Johnson & Johnson

Nose started bleeding spontaneously approximately 4 hours after getting the vaccine. Fast running and gushing. Treated by pinching nose and inserting tissue into right nostril. Lasted about 1/2 hour. Started again at approximately 4 pm - not as fast running as before - same treatment. Started bleeding today (3/14) at around 3 pm. Still bleeding but slower.

Extreme fatigue from 3/11/21 to3/19/21; Severe headache from 3/12/21 to 3/18/21; light-headed sensation 3/12/21 to 3/20/21; fainted 3/17/21; gastrointestinal issues and severe cramping the evening of 3/15/21 to 3/17/21; gastrointestinal issues (constipation followed with diarrhea without cramping).Colo

malaise, aches and pains, feels "like a cold" Caller states that she got the first vaccine ons saturday the 13th and within a couple of days starting having runny nose and sniffles, mild headache, shaking to body/hands/arms (shivering) but no fever. Memory loss. hypertension (pre-existing medical condition she takes medication for) and confusion. she has alternated with APAP, ASA, ALKA-SELTZER. she says she always gets sick from the flu vaccine. s/s have been on/off staff adv to f/u w/pcp. adv s/s reported may be ameliorated with OTC analgesics taken as directed on label as well as antihistamines. adv to call back if any questions. someone will follow up to check on her.

8 hours later bad chills then fever of 101. It was over within 12 hours Three days later had a strange like feeling of flittering near heart area...has happened 3 times since Blood pressure has increased at least 20 points or more since vaccine Swelling in fingers and toes

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".

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.

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.

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.

The day after the vaccine I had a problem with one of my eyes and then the other. It was similar to ocular migraine symptoms. I then started to have stroke like symptoms. I looked at my friends and stated that I did not know their names. I went to a walk-in clinic and then I was hospitalized for three days. My blood pressure was extremely high. All of the tests were negative for stroke and I have worn a Holter monitor. I also had Neurology, Cardiologist consult and many different medications. I have stopped taking all of those medications. I have not had any more symptoms like that since that day and it only lasted less than 15 minutes.

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

Had PVC's, feeling like I was going to pass out...4 days after getting the vaccine. Lightheadedness was off and on for about a month.

ERRATIC HEARTBEAT AND PULSE, PULSE RATE VARIED; LOOSE BOWELS LIKE WATER, DIARRHEA; TIRED; This spontaneous report received from a consumer concerned a 76 year old female. The patient's height, and weight were not reported. The patient's past medical history included loose bowels. Patient had no gallbladder and no known allergies The patient received covid-19 vaccine ad26.cov2.s by 2 paramedics (suspension for injection, route of admin not reported, batch number: 20SA61A and expiry: Unknown) dose was not reported, 1 total administered on 18-MAY-2021 14:00 to left arm for prophylactic vaccination. No concomitant medications were reported. On 19-MAY-2021 (after the vaccination), the patient felt tired. Patient always had loose bowels, now on 26-MAY-2021, the patient could not make it to the toilet, diarrhea and it came out like water. This had been ongoing for two weeks. On 08-JUN-2021, the patient had erratic heartbeat and on the same day at 12:45 pulse rate had been varied (erratic pulse). Patient could not keep anything in her. It was reported that nurse was in last week and informed loose bowels could be probably due to food. Patient did not had any medications. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired on 20-MAY-2021, and had not recovered from erratic heartbeat and pulse, pulse rate varied, and loose bowels like water, diarrhea. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.

ASSESSMENT AND PLAN: 1. Palpitations (Primary) Assessment & Plan: Next step would be to take 1/2 dose metoprolol for any Bp <100/70 but pt doesn't want to do that at this time. Will cont asprin prophylaxis and will check tsh given concurrent fatigue. Will call with results. If normal thyroid, will f/u in 6 months or sooner should condition worsen Orders: - TSH, Reflex Free T4; Future - aspirin 81 mg EC tablet; Take 1 tablet by mouth Daily. Dispense: 90 tablet; Refill: 3 2. Essential hypertension Assessment & Plan: Well controlled at present. Limited by palpitations t hat are controlled by metoprolol but when controlled with metoprolol also occasionally cause some low bp and fatigue of unknown etiology. Will cont for now but may need to decrease metoprolol to 1/2 dose for any Bp <100/70 inf uture. Orders: - metoprolol tartrate (LOPRESSOR) 25 mg tablet; Take 1 tablet by mouth 2 times daily. Dispense: 180 tablet; Refill: 3 3. Fatigue after COVID-19 vaccination Comments: suspect much of fatigue is related to covid 19 vaccination. will monitor 4. Gastroesophageal reflux disease without esophagitis - omeprazole (PRILOSEC) 20 mg capsule; Take 1 capsule by mouth Daily 1 tablet before breakfast . Dispense: 90 capsule; Refill: 2 5. Seborrhea Comments: refilled chronic medications Orders: - desonide (DESOWEN) 0.05 % lotion; Apply 1 Application topically Daily as needed (itch) Apply once daily to prevent ear seborrhea. . Dispense: 59 mL; Refill: 3 - triamcinolone (KENALOG) 0.1% lotion; Apply small amount to affected area(s) two to four times daily as needed: avoid face and groin areas. Dispense: 60 mL; Refill: 3

Nurse reported after vaccination patient ?passed out? Patient appeared diaphoretic, pale, lethargic Patient was able to answer questions Patient seen by medical team, The blood pressure and heart rate low , patient provided with IV fluids, patient advised and agreed to go to hospital Patient was transferred to hospital via ambulance

Patient fainted after the covid shot, she was feeling hot and fell off the chair onto the floor. She hit her left eye and left temple resulting in a bump and a bruise. Patient opened her eyes when I called her name and she was not aware of were she was. Her blood pressure was 95/64 65 bpm laying down and 70/54 114 bpm when sitting. We laid her back down because she was feeling dizzy and the Ambulance arrives 45 mins after called. Because of her bump and her low BP she was taken to the hospital.

Immediate feeling of "oddness" then loss of consciousness. Awoke to consciousness of being surrounded by EMT personnel, oxygen mask in place, IV line in right arm, heart monitoring electrodes on chest. Hearing someone asking questions from a great distance but being unable to answer. Hearing snatches of conversation from EMTs. "Was unresponsive," "heartrate is 30," "BP is extremely low," "Heartrate begins to come up then falls back to 30." Finally was able to speak at first in a faint mumble, then more normally. Heart rate is still in 30s. Was taken by ambulance to hospital.

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

HIGH BLOOD PRESSURE; This spontaneous report received from a consumer concerned a 77 year old female. The patient's height, and weight were not reported. The patient had medical history of high blood pressure. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: 09/JUN/2021) dose was not reported, administered on 26-MAR-2021 on left arm for prophylactic vaccination. Concomitant medications included lisinopril for hypertension, acetylsalicylic acid, ergocalciferol, ibuprofen, magnesium, vitamins nos, and zinc. On 12-APR-2021, the patient experienced high blood pressure, which had increased over 2 days. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 177/93 mmHg at 3:00, 172/86 mmHg before bed, 159/95 mmHg yesterday, and highest reading of 201/104 mmHg. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from high blood pressure. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210427613- COVID-19 VACCINE AD26.COV2.S- High Blood Pressure. 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, UNDERLYING DISEASE

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;

CONSTANT SHORTNESS OF BREATH; LOW BLOOD OXYGEN; WEIGHT LOSS; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 77 year old female. The patient's height and weight were not reported. The patient's past medical history included covid-19 positive. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: unknown) dose was not reported, frequency once total, administered on left deltoid on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. After the vaccine, on 13-MAR-2021 the patient experienced chills, fever and headache. The headache goes go from the left to right side of her head. On an unspecified date, the patient experienced constant shortness of breath, low blood oxygen, and weight loss. The shortness of breath was severe and patient had to take a break every couple 100 steps for rest. On 15-MAR-2021, the patient was hospitalized. Laboratory data (dates unspecified) included: COVID-19 (nr: not provided) positive, oxygen saturation (nr: not provided) low, and weight loss (nr: not provided) 5 pounds and she is down to 86 pounds. The patient was prescribed steroids and nebulizer treatment. The patient had low blood oxygen level. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, headache, chills, constant shortness of breath, low blood oxygen and weight loss was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210442930-covid-19 vaccine ad26.cov2.s -Constant shortness of breath/low blood oxygen/weight loss. 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).

INCREASED BLOOD PRESSURE; SEVERE BURSITIS; TIREDNESS; BLURRY VISION; NUMBNESS ON LEFT SIDE OF FACE AND NECK; SWELLING ON INSIDE OF MOUTH; ANXIETY; FEELING WIRED; NAUSEA; This spontaneous report received from a patient concerned a 77 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergies, and migraine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: JJ1805029, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced blurry vision. On 08-APR-2021, the subject experienced numbness on left side of face and neck. On 08-APR-2021, the subject experienced swelling on inside of mouth. On 08-APR-2021, the subject experienced anxiety. On 08-APR-2021, the subject experienced feeling wired. On 08-APR-2021, the subject experienced nausea. On 09-APR-2021, the subject experienced tiredness. On 25-APR-2021, the subject experienced increased blood pressure. On 25-APR-2021, the subject experienced severe bursitis (arm felt as bugs biting the arm). Laboratory data included: Diagnostic ultrasound (NR: not provided) diagnosed with a severe case of bursitis (units unspecified), EKG (NR: not provided) diagnosed with a severe case of bursitis (units unspecified), and X-ray (NR: not provided) diagnosed with a severe case of bursitis (units unspecified). Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blurry vision, increased blood pressure, and nausea on APR-2021, and tiredness on 11-APR-2021, had not recovered from numbness on left side of face and neck, and swelling on inside of mouth, and the outcome of severe bursitis (arm felt as bugs biting the arm), anxiety and feeling wired was not reported. This report was non-serious.; Sender's Comments: Medical assessment comment not required as per standard operating procedure as the case is assessed as Non-serious

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

My mother reported feeling numbness/tingling in her left fingers/hand on the drive home approximately 30 minutes after receiving the vaccine. She wanted to go straight home. When we got home she reported that the numbness had been felt in her head and tongue and it was a very weird feeling. She was numb on her entire left side. It seemed to resolve after a while. She is still very tired and has a low heart rate, but normal blood oxygenation. There is no visible swelling or reaction at the vaccine site. She still has some slight numbness on the left side. She may call the doctor tomorrow if there is still some concern.

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.

During observation period after COVID vaccine administration, client reported chest pain/pressure 7/10. EMS called. Client escorted to isolated area, mask removed and vital signs taken. Client was alert and oriented x3, no difficulties speaking or answering questions. Neuro check and vitals taken until EMS on site. Emergency Care Flow completed. Client was transported to near by hospital by EMS due to unstable/high blood pressure. Vital signs reported by EMS before transport: BP 210/92, HR 87, Respirations 16, O2 sat 97%, blood sugar 78.

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.

78 year old woman admitted with severe back pain, inability to ambulate and leukocytosis on 3/31/21. History of hypertension, CHF, obesity, chronic kidney disease, and back pain. Work up included multiple consults. The patient was placed on SQ heparin for VTE prophylaxis. Acute L5 fracture was found along with emphysematous changes. Neurosurgical evaluation- no surgery was necessary. During the first 24 hours (before receiving the vaccine), the patient's Hg dropped 9.3 to 6.8 and platelets dropped 130K to 61 K with no apparent bleeding source. PRBC transfusion was given. GI consult was obtained the patient was scheduled to have EGD the following morning (day 3). Cardiology was obtained for elevated troponin and hypoxia. An echo obtained on day 2 showed moderate elevated pulmonary artery pressure, mild to moderate tricuspid regurgitation, and normal sized right atrium and ventricle. The patient received the Janssen vaccine upon request the morning of hospital day 2 (4.1.21 at 11:02). At 11:37PM on 4/1/21 the patient received 5mg IV metoprolol for elevated HR of 132 (BP 129/67). At 0128 on 4/2/21 the patient's heart rate dropped into the 60's and then declined further requiring cardiac resuscitation. The attempt was unsuccessful and the patient expired at 01:43 on 4/2/21. An autopsy was conducted (results available on 4/13/21) showed a 4 cm clot in the patient's right atrium and a mural thrombus in her femoral artery.

with several days of receiving the shot the following symptoms occurred: severe headache backache severe pain in your abdomen or stomach pain in your chest leg pains joint pains shortness of breath

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

FULLNESS; OXYGEN LEVEL NOT GREAT; TROUBLE BREATHING; NOT SLEEPING WELL; FELT WORSE; RASPING; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included copd, cigarette smoking, thyroid disorder, hip replacement, brain tumor, high cholesterol, alcohol user, dry mouth, anaphylactic reaction from carboplatin, drugged feeling like floating at full strength, and exhaustion, and other pre-existing medical conditions included no thyroid but takes thyroid replacement. The patient experienced drug allergy when treated with moxifloxacin hydrochloride for drug use for unknown indication, and drug allergy when treated with venlafaxine hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 at right arm for prophylactic vaccination. Concomitant medications included salbutamol for copd. On MAR-2021, the subject experienced rasping. On 10-MAR-2021, the subject experienced trouble breathing. On 10-MAR-2021, the subject experienced not sleeping well. On 10-MAR-2021, the subject experienced felt worse. On 15-MAR-2021, the subject experienced oxygen level not great. Laboratory data included: Chest X-ray (NR: not provided) clear, and Oxygen saturation decreased (NR: not provided) not great. Treatment medications included: erythromycin, and fluticasone propionate. On an unspecified date, the subject experienced fullness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from trouble breathing on 18-MAR-2021, and not sleeping well, felt worse, and rasping on 15-MAR-2021, and the outcome of fullness and oxygen level not great was not reported. This report was non-serious.

Sores in mouth and within 3 days it traveled to throat and esophagus. She had trouble eating and elevated blood pressure. She now suffers from severe memory loss.

BAD CHEST PAINS, PAIN IN CENTER OF CHEST; FEELING OF HEART NOT BEATING RIGHT; BLOOD PRESSURE OF 212; CELLULITIS IN HER WRIST; This spontaneous report received from a patient concerned a 78 year old female patient. The patient's height was 166 inches and weight was 138 pounds. The patient's concurrent conditions included white coat hypertension, asthma, severe allergy to codeine, abstain from alcohol, and non-smoker. The patient was not pregnant. The patient received vaccination with covid-19 vaccine ad26.cov2. s (suspension for injection, intramuscular, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 09:00 in left arm as prophylactic vaccination. Concomitant medications included estradiol. The patient reported that about 15-20 minutes post-vaccination on 02-APR-2021 as she was waiting in waiting area of vaccination clinic, she started to get bad chest pain which was in the center of her chest. She experienced heavy pressure in her chest. No arm pain or sensation was reported other than her chest. The patient further explained that she could feel that her heart 'wasn't beating right' and reported as 'heart feeling wonky'. The patient felt the top of her heart beating faster than the bottom. The vaccination paramedic took her blood pressure which was 212 (patient did not have any other information on her blood pressure). The paramedics called ambulance and after a 15 minute drive patient arrived at emergency room at 9.30. The patient had an echocardiogram or 'an ultrasound' of her heart and was told that it was not functioning properly that her ventricle was functioning at 40% of normal. The patient was put on nitroglycerin and heparin drip. Blood test was also done which showed troponin levels at 113 or 116, 'somewhere in there'. The patient was told that 'some type of cardiac event had occurred'. The patient's tests were reviewed same night and patient spent the night in emergency room because there were no beds. On 03-APR-2021, the patient was transferred to a hospital where she was put on nitroglycerin and heparin drip. The patient was moved again to another hospital on night of 04-APR-2021. The patient had angiogram and CT of vein and arteries. No clot was found by that time. The patient was discharged on 06-APR-2021. The patient saw a cardiologist on 15-APR-2021 who told patient that 'he thought she had some kind of clot that dissolved in the hospital'. Since patient has been home, she experienced pain and discomfort in arm and wrist with cellulitis in her wrist. The patient was taking cephalexin 500 mg three times a day for 10 days. The patient said it was due to angiogram she had because the angiogram team had hard time with her angiogram and had to go in twice. The patient had been taking percocet 5 mg tablet as needed for pain. The patient attempted to report these events online and left a message for someone to call her back but email did not work as she was unable to send. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bad chest pains, pain in center of chest, feeling of heart not beating right and blood pressure of 212, and cellulitis in her wrist was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: This 78-year-old white (non-Hispanic/Latino) female patient was hospitalized for chest pain, palpitations, and blood pressure of 212 within the hour of receiving COVID-19 VACCINE AD26.COV2.S for the prevention of symptomatic SARS-CoV-2 virus infection. Concurrent illness included white coat hypertension, asthma, severe allergy to codeine; denies smoking and have abstained from alcohol. The patient complained of "bad chest pain" described as heavy pressure on the chest and that she could feel her "heart was not beating right/heart feeling wonky/top of her heart beating faster than the bottom". Blood pressure was 212 when it was checked, the patient was transported to the emergency room where echocardiogram showed that her ventricle was functioning at 40% of normal; Troponin was 113 (or 116). The patient was started on nitroglycerin and heparin drip. CT Angiogram of veins and arteries done 2 days after the vaccination showed no clot; by the attending cardiologist thought that some kind of clot might have been dissolved. Due to difficulty of doing the angiogram, the patient had cellulitis in her wrist with pain and discomfort in arm and wrist; the patient was taking cephalexin and percocet for the cellulitis and pain. No other details reported. The short latency and the advanced age confounded the event. The information available precludes a complete and meaningful assessment. However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded. Additional information was requested.

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.

Pt found down on 5/7 for unknown period of time. Prodromal dizziness reported, but no additional history or witnesses until pt found down. At ER presentation, noted CHI with subdural hematoma and intracranial hemorrhage. Also noted left cortical vein thrombosis. Follow-up imaging after 24 hours demonstrated persistence of above findings. Pt had concomitant humerus fracture and medical instability after being found down. Now stable but below baseline in rehab facility.

SEVERE CHILLS; FEELING WEAK; NAUSEA; VOMITING; EXCRUCIATING TIGHTNESS BETWEEN HER UPPER CHEST RADIATING AROUND TO BILATERAL SHOULDER BLADES AND BACK; MUSCLE SPASM; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included type 2 diabetic - diet controlled, arthritis, high cholesterol, penicillin antibiotics allergy, and sulfa antibiotics allergy. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 28-MAY-2021, the subject experienced vomiting. On 28-MAY-2021, the subject experienced excruciating tightness between her upper chest radiating around to bilateral shoulder blades and back. On 28-MAY-2021, the subject experienced muscle spasm. On 28-MAY-2021, the subject experienced nausea. Laboratory data included: Pain scale (NR: not provided) 10/10. On 29-MAY-2021, the subject experienced severe chills. On 29-MAY-2021, the subject experienced feeling weak. Treatment medications (dates unspecified) included: acetylsalicylic acid, and loperamide hydrochloride. The action taken with covid-19 vaccine was not applicable. The patient recovered from excruciating tightness between her upper chest radiating around to bilateral shoulder blades and back, muscle spasm, severe chills, and feeling weak on 29-MAY-2021, and nausea on 28-MAY-2021, and the outcome of vomiting was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case is assessed as non-serious.

BLOOD PRESSURE FLUCTUATING; RIGHT EYE VISION BLURRINESS; BLOOD PRESSURE DROPPED; RASH ON LEGS, BACK, AND IN PLACES; SWELLING AT SITE OF INJECTION; HIVES; SORENESS AT SITE OF INJECTION; ITCHING ALL OVER BODY; IRREGULAR HEART BEAT; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high risk heart patient, stage 3 kidney patient, penicillin allergy, all different kinds of erythro allergy and allergic to 37 different types of medications (unspecified), non alcoholic, and non-smoker, and other pre-existing medical conditions included she had no history of drug abuse or illicit drug usage. The patient experienced drug allergy when treated with codeine for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 14-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-JUL-2021, the subject experienced itching all over body. On 14-JUL-2021, the subject experienced irregular heart beat. On 14-JUL-2021, the subject experienced right eye vision blurriness. On 14-JUL-2021, the subject experienced blood pressure dropped. On 14-JUL-2021, the subject experienced rash on legs, back, and in places. On 14-JUL-2021, the subject experienced swelling at site of injection. On 14-JUL-2021, the subject experienced hives. On 14-JUL-2021, the subject experienced soreness at site of injection. Laboratory data included: Blood pressure (NR: not provided) dropped. On 15-JUL-2021, the subject experienced blood pressure fluctuating. Laboratory data included: Blood pressure (NR: not provided) fluctuating, and Systolic blood pressure (NR: not provided) went down below 100. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on legs, back, and in places, itching all over body, right eye vision blurriness, swelling at site of injection, hives, soreness at site of injection, and irregular heart beat, and the outcome of blood pressure dropped and blood pressure fluctuating was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as the case assessed as non-serious.

79 y.o. female who presents to ED on 3/16/2021 with body aches, headache and nausea/vomiting. Patient's daughter reports patient received the Johnson & Johnson single-dose Covid vaccine 4 days ago (on 03/13/2021 at about 3 PM.) prior to ED visit. The next morning woke up not feeling well. Has had generalized body aches and headache. Has also had nausea and vomiting. Patient is able to tolerate some fluids, but anytime eats anything will vomit. Reports has had some loose stools. Denies blood in the stool or vomit. Reports aching pain to the abdomen, not worse in any particular area. Has pain to the right side of the chest that has been constant for the last 3 days. Chest pain is worse with movement and standing, but not worse with exertion. Denies difficulty breathing, cough, fever, sore throat or congestion.

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.

EXTREME DIZZINESS; HIGH BLOOD PRESSURE; VOMITED 3 TIMES; FOUR BOWEL MOVEMENTS; HYPERGLYCEMIA; NAUSEA; This spontaneous report received from a patient concerned a 79 year old female. The patient's weight was 65.5 kilograms, and height was 157.48 centimeters. The patient's concurrent conditions included high blood pressure, elevated cholesterol, non-smoker, alcohol user, hyperlipidemia, and hypertension, and other pre-existing medical conditions included patient had no drug abuse. The patient was previously treated with codeine, and acetylsalicylic acid. 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 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included nebivolol hydrochloride for high blood pressure. On 13-MAR-2021, the subject experienced extreme dizziness. On 13-MAR-2021, the subject experienced high blood pressure. On 13-MAR-2021, the subject experienced vomited 3 times. On 13-MAR-2021, the subject experienced four bowel movements. On 13-MAR-2021, the subject experienced hyperglycemia. On 13-MAR-2021, the subject experienced nausea. Laboratory data included: Alanine aminotransferase (NR: not provided) 52 IU/L, Alkaline phosphatase (NR: not provided) 80 IU/L, Aspartate aminotransferase (NR: not provided) 42 IU/L, Bilirubin total (NR: not provided) 1.2 mg/dL, Blood test (NR: not provided) Normal, Body temperature (NR: not provided) 34.4 F, Brain natriuretic peptide (NR: not provided) 34 pg/mL, Chest X-ray (NR: not provided) Normal, Diastolic blood pressure (NR: not provided) 99, 88, 68, 59, 43, 67, 57 mmHg, Heart rate (NR: not provided) 70bpm, 65 bpm, High sensitive troponin I (NR: not provided) <0.003 ng/mL, Oxygen saturation (NR: not provided) 92, 91, 93, 91 %, Respiratory rate (NR: not provided), Systolic blood pressure (NR: not provided) 250, 160, 130, 96, 103, 150, 130 mmHg, and Urinalysis (NR: not provided) Normal. On 13-MAR-2021 11:38, Laboratory data included: Pulse rate (NR: not provided) 62 pm. Treatment medications (dates unspecified) included: hydrochlorothiazide/triamterene, valsartan, omega-3 triglycerides, oyster shell, diclofenac, celecoxib, potassium chloride, ubidecarenone, xantofyl/zeaxanthin, simvastatin, and ascorbic acid/betacarotene/biotin/calcium/chlorine/chromium/copper/cyanocobalamin/dl-alpha tocopheryl acetate/folic acid/iodine/magnesium/manganese/molybdenum/nickel/nicotinamide/pantothenic acid/phosphorus/phytomenadione/potassium/pyridoxine hydrochloride/retinol/riboflavin/selenium/silicon/thiamine/vanadium/vitamin d nos/xantofyl/zinc. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extreme dizziness, high blood pressure, vomited 3 times, and nausea on 16-MAR-2021, and the outcome of four bowel movements and hyperglycemia was not reported. This report was non-serious.

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.

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.

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).

30 min after vaccination patient felt nausea and started vomiting, chest tightness, trouble breathing, "funky" feeling at chest, sudden movements cause dizziness . pt notified us on 05/11 and symptoms have resolved, pt instructed to monitor for continue symptoms especially related to chest symptoms tightness, SOB, etc and to go to ER if symptoms arose again

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).

Patient became asphasic and was unable to keep her eyes open approximately 5 minutes after injection. Placed on stretcher, vital signs stable. Epi pen injected into her left thigh. Started to complain of chest pressure approximately 25 minutes after epi, ambulance called. Triaged by EMS and taken to ER

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.

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.

headache which started 3 days after and has increased in severity, associated with increase in blood pressure

HYPERTENSIVE CRISIS (HIGH BLOOD PRESSURE); DIVERTICULITIS; BOWEL IMPACTION; DIZZINESS; FEELING FATIGUE; BLOOD PRESSURE FALLS TOO LOW AT TIMES; SOME HEADACHES; SHORTNESS OF BREATH; SOME LEFT NECK PAIN; This spontaneous report received from a consumer (reported as daughter) concerned a 79 year old White and Not Hispanic or Latino female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included that she had no known allergies. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, and expiry: unknown) dose was not reported, frequency time was 1 total administered on right arm on 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-APR-2021 (reported as right away after vaccination), the patient started feeling bad which was further elaborated as feeling fatigue, shortness of breath, and had some left neck pain. On an unspecified date in MAY-2021 (reported as on or about 10-MAY-2021), the patient started experiencing some headaches. The patient went to see her doctor on 17- MAY-2021 for routine checkup and got to know that everything was fine, and her blood pressure was fine at this time. On 06-JUNE-2021, the patient was hospitalized with hypertensive crisis, diverticulitis, bowel impaction, dizziness, and fatigue. The patient was discharged from hospital on 11-JUNE-2021. On 28-JUNE-2021, the patient was hospitalized again for second time for high blood pressure, and she was put on 2 different blood pressure medications (unspecified) including a diuretic (reporter was unsure of the medication names/dosages). It was also reported that the patient feels fatigued at times now when her blood pressure falls too low (date unspecified). The results, units and normal ranges for blood pressure was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from some left neck pain, some headaches, and bowel impaction, and had not recovered from hypertensive crisis (high blood pressure), diverticulitis, shortness of breath, blood pressure falls too low at times, dizziness, and feeling fatigue. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210743176 - Covid-19 vaccine ad26.cov2.s - Hypertensive crisis, Diverticulitis, Bowel impaction, Dizziness. 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). 20210743176-Covid-19 vaccine ad26.cov2.s - Fatigue. This event(s) is labeled per RSI and is therefore considered potentially related.

INDIGESTION; FELT LIKE SHE SWALLOWED A ROCK AND IT IS IN HER CHEST; HAS NOT EATEN MUCH TODAY; CHILLS; HEADACHE; TEMPERATURE 101.6; This spontaneous report received from a patient concerned an 80 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 on right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 04-APR-2021, Laboratory data included: Body temperature (NR: not provided) 101.6 F. On 04-APR-2021 01:30, the subject experienced chills. On 04-APR-2021 01:30, the subject experienced headache. On 04-APR-2021 01:30, the subject experienced temperature 101.6. On 06-APR-2021, the subject experienced indigestion. On 06-APR-2021, the subject experienced felt like she swallowed a rock and it is in her chest. On 06-APR-2021, the subject experienced has not eaten much today. Laboratory data included: Blood pressure (NR: not provided) 136/81 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the temperature 101.6, chills, headache, indigestion, has not eaten much today and felt like she swallowed a rock and it is in her chest was not reported. This report was non-serious.

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.

COULD NOT MOVE AND WAS PARALYZED FOR 3 DAYS; HEART RACING; FOGGY; CHILLS; WEAKNESS/NOT HAVING THE STRENGTH; HIGH FEVER(NOT SPECIFIED); FATIGUE; This spontaneous report received from a consumer concerned an 80 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included ovarian cancer 4 years ago., hay fever, non alcohol user, and non-smoker, and other pre-existing medical conditions included patient did not have drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1865020, and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced could not move and was paralyzed for 3 days. On 19-MAR-2021, the subject experienced heart racing. On 19-MAR-2021, the subject experienced foggy. On 19-MAR-2021, the subject experienced chills. On 19-MAR-2021, the subject experienced weakness/not having the strength. On 19-MAR-2021, the subject experienced high fever (not specified). On 19-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not move and was paralyzed for 3 days on 22-MAR-2021, had not recovered from fatigue, foggy, high fever(not specified), and heart racing, and the outcome of chills and weakness/not having the strength was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.

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

Pt received vaccine on 4/8/2021. Pt was diagnosed with COVID-19 on 5/17/2021. Pt was admitted to the hospital on 5/21/2021 for pneumonia secondary to COVID-19.

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.

Approx 4:00pm ,Pt in for J&J vaccine, within minutes of receiving injection, pt?s husband said ?we need help? This writer saw pt begin to slide down in chair and eyes flutter, pt lost consciousness for approx 10 seconds, never completely came out of chair. Paramedics also responded with this writer to assist pt. Pt was assisted onto gurney and first set of v/s was taken, pt has become alert and aware of name/place/date/time. Negative history for meds or medical issues but states she did once pass out before from an injection and believes the thought of this particular vaccine made her nervous and she held her breath while getting vaccinated. 4:05pm bp=128/75, Pulse ox = 95%, R=16. Pt denies HA/dizziness/blurred vision/weakness/nausea. Remains alert . Water and Gatorade given to pt. 4:10pm P=78, pulse ox =95%, pt remains calm/alert/responsive/stable 4:15pm, assisted pt to sitting position, pt denies any adverse s/s. 4:20pm: BP= 134/78, P=78, Pulse ox =96%, R= 16. Assisted pt from sitting on gurney to sitting back onto chair that she started in, states she feels fine. 4:35 pm: pt is able to stand w/o assist, remains alert/aware, states she feels fine and is ready to go get her drink. Pt ambulated on her own to her car, accompanied by her husband and this writer. Pt left clinic in stable condition. Home care instructions given and advised on when she would need to seek further medical assistance. Pt and husband verbalize understanding of info given

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.

Pt was observed post vaccination complaining of dizziness & light headedness, pt brought to triage and attended by the doctor. Ekg was normal, pt sitting on gurney with pt's husband at bedside, EMS was also at bedside, pt was initially hypertensive, the rest of the vitals were normal, pt was give orange and apple juice, tolerated, observed further, vitals improved, pt denies any complaints and discharged. Pt wheeled off unit by nurse.

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.

PAIN UNDER RIBS; FINGERS NUMB ON LEFT HAND; BLOOD PRESSURE 177/79; PAIN UNDER ARM; LEFT ARM HURTING; PAIN FROM SHOULDER TO ELBOW; HEADACHE; This spontaneous report received from a patient concerned an 82 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. Concomitant medications included losartan. On MAY-2021, Laboratory data included: Blood pressure (NR: not provided) 177/79 mmHg. On 07-MAY-2021, the subject experienced headache. On 10-MAY-2021, the subject experienced pain under ribs. On 10-MAY-2021, the subject experienced fingers numb on left hand. On 10-MAY-2021, the subject experienced blood pressure 177/79. On 10-MAY-2021, the subject experienced pain under arm. On 10-MAY-2021, the subject experienced left arm hurting. On 10-MAY-2021, the subject experienced pain from shoulder to elbow. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, left arm hurting, pain under ribs, pain from shoulder to elbow, fingers numb on left hand, blood pressure 177/79, and pain under arm. This report was non-serious.

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.

5/21/21 - HEART RATE 33%, - 911 CALLED - BECAME DELUSIONAL, PATIENT WAS FULLY AWARE OF EVERYTHING - END RESULT PACEMAKER AND STILL DELUSIONAL. HOSPITAL STAY FRIDAY 5/21/21 - 5/27/21 NEVER HAD HEART RATE ISSUES PRIOR

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.

around 7pm I had had a cup of coffee and a brownie and I suddenly felt tight in the chest and abdomen. tums did not help but didnt resolve. the next day I still had issues and was light headed. It did go away eventually. I have a history of indigestion/gas issues.

ARRHYTHMIA; COMPLEX MIGRAINE; BP BOUNCING HIGH AND LOW; TROUBLE MOVING LEGS AND NO STRENGTH; TIRED; EXTREMELY WEAK; TEMPERATURE ELEVATED; ELEVATED BLOOD PRESSURE; TROUBLE WITH ARM HARDLY USE ARM; GROIN PAIN; MUSCLE ACHE; COULDN'T SLEEP; UNABLE TO WALK; This spontaneous report received from a patient concerned an 83 year old female. The patient's height, and weight were not reported. The patient's past medical history included bulbar polio diagnosed at age 15, and concurrent conditions included seasonal allergy, non-smoker, and high blood pressure. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination at right arm. No concomitant medications were reported. On 12-MAR-2021, Laboratory data included: SARS-CoV-2 rapid diagnostic test (NR: not provided) NEGATIVE. On 13-MAR-2021, the patient experienced temperature elevated. On 14-MAR-2021 (Sunday) and 15-MAR-2021 (Monday), she felt bad and had elevated blood pressure (BP) and temperature. On 16-MAR-2021 (Tuesday), she felt lot better but by afternoon, she experienced loss of sight in right saw round circle with black triangle and her BP was 130/111 (77- heart rate (HR)). She developed arrhythmias. Her daughter and husband took her to the hospital. The hospital staff was concern about stroke. Her magnetic resonance imaging (MRI) and two computerized axial tomography (CAT) scans, one with iodine was performed and confirmed that she did not had stroke. Her BP was bouncing around high and low. She had trouble in moving legs were not working no strength. At one point her heavy muscle couldn't move. She reported that her BP was erratic, she was conscious but not mentally functioning, which was hard to explain. She was sent back to do scan with iodine, as health care professional was concern with blockage. Later, her MRI was performed. She started getting better and on the same day she was released from hospital after about 7 -8 hours. After coming home, she felt tired. She was diagnosed with complex migraine. On 26-MAR-2021, she started having trouble with arm and leg and she could not sleep. On 27-MAR-2021, her last muscle ache. Her BP elevated again and can hardly use her right arm. On 28-MAR-2021, her left leg was not in shape, trouble using right arm, groin area muscle is giving out with sharp pains. Treatment medications (dates unspecified) included: amlodipine, acetylsalicylic acid, and metoprolol. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arrhythmia on 16-MAR-2021, and temperature elevated, and unable to walk, had not recovered from elevated blood pressure, trouble moving legs and no strength, complex migraine, muscle ache, groin pain, and BP bouncing high and low, and the outcome of extremely weak, trouble with arm hardly use arm, tired and couldn't sleep was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210353871-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Arrhythmia, Complex migraine, Temperature elevated, Trouble moving legs and no strength, Tired. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). V0: 20210353871-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Elevated Blood pressure, BP bouncing high and low. 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 of High blood pressure. V0: 20210353871-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Extremely Weak. This event(s) is labeled and is therefore considered potentially related.

fever, pancreatic pain, rapid heart rate and breathing. (pancreatic pain was the main symptom that resulted in the patient going to and staying overnight in the hospital)

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.

PER PATIENT, SHE EXPERIENCED HEADACHE AND HIGH BLOOD PRESSURE (182/85) AFTER 2 WEEKS FOR GETTING HER JANSSEN COVID 19 VACCINE. SHE SAW DR. FOR THESE SYMPTOMS. EVENTUALLY HER BLOOD PRESSUE CAME BACK TO BASELINE WITH CHANGE ON HER BLOOD PRESSURE THERAPY REGIMEN. MD WAS NOT SURE IF IT IS RELATED TO VACCINE

On the morning of admission, patient had another episode. She was sitting at the kitchen table and then slumped forward unconscious. She has no memory of the episode. Daughter is unsure how long she was unconscious for. She was taken to the ER via ambulance. Head CT in the ER showed only age-related changes. Chest x-ray showed an increase in infiltrate. Influenza test negative. Rapid COVID-19 test negative. Urinalysis only had 2+ leukocyte esterase. White count of 3.3. Cardiac enzymes negative. BNP normal. remains hospitalized at Hospital - inpatient

Patient received Moderna COVID vaccine at a health dept clinic in February and experienced blurred vision and 3 weeks of fever afterward. CDC consulted and the recommendation was to use Janssen COVID vaccine as second dose with monitoring for 30 minutes. Allergist agreed. After Janssen vaccine, patient was fine for first 28 minutes, then experienced blurred vision, light-headedness. At 10:10 patient became palor and lost consciousness. EpiPen given and patient immediately responded. EMS called and 50 mg IM diphenhydramine given. No SOB, wheezing, or CP. Positive for palpitations

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.

84 y.o. female with PMH of coronary artery disease with prior RCA stent in 2019, atrial fibrillation s/p pacemaker, type 2 DM with diabetic nephropathy, and CKD 4 who was admitted on 4/23/2021 with chest pressure radiating to the arm.

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).

had pink cheeks and tired, a week later woke up with chills and shivering, had heart palpitations, and tightness in upper chest

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 sitting in chair passed out sternal run performed lowered to floor sternal rub performed again responsive breathing shallow lost bowels pulse weak ammonia salts used and EMS called

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.

found my mother lying on the floor Monday morning covered in feces...she had been extremely tired after shot. Her Blood sugar was extremely elevated ...and she was dehydrated

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.

LOWER EXTREMITY SWELLING; TACHYCARDIA; INJECTION SITE PAIN; EDEMA; This spontaneous report received from a patient concerned an 85 year old female. The patient's weight was 113 pounds, and height was 62 inches. The patient's concurrent conditions included ulcerative colitis, okra allergies, non smoker, and nonalcohol user, and other pre-existing medical conditions included 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: Unk) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included infliximab for ulcerative colitis. On 2021, the subject experienced edema. On MAR-2021, Laboratory data included: Blood test (NR: not provided) not reported, and Stool analysis (NR: not provided) Abnormal high. On 18-MAR-2021, the subject experienced injection site pain. On 22-MAR-2021, the subject experienced tachycardia. On 01-APR-2021, the subject experienced lower extremity swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on 09-APR-2021, was recovering from tachycardia, and lower extremity swelling, and the outcome of edema was not reported. This report was non-serious.

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.

Patient is an 85-year-old female with a history of hypothyroidism, hypertension, and osteoarthritis who presented from home complaining of 4 days left shoulder pain that radiates into her left pectoral area. She states she was vaccinated with the Janssen Covid vaccine on 4/8/21 in her left shoulder and her pain started 4/23/21. She is not sure if these were related. It was initially intermittent, sharp, stabbing, however became fairly persistent. She has noted her blood pressure being elevated. On my evaluation her blood pressure is 185/64. Patient states she was recently started on lisinopril for hypertension. She has not taken her lisinopril yet today. Chest x-ray showed no obvious infiltrates. Clear lung fields. Normal cardiac dimensions. EKG shows sinus mechanism with normal axis, intervals, ST segments. Otherwise normal EKG. D dimer was elevated, and VQ scan was negative for PE. Patient was evaluated by Cardiology who recommended outpatient stress test. Echo showed LVEF 60-65%. Trace aortic valve regurgitation. Mild mitral regurgitation. Mild mitral leaflet calcification is visualized. Trace tricuspid regurgitation. The right ventricular systolic pressure is calculated at 28mmHg. Patient was found to have hyperlipidemia and was started on statin. Her pain resolved on the day of discharge. Her blood pressure was controlled with lisinopril and coreg. She is to follow up with Cardiology and her PCP.

J&J vaccine was administered to patient. Consent form states that patient will be receiving J&J vaccine today. Pt is confused per medical baseline. Notified facility nurse, RN that I will be given J&J to patient and was okay with giving. After vaccine was given a second facility nurse, RN confirmed that pt was supposed to received second dose of Pfizer vaccine today. Pt was closely monitored in area for 30 minutes, facility Dr was notified. No acute distress noted, vital sign stable, no reactions noted, no active bleeding noted during 30 minutes of observation. Pt was taken back to her room and 15 minutes after observation at around 09:35AM, facility staff notified pt was desatting, was placed on oxygen and ambulance was called and taken to emergency room.

PALPITATIONS COMMENCED ABOUT ONE WEEK; SWELLING 'TO ALL OVER BODY' LASTED FOR 2 WEEKS; HURTING ALL OVER BODY; PAINFUL RIGHT SHOULDER; PAIN TO LEFT ARM AT INJECTION SITE; This spontaneous report received from a patient concerned an 85 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included ulcerative colitis, non-alcohol user, non smoker, pain to right shoulder, and type 2 diabetes mellitus, and other pre-existing medical conditions included the patient had no known allergies. the patient had no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 01805018 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. Concomitant medications included lisinopril for cardiac, atorvastatin for cholesterol management, infliximab for ulcerative colitis, and mesalazine for ulcerative colitis. On 18-MAR-2021, the subject experienced pain to left arm at injection site. On 21-MAR-2021, the subject experienced palpitations commenced about one week. On 21-MAR-2021, the subject experienced swelling 'to all over body' lasted for 2 weeks. On 21-MAR-2021, the subject experienced hurting all over body. On 21-MAR-2021, the subject experienced painful right shoulder. On 19-APR-2021, Laboratory data included: EKG (NR: not provided) Normal. On 05-JUL-2021, Laboratory data included: X-ray (NR: not provided) Normal shoulder xray. Laboratory data (dates unspecified) included: ECG (NR: not provided) Normal. Treatment medications (dates unspecified) included: diclofenac. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from palpitations commenced about one week, and swelling 'to all over body' lasted for 2 weeks on 14-MAY-2021, hurting all over body on 16-MAY-2021, and pain to left arm at injection site on 21-MAR-2021, and had not recovered from painful right shoulder. This report was non-serious.

FELT INCOHERENT; SHINGLES RASH; COLLAPSED DUE TO DIZZINESS, COULDN'T STAY UP; BODY ACHE; SORE THROAT; MUSCLE ACHE; FATIGUE; HEADACHE; 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 steroid allergy, shellfish allergy, and allergic to x ray dyes. The patient received JNJ78436735 (Ad26.COV2.S) (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 09:30 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the patient experienced fatigue and headache. On 14-MAR-2021, the patient experienced body ache, sore throat, muscle ache and collapsed due to dizziness as couldn't stay up. On 16-MAR-2021, the patient experienced shingles rash. On an unspecified date, the patient felt incoherent. The action taken with JNJ78436735 (Ad26.COV2.S) was not applicable. The patient had not recovered from fatigue, sore throat, headache, muscle ache, shingles rash, collapsed due to dizziness, couldn't stay up, and body ache whereas the outcome of felt incoherent was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210332591-Covid-19 Vaccine AD26.COV2.S-collapsed due to dizziness, couldn't stay up. 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.

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

86-year-old spanish speaking female brought into the ED with concerns of slurred speech and confusion that was noted at 3 PM on 4/8. Patient's last known well was at 10 AM on 4/8. GCS on arrival 15. NIH SS 2 recorded at 18: 12 (for mild right-sided facial droop and mild dysarthria). In the EMS blood glucose was 122, no meds were given. Patient is not on any anticoagulation. Patient's blood pressure was elevated at 233/78. Patient denying any headaches, nausea, vomiting. Per the family no focal neurologic deficits noted except for dysarthria which was improved during the ED visit. Neurology contacted in the ED for stroke code. Patient outside of TPA window. CT head was negative. CT head negative for acute intracranial infarction. Chest x-ray negative for any acute cardiopulmonary findings. Patient was started on nicardipine drip in the ED with the blood pressure reduced to 145/70, then turned off. CBC showed mild leukocytosis (14.8) likely reactive. CMP unremarkable. PT/INR was also obtained. After discussion with neurology given the CT head and CTA head and neck, CTP negative are reassuring for low concern of stroke. ASA 325 once was given. However neurology does recommend an admission for further evaluation with an MRI for notably rule out stroke. After discussion with family and the physicians the patient refused admission. Upon reexamination no further worsening of her initial symptoms, blood pressure controlled. Patient was discharged in a stable condition. She was discharged AMA. Patient was thoroughly explained the risks and benefits of leaving AMA. Patient said she understood and was advised to come back if the symptoms worsen. Patient was discharged with aspirin, Plavix and atorvastatin. Recommended to follow-up with the PCP tomorrow soon as possible. Also advised to return to the ED if any of the symptoms return.

COUGH; CHEST HEAVINESS; VACCINE HURT GOING IN; 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 past medical history included allergy shots, and concurrent conditions included bronchitis in oak and cedar season, and allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medications included fexofenadine hydrochloride for allergy. On 08-APR-2021, the subject experienced cough. On 08-APR-2021, the subject experienced chest heaviness. On 08-APR-2021, the subject experienced vaccine hurt going in. Treatment medications (dates unspecified) included: guaifenesin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from cough, had not recovered from chest heaviness, and the outcome of vaccine hurt going in was not reported. This report was non-serious.

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.

Patient presented to hospital on 3/11 with shortness of breath. History of chronic oxygen dependency at night. Became more sob over last several days and was not able to make it to md appointment. Had a recent abnormal stress test. Family states she was febrile at home. Was low on oxygen level on 2LNC, placed on non-rebreather and then BIPAP. Positive for Rhinovirus. Chest xray showed bilateral lower infiltrates. Patient detiorated through the night and was intubated and placed on vasopressors for septic shock. Patient was made DNR and family refused hemodialysis. Family then made decision to withdraw care.

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 was admitted to the hospital 12 days (3/24/21) after vaccine dose administration (3/12/21) sent in for refractory abdominal pain, nausea and vomiting. On admission, a CT Abdomen/Pelvis with contrast was largely unremarkable including reported demonstration of patent portal vein. During the course of the hospitalization the patient developed a portal vein thrombosis visualized on 3/26 by ultrasound. She also received Heparin SQ from 3/27/21 through 4/2/21 but not sent home on anticoagulation. Her course was also complicated by a seizure and Bacteroides bacteremia. MR Brain did not demonstrate thrombosis

new onset headache (3d post vaccination) no history of similar headaches. increased word finding difficulty (nondense aphasia), decreased alertness/malaise, chest pain

Hallucination, shortness of breath, dizziness, weakness, leg edema and low oxygen level. Patient sent to hospital for evaluation and treatment.

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.

Systemic: Chills-Mild, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Nausea-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Visual Changes/Disturbances-Severe, Systemic: Vomiting-Mild, Systemic: Weakness-Severe, Additional Details: shot 4:23pm, pt complained of seeing stars, being nausous, weak, was going in and out of concsiousness for 30 -45 seconds. Had patient elevate legs a while seated and took bp at 4:30pm was115/36 pulse 52. pt tried to vomit but nothing came up.Took 2nd bp at 4:44pm 137/91 pulse 75. Moved patient inside pharmacy had her lay down flat with legs elevated for 8 minutes. complained of tingliness in both arms up to elbows. 3rd bp at 4:50pm was 127/80 pulse 65, 4th bp 125/82 pulse 77, left at 5pm

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.

Patient received J&J covid injection 4/1/21. From 4/1-4/7 patient felt very fatigued/lethargic. 4/10-4/13 patient was having intense stomach pains and an intense headache, she felt off and states it was like nothing she's felt before. She thought she was going to have a stroke. Pt took her B/P on 4/11 it was 182/104, pt took an Aspirin and a half. An hour later it came down to 133/90. Pt states she wasn't thinking straight, she went to sleep. 5 lb recent weight loss d/t loss of appetite from not feeling well, 4/9 172 lbs, 4/13 167 lbs

Fasting Blood sugar increased from 100 to 150 and stayed elevated for 2 weeks. Felt weak and lost balance.

On 3/24/21, pain in right leg. On 3/30/21, pulse dropped to 37 and she passed out and was unable to recover, so called 911

4/12 3pm patient went to get up from recliner, body was very stiff and had severe muscle spasms and cramps from back, stomach, pelvis, thighs and legs down to feet. Legs swollen (enlarged veins) patient said. Patient slumped over and went down to floor. crawled to bathroom and applied Hemp Vana every few hours until some relief. 4/13 moring took 2 tylenol -muscles from hips down burning, stinging and sore. Called doctors. 4/14 patient continued applying Hemp Vana but then switch to Arnicare pain relief. Patient mentioned diarrhea and nausea with headache(she did not mention before) seemed little better(on and off) 4/16 up at 8am diarrhea and throwing up -muscles very sore -spent day exhausted and resting 4/17 patient used warm wet towels and arnicare. 4/18 diarrhea and nausea stopped 4/19 muscles beginning to relax. leg and thigh swelling going down 4/20 Saw dermatologist for other issue. He lower back and thighs and recommended patient to see ultrasound vascular surgeon for pelvic ingestion syndrome and recommended doctor.

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

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.