Johnson & Johnson

3/18/21 ER Triage Nurse Note: "To er via EMS for eval of weakness and dizziness. States he started with sore throat and head congestion last week. Seen PCP Monday 03-15-21. Started amoxil. Took it for 2 days and became dizzy so he quit taking it. Dizziness got worse and came to ER." 3/18/21 ER HPI: 76 y.o. male who presents with c/o weakness cough and fever for the past seven days. Pt report sx are mod better with rest and worse with movement. Transferred to Hospital, dx: pneumonia dt covid-19 virus

SON REPORTED THAT PATIENT WOKE UP 4/7/21 WITH FLU LIKE SYMPTOMS AND STAYED IN BED ALL DAY. PT DID NOT DRINK ANYTHING OR TAKE INSULIN ON 4/7/21. WHEN DAUGHTER ARRIVED AT PTS HOME THAT EVENING, PT WAS INCOHERENT. SHE CALLED 911 AND PT WAS TRANSPORTED TO THE HOSPITAL WHERE HE PASSED AWAY ON 4/9/21.

Acute metabolic encephalopathy, BPH with urinary obstruction due to blood clot. Patient was vaccinated at a pharmacy with Janssen covid-19 vaccine and experienced headaches and dizziness. Then began to have urinary retention which was believed to be due to a large blood clot requiring 12x 100mL flushes. Patient went to ED at medical center on 3/30/21 and was admitted. He was discharged to nursing home on 4/11/21.

Patient received J&J vaccine 3/30/21 4/21/21 Presented to hospital with syncope and collapse, work-up for NSTEMI and placed on heparin infusion Patient found to have RLE DVT and bilateral PE with right heart strain. Platelet decreased and patient started on argatroban infusion. HIT negative, platelets remaind stable. Discharged 4/25/21 on apixaban

BLOOD CLOT; This spontaneous report received from a consumer concerned a 76 year old male. The patient's weight was 82 kilograms, and height was not reported. The patient's past medical history included angina pectoris, peptic ulcer disease, and tension headache, and concurrent conditions included asthma, atherosclerotic heart disease of native coronary artery, benign hypertension, stage 3 chronic kidney disease, chronic obstructive pulmonary disease with acute exacerbation, cirrhosis of liver, diabetes mellitus type 2, generalized osteoarthritis, morbid obesity, mixed hyperlipidemia, stenosis of bilateral carotid artery, peripheral vascular disease, malignant neoplasm large intestine, carotid artery occlusion, and hepatocellular carcinoma. 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 31-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: cabozantinib s-malate (tablet, oral, batch number was not reported) 40 mg, 4 times every 1 day, from 04-MAR-2021 for hepatocellular/liver cancer. Concomitant medications included apixaban, atorvastatin calcium, carvedilol, ergocalciferol, hydrocodone bitartrate/paracetamol, levothyroxine sodium, losartan potassium, mecobalamin, metformin hydrochloride, salbutamol sulfate, tadalafil, tamsulosin hydrochloride, and vitamin b complex. On 03-APR-2021, the patient experienced blood clot. On an unspecified date in Apr-2021 the patient was hospitalized for one day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210530464-covid-19 vaccine ad26.cov2.s-Blood clot. 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: CONMEDS-OTHER SUSPECT DRUGS, MEDICAL HISTORY

Patient presented to this facility on 5/12/21 as transfer from hospital for treatment of acute hypoxic respiratory failure secondary to COVID pneumonia requiring intensive care unit treatment. Patient did receive a J&J COVID vaccine on 4/7/21. Patient was intubated on arrival. Patient was treated with remdesivir, tocilizumab, steroids, and antibiotics. Patient's ARDS progressed. He developed septic shock, recurrent pneumothoraces, and acute kidney injury on chronic kidney disease. Patient did not improve. Patient was transitioned to comfort care on 5/23/21 and patient expired.

According to the family, he had symptoms of weakness, nausea, headache, difficulty breathing beginning May 15, 2021. They spoke with him on Sunday, May 16, 2021 and he was continuing to have symptoms. On Monday, May 17, he called one of his daughters, but she missed the call. The family tried to call him on May 18- and May 19, but they couldn't reach him. A welfare check was initiated on May 20; however, the police didn't enter the residence. He was found dead in his bed on May 21, 2021, with changes of decomposition.

Patient received Covid vaccine in March (unknown date). He subsequently developed a burning chest pain and cough. Diagnosed with Covid May 20,2021. Admitted to the hospital May 27th with new stroke symptoms and mycoarditis/NSTEMI

According to Patient's son: Patient fell down after reaching home after getting this vaccine. Patient was admitted to ER same evening. According to ER doctor, patient has blood clot in his brain and is in vegetative state.

Patient came in to the Hospital with blood in the urine since July 3. Patient had been on Kleffx, and then called his own pcp. Pcp adviced he get blood work done at the urgent care. Urgent care was only able to do urine test. Kleffix was discontined and patient was then given Bactrium also Zofran. Patient was complaining of eating very little , denied chest pain, denies SOB. Complained of chills and shaking. No other complaints, Patient did have a chest x-ray. Found on x-ray ground glassin the perfary of right lower lobe. Diagnosis was , acute weakneess, phemonia, hematuria.

The patient received the Janssen vaccine on 5-29-21 and had previously well controlled asthma. The patient presented to ED on 6-1-21, 6-13-21, 6-28-21, and 7-19-21 with acute asthma exacerbation. On 7-21-21 the patient was admitted into the ED and later ICU with cardiac arrest related to asthma acerbation and pronounced deceased on 7-25-21. Symptoms: - Wheezing -Shortness of breath - Onset following the day after vaccine administration Treatments: - Albuterol/ipratropium nebulizers - Prednisone -Albuterol inhaler

On March 27, 2021 the patient developed some pleuritic chest pain and shortness of breath. he went to the Emergency Department at Hospital.

Began as Dizziness on 3/31, then double vision, vertigo. Adm to The Hospital on 4/1. Diagnosed with TIA. Home next day. Now on hear monitor.

Symptoms of fever, nausea, and weakness started 3 days following vaccination. Denies any exposure to COVID positive person. Presented to local emergency department on 3/27/21 with nausea, fever, chills, dizziness, and confusion. Due to patient's condition, he was transferred to larger facility for further management. Patient was admitted to hospital and subsequently transferred to ICU on 4/17/21. He was intubated at that time. Patient went into multisystem organ failure and died on 4/18/21.

Patient was giventhe Janseen covid vaccine on 5/5. Apparently the patient 6 days later was reportedly aggitated had hallucinations and trouble breathing. The patient proceeded to lay down to rest. The patient never awoke.

bi-lateral leg pain within 1 week of shot. then severe back pain after 2 weeks. difficulty breathing week 3. Admitted to hospital for multiple blood clots in legs & lungs.

Swelling of left leg. Ultrasound left lower extremity (06/01/2021) showed extensive occlusive DVT. Started Xarelto on 06/01/2021. 15mg twice daily for 21 days. Appointment to see vascular surgeon on 06/04/2021.

MASSIVE BLUNT FORCE TRAUMA; CAR ACCIDENT; BLEEDING PROBLEMS; FELT PUNK; POSITIVE COVID TEST/ CONFIRMED COVID-19 INFECTION; This spontaneous report received from a consumer concerned an 77year old male. The patient's weight was 216 pounds, and height was 65 inches. The patient's concurrent conditions included pacemaker, and copd (Chronic obstructive pulmonary disease), and other pre-existing medical conditions included the patient was on respiratory medications and blood thinners. The patient was previously treated with warfarin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry :unknown) dose was not reported, 1 total, administered on 10-MAY-2021 for prophylactic vaccination. The batch number was not provided and has been requested. On an unspecified date in JAN-2021, Laboratory data included: COVID-19 virus test (NR: not provided) positive. The patient felt a little punk from the vaccine initially. On 18-MAY-2021, the patient was in a car accident. He was driving a truck and got T-boned by a car and pushed 40 feet into a ditch. He was hospitalized and had 2 negative rapid tests for COVID. He decompensated and was intubated. Upon intubation, another rapid COVID test was done and was positive. They did an additional test that was also positive. He passed away on 25-MAY-2021. An autopsy was performed on an unspecified date. It was reported that she believed the cause of death to be the massive blunt force trauma and bleeding problems. He tested positive for COVID with a 5 day test in JAN-2021. During that time, he had received the monoclonal infusion. She noted that he did not get ivermectin. He also got a physical examination done. Laboratory data included: COVID-19 virus test (NR: not provided) not reported, and SARS-CoV-2 rapid diagnostic test (NR: not provided) positive, positive. Laboratory data included: SARS-CoV-2 rapid diagnostic test (NR: not provided) negative, negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of massive blunt force trauma and bleeding problems on 25-MAY-2021, and the outcome of positive covid test/ confirmed covid-19 infection, car accident and felt punk was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender's Comments: V0. 20210554454-COVID-19 VACCINE AD26.COV2.S. Massive blunt force trauma, bleeding problems, car accident. This events is considered unassessable. The events have an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.; Reported Cause(s) of Death: MASSIVE BLUNT FORCE TRAUMA; BLEEDING

Pt developed sudden-onset of severe left-sided chest pain with heavy pressure, shortness of breath and diaphoresis; pt collapsed and had a period of unresponsiveness lasting approximately 10 minutes. EMS was called and noted significant ectopy as well as frequent NSVT on ECG. Pt was transported to the Emergency Department and subsequently admitted for observation.

No appetite for days. The smell of food made patient sick. On week two after vaccine, oxygen stayed at 84%, patient couldn?t stand as he had no energy. Patient began to eat after lots of convincing and seemed to be doing at least 20% by week 3, but oxygen was still in mid 80%. On day 20 after vaccine patient had to be rushed to the ER due to sepsis. All vital organs began to fail and on transport patient suffered a mild heart attack. Patient was a healthy 78 year old male that lived alone and drove and had no major health issues before the date of the vaccine.

He got the vaccine, was not able to breath real good and didn't think about it. It got to the point within 2 weeks that he was not able to get up from the chair due to the shortness of breath. By 4/1/21 he was not able to breath very well, but continued to stay home. Then by 4/12/21 he was not able to breath well at all and his wife took him to the ER. In the hospital they did x-rays and found out that his lungs are full of blood clots and both legs have blood clots in them. He was admitted and gave him Heparin drip for the 2 days to get the blood clots dissolved and was also on oxygen for 2 days. He was discharged home yesterday with Xarelto, and was told that he would be on that for the rest of his life, and is on oxygen for sleep and when he's up and around, but if he's resting and feels he's breathing okay he can remove it. They informed him that it would take approximately 2 months for all the blood clots to dissipate, and that he was full of blood clots, and had both legs and both lungs which are quite full.

Systemic: Blood Disorder (diagnosed by MD)-Severe, Systemic: blood clut in the lungs and legs-Severe, Additional Details: Per patient he went to the hospital on 3/17/21 and 3/23/21 and was diagnosed with a blood clut in his lungs as well as his legs. He was treated with Pradaxa but still continues to have difficulty walking and has overal body aches.

Acute respiratory failure- bilateral pulmonary emboli. Acute renal injury. New onset of atrial fibrillation. Patient in ICU intubation occurred on 4.18.2021

Patient developed shortness of breath, chest pain 'fuzzy head,' headache, rhinorrhea, diarrhea, and increased fatigue around 3/28/21 had clinic appointment 3/30/21, diagnosed with pneumonia. XR CHEST 2 VIEWS (PA AND LATERAL), TRANSTHORACIC ECHO (TTE) ADULT NON CONGENITAL, EKG 12-LEAD completed. given cefTRIAXone (ROCEPHIN-Equivalent) injection 1,000mg IM, and doxycycline monohydrate (MONODOX) 100 mg capsule PO. was evaluated in ED 4/5/21 CT Abdomen Pelvis with IV Contrast Final Result 1. Positive for extensive acute bilateral pulmonary emboli at the lung bases as detailed in the body of the report. DX Chest Portable 1 View Final Result Mild left ventricular prominence is noted. Small right pleural effusion is seen. Minimal discoid atelectatic changes in the left perihilar region and left lung base. Elevated right hemidiaphragm suggests eventration. Admitted to Hospital 4/5/21, per admission diagnosis: Acute pulmonary embolism (*) submassive likely secondary to covid 19 Per hospital course notes:Patient presented with acute hypoxic respiratory failure and was show to have submassive PE with severe pulmonary hypertension seen on TTE. He should be on lifelong therapy given 2nd VTE and severity. Iwould consider unprovoked (COVID in 11/20 wouldn't count I wouldn't think). He was started on eliquis 10 mg BID x 7 days than 5 mg bid. Given his severe pulm htn on TTE, left atrial pressure normal. We would have outpatient sleep study as well He will need VQ scan to assure no CTEPH. Will have outpatient follow up. We discontinued his aspirin on discharge as well.

Atrial Fibrillation began 3-4 hours post vaccination and lasted around 2 days. Patient is back to normal now with no symptoms.

STROKE; SHORT WINDED; This spontaneous report received from a patient concerned a 78 year old White and not Hispanic or Latino male. The patient's height, and weight were not reported. The patient's past medical history included blood clot in leg around 10 year ago, and concurrent conditions included high blood pressure, social drinker, hole in heart from birth, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on left arm on 11-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included acetylsalicylic acid, atorvastatin, clopidogrel bisulfate, colecalciferol, escitalopram, finasteride, gabapentin, hydroxychloroquine sulfate, levothyroxine, lisinopril, thioctic acid, ticagrelor and verapamil hydrochloride were drug used for unknown indication. On 12-APR-2021, the patient experienced headaches, which lasted 1 week. On 18-APR-2021, the patient had CT scan (computerized tomography) result was not reported. Patient was sent home for tension headache. On same day, patient had also experienced no energy. On 19-APR-2021, the patient was Hospitalized for MRI (Magnetic resonance imaging) which showed patient had stroke within 5 days and also had plaque around the brain. Patient was started on Plavix and aspirin. On 21-APR-2021, the patient discharged from hospital. On same date, the patient went to cardiologist to have monitor placed where patient had another stroke and patient was readmitted to the hospital. patient was taken off Plavix and started on Lisinopril and placed on heart monitor. On 23-APR-2021, the patient was discharged from hospital. Patient was hospitalized for 5 days. On APR-2021 patient had experienced down hill, short winded and voice was gone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stroke, and had not recovered from short winded. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0. 20210518146-COVID-19 VACCINE AD26.COV2.S-Stroke. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY

Patient suffered a tiny brain bleed and subdural hematoma and fell from our boat to the pier on the afternoon of April 17. I drove him to the ER for evaluation where a CT scan revealed the brain bleed. He was subsequently transported to the emergency unit that evening. He was disoriented and suffered a concussion as well. He had daily blood work and was treated with Levetiracetam for 5 days post discharge on 4/22.

Per Regulatory Authority it is to be reported if patient gets COVID if fully vaccinated. Per MD note 1. Acute hypoxemic respiratory failure: This is in a patient with COVID pneumonia. The patient was placed on supplemental oxygen. The plan is for the patient to use supplemental oxygen with oxygen by nasal cannula up to 6 L and if oxygen saturation falls below 90% on 6 L oxygen by nasal cannula, he will be transitioned to high-flow oxygen. However, if he is on maximal support with high-flow oxygen with oxygen saturation falling below 90%, the patient should be placed on BiPAP and transferred to the ICU. The patient is a full code. 2. COVID pneumonia: This in a patient who apparently received his Johnson and Johnson COVID vaccine 3 weeks ago. The patient started on treatment with remdesivir. He will get steroids. He is prescribed Tessalon Perles and Robitussin with codeine as needed for coughing. He may be considered for potentially other treatments in the setting of his COVID pneumonia, especially if his respiratory status deteriorates. We will closely follow up in the COVID unit after admission. 3. Alteration of mental status and encephalopathy: This in a patient who is hypoglycemic. However, part of his encephalopathy related to his COVID infection and volume depletion. He is being volume repleted and treated for his condition. He will have frequent neurologic checks done after admission. 4. Generalized weakness and deconditioning: This is in a volume depleted patient with COVID. His COVID will be appropriately treated and he will be volume repleted. He will need to work with physical and occupational therapy towards the end of the hospitalization. 5. Congestive heart failure, systolic plus diastolic dysfunction: The patient does not have any evidence of acute congestive heart failure at the moment. However, we will take care to prevent volume overload in this patient, who requires volume repletion in the setting of his volume depletion. 6. Volume depletion: The patient will get another liter of IV fluids after admission at 80 mL per hour as tolerated. The goal is to avoid excessive IV fluid administration in this patient with COVID pneumonia.

Vaccine was given on 4/1/21. Symptoms started 4/2/21 in the afternoon. Symptoms were described as teeth/gums hurting. At 12:30 am on 4/3/21 his mouth was very swollen and he couldn't talk. Also he had trouble breathing. He went to the ER and was given IV solu-medrol. Patient was sent home 30-40 minutes later with the instructions to take Benadryl PO. In the morning they purchased some benadryl and gave it PO every 4-6 hours all day Saturday, 4/3/21. On Sunday, 4/4/21 at about 5:30 am his gums and lips were swollen again. He made another trip to the ER and was given solu-medrol IV again and PO methylprednisolone for 5 days. At this visit, they also gave lasix IV due to extra fluid around his heart. He was told by the ER provider that he developed congestive heart failure due to the vaccine. Patient followed up with his primary care provider on 4/8/21 and was told that his symptoms of congestive heart failure had resolved. Patient also reported his symptoms of swollen gums and mouth had resolved at this time.

Bilateral arm swelling: 1. Occlusive thrombus is present within the right cephalic vein extending from the upper arm to the elbow. 2. Nonocclusive thrombus is present within the left basilic vein in the mid and distal arm. also developed acute appendicitis 04/06/2021 and underwent lap appendectomy.

I received the Johnson and Johnson/Janssen Covid-19 vaccine at the vaccination pod on Thursday, April 8th, 2021 (04-08-2021) at around 12:45 pm. The next morning, Friday, April 9th, 2021 (04-09-2021), I woke up around 9:30 am and felt fine at first. But after taking a drink of water, I felt nauseous. I also had a pressure sensation in the center of my chest below my collarbone. After contacting my doctor's office, my family called 911 at around 11:40 am to have the emergency squad take me to the hospital to be evaluated for a heart attack. At the hospital, I was diagnosed with an acute ST elevation myocardial infarction. I was taken to the catheterization lab for a heart catheterization and a stent was placed in my left anterior descending artery (LAD). I was admitted to the hospital on Friday, April 9th, 2021 (04-09-2021) and discharged from the hospital on Saturday, April 10th, 2021 (04-10-2021).

Janssen vaccine received 3/6/2021. Had a fall from sudden onset weakness 3/9/21 broke hip then ORIF and cardiac arrest. Now at skilled nursing facility

INCREASING HEADACHE, AND SHORTNESS OF BREATH. Previously frequent bloody nose on 03/30/21, pt is not currently taking any blood thinners, he recently went to the ER on 03/30/21, after the visit the nose bleeding stopped. Pt's wife C/o of edema of the ankles with SOB. C/o severe migraine headaches and back pain. Norco helps the patient with his migraines and pain w/o SEs. Patient has still has SOB on exertion, but it is stable, pt's wife states that he is getting worse, he will c/o of SOB after walking less than half a block. He continues to use 2 L oxygen nasal cannula supplement and his inhalers and nebulizer treatment up to 4-6x a day. No fever and chills. Pt only has occasional cough. When he uses his inhalers, his cough will subside. PATIENT HAS HX OF THROMBOCYTOPENIA, BUT THROMBOCYTOPENIA HAS GOTTEN WORSE AFTER VACCINE.

CONGESTIVE HEART FAILURE; FLUID AROUND HEART; HAD TROUBLE BREATHING; TEETH AND GUMS STARTED HURTING; TEETH AND GUMS STARTED HURTING; GUM SWELLING; This spontaneous report received from a pharmacist concerned a 79 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 01-APR-2021 for prophylactic vaccination about 1:30 pm in left deltoid. No concomitant medications were reported. On 02-APR-2021, the patient experienced gum swelling, teeth and gums started hurting, trouble breathing. His tongue and throat did not swell. On 03-APR-2021, the patient visited the emergency room (ER) about 12:30am and was given Solumedrol intravenously and was sent home advised to take Benadryl. The patient took Benadryl 4-6 hourly all day on 03-APR-2021. The patient visited the ER again on 04-APR-2021 about 5:30 am with swollen gums again and was informed that he had fluid around heart and given Lasix. Emergency department (ED) HCP told patient that the vaccine gave him congestive heart failure (according to patient) and he was given Solumedrol at ED again and sent home on Medrol dose pack. On Monday 04-APR-2021, the patient visited his primary care physician and congestive heart failure had resolved. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from events of gum swelling, teeth and gums started hurting, had trouble breathing an unspecified date in Apr-2021, and from fluid around heart, and congestive heart failure on 05-APR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210420579- covid-19 vaccine ad26.cov2.s-Congestive heart failure, fluid around heart, had trouble breathing, teeth and gums started hurting, gum swelling. 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).

The patient presented with chest pain around 5 pm on 4/4/21. Patient reported "pain came out of nowhere." Patient reported pain was non-exertional and non-positional. He described it as "a constant burning sensation" located in the center of his chest with radiation upwards toward his jaw and shoulders, bilaterally. He was transferred to COVID unit, became hypotensive, hypoxic was seen by house MD. Lung exam crackles bilaterally. IV fluids stopped, patient was given 40 mg Lasix, Morphine 2 mg and started on a small dose nitroglycerine drip. POX 70s, low 80s so Bipap ordered. Patient developed v tach and arrested, resuscitated, defibrillated, received multiple meds, intubated by anesthesia, transferred in ICU on Levophed and Epinephrine. Arrested in ICU. Lines were placed by ICU team, arrested again in ICU. Was maxed out on 4 pressors, despite CPR, pulse could not be obtained, patient was pronounced dead 4/6/21 at 3:31am. 1. Triple vessel CAD 2. Moderately severe LV dysfunction with and EF 30% 3 The recent NSTEMI is secondary to the occlusion of the SVG-OM1. There is a large thrombus in the SVG which makes PCI of this vessel unlikely to be successful. 4 The native OM1 is chronically occluded. It may be possible to attempt to open this with CTO techniques, however, at this time continued medical treatment. 5. Perclose

Developed s/s of COVID on 4/27/2021, hospitalized, then transferred to another HCF was inpatient ICU 5/8-6/21 expired 6/21/21

80 yo male received J&J COVID-19 vaccination on 2/5/21. Pt with history of bladder cancer (s/p TURBT 11/04/2020), COPD (quit smoking 1 month ago) on 2 L nocturnal O2, HTN, CAD, MI s/p CABG x3v, apical cardiac aneurysm s/p repair, recent hematuria requiring cessation of chronic warfarin therapy who presented on 2/14 as a direct admission for evaluation of NSTEMI and new LLE DVT. He was initially placed on heparin and was stopped due to anemia and hematuria. DVT at outside hospital, repeat dopplers negative at our institution. Acute R femoral DVT likely due to patient being taken off chronic anticoagulation with warfarin. Discussed case with heme and not needed for IVC filter......and even though cardiology would like him on long-term AC given high risk for LV thrombus, bleed risk outweigh benefit at this point. He was diagnosed with new HFrEF and NSTEMI. He will stay on hydralazine, imdur, lasix every other day, baby asa, and statin.

4/15/2021 approximately 1030 am client found to be AMS, non-responsive, aphasic, aphagic, left-sided facial droop, teeth clenched, left eye closes, right eye with deviated gaze. 911 called, client to hospital ER, work up/evaluation, admission for stroke related to blood clots found left frontal and right temporal lobes, per spouse. Client discharged 4 days later to home s/p CVA, bed-bound, remains aphasic, aphagic, non-communicative, no response to verbal stimuli. PLEASE NOTE: hospital admission. Unable to complete section 21. Admit for 4 days.

The day after the vaccine, he noticed he didn't feel well. Tired, headache, stomach ache, and shortness of breath. This started out mild and as the week went on got worse. Symptoms were leg swelling, shortness of breath, persistent stomach pain, headache, and chestpain. On 6/24 at 3:30 am he went to the ER where they discovered a large (golf ball size) blood clot in his right lung. He also has been diagnosed with pancreatitis. We have talked to five different doctors and multiple other hospital staff who all say it is a direct impact of the covid vaccine.

Patient caregiver reports that he woke up at 2 a.m. the morning after the vaccine unable to hold his urine which is unusual for him. He also reported extreme acid reflux symptoms whenever he attempted to drink any fluids at that time as well as nausea. This progressed to difficulty breathing at which time the caregiver was alerted and checked his blood pressure. This reading was 88/55 according to the caregiver and the pulse was very high as well but the actual number could not be remembered. The difficulty breathing prompted them to alert emergency medical services where he was picked up and transported to the emergency room via ambulance shortly after for evaluation.

The patient presented to Emergency Department with lethargy, confusion, and hypoxia. Upon presentation to the ED, the patient tested positive for COVID-19 (04/29/21). The patient is currently being treated with dexamethasone and remdesivir.

This 82 year old male hospice patient received the Covid shot on 3/6/21 and went to the ED on 4/6/21 and was admitted on 4/6/21 with respiratory distress, acute hypoxemic respiratory failure, anasarca, atrial flutter, hypothyroid and died on 4/15/21. Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.

Extreme lower extremity swelling and pain. Evaluated in PCP office on 04/22/21, ultrasound of right LE was negative for blood clot. Patient?s symptoms worsened and PCP referred patient to ER on 04/16/21 and CT of cheat revealed 3 clots in the lungs. Patient was admitted to hospital and stated on heprin therapy. Still currently inpatient awaiting approval to transfer for inpatient rehab due to decreased endurance and bilateral lower extremity pain which is affecting ability to ambulated without assistance.

We admitted patient to the hospital DOB 08/30/1938 MR#46977 FIN#98705621120 on 04.30.21 through our ER to Med/Surg for new right middle lobe PE. Pt received the Johnson and Johnson (Janssen) COVID vaccine on 04.02.21 at the Pharmacy (lot# 042A21A). The pt was on warfarin prior to admission for diagnosis afib and therapeutic (INR 2.2) at time of admission so he was placed on heparin high intensity infusion. Pt subsequently developed hemoptysis so heparin infusion was held and pt was transferred to the hospital for hematology/pulmonology/oncology consult. At accepting facility heparin was held on admission and was restarted on 05.02.21.

monitored troponin. Initially came in hospital for sepsis but troponin trended up upon arrival. Continued to monitor. Discharged to skilled nursing facility

Patient called today, He stated that 18 hours after his dose of Janssen he had a nose bleed that lasted 8 hours and expeled 2 large blood clots from his nostils. I asked if he had seen a physician and he had only called his friend who was a PA. I encouraged him to contact his physician and inform him/her of the situation.

No report of negative event after 15 min wait past receipt of vaccine. Notified by Coronor, on 3/11/2021 that this patient expired on 3/11/2021 at home. Not sent to hospital. Pronounced at home. Sent to Funeral Home

Hospice of Compusus nurse called and reported that patient passed away. She reported no adverse reaction and that patient had no complications before going to bed and patient did not wake up from his sleep.

Received Janssen Vaccine on 03/10/2021 IM Left Deltoid. Reported started having "dizzy spells a couple weeks after" receiving his vaccination. Reports then started having "leg heaviness". Was hospitalized with hospital on 04/11/2021 with a blood clot "behind right knee".

3/5/ 21 Received J & J at facility. 3/7/21 Client had troubles walking and went to Urgent Care. then he went home. He did not have good control (wife described that his legs did not have strength but was able to walk. Symptoms started getting better later that day. 3/15 He got up and he said he was not feeling to good. Chest hurt and shoulder hurt. Wife took him to the ER at Hospital. He was transported to Hospital. 3/16/21 Hospital did a Heart catherization. He had a complete blockage in the widow maker and 2 stents were put in. He had 2 blood clots in the Widow Maker. 3/18/21 He was discharged from the hospital. He is doing ok but he has no energy.

I experienced blood clots, also had bilateral leg pain and lower back pain. I currently in the hospital.

Patient with advanced parkinson's, dysphagia, on G-tube feed received J&J vaccine on 6/9 per wife, developed fatigue/general weakness, developed fever, admitted to hospital for aspiration pneumonia/sepsis/acute respiratory failure.

After vaccination that day, patient was too tired to get out of bed to do his evening walking exercises. On 6/10/2021 3:00 am, patient unable to support himself on the commode and was put back to bed. Next couple of days patient was too weak to get out of bed. 6/14/21 1:00 am, patient became very congested and unable to remove fluid in his lungs, wife called medics and patient was admitted to hospital for 2 days with pneumonia. 6/16/21 7:00 pm, patient discharged from hospital. That night, patient became very congested despite continuous suctioning through the mouth, patient experienced respiratory distress and lungs congested with fluids, 2:30 am medics was called and paramedic performed invasive deep suctioning of lungs via his nose on way to the hospital, upon arrival at hospital they performed another deep suctioning of lungs before sending patient to the ICU. 6/21/21 4:00 pm, patient discharged from hospital in stable condition, doing physical therapy and occupational therapy at home.

STROKE; This spontaneous report received from a patient concerned an 84 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfonamide allergy, non alcoholic, and cigarette smoker (one pack per day). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry date: unknown) dose was not reported, administered on 03-MAR-2021,13:36 right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 04-MAR-2021, Patient experienced a stroke. Patient was sent to the ER. The patient was treated per stroke treatment guidelines, The patient was hospitalized for two days. The patient returned to hospital a week later. Professionals at the hospital found reason for blood loss, but could not find reason for the stroke. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stroke on 06-MAR-2021. The reporter causality assessment for stroke was not related. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0:20210340063-Covid-19 vaccine ad26.cov2.s-Stroke. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY

Patient started having abdominal pain on March 26, 14 days after vaccination. Went to ER on March 29 and was admitted. Diagnosed with blood clot in spleen. Discharged from hospital on March 31.

MASSIVE STROKE(PARALYZED ON THE LEFT SIDE); This spontaneous report received from a consumer concerned a 84 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on 08-APR-2021 17:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the patient had a massive stroke and got paralyzed on the left side (arm and leg). The patient was admitted to the hospital on the morning of 10-APR-2021 and was still in the hospital at the time of this report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from massive stroke(paralyzed on the left side). This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210422228-Covid-19 vaccine ad26.cov2.s -Massive Stroke. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

BILATERAL PULMONARY EMBOLISMS; This spontaneous report received from a pharmacist concerned an 84 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: 25/MAY/2021) dose was not reported, 1 total dose administered on 10-MAR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported. 10-MAR-2021 After administration of vaccine on 15-APR-2021, patient had bilateral pulmonary embolisms and was hospitalized in local hospital then triaged to heart institute, Reporter also report patient will get discharged soon. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bilateral pulmonary embolisms was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: This 84 year-old male patient was hospitalized for bilateral pulmonary embolisms 36 days after receiving the Janssen Covid-19 vaccine. Medical history, concomitant medications, social history, family history, diagnostic test results, corrective treatment, and outcome were not reported. Based on the limited information, the event is considered unclassifiable. Additional information is being sought.

Patient received the COVID 19 vaccine on 3/30/21 at home. Per the obituary, he died at home on 5/10/2021.

Apr 10, 2021 ? Jan and I both received Covid-19 Immunization at The Event Center using Janssen (J&J) 042A21A Apr 11, 2021 ? Awoke with slurred speech. Left side of face a little droopy. Vision partly blocked by what I thought was droopy eyebrow. April 12, 2021 ? Made appt to see Dr. After initial checkout and some discussion she sent me directly to ER. Arrived and was checked in and admitted; IV installed, CT Scan, chest ray, MRI and many other tests were administered. One was X_RAY recording me as I drank barium water. I was diagnosed as having had a Stroke by Drs as well as resident Physician. My dosage of (Imdur) Atorvastatin was increased to 80 MG per day. Other meds remain the same. @ Dr: 226.4#, 95% ox, 56hr, 120/72 bp hospital has complete records.

Cause of death not documented. Significant comorbidities include dementia with neuropsychiatric behaviors including anxiety.

Presented with CVA. CTA showed large segment occlusion of L ICA, S/P thrombectomy and carotid angioplasty by IR. Residual L internal carotid 70% stenosis post procedure

Patient received the vaccine on 4/10/21 and a few days later hit his leg, which subsequently became erythematous and swollen. He went to urgent care on 4/13/21 and received a prescription for doxycycline which he stopped taking prior to resolution of symptoms due to side effects from the medication. He was prescribed clindamycin, but did not start this medication. Patient had outpatient labwork this morning which revealed an elevated SCr, for which he was sent to the ED. The patient was found to have AKI with hyperkalemia, as well as left lower extremity DVT and cellulitis. Patient is being treated with heparin and linezolid, as well as Kayexalate. The patient is being admitted to the hospital for treatment.

developed bilateral swelling and cough/subjective shortness of breath. Found to have bilateral DVT with likely several PEs (not confirmed). Patient started on SQ Lovenox.

URINARY TRACT INFECTION; SPINAL NERVE STIMULATOR IMPLANTATION; POSSIBLE STROKE; ARM TURNING BLACK; LEFT ARM SWOLLEN; EYES NOT FOCUSING; UNABLE TO DO DAILY FUNCTIONS; ISSUES WITH BOWEL MOVEMENT; This spontaneous report received from a consumer concerned an 85 year old,male. The patient's weight was 215 pounds, and height was 71 inches. The patient's concurrent conditions included non-alcohol user, non-smoker, and drug allergy not specified, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: unknown and expiry: unknown) frequency one total, dose was not reported, administered on left arm on 18-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 20-JUN-2021, the patient experienced eyes not focusing, unable to do daily functions and issues with bowel movement, and was hospitalized. On 21-JUN-2021, the patient experienced left arm swollen and arm turning black. On an unspecified date, the subject experienced possible stroke, urinary tract infection and spinal nerve stimulator implantation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from left arm swollen, and arm turning black, had not recovered from eyes not focusing, unable to do daily functions, and issues with bowel movement, and the outcome of urinary tract infection, possible stroke and spinal nerve stimulator implantation was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210740972-Covid-19 Vaccine Ad26.Cov2.S -Possible stroke, Issues with bowel movement, Arm turning black, Urinary tract infection, Spinal nerve stimulator implantation, Left arm swollen, Eyes not focusing, Unable to do daily functions. 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).

7/24/21: past 3-4 days, patient had low energy, decreased appetite, drinking very little, and more confused than his baseline. Patient weak and breathing quickly, so came in to ED. found to be COVID positive. Diagnosed with: COVID-19 pneumonia, acute hypoxic resp failure, shortness of breath, acute encephalopathy. Note: patent previously vaccinated with COVID-19 vaccine in April 2021. 7/27: patient still admitted at the time of this form submission.

Patient had the vaccine and within 24-48 hours he began to experience pain on his right side-primarily abdomen area. He lives alone and is 86 years old. The pain got worse so he was taken to the hospital. He reports being told that he had a heart attack. He is still in the hospital at this time, but felt that he should report it. He does not know who is doctor is.

Caregiver called and sai he suffered from three Ischemic stokes 12 days after recieving the vaccine. Spent a few days in the hospital but recovining with no significant deficiets.

Flu like symptoms for 3 days, then continue loss of appetite, weakness, so much so that on April 5, 2021, I was taken to the emergency room for immediate treatment. The hospital then discovered 2 pulmonary embolisms (blood clots), one in each lung and pneumonia. At this time, I was extremely weak and in major physical stress. NOTE: I do not have a history of ever having blood clots.

On 4/9/2021 patient suffered from a Hemorragic Stroke on the left side of the brain making him unable to move his right leg and toes, right arm and hand, slight droop of right lip, and responding mostly in one word answers with delays at times. He was hospitalized in the am hours, sent to ER and then to Neuro ICU for 3.5 days and then moved onto a neuro floor for 1.5 days. On 4/13/2021 he was transported to an acute rehabilitation center to receive OT, PT and Speech Theraphy. On 4/19/2021 patient suffered from Ischemic Stroke on the right side of the brain, he became unresponsive. He was intubated on 4/19/2021, placed into ICU and was removed from intubation, due to poor life outcome from the 2 strokes having affected his body, on 4/21/2021.

The patient reports receiving the Johnson & Johnson Covid 19 vaccine in early April 2021. The patient presented to the local emergency department on 4/28/21 and had suffered an ischemic stroke. Patient had been laying on the floor for a few days prior to hospitalization. Also had traumatic rhabdomyolysis. He was discharged from the hospital and now recovering at a skilled nursing facility.

Daughter reported that on 4/13/21 pt had increased weakness and difficulty breathing, taken to ER for x-ray of lungs, small amount of fluid noted. On 5/11/21 Pt with weakness, shortness of breath, increased edema in lower extremities, taken to ER, admitted to the Hospital with Pneumonia. Pt now home on Hospice.

3 days after vaccination, patient was found down in his home. Admitted to ICU from the ER with severe sepsis, bilateral pneumonia, acute kidney injury and rhabdomyolysis. Patient deceased day after hospitalization.

Biliateral Pulmonary Emboli, Rt leg DVT up to iliac vein. Treated with Eliquis po. -- sent to hospital for further treatment Remains in hospital at this time Symptoms were swelling of Rt foot, normally SOB, no increase in baseline

developed extensive blood clotting left leg within 3 weeks after JJ vaccine. no underlying known malignancy or coagulopathy or prolonged travel. placed on eliquis and will be following with vascular

Was notified by a third party that patient died on morning of 3/15/2021. No other information available.

Rapid decline in ability to perform respiratory gas exchange and build up of carbon dioxide in the blood to life-threatening levels, ultimately leading to death. Rapid decline began about 2 weeks after receiving vaccine. Death would likely have occurred on 5/6/2021 or 5/7/2021 but for hospital intervention via use of a BiPAP machine. Patient had been exhibiting more mild, non-COVID respiratory distress for some time, back to at least late 2020, and likely at even lower levels for several years prior. Signs and symptoms included shallow breathing, extreme fatigue, difficulty or inability to lie down, occasional lightheadedness, etc. Oxygen saturation levels in April, as measured by a pulse oximeter, ranged from about 87%-96%. On May 6, it measured 65% just prior to ER visit.

Patient received COVID 19 vaccination on 3/30/2021 as part of vaccination program. Per obituary, he died at home on 5/13/2021

Pt was hospitalized with A.fib with rapid ventricular response on 4.15, 3 days after receiving the vaccine. Per guidelines, all hospitalizations should be reported.

PATIENT WAS GIVEN JANSSEN COVID 19 VACCINE AT AROUND 12PM WHEN PATIENT WAS ACCOMPANIED BY HIS SON. HE WAS OBSERVED FOR 15 MINUTES AFTER THE VACCINATION AND LEFT PHARMACY WITHOUT ANY PROBLEM. PATIENT'S DAUGHTER CALLED AROUND 6PM AND REPORTED HER FATHER JUST DIED. SHE REPORTED HER FATHER ALL OF SUDDEN WAS SHAKING AND DIED RIGHT AFTER.

About 8 days after receiving vaccine, recipient suffered a mini stroke. He was hospitalized for several days. He was told he had a clogged artery with 60% blockage. They gave him blood thinner. He recovered and was released from hospital. He moves much slower now and receives physical therapy.