Johnson & Johnson

Loss of consciousness Client was said to have  passed out while sitting at the waiting area about 5 minutes after vaccination. He was brought to the First Aid area  on a wheelchair. Client was noted to having urinary incontinence immediately he arrived at the First Aid area. His head was repositioned and ice pack applied to his forehead and client  recuperated and started talking. Duration of witnessed episode lasted for 15 seconds . Patient claimed having similar episodes with last episode occurring 6 years ago while at work. Vital signs was taken, monitored for  additional 30 minutes and was driven home by his significant other. Vital signs recorded Temp: 96.9deg. F; BP: 102/62 MAP: 76; H.Rate: 78; Oxygen sat: 97%.  (Vasovagal syncope). Neurologic: Loss of consciousness (Comment: Patient had Vasovagal reaction with patient having urinary incontinence, lasting for 15 seconds 5 minutes after vaccination. Patient claimed having similar episodes 6 years ago. )

Metallic taste, slight headache and elevated blood glucose numbers (normal 80-120, one hour post no food prior 243)

"patient is observed in the recovery area pale and diaphorectic. v/s taken hr 71 initially,recheck was 51p. ,o2 sat ra 97%, b/p 100/60, resp 18. comfort provided. 13:00 v/s taken hr 80, resp 18, bp 120/80 o2sat ra 98%. still looking pale. comfort and support is provided. 1315 v/s taken hr 80,resp 20,b/p 130/80 02sat ra 100%. after comfort and support provided pt reports feeling well. 13:30 pt continues to be monitored for possible changes. patient reports feeling well. v/a taken b/p 130/80 resp 20,hr 80,o2 sat ra 100% is oriented, and released accompanied by a family member", RN - support staff

seconds after administration patient started losing consciousness. he stated he previously experienced vasovagal syncope after flu shots. he went in and out consciousness several times over the next 5 minutes. he lost color in face and eyes closed when head dropped. his body was stabilized and kept alert with verbal and physical tests. cold compress was applied behind neck and BP monitor placed on arm. he had normal BP/pulse. skin color gradually improved as well as mental acuity. patient could stand after approx 10m and was observed for additional 30m. his phone was used to call his wife and someone came to assist getting home. said felt fine after full observation time and seemed to have made full recovery.

Patient passed out about 5 minutes after vaccine, did not respond to stimulus, 911 called, pt woke up after about 10 seconds, blood pressure 110/58. Pt was awake for about 5 minutes then pass out again, this time was longer with no response to stimulus, patient was moved to the floor from a chair where he woke back up. EMS arrived and monitored patient.

Post-injection patient reported feeling hot, sweaty, dizzy, and flushed. Blood pressure was low. Patient began vomiting. Patient was transferred to a nearby doctor's office for further observation. Patient's symptoms resolved.

3 minutes after vaccination, I started to feel warm, sweaty, and tingling sensation. On-site nurses noticed I started to look pale and clammy and took me into evaluation room and checked my vitals. My vitals came back with low blood pressure and low oxygen levels. After resting and a cup of water, my vitals became all normal.

I started to feel really tired around 7:30pm and got a head ache so I went to bed early. I couldn't sleep well because I got the chills and a fever. I went to use the bathroom around 3am. All of a sudden I got really nauseous, the room spun, everything went black and I fainted in the middle of my bathroom. My wife woke up and helped me back to bed. The next day I was very weak and tired. The chills and fever faded the next afternoon.

Patient came in to the clinic to receive his dose of the Janssen COVID vaccine. Within the 15 minute post-vaccine period, the patient reported feeling warm, sweaty, having clammy hands, and the feeling of almost "passing out". Patient was taken to a patient room to rest, vitals were taken at 13:16 PM with readings of BP: 91/57, HR 72, SpO2 98%, temp 98.5. Patient denies any past medical history, reports he only takes vitamin supplements, and denies any past history of anxiety. He denied any chest pain or SOB. Patient was provided water and was told to rest for a few minutes. Vitals at 1:42 PM were noted to be: BP 108/71, HR 72, SpO2 99%, and temp of 98.1. He says he feels much better and denies any symptoms at this time. ER precautions were given to the patient Called patient again 4/2/21 at 09:59 AM - pt denies any ER visits, hospitalizations, or any visit to any other healthcare provider since his vaccine. The day after his vaccine, he says he developed a headache with left arm soreness (injection site was left upper arm) which was all improved by Monday, 3/22/2020. He says he took Advil, drank plenty of fluids, and rested for his symptoms of headache and arm soreness. He denies any other symptoms of near syncope after his near syncopal episode at the clinic. He denies any symptoms of fevers, CP, SOB, swelling, drainage, or pain at injection site, abdominal pain, dizziness, lightheadedness, or any other side effects/averse effects of the vaccine. He says he is doing well overall

Approximately seven minutes after the patient received the Janssen COVID vaccine, he had called out to his wife/pharmacy technician at the pharmacy stating he did not feel well. His head had fallen back and his eyes were starting to roll back into his head. Patient had saliva starting to foam at the corner of his mouth and it appeared to be the onset of a mild seizure (per wife, patient has had seizure once before after a head injury) and he was turning very pale. Patient seemed to be unresponsive at that time - not answering to questions. At this point, one of the pharmacists ran to the clinic to get help and the other pharmacist administered an Epi-pen to patient's thigh. Patient immediately came around after the injection, looked up and began talking. Staff called 911 and patient was monitored by pharmacy and clinic staff. When the paramedics arrived, the patient was doing better and was able to ride home with his wife.

Pt had a near syncopal episode. With hypotension post vaccinate. Recovered after 30 min went to the ER to get checked out

Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: PT HAS HISTORY OF FAINTING WHEN GETTING ANY INJECTIONS-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: THE PATIENT SAID HE HAS A HISTORY OF FAINTING WHEN GETTING ANY INJECTIONS (BLOOD DRAWS, IMMUNIZATIONS, OR ANY INVOLVING NEEDLES). THIS WAS NOT AN ACTUAL REACTION TO THE VACCINE.

Site: Bruising at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Severe, Additional Details: vasovagel reaction pt layed down on floor with legs elevated for 30 min felt better and coloring came back to skin and he was released, tried to call at 5 pm after clinic to follow up to see how feeling no answer on above phone number

Approximately 5 minutes after the patient received his vaccination, he rested his head on the wall behind him in the chair he was being observed in and passed out and turned white. His wife began slapping his face and screaming his name and the observer called for me. I arrived within seconds and assisted his wife in moving him from the floor to the chair. Within seconds of getting his head to the ground safely, he came back to and was very sweaty, red in the face. He stayed on the ground laying down, and then sitting for approximately 25 minutes. During that time, he told us that he had previously passed out during 3 procedures done at doctors offices. We got him an ice pack and a orange pop as he was complaining of being hot and having only eaten a granola bar all day. He was able to get up to a chair and sat there for an additional 5 minutes, before he was able to walk out on his own accord. I have spoken with the patient twice since, once last evening and once today and he reports he feels great now besides the expected body aches from the vaccination.

Vagal - passed out while driving to observation. Was assessed on site and refused medical treatment. Left against medical advice

Pt fainted in observation room approximately 5 minutes after vaccination in left arm. Pt lost consciousness for approximately 30 seconds. Pt able to converse with medical personnel after that time, able to sit up approximately 10 minutes after episode and able to walk to his vehicle approximately 25 minutes after episode. Pt driven home by spouse.

Ten minutes after the vaccination, pt passed out and came right back. He said he was fine except his hands were tingling. We called 911 and they took him for the vital.

Heart racing the next day after vaccination. I went for a walk in the park and i noticed my hear rate jumped up to 165bpm on my fitbit for a period of time even though i just began walking. I wasnt running or anything. I was foggy and very jittery. I also experienced the same symptoms today, 4.12.21 while also heading for a short walk. Im an athlete and in great shape and ive never had my heart jump to 165bpm just walking. That would happen normally after a sprint or long run, but not just walking.

I waited the advised 15min to assess any allergic reaction. I felt fine aside from a sore arm. I called my wife and drove home. Once on the freeway I felt dizzy. This came on me very fast. I thought I better get off at the next exit.. but instantly blacked out. While unconscious I struck another vehicle going approximatley 65mph, rolled my vehicle on its side, skidded, then rolled back upright. I awoke to my car spun sideways on the freeway, paramedics, and fire dept working the wreck from my window, and no recollection of what happend. It felt instantaneous to me. I ate a breakfast of granola, yoguirt. I hydrated before the shot. I even took extra Vitamin C.

Patient was vaccinated at a pharmacy around 9AM in the morning. An hour later, he was driving on a highway, had a syncopal event and was involved in a single-vehicle MVC where his vehicle struck a guardrail and rolled twice. Patient was brought to the ED at Hospital where he was evaluated by me in the ED. Patient had a normal mental status (GCS 15) and was alert and oriented on exam. He did have some bruising to his forehead from the airbag. Patient denies feeling ill or lightheaded after receiving the vaccine and reports the syncopal event came on very suddenly.

04/13/2021 - 03:30 PM - chills and feverish 04/13/2021 - later that night - severe chills like cold pulse originating from the toes and fever 04/14/2021 - 12.00 PM - reduced fever, chills reduced, tiredness 04/15/2021 - 1.30 AM to 6.00 AM - Severe chest pain, 04/15/2021 - 8.30 AM reduces pain 04/15/2021 - 11.30 AM self medicate Gas-X capsule 04/15/2021 - 1.30 PM self medicate Gas-X capsule

Dizzy; HOT FLUSHES FACIAL; ELEVATED BLOOD PRESSURE; This spontaneous report received from a pharmacist concerned a 40 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known medication and food allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 14:03 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021 14:15, the subject experienced dizzy. On 10-APR-2021 14:15, the subject experienced hot flushes facial. On 10-APR-2021 14:15, the subject experienced elevated blood pressure. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) elevated, and Oxygen saturation (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure, had not recovered from dizzy, and the outcome of hot flushes facial was not reported. This report was non-serious.

Patient reports he had chills and headaches the day after his vaccine. He is reporting SOB at rest that worsens on exertion since having had his vaccine. Pt also reports back pain and chest pressure since the day he got his vaccine

I was working at and, around 5:30 am when I felt some strong pain both side of my chest. Sonner I felt a slight headache and from time to time it intensified to become unsupportable. At that time though about a lack of oxygenation, because I wore mask for the whole time I was working. About 9:am when I drove to home, I saw everything foggy in front of me. When I get home I took some paracetamol and another painkiller, because at that time my entire body was so warm, and the headache was very bad. I slept for 5 hours, when I woke up I went to the mechanic to fix my car. While I got back during the time I saw the same foggy vision.

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

Unusual exhaustion within an hour of the vaccine. Had to go to bed and slept into the evening developing a fever of 103, severe thirst and chills. The fever lasted until 10:00 a.m. the following day, but weakness, thirst, chills and body aches continued for 3 more days intermittently. I would feel like I could finally exercise and then be too weak and tired to go back to routine. My appetite declined for 4 to 5 days as food didn't taste appealing. On Thursday, April 8, I announced to my mom in the morning that I finally felt like I was back at almost 100% and later in the afternoon felt nauseous, incredible pain in my chest and had dry heaves. I finally vomited some and was once again overcome by a fever of 101 and all I could do was sleep from severe exhaustion. I am against medication, but finally agreed to taking ibuprofen and tums. After sleeping into the next day around noon, I finally was able to eat some breakfast but the pain in my chest continued and I could rid it for another day. I intermittently had to sleep and gave up my exercise routine until my body has had time to recuperate. I have not fully recovered, but my appetite is picking up. I still require more sleep than normal.

Pain in chest and back began on Wednesday 4/14. What started out feeling like an uncomfortable pulled muscle in my back/chest area on Wednesday escalated rapidly to very sharp stabbing pains in my chest and back by Thursday afternoon 4/15. After discussing my symptoms with the office of my PCP Thursday afternoon, I was told to go to the Emergency Room for evaluation. I checked into the ER at approx 6pm that Thursday evening on 4/15. While there I underwent a blood test, EKG and a chest Xray. Upon evaluating the results of each test the Dr on assignment stated that there were no problems with major organs but could not diagnose. Small red marks began developing on the right side of my chest that same day and progressively expanded in quantity across the right side of my chest and back. A follow-up visit with my PCP was completed on Tuesday 4/20 and the diagnosis of Shingles was confirmed. Pain has not subsided and has only gotten worse as of 4/21. Prescription treatments began the evening of 4/20.

Drop in platelet count from 65k to 33k admitted to A County hospital two days after vaccine through emergency room. To increase platelets my hematologist recommend steroids Dex 40mg x 4 days and IVIG to bring my platelets up after they rapidly decreased after receiving the JJ vaccination.

Pain developed early on and persisted till ~ 3 weeks remains persistent. Went to internist following tests Positive ANA, Elevated RO-SSA >200, Elevated sed rate, Elevated crp, change in hgb from 14.9 to 12.7, low iron, muscle pain, bilateral leg swelling, joint pain, tightness, rash on both legs, ankle up to knee over 3-4 days, at four weeks out continued pain, weakness, and swelling. Persistent soaking night sweats and low grade fever in the evenings. Purple rash on arms and legs with nodules. Referral made to rheumatologist for further work up.

The evening of the vaccination I began experiencing tingling at the site of the shot, then this extended through the night to chest pains and tightness in the chest. That continued through the night and into the following day. The following day and lasting until present (4/27/2021) I have continued to experience tingling at night, extending to my arm and fingers, random very sharp pains in my chest, and some feeling of strong heart throbbing. This subsides during the day-time (when I'm upright versus lying down) but all of these symptoms return during the evening. These are all things I never experienced prior to the vaccine. Also, I have tested regularly for COVID-19 since my companyconducts covid-19 testing and I have not been infected with COVID-19 at any point during the past year. The continuation of these symptoms is concerning. There have been at least two instances where the sharp pains in my chest were much more intense than the other chest pains I have felt since the vaccine.

Patient lost conscience ten minutes after receiving j&j vaccine. Patient felt dizzy/lightheaded, lost pulse, required CPR and epinephrine. Paramedics were called to the scene, requiring hospitalization.

Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium

Pt experienced syncope episode directly after administration; Slow collapse to the floor; no associated trauma; Regained consciousness within 10-15 seconds; AxO within 1-2 minutes; BP 138/90; initially bradycardic in the 50's and increased in the 80's within 2 minutes; Blood glucose 130; Pt stated he did not eat any breakfast; Pt denied any discomfort after the episode; PO fluids and cracker tolerated well. Released after 15 minutes of monitoring without any issues.

patient complained of pinching at the site left arm deltoid and pressure to the chest area which lasted for 1 minute. Vital signs taken and EKG done. Sinus rhythm on EKG result. Patient discharged home.

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

TRANSIENT HEART PALPITATIONS; This spontaneous report received from a pharmacist concerned a 40 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included controlled hypertension, and smoking. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 27-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 27-APR-2021, the subject experienced transient heart palpitations. The action taken with covid-19 vaccine was not applicable. The patient recovered from transient heart palpitations on 30-APR-2021. This report was non-serious.

Patient within a few minutes indicated he felt dizzy and sweaty. I sat him down within minutes his eyes rolled back and he lost consciousness. He bagan to make gurgling noises as if trouble breathing. His color was grey and he was sweating profusely. 911 was called by a technician and I gave one dose of Epinephrine 0.3 mg into lateral right thigh at approx. 9:40 am. Within this period of time he began seizing. He regained consciousness prior to EMT's arriving and was brought to the hospital.

patient received the Janssen injection and at one minute became vagal and began vomiting at 2 minutes had a temporary loss of consciousness, EMS arrived at 4 minutes and patients heart rate was alternating between 20bpm-40 bpm. EMS transported to ED. Patient was discharged home at a later time.

approx 10 minutes after injection, pressure in head and chest, sweating, blue lips, and white face, mostly lost vision for 10 minutes. recovered at 10 minutes then just exhausted. better next day except fatigue.

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

I experienced after the vaccine, I got super sick for one to two weeks as if I had Covid again, had a terrible headache that has not gone away. Also have horrible vertigo, feel like I am spinning all the time and it has not gone away. I also had SOB and my heart was pounding for one week. My PCP told me that I should wait it out that it was probably my body revolving against the vaccine and I was prescribed a medication for my headache and vertigo. My ear were also checked with an ENT and I have no inner ear problems. I can say that my symptoms came from the J&J vaccine.

April 17th, felt chest pain and fatigue and shortness of breath. After about two weeks of it, I went to ER on the 26th. I was diagnosed with blood clot on my heart. I spent a week at the hospital Heparin blood thinners and antibiotics - discharged on May 2, 2021. They sent me home with Warfarin regiment. I am still on that. I still have some days where I'm good but some days, I can barely stand and get out of bed due to short of breath, fatigue but not as much chest pain. I think the blood thinners are working. I just have to take it easy and make sure to have some calm days. It could take weeks to months to have the blood clot totally dissolve from the system.

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

Patient received his Janssen Covid-19 immunization. The patient arrived at 11:00am on 6/1/21 and completed his pre-screening questions and temperature check. The patient then completed his "Patient Questionnaire and Consent Form." The patient was administered his Janssen Covid-19 vaccine around 11:05am. About 2 minutes after administration, the patient appeared pale and sliding out of his chair. The pharmacy technician responded and held the patient under his arms. The patient convulsed and then became unconscious. We called 911, checked the patient for breathing and responsiveness. The patient didn't stop breathing and became conscious about 1 minute after losing consciousness. We placed the patient on the floor and placed cold compresses under his neck and on his wrists. EMTs arrived and evaluated the patient and made sure the patient was stable. EMTs offered to take the patient to the hospital but the patient declined.

Shortly after receiving the Janssen vaccine, he saw his wife also receive the vaccine after which he felt extremely nauseous and looked very pale. His blood pressure was checked and measured 120/66, he said he was starting to feel warm but did not have any chest tightness, difficulty breathing, or swelling. After about 2 more minutes he said he was starting to feel better and then after 5 more minutes his blood pressure was 120/81, and he was starting to show more color to his face. He said he felt fine to leave. In hind-sight he stated that he has fainted in the past after seeing his wife receive a previous immunization as well.

While sitting five minutes after shot, pt turned white, eyes rolled back. Mother called for help. Reaction walking by an immediately laid pt on floor. Within approx. 10 seconds pt was awake, coherent, and speaking. Was mildly diaphoretic. Remained on floor for five min before sitting up. Still feeling fine up sitting up pt was AOx3. As precaution and at mother's urging pt was taking in wheelchair for brief observation and vitals check. 5:29 SEATED HR 77 RESP 12 BP 165/112 SPO2 99 5:30 LYING HR 69 RESP 12 BP 151/95 SPO2 98 5:35 LYING HR 70 RESP 12 BP 149/95 SPO2 98

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

Patient received COVID-19 vaccine. After approximately ten minutes of sitting in the waiting area, patient began feeling ill. As he was walking up to the drop-off window to tell staff how he was feeling, he fainted and hit the back of his head on the ground. Patient was unresponsive so 911 was called. Patient was extremely pale, hot, and clammy, but slowly started to regain responsiveness. Patient reported blacking out. While waiting for paramedics, two cold ice packs were applied to the patient's head and neck. Paramedics arrived and assessed the patient. They released him from their care as free to go. Patient sat down outside the pharmacy for approximately ten more minutes. Once he decided he was feeling better, he walked around outside the pharmacy until he felt okay to leave. Prior to leaving, patient reported he was feeling better and appeared to be in good spirits. He also reported having fasting labs drawn 45 minutes prior to receiving the vaccine, as well as low blood pressure at his doctor's office. He confirmed ability to drive. Patient left the pharmacy approximately 45 minutes after receiving the vaccine.

Sudden blood Pressure rise, tachycardia, Anxiety disorders. It happens randomly and sometimes wakes me up at night. These events have occurred around 6 to 7 times since the first episode.

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

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

Patient had vasovagal response to receiving the vaccine, became light-headed and briefly lost consciousness. We called Dr. in the attached office and his intern over to make sure Pt. was okay. Gave the pt water and he felt fine after sitting for ~15 minutes

MYOCARDITIS; COMPUTERISED TOMOGRAM; ELECTROCARDIOGRAM; This spontaneous report was received from a health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAER reference number 1395661) and concerned a 40 year old male of unknown race and ethnicity. The patient's height and weight were not reported. The patient had no medical history, no known allergies and no current illness at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 10-MAY-2021 to left arm for prophylactic vaccination. The patient had no concomitant medications. On 11-MAY-2021, the patient experienced myocarditis. He visited emergency room and underwent computerized tomogram (CT scan) and electrocardiogram (EKG); the results came up as myocarditis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from the events. This report was serious (Other Medically Important Condition).; Sender's Comments: V1: This spontaneous report was received from a health care professional via VAERS (ID: 1395661) concerned a 40-year-old man (ethnicity unknown) who experienced myocarditis one day after vaccine. The patient had no medical history, no known allergies and no current illness at the time of vaccination. The patient had no concomitant medications. On day 1, the patient experienced myocarditis. He visited emergency room and underwent computerized tomogram (CT scan) and electrocardiogram (EKG); the results came up as myocarditis. The patient recovered. Information is limited in this case, and the occurrence of myocarditis could represent background incidence of such events in the general population. However, a relationship with Janssen Covid-19 vaccine cannot be ruled out and thus the relationship is considered indeterminate. More information will be requested if contact information is available.

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

Consistent chest pressure beginning day 3 after vaccine. In good health with no previous heart issues. Scheduled appointment with cardiologist.

Pt was vaccinated without issue. Pt advised to sit for 15 mins. After being in observation area for 5 mins, pt stood up and immediately fainted and fell to the floor hitting head on floor. Pt had some bleeding from small laceration on head. 9:50am VS BP 130/80, P 60. Rescue called and was brought to ED for evaluation since he hit his head.

Clerk in observation noted pt looked unwell during observation. Per report no fall at time of reaction, pt was seated and did experience LOC.

Uneasiness/discomfort high up on the left side of the chest, slightly below shoulder. Feeling for a few days. On 5/30, it felt more pronounced and I felt I had difficulty to breathing. Hard to take deep breaths and feel as though I was getting enough oxygen. Was breathing mostly normal by morning. By the time I saw the doctor, only chest uneasiness was still there but not persistent as it once was.

SWELLING IN SPINE; INCREASED HEART RATE WHICH GOT WORSE WITH PHYSICAL ACTIVITY; PAIN IN LOWER PART OF BOTH LEGS; TINGLING IN LOWER PART OF LEGS/TINGLING IN TOES; HEADACHE; This spontaneous report received from a patient concerned a 40 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included no known allergies, no 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: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced headache. On 23-APR-2021, the subject experienced tingling in lower part of legs/tingling in toes. On 23-APR-2021, the subject experienced increased heart rate which got worse with physical activity. On 23-APR-2021, the subject experienced pain in lower part of both legs. On MAY-2021, Laboratory data included: Blood test (NR: not provided) Unspecified, MRI brain (NR: not provided) Unspecified, and Magnetic resonance imaging spinal (NR: not provided) Unspecified. On 03-MAY-2021, the subject experienced swelling in spine. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from increased heart rate which got worse with physical activity on 28-MAY-2021, and headache on 23-APR-2021, was recovering from pain in lower part of both legs, and tingling in lower part of legs/tingling in toes, and had not recovered from swelling in spine. This report was non-serious.

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

Woke up around 5:30AM having to go to the bathroom. Went to Flush the toilet and passed out on the floor. My wife found me unresponsive but breathing on the floor. My wife called 911 and was at the hospital around 6:15AM.

Upon wakening this morning pt reports L arm numbness, tingling and flaccidity. pt walked to kitchen and he began feeling sweaty and hot, the next thing he awoke laying in the floor after passing out . Pt was incontinent of urine during event. He now reports some mild shortness of breath but no acute distress or known injuries from syncope episode. pt advised to go to the ER. Pt's states his wife is on her way home and will drive him to the ER.

Pt passed put after vaccination with the Janssen COVID-19 vaccine. Roughly 5 minutes after administration of the vaccine, the lady who accompanied the patient got the attention of the pharmacist. Pharmacist ran out to assess patient and saw that he seemed unresponsive. Pharmacist then called for an EPIPEN, but pt woke up before the EPIPEN was ready. No EPIPEN was given. We then monitored the patient's BP every 10 minutes or so. Pt stablized after roughly 45 minutes to an hour and then left the store.

Felt tired at 2:15pm, stayed awake a bit longer than napped for a couple hours. At about 10:30pm I started feeling sick, fever of 99.6, muscle and joint pain, chills, dizziness, weakness. Left arm where I got injected also felt like it was falling asleep at some point when it shouldn't have been based on how I was positioned. I finally took an ibuprofen so I could sleep around 2:30am, and felt better a couple hours later or so. Today so far I feel fine but my resting heart rate is about 30 beats higher than normal so I'm still responding to vaccine. I think overall my symptoms aren't out of the ordinary, just way stronger than I was expecting. I felt miserable.

Patient passed out during the observation time. Patient was moved to the floor and feet were elevated. Patient regained consciousness and was monitored by the pharmacist. 911 had been called by the time patient regained consciousness. EMTs arrived and took over scene. Patient was able to walk with EMTs on his own. No medications were given by the pharmacy/pharmacist.

Vasovagal event with syncope and seizure activity fir 15 to 20 seconds Client stated he always responds this way to shots. Hx of TBI at age 4 years. Blood pressure 106/68 pulse 84 and 02 saturation 100%. EMS and Dr on site and client released when symptoms resolved. Advised to seek medical attention later if needed. Client verbalized understanding.

vitals were 155/104, HR 59 and SP02 94% at 11:37. Patient was getting ready to leave after waiting 15 minutes. patient walked to bathroom and started with chest tightness and SOB. Chest discomfort is rate 1/10, no HTN hx. Patient has hx of panic attacks. 1141 patient states the SOB of breath is better than it was when he was walking to the bathroom. Vitals were repulled at 157/98, HR 91. at 11:47 patient denies chest pain and SOB at time. patient having full sentence conversations and laughing. kept for 15 minutes and repeated BP last time: 1208 PB at 139/95, HR 88.

Severe Axillary Lymphadenapathy shown in left side, with pain radiating into back and chest. Slight Axillary Lymphadenapathy shown in right side, tender to touch. Moderate headache treated with ibuprofen.

PT PASSED OUT HAD LOW PULSE AND VASOVAGIL SYMPTOMS. WE CALLED 911 ELEVATED HIS LEGS AND GAVE HIM O2. PT REFUSED TO GO TO ER WITH THE AMBULANCE HAD A FAMILY MEMBER COME PICK HIM UP.

Received vaccine at 2:15pm , waited 15 minutes as recommended left the facility driving home started receiving warm tingly feeling, lost consciousness, drifted off the road crashed my vehicle into a tree head on collision 2:45pm. Cannot hear out of my left ear.

Chills, nausea and headache at 9pm, fever at 10pm peaking at 107.1° at 4am, blood pressure peaking at 216 over 103 at 8am. Fever persisted 41 hours, headache persisted 38 hours, nausea persisted 34 hours.

PATIENT WAS SEATED AND GIVEN VACCINE AND PASSED OUT IMMEDIATELY. PATIENT REGAINED CONSCIOUSNESS A FEW MOMENTS LATER. PATIENT WAS MOVED TO THE FLOOR IN SUPINE POSITION WITH LEGS ELEVATED. PATIENT STAYED CONCIOUS AND RECOVERED IN 20-25 MINUTES. BLOOD PRESSURE WAS 122/78, PATIENT REMAINED AWAKE AND ALERT. PATIENT LEFT STORE UNDER HIS OWN POWER WITH HIS SPOUSE.

I got the vaccine at about 12:55pm. About ten minutes after getting the vaccine, while sitting in a chair, I began to get tunnel vision and felt extremely tired. I broke out in a cold sweat all over my body. I began to lose my vision like I was fainting and I momentarily blacked out or dozed off, then came back awake. I started to get tunnel vision again for a minute, then it faded away. Then I continued sweating for a minute and then it faded away. After a couple minutes I felt fine again. I sat for another several minutes then left at 1:15 feeling ok with just a sore shoulder.

About 10 minutes after shot I asked patient how he was feeling, he said he was hot. I walked out to talk to him and he said he felt dizzy. He turned pale and fell sideways off chair onto floor lowering himself with his knee. He did not bump his head, he was sweating profusely, but did not lose consciousness. I yelled to the tech to call 911. Patient was sitting on floor. He said he did not eat much all day. He was alert and talking. He said he fainted when his wife had their baby. We gave his some orange juice. The paramedics arrived 8 minutes later and checked his vitals. In the meantime we called his wife. Paramedics checked his BP, glucose and questioned patient. Patient refuse to go with paramedics. Wife came and paramedics released him to her.

Patient received vaccine and was instructed to sit for 15 minutes as required for monitoring. About five minutes in, another patient who received the vaccine together with patient told us the patient had fainted. Patient was slumped over to the side when I came to check on patient. I called the patient a few times and patient started to come to. I asked the patient how he was feeling and if he had any difficulty breathing to assess for anaphylactic shock. Patient was breathing normal, but was sweating and a bit confused. Patient reported feeling dizzy. I explained to patient that he fainted for a few minutes and instructed to sit as I did not feel comfortable having patient lay down in the state he was in. Patient was given water and a fan to help cool him down and legs elevated (patient reported feeling much better with the fan blowing on him). Patient sat at the pharmacy for over 30 minutes before heading to the bathroom. At this point, patient were no longer dizzy and I instructed him to get up slowly and assessed that patient was no longer dizzy before letting him go to the bathroom.

Janssen COVID-19 Vaccine EUA: Vaccine recipient experienced near syncopal event and was monitored by medic for 30 minutes. There was no treatment given.

Patient was feeling warm and light-headed at 15 minute mark, so we kept for further observation and gave water to hydrate. At about the 17 minute mark patiently suddenly fainted in his chair for 15-30 seconds. He then began to vomit and woke up in the process. Once he fully came back to, he said he felt remarkedly better and no longer felt light-headed or clammy. Following this episode he reported feeling back to normal and that he had just ate a large breakfast before coming in for the shot, but did not feel bad in any way anymore. We observed for another 30 minutes and patient showed no further sign of issues. He was released with his wife.

About seven (7) days post vaccine injection I began to experience pain and numbness in both arms, numbness and swelling in my lips and face area and a feeling of indigestion/heartburn. I presented to urgent care and subsequently the emergency room on 03.27.2021 with those symptoms and was treated and released. The following day, the symptoms continued, specifically the pain and numbness in the bi-lateral arms and additionally began to experience pain in the chest area and increased resting heart rate (125+ bpm). Again presented to emergency room on 03.28.2021, treated and released.

Seizure and lost of consciousness 3 minutes after vaccine was administered. No treatment was given at pharmacy, but patient was taken by paramedics.

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

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

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

I received the dose at 5:35am on 3/6/21 went home slept most of the day woke up and felt tired, 8:00pm on 3/6/21 I left for work drove a few miles up the road and fainted and crashed my vehicle.

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

Injection Friday. No issues Friday, Saturday, or Sunday other than slight pain at the injection site and slight body aches on Sunday. Monday morning at approximately 0230 i woke up to what i can only describe as lightning pains in my legs. It was a very intense pain shooting from my upper thighs to my knees and slightly bending around to the top of my calves on the outside of the leg. Monday all day i did not feel well. Had a dull pain in center of chest, and my left arm from the shoulder blade to the elbow had what i can only describe as a slight warm sensation. I was also very "foggy" and light headed. On Tuesday the pain in my chest worsened. My left arm kept going numb (and still does today 04.21.2021), my jaw hurt, i was light headed and again very foggy. On Wednesday it was the same thing and I called the VA and they told me to come to the ER for evaluation.

Patient became pale, diaphoretic, and experienced a syncopal episode, laid flat and then had simple partial seizure lasting 10 seconds, became incontinent, IV started, A and O x4 , transported to hospital via ambulance

pins & needles sensation and "twitching" in muscles of bilateral lower extremeties, chest discomfort, abdominal pain, headache

HEART RATE INCREASED; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 41 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug or non-drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1502072, and batch number: 1502072 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021 21:05, the subject experienced heart rate increased. On 11-MAR-2021 21:05, the subject experienced chills. On 11-MAR-2021 21:05, the subject experienced fever. On 11-MAR-2021 21:05, the subject experienced headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 106.7 (units unspecified), and Heart rate (NR: not provided) 120 (units unspecified), 65 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart rate increased, and chills on 12-MAR-2021, was recovering from fever, and had not recovered from headache. This report was non-serious.

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

Bloody nose Left leg / foot pain Entire left side of body not correct Chest pain Shortness of breath Blurred vision Can't sleep

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

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

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

Woke up with shoulder pain the next day. Pain has now persisted for 6 weeks. In the last week has slowly migrated into chest and neck. No shortness of breath or any other symptoms. Somewhat relieved by ibuprofen. Ongoing

Approximately 8 minutes post-vaccination patient started to feel dizzy. Patient then got out of his chair to come tell the pharmacist (myself), during which time I witnessed him starting to sway and attempted to approach the patient. Before I could make it to the patient he passed out and fell to the floor, his bottom hit the floor first followed by his torso. I told the intern to call 911 and stayed with the patient. He never stop breathing and a pulse was always present. He attempted to get up moments after falling and I requested he stay on the ground. After a couple minutes he felt slightly better and I assisted him into a chair. At this point the paramedics arrived and took over patient care while I described

Systemic: Fainting / Unresponsive-Mild, Additional Details: Fainted. Responded after about 10 seconds. Has history of fainting / abscent seizures. Pulse and blood pressure normal immediately after incident occured.

I received the COVID Vaccine at 12:30 PM. My temperature had been increasing all afternoon along with my heart rate. At roughly 8:40 PM, my temperature increased dramatically to approximately 38.9C. This may have happened over a relatively short period of time, since it was 37.9 C at approximately 8:00 PM. My heart rate increased to 150 bpm and I became dizzy. After a minute, my heart rate decreased to roughly 115 bpm. Unsure whether to call EMS or not, I called a friend, who is a Dr. at the local hospital (Dr. is a colleague we do research together.) Dr. was concerned but provided information on what to do and when to call EMS or be driven to the ER. I spent the rest of the evening with a pulse between 105 and 110 and my temperature hovered around 38.9C until at least 12:30 AM. The next day, my heart rate had decreased to roughly 80 bpm and my temperature to approximately 37.8C. I spent most of Tuesday sleeping. Today (Wednesday May 12, 2021) my heart rate is down to roughly 76bpm. My temperature is holding around 37.2C. I have reported this to the CDC through the COVID vaccine reporting app. My resting pulse is usually 62 bpm with a waking pulse of 58-60. My normal temperature is 36.5-36.7C. I have a wellness exam schedule for Monday. Dr. is not my regular GP, but was available at a time when my regular doctor was not available.

Two days after the heart rate went up to 135 and I went to the ER. It was better the next day. By day 13 I started to get intermittent headaches that are very sharp. I am still getting them after three weeks. I have tried muscle relaxants and anti-anxiety medicine but they did not help. At night I am able to sleep but, in the morning, when I get up, I get sharp pains that are like ice picks and last for 3-5 seconds. Some of the headaches are more electric and as the day goes on it gets worse. I have tried taking Magnesium and Vitamin B-Complex and the headaches have changed to where they are starting in the afternoon instead of the morning. The headaches are a seven on a scale of 1-10. Sometimes the headaches come with a low grade fever.

April 30th began to notice dull ache in calf. At first assumed it was a muscle cramp. The pain began to increase through the weekend and into the following week. I went to urgent care on May 6th. They sent me to the ER to get an ultra sound as their preliminary evaluation was that it could be a blood clot. The ER ultrasound confirmed the presence of a superficial thrombosis in my left calf. No blood work was performed. I was told to take ibuprofen and use a heated compress and to wear compression stockings. If the pain grew worse, I was to return to the ER. I scheduled a follow-up with my Primary the next day. Blood tests show all values to be in normal range. I have no history of blood clots and perform cardiovascular exercise on a daily basis.

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

Patient was given the vaccine. After sitting in a chair for a few minutes post vaccination, he said he felt dizzy and then fell over and hit the floor face first but had blacked out and did not remember fainting or passing out. He was bleeding because he had hit his face and his lip was split and his tooth was chipped. He also continued to be very dizzy, was extremely pale, and was sweating profusely. The EMT arrived about 20 minutes later and took him to the emergency room.

Tingling in hands/arms/legs and head. Also have headaches and pressure in head, mostly on left side. Elevated heart rate and fatigue. Dizziness and lack of focus. Overall feeling that something is wrong.

3 days after injection of J&J Covid19 vaccine, I experienced heart palpitations for over 24 hours and went to the clinic for evaluation. A week later I experienced chest pain and was inpatient at the Hospital for 2 days. In patient, I had a variety of tests performed, including angioplasty where no blockage was found. EKG showed minor issue with ventricular palpitation. I almost fainted during my stress test, and tests showed low platelette count to check for CVST (I have family history of CVST). I am to see a neurocardiologist on June 16th for further investigation.

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

At approximately 1105, patient was vaccinated and immediately fainted in vaccination chair. Patient slumped over in chair for approximately 15 seconds and vaccinator held patient in chair. Patient was alert and oriented to person, place, time, and situation. At 1120, EMT assessed patient vitals: blood pressure 132/86 mmHg, pulse 94 beats/minute, and respirations 18 breaths/minute. Patient reported a headache and history of fainting when feeling nervous. Patient given water and assisted to cot to lay down. At 1135, patient vitals reassessed: blood pressure 128/56 mmHg, pulse 59 beats/minute, and respirations 13 breaths/minute. Patient reported his headache was "going away". At 1200, patient vitals reassessed: blood pressure 122/76 mmHg, pulse 61 beats/minute, and respirations 12 breaths/minute. Patient stated he felt "good". Lead nurse educated patient on signs/symptoms of when to seek emergency care, to sign up on CDC site, and to follow up with primary care provider. At 1201, patient left facility with steady gait and unlabored respirations.

Pt. didn't feel good after the shot. Pt. got out of his chair and fell to the ground. It looked like he passed out. We got medical attention and called 911. We also gave him water to hydrate himself. He was sweating. He needed time to recover while the fire dept came and help out.

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

FEELING FAINT, PALE, SKIN COLD AND CLAMMY, ICE PACK APPLIED TO FOREHEAD STATES FEELING FINE WENT HOME WITH FATHER

fainting multiple times, significant drop in blood pressure, sent in ambulance to ER, returned home that evening but remained very physically weak and had spurts of fever for several days following

Extreme increase in average blood pressure (ongoing and current). Approx. 120/75 to 150/105. I was proscribed Lisinopril.

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

Woke up on morning after shot with uncontrollable shaking. I ended up needing to lay under several blankets in order to feel warm and stop shaking. My temperature was normal and shaking was not due to a fever. The shaking stopped about 15 hours after I received the shot but then I continued to have a headache and extreme fatigue. The following day (about 48 hours after injection) I had an extremely high pulse. I took both my blood pressure and was able to take an EKG using a EKG recorder. Both devices came back that I was having an irregular heartbeat. I repeated both tests about a half dozen times and they kept coming up the same indicating an irregular heartbeat. I have never had an irregular heartbeat before in the past. Finally after a couple of hours my heart rate slowed and the irregular heartbeat went away. As of right now (6 days post injection) it has not come back.

Patient fainted a short period after receiving the vaccine. Pt was in a seated state when adverse event occurred. Recovered after 15 minutes.

SHAKY HANDS AND LEGS; CANNOT WORK; CANNOT EXERCISE; MUSCLE PAIN ON FEET AND LEGS; MUSCLE WEAKNESS/WEAKNESS ON FEET AND LEGS; NUMBNESS ON NECK, CHEST, ARMS, FEET AND LEGS; STOMACH PAIN/BURNING SENSATION; COLD SENSATION COMING FROM INSIDE OF BODY LEADING TO HEART; PAIN AROUND HEART, SHOWING UP INTERMITTENTLY; DIZZINESS; HOT SENSATION OVER FEET AND BODY; BACK PAIN ON KIDNEY AND LUNGS AREA; PAIN ON FEET AND HANDS/ PAINS WORSEN AT NIGHT ON FEET, HANDS, LOWER PAIN, AND UNDER ARMPITS; BURNING SENSATION ON FEET AND HANDS; MUSCLES SPASMS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 41 year old male. The patient's weight was 134 pounds, and height was 155 centimeters. The patient's past medical history included covid-19, and covid-19 like symptoms, and concurrent conditions included tomato allergy, alcohol use, non smoker, and gum infection, and other pre-existing medical conditions included the patient has 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: 205A21A and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced muscles spasms. On 17-APR-2021, the subject experienced pain on feet and hands/ pains worsen at night on feet, hands, lower pain, and under armpits. On 17-APR-2021, the subject experienced burning sensation on feet and hands. On 18-APR-2021, the subject experienced stomach pain/burning sensation. On 18-APR-2021, the subject experienced pain around heart, showing up intermittently. On 18-APR-2021, the subject experienced dizziness. On 18-APR-2021, the subject experienced hot sensation over feet and body. On 18-APR-2021, the subject experienced back pain on kidney and lungs area. On 18-APR-2021, the subject experienced cold sensation coming from inside of body leading to heart. On JUL-2021, the subject experienced numbness on neck, chest, arms, feet and legs. On 01-JUL-2021, the subject experienced muscle weakness/weakness on feet and legs. On an unspecified date, the subject experienced shaky hands and legs, cannot work, cannot exercise, and muscle pain on feet and legs. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Unknown, Stool culture (NR: not provided) Unknown, Tuberculosis test (NR: not provided) False-positive, and Urine culture (NR: not provided) Unknown. Treatment medications (dates unspecified) included: omeprazole, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numbness on neck, chest, arms, feet and legs on JUL-2021, dizziness on 19-APR-2021, headache on 13-APR-2021, and fever on APR-2021, had not recovered from stomach pain/burning sensation, pain on feet and hands/ pains worsen at night on feet, hands, lower pain, and under armpits, muscle weakness/weakness on feet and legs, pain around heart, showing up intermittently, muscles spasms, hot sensation over feet and body, back pain on kidney and lungs area, shaky hands and legs, burning sensation on feet and hands, and muscle pain on feet and legs, and the outcome of cannot work, cold sensation coming from inside of body leading to heart and cannot exercise was not reported. This report was non-serious.

have been extremely fatigued, headaches, muscle aches, swelling in my fingers (joints), weak, dizzy, weird feeling in my chest

Approximately 10 hours after receiving the injection, I experienced extreme chills, nausea, elevated heart rate. The last time I experienced symptoms like this was on the first day I started chemotherapy and had an allergic reaction to one of the chemo drugs (bleomycin). I had a delayed reaction hours later and went to the ER. It was determined it was an allergy. So I took Claritin D 24 H and saw the symptoms I was experiencing last night dissipate.

Patient received Janssen vaccine was told to sit for 15 minutes post observation. He came up shortly after (less than 5 mins post imz) saying he didn't feel well, like he was going to pass out. I immediately came from the pharmacy, my tech sat a chair behind him. I called for optical to call a code white. The patient requested to sit on the ground. At this point, his wife was present. He was sweating. I gave him an ice pack, a water after it was determined he was breathing okay. He was pale, extremely lethargic and sweating. After sitting him on floor I told my tech to call 911. I took his blood pressure, it was 99/73, pulse 75. Very low for him. Hes on blood pressure medicine but been having issues controlling it. He later tells me hes terrified of needles. He also tells his wife he hadn't eaten all day. I stayed with the patient until ems left with him because when standing his heart rate dropped 20 points, after they stuck him again to check his blood sugar. They determined then he should be checked out at the hospital and they took him.

Patient passed out immediately after being administered the vaccine as he walked to the observation zone of the ware house. He was caught from behind by pharmacy technician on duty. He was able to respond to questions about his name, where he was and what he was there for. His blood pressure reading was showing "out" on the wrist cuff. Five minutes later the blood pressure was 127/68. Thirty minutes later his BP was 160/84. He called his dad who picked him up

Notified by pharmacy technician that patient had 'passed out' in parking lot. Patient found lying on the ground, pale but awake. Patient had been instructed to wait in the store for 15 minutes after vaccination in case of any adverse reaction but, per police, decided to wait in the car instead. He then began to feel lightheaded and decided to come back into the clinic. He passed out on his way. Civilian notified policeman that patient was passed out and EMS was called. EMS arrived shortly after I went out to parking lot to check on the patient. Patient was alert and oriented for EMS, reported history of HTN. He continued to c/o feeling lightheaded and BP per EMS was 77/48mmHg. Patient taken by ambulance for further evaluation and treatment.

Immediate(3-5 seconds) and rapid injection site swelling and redness, bleeding more than usual from a shot, dizziness, full body sweating, rapid heart rate, hives, as well as general body swelling that caused great difficulty in starting an IV. I did not have any significant issues with breathing. They treated me with a IV fluids, an intramuscular injection and IV injection of Benadryl and a steroid that I cannot recall the name of, I apologize.

Pt had a syncopal episode following covid-19 vaccine. Pt states he has had similar episodes following needle injections. Pt was closely monitored for 30 min following syncopal event. Pt stated that he felt much better and was discharged home.

Around 8pm I became very cold and tired. I took a bath, which is out of character, and tried to sleep. By 9 pm I was alternating between hot and cold sweats. By 10 pm I was vomiting and defeating uncontrollably while still alternating between hot and cold sweats. I dry heaved until around 3 am and then finally passed out. My fever never exceeded right about 100 degrees. For the next 2 days I was incredibly exhausted with muscle aches and a minor headache. I didn?t return to baseline for approximately 6 days after the shot.

Symptoms onset approx 10 hours after dose. Fever of 100.6*F; mild headache; moderate fatigue; elevated heart rate (90-115bpm at rest). Reports felt like active flu. Symptoms persisted for approx 12 hours.

For the 36 hours after my vaccine, I had commonly listed side effects; chills, aches, and shivers. These subsided, and I developed a cough for the next 3 or 4 days. This developed into more of a chesty feeling and lethargic feeling. On the 8th day after my vaccine, my symptoms were similar to those in Covid positive cases; chest tightness, dry cough, and chills. I went to get tested, and was found to be Covid-19 positive. Since then, I have experienced severe headaches, continued tight chest, cough, chills, and sweats.

Patient fainted about 2 minutes after vaccination. Was awake and alert within 2 seconds after fait and falling from observation chair.

KNOT ON LEFT ARM; OFF LABEL USE; INAPPROPRIATE ROUTE OF VACCINATION; INCREASED BP; INCREASED HEART RATE; DIZZINESS SUNDAY AND MONDAY; PAIN IN ARM; DONT FEEL WELL; SOME NAUSEA; TINGLING OF HAND; This spontaneous report received from a patient concerned a 42 year old male. The patient's weight was 239 (unit unspecified), and height was 5 (unit unspecified). The patient's concurrent conditions included allergy, thyroid, sinus infection, elevated growth hormone, non-alcoholic, and non-smoker, and other pre-existing medical conditions included the patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intravenous, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on left deltoid on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced tingling of hand. On 27-MAR-2021, the subject experienced off label use. On 27-MAR-2021, the subject experienced inappropriate route of vaccination. On 27-MAR-2021, the subject experienced increased blood pressure. On 27-MAR-2021, the subject experienced increased heart rate. On 27-MAR-2021, the subject experienced dizziness Sunday and Monday. On 27-MAR-2021, the subject experienced pain in arm. On 27-MAR-2021, the subject experienced don't feel well. On 27-MAR-2021, the subject experienced some nausea. On 28-MAR-2021, the subject experienced knot on left arm. Laboratory data (dates unspecified) included: EKG (NR: not provided) clear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness Sunday and Monday, and had not recovered from knot on left arm, tingling of hand, pain in arm, some nausea, increased blood pressure, increased heart rate, don't feel well, inappropriate route of vaccination, and off label use. This report was non-serious.; Sender's Comments: V1: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.

3/13/2021 began having right forearm wrist was sensitive to touch and skin clammy. 3/14/2021 still clammy in both hands. 3/15/2021 whole body clammy and sticky. Both shins and ankles had burning sensation. 3/17/2021 both ankles painful mostly at night. 3/18/2021 both ankles, shins and legs painful all day. Unable to sleep at night. 3/19/2021 left work early due to nauseated, headache and pain and burning both legs. Blood pressure elevated. 3/20/2021 head pounding and elevated rate and nauseated. Went to ER for continued leg/shins burning and pain. ABI was normal. Diagnosed with neuropathy. 3/23/2021 blood pressure elevated due to pain 3/24/2021 pain to legs and shins continue below know. pain scale 5. 3/26/2021 pain to legs and shins pain scale 7 3/27/2021 pain to legs and shins pain scale 3 3/29/2021 burning and sensitive legs. Sensitivity now present in both arms. 3/30/2021 burning to forearms and legs 4/1/2021 pain scale 3 burning pain to forearms and legs. 4/4/2021 improved pain 4/5/2021 tingling resumed to legs and calves. Pain scale 4. 4/6/2021 sensitive/burning bilateral forearm and wrist and bilateral legs. 4/7/2021 left leg burning more and feels warm. Back ache began 4/8/2021 both legs still burning and tingling. Heart rate elevated. Back pain continues.

Patient received covid vaccine at 12:56pm on March 31, 2021. At 1:00pm he sat down on the floor. He remained conscious but complained of feeling dizzy. HR was 40. Staff was able to assist pt into a wheelchair and escort him into a private side room. Pt was assisted onto a cot and his legs were elevated. At 1:05 his BP was 130/75 and HR 60's. Patient's skin at 1:06pm appeared pink and WNL. 1:13pm = BP 115/75 and HR 67. 1:23pm = 130/75 HR 68. Patient denied shortness of breath/chest pain throughout the entire episode and did not lose consciousness. At 1:23 patient stated he no longer feels faint, just a bit weak. At 1:24pm patient dangled on cot. 1:27pm = 130/80, HR 70. 1:33pm = left facility in the care of his mother who is driving. He stated he feels a little weak, but not faint or dizzy. He left ambulatory. He refused transport or the need for additional medical care. Follow up call was placed to pt on Friday, 4/2/21. Pt denied any residual effects and stated he is at baseline.

He got cold and clamy and passed out in the chair with head slumped. His wife rubbed his chest and spoke to him and I, waved ammonia inhalants under his nose. He immediately came to. We got him a bottle of water and a snack (he had not eaten yet today). I also checked his blood pressure and it was normal. We had him sit a little longer until he felt better. We initially called an ambulance, but called it off at his request.

Drop in blood pressure on the day of vaccination, hives and swollen face/eyes several days after the vaccine, headache and weakness for several days after injection. Resolved after about a week.

About 10 minutes after receiving the shot, patient felt dizzy. He continued walking and fainted. He was caught by his wife and was let down to the floor. After resting, he regained consciousness. After resting longer, he felt better and was able to leave on his own. After about 2 hours, he said he felt fine and had no lingering effects.

Fainting. Patient fainted for about 30 seconds after immunization. Responsive and alert after fainting spell. Watched for additional time, gave water.

Vasovagal / syncope episode with subsequent fall to the ground, striking head; taken to the Emergency Department, stated prior to syncopal episode felt lightheaded, sweaty, clammy. Patient discharged to home within 3 hours of ED admission.

Vasovagal / syncope with subsequent fall to the ground, striking head; transferred to Emergency Department - stated lightheaded, dizziness, clammy prior to syncope and fall. Patient discharged to home in stable condition from facility within 3 hours.

Severe leg pain first, then trouble breather. Shortness of breath and tightness in chest. Thought it was severe congestion... delayed going to the ER. Finally went in due to vomiting trying to get breath. Had LAD 90% blocked and blockage in the right leg still in hospital receiving treatment. Will Catheter scope the right leg to very clots and severity.

Started feeling dizzy and started to respond slowly to things and felt weak around 8pm. Shortly after these symptoms I begin to have uncontrollable chills followed by a fever and Nausea. The whole time starting around 8pm I had pretty bad muscle aches as well. I took a warm shower and bundled up the whole night because I had a fever, aches, chills, and nausea. It was impossible to sleep because of this and sometimes my heart was beating fast as well. The next morning I had a headache that would not go away until I took Tylenol. The whole next day I felt exhausted as well and very weak. I began to feel better on day 3 but still feel somewhat foggy from the shot. I would not recommend this vaccine to anyone and would never get it again and hopefully the foggy sensation goes away.

About 45 minutes after, my left arm started to feel like there was pins and needles all the way down to my finger tips, and I started to feel very lethargic on and off for 2 days and I also had a few rounds of tachycardia. As of Monday I have developed severe lower back pain

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

At the day of vaccine the only side effect was arm sore and tingling on the face. On 04/14/2021 I was at the doctors clinic for an appointment and suddenly felt tingling on the left side, temporal area, after some minutes start having rapid heart rate and blood pressure was high, felt lightheaded, weak. The symptoms last for few minutes.

Received vaccine 3.24.21. Had been incarcerated / in prison system until 4.7.21. Complex past medical history. 4.10.21: Went to ED on 4.10.21 - for hematuria. CHIEF COMPLAINT: BLOOD IN URINE (patient reports hematuria an hour prior to arrival along with spitting up a large clot (hemoptysis). denies rectal bleeding at this time. denies being on a blood thinner. c/o back pain starting a few hours ago. HX aortic aneurysm and scheduled to get surgery in a few weeks. )Urinalysis returned showing moderate amount of blood was 73 RBCs. Patient did not have frank hematuria on specimen. Patient's laboratory work otherwise remains unremarkable. Electrolytes within normal limits. Patient has a stable hemoglobin of 13.8. CT scan showed evidence of acute aortic dissection. There were scattered faint ground-glass opacities along the right upper lobe as well as left upper lobe. COVID-19 testing was added on after results. At this time I do not have a great explanation for the patient's hematuria. I did instructed to follow up with Urology for further evaluation of this. He is hemodynamically stable I do not believe further testing is warranted at this time. Return precautions were discussed including urinary retention, large volume bleeding or any other concerning symptoms. He voiced understanding of this and was discharged stable condition. He was provided a work note as he is on probation and it is for her of his hospitalization at this time. 4.13.21: Went to ED on 4.13.21: CHIEF COMPLAINT: LEG PAIN (pt c.o. right leg swelling/pain that started 3 days ago; had johnson&johnson vaccine on 3/24 and is concerned for blood clots; supposed to have surgery at the end of the month; recently seen for blood in urine; c.o. generalized body aches)42-year-old male presents with right calf pain and reported swelling. On presentation patient is well-appearing and nontoxic, afebrile, hypertensive 134/113 with otherwise normal vital signs. On exam, the patient has no swelling in the bilateral lower extremities, he does have very mild tenderness to palpation in the right posterior proximal calf just below the knee. Remainder of physical examination is otherwise unremarkable. Given history of blood clot and reported right calf pain, right lower extremity duplex venous ultrasound ordered to evaluate for DVT. EKG was obtained on arrival, and showed normal sinus rhythm with no evidence of ST segment elevated for depression, no dysrhythmia, no comparison when compared with prior EKG from July 2019. Right lower extremity ultrasound showed no evidence of DVT. I shared results of the workup with the patient and told him that there is no indication for further workup or treatment at this time. I recommended Tylenol or Motrin as needed for right leg pain. I recommended compression stockings as needed for right leg swelling. I encouraged him to follow up with all specialists physicians as previously scheduled and with his primary care physician as needed. Office visit 4.14.21: Subjective: a 42 yr.. male evaluated with a video visit on 4/14/2021 Currently he complains of headache, hot/cold flashes (no fever), nasal congestion, and Bilat ear pain. R leg is swollen. The symptoms have been present for 2 day(s). Was incarcerated - has been out for about week. He denies a history of chills and fevers He has tried acetaminophen, Flonase for his symptoms. Sick Contacts: none known History is provided by patient There is history of asthma or recurrent respiratory infections. Went to the ER yesterday and 4/10 Had his J&J vaccine: 3/24 COVID19: negative 4/10

As described by the patient: Patient (driver) was feeling anxious, received the shot and almost immediately started to see white spots and was dizzy. The patient asked to be directed out of the vaccine lane (prior to proceeding to the post administration area) to just get some air. The patient got out of the car, felt dizzy and fainted. Patient fell to the ground in a sitting position. Patient was assessed by BLS and refused transport. Patient switched positions and allowed his passenger to drive off scene.

HEART PALPITATIONS; FAST HEART RATE; SHORTNESS OF BREATH; SHAKINESS; WEAK FEET; This spontaneous report received from a patient concerned a 42 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980,expiry: 20/JUN/2021) dose was not reported, administered on 07-APR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced heart palpitations. On 07-APR-2021, the subject experienced fast heart rate. On 07-APR-2021, the subject experienced shortness of breath. On 07-APR-2021, the subject experienced shakiness. On 07-APR-2021, the subject experienced weak feet. Treatment medications included: paracetamol. On 08-APR-2021, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heart palpitations, shakiness, shortness of breath, and fast heart rate, and the outcome of weak feet was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.

PASSING OUT/FAINTING; LOW HEART RATE (30 BEATS PER MINUTE); DECREASED BLOOD PRESSURE (60/50); SHAKING; This spontaneous report received from a patient concerned a 42 year old white, not Hispanic or Latino male. The patient's height and weight were not reported. The patient's concurrent conditions included seasonal allergy, non alcoholic and non smoker. The patient did not had drug abuse or illicit drug use. The patient did not had reactions before with any other vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) frequency one total, dose was not reported, administered on 12-APR-2021 at left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021 after vaccination, the patient immediately experienced low heart rate (30 beats per minute), decreased blood pressure (60/50), profuse sweating and shaking and as the result he passed out immediately. The patient reported that he was under care of the medical staff at the facility and both his heart rate and blood pressure were reassessed multiple times within the hour of observation. The patient reported that vaccination provider advised him that his reaction was not related to the Janssen Covid-19 vaccine and that he fainted only because he was afraid of the needle but the patient denied and stated that he was not afraid of the needle. Laboratory data included: Blood pressure (NR: not provided) 60/50 mmHg and heart rate (NR: not provided) 30 beats per minute. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passing out/fainting on 12-APR-2021, and low heart rate (30 beats per minute), decreased blood pressure (60/50) and shaking on unspecified date APR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210428755 -JANSSEN COVID-19 VACCINE Ad26.COV2.S- Passing out/fainted, low heart rate, Decreased blood pressure. 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).

CHEST IRRITATION; ACHES; CHILLS; NAUSEA; FEVER; This spontaneous report received from a consumer concerned a 42 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced chest irritation, aches, chills, nausea, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, fever, chills, aches and chest irritation was not reported. This report was non-serious.

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

THE PATIENT RECEIVED JANSSEN COVID 19 VACCINE IN THE LEFT ARM. I RECOMMENDED TO SIT FOR 15 MINUTES TO OBSERVE THE PATIENT. PATIENT REQUESTED TO USE THE BATHROOM IN THE PHARMACY RIGHT AFTER VACCINE. PATIENT CAME BACK FROM THE BATHROOM SAYING THAT HE FAINTED AND FELL IN THE BATHROOM AND SLASH OPEN THE LEFT SIDE OF HIS CHEEK WAS BLEEDING A LOT AND HE FELT DIZZY AND NAUSEA. HE FAINTED THE SECOND TIME ON THE FLOOR. 911 WAS CALLED PROMPTLY. POLICE AND AMBULANCE CAME TO GO TO THE HOSPITAL.

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

Patient started filling dizzy about 10 minutes after vaccine. He felt weak and tired and also started sweating profusely. Skin was cold and clammy to the touch. I checked his BP and it was 89/53. I called 911 as precautionary and ems arrived within 5 minutes. Patient had stopped sweating by then and was able to stand and walk with EMS to another area of the store to be evaluated further and monitored.

4/27/21 pt started to have nausea and upper abdominal pain, 4/28/21 presented to the clinic due to nausea, vomiting and abdominal pain. Examination showed elevated BP, mild upper abdominal distention and pain. Pt given Zofran 4mg for nausea, sent home to rest. Pt reported the next day to be feeling better, but got worse that night 4/29/21, went to the ER, diagnosed with a bowel obstruction.

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

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

Systemic: Confusion-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Additional Details: patient was given jassen vaccine. during 15 minutes observation. patients appeared to black out for 3 seconds. patient can breath ok. no epipen injection was given. after 30 min. patient is coherent. BP 117/75. normal sinus rythm. 911 was called. Patient stated that he doesnt want to go to the hospital and doing fine. Patient had pee himself.

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

5/13/21 around 11:30 am Patient received vaccination. Patient directed to post exposure waiting area. Patient after sitting down under a minute started to slouch and fainted. Fell on floor with side of head hitting floor. Patient passed out and then less then 10 seconds later gradually became alert. Patient did not want to lay on floor and was positioned in chair. 911 Call placed and EMS responded approximately 8 to 10 minutes later. Patient declined being sent to hospital. EMS took blood pressure and made sure patient was okay. Patient signed waiver with EMS

started feeling dizzy and faint after about 5 minutes, became clammy and pale and started sweating, was hot and thirsty, I gave him cool wet papertowels, and ice pack a few sips of water and had him sit in imz booth while I talked to him and watched him. He felt better and had his ride pick him.

Cold hands and feet, blood pooling in hands, blurred vision, loss of appetite, palpitations, excessive urination, and pain around left shoulder blade area of back.

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

I had general soreness and stiffness. I took a bath before I went to bed because I noticed a fever. I had a fever of 103 F. I also realized I lost my motor skills. I was not able to do normal functions. Around 3:00am I experienced shakiness, and I experienced the worst headache in my life. I also have bumps that have appeared on my face. My right arm where I did not receive the shot I saw bruises down my arm. April 25,2021 is when I was in the hospital my blood pressure dropped and my pulse because very low. My blood pressure has been very high since I have gotten the vaccine.

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

I noticed few weeks ago that I have spontaneous nose bleeding. I didn?t pay attention at this at the first time, but now I have once or twice a week bleeding from my nose. I did not have these issues before. I manage to stop bleeding by applying mild pressure and putting a towel paper in my nostrils.

RAPID HEART BEAT; FEVER; This spontaneous report received from a consumer concerned a 42 year old male. The patient's weight was 270 pounds, and height was 77 inches. 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: 20621A expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On 26-MAY-2021, the subject experienced rapid heart beat. On 26-MAY-2021, the subject experienced fever. On 27-MAY-2021, treatment medications included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from rapid heart beat, and fever. This report was non-serious.

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

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

Pt with no PMH. Was administered IM vaccine at approximately 08:45. Within 5 minutes endorsed feeling dizzy, appeared pale and slightly diaphoretic. Pt had witnessed syncopal episode at approximately 08:50. Pt seated with nurse and site employees at side to assist in ensuring safety. No injury occurred. Syncopal episode duration approximately 30 seconds. Pt became unresponsive, bradycardic and slightly hypotensive. Vitals: 110/55, 50, 13, 98%. EMS activated, PD called, and Capt called to be made aware of situation. Pt given Gatorade 150 ml and endorsed prior syncopal episodes with vaccines and blood draws. 8:53- Pt able to sit upright independently, drink fluids w/ no complication, AAO x4. Pt vital signs stabilized within 5 minutes with no other interventions other than PO fluids. PD arrived onsite 8:56, asked pt if he required medical assistance, pt declined. PD officer given report by lead RN. RA 51 arrived 8:58, report given by lead RN, pt evaluated, performed EKG finding NSR, and fingerstick glucose result of 163. 09:00- pt reports dizziness resolved, and declined transport to hospital by PD and signed AMA. 09:45 pt remained continuously monitored by site RNs, along with PD assessment. Pt exited site ambulatory with no further incidents accompanied by wife.

Patient was known to have fainting spells due to seeing blood in the past while in his doctor office. Shortly after immunization took place he fainted. We laid him down on the ground and propped his feet up. After a few moments he came to. He confirmed he was able to leave after another 15 minutes of monitoring.

Patient appeared to faint, was sweating profusely and generalized feeling of malaise. Patient was giving water and Fire-Rescue called. Fire-rescue examined the patient and cleared him to leave after feeling better

In the beginning, my feet and hands had poor circulation and became discolored, cold, and painful (like Reynaud's syndrome). I was able to get the circulation going by exercising. This lasted for a couple of weeks. I had cold sweats and chest discomfort, which I thought were symptoms of WPW. I went to the cardiologist. An EKG was done and I was put on a 2-week halter monitor. Everything checked out as not being a heart issue. Blood tests were done, and the results were normal. After the cold hands symptom, I developed palmar erythema. I also developed a lot of abdominal pain. I became really gassy, and my bowel movements became a light yellow. I had frequent urination. My weight dropped from 191 to 180, and I lost my appetite completely; the appetite loss happened for a week and a half. I had to force myself to eat. My hunger is now back, and I currently weigh 187. The gassiness, yellow stools, abdominal pains, and the frequent have all largely subsided. The stools are now a normal color. The palmar erythema is still present, though.

Was having normal side effects including headache, fever, muscle aches which started about 6 hours after injections. Roughly 14-16 hours after the injection (8:30-9am) started getting chest pain and slight shortness of breath. Called my PCP and they told me to go to the ER as the chest pain is not normal. At the ER they did an EKG which came back abnormal and I was rushed into a procedure to check my heart including a catheter, ultrasound, and a few more I will provide below. Outcome after all the test was inflammation which I asked if it could have been in other areas of my body but doctor said it was my chest. My C-Reactive Protein level was double the normal level. They put me on 3 medications, Ibuprofen, one for Gout and Prilosec.

Diagnosed with pericarditis Presented to the emergency department on 7/18/2021 with chest pain (substernal) and does not radiate, but reports heaviness and pressure. The pain was severe at onset. This is exacerbated by exercise but are relieved by nitroglycerine and fentanyl. Family history of CAD. Also reports shortness of breath. Pain onset was abrupt while riding his bicycle. ECG shows diffuse ST selevation in multiple coronary distributions with P depression. Bedside ECHO showed normal heart. EF was ~60%. Hemodynamically stable. Given one dose of Toradol., SL nitro 0.4mg Admitted to the hospital Started on colchicine 0.6mg bid and ibuprofen 600mg tid with plan of 10 days of treatment.

Fever of 104, heart rate in 160's, rigor, severe back pain. 911 called and ambulance brought to Hospital at 1am. Took 3 bags of fluids, Ativan, Tylenol and Toradol to get the heart to the 110's over the 3 hours there. It is now 12:30 on the following day (3/7) and the fever, shakes, and elevated heart is starting up again but not to the extreme of last night

AE: numbness of both arms, fingers, legs and toes Fatigue, dizziness, sweating, skin turned pale, difficulty breathing, numbness on tongue -- 1:20 pm about 5 mins after receiving vaccine Treatment: checked Blood pressure: 117/79 and HR 69. Gave 20ml children benadryl (50mg), water and chocolate bar. 1:30 pm Outcomes: pt stated symptoms gone away around 1:45. numbness on arms and legs gone, dizziness and sweating stopped. pt was able to stand up and walked around and went home

MDM-43-year-old man presents wit syncope versus near-syncope. Differential diagnosis includes vasovagal reaction versus dehydration versus anxiety versus arrhythmia.

Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient did experience fainting with Janssen, though important to note that patient said he has fainted before in past with vaccinations. He said he is fearful of them and it is more \"mental\" and does not attribute it to the vaccine itself.

Had a sudden onset fever which reached 103 the evening of the injection. There was muscle soreness, fatigue, my pulse was above 80 all night and reached 100 during the peak of the fever. By the next morning, the fever had dropped to 100, fatigue remained and a slight headache appeared. The headache was gone by noon, the fatigue remained all day. The evening after the injection, a slight fever returned and then stopped. Two days after the injection, there were no further averse reactions other than slight soreness in the injection site. I am no longer fatigued and feel fine. Hope this information helps.

Narrative: Within minutes of J&J vaccine patient's BP dropped to 60/30 and he then passed out. Patient was arousable but BP remained low -- Was transported to local ER via ambulance for evaluation.

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

On March 15 my blood pressure spiked even taking my medication. My BP was out of control even with medication. I contacted my Dr. asked me to double my high blood pressure medication and has worked since. I do have a follow up appointment with her. Prior to the vaccine I was taking one BP pill with no issues for 8 years.

Patient fainted after vaccine administration. 911 was called and EMTs responded, patient was observed by pharmacist on duty, did not need further medical support.

Date: 3/23/2021 Problem: fainted Notes: Pt was being observed post Janssen COVID Vaccine when the nurse observed pt fall onto the floor from his chair. This nurse began to take VS- BP 144/77 P74 O2 100% T 98.6 RR 18 BS 105. Pt did hit head when falling to floor but answered all questions appropriately. Pt states he is afraid of needles and this has happened to him previously as well. 911 called by head nurse. Pt able to move all extremities. This nurse stayed with pt until EMTs arrived. Pt alert and oriented x4. Redness noted to left cheek, no bleeding noted. EMT found no signs of distress and pt refused to be transported to hospital. This nurse notified pt that he would need someone to take him home. Wife arrived to take pt. Pt showed no signs of acute distress aand left with wife.

Date: 3/23/2021 Problem: fainted Notes: Pt was being observed post Janssen COVID Vaccine when the nurse observed pt fall onto the floor from his chair. This nurse began to take VS- BP 144/77 P74 O2 100% T 98.6 RR 18 BS 105. Pt did hit head when falling to floor but answered all questions appropriately. Pt states he is afraid of needles and this has happened to him previously as well. 911 called by head nurse. Pt able to move all extremities. This nurse stayed with pt until EMTs arrived. Pt alert and oriented x4. Redness noted to left cheek, no bleeding noted. PERLA. EMT found no signs of distress and pt refused to be transported to hospital. This nurse notified pt that he would need someone to take him home. Wife arrived to take pt. Pt showed no signs of acute distress and left with wife.

Fainted about 7 minutes after receiving the vaccine. Came up to consciousness again after 1-2 minutes, but felt lightheaded and nauseas. Vomited 45 minutes after receiving the vaccine.

Strong heart palpitations for 2-3 hours starting about 8 hours after injection. As soon as the palpitations passed I got an onslaught of symptoms including fever, chills, sore muscles, weakness, headache, and light headed.

Patient became dizzy and had a vasovagal response. His heart rate dropped between 40-50 and did not increase how EMS had expected. Patient began to vomit and was transported.

Patient passed out in their seat in waiting area. Struck back of his head on window behind him. Responsive after 20 seconds. Ambulance called to assess patient further. No treatment required and patient's wife drove him home.

Patient felt dizzy after receiving vaccine. Pharmacist went over to assess patient and patient hands began shaking and eyes were moving erratically. Patient would not respond to verbal commands so called 911. The patient came responsive about 1 minute later and had no recollection of the event. Pharmacist checked bllod pressure and it was low (97/46 ) and upopn recheck in 3 minutes it was high (199/90). Paramedics arrived and patient said he felt fine at that point but he would still go to hospital to get checked out.

Fever (101.5), Chills, Aches, Headache, Racing heartbeat for about 4 hours and then started to get a bit better. Took Tylenol and slept. Next morning felt weak and achey, but better. Was find within 24 hours

PATIENT RECIEVED VACCINE 9:49 AM, MOVED TO POST VACCINATION AREA. BECAME DIZZY AND FAINT, WAS MOVED TO FLOOR FROM CHAIR. PASSED OUT AT 9:50 AM. CAME AROUND 9:55AM WITH NAUSEA THAT DID NOT RESULT IN VOMITTING. PATIENT SAT FOR AN ADDITIONAL 30 MINUTES WITH WIFE UNTIL FELT FINE TO LEAVE POST VACCINATION AREA AROUND 10:30AM. NO INJURY RESULTED. PATIENT ADMITTED AFTER VACCINATION THAT THIS IS A COMMON REACTION TO VACCINATION AND NEEDLES IN GENERAL.

20 mins after shot, I nearly fainted - but subsided within minutes. About 6 hours later, had aches, striking headaches, dizziness throughout the entire evening. subsided by the time we woke up - took tylenol.

Customer had dizziness, hot, sweaty, nervous, pass out, call 911 EMT took him to the hospital all his vital signs are fine, he called to let us know that he is at home and is feeling well.

4/9/21 Vaccination Center At approximately 1115 while observing people post vaccination I was summoned by companion to assist pt who was ?feeling faint?. On arrival person was conscious and responsive, pale, diaphoretic, with eyes closed, verbalizing he felt like he was going to faint. BP measured at 77/41, HR via O2 Sat device 39-44. Person coached to take deep breaths, able to transfer with assist of one to wheelchair, transported to observation room, self transferred to stretcher and placed in supine position with HOB approximately 20 degrees. BP 91/54, HR 51. Person verbalized immediate relief when positioned on stretcher. Monitored for 20 minutes, BP 133/61, HR 64. Assisted to sitting position on stretcher, tolerated cranberry juice and graham cracker. Self transferred to wheelchair where he was transported to main waiting room, observed for 20 minutes. Person reported return to baseline, ambulated independently out of vaccination center. Person remained conscious throughout.

Patient is a 43-year-old, male with a history of fear of needles. At 2:39 pm, the patient received a dose of the Janssen vaccine, (lot number 1808980, expires on 06/20/2021) on right deltoid, given by RN. Immediately following the vaccination at 2:40 pm, Patient reportedly slumped his head forward in his seat and was caught by RN, sustaining zero physical bodily injuries. The patient was unconscious for approximately 2 seconds. EMT'S responded immediately at 2:40 pm and took the patient's vitals. At 2:40 pm, the patients vitals were: 117 systolic BP and HR 89 (EMT unable to hear the diastolic BP due to environmental noise). The patient appeared diaphoretic, pale, with warm, clammy hands and a weak radial pulse. The patient was given a water and tolerated intake of water. The patient was assisted by EMT to a anti-gravity chair at 2:43pm. The patient was observed to have a steady gait and reporting no dizziness. At 2:44 pm, the patient's vitals were: HR 54 and 110 systolic BP (EMT unable to hear the diastolic BP due to environmental noise). At 2:50, the patient had a strong, bounding radial pulse with a HR of 70 BPM and 115 systolic BP (EMT unable to hear the diastolic BP due to environmental noise). At 2:55 pm, the patient's vitals were: HR 75 BPM and 115 systolic BP (EMT unable to hear the diastolic BP due to environmental noise). At this time the patient reports feeling "better". At 3:00 pm the patient's vitals were: HR 81 BPM and 118 systolic BP (EMT unable to hear the diastolic BP due to environmental noise). At 3:05 pm the patient's vitals were: HR 77 BPM and 120 systolic BP (EMT unable to hear the diastolic BP due to environmental noise). At 3:10 pm the patient's vitals were: HR 74 BPM and 118 systolic BP (EMT unable to hear the diastolic BP due to environmental noise). At 3:15 pm, the patient was assisted up from anti-gravity chair. The patient had a steady and balanced gait. The patient denied any additional dizziness, lightheadedness, or nausea. EMT provided patient with education related to when to call his HCP (i.e. dizziness, itching of throat). The patient reported he was "ok to drive home" and left to the parking lot at 3:15 pm.

Approximately five minutes after the shot, I experienced vasovagal syncope. I was, reportedly, non-responsive for about three minutes. When aroused, my heart was reportedly beating about 40 beats per minute, my blood pressure was low, and it took me quite a while to regain my senses.

Headache will not go away , shortness of and trouble with breathing , weak after a short time of physical anything , chest pains , veins in legs are showing. These all came on a few days ago and the headache last night was almost unbrarible and i never have headaches

Numbness and weird feeling in left arm (injected in left arm) started like 8pm got worse. Also still felt awful comes and goes cold and feverish again. Felt good a day and a half. Then bad again but was at work. Woke up 2am with pain in chest and arm felt numbness and very strange and pain in chest - which did subside but almost called 911. Will go to urgent cate today to get checked out. Took BP at home and it was normal/ took an aspirin at 2am as well/

(1) Fever 2 days 100.3 - 101.1 (took tylenol every 6-8 hours). (2) Fatigue (slept most of day after injection). (3) Heart rate elevated (woke up 7hrs after injection with feeling of heart pounding in my chest; heart rate over 90 while trying to sleep; believe reducing fever with tylenol helped settle heart rate). (4) Muscle aches 2 days (previously injured muscles/joints became very sore 1-2 day after injection [left hip, right foot, left quad, lower back] - believe tylenol reduced inflammation) --symptoms ended 3-4 days after injection; slight fatigue remains 7 days later.

Had COVID on 2/7/21- Feverish feeling x 1 day, fine after. Tested negative 2/17/21. One half hour after receiving the vaccine, onset of hoarseness. Severe hoarseness persists until today. Eyelids pink, swollen slightly, persisted 2 weeks. Did not feel well. 4/15/21 -Hospital Emergency Room. Chest pain. Elevated blood pressure. COVID test positive. Disharged with azithromycin, zinc sulfate 220mg, ProAir. High blood pressure, new onset. On 4/6/21 BP 160/120 both arms. 4/7/21 Hospital ER. MRI, CT brain showed Dural Venous Thrombosis. To ICU for anti coagulation, until 4/14/21. MRV done. Now on floors, started coumadin. 9 days hospitalization so far. CT done again 4/15/

By midnight after my vaccine: Shortness of breath. Three days later around 6:25 am on April 15, 2020: I got out of bed, next moment I recall is of me on the floor. No memory of falling. I was shaking uncontrollably as if my body was getting many commands at the same time but I had no control over it. I could not call out for help. At one point I was biting my right hand but could not make myself stop until my shaking stopped. Bite did not penetrate skin but I had visible bite mark on my hand. I regained control suddenly and just got up slowly and shaken by the experience. Wife then drove me to the ER. Been feeling pressure on my head.

Prior to receiving dose of the Janssen Cov-19 vaccine, the patient expressed that he had a fear of needles. The vaccine was admistered and the patient was asked to stay seated in the waiting area after the injection. After a few minutes the patient passed out while seated and was moved to being seated on the floor by staff. The patient was given water and his blood pressure was monitored periodically for the next hour before releasing the patient.

I received the shot on 4/10. First 24 hours I had a slight fever and headache. Treated with Acetaninophhen. Since that time, I had relatively mild symptoms 4/11 - 4/13. Mostly fatigue. On 4/14, I had a sudden increase in heart rate, dizziness, tingling sensation in all arms and legs and weakness in my limbs/grip. This prompted me to visit the ER. They ran numerous blood tests amd scans on me but found no abnormalities. Various unusual symptoms have continued to persist since 4/14. For brief moments I feel fine. At other times I have experience fatigue, diziness/vertigo, rapid heart rate, pins and needles feeling in my left hand and left leg. Left leg numbness/tightness and heaviness. The fingers on my left hand sometimes move involuntarily. And my anxiety has also gone up during this time. Tonight it has migratee to my left foot, where I have numbness in several of my toes. I'm looking for advice. Should I be concerned? Should these symptoms still be occurring 11 days after receiving my shot? It has been very distressing and there seem to be very few people who have knowledge on this subject. My care providers keep saying to self monitor and contact them if symptoms worsen. The problem is symptoms don't necessarily worsen, they just migrate from one area of my body to another. The numbness comes and goes in maybe 1-2 hour intervals.

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

COUGH; DIFFICULTY SLEEPING/STRUGGLING TO SLEEP; LOSS OF ENERGY/ESPECIALLY NO ENERGY; SHIVERING; FATIGUE/FEELS VERY TIRED; COLD SYMPTOMS; HEART RATE INCREASED/FAST HEART BEAT; VERTIGO; BRAIN FOG; CHEST PAIN; This spontaneous report received from a patient concerned a 43 year old male. The patient's height, and weight were not reported. The patient's past medical history included pneumonia, and concurrent conditions included covid-19, and other 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 19-MAR-2021 (vaccinated at left deltoid) for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced cold symptoms. On 19-MAR-2021, the subject experienced heart rate increased/fast heart beat. On 19-MAR-2021, the subject experienced vertigo. On 19-MAR-2021, the subject experienced brain fog. On 19-MAR-2021, the subject experienced chest pain. On 19-MAR-2021, the subject experienced difficulty sleeping/struggling to sleep. On 19-MAR-2021, the subject experienced loss of energy/especially no energy. On 19-MAR-2021, the subject experienced shivering. On 19-MAR-2021, the subject experienced fatigue/feels very tired. On 20-MAR-2021, the subject experienced cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold symptoms, and shivering on 20-MAR-2021, and was recovering from heart rate increased/fast heart beat, fatigue/feels very tired, vertigo, brain fog, chest pain, loss of energy/especially no energy, cough, and difficulty sleeping/struggling to sleep. This report was non-serious.

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

Vasovagal episode. After receiving dose patient complained of feeling lightheaded, nauseous and was visibly sweating. Vitals were taken 10:10 106/60 97% HR: 52. At 1015 vitals were 118/10, 98% and HR 65. Patient was given wet towels around his neck and on his forehead. brought cot to patient and patient placed in trendelenburg position. pt given water and stated he was no longer lightheaded or nauseous but continued to have HA. Pt at that time was being evaluated by both doctors. Patient then walked to monitor area where was continuously checked on until 1100 when his vitals were rechecked (118/80, 68HR). Pt stated he felt better and was released and recommended not to drive. Pt says his brother would drive him home. - RN

PT COMPLAINED OF INTENSE PAIN IMMEDIATELY AFTER INJECTING, THEN NAUSOUSNESS, THEN WANTED TO STAND, AS I WAS PREVENTING HIM FROM STANDING HE BEGAN TO SHAKE AND THEN WENT LIMP, I USED SMELLING SALTS AND HE CAME TO, HE WAITED IN PHARMACY HIS BP WAS LOW, WE GAVE WATER AND AFTER ABOUT AN HOUR HE WAS ABLE TO WALK OUT ON HIS OWN

TENDERNESS IN THE CHEST; LUNG INFLAMMATION; COUGHING; SORENESS; TROUBLE BREATHING; THROAT SWELLING; CHEST TIGHTNESS; GENERAL SWELLING; DETERIORATION; DID NOT FEEL WELL; TIRED/FATIGUE; This spontaneous report received from a patient concerned a 43 year old male. 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: 1805020, and batch number: 1805020 expiry: 25-MAY-2021) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-APR-2021, the subject experienced tired/fatigue. On MAY-2021, the subject experienced deterioration. On MAY-2021, the subject experienced did not feel well. On 07-MAY-2021, the subject experienced soreness. On 07-MAY-2021, the subject experienced trouble breathing. On 07-MAY-2021, the subject experienced throat swelling. On 07-MAY-2021, the subject experienced chest tightness. On 07-MAY-2021, the subject experienced general swelling. On 07-MAY-2021, the subject experienced coughing. On 08-MAY-2021, the subject experienced tenderness in the chest. On 08-MAY-2021, the subject experienced lung inflammation. The action taken with covid-19 vaccine was not applicable. The patient was recovering from tired/fatigue, had not recovered from soreness, trouble breathing, throat swelling, chest tightness, general swelling, lung inflammation, and coughing, and the outcome of tenderness in the chest, did not feel well and deterioration was not reported. This report was non-serious.

Blood clot in superficial vein behind right knee as well as vertigo and nausea. Currently on 30mg/day of XARELTO blood thinner (I've been taking since diagnosis on 5/5/21). Will continue to take 20mg/day for the next 30 days. Background: I started to notice my right calf get tight and sore approximately ~3 weeks following my vaccination. I had been doing a lot of running and hill training so I assumed it was a muscle strain/aggravation. After approximately 1-2 weeks I noticed the tightness worsen and also noticed significant swelling around my lower calf/ankle. I went to the doctor on 5/4/21 and was given a D Dimer blood test which came back 1.27 mcg/mL FEU (over the recommended 0.5 mcg/mL). The next day I had an ultrasound of my right leg where they discovered the SVT clot behind my right knee in a superficial vein (but near a major/deep vein intersection). I was immediately prescribed XARELTO blood thinner - to be taken for ~51 days. ~21 days of 30mg/day (15mg twice/day) followed by ~30 days of 20mg/day 1x per day. The morning of 5/20/21 around 6:30am I started to feel nausea and vertigo after returning home from walking my dog. I finished a low-intensity exercise routine at my home and around ~7:15am my symptoms worsened. I went upstairs to my bedroom to lay down on my bed and the room started spinning. I then went to the bathroom and vomited clear fluid. I started feeling a little better after vomiting but was still slightly dizzy and light-headed. I made an appointment and went to the doctor around 10:30am. The doctor suggested doing further bloodwork and a CT scan of my head. Both tests came back normal. The doctor suggested the vertigo and nausea were inner ear related and that I should continue taking XARELTO and to also start wearing a compression sock (especially during exercise/activity).

PAIN IN STOMACH; SWEATS; REDNESS ON BODY LOOKS LIKE SKIN IS DISCOLORED; CHILLS; FEVER; NAUSEA; BODY PAIN; MIGRAINE; EVERY BEAT OF HEART HURTS; HYPERVENTILATION; COULD NOT GET A FULL BREATH; PASSED OUT'; FINGERS WENT NUMB; GOT A CHARLIE HORSE ON LEG; EVERY SINGLE JOINT AND ANKLES HURTS FOR NO REASON; This spontaneous report received from a patient concerned a 43 year old male. The patient's weight was 135 pounds, and height was 66 inches. No past medical history or concurrent conditions were reported. The patient's concurrent conditions included migraine The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered, 1 total to right deltoid on 19-MAY-2021 around 10 am for prophylactic vaccination. No concomitant medications were reported. On 19-MAY-2021, around 7 pm patient started experiencing side effects. After 1 hour of shot patient had his heart hurt at every beats, hyperventilation. It lasted for 1 -2 hours. The patient also had fever, chills, nausea, sweats and had not taken any medication, as he was afraid of another side effects, had redness on his body which looked like skin was discolored and was like hives. The patient also had body pain appeared suddenly. The patient also had pain in stomach which felt like nastiest gas cramp patient had ever and it was continuous like a rock blocking in stomach, he did not know if it is pain or gas but was hurting. Patient had migraine which lasted long time and was continuous than he ever had. The patient was fine as he was speaking at the time of reporting. On MAY-2021 (dates unspecified) the patient experienced Charlie on his leg (muscle spasm) for which he stood up and didn't do anything on leg, he was passed out and fingers went numb, felt every single joint and ankle hurt with sharp pain like a stuffed knife (intermittent pain for 3-5 minutes).He could not get a full breath of air, and was breathing really fast. Then patient tried to slow down breathing as he didn't want to be hyperventilated but it happened. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body pain, hyperventilation, migraine, pain in stomach, chills, fever, nausea, and sweats, and the outcome of passed out, could not get a full breath, redness on body looks like skin is discolored, got a charlie horse on leg, every single joint and ankles hurts for no reason, fingers went numb and every beat of heart hurts was not reported. This report was serious (Other Medically Important Condition); Sender's Comments: V0: 20210540430-COVID-19 VACCINE AD26.COV2.S --Every beat of heart hurts, Passed out. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Patient admitted to hospital with a platelet count = 0. Patient presented with fatigue, mouth sores and body rash and extensive bruising. Patient also tested positive for COVID 19.

Patient stated that starting 3 days after vaccine he started with pain in his left arm and chest, pain in his joints to his bones. He says he has trouble sleeping. He did go to the Emergency Room and was evaluated. He says he still currently has the pain.

Received vaccine, sat down as advised, 3-mins later felt nauseous (about to vomit), got up and walked away from people around me. Fortunately my wife was there, I called out to her because I was getting dizzy, she came over as I was passing out, I grabbed onto her and we both fell to the floor (I used her to cushion my fall). I passed out on her as she screamed for help. Two male customers assisted me into a chair as I was disoriented, my wife asked me what her name was and I didn't her name as I was pale, trembling, and sweating. The pharmacy tech thought I was going into convulsions and called 911. The paramedics arrived and fortunately I was breathing and slowly coming back. Paramedics remained there and took all my vital signs and stayed with me. Since my vitals were okay and my color came back, I felt much better and was coherent again. This event was at least 30-minutes or more. I declined going to the hospital with ambulance and the paramedics told me to call 911 if it happens again.

patient was asked to stay in the waiting are for 15 minutes.he went and sat down then he got up to talk to his wife at that time he felt sick and passed out. his breathing was shallow and he was unresponsive for 2 minutes. he was pale. paramedics were called and they came right away and assessed him. he did not need any medical help. he felt fine. they did not take him to hospital.

After 2 months of vaccine blood pressure shot up about 4 weeks. My typical blood pressure range 130 over mid 90's it has increased to 168/105. It has since went down to normal past few weeks.

Experienced a severe, prolonged nosebleed on June 25. Blood was pouring from left nostril and mouth and took hours to begin to clot. Finally stopped in early afternoon on June 25. Started again in early morning of Sat. June 26. This was accompanied by intense pressure in forehead, behind nose and burning sensation in both eyes (visibly red). Gently blew nose as it was bleeding and passed a large clot the size of a quarter. From wife: We had to resort to using paper towels with sanitary napkins to try to soak the blood. Completely soaked 4 Always Infinity size 5 sanitary napkins in a matter of 10 minutes. Bleeding stopped around an hour later. Considering a minor medical visit due to reoccurrence, headache, eye burning and possible elevated blood pressure.

patient was given janssen covid- 19 vaccine at 4.30 pm and 10 min later the patient fell forward from his chair on his face as he felt very dizzy and sweating.. Patient regained consciousness right away and was doing fine after a few min.

Woke up the next morning feeling sore at shot site and as the day progressed my body started to ache all over. For the next 2 days after this, I will alternate between having the chills and having intense sweats. On Friday 06/25/2021, I woke up to my chest hurting , I could not catch my breath, it felt like I had a very heavy weight on my chest . I went to the emergency room which is a part of the Hospital. After the initial tests the physician told me with 99% certainty that I had had a heart attack. Soon after this they rushed me by ambulance from hospital to hospital which is about 20 miles or so. They rushed me in and completed an arteriogram within minutes of arriving at the hospital. They confirmed with this test that is was not a heart attack and after several more test, the doctor that I had developed Myocarditis due to the vaccine shot. The admitted me into the hospital on 06/25/2021 for observation and to run more test until I was stable enough to go home. I stayed in the hospital for 1 evening and was discharged on 06/26/2021 at about 1:00 or 2:00 that afternoon. The doctor prescribed several medications for me to take for my heart for the next foreseeable future. On 06/30/2021 I had a visit to my new cardiologist in which he ran several test and stating that I was looking better, but he had ordered an MRI to take place on 07/06/2021 at Hospital. I have a follow up visit for my cardiologist slated for 07/19/2021 in which I will find out more information.

"Janssen COVID-19 Vaccine EUA" Seven minutes after recieving the vaccination I started to feel light headed so I sat on the floor and notified medical personnel. I then passed out for an unknown amount of time but long enough to urinate on myself. Medical staff put me on a bed and started taking vitals. My Blood pressure was low but had a high heart rate. Medical Personnel called the ER to see if I needed to be transfered but it was reccommended to continue observation. After an hour or two I was released to go home. I felt weak for over a week after the vaccination.

MYOCARDITIS; SWEATS; CHILLS; ACHY AND SORE ALL OVER; This spontaneous report received from a patient concerned a 43 year old male. The patient's height, and weight were not reported. The patient's past medical history included left knee surgery six year ago, and concurrent conditions included penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A and expiry: 24-AUG-2021) dose was not reported, 1 total, administered on 21-JUN-2021 to left arm for prophylactic vaccination. The patient was now on three different medications for cardiac precautions. Next day of vaccination (on 22-JUN-2021), the patient felt achy and sore all over. On 23-JUN-2021, the patient began alternating between chills and sweats then he went to bed and woke up 03:00 and felt like a gorilla was sitting on his chest, chest heaviness and shortness of breath, the patient went to the ER (emergency room) and admitted for cardiac tests, was told he had a heart attack then the patient was transferred by ambulance and admitted to hospital on 25-JUN-2021. There he had an arteriogram, hospital cardiologist told him it was not a heart attack. After additional lab tests he was told that he developed myocarditis as a result of the vaccine. The patient was discharged on 26-JUN-2021. He was hospitalised for a day. The patient had a follow up with cardiologist for first time on 30-JUN-2021, magnetic resonance imaging (MRI) was done on 06-Jul-2021 (results were not provided) and second follow up visit with cardiologist on 19-Jul-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from myocarditis, and the outcome of chills, sweats and achy and sore all over was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210730558-covid-19 vaccine ad26.cov2.s -Myocarditis. 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).

10 minutes after injection, dizzy spell and vasovagal reaction. Diaphoretic, pulse rate 48, BP 107/71.

pt has h/o htn and take 4 different meds. he has taken all of his meds today . pt received his covid vaccine on 03/13/2021 in the left shoulder and he woke up this morning with pain in the left shoulder radiating down his arm and it originates at the site of the vaccine. pt denies substernal chest pain , dyspnea , doe. he has h/o elevated blood pressures at the level seen today (180/100) when he has poor sleep and he had poor sleep last night due to pain at injection site. no CAD hx. pain is not changed with walking but will be worsened by moving his left arm. PE: a+ox3, in moderate pain left arm: injection site clean and intact. left arm is neurovascularly intact. no bony deformity of the shoulder lung: normal respiratory status, cv rrr no mgr Signed on 3/14/2021 at 11:54am

Patient was given shot and asked to wait in pharmacy area at least 15 minutes. Within about 5-10 minutes his girlfriend comes to the pharmacy window and tells me he's feeling bad. By the time I get to his chair he is very lethargic and slumped over. I sit him up in the chair and his head rolls back and his eyes have rolled back in his head. I place him on the floor and instructed my staff to call 911. The patient presented with sweats and was unresponsive for about 10-20 seconds. When he came to he asked how he got on the floor. The patient never had any trouble breathing heart rate was steady the entire time. When EMS arrived they checked him out and was fine. He refused transport to the hospital. He walked out of the store after about 30 minutes from the point of his passing out.

Reporting employee seated a client for their observation period as they were finishing with her, they turned and saw the client falling from his chair. The client fell on his right side, hitting his right forehead on the floor. The rapid response was initiated at 1748, client was alert & oriented x4 to self, time, and location. Vital signs initiated q5 min all within normal limits. EMS called at 1806. Vital signs performed by Tenzin. Ice packs, water, and food provided to alleviate client symptoms. Client expressed "I'm fine" towards the end of the scenario after the 2nd set of vitals which were taken at 1753.

03/08/2021 11:31 am Patient C/O feeling light headed and dizzy. Patient also noted pale and clammy and laid himself on the floor. Patient stated that he ate a granola and coffee for breakfast. V/S 97.4 temp. BP 101/60, R 18, Pulse 48. Snacks and water offered, water taken only. Patient then stated that he feels sick and cannot sit up on his own, close monitory in progress. 11:34 am Wife called and notified. 911 rescue called. 11:50 am Rescue arrived and assessed patient declined going to the hospital. 12:00 pm. Patient VS 97.7 temp, BP 110/64, Pulse 56, R 16.. Patient left facility with wife.

Rapid onset of nausea and dizzy / lightheaded feeling shortly after standing up from chair within 2 minutes after vaccination. Immediately sat back down to place my head between my knees, and completely blacked out, fallout out of the chair and hitting my head and knee on the floor and nearby fixtures. Regained consciousness on floor about 30 seconds after fainting and immediately felt much better. Pharmacy staff were on hand and promptly called 911, instructed me not to move and took my pulse and monitored me until EMS arrived within 5-10 minutes. Vital signs normal including BP 120/90, 100% o2 levels, normal blood sugar and EKG. EMS assisted in getting me back to seated position and monitored for another 10-15 minutes. Declined transport and had family member drive me home where I rested for a few hours and woke up feeling fine. Very minor bruising / bump on head with no lasting sign of concussion or other trauma. 24+ hours post vaccine no other notable vaccine reactions aside from sore arm / muscles on injection site.

Patient fainted when standing for count. Fell to the floor, lost consciousness, and hit his head against the wall. Reported overnight he experienced chills and lightheadedness

Patient collapsed at the counter, he was helped to the ground, he was asked to lie flat for 10 minutes. After 10 minutes he was able to sit up and he felt a lot better. After 30 minutes he was fine.

pt fainted, the pt was sitting in the chair and fell off. the pt immediately woke up after falling. the pt said he was ok. he said he just wanted to lie down. he did so for about 10 minutes and then sat back up in the chair. we said he was feeling ok. he said he fainted because he was nervous. he did not think that it was because of the covid shot.

- Arm Sore at injection site from 4-6-21 to 4-9-21 - Passed out at 1:00am 4-6-21, and fell to floor with disorientation. - Severe Chills, uncontrollable shaking of body/teeth, 4-6-21 to 4-7-21 - Feverish 04-6-21 to 4-8-21 - Heart Arrhythmia, causing abnormal breathing and inability to breath and sleep 04-6-21 to 4-7-21 - Dizziness 04-06-21 to 04-09-21 - Food/Water/mouth tastes of metal 04-7-21 to 4-8-21 - Loss of Appetite 04-06-21 to present - Bloating, feeling full when haven't eaten 04-06-21 to present - Brain fog, not able to concentrate - 04-06-21 to 04-09-21 - Excessive sweating 04-06 to 04-08-21 - Tired 04-06 to 4-10-21 - Irritability, 04-09-21 to 04-10-21 - Emotional, crying for no reason sporadically 04-06 to 04-9-21

I felt fine all day and went to bed at 9:30pm. I woke up to my body shaking uncontrollably and I was freezing at 10:30pm. My wife felt my skin and she said I was burning up. Unfortunately our thermometer wasn't working so I don't know my temperature, but I have never in my life shaken so badly with a fever. I couldn't control myself and I was shaking so hard that my muscles were sore from it, but I still couldn't stop. I then began vomiting every 45 minutes or so. This happened for nearly 4 hours until 2:18am. Then very suddenly everything just stopped. No more feeling cold (actually I then felt very warm and couldn't cool off. I was sweating quite a bit). No more shaking. No more vomiting. I did get a wicked headache, but I figured it was due to dehydration and took two Advil. The Advil didn't do anything and I was awake until 5:59am because my head hurt too badly to sleep. Finally I slept for about 4.5 hours. Then I just felt worn out for most of the day on the 10th, and couldn't shake the headache. Then on the evening if the 10th, I started getting a sore throat and a slightly runny nose. I went to bed that way. When I woke up on the 11th (today) I still had the sore throat and slight runny nose. The headache was gone, but I felt tightness in my chest. As I went throughout the day, I've noticed that I'm short of breath with doing most things. I have two young children, so even taking care of them I feel like at times I'm struggling for breath. I'm not in bad shape and am a runner, so my cardio isn't bad. So I was surprised by this.

Chest pains- 8 hours after administration for little less than 48 hours; in addition to migraines, extreme fatigue, shortness of breath and sensitive to light.

SYNCOPE/PASSED OUT FOR A COUPLE OF HOURS; SEVERELY DEHYDRATED; FLU; INJECTION SITE WAS SORE; This spontaneous report received from a pharmacist concerned a 44 year old The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: 06-JUN-2021) dose was not reported, frequency 1 total administered on 02-APR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the patient was severely dehydrated a couple of hours after receiving the vaccine, syncope/passed out for a couple of hours (unsure how long), and injection site was sore. On same day, it felt like the patient had the flu, which was described as chills, fever and the patient's throat being sore at the same time. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from syncope/passed out for a couple of hours, severely dehydrated, injection site was sore, and felt like patient had the flu on 04-APR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;20210411188-covid-19 vaccine ad26.cov2. s-syncope/passed out, severely dehydrated. 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).

Left arm felt thick and stiff; fingers on same side began to tingle; became dizzy; sweaty; got up to ask for help as instructed, fainted and hit the top on my head on the counter, I believe; came to; threw up; laid on the floor for a while; moved to a chair; wife came to pick me up; slept for 2 1/2 hours after that; felt better in the evening; typical sore arm

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

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

Felt tightening of chest cavity along with warm ?flush? feeling. After a few minutes left side felt less pressure but pressure persisted in right chest area with pain radiating from right arm to back (behind shoulder blade). The right back pain persisted for multiple days. Sought Urgent Care help after a few days. Was prescribed muscle relaxant and pain relief gel, and advised to continue using inhalers.

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

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

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

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

LOSS OF CONSCIOUSNESS(PATIENT WAS COMING IN AND OUT OF CONSCIOUSNESS); BRADYCARDIA; SEIZURE (EYES ROLLED BACK, HEAD WENT BACK); ARM WEAKNESS; PROFUSELY SWEATING; This spontaneous report received from a consumer concerned a 44-year-old male. The patient's height and weight were not reported. The patient's pre-existing medical conditions included patient did not have any known allergies. The patient did not have any reaction to vaccine before. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 09-APR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, five minutes after vaccination, patient started profusely sweating and he had a seizure (eyes rolled back, head went back) and lost consciousness. Paramedics were on site came and they did a Electrocardiogram. He had bradycardia (heartrate was very low : 30 bpm). During all this time, he kept on coming in and out of consciousness. Patient also had arm weakness. Paramedics took him by ambulance to the emergency room; they administered some kind of medication because of his heart rate. Reporter thought it was atropine and took him to the hospital. In emergency room, they did a chest x-ray, Computerised tomogram scan and blood work, they did not see anything abnormal that would have caused the seizure. Emergency room Doctor determined that, it was the vaccine or a component of the vaccine that caused the reaction. Laboratory data included Blood test (NR: not provided) Normal, Computerised tomogram scan (NR: not provided) Normal, Chest X-ray (NR: not provided) Normal, and EKG (NR: not provided) 30 bpm. Treatment medications included atropine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from seizure (eyes rolled back, head went back) on 09-APR-2021, and bradycardia on 10-APR-2021, and the outcome of arm weakness, loss of consciousness (patient was coming in and out of consciousness) and profusely sweating was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210422272- covid-19 vaccine ad26.cov2.s-loss of consciousness (patient was coming in and out of consciousness), bradycardia, seizure (eyes rolled back, head went back) . 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).

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

1 day after the vaccine (4/28) - low energy level, achy, tired, shortness of breath 2 days after vaccine (4/29) - shortness of breath after physical activity, irregular pulse 3 days after vaccine (4/30) - back to normal - no symptoms

Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Medium, Systemic: Vomiting-Severe

SHORTNESS OF BREATH; ASTHMA ATTACK; DIZZINESS; EXPERIENCING HOT FLASHES; SORE ARM; SWEATING; PASSING OUT RIGHT AFTER VACCINATION; SLEEPY; LOW ENERGY; WEAKNESS; TIRED; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included codeine allergy, penicillin allergy, anxiety, smoker, and alcohol user. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 on right arm for prophylactic vaccination. Concomitant medications included clonazepam for anxiety, and ibuprofen for pain/ and inflammation. On 12-APR-2021, after 5 minutes, the patient started feeling dizzy and passed out. He woke up as nurse pulling his chest hair and nurse was about to give him adrenaline shot. The patient was for his vitals until restabilized and was asked to walk around for sometime. The patient had sore arm. The patient was at facility for 2 hours. On 12-APR-2021, at night, he woke up sweating and experiencing hot flashes as if med going through his body. On 16-APR-2021, the patient was not breathing well at night and woke up with an asthma attack which lasted for about 3 hours and the whole next day. He visited clinic for asthma attack and was prescribed with medicines. He had a week and half of low energy. On 27-APR-2021, the patient stated that he was still feeling sleepy, dizzy and tired sometimes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passing out right after vaccination on 12-APR-2021, experiencing hot flashes, shortness of breath, asthma attack, and sweating, and sore arm on 19-APR-2021, and had not recovered from dizziness, weakness, sleepy, tired, and half of low energy. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210453787-COVID vaccine-loss of consciousness. 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 was starting to feel sweaty, light headed, and had ringing in his ears. Blood pressure was a little low. After giving him water and staying with him, symptoms dissipated and blood pressure returned to normal

Pt had progressive shortness of breath/weakness and fatigue. CT scan did not show PE. CK level was 17000, inflammatory labs were mixed. Rheumatology consult concluded it was myositis related to COVID vaccine. admitted to hospital 4/27-4/30.

Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient fainted after receiving covid vaccine (Janssen). He was sitting for the required 15 mintute interval and collapsed from his seat after about 5 to 7 mintutes. I quickly help position pt. against the wall. He was disoriented and slighlty confused. He was conscious and alert but dazed. I immediately had by technician call 911 and the paramdeics attended to pt. After doing thorough evaluation of symtoms, pt. declined further treatment. His friend picked him up

Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Within a few minutes, pt began to sweat/feel light headed/dizzy/ringing in the ears. Pt stated he felt like he was going to pass out. Pt reported no symptoms related to anaphylaxis. Pt did not lose consciousness and symptoms started improving within 10 minutes. Pt then noticed blurry vision which resolved. Pt's BP was checked: 120/90, pulse WNL. Pt. was feeling fine but per PCP guidance, went to ER for a follow up when I followed up via phone. Reported no further issues after leaving pharmacy

1 hour after shot started sweating along with blurred vision and light sensitivity from outdoor to indoor. 4 hours after chills and mild to medium headache with fever 101.5 along with joint and muscle aches. Also my chest felt heavy with no breathing problem. Headache lasted for about 24 hours. Fever and chills lasted for about 60 hours after shot. Joint and Muscle pain lasted 72 hours. Blurred vision last about 18 hours with sensitivity to light. Took tylenol fever reduces to 99.7 - 100.4 After 72 hours body felt normal

Adverse Reaction Notes: Per NP. Patient had a brief syncopal episode after receiving Johnson and Johnson vaccine , his vital signs remained stable BP 121/76,P68,O2 sat 99%. Patient was awake ,alert, oriented x4,he left vaccination site via ambulance with paramedics to hospital for further evaluation.

Patient had a syncope episode post vaccination. Patient had a know needle phobia and stated passed out one time when had blood drawn.

102 temperature. Strong involuntary shaking. Chills. Back pain. Elevated pulse. Muscle Weakness. Fever broke around 0600. Adverse reaction appeared to be resolved by 36 hours from time of administering vaccine.

HEAD PRESSURE; ABDOMINAL PAIN; STUCK THROAT; DIZZINESS FOR APPROXIMATE HALF A DAY BUT GONE ON THE NEXT DAY; NAUSEA; MILD HEADACHE; HALF OF MY HEAD TO THE NECK IS SO STIFF AND GIVING HEADACHES AND DIZZINESS; CHEST FELT LIKE A TIGHT SQUEEZE; HEAD FELT LIKE A TIGHT SQUEEZE, COMPRESSION AND GIVING ME HEADACHES; This spontaneous report received from a patient concerned a 44 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 drug allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced half of my head to the neck is so stiff and giving headaches and dizziness. On APR-2021, the subject experienced chest felt like a tight squeeze. On APR-2021, the subject experienced head felt like a tight squeeze, compression and giving me headaches. On 06-APR-2021, the subject experienced head pressure. On 06-APR-2021, the subject experienced abdominal pain. On 06-APR-2021, the subject experienced stuck throat. On 06-APR-2021, the subject experienced dizziness for approximate half a day but gone on the next day. On 06-APR-2021, the subject experienced nausea. On 06-APR-2021, the subject experienced mild headache. On 03-MAY-2021, Laboratory data included: Blood test (NR: not provided) Not provided., Chest X-ray (NR: not provided) Not provided, EKG (NR: not provided) Not provided, and MRI (NR: not provided) Not provided. Treatment medications included: acetylsalicylic acid. The action taken with covid-19 vaccine was not applicable. The patient recovered from dizziness for approximate half a day but gone on the next day on 07-APR-2021, had not recovered from head pressure, abdominal pain, stuck throat, nausea, head felt like a tight squeeze, compression and giving me headaches, and half of my head to the neck is so stiff and giving headaches and dizziness, and the outcome of mild headache and chest felt like a tight squeeze was not reported. This report was non-serious.

Patient received his vaccine and sat down in an alternate chair. He stated that he started to feel dizzy and then passed out. The patient regained consciousness fairly quickly. He did fall on the ground out of the chair, but did not hit his head. EMTs were called and he was checked out. He was able to leave saying he felt much better.

Patient was administered Janssen vaccine and instructed to stay seated for 15 minutes as had no prior reactions to drugs or vaccines previously. About 5 minutes after vaccine patient stood up to report to pharmacy counter that he was feeling very dizzy. He was instructed to sit back down. While turning for seat, patient fell and hit mouth on cabinet that resulted in a cut lip. Patient loss consciousness briefly. He was able to respond to verbal commands to roll onto left side. Blood pressure was check and read 94/59 mmHg. Patient remained in this position until feeling well enough to sit up on floor, per ok from paramedics via phone. Patient was perspiring on forehead. Patient took a few sips of water and reported feeling better. Paramedics repeated blood pressure and took patient to hospital. Patient stated he did not remember falling but remembers instruction to roll to side.

Patient was sitting for 15 minute observation and suddenly passed out for about 10 seconds. He was sweaty and pale and mentioned being light headed.

Within a few minutes of receiving vaccine, patient got pale and was sweating. He was fading in and out of consciousness and closing his eyes. He also appeared as if he was going to vomit. I immediately called 911 and they were here within minutes, checked him out and he waited an additional 20-30 minutes before leaving.

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

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

At 12:30am 04/06/21, I was wakened to a nauseous feeling in my stomach, and on my way to the restroom I passed out. My head hit the floor and that is when I woke up and had Diarrhea. Went back to lay down, and I had trouble the rest of the night breathing with intense arythmic activity. It caused me to not be able to breath as my heart was skipping beats very aggressively. This lasted into the morning of 04/06/21, and did not cease until 7-8pm that evening. Symptoms lasted approx 5 days, and dropped off in severity. Other symptoms included the following the day of the 04/6 -4/10/21: - dizziness - metal taste in my mouth - nausea - mental confusion - fatigue - loss of appetite - severe shakes/chills/sweats

Patient presented with wife 6/18/2021. Patient requested Janssen covid-19 vaccine. The immunization was administered at 6:55pm. After 7 minutes of sitting in waiting room, patient started to complain of dizziness, "spinning in head", heavy breathing, and sweating. Patient was very sweaty, pale, and uneasy. Patient then fell to the ground with wife next to him, and lost consciousness briefly. 911 was immediately contacted. Patient did not hit his head or other body parts. Patient was able to be picked up and brought back into his seat. He did lose consciousness again in his seat very briefly but was able to speak to me and answer questions as I spoke with 911. He was very pale and sweaty, but answered questions to check for mental status. 911 police and ambulance arrived and checked his pulse, blood pressure, and asked several questions to examine his mental status. Patient declined going to hospital. Patient did walk out with wife, more color apparent on face, and able to answer questions. Patient and wife were advised to stay home and relax post-vaccination and call 911 if symptoms arise.

Fainted twice after receiving the vaccine. First time 5 days after receding the vaccine, the second time about 6 weeks later. First time I was dehydrated, and fainted at the gym while exercising. The second time I fainted while walking the dog. Both times I broke out in hives, the second time more severely (all over my body). Both times I fell, hit head head and had to get stitches or staples.

Nine hours after receiving vaccine I started "trembling, shaking." Not convulsing, more like really cold. My temperature read 97.2 degrees. My normal temperature is 98.6 degrees. Shaking stopped around 11:30 p.m. I woke up at 3:15 a.m. very hot with my heartbeat racing. I did not measure heartbeat rate. I woke up this morning at 5:30 a.m. with no side effects.

Really bad hurting in chest pain, swollen lips and a headache. Had to go to ER. Forgot to mention the vaccine shot. They finally decided it was an allergic reaction. Gave a steroid shot and Benadryl. Sent home on steroids for 5 days. The next day had rash and itching. The next day it was worse looked like lace pattern rash over most of his body and really bad itching. Like this through the 20th then he took Claritin and put on anti -itch cream. The next day the rash had mostly cleared but still a little itchy. Today the 22 I have had a really bad headache.

PATIENT REPORTED STARTING TO FEEL FAINT AND BLACKED OUT FOR 30-45 SECONDS WITHIN 1-2 MINUTES AFTER RECEIVING VACCINE. HE EXPERIENCED DIAPHORESIS AND FELT HE WAS GOING TO PASS OUT. DENIED SOB, HIVES, SWELLING, STOMACH PAIN. REPORTED HE HAD NO HEALTH CONDITIONS BUT THAT THIS HAD HAPPENED TO HIM BEFORE BUT THIS WAS WORSE - SAID HE HAD NOT EATEN THAT DAY OR DRANK WATER. RPH GAVE PATIENT WATER AND LEMONADE ABOUT 2 MINUTES OR SO INTO REACTION AND PATIENT SAID HE STARTED TO FEEL BETTER AFTERWARD. 911 WAS CALLED AND PARAMEDICS RESPONDED WITH TAKING BLOOD PRESSURE AND BLOOD SUGAR - BP A LITTLE LOWER THAN AVERAGE BUT UNSURE WHAT PT TYPICALLY RAN AT. BLOOD SUGAR NORMAL AFTER DRINKING LEMONADE. PATIENT TAKEN TO ER FOR FURTHER CARE

Patient post Johnson and Johnson vaccination and in observation period when EMS and Nursing staff noticed patient to be unresponsive with 10-20 seconds of mild jerking movements. Patient able to regain consciousness and state that he has a history of seizures Blood pressure124/80, blood glucose 63. Patient transported by EMS to hospital.

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

my husband has asthma and this shot made him very sick. today is day 4 and he still has fever, chills, is perspiring profusely. an hour after his shot was administered, he started to feel cold, shortly after, he was having chest pains, not long after his fever spiked to 104. his side effects were, fever, chills, vomiting, chest pains, perspiring, asthma attaches, sever body aches, head aches.

nausea, faint, migraine, chills, fever, muscle pain, shortness of breath, joint pain, weakness, fatigue, dizziness, heart acceleration, lots of sleep, anxiety, drowsy.

Onset Thursday, 4/08/21 at 03:00 am: Fever, Chills, Severe Body Aches and Joint Pain, Exhaustion. 09:00 am to 1:50 pm: Slept with profuse sweating. Friday 4/09/21 at 12 midnight: Fever with ears red and burning. Applied wet cold towels on body. Vomited once, followed by dry heaves. 10: 00 am Nauseous. Checked temperature with ear thermometer- afebrile. Checked oxygen saturation with pulse oximeter- 96% HR 35. Checked pulse manually with a range of 39-44 and irregular.

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

EMS dispatched to the Vaccine Clinic for the syncopal. Found male supine in vehicle ico event paramedic. Stated male received a Johnson and Johnson vaccine. Stated he drove his car to the medical monitoring location. Stated he had a syncopal episode with muscle rigidity. IV established. Fluids administered. Vitals noted to be hypotensive. Patient-stretcher-ambulance. Patient stated he felt dizzy. Muscle rigidity present. Patient stated he feels his whole body cramping. Stated he remember events that occurred. Denies chest pain. Denies SOB. Denies ABD pain. Denies N/V. Stated he felt healthy prior to the vaccine. No incident during transport. Muscle rigidity resolved PTA at the ER. Patient received 900cc NS. Transfer of care to ER nurse w/ report.

Immediate intense internal heat with excessive sweating; nausea; light headed; faintish; severe dizziness. After 40 minutes, the lightheadedness, faintish and dizziness subsided. However, the intense heat, sweating and nausea continued. By the evening an intense migraine started and by 4/10/21 my sister vomited and started running a fever 100.5. Complete muscle aches, overall feeling extremely ill, totally bed ridden and a migraine that cannot be controlled at all.

Patient passed out, opened ammonia salt within 2 minutes, pt lost responsiveness after 7 minutes, gave Epipen, called EMS. Patient observed for additional 15 minutes, BP and HR stable per EMS review.

Approximately 2.5 minutes post vaccination- patient became diaphoretic, pale, and exhibited a flat affect. Upon opening his car door to further assess, client began to jerk and froth at the mouth. Event lasted <30 seconds. Epi pen administered at 5:20 pm and ambulance called. B/P 88/42, P-120, R-20, SaO2- 96%. Patient evaluated by ambulance personnel, but refused transfer. His girlfriend stated that she would take him via private car to hospital. Patient strongly encouraged to go via ambulance- repeatedly refused.

Became light headed, Fainted, Turned Pale, Sweated. EMTs were called who took BP, Blood Sugar, and ran EKG (I think). and was told all were normal.

States that he got the J&J COVID vaccine Thursday 4/8/21 States that he had immediate muscle pain right away and a cough right away Upper chest is painful and he is having trouble breathing Chest pain has started yesterday- reports the pain has gotten worse States that he exercises every day and ran this AM States that today the chest pain has gotten worse and his breathing has gotten worse as well States that he works around chemicals in a woodworking shop but doesn't think that this is the cause of his chest pain Chest pain is located at the top of his sternum States that he feels queasy and unwell over all Advised that with current symptoms that he needs to be evaluated urgently and advised calling 911 if he did not have someone to bring him in. Patient refuses 911 but agrees to be seen in the ER. Will go to his closest ER now.

Beginning two days after getting the vaccine, I completely lost my appetite and developed severe abdominal pain, my blood pressure and heart rate were elevated and my stomach continued to hurt. I also had chest and back pain, muscle aches, insomnia and cramping. Finally went to the Emergency Room on the third night.

5 minutes after receiving the injection, my husband passed out, starting sweating profusely, and was out cold for a minute. EMS were called and he was seen in ER due to low heart rate and sweating to rule out any heart conditions. He had 2 EKGs - one in the ambulance and one in the ER. He also had to have a CT for falling and bumping his head to rule out that injury. The DX was listed as a vagal response, but we are not so sure we agree given that he is 45 years old, has no priory history or anxiety about shots.

few minutes after patient got vaccine, he fainted, he was pale, dizzy. we laid him down on the floor and after 1-2 minutes he open his eyes and start talking. we observed him for 30 more minutes.

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

Chills and joint pain in the evenings from day 3 through day 7. Mild to moderate Headaches from day 3 through day 9. Shortness of breath, twice between day 5 and 7. Chest pain on the evening of day 6, lasted 3 to 4 minutes.

I had mild pain radiating in my arm within 2 minutes of the vaccine. 1-2 hours later I developed unusual and intermittent pain on the volar surface of my wrist. 8 hours after the vaccine I developed chills, severe fatigue, myalgias, loss of appetite, and a fever up to 101. I was bedridden for 36 hours and then the symptoms gradually subsided by day 3. I then developed a sense of chest tightness intermittently for the next 4 days usually at night. I did not have chest pain, but had tachypnea at times with a respiratory rate up to 22/min. At day 7 this resolved.

This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included acid reflux, and eye twitches. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 09:00 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced eye twitching. On 13-APR-2021, the subject experienced slight pressure on side of head. On 13-APR-2021, the subject experienced burning sensation in chest. On 13-APR-2021, the subject experienced shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from eye twitching, slight pressure on side of head, burning sensation in chest, and shortness of breath. This report was non-serious.

Patient does not remember most of the adverse event. Patient's partner reports that patient started feeling a tingling sensation on his left arm about 10 minutes after vaccination. Partner also reports that patient was hallucinating and sending her confusing text messages during his 15 minute observation period. The patient did not report feeling any adverse symptoms at the checkout station after his 15 minute observation period and before leaving the vaccination clinic. After patient returned home, his partner reports considerable swelling on his left arm, continued hallucinations and trying to dismiss her concerns. Subsequently, that same day, partner reports the patient had a severe migrane and began to lose feeling on his left arm and leg, at which point the patient also lost consciousness. Also at this point, the partner calls 911. After arrival of emergency personnel, the patient regains consciousness, but does not remember name and complains of continued pain on his arm. He is transported to hospital where he spends 3 nights and receives treatment and care for stroke symptoms. Patient reports that he does not remember much of anything 1.5 days after vaccination. After returning home from hospital, patient complains of memory lapses and begins seeing neurologist for minor seizures during his sleep. Wife reports that patient now lashes out and easily loses temper due to the fact that his memory is foggy.

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

5 minutes post vaccination, client left an "adrenalin rush" and "tightness on his chest and tingling and tense all over his body." Client felt very anxious today and he reports having history of anxiety. His BP is 155/97 p 101, after 5 minutes manual BP is 142/90 p 110. 911 was called and medics performed an EKG on site. Client indicates that his symptoms are improving and was not transported to the hospital.

CHEST PAIN; CHEST PAIN RADIATING TO STOMACH ON AND OFF; PAIN LIKE SENSITIVE TO TOUCH ON LOWER BACK OF LEGS BELOW KNEE (RIGHT LEG IS MORE SENSITIVE TO THE TOUCH THAN LEFT); This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient did not known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 13-APR-2021 for prophylactic vaccination. The batch number was not reported, per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 17-APR-2021, the subject experienced pain like sensitive to touch on lower back of legs below knee (right leg is more sensitive to the touch than left). On 20-APR-2021, the subject experienced chest pain. On 20-APR-2021, the subject experienced chest pain radiating to stomach on and off. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain like sensitive to touch on lower back of legs below knee (right leg is more sensitive to the touch than left), and chest pain, and the outcome of chest pain radiating to stomach on and off was not reported. This report was non-serious.

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

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

VIRAL PERICARDITIS; LEFT ARM PAIN; SEVERE HEADACHE; ABDOMINAL PAIN; This spontaneous report received from a patient via a company representative concerned a 45-year-old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and social alcohol drinker, and other pre-existing medical conditions included no known allergies and 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: 09-JUN-2021) dose was not reported, 01 total, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the patient experienced abdominal pain. and severe headache. On 03-APR-2021, the patient experienced severe chest pain and left arm pain. On 04-APR-2021, the patient was admitted to the hospital and diagnosed with viral pericarditis and was discharged on 06-Apr-2021. Laboratory data included: On 04-APR-2021, Angiogram (NR: not provided) Not reported, CT (computed tomography) scan (NR: not provided) Not reported, EKG (electrocardiogram) (NR: not provided) Not reported, Echocardiogram (NR: not provided) Not reported, Troponin increased (NR: not provided) Troponin levels increased, and X-ray (NR: not provided) Not reported. On 05-APR-2021, Laboratory data included: Angiogram (NR: not provided) No blockages. On 06-APR-2021, Laboratory data included: Echocardiogram (NR: not provided) No blockages. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from abdominal pain, and left arm pain on APR-2021, and had not recovered from severe headache, and the outcome of viral pericarditis was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: 20210436265-covid-19 vaccine ad26.cov2.s-Viral pericarditis, Abdominal pain. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210436265-covid-19 vaccine ad26.cov2.s-severe headache, Left arm pain. This event(s) is labeled per Agency and is therefore considered potentially related.

Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Medium, Additional Details: Patient Refused epi-pen. Most likely anxiety-related event per patient and wife/observation. EMS showed up to store within 20 minutes; patient was discharged to home and did not follow up with ER. Spoke with wife at 5PM --patient has been fine all afternoon and went shopping after AE.

Started with nausea, then it followed. Migrane, unable to talk, unable been awake ,I even fainted I don't know for how long but when I woke up was on the floor and sweating, chills, fever, shortness of breath, tireness, muscle pain and cough. Did not go to the doctor or hospital, I have no insurance. Even until today I still have a light cough and shortness of breath. All this stopped me from going to work for 2 weeks, and unenployment did not pay.

Chest pain/discomfort, Heart Palpitations/Abnormal Heart rhythm, Shortness of breath, Exhaustion, Lightheadedness and dizziness. Symptoms are ongoing and of intermittent intensity. Aspirin daily for chest pain. See below for diagnostic tests ordered.

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

Before receiving the vaccination the patient mentioned he had a fear of needles. Patient was asked if he ever fainted after getting a vaccination or injection and patient reported no. The vaccine was administered to the patient and patient appeared to be fine for the next few minutes after getting vaccinated. Patient was told he could take a seat in the waiting area and wait until his 15-minutes were up and he could go. Patient was seated in the waiting area for about a minute but then got up to walk down one of the isles. When walking down the isle patient fainted and collapsed. This occurred approximately 10 minutes or so after he received the vaccine. Patient was helped to a chair and once seated appeared to shake/convulse (almost like a seizure) for approximately 5-10 seconds before snapping out of it and regaining consciousness. Afterwards he was alert and talking but didn't remember fainting. 911 was called and he was checked out by paramedics. After observing him for 15 minutes or so and determining his heartrate and blood pressure were normal and he appeared to be ok, the paramedics told him they can take him to the hospital to be evaluated further, or he was free to leave on his own without going to the hospital. The patient said he felt fine and declined being taken to the hospital. After another 10-15 minutes the patient left under his own power. Patient mentioned he would possibly be calling his physician and alerting them to the episode.

Patient started to experience dizziness, profuse sweating, pale-ashen colored face, and nausea three minutes after the vaccine was administered. Offered to call EMS, but patient declined and remained conscious. Symptoms subsided after approximately 10 minutes. Patient returned home with his girlfriend.

On 5/13/2021 patient developed a cough in the evening. Patient woke up not feeling well on 5/14/2021, and also had nausea and vomiting. Patient was driving a vehicle when he had a seizure. No prior history of seizures. Drifted off the road, no significant damage to vehicle. Patient post-ictal following seizure, seizure activity was witnessed by bystanders. CT brain showed small subdural hematoma. A CTA chest performed due to hypoxemia and tachycardia at Hospital showed Multifocal groundglass type nodular infiltrates throughout the right lung involving the upper lobe, middle lobe, and lower lobe, minimal left lower lobe patchy infiltrate, as well as patient's known thymoma. These multifocal groundglass infiltrates were not previously mentioned on a CT chest performed on 4/10/2021. Patient was transferred to this facility for evaluation by neurosurgery. Patient was mildly tachycardic, hypoxemic to 88% on room air, and tachypneic. Patient reported decreased sense of taste & smell for 1 month, which he attributed to his losartan use. A covid/flu/rsv PCR on 4/10/2021 was negative, and a viral respiratory pathogen panel with covid PCR was negative on 5/14/2021, as was an antigen & NAAT for COVID on 5/14/2021. Patient was treated with antibiotics and admitted for further management.

Janssen COVID-19 Vaccine Vaccine Lot Number: 202A21A Pt reported feeling light-headed 1-2mins after shot. unconscious for 15-20 sec. diaphoresis before passing out. 911 called. M410 transported to HEC Pt suffered no trauma or fall. 12 lead ekg performed with sinus brady and 1st degree. no daily meds, nkda. ran 4 miles today; oatmeal/granola, milk protein bar; 13:28 92/43 p 57 ; 105/71 P 42; 112/66 p 49

Patient experienced a vasovagal reaction, loss of consciousness, sweating over the course of several minutes.

Shortness of breath, numb face , tingling arms and legs, tinnitus in both ears, heart palpitations, blurry vision. Still have tinnitus, hearing sensitivity, vison problems and chest pai.

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

FATIGUE; HEADACHE; CHEST PAIN; TACHYCARDIA; CRAMPS ON HANDS, ARMS AND RIGHT LEG; PAIN ON LEFT ARM; This spontaneous report received from a patient concerned a 45 year old white and Hispanic or Latino male. The patient's height, and weight were not reported. The patient's past medical history included gastritis, and concurrent conditions included glaucoma, avocado allergy(it causes nausea). Patient had Reglan allergy which causes nervousness. Patient was alcohol user (one time a month socially) and non-smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: unknown) dose was not reported, administered on 28-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in APR-2021, the patient experienced chest pain, tachycardia, cramps on hands, arms and right leg and pain on left arm. On an unspecified date in MAY-2021, the patient had fatigue, headache. On 01-MAY-2021, patient underwent PCR Covid-19 test which was negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest pain, headache, cramps on hands, arms and right leg, fatigue, pain on left arm, and tachycardia. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210604719-COVID-19 VACCINE AD26.COV2.S-Chest Pain, Tachycardia. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Patient came to the pharmacy for the Janssen COVID vaccine. He was feeling fine, and was injected with vaccine in the left deltoid at 1:05pm. He remained alert throughout the time information and instructions were provided. Later, he mentioned fear of needles and looked pale. I gave him a Gatorade drink and glucose tablets. At about 1:10pm he fainted while seated in our pharmacy waiting area. He was accompanied by his significant other. He had mild convulsions that lasted less than 5 seconds. Our request to call 911 was denied. Store management responded to our call immediately. Observation and care was provided. Moist cloths were given to patient. He recovered in about 15-20 minutes. He walked out with his significant other. He was very thankful and said he felt normal.

Patient was severly dizziness and took it upon himself to lay down on the floor. He was also experiencing nausea, sweating on his head, and fast heartbeat which was conveyed to the EMT. He also requested an ambulance.

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

dry mouth , shiver and difficulty breathing and tightness in arms complained (05.10 pm)by patient within 15 minutes of administration( 450pm) . Patient was laid down on floor with raised legs and cold packs applied to face and hands. Bp monitored and benadryl given ( 5.15 pm) . patient was still breathing . BP was high. next 10 minutes patient was feeling better. was seated with elevated legs. Drank water and Ems was called . Bp was at 178/112 pulse 83 Per EMS possibly syncope or initial reaction to the shot.

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

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

CHEST PAIN; NUMBNESS IN FINGERS ON LEFT HAND AND LEFT ARM; FELT WEIRD; PAIN; PAIN IN NECK; PAIN IN ARM; PAIN IN HEAD ON LEFT SIDE; LACK OF ENERGY WHEN WALKING OR WORKING; This spontaneous report received from a patient concerned a 45 year old male. The patient's weight was 175 pounds, and height was not reported. The patient's concurrent conditions included glaucoma. The patient experienced does not feel good when treated with metoclopramide. 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 28-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported. On 18-APR-2021, the subject experienced chest pain. On 18-APR-2021, the subject experienced numbness in fingers on left hand and left arm. On 18-APR-2021, the subject experienced felt weird. On 18-APR-2021, the subject experienced pain. On 18-APR-2021, the subject experienced pain in neck. On 18-APR-2021, the subject experienced pain in arm. On 18-APR-2021, the subject experienced pain in head on left side. On 18-APR-2021, the subject experienced lack of energy when walking or working. Laboratory data (dates unspecified) included: CAT scan (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest pain, numbness in fingers on left hand and left arm, lack of energy when walking or working, and pain in head on left side, and the outcome of felt weird, pain, pain in arm and pain in neck was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.

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

Near-syncope followed by mild pain in the upper left chest region. Prescribed 81mg Aspirin (daily), 10mg Atorvastatin Calcium (daily), 0.5mg Clonazepam (twice daily). No further episodes of near-syncope, but mild pain in the upper left chest region continues on occasion.

On 7/6/2021 while on vacation, I started developing sharp tingling feeling in my left leg. I then nearly had a syncopal episode, had trouble speaking and was leaning to the right. My wife had to hold me up. My brother in law had to carry me to the car as my left leg was not working at all. I was taken by ambulance to the nearest hospital and was worked up for possible CVA (which was ruled out). I was also checked for DVT of lower extremities which was negative. I am still having residual numbness and tingling to my left leg. I am still having symptomatic bradycardia with near syncope.

Systemic: Dizziness / Lightheadness-Mild, Systemic: loss consciousness for 10 seconds-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Pt HR at 49-55, loss consciousness for less than 10 seconds, became diaphoretic. BP at 96/62. Pt felt better after 5 minutes.

Vasovagal Syncope - seated talking immediately after vaccine. Suddenly stopped and fell off chair onto gym floor. Regained consciousness after 30 - 60 seconds and was light headed and was diaphoretic. No SOB, swelling, itching, hives, difficulty speaking or swallowing, hoarse voice, palpitations, CP, headache. AO x 3. No hives or rash. Ambulance called but patient declined export. Driven home by a friend. Advised to call 911 if further symptoms.

High fever, chills, nausea, fast heart beat started about 14 hours after the injection and lasted about 8 hours. Very achy and fatigued for an additional 6 hours after the most severe symptoms passed.

HR 126-67; SPO2-98; BP 154/80; pt. was fine after vaccine then got out of car to use bathroom and as soon as he stood up from the car he lost balance and stated feeling dizzy, light headed and didn't feel right. he Slumped over and was caught by an observer and guided to the ground. Hypoglycemic but not diagnosed. B/S 107. pale, nauseaous. care transferred to the paramedics.

Symptoms began immediately. I felt an aching pain in my left arm immediately after the vaccination. It then moved to my scapula. It persisted the rest of the day and all day Tuesday. I also felt soreness of limbs (both arms and legs) intermittently for the 48 hours. I had shortness of breath for the next day. I felt extreme fatigue for the next 48 hours. I felt my heart racing off and on for 24 hours, I felt a loss of strength in both arms and legs for the next 48 hours. Monday Night I woke up sweating as I had a fever. The fever persisted off and on for about 24 hours. I was irritable (probably due to not feeling well) for about 48 hours. My wife had to drive me home.

Patient received dose of J&J COVID-19 vaccine at local vaccine clinic. Reportedly, a couple minutes later, patient experienced vasovagal syncope for which a Code Blue was called by clinic staff. 911 was also called. Patient was evaluated by ED physician on scene at the clinic, where patient had regained consciousness and responded to questions. Patient was then transported to ED next door by ED staff where patient was monitored and ultimately discharged home.

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

vasovagal syncope; This spontaneous report received from a health care professional concerned a 46 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies and no significant past medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 31-MAR-2021, a couple minutes later of vaccination, patient experienced vasovagal syncope for which a Code Blue was called by clinic staff. 911 was also called. Patient was evaluated by ED physician on scene at the clinic, where patient had regained consciousness and responded to questions. The patient was then transported to emergency department next door by the emergency department staff where patient was monitored and ultimately discharged home. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vasovagal syncope on 2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210401417 -COVID-19 VACCINE AD26.COV2.S-VASOVAGAL SYNCOPE. 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

Same day/evening: chills, severe headache, sleeplessness, chest pain Next morning/afternoon: fever, muscle soreness, worn down

He began getting dizzy immediately after vaccine - pale, sweating, and felt like he was going to vomit. He remained in the IMZ room for observation and applied a cool compress to forehead and back of neck. Coloring came back after about 10-15 minutes and he said he felt better. Also mentioned that this happened to him after he got a TDap vaccine about 15 years ago - he said it is a mental thing with him and does not like to get vaccines.

day after, was severe nausea, body aches, low grade fever. headache. 2nd day I was fine, about a week later I had a relapse without the nausea. I have felt off ever since, low grade fever comes and goes 99-100 degrees. My skin feels constantly hot and has become extremely sensitive, scratching my head is painful. I am more shakey in my hands than normal, my head is foggy and cant concentrate at times, insomnia. Which is essential for my work. My heartbeat is rapid at times but my blood pressure isn't up. All of my bloodwork looked fine except for weak anemia which is new for me. the last thing is a rash appeared on my feet and legs but doesn't itch and I started getting shooting pains in my legs, this is new, started about a week ago.

PATIENT REPORTED VISUAL DISTURBANCES (DARKENING OF VISUAL FIELD), SWEATING, AND WEAKNESS ABOUT 5 MINUTES AFTER VACCINE WAS GIVEN.

I could not report March 15 when this occurred because Vaers HHS did not have the Janssen listed as an option to report against at that time. Unusual for me hour long nosebleed resulting in use of a half of box of tissues. It occurred at 3am so doing anything other than homecare didnt seem necessary. After getting this vaccine I felt a brain fog for approx 15 days especially after being awake for about 8 hours, unusual for me as well. The nosebleed was of most concern and with the recent pause I saw on todays news about blood clotting issues. I felt it was important I report my experience on day 8 of vaccine and days 2 thru 15 of vaccine. I would not go back in time and take this vaccine based on my side effects.

Janssen COVID-19 Vaccine EUA I did not feel well within a minute or so of receiving the shot - not an allergic reaction per se. The nurses took my blood pressure and it was 200+/100+ and HR was 108. They continued to monitor and it slowly went down over the course of the 45 minutes I was there. Upon departure, BP reading was at about 160/90. I monitored that evening and Sunday and was normal most of the time. I did have a similar feeling Sunday afternoon and Monday afternoon, and when I checked my BP it was about 150/90 and HR was elevated (between 100-115bpm). Eventually I felt better, excluding expected side effects I've had - fever, aches, and fatigue. As of Tuesday (today as of writing), I am feeling better than yesterday, less fatigue and no fever thus far. I am hoping no more episodes with the elevated BP and HR occur today or in the near future. I did notify my physician about this and he asked me to monitor my BP for the next week, stay hydrated, and report back if no improvement in BP readings.

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

EMS, who was working in the clinic, stated that the patient had a partial seizure and directed the Clinic Lead Nurse to call EMS. Patient became pale, 5 second seizure, dizziness and vomiting. EMS was called and vital signs were taken but patient declined to go to the hospital. Patient recovered and drank some water and ate some crackers. Patient waited another 30 minutes and stated he felt much better. Clinic Lead Nurse called the patient, on April 13, 2012, who stated that he went home, ate some food and relax the rest of the day. He stated he felt better and had no more problems. He did not seek additional medical care.

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

24 hours after the vaccination the patient developed a delayed allergic reaction in the vaccination site (right upper arm). He developed 3 serous filled bulla with the largest measuring 5cm by 2.5cm with surrounding erythema and tenderness to palpation in the area. This was associated with headache, diaphoresis, shortness of breath, substernal chest discomfort, and sensation of throat itching. By 72 hours the bulla had popped and the patient's the only remaining symptom was right upper arm pain.

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

Since receiving the vaccine, I have developed tightness in my chest and shortness of breath. At times, it has been severe. Feeling like I might pass out, I went to Immediate Care on 04/12. They didn?t identify a cause. On 04/15, I went to my Doctor, who noted wheezing in my upper lungs. An inhaler and pantoprazole were prescribed. At times, it feels like I am having something similar to an asthma attack. The inhaler has helped. Prior to the vaccine, I didn?t have any history of breathing problems, nor does it run in my family.

Pain all over the body! Swelling in both feet ankles, fever, stomach pain, fatigue, chest pain and phlegm! Extreme tiredness, pain and swelling in the vaccinated arm, swollen of the shoulder of the vaccinated arm, severe headache

He was in his usual state of excellent health until yesterday. He noticed a small blister over his left upper gum. This burst and was clearly filled with blood. Over the ensuing 24 hours, he has had multiple such blisters and came to the Emergency Room for fear of a reaction to the COVID vaccine that he had had 13 days ago. This was Johnson and Johnson. He had no major reactions to it. On coming to the Emergency Room today, he noticed significant petechiae forming over the lower extremities as well as scattered petechiae forming elsewhere. He presented to the Emergency Room and there was noted to have a CBC showing hematocrit of 51, 4000 platelets, and a white count of 7.7 with an unremarkable differential. INR is 1.1. D-dimer was 0.33. Chemistries were limited, but were within normal limits.

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

Patient presented with shortness of breath and generalized body aches on 3/26/21. Patient has had symptoms for 3 days, with new diarrhea as well. No nausea vomiting, positive fever and chills, no loss of taste or smell. He has chest pain that is pleuritic in nature, central lower sternal region. Patient admitted to the hospital setting from 3/26/21 and still in CCU as of today (4/30/21).

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

Immediately after patient was given vaccine, the patient passed out for 1-2 minutes, then vomited, became light-headed, and broke out into sweats. After 2 minutes the patient regained consciousness, however, the other symptoms persisted for about 10 minutes.

Severe Muscle Aches began 7-8 hours after the shot Chills began 7-8 hours after the shot Elevated Heart Rate - 100BPM Resting - When i woke up the next morning Symptoms started going away roughly 24 hours after injection.

He got the vaccine, at first for about 6 hours he felt okay, did not feel anything, felt fine. Then that day he started getting a headache, feverish, took Tylenol and felt better. The next day he noticed his heart rate would not go down, it will not go down below 100, will shoot up to 130. He went to the ER and at one point went to 150. They prescribed him some medicine to lower his blood pressure and he has been taking that and it has not been helping. He also went to his doctor and told him that it was probably anxiety, and his heart rate will still not go down. He has not had any other reactions other than this and he's scared.

For about 36 hours after vaccine - I started getting headaches and I never get them. I had backaches and my legs were hurting too. My blood pressure was elevated as well. And that was not going away either. I went to doctor. My headaches have decreased. But for the last two to three days I have been getting chest pains. I have called the doctor this morning and I'm waiting to call me back. It's not ongoing pain - just every now and then - I'm not sure what it is.

pt was hot and lightheaded while sitting then fainted in his chair pt reawoke after maybe 2 minutes and then was helped to floor 911 was called and ambulance crew checked pt over he refused to go to hospital after they checked him out and said that he looked fine he sat for maybe 5 more minutes then walked out of pharmacy

Systemic: Hypertension-Medium, Systemic: Seizure-Medium, Additional Details: Pt had seizure like activity / HTN crisis 3 min after injection. Hx of heart problems and phobia of needles. Pt lost airway and then consiousness, Pt was assisted to floor. EMS was called. After airway postioning and sternal simulation pt regained consiousness. Pt was handed off to NP care and then later to EMS after being evaluated. Wife stated they did not go to hospital and later went to dinner, when she picked up vaccine cards.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Additional Details: Patient fainted after receiving vaccine, he tipped forward in his chair and hit his head on counter in front of him. 2 minor laceration on forehead and cut upper lip. Pt unconscious for less than 1 minute. Blood pressure taken about 5 minutes later and was 65/40. 911 was called and paramedics arrive on scene. Care was transferred to them

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

Patient fainted post vaccination. Patient was seated in our post vaccine area in a chair with arms. Within a few minutes patient collapsed into the floor, was hot/sweating and a little disoriented. Patient regained consciousness, applied wet compress and tested in a seated position with head down. Began feeling better. Patient provided with a bottle of water. Patient remained on our site for another 30 minutes until felt better and stable.

Patient got faint, cold and clammy about five minutes after his vaccination and was visibly pale. When we went to assist him he asked to lay on the floor, before we could help him to this position he fainted, we got him on the floor and on his side, within about twenty seconds he woke up and was very aware of his situation. We applied ice packs under his neck and on his forehead. After about twenty minutes he sat up and started to gain his color back. At this point he told us he had fainted before after a flu shot and and donating blood. Several minutes later he was able to stand up and sit in a chair. Cold packs were continued and he drank a bottle of orange juice. Twenty minutes later he said he was back to normal just felt weak like after a work out. He wanted to use the restroom and was escorted, showed no additional signs or symptoms at this point, and wanted to go home.

Patient fainted after receiving Janssen Covid 19 vaccination while sitted for the mandatory 15 minutes observation time. Patient slumped on the chair. Patient was helped to the floor, wet paper towel placed on his head and he became conscious. We immediately dialed 911 for emergency help. Ambulance arrived shortly after and he was transported to the hospital .

3 minutes after injection patient started to stand up to get pharmacist's attention and pharmacist looked over at patient and noticed patient was clammy and looking like he was going to fall over. Pharmacist told patient to sit back down and immediately grabbed e-kit and headed to patient's side. Patient was clammy (like just got out of shower). At 3:45 PM BP was 128/63 and PR was 44. At 3:50 PM BP was 92/56 and PR 51, at this point RPh decided it was more than a vaso-vagal reaction and administered the epinephrine injection at 3:51 PM - EMS was called. At 3:52 PM BP was 130/76 and PR 59, 3:55 PM 134/86 PR 66, 3:58 PM BP was 148/83 and PR 68 at 3:59 PM EMS arrived and patient declined them taking him to hospital via ambulance due to no insurance. He had pharmacist escort him to his car so he could get his cell phone and back to pharmacy so he could call his son to pick him up and take him to the hospital. Unknown if patient ended up going to hospital.

PATIENT BECAME DIZZY AND FAINTED FOR A FEW MINUTES. WHEN PATIENT WOKE UP HE WAS PALE AND I CHECKED TO MAKE SURE HE WAS BREATHING. HE SAID HE WAS BREATING FINE BUT WAS VERY DIZZY. HE GOT NAUSEAS WITH SENSATION OF VOMITING.

Received telephone call stating that he has been having frequent nose bleeds since the date of vaccination. States it is as frequent as 5 times per day with a steady amount lasting approx 5 min.

Vaccine administered at 12:30 pm. By 6:30 pm, a fever and chills started. I woke up at 11:00 pm and had a 104.7 fever with vomiting, nausea, join pains, weakness, fatigue, and headache, along sinus tachycardia. Went to the ER to be evaluated, it was determined that this was an adverse reaction. I was released from care around 2:30 am.

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

Since I got the vaccine I felt cold and I had flu till now and my buddy so tired but the main problem is MY BLOOD PRESSURE IS TOO HIGH SINCE I TOOK IT UNTIL NOW it's over one month. My blood pressure never get down 160.

Patient became non responsive within 2 min of receiving shot. Was lowered to the floor, diaphoretic and pale, revived within 1 min, confused. States he has had this effect during previous shots/ blood draws/ being around ?sick people?. Patient given water and crackers (has only some green beans at noon today). Feels fine 10 min later.

BLOOD CLOT; STROKE; This spontaneous report received from a patient concerned a 46 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 202A21A expiry: 23-JUN-2021) dose was not reported, 1 total administered on 07-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-May-2021, the patient begun to experiencing confusion and could not think straight. On 23-MAY-2021, the symptoms progressed when the patient went to the hospital. The patient was diagnosed with blood clot and had stroke. The patient was hospitalized on 23-MAY-2021 and was discharged on 26-MAY-2021. The patient was hospitalized for 3 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot and stroke was not reported. This report was serious (Hospitalization Caused/Prolonged).; Sender's Comments: V0: 20210554839-covid-19 vaccine ad26.cov2.s-blood clot and stroke. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

elevated heart rate (up to 135 while resting) beginning approximately 8-10 hours after receiving the shot. my heart also had strange, strong beats and did not feel right. I left the hospital before someone would read my EKG because it was crowded and I was worried about infection. The symptoms persisted for approximately 6 to 8 hours and mostly coincided with fever and chills. about a week or ten days later, I had another episode of strong heart beats lasting about 6 to 8 hours. I went to Hospital and was told I had premature atrial contractions. my other symptom has been louder tinnitus, which has not subsided since my shot.

46 y/o male c/o dizziness following Janseen vaccine. Pt was diaphoretic. No PMHx, No allergies, No meds. Vitals: BP=104/65, HR = 78, RR = 22, Sp02 = 97%. BBG = 114. Pt placed on medic stretcher and monitored for 45 minutes. Pt fully recovered and cleared by medical provider to go home with family. Last vitals: BP= 122/75, HR= 65, RR= 20, Sp02 = 98% RA. Cardiac monitor revealed NSR. Pt denied any symptoms when released.

4 Days after vaccine (4/16/21), elevated heart rates while running/exercising. Max HR was 195+ for 46/yo Male. This continued during running for more 12 days (4/28/21), and seemed had resided on 4/29/21. Note: Prior to vaccine only had two runs with a max HR higher than 190, both of those were strenuous endurance events (high altitude or sprinting). 10 Days after the high heart rates, on 5/10 patient experienced another spike in heart rates, and a few. On 5/18 another high heart rate episode occurred but patient didn't see heart rate recover. Patient utilized a new smart watch to check ECG and watch diagnosed they were in AFIB. Patient visited doc / ER and while in ER came out of Afib, patient was placed on Metropol. Patient back into Afib 1 week later, admitted to hospital to undergo Cardioversion. Patient is still working with cardiologist and internist to determine next steps.

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

Patient was known to have fainting spells due to vaccinations in the past. Shortly after immunization took place he became hot and fainted while sitting in his chair. After a few moments he came to and we provided him a cooling pack for the back of his neck. He confirmed he was able to leave after another 15 minutes of monitoring.

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

My dad died after he had symptoms of sweating without doing anything to increase his heart rate. He had stated his heart had been racing recently. He died suddenly and unexpectedly.

Unexplainable dizziness, lightheadedness, body tingling, ringing in ears, fainting, rapid heart beat, unable to focus. All began a few weeks after shot and have not gone away.

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

I had heightened senses after waking up in the middle of the night. I went to the bathroom thinking I was going to get sick. A short time later I blacked out falling to the ground striking my face.

Client received the J& J Covid vaccine injection at the Health clinic and within 40-60 seconds had c/o "feeling funny" and felt like he was going to pass out. Client started to have a seizure-like activity, and loss consciousness two times. Ice packs and cooling clothes were applied to clients forehead and neck after client seizure-like activity stopped, feet elevated. Client was diaphoretic, gray, started twitching (which he said is normal when he gets nervous.) BP was low at 86/64. EMT called and client evaluated. Client refused transport to hospital. Client recovered from episode after an hour and left with his wife from the health department able to walk and communicate on his own.

Day 1: Saturday morning March 6 at 5:00am I was shaken out of my sleep with a nasty migraine, sour stomach, intense body aches, stuffy nose, fever (102f). Classic flu like symptoms. I was extremely sick all day Saturday (level of sick: 8/10). Day 2: Sunday morning March 7 I awoke again extremely sick, just as sick as Saturday. All same symptoms (level of sick: 7/10). Sunday night I was incredibly miserable, all flu symptoms, I did not sleep Sunday night, up all night and up all day the next day Monday. Day 3: Monday I continued to be sick, all same symptoms, all day long. This time the blood shot eyes & bloody nose came on, fever was steady at 101f (level of sick: 6/10). Day 4: Tuesday woke up still stick, same flu like symptoms. I feel the headache has gotten worse, in fact way worse. Fever steady at 101f all day. Overall I'm not as sick except the headache and fever (level of sick: 6/10). Day 5: Wednesday I was really hoping I'd make a full recovery but still still sick, fever dropped for a few hours then came back, fever peaks and bounces around at 101f. Headache is absolutely nasty, I feel intense pain in the back of my neck and head, hard to sleep or lay down. (level of sick: 5/10). Day 6: Thursday I feel like I'm just about kick this sickness, feeling way better. I dont have a fever today but I still have an incredibly nasty headache, really intense, my eyes hurt, back of my neck hurts. (level of sick: 3/10). Day 7: Friday, no flu symptoms, finally!! But the headache continues, really bad. It sort of disables my ability to function with the headache. Back of my neck and back of head hurts, inside my brain hurts. Ugh! Day 8: Saturday, no flu, no fever, although still bad headache. I've been taking Advil all week to help reduce the headache. It helps, but after about 6 hours later the headache returns. Late in the evening Saturday my head was pounding. Day 9: Sunday headache not that bad, mild headache lingered throughout the day, tolerable. Day 10: Monday no headache!! Today was the first full day of full happiness!! *NOTE*: In July 2020 I got COVID extremely bad, spent 4 days in the ICU, couldnt breathe!! I had a fever of 103 for 6 days straight before calling 911 to come and get me. I was in bad shape, lost 30 lbs, had respiratory breathing issue for about 2 months after hospital stay. Most sick I've ever been, total game changer, I will never be the same. To this day I feel my respiratory is at 90%, fatigue still comes around every so often. --- Thank you ---

Patient felt lightheadedness and dizziness about 10 minutes after receiving COVID 19 vaccine. Patient bradycardic and hypotensive.

After 2 minutes felt wave of flush, heart rate accelerated from 55 to 90, blood pressure rose to 150/100. Experienced light headedness. BP and HR returned to normal after 30 minutes. Light headedness remained for 2 hours. After 20 minutes heart started squeezing feeling and remained for two days. After 2 hours, began feeling sharp pains in heart and palpitations, continued for 5 days. After 12 hours began feeling mild aches and chills and fatigue. Continued for 3 days.

Day 1: Saturday morning March 6 at 5:00am I was shaken out of my sleep with a nasty migraine, sour stomach, intense body aches, stuffy nose, fever (102f). Classic flu like symptoms. I was extremely sick all day Saturday (level of sick: 8/10). Day 2: Sunday morning March 7 I awoke again extremely sick, just as sick as Saturday. All same symptoms (level of sick: 7/10). Sunday night I was incredibly miserable, all flu symptoms, I did not sleep Sunday night, up all night and up all day the next day Monday. Day 3: Monday I continued to be sick, all same symptoms, all day long. This time the blood shot eyes & bloody nose came on, fever was steady at 101f (level of sick: 6/10). Day 4: Tuesday woke up still stick, same flu like symptoms. I feel the headache has gotten worse, in fact way worse. Fever steady at 101f all day. Overall I'm not as sick except the headache and fever (level of sick: 6/10). Day 5: Wednesday I was really hoping I'd make a full recovery but still still sick, fever dropped for a few hours then came back, fever peaks and bounces around at 101f. Headache is absolutely nasty, I feel intense pain in the back of my neck and head, hard to sleep or lay down. (level of sick: 5/10). Day 6: Thursday I feel like I'm just about kick this sickness, feeling way better. I dont have a fever today but I still have an incredibly nasty headache, really intense, my eyes hurt, back of my neck hurts. (level of sick: 3/10). Day 7: Friday, no flu symptoms, finally!! But the headache continues, really bad. It sort of disables my ability to function with the headache. Back of my neck and back of head hurts, inside my brain hurts. Ugh! Day 8: Saturday, no flu, no fever, although still bad headache. I've been taking Advil all week to help reduce the headache. It helps, but after about 6 hours later the headache returns. Late in the evening Saturday my head was pounding. Day 9: Sunday headache not that bad, mild headache lingered throughout the day, tolerable. Day 10: Monday no headache!! Today was the first full day of full happiness!! *NOTE*: In July 2020 I got COVID extremely bad, spent 4 days in the ICU, couldnt breathe!! I had a fever of 103 for 6 days straight before calling 911 to come and get me. I was in bad shape, lost 30 lbs, had respiratory breathing issue for about 2 months after hospital stay. Most sick I've ever been, total game changer, I will never be the same. To this day I feel my respiratory is at 90%, fatigue still comes around every so often.

he fainted and passed out for 1 minute as soon as I administered the J&J vaccine to him i laid him on the floor , he regained his consciousness after 2 minutes the EMT came in and handled the situation . he felt okay after 15 minutes

After injection - experienced lightheadedness/dizziness/blurry vision. Patient was hypotensive -and once supine for a few minutes and his blood pressure returned to normal levels.

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

PATIENT LOOKED AT WIFE AND SAID I DON'T FEEL RIGHT, AS I WAS CALLED BACK TO THE CAR HIS HEAD BEGAN TO ROLE FORWARDS, THEN IN A CIRCULAR MOTION. HIS EYES ROLLED BACK IN HIS HEAD AND HE MADE A GASP FOR BREATH THEN PASSED OUT. EPI PEN WAS IMMEDIATELY ADMINISTERED. PATIENT BECAME MORE RESPONSIVE, LAID SEAT BACK IN CAR. PATIENT SWEATING , COULD NOW SPEAK TO ME BUT STILL SOMEWHAT DISORIENTED. VERY FAINT PULSE. 911 WAS CALLED AND COOL WET PAPER TOWEL PLACED ON HIS NECK AND OBSERVED UNTIL 911 ARRIVED WITHIN 5-10 MINUTES. PATIENT TRANSPORTED TO ER DUE TO VERY LOW PULSE EVEN AFTER EPI ADMINISTRATION. PATIENT REMAINED AT ER UNTIL 1:30 PM FOR MONITORING. THEY TRULY FELT IS WAS A VASOVAGUL REACTION. PATIENT WAS OUTSIDE WORKING IN YARD AT 6:30PM WHEN I CALLED TO CHECK ON HIM, HAS NO RECOLLECTION OF RECEIVING SHOT OR EPI PEN, JUST SAID HE REMEMBERS MEDICINE FEELING "HOT" GOING DOWN HIS ARM.

Pt experienced vasovagal syncope within 15 minutes of vaccination. Supportive care provided and pt recovered without incidence.

Fever ranging from 100.4 to 101.2 and lasting from approximately 4 pm on 04/08 until about Noon on 04/09. An accelerated heart rate with occasional minor chest pain was also experienced during this time.

The morning of 2 April, I woke up with a fever, chills, sweating and an excruciating headache. The symptoms persisted for approximately 10 hours. The following Monday, I woke up with sharp pains across my chest and shortness of breath. I was admitted to the hospital Emergency Room for about 7 hours and subsequently diagnosed with pericarditis. It is unknown if the pericarditis was associated to the vaccine but thought it was a good idea to document here.

Patient said he had 2 severe headaches with each followed by a nosebleed that relieved the headache. Both incidences occured 10 days after the shot. Patient called his doctor and is awaiting further instruction.

I would like to report what happened with all the facts. One week after I had vaccine, I had very serious nose bleeding in the morning. I said very serious because I felt it cannot stop by itself. I called 911 and went to ER. First time, I use 911 and ER. All previous nose bleeding is very minor and it will stop in a minute. But this time, I just felt the blood just pouring into my mouth. So I was scared and asked my wife called 911. After 2-3 hours, the bleeding stopped and I back home. To be cautious, I made an appointment with family doctor on next day (24th). But the bleeding happened again in the evening ( cannot remember exactly, but around 9pm). This time I just used the clipper for my nose and it took another 2 hours for the bleeding to stop. I had a very rough night while sitting on bed and had very little sleep. The next morning (24th), the bleeding come back after I used the restroom. The same feeling as the two bleeding before. I rushed to doctor's office even not my appointment yet. The family doctor said he cannot do anything since he cannot observe the place of blooding and he does not have instrument needed. I was referred to a specialist. And luckily I had the same day appointment. We rushed there and after roughly several hours waiting, I was the specialist and finally he did the treatment. Since then, my nose is ok and no serious bleeding again. After I saw the side effects of JJ vaccine, I think it is better for me to report you what happened. I strongly suspect that my serious bleeding was caused by the drop of platelet which was side effect of the vaccine. I will have one blood work today. And will let you know results if you are interested. Again, I never had such serious bleeding before and that is the reason for my suspect. All the best

04/09, ~11:15 a.m.: Received injection in left arm, released at 11:30 a.m. 04/09, ~1:00 p.m.: Mild headache, dizziness and fatigue, mild pain in left arm 04/09, ~7 p.m.: Moderate headache, dizziness and fatigue, mild nausea, spasms in muscle around injection site/itching/redness 04/09, ~8 p.m.: Went to bed and slept 04/10, ~2 a.m.: Awoke with severe headache, fatigue and dizziness, chills/fever, moderate nausea, sleeplessness, moderate pain in arm, moderate joint and muscle pain all over body 04/10, ~3 a.m.: Symptoms progressed to include delirium and hallucinations, rapid heart rate, itching in extremities, neuropathy and hyperesthesia 04/10, ~8 a.m.: Symptoms began reversing in order of occurrence over next 36 hours, starting with delirium and hallucinations; unable to concentrate or function properly 04/12: Lingering mild dizziness and headache, fatigue

Thursday April 8th 1:00PM Shot was injected into my left arm 1:15PM left hand was numb and tingling 2:00 PM left side of my face went numb and tingled. cheek, ear, neck and into my hair line Friday (4/19) midnight my heart was racing for about 2 hours. It was like I drank WAY too much caffeine Sunday (4/11) my hand was back to "normal" Tuesday (4/13) my left side of my face is getting much better, but it still feels a little different

Started sweating a lot and got very pale soon after injection. Hours after injection got chills, muscles aches, and a bad headache that lasted days. Lot appetite for days. Overall felt like I had the flu.

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

47-year old male c/o frontal headache since Friday, 4/9/2021. Received his Johnson & Johnson vaccine on Thursday, 4/8/2021. Still having his headache now. 9/10 pressure-like on the frontal head - constant States, "I never had this kind of headache before". 6/10 burning epigastric pain. Also has bodyaches. Has mild dizziness. Denies any photosensitivity, fever, flu-like sx, nausea/vomiting, chest pain, dyspnea, numbness, tingly sensation, slurred speech, back pain, rectal bleeding.

about 1 hour after injection got a nose bleed, then started experiencing on 2nd week after shot started feeling nauseous and fatigue, 3 rd and 4th week started feeling extreme fatigue, gut issues, no appetite, chills ,sweating profusely, muscle cramping all over body. Went to my Dr. April 6 & 13, all vitals good, had flu and Covid test both negative, Had labs drawn both times, liver enzymes was high with both results. Still currently having all symptoms

Five minutes after injection I broke into extreme sweating, hot flash, nausea, fatigue and head ache. I was at work and requested to go home early. I fell asleep one hour into my arrival and slept for 17 hours. Up to and including today I am having headaches, pain in my legs on left side only, nausea, lack of sleep and a continued smell similar to dried blood after a injury. I have also have and continue to have shortness of breath and chest pains resulting in two panic attacks within the last three days. This has led me to report this and I have doctor visit scheduled for 4/22. I also reported today based on internet search of reactions.

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

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

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

BLOOD SHOT EYES; BLOODY NOSE; DID NOT SLEEP DUE TO FLU SYMPTOMS; FEVER; NASTY MIGRAINE/ INTENSE PAIN IN THE BACK OF NECK AND HEAD, EYES HURT; SOUR STOMACH; INTENSE BODY ACHES; STUFFY NOSE; FLU LIKE SYMPTOMS; EXTREMELY SICK; This spontaneous report received from a patient via a company representative concerned a 47 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 heart coronary artery disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 05-MAR-2021 15:30 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included atorvastatin, hydrochlorothiazide, and losartan. On 06-MAR-2021, the subject experienced extremely sick. Laboratory data included: Body temperature (NR: not provided) 102 F. On 06-MAR-2021 05:00, the subject experienced nasty migraine/ intense pain in the back of neck and head, eyes hurt. On 06-MAR-2021 05:00, the subject experienced sour stomach. On 06-MAR-2021 05:00, the subject experienced intense body aches. On 06-MAR-2021 05:00, the subject experienced stuffy nose. On 06-MAR-2021 05:00, the subject experienced flu like symptoms. On 06-MAR-2021 05:00, the subject experienced fever. On 07-MAR-2021, the subject experienced did not sleep due to flu symptoms. On 08-MAR-2021, the subject experienced blood shot eyes. On 08-MAR-2021, the subject experienced bloody nose. Laboratory data included: Body temperature (NR: not provided) 101 F. On 09-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nasty migraine/ intense pain in the back of neck and head, eyes hurt on 15-MAR-2021, sour stomach, intense body aches, stuffy nose, extremely sick, did not sleep due to flu symptoms, blood shot eyes, and bloody nose, flu like symptoms on 12-MAR-2021, and fever on 11-MAR-2021. This report was non-serious.

Hospitalist Discharge Summary Admission date/time Apr 23, 2021 at 00:19 Discharge date: Apr 26, 2021 Hospital course 47M pmh DMII, HTN, HLD, L basal ganglia stroke, pw right-sided weakness, gait imbalance, double vision and slurred speech beginning at 2:00 p.m. 4/22. on admission, double vision resolved; slurred speech, headache and right-sided weakness imbalance gait remain. 4/23am pt developed L pupil dilation and lethargy, MRI brain demonstrating acute stroke, allow permissive htn treat for sbp>220mmhg or DBP >120mmhg, cont asa/statin; US carotid nonacute/benign; TTE pending; ST/PT/OT. Tele benign. 4/24 BPs remain elevated, allow permissive htn to standards <220/120; cont st/pt/ot, a little improved participation today po intake etc. 4/25 cont to improve slowly, will be good candidate. cont allow permissive htn, no events on tele, cont asa/statin for significant stroke, add plavix. 4/26 pt cont improve clinically, BP stabilizing still permissive htn, recommend start home BP meds within 2-3 days once out of acute phase, pt accepted today, TTE benign doppler benign, but doesn't seem like bubble study done, recommend repeat as outpatient to ensure no positive bubble defer to pt's pcp f/u. double vision persists, pt currently w eye patch relief, recommend outpatient ophtho follow up closely after or during time. cont asa/plavix/statin, then transition to asa/statin as rx per guidelines. no afib on tele, consider zio patch on d/c to ensure no afib in young patient w x2 stroke. recommend hypercoag workup outpatient. Acute stroke, L lacunar -asa/plavix/statin -permissive htn -tele -PT/OT/ST -TTE benign, nml ef, no bobble done? -repeat tte outpatient w bubble to ensure no R>L shunt -US carotid nonacute -MRI Brain 4/23 1. Focal patchy restricted diffusion and FLAIR signal hyperintensity in the left medial thalamus/rostral midbrain compatible with acute lacunar type ischemic infarct. 2. No significant intracranial mass effect, midline shift or extra-axial collection. 3. Chronic left basal ganglia infarct approximating the anterior limb of the left internal capsule involving the head of the left caudate nucleus.

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

Blood clots in nose every day for about 1 week after vaccine administration. Media only reporting about women getting blood clots as it affects their period, but I didn't think it was a side affect until days after I heard that being reported and vaccine being pulled.

Within 5 minutes, patient was sweating, flushed, and stated that he was about to faint. Patient fainted and was unable to respond to verbal or motor commands. Patient had rapid, shallow breathing. Patient's hands/arms were twitching very slightly. Patient was moved onto the floor and rolled onto his side after he started to gag like he would vomit. Once on the floor, patient regained consciousness within 1-2 minutes and was able to sit up after another 5 minutes. Paramedics arrived and examined him. He left under his own power.

Patient experienced a seizure episode immediately after I administered his COVID-19 vaccine. I administered the vaccine at 10:22 AM and a few seconds later Patient started to shake and toss his head back. I immediately called 911/paramedics after his wife and I helped him to lay to his side. His seizure episode lasted about 2 or 3 minutes. He quickly regained consciousness and became fully responsive before the paramedics arrived.

MAXILLARY EMBOLISM; PROFUSE NOSE BLEED; SEEMED TO BE A 3-4 INCH LONG WORM IN THE VEIN OF HIS LEFT OUTER THIGH; FELT LIKE CRAP; This spontaneous report received from a consumer concerned a 47 year old male. The patient's height, and weight were not reported. The patient's past medical history included coronary stent, and concurrent conditions included alcohol use (a beer or two a day after work), and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies and no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, 1total, administered on 05-APR-2021 to left arm for prophylactic vaccination. Concomitant medications included cefalexin for infection, acetylsalicylic acid, atorvastatin calcium, lisinopril, and metoprolol. On 05-APR-2021, within the first hour after vaccination, the patient felt like crap (feeling sick) and took a bath and relaxed after that he felt better. On 14-APR-2021, while he was taking bath he yelled at his wife and also the patient experienced profuse nose bleed which lasted for 20 minutes. These nose bleeds occur at least 4 times daily lasting about 20 minutes each time. On 20-APR-2021, the patient went to emergency room and he had a plug procedure and was discharged. On 25-APR-2021, the patient went to the hospital because his bleeding was ongoing and his Platelet count (NR: not provided) Not reported and treated him with some platelets and cauterization procedure was done. On 26-APR-2021, he was discharged from the hospital. On 27-APR-2021, still his bleeding was ongoing and he was taken back to the hospital. On 28-APR-2021, a surgery for maxillary embolism was performed and he was discharged from the hospital on 01-MAY-2021. This was very stressful for the patient and his entire family. The patient was not prone to nose bleeds and so this has been scary. A week and half after vaccination, there seemed to be a 3-4inch long worm in the vein of his left outer thigh. The patient walked it off and it do go away relatively quickly. The patient's wife was not sure that what will happen next. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from seemed to be a 3-4inch long worm in the vein of his left outer thigh on 14-APR-2021, and felt like crap on 05-APR-2021, had not recovered from profuse nose bleed, and the outcome of maxillary embolism was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210509176-covid-19 vaccine ad26.cov2.s-maxillary embolism, profuse nose bleed. 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). 20210509176- covid-19 vaccine ad26.cov2.s-felt like crap. This event(s) is labeled per RSI and is therefore considered potentially related.

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

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

PT WAS VERY NERVOUS, DIAPHORETIC, PALE, PARAMEDICS ON SITE, BP 99/64, HR 63, SX RESOLVED, REFUSED TRANSPORT, AMA SIGNED.

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

4/11 around 8am my nose just out of the blue started bleeding profusely. I tried about 40 minutes to stop it but wasnt successful so I was transported to hospital ER where they had to cauterize it just to get it to stop. I was advised I could not take anything but Tylenol to try to ensure the bleeding did not start again. It never really got any better and I began developing a weird head pain in my head, which caused severe headaches which the pain being felt in my face and behind my eye area. After the pain continued to get worse on 4/22 I had a virtual visit with Dr. who prescribed a steroid and antibiotic and advised I see an ENT. I havent had any more nose bleeds but I do still get intermitten headaches from time to time

Covid-19 Janssen vaccination administered on 5/24/2021 at approximately 1230. At approximately 1247 patient noted to have flat red rash to left side of neck moving towards chest and same rash on left antecubital space. Patient reported feeling hot. Diphenhydramine 50mg IM administered. Patient reported feeling short of breath, epi-pen 0.3mg IM administered. Respirations at 16 per minute, lungs clear to auscultation. Noted bilateral flat rash to underarms, improved with removing clothing from area. Patient symptoms improved. At approximately 1330 patient reported starting to feel short of breath. Patient self administered albuterol inhaler, two puffs. Lung sounds per auscultated expiratory wheezing bilateral upper posterior lobes and right middle lobe, no stridor. Post inhaler lung sounds very faint expiratory wheezing upper posterior lobe, right middle lobe cleared. At approximately 1400 noted rash to bilateral underarms started to return, rash to left side of neck started to raise, noted dermatography to bilateral sides. EMS activated. Perioral edema noted, patient reported starting to feel short of breath, epi-pen 0.3mg IM administered, oxygen at 2L per NC applied. Ambulance on prison grounds at approximately 1412, left grounds at approximately 1429 to Emergency Room for a higher level of care. Treatment at ER not available. Discharged from ER on same date at 2246. On 5/25/2021 at approximately 0215 patient reported pain in jaw, neck and chest. EKG obtained, normal EKG. Follow up scheduled with medical provider.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Medium, Systemic: Shakiness-Medium, Additional Details: Patient fainted 1 min after receiving vaccine, then started seizing in chair was moved to ground with legs up. Was checked to make sure breathing was occuring, after 3 min patient was back to normal. when woke up felt dizzy asked what year and where they were and answered correctly. Ambulancewas called pt denied being taken to hospital. bp low

Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Additional Details: Pt had syncopal episode but recovered quickly

At 12:29 patient asked for water. Once patient received water, he began to pass out. pharmacist had patient lie down on chairs with legs elevated.Technician called 911 at this time. While technician was on phone with 911 pharmacist began to take blood pressure readings. Blood pressure was low at a reading of 98/58. At 12:32 technician ended phone call with 911. Pharmacist was still monitoring patient. Patient was starting to stabilize. At 12:36 EMS arrives at pharmacy and pharmacist relays information to EMS. EMS evaluates patient, informed him of the choice to go to the hospital or not. At 12:46 After patient sat with EMS monitoring for 10 minutes patient refused to go to hospital. At this time patient was stable and left the pharmacy.

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

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

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

I went home got something to eat felt dizzy and nausea. I went to sleep woke up clammy and sweating. I slept 13 hours and woke up with a fever . I took IB-profrin and the fever continued for about 3 days. I still have chest pains

Fever 101, severe aches, swelling of face, fast heartbeat, bad rash all over body, dizziness and weakness, headache

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

AT ABOUT 1PM, PATIENT BECAME APPEARED TO BE HAVING A SEIZURE WITH HEAD BACK SITTING IN A CHAIR, WAS TONIC, CLONIC AND STIFFENED WITH A SHORT LOSS OF CONCIOUSNESS. CALLED 911 AND ADMINISTERED EPI-PEN X 1 DOSE AT 1:03PM PATIENT WAS ALREADY CONSCIOUS AND TALKING. FELT CLAMMY TO TOUCH AND WAS PALE. BP 144/82 PULSE 97, O2 SAT 98. MOVED PATIENT TO BENCH IN SHADE WHILE WAITING FOR EMS. BP 140/95 PULSE 88 WHEN EMS ARRIVED AROUND 1:20, PATIENT DID NOT WISH TO BE TRANSPORTED TO THE HOSPITAL AS HE WAS FEELING BETTER AND EVERYTHING SEEMED OK. HE REMAINED WITH US AND HAD A CLIFF BAR, COKE AND WATER UNTIL 2:20PM AT WHICH TIME HE LEFT. I FOLLOWED UP WITH HIM AT ABOUT 3PM AND HE WAS STILL DOING WELL. HE WAS ADVISED TO FOLLOW UP WITH PRIMARY CARE PHYSICIAN AND IF HE HAD ANY OTHER SYMPTOMS TO GO TO THE ER/CALL 911.

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

rapid heart rate, excessive sweating, chills, muscle aches, pain all over body, chest pain. Weakness, brain fog, out of sorts, flu like symptoms, break outs on face, trouble breathing. These conditions have lasted over 5 days so far.

Full body sweats, migraine for 2 days, threw up 4 times, shakes, pain at injection site/shoulder/chest, extreme fatigue, body aches

Patient fainted shortly after administering vaccine. Patient lost consciousness about 2 minutes following the vaccine. Patient regained consciousness and then felt like they were going to faint again. Pt reported some chest tightness and then chills after regaining consciousness.

Systemic: Fainting / Unresponsive-Mild, Additional Details: Pt seemed to be fainting after administring the Janssen COVID vaccine - felt better and was normal after administring EpiPen. 911 was called after administring Epipen - they came and cleared the pt to go. Pt sat for another 15 mintutes afterwards and left after assuring us that he was feeling normal - he was accompanied with his wife the entire time.

Pt was nauseous, diaphoretic, and pale. Pt denies eating anything all day. Juice and crackers offered. stated he felt better about 5 minutes later.

After vaccination, patient in observation area complaining of nausea. Patient diaphoretic and pale. Patient denied eating anything prior to appointment. Patient given juice and crackers. Patient began feeling better after approximately 5 minutes.

Severe achiness, leading to spasms in legs and particularly in chest wall muscles, causing difficulty breathing. Nausea, vomiting. Headache.

PRESSURE BUILDING ON THE RIGHT SIDE OF THE HEAD (FELT LIKE SOMEONE TRIED TO STICK A REALLY HOT FINGER THROUGH THE EAR); NOSE BLEEDING WHEN BLOWING THE NOSE; RINGING IN BOTH EARS; Staphylococcal infection; This spontaneous report received from a parent concerned a 48 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and high cholesterol, and other pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 23-MAR-2021, the patient experienced staphylococcal infection. On an unspecified date, the patient experienced pressure building on the right side of the head (felt like someone tried to stick a really hot finger through the ear), nose bleeding when blowing the nose (dark colored blood), and ringing in both ears. Patient's mother was not sure when these symptoms started. All the symptoms have not been resolved. The mother was really concerned that the patient was not getting proper treatment and would like the company to ask for the medical facility to be provided. On MAR-2021, Laboratory data included:Staphylococcus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from staphylococcal infection, pressure building on the right side of the head (felt like someone tried to stick a really hot finger through the ear), nose bleeding when blowing the nose, and ringing in both ears. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210409259-Covid-19 vaccine ad26.cov2.s-Staphylococcal infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

High fever 39.8C; shivers, fast heart beat, high blood pressure, veins on the forehead significantly pulsating and very visible, pain and headache

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

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

Developed symptoms of pain, redness, swelling to left anterior shin on 4/13, symptoms worsening so presented to clinic for evaluation. Has multiple varicose veins in this area.

Headaches? nothing helps Fatigue Right side body pain?especially joints, wrist shoulder and hip and knee Two bumps on right side chest Loose stool General achiness No energy Bad sleep Intermittent nausea Higher bp

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

SHORTNESS OF BREATH; CHEST PINCHING; FAST HEART BEAT; RASHES HAD REDNESS; RASHES AS ITCHY; RASHES ON CHEST AND BACK AS PAINFUL; EASILY GOT TIRED; FELT HEART WAS CONGESTED; COUGH; LITTLE BIT OF HEADACHE; This spontaneous report received from a patient concerned a 48 year old male. The patient's weight was 150 pounds, and height was 170 centimeters. The patient's past medical history included low platelet, and bypass surgery, and concurrent conditions included rashes allergy, non drinker, and non-smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for low platelet. On 31-MAR-2021, the subject experienced little bit of headache. On APR-2021, the subject experienced felt heart was congested. On APR-2021, the subject experienced cough. On 12-APR-2021, the subject experienced shortness of breath. On 12-APR-2021, the subject experienced chest pinching. On 12-APR-2021, the subject experienced fast heart beat. On 12-APR-2021, the subject experienced rashes had redness. On 12-APR-2021, the subject experienced rashes as itchy. On 12-APR-2021, the subject experienced rashes on chest and back as painful. On 12-APR-2021, the subject experienced easily got tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little bit of headache on 01-APR-2021, had not recovered from shortness of breath, chest pinching, fast heart beat, rashes on chest and back as painful, easily got tired, rashes as itchy, and rashes had redness, and the outcome of felt heart was congested and cough was not reported. This report was non-serious.; Sender's Comments: V0- Medical Assessment Comment not required as per standard procedure as the case assessed as non-serious.

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

The patient came in to get his COVID vaccine. The vaccine was administered with no abnormalities. The patient went to sit in the waiting area and fell off his chair. Pharmacy staff rushed to him to find him on the floor conscious and speaking stating he was okay. The patient was assisted to stand and get on a chair. At that point Orange Juice and Water were provided to the patient and the pharmacist sat next to him for ten minutes. Next, the patient was instructed to stay for five more minutes to make sure he was okay. The patient stated this happens to him every time he gets a vaccine and it isn't out of the ordinary at all. Patient also stated he did not eat or drink much all day besides a bag of chips and on top of that was doing strenuous work in the heat all day and this could have contributed to his collapse.

DIZZINESS; SHORTNESS OF BREATH; PULMONARY EMBOLISM; This spontaneous report received from a physician concerned a 48 year old male. The patients weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on 12-MAR-2021 for prophylactic vaccination. Vaccination site was not reported. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the patient experienced pulmonary embolism. Laboratory data included: Computerized tomogram thorax (NR: not provided) positive, Ear, nose and throat examination (NR: not provided) negative and Platelet count (NR: not provided) 197. On 04-APR-2021, the patient experienced dizziness and shortness of breath. Full neuro, cardiac, Ear, nose and throat workup and evaluation was negative in Erectile dysfunction and follow up clinics. Patient had a Wells Criteria of zero, and was hemodynamically stable, platelet was 197. Patient started with DDIMER which was 560 and later chest Computerized tomogram thorax was positive for right lower lobe Pulmonary embolus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizziness, shortness of breath and pulmonary embolism was not reported. This report was serious (Other Medically Important Condition). Sender's Comments: V0: -Covid-19 vaccine ad26.cov2.s-Pulmonary embolism. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Severe chest pain, diagnosed as Pericarditis. No prior history, no prior surgeries, no risk factors, no illnesses. In addition, patient is very healthy, has never had COVID, he is provided free COVID tests and work, has tested negative regularly for months, gets him temperature taken at work every day before entering.

I had some head pressure - dull headache each day for a couple of weeks starting about five days after vaccine; I didn't notice until the evenings when I was relaxing. From day 5 or so - for about two weeks I noticed this head pressure. My blood pressure did rise at that time-it was elevated - within about two weeks after the shot, I couldn't control my blood pressure. I went to the doctor - they had to raise my blood pressure medication to the max because I couldn't get my blood pressure down and I even donated blood. Today I am at 135 over 90 which is good for me but at that time when I noticed the rise after the vaccine - I was running 165 over 115 . I'm still taking the maximum blood pressure medication that I can take currently but it is at a good level currently. I was taking 20 mg pills and after the vaccine we tried to raise it to 25 mg and then raised it up to 30 mg and then they finally said up to 40 mg a day. It's the most I can take. I have chest pains on the right side of my chest -it will start (on a scale from 1 to 10 - it's about a four) - it's shooting pain - in my chest for about 10 minutes and then it will move to my left side - not my pecs - it feels like it's my heart. It's not enough that I feel like I'm having a heart attack - it happens about four days a week. It doesn't last real long - but it's intense. A "4" pain for me is intense. It goes on for about 5 minutes - switch sides and then another five minutes - I try to relax/watch tv during that. I did have leg pains in the middle of all of this time - hand, inner thigh, then on my right leg - single spots of pain that moved - like ant bites - that happened in the beginning - at day five and after - the same time I was getting the head pressure. I would rub over the spot with my hands and then it would go away and go to a different spot.

CHEST PAIN; RIGHT HAND/WRIST WEAKNESS; REDUCED HAND/GRIP STRENGTH; PLEURISY; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, non alcohol user, and non smoker. 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, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced pleurisy. Laboratory data included: Computerised tomogram (NR: not provided) It was clear, and Fibrin D dimer (NR: not provided) Elevated. On APR-2021, the subject experienced reduced hand/grip strength. On 20-APR-2021, the subject experienced chest pain. On 20-APR-2021, the subject experienced right hand/wrist weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain on 30-APR-2021, had not recovered from right hand/wrist weakness, and the outcome of reduced hand/grip strength and pleurisy was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.

Systemic: felt like was about to pass out or faint, but didn't, tunnel vision-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Severe, Systemic: Visual Changes/Disturbances-Medium, Additional Details: at12:12pm pt felt dizzy and faint and was sweating, bp1:12:22pm 117/38 pulse 79, bp2:12:30pm 97/53 pulse 51, bp3: 12:39pm 95/61, bp4: 106/69 pulse 49 at 12:46pm. pt left at 12:50pm advised not to drive had daughter driv ehim home

Patient is now hospitalized with the following: VITT, bilateral PE with left lateral lower lob infarct, left superficial femoral vein occlusive deep vein thrombosis, and thrombosis of the posterior tibial vein according to hematologist.

Patient was scared of Needles; Experienced Syncopy & Fainted about 5 min. after the dose given! Layed on floor with feet up for about 5 min. Sat upright for about 30 min & seemed fine. Walked to car wife was a nurse & with him.

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

LEFT EYE WITH BLOOD SPOT IN THE EYEBALL; PAIN IN THE CENTRAL PART OF THE CHEST; DIFFICULTY BREATHING WHEN DOING ACTIVITIES; HEADACHE; LEFT ARM PAIN WHERE SHOT WAS ADMINISTERED; COULDNT SLEEP THE DAY OF THE VACCINE; BODY TREMBLING; This spontaneous report received from a 48-year-old, male patient The patient's weight was 184 pounds, and height was 74 inches. The patient's past medical history included gallbladder removal. The patient was non-smoker, social drinker (only in holidays mostly), and the patient had no known allergies. The patient did not have any drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 207A21A and expiry: 23-JUN-2021) dose was not reported, 1 total administered on 14-MAY-2021 around 13:15 to left arm for prophylactic vaccination. No concomitant medications were reported. On 14-MAY-2021, the patient experienced left arm pain where shot was administered, body trembling and couldn't sleep on the day of vaccine. On 17-MAY-2021, the patient experienced headache which had diminished, but suddenly they were like stabbing, left eye with blood spot in the eyeball and pain in the central part of the chest, which on occasions varies from right to left with breathing difficulty when doing activities. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body trembling, couldn't sleep, and left arm pain where shot was administered on 18-MAY-2021, was recovering from headache, and left eye with blood spot in the eyeball, and had not recovered from pain in the central part of the chest, and difficulty breathing when doing activities. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 : 20210555889-COVID-19 VACCINE AD26.COV2.S -Left eye with blood spot in the eye ball. 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.

About 2 weeks after I received my Covid vaccine I experienced a sharp pain in my chest. I wasn't on going so I didn't worry about it but another week after that I began to feel palpitations and decided to go to the emergency room at Hospital. I was given an EKG and an X -Ray of my chest. They didn't notice any abnormalities so they told me to follow up with my physician. My doctor made an appointment for me to have a stress test. I was on the treadmill for 6 minutes and my blood pressure dropped so low that Dr. called an ambulance to take me to the hospital. I was there from the 27th to the 30th of May taking test. I also had a cardiac cath test which came back inconclusive. Another symptom that now is troubling me is vertigo

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

PT EXPIERENCED SYNCOPE ABOUT 3 MINUTES POST VACCINATION. HAD A SECOND SYNCOPE EPISODE 5-6 MINUTES POST VACCINATION. PT WAS TRANSPORTED TO LOCAL HOSPITAL BY EMS. PT REPORTED EXTREME FATIGUE, NAUSEA AND VOMITING. ABOUT 5 HOURS POST VACCINATION, PTS WIFE REPORTS PATIENT IS FEELING MUCH BETTER.

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

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

WAS FINE AFTER SHOT, SOAR ARM AND TIRED. IN EARLY MAY NOTICED MY LEFT SIDE OF FACE WAS NOT ABLE TO MOVE, SEEMED DROOPY. I WAITED TO SEE IF THE SYMPTOMS WOULD GO AWAY. ON MAY 28, WENT TO ER. MY BLOOD PRESSURE WAS HIGH AND ALSO MY SUGAR WAS ALSO HIGH. THEY BELIVED I HAD BELLS PALSY.

Fever 99.8 for 24 hours; head ache approx 9 hours; joint pain mostly neck, shoulders, hips continues to persist; muscular weakness which persists as well localized primarily to upper extremities; had sharp pains in mediastinum left side, intermittent for several hours the day after the injection, difficult to tell if the pains were heart or lung related. These pains were the most scary part.; General malaise for about 24 hours.

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

A few minutes after receiving the vaccine, the pharmacist was informed that the patient was falling over in our waiting area. The pharmacist got to the patient and caught him before he hit the floor. He lost consciousness for less than a minute and EMS were contacted. The patient was helped into a sitting position, given water and monitored. The patient was alert and by the time the paramedics arrived. He was assessed by them and the patient did not go to the hospital.

Torso: Pain/Discomfort across front of chest (about 2 inches above nipple) ? started on left side but also presented on the right too. Pain/Discomfort in back on both sides. Sometimes upper back, sometimes lower. Pain/Discomfort and sometimes a burning sensation in ribs. Many times this presented itself at the lower tips of the ribs. Arms: Pain/Discomfort under armpits. Tingling in arms. There was a point where my arms would fall asleep when I was laying down at night. General weakness/fatigue in the arm. Sometimes arms (particularly the forearms) feel tight Leg Pain/Discomfort in calves. Many times, the pain would be a sharp, pointed sensation in both calves. This discomfort always presents itself in the back of my calves. *Weakness/Fatigue in thighs. Many times my thighs will feel weak/fatigued. Neck: Pain/Discomfort in my neck. Primarily this occurs on the sides of my neck. There is also a tightness that occurs on the sides of my neck too. At times, the back of my neck is also tight and uncomfortable. Spine: General tightness and discomfort running down the middle of my back. This occurs primarily in the upper to middle part of my back. Overall: Along with the different sensations listed, I have battled constant fatigue and a feeling of weakness. This weakness could be overall throughout the body or sometimes just in certain regions in my body. For example, some days I might feel like my arms are weak/fatigued, other days it might be my legs, and then sometimes throughout my body. I have also been dealing with persistent headaches from time to time.

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

Vasovagal event without syncope post vaccine. Clammy and nauseous with tingling to hands. EMS and Dr on site. Blood pressure 90/49 at 18.10. at 18.15 blood pressure was 114/81. Released home and advised to seek medical attention later if needed, client verbalized understanding.

9 hours after shoot woke up feeling very poorly and feverish. Went to take Tylenol and passed out. Came to with wife shaking my arm. Suffered trauma to noise and back during fall as a result of passing out including laceration from hitting face on counter. After coming to sever body shakes. Temperature was taken twice and recorded 92.5 and 93.0. Blood pressure and pulse after moving to couch to lie sit down was normal. Next day couldn't do much and was very tired. By second day I was recovered but sealing with injuries from the fall.

Extreme anxiety since day 3. Dry sinus since day 2. Inflamed sinus. Off and on rapid/hard heartbeat since injection. Insomnia. Rapid weight loss. Dry mouth. Loss of appetite. Ongoing chills (10 days after shot). Depression. Lack of energy.

Client lost consciousness and became unresponsive after vaccination in observation area of clinic. Staff nurse in observation area responded, states client was diaphoretic and pale, had weak pulse, and did not observe chest rise. RN administered epi-pen 0.15mg in left thigh, 911 was called. Lead nurse onsite and nurse manager responded after epi-pen administration, client was rousable and responding minimally to questions. BP 124/60, HR 50-60, o2sat 98-100%. Client was intermittently drowsy, remained diaphoretic and pale, oriented x4. 911 arrived 7 minutes after call, assessed pt and transported to hospital.

5 minutes post vaccination, the patient was sitting down and went unconscious. Patient remained sitting at all times during this encounter. A nurse on site talked to him and attempted to rouse him. After a few minutes of being unsuccessful in keeping him awake/aware, paramedics were called to the site. Patient would wake for a few seconds and then go unconscious again. When paramedics arrived, patient was able to remain awake. No treatment was administered. Patient did not have to be taken in an ambulance.

Patient passed out fell to ground and started with jerking motions. Pateinet was taking by ambulance to the emergency room. Pateints blood pressure and pulse where low when checked by paramedics.

After receiving the vaccine, I sat down to rest and gave me tachycardia with difficulty breathing, my feet were weak with tiredness and cold. Then I drank water and fluids and my heart rate stabilized. Then within 2 hours I had 4 tachycardia events but milder and then normalized.

Patient fainted post vaccination. Patient was sitting in observation chair when he fainted. Staff immediately attended to patient, and he regained consciousness rapidly. He was given water/snacks and monitored for an additional 15 minutes and then left and he stated he was feeling fine. Patient was called later for follow-up and said he was still feeling fine/no issues.

AFTER ADMINISTRATION OF THE VACCINE, WITHIN 45 SECONDS, THE PATIENT FELL UNCONSIOUS AND I WAS NOT ABLE TO WAKE HIM UP. THE PATIENT SEEMED TO BE HAVING A LITTLE BIT OF LABORED BREATHING AND PERFUSEOULY SWEATING. ADMINISTERED ONE DOSE OF 0.3MG EPINEPHRINE INTO THE PATIENT'S RIGHT MEDIAL THIGH. PATIENT SLIGHTLY REGAINED CONSIOUSNESS. AT THE SAME TIME, EMERGENCY SERVICES WERE CALLED AND THEY ARRIVED PROMPTELY TO THE PHARMACY AND TOOK THE PATIENT TO THE NEAREST HOSPITAL.

A few minutes after administration of the vaccine, the patient became light headed followed by loss of consciousness for several seconds.

Fever 102, pain, chest tightness, chest pain, difficulty breathing, unable to move limbs or sit up, general pain in muscles, joints, bones, acute pain in wrist

Immediately as the fluid was being injected into my left arm, I felt a sharp pain in my chest/heart. I didn't mention it to the person administering the dose. Afterwards just flu like symptoms. Friend who works for J&J said I should report it for safety.

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

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

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

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

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

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

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

He got the vaccine, He felt as if he was breathing shallow on the bus to get to work, within 15 minutes of the vaccine. He came home and collapsed due to the fatigue which is not normal for him. About 12 hours later his throat got scratchy, achy but doable. He went to work and had to leave early due to flu-like symptoms, felt feverish. Really bad aches now, and his breathing and heart rate are elevated right now. Achy-like headaches. He did take some Ibuprofen 800 mg and seems to be helping. He has had the typical soreness of getting the vaccine in the left shoulder, but otherwise ok. He also has a stuffy nose, scratchy throat and his eyes are a little red and glassy. He was directly exposed to somebody for 25 hours that was positive for COVID, but nobody else in the car got COVID in January.

The vaccine was administered to the patient. The patient waited in the assigned chair in the waiting area. He was observed to lose conscious and fall out of the chair onto his head. He regained conscious and began conversing with the staff. He remained supine for 10 minutes and then sat up. He reported feeling fine, except for the headache, and was allowed to leave with his spouse.

I started having a lot of pain in my right leg. I could actually feel and see that my veins were swollen. It progressed and started moving around. I started having chest pain and headaches. I ended up at ER. They gave me pain meds and did a CT Scan and ultrasound, which were both clear. The next day, I was walking around and my hand and arm started hurting and then went numb. My right wrist was swollen to twice its size. I went to care and they told me to go back to the ER. They eventually did another ultrasound, but the swelling had gone down by then. A few hours later, my left arm started to swell and lasted for about 4 hours. From there, I had pain in my arms and legs for a few days after that, but then I was fine.

Sore arm, extreme exhaustion, fever, body aches, racing heartbeat while resting, headaches out of the blue that's don't fade away, fluid in ears, soreness in left knee/inflamed hamstring, fever, sweaty, post nasal drip, minor cough, rattling noise in lung when breathing

Never felt "right" after receiving vaccine. Occasional dizziness noted, especially upon standing. Deterioration in health 5/16/21: Was on a bicycle ride in the morning and HR monitor read 180 BPM. Rested briefly, did not feel well, rode home. Continued to not feel well throughout the day. Went to the emergency room at 6:00 PM with irregular HR, fatigue, and chest tightness. Heart rhythm irregular with ventricular ectopy. Admitted to the hospital, cardiac catherization done 5/17 8:00 AM, no evidence of CAD, diagnosed with non-ischemic cardiomyopathy. No risk factors and all probably causes ruled out. Non-smoker, healthy lifestyle, no excessive alcohol use.

Patient woke up coughing blood tinged, mucus this morning. Denied fever, vomiting, and diarrhea. Patient was sent to the emergency department.

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

I went to do my annual physical on 5/31/21 and the following symptoms got worse: Nausea, muscle pain, high temperature, cough, chest pain, and pain in the left side of the stomach.

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

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

Resting heart rate increased from 58 to 77 over the course of 7 days. racing heart rate, not correlated with activity, tired, fatigued, unable to sleep, loss of appetite, headache

Pt got Janssen COVID 19 vaccine and within 10 minutes of administration patient was fainting and EpiPen was administered immediately. patient started gaining consciousness within 5 minites of administration, 911 was already called and paramedics team was on its way. by the time paramedics reached pharmacy patient had gained conciousness and was more stable. within 15 minutes of EpiPen administration patient was trying to talk and was trying to express his feelings. paramedics team checked the patient and did their evaluation. Patient was much better at that time so paramedics left, leaving patient at store. Paramedics confirmed that the patient is stable and do not need any hospitalization.

SEIZURE LIKE ACTIVITY; BP 87/64; DIAPHORETIC; PULSE RATE 50; NOT FEELING WELL; This spontaneous report received from a health care professional concerned a 49 year old male. The patient's height, and weight were not reported. The patient's 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: 204A21A, expiry: unknown) dose was not reported, 1 total, administered on 12-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-JUN-2021, health care professional (HCP) reported that patient received Janssen Covid-19 vaccine. About 2.5-3 minutes after receiving the injection, the patient began having seizure like activity. HCP described that as full postured seizure like in the upper extremities and chest, and the eyes had been nystagmus. This activity lasted approximately 45 seconds. Emergency medical services (EMS) staff was on the scene and when they came to, the patient self-reported that he was not feeling well and the HCP described him as diaphoretic and was appearing shaky. EMS took his vitals initially (Blood Pressure, BP 87/64 mmHg, Pulse rate 50 unit unspecified and oxygen saturation 100 percentage). Vitals at 5 Min (Blood Pressure, BP 124/80 mmHg, Pulse rate 76 unit unspecified, oxygen saturation 100 percentage and blood glucose level 125 unit unspecified). An ambulance was called to transport the patient to the ER, and upon arrival vitals were taken again at about 10 Min. Post-ictal (Blood Pressure, BP 115/76 mmHg and pulse rate 76 unit unspecified). Patient was taken to the ER for further evaluation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the seizure like activity, not feeling well, BP 87/64, pulse rate 50 and diaphoretic was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210627629-covid-19 vaccine ad26.cov2.s-seizure like activity, BP 87/64 This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

patient presents to the ER with 2 to 3 month history of cough which started 2 weeks after vaccination. diagnosed with bilateral pulmonary emboli - no other precipitating cause identified

Within a couple of weeks after the vaccine, I started experiencing hear palpitations. They would happen through most of the day on and off at different times. They started a few at a time during a sitting and then started to last for longer periods of the day. Once it grew to the point of scaring me, I booked a Cardiology visit. By the time the doctors were able to examine me, they saw the issue on the EKG and booked a number of follow up tests. I had never had these before nor any heart issue. Since the offices were so busy there was a number of weeks that passed before I could get the first test, a Holter Monitor. At that point since it had been over 3 weeks, the very bad sessions had died down a bit but I still had sporadic hear palpitations. I recorded over 12 instances of what feels like a fluttering or drop in beats in my chest. Following the results which were "within normal parameters" 2 weeks went by until my next appointment. I then had a stress test which showed I did not have any blockages or blood flow issues. Another week or more went by and I had an echocardiogram. While taking the test, I did report and the tester confirmed that they saw skipped beats during the test 2 times. By this point the issue was subsiding and the results reported were not outside of normal parameters for a person my age. At the final meeting, the doctor adamantly claimed that the vaccine had no part in this problem stating that there are no reported cases of this issue due to the vaccine, but to me, timing of this issue and the fact that I never had any of these problems before the vaccine was administered seem to indicate otherwise. That said it should be documented and doctors should know about it. I want people to know I had it post vaccine, and that now the issue seems to be gone. This gave me and my family great anxiety, discomfort and more. I am unsure if these symptoms could be worse for people with heart issues or weaker hearts as well, so I am reporting it.

Strong pain in the hips. Difficulty to walk.Numbness in the legs. Tingling in the legs. Numbness in my fingers. Pressure on the chest. High blood pressure.

Strong pain in the hips. Numbness in the legs. Tingling in the legs.Difficulty to walk. Trouble breathing. Numbness in my left fingers. Pressure on the chest.High blood pressure.

- Severe fatigue, muscle cramps and weakness, dizzy, light headed, blurred vision - numbness and tingling in feet and hands, headaches, chest tightness, - prolonged severe daily headaches, blurred vision, high blood pressure

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

Patient passed out after receiving the vaccine. Patient was moved to the floor and observed closely and regained consciousness quickly. There were no signs of difficulty breathing, redness, or flushing, EMS arrived shortly and examined patient. Patient was cleared to drive home. Patient passed out once after getting a vaccine when he was kid but felt he had grown out of it. He has given blood several times

PLATELET COUNT WENT DOWN TO 96; NEUROLOGICAL SYMPTOMS; ANXIETY; DIMINISHED QUALITY OF LIFE; LOSING INTEREST IN LIFE; DIFFICULTY IN WALKING/ DIFFICULTY GETTING OUT OF THE CAR; GENERALIZED HEAVY MUSCLE PAIN ALL OVER THE BODY ESPECIALLY ON ARMS AND HANDS; FEELING OF ELECTRIC SHOCK ON LEFT SIDE OF BODY ESPECIALLY UNDERNEATH THE LEFT FEET AND LEFT INDEX FINGER; SEVERE HEADACHE MOSTLY ON LEFT SIDE AND TOP PART OF HEAD; This spontaneous report received from a patient concerned a 49 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, pre-diabetes which the patient controls with exercise and diet and no medications, alcohol user (had been drinking vodka for the past few weeks), and non-smoker. The patient had no known allergies and no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 27-MAR-2021 for prophylactic vaccination. Concomitant medications included olmesartan for blood pressure. On an unspecified date before vaccination the laboratory data (dates unspecified) included: Platelet count (NR: not provided) 160. On 18-APR-2021 (3 weeks after vaccination), the patient experienced severe headache mostly on left side and top part of head and ended up in the emergency room at 01:00 AM in the morning. In the emergency room, the patient had a brain scan and he was told that the brain scan showed no blood clot and that his platelet counts were good. After these tests the patient was sent back home. On 27-JUN-2021 (for the past 2 weeks prior to this report), the patient experienced generalized heavy muscle pain all over the body especially on arms and hands and difficulty in walking and getting out of the car. On an unspecified date in JUN-2021, the patient experienced feeling of electric shock on left side of body especially underneath the left feet and left index finger. On an unspecified date, patient reported that his platelet count went down to 96 after the vaccination, had anxiety and had been drinking vodka every night because his quality of life was diminished and he refused to go back to the emergency room. The patient was irritated and he was losing interest in life. The patient had not experienced any fever or nausea. The patient had scheduled an appointment with the physician on 26-JUL-2021 due to his concern about the neurological symptoms. It was reported that, the emergency services were called and informed about the patient. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache mostly on left side and top part of head, platelet count went down to 96, generalized heavy muscle pain all over the body especially on arms and hands, difficulty in walking/ difficulty getting out of the car, anxiety, losing interest in life, feeling of electric shock on left side of body especially underneath the left feet and left index finger, diminished quality of life, and neurological symptoms. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210738395-Covid-19 vaccine ad26.cov2.s-Platelet count went down to 96. 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 experienced a syncopal event. Patient was lowered to the floor, legs were elevated, and vital signs were monitored. Provided ice packs and fluids. Patient returned to a sitting position, and then standing position. Patient was monitored for an additional 30 minutes after event, before stating he "felt better" and was ready to return to his room.

Upon waking the morning after my vaccine, I experienced arthralgia, mainly in the knees, myalgia, injection site pain, head heaviness, palpitations/premature ventricular contractions, and general tiredness/malaise. All AEs lasted the entire day until I went to sleep at 10:30 PM, and all were resolved upon waking the following morning at 7:00 AM.

Syncope, clammy/sweaty/grey skin, loss of bodily function and non-responsive for 1 minute, with O2 sat dropped to 91% after event. Onset approximately 2 minutes following injection.

First, pain around the injection site; it appeared within a few hours after the injection, but it was bearable. Then, after about 23 hours after the injection, bad headache (especially around the eyes - which also caused light sensitivity) and general malaise. Shortly thereafter, low-grade fever (99.5 F) and significant muscle pain, all over the body. The most worrisome side effect was the last one, which appeared during the second night after the injection (about 32-33 hours after the injection): extremely fast heartbeat / racing heart. I did not use any treatments for these side effects.

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

Brief but very painful chest pain. Felt on left side about half way up my ribs. Thought I was having a heart attack for about a minute. No signs of arrhythmia or faintness. Feel fine now.

after taking i didn't feel anything until about 2am Sunday morning when i woke up to use the restroom. i noticed something was running out my nose and i thought i was having a snort running down my nose which was suppring to me because i had not be sneezing or nothing, when i turned on the light to wash my hands after using, i found it was blood that was running down my right nose, i wiped it, took benedry and tylenol and went back to sleep. It didn't happen again until today morning again 4/5/2012 @ 7.10am when i went to use the restroom again and noticed my nose running again and it was blood running down my nose. before this, i have never had a situation where blood runs down my nose until now.

Patient reported syncopal episode, but stated ? he was fine, and didn?t want any medical attention? Patient seen by medical team, refused medical transport and signed form Patient will be driven home by spouse

Injection sight pain Chills Muscle Aches - day 2 Headache - Day 2 and 3 Fatigue - Day 1,2,3+ Coughing Lung pain Shortness of Breath Chest Pain

Started with chills and progressed with body aches, sharp pain in lower back, fever. At 7:30 pm temperature was 101.2. At 11 pm temperature rose to 101.6 and heartbeat was very elevated and felt to be pounding and rapid. Around 4 am fever had diminished and minor soreness. At 7 am no further issues.

Patient began sweating, hyperventilating and "feeling bad like he might pass out" about 5 minutes after vaccine. He lost color in his face about 2 minutes after and asked if he could like down. Paramedics were called and he was taken for care.

Pain and swelling in my throat and severe tightness in my chest thirty minutes after the ijection. Severe ringing in my ears, could not sleep at night up to now. Went to ENT yesterday.

At time of vaccination patient felt fine. Morning after: patient stated he had a fever. At presentation to pharmacy(11:00am) , temperature checked any no fever was present. Patient stated he felt tired and couldn't catch his breath. Patient was encouraged to go home and rest as most of the described symptoms were to be expected. He did not. He reported back to pharmacy after 5:00pm and stated at around 2:00pm he felt dizzy and then went unconscious for a brief time (he did not know exact time frame but stated not long. Again temp was checked and was normal. He stated that his breathing was improving, but he was taking rest of day off.

I received the Johnson and Johnson Covid 19 vaccine on 4/6/21 and the dose code is 041AZ1A. I received it at the Community Center. I'm writing because beginning with the evening after I received the Johnson and Johnson Covid 19 vaccine I've been having abdominal / stomach cramps and stomach pain. Sometimes it is on the top of the abdomen / stomach, other times it's at the bottom. Sometimes it hurts to the point of waking me up in the middle of the night. This morning it started moving into my chest. Do you know if this pain will subside shortly or what is known about this potential side effect? Is there anything I can do to mitigate the issue? I'm contacting my Dr for a visit.

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

BLACKED OUT; RAPID/STRONG HEARTBEAT; TINGLING ARMS AND LEGS; COUGH; WHITE NOISE IN EARS; HEADACHE; This spontaneous report received from a patient concerned 50 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 administration not reported, batch number: 042A21A, and expiry: unknown) dose was not reported, administered on 06-APR-2021 at about 8:30 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, after about 5 minutes of vaccination, the patient experienced 'white noise' in ears, vision changes, had a visual aura (a pattern around side of vision and moved to front of vision) and blacked out only for few minutes. He blacked out in the pharmacy but was not sure for how long. On 06-APR-2021, the patient felt a little dizzy, experienced headache, and tingling in arms and legs (reported as ''arms and legs felt like they were gone''). On the same day, he also had a rapid/strong heartbeat for a while that made him cough and it went away after about 45 minutes. The strong heart beat had come and gone throughout the day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blacked out and cough, and the outcome of white noise in ears, tingling arms and legs, rapid/strong heartbeat, and headache was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210411724 - Covid-19 vaccine ad26.cov2.s- BLACKED OUT. 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.

Immediate onset with pre-syncope. Persistent profound fatigue, diaphoresis, nausea, foggy, weak legs, muscle aches. Improving after 8 days.

8 hours after receiving J&J vaccination, the patient experienced upper stomach pain that radiated into the chest area with an increase in HR to 160 and increase in BP to 220/160. Patient was taken to ER where they treated increased HR and BP. ER found nothing wrong with EKG, enzymes, etc. cardiac work up was unremarkable. Patient again had increase in HR to 165 and increase in BP 2 days later (March 16th) at 6pm with no warning. This time extreme upper abdominal pain that radiated into the chest. Patient again went ER and treated for high Heart rate and BP. Patient was admitted to hospital for 2 days. . 3 weeks later again had episode of increased HR and BP with upper abdominal pain that resulted in ER visit. was released again after treatment.

pt says he started feeling nauseated. He started having severe abdominal cramps that came in waves and raised heart rate. He went to Hospital ER in State. He was admitted for observation. He had blood test and had an EKG. He was given regimen morphine shots. He DX was severe abdominal cramps, raised heart rate and Dehydration. He was told to FU w/ PCP. Pt feels like these symptoms were from taking the vax earlier that day. He did not feel well for about 5 to 6 days. He says he feels better today.

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

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

On top of flu like symtoms that didn't concern me I started experiencing numbness and tingling on the right side of my face. I also had irregular heart beat for 16-18 hours. I have had neurological issues with 2 other medications in the past which calmed my concerns. I had my arms lock up on me while on Humira and I had the exact facial numbness and tingling with Enbrel. Both of those drugs work through TNF cells. I do not know the mechanism with J&J vaccine but wanted you to know that.

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

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

Patient came to vaccination site for the Janssen Covid-19 vaccine on April 09, 2021. After receiving the vaccine, given by a Medical Assistant, he stated that he was ?not feeling himself and was lightheaded?. Medical Assistant, told him to put his car seat back and that she was going to get the automatic BP cuff to take his BP. Medical assistant also let two RNs, know about the incident and they also observed the patient when he was getting his BP taken by Medical Assistant at 9:10am. The first BP was taken on the left arm and was 199/119 and pulse was 72. The second was taken immediately after on the right arm by a RN and was 191/116 and pulse was 78. At 9:22am, RN called our Pharmacist and explained the symptoms the patient was having. She advised the nurses to call EMS. The RNs then took BP again at 9:23 am on the left arm, this time it was 199/116 and pulse was 72. The RNs explained to the patient they were going to have to call EMS to take him to the hospital due to his hypertension. Patient refused EMS transport and stated he would go to his doctor, but that he wants a manual BP taken. The RNs stated he would need to call someone to pick him up to transport him to his doctor. Patient called wife to pick him up. RN stated at 9:27am that a staff member was going to get the manual BP cuff. At 9:35am second RN checked patient and he stated he ?felt fine?. At 9:45am, second RN checked patient again, and he stated he was ?feeling better?. At 9:55am, second RN checked BP with the manual BP cuff on the left arm and it was 215/118 and pulse 75. At 10:00 am second RN gave patient a bottle of water, because he stated he was thirsty. Second RN asked to check BP again at 10:01am on the left arm, manually and it was 194/115 and pulse was 81. Second RN took manual BP again at 10:06 am and it was 190/110 and pulse was 82. Crackers were also given to patient at this time. At 10:18am wife picked up patient and took him to his MD office at 10:18. On April 10th, 2021, at 10:27am, RN reached out to patient via phone but patient did not pick up or call back.

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

Patient passed out walking down the hall to the bathroom about 5 minutes after receiving the vaccine. When patient regained consciousness, he stated he was having a hot flash and was going to the bathroom to get something to wipe off his face.

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

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

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

Pt waiting his 15 minutes, cam to the counter asking for a water because patient was filling light headed. Patient fainted, with seconds patient was awake and knew where he was. he was clammy and in the face. Gave patient a water, he immediately felt better.

I felt sick and fatigue after getting the shot. And the next morning I passed out on my way to work and wrecked my truck.

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

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

Patient was given Janssen vaccine on 05/11/21 at 3:02pm. Patient was asked to be seated for 30 minutes after receiving the vaccine, because he had food allergies. Immediately after administration, patient started complaining he felt dizzy. Pharmacist checked patient's vitals. Pulse was at 46. He was sweating profusely, drowsy, dizzy, not coherent, tingling in right hand, trouble seeing, blacking out. Paramedics were called to the scene by pharmacy technician. Upon arrival, they also checked his blood pressure, pulse, and blood glucose. Patient refused to go to hospital and signed a form provided by EMS. Before leaving, patient was alert and able to walk and carry a conversation on his own.

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

DIZZINESS, COLD SWEAT, PALE, DIAPHORETIC, SYNCOPE (LAST 20 SECS), SEEN BY PARAMADICS, VSS, PROVIDED SNACK AND WATER, SX RESOLVED, REFUSED TRANSPORT, AMA SIGNED.

Patient had syncopal episode after vaccination. Had been recently traveling (flew from Spain with minimal food and sleep in last 24 hours). Patient has history of syncope in the past with Botox injection. Patient regained consciousness spontaneously. No seizure activity or head injury. Symptoms resolved and patient discharged

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

After receiving vaccination patient became incoherent, began having difficulty breathing and was audibly wheezing. Skin became extremely pale. Epinephrine was administered and 911 was called. EMS evaluated the patient and patient declined further medical attention.

pt received vaccine and was waiting the 15 minutes i noticed he was slumping in the chair, i caught him prior to hitting the ground. took his bp and was 80/45. raised his legs and he was feeling better, provided a cool compress a few minutes later bp was 128/88. I slowly sat him up and 20 minutes later was fine to leave

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

Patient said they were passed out and blacked out for couple times while he was in his chair. Patient looked disoriented and sweating. We asked if he would require medical attention and he said yes. We gave him water to hydrate himself. Fire dept. came in and took a look. He did not require hospitalization as he was fine afterwards.

I received the vaccination at approximately 09:40 a.m., as of FRI., Jun. 11, 2021. Later that night, at approximately 12:00 a.m., CDT, Jun. 12, 2021, I began experiencing what I would deem to be adverse side-effects due to the injection of the Janssen Covid-19 vaccine I received at the health-clinic earlier in the day from the healthcare-staffer onsite. I began suffering sharp pain in the head due to what appeared to be the clenching of a blood-vessel in the brain, as if I were experiencing a blockage, or blood-clotting in a blood-vessel in the brain, due to the injection of the Janssen Covid-19 vaccine which I received earlier in the day at the health-clinic building. I also, began experiencing chest pains on that night due to, again, what I trust would have been the injection of the Janssen Covid-19 vaccine at the health-care building by an onsite-agent administering the inoculation on my behalf. I also began to experience what appeared to be a "narcotic"-like stimulation of the central nervous-system due to a a particular chemical-compound appearing in the formula in use by manufactures to develop the vaccine itself. I experienced what to me appeared to be a "narcotic"-like high as one would experience after consuming a substance high in narcotic-content, such as cocaine or alcohol, which triggered a stimulation, as I said, of the central nervous-system on that occasion. Such side-effects are due to the fact the manufacturers in developing the inoculation did not utilize a wide sample-population for study in clinical trials of the dosage in order to determine side-effects caused by the vaccine in certain members of the population who could have an adverse reaction to the formula of chemical compounds appearing in the medication due to its effect on them physiologically. I.e., the need to quickly introduce an antiviral inoculation into the marketplace put pressure on the manufacturers to disregard lengthy clinical trials which would prove the vaccine to have very negative side-effects on certain members of the population who receive it as a vaccination against Covid-19.

1325 Pt lost consciousness and feel to the floor from a sitting position. Per reports, pt hit his head on the floor. EMS team activated. POD Director at pt side along with NP. 1326 911 called and emergency services activated 1327 Pt is not A/O x4 and answering all questions appropriately. 1340 Fire dept arrived. Pt sat up and being transferred to fire care 1341 Patient placed in a sitting position, A/Ox4 and swering all questions appropriately Vitals 1326 HR 50, RR 16, Sat 93% 1328 HR 85, RR 16, Sat 98%, BP 139/83 laying position 1331 Glucose 90 1338 HR 89, RR 16, Sat 99%, 1341 HR 69, RR 16, Sat 98%, BP 140/87 Sitting position 1343 BP 136/83

Nausea; Vomiting; Lightheadedness; Collapsing or losing consciousness. Positive LOC. vomiting x1. EMS was called at 1207 and refused further care. patient waited until a ride came and picked him up.

Chest Heart Burning beginning 5 minutes after injection and continuing for approximately 30 minutes Lightheadedness/dizziness beginning 15 minutes after injection and continuing intermittently for approximately 20 minutes Slight headache at left lower side base of skull. Currently, the dizziness has subsided. Heart burning sensation has alleviated and gone to none and then back to warm but not burning. headache slight still as of 5:15pm

Type 1 diabetic on an insulin pump. Diabetes is well managed with a typical blood glucose level of 110. BG has been in 300s since 6pm 7/3/21. Insulin administration is not able to bring it down. As of 10:30am 7/4 BG is still holding steady at 302 with no food eaten and 3x the usual daily amount of insulin given in the last 12 hours. We are not administering more at this time due to the possibility of BG dropping exponentially once the side effect wears off. Patient also experienced an unexpected low BG of 35 at around 4pm 7/3.

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

Patient became extremely dizzy after receiving the vaccine. He passed out and hit the floor. Patient was going to go to the hospital.

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

15-20 minutes after vaccine pain in chest on left side near heart, sharp for 10-15 sec and than tingling constant dull pain, sharp pain happened multiple times since the injection. Went to ER on advice from physician, had multiple tests including blood work, EKG, CT angiogram d-dimer high, did not show heart issues but it did show minimal basilar atelectasis. Currently still having pain and started incentive spirometer.

CELIAC DISEASE; COLD SWEATS; TROUBLE WALKING DOWN STEPS; TINGLING TIP OF LEFT HAND; HOT FLASHES; TIP OF TONGUE SWEAT; FEET SWEATING; SHIVERS; OVERALL BODY NOT FEELING WELL; SUDDEN HIGH BLOOD PRESSURE; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use (stopped drinking), and nonsmoker, and other pre-existing medical conditions included the patient had no known drug allergies and had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 21-JUN-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 17-JUL-2021, the patient experienced cold sweats, trouble walking down steps, tingling tip of left hand, hot flashes, tip of tongue sweat, feet sweating, shivers, overall body not feeling well and sudden high blood pressure. On 19-JUL-2021 the patient was concerned about sudden high blood pressure and was admitted to the emergency room, the patient undergone stress test and was given lorazepam and was diagnosed with celiac disease. The patient was hospitalized for 1 day and was discharged on 20-JUL-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cold sweats, shivers, trouble walking down steps, tingling tip of left hand, hot flashes, tip of tongue sweat, feet sweating, overall body not feeling well, and sudden high blood pressure, and the outcome of celiac disease was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210745177-COVID-19 VACCINE AD26.COV2.S-sudden high blood pressure, celiac disease, cold sweats, trouble walking down steps, tingling tip of left hand, hot flashes, tip of tongue sweat, feet sweating. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210745177-COVID-19 VACCINE AD26.COV2.S-shivers, overall body not feeling well. This event(s) is labeled per RSI and is therefore considered potentially related.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional Details: Pt previously had episodes of fainting after getting blood drawn in the past

Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Loss of feeling on finger for 30 minutes-Medium, Systemic: Headache-Mild, Systemic: Nausea-Mild, Systemic: Weakness-Mild

Covid vaccine given at 1255, started having tachycardia at 1530 reports heart rate was 143, PCP recommended to wait a couple of hours to see if heart rate would decrease and it didn't so patient went to ER at 1730. Was transferred via ambulance to Hospital at 2213. Diagnosed with Supraventricular Tachycardia on 03-9-21.

Severe chills; fever (101°); tightness in chest; body aches. All seem to have substantially resolved within 8 hours of onset.

PATIENT'S BLOOD PRESSURE INCREASED TO 185/123 ABOUT 3 MINUTES AFTER RECEIVING THE VACCINE. PATIENT STATES HE IS ON BLOOD PRESSURE MEDS AND HIS BLOOD PRESSURE USUALLY RUNS AROUND 146/102

Patient experienced syncopal episode immediately after receiving the vaccine. Patient woke up less than 1min later, assessment and vitals were normal per Guardsman attending patient. Patient was observed for additional 30min prior to release from clinic. Patient noted has exhibited this behavior before with needles.

PATIENT FAINTED. EMS CALLED. PATIENT ASSESSED UNTIL EMS ARRIVAL. PATIENT VITAL SIGNS TAKEN AND ARE AS FOLLOWS; PATIENT ALERT AND ORIENTED, PULSE 82, BLOOD PRESSURE 98/62, RESPIRATION 18, SP02 97%. PATIENT LEFT UNDER CARE OF EMS.

Pt had a feeling like his bp had gone up as well as flushed feeling. He was sent to lie down and administered zyrtec 10 mg PO. Pt then began to have tingling in his fingers. Pt was evaluated by ems. Denied wanting to go to hospital. Pt observered for 1 hr when symptoms resolved. Pt was turned over to wifes care with instructions to f/u with md as well as if symptoms occurr again or worsen to follow up with EMS/ER.

I am diabetic and use a Medtronic Minimed insulin pump. Beginning approximately 4 hours after I received the vaccine my blood sugar increased to unacceptable levels. I immediately began taking extra boluses of insulin to bring my blood sugar back own to normal. I have a chart to use to guide the amount of extra bolus needed to bring blood sugars back down to normal. I followed that chart, which always works, but my blood sugars did not decrease as expected. As a result I took even more extra boluses which lowered my blood sugar nominally but not to normal levels. My blood sugars have continued to be high as of 42 hours after receiving the vaccination.

Patient became anxious and passed out. ambulance called and performed evaluation of patient at that time he informed EMT that this had happened with previous vaccine

Patient experience loss of consciousness, diaphoresis, and urinary incontinence within approximately 10 minutes of receiving vaccine. This resolved within minutes of drinking juice and eating snacks.

Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium

patient had a seizure and lost consciousness; pt regained consciousness after a couple minutes; pale and perspiring, paramedics came and provided care from there

1) Bruise on right shoulder (opposite shoulder from injection) 2) Nosebleed - lasted approximate 5 mins, 2 Kleenexes, only once 3) Bruise on left leg (large ~ 2 inches in diameter, white center)

A few minutes after receiving the vaccine he felt like he was going to pass out. He became pale and diaphoretic, c/o having tunnel vision. He did not loose consciousness.

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

On or about 3/31/21 I began feeling extremely week and lethargic. On 4/6/21 I came home from work about 7:00 am due to an extreme headache and muscle weakness. By the afternoon my fever was up to 101. On 4/7 my fever went up to 102.7 and I was shaking uncontrollably, sweating , dizzy, headache, and had heaviness in my chest. I felt as if I were going to have a stroke. The headache was excruciating. I took acetaminophen 500 x 2 and 400 mg of ibuprofen, and Theraflu to try and alleviate the symptoms. On 4/9/21 my fever broke, but the weakness, dizziness and headaches have continued. I currently have ongoing headaches and dizziness. I have not gone to the doctor because I do not have a PCP. I am looking for one now.

Patient came back to the pharmacy on 4.13.21 approximately at 2:40pm describing on going chest pain and grasped his right side of his chest. Pain first started on Saturday 04/10/21 and has not subsided. Advised patient to seek medical attention/ closest ER to rule out any major SE of Janssen vaccine.

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

At 10 pm I had the chills and went to bed earlier than I normally do. Around 2 am, I was experiencing an irregular and racing heartbeat. My resting heartbeat is normally around 68 to 70. When monitoring my heartbeat through my Watch, I experience a heart rate of 100 to 120 beats per minute and I could feel it was irregular too. I had a very restless night, elected not to go to the ER and the symptoms were gone by about noon, although I did have a terrible headache all morning long.

Approximately 4-5 after receiving the Covid Vaccination, my heart rate dropped, the top of my body was shaking and I passed out. The ambulance arrived and took me to the ER. My heart rate was at 40 . I was in the hospital for observation for 3+ hours.

NOSE BLEED; MUSCLE CRAMPING; MUSCLE ACHES; FEVER; This spontaneous report received from a patient concerned a 51 year old. 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: 041A21A, expiry: unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced muscle cramping. On 08-APR-2021, the subject experienced muscle aches. On 08-APR-2021, the subject experienced fever. On 13-APR-2021, the subject experienced nose bleed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nose bleed on 13-APR-2021, and fever on 10-APR-2021, and had not recovered from muscle aches, and muscle cramping. This report was non-serious. This case, from the same reporter is linked to 20210427147.

HIGH BLOOD PRESSURE; SLIGHTLY DISORIENTED FROM THE SHOT; FELT ANTSY TO GO FOR WALK; This spontaneous report received from a patient concerned a 51 year old white, Not Hispanic or Latino male. The patient's height, and weight were not reported. The patient's concurrent conditions included blood pressure monitoring, overweight, non-smoker, and no alcohol use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1808980 expiry: UNKNOWN) dose was not reported, 1 total administered on 09-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021 in morning, the patient reported his blood pressure was 170/100 which he felt high for him. It was stated that, usually patient's blood pressure was 125-138 systolic blood pressure. On 10-APR-2021, when he first woke up in the morning patient measured his blood pressure as 109/75 and was therefore concerned about the increase. Patient visited physician office for high blood pressure. Patient felt slightly disoriented since he received vaccination and felt antsy to go for a walk. It was stated that patient did not have any fever and felt okay. Laboratory data included: Blood pressure (NR: not provided) 170/100, 109/75. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 125-138 systolic blood pressure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from high blood pressure, slightly disoriented from the shot, and felt antsy to go for walk. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;20210421042-covid-19 vaccine ad26.cov2. s-High blood pressure. 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.

Patient states that he received Janssen Covid-19 vaccine on 3/31/2021 and was exposed to a covid-19 positive co-worker on 4/2/2021 and tested positive for Covid-19 on 4-10-2021. The patient came to the hospital emergency room via EMS on 4/21/2021 at 0912 complaining of shortness of breath. According to EMS the patient had an O2 saturation of 57% on room air and was place on CPAP, 15 liters, and transported to the ER.

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

Patient reports waking up in the morning weeks after vaccine administered with a migraine and feeling generally "same as after the vaccine", upon rising up he experienced strong nosebleed...first time in his life.

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

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

HEART RATE DROPPED TO 36-37 BEATS/MINUTES; SWEATING PROFUSELY; DIZZINESS/ LIGHTHEADEDNESS; This spontaneous report received from a patient concerned a 51 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and non-smoker, and other pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 12-APR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. Patient reported that, he got the Janssen vaccine on Monday 12-April -2021.Right after vaccination patient started experiencing lightheadedness, sweating profusely, heart rate dropped to 36-37 beats/minutes.he did not see his MD and did not go to ED(emergency department) Patient was feeling much better right now. He was not on any chronic medications. Laboratory data included: Pulse rate (NR: not provided) 36-37 beats/minutes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart rate dropped to 36-37 beats/minutes, sweating profusely, and dizziness/ lightheadedness. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210431941-covid-19 vaccine ad26.cov2. s-heart rate dropped. 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.

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

BULGING VEINS IN LOWER LEGS; MUSCLE TWITCHING; NAUSEA; HEADACHE; CHILLS; FEVER; This spontaneous report received from a patient concerned a 51 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: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced fever. On 01-APR-2021, the subject experienced headache. On 05-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced muscle twitching. On 10-APR-2021, the subject experienced bulging veins in lower legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 03-APR-2021, nausea on APR-2021, and headache on 05-APR-2021, was recovering from muscle twitching, and had not recovered from bulging veins in lower legs. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as the case assessed as non-serious.

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

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

Having lunch on 04/29/21, around 11:30 am. Talking with co-worker started noticing by vision went blurry. My hands & feet started tingling. I turned very pale in facial color. Had co worker call 911, paramedics to me to ER. All my vitals showed normal, ekg, blood work, platlet count all good !! Went home and over next few days felt a little off, made regular doctor appt. follow up. Doctor said all my vitals look normal. Not sure what the cause is, had a ultra sound done of my left leg pain also. Showed no blood clots. Waiting for a heart monitor appt. On 05/03/21 woke up at 3 am drenched in sweat. Still feel a little off, for no reason . At times I feel like I might pass out. Had epilepsy as a you child. But out grew with medications. No seizures in 40 years.

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

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

Patient began feeling lightheaded and collapsed out of his chair. The patient did not recall falling from the chair but was conscious when attended to by the pharmacist. He had just started new medications (Lisinopril and Metformin) and had taken them in the morning prior to arriving for his vaccination. The patient did not eat anything in the morning prior to arriving for his vaccination. He was given water, a cold pack, and then orange juice. His symptoms improved and he was able to get up and walk under his own power.

Patient had syncopal fainting and profuse sweating, no difficulty breathing. Ambulance called, assessed patient, transported from pharmacy after about 10 minutes. Patient remained sweating, light headed while still in pharmacy

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

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

Approximately 3 minutes after he received J&J vaccine he passed out while sitting in a chair. He hit his head on the wall next to the chair. Staff immediately supported him and he stayed in the chair. He regained consciousness within a few seconds. A cot was brought to him, he was assisted by staff and laid on the cot, cool cloth applied to his forehead. Within 8 minutes he was feeling better, sitting up on the cot, drinking water. He did report that he has previously passed out at the sight of blood, and there was a small amount of blood at the injection site. We observed him for another 25 minutes and he returned to baseline, stated he was feeling fine. He went home with his step Dad, who had given him a ride to the clinic. I called the patient 2 hours later to check on him. Step Dad reported he was outside and unavailable, but that he has been feeling fine since leaving the clinic.

Noticed Petechiae, bruising and blood blisters in mouth 6/15/21. Went to urgent care and had CBC done and platelets were at 2,000 and was instructed to go to ER. Got second opinion from primary care physician an instructed to go to ER. Went to ER on 6/15/21 and was immediately admitted to hospital. Began steroid IV treatment and had completed blood profile done. Underwent bone marrow biopsy and abdominal ultrasound 6/18/21 - all normal. Was given platelet infusion and human immune globulin infusions. Release from hospital on 6/21/21 with platelet count at 32,000. Continued steroid treatment and regular CBC tests. Platelet count dropped to 6,000 on 7/2/21 and was readmitted to hospital. Given steroid infusions and began 1 of 4 Bitruxan treatments. Released from hospital on 7/5/21. Continuing steroid treatment and Bitruxan treatments with regular CBC tests. Outcome to be determined

Running up a hill and became severely short of breath with significant chest pain in center of chest. Had to lie on the ground to rest and catch breath. Several minutes to catch breath and about 10 minutes for chest pain to resolve. One month later had chest pain in center of chest... went to urgent care... EKG and vital signs showed normal. Two months after vaccine, started having forceful heart beat, lightheadedness, fatigue, pins/needles neuropathy in right foot... Lightheadedness and neuropathy was episodic, sometimes for hours, for a week... Fatigue was worse for a week then gradually eased but remains mild to moderate fluctuating... Forceful heart beat has continued but was worse 3 weeks ago and is always worse lying down and improves when sitting up though can be mildly present sitting up... and continues today. Seeing my primary care doctor to assess. Went to clinic 3 times in last month for this... vitals always normal and one additional EKG normal.

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

5min following administration of vaccine pt passed out. Within moments pt became responsive. Pt was pale and diaphoretic. Bp 76/54. HR 84. Pt was taken to hospital by ambulance. Pt was d/c from hospital 2hrs later. Pt states he received iv fluids and ekg wnl. Pt states he feels much better.

S: Patient is a 53 y/o male c/o having dizziness and nausea while he is walking towards his car after 5 minutes of getting vaccine. Reports having high blood pressure. He did take his medication this morning. O: 1st reading vitals BP 150/70 HR 64 Oxygen sat 94 pain 0/10 resp. 18 2nd reading 130/80 Hr 68 oxygen saturation 96 Clamy to touch. Negative for shortness of breath, throat swelling, facial swelling, negative for rash. Negative for numbness or tingling of lips or throat. Cardio: Negative for arm pain, back pain, weakness, palpitations Neuro: Alert x4, negative for limb weakness, neg for slurring, neg Medications: losartan 50 mg daily, carveidlol 12.5 mg bid, famotidine 20 mg every other day, simvasta

J&J vaccine, Monday at noon. About 6 1/2 hrs later I got bad chills & severe shaking, temp dropped low. Then had severe diarrhea & vomiting for the nxt 12 hrs. Temp also went up to 102.5, body aches & severe fatigue. Tues morning I had to call online dr for prescription nausea meds. Then got a bad headache. Then wed, thurs & fri he just felt like i?d been hit by a truck. Was still foggy headed yesterday. Today I feel tired out easily.

began 24 hours after injection. Hot to touch round, red rash with a knot under skin. Chills with body temp of 98.6F. Body aches and could not get out of bed for 2 days. Chest tightness and trouble breathing.

Feverish chills and vomiting on day 1. On 4/1/21 at 1:00 am patient fainted and had incoherent speech and then went ?lights out? for less than a minute. He was taken to ER. They gave him fluids anti nausea medicine and ran many blood tests. Patient still feeling dizzy and groggy on day 2

Patient started sweating and said he felt he was burning up about 13 minutes post vaccination. He was slightly disoriented. We quickly checked his temperature however it was within normal range. We applied cold packs to his wrists, forehead, and face for about 12 minutes. I checked for normal capillary refill and asked him questions to assess his mental status. About 20 minutes after starting the treatment, patient started improving. He returned almost back to normal in about 30 minutes.

Patient stated feeling dizzy and had syncopal episode witnessed by nurse for 1 minute Patient provided water and seen by medical team The medical team advised patient to be seen in the hospital but patient refused medical transport and signed AMA form Patient agreed to stay in monitoring longer, patients symptoms resolved and was able to ambulate independently with no dizziness

At ~3:10pm, patient received his vaccination for COVID (Janssen brand). Patient was directed to sit in waiting area for 15 minutes for monitoring; during this time, patient started to complain of the following: chest/abdominal pain, "pounding in his head", felt faint, and "scratchy throat" that was not improving. Around 3:35pm, 9-1-1 was called due to worsening chest pain and scratchy throat. EMTs directed me to administer 25mg of diphenhydramine (which as give at 3:46pm) to patient. EMTs arrived shortly thereafter, noting elevated BP (~154/90). Patient left pharmacy area ~4:10pm and was brought to ER via paramedics for further evaluation.

Fever, chills, high blood pressure, headache, malaise, all lasting 10 hours, except for headache which persisted to 14+ hours

Patient reported having history of syncopal episodes After vaccination patient had syncopal episode, was pale, clammy and diaphoretic Patient seen by medical team, refused medical transport and signed AMA form Patient stated symptoms resolved

10 min after receiving vaccine patient became flushed, feels like arms are swollen and itching, nausea, and sweating. Patient went to ER and they noted tachycardia and diaphoresis

Johnson & Johnson Vaccine: Tired and sleepy with a headache starting at 6:45pm April 8. Then his arms started to have pain and aching in the body more on the arm where he did not get the shot. This happened around 8:30pm. Patient chest started to ache. He went to bed. The entire night he experienced aches and pains in his body, his stomach and hips. When he woke up at 8:00 am on April 9 his legs and the back of his thighs were aching. He could barely move. He took two Tylenol that morning. He continued to experience aching in his body all day. He said it felt like flu like symptoms. Then he took more Tylenol that evening. By 9:30pm he started feeling better. He woke up Saturday, April 10 feeling better.

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

Reported not feeling well after receiving vaccine. Nausea, vomiting, diarrhea. Along with chest and epigastric pain, body aches, and chills

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

3/30/21, Tue. Got up and felt dizzy. Went to bed a few times to have a sleep. 3/31/21, Wed. Got up and felt better. Went to work but felt no idea of work related material. 4/1/21, Thu. Got up and felt good, but could not speak too much because of some loss of words. Called for PTO for Thu and Fri. 4/2/21, Fri. Mindset went back but still could not speak too much. 4/2/21, Fri night. After bible study at night, almost all bro & sis said that was symptom of stroke, and suggested us to see emergency doctor. On 11pm, we were at emergency room. 4/3/21, Sat. I was admitted 1-2 am into impatience room. CT diagnosed a big gray area in between speech are and spine. 4/3/21, Sat afternoon. MRI and MRA had been tested. Cardiologist said he could not rule out the last option, which was due to slow heart beat 50-60. But I have slow heart beat since I remembered things from 4-5 year-old. He suggested wearing a heart monitoring device for a 4 weeks after discharged. 4/4/21, Sun noon. Doctor admitted to discharge. They could not find cause, and would like to follow up within 1 to 2 weeks after discharging. 4/13/21, Tue night, I started wiring body monitoring device.

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

Around 5:00-5:30 PM (about 2 to 2.5 hours after the vaccination), I started to feel a bit tired. I took Tylenol, beginning around 5:00 PM. By 8:00, I was feeling tired enough that I went to bed early. By 9:00, I had terrible chills and body aches throughout my body. The aches were worse in my chest / torso -- maybe from so much shaking. I did not watch any of the men's championship game that night. I also felt nauseous but I seemed to lack the strength to vomit. I can not remember a time when I had so much physical pain in my life. My hands felt numb / tingling. I tried to drink some ginger ale but drinking was difficult. Although I was aware that I was breathing and my heart was beating, I thought that I might die. The terrible pain continued for a few hours. Around 10:30 PM, the pain dissipated. However, after about 10 minutes of relief, the pain returned, perhaps worse than before. At around 11:30, my wife came to bed. She suggested that I try relaxing Yoga breathing. I did that and the pain stopped and I fell asleep. The next day, I woke up with a typical headache and took more Tylenol. I continued to improve the remainder of the day.

Onset with severe headache, nausea, diarrhea, vomiting, shortness of breath, difficulty concentrating from 4/3 -4/8. Went to urgent Care on 4/8 where treated for severe dehydration and stomach aligment. From 4/9 - 4/14 continued to suffer from same symptoms and then began to have heart taching, feeling as if there was a bubble in my chest. Went back to Urgent Care on 4/14 and was again treated for dehydration. Outcome is that no one knows why I have been feeling this way except for that it is a direct result of receiving the vaccine.

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

LOWER BACK/KIDNEY PAIN; CHILLS (SEVERE, UNCONTROLLABLE SHAKING, COLD HANDS AND FEET); SORE ARM; NAUSEA; FEVER; This spontaneous report received from a consumer concerned a 52 year old male. The patient's height, and weight were not reported. The patient's past medical history included panic attacks. The patient was previously treated with alprazolam for panic attacks. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 09-APR-2021 10:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced lower back/kidney pain. On 09-APR-2021, the subject experienced chills (severe, uncontrollable shaking, cold hands and feet). On 09-APR-2021, the subject experienced sore arm. On 09-APR-2021, the subject experienced nausea. On 09-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 109 F, and Body temperature decreased (NR: not provided) 102.8 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills (severe, uncontrollable shaking, cold hands and feet), nausea, lower back/kidney pain, sore arm, and fever. This report was non-serious.

SWEATY; BODY ACHES; EXTREMELY THIRSTY; LEFT ARM PAIN/LEGS BURNING; LEFT ARM NUMBNESS; HEADACHE; FATIGUE; LUNG PAIN; LUNG WEIGHT/PINCH IN THE HEART/CHEST DISCOMFORT; This spontaneous report received from a patient concerned a 52 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: 1808609, and batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced lung pain. On 24-MAR-2021, the subject experienced lung weight/pinch in the heart/chest discomfort. On 24-MAR-2021, the subject experienced body aches. On 24-MAR-2021, the subject experienced extremely thirsty. On 24-MAR-2021, the subject experienced left arm pain/legs burning. On 24-MAR-2021, the subject experienced left arm numbness. On 24-MAR-2021, the subject experienced headache. On 24-MAR-2021, the subject experienced fatigue. On 25-MAR-2021, the subject experienced sweaty. Treatment medications (dates unspecified) included: acetylsalicylic acid, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lung pain, lung weight/pinch in the heart/chest discomfort, headache, fatigue, sweaty, body aches, extremely thirsty, left arm pain/legs burning, and left arm numbness. This report was non-serious.

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

Metallic taste right after injection. Two days later I had joint pain, headache with congestion and more use of my asthma inhaler. These are still on-going as well as tightness through the chest and shoulders. Some coughing.

Patient had a syncope episode. Fluids and food were given. EMTs called to the scene. Patient is a type 2 diabetic. Blood glucose was 274 when checked by EMTs. EMT cleared patient after normal EKG and vital signs. Watched patient for an additional 1.

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

Rash on arm, then bad headaches, real bad headaches, When driving this last Monday. I would pass out at the wheel. At least 4 times I jumped the median. Got lost in a nearby neighborhood. Once I figured out what was going on I went straight home.

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

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

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

Patient experienced bruising in the 2 weeks following vaccine with critical platelets of 8. No history of thrombocytopenia prior to receiving the vaccine

After injection patient felt dizzy and fainted. Vasovagal episode. Patient has a history of vasovagal. Patient awaken after ammonia. Vital signs taken by EMS. Patient is hypotensive. Patient was placed on stretcher in trendelenburg . Patient recovered

Patient received vaccine 4/29/21 at 16:45. He fainted for a short period of time during his observation time. EMS was called but patient was not transported. NKDA, no past medical history, no current medications. BP and HR were checked 4 times and all times were unremarkable. Blood sugar was checked by EMS and was 118. Patient did report having the same reaction back in college after receiving his MMR vaccine. Patient was driven home by his wife.

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

Pt had "tingling" on his throat. Bilateral rash on arms. Elevated B/P 170's. Nausea and vomiting Pt was given 25mg Benadryl. Pts b/p lowered. Nausea and vomiting resolved.

Patient got dizzy/and light headed and passed out in the chair. I noticed the patient holding his head and went over and talked to him. He was feeling light-headed and sweaty. We put his feet up in the chair and he briefly passed out for about 10 seconds. He came around quickly and we gave him a drink. He sat for about 10-15 minutes longer and we made sure he was feeling good before he left.

Patient became sleepy, light-headed, and confused within minutes after vaccination. He was nodding off in the observation area. He was difficult to wake up and confused when he did. We called 911 and paramedics came to check him out. They monitored his blood pressure and pulse. His pulse was high (120-130bpm), so they thought it would be best to take him to the hospital so he can be checked out.

Vaccine administered Thursday, 4/1 1:15 p.m. By Sunday I experienced mild headache and upper respiratory scratchiness. By late Monday 4/5 I experienced fatigue, dizziness, upper respiratory scratchiness and increased post-nasal drip, tightness in my chest, muscle soreness and headache. By Tuesday, 4/6 around 10 a.m. in addition to the above symptoms I had a severe headache and lost feeling in my right arm for half an hour, with severe muscle cramps and loss of use in that arm. The muscle issues subsided by early afternoon leaving only fatigue, headache, dizziness and a lingering respiratory tightness and sinus issues. Concerned about vaccine side-effects I was reading about, I made a doctor's appointment for the following week (earliest available), met with a physician's assistant who prescribed an antibiotic (Doxycycline Mono 100 Mg) for the sinus issues but did not address the other issues.

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

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

1st day of vaccine; I felt very tired and fatigued and my joints started to hurt and I could not walk due to the pain in my joints. 3rd and 4th day of vaccine; I started to experience numbness sensation to my hands. I also had numbness sensation to my face, right side and lips and also to my head. I went to Urgent Care where lab work was performed as well as a CT scan of the head to check for blood clots and results came back normal. Also an U/S of the right leg to check for any blood clots was performed which came back normal. I then went to see my PCP who performed more tests and exams, again did lab work to check for blood coagulation and still continued with the numbness sensation to my hands and all to my body. After about 10 days of my vaccine, I noticed that my oxygen level was 87, 96, 86, 92 and where my oxygen level has always been around 98 or 99. I will be also having heart studies in a few weeks. I have not recovered from my symptoms and feel very fatigued and tired all the days.

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

LOW PLATLET COUNT; BLACK AND BLUES; This spontaneous report received from a consumer concerned a 52 year old male. The patient's weight was 194 pounds, and height was 180.34 centimeters. The patient's concurrent conditions included non smoker, and other pre-existing medical conditions included blood work clean in september 2020,no drug allergies. The patient did not had any illness at the time of vaccination, no similar event in the past. He never had any adverse event in past for vaccination. The patient did not had family history of any disease or allergy. The patient did not had medical history of blood clots, heart disease. 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 12-APR-2021 for prophylactic vaccination on left arm. Concomitant medications included doxycycline for drug used for unknown indication. On APR-2021,he noticed black and blues appearing randomly all over his body for no reason whatsoever. They continued to worsen until he went to primacy doctor who did blood work on 29-APR-2021. On 1-MAY-2021 doctor called about blood work to said that he had dangerously low platelet count and to make sure he did not fall and hurt himself. He was instructed to go to the emergency room where they were waiting for him. He was admitted that day. He was treated with steroids for two days with no response, 2 day plasma treatment with minimal response. On May 7-MAY-2021 he was discharged from hospital and was told to continue Doxycycline 2 weeks treatment course. He later had more blood work and the levels have radically dropped again. He had an appointment with a Hematologist/Oncologist specialist on Friday 12-MAY-2021., Laboratory data included: Blood test (NR: not provided) low platelet count. Laboratory data (dates unspecified) included: Blood test (NR: not provided) levels dropped. Treatment medications (dates unspecified) included: plasma, Steroids. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from low platelet count, and black and blues. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210536558.; Sender's Comments: V0: 20210535373-covid-19 vaccine ad26.cov2.s-low platelet count. 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).

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

I experienced dizziness, headaches, SOB, chest pains, diarrhea, nausea, occurred when I am under physical stress. Walking 10ft or up the stairs triggered my symptoms. Once I stopped moving, my symptoms would dissipate. I called my PCP along with a cardiologist up until today. I was tested for blood clots, had complete blood panel, stress test and nuclear stress test. My symptoms are getting better but still have mildly present. My last meeting with the cardiologist, what he saw after the nuclear stress test, that there was a lack of blood flow where to the lower right heart chamber. He said it probably due to a blood blockage or plague and at this time he is trying to figure it out.

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

Within 2 minutes of receiving vaccine, patient became hypotensive, diaphoretic, pale, altered consciousness. Recovered within 35 minutes after monitoring

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

The patient had a vasovagal response after the vaccine injection the patient stated after the injection that he always passes out at the sight of needles or blood. The response lasted five seconds and he became alert and oriented x4. All vital signs were within normal limits. The patient was seated at the time and there was no head trauma. The patient was monitored for 20 minutes after and ingested water juice and food. Upon departure the patient stated he felt much better.

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

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

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

Patient had a vasovagal episode following administration. Per - Pt stated that he faints during vaccines or anything of the sort. Patient fainted. Patient regained consciousness after about 2 mins. PA assisted PT with patient observation. Patient was observed for 30 minutes until stabilized.

Within 5 minutes of receiving vaccine, patient was seeing spots and passed out. 911 was called and patient was treated by EMTs. Epi-Pen and two shots of Benadryl were administered and patient was transported via EMTs to ER for further medical treatment and monitoring.

Patient c/o mild chest tightness, dizziness and nausea about 7 minutes after received Jansen cover-19 while siting in observation area around 11:43. He fainted right after. Patient was lowed from chair to yoga mat with assistance of paramedics. He was positioned in supine with legs elevated. Patient regained consciousness once laying supine. He denies chest pain. His first set of vital signs: BP 140/87; P 51; Res 18; O2 saturation 98% at 11:45. Patient reviewed his past medical history including hypertension and palpitation. He states he des not take medication for hypertension and he takes atenolol 25mg PRN for palpitation. Last time he took it was week and half ago. EKG was performed by paramedics and it was sinus bradycardia. Patient states he felt back to normal. His VS at 11:50: BP 131/85; P 57; Res 18. Assisted Patient sitting up then standing up. Patient denies dizziness, chest pain or tightness. His standing BP was 142/82. Patient was observed for another 15 minutes then walked out of observation area.

Neuropathy, painful burning sensation in feet, restless leg has gotten worse and is all day long. Painful electric shock type pains from feet up calf muscles. Sensation of no circulation in legs when elevated in recliner. Stumbling/tripping, lack of coordination and balance issues. Lack of mental clarity at times. Heart palpitations or PVC sensations. Difficulty urinating, in that the flow stops and starts as if I'm involuntarily doing Koegle exercises.

cough, malaise and fatigue. He states that he started to have symptoms about 3 days ago with chills, subjective fevers, cough, anosmia. He also had some chest pain that he states was left sided/substernal and felt like squeezing/heavy pain. It started yesterday morning and comes and goes. He has some SOB and he also has had a very poor oral intake.

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

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

Reports he fainted for few minutes. History of same symptom to injection or venipuncture Refused to go to ER, refusal form signed

Fever, severe aches and pains still continued into the second day now. Chest pain along with major joint pain

Palpitations. Palpitations seem mild but last for a long time. Last night had a major episode that lasted almost 1 hour. Woke up this morning and still experiencing palpitations.

Pain in the legs and feet. Same with my hands and fingers. Fatigue. Night sweats. Unable to sleep. Muscle pain in the back and chest area. This started at bedtime around 11:00 pm, approximately 12 hours after the dose. Symptoms lasted a full 24 hours. Fatigue being the symptom lasting the longest. As of now, all symptoms have subsided.

This is a spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, non-smoker, abstains from alcohol, environmental allergy, allergy, and hypertension, and other pre-existing medical conditions included the patient had history of allergy shots many years ago. The patient had no allergies to foods. The patient experienced drug allergy when treated with fexofenadine hydrochloride/pseudoephedrine hydrochloride. The patient received COVID-19 vaccine AD266.COV2.S (suspension for injection, route of admin not reported, batch number: 1802070, expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 12:00 on left arm for prophylactic vaccination. Concomitant medications included pseudoephedrine hydrochloride for seasonal allergies. On 07-MAR-2021, the subject experienced spike in blood pressure. On 07-MAR-2021, the subject experienced rhinitis which went away after 30 minutes. But returned around midnight with slightly more severity. Nose running but no congestion. He was currently feeling fine. Laboratory data included: Blood pressure (NR: not provided) 170/100, 180/103. Treatment medications (dates unspecified) included: lisinopril. The action taken with COVID-19 vaccine AD26.COV2.S was not applicable. The patient recovered from spike in blood pressure, and rhinitis on MAR-2021. This report was serious (Other Medically Important Condition). Additional information was received from patient on 12-Mar-2020 following information was updated and incorporated into case narrative: Event outcome for both events, disease (allergy, environmental allergies), past reaction (ALLEGRA D allergy).

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

Patient was given one dose J+J vaccine about 8 minutes after injection- he felt weak and slumped a bit in his chair. In addition to this he felt pain in Right Pectoral Muscle. Patient was noticed with pale and diaphoretic appearance but within few minutes felt better with increased ventilation and cold compress.

Symptom onset: Friday 03/26/2021 no time reported. Patient presented to dialysis on 03/27/2021 with fever 103.5, shakes, chills, tachycardia.

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

Patient received vaccine approx 5-10 minutes patient fainted in his chair. A cardiac nurse was waiting to receive their vaccine and rushed over to help too. Patient began to convulse. We tried to get patient to respond approx 2 min later patient woke up and complained about being thirsty. We gave him Apple juice and placed a cold pack on his neck. Called 911, We took BP it was 77/49 pulse 45, we laid patient down and retook BP 123/73 Pulse 68. After 5 more min BP 135/85 pulse 72. EMS arrived and took patient away

Started with Headache at 10pm (Right between eyes) Pain started spreading through entire body. 1020pm Hands itchy and swelling, chest tight 1020pm Took 2 Tylenol and two benadryl 1030pm Itchy hands and tight cheat subsided by 1130pm Headache and severe body aches throughout entire body continued through and did not get better until 04/08/21. Bed ridden for duration. No fever.

Patient had syncopal episode witnessed by nursing staff Patient appeared pale and diaphoretic Patient seen by medical team and provided with water Patient had history of syncopal episodes and hypotension Patient sent to The hospital via ambulance for low blood pressure and low heart rate

Patient was scheduled for an appointment for a Johnson &Johnson covid-19 vaccine through a drive thru Thursday April 8, 2021 @12:45pm. We arrived early and he received the vaccine at 12:15pm, waited 30 minutes for reaction and he was feeling fine. Later that same evening, the patient was driving to work on the freeway when he felt a dry throat so he coughed hard, at that cough he felt a massive pain in his head, like his "head was going to explode." He immediately had tunnel vision closing in on him, so he pulled over and later woke up in our parked car with flashing emergency lights on, parked on the shoulder of the freeway. Disoriented and confused why he was there, he looked at his watch and saw he lost 15 minutes when he had passed out. MY HUSBAND COULD HAVE BEEN SERIOUSLY INJURED OR KILLED IF HE HAD NOT PULLED HIMSELF OVER WHEN PASSING OUT. Today we reported this to our doctors office and to you!

Woke at 4 am on 4/11/21 freezing, weak nauseous, dizzy and tried to go to bathroom, stumbled back onto bed as I was passing out

The day following the vaccine, patient developed SOB and a cough. Came to the ED on 4/13/2021 and was found to have new atrial flutter. Patient continues to be in atrial flutter, has received anti-arrhythmic and rate control medications

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

SOB, CP, Fever, Nausea, Body aches. Seen in ER for cardiac work up. Labs normal and CT chest normal

11.30 PM chills lasted one hour , treated w/Tylenol 1:30 AM racing heart, 110 bpm, lasted one hour , treated with Tylenol and controlled breathing Following day headache and no energy

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

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

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

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

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

Bradycardia, dizziness, abdominal pain, fatigue, headache. Was not aware of the bradycardia until I went to the emergency room, other symptoms were present Apr 10 - 15. Hospital visit was 13 Apr. treatment was rest, over the counter medications and follow up with doctor.

Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Medium, Additional Details: BP 117/74 HR 62, second reading 122/111 HR 64, 3rd reading 142/81 HR 63. Patient was loss consciousness within 3 minutes of vaccine. I called the paramedics but he regained consciousness after 1 minute so we cancelled the call. He continued to complain of feeling dizzy so I had him stay for an additional 15 minutes. He has history of fainting with IVs/blood draws.

Patient was feeling dizzy, sweating and pale minutes after receiving vaccination. Patient stated had not eaten since last night. After providing a cold pack and orange juice patient was feeling better. Followed up this afternoon and patient stated was feeling much better, was just having a headache. Advised if symptoms were worsening to seek medical attention

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

A 53-yo male patient with a nonsignificant past medical history presented to the hospital with worsening generalized muscle pain, and weakness. Patient reported that he received the Jannsen COVID-19 vaccine 3 weeks prior to admission and symptoms began 8 days later. On the morning of admission the patient also developed pressure-like and pleuritic chest pain. EKG findings showed ST elevations in V5-V6 with depression in aVL. D-dimer was found to be elevated however PE evaluation was negative. Troponins were also found to be elevated. The patient was diagnosed with acute pericarditis and underwent left heart catheterization, selective coronary angiography and left ventriculography. The coronary angiography revealed no significant obstructive coronary artery disease, and left ventriculography revealed normal LV size and function. Patient was subsequently initiated on colchicine therapy for acute pericarditis. He remains admitted at hospital.

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

He fainted 5 minutes after vaccine administration. After he came to on his own, he starting vomiting. Paramedics were called and took him to the emergency room for further evaluation.

The patient lost consciousness a few minutes after receiving the shot while walking back to his seat for monitoring. He came too after just a minute and we gave him a ice pack. His blood pressure was normal and his pulse was also within range. Patient was very warm to the touch.

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

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

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

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

New onset Hypertension within first few wks of receiving vaccine, readings were mostly normal prior to Covid vaccine , 3wk later noted diastolic readings >100 with home monitoring, now requiring anti-hypertensive

Inflammatory storm, crested at 7 weeks post; affected all joints, incl healthy ones. Daily fever by at least afternoon for 7 weeks. New demyelination w inflammation, new vision problems, dysphagia (permanent). Six days post shot, chest pain started, same as post-virally spring 2020. Chest pain, burning sensation ongoing, presumed carditis. Cardiorespiratory performance beginning to lessen further, beyond last year's damage. Day of vaccination, about 1-2 min post injection, strong dizziness, balance problems, identical to past allergic reactions to other injectables, but time limited, only an apparent blood pressure problem - passes in its own, heavy caffeination helps reduce the problem, temporary nuisance only & apparently affected a fair number of folks at the site. Chose not to report that issue at the time, since familiar and not serious, only unpleasant.

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

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

patient experienced a vasovagal type reaction within minutes of receiving vaccine. He fainted and bumped his head on the floor. He came to within seconds of fainting and had not realized he had fainted. An ice pack was given to the patient to hold to his left eyebrow bone (where he hit the ground) in order to reduce swelling. He was guided into a chair and observed for about 20 minutes when he wanted to leave the pharmacy. The patient felt well shortly after the fall. I checked in with him 2 hours later and he still felt well.

Claimant alleges he was given a Johnson & Johnson vaccine after already receiving both Moderna vaccines. Claimant stated he was feeling ill and became unresponsive. He fainted and was transported to hospital.

patient alerted the technician that the patient stated he felt like he was going to pass out. He was visually sweating, clammy, and bending over. The pharmacist then instructed the patient to lean back in his chair and to breathe. next he started to lean to his side to pass out so the pharmacist grabbed him and held him up, the patient was unaware that he passed out. the patient was passed out for about 20 seconds and may have had a small seizure with no history of seizures on file. we applied a cold pack on the patient to help with the nausea he then dry heaved into the trash can. ems arrived and took patient to the hospital.

Fever begain 6/6/21 for 2 weeks along with 15+ lb. weight loss. Went to Hospital and was admitted 6/21 with Tachacardia, high blood pressure and fever. Diagnised with Hyperthyroidism on 6/23 and relleased on 6/24 with bllod pressure and thyroid medicicine. Follinging up with Dr. and trying to get into Endocronologist. Item # 21: 3 days in hospital

Had immediate hot flash with lots of sweating and fainted. Unconscious for 1 minute and woke up feeling better and more cooled. Used ice packs and wet cloth to cool down. Took blood pressure and pulse - BP: 95/60 Pulse: 59; is on blood pressure meds and was told this was his normal by his wife.

At first warm flu like feeling followed by severe flu like feeling without fever. Ear pressure pain and severe ringing in head. Increase in severe muscle weakness in arms and legs for 3 months plus high blood pressure weakness

About 2 days after he received the vaccine he had really bad headaches, which he never gets. They lasted for about 2 weeks off and on. Around two or two in a half weeks later he started having adverse pain in his middle back left side area. Stated it was a sharp stabbing like pain then it started radiating from his back around his left side up into his chest left side. Being concerned his doctor ordered a Cath test but everything was normal. We have been to GI, Cardiologist, his regular doctor, pulumonary and ER and they have done blood work, CT Scans and x-rays and can't find out why my husband is still having severe sharp pains throughout. They just keep telling him to try another type of doctor. He stays in constant pain and states his chest hurts and he has difficulty in breathing from the sharp pains in his chest. He never had this type of pain until he got that J & J vaccine. I am wondering if he has developed Guillain-Barre Syndrome because it sounds like some of the same symptoms. I just want him to stop hurting.

1st of 5 known seizures was an hour after the injection, the 2nd was 2 1/2 hours after the injection, the 3rd was 5 hours after the injection, the 4th was 22 hours after the injection the following day, the 5th was 40 hours after the injection. These seizures were different in nature. His muscles and body tightened heavily for up to 2 minutes, he turned blue and was combative. Muscle spasms for up to 10 minutes after seizure. Aggressively hyper focused and moving around unaware of reality for 20-30 minutes.

I had difficult breathing, I was dizzy, but all my bloodwork shows my red cells decreasing, chest pain, Knee weakness, went to care, 06/01/2021 and I was transferred to hospital and I received a blood transfusion. When I am working I still have shortness of breath.

Patient felt lightheaded, warm 5 minutes after getting the vaccine. It appeared as he was unconscious for few seconds in and out for about 2-3 minute. Upon spouse's request we did call paramedics for help. Patient was doing fine by the time paramedics arrived,. Patient did mention he was very anxious to get vaccines. He did not have any underlying health conditions, His last vaccines was in high school. Patient also mentioned he had no meals the entire day and probably led to lightheaded. Paramedics did not administer any medications.

Vaccinated at approx 1300 hrs. I began feeling chilled 6 hours later. Chills continued for hours. I developed a significant headache. Also experienced some body aches. Took my temperature via oral thermometer at 10:00 PM and it was 101.5. Went to bed at approx 11:00 PM wearing all my clothes and under a quilt and two wool blankets. Chills continued, but then I also began sweating profusely. I did not rest well and was up approx every hour drinking water and urinating. I noticed an elevated heart rate for several hours through the night. cont'd below

Severe chills for several hours, then high temps for several hours, then racing heart rate for 3-4 hours, tightening of chest, inability to sleep . Onset took 6 hours from shot. Conditions lasted about 18 hours.

On Friday, March 19 around 9:10am I had seizures - loss of awareness, very pale, shaking (but not quite convulsions). This happened before 25 years ago and is likely unrelated to the vaccine. Expected cold/flu-like symptoms did occur on March 14 and part of March 15 but things have been fine since then. I've followed up with my GCP and am scheduling a Neuro appointment for followup.

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

After about 10 hours, migraine headache started, took prescription pain meds but was not helping. By 9a.m. my blood pressure taken at home was 180/110 and started having chest pain on left side. Went to urgent care where they felt it was a cardiac reaction to vaccine and they sent me to ER. Underwent EKG and chest xray. Blood pressure still at same level 180/110 and not going down, migraine still at an 8 out of 10, chest pain still present. I was given an IV to treat for migraine pain and within a few hours all symptoms had went away. We started with Urgent Care at about 10a.m. on 4/3/21 and then by the time all was done I was released from the ER at 6:30p.m. on 4/3/21.

Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Severe

Vaccine was given at 11:30AM. Approx. 5 minutes after dose given, patient was lightheaded, broke out into a sweat, pale, cold, and fainted twice in the course of 15 minutes. 911 was called and arrived at 11:45AM.

ELEVATED BLOOD PRESSURE; CHEST PAIN; SHORTNESS OF BREATH; VOMITING; NAUSEA; HEADACHE MIGRAINE; This spontaneous report received from a consumer concerned a 54 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and tension headache, and other 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: 1808980, and expiry: 20-JUN-2021) dose was not reported, administered to left arm, on 02-APR-2021 13:40 for prophylactic vaccination. Concomitant medications included atenolol for high blood pressure. On 02-APR-2021, the subject experienced headache migraine. On 03-APR-2021, the subject experienced elevated blood pressure. On 03-APR-2021, the subject experienced chest pain. On 03-APR-2021, the subject experienced shortness of breath. On 03-APR-2021, the subject experienced vomiting. On 03-APR-2021, the subject experienced nausea. Laboratory data included: Blood pressure (NR: not provided) 180/110 mmHg, and EKG (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure, chest pain, shortness of breath, vomiting, headache migraine, and nausea on 03-APR-2021. This report was non-serious.

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