subject experienced could not stand up. On 06-APR-2021, the subject experienced stomach ache. On 06-APR-2021, the subject experienced burning arm from shot. On 06-APR-2021, the subject experienced painful /sore arm. On 06-APR-2021, the subject experienced nausea. On 06-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not sleep on 07-APR-2021, and lungs with burning sensation like bronchitis, stomach ache, and burning arm from shot on 11-APR-2021, was recovering from painful /sore arm, had not recovered from hot and cold chills, shakes, nausea, fever, and coughing was dry today but productive yesterday (stuff was coming out), and the outcome of sore lungs and could not stand up was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.

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.

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

Emergency room with symptoms of cough, fever, phlegm and sinus congestion since 4/14. He had an outpatient COVID test positive on 4/16. His fevers reoccurred so his PCP obtained a CXR showing atypical pnuemonia, started him on azithromcyin and solumedrol on 4/22. He presents today with worsening shortness of breath, now hypoxic on day 9 of his infection. He got the Johnson & Johnson vaccine on 4/7.

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

Four days after the vaccine I felt a little chest tightness but the next day it was very scary like a weight on my chest. I also had a cough that was an uncontrollable tickle and then I had trouble catching my breath. I went to the Urgent Care they just thought I had Acid Reflux.. Seven days after my cough was worse and I was very short of breath and I had very bad night sweats. I went to the doctor he gave me Asthma medicine. Two weeks after the vaccine I went back to the Urgent care and they thought Bronchitis. I went back to the ER and I saw a Covid-19 doctor and he thought I had Covid-19 symptoms. He gave me Prednisone and Azithromycin. I took the Prednisone for ten days and I finally started to feel better. I was trying to chew some fresh ginger helped the cough. I have a Heart Echo scheduled next week and I am still a little short of breath. Before the shot I used to walk two or three miles a day and go fishing every day but I can?t do that right now. At least I am back to 80% now which is better.

Shortness of breath; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included pulmonary arterial hypertension. The patient received covid-19 vaccine (suspension for injection, route of admin) and dose were not reported, administered on 2021 as prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included macitentan for pulmonary arterial hypertension. On APR-2021, the subject experienced shortness of breath. The action taken with covid-19 vaccine was not applicable. The outcome of shortness of breath was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.

DIFFICULTY BREATHING; LOSS OF APPETITE; DIFFICULTY SLEEPING; UNABLE TO TAKE KIDNEY MEDICATIONS; This spontaneous report received from a patient concerned a 63 year old male. The patient's weight was 180 pounds, and height was 75 inches. The patient's concurrent conditions included kidney failure, dialysis, non smoker, and marijuana drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 882A286 expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced difficulty breathing. On MAY-2021, the subject experienced loss of appetite. On MAY-2021, the subject experienced difficulty sleeping. On MAY-2021, the subject experienced unable to take kidney medications. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the loss of appetite, difficulty breathing, difficulty sleeping and unable to take kidney medications was not reported. This report was non-serious.

SLEPT ALOT; NOT FEELING WELL; FATIGUE; BODY TEMPERATURE OF 99.3 DEGREES FAHRENHEIT; LUNGS FELT HARD TO BREATHE; DIARRHEA; BAD BODY ACHES FROM HEAD TO TOE; VOMITING; HEADACHE; NAUSEATED; This spontaneous report received from a health care professional concerned a 63 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included cancer diagnosis: cutaneous lymphoma, and other pre-existing medical conditions included the patient had no respiratory issues, still maintained 92 oxygen saturation, but could not take care of himself and went out of it in 2 weeks. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 203A21A, expiry: 23-JUN-2021) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On DEC-2020, Laboratory data included: Body temperature (NR: not provided) 102 F. On 2021, Laboratory data included: Oxygen saturation (NR: not provided) 92 %. On MAY-2021, the subject experienced vomiting. On MAY-2021, the subject experienced headache. On MAY-2021, the subject experienced nauseated. Laboratory data included: Oxygen saturation (NR: not provided) 93-98 %. On 28-MAY-2021, the subject experienced lungs felt hard to breathe. On 28-MAY-2021, the subject experienced diarrhea. On 28-MAY-2021, the subject experienced bad body aches from head to toe. On 28-MAY-2021, the subject experienced not feeling well. On 28-MAY-2021, the subject experienced fatigue. On 28-MAY-2021, the subject experienced body temperature of 99.3 degrees fahrenheit. Laboratory data included: Body temperature (NR: not provided) 99.3 F. On 29-MAY-2021, the subject experienced slept alot. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient recovered from lungs felt hard to breathe, and diarrhea on 28-MAY-2021, had not recovered from bad body aches from head to toe, fatigue, and body temperature of 99.3 degrees fahrenheit, and the outcome of not feeling well, slept alot, headache, vomiting and nauseated was not reported. This report was non-serious.; Sender's Comments: V0- Medical Assessment Comment not required as per standard operating procedure ,as the case was assessed as non-serious.

The patient had symptoms start 5 minutes after the vaccine was administered. The patient was diaphoretic, his blood pressure dropped 20 systolic, he stated he was weak, he was dry heaving and having difficulty breathing. He was administered an Epi-pen by the nurse. The patient stayed in the office for 45 minutes and was evaluated by the physician. After waiting 45 minutes the patient stated he felt good and wanted to go home.

Shortness of breath and chest pains after routine workout at the gym. Got worse thru the day. Went to ER in the evening. Tests for heart attack and blood clots were negative. Sent me home next morning feeling slightly better. Next night (6/2) woke up at 3 am with shooting pains in right leg below knee. Back to ER where they repeated heart tests and did sonogram of leg. All normal. Sent me home again. Symptoms continue to this day with slight improvement. Have follow ups scheduled with Cardio and Pulmonary.

Tightening of chest Difficulty breathing Nausea Pain at injection site for over 7 days Fever Tired needing to rest

After receiving the vaccine with in minutes the patients left arm began to swell and bruise. He began to become pale and his eyes rolled back into his head and passed out. He woke up a min later and had SOB. Very pale and almost threw up. Paramedics and Firefighters were called. The eveulated the patients and gave him a liter of sodium choride. His Heart Rate was in the 30's. After several min and a liter of fluid, patient was alert. Once stable he was transported to Hospital.

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

COVID-19 (+) on 3/22/2021 Presented with hypoxemia, cough, dyspnea on exertion. Per ED report, patient had received the Johnson and Johnson COVID-19 vaccine on 3/6/2021 and started becoming symptomatic on 3/19/2021 with dyspnea, fevers, chills, fatigue and cough. He had reported resolution of his fever/chills, however his dyspnea and cough had progressively worsened. He then presented to the ED (3/25/2021 and discharged on 3/29/2021). In addition to his COVID-PNA, he also had a superimposed Pseudomonas PNA and was discharged on Levaquin and oral steroids (Dexamethasone) for a total of 10-day therapy.

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

pt says he had headache, fever, chills, leg pain and SOB. Pt is feeling some better but still has a headache. Pt wants to know if it is safe to take aspirin in case of chance of getting blood clots. Pt will contact his PCP for medical advice.

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.

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

vaccinated on 3/5/2021 with Janssen Covid vaccine. Developed symptoms of covid (runny nose, congestion, cough, shortness of breath) on 4/17/2021 after an exposure to covid.

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

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.

Diagnosed with Bradycardia; Dyspnea; Mobitz Type II A-V Block Low heart rate 30s-40s; Currently monitoring with outcome of pacemaker implant

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.

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

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.

Three weeks into the vaccine, I ended up having shortness of breathe when I laid down. It has eased up now a little. I started having an intermittent cough due to the vaccine (felt like my lungs were not feeling great) This occurred during the evening and at night when I would lay down to rest. I had a fairly mild case of COVID-19 (tested at the beginning) and quarantined for three weeks. A month later I took the blood test for antibodies (actually had COVID-19 last June which is nearly a year ago before taking the Janssen vaccine). My blood sugar is off the charts and my blood pressure has elevated since taking the vaccine (reason for awaiting an appointment with my doctor).

FALLEN SEVERAL TIMES; BARELY MOBILE; DIFFICULTY SPEAKING; SHORTNESS OF BREATH; BARELY ABLE TO SLEEP; HEADACHES; FEVER; This spontaneous report received from a patient concerned a 64 year old male other race and unspecified ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 in total administered to right deltoid on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced fever, headaches and shortness of breath. He stated that he was barely mobile (severe discomfort, feels like a handicapped, needs assistance to do anything) after receiving vaccination about 2 months ago. He felt like a handicapped person who needs assistance to do anything. He was barely able to sleep and found it difficult to speak. He stated he had fallen several times after receiving the vaccine. On an unspecified date, he had been hospitalized at 2 different hospitals and both instances did not help with his symptoms. He stated his HCP was aware and he could not help. He sounded to be in severe discomfort and as stated several times to fix it. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from barely mobile, fever, difficulty speaking, shortness of breath, headaches, fallen several times, and barely able to sleep. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: - fallen several times, barely mobile, difficulty speaking, shortness of breath, barely able to sleep. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). - headaches, fever. This event(s) is labeled per RSI and is therefore considered potentially related.

Heart rate 186, shortness of breath, profuse sweating. Successfully treated with IV adenosine [ADENOCARD]. Diagnosed as SVT (supra ventricular tachycardia), AKI (acute kidney injury), and dehydration.

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 or around March 19 developed a dry cough with shortness of breath. Was hospitalized on March 23 and diagnosed with interstitial lung disease and is currently on a ventilator. The diagnosis is unknown but suspected amiodorone toxicity or Sjogrens. Both are rare side effects. He is on high dose steroids and antibiotics but no improvement. Has never had lung issues prior to the shot. He has never smoked. Onset of disease was rapid and progressed quickly. Is it possible shot triggered the acute lung disease?

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.

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.

johnson and jonson vaccine. He received on 4/1 through the state. that night got chills. ha, n/v. the next day just tired. 2 days later got two pink bumps on his R elbow then enlarged. then developed more on other areas on his body. some have been present in one spot for a week. NO sob or rep sx. no pain. He carries an epipen for insect allergy. on 4/9 he developed sensation of throuat closingand administred an epi pen with relief and went to er. At the er he was given iv prednisone, benedryl and pepcid. He was dischared on a medrol dose pack 7 day. taper (3 days left) and refilled epipen. told to take benedryl. no sob. rash is now stable, no new areas x 2 days, larger areas are much improved..

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

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.

BURNING CHEST; FEVER; DIFFICULTY BREATHING; COUGHING; WHEEZING; FEELS LIKE SOMETHING IN THE BACK THROAT; TOTAL BODY ACHES; 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 pre-existing medical conditions included the patient had unknown allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 14:15 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced difficulty breathing. On 06-APR-2021, the subject experienced coughing. On 06-APR-2021, the subject experienced wheezing. On 06-APR-2021, the subject experienced feels like something in the back throat. On 06-APR-2021, the subject experienced total body aches. On 06-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced burning chest. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning chest on 09-APR-2021, and had not recovered from difficulty breathing, coughing, wheezing, feels like something in the back throat, total body aches, and fever. This report was non-serious.

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

DIFFICULTY BREATHING; CANNOT FINISH EXERCISES; WEAKNESS; SWEATING; NAUSEA (FELT LIKE VOMITING); FEVER; This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. The patient's past medical history included stage 3 colon cancer, and concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and had no history of drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced sweating. On 10-APR-2021, the subject experienced nausea (felt like vomiting). On 13-APR-2021, the subject experienced difficulty breathing. On 13-APR-2021, the subject experienced cannot finish exercises. On 13-APR-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, difficulty breathing, weakness, sweating, nausea (felt like vomiting), and cannot finish exercises. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.

Horrible instant pain when give. Started to feel suck in two hrs . Still very sick, very weak and cant do anything . Get winded .

Patient received the Johnson & Johnson COVID vaccine on 4/11/21 and developed dyspnea, fevers, and nonproductive cough about 2 days later. He continued to feel worse over time and presented to urgent care on 4/22/21. He had a chest X-ray done which showed bilateral infiltrates and he was found to be hypoxic, so he was sent to the ED. Patient was then admitted to the hospital for COVID treatment since he required 4 L O2 in the ED.

Per pt's wife - reported to pharmacy - 2 days after receiving vaccine - pt experienced shortness of breath, coughing, nausea. Patient was not feeling well in general. 2 days after this (so about 5 days after receiving the vaccine) - pt was COVID positive - and is at the moment in the ER.

Patient began having fever, chills, rash, and vomiting night of the vaccine (03/31). Patients symptoms have continued for almost 4 weeks (03/31-4/26)and have worsened. Unable to keep down any food other than saltine crackers and some ginger ale. Patient now has a cough, shortness of breath, and lower left abdominal pain. Patient has not been able to follow up with primary care doctor or lung specialist. Encouraged the caretaker to take patient to PCP, urgent care, or ER. Symptoms typically resolve within first week (fever, chills, and fatigue). Symptoms, especially, fever persisting with treatment of Tylenol and Motrin should be assessed ASAP. Waiting to hear back from doctor follow up and if there were any underlying causes for symptoms.

About 2 minutes after vaccine injection patient became pale, hands became cold and purplish. Patient's head leaned to the left side, started slurring and became unconcious while his eyes were open. I tried to get the patient's attention but saying "hello, are you still with me?" loudly and he did not respond. His eyes were still open at the time. At that point I yelled for help and other colleagues were calling "911" immediately. Based on store protocol and knolwedge of CPR and CDC guidlines, I checked for pulse and respiration - did not have any. I grabbed epinephrine injection 0.3 mg and injected him on left thigh. He immediately gasped for air, then started to faint again. His face color turned pale. At this point he is still sitting upright and EMT has arrived. His blood pressure was lower than normal based on EMT report. I called the patient on 5/12/21 (one day post-event) and patient reported no adverse reaction from vaccine site, he also reported taking 1.5 hours nap. The injection site on epineprhine injection was somewhat painful.

INCREASED SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic obstructive pulmonary disorder, occasional social alcohol user, smoker, and shortness of breath, and other pre-existing medical conditions included the patient had no known allergies and no known drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid, atorvastatin, budesonide/formoterol fumarate/glycopyrronium bromide, and hydrochlorothiazide/losartan potassium. On 14-MAY-2021, the subject experienced increased shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from increased shortness of breath. This report was non-serious.

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

DEHYDRATED; URINARY INCONTINENCE; PLEURISY; CHEST PAIN; This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. The patient's past medical history included neck surgery, back surgery, left knee replacement, and covid-19 infection, and concurrent conditions included alcohol consumer, non smoker, and heart patient, and other pre-existing medical conditions included the patient has no known drug allergies and drug illicit use. the patient also had 29 surgeries. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1802068, and expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. Concomitant medications included alprazolam for drug used for unknown indication, apixaban, clopidogrel, lisinopril, metoprolol, ranolazine, rosuvastatin calcium, and . On 31-MAR-2021, the subject experienced pleurisy. On 31-MAR-2021, the subject experienced chest pain. On 01-APR-2021, the subject experienced urinary incontinence. On an unspecified date, the subject experienced dehydrated. Laboratory data (dates unspecified) included: Chest X-ray (NR: not provided) Pleurisy on left lung, and Diagnostic ultrasound (NR: not provided) No abnormal finding. The action taken with covid-19 vaccine was not applicable. The patient recovered from pleurisy, chest pain on APR-2021, and urinary incontinence on 04-MAY-2021, and the outcome of dehydrated was not reported. This report was non-serious.

that night got a 102.7 fever / Trouble breathing / very bad chest pains . My wife called 911 , went to hospital next morning at 6:30 am , came home that afternoon then 8:30 pm that night called 911 again , was in 3 different hospitals for next 19 days . lost 30 pounds in hospitals, been home now

05/03/2021 Paresthesias both feet, weakness lower extremities. Increased heart rate. Shortness of breath when recumbent. Ataxia. 05/07/2021 Paresthesias both hand, fasciulations, tremors 05/21/2021 Evaluation by neurologist, Dr. Diagnosis

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

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.

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

Patient was being monitored for 30 minutes by EMS due to anaphylaxis to Shrimp. About 15 minutes into monitoring, the patient reported to EMS that he was feeling sweaty and had some shortness of breath. EMS reported BP to be 171/89 and pulse of 88. Patient stated that he does take blood pressure medication and reported that BP was elevated for him. EMS contacted ambulance for transport to Emergency room, patient in agreement to transport.

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.

About 2 hours after administration of the vaccine, veteran reported feeling throat tightness and chest tightness with difficulty breathing. He called 911 and taken to Hospital for acute treatment. He was kept in ED for several hours and discharged with epi pen and script for pepcid

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

Began to feel chest tightness, breathing a little harder than normal. Started to feel very tired the next day, extreme exhaustion. Had to go to bed. He continued to worsen with the exhaustion daily and now can barely get out of bed, or sit up. Before the vaccine he was not spending time in bed during the day. He now has trouble breathing sitting up.

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

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.

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

has the following symptoms: mild dyspnea;myalgia;headache;anosmia/dysgeusia Date of symptom onset: 05/08/21

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.

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.

Patient is a 66 year old male with diabetes and a recent history of stent placement on who received a dose of Johnson & Johnson COVID vaccine today (6/29/21). He also has a history of rash with soma. He was doing okay and talking to the nurse for 10 minutes post vaccine when he became unresponsive mid-sentence. After 1-2 minutes, he started to respond again, and noted that he felt his throat momentarily closed. However, sensation gradually improved. No nausea, vomiting, weakness on one side. After 20 more minutes of waiting, he reports his throat sensation has returned to normal.

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.

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

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.

In office patient evaluation performed 27 days after patient received J & J covid vaccine at a vaccine site. Symptoms at presentation were: 4 week history of post vaccine fatigue, decreased stamina, exertion related tachycardia, and dyspnea on exertion. Patient is a regular exerciser with a high fitness level. Exam was unrevealing. Lab testing included CBC CMP thyroid profile ESR C-reactive protein Lyme titers and D-dimer. All were normal/negative. The reportable lab findings were: SARS-COV-2 IgM and IgG antibody titers were zero on the initial evaluation. Six days later SARS-COV-2 IgG, IgM, and IgA titers were done at Lab. All titers were zero. So 4 and 5 weeks after receiving the J & J vaccine, this patient had no antibody response. He has no underlying disease process known to me to explain this finding. My concern is possible administration of faulty J & J vaccine which may have been distributed before the manufacturing error was identified.

The day after vaccination date patient began to have increased SOB and a headache (Pain Score of 6). Spouse checked BP which was WNL for patient. O2 sat was as low as 88% on room air. Patient then applied O2 at 2LPM via nasal cannula. O2 sats have maintained in the low 90's with home intermittent/on demand O2 in place. Has required O2 24/7 since day after vaccination. Headache has remained persistent with a pain score of 6 - unrelieved with routine scheduled pain medication, along with taking PRN Tylenol and Ibuprofen. Patient verbalizes more fatigue than usual for himself. Has had decreased appetite.

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

extreme fatigue, shortness of breath with exertion, weakness in arms and legs with tremors. occasional word finding problems , and cognitive fog. Startle reflex.

DIFFICULTY BREATHING; FELT LIKE KNIVES IN LUNGS.; This spontaneous report received from a patient concerned a 67 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included lung problems.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown) dose was not reported, administered on 2021 for covid-19 vaccination. Concomitant medications included risankizumab for chronic plaque psoriasis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers On 2021, the subject experienced difficulty breathing. On 2021, the subject experienced felt like knives in lungs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the difficulty breathing and felt like knives in lungs. was not reported. This report was non-serious.

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.

Patient developed acute onset bilateral anterior thigh pain that radiated to the lower back and buttocks, as well as in the posterior hamstrings. The pain was 10/10 and started suddenly over 1/2 days, described as sharp and stabbing in nature. He was able to ambulate but had extreme pain with hip flexion. Associated with this had unintentional weight loss of 10 lbs over 3 weeks, loss of appetite, drenching night sweats for 4 days prior to admission. He presented to the ED on 4/16 with negative work up and was discharged. He re-presented on 4/24 with the same symptoms and was admitted until 5/3. His pain was managed with oxycodone and extensive work up was pursued given concern for systemic inflammation with leukocytosis, elevated CRP, ESR, but normal CK. Eventually pursued thigh muscle biopsy which showed ". At last point of contact at 5/7, he described having two more episodes of bilateral thigh pain after discharge that lasted 30 min in the mornings, but had not had any symptoms the day prior to the call.

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.

Severe Immune Response. Fever, Rash, Itching, High Heart rate, Weakness, Shortness of breath. Treated at Emergency room May 09, 2021 Follow up office visit with Dr May 10, 2021 May 12, 2021 May 17, 2021 and June 03, 2021

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

Developed myalgias and joint pains approximately 48 hours after the injection, then improved. Then about a week after the injection, developed severe myalgias and joint pains. Treated with Medrol dose pack (6 days) with improvement. 3 days later developed pleuritic chest pain as well as shortness of breath. Presented 48 hours after this started for medical care and was diagnosed with acute pericarditis. Started on ibuprofen 600 mg TID and colchicine 0.6 mg BID with significant improvement in discomfort. Discharged from the hospital after 48 hours of observation. Did develop paroxysmal SVT which was felt to be 2/2 to the acute pericarditis. Started on metoprolol tartrate 50 mg BID to help with rate control and sent home with zio patch for additional cardiac monitoring.

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

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

Developed chest pains, Rehabilitation Center moved to hospital on 4/13/2021. Took a turn for the worse in the evening of 4/13/2021. Hospital found fluid on lung x ray. He was placed on ventilator overnight preformed CT Scan the afternoon of 4/14 and discovered several bloods clots In right lung. Patient still in hospital under sedation and on ventilator. Hospital has started him on Heparin.

increased respiratory difficulty beginning at 2pm on 4/7/2021. unable to improve or control respiratory distress overnite despite a change in meds and aggressive treatment at home. sent to emergency room at 0700 on 4/8/2021 at 0700 with acute respiratory distress and intubated. discharged to inpatient hospice on 4/12/2021, did have a prior intubation on 3/20/2021.

fever, shortness of breath, shivering, loose stools, loss of appetite, muscle aches, headache, extreme fatigue.

severe headache, abdominal pain, or shortness of breath and patient states they were consistent for 2 weeks and now they have passed

Flat red rash with bumps started on back day after vaccine. About one week later shoulder and neck pain. A few days after that chills and fatigue and increased neck pain requiring emergency room visit. Had fever, elevated BP and decreased oxygen level with extreme neck pain. Treated and released with medication. Negative CT of head and neck. Next day had extremely swollen uvula and sore throat requiring sleeping elevated to breath. Throat was not examined in ER night before. Unable to get up by himself and slept for 27 hrs except for occasional trip to bathroom. He is recovering now.

Persistent chest infection, difficulty breathing, (started two weeks after vaccine), given antibiotic (refused to take), 3 weeks of orange mass of stringy mucus (very unusual and severe), symptoms almost exclusively left side, steroid inhalants, inhaled iodine spray (seemed to help significantly)

THINNING BLOOD; TACHYPNEA; MUSCLE PAIN; WEAKNESS; This spontaneous report received from a patient concerned a 68 year old male. The patient's weight was 166 pounds, and height was 72 inches. The patient's past medical history included diabetic right foot neuropathy, and concurrent conditions included hypertension, type 2 diabetes mellitus, non smoker, and no alcohol use, and other pre-existing medical conditions included the patient has no known allergies. no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 206A21A, expiry: 07-AUG-2021) dose was not reported, administered on 02-JUL-2021 for prophylactic vaccination. Concomitant medications included insulin detemir for diabetes mellitus, insulin lispro for diabetes mellitus 2, enalapril for hypertension, and hydrochlorothiazide for hypertension. On 02-JUL-2021, the subject experienced thinning blood. On 02-JUL-2021, the subject experienced tachypnea. On 02-JUL-2021, the subject experienced muscle pain. On 02-JUL-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from weakness, muscle pain, and thinning blood, and the outcome of tachypnea was not reported. This report was non-serious.

Patient was exposed to a family member who was COVID-19 positive and tested positive on 7/16. Symptoms start on 7/16 with cough, fever, chills and SOB. Primary care doctor recommended he go to ED and receive casirivimab/imdevimab. Patient received the infusion on 7/21 morning. Then came back to the hospital in the evening due to worsening SOB and was admitted for hypoxia requiring oxygen. Patient was started on remdesivir (7/22) and steroids and lovenox (7/21). No longer febrile starting 7/23. Asymptomatic rash noted on patient's chest on 7/25 and no longer requiring oxygen.

Beginning 24 hrs post injection: every bone and joint in my body began to ache. Then incredibly painful bone pain in the chest - originally thought it was a heart attack. It is random and acute pain in the chest / rib area. It varies in duration and length of time between attacks. The pain is so acute it is hard to manage. Also this appears to have attacked my lungs as I am very short of breath and cannot do any exertion. The body ache, incredible chest bone pain, joint pain and difficulty breathing have continued as I finish day 6 post injection.

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

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

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

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

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

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.

PAIN ALL OVER BODY, FROM ANKLES UP TO HEAD (WORST BACK, CHEST NOT GOOD); SLEEPLESSNESS; FEELING LIKE DYING, NOT MAKING IT; SHORTNESS OF BREATH; NOT EATEN ANYTHING IN DAYS; This spontaneous report received from a patient concerned a 69 year old male. The patient's height, and weight were not reported. The patient's past medical history included horrible accident, right femur replaced, both ankles replaced, both knees replaced, and fuse lower back, and concurrent conditions included artificial hip, blurry vision, ptds (post traumatic demoralization syndrome), and panic attacks. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced pain all over body, from ankles up to head (worst back, chest not good). On MAY-2021, the subject experienced sleeplessness. On MAY-2021, the subject experienced feeling like dying, not making it. On MAY-2021, the subject experienced shortness of breath. On MAY-2021, the subject experienced not eaten anything in days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain all over body, from ankles up to head (worst back, chest not good), and the outcome of sleeplessness, feeling like dying, not making it, shortness of breath and not eaten anything in days was not reported. This report was non-serious.

Patient is a pleasant 69 year old male with PMH significant for recently diagnosed Kappa light chain multiple myeloma with extensive lytic lesions throughout skeleton at time of diagnosis, hyperlipidemia, who is a direct admission from office due to shortness of breath and acute hypoxia. Patient was evaluated at the office today and found to have O2 sats of 90% on RA at rest, however O2 sats dropped to 77-80% with ambulation and in need for 3L O2.

"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.

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

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.

At approximately 9:00PM om March 7, 2021 I started to feel very tired and was starting to have trouble breathing. My O2 level was between 89% and 91% and my heart was racing. The oximeter I have showed 98/99 BPM. I also had a temperature of 99.9 degrees. Most of these symptoms started to subside after about 2 hours

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

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.

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

Four minutes after his vaccination, patient reported feeling "hot", and sweating profusely. Some shortness of breath, and mild chest pain. Patient was responsive, and able to answer questions. By 2:50 PM, pt reported feeling "better" but still "groggy".

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

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

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

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.

Pt had COVID in January 2021 and was released from quarantine on 1/21/21. Patient has been short of breath since vaccine. Cannot pinpoint when it started. States he does have dementia which only effects his short term memory. He has been seen at the clinic and been given an inhaler to use. States his blood pressure has been elevated at times and O2 sats habe been in upper 90s but also dropped to upper 80s when short of breath. He had breathing test and an echocardiogram done

Patient developed cough, poor appetite, decreased po intake, altered mental status, failure to thrive, increased work of breathing, approximately three weeks after vaccine administration. He presented to the hospital where he was found to be covid-19 positive on admission. Patient is currently hospitalized (hospital day 1)

Patient is a 71 y.o. male with past medical history of a-fib on coumadin, ischemic cardiomyopathy s/p ICD, CAD s/p BM stent 2005, and CKD III who initially presented to urgent care per family recommendations d/t persistent cough, SOB and fatigue. CXR was obtained with findings concerning for viral pneumonia vs CHF, rapid COVID was negative at that time with recommendations to come to ED for further evaluation and treatment. Patient subsequently tested + COVID 19 in ED and was hypoxic with ambulation

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

LOST ABOUT 10 POUNDS IN LAST 2 WEEKS; RASH EPISODE ON BOTH FEET/EXTREME ITCHING TO THE POINT OF SCRATCHING TILL BLEEDING; WEAKNESS; SKIN FELT LIKE CREPE PAPER; FEET FELT COLD/WET FEELING IN FEET; FEET FELT SWOLLEN; CHARLIE HORSES WHEN KNEES BENT/HANDS CRAMP AND COULD NOT BENT; TINGLING IN THE FEET, SHOOTING SENSATION; SHORTNESS OF BREATH; SHOOTING PAIN WHEN LAY DOWN; This spontaneous report received from a patient concerned a 71 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, non alcohol user, and cat allergy, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, and batch number: 1821286 expiry: UNKNOWN) 0.5 ml, administered on 20-MAY-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid, diphenhydramine hydrochloride, and melatonin. On JUN-2021, the subject experienced shortness of breath. On JUN-2021, the subject experienced shooting pain when lay down. On 20-JUN-2021, the subject experienced tingling in the feet, shooting sensation. On JUL-2021, the subject experienced feet felt cold/wet feeling in feet. On JUL-2021, the subject experienced feet felt swollen. On JUL-2021, the subject experienced charlie horses when knees bent/hands cramp and could not bent. On JUL-2021, the subject experienced skin felt like crepe paper. On JUL-2021, the subject experienced weakness. On 04-JUL-2021, the subject experienced rash episode on both feet/extreme itching to the point of scratching till bleeding. On 07-JUL-2021, the subject experienced lost about 10 pounds in last 2 weeks. Laboratory data included: Weight loss (NR: not provided) 10 pounds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling in the feet, shooting sensation, shooting pain when lay down, shortness of breath, rash episode on both feet/extreme itching to the point of scratching till bleeding, feet felt cold/wet feeling in feet, charlie horses when knees bent/hands cramp and could not bent, lost about 10 pounds in last 2 weeks, feet felt swollen, skin felt like crepe paper, and weakness. This report was non-serious. This report was associated with Product Quality Complaint: 90000186747. The suspected product quality complaint has been confirmed to be voided (did not meet pqc criteria) based on the PQC evaluation/investigation performed.; Sender's Comments: V0; Medical assessment comment not required as per standard procedure as case assessed as non-serious.

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.

LEGS FEEL LIKE LEAD; PAIN IN THE JOINTS; CHILLS; DIFFICULTY BREATHING; COLD LEGS; LACK OF APPETITE; This spontaneous report received from a patient concerned a 72 year old male. The patient's weight was 170 pounds, and height was 72 inches. The patient's concurrent conditions included allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, expiry: 04-JUL-2021) dose was not reported, administered on 29-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-MAY-2021, the subject experienced difficulty breathing. On 29-MAY-2021, the subject experienced cold legs. On 29-MAY-2021, the subject experienced lack of appetite. On 29-MAY-2021, the subject experienced pain in the joints. On 29-MAY-2021, the subject experienced chills. On an unspecified date, the subject experienced legs feel like lead. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in the joints, cold legs, lack of appetite, difficulty breathing, chills and legs feel like lead was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.

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

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.

Developed symptoms of COVID on 6/24/21, cough, shortness of breath, sore throat, myalgias, and a fever.

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.

Acute - Got Johnson & Johnson COVID-19 vaccine this past Thursday - Thursday night starting cramping with abdominal pain radiating to the back; remained quite bothersome through Friday, Saturday, Sunday - Had nausea but no vomiting; mild HA - Some episodes of loose stools but no blood - No fever and chills but some diaphoresis - Has been drinking water but not eating - Has been a little bit of SOB and dyspnea on exertion - No lightheadedness, syncope or near syncope; no palpitations or chest pain - No clear alleviating factors, worsens when he drinks too much water - no recent history of alcohol intake

vaccine side effect. Patient reports slurred speech, difficulty forming sentences, SOB, R arm tingling x 3 hours. Patient reports symptoms have improved but not resolved. J&J vaccine today at 1045. Denies chest pain, N/V/D, HA, vision changes. Patient is a 74 year old male who presents to ED following a 10 second episode of right arm tingling followed by a 90 minute episode of difficulty finding words. This happened tonight at 8:30pm after dinner when he was with his wife. His symptoms resolved upon arrival at the ED at 10pm. He denies any weakness, no syncope, no chest pain or shortness of breath, no new visual symptoms. He does have a history of CHF, MI in 2013 s/p stend placement, he takes Plavix. He takes a beta blocker for PVC's. He reports he had a J&J COVID shot this morning at 11am and is wondering if his symptoms are a reaction to the vaccine. He is followed closely at Ajou hospital for all his medical care.

3/25/21 To er for eval of cough, chills, shortness of breath x 2 days. States he had Covid January 2020 that left his lungs in " bad condition". Had his Johnson and Johnson Covid vaccine 2 weeks ago. Has not been drinking or eating much in the last 2 days

Approx 10 minutes after injection, pt reported his lower checks were starting to itch and he felt a little swelling in his check bones. Pt also stated he wasn't having any trouble breaking, skin tone look normal, pt was able to communicate with no problems. He stated the symptoms he was experiencing were something he was used to. It happens to him when he eats chicken and certain kinds of foods (especially seafood/shellfish). I offered him benadryl and an ice pack while he was here. He refused the ice pack, but did agree to low dose of benadryl. He took one Allergy Relief 25mg softgel and then continued to set for a little over 30 minutes total before he said he was fine and left with his wife. I contacted him around 11:50am, he was doing fine and enjoying a good lunch.

4/6/12 ER HPI: 74 y.o. male who presents with complaint of shortness of breath that is worse after eating for 3 weeks. Patient said he had received a his copied vaccine 3 weeks ago. No cough, no chest pain, no abdominal pain nausea vomiting, no palpitations and no fever or chills Shortness of Breath: Started 3 weeks ago and getting worse. Received covid vaccine 3 weeks ago and started then. No cough. Dyspnea on exertion. No fever. Early am he has had runny noses. No inhalers or nebs. Not smoker

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

Patient presented to PCP on 05/21/21 from group home with C/O cough, dyspnea, fever, and chills with known exposure to COVID-19. Rapid test in office was positive for COVID-19. Chest Xray showed ground-glass opacities consistent with COVID pneumonia. Patient admitted to the hospital on 05/21/21

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.

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

the ability to take and sustain a deep enough breath to sustain oxygen level ONLY when reclining for sleep. During the day, while ambulatory, vertical or sitting, my breathing is normal. As soon as, immediately, when I get into bed for sleep, my breathing is immediately restricted so I cannot maintain lying down. I have to sit up. I can't sleep. I get exhausted by 3-4-5 a.m. and finally am so distressed I sleep in a sitting up position or catch a snippet of sleep up to an hour or so. Often wake up with panic attack of suffocating, sit up, jump out of bed, get vertical.

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

Patient received Janseen covid-19 vaccine in late March 2021. Developed cough and shortness of breath in mid-May 2021. Tested positive at urgent care around 5/21/21. States wife had cough 2 weeks prior (she was also vaccinated at same time he was; she did not get covid-19 tested). Patient was admitted to hospital on 5/23/21 with covid-19 pneumonia.

New / re-onset of asthma, dyspnea and tachycardia with minimal exertion, cough (persistent for 12 weeks, starting the night Pt received the vaccine and not resolving until early/mid-June). Pt had a remote h/o asthma as a child but had not had any flare-ups since he was 12 years old. He is a never-smoker and does not have COPD.