Johnson & Johnson

Patient developed Severe INflammatory response syndrome . Was hospitalized as her cbc was abnormal and no infection could be found, could not walk or take care of herself

Patient experienced a brain hemorrhage and was hospitalized on Monday, March 15. Despite numerous tests, doctors could not find the source or cause of the bleeding. Over time, the bleeding spread to other areas of her brain including her brain stem. Damage from the bleeding was so severe that she would not recover. She passed away on March 24 after being removed from life support.

Good morning, I have the patient in the hospital. We have had to give her 2 transfusion in the last 2 weeks and 2 days. The patient also had a more pronounced stroke system. We read today that people with the systems of low platelets and stoke system need to report. I have called everyone and have had no help. I believe it has to be the health department.

On the evening of 04/11/21 patient states she began to have some vaginal blood spotting, on Monday 04/12/21 patient reported vaginal blood flow. Patient reports she is post menopausal and has not had a period, spotting, or blood flow in years.

Patient reports that she had pain behind her eye. Went to hospital and was diagnosed with having a stroke. Patient states she lost sight in her left eye and is still blind in her left eye. Optometrist states patient will not regain her vision in her left eye.

initial symptoms- rash, itching, elevated BP, headache, ankle swelling ultrasound on 4/6/2021 - bilateral DVT CBC low platelets - 16 thousand CT chest - moderate burden PE Pt. was hospitalized

Patient woke up to get ready for work and noticed blood coming out of right ear. Clots were in the blood that came out of the ear.

Six days after receiving the Johnson & Johnson/Janssen vaccine, the patient complained about strong pain in the right arm (same as vaccination arm). She went to the ER on the 7th day after receiving the vaccination and after doing EKG, ultrasound, and CT scan, they found multiple blood clots in her right arm where she receive the vaccine.

Pt has a history of DM2, HTN, HLD, HCV cirrhosis (sp treatment, Child Pugh A), CKD3 with baseline Cr 1.5 who presented to the ER after a syncopal episode and with headaches. She has no history of a positive COVID test. She reported receiving the J&J vaccine on 3/6 and reports headaches since then. She also had a syncopal episode that prompted her presentation to the ED. She underwent MRV of the brain looking for sinus thrombosis. The brain portion was normal but she was found to have a LIJ thrombus. She denies prior history of VTE. It is overall unclear if this thrombus is related the her symptoms, to the vaccine, or completely incidental. Pt was started on a heparin drip in the hospital...

I woke up from almost like a pop in my brain and fluid started pouring down my throat and I started choking. I woke up and was able to spit some of it out. It was clear and also tinged with blood. It stopped once I stood up. I immediately thought my brain was leaking. I told my daughter about this the next day. My balance was off and I had a weird flapping in my head for the next few days. As well as a headache. A few days after I heard about the blood clots. I am not 100% sure if it was from the shot but it was literally hours from when I received it. It was very scary.

IDIOPATHIC THROMBOCYTOPENIC PURPURA; This spontaneous report received from a company representative concerned a 60 year old female. Initial information was processed with additional information received from the patient's physician, in response to telephone follow-up, on 26-APR-2021. The patient's weight and weight were not reported. The patient's concurrent conditions included hypertension, hyperlipidemia, and obesity. She was a non-smoker and had no history of acute illness. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) frequency one total, dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included blood pressure medication, vitamins, and a statin (all unspecified). On 21-APR-2021, the patient experienced Idiopathic thrombocytopenic purpura and was in critical condition. The patient presented with petechiae on her legs. Her platelet count was low, less than 9000 and all other labs were normal. The patient was hospitalized on 21-APR-2021 and the duration of hospitalization was not reported. The patient did not have any clots and she was treated with decadron and Intravenous immunoglobulin. On 22-APR-2021, the patient's and improved the next day with platelet of 30,000 and she was discharged same day. on an unspecified date anti-PF 4 antibodies were performed and were normal. Fibrin D-dimer tests were not performed. The reporter stated the discharge diagnosis was Idiopathic thrombocytopenic purpura which could have been related to recent vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from Idiopathic thrombocytopenic purpura. This report was serious (Hospitalization Caused / Prolonged, Other Medically Important Condition, and Life Threatening).; Sender's Comments: V0: This 60-year-old female was hospitalized for immune thrombocytopenia 25 days after receiving the Janssen Covid-19 vaccine for the prevention of symptomatic SARS-CoV-2 virus infection. Concurrent conditions included hypertension, hyperlipidemia, and obesity. She was a non-smoker and had no history of acute illness. Concomitant medications included unspecified blood pressure medication, a statin, and vitamins. Twenty-five days post-vaccination, she developed petechiae on her legs and was found to have a platelet count of 9000; all other labs were normal including anti-platelet factor 4. She did not have clots. She was admitted to the hospital the same day and was treated with dexamethasone and iv immunoglobulin. The next day, her platelet count improved to 30,000 and was discharged. Based on the available information, the relationship with Janssen Covid-19 vaccine is considered indeterminate. Additional information has been requested.

Patient developed cold symptoms with heavy drainage on 4/15/21. Patient took a whole package as directed but continued to get worse. Used Vicks Vapor Rub and took a couple doses of sinus medication after the Coriidin was gone. Started severely hurting with difficulty breathing and chest pain on 4/27/21. Went to The Hospital on 4/28/21. Was diagnosed with pneumonia, pulmonary embolism in left lower lobe pulmonary arterial branches. Patient was admitted. Patient placed on Rocephin 1 gram IVPB daily and azithromycin 500 mg IVPB daily. Patient was started on therapeutic dosing of Lovenox and then transitioned to Eliquis 10 mg BID for 7 days then 5 mg BID. See hos.

From what I understand the night of the dose she had chills and a headache. She had several bad headaches since that vaccine up until her death on April 21st. She was given the J&J vaccine on April 8th at the CVS. Died on April 21. at home. I just saw an article today, May 4th that about 1-2 hours from her death, another female in her 30's got the J&J vaccine on the SAME DATE April 8 and she died on APRIL 19th. Pretty close in deaths and same vaccine. IS IT CONNECTED?

4/6/2021 vaccination. Within an hour, I had hives .5", and spread to smaller all over body. I had a hard time breathing. I was fine for the first 15 minutes. I started to get itchy, neck started to hurt. My head was all broken out. All down my legs. An hour or 2 later is when it started to itch really bad. Burning going down my arm. I went to work and worked rest of the day, hard time breathing. I had major stomach ache. I couldn't eat. The HA kicked in and had asthma attack. Fever started; 102. Stomach cramps. HA was severe for quite a while. Seven days later, I called my doctor. 4/13/2021 Saw PCM; Pneumonia and sinus infection. Put on upper respiratory medication; Sefedna. *Migraine for 12 days, became a HA for almost a whole month. 102 FEVER lasted 7 days vomiting for 2.5 weeks body aches, chills, teeth chattering; first 2 days extreme fatigue 4/12 or 4/19 (?); COVID + *still experiencing muscle and joint pain *felt like breathing bleach whole time

I experienced acute onset of dizziness with chest pain, shaking chills, muscle spasms in my legs, headaches and nausea. I went to hospital where they did lab work, 1280 EKG, gave me fluids, and gave me Zofran medication. They also gave me a prescription for meclizine. They also did a Covid test which was negative. I saw my PCP on 04-11-2021 who ordered a chest x-ray and lab work. I also saw my PCP 05-11-2021, because I had a TIA on Sunday 05-09-2021. I still being worked up on lab work, TIA and an MRI has been ordered for next Monday 05-17-2021.

I woke up Wednesday and I felt like I was hit by a train. I felt like a wet dish rag hanging on the sink. Everything hurt, even taking a step, I just felt bad, tired like the flu but no respiratory issues. By the 14th I started getting short of breath, couldn't walk without SOB, my legs started to swell, joints were sore, I felt tired. Went to the doctor and my blood pressure was high, I was prescribed medication for my blood pressure and fluid pills. It hurt just to brush against the skin on my calf. An ultrasound revealed 4 blood clots in my left calf. Went to the ER at . Hospital in and sent to hematologist Dr. and there were no findings.

POSSIBLE SMALL STROKE; POSSIBLE TRANSIENT ISCHAEMIC ATTACK (TIA); SUPER DIZZY; THROWING UP; COULD NOT OPEN EYES; WIERDLY AND EXCEEDINGLY THIRSTY; COULD NOT WALK; NUMBNESS IN LEFT ARM; COULD NOT STAND; HEAVINESS IN LEFT ARM; NAUSEOUS; HEADACHE; FELT LIKE HAD CHILLS LIKE ONE GETS FROM THE FLU; This spontaneous report received from a patient concerned a 60 year old White, Not Hispanic or Latino female. The patient's weight was 175 pounds, and height was 65 inches. The patient's concurrent conditions included slightly elevated blood pressure, alcohol user socially and on weekends, non smoker, and penicillin allergy since childhood. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, expiry: UNKNOWN) dose was not reported, 1 total, administered on 08-MAR-2021 for prophylactic vaccination. Concomitant medications included valsartan for elevated blood pressure, acetylsalicylic acid, and furosemide. On 10-MAR-2021, the patient felt like having chills like getting from the flu, for couple of hours might be, a headache for several days, might be for 3 days. For that the patient took some Advil 200 mg every 6 hours for the first couple of days. Then that passed and felt fine. On 24-APR-2021, around 04:00 in the morning the patient woke up and felt weirdly thirsty, exceedingly thirsty and super dizzy, nauseous thought was having a heart attack and heaviness and numbness in left arm but could still move the arm, however could not walk and could not open eyes until was in hospital. As a treatment Aspirin was given to the patient by husband. The patient was throwing up, could not stand. About 05:30 went to the hospital and ran many tests. Ruled out brain bleed, heart attack, anything cardiac did a CAT scan; bloodwork found that the patient was low in potassium and it was determined that the patient either had a small stroke or a TIA that dissipated on its own. The patient saw her cardiologist and wore a Holter monitor for 10 days. The patient also has an appointment with a neurologist coming up in June and having another CAT scan. Also seeing a vascular neurologist. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from possible small stroke, possible transient ischaemic attack (TIA), super dizzy, could not open eyes, wierdly and exceedingly thirsty, could not walk, throwing up, numbness in left arm, could not stand, heaviness in left arm, and nauseous on 2021, felt like had chills like one gets from the flu on 10-MAR-2021, and headache on MAR-2021. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: covid-19 vaccine ad26.cov2.s-Possible small stroke, Possible transient ischaemic attack , super dizzy, could not open eyes, wierdly and exceedingly thirsty, could not walk, throwing up, numbness in left arm, could not stand, heaviness in left arm. These events are considered unassessable. The events 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. covid-19 vaccine ad26.cov2.s-Nauseous. This event is labeled per RSI and is therefore considered potentially related.

cardiomegaly, with significant bilateral lung abnormality. in addition, pulmonary edema with extensive bilateral multifocal pneumonia

Patient became dizzy upon standing and experience left sided weakness. Ambulance was called and patient transported to hospital. Upon exam it was determined the patient had a bleed on the ride side of the brain. After 4 or 5 days she was transferred to Rehab. She was then sent back to hospital after complications. Patient began having kidney problems and was undergoing dialysis. 06/16/2021 patient began having bad headaches, CT scan showed multiple previous strokes(clots). Patient currently still in hospital.

Could NOT breathe, Afib increased, could not walk 15 feet without stopping, gasping for air at night when trying to lay down, major edema in legs and feet - this lasted approximately 2 weeks. Then returned on 6/17 & 6/18.

CHEST X-RAY; ELECTROCARDIOGRAM; NUMBNESS IN RIGHT ARM; TINGLING IN RIGHT ARM; COMPUTERISED TOMOGRAM; ULTRASOUND SCAN ABNORMAL; HYPERTENSION; SKIN SENSITISATION; ARTHRALGIA; PAIN; FATIGUE; PERIPHERAL SWELLING; DEEP VEIN THROMBOSIS; PULMONARY EMBOLISM; GAIT DISTURBANCE; FEELING ABNORMAL; DYSPNOEA; INFLUENZA LIKE ILLNESS; MALAISE; This spontaneous report received from a patient via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (ID: 1331063) concerned a 60-year-old female. The patient's height, and weight were not reported. The patient's past medical history included degenerative disc disease (neck surgery (four discs repaired), and knee replacement, and concurrent conditions included fibromyalgia, and arthritis. The patient had no known allergy and current illness at the time of vaccination. The patient received covid-19 vaccine ad26.cov2. s (suspension for injection, route of admin not reported, batch number: 1802072, and expiry: UNKNOWN) dose was not reported, 1 total administered on 08-MAR-2021 15:00 at right arm for prophylactic vaccination. Concomitant medications included diclofenac, ibuprofen, oxycodone hydrochloride/paracetamol. The patient woke up and felt like she was hit by a train (feeling abnormal) and felt crappy for next 3-5 days, everything was hurting (malaise), even taking a step. She experienced gait disturbance, patient felt bad, tired like the flu (influenza like illness) but does not had respiratory issues. On 12-MAR-2021, she had dyspnea. Patient started symptoms shortness of breath, could not walk without SOB (Shortness of Breath), her legs started to swell (Peripheral swelling/edema), joints were sore/pain (arthralgia), she felt tired (fatigue). On 23-MAR-2021, she visited doctor with high blood pressure (hypertension) and edema, she was prescribed medication for blood pressure and fluid pills (unspecified). Four days later, her legs were swollen bigger, and the PCP switched the medication. It hurt to brush against the skin on her calf (skin sensitization). The patient was diagnosed 4 blood clots (thrombosis) in left calf by ultrasound scan. She ended up in the emergency room the following day, and Computerized tomogram scans were performed and they found pulmonary embolisms in the lower lobes of both lungs. The patient was also diagnosed with electrocardiogram, computerized tomogram, Blood test and chest x-ray. Laboratory data included: Computerized tomogram (NR: not provided) pulmonary embolisms in the lower lobes of both lungs, and Ultrasound scan (NR: not provided) 4 clot on left calf (abnormal). She has been taking Xarelto ever since. In JUN-2021, she said that she began feeling tingling numbness in her right arm, from her elbow to her fingertips. It tingles most of the day and wakes her up at night. Patient was on blood thinners. Laboratory data (dates unspecified) included: Blood test (NR: not provided) unspecified, Chest X-ray (NR: not provided) Not reported, and Electrocardiogram (NR: not provided) not reported. Treatment medications (dates unspecified) included: rivaroxaban. The action taken with covid-19 vaccine ad26.cov2. s was not applicable. The patient recovered from feeling abnormal, had not recovered from deep vein thrombosis, skin sensitization, peripheral swelling, pain, malaise, influenza like illness, hypertension, gait disturbance, fatigue, dyspnea, arthralgia, chest x-ray, computerized tomogram, electrocardiogram, and ultrasound scan abnormal, and the outcome of pulmonary embolism, numbness in right arm and tingling in right arm was not reported. This report was serious (Other Medically Important Condition). This case is a duplicate of 20210538232. Additional information was received from patient on 13-JUL-2021. The following information was updated and incorporated into the case narrative: reporter details (first and last name, address, city, zip code, office, email address), Updated disease start date (degenerative disc disease and knee replacement), Events added (pulmonary embolism, numbness in right arm and tingling in right arm), updated event (thrombosis to deep vein thrombosis), Updated event onset date (deep vein thrombosis, ultrasound scan and computerized tomogram) updated lab dates(ultrasound scan and computerized tomogram), updated lab result(computerized tomogram), Added vaccination time and treatment drug(Xarelto) and vaccine facility details (vaccine facility name, city and military information) Upon review following information was amended: Removed partial date (2021) of event Electrocardiogram and lab test (chest x-ray, electrocardiogram and blood test). Additional information was received from patient on 13-JUL-2021. It was determined that (20210538232) was a duplicate of this case. All relevant information regarding this case will be submitted under (20210556305); Sender's Comments: V1-20210556305-Covid-19 vaccine ad26.cov2.s-PULMONARY EMBOLISM and DEEP VEIN THROMBOSIS. Follow-up received regarding Other Information: reporter details, disease start date, Events added, updated event (thrombosis to deep vein thrombosis), event onset date ,lab dates,lab result, vaccination time , treatment drug and vaccine facility details . 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). 20210556305-covid-19 vaccine ad26.cov2.s-Thrombosis, ultrasound scan abnormal. This events are considered unassessable. The events has a compatible/suggestive temporal relationship, are unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.

weakness, nausea, dry heaving, abdominal cramping and headache for a 2 day duration. Abdominal CT showed 5 cm left adrenal mass consistent with acute adrenal hemorrhage. Platelets were 32,000 on admission. On the evening, the patient had a change in mental status; head CT revealed acute subarachnoid hemorrhage and small intraparenchymal hemorrhage.

Neck and back pain night of vaccine... then 30 hours later Heart Attack (Myocardial infarction); Treatment: blood thinners (TNK and Heparin), Stent in coronary artery. outcome: hospitalization 3 days and then recovery and fatigue ongoing...

Patient received the vaccine on 3/23/21 and developed symptoms of COVID on 4/5/21 (abdominal discomfort, heartburn, shortness of breath, and cough). On 4/8/21 she was admitted to hospital with COVID and is currently on supplemental oxygen.

Patient experience flu like symptoms and body aches the same evening after receiving vaccine. On 4/1/21 the patient experienced nausea, high blood pressure, and a headache. Around 7:00 pm that night the patient threw up and became unresponsive. The patient was then transported to the hospital by ambulance. A CT scan showed a brain bleed and the patient was intubated and transferred to another hospital.

Stroke- hearing loss in right ear, extreme headache left temple lobe, nausea, dizziness, diarrhea, inability to move legs. Hospitalized for 5 days Continued weakness left side of the body

Traveled and reported to family that she was disoriented and having some confusion. Was evaluated at ED, had some electrolyte imbalance and UTI. Once resolved, she continued to have neurological symptoms and was diagnosed with a stroke, including early onset dementia per telephone interview with daughter.

The patient presented 3 weeks post injection with cardiac arrest from home. She had a 1 hour downtime. The day previous she had worsening leg swelling and SOB +DOE. Post arrest she was diagnosed with massive PE. She was treated for PE with thrombolytics and improved hemodynamically. She unfortunately at this time has anoxic brain injury.

Patient states that she developed altered mental status approximately 4 days after receiving the vaccine as witnessed by family and friends. Her mental status continued to decline over 2 week period, at which time she was brought to the hospital on April 13th. At that time, it was determined the patient had suffered an age-indeterminant ischemic stroke with hemorrhagic conversion. No neurosurgical interventions were done at this time as patients symptoms have appeared to improve after observation.

severe eye pain left eye 9 days after the vaccine then periorbital swelling and increased intraocular eye pressures and thrombocytopenia platelets 63,000. Saw ophthalmologist who diagnosed idiopathic periorbital inflammation; no fistula or infection seen by mri/mra and carotid angiogram. Patient was treated with prednisone and platelets came up to 130,000 and improvement in pain and swelling and intraocular pressure dropped from 50 to 14.

Whether the adverse events were caused by the vaccine is to be determined. We are available to discuss more details if this information can be used to help others from experiencing these reactions. The morning after getting the vaccine, patient discovered that she could not swallow. As her condition worsened, she was taken to the emergency room. Over the past month, patient went to the emergency room 4 times. The last time resulted in extended hospitalization that continues to this day. In addition to the swallowing problem, two other major adverse events need to highlighted. First, on 27 March, while in the hospital, vaginal bleeding started. On 29 March, her doctor, performed a hysteriscopy/DNC finding " "an unexplained blood clot (hematoma)." The second major event was when patient demonstrated significant confusion and lack of memory. On 7 April, she was diagnosed with Metabolic Encephalopathy. Neurologists at the hospital suspected that her MS was reacting to her UTI and once the infection is eliminated her memory should come back. But as of 10 April, she was still having issues including hallucinations. Although she is eating some as of 13 April, she is still very weak and will likely by moved from the Hospital to a rehab facility. She still does not remember much of the last 37 days.

3/29/21 6 pm - Severe pain lower right leg, ankle, and foot, unable to weight bear on right leg About an hour later I was able to walk a little. Stayed off my feet. Right foot became very cold. 3/30/21 Saw my primary care physician at med center. She sent me for an ultrasound at medical arts. From there I was sent to the emergency room at hospital. I asked the attending physician assistant about a correlation between the blood clot and the Covid vaccine because I had read about it being a concern in other countries. He stated that was a bunch of baloney. Was told to have a repeat ultrasound in a few days and was prescribed a 30 day starter pack of Xarelto and released. 3/30 repeat penis ultrasound of right leg showed the same results. 4/1 appointment with hematologist. Prescribe Xarelto for three months and ordered a repeat ultrasound in three months and bloodwork at that time.

on March 28th I was diagnosed with covid19. The same day I went for the bam treatment at Hospital. On April 7th I was diagnosed with covid pneumonia

Patient received vaccination without noted reaction. On 04/10/2021 patient was transported to hospital via ambulance c/o shortness of breath. Patient was diagnosed with pneumonia. Patient refused admission and returned home with prescriptions for inhalers, steroids, and antibiotics. Patient claims on 02 at home prior to event. Patient also c/o left leg pain (unspecified) but has not sought medical care. Patient treated at Hospital. Patient was advised to follow with her PCP for leg pain.

patient was diagnosed with bilateral pulmonary emboli within 3 weeks of vaccine administration, developed dry cough within 1 week of vaccine that progressed to worsening shortness of breath.

My sister, received the J & J vaccine on March 5th. I now know that she was not feeling well for a few days afterwards. She then felt better until day nine after the vaccine. On the evening of the ninth day, she began having abdominal pain, vomiting & diarrhea, headache. This was Sunday evening. Unfortunately I wasn?t aware of how she was feeling and she didn?t go to the emergency rm. until Tuesday morning. Tests determined her platelet level was low and abdominal CT showed bleeding from her adrenal glands. She was given platelets, pain meds and admitted into the hospital. Later that night staff felt she wasn?t responsive and a head CT was performed. It was determined she had a brain hemorrhage and emergency surgery was performed. It is my understanding that there was brain damage at that point. During the early morning hours of the 10th day, post surgery, a repeat CT scan was done showing more hemorrhaging and blood clots. She also developed a DVT and PE and was kept on a respirator until the 13th day post vaccine to allow family to say their goodbyes. On the morning of the 13th day patient was removed from life support and she passed.

Presented as a TIA (mini stroke) Had vision issues, difficulty speaking, vertigo, could not walk, passed out and taken to hospital by ambulance . Began at around 10am. Felt like I was dying. Placed on Stroke Unit. Scans and tests all negative for stroke and Drs. thought could be panic attack or TIA. Since then my lingering effects point to TIA, Seemed to clear up around 2pm with gradual improvement through the day. Still experiencing some side effects including tinnitus, memory and word retrieval issues, fatigue, anxiety. DO NOT HAVE PANIC ATTACKS. The only time I have had a panic attack was at 26 after the death of my mother.

Bilateral pulmonary embolism. She had chest pain, SOB, tachycardia in 130s. . Presented to ED. CTA positive for bilateral PE with Left popliteal DVT. She was treated with systemic TPA and heparin. She is still hospitalized.

patient came to clinic c/o right lower leg swelling on 4/6/2021, on 4/13/2021 she underwent a doppler us and was dx with right common femoral vein thrombus. her platelets are normal

RLE DVT--Acute, occlusive deep vein thrombosis in the right gastrocnemius vein--started on anticoagulant--apixaban

PEA Cardiac Arrest tx with intubation, CPR, Epi prolonged mechanical ventilation, vasopressors, IVC filter, PEG, Trach. Now off of mechanical ventilation but still vented

For the past 2 1/2 - 3 weeks I have had a pain in my left leg. Today it was extremely painful so I went into the dr. office and after an examination and ultra sound it was determined that I have a blood clot.

3/18/21, Day after Vaccine, drowzy in the morning, around 12:00 p.m. I had a brief period of incoherent speach and a few moments of having trouble putting sentences together. Around 2:00 a moment of temporary blindness in my left eye. 03/19/21 -03/20/21, extreme fatigue, stayed in bed. 03/21/21, fatigue, light-headed, slightly dizzy 03/22/21, right side leg and arm became numb as if asleep. Went to Hospital Emergency. I had a stroke, had a Carotid Endarterectomy at medical center, was in the Hospital for 5 days, two weeks after surgery became seriously enemic and d_Dimers are still elevated THE CONTINUATION PAGE IS INOPT. AND WOULD HAVE LIKED TO EXPLAIN IN FURTHER DETAIL.

My left foot felt very heavy then my left lower leg started to get numb. We all 911 by the time the ambulance came my left arm was getting numb. I was transported in helicopter to regional Hospital I was having a stroke

Pain in right leg in knee area beginning on 4/6/2021. Pain worsened over the weekend. Went to the doctor on 4/14/2021. She sent me for a doppler on my legs where a blood clot was found behind my right knee. I started taking Xarelto that night - 15mg twice daily for 21 days. The pain increased considerable and by 4/20/2021 I could hardly walk. I went back to the doctor that day and she ordered a second doppler study. The blood clot was stable but there was no change. Continued on the Xarelto. Third visit to the doctor on 5/5/2021. Some lessening of the pain by then. Doctor changed the Xarelto dosage to 20 mg. one a day for the next two months. Then we'll schedule another doctor visit and probably another Doppler Study.

right leg pain started 5 days after vaccination. Went to the ER on 5-1-2021 x-rays, ultrasound and blood work done. Diagnosed with a deep vein thrombosis blood clot in the right leg. given Eliquis starter pack 2 tabs 10 mg each twice a day for 7 days, 1 5mg each tabs twice a day, ongoing Tramadol 50mg 1 every 6 hours for severe pain Acetaminophen 500mg 1 every 4 hours for pain Ondansetron 4mg as needed for nausea/vomiting

WAS ON VENTILATOR; SUSPECTED COVID-19 INFECTION; DEATH; This spontaneous report received from a media article via a company representative concerned a 61 year old female of unspecified race and unspecified Ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included exposure to covid-19.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 10-MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. A day later of vaccination patient traveled extensively and returned home nine days later. On an unspecified date in MAR-2021, the patient was not feeling well and had difficulty in breathing. Later, patient's sister drove her to the hospital where she had ups and downs but was eventually put on a ventilator. On an unknown date in APR-2021, the patient died due to unknown cause of death. It was unspecified if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died an APR-2021 and the outcome of was on ventilator and suspected covid-19 infection was not reported. This report was serious (Death, Hospitalization Caused / Prolonged, and Life Threatening).; Sender's Comments: V0: 20210514186-covid-19 vaccine ad26.cov2.s-Death, was on ventilator, suspected covid-19 infection. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH

Developed a DVT in left calf on 5/10/21. Suffered a fractured metatarsal bone in left foot on 4/13/21 and a walking boot was prescribed. Foot healed excellently but developed a DVT .

PLATELET COUNT INCREASED; EXCRUCIATING HEADACHE; INTRAOCULAR PRESSURE DECREASED; ANGIOGRAM NORMAL; ARTERIOGRAM CAROTID NORMAL; THROMBOCYTOPENIA; ARTERY BURST BEHIND HER EYE; OCULAR DISCOMFORT; PERIORBITAL SWELLING; EYE PAIN; ACHES AND PAINS; This spontaneous report received from a patient concerned a 61 year old female, ethnicity unknown. The patient's height, and weight were not reported. The patient's past medical history included hypertension, hypothyroidism, and intermittent pancytopenia, and concurrent conditions included metronidazole allergy, hashimoto's disease, and microscopic colitis. The patient was previously treated with metronidazole. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. Concomitant medications included amlodipine, levothyroxine, losartan, rosuvastatin calcium, and ubidecarenone. On 09-Mar-2021, the patient got the vaccine and after few days she had aches and pains (very mild reaction) and went to bed early. The patient thought she was fine. On 18-Mar-2021, 04:00, she woke up with an excruciating headache above her left eye in her eyebrow. The patient wondered if it was an aneurysm and took 2 tablets of extra strength Tylenol and it helped. The patient stated that after every 5-6 hours, excruciating headache came back. The patient had the same headache for over a week. The patient got tested for Covid-19 and it was negative. The patient thought she had sinus problems but had no other symptoms. On 30-Mar-2021, the patient woke up with headache. Her eye was killing her, was sore and swollen, and felt like it was going to burst and her left eye was swollen shut in a couple of hours. The patient narrated it was excruciatingly painful. The patient's husband drove her to urgent care, where ophthalmology tested the pressure: right eye was normal (she thinks it was 18- normal) and the left eye was 51 (normal is 14-19), units unspecified (intraocular pressure decreased). The eye doctor started prednisone and the patient had a CT scan and lab work done. MRI was also ordered but they were unable to do it right away. On unspecified date in Dec/2020 the platelets were 349 in December and came down to 64, which was very low (low threshold was 150) (thrombocytopenia). The CT scan was performed, they thought she had a cavernous carotid fistula and she was scheduled for an angiogram for a further diagnosis on 01-Apr-2021. The angiogram determined she did not have fistula. The patient was admitted to the hospital after the angiogram and on 02-April-2021, MRI was done. All throughout the process, the ophthalmologist, radiologist and internist all thought it was related to the Janssen COVID-19 vaccine. The prednisone started working and the pressure started dropping in her eye. The patient states that doctors think an artery burst behind her eye. After discharge, the patient was taking prednisone which was helping. On the 13th, she was watching television and saw that the vaccine was being put on hold due to the women with clots whose progression matched hers exactly (severe headaches, low platelets, and required attention). She was on prednisone for a month. Laboratory data (dates unspecified) included: COVID-19 virus test negative (NR: not provided) negative, CT scan (NR: not provided) Not reported, and Platelet count (NR: not provided) 64 (units unspecified). Treatment medications (dates unspecified) included: prednisone, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from thrombocytopenia, intraocular pressure decreased, ocular discomfort, periorbital swelling, and eye pain, excruciating headache on 02-APR-2021, and aches and pains on 12-MAR-2021, and the outcome of artery burst behind her eye was not reported. This report was serious (Hospitalization Caused / Prolonged, and Disability or Permanent Damage). Additional information was received on 25-MAY-2021 following information was updated and incorporated into case narrative: Other identification number, patient contact details, events- Aches and pains, artery burst behind her eyes, excruciating headache, Tylenol drug was added, hospital details was added and narrative was updated accordingly.; Sender's Comments: V1: Additional information updated identification number,hospital details,events- Aches and pains, artery burst behind her eyes, excruciating headache,This updated information does not change the causality of previously reported events. 20210502268-COVID-19 VACCINE AD26.COV2.S-Artery burst behind her eye. Follow-up received regarding Clinical Details. 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 20210502268-COVID-19 VACCINE AD26.COV2.S-Excruciating headache. Follow-up received regarding Clinical Details. This event(s) is labeled per RSI and is therefore considered potentially related. 20210502268-covid-19 vaccine ad26.cov2.s-Thrombocytopenia, Intraocular pressure decreased, Ocular discomfort, Periorbital swelling, Platelet count increased, Eye pain, Angiogram normal, Arteriogram carotid normal. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE

Patient presented to PCP on 05/18/2021 office from group home with C/O cough, runny nose, lethargic, fever, lungs rattling, uncontrollable shaking. Patient had a seizure the night before and had been having weak spells and coughing and fever since that time. Patient admitted to hospital on 05/18/2021 and chest Xray showed pneumonia. Patient tested for COVID-19 on 05/21/2021 after learning of potential exposure at group home and result was positive.

on April 11, 2021 I experienced confusion and unable to read or say a few words correctly. I ended up calling my Dr who insisted I go to the ER. I was admitted to the hospital and after 2 days and many tests it was determined I had a small stroke.

2 Straight Days Headaches 7/20/21-7/21/21 I Don?t Get Headaches 7/22/21 cramps in stomach light blood through 7/23/21 heavy dark blood with light clotting. 7/25/21-7/26/21 large blood clots until 7/28/21. 0n 7/28/21 called Primary Physician for a Consultation it?s scheduled for Friday. I have enormous swelling in my Right leg in rear upper thigh. I have decided to go to Emergency Room. I have a slight headache and after Blood completely stop I am now seeing very light blood. I?m 61 I had stop having periods at 58!started back when I first took John & Johnson shot. I reported here before.

Patient arrived to the outpatient vaccine clinic for her scheduled appointment. Immediately after receiving the vaccine, the patient felt chest pain, dizziness, and passed out. She had swelling of the tongue, lips, eyes, and throat. Patient was admitted to the hospital and treated for anaphylaxis with epinephrine, benadryl, famotidine, methylprednisolone, Duoneb and tylenol. Patient is currently still in the hospital but her condition is stable.

A few minutes after the vaccine my heart began palpatating and I began sweating profusely. My vitals were checked, I was given water and moved to a cooler area of the facility. HR was still elevated but I wasnt feeling as flushed. By 4pm that evening I began having having chills and a fever of 100-100.4 which lasted about 4hrs. Later that evening my HR elevated to 125 with the feeling of feeling I was having a heart attack. By that Wed. my HR was still at 125 in motion and about 75 still so I went to visit my PCP on Thurs and when I arrived the HR was 77 but during the visit it elevated to 125 and blood work was done resulting in my tyroid level elevated and since getting the vaccine my HR had been up and down. When in motion its elevated and when sitting its around 75.

Anaphylactic reaction 10 mins after shot - drop in blood pressure, swelling of lips and upper palate and throat. Treated with epi-pen. Symptoms subsided with some residuals for about 90 minutes.

I started having pain in my left calf on Sunday 4/11/2021. I went to the doctor on the next day, Monday, April 12 at 9am. He sent me to the center where they did an Ultrasound which was positive . I was adviced to go to the Hospital for a CT scan of my lungs and brain. I went to medical center on Monday at 6pm. There I was given an Iodine CT scan. They noticed a small spot of pneumonia. They repeated the Ultrasound of my leg and took a swab for Covid-19. I was given a prescription for Xarelto and an antibiotic , Levaquin, 500mg.. I came home.

Patient's husband called to report that his wife was in the hospital due to a blood clot that formed in her leg. He stated that she was having organ failure. Patient is currently being treated at a local hospital for blood clots that were moving and affecting her organs.

Persistent rectal bleeding and passing blood and blood clots for 7 days since vaccination. Bleeding occurs with stool and throughout the day, requiring the use of pads.

The day after having been vaccinated with Johnson & Johnson/Janssen COVID19 vaccine (04/11/2021), my mother started to feel intense pain, swelling, tenderness and cramping in her legs, especially her right leg, to the point that she couldn't walk. By the fourth day after the vaccine her right leg was completely swollen, twice as big as its normal size, the pain was unbearable and she experienced fatigue and shortness of breath. I took her to the ER on 04/14/2021

I called a message that patient had experienced a stroke recently and had also rececived the Jansson vaccine. I called patient, who had reported that it happened on 4/2. She had woke up and couldn't put her robe on. Her left arm was not working right. She also noted that she had drooled. She kept thinking that she was find and got ready and went to work. During work she was typing and found that her left hand was not working still, but still went throughout her day and typed with her right hand. Later that evening when she got home, her husband took her to the ER. There, she reports that her blood pressure was through the roof. She had a CT scan and MRI and labs done and was diagnosed with a TIA. She was started on Plavix, baby aspirin, and was started on a statin drug (couldn't remember the name as that information was at home and she was at work at time of call). She is on a heart monitor for 4 weeks and has follow ups with her outside PCP and cardiologist. Today she states that she is feeling back to normal and has regained function on her left side. She reports that she had a headache at time that had lasted for a while. She also reports that she feels like she was having issues weeks before because her brain felt foggy and just was not thinking right.

Received the vaccine friday then monday has numbness to the tongue , near syncope, dizziness, ems called taken to ER and admitted to hospital for TIA. CT of neck, head, abd done, chest xray, full blood work, echo, results sent to primary care said all test ok

WE RECEIVED A CALL ON TUESDAY AFTERNOON THE 13TH OF APRIL FROM THE MEDICAL EXAMINER REQUIRING INFORMATION ON HOW TO CONTACTB THE PATIENT'S DOCTOR. WHEN ASKED AS TO WHAT HAPPENED WE WERE TOLD THAT THE PATIENT WAS FOUND DEAD IN HER APARTMENT ON TUESDA.Y. WE DID INFORM THEM THAT THE PATIENT HAD RECEIVED THE JANSSEN VACCINE AT THE PHARMACY ON FRIDAY THE 9TH. WE DONT KNOW THE CAUSE OF ADVERSE EVENT.

I was ill with diarrhea, sick to stomach, blood clots coming out of my rectum for 24 hrs., body aches.

1 week post vaccine had 1 day with a sore throat and runny nose. Developed right calf pain 04/19/2021. Presented to ER on 04/25/2021 w/ a 2 day history of shortness of breath and some chest tightness worse with exertion, with worsening symptoms at time of ER visit. Admitted for observation with "Pulmonary embolism without acute cor pulmonale and Acute respiratory failure with hypoxia"

Patient was seen in my office by me on April 27th. She reports having left leg pain discomfort which started 3 days after receive Johnson and Johnson COVID vaccine. She denies swelling or any other associated symptoms. I ordered Venous Duplex which was done today and revealed b/l femoral DVT. Patient immediately started on Eliquis .

STROKE; RIGHT CAROTID ARTERY BLOCKAGE; This spontaneous report received from a patient concerned a 62-year-old white female, ethnicity unspecified. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, hypertension, hyperlipidemia, and allergy to latex, and other pre-existing medical conditions included allergy to Provaxin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: 06-JUN-2021) dose was not reported, 1 in total administered on 06-APR-2021 for prophylactic vaccination on right arm. No concomitant medications were reported. On 28-APR-2021, the patient experienced stroke. On 10-MAY-2021, the patient was hospitalized. On 11-MAY-2021, the patient was discharged. On an unspecified date, the patient experienced right carotid artery blockage (60 percent). Laboratory data included: CT scan (NR: not provided) stroke, Echocardiogram (NR: not provided) stroke, Laboratory test (NR: not provided) stroke, and MRI (NR: not provided) stroke The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stroke, and the outcome of right carotid artery blockage was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210523342-covid-19 vaccine ad26.cov2.s -stroke, right carotid artery blockage. 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

COMPUTERISED TOMOGRAM; ELECTROCARDIOGRAM; LABORATORY TEST; PULMONARY EMBOLISM; X-RAY; PAIN ON THE RIGHT-HAND SIDE UNDER MY RIBS; MYALGIA; ULTRASOUND SCAN; LUNG COLLAPSED; FLUID IN THE BOTTOM OF HER LUNG; This spontaneous report received from a patient via Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) and concerned a 62-year-old female patient. The patient's height, and weight were not reported. The patient's concurrent conditions included depression, and penicillin allergy. The patient had no current illness. The patient had no heart problems, no pulmonary problem and diabetes. The patient experienced drug allergy when treated with paracetamol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 206A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 11-APR-2021 to left arm for prophylactic vaccination. Concomitant medications included levomilnacipran hydrochloride for depression, and quetiapine fumarate for depression. On an unspecified date in APR/2021, little more than a week after single-dose coronavirus vaccine at hospital facility the patient felt general malaise and minor pain in her right side. The patient had shortness of breath, and she looked anxious and her heart rate was very fast. The vital signs were not stable. The physician suspected that patient had developed pulmonary embolism blood clots in her lungs. When combined with her vitals, the doctor knew it was an emergency. The patient also began to feel mildly ill. She was experienced general malaise, soreness on her right side, and while she was not struggling to breathe, it hurt when she took a deep breath, her right-hand side, like under her ribs, she felt some pain. It was not a bad pain, not enough to take anything for it but just noticed it. The symptoms seemed minor, and at the time. It was reported that by 21-APR-2021, she still was not feeling well and decided to make an appointment at the urgent care center. The patient visited emergency room or department/urgent care facility for treatment of the events. The patient soon learned she had developed blood clots (pulmonary embolism) in both lungs due to the vaccine, a doctor at the hospital told her. One of her lungs also had collapsed. She had developed blood clots in both lungs due to the vaccine, she was there for 10 hours (undergoing tests). The patient underwent a computerized tomography scan and an X-ray. They did everything and got the results of the CAT scan, with pulmonary embolism in both lungs. They immediately gave her some blood thinner and was as hospitalized (date unspecified). It was reported that she would spend five days in the hospital. According to the doctors this was from the vaccine. The patient was also experiencing the pain on the right-hand side and also started getting myalgia, muscle aches just in different parts of her body. The patient's legs also felt weird. So they rushed her down and gave a sonogram in her legs to check for deep vein thrombosis. The pain on her right side grew worse for a day or two, and she was treated with morphine. The doctors surmised the patient had fluid in the bottom of her lung, which her body eventually absorbed. The patient was still on a blood thinner and continued to recover. Laboratory data included: Heart rate (NR: not provided) very fast, and Sonogram (NR: not provided) Not provided. On an unspecified date in APR-2021, Laboratory data included: Computerised tomogram (NR: not provided) pulmonary embolisms in both lungs, Electrocardiogram (NR: not provided) Not provided, Laboratory test (NR: not provided) Not provided, Ultrasound scan (NR: not provided) Not provided, and X-ray (NR: not provided) Not provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pulmonary embolism, had not recovered from computerised tomogram, electrocardiogram, laboratory test, ultrasound scan, and x-ray, and the outcome of myalgia, fluid in the bottom of her lung, lung collapsed and pain on the right-hand side under my ribs was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). Additional information was received from company representative via social media on 18-MAY-2021. The following information was updated and incorporated into the case narrative: patient's city added, events added (pain on the right-hand side under my ribs, myalgia, lung collapsed, fluid in the bottom of her lung), CT scan result updated, lab data updated (Heart rate and Sonogram).; Sender's Comments: V1: The follow up information in this version updates Patient's city, events (pain on the right-hand side under my ribs, myalgia, lung collapsed, fluid in the bottom of her lung), CT scan result updated, lab data updated (Heart rate and Sonogram). The follow up information received in this version does not alter the causality of the previously reported events 20210514298-COVID-19 VACCINE AD26.COV2.S-fluid in the bottom of her lung, pain on the right-hand side under my ribs: 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. 20210514298- COVID-19 VACCINE AD26.COV2.S-myalgia. This event is labeled per RSI and is therefore considered potentially related. 20210514298-COVID-19 VACCINE AD26.COV2.S-Pulmonary embolism, computerized tomogram, electrocardiogram ,laboratory test, ultrasound scan, X-Ray: 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.

Started with weakness, then shortness of breath, multiple syncopal episodes. Bilateral popliteal DVT, multiple bilateral PE's with no other risk factors. Symptoms started approximately 2 weeks ago. Hospital admission date was 5/26/2021. Obstructive shock from PE, required ICU care, vasopressor therapy, and EKOS therapy, IVC filter. Improved from shock after EKOS therapy, no longer need vasopressors. Heparin infusion post EKOS therapy. Will be going home on oral anticoagulation when appropriate for discharge. Shock liver as a complication from the obstructive shock.

BLOOD CLOT FROM GROIN AREA ALL THE WAY TO THE LEG; This spontaneous report received from a patient concerned a 63-year-old female. The patient's height, and weight were not reported. The patient's concurrent conditions included osteoporosis, osteoarthritis, bursitis, rheumatoid arthritis (RA), migraine headache, anxiety, and cholesterol, and other pre-existing medical conditions included patient had no history of blood clots and no prior heart conditions. On 16-Mar-2021 around 09:00, 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, frequency 1 total, administered on left arm for prophylactic vaccination. Concomitant medications included pantoprazole for acid reflux, citalopram for anxiety, simvastatin for cholesterol, and prn 1371 for migraine headache. On an unspecified date in Feb-2021, the patient mentioned (heart doctor) had done some tests on veins making sure the patient's heart was open and does not have any blood clots. Laboratory data included: Diagnostic ultrasound (NR: not provided) Normal, and Doppler ultrasound (NR: not provided) No blood clots. 7 days later the patient was informed everything was fine and she got vaccinated on 16-Mar-2021. On 07-May-2021, the patient reported that her left leg started hurting. On 09-May-2021, the leg started swelling. On 11-May-2021, the patient was admitted to the hospital with a massive blood clot from groin area all the way to the leg. On 14-May-2021, she was discharged from hospital. The patient was hospitalized for 3 days. The patient stated her doctor will let her know if she can move around more next week, the patient is currently in lot of pain. Treatment medications (dates unspecified) included: apixaban, paracetamol, tramadol hydrochloride, gabapentin, and baclofen. The action taken with covid-19 vaccine ad26.cov2. s was not applicable. The patient had not recovered from blood clot from groin area all the way to the leg. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20210500586-COVID-19 VACCINE AD26.COV2.S-This case concerns with 63 year old female – blood clot from groin area all the way to the 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).

J18.9 - Pneumonia, unspecified organism N17.9 - Acute kidney failure, unspecified R56.9 - Unspecified convulsions

Swelling of the right foot and leg. Went to ER and they performed a doppler ultrasound and found a blood clot in the lower right leg. Prescribed blood thinner. So far, the swelling has gone down

Starting on or about June 16th - slight swelling noticed in left ankle, and left calf. Swelling continued in left ankle and left calf even after ice and elevating foot. June 21st scheduled doctor appointment with orthopedic thinking perhaps leg or ankle injury.

Finding of microhematuria on a routine urine dipstick. Repeat urine test confirmed microhemtutria and CBC showed 30,000 platelets. WAs admitted to hospital. No purpura or other signs of bleeding. Was diagnosed as Idiopathic Thrombocytopenic Purpura. Started on steroids with good response.

Patient presented with fatigue and SOB starting about a week after vaccination. Was admitted to hospital SOB. No evidence of TTS. Progressive ARDS and death in 2 weeks after admission. Microbiology negative. No aetiology identified.

PT CALLED ON 3-27 TO REPORT A BLOOD CLOT IN HER EYE AFTER RECEIVING THE VACCINE ON 3-13, STILL PRESENT

Head rush and heart palpitations approximately 10 minutes after injection, and nausea. Assisted by EMTs to monitor heart rate, blood pressure , and blood oxygen level. Went into atrial fibrillation and blood pressure steadily rose. 165/99 was one reading I heard them call out.

1st effect was migraine with left side numbness, woke up at 4 am and was unable to walk correctly. Went to ER 1 and was transferred due to lack of CT Scan, hospital then admitted for stroke. Can also still feel injection site

In the morning I noticed a pinching feeling in my lower right leg. I called my doctor to check on this. She sent me for an ultrasound of the leg on 04/15/2021. During a follow-up visit she informed me that it was a superficial blood clot and set up a second ultrasound on 04/28/2021 for confirmation that it had cleared.

2 weeks and 2 days after receiving the vaccination I had a blood clot blown from my nose no before issues with a bloody nose and not after it was a large blood clot there was not any continued bleeding before or after. Also where the shot was given is still sore in that area and does not seem to get better this is my right arm I am exercising and not any improvement.

Report received from co-worker of patient. Patient received J&J vaccine on 3/13/21. Patient was at work and collapsed 11 days after vaccination. Was intubated at work site and taken to local hospital - the patient was then airlifted to a Medcial Center. Diagnosed with a brain bleed and subsequently died on 4/6/21.

Had Janssen vaccine on 4/9 and within a day developed subjective fevers and dyspnea which progressed until admitted to Hospital on 4/11 and promptly intubated for respiratory distress. Found to be in sepsis and ARDS with multiple negative COVID tests including an extensive respiratory viral panel, we have failed to culture any bacteria from multiple sputum cultures, Legionella antigen and HIV negative. Have been treating as ARDS 2/2 atypical pneumonia, possible aspiration (although no aspiration event reported) with hospital course complicated by VAP. Concern remains for possible reaction to Janssen vaccine. Still admitted to ICU at Hospital.

Patient states she received the Johnson & Johnson COVID vaccine on April 3rd. Patient states on April 8th she went to her dentist for cleaning and do not expiring any gum bleeding at this time. Patient states 2 day ago (April 19th) her gums were bleeding so bad that she could not see her teeth and patient states she had a nose bleed as well. Patient also states she was experiencing headaches. Patient presented the the Emergency Department on April 21st . Patient was found to have thrombocytopenia (PLT = 2). Patient was admitted to Hospital on April 21st (as of April 23rd, patient is still admitted). Hematology was consulted for further management of thrombocytopenia. Patient received 2 platelet transfusions, IVIG x 2 doses, and is receiving corticosteroids.

DEATH; This spontaneous report received from a patient concerned a 63 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, 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 number. No concomitant medications were reported. On an unspecified date, the patient died from unknown cause of death. It was reported that, the patient death occurred after receiving the vaccine. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked.; Sender's Comments: V0: -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

DEATH; FROTHING AT MOUTH; COVID-19; This spontaneous report received from a consumer concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included obese and diabetes. 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 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, (7-10 days after vaccination), the patient developed COVID 19. The patient self quarantined for 14 days. On 14-APR-2021, the patient went to emergency room with the complaint of shortness of breath. Her D-Dimer was very elevated, but had a ventilation/perfusion scan (VQ) scan which came back negative. They treated her with heparin. On 15-APR-2021, early morning at 06:00, the patient coded (cardiopulmonary arrest) and frothing at the mouth. The team gave her epinephrine, but did not get a return to circulation. It did not revive her. The patient coded for 30-40 minutes. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on an unspecified date, and the outcome of covid-19 and frothing at mouth was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0-covid-19 vaccine ad26.cov2.s-Death and Covid 19. 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: PATIENT CODED

Throbbing pain at injection site and entire arm. Unable to move up without assistance. Pain grew more and more intense. Went to urgent care on unspecified date. NP examined me and discovered a lump in my arm. Both the lump and the vaccination site hurt when she pressed on them. She prescribed presdone and gave me a work order for a vascular ultrasound to be performed on my left arm. I went on unspecified date for the scan. It was discovered that a DVT blood clot had formed in my brachial vein in the left arm. I was then prescribed eliquis, 20 mg a day for 7 days and told not to take the predesone. NP called my pcp, his office immediately called me and asked me to come in as they are concerned about the high dosage of the eliquis.

4/11 11:30 vaccination 11:40 I felt had a head rush and my heart started pounding like it never had before. I reported back to the EMTs on site. They monitored me. After another 10 minutes, I was not feeling better, nauseous. My BP rose and I went into a fibrillation. They transported me at that time to the ER. The Afib went away on its own. It was probably an hour at the mobile clinic and ER ride; by the time I had arrived my afib had resolved on its own. Discharged Heart palpitations over the next few weeks. The following Sunday, I started to feel like I was going back into Afib. By the time I got there, everything was ok. They sent me home with a heart monitor for 48 hours. I will get the information on 5/7/2021. *5/7/2021 follow up appointment with PCM to find results of HR monitor.

April 8, 2021- Vaccinated with the Johnson and Johnson vaccine. April 10, 2021 ? Fever, strong headache, unable to hold on, diarrheas, respiratory difficulty. April 14, 2021- She lost her balance and fall, hitting her face. Had a CT scan and no mass nor bleeding was found, only sinus. Discharged home. SARS-CoV-2 test ? Negative results April 18, 2021- Found dead in her sofa. No thromboembolism nor bleeding

Patient was vaccinated on 4/10/2021, with the Johnson & Johnson (Janssen) Covid-19 Vaccine. On 4/14/2021, patient had a stoke and collapsed, falling on her head & face at approiximately 3pm. No signs/symptoms prior to stroke & collapsing. Patient became hospitalized with internal bleeding in her brain and is still unresponsive. ‘Unresponsive' in this case is defined as but not limited to: unable to be mobile / stationary in a reclined bed postion since the incident / no movement of upper & lower extremities / minimal reactionary response in eyes / unable to ingest food by mouth

Upon speaking with patient here at the hospital she reports having vaccine on March 31, 2021 and reports experiencing clot that had been previously reported to CDC and she asked that this hospitalization be reported to hospitalization as concerns that it may be related. Patient admitted for possible stroke/TIA symptoms resolving

Hemoptysis, flank pain, bilateral leg pain, headache. Found to have thrombocytopenia of 44, extensive bilateral PEs, and nonocclusive aortic thrombus. Treated with IVIG x 2 days and argatroban. Course is ongoing at ~48 hours since presentation.

Patient went to ER 4/4/21 with severe headache, inability to stay awake. CT scan of the head revealed multiple areas of SAH (unexplained no head injury) and a very large ruptured MCA aneurysm. Patient was COMPLETELY asymptomatic prior to vaccination. The aneurysm was repaired with success but the cerebral hemorrhages kept appearing - unexplained. Cerebral edema became so severe (midline shift up to 9-10mm) neurosurgery ended up performing a burr hole craniotomy to relieve pressure as well as placement of a ventriculostomy. This patient later ended up with severe vasospasms which results in an ischemic stroke of the L frontal lobe. Patient later died in a rehabilitation facility, all of this secondary to the Janssen vaccine. This vaccine should not be administered until further studied. This was a healthy 63 year old woman. Vitals always WNL labs WNL very active, BMI WNL. Absolutely NO comorbidities. A lifelong nurse who raised 2 nurses of her own. These events took place for over a month. The trauma not only the patient has experienced but her family is unforgivable.

I had no regular symptoms, but a few days later I sat down in my chair and it felt like someone shot me in the stomach, I took oxycodone, it kept getting worse and I dealt with it for a week. I started getting pain in my kidney and went to the ER because of the pain and the pain level on a scale of 1-10 was a 8-9 at all times. I couldn't' breathe and was rushed to the hospital. I have portal vein thrombosis and have three blood clots in my stomach. I tried to figure out what to do to relieve the pain, I couldn't eat or during and was on IV's. I was in so much pain to even eat a cracker, they kept me at the hospital. While in the hospital they did a CAT scan to see if it was diverticulitis and found out that I had 3 blood clots, they also did the dye or contrast. I spent days in the hospital and was transferred to the hospitals skilled nursing facility so that they can watch me because of the clots. I was told that the blood clots could burst in the vein.

BLOOD CLOT IN ARM; HARD TIME BREATHING/COULDN'T BREATH; HIGH FEVER; This spontaneous report received from a a 63-year-old female patient of unspecified of race and ethnic origin and her daughter via a traditional media and via a company representative. The patient's height, and weight were not reported. The patient's concurrent condition included diabetes. The patient never tested positive for coronavirus disease (COVID). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: unknown, and expiry date: unknown) dose was not reported, 1 total, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, in APR-2021, shortly after the vaccination, the patient experienced a high fever. A day later, the patient had a hard time breathing/could not breath and was rushed to the hospital (date unspecified). The patient also developed a blood clot in her arm. The doctors told the patient's kids that the patient might not recover. In a hospital bed, the patient spent 21 days on a ventilator. The patient was recovering in the hospital in the last month of MAY-2021 and was expected to leave the rehabilitation facility by the end of JUN-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from high fever, hard time breathing/couldn't breath, and blood clot in arm. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).; Sender's Comments: V0: 20210619186-COVID-19 VACCINE AD26.COV2.S-Blood clot in arm, Hard time breathing/couldn't breath, High fever. 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).

ISCHAEMIC STROKE; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 63 year old female of unspecified race and ethnic origin. The patient's weight and height were not reported. The patient was healthy and had no underlying diseases. 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, 1 total administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, the patient experienced headache and fatigue for the first 24 hours. On 16-JUN-2021, the patient experienced ischaemic stroke and had visited emergency room (ER).The patient was treated with TPA and the stroke symptoms were resolved The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ischaemic stroke, and the outcome of headache and fatigue was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210651351, covid-19 vaccine ad26.cov2.s, Ischaemic stroke-This event is considered Un assessable. 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.

Shortness of breath, weakness, heart palpitations. and got diagnosed with both bronchitis and pneumonia.

Janssen COVID vaccine was administered on 3/13/21- patient was screened twice and denied receiving any vaccines in the past 2 weeks. after administration it was noted today (3/15/21) that the patient received the Moderna COVID vaccine (one dose) on 3/4/21. I attempted to reach out to patient to discuss and noted that she is admitted to Hospital for a NSTEMI. Per chart notes patient reported symptoms of fever, nausea, malaise on 3/13/21 after vaccination. The next day 3/14/21 developed syncope and chest pain. Patient reported to emergency room and was admitted with NSTEMI

extreme shortness of breath after one week and admitted to hospital with blood clots in both lungs and a collapsed lobe in right lung within two weeks

POTENTIAL DEEP VEIN THROMBOSIS; SMALL BLOOD CLOT; ANKLE CALF BOTH SWOLLEN; This spontaneous self-report was received from a patient and concerned a 64 year old female. The patient's height and weight were not reported. The patient's concurrent conditions included no known allergies and smoker. Other relevant history included no alcohol intake, nor any drug abuse/illicit drug use. The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, route of administration and dose not reported, batch number: 1805029, and expiry: unknown) administered on 14-MAR-2021 on the left arm for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the patient had "ankle calf both swollen" indicating potential deep vein thrombosis. She went to hospital emergency room, and "HCP confirmed small clot". The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The patient was recovering from "ankle calf both swollen" and had not recovered from potential deep vein thrombosis and small blood clot. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This is a spontaneous report of a 64 year old female who developed a swollen calf and ankle swelling indicating a potential deep vein thrombosis 3 days after receipt of Janssen COVID 19 vaccine. Patient was seen in the emergency room by HCP, who confirmed a small clot. No other medical history was reported but patient was noted to be a smoker, reported as 2x a year. Age increases the risk of deep vein thrombosis, but the there is insufficient other details to make a meaningful medical assessment.

6-8 hours following the vaccine, the patient developed a severe head ache, SOB and fatigue. Patient took an unknown OTC medication, this did not help her symptoms. Her headache receded on 04/08, and her symptoms improved, but never fully resolved (per patient's son).

Subarachnoid hemorrhage on 4/20/21. She began complaining of strong pain that caused vomiting, swelling, and hospital visits from about 3 weeks ago. We thought it was her blood pressure but it was consistently normal. She described it as the worst pain she has ever felt.

CLOTS ON RIGHT LEG; HEADACHE; PRESSURE ON BOTH LEGS; PRESSURE ON HANDS; This spontaneous report received from a patient via a company representative concerned a 64 year old Hispanic or Latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure and diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, 1 total administered on 17-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the patient had experienced headache after vaccination. On 27-MAR-2021, the patient began to experience intermittent pain on right leg. On 30-MAR-2021, she experienced headache again and was still having leg pain; she visited the Emergency Room (ER) and was admitted on 30-MAR-2021. On 02-APR-2021, the patient experienced clots on right leg. On APR-2021, a catheter was placed in catheterization procedure and her right leg vein was unclogged of a clot. A second clot did not require removal because the vein had already unclogged itself after medication. The patient was administered unspecified anticoagulants. She was discharged on 5-APR-2021 and was prescribed ticagrelor which was then changed to clopidogrel. On 18-APR-2021, the patient experienced a headache again and feeling of pressure on legs and hands. Patient was advised to visit ER. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from clots on right leg and intermittent pain on right leg on 02-APR-2021, recovered with sequelae from headache on 19-MAR-2021, and had not recovered from pressure on both legs and pressure on hands. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: This 64 year-old Hispanic or Latino female with history of high blood pressure and diabetes was hospitalized for clots in her right leg 13 days after receiving the Janssen Covid-19 vaccine. Concomitant medications were not reported. On the day of her vaccination, she experienced a headache. Ten days later, she began to experience intermittent leg pain. Three days later (ie, 13 days post vaccination), she went to the emergency room (ER) and was admitted to the hospital. During the hospitalization, a clot was removed via catheterization and she was administered unspecified anticoagulants. A second clot resolved on its own without surgical intervention. After 6 days in the hospital, she was discharged with ticagrelor which was later changed to clopidogrel. She recovered from the clots. Thirteen days after discharge, she began to experience headache and "pressure" in both legs and hands. She was advised to go to the ER; no further information was provided. Based on the limited information, the relationship of the serious events with Janssen Covid-19 vaccine is considered indeterminant. Additional information is being sought.

Department of Health received a call from her sister, in response to a call/letter/text sent out to all recipients of the Janssen vaccine. She stated that her sister received the J and J vaccine on 3/12/21 (confirmed in State vaccine system) at the hospital where she receives her oncology care. She reported the following: "She had a massive stroke on MARCH 27TH, 2021 leaving her paralyzed on the right side with the inability to speak, swallow, or see. She was initially diagnosed with Ovarian cancer approximately three and one half years ago. She was chosen for a study with Pharmaceuticals and her diagnosis was changed to a vary rare form of cancer called clear cell carcinoma which originates in the gynecological area. She did have a previous stroke approximately three years ago, (just after original diagnosis) but she was on a different course of treatment at that time...Oncologists have explained that this most recent stroke event would not be considered a side effect of her current treatment routine. She wanted to bring it to the attention of the health department in case it needs to be looked at more closely by the J&J research/scientific team. She passed away on 4/5/21. Her current treatment consisted of palliative chemo only. " Decedent was a resident but was vaccinated in another state. After the CVA she was brought to the hospital and subsequently transferred to the Medical Center where she died on 4/5/2021. Sister is willing to speak with any investigators if deemed necessary.

Anaphylaxis in the form of swelling of the tongue after eating pineapple. Patient had never had an allergy to any food prior to this.

Two days after my vaccine, on March 23 at approximately 2 AM, I had to call 911 because my heartbeat was rapid and irregular and had never happened before. I was concerned it was a result of the vaccine because it was two days after the vaccine. An emergency vehicle came took me to the hospital and they said I had atrial fibrillation and they had to reset my heart by jumping it. Very frightening.

2021-04-23 Patient presents to the ED with right-sided mid-back pain and shortness of breath starting 2021-04-22 evening. Pain is sharp and worsens with coughing and deep inspiration; she feels that she is taking shallow breaths. On ED presentation, no shortness of breath, chest pain, dizziness, fevers, dysuria, or abdominal pain. She does have reproducible pain on her right mid-back area. There is some mild diffuse tenderness in her abdomen, but reports that she always has a tender abdomen due to Crohn's disease. No peritoneal signs. No recent travel. Patient was found to have pulmonary embolism. Hematology/Oncology specialist was consulted and recommended initiation of argatroban for treatment of pulmonary embolism. Patient was admitted to inpatient.

Patient was driving on 3/24 when her vision became blurry in her left eye. She saw her eye doctor on 4/21 and was sent to a specialist. On 4/23 she was diagnosed with a blood clot in her left eye. She is to begin eye injections for treatment.

PULMONARY EMBOLISM/RIGHT SIDED MID BACK PAIN; This spontaneous report received from a health care professional concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included Crohn's disease. The patient was previously treated with infliximab for Crohn's disease. The patient experienced drug allergy when treated with infliximab (Remicade). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, expiry: unknown) dose was not reported, 1 total administered on 31-MAR-2021 to left arm for prophylactic vaccination. Concomitant medications included vitamins nos, azathioprine, dicycloverine, and mesalazine for drug used for unknown indication. On 22-APR-2021 by evening, the patient experienced right-sided mid-back pain and shortness of breath and was presented to ED (emergency department) on 23-APR-2021. The patient's pain was sharp and worsened with coughing and deep inspiration; she felt that she was taking shallow breaths. Upon ED (emergency department) presentation, there was no shortness of breath, chest pain, dizziness, fevers, dysuria, or abdominal pain. The patient had reproducible pain on her right mid-back area. There was some mild diffuse tenderness in her abdomen, but it was reported that she always had a tender abdomen due to Crohn's disease. The patient had no peritoneal signs and had no recent travel history. On 23-APR-2021, the CTA (Computed tomography angiography) of chest was done with and without contrast and found out central and peripheral pulmonary emboli in the right lower lobe. The patient had no CT (computerized tomography) evidence of right heart strain. The patient's ground glass opacities within the right lower lobe was somewhat band like in appearance and concerned for early pulmonary infarcts. It was reported that this might also relate to sub segmental atelectasis or less likely an inflammatory/infectious process. The patient had also small right pleural effusion; no acute inflammatory process in the abdomen or pelvis. On 23-APR-2021, the patient's platelet count was 252 k/mcL and was tested negative for covid test. The patient was diagnosed with pulmonary embolism; she consulted hematology/oncology specialist and recommended with initiation of argatroban for treatment of pulmonary embolism. The patient was admitted to inpatient on 23-APR-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pulmonary embolism/right sided mid back pain was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0;-covid-19 vaccine ad26.cov2.s-Pulmonary Embolism. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

She developed a DVT <4 weeks after receiving the vaccine (first became symptomatic 4/30). She has a potential alternative cause in that she was taking oral estrogen but no other provoking factor.

3 days after vaccination with COVID-19 Janssen, patient developed acute right leg pain and swelling. She did not present to the office until 5/11/2021. She was sent to the ER which showing extensive acute DVT and bilateral pulmonary embolism.

Complaint of cramping in legs on April 26. 2021. Resolved for a short period of time. Earlier in May 2021 Complaint of Left Flank pain with Radiating pain to Left Thigh. Appointment with Orthopod cancelled due to inability to drive with pain. On May 15, 2021 complaint of continued Left Flank Pain Radiating to to Left thigh with burning and discoloration. Unresponsive on May 16, 2021. Pronounced Dead at 1:52pm by County Coroner. Cause of death noted as CV. Nature of death :Natural This is being reported in case another patient complains of these same symptoms. There may or may not be a Correlation with this Death and The Jassen Covid-19 Vaccine

5/3/21 Pt presented to ED with a 3 day history of feer to 103.5, sore throat, SOB and N/V. She had a known exposure to a household member(s) with COVID. NP swab was positive for SARS-CoV-2, Otherwise her labs were unremarkable. CXR showed subtle streaky opacities in left lung base. She had no oxygen requirement and was discharged to home with a referral for monoclonal antibody. 5/6/21 Patient received infusion of BAM+E. During the infusion she was noted to be SOB and O2 sat was 90%. She was sent directly from the infusion center to the ED. HOSPITAL COURSE: patient is a 64 y.o. female with shortness of breath from infusion clinic after getting antibody for covid. Pt was found hypoxia. Pt has been treated with Remdesivir, decadron and supportive care. Pt recovered very well Pneumonia due to COVID-19 virus Acute hypoxic respite failure secondary to above. -Was admitted on May 6, SP remdesivir and IV diuretics -05/11 improving respiratory failure, current on 6 L NC, continue supportive care, ID continue following up -05/12 pt is on 3 L NC without shortness of breath. Pt's CRP trending down 18.3. Pt will be discharged home with home oxygen. She will continue taking 4 days of decadron. Follow up with primary care physician. Return to ER for worsening symptoms or other concerns.

BLOOD CLOT IN BRAIN; BLOOD CLOT IN RIGHT LUNG; BLOOD CLOT IN STOMACH AND NECK; This spontaneous report received from a patient concerned a 64-year-old, female. The patient's height, and weight were not reported. The patient's past medical history included tendonitis in right shoulder, surgeries on right shoulder and concurrent conditions included arthritis in right shoulder, non-smoker, abstains from alcohol, and seasonal allergies, and other pre-existing medical conditions included the normal wear and tear on her body at the time of this 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, one total, administered on 04-MAY-2021 at the right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The Patient reported that on 04-MAY-2021, after vaccination, she began feeling unwell with a low grade fever, her highest body temperature was 102F. She experienced headache that she initially felt on the right side of her head but could not determine the source for sure. On 14-MAY-2021, she coughed up blood, but she didn't think anything of it and continued her normal routine then on 15-MAY-2021, she coughed up more blood but it had some phlegm in it, so she went to the ER (emergency room) on 18-MAY-2021. She received a Computerized axial tomography (CAT) scan of her chest which showed blood clots in her right lung. She got a secondary CAT scan and blood clots were found in her stomach, brain and in her neck. She was admitted to hospital on 19-MAY-2021. The Patient was reportedly hospitalized for 6 days and was supposedly discharged on 24/May/2021. For treatment, she was receiving an Intravenous (IV) blood thinner but later changed to an oral blood thinner. She was also receiving Tramadol for pain. She was receiving other medications when first admitted but could not recall specific names. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot in brain, blood clot in right lung, and blood clot in stomach and neck. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210546778-covid-19 vaccine ad26.cov2.s- blood clot in brain, blood clot in right lung, and blood clot in stomach and neck. This events are considered unassessable. The events 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.

Four days after receiving her Covid vaccination patient started bleeding vaginally. Had blood clots and large amount of blood and it lasted 2 weeks. Patient has been post-menopausal for 10+ years.

Systemic: Stroke-Medium, Additional Details: Caregiver mentioned patient received vaccine on 6/4/21, and was admitted to hospital for a stroke on 6/8/21. Please note this was 4 days after the vaccination, unsure if this is related to vaccine or other health factor. However, have still reported per protocol.

June 2, 2021 became confused, nauseated and dizzy. Kept asking the same questions over and over. Diagnosed with most likely TIA secondary TGA with J and J vac most likely a contributing factor.

Following immunization patient had a fever overnight and feeling of being "hit by a mack truck" which caused fatigue and she had slept it off. Patient had lump that developed behind left knee two weeks after vaccination. She described the feeling of losing the ability to move her left leg and a feeling of a rip when getting out of her boat. She called her chiropractor who told her to get to the ED and stated she likely had a clot. She was seen in the clinic and was taken by ambulance to the hospital and had a surgery to remove a clot she was told was from her left ankle to her left knee. She had a Boston Scientific Wallstent placed (lot number 25506141) and was hospitalized for a week duration. Patient taking Lasix, blood thinner, aspirin, and antibiotic. She was taken off of work for a month duration.

Shingles- on head, scalp, face - treatment valacyclovir, lost of 10 teaching days, Atrial fibrillation - irregular heart beat, 4 EKG ?s, 1 physicians care facility, 1 emergency room visit, 1 urgent care facility, 1 phone call to family doctor, 1 visit to Dr. cardiologist , suppose schedule of a cardiac stimulus procedure ; treatment apixaban and metoprolol

Patient vaccinated by EMS on 3/29/21, EMS notified clinic that patient was taken to the Hospital for a stroke on 4/1/21

Within minutes of getting the injection, became faint with a severe drop in blood pressure. Under observation at the site by Health professionals for 50 minutes. On leaving the facility, on the 15 minute drive home, had some tongue swelling and other indications of anaphlyaxsis, so drove directly Hospital ER. They suggested fluids and prescribed Benedryl and waiting nearby. When symptoms did not worsen, left and arrived at home around 2 p.m. Now 24 hours later, still some swelling of tongue and tinnitus, along with site soreness and dizziness.

anaphylaxis, severe face swelling, throat closing, arm swelling, headaches, ongoing dizziness, equilibreum issues, aches, stomach issues, rash on face, neck, torso and both legs, nausea ongoing, tingling sensations. 8 benadryl in first 30 min. kept me there for one hour - almost two weeks out and still not fully resolved (very dizzy, severe headaches, some swelling remains)

On 4/10/21 to Urgent Care. Found blood clots in my lungs and Pneumonia, Clots removed at Hospital on 4/11/21. Hospitalized until 4/13/21. Treatment - blood thinners (enoxaparin, heprin and steroids), azithromycin, Advair disk, albuterol, Spiriva, Symbicort Outcome: Still trouble breathing, slow moving and sore from the incesion.

The patient presented to the emergency department with altered mental status, dry heaving, and body aches. She was found to have a partially occluding thrombus of the right cephalic vein consistent with venous thrombosis, as well as findings of thrombosis in the anterior segment branch of the right portal vein. She had a d-dimer of 25.77 increased to 35.2, and was thrombocytopenic with a platelet count of 92, which dropped to 36 the following morning. Platelets to present were: 92-36-32-23-19-28. The patient received the Johnson & Johnson COVID-19 vaccination two weeks prior to presentation.

pt says one of her toes on her left foot went completely number. Within a couple of days she started swelling between her left big toe and the toe next to it. Her entire left foot started swelling and then her leg started swelling. She went via ambulance to ER. They did an US of her leg and found 2 blood clots in the back of calve. She was given a RX for blood thinner. She went to 3 pharmacies and could not find it so she went home. She went home and then her right foot swelling as well. She went back via ambulance to ER. She was given blood thinner injection, and IV and took blood work. Pt was admitted where she stayed for 5 days. She was released and prescribed Eliquis. She has to take 20 mg a day for first week and then 10mg a day the following week for 3 months. She still has constant pain and her left foot continues to swell. Pt will have to have another US in 3 months.

Patient admitted 4/12/21 with fatigue and abdominal pain. Found to have UTI but no definite sepsis, and acute renal failure. Treated with iv antibiotics and iv fluids. Over next 48 hours developed worsening encephalopathy and thrombocytopenia. MRI/MRA/MRV showed no acute findings. Hyperammonemia noted, with no known Hx of cirrhosis; US did not show portal vein or hepatic vein thrombosis. Encephalopathy worsened, no clear etiology; EEG just showed generalized encephalopathy. Renal function worsened. Patient became obtunded and was intubated 4/16/19. Platelet nadir of 31k. Dialysis started. Left common femoral DVT developed. Patient had DIC type picture. Respiratory failure worsened, hypotension developed, patient passed away 4/20/21. No clear etiology of encephalopathy and thrombocytopenia identified, unclear if related to J&J vaccine received 2 weeks prior.

On Sunday night, 04/11/2021 around 7:00pm, patient stated she started getting sick to her stomach. She complained of headaches and fatigue. At midnight she vomited, couldn't lay down and symptoms lasted all night. She complained of back pain too. she noticed blood in her urine with a clot of blood in it and had shortness of breath. She vomited twice. In contact by phone with her daughter at the time. Patient refused to go the the emergency room or call her physician. She has a cardiologist who is her primary care physician.

Patient has leg cramps starting on Monday, April 19th. She went to the hospital at later date. Doctor diagnosed her with leg clot.

4/19/2021: Woke up in the middle of the night with an achy arm. Had this for a week. Went to chiropractor as she thought it was neck trouble. Chiropractor states arm is swollen and see MD. MD sent patient for ultrasound and blood clot confirmed in right arm pit. Patient started on eliquis.

Patient Received the COVID Janssen vaccine on 3/9/2021. On 4/11/2021, the patient developed symptoms described as right lower leg weakness (leg "bowed" out, felt, like a "lead" foot). She also complained of right upper arm weakness. She was admitted on 4/12 and determined to have an acute CVA. Her symptoms quickly resolved. She was started on enoxaparin, ASA, and rosuvastatin and discharged on 4/13.

Patient presented to ED on 5/12 with complaints on gradually worsening left leg swelling and pain for 3 days, no with difficulty ambulating. Patient reports she received the J&J vaccine 5 weeks prior.

pt stated about 4 hours after taking the vax she had a terrible headache. pt laid down but when she got up she had very sharp pains shooting from her toes up to her legs. pt said she had a stabbing pain in her left mid thigh. This episode lasted about 15 minutes. the next day she went to a routine exam but her PCP did not seem to think there was anything to worry about. pt had to have blood test 10 days later. She stated she was so tired she could barely get to the lab to get the test. The following weekend on 5/17/2021 she started having SOB and a coughing spell. On 5/19/21 she called to make an appt w/ PCP on 5/21/21. She saw a different physician and she was ordered a D-Dimer test. On 5/22/21 the pt got a phone call stating she needed to get to an Emergency Room since the lab test proved she had a blood clot. She went to ER. They did a US Doppler and CT of lungs. She had 2 pulmonary thrombosis. One in left lung and one in right lung. She had one DVT in left calf. Pt was admitted. She was given heparin IV for 3 days. She was then put on Xarelto and discharged on 5/25/2021. she has to take Xarelto for 90 days and scheduled to have another US on 7/19/2021 to see if the clots are dissolved.

SUBACUTE PULMONARY EMBOLISM IN LEFT AND RIGHT LUNG; DVT IN LEFT CALF; UNABLE TO DRIVE; EXTREME EXHAUSTION; HEADACHE; SHARP SHOOTING PAIN IN RIGHT LEG; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known previous medical conditions and had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: 21-JUN-2021) dose was not reported, once total administered on 06-APR-2021 15:00 in Left Arm for prophylactic vaccination. Concomitant medications included amlodipine, hydrochlorothiazide and losartan for which indication was not provided. On 06-APR-2021, the patient experienced headache while driving back to home and was not sure if it was due to vaccine or traffic conditions. At 18:30, patient got up to walk across the room and felt a strong sharp pain in her right and left leg described as incredible cramping type of pain which her husband had to help sit down to a chair. Patient states that although the pain was in both legs, the left leg felt as though someone had took a knife to her thigh, the pain lasted approximately 15 minutes. On 07-Apr-2021, patient states that she went for a routine doctors visit to her family care physician who wrote her a prescription for routine blood work. On 14-Apr-2021, patient went to get the blood work done and states at this time, she felt extremely exhausted and that due to a bloodwork mix up which required her to drive back to the lab, she was not able to drive back so her husband had to drive her. Around 17-Apr-2021 to 18-Apr-2021 patient had to chase the dog and found that she couldn't catch her breath and that she started coughing. Her daughter who happened to be there asked her why she was coughing and thought that it was not normal and that she should contact her doctor.On 19-Apr-2021, patient called the doctor. On 21-Apr-2021 patient saw the doctor and during examination, patient was instructed to run a D-Dimer test to rule out blood clots. On 22-Apr-2021, doctor stated patient to go to the Emergency Room as the result for the D-Dimer test came positive. The patient was immediately hospitalized where Doppler and CT scan was performed on her and was diagnosed with Deep Vein Thrombosis and Pulmonary Embolism on both the lungs. Patient mentioned that she was treated with Heparin drip from 22-Apr-2021 to 24-Apr-2021 and then she was given Xarelto. On 25-Apr-2021, the patient was discharged from the hospital after 4 days of hospitalization. Patient reports that she was still experiencing extreme exhaustion and that the pulmonologist states that this is the normal course of blood clots and it could take anywhere from 60-90 days for the body to clear up the blood clots. She states she still has bouts of shortness of breath but showing signs of improvement. Patient stated that she was scheduled for another Doppler on 19-Jun-2021 which was recommended by her primary care physician. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sharp shooting pain in right leg on 06-APR-2021 ,had not recovered from extreme exhaustion, and the outcome of pulmonary embolism in left and right lung, dvt in left calf, headache and unable to drive was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210550248-COVID-19 VACCINE AD26.COV2.S, The case concerns with a Caucasian female. Subacute pulmonary embolism in left and right lung, deep vein thrombosis in left calf. 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 event.

Client did not have immediate adverse event following vaccine administration. Client died on 6/11/2021, approximately 8 weeks after receiving COVID19 Janssen vaccine. Cause of death is unknown by this reporter.

I had a number of strokes between April and May. As many as 9 of them. Memorial Day, 31st, I went to the hospital ER at 9:00PM. I had a PFO, which is something like Patent Forman Ovale, heart condition, hole in atrium of heart that causes the blood to go from heart to brain. Blood clots to the brain, venous blood gets into the arterial blood. The clots could have formed everywhere but they go straight up the brain. They went through an artery and put a mesh screen over my heart opening and eventually it will help that. It was done through an artery, 15 minute process. I left the hospital the following Saturday. This week (two days ago) I have really bad tinnitus starting in both ears. My hearing is quite disrupted. I don't know how serious it is right now. I am being treated with an anti-cholesterol drug (Lipitor) and aspirin. I still have a little bit of cognitive impairment and physical fatigue. My coordination is messed up. Physical therapy starts the 15th and Speech therapy on the 23rd. I had just gotten a job two weeks before the strokes.

Patient notified pharmacy today (03/22/2021) that Janssen Covid-19 Vaccine that she received on 03/03/2021 caused Pneumonia. Patient says that on 03/11/2021 went to hospital for treatment and MD told her that Pneumonia was caused by Janssen Vaccine she had received. Patient says was treated at hospital with 2 kind of IV antibiotics.

I got the shot on Tuesday morning, and then by Wednesday morning I had a bad afib event, and still have afib and am at Hospital. I haven't had an event like this in 2 years. The cardiologist here thinks it's related to the vaccine.

Began to experience shortness of breath which got worse and worse, until I couldn't walk across a room without being totally out of breath.

presented to ED 3/22/21 with leg swelling that worsened over past 2 days. Diagnosed with Venous stasis ulcers & Thrombocytopenia

My mom had called saying she's feeling nausea, dizziness, drowsiness and vomiting. We called the emergency services when they arrived she had collapsed. They broke the window and took her to the hospital, upon arrival we were informed that she has got a hemorrhage possible clotting due to high blood pressure. I now know the term is Cerebral Hemorrhage, she has been in ICU on a ventilation machine while they tried to drain the blood and clots. She's currently out of ICU however still complains about headache and back pain. We are informed that she has now developed some blood pressure and diabetes however it could be cleared in the short term. She's at the hospital and unknown how long she would have to stay there.

Right lower extremity DVT's and multiple bilateral pulmonary emboli involving main pulmonary arteries with right heart strain

Got the vaccine on Apr 6 Fever and leg pain started on Apr 7 Sever headache, nausea occurred on Apr 11, called 911 immediately and sent to emergency room of hospital The diagnosis is large volume of subarachnoid hemorrhage in the brain. Surgery conducted on April 11 and the patient is still in ICU now

My symptoms i had sever headache! Once April 1st Hit! Thats Was the day I Had a Heart stroke at store, i don?t remember anything and once i woke up i was at the hospital, and they told me that i had a heart stroke because i had lots of blood clots in my body. And they told me i vomit and peed myself durong the whole situation i went in store

SAW OBITUARY FOR PATIENT IN PAPER SHE HAD JUST RECEIVED VACCINE NOT TO LONG AGO SO WANTED TO MAKE SURE THIS WAS REPORTED

BRADYCARDIA; RAPID ATRIAL FLUTTER; RAPID ATRIAL FIBRILLATION; TACHYCARDIA; SHORTNESS OF BREATH; DID NOT FEEL WELL; This spontaneous report received from a patient concerned a 66 year old white and 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: 1805031, and expiry: UNKNOWN) dose was not reported, once total, administered on 10-MAR-2021 for prophylactic vaccination on right arm. No concomitant medications were reported. On 10-MAR-2021, patient had echocardiogram and the rhythm was normal. On 29-MAR-2021, the patient experienced rapid atrial flutter which became rapid atrial fibrillation and had tachycardia and shortness of breath. On same day patient was hospitalized for monitoring and On 30-MAR-2021, the patient developed bradycardia. It was stated that patient was bouncing between tachycardia and bradycardia which he never experienced before. Also patient stated that if symptoms doesn't resolve he had to have cardioversion procedure. On 31-Mar-2021, patient got discharged from hospital. It was reported that patient's medical doctor was aware about the adverse events and cardiologist does not know about the administration of vaccine. It was also reported that clinician who administered the vaccine to patient advised to take Motrin. Treatment medications (dates unspecified) included: Motrin(ibuprofen) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rapid atrial flutter, rapid atrial fibrillation, shortness of breath, tachycardia, and bradycardia, and the outcome of did not feel well was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210424129-Covid-19 vaccine ad26.cov2.s-Atrial fibrillation, Bradycardia and Atrial flutter. These events are considered not related. The events have 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.

On 04-01-2021, I started to experience fever, chills and terrible headaches. I also developed pneumonia. A chest x-ray was done which demonstrated ground glass opacities. My breathing was also bad. I also have an enlarged heart. I also do not have any blood clots. I did not have problems before the J&J vaccine. To this day I still have headaches that come and go. I do not know if the J&J vaccine attributed to my symptoms and my doctor is till monitoring me.

SWELLING OF LEGS; VENOUS STASIS ULCERS; THROMBOCYTOPENIA; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient has chronic conditions like Patient Medical History of Hyperlipidaemia, hypertension, type II diabetes, coronary artery disease with recent segment elevation myocardial infarction left anterior descending s/p Percutaneous coronary intervention, low ejection fraction 30% from 60% s/p single chamber 6/202. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 10:29 for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the patient experienced swelling of legs, venous stasis ulcers, and thrombocytopenia. The patient on unspecified date was shifted in emergency room and later she was hospitalized. Number of days in hospital the patient was admitted was unknown. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) Moderate to severe pulmonary HTN, and Echocardiogram (NR: not provided) worsening EF- 15% from 30%m Moderate MR. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling of legs, venous stasis ulcers, and thrombocytopenia. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: A 66 year old female, unspecified ethnicity, was diagnosed with venous stasis ulcers and thrombocytopenia 16 days after receiving the covid-19 vaccine ad26.cov2.s. The patient went to the emergency room for the leg swelling (start date unknown) that was progressing over 2 days. Medical history includes hyperlipidemia, hypertension, and type II diabetes. Patient also has coronary artery disease with recent segment elevation myocardial infarction left anterior descending (STEMI LAD) s/p Percutaneous Coronary Intervention, low Ejection Fraction 30% (from 60%), s/p Single Chamber ICD. Concomitant medications not reported. Smoking history not provided. Echocardiogram revealed worsening EF - 15% from 30%, Moderate MR, Moderate to Severe Pulmonary Hypertension. Thrombocytopenia was reported without a reported platelet count. The patient was subsequently admitted to the hospital for unspecified number of days and was reported to have recovered from all events. Given the patient's extensive medical history, there is a plausible alternate explanation for swelling of legs and venous stasis ulcers, and there is limited information to make a meaningful assessment of the report of thrombocytopenia. Additional information is requested.

1-2 weeks after dose of vaccine, developed nausea, chills, diarrhea. Presented 1 month after vaccine to ED with embolic strokes and new renal failure.

Patient presented to hospital with four days chest pain, dyspnea on exertion and weakness. Work up revealed an acute submassive pulmonary embolism without evidence of deep vein thrombosis in bilateral lower extremities.

Ultrasound done on 4-30-2021 for pain in calf of left leg and numbness of the toes for 7 days. Result came back positive for blood clot.

DEATH; BLOOD CLOT; This spontaneous report received from a health care professional concerned a 66 year old White and not Hispanic or Latino female. Initial information received from the health care professional on 05-MAY-2021 was processed with additional information obtained from live follow up with health care professional on 06-MAY-2021. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, diabetes, high cholesterol, non smoker, non alcohol user and other pre-existing medical conditions included no known allergies, no drug abuse or illicit drug use. Lab work was done 3-4 months ago, the results of which were unavailable. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: Unknown) dose was not reported, 1 total, administered on 10-APR-2021 possibly left arm for prophylactic vaccination. Unspecified concomitant medications were reported. On 28-APR-2021, the patient developed right leg pain and right leg swelling also began around this time as well. On 04-MAY-2021, the patient died from blood clot. An autopsy was not performed. The reporter stated that the patient's death was related to Janssen covid-19 vaccination and blood clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of blood clot on 04-MAY-2021. This report was serious (Death).; Sender's Comments: V0:20210509157-JANSSEN COVID-19 VACCINE- Death, blood clot - 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.; Reported Cause(s) of Death: BLOOD CLOT

She been feels ill slightly ill ever since the shot. Always short of breathe. Now she died of a blood clot / heart attack while at night in her chair.

Upper extremity DVT same side of vaccination Left upper arm pain, bruising, swelling Symptoms started approximately 2 days after injection

ON APRIL 16, 2021 I WOKE UP AND I COULDN'T SEE OUT OF MY LEFT EYE, I WAITED A WHILE TOO SEE IF MY SIGHT WILL COME BACK AND IT DIDN'T SO I CALLED MY EYE DOCTOR AND MADE APPOINTMENT AND THEY SCHEDULED ME FOR APRIL 23, 2021. A WEEK LATER I WENT BACK TO THE DOCTOR AND HE TOLD ME TOO GO TO HOSPITAL A.S.A.P. THEY TOOK A CAT SCAN AND SAW THE OPHTAQLMOLOGIST IN HOSPITAL THE DIAGNOSIS WAS A BLOOD CLOT IN MY LEFT EYE AND I TOOK A STROKE.

Developed blood clot in left leg. I was also given Pneumococcal vaccine on 4/12/2021 following covid vaccine.

BLOOD CLOT IN ABDOMEN AND EXTREMITIES; ANEURYSM CLOTS IN THE ABDOMEN; LOSS OF MOBILITY; LOSS OF APPETITE; HEADACHE; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. . The patient's past medical history included stent placed on lower extremities few years ago, and concurrent conditions included former smoker, cardiac issues, non-alcoholic and racing heart, and COPD (Chronic obstructive pulmonary disease) and other pre-existing medical conditions included no known allergies and patient does not abuse drug or illicit drug usage On 03-May-2021, the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: Unknown) frequency 1 total, dose was not reported, administered on right deltoid for prophylactic vaccination. Concomitant medications included rivaroxaban, and sildenafil. On 04-JUN-2021, the patient experienced blood clot in abdomen and extremities, aneurysm clots in the abdomen, loss of mobility, loss of appetite and headache. The patient though the pain was due to medicines she had for cardiac disorder. The pain worsened to the point she went to her gastro intestinal doctor, who did CT scan which showed aneurysm. Her Doctor called cardiologist who suggested referral to a vascular surgeon. The vascular surgeon discovered more blood clots in the abdomen. The CT scan with contrast and Doppler studies were performed. The patient was on blood thinners for 3-4 months. The medicines were started prior to vaccination. None of the doctors were aware that she has taken the Johnson vaccine. The patient stated that she had all the side effects. On 28-JUN-2021, Laboratory data included: Oxygen consumption (NR: not provided) increased. On 28-JUN-2021, Laboratory data included: CT scan (NR: not provided) CT scan with contrast showed clots in abdomen and extremities. On 30-Jun-2021, the patient experienced aneurysm clots in the abdomen. Laboratory data (dates unspecified) included: CT scan (NR: not provided) Not reported, and Ultrasound Doppler (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot in abdomen and extremities, headache, loss of appetite, and loss of mobility, and the outcome of aneurysm clots in the abdomen was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210716346-covid-19 vaccine ad26.cov2.s-Thrombosis. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE

Shortness of breath, hypertension, hypoxia, tachycardia, lips and fingers turn blue, high fever, rash, hives, joint pain, whole body aches, left lower leg burning, artery blockages, infection, weakness, dizziness, tunnel vision, sweating, headache, new onset atrial fibrillation with rvr All of the above symptoms first occurred 30 minutes after injection of vaccine The atrial fibrillation occurred 6 days after injection Left lower leg started burning 15 days after injection The artial blockages and thrombus 18 days after injection by medical diagnosis due to instantaneous shut off of blood to left leg

Initially 2 to 5 days just fatigue. Evening of March 26th unusual fatigue and lower back to middle back discomfort low pain level.

The patient received the vaccine on 3/31/2021. On 4/7/2021, patient developed weakness that continued until 4/14/2021. Patient also developed shortness of breath on 4/14/2021. The patient presented to the ER for weakness and shortness of breath. Patient had labwork, EKG, and an Xray. Troponin, BNP, and D-Dimer were elevated. Sodium was low. Chest xray showed congestive heart failure. Pt required intubation and then coded. Cardiac life saving procedures were started but the patient succumbed to death. Patient death pronounced per MD.

2 weeks 8 days after vaccine, patient suffered which sent pt to emergency room. Husband states she had a "blood clot" to brain with skull fracture and traumatic brain injury. Transferred to Medical Center, then to long term facility. Has not recovered to date. Husband states unable to speak or move.

Acute bilateral lower extremity DVT found on venous duplex after reporting new bilateral leg swelling 7-8 days after receiving Janssen COVID-19 vaccine. No prior history of DVT. Brain MRA pending at time of report w/ concurrent history of new/moderate/persistent headache.

My sister suffered a massive stroke with blood clots. Totally paralyzed on right side and limited speech. Unable to function on her own, receiving care at a Nursing Home

67 yo female with PMH of HTN, DM who has two days of left sided numbness that has progressed to left hemiparesis and dysarthria in the setting of having received the Johnson and Johnson vaccine on Wednesday(48hours prior). Patient was found to have a right parietal multifocal parenchymal hemorrhage measuring 19x36x37mm and small right temporal lobe SAH. Subsequent CTA showed thrombosis of the superior sagittal sinus and the right frontoparietal cortical veins as well has nonocclusive thrombus of right transverse and sigmoid sinus. The patient was also noted to have focal seizure of mouth and tongue and was loaded with phosphenytoin. After discussing case with neurology, nuero IR, NSGY and family it was decided to transfer the patient to sunrise for close monitoring and consideration of cerebral venous sinus thrombectomy if she worsens. I had a long discussion with multiple sisters about the risks of anticoagulation with argatroban given the IPH but the necessity given the cerebral venous thrombosis. I also discussed that argatroban is not readily reversible and that heparin is contraindicated if there is concern about vaccine induced thrombotic thrombocytopenia due to possible PF4 ab related to HIT. The patients VITT modified 4T score is 4 and she is intermediate risk for this being VITT. #Right parietal IPH, right temporal SAH and Superior saggital sinus thrombosis with nonocclusive thrombus of right transverse and sigmoid sinus -concern for vaccine induced thrombotic thrombocytopenia given johnson and johnson vaccine 2 days prior -modified VITT 4T score of 4- intermediate -send fibrinogen, d dimer, consider IVIG 1gm/kg per day for two days if high dimer, low fibrinogen and falling platelets -will start argatroban, avoid heparin until HIT ab (PF4) is resulted, if HIT positive avoid heparin -neuro IR consulted for possible IR intervention if worsens -transfer accepted by sunrise ICU, appreciate transfer for IR evaluation -continue phosphenytoin -SBP goal <150 with nicardipine and esmolol gtts -monitor daily fibrinogen, dimer, coags #AKI- monitoring uop and cr, consider renal US if worsens #DM- ISS #HTN- nicardipine and esmolol gtts for SBP <150, target 140 Patient seen, examined, labs and imaging reviewed, agree with resident note

CHEST POUNDING, HEART RATE SPIKING TO 206 WHILE RESTING ON 3 SEPARATE OCCASIONS, BLOOD PRESSURE AT 160, LIGHT HEADED, EXHAUSTION. DIAGNOSES WAS ATRIAL FIBRILLATION. TREATMENT WAS INJECTIONS TO LOWER HEART RATE AND BLOOD THINNER. PRESCRIBED PRADAXA 150MG X2/DAY AND DILTIAZEM 180MG X2/DAY.

Within minutes of receiving the Janssen vaccine, patient c/o dizziness, difficulty breathing, and feeling like her throat was closing. Her breathing was labored, shallow and fast RR high 30s, 93% RA, HR 120s. Lungs sounds with poor air entry, no wheezing. No rash, injection site unremarkable. Pt disclosed extensive history of allergies and h/o anaphylaxis needing Epi. States that current symptoms feel like previous anaphylaxis events. Called Code. Administered Epinephrine IM L thigh and within 2 minutes patient felt better, vital signs improved to HR 121, 99% RA, 170/86 speaking in full sentences. Allergy fellow and ED team arrived and patient was transported to ED alert and responsive in NAD.

Severe exacerbation of idiopathic capillary leak syndrome 48 hours following administeration of Janssen vaccine leading to profound vasodilatory shock, renal failure and DIC and death

Pulmonary embolism with acute Cor Pulmonale/hypoxia I had shortness of breath, dizziness, coughing. I had Covid test on 3/12/21 that was negative. Went to Urgent Care on 3/12/21. Gave me an albuterol inhaler which was not effective in relieving symptoms. I wasn't improving, so went to emergency room at the hospital on 03/18/2021. I was admitted to hospital and placed on oxygen and kept overnight. I was also given Xarelto. I am at home and on Xarelto.

HYPOCHROMIA; HIGH WHITE BLOOD CELLS; DVT WITH INFLAMMATION AND SWELLING OF RIGHT LOWER LEG; RUNNY NOSE; BILATERAL WATERY EYES; LEFT ARM TENDERNESS POST IMMUNIZATION; URINARY TRACT INFECTION; LOWER BACK PAIN; This spontaneous report received from a patient concerned a 68-year-old female. The patient's height, and weight were not reported. The patient's concurrent conditions included baker's cyst, and reflux sympathetic dystrophy. The patient experienced drug allergy when treated with gabapentin, and prednisone, drug intolerance when treated with codeine, and ibuprofen. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, expiry: UNKNOWN) once a total dose was not reported, administered on 10-MAR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced urinary tract infection. On MAR-2021, the subject experienced lower back pain. On 10-MAR-2021, the subject experienced left arm tenderness post immunization. On 11-MAR-2021, the subject experienced runny nose. On 11-MAR-2021, the subject experienced bilateral watery eyes. On 14-MAR-2021, the subject experienced deep vein thrombosis with inflammation and swelling of right lower leg. On 23-MAR-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) confirmed DVT right lower leg, Urinalysis (NR: not provided) Unknown, and White blood cell count high (NR: not provided) 10.35 increased and was previously 9.23 not reported. Treatment medications included: ciprofloxacin for urinary tract infection. On 24-MAR-2021, the subject experienced hypochromia. On 24-MAR-2021, the subject experienced high white blood cells. Additional treatment medications (dates unspecified) included: rivaroxaban for deep vein thrombosis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from runny nose, and bilateral watery eyes on 12-MAR-2021, and left arm tenderness post immunization on 11-MAR-2021, had not recovered from deep vein thrombosis with inflammation and swelling of right lower leg, high white blood cells, and hypochromia, and the outcome of urinary tract infection and lower back pain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210348648-Covid-19 vaccine ad26.cov2.s-Deep vein thrombosis. 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 with mild shortness of breath for the past month. Travel a week ago. Received vaccine 03/29/21. Admitted on 04/11/21 for increased shortness of breath. CT angio showed extensive segmental pulmonary embolii. Patient doing well and discharged to home on 04/12/21 after being placed on Lovenox then transitioned to Eliquis.

Date and time adverse event started: 04/08/21 evening (stroke at home) Adverse events experienced and are they still occurring now: after the stroke they did a number of test, angiogram, CAT scan with and without contrast, MRI Spoke to her doctor who told her husband to take her to the hospital (husband stated she is doing better she is still in the hospital)

PULMONARY EMBOLISM; THROMBOSIS; COR PULMONALE ACUTE/ DYSPNOEA; HYPOXIA; DIZZINESS; COUGHING; This spontaneous report received from a patient via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAER reference number 1120494) concerned a 68 year old female unknown ethnicity. The patient's weight, height, and medical history were not reported. 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 06-MAR-2021 14:15 for prophylactic vaccination. Concomitant medications included amitriptyline for sleep, and zolmitriptan for migraine. On 07-MAR-2021 08:30, the subject experienced pulmonary embolism, thrombosis, cor pulmonale acute/ dyspnoea, hypoxia, dizziness, coughing, and was hospitalized (date unspecified). On 12-MAR-2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) Negative. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) normal, Blood test (NR: not provided) normal, CT scan (NR: not provided) Pulmonary Embolism, Chest X-ray (NR: not provided) normal, Diagnostic ultrasound (NR: not provided) No blood clots or vein thrombosis, Echocardiography (NR: not provided) Increased pressure on the right side of heart due to blood clots, and Heart rate (NR: not provided) elevated. Treatment medications (dates unspecified) included: oxygen, salbutamol, and rivaroxaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pulmonary embolism, thrombosis, cor pulmonale acute/ dyspnoea, hypoxia, dizziness, coughing was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition); Sender's Comments: V2:Additional version created for MAC update. This updated information does not alter the causality of previously reported events. 20210441745-Covid-19 vaccine ad26.cov2.s-Thrombosis, pulmonary embolism ,Cor pulmonale acute, Hypoxia, dizziness, cough. These events are considered unassessable. These events 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.

Patient reported knee pain at the end of march 3/28/2021 she was seen by a doctor on 4/14 and thought to have arthritis prescribed NSAIDS. Patient had no history of arthritis or chronic prescription use or chronic health conditions. She was referred to an orthopedic and when no arthritis was found she was referred to ER to check for a blood clot on 5/10/2021. Patient was diagnosed with a DVT on 5/10/2021 with no previous history of clots or other risk factors known.

4/13/21 - 7pm Developed confusion and amnesia noted by husband. Taken to local ER where tests showed small acute stroke left temporal lobe and previous (3-4 weeks prior) small stroke right temporal lobe. Hospitalized for 2 days. No neurological deficits. No previous signs or symptoms of stroke prior to 4/13. Wt. 137 lbs, ht 5"7; normal sinus rhythm.

About 1 week in a half later after the vaccine I felt very tired and felt like I couldn't breath. I went to the Emergency room they did lab work & a CT scan and that's when they seen I had a blood cloth in my lungs. I got admitted I was hospitalized for 2 days and they also gave me oxygen to take home when I was released. I am currently still on oxygen and I still feel very tired I can't do a lot of things because I get tired right away. I also have back pain and I have to continue paying for my medication something that was not in my budget.

Patient is a 69 year old female who was admitted on 5/27/2021 for CEREBRAL VENOUS SINUS THROMBOSIS. Patient is a 69 year old female "who lives at home with husband. Patient with a h/o DM2, hyperlipidemia, epilepsy followed by Dr. neurology outpatient, hypertension. Patient on keppra and tegretol with some episodes of partial seizures, sensitive to being off medications. Patient was in usual state of health until today. Daughter noticed around 6 PM patient was confused, altered, dizzy, not able to walk, and had left arm weakness. The patient's sister had a stroke in the past and they were concerned for this and so brought her in for evaluation when she didn't improve. Daughter thinks patient might have started having symptoms around 1 PM. Daughter reports patient was not taking her aspirin, and they never picked up the lisinopril that was prescribed for blood pressure in the past. She did have the J&J covid vaccine 6 weeks ago.

Stroke occurred 4 days after shot administered. Blacked out, right arm limp and of no use. 2 pm 5/17/21. 911 called transported to hospital and then transported/admitted to another hospital. CAT scan and MRI test done. Test show right side of head had stroke, and heart has damage.

SUPERFICIAL BLOOD CLOT IN RIGHT LEG, UPPER THIGH AND VARICOSE VEINS; This spontaneous report was received from a 68-year-old female patient. The patient's height, and weight were not reported. The patient's past medical history included headache, and asthma. Concurrent conditions included high blood pressure (under control with medicines), diabetes (diagnosed 2 years ago; under control with medicines), tetracycline allergy (caused headache), and allergy to cats, dogs, horses, tree (caused asthma). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: 1800031 or 1805031, and expiry: unknown) dose was not reported, 1 total, administered on left arm on 03-MAR-2021 for prophylactic vaccination. The patient was on unspecified medications for high blood pressure and diabetes. On 25-MAY-2021 (two and half month after vaccination), the patient noticed tenderness, warmth on touch, redness, and red lines in the upper inner thigh (above the knee) of the right leg. On 31-MAY-2021, the patient went to the immediate care, and the doctor diagnosed her leg as a superficial blood clot in the leg, thigh and varicose vein. Ultrasound was not available so healthcare professional (HCP) recommended the patient to see her primary HCP the next day. On 01-JUN-2021 (Tuesday), the patient went to her primary HCP (internist). The internist looked at patient's leg and confirmed the diagnosis as a superficial blood clot. On 02-JUN-2021 (Wednesday), at 08:45, she went to the vein specialist and the first ultrasound was performed. Once again, a diagnosis of superficial blood clot in varicose vein was confirmed. On 09-JUN-2021 (one week later), the patient returned for a second ultrasound to make sure the clot did not get any bigger and no improvement was noted. The patient was prescribed oral Aspirin 325 mg, 1 tablet, twice a day (BID) by the doctor. On 29-JUN-2021, the patient stated that she felt better. However, on the same day, a third ultrasound was performed by the ultrasound technician who noticed no improvement. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from superficial blood clot in right leg, upper thigh and varicose veins. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210666967-covid-19 vaccine ad26.cov2.s -Superficial blood clot in right leg, upper thigh and varicose veins. 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).

Vaccinated in March, began having some mild shortness of breath and fatigue around mid April which she attributed to allergies. Fatigue and shortness of breath continued to worsen and she began having some lower extremity edema. She saw her family physician at the time, Dr., who did an EKG in the office which was normal, and recommended that she follow up with Cardiology. In May the shortness of breath and fatigue worsened and she began having pain between her shoulder blades. She saw the Dr. He did a cardiolyte stress test which was reported as negative, and an echo which showed a mild pericardial effusion and they recommended a

Patient was found deceased in her home by her daughter 9+ hours after receiving the vaccine. The was no indication of how long the patient had been deceased prior to being discovered.

Asymptomatic thrombocyctopenia, platelet count of 41 (with plt clumping on micro) on routine screening 2 weeks after vaccination. Pateint had a normal platelet counter for years up until this draw. Again, no abnormal bruising or bleeding.

Patient was vaccinated on 3/30/2021. Found DOA on 4/8/2021. Last time anyone spoke with the patient was on 4/3/2021.

She fell twice. The second time was due to a blood clot on the brain that led to multiple bleeds under dura and the brain. She needed an emergency craniotomy and is now undergoing acute rehab for speech, PT and OT.

Left Popliteal DVT Edema, pain, increased warmth Starting Eliquis 10mg po bid x 7 days f/b 5mg bid x 6 months

Two weeks and two days after I was hospitalized for congestive heart failure. Never before diagnosed. I was treated during a hospital stay and then sent home.

The patient got her single shot Johnson and Johnson vaccine on 3/6/2021. Then, on or about 4/22/2021, she began to complaint of dizziness and left-sided weakness. She presented to emergency room on 4/29/2021 and was found to have a stroke via CT and MRI.

HAD LITTLE WEAKNESS AND TIREDNESS SINCE NEXT DAY AFTER TAKING VACCINE ON 4/7/2021 ON 4TH DAY, MORNING, 8.00 AM, 4/11/2021, WHEN I CHECKED AFTER WAKING UP, PATIENT WAS NOTICED NOT RESPONDING, NOT BREATHING, NO HEART BEAT. 911 WAS CALLED AND ARRIVED AT 8.20 AM. THEY TRIED VARIOUS MEASURES FOR 1 HOUR, AND THEN THEY CONCLUDED THAT THE PATIENT IS NO MORE.

Received the Johnson and Johnson vaccine, went to get haircut. Went home, watched TV, and went to bed. Got up to use the restroom and noticed face was droopy and speech was off. Stayed in bed through the night and roommate cam in the morning and took to hospital

Patient indicated that she had a stroke the evening of 5/4/2021 after she received the Janssen Covid 19 Vaccination.

According to hospitalization discharge summary paperwork, patient presented to Hospital with bilateral leg swelling and calf pain shortly after receiving the Johnson and Johnson Covid-19 vaccine.

Patient received the vaccine on 3-20-21 at the clinic and was admitted to Hospital on 4-6-21 with Covid-19 with Acute Respiratory Failure, Pneumonia, and right femoral DVT. She was intubated on 4-7-21 thru 4-21-21. She is in our facility receiving therapies to recover from illness.

Resident went into respiratory distress during early am of 6/7/2021. Pulse ox dropped to 56%. Resident sent to Medical Center and admitted with Respiratory Failure.

Patient seen in clinic on 6-14 and admitted to observation in the hospital setting. Patient was transferred to Medical Center for higher level of care due to hypotension and elevated troponins on 6/15

Cramping began in right leg off & on over 6wk period. Not thinking much of it just older I guessed. Then on June 6th my calf locked up & could barely walk. Later in evening my toes & foot went numb & cold & no feeling. Called Ambulance to take me to Hospital. 6 days of treatment. Many injections & needles.

Patient is a 69-year-old female with past medical history of coronary artery disease status post double bypass on May 2015, hypertension, hyperlipidemia came to emergency room with chief complaint of chest pain going on since Wednesday. She says that initially the pain started after she ate her food and she has history of gallbladder polyp and hence she thought it might be her gallbladder and indigestion and took Tums. Pain was associated with nausea at that time. Her pain recurred next day after eating and she took nitroglycerin after which she felt better. But today she tried to hurt just toast and nectarine for breakfast after that she had pain again in the middle of the chest and this is when she got worried and she came to the emergency room. She denied any shortness of breath or vomiting or diaphoresis associated with the pain. She says that her previous heart attack, she did not have any symptoms. In the emergency room, her troponin was elevated and given EKG findings of subtle ST changes, code heart was called and cardiology evaluated the patient and canceled code heart as her EKG was pretty stable. She received a dose of aspirin and Brilinta in emergency room and was started on heparin drip. NSTEMI. Cardiac Catheterization performed.

69 YO female received one dose of J&J vaccination on 3/12/21. 4/8: Patient complaint of epigastric abdominal pain almost nightly since March 12 (coincided with her COVID vaccination) described as 10/10, crampy and without radiation. CT abdominal and pelvis with contrast showed infiltrating mass in the left hepatic lobe concerning for intrahepatic cholangiocarcinoma with reactive adenopathy. Additionally, left mid ovarian vein thrombus found. No thrombus in the renal veins or IVC. 4/28: Venous duplex demonstrated bilateral leg acute DVT. Eliquis was started. 5/7: Pt underwent laparoscopic biopsy/paracentesis. Eliquis was held 2 days prior to laparoscope...5/11: Pt presented to hospital with complaints of generalized weakness, fatigue and leg pain. CTPA showed bilateral PE. Pt received heparin drip and was switched back to Eliquis on discharge. Echocardiogram on 5/12 noted mobile round mass in RV junction, right atrial mass; presumed to be a thrombus. Pt additionally with elevated troponin, determined to likely demand ischemia related to PE; EKG without any acute changes. Discharged on 5/24. 5/27: Patient started on chemotherapy with gemcitabine/cisplatin for metastatic intrahepatic cholangiocarcinoma. 6/4: Presented to the ED again due to worsening dyspnea and home pulse ox readings in the 70s. CT chest showed moderate burden of bilateral obstructive pulmonary emboli with no overt RV strain. EKOS and clot retrieval was contraindicated d/t thrombocytopenia. Was noted to have demand ischemia, and transitioned from eliquis to heparin gtt. Vascular was consulted for eval of her ischemic right foot, and deemed that it needed amputation, but would be a high risk surgery. 6/8: Patient was transferred to this reporting institution for second opinion requested by the family. Upon arrival, patient was found to be obtunded and hypotensive requiring heated high flow nasal cannula and vasopressor with norepinephrine. Code status was deemed DNRCCA/Do not intubate per family. Bedside ultrasound was concerning for an LV mass. Cardiology and Vascular surgery were consulted and recommended that the foot be amputated as well, but requested further workup with ECHO and CTA chest/abdomen/pelvis to further evaluate the LV mass. During admission workup, she was incidentally found to be COVID PCR positive. She was started on DEXA-ARDS prednisone dosing, remdesivir, and placed in enhanced droplet isolation. Her hospital course was complicated by acute hypoxemic respiratory failure due to pulmonary emboli, COVID-19 infection, and underlying malignancy requiring heated high flow nasal cannula. Empiric cefepime was started to treat any underlying superimposed pneumonia. Due to extensive clot burden with limb ischemia, as well as + COVID, she was systemically anticoagulated with a heparin drip despite her thrombocytopenia. She was intermittently given platelet transfusions in order to keep platelet count >30. TTE was obtained on 6/11 which showed large masses in right ventricle and right atrium, vegetations on mitral valve, aortic valve, and tricuspid valve, and probable mass in IVC. She also developed AKI with oliguria related to shock and critical illness. Medical oncology was consulted and she unfortunately was not a candidate for further chemotherapy at the time due to critical illness, as well as ischemic limb. (If further treatment was pursued, she would need a left leg amputation, then would require 4-6 weeks of recovery before additional chemotherapy could be given.) She slowly became more encephalopathic and had increased oxygen requirements, requiring continuous heated high flow nasal cannula. Goals of care were discussed with her family. Given her advanced cancer, it was decided to transition to comfort-focused care. Her code status was changed to DNRCC. Symptoms were controlled with IV pain and anxiety medication. She expired on 6/13/2021 at 0225.

SEVERE ABDOMINAL PAIN, BLOOD CLOT IN RIGHT LEG, CONFUSION (CURRENTLY STILL IN THE HOSPTIAL FOR THESE ISSUES)

Patient presented to the ER on 4/10 with complaints of SOB. She has been SOB for a few days prior to admission. She is on 4L of oxygen at home. In the ED, WBC was 36.9, lactate 2.4. Admitted for acute on chronic respiratory failure with hypoxia. Possible trigger of COPD exacerbation could be COVID vaccine. patient also positive for 3/4 SIRS criteria on admission. She did test positive for COVID in February but did not require hospitalization. On 4/11, CTA showed tiny LLL PE. Eliquis began. Possible adverse event r/t clotting disorders after JJ vaccine?

deep vein thrombosis, swelling, pain in both legs and lower abdomen. warm and red skin. red swollen veins.

J&J vaccine 3/15 and on 4/2/2021 I thought I pulled a muscle and my leg started swelling, but my right leg only. I thought it would go down and my leg and foot started swelling up and my foot got really cold. I went to the hospital on 4/11 and they said it was a DVT and they checked my lungs and said I had small blood clots in my lungs as well. They put me on Eliquis to keep my blood thinned out.

Pt had Johnsons and Johnsons vaccine Pt presented to the ER with shortness of breath and left leg pain. She had a CT and ultrasound that showed a PE.

On 3/31/2021 Patient developed blurred vision and excruciating headaches with extreme weakness. Pt went to an urgent care where they found bleeding in brain so they sent her via ambulance to ER at another hospital. She had MRI, CT and blood work. She was admitted into the ICU where she was treated for 3 days and then transferred to telemetry. Pt was discharged to FU w/ Neurologist and Ophthalmologist.

vaccine 3/7/21. 4/9/21 presented in ER with leg pain. dx with dvt. has no prior hx or fam hx of clots. is not a smoker. is on hrt. treating dvt with eliquis.

States she developed leg pain 6 days after shot and didn't think it was anything to worry about until she saw the J&J blood clot news and decided to get checked. Had appt and ultrasound on 4/19/2021 with NP. Found to have two non-occlusive, small blood clots in the right leg.

The pt said she developed a blood clot on her posterior hand. I asked her if it was a bruise on the back of her hand and she said it was a blood clot. She said she slapped the bumb/clot and it subsequently went down/away.

On 4/23/21 she presented to the ED with 4 day history of left sided weakness and slurred speech. She was hypertensive on arrival 249/121. In the emergency room labs remarkable for platelet count 92, INR 1.0, glucose 170, GFR 70.7, AST 48, alkaline phosphatase 167, troponin I 0.039. COVID-19 and other viral serologies not detected. CT of the brain showed a small subacute infarct in the right body of the corpus callosum. MRI advised by radiology. Patient received aspirin, amlodipine 10 mg, enalapril 1.25 mg IV then 0.625 mg IV for uncontrolled hypertension. MRI of brain reveals small subacute infarct involving the body of the corpus callosum, and punctuate acute infarct to the posterior left frontal lobe. Angiogram of brain was performed revealing focal severe stenosis of the mid basilar artery, moderate to severe stenosis of the short segments of both intracranial internal carotid arteries and moderate to severe short-segment stenosis of the intracranial left vertebral artery, felt to be chronic and unrelated to current symptoms. She was started on dual antiplatelet therapy: clopidogrel 75 mg PO DAILY and aspirin 81 mg Tablet, Delayed Release (Dr/Ec) 81 mg PO DAILY. It should be noted that lab work reveals Thrombocytopenia chronically from 2011 forward.

Patient received vaccine on 4/10/21. Went to ED, got IV placed due to side effects. Came to clinic on 5/4/21 with right arm pain. Found to have occlusive cephalic vein clot.

This 70 year old female received the Covid shot on 4/9/21 and went to the ED on 5/5/21 died on 5/5/21.

Patient got small blood clot show on skin 4 days after shot, it went away lighter red in 1.2 week, blood pressure went up and down suddently. Sunday was fine, Monday the 26 was fine, went to bed at 9:00 PM. Was not able to wake up, went to ER around 8:30 AM on 4/27 AM by daughter call 911. In ER for 28 hour and found out she got stroke. Pnewnewmia. ER gave antibootic around 3:00 PM, transfer to intensive care, MRI around 7:00 PM 4/27/2021 due to CT scan shown stroke. Lost Vision on right side and parcial on left side due to stroke.

Systemic: Blood Disorder (diagnosed by MD)-Severe, Additional Details: Patient was diagnosed for first Pulmonary Embolism on 05/12/2021 & second Pulmonary Embolism on 05/18/2021

3 weeks after shot, numbness and tingling in right hand 3 weeks after that speech problems, trouble swallowing, loss of use of hand, went to the ER on May 18 with a blood clot in brain causing stroke.

THE PATIENT WOKE UP A MONTH AFTER VACCINATION & COULDN'T SEE OUT OF LEFT EYE, SHE WAS SEEN BY OPHTHAMOLOGIST & WAS TOLD THAT SHE HAD A MILD STROKE THAT PROBABLY ORIGINATED FROM A THROMBUS IN THE CAROTID

Patient reported J&J COVID vaccine receipt on ?4/28. Symptoms of headache with visual disturbances and abdominal pain began less than 2 weeks later. She presented to the ED about 4 to 5 weeks after the vaccine with chest pain, abdominal pain, and hemoptysis. Work up identified right sided central and bilateral segmental pulmonary emboli, with splanchnic circulation thrombosis of the upper segment of the superior mesenteric vein, splenic vein, main portal vein, and intrahepatic portal veins, as well as dural sinus thrombosis. The patient was thrombocytopenic with elevated heparin pf4 antibody. She was initially started on heparin, but transitioned to argatroban and IVIG, with resultant increase in platelet counts over the course of her stay. She was also started on Diamox 250 BID for increased IOP. The patient was hypoxic on room air, requiring up to 4L of oxygen during her stay, but was down to 1L at the time of discharge. She was discharged on rivaroxaban for continued anticoagulation.

HPI 70 y.o. female with pmh of HTN presenting w/aphasia and R sided facial and extremity weakness onset 15m prior to EMS activation. Per EMS, pt may be on anticoagulation, unk meds. LKW 15 minutes prior to activation pt began slurring her speech and spoused noted R facial droop and R sided weakness. Patient unable to provide history based aphasia however cannot yes or no to questions. Pt is no longer taking medications for BP. Patient positive of intracranial hemorrhage.

OCULAR MIGRAINE; BLOOD CLOTS AROUND SPLEEN; PLATELET COUNT LOW; BLOOD CLOT IN BRAIN; PULMONARY EMBOLISM; STOMACH PAIN; This spontaneous report was received from a patient and concerned a 70 year old white female of unspecified ethnicity. The patient's height and weight were not reported. The patient's past medical history included pulmonary embolism, high blood pressure, and COVID-19 infection (Nov-2020), and concurrent conditions included non smoker and social drinker. The patient experienced hallucinating and itching when treated with hydrocodone bitartrate/paracetamol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 07-AUG-2021) dose was not reported, 1 total, administered to her left arm on 27-APR-2021 at 11:00 for prophylactic vaccination. No concomitant medications were reported. The patient was sick immediately within 4-5 days, which started with a headache. On a doctor's visit "around May 16th or 26th" she was given a prescription for antacid for acid reflux. On 30-MAY-2021, patient experienced sickness which started with a headache followed by stomach pain, chest pain and vision issues. Vision issues were described as zig zag, and sensitive to light. Patient visited eye doctor on an unspecified date and was diagnosed with ocular migraine. On 01-JUN-2021, the patient had severe headache and severe pain on right side of chest, "crazy stomach ache"/stabbing pains, and coughed up blood. She was hospitalized and found to have a pulmonary embolism and blood clots. She was placed on heparin for 2 days in intensive care. On 01-JUN-2021, laboratory data included nucleated blood cell count, C-reactive protein, sedimentation rate manual, Chest X-ray, lipase, and urinalysis; normal ranges and results not provided for all tests. On 03-JUN-2021, laboratory data included: computed tomography angiogram of abdomen and pelvis, computed tomography angiography of head without contrast, and Heparin-induced platelet antibody; results not provided for all tests. On 06-JUN-2021, laboratory data included: magnetic resonance imaging of brain without contrast; result not provided. On an unspecified date abdominal ultrasound scan found that spleen was surrounded by blood clots. Blood clot was also verified in the brain by CAT scan. Heparin "wasn't doing what it was supposed to do". Additional treatment medication (dates unspecified) included: potassium and XARELTO (rivaroxaban). The patient was discharged from hospital on 10-JUN-2021. As of 22-JUL-2021, platelets were still low, patient experiences headaches occasionally, random vision issues and stomach ache after eating. She continued to take XARELTO (rivaroxaban) and had future appointment for verifying if the blood clots have been resolved. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stomach pain, and platelet count low, and the outcome of pulmonary embolism, blood clot in brain, ocular migraine and blood clots around spleen was not reported. Patient recovered from chest pain on 7-JUN-2021. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This spontaneous case describes a 70-year-old white female who developed a pulmonary embolism and was hospitalized 35 days after receiving the Janssen COVID-19 vaccine. The patient has a history of pulmonary embolism, high blood pressure, and a COVID-19 infection in November 2020. During the hospitalization she was also found to have an unspecified blood clot in her brain, blood clots around her spleen, and a low platelet count. She was hospitalized for 9 days and discharged on Xarelto. Test for heparin induced platelet antibodies was performed but result was not provided. The subject's history of pulmonary embolism and COVID-19 infection may have increased the risk for the events to occur. However, considering the temporal relationship with vaccination, a relationship with Janssen Covid-19 vaccine cannot be ruled out. Therefore, the relationship is considered indeterminate.

Dizziness, passed out and fell backwards onto tile floor. (FIRST TIME EVER) Stopped bleeding from cut on back of head. Severe headache for 3 days. Occasional nausea and lightheadedness.

She developed symptoms of right lower leg pain 4 days after receiving the vaccine. It then progressed to right chest pain, tachycardia, and shortness of breath. She was diagnosed with a DVT and PE.

Patient had her Johnson and Johnson Covid 19 vaccine on Friday April 9, 2021. Prior to the vaccine patient displayed no noticeable signs of deteriorating health. Over the next two days, friends of the patient attempted to contact her with no success. Finally after several hours of no contact, the grandchildren of the patients friend went to her apartment and found the patient lying on the couch unresponsive. When the patient was found, her leg was swollen. She was cold and not breathing. She passed away after receiving the Johnson and Johnson vaccine.

beginning the day after the vaccine Patient experienced dairrhea, extreme nausea, cramps, coughing and weakness. This persisted for 3 days. Patient suffered a stroke or multiple strokes either 5 or 6 days after administration of the vaccine. She has since died as a result of the strokes.

"I received the Johnson and Johnson Covid vaccine on March 9th. On March 30 I was admitted to the hospital with excessive blood clots in my right leg and right lung. My Pulmonary Dr felt I should report this to you. I did have blood clots last year and recently ( February 8th) had back surgery both circumstances could of contributed to the issue. If you need any further information or have questions please do not hesitate to contact me.

On 4/16/2021 went to the emergency room with high blood pressure that was noted as a "hypertensive emergency". Was admitted into the hospital the next day where a CT scan confirmed that a blood clot in the brain occurred which led to a basal ganglia stroke. After a 5 day stay in the hospital, patient is now in a full time rehab facility to attempt to recover her cognitive and speech skills, while also attempting to regain use of her right hand which is currently not functioning due to the stroke.

Patient tested positive for COVID 19 on 03/21 after a symptom onset of 03/19/21. She was admitted to the hospital on 03/24 and passed away 04/19. Cause of death is listed as multi-organ dysfunction secondary to hemorrhagic shock, other contributing factors: COVID-19 pneumonia.

pt says she had a few episodes of feeling dizzy before having a stroke. Pts right hand became numb, she had some confusion, she was nauseated and had a severe headache several days prior to going to the emergency room. On 3/28/21 her face was dropping on the right side so was brought ER. She was admitted and given CT and multiple test. She was treated for a Stroke and stayed for about 3 days. She was discharged to FU w/ Neurologist next week.

Patient presented 3-4 weeks after receiving the Janssen COVID vaccine with right MCA stroke with mass effect, mild midline shift and right MCA thrombus. Carotid ultrasound showed thrombosis of the right common and internal carotid arteries and right carotid siphon. She was found down, last seen normal 2 days prior to admission. She was not a candidate for tPA given the delayed presentation and unlikely to benefit from thrombus extraction. She was treated with aspirin and atorvastatin and treated for rhabdomyolysis. Patient is currently still admitted to the hospital but transitioning to comfort focused care.

STOMACH ACHES; GENERALIZED BODY PAIN; ATRIAL FIBRILLATION; HEARTBEAT SPED UP AND THEN SLOWED DOWN/IRREGULAR HEARTBEAT; BRAIN FOG; FEVER; HEADACHE; NAUSEA; This spontaneous report was received from a 71-year-old, White, not Hispanic or Latino female patient. The patient's height, and weight were not reported. The patient's concurrent conditions included Hashimoto thyroiditis, celiac disease, arthritis, autoimmune disease. The patient was diagnosed with atrial fibrillation (Afib) in JAN-2018 and seldom had an episode of Afib since then. The patient had no known allergies and was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (JANSSEN COVID-19 VACCINE) (suspension for injection, route of administration was not reported, batch number: 1808978 and expiry: unknown) dose was not reported, 1 total, administered on 30-MAR-2021 to right deltoid for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, following vaccination, the patient had an episode of atrial fibrillation almost every day unlike the time before vaccination and her heartbeat sped up and then slowed down (irregular heartbeat). On the same day, the patient experienced brain fog, fever (axillary temperature of up to 100 degrees) and headache. Since the vaccination, the patient's nausea worsened. On 31-MAR-2021, the patient experienced stomach aches and generalized body pain. Due to the ongoing concern of reports of blood clots associated with the JANSSEN COVID-19 VACCINE, the patient's doctor put her on a blood thinner (unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach aches, and fever on 09-APR-2021, and headache on 04-MAY-2021, had not recovered from atrial fibrillation, generalized body pain, heartbeat sped up and then slowed down/irregular heartbeat, and brain fog, and the outcome of nausea was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210516760-COVID-19 VACCINE AD26.COV2.S- Atrial fibrillation. 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

Starting -4/12/2021 - initial symptoms cycled through over the first four weeks. Fever, chills, aches, pains, shooting pain in ears (first 9 days); uncontrollable shaking, erratic heart beat (April 17, 18); severe head and neck ache (lasted 2 days), resting pulse 100, head cold, diarrhea, cough, fatigue, weakness, chest tightness, pneumonia (X-ray on 04/30/2021), premature heart beat (EKG on 05/17/2021). As of 05/21/2021, still have heart beat irregularities, weakness, and fatigue.

On drive home anaphylactic reaction (trouble swallowing, swollen tongue), went to Emergency Room, treated with benadryl. Returned to ER a week later with new symptoms, severe headache, nausea, tightness in chest, trouble breathing .

BLOOD CLOTS IN BOTH ARMS; NUMBNESS IN BILATERAL ARMS; REDNESS ON BOTH LEGS; SWELLING OF BOTH LEGS; PAIN IN BOTH LEGS; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included breast cancer. The patient experienced drug allergy when treated with hydrocodone, and oxycodone 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: 1805029, and expiry: unknown) dose was not reported, 1 total administered on 20-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in 2021, the patient felt numbness on both arms. Numbness got worse and patient went to emergency room. On an unspecified date in 2021, Laboratory data included: MRI brain results of which were pending. On an unspecified date in MAR-2021, a week after the vaccination patient went to emergency room due to redness, swelling, and pain on both legs. The doctor prescribed antibiotics which relieved those symptoms and was encouraged to get blood circulation assessed once patient returned to home. On 17-MAY-2021, patient got hospitalized, and on same day, ultrasound test showed a blood clot in each arm. Patient underwent chest X-ray and a test with and without contrast for the lungs. It was reported that patient was started on anticoagulants and physical therapy. On 18-MAY-2021, ultrasound of legs was negative for blood clots. On 19-MAY-2021, test in a machine with and without contrast to look at lungs (Lung scan) was within normal limits. On 19-MAY-2021, the patient got discharged from hospital. Patient stated that, consulted two doctors if it may have been the Janssen covid-19 vaccine that caused this and doctors said possibly and recommended that patient should report the information. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from redness on both legs, swelling of both legs, and numbness in bilateral arms, and had not recovered from pain in both legs, and blood clots in both arms. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210540231-COVID-19 VACCINE AD26.COV2.S-BLOOD CLOTS IN BOTH ARMS, NUMBNESS IN BILATERAL ARMS. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY

Patient's daughter, called and states she is her mom's POA and she stated that she was with her mom when she got the vaccine in the parking lot. About 3 weeks ago her mom started dragging her foot and fell twice, she went to a facility and then was sent to hospital and was hospitalized for about 3 weeks, she has had two mini strokes, she is currently at nursing home. She also provided the name of her mom's PCP.

ER 3/17 HPI: 72 y.o. female who presents with generalized weakness and not feeling well. Patient states that she had her 1st dose of COVID-19 vaccine about a week ago and since then has not felt well. She denies fever or chills, she denies any arthralgias or myalgias, she has had some nausea and vomiting but none in the last couple of days. There has been no diarrhea. There have been no urinary symptoms. 3/22/21 Inpt Admission hpi 72 y.o. female who presents with shortness of breath and hemoptysis. Patient has known history of COPD and also has a history of squamous cell carcinoma of the lung that is in remission. Patient reports she has noticed increasing shortness of breath for the past several weeks. She states the got worse around the noon time today. Patient reports she began having some hemoptysis today. Patient denies any chest pain or palpitations. Patient denies any fevers or chills. Patient denies any sinus congestion or nasal drainage. Patient denies any headaches, myalgias, or loss of sense of taste and smell. Patient does report a 4 day history of intermittent diarrhea. She denies any nausea or vomiting. Patient has had COVID-19 vaccination. Of note, patient's family reports she has lost 10 lb in the past 30 days. 3/30/21 Deceased

Patient went to hospital with chest pain on 3/17 and was found to have a pulmonary embolus. Started on anticoagulant. Had full workup

Pt in previously good health received J&J vaccine 04/09 and felt well until 04/21 when she developed lower extremity weakness and incoordination which became progressively worse and was accompanied by slurred speech on the afternoon of 04/22. The pt's husband helped her into bed and she apparently died during the night of 04/22-04/23.

Patient was admitted with ischemic colitis and hypoglycemia. She also tested positive for C.diff during her hospitalization, unclear if this was from prior antibiotics in March. She did not receive DVT prophylaxis for 2 days. She developed a nonocclusive DVT in the right internal jugular and subclavian veins and a Nonocclusive superficial thrombosis in the right basilic vein on 4/18. She went into PEA and was revived, intubated, and transferred to the ICU. She went into PEA again and was revived after 5 rounds of CPR. The family decided to make the patient comfort care and expired on 4/19

FAST HEART RATE; BLOOD CLOT IN BOTH LUNGS; ACHY; LOW ENERGY; VERY WEAK; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included fibromyalgia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on left arm on 13-MAR-2021 for prophylactic vaccination. Concomitant medications included pregabalin(Lyrica) for fibromyalgia and bad back. The patient reported pregabalin makes her gait off. On 13-MAR-2021, the patient felt okay. On 14-MAR-2021, the patient experienced achy, low energy, very weak, headache, fever of 100 degrees fahrenheit. Laboratory data included: Body temperature (NR: not provided) 100 F. On 13-APR-2021, she had wellness visit. The patient had a fast heart rate. Laboratory data included: Heart rate (NR: not provided) 144 (units unspecified). So immediately her electrocardiogram was taken and she was hospitalized for 2 days in emergency room by ambulance and started running tests. The patient had a computer tomography with dye contrast and it showed blood clots in both lungs. She had many tests, echocardiogram and X-rays. Treatment medications (dates unspecified) included: continuous oxygen via nasal prong (3.2 litre down to 2 litre), warfarin sodium(Coumadin), blood, whole, and rivaroxaban(Xarelto). The patient stated once she had rivaroxaban she felt "free". Currently also had 2 intravenous and taking blood regular. She was also on physical therapy. The therapist came in and made her walk across her room twice according to therapist she did not need oxygen. The patient currently had 2 IV's and taking blood regular. The patient will be discharged with or without the oxygen. The patient has machine on her chest with all kinds of wires. She don't know about her oxygen saturation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achy, low energy, very weak, headache, and fever on 15-MAR-2021, had not recovered from fast heart rate, and the outcome of blood clot in both lungs was not reported. This report was serious (Hospitalization Caused / Prolonged and Life Threatening).; Sender's Comments: V0: This is a 72 year old female, unspecified ethnicity, who experienced tachycardia and was noted to have blood clots in both lungs 32 days (around 1 month) after receiving the COVID-19 vaccine ad26.cov2.s on the left arm. Patient had Fibromyalgia and is maintained on Pregabalin (Lyrica). Patient's height and weight were not reported as well as history of smoking, allergies or drug abuse. One day after receiving the vaccine, the patient experienced fever, headache, weakness and pain, which resolved. During a wellness visit after a month from the vaccine, tachycardia was noted and an EKG was done. Patient was immediately brought to the ER, where the CT Scan (with contrast) showed blood clots in both lungs (detailed result not reported). Other tests done were also not reported. Patient was subsequently admitted in the hospital and was discharged after 2 days. The information provided is insufficient to show that the vaccine is causing the event; hence, this is assessed as indeterminate per WHO causality classification of adverse event following immunization. Additional information requested.

At unspecified date the patient's nephew noticed acute onset change in the patient's mental status. Upon arrival to unspecified hospital by EMS she was aphasic with right facial droop, right gaze preference, right sided weakness. CT and CTA showed Intraparenchymal hemorrhage with 3mm midline shift as well as superior sagittal dural sinus thrombus in the anterior 3rd. Repeat NCHCT showed bilateral parenchymal hemorrhages.

BLOOD CLOT WITH DYING PAIN IN RIGHT SHOULDER; This spontaneous report received from a patient concerned a 72 year old female. The patient's weight was 141 pounds, and height was 164 centimeters. The patient's concurrent conditions included back pain, two cysts on kidney, high blood pressure, anxiety, high cholesterol, non smoker, non alcoholic, and spine issue, and other pre-existing medical conditions included it was unknown that patient had drug abuse or illicit drug usage. she was health healthy and always doing exercises, she lifts 3kg dumbbells and walked and use indoor bicycle for exercise. 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, frequency one total administered on 15-MAR-2021 for prophylactic vaccination. Concomitant medications included citalopram for anxiety, lorazepam for anxiety, oxycodone for back pain, and spine issue, and acetylsalicylic acid for drug used for unknown indication. Patient received vaccine on March 15, 2021 at a local vaccination center. she woke up with pain and had this for several days before. somebody suggested going to the Emergency room. Patient proceeded to ER on 26-March-2021 and was seen by Doctor. Doctor suspected a blood clot and told the if its blood clot it could moved to lung and cause stroke. The patient reports the following tests were performed X-ray, ultrasound and blood tests. Test results all showed blood clot that the patient describes as deep vein in the right shoulder between shoulder and neck. Patient reported that she was given a blood thinner in her tummy and then a prescription for 30 days of Eliquis 5mg. Patient reported that the pain was killing her and stated she was dying of pain. The pain was in the area of the blood clot (right shoulder). Patient was also seen by a specialist who prescribed Eliquis prescription for 1 year. she was taking baby aspirin which told to continued. she finished her 30 days prescription ,she planning to visit ER as pain had not go away. She has been told not to stop the blood thinner as it is dangerous. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot, and dying of pain s in the area of the blood clot (right shoulder). This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210453704-COVID-19 VACCINE AD26.COV2.S - BLOOD CLOT WITH DYING PAIN IN RIGHT SHOULDER. 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.

Client during TC, expressed through the telephone Spanish Interpreter, received the J & J COVID 19 vaccine, in left arm, on 3/14/2021. After receiving vaccine had slight soreness at site, and on 3/27/2021 started having left sided facial droopiness, difficulty swallowing, talking, fatigue, SOB and weakness, around 10:00 am. Per Client, children called 911, and was transported to Hospital. Per Client, was treated at hospital and informed by medical personal, that she probably experienced a stroke. Client was not admitted to hospital, sent home the same day, and instructed to follow up with PCP. Per Client, on 3/29/2021 followed up with PCP, and on 5/12/2021 had a MRI procedure and due to fo

Person died on 5/7/2021 with death note stating acute respiratory failure with hypoxia, thrombocytopenia.

Pt had her J and J vaccine on 5/18/21. now hospitalized from home on 6/15 with a few days of chest pain and admitted with sepsis, UTI, dense rll pneumonia and new svt/tachycardia/NSTEMI, syncope, rhabdomyolysis. her hospital course was very protracted due to recurrent tachycarida/svt and she was eventually discharged to rehab on 6/23/21.

Pt admitted on 7/10 for dyspnea and chest pain. Pt received COVID J&J vaccine on 4/6/2021. Pt was given oxygen ~1.5 days and received dexamethasone and acetazolamide. On 7/14/21, Pt currently on room air. Possible reason for AHRF multifactorial of COVID, acute on chronic anemia and HF exacerbation with severe valvular disease.

After the vaccine the pt said she felt like she had the flu. She was tired and sore and achy. And a week later she went to bed and woke her husband up to help her to go the the bathroom, she collapsed on the way and the husband called 911 and was taken to the hospital and the doctor said she had a massive brain bleed, she was put on life support, she passed away five minutes after being taken off of life support.

Anaphylactic reaction-flushing, lump throat, cough onset within 10 minutes. InER 2hrs home on medication solumedrol, benadryl,pepcid, IV fluids

3/6 vaccination. 6PM HA, neck pain, body aches, chills, fatigue; 12:AM woke up with increased HR. HR was too fast; up to 178-200. 911 called by husband. A fib with rapid pulse, convert with IV medicines. Low potassium and magnesium levels. Nitro administer by husband before EMS arrived; had gone down by time ambulance arrived by was irregular. Kept me in observation floor. *still not feeling 100%; fatigue, high HR

Initially redness, slight swelling and pain at vaccine site. Duration of symptoms five days. Followed by heart attack on April 04,2021.

3 weeks post vaccination patient developed chest pain and shortness of breath. Was able to tolerate symptoms, then had radiation treatment and developed more shortness of breath. Was transported via EMS to hospital where an xray and MRI were completed and showed multiple blood clots in her lungs. Venous Doppler was also completed and blood clots were found in her legs. She was subsequently admitted to hospital.

PATIENT REPORTED SWOLLEN FACE (JAWS) STARTING ON 04/09/2021. TREATED WITH BENADRYL AND SWELLING WAS GONE AFTER A 2 OR 3 DAYS. PATIENT REPORTED AFIB LASTING A 2 OR 3 DAYS STARTING ON 04/09/2021. PATIENT REPORTED ROUND RAISED RED CIRCLE ON SKIN OF RIGHT LEG WITH WHITE CRUST IN MIDDLE. START DATE NOT GIVEN. STILL PRESENT AS OF 04/17/2021.

APRIL 2ND NUMBNESS IN TONGUE, FOLLOWED BY NUMBNESS IN LIP AND PART OF CHEEK, FOLLOWED BY NUMBNESS IN RIGHT HAND. TRIP TO EMERGENCY ROOM . A BLOOD TEST AND MRI WAS GIVEN AND A STROKE WAS CONFIRMED. I WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION IN EARLY MORNING OF APRIL 3RD. ECHO CARDIOGRAM WAS ADMINISTERED ON APRIL 3. I WAS DISMISSED FROM THE HOSPITAL ON APRIL 3. ON APRIL 5 I PICKED UP A HEART MONITOR TO WEAR FOR ONE MONTH. I HAVE A SCHEDULED APPOINTMENT WITH MY PRIMARY CARE DOCTOR ON FRIDAY, APRIL 16.

Patient presented to ER on 4/16/21 complaining of chest pain. Patient stated she had the J&J vaccine a month ago and had been having problems. She was also being seen by a cardiologist.

Patient discovered down and unresponsive with immediate declaration of death. Pronounced dead 4/6/2021 11:45 PM

Severe pain in left thigh groin & knee area. Went to ER, confirmed blood clot. Sent home w/blood thinners - Xarelto

PASSED AWAY; HIGH BLOOD PRESSURE; DIZZINESS; THROWING UP; HEADACHE; This spontaneous report received from a consumer concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. the 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: 1805020, expiry: unknown) dose was not reported, 1 total administered on 16-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. It was reported that the patient received covid-19 vaccine ad26.cov2.s on 16-MAR-2021. On 17-MAR-2021, the patient's only complaint was that she experienced headache. On 14-APR-2021, she complained about dizziness and throwing up that was getting worse and high blood pressure on same day the reporter called the patient's doctor's office at 14:30 p.m. and doctor saw the patient's blood pressure was returned to normal and she underwent laboratory data included: systolic blood pressure (NR: not provided) 113 mmHg, 170 mmHg, 190 mmHg. After few hours, 7 or 10 hours she passed away in her sleep, no pain at the time of death between 12:00 a.m. or 15:00 p.m. on 15-APR-2021. It was unspecified if an autopsy was performed. The reporter was unsure about the true time of death. The reporter did not complaint for a lawsuit as the doctor of the patient did not know if the death was correlated with the vaccine. The patient did not had no other disease, except high blood pressure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient passed away on 15-APR-2021, recovered from high blood pressure on 14-APR-2021, and headache on an unspecified date in 2021, and the outcome of dizziness and throwing up was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: - 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). covid-19 vaccine ad26.cov2.s-High Blood pressure . 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: UNDERLYING DISEASE; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH

Patient developed shortness of breath the day after the vaccine and was diagnosed with bilateral pulmonary embolism and DVT and had to be hospitalized.

Patient received J&J COVID vaccine on 4/10/2021. She underwent elective R total knee arthroplasty on 4/20/2021. On 4/21, patient developed chest pain and was found to have a STEMI (large embolus in the posterolateral branch of the right coronary artery). She underwent thrombectomy and angioplasty on 4/21 with no evidence of CAD elsewhere. She developed hypoxic respiratory failure evening of 4/21 and was found to have bilateral pulmonary embolus with saddle type emboli and distal emboli throughout both lungs. She underwent IR guided thrombectomy on4/22 and had a cardiac arrest intra-operatively. Given timing of onset and recent J&J COVID vaccination, the patient was treated with IVIG, steroids, and placed argatroban. She continued to have multiorgan failure requiring mechanical ventilation and hemodialysis. On 4/26, CT head was positive for small area of subarachnoid hemorrhage. Patient was transitioned to comfort care measures and palliatively extubated on 4/26.

BLOOD CLOT IN LEG; This spontaneous report received from a consumer concerned a 73 year old female unspecified 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, intramuscular, batch number: Unknown, expiry: unknown) dose was not reported, 1 total, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13- MAY-2021, the patient was taken to the emergency room (ER). On 14-MAY-2021, she was hospitalized with a clot/clots in her leg(s). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot in leg was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20210551429 - Covid-19 vaccine ad26.cov2.s-Blood clots in leg. This case concerns with 73 years old female. 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.

Paitent presented to the office for followup to a hospitalization for presumed viral pericarditis. Upon evaluation the patient had persisting tachypnea and orthopnea, She was referred for a stat echocardiography and found to have significant pericardial effusion with tamponade. From the echocardiography department, she was referred urgently to the emergency department and taken urgently to the cardiac catherterization suite where she underwent fluoroscopy-guided pericardiocentesis with drainage of about 360mL of bloody effusion, Pericardial drain was left in place. In total it apperas that approximately 400mL of fluid was removed over the course of the patients hospitalization from the pericardial catheter. The catheter was removed on the afternoon of 05/12/2021 without difficulty. On the date of discharge it was noted that she had mild increase of dyspnea, a chest x-ray was obtained which revealed a right pleural effusion and a questionable infiltrate in the left base. The patient did not endorse any symptoms of cough and she had no wheezing and clinically did not have evidence of infectious pneumonitis at the time of discharge.

My mother experience has been classified as in heart failure and currently in the hospital. After being vaccinated her health declined drastically.

Because of a torn meniscus in my right knee I went to the Emergency Room. They did all kinds of test, including an ultrasound which showed 5 DVTs in right leg (3 in Femoral artery and 2 below the knee).

Four days after receiving vaccine I experienced severe shortness of breath and passed out. In the next week I had 3 more syncope episodes after severe dyspnea. Went to the emergency room and in hospital was diagnosed with stage 3 heart block with LONG pauses (one was 23 seconds). I needed an emergency pacemaker. I was also diagnosed with atrial fibrillation. Eliquis and Bisoprolol added to my medications. I also was diagnosed with pneumonia of unknown origin and unknown type (viral vs. bacterial). Speculation is I aspirated when I passed out.

Initially had chills, fatigue for two days, then on 3/15 awoke with severe weakness in the right lower extremity. Presented to ER, MRI showed acute stroke ( Small acute infarction within the posterior left corona radiata). Admitted for stroke stabilization and rehab evaluation. Will be discharged to home with outpatient PT and OT

Johnson and Johnson Covid-19 vaccine - patient had ischemic stroke approximately 4 hours after vaccination given and was admitted to hospital.

The patient had saddle pulmonary embolism on 3/24/2021 requiring hospitalization and thrombolysis. Currently the patient is on anticoagulation with Xarelto and is doing well.

Patient woke up at 3am not feeling good and confused. Became increasingly confused and uncomfortable. Not very responsive to caregivers. Called an ambulance at 7:30am. ER ran tests that showed Sepsis with n o underlying infection. Patient had to be intubated. Admitted to ICU in hospital. Spent 3 days there and 4 days in regular room at hospital. Then transferred to a rehabilitation clinic where she is currently.

74-year-old female with cardiac risk factors presents with exertional dyspnea over the past 3 days. Patient had low oxygen saturation 81% at the doctor's office which came up to 89 with rest. Patient placed on oxygen here in the emergency department. Patient does not have symptoms at rest. Patient does not have any calf swelling or pleuritic pain. Patient's D-dimer is elevated therefore CT angio of the chest was obtained which shows large, central pulmonary embolism with evidence of right heart strain.

According to POC the resident was transferred to the hospital on 4/8/2021, due to low pressures, high pulse and cough. They certify death by COVID 19, because it affected the lungs.

She is a 74-year female with history of morbid obesity, OA on chronic opioids, T2DM, CKD 3, HTN, and hypothyroidism who presents with 10 days of worsening fatigue and trouble ambulating. She reports that she started feeling unwell about 10 days ago with a sore throat and pain radiated to her left ear. She had trouble swallowing due to the pain and was generally tired, thinking she had strep infection or ear infection. Her sore throat resolved as did her ear pain, however her fatigue worsened and had trouble walking due to weakness. Felt like she had trouble functioning at home, soshe presented to the ED. In the ED, she is hemodynamically stable, satting low 90s on room air. Labs are significant for mild hyponatremia 133 and bump in creatinine 1.84 (previously 1.44). Found to be Covid positive, and CXR with possible right lower lobe infiltrate. Currently, reports feeling tired with poor appetite and body aches though no shortness of breath, chest pain, nausea. She has been eating foods that taste good to her, not following diabetic diet and sugars have stayed appropriate. Denies any sick contacts or leaving the house. Of note had her Covid vaccine (J&J) 3/22 in her house, and does not know where she contracted Covid.

patient came in for routine physical exam on 4/12. had gotten J/J vaccine on 3/17. husband reported onset of dyspnea a few weeks prior, eg starting some time after her vaccine. worsened significantly 2-3 days prior to her physical, but she refused to go to hospital. was found to be hypoxic at her routine physical and sent by ambulance to ED, had large saddle PE requiring thrombolysis, left leg DVT. was in ICU. now home off oxygen on anticoagulation.

Patient received Johnson and Johnson Vaccine around 4/1/21. Patient presented to the emergency department today with chest discomfort and shortness of breath. CT scan results: segmental pulmonary emboli within the superior segment of the left lower lobe and lateral basilar segment of the right lower lobe. Patient does have a history of PE 10/2020 with obvious insult of immobility post gastrectomy and was treated successfully. Patient was not on anticoagulants prior to arrival today.

Patient received J&J vaccine 5/8, developed SOB 2 days ago, came to hospital last night and found to have pulmonary embolism and thrombocytopenia

Patient reported that she started feeling complications the same day. She went to the store and felt dizzy and fell out in the parking lot. The following Wednesday everything she ate she threw it up. She blacked out again. Neighbor called 911. She passed out and awaken in the hospital. She had a server condition of diarrheia. She was hospitalized from the 14th of April to the 27th. They found out that she had blood clots in her arm after the scan. Hard to raise arm up and could hardly walk. Was put on blood thinner to dissolve the blood clot and was dropping blood pressure. Passed out in the shower. Almost hit head. If she is doing any kind of walking her blood pressure drops. Patient stats that she did not have any of these medical problems since she has taken the vaccine. Patient also states that she has lost weight.

death 4/24/2021 causes of death listed on death certificate: 1) Pneumonia Due to COVID 19 2) Acute Respiratory Failure with Hypoxia 3) COVID 19 4) Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Severe pain in right back, right groin, hip and upper leg. Blood clot in right lung. Placed on heparin (IV medication) by healthcare provider. Transferred to a rehabilitation hospital after being hospitalized for 5 days. Currently has home help by nurse, provided blood thinner. Unable to walk.

On 4/7/21 patient administered Janssen vaccine. On 4/8/21 at 7:00 am patient had stroke symptoms and advised to call 911 after conversation with AARP nurse hotline. Patient had difficult speaking and right side weakness. Transported via ambulance and admitted to hospital until discharge on 4/11 at 1:00 pm. Per patient diagnosis was Hypertensive Crisis, Acute Stroke with High suspicion for cardioembolic stroke.

within 10 days I had severe breathing problems that lasted about 4 days, had test that revealed blood clots in my lungs about a week after

Day of vaccine I didn't feel bad, just felt queasy later, I was tired the next day. I don't know when the SOB started but it continued through the month of March. I thought it was an exacerbation of my chronic issues, by Sunday 4/4/20221 I coughed up blood, and on Monday I went to the hospital and had a CT scan and was told I had a pulmonary embolism and a clot in my leg. Now I'm on an injectable blood thinner for the rest of my life and I was told it would take 3-4 months to resolve the blood clots.

Patient came to ED with complaints of syncopal episode. passed out, hit her head, felt mildly short of breath with ambulation.

Patient presents on 4/21 with sudden onset of severe headache start about 4 days ago and has been persistent since. The pain is all over her head with no particular focal area. CT head: RIGHT PARIETAL CORTICAL INFARCT She had an echo on 4/21/2021 showed normal LV size and function with LVEF 55-60% with no regional wall motion abnormalities. Normal RV structure and function. 1+ AI. No PFO by color doppler. No valvular issues. No history of atrial fibrillation. Patient then had two episodes of seizure on telemetry unit on 4/23/2021 followed by post-ictal phase Patient was discharge 5/26/21 to home with neurology follow-up scheduled in 2-4 weeks. Patient will also receive a Holter for 2 weeks.

STROKE; This spontaneous report received from a consumer concerned a 75year 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: 1476806 expiry: 21-JUN-2021) dose was not reported, 1 total administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-APR-2021, the patient experienced stroke. The outcome of stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210517403-COVID-19 VACCINE AD26.COV2.S-Stroke. 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).

75 y/o female w/ PMH significant for COPD, diabetes, GERD, HLD, HTN, CAD, CVA who presented to the hospital ED on 4/2/21 for fever, dyspnea. Pt reports being exposed to COVID 1 week ago, her entire family at home had it. She called her PCP and was placed on multivitamins and prednisone taper when she became symptomatic ~3/27/21. Throughout the week, pt had worsening dyspnea, worse with exertion, as well as dry cough, fevers and chills. Reports her temperature was 102 at home. Pulse ox was 85% at home and pt was instructed to come into the ED. On arrival, O2 82% on RA and pt having some respiratory distress. Patient was intubated and placed on full vent support, but could not be extubated. Patient's diabetes continued to be uncontrolled because of IV steroid. Patient's lactic acidosis improved with IV hydration. Patient continued to be difficult to extubate because of COVID pneumonia with ARDS. Family opted for the patient to be transitioned to hospice care and comfort care. Expired on 4/26/2021.

Mother suffering from sarciodosis, however was improiving until she recieved the Johnson and Johnson vaccination. She became very weak, very hard to breath . She was admitted to the Hospital and stayed for about two weeks. Since released from the hospital she never got her strength back and lost more weight. My mother passed away 5/28/2021.

Systemic: Blood Disorder (diagnosed by MD)-Severe, Additional Details: Patient was diagonised with blood clot few days after J&J covid vaccine. Patient was treated in the hospital and doing better.

On Apr 17, 2021 I had COVID symptoms of cold like symptoms, then a night of chills and coughing, followed by aches then weeks of what I thought may be allergies, but not feeling good. I continued to cough, but thought it was attributed to GERD. I wasn't thinking it could be COVID because I had been vaccinated. By May 18, I was having trouble breathing as it was painful to inhale. I thought I might be having a heart attack so went into the emergency room at Hospital. I tested positive in ER. No heart problem. There were also at least 5 blood clots found in my lungs. It felt like what I imagine it would feel like if my ribs were broken and I was trying to take a deep breath. I continued to have difficulty inhaling because of the pain of doing so into the next day (19th) and part of the 20th. I was administered oxygen and pain meds for the first day. I was put on Eliquis, which I am ordered to take for 6 more months. I was released from ICU on the 20th, which appeared to be a quick turnaround. I still have no energy, lack of clarity of thought, and easily out of breath a month later. In the hospital, I had no fever. The only time I think I did was on April 19th when I had the chills and cough.

SUSPECTED CLINICAL VACCINATION FAILURE; PULMONARY THROMBOSIS; MENTAL IMPAIRMENT; COVID-19; COMPUTERISED TOMOGRAM THORAX ABNORMAL; COUGH; DYSPNOEA; NASOPHARYNGITIS; PAIN; PAINFUL RESPIRATION; ANTICOAGULANT THERAPY; ELECTROCARDIOGRAM; FIBRIN D DIMER; INTENSIVE CARE; SARS-COV-2 TEST POSITIVE; CHILLS; MALAISE; ASTHENIA; This spontaneous report received from a patient via a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) (VAERS ID: 1421473) concerned a 75 year old female of unknown race and ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included osteoarthritis, seasonal allergies, and hypothyroidism, and concurrent conditions included mild cold, and Gastroesophageal reflux disease (GERD). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number:1808078, and expiry: UNKNOWN) frequency 1 total, dose was not reported, administered on 03-APR-2021 to left arm for prophylactic vaccination. Concomitant medications included ascorbic acid, colecalciferol, compounded hormones, esomeprazole magnesium, fexofenadine hydrochloride, fluorometholone, fluticasone propionate, thyroid, vitamins nos, and zinc. On 17-APR-2021, patient had COVID symptoms of cold like symptoms, then a night of chills and coughing, followed by aches then weeks of what patient thought may be allergies, but patient was not feeling good. Patient continued to cough, but thought it was attributed to GERD. Patient wasn't thinking it could be COVID because patient had been vaccinated. Patient experienced pulmonary thrombosis, nasopharyngitis, and mental impairment and was hospitalized on unspecified day. By 18-MAY-2021, patient was having trouble breathing as it was painful to inhale. Patient thought patient might be having a heart attack so went into the emergency room at Hospital. Patient was tested positive in emergency room (ER). Patient had no heart problem. There were also at least 5 blood clots found in patient's lungs. Patient felt like what patient imagine it would feel like if patient's ribs were broken and patient was trying to take a deep breath. On 18-MAY-2021, patient experienced suspected clinical vaccination failure. Patient continued to have difficulty inhaling because of the pain of doing so into the next day 19-MAY-2021 and part of the 20-MAY-2021. Patient was administered oxygen and pain meds for the first day. Patient was put on Eliquis, which patient was ordered to take for 6 more months. Patient was released from ICU on the 20-MAY-2021. Patient still have no energy, lack of clarity of thought, and easily out of breath a month later. In the hospital, patient had no fever. Patient thought that the only time patient thought was on 19-APR-2021 when patient had the chills and cough. patient was hospitalized for 3 days. Laboratory data included: Computerised tomogram thorax abnormal (NR: not provided) Not Reported, Electrocardiogram (NR: not provided) Not reported, Fibrin D dimer (NR: not provided) Not reported. On 18-MAY-2021, laboratory test included, SARS-CoV-2 test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid-19, asthenia, chills, computerised tomogram thorax abnormal, cough, dyspnoea, malaise, mental impairment, nasopharyngitis, pain, painful respiration, pulmonary thrombosis, anticoagulant therapy, electrocardiogram, fibrin d dimer, intensive care, sars-cov-2 test positive and suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged and Life Threatening). This report was associated with product quality complaint: 90000185984. The suspected product quality complaint has been confirmed to be not voided. The reported allegation could not be confirmed, a manufacturing related root cause could not be identified, based on the PQC evaluation/investigation performed. Additional information was received from Consumer Complaint Vigilance Organization on 16-JUL-2021. The following information was updated and incorporated into the case narrative: Investigation result added.; Sender's Comments: V3: In this version following information was updated and incorporated into the case narrative: Investigation result. This updated information does not alter the causality of the previously assessed events. 20210705031-COVID-19 VACCINE AD26.COV2.S -19- Pulmonary Thrombosis, Mental Impairment, Covid-19, Asthenia, Chills, Cough, Dyspnoea, Malaise, Nasopharyngitis, Pain, Painful Respiration. 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: 20210705031-COVID-19 VACCINE AD26.COV2.S -Suspected clinical vaccination failure. 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: SPECIAL SITUATIONS 20210705031-COVID-19 VACCINE AD26.COV2.S -19- Computerised Tomogram Thorax Abnormal, Anticoagulant Therapy, Electrocardiogram, Fibrin D Dimer, Intensive Care And Sars-Cov-2 Test Positive . 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).