Johnson & Johnson

On 3/11/21, patient had a CVA, resulting in hospitalization. Testing during admission indicated a need for a carotidectomy. Pt had the procedure on 3/17/21, when a second CVA occurred. Pt has returned home, but requires assistance with ADL's. Family notes that patient had an ultrasound of arteries completed January of 2021, results were "normal".

Pain, reddness, swelling in right leg, below the knee, when I got up in the morning. Symptoms continued over the weekend. Called Dr. on Monday, April 5, 2021 and got an appointment for the following day. Dr. diagnosed it as phlibitis and sent me for an ultr sound. Prescribed Xarelto 15 mg twice a day for 21 days, then decrease to 20 mg daily.

Pt stated that approximately two weeks after vaccination she went to her physician office for an issue with her eye. Her eye was severely red. At the physician's office, the physician told the patient that there was a small blood clot in her eye. The patient stated she didn't think anything of it at the time, but now that the CDC came out with the statement about the Janssen vaccination, she decided to report to the pharmacy.

MY MOTHER, PATIENT, HAD BEEN MANAGING HYPERTENSION AND DIABETES FOR NEARLY 30 YEARS VERY WELL. SHE RECEIVED THE J&J VACCINE ON 4/7. PEOPLE WHO SAW HER AND SPOKE TO HER DAYS AFTER REPORTED SHE FELT GOOD AND LOOKED GOOD. ON 4/12, 5 DAYS LATER, PATIENT, WAS DEAD. SHE WAS FOUND DECEASED IN HER APARTMENT ON 4/13 SLUMPED IN A CHAIR. SHE HAD EATEN BREAKFAST, GOTTEN DRESSED AND APPEARED TO BE ON HER WAY OUT THE DOOR TO AN EYE DOCTOR APPT WHEN SHE SAT IN A CHAIR TO TAKE A REST. THE MEDICAL EXAMINER'S OFC REFUSED TO DO AN AUTOPSY, STATING HER PRE-EXISTING CONDITIONS, DESPITE HER RECENTLY GETTING THE J&J SHOT.

Presented to Hospital for dyspnea. Diagnosed with large right sided pulmonary embolism; platelet count 138 T/UL at time of ER visit. Transfer to larger facility for higher level of care on 4/19/21.

Patient presented EKG consistent with anterior ST elevation MI with chest pains. Due to the presentation I feel she should undergo urgent cardiac catheterization.

Patient stated receiving J&J vaccine on 03/19/21. Patient came to ER with acute DVT in left lower extremity on 04/21/2021.

Pt received Janssen vaccine on 4/5/21 and did complain of arm soreness on 4/6/21. Arm assessed small bruising noted. Pt working with therapy on 4/8/21- she was complaining of pain, nsg assessed arm and found the RUE was blue in color and hard to touch. NP made aware, ordered warm compresses as needed to arm. MD assessed pt on 4/9/21 for a poss. UTI- IV Rocephin ordered and adm. Pt had an allergic reaction to IV Rocephin, pt sent to ER for eval and treatment. Pt was adm on 4/9/21 and returned to health on 4/15/21. When pt arrived her entire rt arm/hand is black in blue in color. Per patient and daughter- the bruising continued to get worse day by day after she had received the vaccine

03/28/2021 to 03/30/2021- Admitted Ip via E/R , Dx: Pneumonia, Cardiomegaly, Small pericardial effusion, Esophageal stenosis (s/p dilation), Small hiatal hernia. F/U with PCP for Hopital F/u on 04/01/2021. Visit ER on 04/03/2021- 04/05/21 04/14/21-ReAdmitted IP via E/R. -Dx: Dx: Chest pain, Pericarditis w/ mod-large Pericardial effusion (s/p pericardiocentesis), Hypokalemia, Pleural Effusion (s/p thoracentesis)

patient had a blood clot 2 days after receiving the J & J vaccine; she was hospitalized and released. We just learned of this when the patient was in to pick up a Rx--we are unsure if this was already recorded by the hospital that treated her--we were advised by our market manager to submit just in case they didn't submit at the hospital.

Kidney transplant on 4/11. Immediately after surgery severe R groin pain. Within 7 days, leg continued to swell, pain continued, and clots (DVT?s) were found via ultrasound in the R groin, R calf, L calf. Readmitted to the hospital where anticoagulant therapy found unsuccessful. Clots continued to grow. Pt was put on heparin. Pt has no history of blood clotting disorders.

Chills (no fever) within 24 hours of the Janssen vaccination, lethargic, no appetite. Very dizzy and lightheaded on day 5 and day 6 after the Janssen vaccination with continued lethargy and loss of appetite for approximately 3 weeks. Heavy nosebleed in left side of nostril with large blood clots for 1.5 hours approximately 3 weeks after the Janssen vaccination

Fell two weeks after immunization. Developed blood clot after procedure. Husband concerned immunization is cause of clot and not the surgery or down-time after the procedure. Transfered to new hospital from previous hospital and had significant stroke due to clot

Ischemic Stroke on 4/15/2021; Extensive and closely adjoining foci of acute infarction in left, extending from parietal operculum through insula and external capsule to eat ependymal margin of left lateral ventricle;

10 days after receiving the Janssen vaccination I was driving and experienced blurred vision. Pulled over, waited a while then continued driving when vision improved. Arrived home and family member noticed facial drooping on right side as well as slurred speech. Immediately called 911 and was transported to hospital within 30-45 minutes.

DEEP VEIN THROMBOSIS; PULMONARY EMBOLISM; This spontaneous report received from a patient concerned a 77 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry: Unknown) dose not started, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 28-MAY-2021, the patient developed deep vein thrombosis and had pulmonary embolism throughout the body. The patient was prescribed with xarelto ((but had not started) to treat deep vein thrombosis and pulmonary embolism. The patient stated that she had no health conditions or concerns before the vaccine. The patient took no medications nor she did any pharmacy coverage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pulmonary embolism and deep vein thrombosis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210558443-covid-19 vaccine ad26.cov2.s -pulmonary embolism ,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).

severe headache 2 weeks later, dizzy spells for about a week. Had a CT scan and found out it was a stroke.

Death 5/15/2021 Causes of death listed on death certificate: 1) COVID 19 pneumonia 2) Acute respiratory failure with hypoxia 3) Pulmonary embolism 4) Paroxysmal atrial fibrillation Other: obesity, hypertension

During the morning hours of 7/14/21 patient became increasingly SOB and eventually went unresponsive, with no pulse or respirations, CPR initiated and EMS transported to Medical center.

developed COVID after vaccine, sx onset 4/21/21, hospitalized 4/24-4/27, treated with remdesivir and steroids, improved, then readmitted 5/2/21 with respiratory failure, required ICU admission 5/21/21, intubated, PEA arrest, passed away 5/24/21.

3/11/21- pt was feeling fine. She stood up got dizzy and seamed to have a seizure. when she came to she did not know that it had happened. about 5 hours later she stood up again got dizzy and seamed to have had another seizure. her husband called 911. EMTs took her vitals but did not detect anything to be wrong at the time and was advised to see PCP. Next day 3/12/21 she went to her PCP. She had blood work which showed high enzymes for heart failure so was sent to hospital to be admitted. Pt had blood work, chest xray which showed blood clots in both lungs. She was administered blood thinner. MRI of head was clear. Echocardiogram was clear. Pt stayed about 4 days. Enzymes for heart failure was clearing up. Pt was released and had a FU appt w/ PCP on 3/22/21. Pt found out that she also had bilateral deep vein thrombosis in both legs while she was in the hospital. Pt is improving and is almost back to normal.

pt with a history of eosinophilia treated with xeljanz 5 bid presented 9 days after covid vaccine with symptoms of acute LCMA ischemic stroke and was treated with tPA.

after receiving vaccine, felt tired, had runny nose on 4/5/21 visited patient around 10am, told us she was going to see the doctor next day 4/6/21 called patient 3x and no one picked up learned that patient suffered from stroke sometime prior night, learned that from sister (approximately 12 hours before patient was discovered in her home) - 911 called and rushed patient to ER patient spent time in ICU, conditioned stabled - continues to stay in hospital, condition continues to be monitored

Patient had vaccine on 03/15/2021. Started complaining of extreme pain in RLE by that evening. Patient contacted health agency and portable x-rays came out to view RLE. No fractures were seen. Pain continued and was unmanageable by 03/20/2021 and patient was transported to the ER. Patient was found to have blood clot in RLE and admitted to ICU. Patient further declined while admitted having multiple system failure and passed away on 03/25/2021.

Patient received Janssen COVID19 vaccine on 3/18/21. The week of 4/12/21, patient noted right calf pain. No swelling or redness noted. Patient was seen in MD office on 4/21/21 and mentioned pain in right calf and that it was improving. MD ordered venous US and D-dimer and both tests were completed and resulted on 4/21/21. D-dimer is positive and venous US is positive for DVT in right gastrocnemius vein. Patient will start on Eliquis 10mg twice a day for 7 days, then Eliquis 5mg twice a day for 6 months. Will have Chest CT to rule out PE on 4/22/21.

Pt states that she experienced headaches off and on from 03/26/21-04/09/21. Pt states she went to hospital 04/09/21 and was diagnosed with TIA. Pt states that she is now showing signs of improvement with no more headaches (04/21/2021).

Ischemic Stroke requiring hospitalization. Significant reduction in field of vision. Loss of nearly all Left Side peripheral vision

Patient was discharged from the hospital after massive PE. She went to the hospital at 2am last Saturday. Patient described unbelievable pain from shoulder neck and arms. She could hardly walk to her car. Went to ER. There they ran tests and found many blood clots in lungs. Blood clots had stopped the blood in that area. They were not definitive but said it sounded like that. Got a breathing apparatus after because it's been hard to breathe and she has been shaky. Her shot was administered 04/12 during chemo. Hospital April 24. She was discharged and given a blood thinner and pain medication - Oxycodone & Eliquis.

4-10 and 4-11-2021 Complained of headache; 4-12-2021 Sister-in-law stopped by around 5pm and noticed facial drooping on left side. My brother took her to a stand alone ER, She was given a CT Scan and nothing was seen on the CT Scan. Asked her to do various actions and was diagnosed with Bell's Palsy. It was recommended for her to go to a hospital ER or follow up with primary doctor for an MRI. 4-13-2021 Early AM lost her balance and fell down. Complained of legs cramping. Lost strength on leftside of body especially hand and legs. Appointment with primary doctor made for next day. 4-14-2021 Had 11 am appointment with primary care doctor who scheduled an MRI for 1:20pm. Sent to hospital ER following a positive result for an ischemic stroke in frontal lobe. Evaluated at hospital ER around 3:15pm. Admitted into hospital ER at 7:33pm.

Patient vaccinated against COVID-19; received COVID-19 Janssen vaccine on 3/10/2021. Patient developed symptoms last week of March. Called Provider with symptoms and then presented to the hospital (admitted on 4/1/2021). Tested for COVID and found to be positive. 4/1/2021. Patient declined, admitted to ICU on 4/3/2021. Patient died on 4/4/2021. Chief Complaint: HPI: Patient is a 79 y.o. yr. old female who presents today for COUGH (has had cough for a little over a week) and FEVER (on and off for about a week)Patient was seen due to feeling ill for over week. Patient states that she was trying to fight it on her own but symptoms have been progressing. Patient has felt feverish no known fevers. Has had a persistent now worsening cough. Patient is feeling very tired and weak due to being sick for over week. Patient does live alone. Patient is coughing which is productive with sputum. Patient is eating and drinking well. No N/V/d. No loss of taste or smell. No recent ill exposure.; Has had covid vaccine. Patient did get the Johnson and Johnson vaccine over a month ago. Patient is feeling very fatigue; Having feverish/chills. Patient is taking OTC nightquil which is no longer helping. Patient does see oncologist for her CLL. DISCHARGE DIAGNOSIS: 1. Deceased 2. COVID-19 with hypoxia 3. Asthma 4. Anemia DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: COVID-19 HOSPITAL COURSE: Patient is a 79 year old female who was admitted on 04/01/2021 for COVID-19 pneumonia with complications of hypoxia. Patient's symptoms of cough and shortness of breath have been present for approximately 2 weeks. It was noted that 1 month ago she did receive the Johnson & Johnson vaccine. Upon admission patient was treated with azithromycin, Rocephin to cover for secondary bacterial infection. She was not a candidate for remdesivir due to the length of her symptoms. She was started on Decadron, as well as gentle fluids due to tachycardia for approximately 12 hours. During the night of 4/2-4/3 patient progressively declined requiring more oxygen she was transferred to the intensive care unit. Patient was a do not resuscitate continued decline and after exacerbating all treatment options patient was switched to comfort care earlier this evening. Pronounced dead at 6:45 a.m.

Patient presented on April 1st, 2021 with COVID 19 pneumonia, B/L Pulmonary emboli and bilateral lower extremity DVT's. She was treated with heparin and warfarin for VTE. For COVID pneumonia, aptient was treated with steroids, remdecivir and actemra.

bilateral ovarian vein thrombus, thrombocytopenia - Fever, sepsis, altered mental status, nausea, vomiting

2 days after vaccination, patient started having vertigo, nausea and headaches. That day she tried to notify her doctor unsuccessfully. 2 days after that patient's headache became extreme and she lost her vision in one eye. Family doctor prescribed migraine medication and referred her to her eye doctor for the next day. The eye doctor told her he believes she had a stroke after a full exam. Stroke confirmed with MRI per family doctor. The stroke was in the occipital area. Referred to neurologist at present time. Vision loss persists. Patient is starting physical therapy and following up with neurologist, eye doctor and cardiologist.

recurrent acute embolic stroke noted on MRI brain. Received vaccine on 4/10. Seen in ER 4/11 with confusion. CT head negative and discharged home. Admitted 4/13 with worsening L weakness and fall at night. Acute stroke noted on MRI imaging.

Patient was in store and top of chest started hurting and down left arm. Patient states that they called 911 and ambulance took her to the hospital. She was tested and found to have mild heart attack with blood clot in vein of her heart. Had procedure to remove clot was put on blood thinner and is now wearing a heart monitor for the next 30 days. Is on Brelinta for the next 30 days as well. Patient went back to ER on Tuesday night (4/13/21) due to SOB spent 12 hours at ER before being transferred back to hospital. She spent another day and half before discharge diagnosed with fluid buildup.

Woke up with lost of vision in left eye for 4 to 5 hours on April 6th, 2021 in the morning. Patient went to her ophthalmologist that afternoon. The sight came back but very blurry. Retina specialist seen her on 4/13/2021 and diagnosed mini stroke (TIA) of her left eye. He urgently Guide her to go to ER on 4/13/2021.

DVT to left arm, pt came to appt reporting left arm redness and swelling. Sent to hospital for venous doppler ultrasound that confirmed DVT to site. Pt started on blood thinners at this time.

Details of Hospital Stay History of Present Illness The patient is a 79-year-old woman with a past medical history of hypertension, hypothyroidism, lumbar compression fracture, hiatal hernia, metastatic adenocarcinoma primary lung to bone and question liver, on immunotherapy pembrolizumab started 12/3/2019, changed to osimertinib, right leg superficial thrombosis, on Xarelto presented to hospital on 3/10/2020 with complaints of 2 months duration shortness of breath, worsened over a 4-day period. She was admitted to the hospital with a diagnosis of acute respiratory failure with concerns of acute PE. For all details regarding the patient's initial presentation please refer to history and physical exam dated 3/10/2021.

Receive vaccination on 4/7/21, on 4/17/21 evening minor chest pain simulating heartburn started, on 4/19/21 progressed to severe pain, went to Emergency Room, where she was admitted the FIRST TIME, several test were done and they could not locate source of pain, Just treated with Morphine for pain; my mother was discharged on 4/21/21 with NO answer to the cause for SEVERE pain, just chest ray showed a SMALL amount of fluid. Upon release my mother continued with mild pain, Until it was unbearable on 4-30-21 Admitted for the SECOND TIME until this present, This time alot of fluid was found outside her lungs, then moved to around her heart causing cardiac unrest AND STILL IN HOSPITAL....A biopsy of the fluid was done before her cardiac unrest and hospital is still waiting for results of Fluid Biopsy.

TRANSIENT ISCHAEMIC ATTACK; BLINDNESS UNILATERAL; VISION BLURRED; COMPUTERISED TOMOGRAM HEAD; ECHOCARDIOGRAM; MAGNETIC RESONANCE IMAGING HEAD; ULTRASOUND DOPPLER; This spontaneous report received from a patient via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAER reference number 1231357) concerned a 79 year old female of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included congestive heart failure, and atrial fibrillation, and concurrent conditions included diabetes, and other pre-existing medical conditions included patient has no allergy or illness. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, expiry: UNKNOWN) dose was not reported, 1 total, administered on left arm on 08-MAR-2021 for prophylactic vaccination. Concomitant medications included ergocalciferol, magnesium, and mecobalamin. On 06-APR-2021, the patient woke up with lost of vision in left eye for 4 to 5 hours. Patient went to her ophthalmologist; the sight came back but very blurry. Retina specialist had seen patient on 13-APR-2021 and diagnosed transient ischaemic attack of left eye. The patient was guided to go to ER on 13-APR-2021. On 06-APR-2021, the patient experienced blindness unilateral, vision blurred. The patient was admitted in the hospital on 13-APR-2021 and was hospitalized for 3 days. Laboratory data included: Computerized tomogram head (NR: not provided) UNKNOWN, Echocardiogram (NR: not provided) UNKNOWN, Magnetic resonance imaging head (NR: not provided) UNKNOWN, and Ultrasound Doppler (NR: not provided) UNKNOWN. Laboratory data (dates unspecified) included: Eye exam (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blindness unilateral, transient ischaemic attack, vision blurred, computerised tomogram head, echocardiogram, magnetic resonance imaging head, and ultrasound doppler. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210500771 - Covid-19 vaccine ad26.cov2.s- blindness unilateral, transient ischaemic attack, vision blurred, computerised tomogram head, echocardiogram, magnetic resonance imaging head, and ultrasound doppler. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

BLOOD CLOT IN LEFT CALF; PAIN IN ANKLE; PAIN SLOWLY MOVING UP TO THE CALF; SLIGHT HEADACHE; This spontaneous report received from a patient concerned a 79 year old female of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and penicillin allergy. The patient experienced drug allergy when treated with ciprofloxacin, and pethidine hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: 21-JUN-2021) dose was not reported, 1 total administered on 02-APR-2021 to left arm for prophylactic vaccination. Concomitant medications included blood-pressure pills, water pills and Omega-3. On 02-APR-2021, the patient experienced a slight headache for about 2 days. On 29-APR-2021, the patient felt some pain in ankle, which was slowly moving up to the calf (left leg). The patient was brought to the emergency room, where an ultrasound and blood work was performed. Ultrasound detected a blood clot in her left calf and prescribed with Xarelto daily for 3 months. Patient stated that pain reached its most intense status on 01-MAY-2021 and is slowly getting better. Treatment medications (dates unspecified) included: rivaroxaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 04-APR-2021, was recovering from pain in ankle, and pain moving up to the calf, and had not recovered from blood clot in left calf. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210520686 -JANSSEN COVID-19 VACCINE Ad26.COV2.S-Thrombosis. The 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).

after getting the vaccine in morning, later that same evening patient felt sluggish, nauseaus, tired. Daughter finally convinced patient to see a doctor. Md prescribed her a cough medication. She still felt bad for another 2-3 weeks, so she finally went to the emergency room where she diagnosed with blood clots in the legs and the lungs. She staying in hospital approx. 4-5 days before being released.

Eleven days after getting the shot, my mother in law was experiencing severe back pain and was not able to get comfortable or sleep at night. Before we could take her to see a doctor, she fell while trying to get out of bed at 7am the next morning. She had trouble getting up and exerted a lot of energy trying on her own. She called for my husband and I to help her get up. I grabbed her around the waist and my husband held her walker for her as support. Upon rising (mostly of her own ability) she was so exhausted that we had her sit on her walker and rest a moment. My husband went to check on her twice over the next 15-20 minutes, but when he returned again she was showing classic stroke signs and EMS was called. They arrived quickly and agreed. She was taken immediately to the ER, where they also agreed that it looked like a stroke. She was admitted as they continued to run tests, but she continued to decline more and more each day at the hospital losing motor skills and ability to speak. She was not able to move her right side at all and the left side was fidgety and had uncontrollably flailing that left her bruises on her arm and leg. She was also excessively sleepy. After loads of testings and images, the MRIs finally showed that the brain stem was extremely inflamed and it was an auto-immune response. By this time, she was already a vegetable in the ICU ward under incubation, IVs and a feeding tube. They continued to run more tests and brought in infectious diseases, but they ultimately said her body was fighting an infection that she did not have. They attempted a hemoglobin treatment with an oncologist to shut down her immune system but never consulted with her renal doctor, even through they were very concerned about renal failure. She could not complete the treatment and only received 4 out of the 5 doses they wanted to give her because of her kidney counts. They said that the auto-immune attack was very aggressive and they could not shut it down. In the early morning of 4/28/21, they finally contacted her kidney doctor and she was put on dialysis as a last effort to try to save her, but it was too late and all her organs were failing. She passed at 1:56 pm. Patient was homebound during the pandemic and did not leave the house unless she was visiting her doctor's office. My husband and I have limited contact at our jobs, as we work in small offices, and our children (that also lived with her) were being schooled virtually. There is nothing that I know that could have caused her immune system to go into overdrive, except for the vaccine that was administered less than 2 weeks (which is considered the time frame for vaccine immunity) prior to her symptoms.

DEEP VEIN THROMBOSIS (BLOOD CLOT); FELT UNWELL; SLIGHT HEADACHE; FELT TIRED; This spontaneous report received from a patient concerned a 79-year-old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and other pre-existing medical conditions included the patient had not been tested positive for covid-19 and did not had covid-19. The patient experienced drug allergy when treated with ciprofloxacin, and pethidine. On 02-Apr-2021, the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1808980, and expiry: Unknown) dose was not reported, 1 total administered on left arm for prophylactic vaccination. Non-company suspect drugs included: rivaroxaban (form of admin, route of admin, and batch number were not reported) 15 mg, 2 times every 1 day, from APR-2021, and 15 mg, every 1 day, from 04-MAY-2021, frequency was not reported for deep vein thrombosis. The patient was not taking any concomitant medication while reporting. On 03-Apr-2021, the patient experienced slight headache and felt tired. On the evening of 29-Apr-2021, the patient went to the hospital where the sonogram was performed. Laboratory data included: Sonogram (NR: not provided) Not reported. On Friday, 30-Apr-2021, the patient could hardly walk and had painful leg (pain in back of legs especially calf area and spreading) and on 30-Apr-2021, was admitted to the hospital. The hospital asked her to see family doctor. After discharge, the hospital told that patient had deep vein thrombosis (blood clot). The patient was prescribed Xarelto (rivaroxaban) in hospital and the patient went to family doctor next morning. The family doctor told her to start Xarelto. She was started on Xarelto 15 mg (30mg daily) twice a day from hospital discharge. The family doctor changed the dosage due to age and small size after 5 days to 15 mg daily because patient felt unwell on twice a day dose. The patient had been on Xarelto 15 mg daily since 04-May-2021. The patient would follow up with family doctor on 07-Jul-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight headache on 06-APR-2021, and was recovering from deep vein thrombosis (blood clot), and felt tired. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210556796-COVID-19 VACCINE AD26.COV2.S- Deep vein thrombosis. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

Difficulty breathing 3/16/21. Taken by ambulance to hospital 3/17/21. Hositalized and treated for double pneumonia.

DVT Left lower extremity, pain developed about 10 days after vaccine, diagnosed 4/19/21 on Ultrasound, no prior history

Patient family called on 4/23/2021 and reported that patient was hospitalized on April 9th and 13th , 2021 for blood clot in the lungs after taking the Johnson & Johnson covid-19 vaccine on 3/09/2021. During the time of the report patient's family state that patient was stable and she is doing okay.

4/13/2021 heartburn like symptoms started. 4/20/2021 admitted to emergency room, received diagnosis of 3 blood clots in the heart, 4/27/2021 died as a result of blood clots in heart

pt told me she had the Johnson and Johnson one covid shot and slept for 3 days afterwards and then had to be hospitalized for a blood clot

Reported to me by patients niece, who developed similar symptoms around the same time: Patient developed cough aches, fartigue and shortness of breath about 8 days after receiving COVID vaccine. After another 10 days of illness was taken to hospital by ambulance as too weak to stand., and died in hospital about 5 days later, on or about 5/22/21

Patient's caregiver reported to pharmacy staff today that the patient was hospitalized ~1 week after receiving her COVID vaccination for blood clots and has since been in the hospital. She stated she thought the patient's hospital physician said the patient may had some type of clotting disorder which may have contributed, but recommended she let us know to report since she got the vaccine with us. The patient is currently still in the hospital per the caregiver and has also had a heart attack since being inpatient.

DYSSTASIA; COVID-19; SARS-COV-2 TEST POSITIVE; ASTHENIA; FATIGUE; DYSPNOEA; COUGH; PAIN; ILLNESS; DEATH; This spontaneous report received from a health care professional concerned an 80 year old female of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, and hypertension. The patient experienced drug allergy in past when treated with ACE (angiotensin-converting-enzyme) inhibitors for an unknown indication. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 205A21A, and expiry: unknown) dose was not reported, frequency time was 1 total administered on left arm on 30-APR-2021 for prophylactic vaccination. Concomitant medications included Amlodipine, Atorvastatin, Bupropion, Escitalopram, Furosemide, Lantus (insulin glargine), Levothyroxine, Metoprolol, Mirtazapine and Pantoprazole for an unknown indication. On an unspecified date in MAY-2021 (reported as about 8 days after vaccination), the patient developed cough, aches, fatigue, and shortness of breath. After another 10 days of illness, the patient was taken to the hospital by ambulance as she was too weak to stand. On 22-MAY-2021, the patient experienced Covid-19, dysstasia and she had her SARS-COV-2 (severe acute respiratory syndrome coronavirus 2) test positive. On an unspecified date in MAY-2021 (reported as on or about 22-MAY-2021), the patient died from unknown cause of death in hospital about 5 days later. 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 MAY-2021, and had not recovered from asthenia, cough, covid-19, dyspnoea, dysstasia, fatigue, illness, pain, and sars-cov-2 test positive. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender's Comments: -covid-19 vaccine ad26.cov2.s. Death, cough, covid-19, dyspnea, dysstasia, illness, pain, and sars-cov-2 test positive. This events are considered unassessable. 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 covid-19 vaccine ad26.cov2.s. Asthenia , fatigue, This events are labeled per RSI and is therefore considered potentially related.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH

Within 4 days of the vaccine she became weak, nauseous, body pain and developed a fever. She was unable to get out of bed at all. One week after vaccine she suffered a stroke.

Patients daughter reported her mother had a stroke (cerebral thrombosis). Patient was admitted to hospital on 3/28/21. Patient has surgery and was admitted to the ICU. Patient also has rehabilitation. Patient is currently recovering at home .

Weakness loss of appetite 1wk after trouble breathing body hicups heart attack death (almost 2 wks after)

Pt received vaccine in her home state, unable to get details of vaccine administration such as date, site, lot #, etc. Per ED MD note : 81-year-old female with reported history of atrial fibrillation found down at hotel room. Patient states she has been on the ground in the room for 3 days, she was found covered in feces. Alert and oriented x4 however intermittently appears confused and has varying history. She does not know how she got on the ground, however denies fall or syncope. No significant current complaints. Slightly tachycardic and febrile, slightly hypertensive, exam without any significant acute findings, no obvious skin source of ulcer or infection, no focal neurological deficits, no pain. Initiated aggressive fluid hydration and sepsis work-up. EKG appears normal with no signs of ischemia or arrhythmia. Labs show slightly elevated troponin, low magnesium, metabolic/lactic acidosis. VBG relatively normal. Urine negative for infection chest x-ray without evidence of pneumonia, no clinical signs or symptoms to identify source of infection. Nothing to suggest meningitis at this time. CT head is negative. Unclear source of fever however empirically treated with antibiotics and fluids. Patient remains hemodynamically stable with no hypotension. She did arrive slightly hypoxic and with increased respiratory rate however clear lung sounds and no indications of heart failure, COPD/asthma. CT chest without evidence of pulmonary embolism, focal pneumonia, or fluid overload. Respiratory status possibly related to compensation for metabolic acidosis that is likely due to lack of fluid intake due to being on the ground. CK is normal and kidney function is normal. Consulted medicine for admission for further evaluation and treatment. Cardiology was also consulted for NSTEMI, agrees with current plan. per H&P 4/28/21: Altered mental status (R41.82): Etiology is not clear. Patient states she had J&J Covid vaccine about 3 weeks ago. Need to rule out cerebral venous sinus thrombosis. Get a CT scan of the brain with contrast. If negative will get CT venogram or MRV and MRI of the head. Neuro checks. Request PT OT and speech therapy evaluation. Check urine drug screen. Check blood alcohol level. Non-STEMI (non-ST elevated myocardial infarction) (I21.4): Start argatroban drip until cerebral vein sinus thrombosis is excluded then we can switch to heparin drip. Start aspirin and statin. Check fasting lipid panel. Monitor on telemetry. Trend troponin. Request echocardiogram. Cardiology to consult. Dr. was consulted from the ER. » Beta-Blocker Ordered: Beta-Blocker Ordered » Aspirin Ordered: Aspirin Ordered » Statin Ordered: Statin Ordered Fall (W19.XXXA): Plan as documented above. Rhabdomyolysis (M62.82): Hydrate and recheck CPK. Elevated liver enzymes (R74.8): Check hepatitis panel. Monitor levels. Fever (R50.9): No clear source of infection. Follow up on blood cultures. CT chest negative for infectious process. Check CT of the abdomen and pelvis.Start empiric antibiotics: Vancomycin and Zosyn. Hypomagnesemia (E83.42): Administer magnesium sulfate. Repeat level in the morning. Diabetes (E11.9): Start sliding scale insulin. Monitor fingersticks. Hypoglycemic protocol. Check hemoglobin A1c. Hypertension (I10): Fortunately patient is hemodynamically stable. We will cautiously start metoprolol. Adjust antihypertensives to optimal blood pressure control. Acidosis, lactic (E87.2): Likely due to profound volume depletion. Rule out sepsis. Hydrate and trend level. VTE: Argatroban. » VTE Prophylaxis Assessment: Risk Level documented as Low Risk Discharge Planning: » Discharge Planning: » Discharge To, Anticipated: Home independently Per Intensivist note 4/30/21: . Another consideration was TTP, however, patient has normal renal function with no significant evidence of microangiopathic hemolytic anemia (no schistocytes on smear). Also does not seem consistent with ITP. Suspect more a result from sepsis given bacteremia Per attending note 4/30/21: Altered mental status (R41.82): Likely septic encephalopathy due to sepsis. No cerebral venous sinus thrombosis. MRI negative for stroke. AMS has resolved. Continue antibiotics. Per attending note 5/2/21: Addendum by MD, on May 02, 2021 09:58:55 (Verified) Discussed with cardiologist, Dr. . Possible need for TEE with regards to persistent bacteremia. We will keep n.p.o. overnight for TEE tomorrow. Repeat blood culture from 4/30/2021 just came back positive for Enterococcus. Suspect endocarditis due to TAVR. ? need for TEE to evaluate the valves (TAVR) more closely. Duration of antibiotics depends on bacterial clearance: To be determined. Get another set of cultures. On Zosyn. per attending note 5/4/21: Enterococcal bacteremia (R78.81): Etiology not entirely clear but suspect GI source or endocarditis. Repeat blood culture from 4/30/2021 is positive for Enterococcus. PCP he is accepting to follow-up for IV antibiotics management: Will arrange home IV infusion through care . Antibiotics end date to be determined: Pending bacterial clearance. Repeat blood cultures pending. Infectious disease specialist following: Patient is currently on Unasyn. Will need 4 weeks of IV antibiotics.

Pt w/significant cardiac hx p/w from LTC facility w/increasing confusion, decreased appetite, weakness over 4-5 days. No reported hx of cough, SOB, N/V, fever, or URI symptoms. CXR findings were clear. Ther was concern for dehydration due to worsening renal function. Pt tested positive for COVID-19 (4/24) despite Janssen vaccine (4/7) and pt stating they had COVID in December 2020. Pt admitted for additional management of COVID-19 infection w/acute metabolic encephalopathy, acute on chronic CHF, & AKI. Treated w/dexamethasone & remdesivir. Ultimately discharged 5 days later (4/28).

Presented to ER with weakness and tired last couple of days. Left side of neck pain and headache, shortness of breath.

81 year old female admitted to healthcare facility for deep vein thrombosis and pulmonary emboli. Hospitalized x 14 days; treated by healthcare provider. Patient sought care after Chiropractor noted her right leg was swollen and he told her she should investigate this problem. Patient was then seen by healthcare provider who sent her for diagnostic testing - Doppler of lower extremities, and CT scan of Lungs. Pt was referred to a pulmonary specialist; Pt was hospitalized and treated with Heparin and Coumadin, and Oxygen.

Recent J and J vaccine on may 14th and then hospitalized on 5/31/21 till 6/7/21 with new onset rapid afib/new non ischemic cardiomyopathy ef 35%/ elevated inflammatory markers, new pleural effusions/sob-CTA chest neg for pulmonary embolism. , Pt did not have her vaccine card for her lot number. Reports her friend stole her card because she wasn't vaccinated and wanted it so she stole it but reports she has had the J and J on May 14th in her right arm. Pt was transferred to a larger teritary care hospital on 6/3 where she had cardiac cath and was evaluated by the heart failure team and discharged home with home health care services on 6/7/21. Her cardiac catheterization revealed patent 2 vessel bypass grafts/non ischemic cardiomyopathy. Cause for sudden cardiomyopathy and new atrial fibrillation unknown. discharged on amiodarone, entresto, demedex and eliquis.

My mom had a stroke on 6/17/2021 and was hospitalized. A week or so before the stroke, my mom lost feeling in the fingers of her right hand and didn?t feel well...but she didn?t feel sick, just not her normal self. The stroke spidered out over both sides of her brain. Mom is off balance, her mouth droops on the right and that side of her face is numb. The doctors in hospital could see what happened to my mom but were puzzled why because she?s so healthy with no prior issues which would cause a stroke. We saw mom?s primary care doctor after release from hospital. She was very surprised that mom had a stroke as nothing in blood work, her health or family history would indicate that this would happen. Doctor said it was probably the COVID-19 vaccine.

on 3/22/2021 pt developed altered mental status, right sided weakness, right sided gaze, aphasic. Patient was administered 65 mg IVPB alteplase 3/22 1245 with last known well 3/22 1000. Received Covid vaccine 3/18/21. Pt was usual state of health prior to stroke with no illnesses. initial NIH score was 18. post tpa NIH of 12 am of 3/23.

I am an investigator with the coroner's office. We have a death that occurred on 4/12/2021 that we ruled a natural death due to atherosclerotic cardiovascular disease. The family is concerned that the decedent was doing "fine" until she took the J&J COVID-19 vaccine on April 9, 2021. We DO NOT KNOW if the J&J vaccine caused this death, but are reporting it due to the close proximity of the vaccination to the death itself.

Supraficial blood clot in lower left leg. Pt contacted PCP, told to take 2 X 81mg aspirin for two weeks. Symptoms have resolved as of 4/13/21 when first reported to pharmacy.

Dyspnea developed one day after vaccination. Symptoms have persisted until today, when she presented to office

Janssen COVID-19 Vaccine EUA Patient received J&J COVID Vaccine on 3/15/2021 per vaccine card. Patient had an ED Visit on 3/17/2021 for a chief complaint of lightheadedness and was diagnosed with Pneumonia with Chest X-ray showing small bilateral pleural effusions with underlying atelectasis or consolidation. On 4/12/2021, Patient presented to ED as instructed by outside physician for finding of blood clot on CT the morning of 4/12/2021 (Pulmonary emboli at the left upper lobe). The patient had CT scheduled during an office appointment on 4/5/2021. Patient admitted for treatment of pulmonary embolism.

Janssen COVID-19 Vaccine EUA HPI The patient presents urgently with a friend after right lower extremity venous dopplers revealed an acute DVT. The patient apparently presented to podiatry, for foot pain and the doppler was ordered. When the result was positive yesterday, office reportedly told radiology to call my office after I had already left the office. The patient reports the pain in her RLE is improved. The patient denies any trauma to the leg or recent prolonged immobilization including car/plane trip. Of note she does say she received the J&J covid vaccine a month ago. Discussed risks of DVT and treatment options. Discussed association with breast cancer and Arimidex as well as covid vaccines. Will try to treat with Eliquis 10mg bid for a week then 5mg bid. Will discuss with oncology whether she may stop Arimidex. If she can, will likely treat with Eliquis for 3 months; otherwise will treat with Eliquis until she completes her course of Arimidex. Will report possible adverse event to VAERS. 5/7/21 ADDENDUM Discussed case with oncology, who corrected me that Arimidex does not increase risk of VTE. Will continue Arimidex with long term anticoagulation. Patient will be notified.

stroke-like symptoms; left side extreme weakness; gran mal seizure with loss of cognitive function; gran mal seizure with cognitive awareness; loss of depth perception and dizziness. Treatment: increase in lamotrogine from 200mg/150mg to 200mg/200mg

Resident received J & J vaccine on 4/10/2021, on 4/13/21 noted to have mild pain and edmea to left lower extremity. 4/14/21 MD ordered doppler which showed DVT to left popliteal and left posterior tibial veins, orders for anti-coagulant given. 4/15/21 resident stating mild pain, no other adverse effects noted.

Shortness of breath and rushed to ER - they found massive blood clot in both lobes of my lungs. No sign of Deep Vein Thrombosis - seems a mystery. Almost fatal if not gotten to ER so quickly they said. I was in the ICU from 4/7 - 4/10

On Saturday, 4/10/21, approximately 2 hours post vaccination, patient noted a knot on her left lower leg. No pain, redness or swelling noted to left lower leg. Patient took it easy the rest of the day. On Sunday, 4/11/21, patient began to have N/V, diarrhea and fatigue. No fever noted at this time or up to time of this report. As of 4/13/21, at 12:00pm the knot still remains present on left lower leg, along with fatigue and nausea. Patient was instructed to call PCP. Patient has an appointment with PCP on 4/14/21 at 1030am.

Patient collapsed when being helped out of her son's car. EMS promptly on scene. Patient in PEA and was transported to Hospital, where she died. Was reported to be in usual health before event.

Presented to Emergency Dept in full arrest. Patient was working outside when she began having a severe headache and lost responsiveness. CT head in ED revealed large subarachnoid hemorrhage.

Admitted with intractable back pain (known compression fracture). Per ED note, patient found to have cough and labored breathing. New onset A fib

Pt presented to ED w/2 week hx of malaise, myalgias, weight loss associated w/dyspnea and dry cough. Found to be hypoxic, in which she responded well with 2L O2. Labs confirmed COVID-19 positive w/elevated inflammotory markers (lactic acid). Pt had received Janssen vaccine (3/31/21). Was admitted for additional management of her acute hypoxemic respiratory failure w/COVID-19 on 4/23/21. Was treated with dexamethasone, remdesivir and empiric antibiotics which were stopped early. Pt ultimately discharged 3 days later w/follow-up scheduled in 3-5 days.

Janssen Covid-19 EUA 3/22 started feeling ill. 4/4 went for nasal swab Covid test 4/9 results negative. 4/12 went to doctor with extreme abdominal pain, shortness of breath, blurred vision. Ran bloodwork. Sent to ER for cat-scan. Results were colitis. Back to ER x3. Finally admitted and put on antibiotics, and fluids. Released home to hospice after 4 days. Died on 4/30 with cause of death, colitis.

Bacteremia - strep epidermidis, developed respiratory distress required intubation for hypercapnic respiratory failure. Developed PEA on 3/28 died.

As described to me by her son: 04-01-2021 received vaccine , no issues, waited the 15 min and said she felt fine. Left with no issues. had been to see her MD that morning for routine visit and everything was fine. 04-02-2021: No issues - felt fine. Went shopping and out to eat. Was a bit tired that evening. Son left her home at 6pm and all was good. 04-03-2021: son text her in the morning and no answer. Thought she might be in the shower and text again and no answer. He called her and no answer, so he went over and found her non-responsive laying on her back on her bed with the same clothes she left her with the prior evening. sheriff's office pronounced her dead on 04-03-2021 with what appeared to have been a heart attack.

New embolic strokes requiring hospitalization and mechanical ventilation due to mental status. New lower and upper DVT, unable to anticoagulated due to new strokes. Symptoms started acutely on day of admission, 4 days after vaccination

My Mom received the J&J Vaccine. Apprx 10 days later fell, fractured hip, Surgery April 3rd - On April 5th doctor at medical center said she has a blood clot and low platelets. Was in Hospital from April 2 to April 12th

Patient complained of not being able to read 1 week after vaccine. 1 week and one day, became very disoriented. Taken to ER on 1 week and 2 days after the shot and diagnosed with a stroke in the left occipital lobe of brain. Also diagnosed with atrial fibrillation same day. (for first time.). Patient had no history of blood clotting disorders nor heart problems. This stroke rendered patient with restricted vision. She is now unable to drive, and still quite foggy, though she is likely to recover almost fully.

left anterior descending coronary artery thrombus requiring thrombectomy, presented as acute anterolateral STEMI

patient reports development of peroneal vein thrombosis about 1-2 weeks after J&J vaccine. patient was on a flight at this time. she saw her PCP for swollen legs are was diagnosed with superficial thrombophlebitis. patient started asprin 325mg BID. after an ultrasound was done, it was revealed that the patient had right peroneal vein thrombosis as well as superficial thrombophlebitis of the medial right thigh. she was started on Xarelto 10mg daily. since taking Xarelto "tender lumpy spot on right upper thigh has gotten much better". patient has been referred to hematology to follow up.

Severe reflux within two days of vaccine; Severe abdominal pain and probable gastric bleed within 6 days of vaccine; Daily heart palpitations within two weeks of vaccine; Two acute strokes within a month of vaccine and a third stroke event after the first two acute strokes causing paralysis on right side and noticeable cognitive dysfunction.

The hospital gave my mom the Johnson shot on May 18,21.( I was not informed about it until my my told me on May 20th ) she said she had a headache and stomach, My mom was scheduled for an angiogram that day but they couldn't do it then because the doctor had an emergency. So they schedule it for Saturday but they couldn't do it because my mom had an upset stomach. They then schedule it for the 24th but they couldn't do it because her vitamin k and plasma level's were off. So they gave her vitamin k and plasma in the morning of the 25th and said they could do the angiogram. When she came back to the room her blood pressure was extremely low and she was very bloated. I was told they couldn't do the procedure because she had blood clots in her leg. And the bloating was due to fluids they gave her to flush out the heparin they gave her. Later that evening she passed away

CAT SCAN HEAD - SOMETHING IN HEAD; FEELING LIKE A BLOOD CLOT ON INNER UPPER THIGH OF RIGHT LEG; DIFFICULTY BREATHING; CALCIFICATION OF LUNGS; NUMBNESS IN BOTH FEET AND TOES; DIZZINESS; OFF BALANCE; RIGHT LEG TINGLING/FEELS LIKE WATER RUSHING; FELT LIKE BUGS RUNNING IN HEAD; ELECTRICAL SHOCK LIKE BUGS IN HAIR; SQUEEZING IN FACE; WHOLE BLOOD WAS DROPPING OUT OF BODY; This spontaneous report received from a patient concerned an 84 year old female. The patient's weight was 230 pounds, and height was 66 inches. The patient's past medical history included stroke, and concurrent conditions included atrial fibrillation, allergy to medications, non-smoker, and non-alcohol user. The patient was not pregnant at the time of reporting and the patient had no drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: 05-AUG-2021) dose was not reported, 1 total, administered on 04-APR-2021 to right arm for prophylactic vaccination. Concomitant medications included diltiazem hydrochloride for atrial fibrillation, and warfarin sodium for stroke. On 01-MAR-2021, the patient's laboratory data included Doppler scan and results were normal. On 04-APR-2021, the patient got dizzy right after the vaccination and off balance which exasperated everything. On the same day, the patient experienced tingling in right leg, felt like water rushing, both feet toes were numb, on right side felt like a blood clot on inner right thigh, difficulty breathing, calcification of lungs, felt like bugs running in her head, electrical shock, like bugs in her hair and squeezing in her face. The patient felt like her whole blood was dropping out of her body. The patient described everything comes and goes and one day it was there and another day it was not, then it came back. It was reported that, the patient visited her physician for the tenderness in her leg for possible blood clot issue and she did not know the results. On 29-JUN-2021, the patient's laboratory data included computerised tomogram (CAT scan) of brain and lungs which was abnormal, showed calcification on the lungs and that something was in her head. The patient had visited an ear, nose, throat (ENT) physician, internist, pulmonary physician, and cardiologist and it was made aware that all the side effects were from the vaccination. The patient had scheduled upcoming appointment with gastroenterologist physician. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness on 04-APR-2021, had not recovered from right leg tingling/feels like water rushing, numbness in both feet and toes, feeling like a blood clot on inner upper thigh of right leg, difficulty breathing, calcification of lungs, felt like bugs running in head, squeezing in face, electrical shock like bugs in hair, and whole blood was dropping out of body, and the outcome of off balance and CAT scan head - something in head was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210728298-covid-19 vaccine ad26.cov2.s -this case concerns a 84 year old female-feeling like a blood clot on inner upper thigh of right 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).

Patient was vaccinated in her home (COVID J&J) on 3/8. Vaccinator obtained consent and confirmed throughout the process that patient as at baseline since patient was nonverbal and bedbound. Later that same day she experienced an emergency and was take to the hospital and subsequently admitted to ICU. She died on 3/10, family present, on comfort care. Per HPI, "Patient is a 85 y.o. female with advanced dementia (non verbal, wheelchair bound at baseline), chronic aspiration, recurrent UTIs, voiding dysfunction currently self-straight cathing, has suspicious bladder and gallbladder masses (being worked up), has right sided hydronephrosis, BIBEMS for acute hypoxemia, difficult to bag en route, ED had difficulty intubating and so performed cricothroidotomy. Patient had brief PEA arrest due to hypoxia. ED provider noted "excessive pulmonary edema in airway, unfavorable anatomy, and airway swelling." Suspected insult stemming from J&J COVID vaccination reaction.

Patient received Johnson and Johnson vaccine at approx 1:30 pm and passed away on 11:03 pm - May 24, 2021. Was told around 10;20 pm, the patient was experiencing trouble breathing, cold, clammy, non-responsive .

Friday 3/19 Confusion, did not know her granddaughter, which grandchild she was kept confusing family names. That was very unusual for her. Saturday 3/20 didn't feel good that day, Sunday 3/21 around 3am got up to go to the restroom got very light headed and fell/fainted hitting her head on the night stand and falling to the floor. When EMS arrived she was in A-fib. That had never happened before. No known heart problems.

04/0821 resident receive J&J Covid vaccine at the facility in the left deltoid and on 4/13/21 swelling was noted to her left upper and lower extremities. Physician was notified and orders were obtained to perform a Doppler of the affected extremities and to commence Eliquis 5mg po bid . 1st dose of Eliquis was administered on 4/13/2021 @ 1900-2300.

Feeling quite ill. Did not sleep night before trip to hospital. Terrible taste in mouth. Taken to hospital emergency room morning of April 18, 2021. Admitted to hospital by ER physician. Reason: blood c lots in both lungs.

BLOOD CLOTS IN BOTH LUNGS. SHORTNESS OF BREATH. UPPER BACK PAIN. WEAKNESS. SWEATING AND COLD. NO COLOR IN FACE -- GREY. LOSS OF EYE SIGHT -- STARTED WITH BLURRED VISION.

Client did not experience any immediate adverse events following vaccination. Client died on 6/8/2021, approximately 8 weeks after vaccination with Janssen product. Cause of death is unknown to this reporter.

Extreme pain occurred in left thigh on 4/25/2021, went to ER. Was diagnosed with spontaneous bleed in gluteus muscle. Sent home from hospital 4/28/2021. Pain reoccurred 5/5/2021 and was again admitted to the hospital. Doctors unable to determine exact site of bleed. Stopped blood thinners to allow bleeding to stop and leg to heal. Inserted IVC filter on 5/9/2021. Had to go to to a rehab facility from 5/11 to 5/19. Saw doctor on 6/21 who ordered an MRI to be sure of no blood clots. Found out on 6/23 that there were blood clots in the lungs and was sent to the ER. Admitted to the hospital again. Had to stay until they could take out the IVC filter which was done on 6/28/2021 and she went home on 6/29/2021.

Patient stayed in health center under routine observation for 15-20 minutes after vaccine injection and showed no symptoms and was subsequently released to go home. A friend drove her home after her injection. On 3/19/21 at 09:09 a.m. a medical assistant from our facility called pt. to inform her of normal lab results. On 3/21/21 at approximately 05:43 p.m. the on call provider took a call from Deputy from the Sherriffs office informing us that pt. was found deceased in her bed on the afternoon of 3/21/21.

Family reports general malaise post treatment, followed by fever and chills 4/3/2021, and cardiac arrest 4/4/2021.

PATIENT WOKE UP AT 12 AM THROWING UP BLOOD AND FEELINGS OF PASSING OUT, 911 WAS CALLED AND AMBULANCE TOOK HER TO HOSPITAL, WHERE THEY DETERMINED IT WAS A STROKE AND MOVED HER TO ANOTHER HOSPITAL, WHERE CURRENTLEY BEING TREATED DETERMINED BLOOD CLOT IN BRAIN. MOST LIKELEY DUE TO VACCINE SHOT.

vomiting, shortness of breath, hospitalized, chart shows she suffered from blood clot, hospital has extensive records from tests

SINUS ACTING UP; HOT FLASHES; LEG CRAMPS; LOOSE BOWELS; DIFFICULTY IN REMEMBERING; SWELLING INSIDE THROAT; ACHINESS ON SIDES OF NECK; DIZZINESS; NOSE BLEED; ACHINESS ON INSIDE OF LEFT ELBOW AND RIGHT KNEE; NAUSEA; TIREDNESS; MUSCLE ACHES; BLOOD PRESENT ON UNDERWEAR NEAR THE GROIN AREA; SHORTNES OF BREATH; FEELING OF BLOOD RUSHING TO HEAD; This spontaneous report received from a patient concerned an 86 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to sulfonamide derivatives, non-steroidal anti-inflammatory drugs (NSAIDs), sulfa antibiotics, penicillin, and cephalexin, asthma, and dry eyes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, 1 total dose administered on 06-APR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On 06-APR-2021, the patient felt rush of blood to her head almost causing her to pass out. On 07-Apr-2021 (in morning), she developed muscle aches, shortness of breath, a nosebleed one and hot flashes. She experienced trouble while remembering which was never a problem before. She developed leg cramps, loose bowels (for 1 week), swelling in her throat, achiness on both sides of her neck, dizziness, nausea if she ate something that did not agree with her, tiredness and an unusual blood stain in her underwear near the groin area (but not the private parts). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood present on underwear near the groin area, nose bleed, and achiness on inside of left elbow and right knee on 07-APR-2021, feeling of blood rushing to head, sinus acting up, leg cramps, swelling inside throat, and achiness on sides of neck, loose bowels on 14-APR-2021, dizziness on 11-APR-2021, and nausea on 09-APR-2021, was recovering from muscle aches, and had not recovered from shortness of breath, hot flashes, difficulty in remembering, and tiredness. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 :-covid-19 vaccine ad26.cov2.s-BLOOD PRESENT ON UNDERWEAR NEAR THE GROIN AREA. 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.

During the middle of the night she fell out of bed for no reason and hit the floor causing a blood clot to the brain. Taken to hospital by ambulance and then transferred to another hospital. After 18 days was transferred to a Rehabilitation facility. As of this date, she still a patient.

Janssen vaccine given on 3/9/2021; Admitted to the hospital on 3/16/2021 for COVID-19 infection, pneumonia, new onset a-fib, and COPD exacerbation.

Patient's daughter came to the pharmacy on 04/24/2021 and stated that her mother, the patient, got the Janssen vaccine here and within a week, she had a blood clot and has been in the hospital ever since. This is all the information we received.

Following the injection, the patient began to experience atrial fibrillation with RVR. The patient was taken by EMS to Medical Center, and was hospitalized on 04/03/2021 The patient was discharged from the hospital on 04/07/2021.

On 2/27/21, pt had new onset chest congestion, exhaustion and shortness of breath, but no fevers (measured at home) nor orthopnea. Visited primary doctor who urged her to visit ED. On ED visit on 3/4/21, she was found to be in afib RVR (heart rate to 170s) that was refractory initially to dilt push, dilt oral, dilt gtt. On 3/7/21, stroke alert was called because of new right arm dis-coordination, and on 3/8/21, MR brain showed an acute right cerebellar artery infarct (which did not leave deficits). Prior to the vaccine, pt had absolutely no symptoms of heart failure or cardiac diagnoses. She was hospitalized from 3/4/21-3/13/21, 3/18/21-3/23/21 for afib RVR, congestive heart failure, and acute kidney injury which required dilt and diuretics. However, she was later hospitalized on 4/8/21-4/11/21 again for afib RVR, congestive heart failure and acute kidney injury. Finally after continued outpatient amiodarone, she returned to normal sinus rhythm. Patient has shared that she has never experienced such drastic health changes in her life and these frequent hospitalizations occurred after her Janssen shot.

Pt had Her Johnson and Johnson COVID shot on April 1. three days after this have coughing, and this was followed by a steady decline in her mental status and functioning. She was walking , talking , feeding self prior to time she go the shot. She could shortly not do any of these.

Patient died approx. 5 hours after shot was administered. Cause of death reported is Atherosclerotic Cardiovascular Disease. The death certificate was signed by the county coroner without autopsy, based on the report by the onsite deputy coroner. No doctors or hospitals were involved. This report is FYI only; there has been no direct connection made between my mother's death and the vaccine other than one followed shorty after the other.

BLE EDMEA/PAIN, GAIT DISTURBANCE, GENERALIZED WEAKNESS PRESENTED TO ER ON 5/1/2021 SYMPTOMS STARTED ON 4/30/2021. SHE WAS FOUND TO HAVE BLE DVT. NO EVIDENCE OF CT PE. REPORTED HAD J&J COVID VACCINE ON 4/6/2021. RECENT HOSPITAL ADMIT FROM 4/28/2021 TO 4/30/2021 WITH ACUTE RENAL FAILURE AND ACUTE CYSTITIS. PT ADMITTED TO MED SURG FLOOR. CALL REC'D FROM PROVIDER NOTIFIING OF RECENT COVID VACCINE AND NEEDED VAERS REPORT COMPLETED.

Patient presented to the ED 5/18/21 with voice slurring, headache, leg swelling. Patient with symptoms starting on Friday 5/14/21. Patient with profound weakness of her lower extremities, unable to ambulate around the house which is new. Patient also reporting she feels "different/wrong." While here in the Emergency department, patient fell onto her rear while at ultrasound, did not hit her head. Unable to stand on her own after. Patient was found to have an acute left lower extremity DVT on 5/17/21: Acute deep venous thrombosis throughout the left lower extremity with most proximal extension of thrombus into the common femoral vein noting that the external iliac vein could not be visualized

Resident had been experiencing cognitive decline over approximately the last month. Resident was treated for UTI on 4/29/21, labs were obtained on 5/3/21 and were unremarkable. Resident had seizure like episode at approximately 0830, resident was DNR Comfort Measures and resident's family did not want resident sent to hospital. Resident expired at 0920 on 5/21/21.

Acute basilar artery occlusion resulting in CVA: Patient presented as a stroke alert with rapid onset of altered mental status with nonsensical speech, followed by aphasia. Initial NIH of 20. No history of stroke. No history of COVID.

Janssen COVID-19 Vaccine EUA Patient was found on the ground in home and admitted for observation on 6/24/21, reported frequent fals. Patient was provided J&J COVID Vaccine on 6/25/2021. On 6/26/2021 at 8:14 pm patient was noted to have left sided facial droop. Pt alert, confused. Can lift arms and legs for full 10 seconds. No weakness noted. Pt unable to tell when touching her left arm with her eyes closed x 3 attempts. Denies tingling/numbness in this arm. Not present in face/left cheek or left leg. 14 MRI brain showed small right MCA infarction on the background of considerable chronic microvascular changes. MRA head and neck showed diffuse intracranial and atherosclerosis without significant. stenoses or occlusion.