Johnson & Johnson

Patient's mother called nurse to vehicle to report daughter was having a seizure. Patient had 2 seizures in the car immediately after receiving Janssen Covid-19 vaccine. Patient then placed on the ground beside the vehicle and patient continued to have 3 more grand mal seizures. Nurses kept patient safe from any injuries. EMS called and responded. Patient transported to medical facility.

Janssen COVID-19 Vaccine EUA: twelve days after vaccination patient presents to emergency department with a headache that started seven days prior to arrival. Patient describes headache as different than normal headaches: worse with movement and episodes of dizziness. Patient also has rash/redness on right cheek of the face. Vital signs within normal ranges except blood pressure 141/96 mmHg. Patient admitted to hospital for further testing and management.

Chills/shaking began approximately 8 hours after injection. Other symptoms of an achy upper body, temperature of 103.1, and nausea came shortly after initial symptoms (within 1 hr.). In the middle of the night, I began heavily sweating (something I have never experienced). I was drenched with sweat and needed to change in the middle of the night. Absolutely no energy and a horrible headache. 24 hrs. after the injection I no longer had a high fever. However, consistently for a week, every day, I had at least one symptom (headache, nausea, chills, or lack of energy) at some point throughout the day. When I received the injection, I was on day 2 of my period. It ended one day later than normal. However, what was not normal was that on 4/3/21, I began to bleed again. I passed 2 clots and had spotting for an additional 5 days. This is in no way normal to my cycle.

High fever for 3 days, lost of taste. Stomach pains and heavy menstrual cramps and bleeding. Blood cloths while menstrual cycle.

I went on Sunday March, 14, 2021 to get the Johnson and Johnson shot offered through the school system. I noticed that my blurred vision intensified. I went to the eye doctor 3/16 and that is where they found blood clots behind my right eye close to my center. I was referred to a Retinol specialist 3/26/21 and sent me to get a physical to check for diabetes. It had started to heal a little. There was not clear diagnosis on what could have been causing the the blood behind my eye. 4/2/2021 Went for physical at PCP and results of physical was good with no Diabetes.

Seemed to very much effect my menstruation. My period came 10 days late, then this month?s period was 2 weeks early. Very bad clotting with menstrual bleeding. I am normally very regular so this was extremely unusual.

Patient is a healthy 40 y/o female who received J&J vaccine on 4/7/21. She started having intermittent fevers and headaches 24-48 hours after. Headache became so bad she seeked medical attention on 4/16/21, and was found to be profoundly thrombocytopenic. She additionally had a CT scan that was concerning for a right sided subdural/epidural fluid collection and a MRI that confirmed that she had multiple epidermoid cysts. A full thrombocytopenia workup was completed and the patient was diagnosed with ITP and started on high dose steroids and IVIG. Patient's lowest platelet count was 9K.

After my J&J vaccine, I experienced low platelet count, excessive bleeding more than normal bleeding issues and had trouble breathing. my symptoms went away after 14 days. I contacted physician if this was normal, they told me to go to ER if my nose bleeds did not stop or if I felt light headed.

Started with a fever, on day 3 fever was higher and I was short of breath as well as wheezing. On Thursday the 15th I went to the dr. The x-ray didn't show anything however my cbc was of concern and she also did a d timer. It came back elevated, so she sent me over for a CAT scan with contrast. It showed pneumonia in my upper and lower right lung and also my lower left lung. She sent me home to try and treat it there. Over the weekend I felt worse and my husband took me to the ER. Upon arrival my blood pressure was 160 over 120 and heart rate was 140. They admitted me to the hospital for treatment of sepsis and pneumonia and pain management. I was there for 4 days. I was released on the 22nd of April and I am still feeling all of these effects on my body. Headache that I have not been able to get rid of even with the help of prescription medication.

DEATH; BLOOD CLOT; This spontaneous report received from a consumer news/social media platform concerned a 5 decade old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 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 patient developed a rare blood clot and died within two weeks of getting the Janssen covid vaccine. On an unspecified date, the patient died from unknown cause of death. It was unknown whether autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was not reported. This report was serious (Death, and Other Medically Important Condition). This case, from the same reporter is linked to.; Sender's Comments: V0-covid-19 vaccine ad26.cov2.s-This case concerns with 5 decade old female. Death, Blood clot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH

7 weeks at vaccination due date 11/14/2021 was due third pregnancy had successful pregnancy, Normal pregnancy and next two days was very sick, body aches, fatigue, Tues. Tuesday 03-30-2021 she experienced bleeding and at that time was 7 weeks 2 days pregnant ER went to the doctor and they indicated that she would need to return, then on Thursday 04-01-2021 she had a miscarriage and it was confirmed that she was having a miscarriage.

The patient developed headache approximately 2 weeks after receiving her vaccine and was found to have intraparenchymal hemorrhage (i.e. hemorrhagic stroke) and intraventricular hemorrhage in the setting of thrombocytopenia with a platelet count of 47 thousand. She was intubated and mechanically ventilated. Platelet count normalized 9 days after admission. She underwent ventriculoperitoneal shunt placement 11 days after admission and was extubated 4 days later, then transferred out of the ICU 2 days after that. Course complicated by pulmonary embolism diagnosed 4 days after she left the ICU which is being treated with apixiban. She has a right hemiparesis and continues to have dysphagia and dysarthria. She is dependent on NG feeds for nutrition. Anticipate discharge to long-term acute care within the next 2-3 days.

Was diagnosed with a DVT 3.5 weeks after vaccination. Started experiencing symptoms of DVT 20 days after the vaccine. Symptoms were not atypical and were almost not checked for DVT at ER. Started with twinges in my right leg for several days. Then pain in my back right behind my heart. Then developed sporadic chest pain and heart palpitations. I was afraid to go to the ER because of COVID because my 12-year-old daughter has a heart condition. Then on April 30 mid-day my right thigh began to hurt like a pulled muscle although I had not injured it or pulled it. I couldn't walk on my leg the pain was so intense. My family was very worried about a blood clot because of the Johnson and Johnson vaccine. That night I had really sharp chest pains and my thigh pain was no better by the next morning. I went to the ER told them my symptoms. After the ER doctor examined me he said he was 99% sure I didn't have a blood clot because my pain was in my thigh and there was no redness or swelling. He told me my chest pain was probably due to anxiety. I asked if he would check my leg anyway. Once the ultrasound of my leg was done the DR came back and said I had a DVT. Then I had to have an MRI of my chest which he told me was a lot of radiation. I did not have a PE. They did not prescribe Heparin because they felt the DVT was from the vaccine. So I was giving Eliquis. Since then my family DR has run more tests and I do not have any genetic reason to have the DVT. I do not and have not taken birth control in the past 20 years. I am now on a blood thinner for at least 90 days if not longer and I am continuing to have twinges and chest pain twinges.

Vaginal bleeding one week post partum. Due date 4/6/2021. Delivered on 4/11/2021. Healthy boy, 7 lbs 6 oz. Forecept-assisted delivery. Bleeding started one week later. Large amount of bleeding. Three units of blood transfused. In ER/ICU for approximately 40 hours.

ANAPHYLAXIS; HOT AND BRUISED SHOULDER; FLUSHING; BODY ACHES; LOSS OF FEELING IN FACE; LOSS OF APPETITE; VOMITING; CAN NOT SLEEP; CAN NOT DRINK WATER; STOMACH FEELS LIKE SODA; SWOLLEN ARM AND SHOULDER; COULD NOT MOVE FINGER; VERY HOT LEFT ARM; LEFT ARM SENSITIVE TO TOUCH; HOT SHOULDER; LOWER BACK PAIN; DEHYDRATED; SORE ARM; RASH; HIVES AND BUMPS AROUND THE INJECTION SITE; WEAKNESS; INJECTION SITE PAIN; HEADACHE; VERY TENDER ARM AND SHOULDER; TERRIBLE NAUSEA; FEVER; LOSS OF TASTE; LOSS OF SMELL; BRUISE ON LEFT WRIST; PALMS TURNED BLUE FROM CLAPPING; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included smoker, non-alcoholic, crohn's disease, heart murmur, chronic vertigo, panic attack disorder, depression, drug allergy, fish allergy, and perimenopause, anxiety and other pre-existing medical conditions included patient had no drug abuse or illicit drug, patient is allergic to all the narcotics, passes large clots of blood during menstruation. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: unknown) dose was not reported, administered on 06-MAY-2021 13:15 for prophylactic vaccination. Concomitant medication included meclozine for vertigo. After receiving vaccination the first thing she felt like there was hot lava going down her left arm ( where she got injected) and she could not move her finger then that went away after 10-15 minutes later. they told her that symptom was normal and everyone experience the same kind of symptom. She completely lost her appetite, the smell of food made her sick ever since she got the shot. Patient stated her left arm was very hot, sensitive to the touch, bumpy around the injection site and sore. all these symptoms were the same day of her shot (on 6-MAY-2021). since the injection she had the headache and it wont go away and she still has the headache today. her relative was telling her that her shoulder was hot. she had body aches ( lower back pain and everywhere, the pain was moving though her body). the second day everything got worse; her arm where she received the injection her whole shoulder was black it looks like if someone threw brick at her, she had hives and bumps around the injection site. she cannot sleep, she cannot eat and she cannot drink water. she was tired and she was not feeling good. she had anaphylaxis 30 hours, dizziness, loss of feeling in her face, her heart was racing. she took two tablets of antihistamine to manage the anaphylaxis reaction. 30 hours after the vaccination she has dizziness, wheezing, she had flushing , rapid pulse, she was throwing up for hours then she had to take the antihistamine. On an unspecified date patient had weakness. Patient said that her fever gets worse every day. On the day of vaccination (on 6-MAY-2021) her temperature was 99.4, and has checked it 5 to 6 times with the same reading. on 7-MAY-2021 it was 99.6 and on 8-MAY-2021 it was 100.3. she said it felt like both sides of her throat were touching. Patient had barely been able to eat since 6-MAY-2021, but has been able to drink small amounts of water. Patient stated her saliva makes her nauseated. On 10-MAY-2021 she clapped her hands and they turned blue and also developed an egg shaped bump/hematoma on her left wrist after bumping it. She went to urgent care where she was instructed to use ice pack for bump, which gave her no relief. There, she was stuck with a needle 4 times to get blood work because she was dehydrated. Patient stated that her whole body felt like a walking pin cushion and skin was hypersensitive. Urgent care checked platelets and hemoglobin which came back normal. Patient stated her menstrual cycle started on 10-MAY-2021 was different than usual with super heavy, red flow, no clots, and soaked pad in an hour, it was slowed down since but flow was heavy. Urgent care advised this may be normal due to change of hormone during perimenopause. As of today, patient could not smell or taste anything. Patient was taking antihistamines 2 a day. Temperature was normal. Patient stated nausea and vomiting were better but would definitely come back if she stopped taking meclizine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not move finger, had not recovered from sore arm, headache, loss of appetite, vomiting, injection site pain, stomach feels like soda, terrible nausea, swollen arm and shoulder, feels like both sides of throat are touching, weakness, bruise on left wrist, loss of taste, and loss of smell, and the outcome of sore body, hot and bruised shoulder, rash, anaphylaxis, flushing, body aches, not feeling good, dizziness, loss of feeling in face, wheezing, rapid pulse, hives and bumps around the injection site, can not sleep, can not drink water, fever, very tender arm and shoulder, very hot left arm, left arm sensitive to touch, hot shoulder, lower back pain, palms turned blue from clapping and dehydrated was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210516682-COVID-19 VACCINE AD26.COV2.S-Anaphylaxis. This event(s) is labeled per RSI and is therefore considered potentially related.

MULTIPLE BLOOD CLOTS ON BOTH SIDES OF THE LUNGS/NAUSEA(THREW UP BLOOD TWICE)/BLACK STOOL (WAS LIKE DIARRHEA)/FEVER/OXYGEN WAS ON 80S/; WEIRD TASTE (AWFUL); BONE PAIN/BONE PAIN AS BONES FELT LIKE A GLASS/PAINFUL (ANYTHING THAT TOUCHED WAS HURTING); SORE ARM; POSITIVE COVID TEST (RAPID TEST)/CAME POSITIVE BOTH TIMES; HEADACHE; This spontaneous report received from a patient concerned a 40 year old White and Non Hispanic or Latino female. The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose was not reported,1 total dose administered on 10-APR-2021 on left arm as prophylactic vaccination. Batch/Lot number was not reported and has been requested. No concomitant medications were reported. The patient was not pregnant at the time of reporting. On 10-APR-2021, 5 hours after the vaccination, the patient started experiencing headache. On an unknown date the patient experienced sore arm for about a week. On an unknown date the patient experienced bone pain as felt like a glass, painful and anything that touched was hurting. On an unknown date the patient experienced weird taste that was awful. On 16-APR-2021 the patient tested positive for covid-19 (rapid test) (coded as: suspected covid-19). On 17-APR-2021 the patient was again tested positive for covid-19 (rapid test) on both time tested as positive. On 17-APR-2021 the patient experienced 2 episodes nausea (threw up blood twice) before visiting hospital and at the hospital. On an unknown date the patient experienced black stool (was like diarrhea). On 18-APR-2021 the patient had body temperature 100.8 to 100.9 and went to hospital again there diagnosed with multiple blood clots on both sides of the lungs. On an unspecified date the patient was taken with tums and pedialyte for an unknown indication. The patient was treated with tylenol (for an unknown indication), nausea medicine, steroids, blood thinner and oxygen (for oxygen level in 80s). On 21-APR-2021 the patient was discharged from hospital. The patient was hospitalized for 4 days. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. On 26-APR-2021 the patient was recovered from headache. On an unknown date the patient was recovered from sore arm and not recovered from multiple blood clots on both sides of the lungs/nausea(threw up blood twice)/black stool (was like diarrhea)/fever/oxygen was on 80s/, and the outcome of positive covid test (rapid test)/came positive both times, weird taste (awful) and bone pain/bone pain as bones felt like a glass/painful (anything that touched was hurting) was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000179162 The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria) based on the PQC evaluation/investigation performed. This case, involving the same patient is linked to 20210521944.; Sender's Comments: V0: 20210520244-Covid-19 vaccine ad26.cov2.s-multiple blood clots on both sides of the lungs. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

BLOOD CLOT IN RIGHT CALF; BLOOD CLOT IN LEFT LUNG; COULDN'T WALK; FATIGUED WHEN WALKING; MUSCLE PAIN; WALKING SLOW / STUMBLING; LEFT CALF PAIN; This spontaneous report received from a consumer concerned a 40-year-old female of unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number:1808980 00040604, expiry: not reported) dose was not reported,1 total, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. In APR-2021, about a week after vaccination, the patient experienced right calf pain/right lower leg pain and muscle pain. Patient was unable to walk, experienced fatigue while walking and was out of breath/unable to breath and on 20-APR-2021, the patient went to the urgent care (Emergency room) and then to the hospital. At hospital, patient had done Ultrasound Test and found blood clot in right calf (right leg) and in left lung. Patient was unable to breath. At hospital, patient was given with medication for blood clotting. After taking medication, patient was able to take breath. On 21-APR-2021, patient was discharged from hospital with medication to prevent blood clotting. Patient was hospitalized for 2 days. Patient was taking the medication one each in morning and evening. On 02-JUN-2021, patient was still walking slowly, tumbling and was not able to walk. On same day, patient also had a pain in left calf and fatigued. On 03-JUN-2021, patient went to the Emergency room(ER). Laboratory data included: Ultrasound scan (NR: not provided) which showed a blood clot in the right leg and left lung. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fatigued when walking, had not recovered from couldn't walk and left calf pain, and the outcome of walking slow / stumbling, muscle pain, blood clot in right calf and blood clot in left lung was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210607546-covid-19 vaccine ad26.cov2.s -Blood clot in right calf, Blood clot in left lung, Couldn't walk. 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). 20210607546-covid-19 vaccine ad26.cov2.s -Fatigue when walking, muscle pain. This event(s) is labeled per RSI and is therefore considered potentially related.

patient started having headache a week after vaccination. Within 6 weeks, patient was found to have headache on the left side of her head, and then developed right sided blurry vision and RUE numbness/weakness. Per EMS, patient was having word-finding difficulty. Last known normal: 19:10 5/17/21. Patient got diagnosed with acute ischemic stroke that required tPA.

pt started with arm pain that would not go away. On May 6, 2021 her arm swelled up to 3 times its size. She went to an urgent care and was diagnosed with a blood clot. She was given a prescription for Eliquis. She was not hospitalized and is doing OK now. She reported this to us on 06/10/2021

Received vaccine on 6/9/2021, the next day she started feeling cramp in left leg and swelling. Went to see her physician. Diagnosed with blood clots to left leg. Given 1 lovenox shot at time of visit and put on 81 mg ASA twice a day for 2 days.

patient was admitted overnight to ER, found 2 embolism and was diagnosed with pulmonary embolism. being treated with blood thinners. discharged 6/19/21

BLOOD CLOTS NEARBY RIGHT THIGH; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 1 total administered in an unspecified date in 2021, around April for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in 2021, after vaccination, the patient experienced blood clots nearby right thigh and later blood clot increased in centimeters. The physician advised her to take rivaroxaban (Xarelto). The patient was bit nervous and stated that she never experienced blood disorder issue before. The patient also has send her reports for further review. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots nearby right thigh was not reported. This report was serious (Other Medically Important Condition). This case was reassessed as serious based on additional information received from the patient on 04-JUN-2021, the following information was updated and incorporated into case narrative: event added (blood clots nearby right thigh), product tab: suspect added, vaccine facility added and narrative updated. Upon review following information was amended: Source added as spontaneous, deleted the disease history, deleted events such as off label use and incorrect initiation dose of rivaroxaban, Drug Xarelto added as drug used to treat AE.; Sender's Comments: V2: 20210612004-covid-19 vaccine ad26.cov2.s-blood clots nearby right thigh . 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'm not sure if related still would like to report complications to CDC. On Wed May 26 I had episode of bleeding during night around 2am. I went to the ER me and the baby was monitored for 24 hrs. Since I had no additional bleeding sent home. On Fri June 4 had the same episode went to the ER I was 37 weeks my doctor decided to induce my labor. I delivered, baby was healthy then I started hemorrhaging. I got to a stage 3 hemorrhaging became more got different shots. I lost a couple liters of blood now I'm doing fine now.

Subconjunctival hemorrhage. Petechiae. Headache. Cardiac insufficiency. SOB. Syncope. Fever. Splinter hemorrhages.

I, patient was vaccinated on March 30, 2021 at the time mentioned above in the form with the Janssen COVID-19 vaccine at a Medical Center hospital, for 24 hours after the vaccination, I am unwell general: (headache, body ache, diarrhea, stomach ache, chills, fever and discouragement), at the hospital they recommended taking tylenol, after 24 hours all symptoms started to improve, then I was able to go back to my work. As the days passed, I began to present discomfort in my legs: (extreme fatigue, pain, swelling, redness and a lot of itching) being the symptoms more severe in the right leg, I also had a headache, chest pain and back. By April 15, 2021, I could no longer bear the By April 15, 2021, I could no longer bear the discomfort and pain so strong and decided to go for emergencies to the Bergen New Bridge Medical Center hospital, where I was hospitalized for two days, on April 15 and 16, 2021, there too. . I was diagnosed with venous thrombosis in my right leg due to the Janssen COVID-19 vaccine. After leaving the hospital, I was prescribed a medicine of (Xarelto) 20 milligrams, for 3 months and 10 days of disability, being able to return to work on April 28, 2021. After 3 months and I finished my medication on July 9, 2021, after 7 days I returned to present the same symptoms that I had presented on April 15, 2021, seeing myself in the obligation to return to the emergency center of the Medical Center hospital, there they gave me medications until July 21, 2021 where I had my follow-up appointment with my general practitioner MD, that day my doctor told me that I had not had any improvement and would have to send me medications again for another month until next month where I will have a follow-up appointment for my illness. Personally I feel that I am not evolving for the better, I feel more and more tired in my legs and the pains and swelling are getting stronger. In advance, I thank you very much for your attention.

10 minutes after shot administered in left arm upper bicep. Anaphylactic Reaction: sore throat went to very sore strep throat feeling, throat felt like closing, difficult breathing 15 minutes: coughing asthma began. Blood sugar felt it was dropping ( 20 min prior had breakfast sandwich before shot). Right arm hand tremors began, week in legs even when sitting sever headache. Asked staff get a Benadryl- call 911. Took 25 mg tab benedryl 5 min prior to EMT arrived. Same time another woman started difficulty breathing and staff at facility asked if Emt could look at her too. Emt called another ambulance to scene as strap into gurney. Way to ER gave me liquid steroid. ER given epi, nebulizer breathing treatment Abuterol help breathing, pepicid too. Discharge after 3:30 pm. 40 mg prednisone ( 2 tabs a day for 4 days) and instructed Benedryl 4-6 hours. Use epi pen if throat and sever sore throat comes back- return to er.

Pt states that she experienced low back pain and extreme fatigue after imz but resolved in 24 hours. On Sunday, (4/11/21) which is roughly 3 weeks later pt noticed pain in lower right leg (calf) which was warm and tender to touch. Pt went to urgent care and was immediately sent to ER. Diagnosis was DVT in right lower leg . Pt was administered 2 shots of heparin injection in abdomen and discharged on Eliquis. Pt followed up with PCP on today 4/14/21 and was told to continue Eliquis and to follow up in 1 week for another ultrasound to ensure medication is working.

Dx: Acute DVT of the left posterior tibial vein (distal to popliteal) shown on US, opted for repeat CBC next AM to confirm platelet count stability and US in 1 week to assess DVT progression vs stability Symptoms: Headache, nausea, myalgia, shortness of breath, forgetfulness, leg pain starting from bilateral feet cramping

Immediately after the JANSSEN vaccine I felt tenderness in my jaw that lasted for about two days. My body was sore, my Legs felt like I was having cramps ?growing pains? I also was experiencing allergy/asthma like symptoms that included difficulty breathing and shortness of breath that worsened over time I couldn't speak in full sentences or laugh I was unable to walk 10 steps without gasping for air, after a couple of days of trying to maintain and cope with my theses symptoms. I couldn?t take it anymore, as I was preparing myself to go to the emergency room. I got into the shower the steam from the shower felt like it was suffocating me and I passed out my children took me out of the bathtub and rushed me to the emergency room where I was given several tests that include x-ray, CAT scan, artery bloodwork and vein bloodwork. I was being treated for asthma and given several different breathing treatments and steroids, unable to keep my stats at a decent level and the hard rebound even after continuous treatments, I was admitted because the breathing treatments were not effective. I am still uncertain of the ?actual outcome? the Hospital doctors treated me for an asthmatic episode and gave me directions how to handle my asthma i was prescribed prednisone and referred to my primary that would then refer me to a pulmonologist and cardiologist. At the hospital I was told that there was black spots on my lungs I was told that I was being treated for infection, but then also told it could be pneumonia no certain answer was ever given and i was given and antibiotic and was also told that I needed to see my primary for a way to maintain my asthma. The antibiotics seem to work for a couple of days and again I'm back to having difficulty breathing, shortness of breath, muscle pain soreness and mild lingering headaches. STATUS ASTHMATICUS ASTHMA EXACERBATION ACUTE TRACHEOBRONCHITIS SHORTNESS OF BREATH

? Acute CVA (cerebrovascular accident) Hospital Course/test results: Work up with MRI showed 2 small acute infarcts in R temporal lobe region, and findings which could represent subacute infarcts in L frontal lobe. Neuro deficits now resolved. Neurology consulting. Suspicious for embolic phenomenon. She does also have a IUD to treat her menorrhagia, which may predispose her to clotting. However when we did further research Mirena IUDs were not found to raise the risk for blood clot-related heart attack and strokes but the company does recommend clinical consideration for removal in such situations. We contacted OBGYN oncall physician and spoke to doctor today. From his recommendation is not to remove the IUD at present time because the risk is very low comparing to the higher risk of severe menorrhagia that patient had experienced in the past. Since she will have annual visit with her GYN at OBGYN, patient should have that conversation with her GYN for options. Patient remains stable and symptoms free. Repeated brain MRI and new MRV did not reveal new findings. Her HA resolved on its own. She was initially started statin and full dose of ASA then changed to low dose ASA plus Plavix (21 days) then ASA as monotherapy after. Currently hypercoag panel is still pending. Echo showed no evidence of intracardiac shunting with fair quality and technically adequate study. Neurology recommended outpatient follow up with neurologist and 30 days heart monitor to look for Afib/flutter. Currently her headache is resolved as well R hand weakness/tingling is resolved. She is stable to go home today. A1C is 7.3 while on Metformin (2000mg daily). She may need additional agent to get A1C < 7 as outpatient. Neuro also recommended outpatient sleep study.

I took the vaccine at 2:10pm on 4/8/21 and 20 minutes later at 2:30pm on 4/8/21 my cycle started a whole week early, which is very abnormal for me. I am bleeding clots of blood for 5 days now with weakness and pains. My normal cycle is very regular and lasts 3 days, the first day is heavy then moderate, then light on the third day i barely need a liner. This has been heavy bleeding with sizable blood clots.

Delayed menstrual cycle by 4 days, when started very painful and heavy. Much more clots than usual and lasting longer than usual. Uncomfortable enough to require rest. Still going heavy when it should be tapering off.?

My period was supposed to start on 04/09 the day I got the vaccine. It was delayed until 04/13 when it began to bleed BLACK clotty sticky sludge. It had the appearance and consistency of vegemite or molasses. Black sludge. At first it was extremely heavy with very large black clots. Then it became tiny little black clots suspended in a brown sludge. This continued for 6 days until 04/18. Then on 04/19 my menstruation turned bright red with no clots, but has not abated at all for another 4 days. I am currently today on Thurday 04/22 still bleeding almost 2 weeks after taking the J&J shot. I cannot believe I am still bleeding after 10 full days!!! Never in 30 years of menstruating have I had a 10 day period. I am very scared and upset.

Left calf and thigh pain and swelling on the 6th day following vaccine which continued intermittently for a total of 12 days. I was seen at an urgent care, a left leg ultrasound was completed and I was diagnosed with deep venous thrombosis. I was prescribed Xarelto.

Patient received J&J vaccine on April 9th. She stated to experience a left sided headache on 4/14/21. She was hospitalized late on 4/17/21 and was diagnosed with a pulmonary embolism on 4/18/21.

Deep venous thrombosis at the site of vascular access line-Initially started on heparin, now switched to Rivaroxaban Thrombocytopenia-Supportive treatment and monitoring

As soon as I took the vaccine shot I had an immediate headache, after taking the vaccine I took Tylenol and slept in the rest of the day. The next day I woke up and my arm was red and swollen. I was running fever, still had the headache and now blurry vision. My entire body was hurting. My left side of my body felt numb and tingling. The next two days the pain became worse. I did not really have an appetite. When I did eat I could barely hold my food down. On Wednesday morning I could barely get out of bed, I also felt extreme pain in my lower legs, stabbing pain in stomach and right lower side. I also had ringing in my ears, more in the right ear. I then notice a bruise on my left leg, that it was not originally there, and was also tender to touch. I went to the emergency room on the same day and I was admitted. I was in there for 4 days, they tested my leg and stated it was not a blood clot, although it look and felt like one. They discharge me and advise me that it was a migraine that was causing all my pain. This was on Sunday, I had a follow up with my PCP on the Friday, however to being in so much pain and shortness of breath, and arm pain I was advise to go to the ER on the Thursday and was admitted again. I was told in the ER I had a blood clot in my right arm and it was most likely from the IV from the previous visit. My blood pressure and heart rate was so high that they put me on medication. No matter the pain medication they gave me, it would not completely take the pain away. They discharge me again on Monday and after me begging them to get run any and all test, they said they found nothing. I'm still in the same amount of pain and same symptoms, still having trouble keeping my food down. The only thing that changed is my left arm is not as sore, however I still have a huge knot and its still warm to touch. I don't know what else to do that is why im contacting the CDC for help. I'm in a extreme amount of pain and pounding headaches. Please help

Next day full body red rash, 103-104 degree fever, deep body aches, skin sensitivity, joint pain, headache, brain fog,lasted 4 days, One week later period started with large chicken-egg sized blood clots, heavy flow lasted 2 days longer than typical period for me. Second cycle after vaccine started 4.22.21 with same very large clots, intense cramping and bloating

Symptoms - Difficulty breathing, chest pain, fever, headache Diagnosis - Pulmonary embolism Treatment - Xarelto and pain medications (Narco, Tylenol)

when I first started feeling symptoms, I was achy, I wear a pain patch for my syndrome, achy all over, muscles felt like they were cramping, headaches, nauseated , tickle in my throat, and then a cough I couldn't get rid of. I gradually got sick and tested positive for Covid 19 on April 6 . I couldn't breathe, I couldn't walk. I had bilateral pneumonia

I went in for a scheduled MRI of my foot and the MRI found that I have a 7mm blood clot on my foot. It was found on my left foot plantar region (bottom of my foot). A few days after the vaccine I had swelling on the top and bottom of my left foot. I got two vascular images completed and the MRI was never sent to the vascular department. My podiatrist confirmed the blood clot on an ultrasound. I'm still experiencing swelling.

Short of breath, swelling in limbs, chest pain over the next few weeks. Diagnosed with diastolic dysfunction/congestive heart failure.

NAUSEOUS; PULMONARY EMBOLISM; FELT LIKE TRYING TO GET SICK; FELT LIKE COMING DOWN WITH A COLD; This spontaneous report received from a patient concerned a 41 year old African American, not Hispanic or Latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure and the patient did not have any history of previous clots and no medical condition reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 042A21A expiry: 05-AUG-2021) dose was not reported, 1 total administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, after vaccination, the patient felt like she was trying to get sick, and felt like she was coming down with a cold but did not really get sick. On 30-MAY-2021, the patient was working and ended up getting admitted in the hospital on 17-JUN-2021 night at 7 PM. On an unspecified date in JUN-2021, laboratory data included: chest X-ray (NR: not provided) multiple clots in both the lungs, and scan with contrast (NR: not provided) multiple clots in both the lungs and was diagnosed with pulmonary embolism. The physician were not sure if it was because of the vaccine. The patient was hospitalized until 28-JUN-2021 or 29-JUN-2021. The duration of hospitalization was 12 days. On an unspecified date, the patient felt like there was something sitting on her chest, was nauseous so she thought she had food poisoning. The patient had been a little short of breath, thought it was because she just started working out but it was not much noticeable. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pulmonary embolism, and the outcome of felt like coming down with a cold, nauseous and felt like trying to get sick was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210713153-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). 20210713153-COVID-19 VACCINE AD26.COV2.S-Nauseous. This event(s) is labeled and is therefore considered potentially related.

Since the vaccination, my menstrual cycles are not the same. They last way longer and I pass very large blood clots that are not normal for me, to the point that I feel very weak. They have been like this every month since, the pain it?s excruciating at times and I?m not someone that complains, but this doesn?t feel normal.

severe headache, bad bruising, extreme fatigue, very sore muscles, odd sensation in muscles in back bled terribly after injection

Felt tired after the vaccine and continued to be more and more tired each day after the vaccine. 3 days after the vaccine I had to leave work to sleep and felt terrible (weak, shortness of breath, extreme exhaustion) on the 5th and 6th days after the vaccine with shortness of breath. On the 7th day, I went to the ER and was diagnosed with pneumonia.

Woke with: Blood Clots in my left arm at injection pt and lower arm, wrist, hand. Blood Clots in my left leg, mainly calf, lower leg, ankle, some in thigh. Larger, more numerically present than in past from antihistamines. None present before Vax, allergen-free diet prevents usually.

FEELING COLD; PAIN IN LEFT ARMPIT; PAIN IN LEFT SIDE OF NECK; BODY ACHE; PAIN IN THE INJECTED ARM (LEFT SIDE); ANAPHYLAXIS; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection on an unspecified date in MAY-2020. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, frequency 1 total, administered on 03-APR-2021 around 11:00 a.m. on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in MAY-2020, Laboratory data included: COVID-19 antibody test (NR: not provided) positive, (3.72). On an unspecified date in 2021, Laboratory data included: COVID-19 antibody test (NR: not provided) level of 0.2. On 03-APR-2021, the patient experienced anaphylaxis. It was reported that within 5 minutes after vaccination patient experienced tongue was swollen, throat started closing, throat breaking in hives. The pharmacy called the emergency service, and the consumer was taken to the hospital. On 04-APR-2021, the patient experienced feeling cold, pain in left armpit, pain in left side of neck, body ache and pain in the injected arm (left side). She was treated with routine treatment for anaphylaxis, and she was put on prednisone and Benadryl. It was reported that, the treatment was still on. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from anaphylaxis, and had not recovered from feeling cold, pain in the injected arm (left side), pain in left armpit, body ache, and pain in left side of neck. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to AER20210409478.; Sender's Comments: V0 20210410075-Covid-19 vaccine ad26.cov2.s Anaphylaxis. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s).

Date of vaccine 4/5/2021. Date of adverse event: 4/15/2021 acute onset of worst headache of life and imaging consistent w/ subarachnoid hemorrhage likely from rupture of anterior communicating artery rupture. She was seen in ER and transferred to Hospital and is admitted, awaiting cerebral angiography. Has not had an intervention. Available records will be faxed today to your fax number listed.

Aching left heel: April 26, progress into calf with swelling of foot, ankle & calf: evening April 27, dvt found in left leg, pulmonary emboli in both lungs, right worse than left lung, shortness of breathe, tachycardia

BODY ACHES; CHILLS; FEVER; DEEP VEIN THROMBOSIS; This spontaneous report received from a patient concerned a 42 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: 21-JUN-2021) 1 total, dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the patient had body aches, chills and fever. In APR-2021 (a week after vaccination), the patient experienced right leg pain and felt heavy and visited her primary care physician who recommended ultrasound scan of the leg. On 10-MAY-2021, the patient's ultrasound scan revealed deep vein thrombosis and she was treated with unspecified blood thinners. The patient was also put on Xarelto (rivaroxaban) therapy 15 milligram for 21 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, and fever on 11-APR-2021, and the outcome of deep vein thrombosis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;20210520235-covid-19 vaccine ad26.cov2.s -Deep vein thrombosis. 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 two weeks later, I started to get a headache. The pain was massive and it was on one side of my head. I thought I was having a stoke. I took Excedrin and went to sleep and woke up and it was a vain popping out of my head. I had blood clot in my leg.

Anaphylactic shock-5 minutes post injection Throat and tongue swelling Required 3 epipen injections EMS to the hospital 50 mg of IV Benadryl and IV Pepcid

PNEUMONIA; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. The patient's was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 27-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-APR-2021, after 45 minutes of vaccination the patient experienced shortness of breathe and chest pain. On MAY-2021, the patient had a computed tomography (CT) scan that shows pneumonia and the patient was under treatment with antibiotics. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pneumonia. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210548936-COVID-19 VACCINE AD26.COV2.S-Pneumonia. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Patient received J&J vaccine on 4/7 and suspected to have CVST on 5/5 when she presented to hospital with significant headaches and seizures. Patient was started on bivalirudin and steroids and given 1 dose of IVIG. Unclear etiology, patient followed by Neurology and Hematology to determine anticoagulation and management of headaches.

Patient presented with leg pain and shortness of breath to the emergency department. Was subsequently found to have a DVT

JOINT PAIN; INFLAMMATION OF THE RIBS; VAGINAL BLEEDING/CLOTS; CYSTS ABOVE THE LEFT ELBOW; FATIGUE; ANXIETY (TINGLING ALL OVER THE BODY ESPECIALLY THE WAIST, SHORTNESS OF BREATH, WEAKNESS); BACK PAIN; NECK PAIN; This spontaneous report received from a patient. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol consumer, and non-smoker, and other pre-existing medical conditions included patient had no known drug allergies, no relevant medical history prior to the start of these symptoms. 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 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JUL-2020, Laboratory data included: COVID-19 PCR test (NR: not provided) Negative, Negative. On 2021, Laboratory data included: Biopsy (NR: not provided) Not reported. On 28-MAR-2021, the subject experienced anxiety (tingling all over the body especially the waist, shortness of breath, weakness). On 28-MAR-2021, the subject experienced back pain. On 28-MAR-2021, the subject experienced neck pain. On 30-MAR-2021, the subject experienced fatigue. On 31-MAR-2021, the subject experienced vaginal bleeding/clots. On 31-MAR-2021, the subject experienced cysts above the left elbow. On 05-APR-2021, the subject experienced inflammation of the ribs. On 06-APR-2021, the subject experienced joint pain. Treatment medications (dates unspecified) included: paracetamol, salbutamol, norethisterone acetate, trazodone, and hydroxyzine embonate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from cysts above the left elbow, and had not recovered from back pain, neck pain, anxiety (tingling all over the body especially the waist, shortness of breath, weakness), vaginal bleeding/clots, joint pain, fatigue, and inflammation of the ribs. This report was non-serious.

Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Additional Details: Patient received the injection. After a couple of minutes, patients breathing became rapid. I tried to calm her down. A couple of minutes the patient said her throat was closing. She made some gasping sounds. I gave her an injection of epinephrine 0.3mg. i called 911. EMS took her to unspecified hospital after treating her.

COVID-19; BRONCHITIS; This spontaneous report received from a consumer (patient's husband) concerned a 43 year old female. The patient's height, and weight were not reported. The patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 042A21A, and expiry: 21-JUN-2021) dose was not reported, administered at Left Deltoid on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the patient was given a dose of the vaccine and she did not show up. On next day 10-APR-2021, she started shivering very badly and was feverish. On 11-APR-2021, the patient also had a headache. On 12-APR-2021, all symptoms gone. The next day on 13-APR-2021 when she got up she had chest tightness and went to doctor due to fever, chills, headache resumed. Since that day was the clot information in the news and they did testing for clot stuff which was all negative. Also the patient diagnosed with bronchitis. After the 13th she had 'on/off' days of experiencing symptoms. On 16-APR-2021, she tested for covid-19 via 'non-rapid' test and the results of test came on the 17th were positive for covid-19 (diarrhea, vomiting, chest tightness, shivering, chills, headache, feverish and nausea). On 17-APR-2021, she developed diarrhea and vomiting. By the 19-APR-2021, they went to the hospital where she received unspecified fluids and pain pills for the fever and to calm her down. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bronchitis and covid-19 was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20210443606 - Covid-19 vaccine ad26.cov2.s-Covid 19. 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 present to ED on 5/3 with leg pain. found to have blood clot in left leg via ultrasound. started on rivaroxaban and discharged

she?s had blood clots and has had surgery 3 times, she is unconscious at the moment. the whole left side of her brain has been removed and she is paralyzed on the left side. this is definitely from the shot.

Stroke requiring 911 call and subsequent hospitalization after ER visit. Heart arrhythmia after stroke and subsequent hospitalization after ER visit.

4/3/2021 - severe headache, nausea, and vomiting. I experienced fatigue in subsequent weeks. 4/6/2021 - virtual nurse visit. Lab work. Low vitamin D identified. 4/13/2021 - 11;30 PM - numbness on right side 4/14/2021 - 12:00 PM - numbness on right side (arm, face, tongue, toes), weakness - right leg. Called nurse triage and was advised to go to emergency room. Was admitted as a stroke alert. CT, MRI, echocardio - all negative. Diagnosed with parasthesia. Medical records indicate I had a TIA. Discharged on 4/16/2021. 5/05/2021 - Hospital follow up visit with neurologist. Prescribed baby aspirin for TIA and additional lab work to rule out blood disorder.

Janssen COVID-19 Vaccine EUA I got the vaccine the evening of 03/23/21. Overnight I noticed my body starting to hurt and felt chills. The morning of 03/24/21 I woke up with full body aches, chills, and fever over 100 F. These symptoms lasted all day. Fever went up to 102 F. Recently I have noticed a change in my menses since having the vaccine and I wonder if it is linked. I have been on birth control since last year to control heavy bleeding. It was helping very well. The period I had in April and May were like it was before I started the pill. It was heavy and I had numerous large clots. I will be scheduling an appt with my ob/gyn regarding this change.

Systemic Allergic Reaction 20 minutes after injection. Felt it hit my spine, torso and head felt flush and hives started on torso. Had I not taken the Allegra D that morning and Famotidine 1 hour before the shot, I would have gotten hives all over my torso and face and swelling would have started in my face. I had an anaphylactic reaction but the histamine blocker and anti histamine kicked in after about 10-15minutes and I felt better. Had I not taken the medicine I would have ended up in the Emergency Room. That night I developed Oral Lichen Planus. This became extremely bad and uncomfortable for the next 48 hours. Then it started to heal. It fully went away after 6-7 days.

LEFT SIDE OF TONGUE FEELS LAZY AND LINGERING; UNABLE TO PRODUCE WORDS OUT OF MOUTH; NOT ABLE TO SEE DUE TO SWOLLEN EYE; LEFT EYE ALMOST SWOLLEN SHUT; RIGHT SIDE BACK PAIN/KIDNEY-MID LOW BACK RIGHT SIDE; INNER THIGHS BOTH VEINS POPPING OUT; ANAPHYLACTIC SIDE EFFECT; LEFT EYE FELT NUMB/ LEFT EYE PIERCING; HEADACHE; FEEL WEIRD; This spontaneous report received from a patient concerned a 43-year-old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy (itchy throat/swelling), and doxycycline allergy (throat swells shut and marbles in there). The patient was previously treated with escitalopram oxalate (Lexapro 20mg). The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported,1 total administered on 09-APR-2021 15:30:00 on left deltoid for prophylactic vaccination. No concomitant medications were reported. It was reported that after vaccination on 9-APR-2021, the patient immediately got headache but her left eye felt numb. She waited 30 minute because she had anaphylactic side effects and it felt really weird. The headache and left eye felt numb/left eye piercing while she was driving back (from vaccination center) which lasted for hour and half (short lived and resolved). On 11-APR-2021 she experienced right back pain (that radiates) which lasted for about five days. After that her inner thigh veins all got bright red for 2 days (only inner thigh nowhere else) and she thought she had something on her and tried wiping it off. On 16-APR-2021, she went to the doctor it was about one week from she received the shot, her left eye was swollen almost shut and that swelling lasted about five days. She was not able to see out of her eyes. She was not able to produce a word which was kind of weird for her. After that, the side effect she had, was her left side of tongue felt lazy and was lingering. She went to the doctor 3 days later news of clot came out doctor said those were the side effect of Janssen COVID-19 vaccine and there was nothing to worry about. She was trying to figure out why her eye was so big and performed D-dimer test which came back normal. She attempted Benadryl for 2 days did nothing but made her tired and she stopped taking it. She thought may be those were allergies at that time. She used an ice pack on her eye, so that swelling would go down a little. There was no discharge from her eye it was just swollen. In APR- 2021, Laboratory data included: Fibrin D dimer (NR: not provided) as Normal. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride (Benadryl). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left eye felt numb/left eye piercing, and headache on 09-APR-2021, right side back pain/kidney-mid low back right side on 16-APR-2021, inner thighs both veins popping out on 13-APR-2021, and left eye almost swollen shut (not able to see due to swollen eye) on 21-APR-2021, had not recovered from left side of tongue feels lazy and lingering, and unable to produce words out of mouth, and the outcome of anaphylactic side effect, feel weird was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210624549-COVID-19 VACCINE AD26.COV2.S-Anaphylactic reaction. This event is labeled per RSI and is therefore considered potentially related.

04/01/2021 I went to the Emergency Room and was diagnose with pneumonia, I then went back 2 more weeks in a row with symptoms not getting better. My chest stills hurt, headaches getting worse, body aches getting worse, rash, vision is blurry. My doctor has no clue why I'm still having these symptoms. I a 43 YO female that suffer from hEDS,

Developed pneumonia and is still having on-going problems which I'm being treated for now. Haven't been able to work since 04/19/2021

5 days after my shot, I began to bleed. I continued to bleed vaginally for 5 days. have been post menopausal for about 2 years.

I had some dizziness, headaches, right side neuropathy. I was also tired all the time. I went to the doctor where my doctor tried looking for other things aside from the pulmonary embolism. A brain MRI was done which came back normal. A thyroid test was done which showed hypothyroidism. I went to a specialist after this where a thyroid ultrasound was done and showed a swollen thyroid. I was diagnosed with Graves? disease. I have never had this before. I am now on methimazole 20mg/day. I had labs drawn to see if dose needs to be adjusted. I was told that it will be about 2 years before it can be determined if that medication is working. I also experience brain fog. I have lost 10 lbs in the past months due to this as well.

On 7/14/2021 pain started in left leg. On 7/15/2021 my primary doctor sent me to the ER where tests were performed. On 7/15/2021 diagnosed with DVT blood clot in left leg in the popliteal vein. Prescribed Eliquis 10mg twice a day for 7 days then 5mg twice a day for 3 months. My allergy and primary discussing a CT scan of brain.

I started having an annaphylaxis reaction a short time after i left. At first it was intense all over body itching that felt like it was from the inside out. By the time i got home i was getting red blotchy patches over my face, neck, and chest. I took benedryl which did nothing to subside the reaction. When my chest started feeling tight i went to the emergency room. My lips were itching and puffy. At the er i received treatment for annaphylaxis once and about a half hour to forty minutes before i was to be discharge i had a reoccurance of symptoms and was treated for it a second time and admitted to the hospital. This was from the March 31st clinic held at the fire department.

Had chest pain on and off for 5 days (started Thursday 3/25), which I thought was related to acid reflux. On Tuesday 3/30 when it became worse and was no longer managed with ibuprofen I went to patient 1st. I was given an ekg which was abnormal and then sent to ER. There it was determined that I had a blood clot and 100% blockage in my right coronary artery. That night I had surgery and they placed a stent.

Patient started not feeling well on 3/24. She was experiencing dizziness, headache, chills and fever. She contacted her doctor on 3/25 and he thought maybe she had an inner ear infection. Symptoms continued to worsen and eventually an ambulance was called on 3/27 because patient stated she was having severe SOB and headache along with dizziness and fever. Patient was transported to Hospital where they tested her for covid and pneumonia. Both came back negative. After several tests it was confirmed she had a blood clot in her lung and was also told she had clots in her leg and heart as well. She was in the hospital for 3 days where she was given heparin and several medications for the headache. Patient was discharged on lovenox and coumadin and eventually switched to xarelto by pcp who is managing her anticoagulation. She still has follow up appointments with a cardiologist and neurologist. She said she is still experiencing some dizziness and SOB but overall doing better

Came to the ED for shortness of breath for the past 3 days; also claims was treated for anaphylaxis at other institution after receiving the vaccine (patient has schizoaffective disorder). Patient tested positive for COVID-19 on 3/20/21 and treated with remdesivir and convalescent plasma

According to patient, she woke up at 2:00 a.m. to use the restroom and noticed she had a very dry mouth and was thirsty. She passed out and when she came to she experienced decreased vision. She was taken to the emergency room via ambulance for tests. She was diagnosed with a blood clot to her lungs after CT scans. She also had aditional scans and blood work and stayed at Hospital in town (I am having trouble adding this to the shaded area in question 21).

Started to feel chest pain and shortness of breath 3 days after the vaccine. Ended up in the hospital 5 days after the vaccine and diagnosed with blot clots in the lungs.

COVID-19 - Janssen ADR Come to ER on 4/8/2021 with chills, fever, weakness and dx with pneumonia after receiving COVID-19 vaccine 1 week ago and discharged on azithromycin. On 4/13/2021, came back to ED with worsening SOB, weakness, nausea and now with right thigh and leg pain, ground glass findings on CT thorax, positive for acute DVT on right leg and negative COVID testing. 4/14/2021 - right femoral vein thrombectomy and right external iliac vein angioplasty

1 hour after the vaccine I was walking with my sister and began experiencing neurological adverse effects--I was dragging my right lag and slurring my speech. 3 hours after the vaccine my right arm and right leg began tingling, went numb, and became weak. These symptoms persisted and my doctor advised me to go to the ER for brain imaging 24 hours after the vaccine. On day 3 after the vaccine, my symptoms had diminished but not subsided and I began to have new symptoms: extreme heat and pressure starting at my right ear and spreading through my face and head. The heat has subsided but not the pressure, as I am writing this it is day 13. Tests came back normal, but weakness and pressure neurological symptoms persist.

My first menstrual period following the vaccine was exceedingly heavy in flow for the first two days, which is atypical for me. Heavy clots of menstrual discharge were observed. It is not yet known whether these side effects will continue for my next menstrual cycle. Lesser effects followed two days after the vaccine with fatigue, sore arm, armpit, and glands in the injection arm. These side effects dissipated by day 3 status post vaccine administration.

First 2 days: fever 101.5, whole left side pain, abdominal pain, headache, lower right leg pain 3rd day: low grade fever 100.5, lower right leg pain, left arm pain 4th day: lower right leg pain increased along with redness, swelling, red lines, and eventually I couldn't apply weight on my right leg. After visiting Urgent Care hospital, blood clots were found in my small veins.

Pt received vaccine 4/1/2021, started to feel ill 4/11/2021 thought it was allergies. Continued to current date 5/6/2021. Had 3 different occurrences where she passed out. Dates were 4/30/2021, 5/5/2021, and today 5/6/2021 which lead to current admission. Came to ER found to have saddle PE from CTA scan. Went to Cath Lab and had INARI procedur to remove clot. Sent to ICU afterwards, was found to have DVT in left leg from ultrasound, started on argatroban. Currently is still in ICU, was admitted to ICU from cath lab today.

Janssen COVID-19 Vaccine EUA Patient had her Janssen vaccine on May 10th at a Pharmacy. On May 18th the patient presented to the ED with complaints of abdominal pain and chest pain. At that time troponin was negative, ECG was without acute ischemia or ectopy, D-dimer = 1.94. CT was negative for acute pathology, Ultrasound negative for hepatobiliary etiology. Patient requested discharge home and was referred to GI and cardiology. Patient presented to ED again on 5/19 with worsening symptoms. Repeat CT consistent with bilateral adrenal hemorrhage. Heparin Induced Platelet Antibodies PF4 Absorbance elevated at 2.138 and interpreted as positive. D-dimer greater than 20, and platelet count less than 79.

tongue swelling that patient felt was onset of anaphylaxis, began about 5 minutes after vaccine was given, pt was given one dose of EpiPen and went to ER where they received IV steroids, benadryl, pepcid and observed for 45 minutes. Upon discharge they were prescribed a 5 day course of prednisone

STROKE/NUMBNESS OF LEFT SIDE OF BODY/INABILITY TO WALK; This spontaneous report received from a patient concerned a 44 year old. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 13-MAY-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 27-JUN-2021, the patient woke up with numbness in left side of the body. The patient visited emergency room and diagnosed with stroke, and was hospitalized in intensive care unit (ICU) (date unspecified). The patient also experienced inability to walk after the stroke and visited physician's office and currently in rehabilitation. The number of days of hospitalization was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stroke/numbness of left side of body/inability to walk. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210716287-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).

BROKEN ANKLE; TWO DEEP VEIN THROMBOSIS IN LEFT LEG; PULMONARY EMBOLISM IN BOTH LUNGS; This spontaneous report received from a patient concerned a 44-year-old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient had no known allergies and no relevant medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown and expiry date: unknown) dose, start therapy date were not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drug included Skyrizi (risankizumab) [form of administration unknown, subcutaneous, batch number and expiry date were not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. No concomitant medications were reported. On an unspecified date (reported as several months earlier), the patient broke her ankle. On unspecified date, in JUN-2021, the patient had pain and swelling in her left leg. The patient went to an urgent care to check it and discovered that she had two deep vein thrombosis in her left leg and pulmonary embolism in both lungs. She received treatment (unspecified) for it and was recovering. The patient's physician felt that the events was not due to Skyrizi but possibly due to Janssen covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from two deep vein thrombosis in left leg, and pulmonary embolism in both lungs, and the outcome of broken ankle was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210729466-covid-19 vaccine ad26.cov2.s – two deep vein thrombosis in left leg, and pulmonary embolism in both lungs. This event(s) is considered unassessable. The event(s) has a unknown temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Diagnosis: Cortical vein thrombosis, massive intracerebral hemorrhage with tentorial herniation, thrombocytopenia. Clinical Presentation and Course: 1 week after receiving Janssen COVID19 vaccination, patient developed gradually worsening headache. On March 17th, patient presented to Hospital with dry heaving, sudden worsening of headache and L sided weakness. Evaluation with head CT revealed a large R temporoparietal intraparenchymal hemorrhage with 1.3cm midline shift. She ended up getting intubated for worsening mental status. On evaluation at arrival in Medical Center, she was noted to have extensor posturing. Repeat imaging revealed worsening midline shift to 1.6cm. CTA showed cortical vein thrombosis involving the right transverse and sigmoid sigmoid sinus with tentorial herniation. Patient developed brain herniation and brain death was pronounced on March 18th, 2021.

My sister received the Janssen vaccine on March 13, 2021. One week later, March 20, 2021, she started complaining of severe headaches, dizziness and vomiting. This continued so she visited the ER on Wednesday, March 24, 2021, where she suffered a cerebral venous sinus thrombosis. She was pronounced brain dead on March 27, 2021, which is also the same day she was pronounced dead.

Vaginal spotting 24 hours after vaccination , on 4-9-2021 Headache, arm soreness noted 48 hours after vaccination, lasting ~ 24 hours , noted 4-10-2021 Bruise at site of injection noted on 4-12?may have been present prior to this date but went unnoticed

DAY 1- two hours after vaccine my right arm and right leg felt restricted, numb and had some tingling in my hand, dull headche, muscle pain and dizziness. Day 2- mild pain at injection sight, muscle pain and general tirednes, dull headache,dizzy, right arm& left arm felt restricted and numbness in right pointer finger. Right leg felt restricted and pain behind the knee. Day 3- dizzy, dull headache, faint, high blood pressure, right arm & leg and left arm felt restricted and numbness/tingling in right hand. Pain behind right knee persisted. Went to ER Sunday early afternoon. Diagnosis is a cerebral venous thrombosis in sinus cavity. Still experiencing general weakness/tired, dizzy/unbalanced.

I had horrible pain in my left calf that travelled to my thigh. I went to the hospital 2 weeks later a d found that I have a blood clot in my lower leg (front ankle area). I am on blood thinners and will be seeing a Hematologist.

Per client self report: Experienced LLE extremity pain beginning on 4/11/2021, but thought nothing of it at the time. Client was previous scheduled for testing/procedure for asthma with pulmonologist on 4/15/2021, with pre-test/procedure lab work scheduled for Monday, 4/12/2021. Client presented for lab work on 4/12/2021 as scheduled and shortly thereafter received phone call from pulmonologist's office stating that the labs showed and elevated D-dimer and that she would be scheduled for a follow-up CT Scan of the chest and ultrasound of the lower extremities, which was scheduled on 4/14/2021. Client presented for CT scan of chest and ultrasound of lower extremities as directed and returned home on 4/14/2021. Client reported in conversation that she "didn't feel right" and noticed some SOB, and had planned to rest outside of going in for scheduled tests. Client received a phone call on 4/14 from pulmonologist's office advising her to go immediately to the emergency room due to a blood clot being found in the left lung as per CT scan report. Client presented to Emergency Room and was started on Eliquis 5mg tablets - 2 tablets by mouth twice daily X1 week and then 1 tablet by mouth twice daily and discharged to home. Client remains at home at the time of interview with no additional or worsening symptoms.

DVT left leg requiring surgical procedure 04/13/2021. Went to ED on 4/12/2021 with severe leg pain, warmth of area.

Shortness of breath for several days, feeling fatigue and week, pain in right elbow Diagnosed Apr. 17 in ER setting: acute segmental and subsegmental pulmonary embolism without acute cor pulmonale Acute thrombosis of superficial vena basilica right arm

LOSS OF BLOOD; VOMITING; BACK PAIN; ABDOMINAL PAIN; FEELING WEAK; HEADACHE; BLOOD CLOTTING; COULD NOT MOVE; ONLY COULD DO 5 MINUTES OF WORK; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included fibroids. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070CCHD,expiry: UNKNOWN) dose was not reported,1 total administered on 20-MAR-2021 for prophylactic vaccination to left arm. No concomitant medications were reported. On 22-MAR-2021, the patient experienced blood clotting which lasted for three weeks and resolved as per physician on same day the patient experienced headache which got resolved on 22-Apr-2021. On 18-APR-2021, the patient experienced loss of blood, vomiting, back pain, abdominal pain and patient felt weak. On an unspecified date in 2021, the patient went to hospital, it was also reported that patient was not able to move and could do only 5 minutes of work. Patient got confused between clotting with menstruation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood clotting on 12-APR-2021, and headache on 22-MAR-2021, was recovering from loss of blood, feeling weak, vomiting, back pain, and abdominal pain, and the outcome of could not move and only could do 5 minutes of work was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: In narrative of source document vaccination date is 20-Mar-2021 and in the structured field of source document vaccination date is 20-Apr-2021. So as per conservative approach, date given in narrative 20-Mar-2021 is taken as vaccination date. V0 20210440392-COVID-19 VACCINE AD26.COV2.S-Blood clotting and loss of blood. 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.

Symptoms: Severe chest pain, shortness of breath Emergency Room screening, CT Scan, chest x-rays and blood work. Findings: Pulmonary embolism in the right middle lung. Treatment: Hospitalization, 24 hour heparin drip for 3 days

3/13 vaccination. 3-4 hours later, I started having symptoms to include tickle in throat, post nasal drip. By 11:40 I had a HA, I was very tired, quite a bit of secretion. I continued taking Benadryl every 3 hours. At 2 :30 PM, heart palpitations and angina. My BP was 98/69. I took more Benadryl, drank some fluids. By 4:15, I was getting drowsy and tired, having pain in multiple joints through my body; 8/10 scale, especially in my hands in feet. I took something for pain. My arm was very sore. I had mild to moderate slight cough. By 7:40 PM I took my regular medication. I was having a sudden intense HA and pain in joints was 9/10. I was having stiffness, chest congestion, feeling 'flu like' symptoms, brain fog, and weird pains / electro shock pains on extremities. By 830, my symptoms increased to almost a really bad allergic reaction. I couldn't think well, dizzy, cough, chest congestion and my lungs started to hurt. By 10:30pm, I started to have a low grade fever, pain 9/10, I took Ibuprofen and Benadryl every 3 hours. 3/14 Ibuprofen, slight fever, slight HA, joints were swollen and stiff; 8/10 on pain and stiffness. I had muscle pain and brain fog, could not say words. Dull pain back of head. My kidney area, I felt like it hurt, severe anaphylactic reaction it felt like. I still had photophobia. It continued into the evening. I continued taking the Benadryl and ibuprofen. Around 6pm, I had 101.5 temperature, nauseated, crying, chest congestion. By 10:45, my temp was going up again. Monday I had low grade fever, continued medication. Symptoms continued for a few more days with palpitations, brain fog, pain in lungs and kidneys. I couldn't do anything. By the end of the week, I started to recover. *My PCM knew before I got the vaccine they were on board and knew what was going to happen in regards to my reaction, EKG, I had epi pen, didn't pass out, I decided I was going to stay home. *It took me a good couple weeks to recover to my baseline. But it was pretty tough.

6 hours after she started feeling VERY ill. Body aches, fever, cough. she went to urgent care 3 days later and tested positive for covid. 2 days after that she tested positive for pneumonia. SHe was perfectly healthy before this shot.

Janssen COVID-19 Vaccine EUA NO PAIN, just a weird sensation, can only describe as "bubbles" in both my legs: behind the knee and calf. Started the night of May 25th and I didn't think any of it cause I have always had "jumpy" legs when I'm falling asleep. But Then the sensation was getting more intense the night of May 26th so the morning of May 27th I went to the ER.

It started the next day after taking the vaccine (achy, flu like symptoms and hot flashes). I break out in a sweat and get extremely hot. Two days later I experienced lung issues and went to the Dr.

HEAVY VAGINAL BLEEDING WITH CLOTS; SPOT; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, and other pre-existing medical conditions included the patient had no known allergies. the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAY-2021, the subject experienced spot. On 29-MAY-2021, the subject experienced heavy vaginal bleeding with clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heavy vaginal bleeding with clots, and the outcome of spot was not reported. This report was non-serious.

THE MORNING AFTER MY VACCINE MY TOES AND LEGS WERE NUMB AND TINGLY AND FELT HEAVY AND FELT WEIRD WALKING. I HAVE NEVER FELT THIS FEELING BEFORE, IT WENT AWAY PRETTY MUCH AFTER A COUPLE DAYS AND THEN CAME BACK A WEEK LATER E VEN WORSE THEN BEFORE AND STAYED FOR AT LEAST 3 DAYS SO I WENT TO URGENT CARE AND THEY SAID IT WAS NOT A BLOOD CLOT AND THEY DIDNT KNOW MUCH ABOUT THE VACCINE. NOW OVER 3 WEEKS LATER I STILL HAVE NUMBNESS IN MY TOES AND LEGS. IT COMES AND GOES, SOME DAYS ARE WORSE THAN OTHERS.

Patient had an anaphylactic reaction, her throat began to swell shut. She was given 3 doses of epinephrine 0.3mg SQ (left thigh, left thigh, and right thigh). 911 was called and EMS arrived in approximately 10 minutes, they proceeded to take her to the hospital. She was being monitored after the vaccine for 30 mins due to multiple allergies including anaphylactic reactions to bee stings and food allergies.

I developed ITP and was hospitalized June 2-4 to stabilize my platelet numbers after hemorrhaging on my period for the second month in a row.

PARALYSIS ON LEFT SIDE; NO FEELING OR STRENGTH IN LEFT SIDE; BLOOD CLOT IN THE BRAIN; CONFUSION; SLURRED SPEECH; UNSTEADY WALKING; FEELS DIZZY; NO ENERGY FOR ANYTHING; AGITATION; LOSS OF HEARING IN LEFT EAR; This spontaneous report received from a patient and her husband and concerned a 45-year-old female patient. Initial information received on 07-JUN-2021 was processed together with additional information received via 2 telephone calls to and from the patient's husband on 11-JUN-2021. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient had no family history of any blood/clotting disorders and that she did not travel anywhere prior to receiving the vaccine. The patient received COVID-19 vaccine Ad26.CoV2.S (suspension for injection, route of administration not reported, batch number unknown), dose not reported, administered once in total on 13-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. On an unspecified date, the patient experienced feeling dizzy, and had no energy for anything. On 14-MAY-2021, the patient started feeling confused, her mouth started feeling like it was drawing, and her speech started slurring. On 28-MAY-2021 she went to bed and got up and she couldn't feel her left side, with paralysis. She was also drooling and her husband took her to the hospital. The patient was flown by helicopter to another hospital. During the telephone call to the reporter, he reported that his wife's laboratory results were all within normal ranges at the second hospital, including her platelet count at 189,000 (units and normal range not reported). On 29-MAY-2021, a magnetic resonance imaging (MRI) scan of her brain revealed a 12 mm blood clot in the thalamus. The patient was treated with Aspirin (acetylsalicylic acid) and Plavix (clopidogrel bisulfate). It was reported that the clot could not be cleared before she was discharged after 4 days hospitalization on 31-MAY-2021. As of 07-JUN-2021, the patient reported being highly agitated and could not hear out of her left ear, had no feeling or strength on her left side and was very unsteady walking. As of 11-JUN-2021, the patient's husband reported that the patient was still experiencing weakness of the left side of her body with no energy for anything (reported as being very active prior to vaccination), trouble walking, feeling dizzy sometimes, trouble hearing with her left ear, was very agitated and was frustrated that these events had happened to her. The patient was on medical leave from work at the time of reporting. The action taken with COVID-19 vaccine Ad26.CoV2.S was not applicable. The patient had not recovered from the events. This report was serious (life-threatening, disability or permanent damage, caused/prolonged hospitalization and other medically important condition).; Sender's Comments: V0: This spontaneous report received from a patient and her husband concerned a 45-year-old woman who experienced blood clot in the thalamus 15 days after vaccine. No past medical history or concurrent conditions were reported. The patient had no family history of any blood/clotting disorders and that she did not travel anywhere prior to receiving the vaccine. On day 15, the patient went to bed and got up and she couldn't feel her left side, with paralysis. She was also drooling and her husband took her to the hospital. The patient was flown by helicopter to another hospital. During the telephone call to the reporter, he reported that his wife's laboratory results were all within normal ranges at the second hospital, including her platelet count at (189,000). On day 16, a magnetic resonance imaging (MRI) scan of her brain revealed a 12 mm blood clot in the thalamus. The patient was treated with aspirin and clopidogrel. It was reported that the clot could not be cleared before she was discharged after 4 days. As of day 25, the patient reported being highly agitated and could not hear out of her left ear, had no feeling or strength on her left side and was very unsteady walking. As of day 29, the patient's husband reported that the patient was still experiencing weakness of the left side of her body with no energy for anything, trouble walking, feeling dizzy sometimes, trouble hearing with her left ear, was very agitated and was frustrated that these events had happened to her. The patient was on medical leave from work at the time of reporting. The occurrence of blood clot in the thalamus could represent background incidence of such events in the general population and the normal platelet count exclude thrombosis with thrombocytopenia syndrome. However, a relationship with Janssen Covid-19 vaccine cannot be ruled out and thus the relationship is considered indeterminate.

7.2.21: patient seen in ED and diagnosed with COVID-19. 7.5.21: Patient returned to the ED due to symptoms worsening. Symptoms included: myalgias, weakness and cough. Hospitalization due to COVID-19 infection. Diagnosed with community acquired pneumonia and hypoxia. Remdesivir started. 7/8: Completed a 4 day course of remdesivir and was discharged home.

Pelvic achiness 18 hours post vaccination. Having vaginal bleeding/spotting 24 hours post vaccination. Am currently on beginning of week 3 of birth control pills - normally have no issues with spotting - always very consistant.

Menstrual bleeding (I have not had a period in 3-4 years) Pain and knot at injection site (after 5 days it is worse)

Pt received vaccine and had a safety barrier bandaid put on. Seconds later, the injection site started heavily bleeding over and around the bandaid. Rph applied constant pressure using cotton balls to the area for 5-7 minutes. Bleeding had stopped and a new bandaid was applied. Injection site adverse event was then resolved. Pt expected this due to her having a medical condition of anemia and taking subsequent B-12 injections. Pt was observed for 30 minutes and no bleeding re-occurred or was seen. Pt was directed to put ice and pressure on it for further home care.

Massive nose bleed with a huge blood clot to follow. Went to urgent care but it had stopped by then so they sent me home and told me if it happened again to go to ER. I haven?t had a nosebleed in years so it was scary to get it the day after my vaccine. The nose bleed lasted about 10 minutes and was very strong once the clot came through it slowed down and then stopped and did not return again.

Approximately three days after vaccine, I experienced a blood clot. This caused an acute ischemic stroke in my left frontal lobe, resulting in muscle weakness and partial loss of use in my right leg.

Shortness of breath, nausea, headache, incident of blurred vision in one eye. Had visit with PCP on March 26th with follow-up testing on March 30th and 31st. Condition worsened and went to emergency room on April 4th and was admitted to ICU. EKOS procedure performed on April 5th. Discharge diagnosis on April 7th: 1) Acute bilateral PE (Pulmonary Embolisms/Blood Clots) with significant right heart strain status EKOS cath directed thrombolytics on April 5th. 2) Extensive bilateral deep vein thrombosis. 3) Significant right heart strain confirmed on the echo 4) Mild anemia 5) Metabolic acidosis with mild hyponatremia 6) Hypercoagulable workup, most results pending at discharge 7) Acute hypoxic respiratory failure

6 days after receiving vaccine, I experienced an episode where I got extremely hot, sweaty in neck and chest area, dizzy, loss of balance, blurred vision and blacked out for a few seconds. The episode lastly apprx. 4-5 mins. I laid down and fell asleep for about 20 mins afterward and woke up to moderate headache and slight burry vision still on left side. I saw my primary dr the next morning on 4/1/21 and reported issue.

Received Janssen vaccine 4/6. Started menstrual cycle 12 hours after vaccine even though had just completed last cycle 1 week prior. Normally cycles are 28-30 days apart. They have not been quite as regular since Covid and has had some shorter periods between normal cycles. After the vaccine bleeding was heavier than normal with large clots but by end of last week had changed color and looked like it was ending. Today had no discharge upon awakening but again has a small amount of bright blood. Of course, there is concern for coagulopathy related to the vaccination. No leg pain, no shortness of breath. Has had HA off and on since had Covid but no worse now than in previous weeks. Left ear pain has been painful since Covid but now has pain in both ears when that occurs. Quit taking ibuprofen last week for discomfort and switched to Tylenol.

We got a call from Doctor from ER to inform us that this patient came to the ER today & got swollen arm @ the injection site (left arm). They did the ultra sound & found there's a clot in brachial vein on the opposite arm (right arm). Doctor said they'll give pt Eliquist today.

I received the Janssen vaccine on 3/5/2021. My first menstrual cycle after the vaccine, which started on 3/21/21, was significantly different than any other period. I woke in the middle of the night to extreme pain in my abdomen and bled along the floor as I walked to the bathroom. There were clots in the blood in addition to extraordinarily heavy blood flow. The period was so significantly different from any other that I scheduled an appointment with a nurse practitioner that works with my primary care doctor. I asked her to "run" all tests that were available and approved by insurance, which she did. All came back normal. Due to the significant difference in my period this month, the ARNP requested an inner-uterine ultrasound which found the below:

Patient received J&J COVID vaccine on 4/9/21 at pharmacy . Today (4/22/21), patient is admitted to our facility with VTE, submassive, unprovoked, with bilateral high-burden PE and LLE DVT, and right heart strain / acute cor pulmonale; in patient with H/o R PE, provoked 2014 after transcontinental flight, s/p Warfarin x 6 months, reportedly negative hypercoagulable panel; with strong family history of venous thrombosis in mother and sister. Heparin drip started, plan to start DOAC tomorrow. Anticipate hospital admission for at least 2 nights.

Immediately following vaccination: Flu like symptoms. 24 Hours after vaccination: Very severe headaches started and continued. 12 Days after vaccination severe Stroke/Hospitalization/ICU

CLOT BLOOD; ACUTE ISCHEMIC STROKE IN LEFT FRONTAL LOBE; PARTIAL LOSS OF USE IN RIGHT LEG; MUSCLE WEAKNESS; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included amoxicillin and flexeril allergy, and migraine. The patient experienced drug allergy when treated with cyclobenzaprine hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 11:30 on left arm for prophylactic vaccination. Concomitant medications included ascorbic acid, ascorbic acid/ergocalciferol/folic acid/nicotinamide/panthenol/retinol/riboflavin/thiamine hydrochloride, ergocalciferol, iron, and withania somnifera. Approximately three days after the vaccine, on 11-APR-2021 08:20, the patient experienced clot blood. Which caused an acute ischemic stroke in left frontal lobe resulting in partial loss of use in right leg and muscle weakness. The patient had a blood test, CT scan, Carotid artery ultrasound, diagnostic ultrasound, electrocardiogram (EKG) and an MRI, results are unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from clot blood, acute ischemic stroke in left frontal lobe, muscle weakness, and partial loss of use in right leg. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This is a report of a 46 year old, female patient who experienced a blood clot that caused an acute ischemic stroke in the left fontal lobe 3 days after receiving the covid-19 vaccine ad26.cov.2. Patient's height and weight were not reported. Patient has migraine and allergies to amoxicillin, flexeril and cyclobenzapine hydrochloride. Concomitant medications included ascorbic acid, ascorbic acid/ ergocalciferol/folic acid/ nicotinamide/ panthenol/retinol/ riboflavin/ thiamine hydrochloride, ergocalciferol, iron, and withania somnifera. Smoking history, drug abuse and alcohol intake were not reported. Three (3) days after receiving the vaccine, patient was noted to have a blood clot (unspecified area) that caused an acute ischemic stroke in the left frontal lobe, resulting in muscle weakness and partial loss of use of the right leg. Patient had blood tests done as well as CT Scan, carotid artery ultrasound, electrocardiogram and MRI but the results were not reported. The information provided precludes a meaningful medical assessment. Additional information requested.

Patient is a 46 year old female who was admitted on 4/27/2021 for ACUTE DVT, UNSPECIFIED VEIN. 46 year old female with past medical history of POTS and on chronic hormonal oral contraceptive medication, and reported history of recurrent renal stones. Patient presented to ED after several days of left upper quadrant pain and tenderness, that worsened and became associated with nausea and vomiting. Initial evaluation by imaging demonstrated left renal stone in left renal pelvis with associated mild hydronephrosis. Incidentally on imaging, patient had DVT noted in right illiac vein with continuation into IVC. Subsequently admitted and started on heparin drip and pain control.

Pt had headache for the last week. J&J vaccine on 4/10, dxed with cerebral venous thrombosis. Pt's age is 47, not 46. Form would not allow me to put in pt's age and cited an error with pt's DOB.

flu like symptoms with headache 4/8/21. Chest pain, nausea, sweating, lightheadedness started 4/10/21, was seen in ER and discharged home. White count was noted as 2.8. Chest pain went away after 24 hours and palpitations started 4/11/21, severe at times for several hours at a time. Saw my cardiologist on 4/15/21 for severe palpitations and he ordered a halter monitor to be worn for 2 weeks. I stated to him that I felt like I was in SVT, or something stronger than just palpitations. This continued for several hours a day from 4/11/21 to 4/24/21, when I was on the telemetry pack at work and went into an arrythmia that was later evaluated by my cardiologist as SVT and A FIB. On 4/25/21, I had mild "palpitations" but have not had any incidences since. I am now on metoprolol to control it and did not have a cardiac issue prior to receiving the vaccine.

Headache onset 2 weeks after vaccination. Brain MRI on 4/30/2021 showed subacute dural venous sinus thrombosis affecting the superior sagittal, left transverse and sigmoid sinuses.

Spotting one day after shot and now 3 days after moderate vaginal bleeding. I have an IUD so I do NOT get periods or have vaginal bleeding.

The same day I took vaccineon April 6, 2021, I had pelvic pain and cramping that increase over the next two. Weeks. I made a appointment with my physician. On 4/29/2021 I was examined by my physician and was told to go to the ER. I had my appendix removed ans the pathology report showed that I had a bllod clot.

2 weeks after receiving johnson and johnson vaccine I began a second period in one month. I am very regular with my menstrual cycle so it was weird. And what is very strange it has large clots and not alot of bleeding. I have never had an period like that since I am 11 years old.

She developed shortness of breath the day after receiving the vaccine. Three days later she presented to ED and was found to have extensive right DVT and bilateral PEs. She has no prior history of DVT/PE. She had taken a flight 6 days before getting the vaccine. She has responed to treatment and was discharged the next day.

05/25/2021 - 6:00am - 2:00pm: Nauseous, 2:00pm - 5:00pm Dizzy 05/25/2021 - 05/26/2021 5:00pm: Headache on and off 05/26/2021 - 5:00pm : Migraine, light sensitivity: Took Aleve 05/26/2021 - 8:00pm : Migraine, light sensitivity : Emergency Room, Received shot for migraine and CT scan, saw bleeding on brain Transferred to Hospital by ambulance. CT scan done found blood clot in left side of head and blood work showed blood platelets were low. Diagnosis: Cerebral Venous Sinus Thrombosis, Thrombocytopenia. 05/27/2021 : Admitted to hospital in the Neuro ICU Transfusion of Nonautologous Globulin into Peripheral Vein Transfusion of Nonautologous Platelets into Peripheral Vein Placed on blood thinners. 06/02/2021 Discharged from hospital into Doctors' Care

On 04-24-2021 I had four days of extreme headaches that would not go away so I went to the ER where I got checked out. Also on 03-28-2021, I woke up with extreme left leg pain. I had difficulty holding things with my arms and I almost collapsed to the floor due to my left leg pain and weakness. I also had heavy menstrual bleeding with giant clots for the Month of March 2021. I can say today I have no symptoms of my left leg or headaches today.

Anaphalatic Shock - Rash / Hives / redness / heat / inability to communicate / swelling of the throat. Epi pen , Epinephrane in Ambulance, Steroids and Benedryl, overnight stay

FIRST DAY: *HIGH GLUCOSE; *NAUSEAS; *LITTLE HEADACHE; *CHILLS; *TIREDNESS. SECOND DAY: *HIGH GLUCOSE; *TIREDNESS; *HEADACHE; *SMALL BLEEDING. THIRD DAY: *HIGH GLUCOSE; *MODERATE BLEEDING. FOURTH DAY: *HIGH GLUCOSE; *MODERATE BLEEDING. FIFTH DAY: *HIGH GLUCOSE; *MODERATE BLEEDING. SIXTH DAY: *HIGH GLUCOSE; *MODERATE BLEEDING. SEVENTH DAY: *GLUCOSE A LITTLE MORE CONTROLLED; *MODERATE BLEEDING. EIGHTH DAY: *GLUCOSE A LITTLE MORE CONTROLLED; *ENOUGH BLEEDING; *WEAKNESS.

Patient states that she had acute onset of left arm weakness, numbness, difficulty speaking and slurred speech that started at 22:50. Patient was seen as a code stroke, was FANG?D +. Patient underwent MRI and MRA of the brain which showed multifocal small acute infarcts along the right frontal and right parietal lobes, as well as punctate acute infarcts in the right occipital lobe. No evidence of intracranial bleeding. Also noted a filling defect in the right carotid bifurcation causing severe stenosis of the right ECA origin and moderate stenosis of the right ICA origin. Patient was not given TPA, and was started on heparin drip and admitted to the ICU. Patient did receive the Johnson & Johnson Covid?19 vaccine on 4/9. Patient also complained of right ear and right jaw discomfort, pain behind L eye and L aura, as well as burning discomfort of the back of her tongue for the past two days Started on heparin drip initially and then converted over to argatroban drip based on CDC guidance. No IVIG given as platelets are > 500

About 4 days after I started having abdomen pain, it was like having contractions, then bleeding and spotting, and it was a different type of color instead of a period color, more burgundy. it lasted 26 days, when I'd eat it would start again, I started having headaches, and had vision problems, then SOB started and I used the inhaler to help. I also had a low grade fever of 99.8 - 100 that lasted up until about 5 days ago. I started having bruising and leg pain, the bruising would be if someone helped me get up, I have little bruising dots over my body. I went to the ER 3/16/2021 because the stomach and headache pains, they did a MRI and Ct and said it was acute stomach pain and migraines and told me to see a OBGYN for the bleeding and gave me meds for stomach pains. Bentel for stomach and Floraset for headaches but it never worked. I had a nerve block on my head for the migraines but it didn't work. The GYN gave me something to stop the bleeding and she's wants to do a D&C. I'm waiting to see my PCP on the 19th. I still have the purple dots and headaches, I still get the contractions and the stomach issues have settled some.

03/24/2021 Blood clot appeared on left arm area of mid forearm. Blood clot raised skin and was painful to touch. Treated with hot pack for approximately 20 min. Blood clot remained for approximately 8 hours and then broke the vein and I was bruised for approximately 5 days.

I am a menopausal woman with last date of period August 2019. On 4/7/21 I developed abdominal bloating and cramping related to menstruation. On 4/8/21 I developed mild mucous vaginal discharge with blood streaks. Thereafter, I developed tan discharge for a few days. I've continued to have upper GI pain for the next 2 weeks. I went to the ER on 4/18/21 for lab work up and they performed a right upper quadrant Ultrasound. I have a GI appointment today for further work up.

Symptoms include: vaginal spotting (blood) (not on period at the time), headache, urinary tract infection

BLOOD CLOT IN ARM; FEELING SICK; This spontaneous report received from a patient via a company representative concerned a 47 year old female. The patient's weight, height, and medical history were not reported. The patient was not pregnant at the time of report 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 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in APR-2021, the patient experienced burning sensation in arm, tenderness of arm, and pronounced veins on arm; also she was feeling sick. She saw the healthcare professional (HCP) after these symptoms. She was told about a blood clot (tenderness / burning sensation/ pronounced veins) in the arm. HCP recommended her taking aspirin and applying heat to the arm. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot in arm, and the outcome of feeling sick was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: This 47-year-old female patient reported burning sensation and tenderness in arm, pronounced veins in arm, and feeling sick after an unspecified duration from receiving COVID-19 VACCINE AD26.COV2.S for the prevention of symptomatic SARS-CoV-2 virus infection. HCP was consulted and was "told" about a blood clot and prescribed aspirin with advice to apply her to the arm. 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.

CAVERNOUS SINUS THROMBOSIS; THROMBOCYTOPENIA; COMPUTERISED TOMOGRAM HEAD ABNORMAL; FIBRIN D DIMER INCREASED; MAGNETIC RESONANCE IMAGING HEAD ABNORMAL; PLATELET COUNT DECREASED; VENOGRAM ABNORMAL; FULL BLOOD COUNT; This spontaneous report received from a patient via a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) and concerned a 47 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included aspirin allergy, and hypertension. On 31-MAR-2021, the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered in left arm for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow up for Batch/lot numbers. The concomitant medications included unspecified natural pills. On 05-APR-2021, the patient was hospitalized for venous thrombotic cavern sinus and thrombocytopenia 25,000, computerised tomogram head abnormal, fibrin d dimer increased, magnetic resonance imaging head abnormal, and developed platelet count decreased, venogram abnormal. On 05-APR-2021, the subject experienced full blood count. The patient was hospitalized (date unspecified) for 12 days. The following laboratory data (dates unspecified) included: CT scan results not provided, Complete blood count results not reported, Fibrin D dimer was elevated (value not provided), MRI results were not reported and Venogram was abnormal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cavernous sinus thrombosis, thrombocytopenia, computerised tomogram head abnormal, fibrin d dimer increased, magnetic resonance imaging head abnormal, platelet count decreased, venogram abnormal and full blood count was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening). This case version (1) was created on 30-APR-2021 for the purpose of quality improvement the following corrections were made. The MAC was added to the pharmacovigilance narrative.; Sender's Comments: V1: This spontaneous report received from a patient via VAERS (ID: 1238777) concerned a 47-year-old woman who experienced cavernous sinus thrombosis with thrombocytopenia 5 days after vaccine. Concurrent conditions included hypertension and concomitant medications included unspecified natural pills. Five days after vaccine, the patient was hospitalized for venous cavernous sinus thrombosis and thrombocytopenia (25,000) with an elevated D dimer (unspecified.) CT head and MRV were performed with results not provided. The patient was hospitalized for 12 days and treatment details were not provided. Based on evolving knowledge of Thrombosis with Thrombocytopenia Syndrome (TTS, per definition from Brighton Collaboration-BC), the low platelet count and temporal relationship to vaccination (BC Criteria level 1), the events are assessed to have a plausible relationship with vaccination. Reporter contact information was not provided which precludes meaningful additional information in this version.

Heavy vaginal bleeding a day or so later. The bleeding was like a pouring out of blood so severe that it caused me to need a blood transfusion in the emergency room at hospital.

possible adverse reaction of blood clot following J&J CoVid vaccine. J&J Vaccine received: 4/5/21 Fracture of 5th proximal phalanx: 4/16/21 Pt wearing constrictive device at location of DVT after 4/16/21 Pt taking OCP daily for years

3 weeks plus 1 day following vaccine, i developed pain in my left calf. After having an ultrasound, two blood clots were discovered in my left leg (one DTV and one superficial). I was sent to the ER, a CT was performed, blood work was taken, and I was sent home with a prescription for Xarelto blood thinner. I have to be on this for 3 months, and we will evaluate to make sure I'm no longer at risk. My medical bills for the date of 5/3/21 were over $11,000, and my portion so far is over $3300 after insurance.

LEFT ANKLE STARTED SWELLING, LEFT ANKLE SWELLING INCREASED AND REACHED LEFT THIGH, WENT ULTRASOUND WHICH RESULT BLOOD CLOT; This spontaneous report received from a patient concerned a 47 year old female. The patient's weight was 95.70 kilogram, and height was 167 centimeter. The patient's concurrent condition included Cholesterol. Patient was non alcohol user and non smoker.. Patient had no known allergies and 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 and expiry date were unknown) dose was not reported, administered on 11-MAR-2021 in right arm for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included pravastatin for cholesterol. Around 19-MAR-2021 (approximately 1 week after the vaccine), the patient experienced left ankle swelling (as per patient, she did not think much of it, and just elevated her leg and applied hot-cold compress). Around 26-Apr-2021 the patient experienced increased left ankle swelling and had reached her left thigh. On 26-April-2021 patient went to the hospital and was hospitalized, was given an ultrasound procedure which result stated that she had blood clot. Patient was given Eliquis right away, while in the hospital. On an unspecified date patient was discharged and upon discharge she was prescribed Eliquis 5 mg for 2 times per day. Patient stated that she will go back to the doctor will be doing another ultrasound. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot. Patient stated her left leg swelling was not yet completely resolved, but not as worse, whenever she elevates her leg, the pain and swelling gets better, but once she gets up and move around, the swelling starts again. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210529680-covid-19 vaccine ad26.cov2.s ,LEFT ANKLE STARTED SWELLING, LEFT ANKLE SWELLING INCREASED AND REACHED LEFT THIGH, WENT ULTRASOUND WHICH RESULT BLOOD CLOT. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Bells Palsy diagnosed on 5/31/2021. Steroid and antiviral medication. Pulmonary embolism on 6/9/2021. EKOS procedure on 6/10/2021. Heparin IV for 3 days. Oral medication eliquis prescribed.

COULD NOT SPEAK A FULL SENTENCE; VERY PAINFUL INFLAMMATION OF CHEST, INFLAMED CHEST WALLS; CRAZY RIDICULOUS VAGINAL BLEEDING; ANEMIC; ALMOST DIED; FAINTING AFTER BLOODWORK; CRYING FOR NO REASON; DOING REGULAR THINGS AT A SLOWER PACE; SLOWLY DYING; This spontaneous report received from a patient concerned a 47 year old, female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, 1 total administered on 21-MAR-2021 for prophylactic vaccination. Concomitant medications included iron for anemia. On 21-MAR-2021, shortly after vaccination patient became very tired and felt like getting sick and felt like as it was the expected. Patient stayed on couch next day. On 23-MAR-2021, bleeding was started which was not normal bleeding. Patient knew that she had to see hematologist as oxygenated blood was leaving her body. Patient experienced very heavy vaginal bleeding. Patient called gynecologist and was advised to go to emergency room, if patient bleed more than a pad an hour. Patient went to doctor shortly because patient felt this was not normal and something else was going on. When doctor took patient's blood, she fainted. Patient was healthy before shot and never had this before. Patient had intravenous (IV) so that patient could drive home. Patient was doing regular things at slower pace. Some weird things happened at 17.00 daily, patient cried for no reason. Blood test was received with something low. Patient went to the emergency room where they gave her blood, which patient never needed before in her life. Patient needed 2 units of bloods. Patient was slowing dying but did not know it. Patient was now anemic and needed 4 iron infusions and maybe needed 5th also. Patient had been told to follow-up in august. Patient was not sure that her body was making her own blood again. Patient felt almost died. Patient could not speak a full sentence even after the emergency room visit. Patient was still bleeding. Patient also experienced inflammation in chest which was very painful. Patient started birth control on 14-MAY-2021 and 15-MAY-2021 and stayed on until 24-MAY-2021. Patient started bleeding again on 25-MAY-2021 which continued till 29-MAY-2021. Patient had a lot of shortness of breath and thought may be a blood clot but on 20-MAY-2021, X-ray showed no clots. Cardiologist said this was most likely from the COVID Shot and likely inflammation. Patient chest was still painful to touch and it was better than before. Patient was on iron pills but stopped after the 3rd infusion of iron and patient's anemia levels was improved. On 23-MAR-2021. Laboratory data included: Blood test (NR: not provided) showed low hematocrit and hemoglobin. Laboratory data (dates unspecified) included: Gynecological examination (NR: not provided) fine, and Physical examination (NR: not provided) fine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from crazy ridiculous vaginal bleeding on 29-MAY-2021, fainting after bloodwork on 09-APR-2021, and crying for no reason on 13-JUN-2021, was recovering from anemic, and could not speak a full sentence, had not recovered from very painful inflammation of chest, inflamed chest walls, and the outcome of almost died, slowly dying and doing regular things at a slower pace was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210651060- JANSSEN COVID-19 VACCINE Ad26.COV2.S –Fainting, Almost died, Vaginal bleeding, Anemia, Could not speak, Chest wall 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).

Patient currently hospitalized with profound bleeding and clotting, suspect dysfibrinogenemia, otherwise healthy without history of dysfibrinogenmeia

Patient went to bed and woke up having something like a grand mal seizure around 10 p.m.. She felt hot but didn't take her temperature. She is perimenopausal and couldn't say for sure if she was having a hot flash or a fever. Her previous seizure was a year ago she said. Around 2:00 a.m. she woke up with stretching movements with her arms over hear head that she couldn't control, but didn't feel like a seizure to her. Patient went back to bed, but woke up around 5:30 a.m.. with temp of 102 degrees F. She took 2 ibuprofen 200mg (total dose 400mg) every 4 to 6 hours starting at 5:30 a.m. for a total of 3 doses. She felt better by later afternoon. She complains that her arm is still sore today. She just reported this to us this morning when she was back in the pharmacy.

My coughing from Allergies came worse. Fatigue, diarrhea, headaches. I had itchy toes on the 8th of April and developed a blister between my toes. This happened the first time I had covid. I tested positive for Covid for the second time on April 11, 17 days after the vaccine, after going in for antibiotics for sinus /lung infection. I tested positive for Covid October 9, 2020 in. Pneumonia continued through December. I have had long hauler symptoms since then.

Slight fever 12 hours later. Headache the next day. Severe headache with nausea two weeks later that lasted more than a day. Notice a small clot in left forearm. No pain, though.

Cerebral infarction 163.9. I was admitted to the hospital on April 4th, 15 days after taking the Janssen shot. My initial symptoms included tingling, numbness, and inability to walk. The doctors confirmed during MRI that I had had a stroke. I was in the hospital for four days, and released to PT/OT three times a week for the next 4 weeks to regain full use of the right side. I am also unable to work during this time.

A Fib with RVR, chest pain and weakness. Lasted for hours on 4/16/2021. Has had shorter episodes for the past week .

Pt states she noticed Tues left leg cramping in calf back and knee and thigh that feels like a charlie horse. denies hx of blood clots or long travel Left calf swollen cool to touch. Pt states her foot is more swollen to her. Patient found to have an indeterminate age deep vein thrombosis. Discharged home from the emergency department with a prescription for Apixaban.

It started with pain on the left side and shortness of breath. She was taken to Medical Center and there diagnosed with splenic infarction due to blood clotting. Was prescribed pain medication and blood thinners (Lovenox) to be injected daily for three months.

Patient had severe lower quadrant abdominal pain and fever to 38.2 C at home. Fever starting on 4/20, abdominal pain starting on 4/21. Presented to ED and was found to have bilateral ovarian vein thromboses. Was found to be septic with WBC 23.1, blood culture growing GPC in pairs and chains (anaerobic bottle) and GPC in chains (aerobic bottle). Further speciation pending.

Events: Vaccine was given on 3/19/21; Hysterectomy on 3/25/21; blood clots diagnosed on 3/30/21 Left forearm was swollen, with a light reddish tint to it, and tender. After getting an ultra sound on my forearm a DVT was found and I was sent to the emergency room. I then had a CT scan done of my chest and it was discovered I had several pulmonary emboli. I was admitted to the hospital and put on a heparin drip. I am currently taking Eliquis and will be following up with a pulmonologist and a hematologist in a week or two.

Went to er on April 11 th for cough and shortness of breathe they said nothing was wrong and sent me home. Did a virtual apt on 21st because my leg hurt and shortness of breathe. They told me to go see doctor in person . Went to Er April 23rd and was diagnosed with a massive blood clot in my lower right leg.they prescribed xarelto.

Patient came in this evening 4/26 after emergency room visit for blood clot in leg/shin. She received Janssen IMZ 4/10. Her symptoms of painful leg began several days after her IMZ and continued to worsen with her leg shin swollen, painful, bruised with a knot until she sought medical help in the ER. Ultrasound was done and ruled out deep vein thrombosis, determined to be peripheral blood clot. She was sent home on meloxicam for pain and inflammation.

weakness, Lethargy, uncharacteristic irritability beginning one day post vaccine 3/23/21. Labs: Thrombocytopenia: PLT 85 4/23/21, repeat PLT 4/26/21 75, repeat PLT 4/28/21 pending

Cerebral vein thrombosis - saggital sinus, right sigmoid and trasnverse extending to right jugular vein thrombocytopenia SAH bilateral frontal sulci

A few days after the vaccine my leg became complete cramped which caused me to go to the ER where several testwere performed and a vascular X-ray was also performed where it revealed a DVT was present in my lower left leg. I am currently taking Eliquis and various additional testing has been done to see why this has occurred but are pending the results. I still have edema and the minor cramping in my leg and foot also.

Patient received the Janssen COVID 19 Vaccine on 04/07/2021. No physical adverse assessment findings observed during the post-vaccine administration observation period. During the observation period, the patient verbalized that she was "feeling fine and had taken an Alive(medication)". Patient was later seen, after the observation period and engaged in a discussion stating that she "continued to feel okay but felt a little queasy (confirmed as nauseated)" and denied additional symptoms requiring immediate medical attention. On 04/29/2021, patient informed the clinical nursing team at the administering facility that she experienced adverse side effects 13 days after receiving the vaccine and was hospitalized on 04/20/2021 - 04/24/2021. Patients adverse side effects related to the vaccine are self-reported as blood clotting. Medical documentation not provided. The vaccine administrating facility's clinical staff is not unable to be verified by and confirm are deny adverse medical findings at the time of this dictation. Please contact patient for the selected healthcare provider where care was rendered for detail specific related adverse medical event.

PROFOUND BLEEDING; CLOTTING; SUSPECT DYSFIBRINOGENEMIA; This spontaneous report received from a health care professional via a Regulatory Authority and concerned a 48 year old, female. The patient's height, weight and medical history were not reported. The patient was not pregnant at the time of reporting. The patient had no other illness at the time of vaccination, no chronic or long-standing health conditions, the patient was healthy without history of dysfibrinogenemia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the patient experienced profound bleeding, and clotting and was suspected to have dysfibrinogenemia. The patient was currently hospitalized for the events (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from profound bleeding, clotting, and suspected dysfibrinogenemia. This report was serious (Hospitalization Caused / Prolonged, Other Medically Important Condition, and Life Threatening). Sender's Comments: VO:-covid-19 vaccine ad26.cov2.s -profound bleeding, clotting, suspect dysfibrinogenemia. 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).

POSSIBLE BLOOD CLOT; INCREASED HEART RATE; CHEST TIGHTNESS; HIGH BLOOD PRESSURE; NECK PAIN; ARM PAIN; HEAD PAIN; BODY SHAKING; CHILLS; HIP JOINT PAIN; BACK PAIN; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, osteoarthritis, fibromyalgia, non smoker, and non alcohol user. The patient experienced drug allergy when treated with diphenhydramine hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022) dose was not reported, 1 total, administered on right arm on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14- MAR-2021, around 9 pm the patient experienced body shaking, and chills for which she took Theraflu. On 15-MAR-2021, morning the patient experienced high blood pressure, chest tightness and increased heart rate of 156 BPM for which she went to the ER. She also experienced neck pain, arm pain and head pain. lung and chest examination was normal. Laboratory data included: Blood pressure (NR: not provided) increased, Fibrin D dimer (NR: not provided) 780, and Heart rate (NR: not provided) 156 pm. As the- d dimer test result was high, the doctor said she has a blood clot. She was given a shot of Toradol at the ER. On 17-MAR-2021, Laboratory data included: Fibrin D dimer (NR: not provided) 650. On 30-MAR-2021, She had another episode, she was in a lot of pain. She went back to ER. Laboratory data included: CAT scan (NR: not provided) normal. They sent her home and prescribed her Meloxicam. The patient went to see her Cardiologist after that, She stated that her cardiologist didn't do any blood work or mention anything regarding a blood clot. Treatment medications (dates unspecified) included: ketorolac tromethamine, acetylsalicylic acid, meloxicam, and dextromethorphan. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from high blood pressure, chest tightness, increased heart rate, body shaking, chills, and head and neck pain and arm pain on MAR-2021, had not recovered from hip joint pain, back pain, and the outcome of blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:-covid-19 vaccine ad26.cov2.s-possible blood clot. 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).

Large DVT and pulmonary embolism requiring anticoagulation and hospitalization. Also found to have a large fibroid uterus compressing IVC which likely contributed to IVC. Patient ended up needing mechanical thrombectomy to help relieve clot burden.

Patient received Janssen COVID 19 vaccine on 04/07/21 at another location. She presented to ED on 04/19/21 and was seen by Dr where she was diagnosed with a DVT in her left leg. She was started on Eliquis. She saw Dr on 04/26/21 and doctor on 05/03/21 for follow ups. Still showing signs of cramping and "charlie horse" like symptoms in the leg at follow up.

BLOOD CLOT IN LEFT LEG; This spontaneous report received from a patient concerned a 48 year old, White and Hispanic or Latino female. The patient's height, weight and medical history were not reported. The patient had no blood clots in the past or no recent trauma and surgery. The patient was not on any medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072 and expiry: UNKNOWN) dose was not reported, 1 total, administered to the left arm, on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAY-2021, the patient came into the hospital with swelling in left leg, a lot of heat and a lot of pain. In emergency room (ER) they did scans and tests and it was found that the patient had a blood clot in left leg. The patient has to stay in the hospital for 24 hours until the blood clot was resolved. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot in left leg. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0;20210516127- covid-19 vaccine ad26.cov2.s-Blood Clot in left leg. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

On Saturday, April 10, 2021, I had started having pain and swelling in my right calf that lasted for several days on and Tuesday, April 13th, I started having pain on the left side of my chest. On Thursday, April 15th, I went to the ER due to pain and selling in my leg and it was discovered that I had 2 clots in my leg (on at my calf and a second one on the right side of my knee). Not realizing my chest pain was related, I discussed with my primary care at a follow up visit on Monday, April 19th, and a CT scan was performed confirming I have an pulmonary embolism (extensive pulmonary emboli in both lungs). I was immediately put on Xarelto blood thinner and sent home.

started out with severe headaches , then started getting out of breathe, which became really intense , admitted to emergency on 5/13/21 released 5/21/21 with mini heart attack and multiple blood clots in the lungs. No blood clots in the legs which would have been from the estrogen pill. Oncologist stated that the clots form in the legs if from the estrogen pill, this formed in both lungs. Been on the tamoxopine for over a year and no side effects at all. Headaches and breathing issues all started after the vaccine

blood clots in my Lungs.. pulmonary embolism. had a catscan. and blood thinner at hospital treatment from june 9-till june11. was discharged. had to go too the emergency room with pain in my left side of chest. then they found blood clots..

12 hrs after vaccinated: loss of taste/smell 4/19-26: fatigue 4/26-5/9: shortness of breath during night.. restless sleep 5/10-13: periodic shortness of breath throughout day 5/13-20: admitted to hospital - pulmonary embolism & congestive heart failure IV treatment: heparin 5 days Several medications each day/night taken

ITCHING; JOINT PAIN; HEADACHE; ADMINISTERED HALF DOSE OF JANSSEN COVID-19 VACCINE; OFF LABEL USE; ANAPHYLACTIC SHOCK; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included mast cell activation syndrome, non smoker, and non alcoholic, and other pre-existing medical conditions included no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with moxifloxacin hydrochloride, azithromycin, methylprednisolone, phenelzine, and bupropion hydrochloride for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, one total, administered on right deltoid on 17-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included Benadryl continuous IV - 300 mg/24 hours for drug used for unknown indication and takes rescue Benadryl - 50 mg as needed for drug used for unknown indication. On 17-JUN-2021, Doctor administered half dose of vaccine because of patient's condition (mast cell activation syndrome). On 17-JUN-2021, patient went into anaphylactic shock 3 minutes later after vaccination and was administered Epi-pen (epinephrine). On 17-JUN-2021, the patient experienced headache. On 19-JUN-2021, the patient experienced itching and joint pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from anaphylactic shock, and headache on 17-JUN-2021, was recovering from itching, had not recovered from joint pain, and the outcome of administered half dose of Janssen covid-19 vaccine and off label use was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210660183- Covid-19 vaccine ad26.cov2.s- Anaphylactic shock, itching. 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 20210660183- Covid-19 vaccine ad26.cov2.s- Joint pain, headache. This event(s) is labeled per RSI and is therefore considered potentially related.

1. DVT in right upper leg found on 3/26/2021. Treated with Xarelto. No symptoms-NP discovered Ddimer was high and sent me in for a CT scan on chest and ultrasound on leg. 2nd blood clot discovered after follow-up on CDC announcement re blood clots. As of July both clots are gone, but continuing Xarelto until October per hematologist suggestion. 2. Nerve spasms in left arm and legs-noticed on 5/9/2021-Pulmonologist started Gabapentin on 6/24/2021. 3. Left side shoulder/chest/lower side discomfort/increased pain after mild activity or cardio-visited NP again for concern of pain. She changed Gabapentin to Cymbalta to try and calm whole nervous system and help stop the spasm/tingles. She ordered an MRI of the spine and neck to rule out nerve damage.

I had severe arm burning while shot going in. It never went away and was noticeable when laying on the arm. I?ve started working out and the pain has intensified to the point that it is radiating to my neck and back and I cannot sleep on that side. It sometimes is a deep throbbing pain and other times feels like sand paper. Last week I noticed a small scab right where the shot was. I picked it off and it bled a lot. Since then the pain is almost constant and limiting my daily abilities. Red dot remains where the shot was administered. Sometimes feels warm to the touch. This is staring to cause me distress and worry. I had two boys that just got first vaccine but I don?t think I will be getting them the second. I work in health care and I?m finding it difficult to do my job at times.

Day 1 Sweats, Severe Headache, Fatigue and aches Day 2 Headaches and Sweats Day 3 Profuse sweating, fatigue, headache and aches Day 4 Sweats, Headache Day 5 HIVES, Headache Day 6 HIVES, ANAPHYLAXIC Swelling in hands, feet, tongue & throat. Had to go to the ER! Day 7 Swelling, hives Day 8 Hives Day 9 Hives Day 10 Hives Day 11 Hives Day 12 started to subside

Patient presented to Medical center with right sided MCA stroke (proximal M1) occlusion. She underwent tPA therapy and is recovering. She has a history of breast cancer that was treated in 2017. It?s unclear to us whether or not these events are related. However, given the thrombosis occurred on the same day as the vaccine was administered, we felt it was a reportable event

Doctor determined superficial thrombophlebitis on left hand where IV 4 weeks before was taken out while at ER for kidney stone 2/18/2021. Hand was somewhat sore for weeks before vaccine. J & J vaccine on 3/12/2021. 5 days later 5/17/2021 left hand very painful and huge blood clot. Went to doctor and diagnosed blood clot and precribed clindamycin 300 mg 3X a day for 7 days. It wasn't until the 7th day the pain was gone and swelling of the vein back to normal.

Right calf pain similar to previous DVT pain she had experienced in the past. Symptoms starting 4/11/21 day 2 after receiving COVID 19 vaccine.

My mother received the Jansen vaccination on April 6, 2021. 2 days post vaccination she had 2 asthma attack at work. That following Friday she was not able to attend work due to shortness of breath. Saturday morning she cold not inhale and couldn?t stop coughing. She was then attempted to be taken to urgent care, but upon arrival she was coughing up blood and was instructed to go straight to the hospital. At the hospital upon test being done she was admitted to the covid unit and diagnosed with pneumonia due to covid 19 virus, bilateral pulmonary embolism in both lungs. She is now home in quarantine taking blood thinners for the next three months and unable to work.

Nearly a week after injection, injection site is still visibly swollen, slightly warm to touch. Blood clot passed vaginally (outside of normal menstruation schedule).

I have a history of untreated fibroids that were diagnosed in December 2019. Because the coronavirus pandemic began in February 2020, elective surgeries were not allowed in my state. My bleeding and blood clots were caused by the fibroids during menstruation. On March 20, 2021, I received the Johnson & Johnson 1-shot COVID vaccine. By March 26th, the blood clots that were coming out of my body were enormous. They had NEVER been that large. Being concerned, I immediately saw my doctor as soon as my period ended. Today, I learned the J&J vaccine has been paused due to blood clots. I believe that my blood clots became so large because I was given this particular vaccine. WOMEN SHOULD BE ADVISED THAT IF THEY HAVE BLOOD CLOT CAUSING FIBROIDS, DO NOT TAKE THE JOHNSON & JOHNSON COVID-19 VACCINE.

About a month after the shot, I developed a blood clot in my lung. The clot was found by a CT scan. I am currently taking Eloquis to hopefully dissolve the clot. I have been overly tired with little energy and some muscle/body aches.

The usual arm soreness and feeling of fatigue for a few days after. Not sure the following is related, but mentioning here due to the small number of women who experienced severe issues related to blood clots. Light nose bleeds - mostly when blowing nose - chunks - persists. Also, have been menopausal but am now having a cycle - thin and light bleeding.

ON 4/15 had an anaphylactic reaction and went to the ER at medical center (throat closing and body swelling) saw MD, no admittance sent home, provided bendadryl, steroids and Pepcid . No blood work or scans. On 4/16 had collapsed/fainted at home. Went to ER at different medical center. Saw MD Just gave fluids, CT scan and chest X-ray and blood work. sent home.

Patient arrived to ED with C/O vision changes and dizziness after vaccine on Saturday (unknown) patient was transferred to Main campus for Occipital Stroke at neuro facility., This facility did not give the vaccine

Symptoms of tiredness and head sinus pressure came on throughout the day monday 3-29-21. Symptoms were unchanged tues morning 3-30-21. She died Tuesday 3-30-21 between 10:34 am and 12:00 pm. She was found unresponsive at 12:07 pm when husband returned home for lunch. Autopsy results still pending.

HAD BODY ACHE; HAD HEADACHE; PULMONARY EMBOLISM IN BOTH LUNGS; SHORTNESS OF BREATH; CHARLIE HORSE IN LEGS IN MIDDLE OF NIGHT; LOWER EXTREMETIES HURTING AND SWELLING; HAD FLU-LIKE SYMTPOMS; TIRED/LETHARGIC; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient was a non alcohol user and non smoker, and he took vitamins.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 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date progressively 4 days after receiving vaccine the patient had headache and had body ache. On 21-MAR-2021, the patient had flu-like symptoms and felt tired/lethargic. On 24-MAR-2021, the patient had lower extremeties hurting and swelling. On 26-MAR-2021, the patient felt charlie horse in legs in middle of night. On 01-APR-2021, the patient had shortness of breath and he could not catch her breath. At that point patient went to emergency room. In emergency room the patient underwent CT scan and revealed with small clots in lower lobe of both lungs. The patient was treated with 40 mg Eliquis for treatment. The emergency room doctor advised consumer to saw pulmonary specialist and follow up with him primarily. On 15-APR-2021, the patient had pulmonary embolism in both lungs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from had flu-like symtpoms, and had not recovered from pulmonary embolism in both lungs, lower extremeties hurting and swelling, shortness of breath, tired/lethargic, charlie horse in legs in middle of night, headache, and body ache. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This is a 49 year old female patient, African American, who experienced pain on lower extremities and was noted to have small clots in the lower lobes 5 days and 13 days, respectively, after receiving the the COVID-19 vaccine ad26.cov2.s. Patient's height and weight were not reported. Patient is a non smoker and non alcoholic beverage drinker. Past medical history not reported and patient denied taking medications, except vitamins. Four (4) days after receiving the vaccine, patient experienced flu like symptoms. lethargy, headache and body ache which were noted to resolve. Five (5) days after receiving the vaccine, patient developed pain on the lower extremities and patient noted to fell charley horse (muscle spasm and pain). Thirteen (13) days after receiving the vaccine, patient experienced shortness of breath, which prompted consult at the emergency room. CT Scan done revealed small clots in the lower lobe of both lungs. Patient was noted to have pulmonary embolism. The temporal relationship may be consistent but there is insufficient evidence for the vaccine to cause the events; hence this is assessed as indeterminate per causality classification of adverse events following immunization. Additional information requested.

HEADACHE/PAIN IN HEAD; HEAD FELT FLUIDY,FLOATING,FOGGY,/FREAKING OUT; FLUCTUATING LUCIDITY/FELT LUCID; PAIN IN NECK; WOKE UP AND STUMBLED; RED BLOOD (AND CLOT) WHEN BLEW NOSE; RED BLOOD (AND CLOT) WHEN BLEW NOSE; DREAMING DIZZY/DIZZY; FEELS JITTERY/NOT FEELING WELL; This spontaneous report received from a 49 year old female patient reporting on self. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982,expiry: UNKNOWN) dose was not reported,1 total administered on 12-APR-2021 09:00 in right arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, in the evening she had headache. On 12-APR-2021 the patient was dizzy and not feeling well at night she woke up in sleep feeling dizzy as she was dreaming dizzy, got up from bed and stumbled. She told her husband not feeling well but he tried to brush it aside. up from bed and stumbled. She took Advil. The doctor on-call told her to calm down and to take 2 Advil and went to sleep and if it did not went away to ER. The consumer did so. On 13-APR-2021, (Tuesday morning) the consumer blew her nose and noticed red blood and clots (coming from further up higher than sinuses). She was concerned and talked to people (friends). On 14-APR-2021, around 3:00 Wednesday morning she was freaking out she called her doctor and was not available she was referred to another physician. The patient was lucid, head felt fluidy, floating and dizzy. She had pain in the head and the neck. On 15-APR-2021, Thursday morning the physician called her back and said to stop taking Advil and went to ER. Her head was heavy and fog, everything was slow and lucid. In the hospital as soon as they gave her saline IV fluid, the fog was half lifted. Laboratory data (dates unspecified) included they also did MRI and blood work which were normal. They discharged her the same day and suggested she could take Tylenol which she did Thursday night. On 16-APR-2021, Friday she felt jittery but good and will buy some Gatorade for hydration and patient also stated that both dizzy and heavy head was reduced to faint (coming down from 10 to 3.5 on a scale). The consumer suggested that the dose of the vaccine may be too much for certain individuals and suggested to reduce the dose to like half the dose or to give it in 2 shots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from red blood (and clot) when blew nose, and stumbling on 15-APR-2021, was recovering from dizziness, fluctuating lucidity, head felt fluidy, floating, foggy,/freaking out, pain in neck, and feels jittery/not feeling well, and the outcome of headache/pain in head was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210436432- covid-19 vaccine ad26.cov2.s-head felt fluidy, floating, foggy,/freaking out, red blood (and clot) when blew nose. 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).

Shortly after getting the shot she reported feeling "off" as she was driving she started feeling short of breath and her heart was racing. When she got home around 5 PM she was still feeling short of breath and reported that her heart was racing. She was unable to speak clearly, but was stating that it was due to be being short of breath. She also reported feeling lethargic and fell asleep until the next morning. She slept until approximately 12 pm the next day. When she woke up she reported feeling right sided cheek tingling. At that time she thought she had just slept wrong. When she attempted to walk down stairs she was limping and reported just feeling very weak on her left side. On Wednesday she slept in late again complaining of lethargy. When she awoke that Wednesday (3/10) her speech was markedly slurred. She was also saying things that didn't make sense. She was dragging her left leg when she tried to walk. We immediately took her to the ER and she was worked up for stroke. When she was triaged in the ER we mentioned that she had just had her COVID vaccine and voiced concerned that maybe she had a reaction to her COVID vaccine. She was admitted to hospital on 3/10 for a possible stroke. Her MRI was done later on 3/11, Her MRI showed that she has strokes on both sides of her brain in the frontal, parietal and occipital lobes. The doctor referred to her stroke as being caused by a "showering of clots". The doctor said this usually only happens to someone with cardiac issues. My mom has no cardiac history. Her doctor ordered an 2D Echo of her heart and no abnormalities were found (3/12). She is still disabled from her stroke. She was hospitalized from 3/10 - 3/16. She was the discharged to other care facility from 3/16-3/26. She is currently needing outpatient rehab in a day neuro program. She attends this at outpatient facility. She has to walk with a cane due to persistent left leg weakness. Her speech has a slight slur, and she suffers from short term memory loss. She intermittently has trouble with her equilibrium and reports feeling dizzy. She sometimes has a hard time swallowing or says that it doesn't feel right when she swallows. She also trouble with word retrieval. She has left-sided neglect which correlates left eye visual deficits. She currently requires care from a general physician, neurologist, physical therapist, occupational therapist, speech therapist, neuro ophthalmologist and neuo psychologist. She was started on a new medication regime 325 mg aspirin daily, plavix for 21 days (now completed), metformin, amlodipine, coreg and losartan. She is going to need outpatient rehab until at least June from the last update we received from her rehab doctor.

DEATH; This spontaneous report received from a company representative concerned a 49 year old female. 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 ad26.cov2. s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, frequency 1 total, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-APR-2021, the patient died from unknown cause of death after 4 weeks of Johnson and Johnson vaccination. An autopsy was performed on an unspecified date and there was no sign of high blood pressure, heart disease, or diabetes to patient as per report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0. 20210505962-covid-19 vaccine ad26.cov2.s -Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH; Autopsy-determined Cause(s) of Death: UNKNOWN CAUSE OF DEATH

(4/23/21) Symptoms included intermittent (R) lower leg pain. After 3days, started myself on Aspirin which seemed to improve Sx somewhat. Stopped the Aspirin. Then learned of the link of J&J Vaccines to blood clots. Called my primary physician (5/6/21) who suggested testing to r/o DVT. (5/7) Venous ultrasound confirmed a DVT/ blood clot in (R) lower leg. Was then sent directly to ER for further exam and initiation of anti-coagulation therapy. Started on Eliquis starter pack: Initially 10mg BID, then 5mg BID.

Multiple pulmonary emboli on CT angio 49 yo F with a PMH IDA with menorrhagia, OSA on CPAP, HTN, and hypothyroidism who presents to ED on 5/10/21 with chest pain. She states her chest pain began during an iron infusion 2 days ago on Friday 5/8. The infusion was briefly stopped and she was given steroids and the pain went away. The next day, however, the same pain recurred and remained until she came to the ED. She describes it as a "pinching" chest pain, constant x 1 day, worse upon inspiration and exertion, and radiating down her left arm and lower back, 10/10 in severity at its peak. She denies chest pressure. Nothing improved the pain in particular but she acknowledges it at rest. Her pain is much improved after being in the ED but is still present. She does not recall having the pain before. She denies cough, wheezing, palpitations, fevers, chills, nausea, vomiting, abdominal pain, diarrhea, constipation, or dysuria. She has never had COVID-19 before but had the Johnson & Johnson vaccine (1 dose) about a month ago. Pt admitted to the hospital, placed on heparin drip and transitioned to Xarelto on discharge.

J&J Dose 4/10/21 (1808980) COVID Positive 4/27/21 4/29/21: Presented to ED and admitted. 4/30/21: Pt. is a 49-year-old female with history of persistent asthma who was diagnosed with COVID-19- 5 days ago. The patient tested positive for COVID-19 infection on 04/25/2021. Since then she had dry cough, on and off wheezing, worsening shortness of breath. Since yesterday she became extremely short of breath for which she decided to come to the emergency room. Earlier yesterday she was evaluated by an ED physician and she was advised to be admitted because of hypoxemia and pulse oximetry of 87%. Patient declined admission and went home. She came back with worsening shortness of breath. On exam patient was comfortably breathing on 2 L with oxygen saturation 95% ; chest examination was significant for bilateral extensive rhonchi with good air entry and no wheezing. Blood work shows sodium 133, potassium 2.4, BUN 5, creatinine 0.5, albumin 3.4, D-dimer was elevated at and follow-up with CT of the chest with contrast was done. It showed bilateral extensive multilobar pneumonia . There was no pulmonary thromboembolic disease. 5/4/21: Patient is a 49-year-old female who was diagnosed COVID positive on 4/25/2021. She presented to the emergency department on 4/30/2021 with worsening shortness of breath and was noted to be hypoxic. She was admitted to the medical floor with acute hypoxic respiratory failure, secondary to bilateral COVID-19 pneumonia. She received 1 unit of convalescent plasma. She was started on Rocephin, Zithromax, dexamethasone, and Remdesivir therapies. She had a persistent dry cough for which codeine/guaifenesin was effective. Her potassium was also noted to be low, and it was supplemented. She was started on oral therapy and this has maintained it. She is no longer requiring supplemental oxygen. She reports she is feeling much better. She has completed her Remdesivir therapy today and is requesting to go home.

Patient, 5/8 for anemia/iron deficiency readmit 5/9 for stroke symptoms and transferred to Hospital after receiving tPA. The patient received a J&J COVID vaccine 5/5. Patient found to have a right MCA stroke and went to IR for thrombectomy with partial recanalization. Patient with hemorrhagic conversion 5/11 leading to right hemicranectomy for mass effect. Patient with risk factors for stroke of HTN and obesity. Cannot confirm or rule out relationship to COVID J&J vaccine. This was not a case of the stroke type that has been associated rarely with the J&J vaccine (cerebral venous sinus thrombosis) but shall report to the FDA VAERS program.

It was really bizarre, I remember feeling like all my senses were heightened , I got my period, it didn't stop for 3 weeks. Called my OBGYN, they said let it run it's coarse and they had they had many similar phone calls. I take a Nuva ring for birth control, I was concerned about estrogen and the blood clots. I did not feel well at all for about a week after my vaccine, everyday around 4pm I would get really bad headaches for about 3-4 weeks. I was nauseated and sweating.

Patient does not report pain. I am her sister and Legal Guardian and I believe she had symptoms prior to 5/24/21. On 5/24/21, she did not report feeling sick or having a headache and threw up around 11 am. Throwing up was the only way I knew to ask her how she was feeling. She said, I think I threw up because my head hurt. I asked her where it hurt and she said, in the back. I took her to the ED and she had a brain bleed and 5 blood clots in the major veins and sinuses of the left hemisphere of her brain. Her medical team said this is a very rare part of the brain to have blood clots. I would like further investigation into whether this was related to the vaccine.

Injection site swelling under arm for 2 weeks, 3 weeks after injection had an A-Fib event, now on blood thinners and heart meds, no issues BEFORE vaccination

4 hours started to feel weak, tired, heart felt heavy, had a hard time catching my breath and progressively was getting worse. Stayed in bed, the first day and all day the second day, by the third day finally got up and went to work, still tired, weak etc. but thought it would go away, it was just a side effect from the injection which I was told would happen. At work walked about 200 yards and literally couldn't breathe, heart beating very fast and at that point knew something was terribly wrong and went to the doctors.

Stroke?? Full Week in the hospital in two weeks at In patient Rehabilitation Hospital. Outpatient hospital now definitely!

Janssen COVID-19 Vaccine EUA I blacked out while getting ready for work. I was feeling a little light headed and thirsty. Next thing I know, I was on the floor. When I came to, I was disoriented and very sweaty. The fall caused a cut to my head, bleeding and a bruised elbow. Within an hour, I was feeling less dizzy.

She received the Johnson and Johnson vaccine on Wednesday and died on Sunday 3/14/2021. Her autopsy is pending.

Patient appeared in no distress the day after vaccination other than complaint of nausea. It is unclear but patient expired sometime the night of 4/3/21 or early morning of 4/4/21

She had the vaccine and within 1 minute she had tingling in her tongue and numbness that went away immediately. She did not have any other symptoms until 8 days later when she had 104 fever, could not walk, had stiffness in all of her muscles and aching, diarrhea. They went to the doctor office and he did a COVID test that came back negative. The fever still continued and her husband took her to the hospital on Tuesday 3/16/21. They ran fluids on her and at the end of the day they said she was okay to go home. The next day the fever started again and he ended up calling an ambulance to take her to the hospital. She went to Hospital on 3/16, who took her to another Hospital. They sent her home about 4 days later and said that her symptoms were from the vaccine. He called and he filed a report with them. They sent her home the next day, got another high fever, and her husband took her to the ER at again that evening. She had high fever, extremes aches and pains and headaches. They kept her a couple of days and then released her again. She was home for a couple of days and they were managing her fever as it would spike at night. She also had 8 other medications to take. She then woke up yesterday 4/4/21 with severe back pain, cannot walk real well, and her husband called the ambulance again. Now she has swelling in her heart, swelling around her heat and not breathing very well, and 104 fever and getting progressively worse They said that she now has pericarditis and pericardial effusion and are going to release the fluid today. She is still in the hospital.

Develop a blood clot lost vision in left eye due to stroke. I?m still in the hospital. I am 50 and had a stroke a week at getting that vaccine TPA shot. Given. Clot buster

10 days after the vaccine I developed dizziness, tachycardia, dry mouth,chest pressure, shortness of breath and felt like I was going to pass out, and I had a feeling of extreme doom. I was transported to a clinic. There I had a heart rate of 140 with irregular beats. Continued feeling of doom. An EKG showed ST depression. Symptoms improved with nitroglycerin. The clinic didn't have the technology to provide care so I was emergently transported again. At that hospital my D-dimer was positive and that lead to a CT Angiogram. This showed a pulmonary embolism. Doppler studies of both legs were negative. I was placed on Heparin for several hours and then switched to Eliquis. About 6 hours after being on Eliquis I had the exact same original symptoms and again nitro was given which helped the symptoms. I was placed back on Heparin for a longer period of time. Once I was anticoagulated I was then switch to Eliquis 10mg BID for 7 days then 5mg BID for 6-9 months. I had a CT Angiogram of the head and neck which was normal. At this time I still have dizziness with standing and intermittently with sitting, extreme fatigue, shortness of breath.

I had rear end pain started March 20 in the morning, it gets worse and worse till 3/23 that I can not tolerate and had to call clinic to make appointment. They got me in on March 25 (Thursday). Dr inspected and told me it's thrombus that caused huge pain. They did the surgery right away, removed thrombus. I never had blood clots problem and I was healthy, which my blood test result can prove. Thrombus generated 12 days after my J&J vaccine shot, I am reporting this side effect. You may find all my medical record from Doctor's office.

Severe headache 2 days in duration with associated nausea and vomiting, admitted with hypertensive urgency, Cerebral Venous Sinus Thrombosis diagnosed via MRV and CTA

Patients mom states 12 hours after vaccination dev: fever, chills, stiff neck. Symptoms got progressively worse throughout the day. on the evening of 4/8/21 patients mom describes patient talking "out of her head", fever, chills, leg pain, "bad" headache. On 4/9/21 patient woke up around 5:30 AM, sister helped to bathroom. reported leg pain, neck pain, headache. Laid back down. Sister found patient unresponsive around 9:00 AM. Sister performed CPR. Pronounced dead at patient's home by EMS.

On 4/13/2021 at 11:00 AM pt. began experiencing left leg pain with swelling noted around left knee and extended above knee. By 11:00 PM pt. felt faint and nauseated and left leg was swollen and discolored. Rescue squad was called and took pt. to Hosp where she was told it was sciaticia. After showing the medical professionals her leg and insisting upon an ultrasound of her leg she was told the "machine" was not available and she would be called the next day to be scheduled. Per pt's daughter, she was never called and daughter called hospital to have U/S scheduled. Pt. went back to hospital on 4/14 at 3:15 PM for U/S and she was diagnosed with multi DVT's in left leg which at that time had swelling all the way down to her foot. Pt. was put on Coumadin.

On 4/15/2021 patient presented with chest pain and left lower extremity pain, which started about 2 days prior to admission. CTA showed large volume multifocal bilateral pulmonary emboli throughout numerous right lower lobe, right middle lobe, right upper lobe, left upper lobe, and left lower lobe segmental branches. Left lower extremity venous ultrasound showed no evidence of deep or superficial vein thrombosis; the right lower extremity was not scanned. Patient denies personal or family history of VTE. She states that she does not smoke and has no history of smoking. Patient was treated with apixaban 10 mg po BID x7 d followed by 5 mg po BID. Platelets were 295 on admission.

04/14/21 8:00 PM; Pain on right side of head with blood inside of right eye. Drove to emergency room. Had pressure and pain 4 more times while waiting in emergency room. Evaluated in Emergency room. Admitted to hospital 04/15/21. Had testing CAT scans and MRI determined minor stroke or Ischemic stoke. Numbness on Right side involving right cheek, weakness in RH leg and arm, speech is a little slow; during hospital stay and continued after into April 17th. Released from hospital at 6PM on April 16. As of April 17 at 10:30 AM Still having issues, difficulty thinking, headache, numbness and slight pain in head and arm. Right leg is weak. Will call doctor on Monday April 19 to set up appointment.

She started to have heavy vaginal bleeding. On 04/14/2021 she started to have back pain that radiated to the left leg and anterior abdomen.

TINGLING IN LEGS; CHILLS; FEVER; HEADACHE; LOWER LEG PAIN; This spontaneous report received from a patient concerned a 50 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 12-APR-2021 09:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced lower leg pain. Laboratory data included: Fever (NR: not provided) 101. Treatment medications included: ibuprofen. On 12-APR-2021 15:30, the subject experienced chills. On 12-APR-2021 15:30, the subject experienced fever. On 12-APR-2021 15:30, the subject experienced headache. On 13-APR-2021, Laboratory data included: DVT (NR: not provided) 1.46 H. On 14-APR-2021, the subject experienced tingling in legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 13-APR-2021, was recovering from lower leg pain, and had not recovered from headache, and tingling in legs. This report was non-serious.

Experienced blood clots in my nose every night for about 10 nights after receiving vaccine injection. Didn't think anything of it until I mentioned it to my mom who received her vaccine at the same time & place from the SAME BOTTLE and she too was waking with bloody clots in her nose. I experienced a reoccurrence for 4 days in mid April. I wouldn't have said anything but friends nagged us after the J&J blood clotting issue. (We both also experienced severe piercing & throbbing pain in the bone beneath the injection for about 14 days.) I mentioned both events to my GP on 3/26/21

I had 2 adverse reactions to the Janssen Covid-19 Vaccine EUA: AE #1) Roughly 15 minutes after receiving the vaccination, the lower half of my face went numb for approximately 3 hours. The people who administered the vaccine made me stay at the site for about an hour and a half to make sure that the reaction did not get worse. AE #2) 10 days after receiving the vaccination, the lower part of my left leg began to swell significantly. I went to the emergency room on 4/13/2021. When I was there, they did tests and confirmed that I have a blood clot behind my knee. To treat the blood clot, the emergency room doctor gave me lovenox 110mg and warfarin 5mg. Since then, I have followed up with my primary doctor who has me taking warfarin 10mg ( 1x daily) and lovenox (as needed).

Patient presented post-seizure. Reported 1 week of headache prior to presentation. Found to have cerebral venous sinus thrombosis, small areas of hemorrhage in the right frontal lobe, and bilateral pulmonary emboli, as well as thrombocytopenia (previously had normal platelet count). Per MD "Clinical picture is entirely consistent with VITT. See no other obvious explanation for this constellation of clinical findings. "

Patient received J&J vaccine at 4/6/21. She began complaining of calf pain 1 week later. She was diagnosed with DVT and started on Eliquis 10 mg PO BID x 7 days on 4/15/21, followed by 5 mg PO BID on 4/22/21. She continued to complain of shortness of breath. CT chest was done to rule out PE. She was diagnosed with PE and sent to the emergency room for a continuous heparin drip (despite adequate anticoagulation with Eliquis) She is saturating at 97% on room air. Her BP is stable. She is afebrile Of note, she is morbidly obese Her height is 64 in (5' 4") Her weight is 106 kg (233 lbs) Her BMI is 39.99 kg/m2 She is not on any hormone replacement therapy, contraceptives, etc. Her last known use of oral contraceptives was 10 years ago. She is not an active smoker

BLOOD CLOT; LEG CRAMPS; ACHE; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included overweight, high blood pressure, and high cholesterol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: unknown) dose was not reported, 1 total administered on 06-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the patient experienced a mild fever. On 08-APR-2021, the patient was achy and had a mild headache. The headache continued for several day and became pretty bad for about two days. On an unspecified date in Apr-2021 the patient was treated with Tylenol for headache. On 12-APR-2021, the patient experienced leg cramps in her right leg. On 15-APR-2021, the patient had an ultrasound and a blood clot was found in her right leg. The patient started on Apixaban (Eliquis). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on an unknown date in APR-2021, and the outcome of blood clot, ache, leg cramps and fever was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This 50-year-old female was found to have blood clot in her right leg 9 days after receiving Janssen COVID-19 vaccine for the prevention of symptomatic SARS-CoV-2 virus infection. There was reported mild fever, headache, and "aches" 1 to 2 days after vaccination that was treated with Tylenol. The symptom reported was leg cramps on right leg 5 days after vaccination, and ultrasound showed blood clot in her right leg 3 days after the symptom of cramps was noted. No other laboratory/diagnostic test reported. The patient was treated with apixaban. The outcome of blood clot in leg was not reported. Based on the information that is available, the event is assessed as plausible with the causal association to immunization, per 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 is requested

ITP diagnosed 9 days following vaccination; platelet count 5000. Testing for VIPIT was negative: brain/head imaging negative for thrombosis, d-dimer and PT/PTT/INR within normal limits, heparin antibody ELISA negative. She was treated with IVIG and corticosteroids with a partial response (platelet count up to 43000), then placed on Promacta.

This patient received the Janssen COVID-19 Vaccine on 4/10/2021. She was subsequently admitted for ischemic stroke of unknown etiology on 4/16/2021. She was found in the bathroom down on the floor, confused, with right-sided weakness, and aphasia. Patient was treated with TPA.

Hospital called at 4:00 PM on 4/29 to let us know that the patient was being admitted due to several small PEs.

a few days after the shot i was having a hard time breathing, made appointment with Pulmanologist he ordered a ct scan but no ultra sound. ct scan showed no clots in the lungs at that time. Woke up a day or two later with severe back and leg pain was transported to the emergency room. I was then transported to facillity because i could not move my left leg and was in severe pain. During my stay i coughed up a blood and requested the doctor to do blood work. The blood work showed high levels of clots. I was not taken to the hospital or treatment for the clots at that time. When i left the facility i saw my Doctor she ordered immediatly another ct scan of the chest and an ultra sound

TACHYCARDIA; DRY MOUTH; DIZZINESS WITH STANDING AND INTERMITTENTLY WITH SITTING; PULMONARY EMBOLISM; FEELING OF DOOM/ FEELING OF PASSED OUT; FATIGUE; This spontaneous report received from a patient via a company representative via the VAERS (Vaccine Adverse Event Reporting System) concerned a 50 year old female unknown ethnicity . The patient's height, and weight were not reported. The patient's concurrent conditions included osteoarthritis, gluten intolarance, and diflucan allergy. The patient was previously treated with fluconazole. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029, expiry: UNKNOWN) with unspecified dose on left arm, on 27-MAR-2021 11:00 for prophylactic vaccination. Concomitant medications included amino acids NOS, biotin, cannabidiol, collagen, ethinylestradiol/norethisterone acetate, and hyaluronic acid. On 07-APR-2021, the patient experienced dizziness with standing and intermittently with sitting, tachycardia, dry mouth, chest pressure, shortness of breath, and feeling of extreme doom. On an unspecified date, the patient was transported to the clinic. In the clinic the patient had heart rate of about 140 with irregular beats. The patient had undergone Electrocardiography test which showed ST Depression. The patient's symptoms were improved by taking nitroglycerin. As the clinic did not have the technology to provide care so the patient was emergently transported to the hospital. In the hospital the patient's D-dimer level was positive. Later the patient undergone Computerized Angiogram for lungs which showed pulmonary embolism. The patient undergone Dopplers studies of both legs which showed as negative. The patient had received Heparin treatment for several hours and then later switched to Eliquis. After 6 hours being on Eliquis treatment the patient had same original symptoms and for that again nitroglycerin was administered. The patient was placed back on heparin for a longer period of time. Later on the patient got switched to Eliquis 10 mg twice daily for 7 days and further to 5 mg twice daily for 6 to 9 months. The patient had undergone Angiogram of head and neck which was normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tachycardia, feeling of doom/ feeling of passed out and dry mouth on APR-2021, had not recovered from fatigue, dizziness with standing and intermittently with sitting and pulmonary embolism. This report was serious (Hospitalization Caused / Prolonged, Other Medically Important Condition, and Life Threatening). Sender's Comments: V0 -covid-19 vaccine ad26.cov2.s-Pulmonary embolism , Feeling doom, Tachycardia, Dry mouth, Dizziness with standing, Fatigue 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).

Right Lung Pulmonary Embolism - Shortness of Breath - Chest Pain. Currently on Oxygen and Anti-Coagulation Therapy (Lovenox Injections and Pradaxa Oral)

Presented 5/13 to Hospital. Presented to Hospital on 5/13 with one week of symptoms including cough, dyspnea, diarrhea. COVID-19 testing was positive on 5/8. Treatments prior to arrival included remdesivir and dexamethasone, started 5/13. She was also placed on pulse dose steroids 1000 mg/day methylprednisolone given her history of ground glass lung opacities in 2018. Progressed to high-flow nasal cannula, then BiPAP on 5/14, and was intubated on 5/17. Paralysis and proning initiated. Transferred to another hospital for possible VV ecmo candidacy. Patient with severe acute respiratory failure d/t covid who has failed treatment with the ventilator despite paralysis and proning. CTS asked to place patient on VV ECMO. 5/20/21 1135am initiated ECMO Patient is a 50yr old female with past medical history of hypertension, asthma, OSA and obesity BMI 41.5 who presented to hospital on 5/13 with progressive cough and shortness of breath for about a week. Of note, patient also has a history of respiratory failure presenting with ground glass opacities on CT scan in 2018 with unclear etiology despite bronchoscopy and serologic studies which resolved with high dose corticosteroids. Patient recently tested positive for COVID on 5/8 and received johnson and johnson vaccine in April. Patient was admitted on 5/13 and treated with decadron, remdesivir and tocilizumab. Course complicated by progressive respiratory failure requiring HFNC followed by Bipap and ultimately intubation on 5/17. Due to elevated d-dimer, lower extremity dopplers were obtained which were negative, however a heparin gtt was initiated. Course further complicated by cold left lower extremity; arterial duplex demonstrated distal popliteal artery thormbus extending into the peroneal, anterior tibial and dorsalis pedis arteries. therefore heparin was switched to argatroban and a HIT panel was sent. On 5/19 patient continued to decline despite paralytic and pronning. Patient transferred to ICU for further level of care and VV ECMO evaluation. On arrival patient was started on veletri; however due to continued respiratory decline a shock call was placed for VV ECMO and patient cannulated for VV @ 1200. Cannulation was difficult and patient was felt to have an IVC thrombus as clot was seen going into the ECMO circuit during cannulation. Post cannulation she developed worsening septic shock and DIC. She received 2uprbc, 1unit cryo, 1 platelet, 2 FFP, 5 liters crystalloid and 1L albumin. Blood cultures positive for GPC in clusters. Escalating vasopressors (Epi/NE/vaso) and ongoing hypoxia family opted to change code status to DNR. Patient then continue to have worsening hemodynamic instability and went into PEA and ultimately asystole. She was pronounced deceased at 1815. Family was en route already due to her instability thus will be notified of her passing once they arrive. Dr. was notified of patients death.

About 1 week after vaccination. I had pain in my legs and swelling in my feet, it made it difficult to walk. It was like I was carrying around a dead leg. I did have blood clots in leg. I ended up up being hospitalized 3 days to receive blood transfusions due to anemia after taking blood thinners.

Pulmoary Embolism - Chest Pain, Shortness of Breath Hospitalization of 3 days Treatment of blood thinners

SMALL STROKE; PAIN IN RIGHT LEG/BLOOD CLOT IN RIGHT LEG/DVT; ARTHRITIS PAIN IN JOINTS; FEVER; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's concurrent condition included low blood pressure. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: 05-AUG-2021) dose was not reported, 1 total, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, on first night, the patient developed fever of 100 F. On 08-APR-2021, by morning fever was gone. On the same day, she developed arthritis pain in her joints, it stayed for few days then it went away. In MAY-2021, she experienced pain in right leg, the pain elevated, and she wasn't sure what it was. On 08-MAY-2021, she had small stroke, blood clot in right leg and deep vein thrombosis (DVT) and she was taken to the emergency room (ER) and admitted to the hospital for 1 night. She received treatment with blood thinner Eliquis (apixaban) for DVT. She has blood pressure (BP), her ER doctor was concerned about her BP and her doctor advised her to monitor her BP. She also informed that she uses wheelchair all the time. Also, if her leg remained down for more than 20 minutes it turns, and she tried to elevate it most of the time. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arthritis pain in joints on APR-2021, and fever on 08-APR-2021, and had not recovered from pain in right leg/blood clot in right leg/DVT, and small stroke. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This spontaneous report received from a patient concerned a 50 year old White (not Hispanic or Latino) female who experienced right leg pain and small stroke and was noted to have deep vein thrombosis 31 days after receiving the Janssen Covid-19 vaccine. The patient's height and weight were not reported, but patient claims that she was a little overweight. Patient claimed to be in good shape and used to have 'low blood pressure'. Patient has no family history of clotting disorders but she claimed to have history of bleeding/clotting problems even before receiving the vaccine. Information regarding allergy, smoking history, illicit drug use and alcohol abuse were not provided. No concomitant medications reported and patient did not take oral contraceptive pills (OCP's). Patient had a fever the night day the patient received the vaccine. Fever was gone the following day but patient experienced arthritic pain in her joints (unspecified) but resolved after a few days. Later, patient developed pain on right leg that was progressing. Thirty-one (31) days post vaccine, patient sought consult at the emergency room (ER). She was noted to have blood clot in the right leg and was diagnosed with deep vein thrombosis (DVT) on the right leg. She was also diagnosed with stroke. She was admitted to the hospital for 1 night and treatment with apixaban (Eliquis) was started. As of this report, patient still used wheelchair. She still kept her leg elevated most of the time since it turned purple if left dangling for 20 minutes. The information available precludes a complete and meaningful assessment. The occurrence of DVT and stroke could represent background incidence of such events in the general population. Hence, a relationship with Janssen Covid-19 vaccine cannot be ruled out and thus the relationship is considered indeterminate. Additional information has been requested.

7/21/2021 presented to ED for SOB and cough. Patient stated that she developed cough, congestion and body aches 7/14/2021. Patient son tested positive for COVID and she subsequently went to Urgent care to be tested positive for COVID 7/18/2021. Patient stated that she received the Johnson and Johnson vaccine in April 2021. diagnosed with COVID-19 pneumonia and viral sepsis, acute hypoxic resp failure. Remdesivir through 7/26. 7/26: patient still admitted as of the time of this report submission.

Following the vaccine injection which was provided by the personnel, I have developed minor fainting spells and angina for the past 10 plus days. A large dried blood clot was noted on the first day of my period which occurred on March 16th. I continue to pass large blood clots while I was having my period. I also want to point out that a personnel who gave me an injection was incorrectly injected the vaccine outside of the area of the preferred injection zone. I have reported this event to the supervisor who was on site. I have not yet contacted my health care provider at this time but plan to contact her tomorrow as these symptoms have been persisting.

She developed a large pulmonary embolus, and she died on 3/17 at Hospital. She developed symptoms of SOB on 3/11, and was admitted to the hospital. She was initially stable and not requiring oxygen and was sent home on anticoagulation. However she returned the same day with worsening symptoms, troponin now elevated, and ECHO showing signs of right heart strain. Embolus on imaging had increased in just over days from previous CT scan. She became pulseless and died despite resuscitative efforts. It is my opinion (Dr.) that she died of a pulmonary embolus, and an autopsy is pending.

I developed pneumonia 9 days after the vaccine. It came on very sudden. I?ve been sick for nearly two weeks and even with several prescriptions I don?t feel that I?m am getting any better.

I first had symptoms of nausea, chills, fatigue and wooziness for 7 days after the vaccine, then developed pneumonia a week after taking this vaccine. I had chest pain and pressure and ended up in the urgent care. After 3 weeks and zpak I am feeling better but not back to normal.

Headache, cough, fatigue start on 3/25/21 Fatigue, short of breath, dizziness, more coughing 4/1/21 trata show pneumonia.

Bruising. Petechiae - had blood test 3/25/21 - sent to ER low platelets; Also had high BP. Given platelets, admitted 3/26/21, given steroids and BP meds. D/c'd 3/28/21. Dx: ITP. Given 4 day dose of Dexamethasone. Platelets increased. 1 week later platelets dropped. By 4/15/19, they dropped some more and seem to have leveled out (4/19/21), but still testing weekly. ANA blood work positive, but no other symptoms to fit most common autoimmune diseases. Saw rheumatologist today for more blood work.

Patient reports right hand severe swelling starting one week after Johnson and Johnson covid vaccine with pain in the hand. She went to ER and US showed a DVT in forearm. Patient was placed on aspirin and states the swelling has improved some but still has some swelling and pain.

03/19/21 woke up with numbness on whole right side of body (head to toe). Referred to ER by Family Physician on 03/20/21. admitted to hospital for testing. MRI confirmed a blood clot caused a Lacuna Infarcts Event (type of mini stroke) The patient continues to have numbness and difficulty walking, driving and has affected her normal daily activities. The patient will be required to start Plavix and baby aspirin. Waiting for requirement for Prolong numbness which affects her daily activity.

51 female with h/o HTN (improved, off meds) presented to ED from her PMD office for further work up due to right leg weakness since yesterday and was dx with a stroke. Patient has received JJ vaccine 4/10/21. Patient denies f/c, n/v/d, CP, SOB, abdominal pain. Patient reports mild posterior right hip tenderness. She denies numbness.

Patient has had chronic intermittent pain on her left lower leg for the past 5 years. However, she has noticed more pain on the left lower leg since having the COVID-19 Janssen vaccine on 3/19/2021. She is a chronic smoker. Thus, a left lower extremity arterial doppler was done on 5/20/2021 which incidentally revealed a DVT in the gastronemius vein of the left lower extremity. A subsequent bilateral US venous doppler of both lower extremities was done which revealed no DVT. Therefore, a repeat venous doppler of the left lower extremity was ordered for today, 5/21/2021, and remains pending at this time. Of note, patient was started on eliquis on 5/20/2021 (10 mg BID for the first 7 days with subsequent decrease to 5 mg BID thereafter). She will be referred to a hematologist for continued management.

Unresponsive and unable to speak at home. Hypoxic, CT showed large bilateral pulmonary embolism with heart strain, as well as bilateral femoral DVT.

Both sides of my neck were very swollen. There was extreme pain on my right arm. The pain was severe and numbness in my finger. I went to the ER and they said I have radial thrombus, a clot in the radial artery. Before the shot, my heart was checked multiple times and I was fine. After the shot, my coronary arteries are now very small. There are now luminal changes inside my coronary arteries which are still now very small. I now have been diagnosed with CAD. I had a heart cath on March 29. My arm is still in a lot of pain. My neck is still swollen.

Patient had noticed some mild bruising 1 month ago and had recently received Janssen vaccine on 5/21/2021. She developed severe bruising to the site of injection on left arm. Later she developed more bruising on abdomen, wrist and arms. She presented to the hospital with right flank pain with kidney stone and found to be severely thrombocytopenic of which likely was ITP. Received IVIG and steriods with improvement in her platelet response. Thankfully no bleeding. Patient has been in hospital for 4 days and still hospitalized at the time of this report.

On May 15th, she got the J&J vaccine. Then on May 17th, while she was walking, she tripped on a curb and fell and then landed on her left knee. Then, this past Thursday on May 20th, she noticed swelling and pain in the left leg. She presented to urgent care the following day on Friday and had an ultrasound done that revealed blood clot in the superficial veins. Patient recalls of had a similar episode of superficial vein clot about 6 years ago. Referred to vascular and second ultrasound done revealing DVT

ABDOMINAL PAIN; LEG PAIN; HEADACHE; BLOOD CLOT IN THE RIGHT FEMORAL VEIN IN THE RIGHT THIGH; This spontaneous report received from a consumer concerned a 51 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 03-APR-2021 to right deltoid for prophylactic vaccination. Concomitant medications included valsartan 40mg. On 20-JUN-2021, the patient experienced blood clot in the right femoral vein in the right thigh which was found through computerised tomogram which was done when the patient had visited the doctor about the other symptoms of abdominal pain, leg pain and headaches. The health care professional had intended to visit another health care professional specialized in blood clot related issues. Laboratory data included: Computerised tomogram scan (NR: not provided) Blood clots observed in right femoral vein in the right thigh. On an unspecified date, the patient experienced abdominal pain, leg pain, and headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot in the right femoral vein in the right thigh, leg pain, headache and abdominal pain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210654370-COVID-19 VACCINE AD26.COV2.S-blood clot in the right femoral vein in the right thigh. 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).

J&J Covid one shot has made me so incredibly ill. First my husband was so ill immediately after the shot for one week and he is still sick. I haven't been sick in years and now I am dealing with pleurisy and pleural effusions in my lungs; pneumonia, and on many different medications and can't breathe.

PERIOD NOT AS HEAVY AS NORMAL; SPOTTING CONTINUED FOR 3 WEEKS; LOW BODY TEMPERATURE; DOES NOT FEEL NORMAL OR RIGHT; SWELLING IN LEGS AND FEET; DID NOT FEEL GREAT; FELT FEVERISH; HEAVY MENSTRUAL BLEEDING FOR 2.5 WEEKS; WATER RETENTION IN LEGS AND FEET DAILY; WEIRD BLOATING; PERIOD (BLOOD VOLUME) UP AND DOWN; 28 TO 30-DAY CYCLE ERRATIC, PERIOD WOULD START AND STOP AND MONTHLY CYCLES THROWN OFF; DID NOT HAVE A PERIOD AND PERIOD STOPPED; ANAPHYLAXIS REACTION; HEAD AND NECK NUMB; IV INFILTRATED; RED ARM; SWOLLEN ARM; FATIGUE; This spontaneous report received from a patient concerned a 51 year old white female of not hispanic or latino ethnicity. The patient's weight was 179 pounds, and height was 64 inches. The patient's past medical history included 28 to 30-day menstruation cycles with heavy bleeding for the first 4 days then tapers off, water retention, and swelling, and concurrent conditions included daily over the conter medication allergy, allergy related to asthma, flu shot has similar sore arm, bees allergy, dust mites allergy, cats allergy, dogs allergy, alcohol drinker (occasionally, special occasions, 2 per month), and non smoker, and other pre-existing medical conditions included patient had no menstruation changes since 13 years. patient was uses medications prn and patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 10-APR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the patient experienced anaphylaxis reaction. Before the needle got out of the patient's arm the patient experienced hives on wrist and arm on the same arm used for vaccination after that the patient's throat began to close. On the same day the patient head and neck numb. Patient further described that it was not numbness but rather the blocked of oxygen due to her throat swelling. Soon after patient was taken to the emergency room through ambulance and treated her with diphenhydramine hydrochloride, epinephrine, and prednisone. Patient experienced iv infiltrated while in the ambulance ride. Patient remained in the emergency room for the protocol specified number of hours for monitoring. Patient had electrocardiogram (NR: not provided) Normal. Patient got released from hospital the same day when stable and normalized. On10-APR-2021, the patient experienced common vaccine reaction of a red and swollen arm, the patient did not have a period and period stopped and patient experienced fatigue. On MAY-2021, the patient experienced 28 to 30-day cycle erratic and period would start and stop and monthly cycles thrown off. On JUN-2021, the patient experienced spotting, water retention in legs and feet daily, weird bloating and period (blood volume) up and down. On JUL-2021, the patient experienced heavy menstrual bleeding for 2.5 weeks. On an unspecified date, the patient experienced low body temperature. period not as heavy as normal, spotting continued for 3 weeks, more menstrual bleeding, extensive time frame for period, does not feel normal or right, swelling in legs and feet, did not feel great, and felt feverish. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) Low. Additional treatment medications (dates unspecified) included: hyetellose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from anaphylaxis reaction, and head and neck numb on 10-APR-2021, period not as heavy as normal, and weird bloating, and fatigue, and felt feverish on 21-JUN-2021, was recovering from did not have a period and period stopped, 28 to 30-day cycle erratic, period would start and stop and monthly cycles thrown off, water retention in legs and feet daily, and swelling in legs and feet, had not recovered from spotting continued for 3 weeks, and period (blood volume) up and down, and the outcome of iv infiltrated, red arm, did not feel great, low body temperature, heavy menstrual bleeding for 2.5 weeks, does not feel normal or right and swollen arm was not reported. This report was serious (Life Threatening). This case, from the same reporter is linked to 20210757746. .; Sender's Comments: V0: 20210745140- Covid-19 vaccine ad26.cov2.s-Anaphylaxis reaction. This event(s) is labeled per RSI and is therefore considered potentially related.

Covid shots administered at airport for employees. I received shot, and within a minute or two- my lips and tongue started to tingle, swell and go numb. My throat started to swell too. Had a hard time starting to breathe and took my xopenex inhaler. I had taken a benadryl beforehand, and ended up taking two more as EMT came over to help me there at the site. She kept an eye on me. My A Fib was speeding up and getting irregular too. After about half an hour, it stopped getting worse and seemed to level off. They offered to take me to ER, and had me promise to call 911 if it got bad again. Still felt bad the rest of the day. Felt a little better later the next day, and a little better (today is day 3), but still not 100%. I did contact my doctor to check in

I had a blood clot in my left lung. went to ER , spent three days in the hospital was given medications (Xarelto ) required to taking medication now for a least a year.

Patient developed a severe headache, nausea, and vomiting on 4/5 PM. She continued to have severe headache, improving to a 5 and then worsening to a 10 for several days. She had some chills develop the AM of 4/6, but no fevers, myalgias, rash, or other side effects. She went to ED on 4/9 and was transferred to our facility. Found to have subarachnoid hemorrhage. CT angio without evidence of clot. No clear etiology for bleed per neurosurgery

Patient had the vaccine on 3/5/21. She then had major abdominal surgery which included abdominal reconstruction, hernia repair and excess skin removal on 3/19/21. She was released from the hospital on 3/22/21. She was readmitted on 4/4/21 for blood clots.

on 3/24 I had a TIA with an intense heat pressure behind the right temple which resulted in complete numbness, heaviness, and tingling on my entire right side of the my body. I was transported by ambulance to the hospital. A CT and MRI was done, no signs of blood clots or stroke. I am still experiencing numbness and tingling in the right arm. Follow up appointments with the eye doctor indicate additional vision loss in the right eye with pressure behind the eye. I have a follow up appointment today with the neurologist for a brain scan and tomorrow for an eeg. My PCP, eye doctor, and neurologist believe it may be a blood flow issue. I have not had this type of event before.

Lady had vaccine, was told it was Janssen but lot # is Moderna. She got the vaccine, the night of the vaccine around 5:30 she got a raging headache (she does get reactions to most vaccines). She took Tylenol and her arm did hurt. The next day she was still really hurting, her headache was really, really bad, and it stayed until Sunday. Then on Sunday she was ok. On Monday when she went to work and her right arm went limp, and while she was walking her right leg gave way and almost fell, grabbed hold and steadied herself. The raging headache/migraine came back and she started getting nauseous, her lower back hurt, her upper neck area hurt like somebody was pounding her neck. Then she got diarrhea and really really tired on Monday and Tuesday and also had loss of appetite. Then yesterday 4/13/201 she just had the headache and a sound in her ear, went to UC and got drops for it. Her temperature was 96.5, and her normal is 98.7, and was told that she was really cold. Her PB was really high and the doctor took it again but it was not as high, attributed it to anxiety. Last night the lower abdomen pain started, feeling like she was getting her period which she has not had in over a year. She saw a little blood on her panty liner, and was thinking she was going to have a period, but the pain is excruciating in her lower abdomen. She has also taken Tylenol off and on for her symptoms, and feels like she is cramping. She is having hot/cold flashes as well, and has not had these issues from menopause.

Patient suffered from SOB 4 days after receiving injection, was diagnosed on 4/14/21 with bilateral PE's. Admitted to hospital.

52-year-old previously healthy female who received first dose of Janssen COVID-19 vaccine on 4/7/2021. She started having periorbital right headaches starting on or about 4/14/2021. Headaches were alleviated with OTC Advil. On the morning of 4/18/2021, she awoke with RIGHT arm weakness which, over the course of several hours, progressed to include right-sided leg weakness and aphasia. Initial CT head showing multifocal hemorrhage within the LEFT frontal lobe. Course complicated by epileptic seizure. MRI brain with and without contrast and CT venogram brain notable for superior sagittal sinus thrombosis involving the mid and anterior segments of the superior sagittal sinus. Patient found to have new thrombocytopenia on admission with platelet level 78k; previously had normal platelets 6/4/2019. D-dimer elevated > 4.00 mcg/ml FEU. Started on Argatroban gtt, nicardipine, and IVIG.

Presented with heahache Head CT showed dural sinus venous thrombosis currently treated with argatroban

Patient presented with 4 weeks of episodic jaw pain following the JJ vaccine. Presented acutely to our hospital w/ substernal chest pain, found to have STEMI on EKG. Taken to the cathlab, no evidence of obstructive coronary disease. After cath, patient went into progressive cardiogenic shock. Repeat Left heart cath showed no evidence of obstructive coronary disease but RHC indicative of cardiogenic shock. Cardiac MRI consistent w/ multifocal infarcts. Further ischemic workup negative. Autoimmune workup negative.

I began having pain in my lower left leg later on Sunday (felt like a pulled muscle) but by Monday it was more painful. Since I had surgery (see above) my doctor sent me fir an ultrasound where a clot was found. Went to emergency room to further evaluate and get treated. Was given elequis and am taking for 3 months. Was told clot was likely related to immobility from injury, but wanted to report just for your consideration

ANAPHYLACTIC REACTION; LIGHT HEADED; SYNCOPE/LOST CONSCIOUSNESS; STOPPED BREATHING; VOMITING/PERSISTENT EMESIS; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, and anaphylaxis to peanuts. 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 02-APR-2021 to right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-APR-2021, after vaccination patient experienced an anaphylactic reaction. The patient was at her local pharmacy and was waiting in chairs as instructed; then she walked to her vehicle and began to feel light-headed and lost consciousness. Her husband was with her and was able to administer life saving measures, the local pharmacist was able to administer an epi-pen to her right thigh. On 02-APR-2021, the patient stopped breathing and was then transported to the local ER(emergency room) where she was treated. She regained consciousness and had persistent emesis and the patient was kept in hospital for 24 hours before being discharged. The patient was hospitalized for one day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from syncope/lost consciousness, and was recovering from light headed, vomiting/persistent emesis, and anaphylactic reaction, stopped breathing. This report was serious (Hospitalization Caused/ Prolonged, and Life Threatening).; Sender's Comments: v0 A 52-year-old female patient with the past medical history remarkable for anaphylaxis to peanuts experienced anaphylactic reaction the same day the Janssen COVID-19 Vaccine Ad26.COV2 was administered. The patient began to feel light-headed and lost consciousness, an epi-pen was administered. The next day the patient stopped breathing and was treated in the local ER (emergency room). Later she had persistent emesis. Given the close temporal relationship and history of anaphylaxis to peanuts the events are considered related.

Vomiting, vision impairment (read very slow to me), and seizure(s). Rushed to ER in ambulance. Was put on a ventilator (sedation). Received a CT scan showing a CVST and hemorrhaging in her right temporal lobe. Life-Lined to Hospital. Wore an EEG on her head to monitor seizure activity for 4-5 days. Was put on 4 types of seizure medication and blood thinner for the clot. Did another CT scan which showed her Mid-Line shift was pushing into the left side of the brain by 15mm. Discharged from Hospital on 3/27/21 to Rehabilitation Hospital. She was discharged to home with a caregiver on 4/16/21. She will continue outpatient therapy at the rehabilitation hospital. She will see Speech, Vision, PT, and OT every week until further notice.

52 yo female received J&J COVID-19 vaccination on 3/10. On 3/18, she presented to the ED with chief complaint of SOB and anemia. CT confirms bilateral submassive PE seen in segmental and subsegmental lobes. Symptomatic with tachypnea, pleuritic CP, tachycardia. Patient has history of PE 3 years ago as well, and was on warfarin for 6 months. Only family history of clots is elderly grandmother with DVT's. No sudden death in family. Age-appropriate cancer screening up to date. Patient is wheelchair bound and was dehydrated 2/2 gastroenteritis which made her high risk for VTE. Less likely due to hypercoagulable disorder. At discharge, she is hemodynamically stable...Tachypnea and pleuritic chest pain resolved. Myeloproliferative neoplasm panel negative. She was started on apixaban (will finish loading doses 3/26, and continue 5mg BID indefinitely). Will be referred to hematology as outpatient for PE + anemia.

Patient had a stroke, left leg felt heavy, started having breathing problems, and you entire left side went numb and weak. Patient went to the hospital, referred to Medical Center

4/17 Vaccination @ 530PM 4/18 woke up with stiff neck. Unsure if chest pain started on 4/18 or 4/19. Stiff neck felt like 'being choked'. 2 sharp pains in between breasts. Little pains on left breast, worked up to neck and ear. 4/19 ER. 4/20 ER ultra sound 4/21 cardiologist cb to tell me I had a pulmonary embolism. The Dr. said I needed to go to larger clinic. 4/22 Larger Clinic. They ran some scans with contrast of neck because of pain. CT. Taking blood clot medication. 4/26/2021 Extremely dizzy; going to have a CT scan today **dizziness is so bad right now. *4/29 appt with pulmonologist

5 weeks and 6 days later I suffered a PE with Infarct. was hospitalized 6 days. anticoagulants, IV antibiotics, s/s pain, fever,shortness of breath.

STROKE; LEFT SIDED PARALYSIS ( (INCLUDES FACE AND BODY); This spontaneous report received from a consumer concerned a white and Not Hispanic or Latino, 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included down's syndrome. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) dose was not reported,1 total, administered on left arm on 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 16-MAY-2021 stroke and left sided paralysis on face and body. Ambulance was arrived around 20:00. The patient was hospitalized over night. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stroke, and left sided paralysis. This report was serious (Other Important Medical Condition).; Sender's Comments: V0: 20210532320- Covid-19 vaccine ad26.cov2.s- Stroke, left sided paralysis- 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.

Sudden numbness in leg 5:20pm. Went to emergency room via ambulance. Did a CT scan, found blood clot in upper leg. Sent via ambulance to Hospital had Surgery at 10pm to remove clot and save leg.

Persistent headache found to be a large subdural hematoma. Hospitalized after surgery x 7 days from 5/22- 5/28. Also onset of AFib.

Bilateral peroneal vein deep vein thrombosis involving the calves. (No deep vein thrombosis at or above the knees.)

I started with getting red, hard knots in my leg. They were hard, hard knots. Almost felt like blood clot. My blood pressure rose extremely high like never before. Then I got edema. I went to the vein doctor. I saw the nurse assistant and they said it wasn't a blood clot. Finally, I got to see him at another visit and he thought it was bug bites. But it sounded odd like that I would have these red splotches up and down my legs and they were hard and he put me on Prednisone. The symptoms disappeared completely. About 4 -6 days after the medication was over, all the symptoms re-appeared. At some point, I went to the ER - because I was worried about blood clots. They gave me Cephlex - as they thought it was bug bites - so I was on that for 6 or 7 days. And the symptoms got better with this medication - made it better but not disappear like Prednisone did. Then after that, it was horrible again - the symptoms. I have an appt tomorrow to get checked again. I have never have had this stuff before in my life. My blood pressure is elevated but not so high as it was in the beginning. My legs are in pain - I can't even touch them. My skin so red - it looks like it's on fire. I went to Orthopedic doctor thinking it was related to a previous injury or sprain. But they said it wasn't related to that at all .The skin so tight gets so tight and sore that I can barely walk. The skin is broken like it's thin and very fragile. My left leg is significantly worse than the right leg in the calf area (it's two times the size as the right calf). Still have edema I can't hardly wear shoes. At the end of the day, it's worse, but still in the morning now they are still swollen.

POSSIBLE BLOOD CLOT ISSUE; ELEVATED HEART RATE (OVER 100 AT REST); KIDNEY PAIN; NO APPETITE; FLU LIKE SYMPTOMS; SWOLLEN GLANDS IN NECK; SERIOUS BRAIN FOG; DIARRHEA; SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to contrast dye. 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 10-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-JUN-2021 after getting vaccination, the patient experienced elevated heart rate of over 100 at rest for four days. On an unspecified date in JUN-2021 after vaccination, the patient also experienced shortness of breath, headache, kidney pain, diarrhea, no appetite, flu-like symptoms, swollen glands in neck, aches and pains and had severe fatigue. On 14-JUN-2021, after four days of vaccination, the patient heart rate decreased to a healthier range but shortness of breath, headache, swollen glands, extreme fatigue and diarrhea continued. The patient also had serious brain fog. On 21-JUN-2021, after 11 days of vaccination, the patient had a severe shortness of breath and the patient's PCP (primary care physician) directed patient to visit an emergency room in a hospital. The patient took blood test and showed an elevated d-dimer indicating possible blood clot issue. The patient could not perform lung CT (computed tomography) or angiography due to a severe allergy to contrast dye. The patient also had an MRI (magnetic resonance imaging) of brain and ultra sound of the legs and the results were normal. The patient was on day 16 post vaccination at the time of this report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated heart rate (over 100 at rest) on 14-JUN-2021, had not recovered from flu like symptoms, swollen glands in neck, possible blood clot issue, serious brain fog, and diarrhea, and the outcome of shortness of breath, kidney pain and no appetite was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210660381-Covid 19 Vaccine ad26.cov2.s-Possible blood Clot. 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).

NON-ISCHEMIC CARDIOMYOPATHY; CONGESTIVE HEART FAILURE (TROUBLE BREATHING, FLUID RETENTION, SWOLLEN HANDS, ABDOMEN EXTREMELY DISTENDED, ACUTE SYSTOLIC HEART FAILURE, HEART WAS EXTREMELY ENLARGED); PREMATURE HEARTBEAT; BLOOD CLOT; KIDNEY STONES; SORENESS IN THE LEFT ARM; PAROXYSMAL ATRIAL FIBRILLATION (SYNCOPE, COLLAPSE); This spontaneous report received from a patient concerned a 52 year old female. The patient's weight was 240 pounds and height was 174 centimeters. The patient had no known allergies and no heart condition before the vaccine administration. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 42A21A and expiry: unknown) dose was not reported, 1 total administered on 06-APR-2021 around 11:30 on the left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, right after the administration, the patient experienced soreness in the left arm, but nothing patient could not handle. Since 06-APR-2021, the patient experienced syncope/ collapse episode and was in detox several times, had to have a loop monitor inserted into her chest. Patient was diagnosed with paroxysmal atrial fibrillation. On 17-APR-2021, around 09:00 patient had trouble breathing, abdomen was getting distended, by 15:00 patient was looking like 9 months pregnant, patient's hands were very swollen, abdomen extremely distended. Patient was admitted to the emergency room (ER) and was made stabilized. Patient had a computerised tomogram (CAT) scan and all sort of testing and it was determined that patient had fluid retention. Patient was treated with Lasix (furosemide) to get the fluid off. On 19-APR-2021, patient underwent an echocardiogram and was diagnosed with congestive heart failure, non-ischemic cardiomyopathy, acute systolic heart failure (with ejection fraction= 25%). Patient was sent to another hospital with a cardiac center, where was told that arteries were clean but heart was extremely enlarged. Then patient was hospitalized for 4 more days and sent back home. Cardiac team put patient on high blood pressure medicine because they wanted patient's blood pressure to be around 90/60. Treatment medications were started which included metoprolol 25 mg 3 times a day, then lowered to 25 mg twice a day. Patient was also started with Xarelto (rivaroxaban) 20 mg once a day. On MAY-2021, the patient had kidney stones. On 28-JUN-2021, the patient had first blood clot under the blood thinner. Patient had shortness of breath (extremely painful, like someone was stabbing). From that patient was taking Lovenox 110 U twice a day and was told that would need to take that for the rest of her life. Patient had second blood clot six days after the first one, it was smaller than the first one but extremely painful too. On an unspecified date, the patient had premature heartbeat. Laboratory data showed elevated troponins. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the soreness in the left arm, blood clot, paroxysmal atrial fibrillation (syncope, collapse), premature heartbeat, kidney stones, congestive heart failure (trouble breathing, fluid retention, swollen hands, abdomen extremely distended, acute systolic heart failure, heart was extremely enlarged) and non-ischemic cardiomyopathy was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210730842-covid-19 vaccine ad26.cov2.s-blood clot, congestive heart failure (trouble breathing, fluid retention, swollen hands, abdomen extremely distended, acute systolic heart failure, heart was extremely enlarged), non-ischemic cardiomyopathy, paroxysmal atrial fibrillation (syncope, collapse), kidney stones. 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 filled out vaccine consent form stating no to all questions (denying anything that might exclude her from receiving the vaccine), fever was taken (non-feverish), and signed under the bolded statement stating the patient is to wait in the pharmacy at least 15-20 minutes after receiving vaccination. Patient was then given the J&J covid-19 vaccine in left deltoid and told that it is recommended by CDC to wait in the pharmacy for 15-20 minutes after vaccination. However, the patient immediately proceeded to leave. Patient states upon getting to her car in the parking lot, she started noticing signs of anaphylaxis such as throat swelling, however patient did not come back into the pharmacy and left the premises. Patient did not report seeking any sort of treatment for her anaphylaxis side effects. Patient received vaccine on 3/30/21, did not report this event to the pharmacy until 4/2/21. Patient also states she is a registered nurse.

On 4/3/21 the patient presented with a 1 week history of slowly progressive shortness of breath and 3 day history of left upper quadrant pain. CT revealed bilateral segmental and subsegmental pulmonary emboli, moderate splenic enlargement, and small volume perisplenic hemorrhage. Continuous infusion heparin was started for the bilateral PE. On 4/4 an inferior vena cava filter was placed and patient was vaccinated with Acthib, Bexsero, and Prevnar vaccines in anticipation of splenectomy. On 4/7 a laparoscopic splenectomy was performed. The spleen was evaluated by pathology which reported "Organizing blood clot on surface, consistent with rupture. No evidence of malignancy." The patient remains inpatient while recovering from surgery. On 4/12 she was transitioned to rivaroxaban for therapeutic anticoagulation. Please note as of 4/13 the patient remains hospitalized.

On 3/12/21 developed pain in left calf area. Pain continued to progress and became extremely painful by April 2, 2021. April 3rd went to urgent care for assessment. Sent from urgent care to Lab for ultrasound of left calf which came back positive for DVT. Sent to ER and started on IV heparin. Also received CT Scan of Chest and Abdomen which showed PE in right lower lobe of lung. Admitted to Vascular unit. Doctor ordered an upper Endoscopy to check for bleeding due to low HGB and FE. The Scope was negative for bleeding. Lab work was ordered on 04/06/21 and due to very low HGB and FE patient was given an FE (iron) infusion the evening of 4/06/21 and again the morning of 04/07/21. The patient also received a unit of blood the morning of 04/07/21 prior to being discharged from the hospital. Patient was started on Eliquis 5mg 2x a day, Ferrus Sulfate 325mg 1x a day and Omeprazole 20mg 1x a day as discharge medications.

Patient started experiencing headache, nausea, body aches, exhaustion, unclear thinking, strange behaviors per patient's son on April 4, 2021. These symptoms didn't get any better the day after. Patient lost appetite, and no energy and started shortness of breath started April 5, 2021. On April 6, breathing problems got worse, and too tired to work. Patient woke up with nausea, headache, no energy, shortness of breath and on going problems until April 12 when patient came to the ER due to irregular heart beat and Atrial fibrillation, and patient can't function.

Patient received the COVID 19 vaccine on March 18, 2021 @6:00pm. On April 5, 2021 @8:00am the patient began to feel pain in L leg which progressed to area red and tender to touch and increased in pain with each day. Patient went to the ER on April 9, 2021 and an ultrasound revealed a 10 cm blood clot in left leg. Patient was not admitted but sent home on Zarelto 15 mg 2x daily. Patient did see physician as a follow up.

Patient reports tear in esophagus on 3/24/21 in the evening whenever she felt sick to her stomach. She did not feel well, drank one beer, and ate a packet of tuna. She continued to not feel well and felt the food did not go down correctly, so she reached into her throat and noticed blood. She called her doctor and the doctor recommended monitoring for increased bleeding. Later that night, she reports not feeling well again, made herself throw up, and noticed the vomit was all blood. The patient then called 9-1-1, and presents to the hospital. During the hospital visit she noticed that she saw 'blood clots about the size of a quarter' when she went to the bathroom. Patient reports the hospital gave her 4 pints of blood, 4 bags of 'yellow stuff' (patient assumes its plasma), protonix, antibiotics, and NS. Patient was in the ICU and reports being in the hospital for about 5 days total, whenever the doctor recommended being put on hospice. The patient did want to be put on hospice and wants to be treated, so she contacted her heart doctor and is waiting on an appointment with him on the 28th of April. Patient reports that doctor told her that she 'needs a new heart', but that she is not a good candidate, and that the Dr. told her this just a day or two ago. Patient reports that she did not know it was a tear in her throat (esophagus) until they "stuck a scope down there".

4/11/2021 830PM I NOTICED MOISTURE IN MY UNDERWEAR. WENT INTO BATHROOM , PANTIES BLOODIED, BRIGHT RED AND A QUARTER SIZED CLOT WAS INTHE TOILET. I SUFFERED NO PAIN. HOWEVER I HAD A TOTAL HYSTERECTOMY IN 1997, AND SHOULD NOT HAVE ANY BLEEDING WHATSO EVER. TOOK A SHOWER, ADVISED MY HUSBAND OF THE INCIDENT. WENT TO BED , 230AM 4/12/2021 SAME THING HAPPENS, ONLY NOW I AM WIPING BRIGHT RED BLOOD AND I FELT A LARGER SIZED CLOT LEAVE MY BODY. I WENT TO THE ER IMMEDIATELY.

Patient presented to Emergency Department on 4/17/21 with a severe headache that started 5-7 days prior. CBC and Chem-8 were normal with platelets of 314. Findings from CT head venogram showed irregularities of the left transverse sinus with possible sinus thrombosis. Patient was admitted for further work-up and treatment. Patient was followed by Neurology. On 4/18 MRI revealed no cavernoma seen and no stroke or hemorrhage. Per Neurology, the areas of filling defects seen on CTV are still present which could be nonocclusive thrombus vs stenosis with prominent arachnoid granulations, but given history and risk factors, would treat as cerebral sinus venous thrombosis. Patient was treated with heparin then transitioned to apixaban, which she was discharged on. Patient was instructed to follow up with neurology in 3 months for a repeat CTV. Patient was discharged 4/19/21.

patients PCP office called to inform us that patient was positive for a DVT today. She was calling to inform us of the adverse event following her vaccination 04/12/2021. Blood clots were the reason that was reported for this vaccine to be pulled from the market the very next day 04/13/2021. Called the office back and left message with them to report as well since they have lab work and other patient information

patient had a headache, weak arm, slept a lot more, experienced pain in arm as well, and a "funny feeling" in her chest. Patient went to the ER and said they found a blood clot.

STROKE; BRAIN BLEED; BRAIN FISTULA; VOMITING; HEADACHE; This spontaneous report received from a patient concerned a 53-year-old female. The patient's height, and weight were not reported. The patient's past medical history included hormone replacement therapy: bioidenticals, and surgery. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported 1 administered for prophylactic vaccination. Vaccination site was unknown. 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, after two week of vaccination, the patient had a brain fistula which was considered as a stroke because it was a bleeding not a clot. She had really bad headache and was throwing up all night (vomiting). She called her primary health care physician they told her to visit hospital. First she went to the community hospital in her local city from where she was transferred to another hospital for surgery. The surgery occurred in first week of April. She was currently hospitalized. Number of days in hospital were unspecified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, vomiting, brain fistula, brain bleed and stroke was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments:-covid-19 vaccine ad26.cov2.s-Haemorrhagic 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).

Pt. developed right lower medial leg pain on Friday. She states the pain radiated up her leg and she felt there was warmth to the area. She denies injury. She states she had the J&J covid vaccine two weeks ago and has concerns of a DVT. There is minimal swelling and ecchymosis in the area. There is no redness or warmth noted. There is no tenderness, redness or warmth noted in her calf area. She has good pedal pulse and good capillary refill of her nail beds. She has no significant PMH and denies any recent air travel, long car rides or prolonged sitting. She states she is active.

Had several myclonic seizures during the morning which ended in a grand mal seizure later in the morning of March 25th which resulted in my shoulder being shattered. This led to me having a reverse shoulder replacement.

BP went up to 210/111 the day after vaccine was administered. On 4/24/2021 patient went to ER for double vision. BP was 200/100's again. Given IV BP meds, did CT scan that showed no abnormalities noted. K+ was 2.9. On Sunday, 4/25/21 back to ER for double vision again. BP 160/90's. Observed, given more BP meds and sent home again. Went to PCP, clinic 4/26 who referred to Ophthalmologist. Opthalmology, found optic nerve damage and believes related to mini stroke possibly from Covid vaccine.

PULMONARY EMBOLISM; HAEMOPERITONEUM; MESENTERIC HAEMORRHAGE; SPLENIC HAEMORRHAGE; SPLENIC RUPTURE; SPLENIC THROMBOSIS; SPLENOMEGALY; LEFT UPPER QUADRANT/ABDOMINAL PAIN; DYSPNOEA; This spontaneous report received from a physician concerned a 53 years old female The patient's height, and weight were not reported. The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, 1 total administered on 16-MAR-2021 for prophylactic vaccination. Concomitant medications included Centrum Multi-Gummies for Women. On an unspecified date in MAR-2021 the patient began to experience slowly progressive shortness of breath; on 01-APR-2021 she had left upper quadrant pain. On 03-APR-2021 the patient presented to the emergency room. Laboratory data included: Pulmonary Angiogram/CT Chest - abnormal and computerised tomogram abdomen/pelvis at 09:37, showed segmental and subsegmental pulmonary emboli in the lower lobes of both lungs. Small volume perisplenic hemorrhage and small volume pneumoperitoneum in the pelvis or findings concerning for spontaneous splenic rupture and moderately enlarged spleen. Additional CT abdomen and pelvis with IV contrast at 23:05 showed: Small to moderate amount of hemoperitoneum, slightly increased since the earlier study. There is definitely new blood adjacent to the liver. The hemorrhage adjacent to the spleen appears similar to the earlier study. Due to the timing of the scans with relation to the contrast injection, the physician could not confirm a splenic laceration, although it was suspected to be the source of hemorrhage. Small amount of mesenteric blood was slightly increased. Continuous heparin infusion was started for bilateral pulmonary embolism. On 04-APR-2021, an inferior vena cava filter was placed and patient was vaccinated with Acthib (HIB Vaccine), Bexsero (meningococcal vaccine) and Prevnar (pneumococcal vaccine) in anticipation of splenectomy. On 07-APR-2021, a laparoscopic splenectomy was performed. The spleen was evaluated by pathology which reported that organizing blood clot on surface was consistent with rupture. No evidence of malignancy was reported. The patient was also treated with anticoagulant therapy (dates unspecified). The patient remained inpatient while recovering from surgery. On 12-APR-2021, the patient was transitioned to rivaroxaban for therapeutic anticoagulation. Patient remained hospitalized as of 12-APR-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pulmonary embolism, haemoperitoneum, mesenteric haemorrhage, splenic haemorrhage, splenic rupture, splenic thrombosis, splenomegaly, dyspnoea, abdominal pain upper, and left upper quadrant/abdominal pain. This report was serious (Hospitalization Caused / Prolonged, Disability Or Permanent Damage).; Sender's Comments: V0: This 53-year-old female patient of unspecified ethnicity was found to have pulmonary embolism and spontaneous splenic rupture 18 days after receiving COVID-19 VACCINE AD26.COV2.S for the prevention of symptomatic SARS-CoV-2 virus infection. No concurrent illness and medical history reported. Emergency room consult for slowly progressive shortness of breath and left upper quadrant pain that starts on an unspecified date after vaccination. Pulmonary Angiogram/CT Chest showed segmental and subsegmental pulmonary emboli in the lower lobes of both lungs; small volume perisplenic hemorrhage and small volume pneumoperitoneum in the pelvis; moderately enlarged spleen with findings concerning for spontaneous splenic rupture. CT abdomen and pelvis with IV contrast showed small to moderate amount of hemoperitoneum, slightly increased since the earlier study; definite new blood adjacent to the liver. Continuous heparin infusion was started; vaccinated with Acthib (HIB Vaccine), Bexsero (meningococcal vaccine) and Prevnar (pneumococcal vaccine). Laparoscopic splenectomy was done 22 days after vaccination; pathology report is consistent with splenic rupture with no evidence of malignancy. The patient was shifted to rivaroxaban. No other details reported. The information available regarding splenic rupture precludes a complete and meaningful assessment. Based on the information that is available, the event pulmonary embolism 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; considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, the potential vaccine contribution cannot be excluded. Additional information was requested.

Blood clot in right wrist area: On the evening of 3/17/21, I felt sudden pain in the palm of my right hand, just above the wrist. Then the vein just below my wrist swelled up and turned blue. The next morning when I woke, the vein was no longer swollen, but the area below my wrist had a large bruise, which lasted several days. I contacted my physician that day (3/18) who said just to monitor/observe and come in if continuing issues (which there were not).

Pulmonary Embolus Insidious onset of dyspnea on exertion with her daily walks, stairs, muscle fatigue the week after her vaccine Initially attributes sx to donating blood ( 3 days after vaccine) When sx persisted came to office for eval. D Dimer positive Chest CTA shows RLL PE No hypoxia, no chest pain, clinically stable Plan is for oupt tx with Eliquis and stop OCP

4/29/2021 1. Localized edema 2. H/O factor V Leiden mutation 3. History of deep vein thrombosis (DVT) of lower extremity - patient had Johnson and John vaccine on 4/9/2021. She then developed bilateral leg pain with calf swelling, redness, and warmth about 1 week ago. Patient has a history of DVT and factor V Leiden mutation. She has previously been treated with Eliquis for DVT. Patient concerned for repeat DVT. Recommended bilateral venous dopplers. - VAS US Doppler Venous Lower Extremity Left; Future - VAS US Doppler Venous Lower Extremity Right; Future . Acute deep vein thrombosis (DVT) of calf muscle vein of left lower extremity (HCC) 5. H/O factor V Leiden mutation - patient diagnosed with a new DVT on 4/29/2021. She is currently anticoagulated with Eliquis 5mg 1 tablet BID with plan to continue anticoagulation for at least 6 months. Patient follows with hematology

I am on menopausal replacement estrogen and take progesterone a few times a year to force a "period". While on progesterone I dont have bleeding until I stop the progesterone I got the shot and had my period while ON the. progesterone.. Usually because I am menopausal I have 2 days of light panty liner bleeding. I was taking my progesterone (May 18-may 28) and got the vaccine on May 21. By May 25th I started a heavy period with significant bleeding and clotting. The heaviest period I ever remember in my life. It was heavy flowing . while in the shower or on the toilet. Very strange never experienced anything like it before. other symptoms cramping etc were normal level based on the bleeding. Day #6 still have some bleeding but mostly over at this time. As a pharmacist I am aware of other possible clotting disorders so I am watching and looking for other adverse events within the next few weeks to assure I have no other problems. So far besides exhaustion it seems like the vaginal/endometrial bleeding is the only issue.

Patient without a prior history or risk factors for DVT, developed acute DVT left leg confirmed by U/S; WBC mildly elevated and platelets were low. Treated with DOAC

The patient reports right calf pain 5 days after vaccination, followed by palpitations and dyspnea for the past two week. She presented to the ER today, June 12 2021, and was found to have a right calf DVT as well as multiple bilateral pulmonary emboli. Her ER visit today also shows newly diagnosed metastatic lesions in the liver and a colonic mass. It is not clear if any of the thromboembolic disease is secondary to the Covid vaccine at all, or all related to the new metastatic disease. Decision was made to report this event due to her reported timing of symptoms and patient request to report as well. She is being transferred to Medical Center for hospitalization and treatment.

Patient presented to ED on 6/13/21 with left sided chest pain for 3 days with radiation to left arm and left neck, improved with nitroglycerin sublingual. EKG unremarkable, troponin 0.23. D-dimer 0.66, CT angiogram chest negative for PE. Patient admitted and cardiac workup done, CT coronary score 0, new onset atrial fibrillation started on Multaq and Eliquis, Pt converted to NSR, chest pain improved. Final diagnosis = chest pain due to myopericarditis, elevated troponin due to acute myopericarditis unlikely NSTEMI, new onset paroxysmal atrial fibrillation.

INJECTION RELATED REACTION; WEARING OFF EFFECT; INJECTION SITE REDNESS; INJECTION SITE BURNING; ANAPHYLACTIC SHOCK; PAIN; This spontaneous report received from a patient concerned a 53 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient felt pain a few days before next injection was due. She was going on this way for years. She loved it, and did not want to stop because of this. She had injections burn but insurance, did not want to allow citrate free version. She gets a red spot. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown expire: unknown) dose was not reported, 1 total, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: Humira (adalimumab) (solution for injection, subcutaneous, batch number: 1136781 and expire: Unknown) dose, frequency, and therapy dates were not reported for ankylosing spondylitis. Non-company suspect vaccine included: influenza vaccines (form of admin, route of admin, and batch number: Unknown expire: Unknown), dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On unknown dates, the patient experienced reaction to flu injection, feels pain a few days before next injection was due and burning on injection/gets a red spot. On an unspecified date in 2021, the patient experienced pain. On an unspecified date in Mar-2021, the patient experienced anaphylactic shock from covid vaccine. On an unspecified date in 2021, the anaphylactic shock from covid vaccine and pain resolved. COVID-19 VACCINE was also considered suspect. Epinephrine was given and cleared up within a few minutes. She got a reaction to flu injections too. She did not take Humira for 56 days while getting the covid vaccine. Physician said to take a break as long as possible. She went as long as she could, but she was having a lot of pain. The patient was taken Flu injection as a co-suspect drug. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from anaphylactic shock on an unspecified date in 2021, had not recovered from pain, wearing off effect, and injection site burning, and the outcome of injection related reaction and injection site redness was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20210661838-covid-19 vaccine ad26.cov2.s -Anaphylactic shock, Pain, Wearing off effect, Injection related reaction. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s).20210661838-covid-19 vaccine ad26.cov2.s -injection site burning ,injection site redness. This event(s) is labeled per other facility and is therefore considered potentially related.

On April 20th I got an extreme headache that would not go away. I went to the ER and got migraine medicines, but it still did not help. I went to my family doctor no less than 6 times over the next 2 weeks. After a couple days I started having eye disturbances. Not double vision, but halos and problems focusing. My head still hurt. On May 3rd I went back to the ER because my left arm was numb. I thought maybe it was a heart attack. Still had the eye disturbances and headache also. They did a CT with contrast at the hospital and confirmed that I had had a stroke. On May 10th I saw a neurologist that ordered an indepth MRI and he found a brain aneurysm.

Felt severe pain in leg for over week. Went to hospital. Hospital reported nothing wrong. A week later, ER, Afib, In ICU for 4 days. Developed completely neuropothy, starting with legs. Feel like "electrical system is fried."

PULMONARY EMBOLISM; DID NOT FEEL GOOD; This spontaneous report received from a health care professional (nurse) concerned a 54 year old unspecified race and ethnic origin female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on 2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Non-company suspect drugs included: Hizentra (immunoglobulin human normal), (infusion, subcutaneous, batch number: Unknown and expiry; Unknown) 10 gram of weekly infusion, from 28-MAR-2021 for primary immunodeficiency. Concomitant medications included Tylenol (paracetamol) for unknown indication. Earlier this year (unspecified date), after receiving Covid-19 vaccine (Johnson and Johnson), per patient, things started to spiral down. On 25-JUN-2021, the patient took previous infusion Hizentra. The patient did not feel good after the infusion but ignored these symptoms, which tends to be her state post infusion. On 27-JUN-2021, the patient was having mucus and started coughing blood. On the same day, she was sitting on her couch, and her watch alerted her of a tachycardia rhythm. The spouse took the patient to the emergency room (ER), where a computerised tomogram (CT) scan was ordered, and a blood clot (pulmonary embolism) in the lungs was confirmed. The patient did not confirm any hospital admission. Still, the physician for Hizentra decided to hold her infusions for four weeks to monitor the patient and let the new medication, Eliquis (anticoagulant), settle in the system. The patient adds that on the brighter side, her IgG levels were in the ideal range. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pulmonary embolism and did not feel good was not reported. This report was serious (Other Medically Important Condition, and Life Threatening).; Sender's Comments: V0: 20210738853-covid-19 vaccine ad26.cov2.s -pulmonary embolism. 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: CONMEDS-OTHER SUSPECT DRUGS

Patient with known history of ITP status post splenectomy in 2018, with stable platelet counts off treatment, developed petecchial rash in lower extremities 2 days after receiving COVID vaccine during a mass vaccination campaign. Platelet counts check 2 days after the vaccination was 1,000. Patient was admitted to the hospital for ITP, received 2 doses of IVIG and was initiated on prednisone with improvement in platelet count to 72,000 by 03/14/2021. Give

ANAPHYLACTIC REACTION, NAUSEA, VOMITING, DIARRHEA, PAIN, DISTRESS AND HEADACHE.; BLOOD PRESSURE ESCALATED; TINNITUS AND RINGING; NUMBNESS; TINGLING OF THE EARS; HYPERSENSITIVE TO SOUNDS; This spontaneous report received from a physician and concerned a 54 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination on left deltoid. No concomitant medications were reported. On an unspecified date, the patient experienced anaphylactic reaction, tingling of the ears, numbness and tingling of ears, blood pressure escalated, hypersensitive to sounds, pain/distress, diarrhea, vomiting, tinnitus, headache, and nausea. Treatment medications (dates unspecified) included: epinephrine, triamcinolone acetonide, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling of the ears, numbness and tingling of ears, and vomiting, had not recovered from headache, nausea, diarrhea, and tinnitus, and the outcome of anaphylactic reaction, blood pressure escalated, hypersensitive to sounds and pain/distress was not reported. Initial information was processed along with the additional information received on 27-mar-2021. additional event of tinnitus was added. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210350839-Covid-19 vaccine ad26.cov2.s-Anaphylactic reaction. This event is considered related. The event has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. V0: 20210350839-Covid-19 vaccine ad26.cov2.s-Blood pressure escalated, tingling of ear, numbness, hypersensitive to sound, tinnitus. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.

Severe leg pain. Ultimately diagnosed with pneumonia but the Emergency Department did not take my complaint seriously. I still have pain in legs.

I received the Jannsen Covid Vaccine on April 05, 2021 at 08:50 am. On April 09,2021 at around 04:30 am I woke up with vaginal spotting. I had a full hysterectomy in 1999, 21 years ago. Alarmed. I took myself to urgent care. I was tested for a Urinary Tract Infection and a Yeast Infection by pelvic examination. Both tests were NEGATIVE. I was prescribed Diflucan 2 doses 150mg each to take 3 days apart. I discontinued the Diflucan upon learning of the negative result for yeast. April 10, 2021 I was still experiencing Vaginal bleeding upon waking up. April 11, 2021 the spotting had ceased.

DVT right common femoral vein, sent to hospital for Heparin, transitioned to Eliquis. Monitoring. Will follow-up with vascular specialist.

The week of April 5, I believe it was April 5 & 6, I thought that I was coming down with a sinus infection. I was having some blood when blowing my nose and remember seeing some small, hard balls which I now realize were clots. I did not go to the doctor because my back was very bad and I was in a lot of pain and I had an upcoming appointment with my doctor. I believe that the symptoms resolved after 2 or 3 days and I did not even mention it to my doctor when I saw him. I felt a lot of pain in my leg, but this is probably due to my ongoing sciatica/radiculopathy /bursitis problems that I experience.

Bilateral Pulmonary Embolism: Symptoms began acutely at 8pm on 4/12/2021. She developed chest pain, shortness of breath and nausea. Sharp pain. She was seen in the emergency department and at that time D-dimer was elevated to 1338. She had a subsequent CT scan that showed Subsegmental pulmonary emboli in posterior basal segments of lower lobe bilaterally

abdominal pain associated with MORE vaginal bleeding 1day after vaccine (pt already had vaginal bleeding preceding vaccine)

BILATERAL DEEP VEIN THROMBOSIS TO LOWER EXTREMITIES; PULMONARY EMBOLISM IN BOTH LUNGS; BODY ACHE; CHILLS; This spontaneous report received from a consumer concerned a 54 year old female. The patient's weight was 190 pounds, and height was 66 inches. The patient's past medical history included cancer, and concurrent conditions included no alcohol use, and non-smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient had no known allergies and drug abuse/illicit drug usage. The patient received JANSSEN COVID-19 VACCINE (covid-19 vaccine ad26.cov2.s) (suspension for injection, route of admin intramuscular, batch number: 1805031, and expiry:not reported) dose was not reported, 1 total, administered in left arm on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-MAR-2021, the patient experienced chills. On 06-MAR-2021, the patient experienced body ache. Since 09-APR-2021, patient started experiencing leg pain and was admitted to a hospital on 10-APR-2021. The patient was diagnosed with 2 deep vein thrombosis (DVTs) to the lower extremities with pulmonary embolism. The patient was on therapeutic Lovonox (enoxaparin sodium) and was prescribed Lovonox injection twice a day for 6 months. The patient had visited emergency room and hospitalized for 5 days. The patient was discharged from hospital on 13-APR-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, and chills on 10-MAR-2021, and was recovering from bilateral deep vein thrombosis to lower extremities, and pulmonary embolism in both lungs. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This 54-year-old obese female with BMI of 30.7 was hospitalized due to bilateral deep vein thrombosis (DVT) to lower extremities and pulmonary embolism (PE) in both lungs 35 days after receiving JANSSEN COVID-19 VACCINE (covid-19 vaccine ad26.cov2.s) in left arm for prophylactic vaccination. The patient's past medical history included cancer. The subject had chills 2 days prior to the vaccination and body ache 1 day post vaccination. The symptoms resolved 5 days post vaccination. She started experiencing bilateral leg pain 33 days post vaccination and chest pain 34 days post vaccination. The patient visited emergency room and was hospitalized. She was diagnosed with bilateral DVTs to the lower extremities and PE in both lungs. Details of the hospitalization were not reported. She was discharged after 5 days of hospitalization with prescription of enoxaparin injection twice a day for 6 months. The patient was recovering from bilateral DVT to lower extremities and PE in both lungs. Based on the available information, with risk factors of obesity and cancer, DVT and PE are assessed as indeterminate with causal association to immunization, per WHO causality classification for adverse events following immunization. Company causality is considered not related to JANSSEN COVID-19 VACCINE. Additional information has been requested for further assessment.

Patient states that while vacationing, 3 weeks and 1 day after receiving her Janssen vaccine, she woke up at 8:30am with numbness in her left foot. When attempting to stand she fell to floor. After checking her blood pressure and blood sugar she took 2 tylenol and sat down to rest. Around 10:30am she began to have numbness in her left hand and on the left side of her face. She was taken by ambulance at that time to Hospital. While there they ran a number of tests and scans diagnosing her with have a stroke caused by a small blood clot in right side of her brain. She was admitted to the hospital and was not discharged until 4/3/2021. Upon returning home, she has been seeing her PCP, APRN and a neurologist. She has since been released on 4/19/2021 to go back to work and has no residual side effects from stroke. She states she is now on blood pressure and cholesterol medication and is taking a daily baby Aspirin.

BILATERAL PULMONARY EMBOLISM; UNSPECIFIED ISSUE WITH SPLEEN; DIZZINESS; HEADACHE; This spontaneous report received from a healthcare professional (nurse practitioner) via a company representative concerned a 54 year old female patient. The patient's height, weight were not reported and medical history was not known. 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 (anatomical vaccination site unspecified) on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in MAR-2021, "about one week prior to admission", the subject experienced headaches and dizziness. On 03-APR-2021, the patient was admitted to hospital for bilateral pulmonary embolism and something with her spleen. The reporter believed that the patient had tests done on spleen (not further specified). Initially it was reported that the patient was out of hospital now and doing much better, but later it was clarified that patient has not yet been discharged from hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bilateral pulmonary embolism, unspecified issue with spleen, headache and dizziness was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This 54-year-old female patient experienced headache and dizziness unspecified days after receiving covid-19 vaccine ad26.cov2.s for prophylactic vaccination. The patient was hospitalized 1 week later for bilateral pulmonary embolism (PE) and unspecified issue with spleen. Medical history and concomitant medications were reported. No other details of the events were reported. The patient had not yet been discharged from hospital. Based on a limited information, the events of bilateral PE, unspecified issue with spleen, headache and dizziness are assessed to have an indeterminate causal association to immunization, per the organization causality classification for adverse events following immunization. Company causality is considered not related to covid-19 vaccine ad26.cov2.s. Additional information has been requested for further assessment.

Patient had a syncopal episode while on the toilet and moving her bowels on night of 4/15. She struck head and sustained left peri-orbital laceration. Was seen at ER on 4/16. Had CT of head showing cutaneous injury only. Was discharged home. On 4/20 she first noted swelling in right calf. This worsened and was seen in Care Center on 4/23. Had high D-dimer and had ultrasound of leg at ER. This showed right leg DVT extending from the distal femoral vein through the popliteal and posterior tibial veins. She had a long wait and left. She called PCP's on 4/24 on was prescribed Eliquis. She had trouble getting prescription filled due to cost and need for insurance pre-approval. Finally picked up and started Eliquis on the morning of 4/25. She contacted PCP's office on morning of 4/26 with new complaint of "terrible shortness of breath and lightheadedness". Patient was seen. CTA of chest done at hospital. showed "a large bilateral acute bilateral pulmonary embolism with saddle embolus, involving the right and left main pulmonary arteries, as well as the lateral lower lobe, upper lobe, right middle lobe, and lingular segmental and subsegmental branches. There is slight bowing of the interatrial ventricular septum to the left consistent with right heart strain." Patient to be admitted for thrombectomy

She got the vaccine, when they put the needle in she said it was far in. The pain was bad, but she could deal with it. Then 5 days later something hit her and hit her bad. She went to the ER and they gave her Bentyl, diarrhea medicine as she was vomiting, not eating anything, and they gave her some anti-vomiting medicine. They sent her home and said she would feel better. The diarrhea and vomiting stopped but she then started with a rash. it's all over her hands, arms, back, itching, and taking Claritin for it. it won't go away. Her symptoms continued to worsen, and woke up one morning and had so much pain that she could not move or breath and her husband called an ambulance and they took her hospital and diagnosed with a blood clot. She was in the hospital for 3 days and now discharged on Eliquis. She has bruises all over her coming out and very upset that she is still feeling bad and doesn't know how the rash is going to go away. She was also prescribed Oxycodone for pain and also Tessalon Perls to take for coughing.

RIGHT LEG DEEP VEIN THROMBOSIS; PERIPHERAL VEIN OCCLUSION; This spontaneous report received from a patient via VAERS (Vaccine Adverse Event Reporting System) (VAERS ID: 1201107) concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and chronic obstructive pulmonary disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. Concomitant medications included ferrous sulfate, ipratropium bromide/salbutamol sulfate, montelukast, salbutamol sulfate, budesonide, ipratropium, olodaterol hydrochloride/tiotropium bromide monohydrate and prednisone for chronic obstructive pulmonary disease. On 07-APR-2021, the patient experienced right leg deep vein thrombosis. Patient was hospitalized for 4 days. On 07-APR-2021, the patient experienced peripheral vein occlusion. On 07-APR-2021, the patient had ultrasound scan abnormal. Laboratory data included: Ultrasound Doppler (NR: not provided) unknown, and right leg duplex Ultrasound Scan confirms right leg occlusive DVT involving common femoral, superficial femoral, and popliteal vein. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right leg deep vein thrombosis, and peripheral vein occlusion. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210447773-Covid-19 vaccine ad26.cov2.s-Right leg deep vein thrombosis. 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 events.

I woke up at approximately 9:30 AM the morning of Sunday May 2nd 2021 the day after getting my covid vaccine and had to rush to the bathroom. I proceeded to have blood and blood clots come out my urethra very urgently. I had abdominal pain and pressure. I proceeded to need to urinate blood and blood clots for approximately 4 hours urgently. I could not go far from the bathroom without having to return quickly to the toilet. I wet myself several times. The clots stopped coming around 1:30 PM. I proceeded to have to have no control over urination urge and could not leave the bathroom. Around approximately 2:00 PM I could leave the bathroom without fear of wetting myself. I continued to have a small amount of a mix of blood and normal urine passing for another hour or so. I have a picture of the blood and clots that came out of my urethra. I continue to have dull pain and pressure in my abdomen.

My sister experienced 18 days later a stroke after receiving her J&J vaccine. She was at the hospital for two weeks and was then discharged on 06-13-2021 to go home. At the hospital they performed extensive lab work and medical imaging and nuclear medicine study as well. Then on 06-13-2021 she went back to the hospital due to thrombosis in her right leg. My sister is at home now and is receiving physical therapy at this time. My sister can not walk at this time and is taking medications. The doctors at the hospital stated she is doing very well from the stroke and the hemorrhage has stopped and is almost 100% and at this time her right leg is still in pain due to the thrombosis and is bed ridden.

HEART ATTACK; SEVERE LETHARGY; FEVER LIKE TEMPERATURE; This spontaneous report received from a patient concerned a 54 year old female. 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 no known drug or non-drug 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: 1808962, expiry: 23-JUN-2021) dose was not reported, 1 total, administered on 18-MAY-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On 18-MAY-2021, Patient experienced severe lethargy, fever-like temperature. On 23-MAY-2021 at about 09:40 pm, she began to severe chest pain from breast and upward. She was taken to emergency room with Electrocardiogram readings off the chart, that lead to a heart attack. She received double stent placement in her heart. Several weeks later, she was on several medications. Patient's coworker mentioned that it had to do with J&J/Janssen vaccine. Her lifestyle had detrimentally changed from healthy to living with a comorbid condition. She was treated by a cardiologist in hospital. On 27-May-2021, she was discharged from hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever like temperature, recovered with sequelae from heart attack, and had not recovered from severe lethargy. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210738717 covid-19 vaccine ad26.cov2.s -Heart attack. 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 started developing hives first down my right leg, then on my stomach and on my tailbone starting 4 days after receiving the vaccine. So far, I continue to develop them slowly. No anaphylaxis, but a strange systemic reaction.

03/16/2021 complained of headache, and lump with warmth/swelling/tenderness to Left lower leg 04/01/2021 complained of lump with warmth/swelling/tenderness to Left lower leg, Rash to Right lower leg and heaviness of upper extremities. 04/12/2021 lump with warmth/swelling/tenderness to Left lower leg

Charlie horse began 10 days after vaccine, leg felt full with cramping not allowing motion, went to ER diagnosed with blood clot in left calf

4 hrs after onset of severe headache and body pain in lymph nodes under arm pit breast, on top of kidneys and in stomach fatigue low fever. After 4 days of that I got a really super heavy period with cramping and blood clots in my menustral flow. It was a horrible period, while the one after the surgery in Feb was very light. Dizzy and fatique 10 days after shot on the April 8 I took a fall from a chair outside, and from Thrusday to the Saturday 10th I ended up in the Emergency room with a concussion and head symptoms including dizziness and nose bleeds. This was from a simple fall, and i suspect the covid shot might have caused complications after the fall with additional swelling and brusing.

Patient started noticing left arm swelling and pain about 2-3 weeks after the vaccine. She then presented to the hospital 4/16/21 and was found to have a deep vein thrombosis in her left brachial vein as well as a thrombosis in her right internal jugular vein. She is currently being further worked up and will be admitted to the hospital for anticoagulation.

The patient had her Janssen vaccine on 4/7/21. On 4/15/21 she began having a very severe headache (10/10). This was followed by dysarthria and facial droop. The symptoms persisted until the following day at which point she went to urgent care and then here to our ER. We did a head CT which showed she has and acute/subacute stroke in the right posterior MCA territory. I am the Hospitalist physician that admitted her yesterday. I have and MRI of the brain as well as an MRA and MRV ordered though not performed yet. Her symptoms are improving.

NAUSEA; NUMBNESS OF FACE; TINGLING OF FACE; INJECTION SITE PAIN BUT PAIN UNDER RIGHT ARM; ANAPHYLACTIC REACTION ( FEELING HOT, AND THROAT FELT CLOGGED); This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's height, and weight were not reported. The patient's past medical history included anaphylactic reactions with other vaccines, and concurrent conditions included antibiotic allergy (except ciprofloxacin), non-alcoholic, non-smoker, cancer, cerebral palsy, and pheochromocytoma. 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, 1 total, administered on right arm on 27-MAR-2021 12:15 for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021 12:21, the patient experienced anaphylactic reaction (feeling hot and throat felt clogged and closing). The patient was taken to the emergency room and given epinephrine. Anaphylactic reaction continued during the transport to the emergency room. On 28-MAR-2021, the patient experienced injection site pain but pain under right arm, numbness of face and tingling of face. On an unspecified date, the patient experienced nausea. Patient also received a rapid COVID-19 test on 07-APR-2021 and waiting on lab results. The patient was worried about the cancer surgery planned after 5 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from anaphylactic reaction ( feeling hot, and throat felt clogged) on 27-MAR-2021, was recovering from injection site pain but pain under right arm, numbness of face, and tingling of face, and the outcome of nausea was not reported. This report was serious (Life Threatening).; Sender's Comments: V0: A 54-year-old female experienced anaphylaxis 6 minutes after vaccine. Past medical history included anaphylactic reactions with other vaccines, and concurrent conditions included antibiotic allergy, cancer, cerebral palsy, and pheochromocytoma. Six minutes after vaccine she reporting feeling hot and throat felt clogged and closing. The patient was taken to the emergency room and given epinephrine and recovered the same day. Given the close temporal relationship, history of anaphylaxis to other vaccines as well as antibiotic allergy, the event is considered related.

BLOOD CLOT IN LEFT THIGH; SWELLING; FATIGUE; This spontaneous report received from a consumer concerned a 55 year old female. Initial information received on 13-APR-2021, processed along with information received via telephone communication on 15-APR-2021 The patient's weight was 100 pounds, and height was 152.4 centimeters. The patient's concurrent conditions included progressive multiple sclerosis, swelling of the left leg and foot, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies. the patient was not a pregnant at the time of reporting. The patient had no family history of thrombosis, no prior deep vein thrombosis (DVT). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, 1 total, administered on 22-MAR-2021 for prophylactic vaccination. Concomitant medications included baclofen, escitalopram oxalate, and risedronate sodium (received 2 doses and stopped after the event). The patient's husband reported that in MAR-2021, the patient had symptoms of fatigue. On 23-MAR-2021, the patient had swelling and fatigue. Her fatigue was resolved on 24-MAR-2021 and swelling was resolving. On 05-APR-2021, the patient developed left thigh swelling. On 06-APR-2021, the patient's swelling was not going down and she visited her primary care physician. The physician could not determine the cause of swelling (left thigh very noticeable clot swollen around where clot was located) and the physician suspected clot and performed an AD dimer (fibrin degradation) test to look for potential blood clotting. The patient also had a venous duplex ultrasound that showed left leg clot. At 19:00 on the same day, the patient's physician advised to visit emergency room and determined there was a clot on left thigh and she was prescribed Eliquis Starter Pack (apixaban) for 3 months treatment and recommended another scan in several months. On 06-APR-2021, the patient's vitals were reported as blood pressure 124/70 mmHg, heart rate 88 bpm and oxygen saturation of 99%. Laboratory data included prothrombin time (PT) 13.4 sec , International normalized ratio (INR) 1.2 and activated partial thromboplastin time (APTT) 34.8 sec. (Normal range not reported for all) d-dimer and platelet count results were not available and Covid-19 test was not performed. Body max index was 19.5 kg/m2. On an unspecified date the patient was feeling better but had not recovered from the event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue on 24-MAR-2021, had not recovered from blood clot in left thigh, and recovering from swelling. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This case concerns a 55-year- old female subject, immobile due to progressive multiple sclerosis who developed a left thigh swelling 12 days after Janssen COVID-19 vaccine was administered intramuscularly for the prevention of symptomatic SARS-CoV-2 virus infection. The patient's concurrent conditions included body max index of 19.5 kg/m2, progressive multiple sclerosis and swelling of the left leg and foot. She is a non-smoker, no known drug allergies, no family history of thrombosis, or prior deep vein thrombosis (DVT). Symptoms started with swelling of the left thigh and fatigue. The fatigue resolved the next day. The patient's swelling in the left thigh was not going down and she visited her primary care physician who checked her D-dimer dimer (level not known to patient) and scheduled a venous duplex ultrasound that showed a clot in the left thigh. Her vital signs were blood pressure of 124/70 mmHg, heart rate 88 bpm and oxygen saturation of 99%. and she was prescribed Eliquis Starter Pack (apixaban) for 3 months treatment and recommended another scan in several months. Laboratory data included PT 13.4 sec, INR 1.2 and APTT 34.8 sec. D-dimer and platelet count results were not available and Covid-19 test was not performed. The patient is feeling better but had not recovered from blood clot in the left thigh, and is recovering from the swelling. Given underlying progressive multiple sclerosis with immobility and preexisting swelling of the left leg and foot on the same lower extremity, the clotting of the left thigh is considered not related to Janssen COVID-19 vaccine. Additional information has been requested.

POSSIBLE PULMONARY EMBOLISM; ELEVATED D-DIMER; This spontaneous report received from a patient concerned a 55 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: ER8729, and expiry: UNKNOWN) dose was not reported, 1 total administered on 07-APR-2021 at around 10:00 on left arm for prophylactic vaccination. No concomitant medications were reported. On 16-APR-2021, the patient experienced shortness of breath that worsened with exertion, and at the time of reporting at rest. Patient called her physician (MD) (internist) and went to the office on 23-APR-2021 for some testing. She had an elevated d-dimer level. Laboratory data included: Fibrin D dimer high (NR: not provided) Elevated. The physician treated her for possible pulmonary embolism. On same day she experienced pressure in her chest. At the time of reporting patient had shortness of breath and occasionally some pressure in her chest. Patient did not take any medications for her symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from elevated d-dimer, and possible pulmonary embolism. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This spontaneous case describes a 55-year-old female who experienced shortness of breath which worsened with exertion 9 days after receiving the Janssen COVID-19 vaccine. She then experienced chest pressure 16 days after vaccine administration, and saw her physician that day. D-dimer level was elevated, and the physician treated her for a possible pulmonary embolism. Medical history and concomitant medications were not provided. The patient had not recovered from the events. There are insufficient details in the case to make a meaningful medical assessment. The case will be assessed further when additional information is received.

blood clot in my left eye, swelling of the eye and under the eye. headaches at the base of my skull so bad nothing helped. Joint pain so bad I couldn't walk for 2 days.

Patient is post menopausal and has not experienced vaginal bleeding for years. She experienced vaginal bleeding beginning about 9 days after being vaccinated.

Patient spouse came to our clinic on 4/29/2021 to report that on 3/18/2021 patient had a "brain bleed" and required emergency treatment. Patient died on 3/20/2021. Death certificate list cause of death as subarachnoid hemorrhage due to ruptured aneurysm

Client rec'd her vaccination on 04/09/2021. Approximately 2 weeks later, family states client started to not "feel well." Patient had leg pains and fatigue, as per family. On Saturday, May 8th, client drove her self to the ER, due to worsening symptoms of cough, leg pain, and shortness of breath. Client was evaluated in the ER and evaluation showed clots in bi-lateral lungs and lower legs. Surgery was performed to remove clots in lungs. Client was admitted. On 5/9/2021 client was intubated, and had an ECMO procedure. Client i remains in the hospital.

ANAPHYLACTIC REACTION; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included thyroid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: 25-MAY-2021) 1 total dose was not reported, administered on right arm 18-MAR-2021 for prophylactic vaccination. Concomitant medications included levothyroxine sodium for thyroid. On 18-MAR-2021, the patient received the shot and felt the room was coming in and out. she was probably just nervous, sat in room for duration of waiting period, felt like she had to throw up and felt hot and sweaty. She got a trash can, wanted to get some fresh air, everything and face went numb and unable to recall details, can recall nurse asking for recovery kit and oxygen. On same date, she was transported to ER (emergency room) and tongue swelling and hanging out of her mouth and was blue in color and throat was swollen Nurse assisted in lifting her head to open her airway to assist in breathing. It was diagnosed as anaphylactic reaction. Epi, steroid and benadryl received prior to transport. She was discharged on 19-MAR-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from anaphylactic reaction. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: 20210503257-JANSSEN COVID-19 VACCINE-Anaphylactic reaction. This event is labeled per RSI and is therefore considered potentially related.

BLOOD CLOTS GALORE; FEELING SICK (NOT FEELING WELL); FEELING OF WOULD NOT MAKE IT AND SAYING GOODBYE TOMORROW; MUSCLE ACHES; TIRED; LETHARGIC; BODY ACHES; This spontaneous report received from a consumer concerned a 55 year old female of unknown race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry date: UNKNOWN) dose was not reported, 1 total, administered on 16-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 16-APR-2021 after vaccination, the patient got tired, lethargic, was not "feeling well" and body and muscles started to ache and progressed further. The consumer reported that on 08-MAY-2021, the patient was feeling sick and drove herself into the hospital. On 11-MAY-2021, the patient had blood clots galore and was on dialysis. On 12-MAY-2021, the consumer had one note stating the patient was holding steady and during night the consumer stated there's no change in patient's condition. On 13-MAY-2021, patient was going through with computerised tomography scan and told later that patient would not make it and would be saying goodbye tomorrow. On 13-MAY-2021, Laboratory data included: CT scan (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clots galore, and the outcome of tired, lethargic, body aches, feeling sick (not feeling well) and muscle aches was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210529809 - Covid-19 vaccine ad26.cov2.s- blood clots galore. 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).

4/16/2021 9:45pm Severe nose bleed, went to Emergency Room, stopped bleeding, used Afrin to constrict nasal vessels, sent home - 2.5 hrs 4/18/2021 11:45pm Severe nose bleed, went to Hospital Emergency Room, stopped bleeding, used Afrin to constrict nasal vessels, sent home - 3.5 hrs 4/19/2021 8am Severe nose bleed, went to ENT, doctor packed nose for 5 days, sent home - 2 hrs **DOCTORS ESTIMATED 2 PINTS OF BLOOD LOSS TOTAL**

DEATH; COMPUTERISED TOMOGRAM HEAD ABNORMAL; MULTIPLE ORGAN DYSFUNCTION SYNDROME; HYPOXIA; HYPOTENSION; CONTINUOUS HAEMODIAFILTRATION; ENDOTRACHEAL INTUBATION; DEEP VEIN THROMBOSIS; ULTRASOUND DOPPLER ABNORMAL; LUNG ASSIST DEVICE THERAPY; DYSPNOEA; PAIN IN EXTREMITY; PERIPHERAL SWELLING; HYPOXIC-ISCHAEMIC ENCEPHALOPATHY; BRAIN INJURY; BRAIN OEDEMA; ACUTE KIDNEY INJURY; MENTAL IMPAIRMENT; HEPATIC STEATOSIS; THROMBECTOMY; PULMONARY EMBOLISM; PULMONARY INFARCTION; RIGHT VENTRICULAR DYSFUNCTION; ANGIOGRAM PULMONARY ABNORMAL; WITHDRAWAL OF LIFE SUPPORT; This spontaneous report received from a health care professional via a Regulatory Authority, VAERS (Vaccine Adverse Event Reporting System), concerned a 55 year old female. The patient's height, and weight were not reported. The patient's past medical history included ethyl alcohol abuse, and concurrent conditions included hypertension. The patient had no known drug allergies. The patient had no known other illness at the time of vaccination. The patient was not pregnant at the time of vaccination. The patient had not taken any prescriptions, over the counter medications, dietary supplements or herbal remedies at the time of vaccination. The patient had no adverse event following any previous vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 21-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 08-MAY-2021, the patient's laboratory data included CT (computed tomography) angiography of chest showed severe burden of acute pulmonary embolism (PE) with severe right heart strain, small early infarct posteromedial left lower lobe (LLL), hepatic steatosis and interventional radiology (IR) thrombectomy procedure showed large bilateral pulmonary emboli. On 09-MAY-2021 (approximately 3 weeks after vaccination), the patient was presented to the emergency room due to progressively worsening shortness of breath. The patient also had pain and swelling in the left calf and leg. On the same day, the patient experienced brain injury, brain oedema, acute kidney injury, hypoxic-ischaemic encephalopathy, mental impairment, pain in extremity, peripheral swelling and had lung assist device therapy. The patient was hospitalized on an unspecified date. On 10-MAY-2021, the patient's ultrasound venous Doppler showed complete thrombosis left femoral, popliteal, posterior tibial, peroneal and anterior tibial veins, partial thrombosis of left common femoral vein. The patient underwent urgent thrombectomy, however, on 11-MAY-2021 (the next morning), she became more hypoxic and hypotensive and was intubated and was urgently placed on extracorporeal membrane oxygenation (ECMO). The patient developed multi-organ failure and was started on continuous veno-venous hemofiltration (CVVH) for oliguric renal failure. On 13-MAY-2021, CT computerised tomogram (CT) scan of the patient's head showed diffuse cerebral edema, which was most likely a result of hypoxic encephalopathy. With no improvement in her mental status over the course of the next few days, the patient was taken off life support and died on 15-MAY-2021 due to unknown cause. The patient was in hospital for 7 days. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death, multiple organ dysfunction syndrome, hypoxic-ischaemic encephalopathy, brain injury, brain oedema, acute kidney injury, mental impairment, deep vein thrombosis, pulmonary embolism, pulmonary infarction, hypoxia, dyspnoea, pain in extremity, peripheral swelling, hepatic steatosis, hypotension, right ventricular dysfunction, continuous haemodiafiltration, endotracheal intubation, thrombectomy, lung assist device therapy, withdrawal of life support, angiogram pulmonary abnormal, computerised tomogram head abnormal and ultrasound doppler abnormal on 15-MAY-2021. This report was serious (Death, and Hospitalization Caused / Prolonged). This case, involving the same patient is linked to 20210542597. Additional information was received from patient on 01-JUN-2021. The following information was updated and incorporated in to the case narrative: Patient demographics (race, ethnic origin), added patient history, added ethyl alcohol abuse in disease tab, added batch number, added facility type and other identification numbers updated.; Sender's Comments: V1: This spontaneous report received from a health care professional via Regulatory Authority VAERS (Vaccine Adverse Event Reporting System), concerns a 55 year old female patient, who was noted to experience acute pulmonary embolism (PE), with severe right heart strain, 18 days after receiving the Janssen Covid-19 vaccine. The patient sought consult at the emergency room due to worsening of the shortness of breath. The patient also had pain and swelling in the left calf and leg. Computed Tomography Angiography (CTA) of chest showed acute pulmonary embolism (PE) with severe right heart strain, small early infarct posteromedial left lower lobe (LLL), hepatic steatosis. Venous doppler showed complete thrombosis left femoral, popliteal, posterior tibial, peroneal and anterior tibial veins, partial thrombosis of left common femoral vein. The patient underwent urgent thrombectomy. However, she became more hypoxic and hypotensive, was intubated and was urgently placed on extracorporeal membrane oxygenation (ECMO). Later, she developed multi-organ failure and was started on continuous veno-venous hemofiltration (CVVH) for renal failure. Nineteen (19) days after receiving the vaccine, Computerised tomogram (CT) scan of the patient's head showed diffuse cerebral edema, which was most likely a result of hypoxic encephalopathy. With no improvement in her mental status, life support was said to be taken off which resulted to death. It was unknown if autopsy was performed. Patient's height and weight were not reported. The patient's past medical history included ethyl alcohol abuse and concurrent conditions included hypertension. The patient had no known drug allergies. The patient was not pregnant at the time of vaccination. Information is limited in this case. However, a relationship with Janssen Covid-19 vaccine cannot be ruled out and the relationship is considered indeterminate. Additional information has been requested.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH

Bloody nose on March 20th - threw up blood clot. Bloody nose again on March 21st, same clot formed. lasted about 15 minutes each time. Seeing my PC doctor today March 22nd.

Couple of hours after the vaccine I got a fever I had a fever on 3/13/2021 & 3/14/2021. I've been through menopause & on 3/15/2021 I got my period after 18 month not getting it. It lasted for 5 days. I seen my on 3/16/2021 and she did an internal exam & she did say it appeared to be a regular period & she ordered additional tests.

Pt had J&J vaccine 1 week ago and developed spontaneous afib with RVR rates to 150, difficult to rate control, admitted to hospital for conversion. Reports se felt myalgias, rhinorrhea, headache, and fatigue for several days. Today she is extremely tired.

She had a slight fever after administering vaccine. On Mar15 till 10:30PM she is doing good, working on household chores. All of a sudden she complained about a pain behind ear that creeped to her Head (Unbearable pain). With in a minute she became unconscious and we called 911, they took her to Medical Center and moved her to another Medical Center Neurosurgeon is available. As per doctors, cause of death as per Death Certificate are as follows: Cerebral Herniation Malignant Cerebral Edema Anoxic Brain Injury Aneurysmal Subarachnoid Hemorrhage

Findings in the great saphenous, common femoral, and proximal femoral veins suggesting nonocclusive thrombus.

Day 1 & 2 after shot - left arm hurt around injection site. Day 2 I felt very tired and some body aches. By Day 5 or 6 - full body aches and my arms felt like there was pressure on them. I was feeling very tired. As more days passed; I was feeling tired, could not raise my arms, legs were weak and hurting. If I did anything (shower or carry a simple laundry basket) my arms would hurt so bad, I was out of breath and my heart was pounding so hard. By the week of March 29th - I was laying down in the middle of the day, no energy at all. Called the doctor and because of the shortness of breath & Body aches, they would only schedule a video visit for Monday, April 5th. After talking to me, they schedule to see me that day at 11:45 AM. I had weak muscle response in my arms, pale, and out of breath. They did blood work. Two hours after getting home; they called and said I needed to get to the emergency room. My red blood cell count was dangerously low, and they ordered a blood transfusion. I sent 6 days in the hospital.

On April 7th received Janssen COVID vaccine at pharmacy. On April 13 started developing shortness of breath and dizziness/light headed. Had knee surgery at hospital the 14th on right knee to remove cyst (scheduled surgery). On 15th still short of breath and felt like had cold. Worsening SOB on 16th. On 17 was SOB walking from bathroom. Talked to daughter on phone and she said to go to ER. Went to ER about 8pm and Was diagnosed with bilateral blood clots in lungs and admitted to step down on heparin drip. Getting Echo TEE on Monday 19th and bilateral leg ultrasounds today on 18th

Intermittent shortness of breath a few days prior to presenting on 4/22/2021. Patient also c/o bilateral lower leg pain, hand pain, and difficulty sleeping. Evaluation by CTA revealed Pulmonary Emboli.

PULMONARY EMBOLISM; SHORTNESS OF BREATH; MIGRAINE HEADACHE; ELEVATED BLOOD PRESSURE; NAUSEA; FATIGUE; DIZZINESS; This spontaneous report received from a patient concerned a white 56 year old female. The patient's weight was 185 pounds, and height was 67 inches. The patient's past medical history included minor surgery on 14-APR-2021 to have a cyst removed from knee. The patient had a thyroidectomy in 1997 or 1998. Concurrent conditions included migraines when she was a child (only has 1 to 2 migraine a year), allergy to penicillin, social alcohol drinker, and was non smoker. The had 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: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the patient experienced shortness of breath, dizziness, nausea, and fatigue. On 14-APR-2021, the patient experienced elevated blood pressure. On 17-APR-2021, the patient experienced pulmonary embolism and was hospitalized. Blood pressure was measured at 199/98 (approximately); blood test revealed "some kind of count from heart being elevated" and CT (computed tomogram) revealed multiple blood clots in both lungs. On 18-APR-2021 was admitted into the ICU (intensive care unit) and on the same day also experienced migraine headaches. On 19-APR-2021, a diagnostic ultrasound was negative for clots. At 17:00 the patient was discharged. Patient was hospitalized for 3 days. On 20-APR-2021, magnetic resonance imaging (MRI) and magnetic resonance venography (MRV) were performed by her pulmonologist, results not provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, dizziness, and nausea on 20-APR-2021, and migraine headache on 22-APR-2021, had not recovered from pulmonary embolism, and fatigue, and the outcome of elevated blood pressure was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210453258-COVID-19 VACCINE AD26.COV2.S-Pulmonary embolism and shortness of breath. 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).

Vaccine Induced Thrombotic Thrombocytopenia - confirmed with Lab testing Elisa PF4 highly positive 1.chills, generalized body aches, and noted that some glands in her neck were swollen. for 24-48 hours post vaccine 2. 4/27/2021, worsening headaches, bifrontal, along with some bruising in her right leg and left wrist area. Evaluated at ER. white count was 6.1, her hemoglobin was 12.5 and her platelet count was 91,000.( PLT previously 301,000). MR venogram of the head was performed with and without contrast. There was no dural, venous, sinus thrombosis or significant stenosis. The clinical impression at the time of the treating ER physician was that she had acute sinusitis 3. 4/30/2021 PCP visit Additional testing was obtained PLT 149,000. white count and hemoglobin were in the normal ranges. D-dimer was elevated at greater than 20. The fibrinogen was low at 143. Heparin platelet antibody test - lab - Negative 4. 5/3/2021 presents to Hospital. 12 to 16-hour history of back pain, bilaterally, left greater than right. It also was very painful to take a deep breath. She also noted that her fatigue was progressively worsening. CT Pulmonary Angiogram shows Thrombus within multiple right lower lobe, right middle lobe and posterior left upper lobe and medial left lower lobe pulmonary arteries. white count of 11.4, a hemoglobin of 13, and a platelet count of 254,000. Her ANC was 9. Her reticulocyte count was 1.3 and absolute reticulocytes were 0.06. Treated with Non heparin anticoagulant - argatroban IV infusion titrated to PTT lab results Discharged from Hospital with rivaroxaban ( Xarelto) 5/6/2021

HEART ATTACK; SEVERE PAIN; SEVERE HEADACHE; This spontaneous report received from a parent concerned a 56 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included was that the patient had lot of medical problems but the caller was unable to elaborate (unspecified medical problems). 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 to left arm on an unspecified date in APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in APR-2021, right after the vaccination the patient experienced severe headache. The patient also had a heart attack couple of days after vaccination. It was reported that the patient made it through the heart attack. On follow up with the parent, it was reported that the patient did not had a heart attack diagnosed by a doctor and was not hospitalized or seen in an emergency room (ER). It was also reported that the patient did not like to go to hospital and just stayed in bed. The patient experienced severe pain, started in her head as a real deep pain. The reporter was not sure about the symptoms of the reported event heart attack. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart attack on an unspecified date in 2021, and the outcome of severe headache and severe pain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20210507105-COVID-19 VACCINE AD26.COV2.S -Heart attack,severe pain,severe headache.. 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).

POSSIBLE CVA; HIGH BLOOD PRESSURE; HEADACHE; POTENTIAL BLOOD CLOT; STOMACH PAIN; LEG PAIN; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included polycythemia, and Meniere's disease, and other pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, expiry: 25-MAY-2021) dose was not reported,1 total administered on 10-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the patient had no side effects right after the vaccination. On 25-MAR-2021, the patient felt a really bad leg pain in left leg behind the knee which had lasted for five days until 31-MAR-2021 or 01-APR-2021. On 31-MAR-2021, the patient had very bad stomach pain and felt if somebody was stabbing her until 11-APR-2021. On 23-APR-2021, the patient had pain in head, it woke the patient up in her sleep; the patient had no control over the right side of body and was not able to see, walk or talk. The patient did not know how long it lasted. On 24-APR-2021, the patient was lying in bed and felt that somebody taken the bottom of the bed and flipped her out; she also had blurred vision. On 26-APR-2021, patient went to the hospital. The patient underwent a CT (computed tomography) scan and found no bleeding in brain but a possible CVA (cerebrovascular accident-stroke). The patient was asked to admit in the hospital but the patient wanted to go back home. The patient's blood pressure was really high although she had a perfect blood pressure and never took medication before. The patient was scared to take the pill and left the hospital. On an unspecified date, after coming back home, the patient suddenly lost control over left side of the body while taking bath and had blurred vision. The patient was taken to the hospital and found no bleeding in her brain. On an unspecified date in MAY-2021, a week prior to this report, the patient undergone phlebotomy and had to draw 500 ml of blood because patient had polycythemia and her blood was super thick. The patient also had a CT (computed tomography) scan and the results were unknown. On 13-May-2021, the patient had MRI (magnetic resonance imaging) and all were normal. On 14-MAY-2021, patient would be taking CT (computed tomography) angiography for finding out blood clot in brain. The patient was concerned about all events and was scared to find out if there would be blood clots in her brain. The PCP (primary care physician) of two hospitals she visited told her that she should not have taken the vaccine shot because of her polycythemia. On 14-MAY-2021, the patient's blood pressure was 175/112 (unit unspecified) and in the morning it was 156/117(unit unspecified). The patient was started with unspecified blood pressure medication and also acetylsalicylic acid (Aspirin) to thin her blood. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach pain on 11-APR-2021, and leg pain on 31-MAR-2021, had not recovered from high blood pressure, and the outcome of headache, possible cva and potential blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;20210530382-COVID-19 VACCINE AD26.COV2.S-Cerebrovascular accident, Thrombosis, Hypertension. 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

Two weeks after receiving the vaccine my legs started swelling. I went to my PCP and he measured my legs and sent me to hospital because he said that it looked like I had blood clots. While in the ER, they started performing tests, and they found a DVT in the left leg and to PE's, one on each lung. I was under observation because I was given Lovonex to thin my blood. While in the hospital the swelling started to go down and that is when I was discharged. I am now seeing a vein specialist and a pulmonary doctor. I was given Eloquis 5mg 2x per day. I am still having pain and swelling in both legs, but the leg with the DVT is worse. It is very hard to walk around because my left leg will swell a lot.

BLOOD CLOT IN RIGHT ARM; ARM SWOLLEN; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, alcohol use (beer at home), and smoker. The patient experienced drug allergy when treated with acetylsalicylic acid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on 05-APR-2021 to right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The patient did not feel sick after vaccination. On an unspecified date in 2021, the patient believed that, she had a blood clot in right arm. In past 2-3 weeks, it had been getting bigger and was moving up in her arm. She probably had the clot for longer but started noticing it more 2-3 weeks ago. Clot was moving from her elbow to the shoulder blade and arm was getting big. Patient did not have any pain but her arm was swollen and due to dark skinned she could not tell if her arm was red. Patient called emergency medical service and told them that she had a blood clot, she could feel and see the blood clot and it was told that she needs to go to the doctor but she did not bother. The blood clot kept moving up. Patient had a regular doctor but she did not inform her doctor. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot in right arm and arm swollen was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210547027-covid-19 vaccine ad26.cov2.s- blood clot in right arm. This event 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.

My last menstrual cycle started on June 15th and ended on the 19th as usual. I received the shot on June 25th at 10am. 36 hours after receiving the vaccine, I passed a 2? x 1? clot . I have always been very regular, so this is extremely irregular.

Pt called Health Department to report that she was hospitalized for a "large blood clot" in her lungs that they had to dissolve. Pt further states she was hospitalized from 6/14/2021-6/22/2021. Pt also verbalized she will now be on Warfarin for the rest of her life.

Started getting short of breath around 3:30. I was not sick before this. Around 7:30 it got worse. On 5.15/21 breathing got really bad all day. Tried to go to bed around 10pm but breathing go to where I could hardly catch a breath. Had to calll 911. Oxygen go to 82%. Diagnosed with pneumonia both lungs and sepsis. Admitted same day and discharged on 5/22/21 with an oxygen tank. They also had delivered an oxygen concentrator to my home. Was discharged and I should not have been. Discharged without any medication. I could hardly walk and was very dizzy. On 6/3/21 I saw pulmonologist and my oxygen level was at 80% without my oxygen. Had to start respiratory therapy but could not go due to no transportation.

Pt admitted to inpatient rehab hospital following a stroke with PMH significant for hypertension and hyperlipidemia. She had multiple cardiac arrests secondary to massive pulmonary embolism and right ventricular failure. Patient expired on 5/20/2021 upon chart review it was identified patient had received J&J vaccine on 4/7/2021.

SWELLING OF THROAT, DIFFICULTY BREATHING/SPEAKING. ANAPHYLACTIC REACTION. RECIEVED 0.3ML EPHRINEPHRIN, EMS CALLED AND PATIENT EVALUTAION WAS PERFORMED. PATIENT WAS RELEASED ON OWN ACCORD. PATIENT DENIED FURTHER TREATMENT.

Shortness of breath started 48 hours post vaccine. Ended up in the ER at hospital on 4/4 with sever shortness of breath and pain in back between shoulder blades. CT and blood work revealed massive Pulmonary Embolism in both lungs and enlarged right ventricle of heart. Pulmonary angiogram was completed, bed rest, ICU and EKOS catheter. Released from hospital on 4/6.

Reported to local health department by physician office. Patient reported lower left leg swelling that started on 4/11/2021. Also, reported shortness of air. Venous doppler performed and positive for DVT on 4/12/2021. Patient admitted to hospital on 4/12/2021. Inpatient currently at facility. On Eliquis. Also, tested positive for COVID upon admission to hospital.

The patient had an uneventful post-operative course and was discharged on post-op day 2. By report, on post op day 4-5, the patient began complaining of headache, back pain and abdominal pain. Continued home meds for post-op pain and constipation. On POD 8/9, the patient notified her daughter that she woke up short of breath. She was transferred by EMS to Hospital where she reportedly expired (this event was reported by the patient's daughter to doctor's office, the spine surgeon who managed her while inpatient at Hospital

I already have Thrombocytopenia, but platelets (which were averaging 90,000-95,000) dropped to 59,000

Large saddle pulmonary embolism. No DVT. Patient stable, hospitalized. Form competed upon admission, unknown duration of hospitalization at this time

PAIN; DEATH; HEART FAILURE; This spontaneous report received from a consumer concerned a 57 year old female. The reporter obtained the information from news/media. The patient's height, and weight were not reported. The patient's concurrent conditions included bronchitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 1 total start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient took vaccine and experienced pain. On 09-MAR-2021, the patient experienced wet cough; she said her cough was different. On 11-MAR-2021, the patient went to work and sweat profusely and blamed the A/C in her office. On 12-MAR-2021, the night before the patient passed, she was exhausted and went to bed. On 13-MAR-2021 08:00, the patient made a horrible noise, tried to revive in her bed to no avail. The paramedics worked on her on the floor of her bedroom, ambulance and finally the hospital. On 13-MAR-2021, the patient experienced heart failure. On 13-MAR-2021 09:00, the patient died from unknown cause of death. An autopsy was performed on an unspecified date. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart failure and pain was not reported. This report was serious (Death, Other Medically Important Condition).; Sender's Comments: V0: 20210417613 -covid-19 vaccine ad26.cov2.s -Death and heart failure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH

Healthy, active menopausal woman on estrogen containing hormone replacement therapy developed posterior knee and upper leg pain was found to have a RLE DVT 4 weeks after the J and J vaccine without any other inciting events or risk factors.

Left lower medial aspect swelling , warmth and thrombosis noted. Placed on Naproxen 500mg BID Compression stockings Heat and Cold compresses

immediately following vaccine patient developed chills and headache. Headache has continue to this date. 4/22/21 developed chest pain went to the emergency room and was diagnosed with a bilateral pulmonary embolism.

Patient reported left calf pain on 4/6/2021. She underwent lower extremity duplex which was positive for left deep vein thrombosis.

Pain in both pelvic limbs, left predominance, admitted to hospital for observation, admission April 23, discharged April 25, next appointment to angiologist May 3

TRANSIENT ISCHEMIC ATTACK (TIA)/STROKE; FELT LIKE GOING TO DIE; This spontaneous report received from a patient concerned a 57-year-old Asian and not Hispanic or Latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included blood pressure, and numbness. The patient received covid-19 vaccine ad26.cov2. s (suspension for injection, route of admin not reported, batch number: 042142114, and expiry: UNKNOWN) dose was not reported, 1 total administered on 12-APR-2021 to left arm for prophylactic vaccination. On 15-APR-2021 the patient called paramedics due to right side felt numb. Paramedics diagnosed her wrong as having a panic attack. On 17-apr-2021, the patient started feeling numb and disoriented and close to midnight she felt like going to pass out. She also felt right side was not working and she called paramedics again and was taken to emergency room. Her blood pressure was at 172/111 and she was shaking a little. She underwent the laboratory test magnetic resonance imaging (MRI), computed tomography scan, magnetic resonance angiogram and blood work was performed. On 18-Apr-2021, At 17:00, the patient was informed that she was moved to another hospital since she was diagnosed with and she was diagnosed with transient ischemic attack (TIA)/Stroke. The patient described that her side was still numb so they performed magnetic resonance angiogram (MRA). No Damage was found hence she was discharged from the hospital on 20-Apr-2021. The patient was hospitalized for 4 days. The patient was prescribed with amlodipine for blood pressure and clopidogrel bisulfate for a blood thinner. Patient reports continuing to "feel a little numb" intermittently. She describes the initial symptoms as "feeling like I was going to die". She stresses that she "has never been to an emergency room in her life". The action taken with covid-19 vaccine ad26.cov2. s was not applicable. The patient had not recovered from transient ischemic attack (tia)/stroke, and the outcome of felt like going to die was not reported. This report was serious (Hospitalization Caused / Prolonged); Sender's Comments: V0: 20210453183-COVID-19 VACCINE AD26.COV2.S-transient ischemic attack (tia)/stroke. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY

Anaphylaxis. Patient experienced shortness of breath, tingling in hands and arms, cold chills, and feeling faint.

PAIN; RASH; WEAKNESS; THROMBOCYTOPENIA; VEIN ENLARGEMENT; This spontaneous report received from a health care professional concerned a 57-year-old female. The patient's height, and weight were not reported. The patient's past medical history included previous liver disease/unknown etiology, and concurrent conditions included poorly controlled diabetic, and hyperlipemia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802068, and expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 13:20 for prophylactic vaccination. No concomitant medications were reported. on 26-APR-2021, the patient came to hospital with complaint of rash and medical team noticed bruising in her legs and found she had thrombocytopenia. Additionally, the rash was noted along with vein enlargement and she had weakness. The patient was referred to intensive case unit (ICU) and hospitalized. On an unspecified date, the patient experienced pain. She was on Motrin and now switched on Mobic for the treatment of pain. The patient was hospitalized from 4 days and still in critical care unit. Laboratory data included: Antinuclear antibody: Negative, COVID-19 virus test: Negative, Fibrin D dimer: 0.50 (range is <0.50 mg/L), Heparin-induced platelet antibody: Antiplatelet factor 4, Heparin-induced thrombocytopenia: negative, and Platelet factor 4: Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from thrombocytopenia, and the outcome of pain, rash, weakness and vein enlargement was not reported. This report was serious (Hospitalization Caused).; Sender's Comments: V0- 20210456582-COVID-19 VACCINE AD26.CCOVID-19 VACCINE AD26.COV2.SOV2.S-Thrombocytopenia,Pain,Vein enlargement. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). V0 - 20210456582-COVID-19 VACCINE AD26.COV2.S-rash,weakness. This event(s) is labelled per RSI and is therefore considered potentially related.

I have been in menopause for 7 years, taking Estradiol-Norethindrone.5-.1 mg daily for the last 16 months. I have not had a menstrual cycle for more than 7 years. I began menstrual bleeding around 36 hours after receiving Jansen COVID 19 vaccine. Experienced continuous daily bleeding for 6 days. Did not experience ant other symptoms.

Went into A-Fib 2 days after receiving vaccine. The heart rate variability recorded by my apple watch jumps 5 fold and has stayed at that level since. Had a regular heart rate before and no heart problems

Vaccine on 5/5/2021 on 5/11/2021 the patient went into cardiac arrest. The patient has a history of Acute respiratory failure with hypoxia, on O2

Day 12 post-injection hard a sharp pain in lower part of torso, then immediately passed a large clot from my vagina, bright blood accompanied. Then no post-period or anything with it. I'm post-menopausal and have no women health issues at all and haven't had a period in about one year.

Started out with what I thought were flu like symtoms - chills, then I was warm- extremly tired Then my chest started hurting- I thought this was the vaccine working- then I started getting short of breath- still thinking this is the vaccine working- then my chest started hurting extremely bad- and my abiity to breath became worse- finaly I contacted my doctor-because I thought maybe I had gotten bronchitis- so she prescribed an inhaler in the mean time - I ordered a oygen meter- and my oxygen was registering in the 80s- then my chest was getting more and more painful. And then a few days later, my oxygen started dropping down to the 70s and my body temp dropped to 95.1- I was passing out at home, although I didnt realize that is what was happening, I would just wake up and an hour would have passed and I didnt even realized I was out, and this kept happening especially during the time that my temperature kept dropping below 95. I rushed to the emergancy room which after I had been there a long time- they found that I had a *************** *********BLOOD CLOT- MASSIVE********************** A SADDLE BLOOD CLOT ************** IN LUNGS They immediately admitted me, and immediately started me on Lovonox and Coumidin I am currently on oygen and I will have to take Coumidin for the rest of my life. Due to the size of the clot (5-6 inches) they were concerned about my heart, the clot caused a strained on the right side of my heart, so they put my on a different beta blocker Coreg to slow my heart rate down, I will also have to take this medication for the rest of my life

Death 4/29/2021 Causes of death listed on death certificate: 1) COVID 19 Pneumonia 2) Acute hypoxic respiratory failure 3) advanced amyotrophic lateral sclerosis

Cramps, stroke like symptoms, headaches, quickly get tired, back aches, can't stand straight, knee pains, assistance with getting up and laying down, numbness, blood clot in left hand, left knee swells and pains , unable to do the things that she used to do

Patient was febrile at 104F. Found passed out on floor at home. SIRS from vaccine administration is the likely cause of this event

Was reported by the patients primary care provider that the patient experienced a stroke approximately 4 days post vaccination.

Approximately 15 minutes after administering the vaccine, the patient reported feeling dizzy. I checked her blood pressure and pulse and both were normal. On 4/8/21, an email from our manager of Human Resources stated that the patient was in the hospital since 4/7/21. It also stated she had a heart attacked and issues with her gallbladder.

Blood Clot blocked oxygen to the brain. Suffered a severe stroke Was hospitalized Suffered brain swelling Lost brain function Died.

PULMONARY EMBOLISM; FEVER; SLIGHT COUGH; FEELING ACHY; CHILLS; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's past medical history included right leg deep vein thrombosis (2011), arthroscopic meniscus surgery (2011), and superficial thrombophlebitis on left leg from mid-calf up to mid-thigh (AUG-2020), and concurrent conditions included factor V Leiden mutation. (2011). The patient was not on oral contraceptive pills. No immediate family had history of clots. A family member on mom's side has had clots. She had right leg deep vein thrombosis in 2011 after arthroscopic meniscus surgery on right knee, followed by long car ride. She was diagnosed with Factor V Leiden mutation in 2011 at the time of that clot. She was on warfarin for about 4 months then taken off. She did well for almost a decade. In last AUG-2020 had a superficial thrombophlebitis in left leg from mid-calf up to mid-thigh. She was Xarelto (rivaroxaban), monitored with ultrasound, taken off on 15/17-JAN-2021. The patient was previously treated with warfarin for right leg deep vein thrombosis, and rivaroxaban for superficial thrombophlebitis on left leg from mid-calf up to mid-thigh. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980), administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, the patient felt good with slight cough on the day. She experienced achy by 7 PM, went to bed, then started getting the chills. At 2 AM on 31-MAR-2021 she had fever of 102 F. The laboratory appointment on Thursday, 01-APR-2021 unrelated laboratory was ordered. On 01-APR-2021, she was walking from parking lot to a building and was very short of breath. On 03-APR-2021, she was going up one flight of stairs, and felt severely short of breath and had dry cough. On 4-APR-2021, she experienced pain between shoulder blades in back. Oxygen saturation at home was 93-94% on RA while resting. On 4-APR-2021, she went to emergency room at a computerized tomogram (CT) of chest with contrast around at 6:30 PM showed massive pulmonary embolism. The right chamber the heart was enlarged due to the blockage from the embolism. Blood levels for "stress on heart" came back high. The patient went to cath lab for pulmonary angiogram on 4-APR-2021 and had EKOS catheter direct thrombolysis. She was started on heparin and transitioned to Xarelto (rivaroxaban) on 5-APR-2021. She was on blood thinners and the left lung was cleaned up and removed. The clot was still on the right lung, unable may or may not be cleared. The patient was discharged on 06-APR-2021. The patient was hospitalized for 2 days. On 04-APR-2021, Platelet count was 181 (normal range 140-440), on 5-APR-2021, Platelet count was 160 (normal range 140-440), on 6-APR-2021 Platelet count was 154 (normal range 140-440). At the time of this massive PE event, the patient was not on any anticoagulation and since the event, had been restarted on Xarelto, and she was told she needs to continue for life. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pulmonary embolism, and the outcome of feeling achy, chills, fever and slight cough was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).; Sender's Comments: V0: A 57-year-old woman with a history of Factor V Leiden deficiency (off anticoagulation for several months) and previous DVT 10 years ago was hospitalized for pulmonary embolism four days after vaccine. The same day after vaccine, the patient reported chills and a 102 F fever. Two days after vaccine she experienced shortness of the breath and four days after vaccine, the shortness of breath became worsened with pain in the back between the shoulder blades. The patient went to the hospital and was diagnosed with massive pulmonary embolism with enlargement of the right side of the heart. She underwent direct catheter thrombolysis in the cath lab and was started on Xarelto. The patient was hospitalized for 2 days and is doing well. Although there is a close temporal relationship, the history of Factor V Leiden with previous DVT provides plausible alternate explanation for the event.

STROKE; This spontaneous report received from a patient concerned a 58 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) with unspecified dose, 1 total, administered on 12-MAR-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 14-MAR-2021, 2 days after administration of vaccine, the patient had stroke, and the patient was hospitalized on an unspecified date for unspecified duration and had since made a full recovery. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stroke. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210428874-Covid-19 vaccine ad26.cov2.s -Stroke. 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.

Pt was vaccinated on 3/16/2021 with J&J COVID 19 vaccine. Pt developed increasing URI sx @ 4/5/2021. The symptoms progressed and she noticed that she was feeling more and more sob, fatigued, and had developed some mild cp. She presented with a pulse ox of 94% on RA. No acute distress. Lung sounds diminished.

After vaccination, at 10pm I started feeling flu like symptoms, fever chills shakes feeling miserable and this lasted 3 days straight, I also had diarrhea, nausea and vomiting. I woke up with a swollen juggler vein that ended up being a blood clot, 10 days later my arm was swollen up twice the size of my leg, the juggler was still swollen. I call the urgent care nurse they said to go to ER. I went to hospital got a CAT scan and ultrasound, I was given a shot of warfarin that was supposed to last for 12 hours. I went home and the next morning instead of going to the hospital, I went to hospital and they found 2 blood clots in brain, arm and leg and neck. I have had no history of blood clots and this all happened after the J&J vaccine. They did a procedure where they tried to put a balloon to relieve the pressure. The blood clots in the brain cannot be removed because of their location and it would be dangerous to remove and I am on blood thinners for the rest of my life. Multiple blood clots in body brain, arm and shoulder.

Progressive headache, leading to ER admission, diagnosis of Left sigmoid sinus thrombosis accompanied by severe thrombocytopenia. Diagnosis confirmed as vaccine-induced immune thrombocytopenia and thrombosis (VITT)/vaccine-associated thrombosis and thrombocytopenia (VATT).

April 14, my sister was transported to hospital feeling faint and numbness in her left leg. As a result, she was admitted and treated for: ? blood pressure readings as low as 82/43, 76/50 while standing ? blood clots on her heart that traveled to her brain that were causing multiple mini strokes ? 95% blockage in her right heart vessel which required a stent ? 50% and 60% blockage in other chambers that will require attention She was given heparin and then switched to a different blood thinner to dissolve the clots. she was discharged on April 23rd with instructions to followup with her cardiologist and neurologist.

Patient developed acute dyspnea with exertion 04/27. Went to hospital ED, found to have acute hypoxic respiratory failure. CT-PE showing submassive saddle pulmonary embolism with several large emboli in bilateral upper and lower pulmonary arteries. Transferred from outside hospital to another Hospital. Started on IV Heparin infusion with transition to Enoxaparin. Had significant drop in platelet count and developed peripheral thrombi in all extremities. Concerned for HIT at that time, and review of CDC recommendations for COVID vaccine-associated thrombi, patient transitioned to Fondaparinux and remains on at present.

LEFT SIGMOID SINUS VEIN THROMBOSIS; PORTAL VEIN THROMBOSIS; SPLENIC VEIN THROMBOSIS; SUPERIOR MESENTERIC VEIN THROMBOSIS; LEFT INTERNAL JUGULAR VEIN THROMBOSIS; THROMBOCYTOPENIA; ABDOMINAL PAIN; HEADACHE; This spontaneous report was received from a physician and concerned a 58-year-old white female. Initial information was received on 27-APR-2021, with additional information obtained via telephone follow up from the physician on 29-APR-2021. The patient's specific height and weight were not reported. The patient's past medical history included fatty liver, and the patient was overweight. Family history was significant for a deep venous thrombosis treated with anticoagulants in the patient's mother, and a history of unspecified blood clots in her maternal grandmother. The patient was on no medications, including no estrogen containing pharmaceutical products or supplements. She has never been exposed to heparin. The patient had no history of COVID-19 infection. The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, route of administration not reported, batch number not reported) on 12-APR-2021. The batch number has been requested. No concomitant medications were reported. On 18-APR-2021, 6 days after receiving vaccine, the patient developed a headache. On 23-APR-2021, 11 days after receiving vaccine, the patient presented to the hospital with complaints of headache and abdominal pain. COVID test in the emergency room was negative. On 23-APR-2021, imaging of the head and abdomen revealed: left sigmoid sinus vein thrombosis, portal vein thrombosis, splenic vein thrombosis, superior mesenteric vein thrombosis, left internal jugular vein thrombosis. The patient also had thrombocytopenia, with platelet count on presentation 22,000 (units not provided). D-dimer was elevated at >12.8 (units not provided), Fibrinogen was low at 103 (units not provided), HIT antibody test by ELISA was positive, and physicians made the diagnosis of Vaccine-induced Thrombotic Thrombocytopenia (VITT). The patient was hospitalized in the intensive care unit. Treatment medications included argatroban, steroids and IVIG. Following treatment, the platelet count remained low, with a nadir of 17,000. On 27-Apr-2021, she underwent thrombectomy and thrombolysis of the intra-abdominal clots. This was performed due to the potential for portal hypertension in the future, given the extent of the thromboses. Repeat CT venogram of the head on an unknown date, revealed resolution of the sigmoid sinus vein thrombosis; the internal jugular thrombosis persisted. The patient has steadily improved since the thrombectomy. Abdominal pain and headache are improving. Platelet count has steadily risen, to 138,000 on 29- Apr-2021. Her transaminases were slightly elevated on admission and have not worsened, and she appears to have no organ dysfunction. A dialysis catheter had been placed in the event she would require plasmapheresis, but this was never used. Additional laboratory data included: IgG and IgM antibodies against the SARS-COVID-2 nucleocapsid protein positive; Protein C deficiency negative; Protein S deficiency negative; Homocysteine level (NR: not provided) negative. Serotonin release assay, anticardiolipin panel and Factor V Leiden tests were pending. The plan was to transition the patient to an oral anticoagulant and remove the dialysis catheter on 30-APR-2021, with a possible discharge on 01-MAY-2021. The patient had not recovered from left sigmoid sinus vein thrombosis, portal vein thrombosis, splenic vein thrombosis, superior mesenteric vein thrombosis, and left internal jugular vein thrombosis, and was recovering from left sigmoid sinus vein thrombosis, thrombocytopenia, headache and abdominal pain. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening). Additional information was received from physician on 29-APR-2021. The following information was updated and incorporated into the case narrative: patient history, disease course, events, outcome, lab data, concomitant drugs.; Sender's Comments: V0: This spontaneous report concerns a 58-year-old female patient who experienced left sigmoid sinus vein thrombosis, portal vein thrombosis, splenic vein thrombosis, superior mesenteric vein thrombosis, left internal jugular vein thrombosis, thrombocytopenia, headache and abdominal pain, 11 days after receiving COVID-19 VACCINE AD26.COV2.S. The patient is overweight and there is a family history of clots in her mother and maternal grandmother. Imaging of the head and abdomen revealed multiple sites of thrombus formation, platelet count was 22,000, D-dimer was elevated at >12.8 (units not provided), Fibrinogen was low at 103 (units not provided), and HIT antibody test by ELISA was positive. Physicians made the diagnosis of Vaccine-induced Thrombotic Thrombocytopenia (VITT). The patient was treated with argatroban, IVIG, and steroids. Platelet counts remained low and she underwent thrombectomy of the intra-abdominal thrombi. Following thrombectomy the platelet counts rose and abdominal pain began to improve. Lab data included a positive test for IgG and IgM antibodies against the SARS-COVID-2 nucleocapsid protein. Based on the evolving knowledge of Thrombosis with Thrombocytopenia Syndrome (TTS, per definition from Brighton Collaboration), the low platelet count and temporal relationship to vaccination, we consider the events to have a plausible relationship with vaccination.

pt stated she was watching TV about 10 days after taking the vax she had a stroke. She became where she couldnt talk and was speaking jibber jabber. Her eyes blurred. These symptoms went away and she felt better. On 4/23/21 she went to ER. Her BP was 212/117. She had multiple test. She was diagnosed w/ Stroke. She was prescribed water pills and sent home to FU w/ PCP. On 5/3/21 she saw PCP. He prescribed blood pressure medicine. She is waiting on them to call her back w/ appt date for a Carotid US. She feels better but says she has brain fog, has fatigue and right eye is still blurry.

lips and nail beds blue, 4/3/21 bumped left leg,,big bruise, felt clots, headache, metallic taste in mouth,

BLOOD CLOTS IN BOTH LOWER LEGS; LEG CRAMPS; This spontaneous report received from a patient concerned a 58 year old white non-Hispanic or Latino female. The patients weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, expiry: 25-MAY-2021) dose was not reported, frequency 1 total, administered on 18-MAR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the patient started experienced leg cramps. On 22-MAR-2021, the patient diagnosed with blood clots in both lower legs by ultrasound. Patient was put on unspecified blood thinner and started RX on 23-Mar-2021 Laboratory data included: Diagnostic ultrasound (NR: not provided) Positive for bilateral blood clots in lower legs. On 04-Apr-2021 patient went to ER for severe leg cramps, Patient got RX for Soma and started taking on 05-Apr-2021. Treatment medications (dates unspecified) included: carisoprodol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clots, lower extremities, and leg cramps. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210506805 - Covid-19 vaccine ad26.cov2.s-Blood clots in both lower legs. 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.

Recall right knee pain about 10 days after injection. Have had previous knee surgery years ago and discounted it. Then on morning of 5/02 had two episodes of severe shortness of breath with elevated, resting heart rate (high 130 beats per minute) per Fitbit. Went to Emergency Room at 1 PM and was diagnosed with two large, bilateral pulmonary embolisms and two DVTs in right leg. Transferred to another Hospital as this hospital did not have a Pulmonologist on site for the weekend. Admitted ICU at about 6 PM.

THROWING UP BLOOD; FEELING LIKE BEING CHOKED; HEAVY FEELING IN CHEST; FELT SHAKY; FELT SICK; STROKE-LIKE SYMPTOMS; PAIN IN BASE OF SPINE; LEFT TORSO AND BOTH ARMS ITCHING; DEHYDRATION; This spontaneous report received from a patient concerned a 58 year old female. Initial information was processed along with additional information on 04-JUN-2021. The patient's height, and weight were not reported. The patient's past medical history included vertebral dissection of right vertebral artery in 2000, hiatal hernia, chemotherapy, radiation, vertebral tear, 5 years of cancer drugs and stroke-like symptoms, and concurrent conditions included 2 times breast cancer survivor, non-smoker, and sulfa drug allergy cause night time swells in mouth and tongue. The patient experienced pain in base of spine when treated with pegfilgrastim for breast cancer. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, 1 in total administered at left arm on 09-APR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid, and pravastatin. On an unspecified date in 2021, the patient had elevated lactate level of 2.5 (unit unspecified) and was 1.5 (unit unspecified) on repeat and also had elevated chloride level was 110 (unit unspecified). The patient was dehydrated. On 09-APR-2021, the patient had left torso and both arms itching for 4 hours, started within half hour after received vaccine. On 10-APR-2021, the patient experienced pain in base of spine, which was exactly the same as when she received Neulasta during a previous cancer treatment regimen and patient experienced headache for 3 days. On 21-APR-2021, the patient woke up with left side numbness from head to toes, feeling like being choked as if like an allergy, felt heaviness in chest, within one hour patient felt shaky and like she was going to faint, felt dizziness/lightheaded and laid down for 2 days, later felt like her eyes were going to pop out of her head, was putting Refresh eye drops in her eyes and was having problems focusing her eyes (vision disturbances). The patient was only able to stay up for 2 hours, then had lie down because felt sick and weakness and had sever fatigue. All like stroke-like symptoms. The symptoms started on 21-APR-2021. The patient went to emergency room on 24-APR-2021 and discharged on same day. On 28-APR-2021, the patient had computed tomography scan and showed occluded right Vertebral artery. The patient had a computed tomography scan one year ago and there was no occlusion. They did a computed tomography scan that showed a same occlusion as on 28-APR-2021. On 28-APR-2021, the patient had stenosis of right carotid artery. The patient went back to emergency room on 15-MAY-2021 because she was throwing up blood and dizzy and she was told to go to emergency room. On 11-JUN-2021, she was going to see a stroke neurologist specialist a neurosurgeon 16-JUN-2021. On 15-MAY-2021, the patient went to emergency room and they re-performed a computed tomography scan and it showed an occluded right vertebral artery just as first scan did. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left torso and both arms itching on 09-APR-2021, had not recovered from pain in base of spine, and stroke-like symptoms, and the outcome of heavy feeling in chest, feeling like being choked, felt shaky, felt sick, dehydration and throwing up blood was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This spontaneous report received from a patient concerned a 58-year-old female who experienced stroke-like symptoms and occluded vertebral artery 15 days after vaccine. Past medical history included vertebral dissection of right vertebral artery in 2000, hiatal hernia, chemotherapy, radiation, vertebral tear, 5 years of cancer drugs and stroke-like symptoms, and concurrent conditions included 2 times breast cancer survivor. Concomitant medications included acetylsalicylic acid, and pravastatin. On day 12 after vaccine, the patient woke up with left side stroke-like symptoms. The patient went to emergency room on day 15 and discharged on same day. On day 19, the patient had computed tomography scan and showed occluded right Vertebral artery. The patient had a computed tomography scan one year ago and there was no occlusion. She was discharged and evaluated by stroke neurologist. There is no report of thrombocytopenia to suggest thrombosis with thrombocytopenia syndrome. Given the pre-existing history of vertebral artery dissection, there is a plausible alternative explanation for the event.

Pt is a 58 yr old female with past medical hx of copd on oxygen, pulmonary cachexia, previous strokes secondary to trauma as a result of severe spousal abuse resulting in seizure disorder who received her J and J vaccine on 6/5/21 and was admitted to the hospital on June 18th c/o 3-5 days of fatigue, increasing shortness or breath and cough, poor appetite, and was diagnosed with R middle and R low lobe pneumonia, sepsis and acute hypoxic, hypercarbic respiratory failure to the ICU where she remains admitted in critical condition as of June 24th. Prior to this she was in her usual state of health and had not been hospitalized in 19 years. She has persistent lymphopenia on her cbc and differential. She is requiring high flow oxygen and bipap support. She is being treated with antibioitics, a naso gastric feeding tube and physical therapy.

Blood clot in right calf and lungs. Blood thinners were given to dissolve the blood clots while hospitalized. Blood clot in the leg has not gone away and I continue to take Eliquis. Doppler Ultrasound performed on 6/21/2021 at doctors office and instructed to continue taking Eliquis for 3-6 months. I was on vacation at the time of receiving vaccine and hospitalization for blood clots, I have since returned home.

Significant amount of blood in urine from 23Jun2021 to 07Jul2021. Massive bleed in first few days with blood clots...over the duration the appearance slowly diminished. Soreness in right side, No urgency, pain or infection. No previous history of urinary or kidney issues. 09Jul2021 - UroScan and Scope of bladder - normal

I am 8 years through menopause and I am now having monthly bleeding (period) May was just 2 days of very very lite spotting, June was 3 days of lite spotting, July 4 days of lite bleeding. Read that it could last several months and go away again.

Patient had 5 days of bruising and left leg swelling prior to presenting to the emergency department 3/26/21, where she was found to have an extensive occlusive DVT of left lower extremity as well as thrombocytopenia of 15,000. That evening she was taken to the Cath Lab and had an IVC filter placed. The next day patient began to have paresthesias and discoloration of the right lower extremity. Ultrasound showed high-grade occlusion of the right proximal superficial femoral artery. Patient was pre-treated with platelets and taken back to Cath Lab emergently. In addition to the right SFA there is also thrombotic occlusion of bilateral iliacs. Patient had bilateral thrombectomy and bilateral common iliac stent placement. The following day developed gross hematuria.

Headache and vomiting starting one week later (4/3/2021); seizure due to hemorrhagic stroke 04/ 5/2021; continued bleeds 04/06/2021, 04/07/2021; life support removed 04/08/2021.

Janssen: Patient's son reports his mother woke up the morning of 4/7/2021 and c/o a severe headache and neck pain; around 10:45 a.m. patient collapsed and was taken to Hospital by paramedics and then later was airlifted due to a massive stroke. Patient remains hospitalized in the Neuro ICU.

As described above, about 13 hours after the vaccine I woke up at 3 am with a severe pounding and constant headache. I was also extremely fatigued so much so that I did not get out of bed or do anything all day 4/11 and didn't start feeling better until the following Monday. Then I hear in the news about the 6 adverse reactions and the J&J vaccine shutdown, possibility for blood clots etc. and to keep an eye out for various symptoms over next 2-3 weeks! It was stressful enough registering and not being able to secure the Moderna or Pfizer so I just said ok and got the J&J. Now I have something else to worry about. Heart and blood clot issues are in my family. I do not take any blood thinners and don't plan to. But now am questioning whether I should have gotten the vaccine at all. I have had enough chronic illness in my life. In fact, December 2019 I was in another town taking care of my mother and her subsequent death when I caught someone's cough. Urgent care diagnosed me with pneumonia, fluid in the lungs, put me on course of antibiotics. I couldn't breathe, needed a nebulizer etc. They called me and said it was not pneumonia or flu a or b (I get the shot every year) and to go to the ER if it got worse. I couldn't eat or move much for three weeks and breathing was extremely difficult. I had to get a nebulizer. Eventually went away. Then in March Covid 19 became official. When I tested for Covid 19 here at a state site in 2021, I tested negative.

Low grade fever, aches & chills on 3/13/21 & 3/14/21. Felt better 3/15/21 through 3/18/21. Side effects ( fever, aches, chills ) returned on 3/19/21 & 3/20/21. Suffered stroke on 3/21/21 at 3:30 AM due to blood clots. Passed away on 3/22/21.

Patient received J and J covid vaccine on 4/11/21 at an unknown location. Patient presented to hospital in cardiac arrest on 4/12/21. Patient was resuscitated and it was noted the patient had a ST elevation myocardial infarction. Due to the patient's size (246.7kg) she was unable to be treated for her condition with our equipment as she was over the weight limit for our equipment. She was transferred for additional care

patient developed DVT and stroke on 4/8 however she had been in hospital from 3/31 to 4/5 with SMART syndrome and L sided weakness . after discharge she was inactive. returned to hospital on 4/8 with stroke in the region of SMART syndrome. Smart syndrome can cause stroke, but does not cause DVT. platelets are normal.

Eight days after receiving the vaccine, my wife developed shortness of breath, headache, fatigue, and unusual vision problems. She was taken to the emergency room on 4/15 where she underwent a battery of tests (see details below). She was admitted to the hospital (where she currently is) and was diagnosed with blood clots in the lungs and two strokes in the area of the brain that affects vision. She then underwent ultrasound tests of her legs and carotid artery, which were negative for signs of blood clots. Although my wife's symptoms are different than the symptoms of others that led to the vaccine pause, her doctors strongly encouraged us to report it to the VAERS. My wife had no underlying or pre existing conditions that would lead to blood clots in her lungs, and stroke. After extensive testing there is no evidence that the blood clots in her lungs as well as the clot/clots that went to her brain initiated in her legs. They believe that some sort of "event" would have had to happen to cause these blood clots, and the only unusual thing in the time frame of this condition is the vaccine. As I mentioned earlier, my wife is still hospitalized.

On 3/17/21 patient returned to clinic complaining of sudden onset of dizziness, weakness, shaking, some SOB and anxiety. Patient reports this started suddenly at noon. She reports associated lightheadedness and difficulty with focusing her vision. She reports "feeling like I am going to pass out and not wake up". Denies nausea, vomiting, head injury, fall, slurred speech, confusion, or chest pain. Last meal was previous night, has not eaten that day. She denies recent alcohol use, did admit to smoking marijuana prior to episode starting. She did have the Johnson&Johnson Covid vaccine on 3/12/21, only has had a sore left arm, denies other side effects. Patient was sent to the emergency department via ambulance for further evaluation. Work up at the emergency department showed bilateral pulmonary embolisms.

Patient reports muscle spasms and soreness following vaccination. She states that the spasms are within her pectoral muscle. She presented to her physician who diagnosed her with upper body systemic inflammatory response and recommended she go on a supplement to help with inflammation. She has a follow up scheduled with her provider on 04/22/2021.

Cerebellar IPH with IVE requiring intervention (failed angiogram, then craniotomy with clipping) Dural arteriovenous fistula

On 04-12-2021 at night, I noticed blood in my urine. I saw my PCP on 04-13-2021. On 04-14-2021, I again had blood in my urine. I called my urologist and was seen on 04-14-2021. My blood platelets were extremely low. I was then referred to see a hematologist who sent me to the hospital. I was admitted at Hospital where they performed lab work, MRI's and CT scans. I stayed two days at the hospital. The hematologist who saw me said I have thrombocytopenia. Other tests were also performed and they checked me for stroke and I did not have a stroke. I am concerned due to my thrombocytopenia, if I get cut, I will bleed a lot and this is interfering with my job and to carry out my daily functions. I am still not recovered and my platelets are low. I still have to follow-up with my PCP and my hematologist has to check my bone marrow as the next step of treatment.

Experienced an unusual headache on about April 8th. It felt like it was behind my left eye, and in front of my left ear. Pain subsided in about an hour after resting. On April 28th, I experienced vaginal bleeding. I awoke to a dry cough and felt the leakage. The blood was bright red and I'd estimate 4-6 Tablespoons. I feel light-headed, concerned, but otherwise fine.

Cough, fatigue and dyspnea on 3/22/21 ER visit on 4/1/21 diagnosed with COVID pneumonia Pain and swelling in right leg Positive for DVT in lower extremity Hospitalized and diagnosed with PE

Pt developed pain in the left groin after 3 days. Patient had a venous doppler and is diagnosed with DVT of the left anterior tibial vein

On 04/21 left knee pain, outside/back of knee 04/23 - left side tingling , went to urgent care and then referred to ED due to concern about stroke. Sent home after leg scan - was told it was normal and referred to neurologist 04/29 - back to ED, admitted overnight, scan from 04/23 showed blood clot behind the knee. Also diagnosed by neuro with TIA Also stated she had swelling, redness, and headaches for 4-5 days after vaccine

On 4/19, I woke up with severe abdominal cramping, vomiting and diarrhea. The diarrhea turned to bright red blood, so I went to the ER. I was diagnosed with severe sepsis and colitis. Although I was diagnosed with sepsis, I never had a fever and all blood cultures came back negative. Before I was released, I went into uncontrolled atrial fibrillation. I never had any history of colitis or atrial fibrillation prior to this. No one can explain why there was no fever or pathogen detected.

Patient reported heart attack due to blood clot. Patient report catheterization with stent placement.

CONTINUED TO BLEED; HAEMORRHAGIC STROKE; VOMITING; HEADACHE; PLATELET COUNT DECREASED; BIOPSY SOFT TISSUE; BRAIN SCAN ABNORMAL; POSSIBLE CEREBRAL VENOUS SINUS THROMBOSIS; BRAIN COMPRESSION; BRAIN STEM HAEMORRHAGE; BRAIN STEM SYNDROME; CEREBRAL HAEMORRHAGE; HEMIPLEGIA; SEIZURE; This spontaneous report received from a health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAER reference number 1244328 and 1199143) concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included pre-diabetic. It was unknown if patient was taking any prescriptions, over-the-counter medications, dietary supplements, or herbal remedies at the time of vaccination. No allergies to medications, food, or other products was reported. The patient was not pregnant at the time of vaccination. The patient did not have an adverse event following any previous vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 (also reported as 27-MAR-2021) for prophylactic vaccination. Anatomical vaccination site were not reported. No concomitant medications were reported. On 03-APR-2021, one week after vaccination, the patient had headache and vomiting. On 05-APR-2021, the patient had seizure due to hemorrhagic stroke. On an unspecified date, the patient experienced brain compression, brain stem haemorrhage, brain stem syndrome, cerebral haemorrhage, hemiplegia, possible cerebral venous sinus thrombosis, biopsy soft tissue, and brain scan abnormal, and was hospitalized. On 06-APR-2021, the patient had a surgery to remove pressure on brain and brain stem (craniectomy). The surgeon noted alarmingly low platelet counts (results unspecified). The patient had platelet transfusion. The patient was hospitalized for '4 days'. The patient continued to bleed on 06-APR-2021 and 07-APR-2021. The patient was removed from life support on 08-APR-2021. The patient died on 08-APR-2021. It was unknown if autopsy was performed. Laboratory data reported following: Brain scan was abnormal and showed abnormal, multi-focal brain bleeds and increased compression of brain. On 07-APR-2021, Brain scan abnormal which showed increased bleeding and brain stem injury. On 08-APR-2021, the patient died from possible cerebral venous sinus thrombosis. Laboratory data (dates unspecified) included: Biopsy soft tissue (NR: not provided) unknown, Pathology test (NR: not provided) unknown. On 08-APR-2021, the subject died from possible cerebral venous sinus thrombosis. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of possible cerebral venous sinus thrombosis, brain compression, brain stem haemorrhage, brain stem syndrome, cerebral haemorrhage, hemiplegia, seizure, haemorrhagic stroke and continued to bleed on 08-APR-2021, had not recovered from headache, vomiting, and platelet count decreased, and the outcome of biopsy soft tissue and brain scan abnormal was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged). This case, involving the same patient is linked to 20210441454. Additional information was received on 24-MAY-2021. Following information was added and incorporated into the narrative. Additional events of haemorrhagic stroke and continued to bleed were added, seriousness of events platelet count, vomiting, and headache was updated, additional reference numbers were added, additional vaccination date added in narrative, labeling updated, and course of event and laboratory data updated. It was determined that Manufacturer Case Number 20210441454 was a duplicate of this case. All relevant information regarding this case will be submitted under Manufacturer Case Number 20210500861. Upon review, the following information was amended: events biopsy soft tissue and brain scan abnormal was updated from non-serious to serious as this was on the earlier VAERS report.; Sender's Comments: V2: Additional information received regarding updates in seriousness of events, labeling, course of events, case identifier; and additional evets of hemorrhagic stroke and "continued to bleed" did not alter prior assessment. This fatal spontaneous report (VAERS ID 1244328) concerned a 59- year- old female who experienced vomiting, headache and seizures and was hospitalized for brain compression, brain stem hemorrhage, brain stem syndrome, cerebral hemorrhage, hemorrhagic stroke, hemiplegia, possible cerebral venous sinus thrombosis 16 days after Janssen COVID-19 vaccine was administered for prevention of symptomatic SARS-CoV-2 virus infection. The patient's height, and weight were not reported. The patient was pre-diabetic with no known allergies. Concomitant medications were not reported. Biopsy soft tissue was done (results not reported) and brain scan showed multi-focal brain bleeds and increased compression of brain; the patient underwent neurosurgery. The platelet count was decreased (result not reported) and received platelet transfusion. Follow-up scan next day showed increased/continued bleeding and brain stem injury and a day later she died from possible cerebral venous sinus thrombosis. It was unknown if an autopsy was performed. Although the subject's pre-diabetic status may have contributed, based on evolving knowledge of Thrombosis with Thrombocytopenia Syndrome (TTS, per definition from Brighton Collaboration - BC) and considering the low platelet count and temporal relationship to vaccination (BC Criteria level 5), the events are assessed to have a plausible relationship with vaccination.; Reported Cause(s) of Death: POSSIBLE CEREBRAL VENOUS SINUS THROMBOSIS

MI-had catherization 4/3-transferred to hospital for possible CABG but had acute renal failureso deferred. Underwent another cath 4/20 with stent placement

I came home from work on the 14th and I was freezing cold. I laid on my bed and bundled up in 5 0r 6 blankets even though it was 110 degrees outside. I got up and took a couple of Tylenol and went to sleep. Got up the next day and went to work and worked through my day and took my grandchildren somewhere and I got home and I was freezing and miserable. I took a couple Tylenol. On Wednesday, my husband said "This isn't normal" and he took me to Urgent Care - and they tested for COVID it came back positive for COVID. Gave me a cough medicine prescription - but it was starting to upset my stomach. Had my husband to give me bananas and applesauce and when I eat that then I take the medication so it won't upset my stomach. And I can't breathe, I cough and have fevers and pain. I am pretty sure right now I have blood clots in my legs. I get up every once in a while to get something to eat and I'm really light headed and dizzy. Have to hold on to walls - don't feel stable in walking. And then I lay down in bed again. I did get my doctor to call in a large dose of Zofran. I've got Zofran now and two different cough medicines. Other than the cough medicine (which makes me dizzy when I call back) - it does prevent me from coughing. Symptoms ongoing. I've tried to force myself to get up more today and move around more to do a few things. I have had to take my work in small portions to fold three or four pieces of clothing and then rest a while. I don't have the energy to hardly do anything. I'm nervous to going back to work. I'm in the process of recovery.

Massive pulmonary embolism necessitating a thrombectomy. Hospitalized from 6/15/21 - 6/23/21. Also anticoagulated with heparin and then transitioned to apixaban. Was not accompanied by thrombocytopenia

Reporter stated that patient got real ill and new symptoms arrived everyday from the day she reviewed the vaccine.. loose stool, fatigue nausea and pain in her spine and headaches. . A few days after the vaccine patient went to the hospital and tested positive for COVID. Patient went to the Hospital on June3rd around 5pm. Test was perform and said she was filled with inflammation of the spine. Patient was release from hospital on June 4th with pain killers and steroids. Patient was pronounced dead on June 6th.

Patient have Severe Covid-19. Admitted Yesterday with positive PCR Covid-19 test. On Mechanical Ventilation, in ICU with Severe Respiratory Distress, Coded 2 times yesterday.