Johnson & Johnson

PATIENT RECEIVED THE VACCINE, AND WILL SITTING IN THE RECOVERY ROOM, FELT HOT, DIZZY AND SWEATY AS WELL AS OBTUNDED. BP 90/42, HR 55 SAT 97 RR12 DIAPHORETIC, AROUSABLE, COHERENT CV PULSE DIFFICULT TO PALPATE, BRADYCARDIC PHYSICAL EXAM OTHERWISE UNREMARKABLE PLACED ON STRETCHER. MENTAL STATUS IMPROVED. VS 115/97, 75, 12, SAT 98 TRASNFERRED TO EMERGENCY ROOM FOR EVALUATION

Substantial rise in blood pressure to 205/110. This was recorded 20 minutes after injection. The dizziness associated with the high blood pressure started within 5 minutes of the injection.

Received COVID-19 Vaccine on 03/08/2021. About 7:00 am the next morning began having N/V x4 past 12 hrs, diarrhea x 6, headache and blood in urine. Chronic illness of stage 4 kidney disease with bilateral nephrostomy and acute bloody discharge, ulcerative colitis with colostomy and acute high output, CAD with 7 cardiac stents and 2 CABG. A&Ox4, Malaise, tachycardia and hypotension, afebrile. Patient reports chronic abdominal pain unchanged today. Denies back pain, chest pain, cough, or SHOB. Afebrile. Patient has new diagnosis of UTI. IV fluids administered, IV Zofran, Meropenem, and po Hydrocodone/APAP. Transferred due to creatinine of 4.3, bloody urine, and UTI. T: 98.1 HR 91, R-14 BP 106/71, O2 sat 97%

Patient became hypoxic with chest pain. Wheezing noted throughout lung fields. SPO2 80% on room air. Tachycardic 115 with decreased level of consciousness. Admitted to hospital with diagnosis of COPD exacerbation with Hyperkalemia (6.2). Currently stabilized on O2 at 3l/m

PATIENT WAS CALLED BY OUR PHARMACY TO CHECK IF PATIENT WAS OK AFTER ADMINSTERING THE VACCINE. PATIENT REPORTED HE WENT TO THE EMERGENCY ROOM THE EVENING AFTER HE GOT THE SHOT. HE REPORTED A HEART RATE OF OVER 120. HE STATED THAT HE FELT HIS HEART RACING AND DECIDED TO GO TO THE EMERGENCYROOM AND WAS OK AFTER THAT. THE PATIENT DID NOT TELL HIM WHAT HE WAS TREATED WITH.

Felt poorly with myalgia, weakness and chills on first day after vaccine that did not resolve. Developed severe shortness of breath and chest pain on day 9 after vaccine and found to be in atrial flutter with rate of 160 on day 10 after vaccine. Has long ho diabetes, but no cardiac history.

Roughly a week following vaccination he cut his hand and was unable to stop the bleeding. 2 days later he developed mucosal lesions inside his mouth which began to bleed without resolution. He also cut himself shaving with prolonged bleeding. Following this event his rehabilitation center performed a CBC and he was found to be profoundly thrombocytopenic with platelets of 7. He presented to hospital where he was transfused with platelets which did not resolve his thrombocytopenia. He was transfused 2 more units with immediate CBC followup which did not improve his platelets; this was very suggestive of a consumptive process. Hematology was consulted and per their recommendations steroids were started. After initiation of systemic IV medrol platelet count began to rise. Per our hematology team, most likely culprit is the COVID vaccine. Patient had no medication changes, had been stable in his chronic conditions, and had never had any autoimmune or thrombocytopenic event before this time.

COVID infection post vaccination 1 day following vaccination, patient experienced fatigue, myalgia and low grade fever. RA test positive. That evening, patient with increasing SOB and increasing oxygen requirement and was admitted for hypoxia + LE swelling. Although SNF where vaccination took place denied symptoms at time of vaccination, per H&P, increasing oxygen requirements were noted 3 days prior to vaccination. See H&P below He is currently residing in a rehab facility following a hospitalization detailed below, but essentially he noted some shortness of breath about 4-5 days ago. They checked his oxygen saturation and noted that he was hypoxic, so started him on oxygen (reportedly 4L NC?). He reports a worsened productive cough; sputum is dark but not bloody in color. He has been fatigued and chilled; he thinks he's been intermittently febrile. No nausea, vomiting, or constipation. He endorses twice daily diarrhea, but he associates this with his bowel regimen. He also has a fair amount of lower extremity swelling which is bothersome to him; he says this has been ongoing since his MVA in January.[KE.4] He was recently seen in Nephrology clinic, where he was started on lasix 40mg daily and started on a low sodium diet[KE.3]. He is unsure if the lasix is helping his swelling, but does have robust urine output after he takes it

"Client received Johnson & Johnson vaccine on 3/19/21 and started with symptoms on 3/21/21, he assumed it was a reaction to the vaccine." Client admitted to Hospital on 3/29/2021. Per hospital 3/30/2021: Presented to the ER with SOB and low oxygen saturations that started on 3/30. The patient did not have any complaints of shortness of breath up until that morning. He received the Johnson & Johnson vaccine on 19 March, then developed fevers, fatigue the Wednesday after his vaccine and tested positive for Covid on March 26. Patient does complain of fevers of 103 at home. He resides at home with his wife who is also sick with Covid. He was admitted with Covid pneumonia and new oxygen needs. Tested positive on 3/26.

RAPID HEARTBEAT; INJECTION SITE SWELLING; This spontaneous report received from a patient concerned a 60 year old male. The patient's weight was 165 pounds, and height was not reported. The patient's pre-existing medical conditions included the patient had no known allergies illness at the time of vaccination: no past history of similar event? no pre-existing acute illness 30 days prior to vaccination? no family history of any disease (relevant to vaccination) or allergy? no. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced rapid heartbeat. On 20-MAR-2021, the subject experienced injection site swelling. Laboratory data included: Heart rate (NR: not provided) 100 beats per min. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site swelling, and rapid heartbeat. This report was non-serious. Additional information received from patient on 31-march-2021 The following information was updated and incorporated into the case: patient weight added.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious

Patient informed us of previous reaction (fainting) to tetanus vaccine. Covid vaccine was administered and patient remained seated for precaution. Patient fainted and was moved to the floor in a lying position. EMS was called. Pharmacist took patient's blood pressure (148/94). Patient was able to answer questions correctly when asked. EMS arrived and checked patient's vitals. Patient declined EMS transport. Patient left to go home with wife and daughter. Pharmacist called daughter at 6pm to check on patient. Patient had a headache at that time. Will follow up with patient today.

CHEST HEAVINESS; BODY ACHE; FEVER; CHILLS; FATIGUE; This spontaneous report received from a consumer concerned a 60 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic type 2, hypertension, hyperlipidemia, and social alcohol drinker, and other pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 11:00 for prophylactic vaccination on left arm. Concomitant medications included acetylsalicylic acid for drug used for unknown indication, ascorbic acid for drug used for unknown indication, ergocalciferol for drug used for unknown indication, losartan for drug used for unknown indication, atorvastatin, empagliflozin, fish oil, and metformin. On 03-APR-2021, the subject experienced body ache. On 03-APR-2021, the subject experienced fever. On 03-APR-2021, the subject experienced chills. On 03-APR-2021, the subject experienced fatigue. On 04-APR-2021, treatment medications included: paracetamol. On 05-APR-2021, the subject experienced chest heaviness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body ache, chills, and fatigue, and had not recovered from fever, and chest heaviness. This report was non-serious.

Approximately five minutes after vaccination patient began to appear sleepy while in observation area. I walk over to the patient and by the time I got to him the patient was unresponsive. His body was rigid and breaths were erratic. He regained consciousness after about a minute or so and appeared to be alert. EMT's then arrived and took over.

Patient has a long-standing history of cardiac issues (pulmonary hypertension and rheumatic mitral stenosis). He presented for follow-up in CT surgery clinic 4/5/2021. At that time referred to ED for new onset atrial flutter, hypoxia, and hypotension. Admitted to ICU. Platelet counts normal on admission. Patient started on heparin. 4/10/2021 platelet count dropped to low 60K and remained in this range. Differential diagnosis is heparin induced thrombocytopenia versus vaccine adverse event.

Immediately after giving the vaccine, the patient started sweating profusely and stated he had trouble breathing. He proceeded to pass out. The patient woke up within 30 seconds without the administration of an Epipen and was fairly alert. He continued to sweat and when EMS arrived he was reported to have a pulse of 54. BP was not reported

3/31/2021: 6-7 HOURS S/P VACCINATION: HEADACHE, FEVER, COLD CHILLS, SWEATING, AND DRY HEAVES 3/31/2021-4/1/2021: UP AND DOWN ALL NIGHT, DIARRHEA, BODY ACHES, STOMACH ACHE, HEADACHE, DRY HEAVES 4/1/2021-4/4/2021: ABOVE SYMPTOMS CONTINUED . 4/4/2021: STARTED HAVING CHEST PAIN AND WENT TO MEDICAL CENTER - ER . WAS ADMITTED TO HOSPITAL FOR TREATMENT OF A-FIB. 4/8/2021: DEVELOPED A RASH ON BACK.

Patient began experiencing back pain on March 14 and on or around March 18 he started coughing up blood clots according to a coworker. Patient lived alone and was unable to be reached on Sunday March 21. I went over to his house and found him deceased in his bed. Patient had a trashcan beside his bed and it appeared to have some blood in it. Patient had thick mucus coming out of his mouth and blood coming out of his nose. According to paramedics he had passed a few hours before finding him. Unfortunately Patient has been cremated so there is no way to say that this was related to the Covid 19 shot from Johnson and Johnson, however there are new reports that blood clots have been a side effect. I would like to speak with someone from the Department of Health to discuss this further. I feel this could be related to the vaccination and I would to know how long the Health Department knew about this possible side effect. If patient would have known sooner that the blood clots were a side effect I feel he would have gone to the Emergency Room. Patient had no health insurance and he was trying to prevent getting Covid. This has caused our family so much heartache and we are all very apprehensive about getting the Covid Vaccine ourselves. Please contact me as soon as possible, I am also patient's executor so I am able to speak to you on behalf of patient and our family. Thank you.

SWEATING REALLY BAD; WHOLE BODY HURTS; LIGHT HURTING EYES; HIGH ANXIETY; HEART RACING; FEELS LIKE SHIT; PAIN AT THE INJECTION SITE; HEAD WAS HURTING REALLY BAD; This spontaneous report received from a patient concerned a 60 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: 23/JUN/2021) dose was not reported, administered on 08-APR-2021 14:50 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced head was hurting really bad. Treatment medications included: ibuprofen. On 09-APR-2021, the subject experienced sweating really bad. On 09-APR-2021, the subject experienced whole body hurts. On 09-APR-2021, the subject experienced light hurting eyes. On 09-APR-2021, the subject experienced high anxiety. On 09-APR-2021, the subject experienced heart racing. On 09-APR-2021, the subject experienced feels like crap. On 09-APR-2021, the subject experienced pain at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from high anxiety, and heart racing, had not recovered from sweating really bad, whole body hurts, light hurting eyes, feels like crap, and pain at the injection site, and the outcome of head was hurting really bad was not reported. This report was non-serious.

On Thursday around noon, pt. had a headache, chest pains, numbness in left arm, the ER checked his heart rate and it was 215, they did blood work which came back normal & took more blood 4 hours later to check for heart damage, They admitted him to the hospital and did an EKG the next day that did not show any negative results (you'd have to get that from the hospital) They completed an Angiogram and found no blockage. Today, April 17th, I believe they did a cat scan of his lungs to check for blood clots and I am not sure of the results.

60 year old male died unexpectedly at home, found 04/11/2021. Last known contact was by phone with his brother on 04/10/2021. Cause of death was determined to be MI due to ASCVD due to tobacco dependence, cigarettes. Autopsy was not requested. This medical examiner was later contacted by the daughter of the decedent to report that he had received the Johnson & Johnson COVID vaccine on 04/08/2021, 2-3 days prior to his death.

Tues 4/13/21- Headache and dizziness started about 4p. Wed 4/14/21- Could not go to work because of headache and dizziness. Made appt for 4/15 at 6:45a with Dr Thur 4.15/21- Awoke with intense headache and dizziness. Ready to go to appt but emergency room called at 6:37 to switch to a Virtual appt. I never received a call so I walked to the office. They told me they would not see me as I had Covid 19 symptoms. Went to airport and received a Negative Covid test. Went o Clinic and was diagnosed with fluid in the ears and a sinus infection. Went to work and only stayed 2 hours. Drove myself to the emergency room with weakness, shortness of breath and intense pain under the sternum. Diagnosed with a blood clot in the right ventricle. The cardiac cath lab removed it. Was in intensive care Thur-Sat.

10 days after the shot, my blood pressure rose to 198/112 and my pulse went to 161. and i called 911 and went to hospital. i had a severe headache for 3 days leading up to calling 911. finally on the April 1st, i went to hospital. i had a lump on my right shoulder never there before and i felt like the lump was causing my right side of my face to be numb. The hospital refused to believe me that i had some blood clot, they downplay the incident and instead gave me a brain CT SACN and brain MRA which was negative, they kept me for observation overnight and let me go noon the next day. since i have had follow ups with my regular doctor, a cardiologist and my nephrologist. I know that reaction was due to medication, either way glad i got the shot. BUT Since this time, I am retaining water, i know this because my rings do not fit anymore, rings i had for 20 years, never ever once had a hard time to put on or remove. I know my body, thats not the worse of it. i test my blood pressure every day at requesting of my kidney doctor, since the incudent of my pressure 198/112 my diastolic on average is raised 20 points. I log this daily. here are some examples from before the medication 111/67 , 109/63 , 129/64 , 105/62 120/81. now my pressure is totally different for example, 155/88 150/91 157/90 , 134/88. nothing else changed in my life, I am exactly the same as before only now i have covid shot.. yesterday i saw the 4th doctor since i am shot up and she gave me a new pill olmesartan medoxomil, only on it one day but my diastolic pressure is still much higher than before. i dont want to die, i dont want a stroke, or a heart attach, i have a lot to live for still. nobody is helping me, doctors are just throwing pills at me and not treating root cause which i feel strongly to beleive it is from covid shot.

WEAKNESS; TIREDNESS; FEVER; NAUSEA; HEART RACING; DIZZINESS AND LIGHTHEADEDNESS; This spontaneous report received from a patient. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported On 06-APR-2021, the subject experienced heart racing. On 06-APR-2021, the subject experienced dizziness and lightheadedness. On 06-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced weakness. On 07-APR-2021, the subject experienced tiredness. On 07-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart racing, dizziness and lightheadedness, weakness, tiredness, nausea, and fever on APR-2021. This report was non-serious.

I have severe swelling in both legs from knee to my feet, severe itching and hives, legs have blistered and burst open. I also have a Blood clot in my lower left leg. Have tried 2 kinds of antibiotics, I am on Xarelto 10 mg tab for the blood clot

STROKE; This spontaneous report received from a consumer concerned a 60 year old white, Not Hispanic or Latino male. The patient's height, and weight were not reported. The patient's past medical history included epileptic seizures when seeing flashing lights, he had no prior history of stroke or any surgery, and concurrent conditions included high blood pressure, and type 2 diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) dose was not reported, administered, on 16-MAR-2021 around 10:30 in the morning for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 25-MAR-2021, the patient had stroke. The reporter did not know what kind of stroke the patient had. He was not found immediately when he had the stroke and when patient arrived at the hospital he was paralyzed on the left side and was put on the feeding tube and ventilator and moved to hospice after 8 days. On 09-APR-2021, the patient died from stroke. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210428085-COVID-19 VACCINE AD26.COV2.S -Stroke. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE.; Reported Cause(s) of Death: Stroke

I'm reporting just in case others had a mini stroke after receiving this Johnson and Johnson shot, doctors at hospital say they have seen it causing Big strokes but not mini strokes but if J&J shots causes big strokes it can also cause mini strokes I believe, A stroke is a stroke. My husband is a healthy 60 year old with no real heath issues. all his test in hospital showed no reason for his stroke and they did them all...?..but test did show he had a stroke His arm and leg went numb at about 8 pm Friday at home so I took him to hospital and test showed he had a spot on his brain saying it was a stroke, they kept him 2 days running test and they found no reason he had a stroke but he did and I believe it was caused by the COVID-19 vaccine shot from Johnson and Jonson

LETHARGIC; FLUSHED; FEELS WORSE EVERY DAY; WOOZY AND UNSTEADY; A BIT TIGHT IN THE BOTTOM OF HIS CHEST; NO ENERGY; PAIN IN ALL MAJOR MUSCLES, HURTS EVERYWHERE; NAUSEA; LOW GRADE FEVER UNDER 99F; SPLITTING HEADACHE; TIRED; RESTLESS SLEEP; This spontaneous report received from a patient concerned a 60 year old male. The patient's weight was 350 pounds, and height was 75 inches. The patient's concurrent conditions included high blood pressure, chronic lyme disease, seasonal allergies, arthritis, hives allergy, non smoker, and alcohol user. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Concomitant medications included ibuprofen for arthritis, naproxen sodium for arthritis pain, lisinopril for high blood pressure, and fexofenadine hydrochloride for seasonal allergies. On 11-APR-2021, the subject experienced flushed. On 11-APR-2021, the subject experienced feels worse every day. On 11-APR-2021, the subject experienced woozy and unsteady. On 11-APR-2021, the subject experienced a bit tight in the bottom of his chest. On 11-APR-2021, the subject experienced no energy. On 11-APR-2021, the subject experienced pain in all major muscles, hurts everywhere. On 11-APR-2021, the subject experienced nausea. On 11-APR-2021, the subject experienced low grade fever under 99 F. On 11-APR-2021, the subject experienced splitting headache. Treatment medications included: paracetamol. On 12-APR-2021, treatment medications included: acetylsalicylic acid/caffeine/paracetamol/salicylamide. On 13-APR-2021, Laboratory data included: Blood test (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tired, restless sleep, splitting headache, pain in all major muscles, hurts everywhere, no energy, lethargic, nausea, low grade fever under 99 F, flushed, feels worse every day, woozy and unsteady, and a bit tight in the bottom of his chest. 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

LOSS OF VOICE; CHEST TIGHTNESS; CRAMPS IN THE STOMACH; SORE THROAT; BAD HEADACHE IN THE BACK OF THE NECK; NAUSEA; This spontaneous report received from a patient concerned a 60 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced loss of voice. On 12-APR-2021, the subject experienced chest tightness. On 12-APR-2021, the subject experienced cramps in the stomach. On 12-APR-2021, the subject experienced sore throat. On 12-APR-2021, the subject experienced bad headache in the back of the neck. On 12-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bad headache in the back of the neck, sore throat, nausea, loss of voice, cramps in the stomach, and chest tightness. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.

PULMONARY EMBOLISM; CHEST PAIN; This spontaneous report received from a patient via a company representative via the local news, concerned a 60 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) at an unspecified dose on 06-MAR-2021 for prophylactic vaccination. The anatomical vaccination site was not reported. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On 01-APR-2021, 26 days after vaccination, the patient went to hospital due to chest pain. On 08-APR-2021, 33 days after vaccination, the patient was diagnosed with pulmonary embolism, and was hospitalized. The patient reported he suffered a blood clot after receiving the vaccine and was diagnosed with a pulmonary emboli. On 11-APR-2021, the patient was discharged. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pulmonary embolism and chest pain was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: A 60-year-old man experienced chest pain 26 days after vaccine and was hospitalized with pulmonary emboli 33 days after vaccine. Medical history and concomitant medications were not reported. The latency of greater than 3 weeks makes this unlikely related to vaccine. There is insufficient information to make a meaningful medical assessment. Additional information has been requested, including contacting the news station that reported the event.

The patient developed thrombotic thrombocytopenic purpura (TTP), a week after the Janssen vaccine (Started having symptoms on March 15, 2021- speech difficulty, petechiae, fatigue, and easy bruising). TTP was confirmed by ADAMTS13 level < 5% and the presence of inhibitor on March 19, 2021. In addition, he had schistocytes, thrombocytopenia, and elevated lactate dehydrogenase. He was treated with PLEX, steroids, and Rituximab. He is currently closely monitored at Clinic.

Guillain Barre syndrome. Severe progressive motor impairment upper and lower extremities. Respiratory distress severe widespread edema, hypertension increase,

Medical team dispatched to the residence of the the name person on April 10, 2021 at 2327. Pt assessed by medic on scene and determine patient with obvious death. Pt found halfway on the couch and to be pulseless, apneic, and with rigor mortis. Unknown down time and when further assessed, patient death determine by EMS. pt had fixed and dilated pupils, non-responsive to painful stimuli, absent breath sounds, no heart sounds auscultated. Pt was also placed on the monitor and found to be in asystole in 2 contiguous leads. CPR with held and no resuscitative measures performed.

HEART ATTACK; This spontaneous report (social media) received from a patient via a company representative concerned a 60 year old male. The patients 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: not reported batch number: Unknown) dose was not reported, 1 total administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient took vaccine and at night patient experienced heart attack and died due to heart attack. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to; Sender's Comments: V0-Covid-19 vaccine ad26.cov2.s -Heart attack. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: HEART ATTACK

Day 2 following the vaccine, patient began to experience flu-like symptoms (fatigue, head ache, body ache). Followed by a syncope episode, did not follow up with any emergency care. Did not contact primary care or go to the hospital, or take any medication to treat symptoms. Mentioned having eye soreness, eyes feeling fatigued which is not usual for the patient and coincide with timing of adverse effects.

60 yo male with BMI 30 and vodka x 2-3 bottles per day. In hospital 4/9-14 for obstructive uropathy of undetermined origin. In hospital on 4/12 and got J & J there. 4/13 with no prior history developed a DVT. D/C'd on 4/14 on Eliquis. Found unresponsive 4/19. At autopsy, found pulmonary thromboemboli

Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Medium, Systemic: Seizure-Mild, Systemic: Shakiness-Medium, Systemic: Vomiting-Mild

Three weeks after the vaccine my ankles were swelled up. I gained 30 pounds over the course of fourteen days. I was having trouble breathing. I was admitted to the hospital and diagnosed with Atrial Fibrillation and Congestive Heart Failure. I also had water in my lungs. I have not had any heart symptoms before that. I tested positive for Covid-19 antibodies in June of 2020. I had multiple tests on every organ. There were no clogged arteries and no heart problems except for AFIB. My blood pressure is fine but I am taking half a blood pressure pill. I am trying to lose weight. I am scheduled to see a cardiologist on 05/25/2021

Patient had SOB, upper chest and back pain, diagnosed with small pulmonary embolism in right upper lung

About 5 min after getting immunization the patient started to stand to tell an associate that he was having a reaction. He got light headed and started to pass out. A pharmacy technician was able to get to him in time and guide him to the ground. He was unresponsive for 10-30 seconds. Before we could take further action he regain consciousness. After a couple minutes he wanted to go back to chair. Within a minute he lost color and passed back out. This time he came back sooner and stayed on the ground till EMSA arrived. Only BP we got was several minutes into the event 124/82 HR 54. Paramedics did not transport the pt.

Rapid heart rate. My normal heart rate (which has been under control after surgical procedures and with medications) averages 70 bpm at all times. About 10 hours after receiving the Johnson and Johnson vaccine this morning, my heart rate has crept up to 135 bpm and has not yet gone down.

It started with severe fatigue, muscle aches & pain. High blood pressure started about 10 days after getting vaccine and peaked at 185/117. At this point I called my doctor and started blood pressure medication, amlodipine. I then noticed heart rhythm issue and rapid pulse rate and went to cardiologist.

Within 30 minutes after the injection, my face became flush and my heatrate was racing. I went back into the clinic where I received the injection and was checked by EMT's. I was experiencing chest pain and my bloodpressure was extremely high (195/125) An EKG was done which showed irregularities and I was given Baby Asprin and Nitrogylicern. I was then transported by ambulance to Hospital and kept overnight. Several Tests were conducted including EKG's, Ultrasound, Nuclear stress test, and Enzyme Test to determine if I had a heart attack. In the end, all tests were negative and I was released from the hospital the following evening (8:00 pm). I was extremely fatigued and weak for the next two weeks and eventually recovered. The chest pain was determined to be a pulled chest muscle wwas exacerbated by the high blood pressure.

Patient had a stroke on June 4. Developed unusual headache evening of June 3. Went to see doctor on June 4 . Bp remained elevated even after taking bp medicine . Doctors office sent him to ER. First it was said he had a aneurysm in heart which was ruled out . Then it was advised to us he had a brain stem stroke . Patient still in icu. Still in hospital as of today .06/16/2021. Patient will be going to pt therapy snd of therapy . Has dysphagia unable to eat and left side weakness . Peg tube inserted . Want to establish if Johnson and Johnson vaccination was linked to him having stroke . Patient current illness was maintained and under control until this event happened suddenly .

Began feeling like trying to catch a cold. Tired, tight chest, muscles sore. Symptoms continued for a couple weeks then a deep pain in side started. Could not stand the side pain and went to ER. Scan showed enlarged cardiac silhouette. Further tests showed fluid completely surrounding heart with inflammation in duodenum. Was taking into surgery to have fluid from heart sac drained then a drain put in.

Covid vaccine received on 5/20/2021. Patient went to another state over weekend and reported spending most of Sunday, June 13, 2021 in a vehicle. Patient presented to cardiology outpatient appointment with dyspnea on 6/16/2021. Later that same day was loading hay in very hot weather (around 100 degrees Fahrenheit) and became dizzy. Later, that same day the dizziness remained and new symptoms of chest pain and shortness of breath. Patient presented to ER that evening, and was admitted to the hospital for bilateral pulmonary emboli extending into all lobes of the lungs.

AE: Dizziness, extreme fatigue, inability to stand or walk immediately after administration of vaccine. Treatment: Vitals taken; stable. Blood glucose taken; not hypoglycemic. Gave Pt water to sip on. Pt assessed by PCP and cleared to go home.

I had no symptoms up until May 3rd. I had high blood pressure - it was through the roof. - It was 193/101. I was experiencing dizziness and wobbly - not sure on my feet. ER. Changed dosage to - higher dosage - Lisinopril and Amlodipine. Primary care doctor decided to give me Prednisone - I did the series of it and I no longer take it. Blood pressure is still high and racing with the heart issues and working with the doctor to still get it under control and taking the meds. They did issue me Meclizine - in case I have a vertigo feeling. May 26th - I told her I am not going to use her services anymore and so I'm seeing Dr. now. Remicade infusion every 8 weeks. I still go to work right now.

A few weeks receiving the Jansen vaccination, I started having chest pressure and pain. On June 2, 2021, I had severe pressure and pain in my chest. I went to the ER. An EKG indicated an abnormal heart problem. An angiogram revealed an artery blockage. A stent was inserted into the artery to resume blood flow.

Hospitalization Case began symptoms on 06/25/2021 consisting of productive cough, diarrhea, syncope, chest pain, and chills - reports pneumonia, diabetes mellitus, cardiovascular disease, and chronic liver disease as pre-existing medical conditions - case was transported to hospital via EMS, admitted 06/25/2021-06/28/2021

Patient was taken to the ER by his wife, on 4/12/21 with shortness of breath. He was sent home on continuous O2, which was never needed prior to his vaccination. Wife denies any chronic health conditions and reports that pt has been to more that one specialist because of his continued need to be on O2. She reports his saturation drops with minimal exertion and that the client has not even been able to return to work. When asked what the doctors had said, she reported that they blamed it on his weight. She reports that his weight has been the same since well before the vaccination.

I was achy and became weak and dizzy about 1pm. By 2pm , I developed Ortho static hypotension which caused my blood pressure to drop and travel to ER via ambulance .

Developed 3 small blood clots in his left lower leg on Saturday, 3/10/2021 - swelling and slight redness along with pain

Had suddenly didn?t feel good. Passed out was out for five minutes, Had a strange reaction when he came to, His vision was blurred, he has vomited 6-7 themes. I contacted the pharmacy where the sot was given and the clinic. He refused to go to E R The have taken notes to this. He sat in his recliner and took a nap. Took temp he does not have a fever. If his symptoms get worse I will call for ambulance.

After receiving vaccination, patient proceeded to observation area. He passed out briefly, then regained consciousness, but was sweaty, disoriented, dizzy and drowsy. EMS was called, he asked to lie down and was helped to ground into a recovery position. EMS arrived and took him for further evaluation.

Patient arrived at vaccine clinic SOB and acutely decompensated around the time of vaccination. He was found to be in acute respiratory distress with a pulse of 62%. EMS called and pt was transported to the hospital. He has found to be in acute CHF and hypertensive urgency. Initial BP 249/138 He was given IV lasix, IV lopressor and started on oxygen. He was admitted to the Facility on BIPAP. Over the course of the next 2 days he had good diuresis and able to be weaned off oxygen.

Got covid shot and then told staff at clinic didn't feel good. Patient was pale and cool and sweaty and so given epi. Medics got there and blood pressure high and heart rate high and patient was non verbal and having intermittent jerking. At time of evaluate patient intially refused to speak to me but then would speak. Having intermittent jerking and when would be touched would jerk violently in arms and legs but this was distractable. States when got shot felt pressure in head which going away

Patient's wife contacted office after husband was taken to hospital due to experiencing chest pain and difficulty breathing. Upon admissions, she stated he was tested for COVID and the test came back as positive. Wife upset due to the belief that the shot has caused her husbands condition and that we should be aware that hospitals are still testing for COVID and considering it positive even though her husband had been vaccinated. I tried to explain that he had not had the two full weeks since being vaccinated to have full immunity and that he could have been exposed early enough that he was still able to develop into actual illness.

Vaccinator called EMT, client looked pale. Reevaluated by EMT, BP 157/111 @ 3:03 pm with elevated heart rate. Client alert and talking. Client stated was seen at home earlier today for BP concerns. Transported to ER by EMS

Soon after shot felt sweaty - dizzy - that is all he remembers. States he was very nervous on arrival and does not like needles. Patient observers states they noticed patient coughing and then he passed out.

The patient called today to inform us he has adverse events on Saturday evening, 40 minutes after getting the Covid Vaccine, he had a sensation of floating, and 4 hours later sharp chest pain which occurred every 3 minutes , lasting 10-15 seconds for a duration of 3 hours, he could not move. then at 2am Sunday morning, he woke up gasping for air, he drank some water and tried drinking coffee which he spilled and blacked out, by Sunday afternoon he felt better, and today he is feeling a lot better

Janssen COVID-19 Vaccine EUA. One day after vaccine, patient reports onset right sided weakness (face, upper and lower extremities). Found to have stroke on brain imaging: L inferior M2 branch occlusion.

Patient was admitted on 4/9 to hospital with left facial, upper and lower extremity numbness that last 5 min and resolved. In ED had similar symptoms. CT head, MRI brain, MRA head and neck unremarkable. Hgb 6.6 and Plt 13. Transferred to Medical Center on 4/10 for more care. Diagnosed with TIA and possible TTP (ADAMTS13 pending, meets other criteria). Started on high dose methylprednisolone 1000 mg IV x 3 doses on 4/11, plasmapheresis on 4/11, and weekly rituximab on 4/11. Status/outcomes pending

Pt reports that 36 hours after he received his vaccine he developed vertigo and went into a cardiac arrhythmia. He took an ambulance to the ER, he was given IV fluids and had lab work done. He reports he is now starting to feel better (5 days later)

PT RECEIVED HIS COVID-19 VACCINE AND WAS WAITING IN THE OBSERVATION AREA. AFTER ABOUT 10 MIN MY TECHNICIAN NOTICED HIM SIT ON THE FLOOR FROM HIS CHAIR AND SHE CAME TO GET ME. AS I APPROACED HIM HE LOOKED DAZED AND SUDDENLY BLACKED OUT. IN ABOUT 15-20 SECONDS HE AWOKE AND ABOUT 1 MINUTE LATER HE WAS SPEAKING. ROUGHLY 5 MINUTES LATER, EMS ARRIVED AND CHECKED HIS VITALS, BLOOD SUGAR AND EKG. ALL WERE WITHIN NORMAL LIMITS. WHILE TALKING TO PATIENT AND THE TWO LADIES WITH HIM, WE FOUND OUT HE HAD DRIVEN 3 HOURS FROM HIS HOME TO COME TO OUR PHARMACY FOR THEM TO GET VACCINATED. AND THEY PLANNED TO GET ON THE ROAD AND RETURN. EMS SUGGESTED HE GO TO THE HOSPITAL, BUT AFTER 20 MINUTES HE WAS WALING AND TALKING AND DRINKING WATER. HE AND HIS FRIENDS DECIDED THEY WOULD NOT GO TO THE HOSPITAL. I FOLLOWED UP WITH HIM 2 DAYS LATER ON 4/9 AND HE FELT FINE EXCEPT FOR SORENESS AT THE SITE OF INJECTION. HE ALSO RECALLED A TIME WHEN HE HAD PASSED OUT FROM AN INJECTION WHEN HE WAS A TEENAGER

Feeling unwell. "Burning" head to toe, shakes, near syncope, sweats, tiredness, dizziness, lightheaded. Onset of symptoms less than 1 hour. Patient denied symptoms of chest pain, (L) arm pain, or SOB. Patient sent by EMS to local emergency department.

CHEST TIGHTNESS; LEG HEAVINESS; LEG TIGHTNESS; TIREDNESS; THROAT CLOSING UP ON HIM; SWEATING; DIZZY; This spontaneous report received from a patient concerned a 61 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high cholesterol, pollen allergy, asthma, chronic obstructive pulmonary disease, colon disorder, non smoker, and non alcoholic, and other pre-existing medical conditions included no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with cefalexin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: 25-MAY-2021) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, Laboratory data included: Blood test (NR: not provided) high cholesterol. On 06-APR-2021, the subject experienced throat closing up on him. On 06-APR-2021, the subject experienced sweating. On 06-APR-2021, the subject experienced dizzy. On 07-APR-2021, the subject experienced tiredness. On 13-APR-2021, the subject experienced chest tightness. On 13-APR-2021, the subject experienced leg heaviness. On 13-APR-2021, the subject experienced leg tightness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, and dizzy on 06-APR-2021, and had not recovered from throat closing up on him, tiredness, chest tightness, leg heaviness, and leg tightness. This report was non-serious.

HIGH BLOOD PRESSURE 155/110; This spontaneous report received from a patient concerned a 61 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included borderline high blood pressure usually around 120/83-84. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 042A21A and expiry: UNKNOWN) dose was not reported, 1 total administered on 06-APR-2021 to left arm for prophylactic vaccination. Concomitant medications included 10mg enalapril as maintenance for borderline high blood pressure. On 07-APR-2021, 24 hours after receiving the vaccine, the patient experienced high blood pressure 155/110 and the patient also had slight dizziness and severe headaches. Laboratory data included: Blood pressure (NR: not provided) 155/110. For treatment, the patient took 20mg enalapril after measuring blood pressure which was not therapeutic, so the patient took nifedipine 10mg which was effective. The patient was feeling well and had no symptoms or complaints at the time of this report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from high blood pressure 155/110, slight dizziness, and severe headaches on APR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210420121-covid-19 vaccine ad26.cov2.s - High blood pressure 155/110. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: UNDERLYING DISEASE

PT STATED HE WENT TO THE CLINIC AND THEN THE ER WITH A BUMP ON THE BACK OF HIS LEG. PT WAS TOLD IT WAS A BLOOD CLOT.

shortness of breath, foot swelling, chills, body aches, dry mouth, fatigue, wheezing, eye burning sensation, joint pain, Blood clots in lungs, prescribed Xarelto

since getting the COVID 19 vaccine on April 7, I had at least 6 times "heart beat stopped" feeling, two times I almost passed out. I never had that kind of feeling before.

Swelling in right leg following workout. Became painful as day went on. Swelling, pain continued. After three days, visited doctor.

Fever, chills, generalized weakness after vaccine 4/27 4/28 altered mental status, hypotensive, tachycardic and admitted to the hospital

Patient fainted and fell on the floor, as soon as he left the room to wait in the observation area for 15 minutes. He was conscious and oriented, We called 911, they took care of him and got him out of the store. He didn't go to the hospital, and said that he felt much better as soon as they gave him water.

For the first two weeks, there was only mild headache and fatigue. But on day 12 (or 13) following the shot, my husband had severe abdominal pain and black, tarry poop. He passed out on the toilet in the middle of the night and hit his head, woke up in a puddle of blood (from hitting his head) . He was severely lightheaded, short of breath, could not walk. He had to crawl back to bed. He continued to have severe lightheadedness, shortness of breath, muscle aches, abdominal pain, and also ringing in his ears. He called me early Saturday morning and told me what happened and that he called out from work. (We do not live together. He is 280 miles away because of his job.) That man has called out sick only one time since I've met him in 1998; so when he told me he did not go to work, I knew it had to be really bad. I drove up there ASAP the same day, and I took the pulse oximeter with me. His oxygen levels were all over the place. They were usually better (like high 70s to low 80s) while he was lying down. When he would sit up or stand up, the number would plummet, reading so low I thought he was going to die. One time his finger was so cold that it took me 4 tries to get a reading. It read at 55, but I realize that might be because his finger was too cold.

Within 24 hours pain in left side of left chest, in 48 hours pain on full left side of chest, within 72 hours pain through entire chest. Hospitalized within 72 hours, chest pains, catheterized within 120 hours, had a blood clotting issue, put into medically induced coma for three and a half days, followed by a pulmonary embolism and four (4) clogs, two (2) in either leg, within two weeks. Hospitalized twice, currently on three blood thinners, a beta blocker, pepcid, a statin, and one other. Expected to be on three blood thinners for at least three (3), most likely six (6) months. Start cardiac rehab on 5/19/21. Have chronic cough and chest discomfort. Expected recovery time: six (6) months.

Patient had onset of right calf pain and swelling several hours after receiving vaccine. Was seen on 5/10 and diagnosed with right lower extremity DVT.

Wasn?t able to stand up at all... nausea fainting dizziness etc... had to take rescue twice within 5 days... was in the ICCU unit at one point.. diagnosed with orthostatic hypotension

pt received Johnson and Johnson vaccine on 5/21/2021, PT had been complaining of shortness of breath since getting the vaccine yesterday and today, pt collapsed at home, wife started CPR, EMS continued compessions and ACLS protocol when they arrived to ED he was in Vfib, After multiple shocks, Epinephrine, bicarb, lidocaine and multiple other life saving medications were administered to no avail, pt expired on 5/21/2021 at 1729

Patient began sweating and feeling lightheaded shortly after vaccination at approximately 1125. Patient then fainted in his chair and was initially non-responsive to the nurse. At this time I called 911. The nurse administered a single epi pen in patient's quad and he woke up. The nurse then took patient's vitals at 1138: BP - 109/73; P-84; SPO2-99%; T-97.4; R-16. Patient stating he was still feeling dizzy and fatigued. The paramedics arrived and took patient to hospital for continued evaluation. I called patient later in the afternoon and he had already been discharged and was at home resting and feeling better.

MINI STROKE IN LEFT ARM, HAS LEFT ARM WITHOUT STRENGTH, NO MUSCLE CONTROL OF 3 LEFT HAND/LEFT SIDE FINGERS. ARM/WRIST JERK UNCONTROLLABLY. DR. VISIT 8 DAYS AFTER STROKE. LAB TESTS DONE. PRESCRIBED atorvastatin 40 MG 1 PILL AT NIGHT. URGENT CARE VISIT 5/18/21 LEFT HAND AND FINGERS UNCONTROLLABLE, HAND HAD SEVERE SWELLING. PREDNISONE PRESCRIBED

Patient presented in the office on 5/12 complaining of edema. The edema involves the left lower extremity. Onset was gradual 2 month(s) ago. Onset followed starting a new medication (around J and J vaccine). The symptoms occur intermittently. The patient describes this as unchanged. Symptoms are exacerbated by prolonged standing. Symptoms are relieved by leg elevation. Associated symptoms include calf pain (in upper thigh) and calf swelling, while associated symptoms do not include dyspnea, decreased urinary output, ascites, diarrhea, localized redness, localized warmth or fever. No chest pain

After administration of the vaccine at 9:50 AM, the patient went out to the waiting area to wait the 15 minutes after the vaccine. About 10 minutes into the waiting time, patient became very pale, and stated that were having chest pain. Patient was given water and their blood pressure was taken, it resulted in a BP of 70/60. The patient was laid down on the ground, and legs raised, and after another 10 minutes the BP was taken again and resulted in 118/78, at this point the patient was feeling much better. However, to be precautious, the patient was rolled out in a wheel chair to make sure hypotension did not occur again. Patient stated that at 11:30 they had a scheduled appointment already with their doctor and said they would discuss with them the adverse reaction of the previous couple hours.

Patient received vaccine on Thursday evening. He began to feel very tired Monday and Tuesday. Wednesday he woke up in alot of abdominal pain. We went to healthcare facility at 4:30pm. He was diagnosed with Acute Pancreatitis. He was sent home at 10:30pm We went back to ED at 1:30 am Thursday. He was admitted during the day. In the early morning of Friday May 28th his blood pressure tanked and he became unresponsive. His heart stopped and they did compressions for 8-9 minutes. He was put into ICU. By 3am we were told he may not survive. By 5 am we were told his organs were shutting down. He passed around 7:45am. In researching the vaccine we discovered the SARS virus used in vaccine can attack the pancreas. We believe he died as a result of the reaction to the vaccine and his body and organs could not fight.

PLATELETS WERE REALLY LOW DOWN TO 6; COUGHING SPOTTY BLOOD/COUGHED UP A MOUTH FULL OF BLOOD; SINUS INFECTION; BUNCH OF RED LITTLE DOTS ALL OVER BODY/WORSE ON RIGHT LEG/LIKE HEAT RASH; This spontaneous report received from a patient concerned a 61-year-old white and not Hispanic or Latino male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAY-2021, the patient experienced bunch of red little dots all over body which was worse on right leg like a heat rash. On 29-MAY-2021, patient thought he had sinus infection and started coughing spotty blood and then coughed up a mouth full of blood on 30-MAY-2021, went to emergency room because he was still coughing out blood. Patient's doctor found that patient's platelets were really low down to 6. Patient's doctor gave him bunch of steroid and platelets. Patient was hospitalized on 30-MAY-2021 and discharged on 01-Jun-2021 and was given a steroid 40 mg a day. The patient recovered from coughing spotty blood/coughed up a mouth full of blood on 01-JUN-2021, and sinus infection, recovered with sequelae from platelets were really low down to 6 on 01-JUN-2021, and was recovering from bunch of red little dots all over body/worse on right leg/like heat rash. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 : 20210616684- JANSSEN COVID-19 VACCINE-Coughing spotty blood , platelet were really low below 6. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Patient denied history of fainting. Patient received Janssen vaccine at 11:49. Immediately after receiving vaccination patient was complaining of arm pain. Patient was asked by charge RN to stay seated at table instead of moving to observation area. Patient started complaining of feeling dizzy at 11:53 am. RN asked patient to lie down. Patient wanted to remain seated. Patient asked if he was diabetic. Patient confirmed he had type 2 diabetes and was unsure of last time he ate and blood sugar. Snack and cold water was obtained for patient. Patient became diaphoretic and was breathing fast. Blood presssure obtained and read 195/177. Blood glucose was obtained and read 132. RN asked for assistance lowering patient to ground. Patient's eyes rolled back while lowering patient. Patient was unconscious for approximately 60 seconds. EMS was called by bystander. Patient came back to consciousness and was alert and oriented. Patient's Blood pressure was obtained adnd read 156/80. HR was 58. EMS arrived and obtained vitals. Patient refused further treatment by EMS. Patient had ride pick him up at 12: 40. Patient was alert and oriented and no other symptoms upon leaving vaccination site.

Immediate vasovagal syncope at time of injection AEB brief loss of consciousness, diaphoresis, and pallor noted. Lowered pt to floor and elevated BLLE w/ chair. Pt awakened to smelling alcohol pad and verbal cues. calm and cooperative, AOx4. Denies pain, denies SOB. Taken to MedObs via litter where pt was assessed and encouraged to eat snack and drink water as pt reports he has not eaten or had any fluids today. Pt drank 1 bottle of water and declined a snack. Pt VSS though BP elevated and pt encouraged to monitor daily at home and f/u w/ provider. Pt allowed to leave at approx 1405 after 30 minutes, VSS and reported feeling "fine" Not edema, erythema, hives, SOB or any other s/s allergic reaction noted VITALS 1337 sitting HR 86, RR 18, BP 163/98, O2 96%RA 1342 sitting HR 84, RR 16, BP 146/96, O2 96%RA 1347 sitting HR 74, RR 18, BP 161/100, O2 96%RA 1354 sitting HR 76, RR 18, BP 156/94 (manual BP), O2 98%RA 1400 standing HR 80, RR 18, BP 168/98, O2 96%RA

I had severe shortness of breathe, rapid heart rate, bruising on the arm of the vaccinated. I still experience them to this day.

Respiratory Failure related to positive covid test. PCR positive on 07/01/2021 and PCR positive 07/07/2021. Patient placed on BIPAP due to hypoxia in ER and admitted. Remdesivir and decadron administed as inpatient. unknown exposure date admitted 07/07/2021

sat-ok, sun sore arm weak sleep all day,mon tired weak left arm restricted tues tired left arm weak bad headace wed seem better left arm weak, sharp pain in center chest slightly labored breating, thur severe pain still in center chest like something is stuck. the pain subsided , fri sore area center chest , tired. seem better sat tired weak. have been slow and weak since. through july . otherwise ok but tired and sleeping alot.

Chest pain, loss of energy, no sleep, loss of consciousness while walking, coughing, change in bowel movements, weight loss.

Sudden onset of severe headache, chest pain, difficulty breathing, fatigue and nausea, ~72 hours post vaccination. After 16 hours of bad symptoms that got worse, I took my husband to the ER, as he was having difficulty breathing and moving. (He is normally very fit, active and healthy). In hospital, they ran a battery of tests and found signs of inflammation in chest and lymph nodes. They gave him fluids, and intravenous pain meds (acetaminophen, Toradol), which helped slightly. Symptoms diminished slowly over next 24 hours, and he was feeling 90% better by Saturday afternoon.

blood pressue 96/42. patient sweating. feeling dizzie like he was about to pass out. provided food/water and constant monitoring until symptoms resolved

Systemic: Fainting / Unresponsive-Medium, Systemic: Fainted but seems responsive-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Patient fainted from sitting after vaccination. No difficulty breathing/swallow, thus gave water and gatorade. He was responsive to my questions. He has history of anxiety to needles and he did not eat lunch before vaccine. He stayed seated for 1 hour to monitor. Then, walked an aisle before driving home. Asked him to eat first before driving home. Called him twice and he is home and feeling okay. Counseled to call pharmacy if any symptoms of allergic reaction to vaccine.

6 hours after shot, severe headache and chills. 10 hours after shot vomiting every 1/2 hour for over two hours. 12 hours after shot went to ER . could not hold down fluids. was given IV and anti-nausha medicine. headache lasted two days.

On Monday March 8th I went to the Pharmacy to get the Johnson & Johnson Covid vaccine under the new 1b guidelines. I am a 62 year old white male with type 1 diabetes, insulin dependent for the past 49 years. I filled out the question form I was presented by the staff and then was given a dose of the J&J vaccine. This vaccine was administered at approx. 1:30 p.m. I was asked to wait 15 minutes to see if I had and acute reaction, following none, I was told I could leave. There rest of the day I was fine. I went to bed at 11:00 p.m. and within 15 minutes I was cold, shaking and sick on my stomach. I took my temp and it was 100.2 F My O2 sat was 95% and heart rate was 120 with feelings of palpitations from time to time. I went to the bathroom and stayed there the rest of the night with frequent vomiting and loose stool. Stomach cramps all night long. Several BGL were taken and even with an insulin pump I was not able to lower my 299 level for over the next 24 hours of repeated bolus. I was finally able to stop dry heaves and fall asleep for moments at a time around 5:00 a.m. My temp finally broke around 11:00 a.m. the next day Tuesday. I had a headache this entire time. I called hospital ( Ask a Nurse ) on Tuesday morning around 8:00 a.m.and enquired about side effects for this vaccine and effects on a type 1, they basically told me to go to the ER or Clinic and be seen by a Physician. I choose not to do either, but to monitor myself and see how the rest of the day went. The first time, other than a headache and complete body soreness my vitals and BGL, were WNL, was late Tuesday evening around 7:00 p.m. This was a horrible set of side effects. Onset was within 11 hours from injection. No warning for type 1 people to be careful for the possibilities of increased BGL. Today is Wednesday March 10th, and my vitals have remained WNL, but I still have a mild headache and body soreness, some maybe from the vaccine but I believe mostly from the throwing up. Today is March 11th, my vitals are still WNL and BGL is in target. BGL control is responsive to pump therapy now. The past 2 nights I have awoken in a cold soaking sweat that cannot be tied to a low BGL. My body is somewhat still soreness.

Janssen COVID-19 Vaccine EUA 2 1/2 days of severe flu symptoms. Nausea, Fever, Chills, weakness,no sleep. The next days nausea and light headedness Day 7 (today 3/20/2021) nausea, weakness, and fainting spells. Fainting spells include vision impairment (everything looks fuzzy like a bad tv reception).

Patient experienced a period of unconsciousness while waiting during the post-vaccine period of 15 minutes

Patient experienced perspiration, dizziness, and fainting with no loss of consciousness. Patient was talking and answering questions appropriately. B/P 120/80, FSBS 131 @ 1:52PM. EMS was notified and Patient was transported to local hospital. I spoke with the patient today and he states he was discharged from hospital and everything was fine. He states he is doing good today.

Six days after receiving Janssen vaccine at approximately 4:00 pm, left hand experienced numbness. As the evening wore on, weakness spread through the left side of body and speech began slurring. The next day, after no improvement, went to hospital to find from CT scan that he had suffered a stroke. He had no precursors that would lead to being prone to strokes.

Male patient received vaccine in the morning, then around lunch time started feeling symptoms of headache, runny nose and ringing in ears. He then got shortness of breath, which got exacerbated so Pharmacy called ambulance and because patient became hypertensive , it was recommended he go to the E.R. Patient is currently at the E.R. at time of this report

patient was given covid vaccine. he stated that he had needle phobia. the vaccine was given without issue. he proceeded to the waiting room to be observed for 15 minutes. customer in line and technician at registered saw patient lost contentiousness briefly but quickly came back. pharmacist came immediately out to patient. he was confused and disoriented but responding appropriately to questions. 911 was called. pharmacist on duty stayed with and observed patient until paramedics arrived.

I got the shot on a Saturday. On Sunday morning i felt ill, my chest was hurting. By 3:00 pm it started to feel worse. I took my blood pressure at home and it was extremely high. My wife called my Doctor who said go to the E.R. Once there they took my blood pressure and it was over 200. The ER Doctor gave me a nitroGlycerin pill to get the blood pressure down. They did multiple test on my heart. The pain went away once the blood pressure went down. I spent the nite in the hospital and was released after numerous test the next day.

Patient fell to right side while sitting in chair hitting back of head on wall and floor. Unresponsive, diaphoretic and pale . Patient was unresponsive for approximately 30 seconds. He said "the last thing I remember is feeling like I needed to take my mask off, then I saw yall standing over me." Pt denied "passing out" in the past. EMS called and the patient was taken out on a stretcher by EMS but refused to be taken to the hospital.

Rapid Heart Beat above 90 bpm began 11 hours after covid-19 vaccine. Rapid heart beat was constant for just over eight hours. Could not sleep that night because of this. Fever was 101° stuffed up nose, swollen tonsils and extream body aches with joint pain lasted 24 hours.

ELEVATED BLOOD PRESSURE; RUNNY NOSE; HEADACHE; TIREDNESS; This spontaneous report received from a consumer concerned a 62 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced headache. On 09-MAR-2021, the subject experienced tiredness. On an unspecified date, the subject experienced elevated blood pressure, and runny nose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the elevated blood pressure, runny nose, headache and tiredness was not reported. This report was non-serious.

Pt feeling weak in observation area while sitting down after vaccine administration. Pt slowly lowered to ground by clinical staff,911 called lost consciousness for less than 2 mins aprox., pt afterwards aaox3, ambulance arrived, transported to ER

client was injected at 1:36p.m. and passed out at 1:39 p.m. client was in and out of consciousness until 1:40p.m. This happens every time client gets a shot

Warm feeling followed by fainting and slight convulsions. Nausea, gas, feeling faint, and usability to drive a vehicke for approximately 75 minutes. Slept for several hours, faint feelings subsided after 15 hours.

After 10 minutes of vaccination, patient was sweating and dizzy. Ambulance team arrived check the vital signs which were stable. Patient was alert and conscious at the movement. He indicated that he wanted water. The ambulance team allowed him to drink about 1 sip (10-15 ml) of water. Then he had tachycardia. Then ambulance took him to the hospital. His wife was with him.

Appx 3 hours post-injection, developed Acute STEMI, Proximal LAD lesion, and had aspiration thrombectomy and drug eluding stent placement.

Got heaviness in chest and ring finger turned white and numb around 8:30 a.m. Got heaviness in chest again around 6:00 p.m. and it would not subside so I went to the ER and they gave me 3 nitroglycerin and did several tests to check my heart but could not find anything wrong. I am scheduled for a stress test April 20. The person in the bed next to me had similar symptoms and received he Janssen vaccine the same day I did but about 10 minutes earlier.

patient called and notified us that the was having symptoms of headache, fatigued, weakness, and chest heaviness a day after receiving the Janssen COVID immunization. Symptoms present for 4 days. Patient sent to ER for evaluation of chest heaviness on 4/13/2021 when patient called office.

Patient experienced nausea. Also her irregular heartbeat kicked in. Patient had shakes for about 15 minutes. Eventually we decided because of heart and weakness to transfer to hospital for follow up. Patient as of 6pm 4/13/2021 is fine.

About 10 minutes after getting the shot, while waiting in the Doctor's waiting room, I began to feel dizzy and began sweating. They moved me into an exam room, and which time I passed out. I was awoken by the doctor standing over me, rubbing my chest. I was subsequently transferred to the ER.

Patient received vaccine at mass vaccination clinic. Proceeded to observation area and fainting sitting in chair. Patient protected in chair from fall but loss consciousness 2 more times. Episode lasted 46 minutes. Patient given ginger ale and recovered.

Pt reported to Urgent Care with paralysis and numbness on his left side. Left-sided neck pain radiating into the top of the shoulder.

The patient had a ventricular fibrillation cardiac arrest on 4/12/21. He has new complete heart block requiring transvenous pacing and myoclonic jerks. The latter are likely a result of hypoxic brain injury.

Per patient's sister, Patient was administered the Janssen/Johnson & Johnson COVID-19 vaccination on 3/23/21, then on 4/3/21 he was hospitalized for a brain bleed and has been hospitalized in the ICU ever since.

I was fine until the vaccination, 8 days later after running a low fever for the 8 days I got tested positive for COVID-19. I have had severe breathing issues and am still not well. I started 6 days ago and is not gone. The vaccine should be outlawed. I have never in my life been so sick after the vaccine!!!!!

Patient was diagnosed with a DVT. Also had symptoms of nausea and vomiting which preceded the vaccine.

PATIENT CALLED AND STATED THAT HE HAD A HEART ATTACK ON 3/14/21. (TEN DAYS AFTER THE VACCINATION) HE STATES THAT HE CALLED THE DEPARTMENT OF HEALTH AND WAS TOLD TO CONTACT THE LOCATION WHERE HE RECEIVED THE VACCINATION.

Patient presented with with on going shortness of breath. Patient was swabbed and diagnosed with COVID-19. CT of the chest shows that the patient had bilateral pulmonary emboli. Patient is currently being treated at our hospital for COVID-19 and PE

I received the Janssen vaccine on March 13. By the next weekend, I had what I thought was a spider bite on the inside of my left thigh. That "bite" got worse--bigger, hot to the touch, and then red. On the weekend of the 27-28 of March, it was red, raised and very painful even when not touched. I called my family doctor on Monday morning, the 29th of March, and I was sent to the Emergency Room, where I was diagnosed with a 7cm thrombosis in my left greater saphenous vein, which is treated the same as a DVT. I was treated first with Lovenox injections, then Eliquis 10 mg 2x daily, now 5 mg 2x daily. The blood clot is still painful to the touch.

Experienced a TIA (Transient Ischemic Attack - mini stroke) approximately 40 hours after receiving vaccination.

Patient started with Left lower leg pain and redness on 4.1.21. Went to Emergency dept on 4.4.21 and diagnosis of Left leg cellulitis and prescribed Doxycycline. Patient came to PCP office on 4.6.21 with worsening left lower leg pain and swelling. Order L lower leg doppler. Diagnosis of L lower leg deep vein thrombosis of tibial vein on 4.7.21 and prescribed Apixaban 5mg 2 BID x 7 days on 4.7.21

Superficial vein thrombosis in left thigh that was reported to a primary care provider on 3/19, 6 days after the vaccine was given.

Received the vaccine approximately 12:22 PM on Saturday, April 10, 2021. At approximately 6:55 pm that same day (Saturday, April 10, 2021) my husband collapsed in our living room. I called 911 and the operator talked me through how to do chest compression CPR on my husband until the paramedics arrived. My husband was then taken by ambulance to hospital where doctor performed an emergency procedure wherein he removed the blood clot in one of my husband's stints (he has three) that he had put in in 2017. Doctor was able to eventually stabilize my husband's heart. My husband spent 5 days in the hospital as a result of this.

Left leg pain started about 4/16/21. Reports evaluated by nurse practitioner at the medical office of primary care provider on 4/23/21. Ultrasound ordered a hospital and diagnosed with a blood clot in the left leg on 4/23/2021. Placed on a "blood thinner" to take orally BID for one month then once daily for undetermined duration. States MD is not considering the vaccination as the reason for the blood clot because of the duration of time between when the vaccine was given and the onset of the blood clot. When asked, pt reports a platelet count was done.

Johnson and Johnson COVID Vaccine use for COVID-19 under Emergency Use Authorization (EUA): Patient admitted to hospital for myocardial infarction one week following the J & J COVID-19 Vaccination. required emergent PCI with drug-eluting stent for occluded left anterior descending coronary artery. Patient subsequently developed congestive heart failure and a left ventricular thrombus requiring long term anticoagulation therapy.

He received the vaccine, had very painful going in and tingling going down his left arm and to the elbow which was numb, and the left little finger was numb, and a dizzy spell afterward which was typical for him. He then on the 9th day had extreme intercostal pain in the ribs on the right side and his right shoulder extremely painful, low grade fever, chills, fatigue and inability to draw a full breath. He called the doctor and they were on the way to the clinic they told him to go to the ER based on his symptoms. He went to the ER and they admitted him and did blood work, and then did a chest x-ray, then a chest CT scan and it was positive for pulmonary embolism. He was treated with an anti-inflammatory through the IV and a blood thinner to the stomach. He was hospitalized for 1 full day, and discharged home with Eliquis double dose for 14 days and then a single dose until further notice. He is still having fatigue and aches on the right side of his brain and aches in his feet, but is to see a pulmonologist for his lungs, as it will take up to 6 months for it to resolve. He also has damage to the right side of the heart and lung. Is waiting to get a CT of the brain.

Flu-like symptoms chills fever up and down shortness of breath itchy skin dry cough shaky hands restless urinating frequently urination blood clotting in calves

hx RA on Humira, HTN, IDDM, obesity, OSA untreated, essential tremor, TIA's, recent J&J covid vaccine on 4/8. He began developing symptoms of covid on about 4/14, testing positive on 4/16. Presented due to COVID 19 symptoms including dyspnea.

Systemic: Unusual heavy nose bleeding -Medium, Additional Details: Patient wife called pharmacy 5/6/21, reporting heavy nose bleeding starting 5/5 and continuing until today. RPh on duty instructed to have pt seek medical attention

Site: Pain at Injection Site-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Tingling was only located in fingers and hands. Patients Blood Pressure after event was recorded at 106/58. Patient states he naturally runs lower blood pressure and heart rate. Also mentioned that he has a fear of needles.. Patient is now responsive and feeling better.

Started at 430 am on the 13th of April, my stomach started hurting. It does not matter if or what I eat, it still hurts. I got headaches, those have also continued since the 13th. The following week my mouth began to hurt, I started coughing more than normal. First a dry cough, now I'm coughing up phlegm with specks of blood. And I can not stop itching, and I'm getting tired of taking benadryl for it. I contacted my doctor, all I got was these are normal reactions to the vaccine. They last 2 to 4 weeks. I already get migraines, my gut is picky since that shot. I used to eat hot peppers, now if I use pepper on my dinner my stomach is in pain. These side effects should be gone by now. I am one pissed off person.

Janssen COVID-19 Vaccine EUA. Severe headache in the night of Vaccine followed by vomiting. Sleepiness and disorientation the next two days. Hospital ER and discovery of bleeding in the brain and admission to the NICU

Temporary partial blindness in the left eye. Event lasted 1 minute. One quarter of the top portion of sight in my left eye was blocked by what appeared to be a dark curtain, this went away after 1 minute. Had an exam by eye doctor the same day , no eye problems were found. Had an exam by cardiologist the following day. He prescribed a imaging order for a head scan and prescribed Clopidogrel 75 mg and to monitor a fib for 30n days with Apple Watch.

I started to get a weird feeling in my chest a week after the vaccine. It was a burning sensation and I thought it was vaping at first. It started to get worse and worse. A week later I went to the ER and they ran some tests. After testing it was confirmed that I was having a heart attack. I had blot clot in my OM1discovered on 04/07/2021. I had had an angiogram in 2019 and there were no problems then. I was hospitalized for four days and I was given a Stent which ended up getting a blood clot. The original Stent was removed and a larger one was put in. I am now taking some blood thinners, Aspirin, Atorvastatin, Carvedilol 6mg, Prasugrel 10mg, and I am scheduled to see a cardiologist because I still a have a little chest pain.

I experienced day after vaccine, really horrible chest pains. I went to ER after 8 hours, and had blood pressure 160/100 and pulse of 120. They did x-rays, treated like a heart attack and gave me medicine for an ulcer and some other type of injection placed in IV line. On Sunday I have breathing issues, wheezing and could not catch my breath.

CARDIAC ARREST (SEVER CHEST PAIN); CLOGGED VEIN; LEFT ARM GOES TO SLEEP; This spontaneous report received from a patient concerned a 62 year old white male. The patient's past medical history included blood clot, heart attack, lump in leg, and stents in main arteries, and concurrent conditions included heavy smoker, and heart issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808025, expiry: UNKNOWN) dose was not reported, 1 total administered on 12-MAR-2021 to left arm as prophylactic vaccination. The patient was previously treated with clopidogrel bisulfate for blood clot. On an unspecified date in 2021, Laboratory data included: Echocardiogram (NR: not provided) unknown, and Lab test (full workup)(NR: not provided) unknown. On an unspecified date in Mar-2021, a week later vaccination, the patient experienced that left arm went to sleep which felt worse next day, on 25-APR-2021, patient experienced severe pain in chest, called ambulance and was taken to hospital. On same day patient was hospitalized. Patient went to full cardiac arrest twice same day. It was stated that vein that was 60 percent good earlier was 100 percent clogged (clogged vein) in one month after getting the vaccine. They tried to put stent in, clear vein out, and put piece of metal and expanded it, to make alley way for blood flow. Patient stated that patient would not take Plavix this time. According to patient, stent was reacting with Plavix, and decided to take something different. They did same job twice. It was stated that patient was discharged on 05-May-2021 from hospital. On 12-MAY-2021, patient went to consult the health care professional to make sure everything was okay. The patient gave lot number 1808025, then stated that, patient thinks it is 180, and then either 5 or 8, and next it was either D or 0, and then after the space it is 25. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cardiac arrest (sever chest pain), left arm goes to sleep and clogged vein was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210523134-COVID-19 VACCINE AD26.COV2.S-CARDIAC ARREST (SEVERE CHEST PAIN), CLOGGED VEIN. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE

Light-headed, vertigo, fast pulse, high blood pressure over 2 days. EKG was negative. Holter heard monitor results pending

I had severe dizziness and difficulty breathing where i just could not catch my breath, and something was going on with my heart where my heart was doing flip flops, I took benadryl for the breathing issue and caffeine for the chest issue. the symptoms lasted two days and were very severe.

Today 7/8/2021 patient walked into the Pharmacy and reported that he had adverse reaction as result of his Janssens covid-19 vaccination from 4/8/2021. he reported that he had headache for three weeks which went away, then on June 4th 2021 he was coming down a stairway and passed out. He was take to urgent Care and was treated for Hypertension and re-aggravation of concursion according to patient.

Significant change in blood and imaging tests after the vaccine compared with the same tests prior to the vaccine. They had been stable to improving for several years.

Excruciating Inflammation, blood clots, pains in joints and muscles, and burning nerve sensations in legs/feet and slight numbing in hands.

In May patient noticed progressive painful lower extremity edema (left greater than right). On June 11, patient came to the hospital with sudden onset dyspnea, palpitations, lightheadedness and dizziness while refereeing a basketball game. Ultrasound of lower extremities found non-occlusive thrombus in the left common and profunda femoral veins/occlusive thrombus throughout the left femoral vein/popliteal vein, and tibioperoneal trunk. Patient started on heparin drip and admitted to stepdown unit for concern of submassive PE given elevated BNP, DVTs, and dyspnea, and confirmed via VQ scan. Patient was transitioned to oral anticoagulation (apixaban). Swelling of legs greatly improved, and dyspnea improved though cough persistent by the time of discharge. Of note, patient also has a history of elevated PSA (to 80s), but patient has not seen urology for follow-up for possible malignancy. Patient also found to have UTI (klebsiella) secondary to his chronic urinary retention.

Pt was held for 15 minutes. Past 15 minutes, patient was ready to leave but complained of nausea. Asked pt to stick around. Took blood pressure. It was low ~90/55. Asked again how he was doing, stated okay but feeling chills/cold. Started to shake uncontrollably. Ask pt if he thought a hospital visit was necessary; he stated no at that time. Decision was made to call squad; BP was elevated now and still shaking. Transported at that time.

Four hour after injection I started to shiver almost uncontrollably. My temperature around midnight spiked to 103 and my heart rate was constant at 150. I was dizzy. Very little sleep. Temperature broke at 4:00AM

At 9:15 pm. he took three steps and he started shaking. Got home and went to sleep, woke up every couple hours with a stabbing chest pain, chills and sweating. About 10:30 a.m. the next day, he took 800mg of Ibuprofen and slept for a while and feels better.

Patient passed out after receiving janssen covid-19 vaccine. There was no injection site reaction, no wheezing, or rash/hives. Patient had vision loss, dilated pupils, sweaty, unable focus or respond to use questions being asked, and was having trouble hearing-said he had ringing in his ears. We were able to lay him on the floor without injuries-he did not fall. I was fanning him and we were talking to him. He got a little worse but then got better. When he was better, he said that he had passed out before when having blood taken. He did not mention this to me before the vaccine was administered. I do not feel that the Janssen COVID shot was the cause, I think he just passes out from injections or needles. We did call 911 when he was getting worse. By the time they got here, he was better but they did check him.

The patient presented to the ER after having the vaccine several hours earlier in the day complaining of chills, shortness of breath, chest tightness, abnormal jaw movements and twitching of his eyelids with uncontrollable movements of his eyes as well.

PATIENT WAS ADVISED TO WAIT FOR 15 MINUTES. THE PATIENT AFTER LEAVING THE PHARMACY FELL ON THE GROUND REPORTED BY ANOTHER PERSON WHO CAME TO THE PHARMACY. HE SAID HE GOT DIZZY AND FELL AND SUFFERED A WOUND ON HIS HEAD. PARAMEDICS CAME AND THE BLOOD PRESSURE WAS FOUND TO BE LOW. PATIENT WAS BROUGHT TO THE HOSPITAL

Sx: Perfuse sweating, loss of consciousness, vomiting, inability to answer questions, decrease in HR, loss of color to face. Txt: HR, observation, patient remained seated as they were seated when they lost consciousness and were vomiting concurrently, 911 called, BP, HR taken Outcome: Post emesis patient regained consciousness within 2 minutes regained normal color and was alert and oriented

POSSIBLE SYNCOPE-PT FELT DIZZY PULSE WAS 51, BP WAS 133/91. FRONT ASSOCIATE CALLED 911 AND AMBULANCE CAME AND REFUSED TO GO AND WAS ABLE TO GET UP AND WALK OUT

After vaccination, pt sitting in observation area. Patient fell to right side out of chair and hit his head on concrete wall while falling. Pt was unresponsive, diaphoretic, and pale after fall. Unresponsive for approximately 30 seconds. ?The last thing the patient remembered was feeling like he needed to take his mask off. Next thing I knew, everyone was standing over me.? Patient denied history of passing out. Patient was transported via stretcher to outside ambulance where he was evaluated. Pt refused to be transported to hospital. Follow up call to patient 4/7/2021 at 6pm ? Pt states bp elevated, but hx of hypertension. Patient calling PCP to discuss medication. Pt adivised if problems arise, call 911 or go to ER.

Severe head ache began approx. 2- 3 hours after injection. Followed by fever of102 degrees. Day two fever persisted, nauseous, weakness. Spent entire week with high fever, averaging 101-102 degrees. Day 4 severe diarrhea and vomited. Fever finally broke on 4/11. Currently have heavy chest, cough and weakness. Have spent entire week in bed using Tylenol only.

I experienced after my J&J vaccine, tinnitus worse, R>L. I got skin rashes, eczema on my face and scalp and nose bleeds. I also experienced chills,, fatigue for the first two days. I still continue with skin rashes, eczema on my face and scalp and nose bleeds. I have been seeing my ENT and PCP at this point since I still continue with symptoms.

around 3 AM patient got dizzy and passed out. When I talked to patient at 6:30 AM, he stated to me that he was dizzy and fell during the night, his voice was very slurred and I could hardly understand him, he was also very disoriented. Took him to hospital ER around 7 AM

FATIGUE; BODY ACHES; HEART PALPITATIONS; LOW GRADE; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included g6pd deficiency.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 28-MAR-2021, the subject experienced body aches. On 28-MAR-2021, the subject experienced heart palpitations. On 28-MAR-2021, the subject experienced low grade. On 29-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, heart palpitations, low grade, and fatigue on 2021. This report was non-serious.

Janssen shot on Mar 12, 2021. On Mar 25,2021 at 10 AM, I woke up with a headache, sore joints, nausea. Also blurry vision and inability to read words on a page. Sensing something wrong, my sister drove me to emergency room at Hospital where I was admitted. I was later told I suffered a stroke. I was in the hospital for 5 days, receiving various tests. (Hospital has all info on record). I am awaiting surgery to remove blockage from carotid artery. Doctor has all my information and should be reporting the event also to VAERS.

63 year old male with progressive weakness at bilateral faces and extremities, LEs > UEs, absent DTRs throughout x 2 weeks. Received J&J vaccine at 3 weeks ago. His current neurological examination and clinical history is suggestive of GBS NEUROLOGICAL EXAM: MSE: A+Ox 3 Language: no aphasia CRANIAL NERVES: 2nd CN: bilateral pupils are equal round and reaction to light, visual field-full 3rd,4th and 6th CN: EOM-I 5th CN: no sensory deficite 7th CN: face: symmetric, not able to smile or blowing air or holding water 8th CN: hearing loss: no 9, 10th CN: no dysarthria, palate movement:normal 11th CN: no neck weakness 12th CN: tongue: middle, no atrophy MOTOR EXAM: Tone: normal Strength: 4+/5 at bilateral UEs, 4 Pt symptoms started very early. Narrative from family below: "Day 1 (The day he took the vaccine): My father was complaining of very heavy chest pressure (said he felt like his chest was being pushed down with force.) He felt really tired and had a nasty headache. Day 2 He began to feel tingles in his legs and arms. Said he felt sore and had mild pain around his back, feet, legs, hands, and arms. The headache came in and out. Day 3 He began feeling more severe pains in both legs + headache. More tingling around his face, lips, and jaw. Day 4 Severe pain continued around his entire body. Had an episode where he lost vision from 1 eye (he described it as blurry vision) felt like he was going blind from one eye. Day 5 Could barely stand on his two feet and could no longer go to work. He stayed in bed and then hospital visits began. My mom took him to emergency for the first time. I was able to get details of the location where he was vaccinated and onsite contact information. The info is below:

He had his vaccine in different state while visiting his daughter. Returned home and was found to have a blood clot behind his left knee. Also, he called the doctor last week and told him that he believes he has another one above the left ankle. He has an appointment on Thursday to see him again. He had two venous ablation procedure in both legs in late November/December of 2020. He was taken off of the baby aspirin and then put on Xarelto. The 2nd possible blood clot appeared about 10 days ago above the left ankle.

started coughing on 03/27/2021 and was taking to hospital on 03/30/2021. There he was treated for blood clots with anticoagulants and a filter placed in the vena cava.

Patient reports that several hours after receiving the vaccine that he became short of breath, he was taken to the hospital via ems, Diagnosed with blood clots at hospital. Reports he is now on blood thinners. I spoke with the patient and told him I would be reporting this information and that he may be contacted.

5 hours after had mild stroke like effects to include blurred vision followed by headache. 5 days after had muscle and joint aches in the night which are continuing.

PATIENT DEVELOPED RIGHT POPLITEAL DVT IN LEG AFTER JANSSEN/JOHNSON AND JOHNSON VACCINATION. PRESENTED TO MEDICAL GROUP 2 WEEKS AFTER VACCINATION WITH A 2 WEEK HISTORY OF LEG PAIN AND WAS DIAGNOSED AT THAT TIME. HE RECEIVED JOHNSON AND JOHNSON VACCINE AT MEDICAL CENTER.

Patient had severe pain in one leg since 03/14/2021 Went to the emergency room on 03/21/2021 where he was notified that he had a clot in his lung. It caused a bilateral pulmonary embolism.

Monday - extreme tiredness, some chills running nose Tuesday - deep chills temp 95 deg, pulse running 30-40 pts higher, blood pressure ok, visited Dt , said it could be reaction to Janzen shot, said i need to hydrate better, drink lots of Gatorade Friday - Went to Hospital ER, Oxygen level low 90, temp 103.4, high bp - IV'd, Tested positive for Covid -19 gave me 4mg methylprednisolone - 4 days

Patient reported on 04/21/21 that he has experienced severe headache for 10 days, increase in blood pressure (189/82, 171/82 vs regular values for him of 150/77), increased blood glucose ( afternoon reading of 289 vs usual 140), abdominal pain, leg pain, all of this for about 10 days. Patient is reporting that he is feeling better and has seen the doctor today.

Found seizing approximately 48 hours after vaccine. It was confirmed that he had a stroke on 3/12/21.

Patient presented to the ER with chest pain, non radiating, heavy weight. Patient was found to have acute DVT.

3/16 - 3/23 : fewer ( 100 -101 F), headache. used Tylenol 3/24 : fewer, headache, nausea, vomiting. used Tylenol 3/25 : fewer, headache, watery eye. stayed in ER. diagnosed sinus infection. treated with Amox/clav 875mg-125mg; claritin; Tylenol 3/26 - 3/28: fewer, serious headache, double vision. continue used butal/apap/caf 50-325-40; Amox/clav 875mg-125mg; waiting for schedule MRI. 3/29 - 3/31: fewer, serious headache, double vision. stayed in hospital. continue used butal/apap/caf 50-325-40; Amox/clav 875mg-125mg.

Feel winded, short of breath, with moderate physical exertion . ex briskly walking up a long flight of stairs a couple of time wearing a mask caused me to breath every hard. Seems more than normal....I had to keep the mask on Typically, with heavy physical exertion I would feel this way. Also, The first time this happened I did feel a little light headed and noticed a higher than normal heart rate.

Patient had the Janssen vaccine as noted. He presented with significant superficial clot in the lower leg. Ultrasound read Mixed partially occlusive and occlusive superficial venous thrombosis in the right greater saphenous vein. This originates 2.2 cm from the junction with the right common femoral vein. He presented with 2 days of leg swelling without clear trigger such as travel, trauma etc.

AE = PE/DVT. Difficult to say if vaccine played an ancillary role (very short time course). Treatment = anticoagulation with apixaban. Outcome = patient discharged from hospital in good condition after 2 days.

BLOOD PRESSURE INCREASED 147/60; TACHYCARDIA; ACHINESS; FATIGUE; SEVERE LEG PAIN; UNABLE TO WALK LONG DISTANCES; SORENESS IN ARM; This spontaneous report received from a consumer concerned a 63 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total dose administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the patient experienced soreness in arm. On APR-2021, the patient experienced unable to walk long distances. On APR-2021, the patient experienced severe leg pain. On 01-APR-2021, the patient experienced fatigue. On 05-APR-2021, the patient experienced achiness. On an unspecified date, the patient experienced blood pressure increased 147/60, and tachycardia and his EKG came back clear on a suspected heart attack. His blood pressure was normally low. On 19-APR-2021, the patient was hospitalized. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 147/60 mmHg, 110/60 mmHg. Treatment medications (dates unspecified) included: sodium chloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood pressure increased 147/60147/60, had not recovered from soreness in arm, unable to walk long distances, fatigue, achiness, and severe leg pain, and the outcome of tachycardia was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0 20210440548-COVID-19 VACCINE AD26.COV2.S-Blood pressure increased, Tachycardia, Unable to walk long distances and Achiness. This event(s) are considered unassessable. The event(s) have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). V0 20210440548-COVID-19 VACCINE AD26.COV2.S-Soreness in arm, Severe leg pain, Fatigue. This event(s) are labeled per RSI and are therefore considered potentially related.

Employee developed a fever and chills on 01-Apr-21 which he managed with Tylenol. Symptoms resolved as per patient who contributed the symptoms as a result of the J&J vaccine. On 10-Apr-21 he developed a cough and requested a day to rest. On 11-Apr-21, he went to Hospital to be evaluated by the physician who ordered some labs which were normal. He was then advised to complete PCR swab and was notified on 12-Apri-21 that his test is positive. As per the protocol, all COVID-19 positive individuals must report to the Health Center within 24 hours of notification and complete 10 days home isolation. During isolation, on 17-Apr-21, patient developed hemoptysis and difficulty breathing a breathing and notified his supervisor who called 112 for an ambulance. He was transferred to Hospital. Evaluated and started treatment for pneumonia and was transferred to Hospital on 18-Apr-21. His condition started declining on 21-Apr-21 as he became hypoxic and tachypneic and was subsequently sedated and intubated. As he became HD unstable, Levophed and Vasopressin were started and reached maxed doses. On 25-Apr-21 Dr. from the hospital called and stated that patient expired at 0830.

Patient received Johnson Johnson COVID vaccination on March 5th (Its not listed as an option for me to choose - Hence Janssen). Two weeks later patient and wife described symptoms of significant abdominal pain and headache, which improved after 24 hours, since then, abdominal pain on and off with worsening, nausea vomiting and diarrhea. Presented to Hospital with sepsis, negative evaluation, possibly GI etiology, given symptoms. MRI of the abdomen shows left portal vein thrombosis/which is an unusual site. Patient has no liver cirrhosis or metastatic cancer. Is being investigated for idiopathic or acquired thrombophilia

On Jan. 26, 2021, I had an accident at home an suffered broken ankle, tibia and fibula broken from tarsus. I was rushed to hospital and had ORIF surgery. I later found out the surgeons failed to order blood thinners and about a month later, I was rushed to the hospital with 5 blood clots, one in each lobe or each lung and one forming in the calf muscle on the left leg. I have been taking Eliquis since late February and will be on it through May. I have had an echocardiogram which was normal but the doppler I had on my legs may have indicated the problem is still on-going. I don't know yet. I did contract JCCT to ask if I should get checked out due to recent clotting incidents and was told I did not. I decided I should report it anyway and my clotting situation probably has nothing to do with vaccine but I just want to make sure.

UNKNOWN CAUSE OF DEATH; ELEVATED HEART RATE; HYPER RESPIRATIONS; FLU LIKE SYMPTOMS; MENTAL CONFUSION; WEAKNESS WORSENED; This spontaneous report received from a consumer concerned a 63 year old male. The patient's height and weight were not reported. The patient's pre-existing medical conditions included the patient did not had medical and underlying condition and was healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 041A21A, expiry: Unknown) frequency one total, dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The patient was not taking any concomitant medications. On 03-APR-2021, the patient experienced elevated heart rate, hyper respiration, flu like symptoms including chills, weakness, fatigue, cough; the patient also had mental confusion and nausea. He was called in urgent care centre and they treated him with over the counter medications, Tylenol (paracetamol). On 16-APR-2021, the patient died due unknown cause. The daughter stated that she was taking him to emergency room the day he passed away. It was unknown if the autopsy was performed. The cause of death was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of unknown cause on 16-APR-2021, had not recovered from mental confusion, and the outcome of weakness worsened, elevated heart rate, hyper respirations and flu like symptoms was not reported. This report was serious (Death).; Sender's Comments: 20210439259-COVID-19 VACCINE AD26.COV2.S -Unknown Cause Of Death. 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.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH

Emergency room with symptoms of cough, fever, phlegm and sinus congestion since 4/14. He had an outpatient COVID test positive on 4/16. His fevers reoccurred so his PCP obtained a CXR showing atypical pnuemonia, started him on azithromcyin and solumedrol on 4/22. He presents today with worsening shortness of breath, now hypoxic on day 9 of his infection. He got the Johnson & Johnson vaccine on 4/7.

Developed Covid 19 infection 28 days after Johnson and Johnson vaccination. This was further complicated by bilateral pulmonary embolism requiring mechanical thrombectomy and ICU admission.

Within a minute I had a hot flash that started in my calf and went through my body. In less than a minute I was lightheaded and almost passed out (or fell asleep). I beeped my horn and the nurse came right over. They took my blood pressure and it was 150 over 120. (I've never had high blood pressure before. The second reading was 140 over 110. In about 5 minutes my BP was normal 120 over 80.

One week after vaccination, I had to all 911 and was put in the hospital, I had a stroke, I had a blood clot in my brain, and severe abdominal pain, and terrible headache where the clot was, I couldn't see, my legs weren't working right. My head was sensitive on the right side, like a tingling and sore to touch, then the headache started in the center of my head. I stayed in the hospital for 3 weeks. I'm home but have slurred speech and I use a walker now.

Four days after the vaccine I felt a little chest tightness but the next day it was very scary like a weight on my chest. I also had a cough that was an uncontrollable tickle and then I had trouble catching my breath. I went to the Urgent Care they just thought I had Acid Reflux.. Seven days after my cough was worse and I was very short of breath and I had very bad night sweats. I went to the doctor he gave me Asthma medicine. Two weeks after the vaccine I went back to the Urgent care and they thought Bronchitis. I went back to the ER and I saw a Covid-19 doctor and he thought I had Covid-19 symptoms. He gave me Prednisone and Azithromycin. I took the Prednisone for ten days and I finally started to feel better. I was trying to chew some fresh ginger helped the cough. I have a Heart Echo scheduled next week and I am still a little short of breath. Before the shot I used to walk two or three miles a day and go fishing every day but I can?t do that right now. At least I am back to 80% now which is better.

DIARRHEA; CHILLS; UNBREAKABLE FEVER OF 104F; CARDIOGENIC SHOCK; KIDNEY FAILURE; IMPAIRED LIVER FUNCTION; HIGH BLOOD PRESSURE (200/100); ABNORMAL WHITE BLOOD CELL COUNT (16000); BLISTERS ON CONJUNCTIVA OF BOTH EYES; This spontaneous report received from a physician concerned a 63 year old white male. The patient's weight, height and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) frequency one total, dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The physician reported that one day after receiving vaccine, on 08-MAY-2021, the patient experienced nausea, vomiting, shortness of breath, diarrhea, fever, chills, sweats, and severe chest pain. The patient was admitted to hospital for suspicion of heart attack. He was checked and no blockages were found. Laboratory data included: Scan (NR: not provided) No blockages were found. On 10-MAY-2021, he was transferred to another hospital where he was currently on a ventilator. The doctor reported that he had had fever of 104 f that was unbreakable. His blood pressure was 200/100 mmHg and his pulse oxygen was not good. His white blood cell count was 16000 and he was tested negative for covid-19. The doctor also reported that patient was in cardiogenic shock and was in kidney failure. He reported that the patient's liver function was getting better and patient's face and chest was very red. The patient also had blisters on conjunctiva of both eyes. It was unknown where patient received the vaccine as of this time. No further information was available since doctor had patients to see. Laboratory data included: Blood pressure (NR: not provided) 200/100 mmHg, Covid-19 virus test (NR: not provided) Negative, Body temperature increased (NR: not provided) 104 f, Pulse Oxygen (NR: not provided) Not good, and White blood cell count (NR: not provided) 16000. The patient was admitted to the hospital on 08-MAY-2021 and the duration of hospitalization was 6 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from impaired liver function, had not recovered from blisters on conjunctiva of both eyes, kidney failure, abnormal white blood cell count (16000), high blood pressure (200/100), cardiogenic shock, and unbreakable fever of 104f, and the outcome of diarrhea and chills was not reported. This report was serious (Hospitalization Caused / Prolonged and Life Threatening).; Sender's Comments: V0: 20210525538-covid-19 vaccine ad26.cov2.s-cardiogenic shock, kidney failure, impaired liver function, high blood pressure (200/100), abnormal white blood cell count (16000), blisters on conjunctiva of both eyes, diarrhea, chills, unbreakable fever of 104f. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Patient presented to hospital emergency department on 5/19/2021 with complaints of headache, myalgia, nausea, vomiting with hematemesis and severe abdominal pain (rated 8/10) that began on the 5/16. Patient started on argatroban for treatment of mesenteric vein thrombosis. Treatment course pending.

HEART RATE INCREASED; HEART RATE UNSTABLE; FELT LIKE FIGHTING COLD OR FLU; RESPIRATORY TRACT CONGESTION; VOICE NOT NORMAL; FATIGUED; This spontaneous report received from a patient concerned a 63 year old white (non-Hispanic or Latino) male. The patient's height, and weight were not reported. The patient has not been on any medication and had not seen a doctor for years as he had been feeling really good for years until the last 7-10 days. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, 1 total dose administered on 08-APR-2021 in the late afternoon to left arm for prophylactic vaccination . No concomitant medications were reported. The patient used fitbit and his resting heart rate was high 50s or into 60s beats per minute. On APR-2021, the patient reported that he had been fatigued the first 2 days by following the shot (laid down and watched tv), then went back to normal. Starting one week to 10 days ago, on MAY-2021, his resting heart rate increased to in the 90s beats per minute which could not get below that. On 11-MAY-2021, the patient's heart rate became totally unstable and he had to go to emergency room at 11:00 with heart rate spiking in the 190s beats per minute. His heart rate was in the 180-190s beats per minute, but it was bouncing all over (for example 120, 90, then 190s beats per minute.) Heart rate would bounce around within seconds of each other. He was transferred into hospital and admitted to hospital on 11-MAY-2021 at 22:00 until 12-MAY-2021 at around 17:00. The patient was hospitalized for two days also was put on medications (blood thinner, beta blocker and another medication) while in hospital. It was reported that in hospital they were going to use paddles to shock, but heart rate stabilized on it's on so he was able to be discharged. On 12-MAY-2021, while in hospital heart rate stabilized to around 74 beats per minute. If he moved around at all heart rate went back into the 90s beats per minute. He told that this never happened to him before. On 13-MAY-2021, the patient reported that heart rate high around 80s to 90s beats per minute while resting and over 100 beats per minute when moves around. On MAY-2021, the last 7-10 days he started feeling fatigued, like fighting some kind of cold or flu (but didn't have either) and chest congestion, voice was not normal. He felt like having vaccine response or immune response. This was still going on. Laboratory data included: COVID-19 virus test (NR: not provided) negative (units unspecified), and Heart rate (NR: not provided) 190s beats per minute. Treatment medications (dates unspecified) included: metoprolol tartrate(Lopressor), and apixaban (Eliquis). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart rate increased, felt like fighting cold or flu, respiratory tract congestion and voice not normal, fatigue and heart rate unstable was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210525842-Covid-19 vaccine ad26.cov2.s-Heart rate increased ,heart rate unstable. These events are considered unassessable. The events has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.

LOC with cardiac arrest within 15 minutes of injection. CPR started and patient did recover on his own. EMS transported to ED.

Patient has severe phobia of needles. About 10 minutes following administration of Janssen vaccine, patient began turning pale and said that he felt dizzy. Moments after, patient fainted and was out for about 30 seconds. During this time, 911 was called and then patient came to but was still very pale and lips were blue. EMTs came minutes later and took patient to ambulance to be checked out. Patient was feeling better by then and did not leave in ambulance.

I didn't have anything for two weeks. But then a lot of pain in arm. from a sound sleep. I took ibuprofen. Over the next few hours, the pain radiated down my left arm. Wave would come and go (of pain). The pain came on to my chest - and I decided to go get check. Had very low energy for about four days - after that. My left arm, I lost the strength in it - I could barely lift 10 lbs over my head. Swimming - I couldn't pull my arm with my elbow high - I could barely skim the top of the water. This is still happening. I had a doctor appt - yesterday but that was for arthritis pain that is in my knees, wrists etc - he gave me arthritis medication and I noticed the positive affects of it already. But it didn't address the arm that I can't pull up over my head. It seems like my immune system is attacking me- a couple of years ago this happened when I had a virus and it took me almost a year to get that muscle to start working again.

Yesterday felt dizziness and queasy and deep pain in the venter of my chest, about 1am it was exacerbated and felt it was symptoms of a heart attack and I took a baby aspirin.

Combine a status asthmatic event lasting with a serious sinus and chest cold as well as occasional racing heart. That is how I felt. It felt like sudden pneumonia and chronic bronchitis onset. The second day was very serious in the third day and the fourth day I started to regain strength. I received an antibiotic on day 2 after my vaccine. I went from my normal daily activities to bedrest for 3 1/2 days straight. I called out sick from work because of it. I'm glad I was well versed with my chronic illnesses because it helped me handle the adverse event that started after receiving my vaccine. I feel that if I was a normal person I would have gone to the hospital.

My tinnitus is worse on right ear, gotten worse than on my last visit. My tinnitus had not gone away. I I went to see my doctor who ordered MRI of the brain and ears with and without contrast. My MRI was negative, nothing abnormal. Also did a full hearing test, other than normal range of hearing loss. The tinnitus is more variable, louder than it was, get periods of quietness. I have noticed that my tinnitus gets louder during exercise. I can not find rhyme or reason that my tinnitus gets quieter and louder. I have no problem for the CDC to contact my PCP to help with my diagnosis. I also had severe nose bleeds, which have subsided now. My skin rashes are also gone and get treated with topical creams. Before my vaccine, I had oily skin and now I noticed my skin started to get dry, along with tinnitus, and also dry skin on my scalp. When I get dry skin I apply topical lotion.

The patient had symptoms start 5 minutes after the vaccine was administered. The patient was diaphoretic, his blood pressure dropped 20 systolic, he stated he was weak, he was dry heaving and having difficulty breathing. He was administered an Epi-pen by the nurse. The patient stayed in the office for 45 minutes and was evaluated by the physician. After waiting 45 minutes the patient stated he felt good and wanted to go home.

Shortness of breath and chest pains after routine workout at the gym. Got worse thru the day. Went to ER in the evening. Tests for heart attack and blood clots were negative. Sent me home next morning feeling slightly better. Next night (6/2) woke up at 3 am with shooting pains in right leg below knee. Back to ER where they repeated heart tests and did sonogram of leg. All normal. Sent me home again. Symptoms continue to this day with slight improvement. Have follow ups scheduled with Cardio and Pulmonary.

Patient reported back to the pharmacy 1 week after his covid vaccination to inform us that he suffered a stroke shortly after receiving the vaccine. He is currently released but still recovering.

HEADACHES, SOMETIMES BLURRED VISION, AND SLITHG PAIN IN THE STOMACH, ALONG WITH SOMETIMES LIGHTHEADED (DIZZINESS) C.HEST PAINS

Patient's wife stated he has been suffering from blood clots and is currently being treated with anticoagulants.

PASSED OUT; HEART RATE DROPPED; This spontaneous report received from a patient concerned a 63 year old White and Not Hispanic or Latino male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: Unknown) dose was not reported,1 total, administered on 01-MAY-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 01-MAY-2021,after the vaccination, patient was waiting in holding area. After five minutes of vaccination, patient experienced heart rate dropped and passed out. Patient was attended by EMS (emergency medical services). On same day, patient was transported to local hospital for monitoring. After half hour, patient stated that he was normal. Patient was recovered quickly. Patient was released from local hospital in approximately two hours. Patient was consulted with HCP. Patient was little hesitant to have the vaccine. Laboratory data included: Heart rate (NR: not provided) Decreased. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passed out, and heart rate dropped on 01-MAY-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210703705-COVID-19 VACCINE AD26.COV2.S.Passed out. 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.

More tired than before and now have a low red blood cell count, as does my sister and niece, all who got the J&J vaccine. My sister got hers at the same place I did about an hour apart, and my niece got hers a couple weeks later. Now we're ALL anemic. I'm also a heart patient, so it's hit me pretty hard, where all I want to do is sleep. Someone called from VAERS and asked about my text report, and I said nothing was wrong. That's how out of it I've been. These vaccines were given WAY too early to know the long term, or even really, the short term effects beyond a few months. I now regret getting it, and would've been fine to just continue to mask up and social distance.

Patient had autoimmune appearing reaction with rash, iridocyclitis, DVT right femoral vein, thrombocytopenia, lymphadenopathy, aphthous ulcers, pharynigitis rheaumatology consultation, anticoagulation, ophthalmology care, hematology consultation, ENT consultation

Tightening of chest Difficulty breathing Nausea Pain at injection site for over 7 days Fever Tired needing to rest

After receiving the vaccine with in minutes the patients left arm began to swell and bruise. He began to become pale and his eyes rolled back into his head and passed out. He woke up a min later and had SOB. Very pale and almost threw up. Paramedics and Firefighters were called. The eveulated the patients and gave him a liter of sodium choride. His Heart Rate was in the 30's. After several min and a liter of fluid, patient was alert. Once stable he was transported to Hospital.

10 minutes after receiving the vaccine, the patient claimed he was feeling light headed and needed to lay down. After speaking, his eyes then went closed, and he clenched his fists and he started coughing up liquid. He was not responsive. He was moved to the ground and turned on his side. He became alert about 3 minutes after becoming unresponsive. He claimed this happens to him when he is at doctor's offices or receiving vaccines/procedures. He claimed it was "normal." He said he felt fine/normal, and this has happened in the past, though he did not mention this to the pharmacist prior to administration. 911 was called and examined him. He was allowed to go home on his own, did not go to the hospital.

Site: Bruising at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Mild, Additional Details: Paramedics and Firefighters came out. Gave him 1 liter of normal saline. His heart rate was in the 30's. They stablizied the patient and took him to hospital.

Patient received vaccine on 3/13, initially had fatigue and myalgia the day after, which resolved, but also on 3/14 began having mild intermittent coughing, nonproductive, occurring every two hours or less. Patient began having some blood in his sputum since this morning at 4AM, and that occurred twice more with intervals of a few hours, both continuously improving and less blood. No other symptoms. No history of TB, no exposure to sick contacts, no recent travel. Unlikely a pulmonary embolus given normal vital signs and no risk factors. Patient was doing outdoor work in his yard for the past few days before the symptom onset and was working on mulch and compost. Although unlikely to have fungal infection currently, may be bacterial pneumonia

I was being treated for severe mitral stenosis prior to vaccination. The day of vaccination my condition significantly worsened and I was readmitted to hospital. Diagnosed with AFib. I had been AFib negative since a valve replacement two years prior in conjunction with MAZE procedure.

COVID-19 (+) on 3/22/2021 Presented with hypoxemia, cough, dyspnea on exertion. Per ED report, patient had received the Johnson and Johnson COVID-19 vaccine on 3/6/2021 and started becoming symptomatic on 3/19/2021 with dyspnea, fevers, chills, fatigue and cough. He had reported resolution of his fever/chills, however his dyspnea and cough had progressively worsened. He then presented to the ED (3/25/2021 and discharged on 3/29/2021). In addition to his COVID-PNA, he also had a superimposed Pseudomonas PNA and was discharged on Levaquin and oral steroids (Dexamethasone) for a total of 10-day therapy.

Janssen COVID-19 Vaccine EUA , Accelerated Heart Rate of 115 / 120, Acclerated Respirations, Fever with temp of 101.6 lasting for 23 hrs, Extreme body aches, headache, feeling very tired, minor dizziness, minor nausea

Patient had syncope from a sitting position, history of vasovagal syncope, occurred 10 minutes after receiving vaccine. Patient recovered in the recovery area, advised to follow up with MD

Severe burning chest pains extending to arms and upper body on days 2 and 3. Body aches, low grade fever on days 3 and 4.

Light-headedness, high blood pressure, high blood sugar. Approx. 8 hours after injection, blood pressure reading was 163/89. It is going down slightly each day. Blood sugars have been higher than normal, ranging from 140 to 223.

Symptoms: numbness/tingling and cold skin all over body (both sides of body), headache, facial droop, blurry vision. Stoke, CVA.

Blood clots in both lungs. Admitted to the hospital with severe pain in chest, trouble breathing, within 5 days of vaccination. Put on blood thinners to help get rid of the clots. Extreme fatigue before admittance to the hospital as well as ongoing extreme fatigue.

It started from the chest and went abnormal serve pain couldn?t walked. Went to the emergency room and gave me pain.

Patient experienced syncope approx. 5 minutes after receiving dose. Hypotensive with approx. BP of 80/40. Was transported to hospital by emergency first responders

HOSPITAL COURSE: Patient is a 64 y.o. man admitted on 4/8/2021 with hx of HTN, HLD, tobacco use, Hypothyroidism, and OSA who presented with acute right facial droop in setting of 8 days of headaches and paresthesias, found to have acute ischemic stroke. New slurred speech and worsening of facial droop 4/9 AM, but no new findings on repeat MRI. .

Patient received his J&J vaccine for COVID-19 on 03/10/2021. On 3/17, he was at the grocery store when he felt a sting on his left lateral ankle. When he pulled up his pant leg, he saw the small little red spots that were exquisitely tender. He went immediately to his primary care physician's office, where he was prescribed Bactrim for suspected cellulitis. The rash steadily worsened with extension up his left leg and onto his right leg and blistering of some of the lesions most markedly in his groin. Pain associated with the rash increased and remained most severe on the lateral aspect of the left ankle. He presented back to his primary care physician's office on 3/19, where he was given methylprednisolone 80 milligrams IV, discharged with a prescription for prednisone 60 milligrams daily for the next few days. Pain worsened the morning of 3/20/21 to the point that he was unable to bear much weight on the left leg prompting his presentation to the emergency department.

About an hour after I received the vaccination, my left leg fell asleep. That never has happened before. on 4/7/2021, at approximately 1:00 pm, I stood up, got light headed and blacked out for a few seconds. I took my blood pressure and it was in the normal range. I didn't think much of this until the recent reports on the Johnson and Johnson vaccine started circulating. I've had no other issues.

Patient's wife notified our corporate office on 4/15/21 that her husband received a J&J COVID vaccine from our pharmacy on 3/23/2021 and that he passed away one week later, 3/30/2021, in their yard after having a heart attack. Phone number provided is the wife's.

Patient was found on the floor next to his chair facing forward in observation area. When we attended patient alert, awake and oriented x3. Denied any resp distress. No HA. No n/v. Patient has h/o dvt on coumadin. No h/o DM. recommended further evaluation in ER due to patient had syncope, on coumadin, hit his head to ground. But pt declined and signed AMA. patient reported that he will seek emergency if he feels any worsening symptoms.

03/24/21, patient hotel , patient fainted , tried to revive by family , ems was called , patient underwent surgery , patient did not survive surgery , death certificate was for acute infarction and dyslipidemia , patient passed

Patient awoke 04/09/2021 with visual disturbance and limited field of vision. Went to eye center and was evaluated. MD at eye center sent him to ER and told patient that it appeared he was having a stroke. Admitted to medical center 04/09/2021. Patient reports he was diagnosed with a stroke affecting the occipital region that affects his vision. Patient was discharged from the hospital 04/11/2021.

Experienced chest pain. Went to ER. Was rushed in and determined to have Pericarditis - swelling and irritation around the heart.

6 days after receiving the Covid19 J&J vaccine I had sustained arrhythmia of 142bpm for 2 hours & received emergency intervention at the Hospital and 1 night observation. They were able to cardiovert me with abimondiron drip. 17 days later my heart started racing again & I received 2 consecutive shocks from my internal defibrillator and was transported to the hospital and stayed 1 night for observation. 22 days after receiving the above vaccine, I again developed a ventricular tachycardia rhythm & received 2 consecutive shocks and was transported to the hospital and stayed 2 nights. I do have a history of v-tach but prior to being vaccinated it had been two years without any incident of VTach or therapy.

PATIENT WAS GIVEN THE JANSSEN COVID VACCINE. ABOUT 5-10 MINS LATER, PATIENT REPORTED HAVING SOME DIZZINESS WITH SOME CHEST PAIN. BENADRYL WAS PROMPTLY GIVEN @1202PM. THEN AT 1209PM, PATIENT BP WAS TAKING, IT WAS HIGH AT 160s/90s. PATIENT STATED THAT HE DOES HAVE HBP IN WHICH HE DOES TAKE MEDICINE FOR. HE ALSO STATED THAT, AT THAT PRESSURE, IT WAS NORMAL FOR HIM. PATIENT WAS MONITORED TILL AROUND 1245PM, HE STATED THAT HE WAS FEELING BETTER AND HIS WIFE HAS TAKEN HIM HOME. A FOLLOW UP PHONE CALL WAS CALLED AROUND 105PM. AT THAT TIME PATIENT WAS A HOME AND SAID THAT HIS SYMPTOMS HAS SUBSIDE BUT JUST FEELS SLEEPNESS FROM THE BENADRYL.

Patient developed life threatening thromboembolism ( PEs) which potentially could have been caused by the Janssen vaccine

Patient received Janssen vaccine on 4/12 and developed left arm pain a few days later. Presented to the ED with left arm swelling 10 days after vaccination and was found to have a left upper extremity DVT.

BLOODSHOT IN EYE/EYES WERE RED; KNOT IN CENTER OF RIGHT ARCH OF FOOT; NECK HURTS/COULD NOT MOVE NECK; HEAD SWELLING AND TENDER; SLEEPY; HEADACHE; CHILLS; HEART ACHE; This spontaneous report received from a patient concerned a 64 year old African American, not Hispanic or Latino male. The patient's height, and weight were not reported. The patient's concurrent conditions included blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: unknown) dose was not reported, 1 total administered on 08-APR-2021 between 09.30 and 09.40 to left arm for prophylactic vaccination. Concomitant medications included acetylsalicylic acid (Aspirin) for blood pressure. On 08-APR-2021, 20 minutes after vaccination, the patient started having symptoms. The patient's heart started aching and that lasted for 15-20 minutes and then went away. On 09-APR-2021, the patient had chills that had lasted for four hours. On 10-APR-2021, the patient could not move his neck left or right and back of his head felt like it was swelling and tender; he also had a headache, and he was extremely sleepy. The patient's neck and head tenderness lasted three to four days. On 11-APR-2021, the patient eyes had blood shot and were red and reported that he might had a stroke or blood clot. On 17-APR-2021, he had a knot came up in the center of right arch on foot. On 19-APR-2021, at the time of this report, the patient's eyes were still red and had a slight headache; the patient's neck still hurts, he was sleepy, and the knot was still there on his right arch of his foot. The patient took acetylsalicylic acid (Aspirin) but he was already taking that for his blood pressure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart ache on 08-APR-2021, head swelling and tender on 14-APR-2021, and chills on 09-APR-2021, and had not recovered from neck hurts/could not move neck, bloodshot in eye/eyes were red, headache, sleepy, and knot in center of right arch of foot. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This 64-year-old African American (non-Hispanic/Latino) hypertensive male patient reported "heart aching" 20 minutes after receiving COVID-19 VACCINE AD26.COV2.S for the prevention of symptomatic SARS-CoV-2 virus infection. The event lasted for 15-20 minutes. Other associated symptoms developed in the succeeding 3 days: chills that lasted for hours, could not move his neck and felt it was swelling and tender, headache, sleepiness, blood shot eyes. Nine days after vaccination, the patient reported he had a knot in the center of arch right foot. The patient took Aspirin. No other details was reported. The event is confounded by the underlying hypertension. 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.

4/25/2021 - He was apparently well until 2 days prior to admission when he developed spontaneous left calf pain and swelling. He denies any associated trauma, recent travel and immobility. He is not taking any new prescription, including steroids. One day prior to admission, he started experiencing left-sided pleuritic chest pain up to 9/10 in intensity and exertional shortness of breath. He denies any fevers, hemoptysis, sputum production, diaphoresis, nausea, vomiting, abdominal pain, dizziness or lightheadedness. The pain was persistent throughout the day. Today, his chest pain persisted and his shortness of breath had progressed. He also noted left arm swelling with mild discomfort. He felt that his left leg swelling and pain had improved today. Nevertheless, given persistent symptoms, he decided to come to the emergency room for further evaluation management. In the emergency room, his initial blood pressure was 218/104 with mild tachycardia of 99, normal oxygen saturation and no fevers. CBC showed a white count of 12.35, hematocrit of 50.4 and normal platelet count 198. INR was normal at 1.06. BMP showed mild hyperglycemia at 148. Troponin was 5 and BNP was 8. Imaging studies show extensive left upper extremity DVTs that involved the left subclavian vein, left lower extremity DVTs and bilateral lower lobe pulmonary emboli. 4/30/2021 Presumed unprovoked extensive DVT of the left upper extremity and left lower extremity. However, he did recently receive Johnson & Johnson Covid vaccine. Now status post catheter directed thrombolysis to the left upper extremity.

Diagnosed with Bradycardia; Dyspnea; Mobitz Type II A-V Block Low heart rate 30s-40s; Currently monitoring with outcome of pacemaker implant

PATIENT BECAME FAINT ANDTHEN ADMIN UNRESPONSIVE AFTER RECEIVING VACCINE . STARTED TO SWEAT . EPIPEN WAS ADMINISTERED AND PARIENT SLOWLY RETURNED TO NORMAL. PATIENT STATED THAT THEY HAVE REACTION TO INJECTIONS OR NEEDLES AND IT HAS HAPPENED BEFORE AND CONSIDERS IT PSYCOLOGICAL.

Approximately one month after receiving vaccine, he had a left thalamic infact acute (CMS-HCC). The was taken to Hospital immediately and was treated there. Symptoms included right sided paralysis and weakness and slurred speech. Blood pressure was also elevated(184/97). Glucose(286). Hospital stay was three days.

I felt dizzy and had problems with breathing right away after the injection. A doctor from that site who checked my vitals wanted to call an ambulance to take me to a hospital. I couldn't let this happen as I was 120 miles away from my apartment, where two dogs were left unattended. I decided to come back home and monitor my vital signs. Since that time, I had almost every other day a chest pain and high blood pressure and low level of O2 but was too busy at work to care of myself. On 04.30.2021 around 3am I decided to drive into ER at where I was admitted and had CABG surgery on Tuesday 05/04/2021.

BLOOD CLOTS BOTH LEGS; POSSIBLE HEARTBURN; SWELLING AT INJECTION SITE; This spontaneous report received from a patient concerned a 64 year old male. The patients 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: 1805022, and expiry: UNKNOWN) dose was not reported, frequency 1 total, administered on 16-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the patient experienced swelling at injection site. On 19-APR-2021, patient had blood clots (1 in each leg), Hematologist put him on xarelto 10mg, in hospital for few days for blood clots. Patient initially went to hospital ER on 19-APR-2021 because he thought having chest pains or heartburn. Emergency Room ran tests and heart was normal, but found blood clots in his both legs. Lab test (NR: not provided) Heart normal. Treatment medications (dates unspecified) included: rivaroxaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from thought having chest pains/heartburn on 22-APR-2021, had not recovered from blood clots both legs, and the outcome of swelling at injection site was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210504455-COVID-19 VACCINE AD26.COV2.S-Blood clot both legs. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Patient developed acute coronary syndrome, ST-elevation myocardial infarction, and ventricular fibrillation cardiac arrest on April 9, 2021. He had no prior history of coronary artery disease.

Initially I experienced nerve pains across my body, including under both of my armpits, in my groin area, in my arms including my triceps, forearms and they were very sharp pains. Then I started to get a severe headache that was pretty constant. After multiple days, my face became paralyzed. I also experienced severe fatigue. This was over 10 days. Once paralysis happened we went to the Medical Center. I was treated with IVIG for many days and oral steroids. I was in the hospital for 6 days. I also experienced my BP spiking. I had an abnormal EKG. I'm still unable to chew properly. I was told that now I have Encephalitis and GBS (Gillian Barres syndrome).

He received vaccine on 3/10 and on 3/12 was admitted to hospital with a brain bleed. his INR was 10 However he had INR done 3/2/21 and it was 2.5. Dr not sure if related to vaccine or not He underwent surgery on 3/13 and was in hospital 43 days

Three weeks into the vaccine, I ended up having shortness of breathe when I laid down. It has eased up now a little. I started having an intermittent cough due to the vaccine (felt like my lungs were not feeling great) This occurred during the evening and at night when I would lay down to rest. I had a fairly mild case of COVID-19 (tested at the beginning) and quarantined for three weeks. A month later I took the blood test for antibodies (actually had COVID-19 last June which is nearly a year ago before taking the Janssen vaccine). My blood sugar is off the charts and my blood pressure has elevated since taking the vaccine (reason for awaiting an appointment with my doctor).

I started feeling bad the first night. I woke up with energy @ 1am and then later that day I started feeling extremely drain and exhausted and very tired and weak. I woke up @ 11:30pm and I passed out and hit hit the floor, face first and my wife don't know how long I was passed out up to 30- to 60 mins. I had to put frozen meat on my face. I felt like I was about to pass out again. Felt like my legs was giving out. I do have a spinal disease and it felt worse then that. Then it took my headache away. I felt like a different person.

ONCOLOGY/HEMATOLOGY SUMMARY: -4/7/2021. Patient received COVID-19 vaccine Johnson & Johnson. A week later he developed an eruption on his trunk which resolved followed by extensive bruising and asymptomatic mucosal bleeding. -5/4/2021. Leukocytes 7.4, hemoglobin 14.9, platelets less than 5K, creatinine 1.02, liver function within normal range. Initiated dexamethasone 40 mg daily x4. -5/7/2021. Platelets improved to 31K, leukocytes 16.6, hemoglobin 14.5, CRP 3.6, ESR 4. Negative serology for HIV, Hep B, C, tick borne disease. Normal ANA. Normal b12, folate levels, low TSH but normal freeT4. -5/10/21. Platelets decreased to <5K. Started prednisone 1mg/kg at 80mg daily with poor response, thus tapered off in 15-20 days. -5/17/21. Bone marrow biopsy. Results pending. -5/18/21-5/20/21. IVIG 1gm/kg x 2. - 5/24/21. Improved platelet count to 133K/uL

April 20, 2021. PT needed to use the restroom. We stopped, he walked to the restroom, I went to the gift shop. Upon returning, I saw PT sitting on a bench. He was leaning to his left, could not see out of his left eye, very unstable when sitting. We missed lunch, so we thought it was his sugar dropping. I started to feed him jam and a chocolate bar. After 2 hours, his vision returned & he seemed better. He drove us back to the rental cabin. He rested the next 2 days. Then on Friday, we packed up our vehicle and Pt drove us back home. After arriving home, Pt's condition got worse. We went to the Dr, explained the events of the previous week & she came to the same conclusion, Diabetes spell. His condition continued to worsen, we went back to Dr several times, the ER 2 times and finally we got into see a Neurologist. That appointment, the doctor said he thought stroke. Dr scheduled a MRI for June 1, 2021. Results of that MRI was a definite stroke. Now he has started outpatient rehab with no promise he will ever regain full mobility. He can no longer drive, mow grass, walk without a cane and help, etc. Life has changed dramatically for both of us.

Heart rate 186, shortness of breath, profuse sweating. Successfully treated with IV adenosine [ADENOCARD]. Diagnosed as SVT (supra ventricular tachycardia), AKI (acute kidney injury), and dehydration.

Patient had Janssen COVID-19 vaccine on 5/8/21. Developed calf tightness, pain, and swelling 5/13/21. Sought medical care 5/20/21. Diagnosed with DVT 5/20/21

On 6/7/21 I noticed my right lower leg was swollen. On 6/9/21 I went to my PCP and she sent me to get an ultrasound. The Ultrasound showed a large DVT and I was sent to emergency room. In emergency room a Cat scan of my chest was completed and showed several pulmonary embolism. I was admitted overnight and started on Eliquis. I was told to follow up with my PCP.

15 min. after receiving vaccine in left arm, felt tingling in left hand. Two weeks later left arm went completely numb, temporary loss of fine motor control, ok after a couple days. About a week later arm went numb with an icy cold prickly feeling. Lasted about a week, with a little residual numbness still present. About May 1st, also noticed swelling of left ankle. During the month of June had pain behind knee and continual pain and stiffness in left leg. End of June left leg became noticeable swollen. Went to Urgent Care on June 30, 2021. Sent for ultrasound, found four blood clots (DVT's) in left leg (3 upper thigh and one behind left knee). Sent to ER, started on Eliquis, will follow-up with primary care next week. No history of blood clots before, and I am quite active.

patient developed right lower extremity DVT diagnosed ultrasound 7/20/21. He started with acute pain right leg Saturday 7/17 and woke up on Sunday 7/18/21 with swelling right upper thigh and bruising and swelling of right foot. His swelling and pain increased and was seen urgent care where he was referred to emergency room for evaluation DVT.

Patient admitted to the hospital 7/21/21 through the ED and tested positive for Covid19 via rapid molecular test. Patient states he was vaccinated "months ago" and received one dose. He complained of fever, diarrhea, and fatigue. His Chest XR consistent with patchy airspace opacities. He was found to have orthostatic hypotension and hyponatremia attributed to dehydration.

patient reported having joint pains about 3 or so weeks after the vaccine then was found to have DVT 4 months later.

65m received J&J vaccine, 10 minutes after admit c/o a gripping pain mid sternum, a 2 on scale of 1-10. Pt brought ot observation area, pain non changing after 15 minutes, eval'd by on site EMS. Transferred to ED for eval. Pt notified his daughter prior to leaving vaccine clinic. He had no complaints of other symptoms. Per electronic health records, pt drove himself to ED.

we administer Janssen Covid-19 Vaccine , 5 to 10 minutes later the patient fainted in the waiting area. the associate who is watching our patient notified me that the patient is dizzy. I went outside and I noticed that the patient is leaning on the table and he fainted i put him down on the floor and lifted his feet up. he woke up in few seconds we also called 911 and they took the patient to the ER

Fever 101.9 degrees, dizziness, Elevated pulse 105 bpm. (Normal pulse rate ranges between 75-78.) Elevated BP 175/100. (Normal BP in the 125/78 range. Nausea. Severe headache. Fever, headache and nausea subsided after 5 days. Heart rate and BP still elevated, Pulse will "race." I contacted my family physician . He suggested I keep close check on BP and go to ER if major symptoms persist after 4 days.

Shopping, climbed a single level stairway, became winded, nauseous, got bad heartburn feeling, felt flush and started getting dizzy. Took Tums, no help went to Emergency Room and was told that there was an enzyme in my blood which showed I had a heart attack

On Tuesday March 16 started having difficulty breathing went to ER. Blood Clots in both lungs. Was admitted and was treated in hospital until Friday March 19.

Patient presented to clinic 9 days after vaccination in acute distress, shivering, tachypneic and having difficulty with speech. Heart rate at 130 beats per minute, Spo2 91% on room air, temp 99.9f oral. Initial difficulty obtaining blood pressure due to shaking. Patient was treated with 500mL NS and 2L O2 via nasal cannula, which immediately improved symptoms. Due to elevated glucose and minimal austere conditions, patient was evacuated from camp to hospital. There, patient diagnosed with COVID-19 infection, bilateral basilar and right apical pneumonia, diabetes and sepsis.

High blood pressure since 4/11 night (164/95 ) 4/12 morning (176/99 ) (175/103 )(182/107) . went to ER, 4/13 morning (184/102) (193/97) (205/128) went to ER again 4/14 (171/108) (176/104)

Emergency Department Note (Verified) Visit Date: 04/13/2021 CHIEF COMPLAINT: Shortness of breath. HISTORY OF PRESENT ILLNESS: The patient is a 65-year-old male with a history of hypertension and congestive heart failure, presents with shortness of breath that started on Friday and worsened significantly this morning. He does have some chest discomfort with this. No fevers, chills, or other complaints. Discharge Diagnoses 1. Hypertensive emergency, 04/13/2021 2. Chest discomfort, 04/14/2021 3. Heart failure, systolic, 04/13/2021 Assessment and Plan 65M w/ HTN and HFrEF p/w hypoxic respiratory failure i/s/o a hypertensive emergency. BP and respiratory status much improved, admitted to CCU for acute BP management and medication titration. #HTN Emergency Likely precipitated by lack of medication non-adherence since 04/11, when he ran out of his medications. SBP approx 220 at time of presentation, good response to enalapril and nitro gtt. Decreased work of breathing with Bi-pap. MAP 130-140 on presentation, will attempt to lower by 20-25% in first 2-6hrs w/ MAP goal of approx 100, while aiming towards normotensive in next 24-48 hrs while transitioning from IV to PO meds. -TTE ordered -cont incremental BP mgmt: -goal MAP < 110 -prn hydralazine -gradual goal towards normotensive over next 24-48hrs thereafter -cardiac monitor -will ensure that patient has anti-hypertensives prior to DC -q4hr neuro checks #Acute Hypoxic and Hypercapnic respiratory failure Decreased work of breathing with Bi-pap. Likely related to HTN emergency as above in addition to moderate-severe volume overload as seen on CXR. VBG in am of 4/13 showed pH 7.17, pCO2 64, pO2 58, bicarb 24. -cont Bi-pap, will wean as tolerable -repeat VBG this am for resp acidosis #HFrEF w/ acute exacerbation Last echo 04/14/2017, LVEF 38%, cxr on admission shows moderate-severe volume overload. -TTE ordered on 4/13 -may consider additional diuresis, given furosemide in ED on presentation, mindful of BP -goal net negative 1-2L/24hrs as pressures permit -daily standing weights -fluid and sodium restriction when off Bi-Pap #NSTEMI Likely type II given HTN emergency, did have chest pain on presentation which was relieved with BP control. -trend trops until flat, next at 08:00 #type II DM Hgb A1c 7.5% on 4/13, mild hyperglycemia on presentation -SSI #polycythemia Could be indicative of undiagnosed OSA vs manifestation of heart failure. Additionally, hemoconcentration from CHF i/s/o HTN emergency is another possibility. -TTE as above -ctm w/ am labs #lymphocytosis Afebrile, no urinary symptoms. Hypoxic on presentation, likely related to edema i/s/o HTN emergency as above. No suspicion for infectious etiology at this time, no white count. -ctm w/ am labs #HLD -cont statin #QTC prolongation 561 on 4/13/2021 -avoid QTc prolonging medications

Patient presented to ED on 4/14/2021 with 24 h of progressive painful/pruritic palpable purpura of distal upper and lower extremities. No evidence of additional organ involvement.

I started having migraine headaches on 3-19-2021 , this lasted for 3 days. On 3-23 started coughing up blood , that progressively became worse. Went to emergency room and was admitted CAT scan of lungs showed that I had 3 blood clots.

Patient right leg became very swollen from knee down and was very painful to walk. Patient went to Urgent Care and was told that he would need to have ultrasound done to see what was going on. Patient went to Imaging and was told that he had several blood clots through out his right leg. They advised him to go to emergency room evaluation. Patient went to Medical Center and it was confirmed that patient had blood clots and was put on Xarelto for treatment.

My father had a massive stroke 3 days after taking his shot. He is now currently paralyzed on his right side and not speaking

BURNING CHEST; FEVER; DIFFICULTY BREATHING; COUGHING; WHEEZING; FEELS LIKE SOMETHING IN THE BACK THROAT; TOTAL BODY ACHES; This spontaneous report received from a consumer concerned a 65 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had unknown allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 14:15 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced difficulty breathing. On 06-APR-2021, the subject experienced coughing. On 06-APR-2021, the subject experienced wheezing. On 06-APR-2021, the subject experienced feels like something in the back throat. On 06-APR-2021, the subject experienced total body aches. On 06-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced burning chest. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning chest on 09-APR-2021, and had not recovered from difficulty breathing, coughing, wheezing, feels like something in the back throat, total body aches, and fever. This report was non-serious.

Big blood clots following Prostate Surgery 3 days after Vaccine applied Please see attached explanation and pictures

On April 16 patient came home fatigue, pale and legs hurting. The next day complained of right knee pain, Fatigue and looked pale. He woke up in the middle of the night complaining of right calf tightness and pain. On Sunday 18th he started to limp and when we looked at his calf it was double in size, warm to touch, and redness. We then went to the ER and had an ultrasound and CT scan . We were told he has multiple blood clots in the right leg and clots in both lungs. He was then transported to a hospital and given blood thinner shots in stomach. He was released from the hospital 4/20 and given blood thinners and assigned a hematologist. He?ll be on blood thinners 6-12 months, out of work a month and tested regularly to check platelets.

Patient received the Johnson & Johnson COVID vaccine on 4/11/21 and developed dyspnea, fevers, and nonproductive cough about 2 days later. He continued to feel worse over time and presented to urgent care on 4/22/21. He had a chest X-ray done which showed bilateral infiltrates and he was found to be hypoxic, so he was sent to the ED. Patient was then admitted to the hospital for COVID treatment since he required 4 L O2 in the ED.

HEADACHE; BACK PAIN; RIB PAIN/THE LEFT SIDE OF THE RIBS UNDER THE ARM; SEVERE BODY PAIN; ITCHY RED SPOTS ON LEGS/SPOTS ON BOTH LEGS, UPPER LEG, LOWER PART ANKLE, AND ONE ON THE FEET, SMALL LIKE A DIME; BLOOD SUGAR FASTING RESULTS WAS 450 MG/D; This spontaneous report received from a patient concerned a 65 years male. The patient's weight was 175 pounds, and height was 68 inches. The patient's concurrent conditions included diabetes, and high blood pressure, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 in left deltoid for prophylactic vaccination. No concomitant medications were reported. Patient reported that, received the COVID-19 vaccine on 11-MAR-2021on the left arm. Patient's main reason for calling was the severe body pain on the right back and the left side of the ribs under the arm. Patient was taking Tylenol 500 mg 2 tablets in the morning for the past weeks to ease the pain, which was not normal for him, living on tablet for a couple of week. The pain on the ribs, come on hard, and it might stay like 10-15 mins then it cools off. Patient mentioned that he had headache too and had red spots on his legs that started out to be itchy. Patient had spots on both legs, upper leg 3, lower part ankle 2, and one on the feet, small like a dime. Lastly, patient said that his blood sugar fasting results is 450 mg/dL and that was not normal for him (his normal is 110/180-200mg/dL). However, Patient's blood pressure is under control. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blood sugar fasting results was 450 mg/d, and had not recovered from headache, back pain, itchy red spots on legs/spots on both legs, upper leg, lower part ankle, and one on the feet, small like a dime, rib pain/the left side of the ribs under the arm, and severe body pain. This report was serious (Other Medically Important Condition). .; Sender's Comments: . 20210438296- Covid-19 vaccine ad26.cov2-blood sugar fasting results was 450 mg/d. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: UNDERLYING DISEASE

pt had severe vomiting with red color and an order it. He had massive pain in his leg. Patient had loss of appetite, nausea, and headaches. His eyes were rolling in the back of his head, which this symptom would come and go. He would have hallucinations. On unspecified date Pt woke up screaming the house was on fire and there was a dog by the bed and a person in the closet, talking out of his head. An ambulance came and brought him to ER. Pt coded in the ambulance and brought back. Pt was coherent upon arriving to the ER. He had to be intubated and bagged and died about 15 minutes later. Pt had blood work which was totally out of whack. Family was told they did not understand what had happened to him. The only thing the family could think of that was different was he had recently been vaccinated.

HEART ATTACK; COVID-19 PNEUMONIA; SUSPECTED CLINICAL VACCINATION FAILURE; ELEVATED CREATININE; This spontaneous report received from a consumer concerned a 65 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included congestive heart failure. He was sick two weeks prior to hospitalization due to congestive heart failure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) dose, 1 total, administered in the beginning of MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included blood pressure and cholesterol medications. On 07-APR-2021, the patient went to the emergency room (ER) and was admitted to the hospital and was diagnosed with COVID-19 pneumonia and heart attack. He had suspected clinical vaccination failure. She reported of a positive COVID-19 test that was taken in the hospital and lab values showed everything as elevated. The reporter (daughter) also stated that her father had no issues with kidneys before but during hospitalization, he had elevated creatinine. During hospitalization, the patient received remdesevir, dexamethasone and was on heparin drip for first 4 days and was on bilevel positive airway pressure (BiPAP) machine and oxygen. He was stable and was going to be discharged from hospital later this afternoon on 13-APR-2021. He was hospitalized for 7 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from heart attack, and covid-19 pneumonia, and the outcome of elevated creatinine and suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused).; Sender's Comments: 20210424651-covid-19 vaccine ad26.cov2.s-Heart attack. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY 20210424651-covid-19 vaccine ad26.cov2.s- Covid19 Pneumonia. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210424651-covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. 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: SPECIAL SITUATIONS

About 2 minutes after vaccine injection patient became pale, hands became cold and purplish. Patient's head leaned to the left side, started slurring and became unconcious while his eyes were open. I tried to get the patient's attention but saying "hello, are you still with me?" loudly and he did not respond. His eyes were still open at the time. At that point I yelled for help and other colleagues were calling "911" immediately. Based on store protocol and knolwedge of CPR and CDC guidlines, I checked for pulse and respiration - did not have any. I grabbed epinephrine injection 0.3 mg and injected him on left thigh. He immediately gasped for air, then started to faint again. His face color turned pale. At this point he is still sitting upright and EMT has arrived. His blood pressure was lower than normal based on EMT report. I called the patient on 5/12/21 (one day post-event) and patient reported no adverse reaction from vaccine site, he also reported taking 1.5 hours nap. The injection site on epineprhine injection was somewhat painful.

Lightheaded, extreme fatique, red dots on skin and in mouth, bruising, low blood platelets, low hemoglobin

Stoke occurred, including symptoms of: severe headache, shortness of breath, trouble speaking, plus leg pain

DEHYDRATED; URINARY INCONTINENCE; PLEURISY; CHEST PAIN; This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. The patient's past medical history included neck surgery, back surgery, left knee replacement, and covid-19 infection, and concurrent conditions included alcohol consumer, non smoker, and heart patient, and other pre-existing medical conditions included the patient has no known drug allergies and drug illicit use. the patient also had 29 surgeries. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1802068, and expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. Concomitant medications included alprazolam for drug used for unknown indication, apixaban, clopidogrel, lisinopril, metoprolol, ranolazine, rosuvastatin calcium, and . On 31-MAR-2021, the subject experienced pleurisy. On 31-MAR-2021, the subject experienced chest pain. On 01-APR-2021, the subject experienced urinary incontinence. On an unspecified date, the subject experienced dehydrated. Laboratory data (dates unspecified) included: Chest X-ray (NR: not provided) Pleurisy on left lung, and Diagnostic ultrasound (NR: not provided) No abnormal finding. The action taken with covid-19 vaccine was not applicable. The patient recovered from pleurisy, chest pain on APR-2021, and urinary incontinence on 04-MAY-2021, and the outcome of dehydrated was not reported. This report was non-serious.

that night got a 102.7 fever / Trouble breathing / very bad chest pains . My wife called 911 , went to hospital next morning at 6:30 am , came home that afternoon then 8:30 pm that night called 911 again , was in 3 different hospitals for next 19 days . lost 30 pounds in hospitals, been home now

05/03/2021 Paresthesias both feet, weakness lower extremities. Increased heart rate. Shortness of breath when recumbent. Ataxia. 05/07/2021 Paresthesias both hand, fasciulations, tremors 05/21/2021 Evaluation by neurologist, Dr. Diagnosis

SHARP STABBING HEART PAIN; This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high cholesterol, non smoker, and non alcoholic, and the patient had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: unknown) dose was not reported, 1 total administered to left arm on 24-MAY-2021 at 11:00 for prophylactic vaccination. Concomitant medications included simvastatin for high cholesterol. On vaccination at about 15:00, the patient began experiencing side effect of sharp stabbing heart pain which was lasted for about 5-7 seconds. He took one low dose aspirin and was doing well now. He had reported this adverse event to the vaccine facility and was not going to see his doctor. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sharp stabbing heart pain on 24-MAY-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210551413-Covid-19 vaccine ad26.cov2.s -Sharp stabbing heart pain. This event(s) is considered un-assessable. 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).

Pain at injection site followed by Angina, Heart palpitation, Tightness in chest, lowered pulsox, dizziness. Followed by admission to emergency room with diagnosis of ABNORMAL ECG, lowered pulsox, Atelectisis (Chest Xray) Followed by referral to Cardiologist Symptoms are persistent Undergoing further treatments and further tests scheduled as of the date of this report.

On April 7, my husband received the J&J COVID vaccination. On April 17, he started to feel ill and developed severe abdomen and back pain, which were not normal symptoms of his other health conditions. He ate very little on that date (and that was the last food he had). At 3:30 a.m. on Monday, April 19, I took him to the ER because of severe pain. They gave him multiple tests, including CT scan, labs, EKG, ultrasound, and others. He was admitted to the hospital, and multiple other tests were performed during his stay. During his stay, his sodium and other electrolyte levels dropped to dangerously low levels, he experienced major swelling, his pain persisted, his swallowing ability diminished, he didn't eat, and his heart consistently ran at a high rate. He was transferred home (with comfort care/hospice) on Tuesday, April 27, and died on Wednesday, April 28, at about 9:30 p.m.

Day after shot patient was tired, he was not feeling well, & he never fully recovered. He went to work on Monday, May 10th & worked until 6:00pm. Returned home eat a little & went to bed. Tuesday, May 11th he worked at home, Wednesday, May 12th we had coffee, laughed & joked around & he went back to work at home. I went to check on him about five minutes later & he was sitting up sleeping. He would usually wake up & say I took a power nap but he was not breathing. I started mouth 2 mouth but he did not respond. My sister told my nephew to call 911 & they told us to lay him on the floor & start CPR until the paramedics arrived. Once they arrived & took over they tried to get him to breathe & restart his heart. The paramedics worked on him for a long time giving us updates on what they were trying to do. Patient never regained consciousness. They indicated probably a heart attack.

Dont know if related or not-- around vaccine date noticed I was "dribbling" when drinking out of water bottle about 4-20-21-, mentioned to Doctor have been dribbling last week or 2 - look at me- told me right side of mouth not moving- thought I had stroke and told to go to e.r where they confirmed there was a stroke and I also had 30 % blockage in right carotid artery. Could also be related to ADD med( Vyvanse have been taking for last 10 years)- as med causes spike- high blood pressure.

Acute Ischemic Multifocal Posterior Circulation strokes resulting in L sided weakness, L facial droop and dysphagia. Hospital course complicated by respiratory failure. Patient had placement of tracheostomy en g-tube given failure to wean off the ventilator and prolonged dysphagia with poor mental status to aid in swallowing

Right leg swollen, went to ER on July 17, 2021and was diagnosed with Deep Vein Thrombosis (right leg - blood clot). Currently taking Xarelto 15 mg 2x a day for 3 weeks, then Xarelto 20 mg for 6 months.

Patient was being monitored for 30 minutes by EMS due to anaphylaxis to Shrimp. About 15 minutes into monitoring, the patient reported to EMS that he was feeling sweaty and had some shortness of breath. EMS reported BP to be 171/89 and pulse of 88. Patient stated that he does take blood pressure medication and reported that BP was elevated for him. EMS contacted ambulance for transport to Emergency room, patient in agreement to transport.

Approximately ten minutes following vaccination patient decided to check his blood pressure at the automated machine because he didn't feel well. Patient passed out sitting at the machine and lost control of his bladder. Patient's eyes were open and he was making snoring noises. Upon checking pulse, it was faint. Patient was breathing. Team moved patient to lying position on the floor. Pulse became more prominent and patient woke up. EMS arrived and took patient to local hospital for precautionary testing. Patient discharge home 2 hours later.

the day following vaccine patient had episode of afib. they had never previously had a diagnosis of afib.

Body chills. In going to bed I had heavy clothing, bathrobe and multiple blankets to offset the chills. During the night I woke up overheated and bathed in sweat. Got up to go to the bathroom for BM but was nauseous, feeling need to vomit at the same time. After BM I stood and still felt need to do one or the other or both when I passed out. Wife came upstairs and found me sitting up against the corner wall. She was able to shake me awake while calling 911. I was groggy but aware I was still nauseous and stayed down next to toilet until stomach settled. I came downstairs and EMTs arrived. Took blood pressure. Result was it was low. Took EKG and that was normal. Second blood pressure test showed that I rebounded. When offered I felt it unnecessary to go to hospital.

This patient came for his COVID vaccine today. Post vaccine while in the waiting area, patient became pale and diaphoretic. Pt then became unresponsive, laid him to the ground and elevated his legs, pt quickly become responsive with any further intervention. Continued to monitor the patient who left with his wife 30 minutes later with no complaints or deficits.

Had lower blood pressure since day 6. No treatment. dizziness some times. PS: day 1: blood pressure was <120/<80, day 6 to present: blood preesure was 89-112/60-81 PS: blood pressure monitor: Omron (model# BP7100) from pharmacy

Brought to the ER as a code blue, 50 minutes down. CBC, CMP, and HIV screen completed. Deceased despite attempts of revival. Wife reports patient reported not feeling well, c/o feeling short of breath, started having foaming at the mouth, loss consciousness. He had pink sputum on arrival.

About 2 hours after administration of the vaccine, veteran reported feeling throat tightness and chest tightness with difficulty breathing. He called 911 and taken to Hospital for acute treatment. He was kept in ED for several hours and discharged with epi pen and script for pepcid

Massive Pulmonary embolism with evidence of right heart strain, acute hypoxic respiratory failure, Axute DVT of right lower extremity. No obvious known provoking factors

tension and heart palpitation, beginning 4 days after my vaccination and continuing after 2 weeks, tension builds during the day and diminishes overnight, palpitation is intermittent with no apparent pattern

On 4/16 at around 10:24AM, patient presented to emergency department via EMS status post a witnessed cardiac arrest. After the witnessed cardiac arrest, EMS was called and reported that the patient was unresponsive. Per EMS, patient was immediately intubated and chest compressions started. EMS reports an initial cardiac rhythm of VFib and shocked patient once. Patient was given 3 epinephrine and brought into the ED. After prolonged CPR and resuscitation for more than hour and a half, the patient was made DNR/DNI and was pronounced dead at 11:45AM.

MODERATE CHEST PAIN; MODERATE UPPER ARM PAIN; FELT LIKE PULLED MUSCLE; This spontaneous report received from a patient concerned a 66 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and batch number: 1802068 expiry: 25-MAY-2021) dose was not reported, once a total administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced moderate upper arm pain. On 09-MAR-2021, the subject experienced moderate chest pain. On 09-MAR-2021, the subject experienced felt like pulled muscle. Treatment medications (dates unspecified) included: menthol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from moderate upper arm pain, moderate chest pain, and felt like pulled muscle. This report was non-serious.

Six days prior to Vac. had physical and BP was 127/72 Blood pressure went up to 192/103 pulse 60 at dentist appt. Checked several times in the evening and pressure remained very high over 180 and 100

Began to feel chest tightness, breathing a little harder than normal. Started to feel very tired the next day, extreme exhaustion. Had to go to bed. He continued to worsen with the exhaustion daily and now can barely get out of bed, or sit up. Before the vaccine he was not spending time in bed during the day. He now has trouble breathing sitting up.

DIARRHEA; LETHARGIC; GENERALISED ACHING; HEADACHE; SWELLING AT INJECTION SITE; REDNESS AT INJECTION SITE; BLOOD CLOT FROM THIGH TO CALF; This spontaneous report received from a consumer concerned a 66 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included paralyzed on left side from a previous injury and not very active. 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 1 total administered on 06-APR-2021 on right arm for prophylactic vaccination. The batch number was not reported and it has been requested. No concomitant medications were reported. On 07-APR-2021, the patient had blow-out diarrhea, lethargic, body aches, headache. On APR-2021, the patient experienced leg pain (started week ago), swelling at injection site and redness at injection site. His left foot was swollen, and called physician to check for blood clot or break. The doctor said that the test showed a blood clot from his thigh all the way down to his calf that was a medical emergency. Reporter thinks there was a possibility that they were already exposed to COVID. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot from thigh to calf, diarrhea, lethargic, generalised aching, headache, swelling at injection site and redness at injection site was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210450241- COVID-19 VACCINE Ad26.COV2. S -Blood clot. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Patient was administered the Johnson and Johnson Janssen COVID-19 vaccine. Shortly after, a few seconds, the patient stated he felt flushed and head started to fall back. Staff member cradled his head and called another staff member over. Staff member called 9-1-1. Patient went unconscious and his eyes rolled back for approximately 30 seconds. When aware, we (staff members) transferred patient from the chair to the floor where staff member supported his back and fanned him due to his profuse sweating. Staff member continued talking to him when he became unconscious again, this time gasping for air and turning pale. We kept saying his name until he came to again and was somewhat aware of his surroundings. He fainted one last time. After this time, he sat up on his own and seemed to be very coherent. The EMS arrived shortly after and took over. They said they would take him out to check him out but he seemed to be doing better. An EMS personnel let us know the patient did tell him that he has fainted from vaccines before. However, he did not disclose this to us on the PQCF form or when asked verbally.

Woke up with heart racing/pounding on 04/05/2021, went to ER where blood pressure was 193/110, heart rate 108, given IV meds-metoprolol and discharged with instructions to see PCP and cardiologist. Patient states he saw Dr. who said he "didn't know what to do", sent to cardiologist who put patient back on metoprolol 12.5mg. Patient reports he continues to have extreme fatigue with minimal exertion.

HARDLY EATING; SKIN IS PALE; PNEUMONIA; BACK HURTING REAL BAD; LOST 30 LBS; This spontaneous report received from a consumer concerned a 66 year old white, Not Hispanic or Latino male. The patient's height, and weight were not reported. The patient's concurrent conditions included patient might have a touch of emphysema, alcohol use (used to drink beer, about 12 pack once weekly), and non smoker, and other pre-existing medical conditions included patient had no known allergy, the patient had no history of drug abuse/illicit drug use. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered, 1 total to right arm on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The patient was diagnosed with pneumonia and had lungs hurting on deep breath on 14-MAR-2021. Lung specialist which patient consulted did not know whether patient had covid-19 or not. The patients's pneumonia had got worse which resulted in weight loss of 30 lbs (pound). The patient had underwent CT (computerized tomography) scan by regular physician to determine pneumonia. The patient was put on prednisone and Doxycycline. The patient had subsequently went to lung specialist and was prescribed with Trelegy and 30 days of generic Augmentin. on 14-MAR-2021 patient had his back hurting very bad, was put on Flexeril for back pain, Flonase, Montelukast 10 mg and Tessalon. Subsequently patient was put on dexamethasone (unsure), 6 mg (milligram) once daily and was feeling better, but condition started going back. On 30-APR-2021, the patient experienced skin as pale. The patient still had shortness of breath, not coughing much at the time of reporting. Laboratory data included: CT scan for diagnosing pneumonia and Weight (NR: not provided) lost 30 lbs.. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from back hurting real bad, and had not recovered from pneumonia, lost 30 lbs (pound), skin is pale, hardly eating. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210518214-COVID-19 VACCINE AD26.COV2.S-Pneumonia. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Patient complains of easy bruising since receiving his Covid 19 vaccine. Was into the clinic to establish care and reports this. Labs taken and noted platelet count of 25. He states that he has not had any prior issues with this that he is aware of.

Per patient via phone call on 6/1/21: Woke on Sunday, 5/23/21 with high fever, sweats and swollen veins on hands. Went to ED on 5/25/21. At that time, he thought he had an infection "eating him away from the inside". Now he believes, after thinking about it, that it must be a reaction to the COVID vaccine he received on 5/21/21. He stated that he still has weak, cramping hands and swollen veins in his hands.

Next day - Patient had onset of shortness of breath, CXR and CTA chest were negative. EKG showed possible old MI, no acute findings. Cardiology referral was made. He wasn't seen. He came in on 5/6/2021 and ended up being admitted with non STEMI and new CHF.

Vaccine was given on 4/3/21. Pt. presented to this facility with chest pain, pneumonia, hypotension on dehydration on 5/28/21

That day, light headed ness and heart palpitations. Heart palpitations for short time only but felt periodically over the next few days. June 11, lower left led swelled and painful and shortness of breath. June 14, went to ER. They found multiple blood clots in upper thigh, behind knee and lower left leg. They also found approximately 20 clots in the lungs and administered Heparin drip and I was impatient. They put me on Eliquis and released me the next day. Now convalescing at my daughter?s house. Diagnosis. Acute Deep Vein Thromboses and Pulmonary Embolism bilateral.

PAROXYSMAL ATRIAL FIBRILLATION; FEELING OR SENSATION OF DRAINAGE IN LEFT NOSTRIL; OCCASIONAL PRESSURE IN BOTH EARS; SLIGHT BURNING SENSATION IN JUST LOWER LIP WITH SMALL, TINY PROTRUSIONS; LOCALIZED BACK PAIN BILATERALLY INFERIOR TO THE POSTERIOR RIB CAGE BUT MOSTLY ON LEFT SIDE; SLIGHTLY HIGH PITCH SOUND IN LEFT EAR; HEADACHE; FATIGUE; SMALL AMOUNT BLOOD IN STOOL; NODULE IN CUBITAL FOSSA AREA ON MEDIAL SIDE OF ARM; SMALL AMOUNTS OF BLOOD IN PHLEGM; IRREGULAR, LESS FREQUENT AND MORE SOLID BOWEL MOVEMENTS; INCREASED URINATION LASTED 2-3 WEEKS; OCCASIONAL LOCALIZED PRESSURE AND HEADACHES IN OCCIPITAL, FRONTAL, AND TEMPORAL AREAS; This spontaneous report received from a patient concerned a 66 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19 (experienced all the typical symptoms, but waited 13 days to get tested) and concurrent conditions included paroxysmal atrial fibrillation (last time he had an episode until after he received the vaccine). He did not have any recent episodes of atrial fibrillation The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 29-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 29-MAR-2021, the patient experienced occasional localized pressure and headaches in occipital, frontal, and temporal areas which were intermittent and pulsating in nature. On APR-2021, the patient experienced small amount of blood in stool and had irregular, less frequent and more solid bowel movements about 2-3 weeks post vaccination. He mentioned around the same time he was urinating more (increased urination lasted 2-3 weeks), and then his bowel movements and urinations became regular again. He also experienced a nodule that appeared in the cubital fossa area on medial side of his arm two weeks after the vaccination and then gradually resolved over 2.5 weeks after it appeared and small amounts of blood in his phlegm which appeared 1.5 weeks post vaccination and he continued to experience this on week 2, week5 post-vaccination and then resolved. On 14-APR-2021, Laboratory data included: Antibody test (NR: not provided) Negative, Complete blood count (NR: not provided) unknown, and Platelet count (NR: not provided) Normal. He reported experiencing 5 episodes of atrial fibrillation within the 7 weeks after vaccination, a diagnosis of paroxysmal atrial fibrillation was confirmed by his cardiologist. He also experienced fatigue about 5-6 weeks after vaccination. He had intermittent waves had fatigue throughout the day which lasts for an hour and then came back later in the day, with no consistency and stated this was still unresolved. (Later on he stated he had no fatigue spells lately and considered this resolved). On an unspecified date, he experienced feeling or sensation of drainage in left nostril, (even though had no excess blood or fluid) which started a few weeks after received the vaccine and then lasted for several months but now resolved and occasional pressure in both ears (opening and closing his mouth did not relieve the pressure) and slight high pitched sound in the his left ear. His ear side effects came and gone and considered them to be resolving but not fully resolved. He noticed a few weeks after vaccination he had slight burning sensation in just his lower lip with small, tiny protrusions (He initially said this was unresolved, but then later said this was resolved). He also experienced localized back pain bilaterally inferior to the posterior rib cage but mostly on the left side. He mentioned he have a checkup next week and will discuss his concerns since this side effect was still unresolved and headache. The patient stated he did not experience any of these side effects before receiving the vaccine. He was generally healthy and tried not to take medication if possible. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from paroxysmal atrial fibrillation, nodule in cubital fossa area on medial side of arm, feeling or sensation of drainage in left nostril, slight burning sensation in just lower lip with small, tiny protrusions, and fatigue, and small amount blood in stool, small amounts of blood in phlegm, irregular, less frequent and more solid bowel movements, and increased urination lasted 2-3 weeks on APR-2021, was recovering from occasional pressure in both ears, and slightly high pitch sound in left ear, and had not recovered from headache, localized back pain bilaterally inferior to the posterior rib cage but mostly on left side, and occasional localized pressure and headaches in occipital, frontal, and temporal areas. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210667239-COVID-19 VACCINE AD26.COV2.S. Paroxysmal atrial fibrillation. 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: UNDERLYING DISEASE 20210667239-COVID-19 VACCINE AD26.COV2.S. Small amount blood in stool. 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.

(3) syncopal episodes following vaccination, one of which resulted in a fall with direct injury to the base of neck, head, and right flank. Pt reported chest pain prior to syncope.

Suspected pneumonitis. Patient presented on day following vaccination as shortness of breath, nausea, and diarrhea were not abating with home management. They had started later in the day after the vaccination. At ER admission - SpO2 = 80% room air. Nasal cannula was applied and SpO2 recovered quickly. BNP was elevated so acute exacerbation of heart failure was suspected and treated. However, patient did not improve with diuresis. Viral workup and bacterial cause workup negative. No acute cardiac events discovered. Patient continued to decline. Transferred to ICU on 3-19-21 to use BiPAP with 65% FiO2 and able to take breaks to 15L nasal cannula. Borderline blood pressures at this time. Infectious disease, pulmonology, cardiology, nephrology, and critical care anesthesia services evaluated and ruled out multiple possible diagnoses and patient continued to decline. Diagnostic bronchoscopy on 3-22-21 with BAL lead to patient ventilator dependent with profound hypotension. Aggressive ICU management ensued. Bronchoscopy very clean with no real secretions - in line with CT evidence of pneumonitis. Despite aggressive care and maximized pressor support, patient expired on 3-29-21 when family chose to withdraw care as blood pressure declined again.

Patient reported having 6/10 chest pressure, head pressure, diaphoretic, and heart palpitations Patient had history of heart attack 2 years ago Patient seen by medical team, vitals stable but heart rhythm showed controlled atrial fibrillation per paramedic Patient refused medical transport but son will be driving patient to hospital Patient signed AMA form

In office patient evaluation performed 27 days after patient received J & J covid vaccine at a vaccine site. Symptoms at presentation were: 4 week history of post vaccine fatigue, decreased stamina, exertion related tachycardia, and dyspnea on exertion. Patient is a regular exerciser with a high fitness level. Exam was unrevealing. Lab testing included CBC CMP thyroid profile ESR C-reactive protein Lyme titers and D-dimer. All were normal/negative. The reportable lab findings were: SARS-COV-2 IgM and IgG antibody titers were zero on the initial evaluation. Six days later SARS-COV-2 IgG, IgM, and IgA titers were done at Lab. All titers were zero. So 4 and 5 weeks after receiving the J & J vaccine, this patient had no antibody response. He has no underlying disease process known to me to explain this finding. My concern is possible administration of faulty J & J vaccine which may have been distributed before the manufacturing error was identified.

Increasing chest pain and colon discomfort. I went to hospital on Friday April 9th because of this. Troponin levels were normal. Symptoms have been coming and going and are still present. At times I feel like I am going to black out. I feel generally unwell and the chest pain is concerning.

Since March 7 (the day I got the J&J shot coincidentally), I have been experiencing dizziness (lightheadedness), weakness, racing heart from time to time (very badly after I did a work out on the day of the vaccination), tingling in my feet, jitters (like having too much caffeine), fatigue, and being cold (more than usual). Things have gotten progressively worse as I now cannot walk up a flight of stairs without a racing heart and heavy breathing and extreme exhaustion. (FYI, before this I was running 4-5 miles 4-5 times a week). In addition, my doctor tells me that I have no Covid-19 protection based on blood tests.

Per history, patient experienced a ground-level fall early 4/16, and was noted to have weakness on his left side. Patient was brought to the ER 4/18 with concern for CVA, found to have acute pulmonary embolism.

Patient admitted with DVT, acute occlusive venous thrombosis in the left posterior tibial and peroneal veins.

The Headache/Pressure is there in the morning, and I feel fatigued, like I really didn't get any rest in the night., And the headache/pressure stays with me all day., But I don't believe it wakes me in the night, I did developed blurry vision, but only in one eye (right)., I went to Eye doctor, and they said it appeared a cataract had developed since the last visit. but the blurry vision has somewhat improved with reduction of the blood pressure., as far a dizziness., I would not feel comfortable going out and flying a plane since the covid vaccine shot, so I'd say I am a little unstable on my feet right now.....

Patient and wife stated that he has had many vasovagal syncope events when he has had vaccines administered, both more recently, and in the past. The patient was seated in a chair with arms. Within a couple of minutes of administering the vaccine, his eyes rolled back in his head, he broke out in a cold sweat, BP was 75/55, pulse 55. He never stopped breathing (was snoring); epinephrine for an anaphylactic reaction was not indicated. I offered to call 911 multiple times but his wife said this was the normal course of his reaction and held an icepack on his neck for the duration. After 5-10 minutes the patient was once again responsive. He sat for an additional 10 minutes and then said he was ready to leave. His wife walked him out of the store.

patient stated he received the Johnson and Johnson shot on 5/5/2021, on 5/6/2021 patient stated he is experiencing pain at injection site along with muscle aches and tired

Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Medium, Systemic: Nausea-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Severe

On 5/2/21 patient presented to Emergency Room with Rt upper chest pain that is worse after meals and associated with vague nausea and some sob. Reported that pain was constant and burning in nature. Pt was admitted to hospital with mildly elevated troponin. D-dimer was greater than 20. Pt had a VQ lung scan which confirmed the diagnosis of pulmonary emobolus. Pt was given Enoxaparin 100 mg subcutaneously every 12 hours from 5/2-5/7. Then patient was started on Apixaban 10 mg po bid x 7 days which will transition to 5 mg po bid. Pt improved and will be discharged today 5/7/21.

Hypoxia readmission 1 hour after discharge from initial admission for seizure, hyperglycemia, and trach procedure

Brief HPI and Hospital Course: 67 year old male with unknown past medical history was brought in by EMS as post-cardiac arrest. Patient was found on unresponsive on sidewalk, possible collapse. ACLS started by EMS, approx 10-15 minutes. Initial rhythm was junctional PEA. Was given 2 epi and intubated by EMS and had ROSC, Initial ROSC rhythm was SVT which slowed to 90s on its own. On arrival to ED, left femoral central line placed. Tox screen was positive for cocaine and ETOH. Was placed on ACS protocol for possible NSTEMI. Tested positive for COVID19 on admission. Patient required pressor support on admission. Hypothermia protocol was initiated. Patient was rewarmed per protocol, normothermic as of 5/5. Brief Narrative of Events leading to Patient's Death: Patient remained normothermic with persistent septic shock, multi organ failure, ARDS secondary to COVID19. Multiple attempts to reach family members made by ICU team and palliative care team daily without answer. Patient made DNR by two-physician consent. Patient's BP low despite maximum levophed support.

Developed LLE DVT and R sided PE. Unclear time correlation with vaccination. Symptoms worsened about 3 weeks ago.

To ED via ambulance for chest pain and shortness of breath. Decompensated during transport, hypoxic, cyanotic, hypotensive. Intubated in ED. CTA of chest positive for saddle embolism. 1/2 TPA/heparin given. Admitted to ICU. Change in mental status, CT of head showed intracranial hemorrhage. Patient had reportedly been sick about a week or 2 earlier, covid positive PCR on admission to hospital.

Severe Immune Response. Fever, Rash, Itching, High Heart rate, Weakness, Shortness of breath. Treated at Emergency room May 09, 2021 Follow up office visit with Dr May 10, 2021 May 12, 2021 May 17, 2021 and June 03, 2021

Increased fatigue, lightheadedness, nausea, intermittent left arm pain and underarm pain and swelling. Left sided chest discomfort - pain worse with breathing and coughing non productive cough

Developed myalgias and joint pains approximately 48 hours after the injection, then improved. Then about a week after the injection, developed severe myalgias and joint pains. Treated with Medrol dose pack (6 days) with improvement. 3 days later developed pleuritic chest pain as well as shortness of breath. Presented 48 hours after this started for medical care and was diagnosed with acute pericarditis. Started on ibuprofen 600 mg TID and colchicine 0.6 mg BID with significant improvement in discomfort. Discharged from the hospital after 48 hours of observation. Did develop paroxysmal SVT which was felt to be 2/2 to the acute pericarditis. Started on metoprolol tartrate 50 mg BID to help with rate control and sent home with zio patch for additional cardiac monitoring.

BLEEDING IN BRAIN; COULD NOT SEE WITH HIS EYES; COULD NOT WALK; PAIN IN LEGS; SHARP PAINS THROUGH HEAD; BLEEDING FROM HIS EYES; BLEEDING FROM HIS EARS; SICK; This spontaneous report received from a consumer (patient's sister) concerned a 67-year-old, White, not Hispanic or Latino male patient. The patient's height, and weight were not reported. The patient's past medical history included covid-19. His concurrent conditions included inability to see after he got something sprayed into one of his eyes in jail and wheelchair user. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on 31-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. Since the day of the shot, the patient had been sick. On 02-JUN-2021 (about 2-3 days after the vaccination), the patient experienced side effects. He had bleeding in his brain due to which he could see with his eye, could not walk, had so much pain in legs, and sharp pains through his head. The patient was getting worse. On an unspecified date in JUN-2021, the patient had bleeding from his eyes and ears. The patient could not walk at the time of reporting. He had one good eye (not the eye with which he could not see due to bleeding in brain) but could not see from it too as he got something sprayed into it previously. Hence, he lost both eyes and could not see at all at the time of report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bleeding in brain, could not walk, could not see with his eyes, pain in legs, and sharp pains through head, and the outcome of bleeding from his ears, bleeding from his eyes and sick was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 - 20210632304 - Covid-19 vaccine ad26.cov2.s - BLEEDING IN BRAIN , COULD NOT SEE WITH HIS EYES , BLEEDING FROM HIS EYES . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Patient stated that he had normal symptoms after the vaccine for the first couple days and fatigue for at least five days. On the 16th of march patient felt flutterers in his heart he went to the ER and was there for over 8 hours. They ran test and advised he see a cardiologist. He has been going back and fourth to the DR. since March about heart and blood pressure.

Patient stated that he had normal symptom after the vaccine for the first couple days and fatigue for at least five days. On the 16th of march patient felt flutterers in his heart he went to the ER and was there for over 8 hours. They ran test and advised he see a cardiologist. He has been going back and forth to the Dr since March about heart and blood pressure.

PULSE RATE; HEADACHE(COMING AND GOING); NAUSEA; FEVER; This spontaneous report received from a patient concerned a 67 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207821A, expiry: UNKNOWN) dose was not reported, administered on 03-JUL-2021 09:30 for prophylactic vaccination. No concomitant medications were reported. On 03-JUL-2021, the subject experienced pulse rate. On 03-JUL-2021, the subject experienced headache (coming and going). On 03-JUL-2021, the subject experienced nausea. On 03-JUL-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 F, Body temperature decrease (NR: not provided) 97.1 F, and Pulse rate (NR: not provided) not reported. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 03-JUL-2021, had not recovered from headache(coming and going), and the outcome of nausea and pulse rate was not reported. This report was non-serious.

Cough. Body aches Sharp pain shoulders, neck, torax. Could not move his head, could not move his arms. Fever, chills. Short breath Sharp pain right wrisk (fractured long ago and healed) - X-Rays showed arthritis. He did not complain before or it did not bothered before. A sharp pain in a specific point of his head (Right - front - up side). Not being able to laid down. Moving hurts.

LOW HEART RATE; This spontaneous report received from a patient concerned a 67 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. Concomitant medications included amlodipine for high blood pressure, and lisinopril for high blood pressure. On 25-APR-2021, the subject experienced low heart rate. Laboratory data included: Heart rate (NR: not provided) below 60 bpm. On 24-JUL-2021, Laboratory data included: Heart rate (NR: not provided) 69 bpm. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 115/72 mmHg, and Heart rate (NR: not provided) 68-78 bpm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from low heart rate. This report was non-serious.

Chills, headache, sinus congestion began 7/18/2021 Chest congestion and cough began 7/19/2021 Chest congestion, productive cough with thick mucus and hard white chunks began 7/21/2021 Difficulty breathing , wheezing, and continued cough 7/22/2021 First Emergency Room visit on 7/24/2021 for worsening Congestion, cough, and decreased 02 saturation. Second Emergency Room visit on 7/25/2021 for same complaint Third Emergency Room visit on 7/26/2021 for above complaints and fall from LOC

I didn't have pain in the arm, after an hour I had a slight headache. The headache lasted about a day. After the 3-4 day I had serve diarrhea and stopped taking my supplements. It stopped for a couple days then came back for a day. I had no headache or pain, just 3 bad episodes of diarrhea. On March 24th I went into the Hospital with severe pain in my lower left back side. I thought I was passing a kidney side, with the pain I was having. When I got there they did a CT scan and blood work and it wasn't kidney stone but I had a blood clot on the lower left side of lung and the right side as well. They immediate put me on blood thinners. I was there for a day and a night. They released and put me on medication. I've had minor pain but nothing like the pain I had before. I have since followed up with a Pomologist and PCP. Pulmonologist said I had blood clots but couldn't give me a cause. My PCP said she thought I had or have Covid. I asked to have my blood drawn and she said it was too late for that because I had taken the vaccine already.

About 24 hours after the vaccine administration, he became unresponsive at the nursing home. He was sent to the hospital where he is now on a heparin drip due to bilateral Pulmonary Embolisms and multiple DVTs.

Patient was unresponsive initially, slow breathing , pallid color, called 911, patient came too and felt nauseous and needed to use the bathroom, Paramedics check him out and he left with his wife (did not go to the hospital)

Had vaccine 7-March at 4:15 PM. One week later, 14-March, woke up at 8:15 AM with severe BPPV. Went to doctor and had Epley Maneuver performed a few days later. Then on 23-March woke up at 4:15 AM with another BPPV event. Again, returned to doctor for Epley Maneuver. Then on 2-April went to ENT Doctor to have ears checked. She performed the Epley Maneuver and everything was fine; there was no nystagmus. Then she laid me down on my back and tilted my head off the table and I had the worse dizziness ever, but no nystagmus. She sat me up. My BP jumped to 190/100; pulse 100. I couldn't stop being dizzy. Paramedics took me to emergency room. After 2 hours the doctor performed the Epley Maneuver, but there was no nystagmus so it wasn't BPPV. Had CT scan and MRI and everything was clear. What changed and what may have caused all this was that I had the J&J vaccine prior to all the dizziness.

Developed chest pains, Rehabilitation Center moved to hospital on 4/13/2021. Took a turn for the worse in the evening of 4/13/2021. Hospital found fluid on lung x ray. He was placed on ventilator overnight preformed CT Scan the afternoon of 4/14 and discovered several bloods clots In right lung. Patient still in hospital under sedation and on ventilator. Hospital has started him on Heparin.

Patient got vaccination on left arm. Palm of right hand turned blue and patient had pain closing right hand. This developed about 2 days after vaccination and lasted about 1 week. Patient has never had this before. Since then, has gone away and has not come back

Severe headache with fatigue started 04/12/2021. 04/14/2021 tightening in chest. went to local urgent care clinic for rapid test and treatment. EKG done also. Showed abnormal.,sent to local ER. Diagnosed with possible STEMI. Ems ride to north cath lab. Heart cath diagnosis of Pericarditis.

The patient called the pharmacy on 4/7/2021 and said that he had vomited and had been experiencing an excruciating headache that he said was worse than any headache he had ever had and was concerned about how he was feeling since he had just had his Covid vaccine on Monday. I told him that headaches were a very common adverse reaction and that many people had experienced headaches after vaccination. I told him that from my experience it usually didn't last more than a day for others and I assured him that it should go away soon. I later talked to him and found out that he had went to the Emergency room that Wednesday evening (4/7/2021) because the headache was so bad. He was seen in the ER, observed overnight, released the next morning, and then had a follow up appointment with his primary care physician on 4/15/2021. He also had a very high blood pressure reading he told me in the Emergency room that evening he was evaluated.

DVT (LEFT CALF); PULMONARY EMBOLISM (BOTH LUNGS); ATRIAL FIBRILLATION; BLOOD CLOT IN RIGHT VENTRICLE; This spontaneous report was received from a consumer (patient's wife) and concerned a 68 year old male. The patient's weight was 250 pounds and was obese (body mass index 40) and sedentary. His height was not provided. The patient's concurrent conditions included high blood pressure, and 2 gout attacks in the last 8 months. The last gout attack was 2 weeks ago in the left foot. There was no history of clots or atrial fibrillation. He had a strong family history of thrombosis: his father had 2 episodes of deep vein thrombosis and his mother had a pulmonary embolism. No testing to identify any familial clotting issues have been performed. The patient developed a cough starting 29-MAR-2021 and, prior to vaccination, took a COVID-19 test on 31-MAR-2021 which was negative. On 02-APR-2021 a rapid COVID-19 test also came back negative. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) on 02-APR-2021 at approximately 19:00 in the left arm for prophylactic vaccination. Concomitant medications included amlodipine, hydrochlorothiazide, and losartan for high blood pressure. On 03-APR-2021, the patient's cough persisted but had not worsened and he developed pain in the ribs on the right. His wife checked his pulse, which seemed fast and irregular. His respiratory rate was 22 breaths per minute and his oxygen saturation with a home pulse oximeter was in the 70s. He was not in distress at the time. The patient called his physician and the doctor suggested to go to Emergency room. The patient went to Emergency room at approximately 10:00. An echocardiogram revealed a number of clots in the right ventricle which were "bouncing all around". He was also found to be in atrial fibrillation which the doctors said was secondary to the ventricular clots. Unspecified tests revealed a saddle pulmonary embolus and a deep vein thrombosis on the left. He was diagnosed with deep vein thrombosis (left calf), pulmonary embolism (both lungs), blood clots in right ventricle and atrial fibrillation. Platelet count was not known by the reporter; it is unknown if D-dimer and fibrinogen levels were performed. He underwent emergency surgery at 19:00, during which most of the ventricular clots and the pulmonary embolism were removed. He was placed on heparin after the surgery. He spent 5 days in the Intensive Care Unit (ICU) and 2 additional days in the hospital. The patient was discharged from the hospital after 1 week and had recovered from the events of deep vein thrombosis (left calf), pulmonary embolism (both lungs), atrial fibrillation, and blood clots in right ventricle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The reporter did not believe that the covid-19 vaccine ad26.cov2.s had caused deep vein thrombosis (left calf), pulmonary embolism (both lungs), atrial fibrillation, and blood clot in right ventricle This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: a 68-year-old male experienced left deep vein thrombosis, saddle pulmonary embolism, right ventricular thrombosis, and atrial fibrillation, approximately 15 hours after receiving the Janssen COVID-19 vaccine for prevention of COVID-19 infection. The patient has a history of hypertension, is obese (BMI 40) and has a strong family history of blood clots. He tested negative for COVID 2 days before and the day of vaccine administration. He developed a cough 4 days prior to vaccination. The morning after vaccination, he developed right rib pain; his heart rate was rapid and irregular, and oxygen saturation with home pulse oximeter was in the 70s. Upon arrival in the emergency room, he was found to have clots in the right cardiac ventricle, a saddle pulmonary embolus, left deep vein thrombosis and new-onset atrial fibrillation. He underwent surgery for removal of the ventricular clots and pulmonary embolism. No laboratory details were provided. Given the symptoms which pre-dated vaccine administration, the short latency between the vaccine administration and the event, and multiple risk factors for embolism and thrombosis (family history, obesity, sedentary nature), the events are assessed as inconsistent with the causal association to immunization, per the WHO causality classification for adverse events following immunization. Therefore, company causality is considered not related to the Janssen COVID-19 vaccine.

On March 1st, I had a sonogram of the veins in both of my legs and nothing was found, on March 5th I received the COVID-19 vaccine after standing in line for 2&1/2 hours. By March 8th the swelling and pain in my left leg was so bad I made an appointment with Dr. for March 11th. He ordered another sonogram and found 2 DVTs in my left leg, and prescribed anti-coagulants whyich I am still on. At the time the Doctor said that this was most likly a result of having stood in line for 2&1/2 hours.

1 bout of Violent diarrhea that occurred on 4/9/21 or 4/10/21- passed out on the bed after the episode, exhausted. Nausea followed the diarrhea. Comes and goes. Still happening. Experienced heart palpitations at night on 4/12/2021, never experienced before. Got EKG the next day- normal. Back ache began on 4/15/21 to 4/16/21. Not experienced this before. The ache comes and goes. Fatigue and weakness in the whole body. Comes and goes. Better after food.

Came to ED on 4/15 with c/o anginal symptoms, found to be in rapid afib. EKG showed ST elevation in later precordial leads, went for emergent left heart catheterization. Went into V-fib arrest requiring defibrillation (x2) in addition to CPR in cath lab. Angio showed acute thrombotic occlusions of LM, LAD and RI, underwent mechanical thrombectomy of LM and LAD with balloon angio of RI (recent cardiac cath in March 2020 showed clearly patent stents). Placed on Impella bypass. Currently in CVICU care, intubated with Impella.

SEVERE INSOMNIA; ELEVATED HEART RATE; CHEST PAIN; STOMACH ACHE; WEAKNESS; WHOLE BODY SHAKING; SWEATING; SEVERE PSYCHIATRIC REACTION; SUICIDAL IDEATION; HEAD TURNED INTO A CLOUD; EXCRUCIATING PAIN IN THE PALM PART OF LEFT HAND NEAR THUMB; FRONTAL LOBE HEADACHE, TO THE LEFT AND RIGHT OF FRONT LOBE; This spontaneous report received from a patient concerned a 68 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and nonsmoker. The patient had no known allergies or drug abuse. The patient's genetic test showed he came from all around the world. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, 1 total dose administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, 1.5 hours later, the patient experienced "severe brain symptoms". He has developed several incidences of severe insomnia (no sleeping pills have help), for which has been awake for 24 hours at a time. He experienced head turned into a cloud, frontal lobe headache, excruciating pain in the palm part of his left hand near his thumb in which he had previously injured. On 20-MAR-2021, he developed severe psychiatric reaction to brain, he could not have control over his body, and he was afraid of the Psychological Evaluation Team. His health care professional (HCP) deployed a team to arrest his for-psych evaluation. On Mar-2021; event head turned into a cloud was resolved. On 09-APR-2021, he developed most severe symptoms of entire body shaking, nervous feeling of shaking, weakness, sweating profusely, unsure if he has a fever or not. On an unspecified date, he also developed stomach aches, elevated heart rate, chest pain and weakness. There were days where his heart rate was high around 160 bpm for 3-4 days in a row (normal 80-100 bpm). His chest pain was still ongoing. Laboratory data (dates unspecified) included: Heart rate increased (NR: 80 - 100) 160 BPM. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from head turned into a cloud, had not recovered from frontal lobe headache, to the left and right of front lobe, excruciating pain in the palm part of left hand near thumb, suicidal ideation, severe psychiatric reaction, severe insomnia, whole body shaking, weakness, sweating, and chest pain, and the outcome of elevated heart rate and stomachache was not reported. This report was serious (Other Medically Important Condition, and Life Threatening).; Sender's Comments: V0: 20210420137 - COVID-19 VACCINE AD26.COV2.S - SUICIDAL IDEATION. 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.

ITP with platelet count of 2K. Presented with subdural hematoma. Platelets recovered with dexamethasone 40mg PO daily and IVIG 400mg/m2 daily x 4 days. No further brain bleed.

Flat red rash with bumps started on back day after vaccine. About one week later shoulder and neck pain. A few days after that chills and fatigue and increased neck pain requiring emergency room visit. Had fever, elevated BP and decreased oxygen level with extreme neck pain. Treated and released with medication. Negative CT of head and neck. Next day had extremely swollen uvula and sore throat requiring sleeping elevated to breath. Throat was not examined in ER night before. Unable to get up by himself and slept for 27 hrs except for occasional trip to bathroom. He is recovering now.

The following evening after the shot, he had severe pains in his back and shoulders, headache, nausea (vomited). 2 days later, felt severe pain in his stomach, along with pain in his shoulders and back, with a headache, also vomited.

"Janssen COVID-19 Vaccine EUA" 3/18 twitching of foot...severe leg pain 7:45 PM 3/19 involved in a motor vehicle accident with cardiac arrest and a dissecting aortic aneurysm 12;45 PM

Patient's body was found on May 1st. Since the shot , he was complaining of tinnitus, sore legs, dizziness (passed our several times), loss of bowel control, and unable to maintain a stream of thought, which are stroke symptoms. He has had surgery for blood clots in the past. He seemed to get worse in the weeks following the Jansen shot.

had redness and tightening of the legs, went to ER, found very small blood clot in right calf. Gave rx blood thinner eloquis along with current plavix and asa

BODY ACHES; BODY TEMPERATURE 95.5 F; LETHARGY; NOT FEELING LIKE HIMSELF; CHILLS; HEADACHE; FEELING WORSE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: 23-JUL-2021) dose was not reported, administered on 14-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced feeling worse. On 15-JUN-2021, the subject experienced body aches. On 15-JUN-2021, the subject experienced body temperature 95.5 f. On 15-JUN-2021, the subject experienced lethargy. On 15-JUN-2021, the subject experienced not feeling like himself. On 15-JUN-2021, the subject experienced chills. On 15-JUN-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 95.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body temperature 95.5 f on 17-JUN-2021, and had not recovered from headache, body aches, chills, lethargy, not feeling like himself, and feeling worse. This report was non-serious. This case, from the same reporter is linked to 20210651363.

Extremely large amounts of bleeding into bladder during the release of kidney stone. Taken to OR for insertion of urethra tube. Follow-up Fragmentation procedure on 6/7/2021 caused large amounts of blood loss and blood clots the size of quarters into the urine. Blood loss and excessive clotting lasted for 5+ days.

After five days, I experienced a lot of pain and was hospitalized. The pain returned and I was recently hospitalized as well. I feel heart pains and don't feel the same, fatigue and extreme nervous.

Patient was exposed to a family member who was COVID-19 positive and tested positive on 7/16. Symptoms start on 7/16 with cough, fever, chills and SOB. Primary care doctor recommended he go to ED and receive casirivimab/imdevimab. Patient received the infusion on 7/21 morning. Then came back to the hospital in the evening due to worsening SOB and was admitted for hypoxia requiring oxygen. Patient was started on remdesivir (7/22) and steroids and lovenox (7/21). No longer febrile starting 7/23. Asymptomatic rash noted on patient's chest on 7/25 and no longer requiring oxygen.

3/12/21 Sudden cardiac arrest at home; unable to be resuscitated at scene (Brother) Caller is a family friend who was asked by family to call and report incident. If f/u is needed, please contact him first. Current Medical History: unknown by caller Current Medications: unknown by caller

Beginning 24 hrs post injection: every bone and joint in my body began to ache. Then incredibly painful bone pain in the chest - originally thought it was a heart attack. It is random and acute pain in the chest / rib area. It varies in duration and length of time between attacks. The pain is so acute it is hard to manage. Also this appears to have attacked my lungs as I am very short of breath and cannot do any exertion. The body ache, incredible chest bone pain, joint pain and difficulty breathing have continued as I finish day 6 post injection.

Swelling in the eye on the bottom, and a little on the face, itchy, red, and is claiming to have tachycardia These symptoms are likely not due to COVID vaccine. Check with cardiologist for tachycardia and make sure eye drops have not expired or have not been contaminated. If symptoms worsen seek medical help.

PT had no reactions post administration. About 36 hours after administration, the patient had a CVA. Pt experienced numbness in his left arm and shortly after proceed to have slurred speech and loss of balance and gait. Patient take to Emergency Room where he received the diagnosis. the patient was hospitalized. After several days, patient was discharge and was recovering.

Patient's daughter called phamacy today 4/13/21 to report that her father suffered a fall at his home on 4/4/21, the following day after patient received Janssen covid vaccine at pharmacy. Patient's daughter stated on phone that she took her father to hospital after she learned that he fell on 4/7/21 to be examined. Patient's daughter stated that he was diagnosed at hospital with having a stroke and discharged to return home on 4/8/21.

Daughter reported patient was not feeling well. Took blood pressure reading and results were low. Called ambulance to take to hospital. Patient currently in ICU with unknown condition

PATIENT SUFFERED AN ISCHEMIC OCCIPITAL LOBE STROKE, CONFIRMED BY CT SCAN, ON 4/2/2021. PATIENT WAS TRANSFERRED TO AND ADDMITTED TO HOSPITAL. PATIENT WAS NOT ADMITTED TO THE ICU PER HIS WIFE. PATIENT WAS RECENTLY TRANSFERED TO REHAB WHERE IS HE IS CURRENTLY AS OF 4/13/2021. PATIENT LOST VISION IN LEFT EYE AS WELL AS FUNCTION IN HIS LEFT ARM PER THE PATIENTS WIFE. PATIENT IS REGAINING SIGHT AND STRENGTH IN BOTH HIS LEFT EYE AND ARM BUT PROGRESS IS SLOW, PER HIS WIFE.

I received the vaccine on March 8th, and got dizzy and was taken to Hospital by Ambulance. Diagnosed with Pulmonary Embolism, and was operated on the next day and put on Blood thinner, Eliquos. Happened 20 days after THE VACCINE WAS GIVEN, and I almost died.

on March 18, 2021 ( the day following my J&J vaccination ), While on my way back from a 2 mile run , I experienced left-sided listing and lack of control of my left leg and arm. I was dizzy and saw black spots. My wife and son took me to emergency room. My symptoms abated while at the hospital. Hospital staff conducted many tests and I was kept overnight and discharged the next day around 5:00 p.m. with possible TIA as diagnosis.

PATIENT PRESENTED TO CLINIC FOR ANNUAL WELLNESS VISIT ON 4/12/2021 AND RECEIVED THE JANSSEN COVID-19 VACCINE FOLLOWING HIS VISIT. ON 4/14/2021 PATIENT CALLED EMS FOR C/O CHEST TIGHTNESS. DISCOMFORT HAD RESOLVED BY THE TIME EMS ARRIVED. PATIENT WAS TAKEN TO ER FOR FURTHER EVALUATION. PATIENT REMIANED FREE OF CHEST TIGHTNESS/DISCOMFORT THROUGHOUT THE VISIT AND CARDIAC WORK-UP AT THE ER WAS ESSENTIALLY NORMAL. PATIENT WAS DISCHARGED HOME WITH F/U INSTRUCTIONS. ON 4/15/21 RN RECEIVED A CALL FROM THE COUNTY MEDICAL EXAMINER STATING THAT PATIENT WAS FOUND DECEASED IN HIS DRIVEWAY THIS MORNING AT AROUND 09:41 AM. THERE WERE NO SIGNS OF FOUL PLAY AT THE SCENE. PATIENT'S RECENT PHYSICAL AND LAB WORK WITH HIS PROVIDER ON 4/12/2021 SHOWED NO FINDINGS OF CONCERN. PATIENT HAD NO CHRONIC ILLNESSES, WAS ACTIVE, AND OFFERED NO MEDICAL CONCERNS AT HIS VISIT ON 4/12/2021.

Patient reported no adverse reactions after and the days after receiving JJ Covid vaccine. Fast forward, as he was talking to me on 4/16/21, he revealed that he did have one event that occurred the morning after he received the vaccine which was 3/9/21. He said that he had reservations reporting it to me at the time. He did contact his primary doctor about it and had a check up. On the morning for 4/9/21, he walked into his shower then looked down at his feet, he notice blood on the floor of the shower. At this time, the water was not on yet. He described the blood as pink. He said he thought he lost about 1-2 ounces of blood. He only had one incident and none other.

PTS WIFE NSTATES NPT REFUSED TO GO TO HOSPITAL AFTER DEVELOPING CHILLS, LOW BODY TEMP @ 95, VOMITING, FATIGUE, WEAKNESS, AND LOSS OF APPETITE. SHE FED HIM CHICKEN NOODLE SOUP, PENTY OF BLANKETS, AND GATORADE. ITS BEEN 1 WEEK AND HE IS STILL ILL AND STILL REFUSING MEDICAL ATTENTION

On 4/9/2021 started with left sided pleuritic CP and went to ED and found to have bilateral pulmonary emboli. On Eliquis 5mg BID No underlying chronic conditions for increased risk of PE Extensive work up without a direct cause found, no underlying malignancy noted

Started 1 week after injection. Swelling in lower legs, felt like balloons. Feeling of swelling in lips. Headache started in left temple area of head; after a couple of days went across forehead and on back of head with intensity increasing but not extreme pain. Slight nausea; no vomiting. Some abdominal pain that would come and go. Periods of shortness of breath; tightness feeling in upper chest. Loss of energy and some light headed feeling.

patient developed severe chest pain, ambulance was called and patient was taken to ER. Patient was transferred to higher level facility and was told he had a heart attack and that it was caused by a "blood clot"

initially had mild headache and diarrhea but this resolved after a few days. Then around 4/25, developed atraumatic bruising and swelling and pain to the left biceps region (opposite side from vaccine). denied current headache/visual symptoms/abdominal pain or other bleeding/bruising.

Patient found to have pulmonary embolism 22 days after receiving vaccine. Onset of symptoms occurred 18-19 days after receiving vaccination, however, very likely PE related to patient hx of small cell lung cancer. He is currently hospitalized for respiratory distress as of 4/30/21

DEEP VEIN THROMBOSIS IN RIGHT LEG (PAIN AND SWELLING); This spontaneous report received from a physician concerned a 69 year old White and not Hispanic or Latino male. The patient's height, and weight were not reported. The patient's concurrent conditions included arterial fibrillation, and sedentary lifestyle. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 207A21A expiry: 23-JUN-2021) dose was not reported, frequency 1 total, administered on 11-APR-2021 at left arm for prophylactic vaccination. Concomitant medications included apixaban for chronic atrial fibrillation. It was stated by internist that, on 26-APR-2021, the patient experienced deep vein thrombosis in right leg with symptoms pain and swelling, and was hospitalized on unspecified date. On unspecified date doctor was screening patient for covid-19 infection. On 27-APR-2021, Laboratory data included: Platelet count (NR: not provided) 167000. Laboratory data (dates unspecified) included: Duplex ultrasound (NR: not provided) definite clot in right leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of deep vein thrombosis in right leg (pain and swelling) was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210455157-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Deep vein thrombosis. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE.

On March 30th the patient had loss of appetite and headache. On March 31st the patient collapsed and was taken to the ER, the patient's oxygen was low. Patient's blood pressure had dropped and you could not wake him up all afternoon. The Ambulance took him to the hospital on April 1st where he had shortness of breath and blood clots in lungs. On April 1-2 the patient was leaking blood but the hospital staff could not find where so they gave him 3 units of blood. Patient also received 3 antibiotics for a rare pneumonia.

I was kinda weak, not feeling real well. I went to see my cardiologist and let him know that I had discovered blood in my stool. They ordered blood work and my hemoglobin and rbc was so low the told me to go straight to the hospital. They gave me 3 units of blood. They did a colonoscopy and endoscopy, and have not determined the cause of the bleeding. I was admitted in the Hospital for 3 days.

Hypoxia, increasing oxygen requirement starting at 8:15 am the day after the vaccine (from 2-4L to 6L), then increasing over the next several hours to 13L O2 via nasal cannula by 5 pm

Blindness in left eye, blood clot in left eye- no treatment available. Permanently blind in left eye now.

Patient is a pleasant 69 year old male with PMH significant for recently diagnosed Kappa light chain multiple myeloma with extensive lytic lesions throughout skeleton at time of diagnosis, hyperlipidemia, who is a direct admission from office due to shortness of breath and acute hypoxia. Patient was evaluated at the office today and found to have O2 sats of 90% on RA at rest, however O2 sats dropped to 77-80% with ambulation and in need for 3L O2.

"Janssen COVID-19 Vaccine EUA" This patient's wife called me on 06/14/21 after the patient being in a hospital all weekend in another state. She stated the patient had a blood clot in his lung and had passed out due to lack of oxygen. Patient is improving now but their MD at the hospital told patient to report this to me, vaccine provider, since this blood clot occurred within 6 months of receiving the covid vaccine on April 1, 2021.

HEART INFLAMMATION LEADING TO MILD HEART ATTACK AND PNEUMONIA. 6 DAYS IN HOSPITAL, 3 STENTS IN ARTERIES, 6 WEEKS OF CARDIAC REHAB NEEDED.

I experienced 3 strokes consecutively. First one came when I was sitting in the couch and they took me to the hospital. They took me in and we stayed there for about 2-3 days (Can't focus) and then they dispatched me. I was pretty messed up. Then I spent like the next 2 weeks with micro strokes. I didn't know what was going on and went back to the hospital only for them to send me back home. Shortly after that, I saw Dr. and told him that I wasn't feeling well and went home. At about 4 o'clock I took a shower and didn't feel well. My wife drove me to the hospital and when I went I couldn't do anything. I got shots for strokes and took me to a bed. That is where I stayed and saw Dr. who told me that I got a stroke. I stayed there for 3 days and they sent me home. By now, I have lost my eyes, speech and it is really hard to focus or remember everything. I was going to a speech therapist and walk funny. I was stumbling at home.

Wife reports that patient went to see his cardiologist on 6/7/21 for a follow up to the aortic valve replacement on 10/1/20. He received a good report from the cardiologist and was going to be taken off Warfarin the following week. On the way home he complained of a headache and felt like it was sinus headache. When he got home he went to bed as the headache had worsened. His wife assisted him up to the bathroom and back to bed and he went to sleep. She could hear him breathing from the other room. Later in the evening she became aware that she could not hear him breathing and upon checking on him she found him unresponsive, not breathing and he was blue in the face. She call 911 and they attempted to resuscitate him without success. Wife also reported that after the aortic valve replacement in 10/20, her husband went to the hospital with a fever and was diagnosed with covid and sepsis on 12/14/20. He was admitted and started on IV antibiotics and was hospitalized for 5 days. He had home health care coming into his home for 6 weeks of IV antibiotic therapy. He made a good recovery and was followed by an infectious disease doctor who put him on Amoxicillin po tid until the end of May. She states that he was doing very well physically and was playing golf, walking and felt better than he had in a long time.

At approximately 9:00PM om March 7, 2021 I started to feel very tired and was starting to have trouble breathing. My O2 level was between 89% and 91% and my heart was racing. The oximeter I have showed 98/99 BPM. I also had a temperature of 99.9 degrees. Most of these symptoms started to subside after about 2 hours

Patient got up from chair to pick up his phone and collapsed, diaphoretic. There was no loss of consciousness. Initial BP = 80/60 and HR =84. He had no symptoms other than sweating and dizzyness. He stated he felt dizzy after the vaccine but had not eaten since the night before. He also said sometimes gets dizzy after shots. Repeat BP was 110/60 EKG by EMS demonstrated ST wave changes and patient was sent to Medical Center by EMS.

Severe Head ache on the day after, nausea, fever of 100 degrees, felt a lot better on March 13th. Woke up on the 14th with head ache and muscle pain all over especially in my chest area. Treated with Tylenol. During the night on the 15th I had a fever of 102.5 with severe headache and vomited. Tylenol has not worked. Call my PC and let him know my symptoms. It is now late in afternoon on the 15th, still have weakness and headaches and muscle aches. Fever is down to 100.0

Patient had cardiac arrest secondary to MI less than 24 hours from receiving the vaccine. Now on 3 pressors. Although due to the patient's health condition, this may not have been attributed to the vaccine.

Patient started to experience dizziness a couple seconds after the shot. Provided patient with water and he waited another 30-45 minutes and he started to experience nausea and chest pain that was rated a 3/10. 911 was called and his blood pressure was measured at 210/110 (previous blood pressure was 190's/110. Nitroglycerin was given but it did not help with his chest pain and he began to have a headache. He was taken to the hospital. He stated that he was not feeling good a couple days before today. He felt better today and received his J&J vaccine. Fired his cardiologist and was looking for a new one.

PASSED OUT ABOUT 15 MINUTES; DOES NOT REMEMBER ANY OF IT; RASH ALL OVER HIS BODY; This spontaneous report received from a patient concerned a 70 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, once in total administered on 18-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. In MAR-2021, the patient broke out in a rash all over his body and passed out and was out for about 15 minutes or more. The patient's neighbor helped to get into bed. The patient does not remember any of it and don't know if it was vaccine or whatever was wrong with him. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rash all over his body, does not remember any of it and passed out about 15 minutes was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210347765 and 20210347766. Version created to amend previously reported information on 21-MAR-2021. Upon review, following information was amended: The case upgraded to serious and new event passed out about 15 minutes added in case.; Sender's Comments: V1: Version created to upgrade case to serious with event (passed out about 15 minutes added). 20210342307-Covid-19 vaccine ad26.cov2.s-passed out for about 15 minutes or more. 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).

Flank chest pain (pain under right rib cage) and Dyspnea on exertion; woke pt up at 0300 on 4/9/21 Chest pain with deep breathing., fever, and nausea upon presentation to ED Pt denied recent travel or prolonged immobilization Patient diagnosed with bilateral pulmonary embolism per CTA

pulmonary embolism with chest pain symptoms on 4/9, improved with anticoagulation. Patient also had laparoscopic paraesophageal hernia repair on 3/25 and so could also have been a provoked pulmonary embolism.

Left upper extremity DVT in brachial vein. Left upper extremity SVT in basilic vein. Started on xarelto, plan for 3 month course. Sepsis - no source

Abdominal Pain Narrative: Patient is a 70 year old male who received Janssen COVID-19 Vaccine (Lot# 1802070) on 3/9/21. Vaccine was administered with no complications and patient was advised to remain in facility for 15 minutes following administration. On 3/15/21 patient contacted hospital reporting that he has had diarrhea every day since his vaccination. Reported bowels on 3/15 turning pink and noted blood in stool with most recent BM. Patient also reports occasionally abdominal pain (4/10). States no improvement after taking Imodium. Patient was recommended to visit hospital for evaluation. Patient was admitted to hospital from 3/15 for observation with dx of leukocytosis, diarrhea and orthostatic hypotension. No complications during stay and diarrhea resolved resulting in discharge on 3/17.

I experienced a mini-stroke (TIA) in which my speech was affected and which resulted in me being hospitalized. For about 5 minutes, I was unable to find words and properly communicate. I went to the ER and was admitted and had a battery of tests, kept overnight, and discharged the following day My statin dose was increased, and I was put on a baby aspirin, in addition to Pradaxa blood thinner. i believe that I may have had a vascular thrombi related to the effect of the medicine/spike protein.

Heart went into Atrial fibrillation causing blood clotting. He has no prior heart condition. A blood clot traveled to his brain causing a Posterior Cerebral Artery Stroke. He has been in ICU since 04/22/2021.

Per my aunt (uncle's wife), my uncle complained of severe headache especially on the right temple area, nausea, and dizziness at around 6am on 4/11/2021. Soon afterward, she noted my uncle has left side weakness and drooling when drinking.

Patient developed cough, fever, shortness of breath on 4/22/21. Tested positive for COVID-19 and was found to have a pulmonary emoblus in the ER on 4/27/21. She is currently admitted at Hospital, under my care. I'm also her primary care physician.

Right lower leg sudden onset severe swelling, pain, redness. Went to urgent care doctor who then performed assessment, blood work and ultrasound. Placed on Xarelto 15mg twice daily for 21 days.

Four minutes after his vaccination, patient reported feeling "hot", and sweating profusely. Some shortness of breath, and mild chest pain. Patient was responsive, and able to answer questions. By 2:50 PM, pt reported feeling "better" but still "groggy".

Veteran scheduled for CT scan for screening for malignancy due to unintentional weight loss. Incidental finding of Tiny linear pulmonary embolus in lower lobe pulmonary arteries on the right that is nonocclusive. Follow-up MRI negative for malignancy. CT scan was completed 4/14/21. Patient was asymptomatic in terms of PE symptoms

BLOOD SUGAR SPIKE; TERRIBLE SICKNESS; TOTAL FATIGUE; This spontaneous report received from a patient concerned a 70 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1808980, expiry: Unknown) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced terrible sickness. On 01-APR-2021, the subject experienced total fatigue. On 15-APR-2021, the subject experienced blood sugar spike. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from total fatigue on 15-APR-2021, and had not recovered from terrible sickness, and blood sugar spike. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non serious.

PT IS REPORTING EXTREME EXHAUSTION AND VERY PALE TO COLOR 6 DAYS POST VACCINE. PT STATES HE WAS DIAGNOSED WITH COVID IN NOVEMBER 2020, BUT HAD NO SYMPTOMS AND RECEIVED NO TREATMENT FOR COVID.

CARDIAC ARREST DURING ANESTHESIA FOR A SCHEDULED HEART SURGERY; ATRIAL FIBRILLATION; This spontaneous report received from a patient concerned a 70 year old White and Hispanic or Latino male. The patient's height, and weight were not reported. The patient's past medical history included general anesthesia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: not reported) dose 1 total, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the patient experienced atrial fibrillation. On 02-APR-2021,the patient went to the hospital for ablation of atrial fibrillation and experienced cardiac arrest during anesthesia for a scheduled heart surgery. Patient heart was stopped suddenly but cardiologist were able to revive patient .Patient had tested for Catheterization of heart ,CAT scan and stress test for heart prior 2-3 weeks before heart surgery. All the test were normal .On 02-APR-2021,After an event ,Patient was hospitalized for 5 days. The surgery for heart was pending. On MAR-2021, Laboratory data included: CAT scan (NR: not provided) normal, Cardiac catheterization (NR: not provided) normal, and Stress test (NR: not provided) normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cardiac arrest during anesthesia for a scheduled heart surgery on APR-2021, and the outcome of atrial fibrillation was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0. 20210512607-COVID-19 VACCINE AD26.COV2.S-Cardiac arrest, Atrial fibrillation. 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)

om 5/8/21 at 9:00 PM, felt light headed, stepped outside for air, returned to closest chair, calling to significant other, I feel dizzy. Sat in chair, staring blankly, not responding to calling, or physical touch. breathing shallow, facial and lip color pale, pasty white gray. weak pulse. 911 called, and responded 8-9 minutes later. By the time they arrived, patient had aroused and aware of his surroundings,. Although color was slow on returning to normal. EMS arrived, BP 120/80. Patient refused to go to ER . On 5/10/21 at 2:00am, patient woke up and had a nosebleed lasting 2 hours, pouring from nose. 911 called and transported to medical center for cauterization, nasal packing and observation. 5/11/21 developed a reddened rash on right hand, lasted 5 days. Nasal packing removed on 5/13/21. No further complaints at this time.

BLOOD CLOT IN LEG; SWEATING; This spontaneous report received from a consumer concerned a 70 year old male of unspecified ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in 2021, the patient experienced sweating which lasted about one day. It was stated that patient received vaccine around 18-APR-2021. It was also reported that actual date of vaccination may have been prior to 18-APR-2021 but definitely in April. On 17-MAY-2021, patient visited hospital and got diagnosed with blood clot in leg. The patient was on unspecified medications to dissolve clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating on 2021, and had not recovered from blood clot in leg. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20210534558-Covid 19 Vaccine- This case concerns a 70 yr old male. Blood clot in leg, Sweating. 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).

MAJOR HEART ATTACK, GOT PLACED WITH A STENT; This spontaneous report received from a patient concerned a 70-year-old male. The patient's weight, height, and medical history were not reported. Prior to the vaccination, patient was never on any medication. Patient had no pre-existing conditions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: not reported) dose was not reported, 1 total administered on 04-MAY-2021 at 15:00 to left arm as prophylactic vaccination. No concomitant medications were reported. On 08-MAY-2021, four days after vaccination, the patient experienced major heart attack due to which he went in an ambulance (his spouse called 911) and was hospitalized on the same day. Patient was placed in ICU (intensive care unit) and got step down. On 10-MAY-2021, patient was discharged and he went home with a life vest. Patient was hospitalized for 3 days. No other side effects were reported. Patient got placed with a stent. Patient was discharged with Treatment medications (dates unspecified): lipitor 80 mg, losartan potassium 25 mg, plavix 75 mg, metoprolol succinate extended release 50mg, and baby aspirin 81 mg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from major heart attack on 17-MAY-2021. This report was serious (Hospitalization).; Sender's Comments: V0; 20210535227 -covid-19 vaccine ad26.cov2. s major heart attack. 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.

I had a incident of atrial fib, which required me to be cardioverted to correct it. I went to my cardiologist.

RIGHT LEG DEEP VEIN THROMBOSIS; RIGHT ARM PAIN; PULMONARY EMBOLISM; This spontaneous report received from a patient concerned a 70 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, alcohol user, non smoker, tree allergy, onion allergy, topical iodine cleanser allergy, and weeds allergy, and patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070 and expiry: UNKNOWN) dose was not reported, 1 total administered on 19-MAR-2021 on left arm for prophylactic vaccination. Concomitant medications included amlodipine, atorvastatin, cetirizine, fluticasone, levothyroxine and omeprazole used for unknown indication. On 05-APR-2021, the patient experienced chest pain, shortness of breath, extreme shortness on upper back, right arm pain, right rib cage pain. On 19-APR-2011 patient was travelling, took a bus, when patient arrived, symptoms were so severe that patient could not pick up the luggage. Patient arrived around 5:30pm to his destination and was taken to the ER (emergency room). Patient had x-rays and an MRI done, and was admitted to hospital. Patient was discharged on 24-APR-2021 (hospitalized for 5 days) with diagnosis of acute pulmonary embolism, Shortness of breath, right leg deep vein thrombosis, pain in chest, elevated troponins. Patient was prescribed Eliquis during this admission and patient was currently taking it. On 11-JUN-2021 Patient went to the hospital out of town and was admitted. Patient had chest pain and right arm pain, and right side rib pain. Patient was discharged on 12-JUN-2021 and diagnosed with pulmonary embolism. Patient stated that the chest has improved since starting to take Eliquis, but still feels pressure on the right side of rib cage and felt has not fully recovered yet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from right arm pain, and had not recovered from pulmonary embolism, and right leg deep vein thrombosis. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210629366-COVID-19 VACCINE AD26.COV2.S- Pulmonary embolism, right leg deep vein thrombosis, right arm pain. 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. 20210629366-COVID-19 VACCINE AD26.COV2.S- right arm pain. This event is labeled per RSI and is therefore considered potentially related.

Patient experienced severe diarrhea, sore arm, achey joints, fatigue, depression, chest and lung pressure, injection site pain, leg pain. 2 to 3 weeks after the vaccine, patient experienced tinnitus and head pressure Patient noticed a blood pressure increase

BLOOD CLOTS (RIGHT HAND AND LEFT LOWER LEG); BLOOD CLOT IN THE LUNGS; This spontaneous report received from a patient concerned a 70 year old male. The patient's height, and weight were not reported. The patient's past medical history included lung cancer, tumor removal surgery, four chemotherapy sessions, and surgery to remove the blood clots, and concurrent conditions included non-smoker, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: unknown) dose was not reported, 1 total administered on 11-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAY-2021, the patient developed blood clot in the lungs was reported. On 14-MAY-2021, (three days after) the patient experienced shortness of breath was reported. On 20-MAY-2021 went to Emergency room (ER) and was subsequently admitted to Intensive Care Unit (ICU). On 21-MAY-2021, the patient underwent through surgery to remove the blood clots on the lungs along with this on same day patient developed swelling of left leg and right arm was reported. On 22-MAY-2021, the patient developed blood clot right hand and left lower leg. On 29-JUN-2021, patient underwent through laboratory test included: Computed tomography (CAT) scan revealed negative for blood clots. It was also stated that patient was on Eliquis (apixaban) for anticoagulation due to blood clots. Treatment medications (dates unspecified) included: apixaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood clot in the lungs on 21-MAY-2021, and had not recovered from blood clots (right hand and left lower leg). This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20210702546-Covid 19 Vaccine ad26.cov2.s- Blood clots in the lungs, Blood clot (right hand and left lower leg). 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

Stroke on 07/192021 at ~05:30am of unknown cause. Rushed by ambulance to hospital () Was in hospital for 3 days and was administered many tests. Please contact Hospital for detailed records

Occipital stroke involving vision on 3/14/21, was seen at ophthalmologist and sent to Hospital and stroke confirmed on MRI.

3/22/21 Admission HPI: 71 y.o. male with a history of poorly controlled diabetes mellitus and COPD. He presented to my office today acutely with a several day history of increasing shortness of breath. He has increased his prednisone at home recently and been increasing the frequency of his DuoNebs. Despite this, he states that his oxygen saturations have been staying in the low 80s. He has a hard time walking due to the shortness of breath. He states previous to about a week ago he was doing very well. He denies any fever. He denies any known exposure to coronavirus (COVID-19). In the office today his oxygen saturations were 88% on 4 L. Because of his failure of outpatient therapy, he will be admitted to the hospital for further evaluation and treatment. This patient has a history of severe respiratory decompensation that happens very quickly. Therefore, it is medically urgent we get him into the hospital. 3/25/21 Admission HPI71 y.o. male with a known history of severe COPD and type 2 diabetes mellitus. He came to my office with a several day history of increasing shortness of breath. He had increased his oral steroids and breathing treatments at home and despite this was still having oxygen saturations in the low to mid 80s on 2-4 L of supplemental oxygen. In my office he was extremely diminished and had basically failed outpatient therapy. Therefore he was admitted to inpatient status for acute treatment of a severe COPD exacerbation requiring IV antibiotics and IV steroids. He was admitted and treated with IV treatments. He did recover nicely. However, he was found to be extremely physically deconditioned. Because of this he was thought to be an excellent candidate for swing bed and is being transitioned to swing bed. 4/5/21 ER Practitioner Note: Upon arrival to ED trauma room I found patient to be in cardiac arrest, CPR in progress. History is that EMS was called to the scene for a patient with chest pain. Shortly after arrival at his home patient developed a cardiac arrest. They followed standard ACLS protocol and the patient was intubated. Blood sugar normal. As CPR was given, medications were administered consisting of epinephrine and 1 mg in 2 different doses along with 1 amp of bicarb. IV access via an IO. Patient was then transported to the emergency department. Upon arrival, CPR was continued and oxygen supplied via endotracheal tube with good tube placement verified by auscultation and good sat readings. Monitor was placed and patient demonstrated initially a sinus rhythm but there was no pulse. Therefore, diagnosis was PEA and no reversible causes were identified. ACLS protocol was followed with epinephrine 1 mg IV every 5 min. He received a total that including EMS, 5 mg of epinephrine and 1 amp of bicarb. Monitor at this point revealed the rhythm changed to an agonal rhythm. When CPR was given, there was good results from the CPR. However, CPR discontinued and there is no pulse and patient had an agonal rhythm for several minutes, pupils were fixed but not dilated year. Lungs demonstrating clear bilateral breath sounds when he was bagged via the endotracheal tube. No external signs of any trauma noted. The patient's sister is here and she is a registered nurse. We had discussed management at this point with her and all were in agreement that the code be terminated. At 1015, patient was pronounced deceased.. ACLS protocol was followed. See nursing record for medication and vital sign details. Code outcome: Deceased CC time 20 minutes.

Two weeks after the shot, he noticed bloody noses, hematuria, ecchymoses all over his abdomen, bruises on the top of his mouth. Fatigue

Pt had COVID in January 2021 and was released from quarantine on 1/21/21. Patient has been short of breath since vaccine. Cannot pinpoint when it started. States he does have dementia which only effects his short term memory. He has been seen at the clinic and been given an inhaler to use. States his blood pressure has been elevated at times and O2 sats habe been in upper 90s but also dropped to upper 80s when short of breath. He had breathing test and an echocardiogram done

Patient admitted 4/14/2021 to the ICU from ED. Patient was experiencing hand weakness. Patient given TPA as treatment for a potential stroke. Patient with known stroke on CT imaging, unable to further verify with MRI imaging. Upon further investigation/discussion with the patient, he reports receiving the Johnson & Johnson Vaccine 10 days prior to admission. Patient with known comorbidities which increase his risk of an embolitic stroke however with recent findings from the CDC, unsure if this needs to be further investigated. Patient had 2 head CT scans, showing no intracranial abnormalities and MRI was unable to be completed due to patient's size. Neurology states high probability of stroke within their consult note. Patient's risk factors for stroke include: uncontrolled hyperlipidemia (LDL 132 on Crestor 40 mg daily PTA), hypertension (as high as 182/92 mmHg in ED), physical inactivity (BMI 76 kg/m^2), and male. Low suspicion of CVST based on patient's platelet count of 212 on admission and no abnormality on head CT. MRI would have been beneficial in potentially diagnosing CVST, as well. Our recommendation is to submit this information to the VAERS database as a possible ADR from the vaccine. The patient fits the timing of an ADR, within 6-13 days of vaccine administration, and CDC recommends watching for neurological symptoms based on their most recent press release.

Patient is a 71 y.o. male with past medical history of a-fib on coumadin, ischemic cardiomyopathy s/p ICD, CAD s/p BM stent 2005, and CKD III who initially presented to urgent care per family recommendations d/t persistent cough, SOB and fatigue. CXR was obtained with findings concerning for viral pneumonia vs CHF, rapid COVID was negative at that time with recommendations to come to ED for further evaluation and treatment. Patient subsequently tested + COVID 19 in ED and was hypoxic with ambulation

On 5/3/2021 was found to be unresponsive with low BP and slow heart rate. 911 was initiated and CPR started. Resident was admitted to Hospital with diagnosis of respiratory failure

After getting home, pt lost all control of his arms/legs and body, then blacked out. Neighbor found him passed out in hallway and called ambulance to take to ER. Kept in hospital for 3 days. Patient still has problems with legs as of today not wanting to function

Right after the vaccine, I experienced no symptoms. I had stomach problems and I felt very woozy and had diarrhea, and I also fainted. I hit my head but not bad at all. I went to the ER. I was dehydrated and they gave me IV. They told me drink liquids and Gatorade. It did help with symptoms. They said that it could have been a virus that was going around or it was food poisoning, one or the other.

Patient presents to ED with left hand swelling, fever, and left arm pain on 3/10/21 after receiving his COVID 19 vaccine at Clinic on 3/4/21. I'm unable to determine the route of administration from the immunization documentation. Patient reports that the swelling significantly increased over the past day with increased swelling in his left hand and pain from his left clavicle to his left hand. Patient is febrile upon presentation with a documented temperature of 38.7 and sinus tachycardia. EKG is otherwise unremarkable. Patient has been diagnosed with left arm cellulitis and is being admitted to our hospital. He has been started on vancomycin 800 mg and Zosyn 3.375 g IV.

Site: Pain at Injection Site-Mild, Systemic: Fever-Mild, Systemic: Headache-Severe, Systemic: Tachycardia-Medium, Additional Details: Patient's heart rate is typically in the 80's. After vaccination, night of and morning after, patient's heart rate went up to 113.

I got the J&J one shot and 12 hours later took myself to ER when BP hit 180/96. It went down in about 4 hours to 150/83 without treatment and all blood work etc was normal range. I was dismissed. My BP is normally in the 120-130/80 range and has since returned to this. I report this because I saw a comment in the newspaper by someone who said their 86 year old father had a HI BP episode after the shot that landed him in hospital and required treatment. That's two then, so I thought it best to report it in case there are more.

6 days after vaccine patient had ICH/IVH or (R) spontaneous aneurysmal hemorrhage. On April 8th while in acute rehab he had (L) brainstem infarct.

BLOOD PRESSURE INCREASED; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 72 year old male. The patient's height, and weight were not reported. The patient's past medical history included death of wife, and concurrent conditions included high blood pressure, stress, and anxiety. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: 13-JUN-2021) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced injection site pain. On 09-APR-2021, the subject experienced blood pressure increased. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on 05-APR-2021, and had not recovered from blood pressure increased. This report was non-serious.

72-year-old male history multiple medical problems including coronary artery disease with stents Barrett's esophagus asthma enlarged prostate hypertension presents from the infusion center secondary to being found to have hypotension after receiving his immunoglobulin infusion today for COVID. Patient states he has been feeling ill for the past few days due to COVID he has been eating and drinking much. Patient states that he felt no different during his infusion or after but the blood pressure being low specially felt lightheaded when he stood up he was sent down to the ER for further evaluation. Patient denies any chest pain associated with this no palpitations he is awake alert and not diaphoretic in no significant distress on my evaluation. Patient denies any recent blood in stools. Note is the patient did receive the COVID vaccine Johnson and Johnson approximately 10 days ago. He was diagnosed with COVID infection 4 days after that.

Chief Complaint Patient presents with ? BLOOD PRESSURE coming from facility round 10am, staff went to check on him and he was only responding to painful stimuli, baseline A&O3. Found to be hypotensive by EMS 50s/30s ? Altered Mental Status Patient presents via EMS from his nursing facility for altered mental status. He was last seen as normal at 10 AM. Patient had an appointment with his doctor but when they went in to check on him he was minimally responsive. He is normally a and O ×3. He was found to be hypotensive by EMS. No fever. No known trauma or injury. Upon arrival his blood pressure improved. No other acute issues, symptoms, complaints. Patient is unable to provide a history. 5/5/2021 admitted to the hospital tested + for Covid 19

fever, chills, chest pain/dizziness for 4 days starting 48 hours after vaccine - dizziness - SOB since

About 2 weeks after receiving the J&J Covid-19 vaccination, I became ill with confusion, lethargy, and disorientation. Taken to hospital in town to rule out possible CVA. MRI, CT, Carotid sonograms, were all negative. While waiting on lab, the preliminary DX was metabolic Stroke. After all lab returned, the diagnosis was Hemolytic Uremic Syndrome (HUS). Transferred to ICU in different town for dialysis and plasmapheresis. Hospital in another town had closed their department for holiday. I spent about 2 weeks at hospital. My Hgb on admission was 7.0 and kidney function was 20% . the platelets were being destroyed in the glomeruli. Blood transfusion and platelets were contraindicated.

Shortly after vaccine, upper respiratory issue started. Fatigue, falling, soiling bed sheets and pants regularly. Then went to hospital on june 7th with abdominal pain. Low bloid pressure and hight white blood count. Had blood clot. Urinary Infection Possible sepsis. Still in hospital.

Patient presented to the ED on 6/7/21 with abdominal pain that had started earlier that day. CT abdomen, CXR, and urinalysis were done and all came back negative. Patient denied any respiratory symptoms. On physical exam, he was found to have severe swelling, erythema, and ecchymosis on his left leg extending into the upper thigh and knee. A lower extremity doppler was done and found extensive occlusive thrombosis within the left lower extremity beginning in the external iliac vein and extending into the common femoral, femoral, profunda, popliteal and visualized deep calf veins. No evidence of PE or DVT in the RLE was found. Vascular Surgery was consulted, who did not recommend any procedures, but patient was started on a heparin drip. Hematology later saw the patient and changed the heparin drip to rivaroxaban on 6/9/21. Infectious Diseases was also consulted for possible sepsis.

On May 20th he came down with a cough and not feeling well. Went to hospital on May 22 and was diagnosed with pneumonia. Gave iv antibiotics and fluids. Sent home. On may 24 went back because he was worse. Temperature and high blood pressure and a headache. They admitted him to the hospital then checked him for covid. He was positive. They gave him a shot on may 24 and May 25th in the stomach for blood clots. On may 25th they sent him home. He started feeling better may 28. Then on June 17th he fell out of his chair complaining of severe dizziness. Called 911 and they transported him to hospital. Did a procedure to see if there were any blood clots. It was determined that he had a blood clot in his artery in the neck. They gave him tPA to break up the clot right away. Then transported him to the hospital to the icu. It was determined that the blood clot caused the stroke. Still having severe dizziness. Released him to rehab on 6/18 @ 4:30 pm

swelling began in feet and moved up legs to abdomen; 25 lb weight gain in two weeks between routine doctor exam and emergency visit leading to hospital admission for 6 days where an atrial flutter was detected that was not present in May 19th exam. Diuretics in the week since admission have pulled off over 35 lbs and vastly reduced swelling but heart damage remains.

"Pt c/o flushing/sweating and dizziness 3mins after vaccination. Vitals significant for bradycardia. @13:08 BP 100/58, HR 39, RR 12, SPO2 99% -- > @ 13:12 83/40, 41, 100% -- > @13:22 87/43, 50, 100% -- > @13:23 107/67, 61, 100%. 911 Called at 13:15 and paramedics arrived 13:20. At 15:15 pt elected to leave vaccination site . form signed. Pt driven home. Unknown PMH or current medications."

Thursday, March 11, 2021 (approximately 8:30 am) Patient experienced blurred vision, unbalance, and slurred speech and had an irregular heartbeat. March 11, 2021 (approximately 11:30 am) Patient was admitted to Hospital administered CT scan, MRI and multiple blood tests. Diagnosis - Ischemic Stroke

My husband is still in hospital trying to recover. He had bad headaches that then led to seizures and confusion ,blood clots, and has been hospitalized since. He's literally fighting for his life and tomorrow Wednesday April 14 th he will be transferred to a rehabilitation center.

Patient developed chest pain and shortness of breath 4/15 Presented to hospital emergency department 4/17 found to have a pulmonary embolism without heart strain, however with pulmonary infarction of left lower lobe with associated right lower extremity DVT Patient admitted to the hospital, initiated on therapeutic anticoagulation with Lovenox, started on oxygen therapy for acute hypoxic respiratory failure Discharged home 4/20 on therapeutic anticoagulation with Xarelto and home oxygen as needed

Intermediate Risk PE-diagnosed due to symptoms of pre-syncope, palpitations. Clinical history includes long car ride

DIARRHEA; INCREASED PULSE; WEAKNESS; This spontaneous report received from a patient concerned a 73 year old male. The patient's height, and weight were not reported. The patient's past medical history included blood in brain, and concurrent conditions included headaches. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Concomitant medications included paracetamol for headaches. On 12-APR-2021, the subject experienced increased pulse. On 12-APR-2021, the subject experienced weakness. Laboratory data included: Pulse rate (NR: not provided) 110 (units unspecified). On 14-APR-2021, the subject experienced diarrhea. On 15-APR-2021 05:36, Laboratory data included: Pulse rate (NR: not provided) 87 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from increased pulse, and had not recovered from weakness, and diarrhea. This report was non-serious.

INCREASED BLOOD PRESSURE; BONE PAIN IN LEFT ARM; DIZZY; This spontaneous report received from a patient concerned a 73-year-old male. The patient's height, and weight were not reported. The patient's past medical history included heart stent for heart attack. The patient was non-alcohol user, and non-smoker. The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, 1 total, administered on 10-MAR-2021 at right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-MAR-2021, the patient experienced significant increase in blood pressure (200/110)/headache and bone pain in left arm (vaccine was administered on right arm). On the same day, he also experienced headache and felt dizzy. Laboratory data included: Blood pressure (NR: not provided) 200/110 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy on 10-MAR-2021, and had not recovered from increased blood pressure, and bone pain in left arm. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210430234-COVID-19 VACCINE AD26.COV2.S- Increased blood pressure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY.

73 y.o. male former smoker with PMH significant for coronary artery disease with history of CABG in 12/22/2020, hypertension, hyperlipidemia, type 2 diabetes mellitus, GERD, hypertension, non proliferative diabetic retinopathy, sleep apnea presents to emergency room complaining of generalized fatigue and body aches ongoing for 2 weeks. Patient received Johnson and Johnson COVID-19 vaccine 2 weeks ago. Patient denies any fever or chills. Denies any chest pain or shortness of breath. No nausea or vomiting. Poor appetite. Patient had is the cardiac catheterization rehab post CABG, last session was 1 week ago. Denies any sick contacts. ED vitals stable, afebrile. Patient on room air. Labs remarkable for lymphocytes 15.3, monocytes 10.9, glucose 190, BUN 21, creatinine 1.3, sodium 133, potassium 5.3, chloride 97. Lactate normal at 1.6, troponin 14, Last A1c 6.7 from 12/19/2020. EKG no acute ST wave changes EKG changes. CTA chest no pulmonary embolism seen. Patchy airspace disease of the lungs suspicious for mild to moderate bronchopneumonia. Ultrasound Dopplers of the lower extremity right negative for DVT. COVID-19 positive. Patient received Rocephin, Zithromax in ED, ER asked to admit patient the hospital for observation due to ongoing fatigue and body aches from COVID-19 pneumonia.

Patient felt L sided weakness and couldn't stand up, had some slurred speech-admitted to PHC 4/26/21 At hospital-EKG- within normal limits, PTT elevated not a TPA candidate, CT of head unremarkable, no acute intercranial findings, unremarkable Circle of Willis and MRI of brain -pending.

Patient experience rapid heart rate / tachycardia 36 hours after receiving vaccine. Next day, Cardiologist diagnosed atrial fibrillation. Patient now taking digoxin. No improvement. 10 days following vaccine, at follow up appointment with doctor, doctor recommends cardioversion. Patient continues to experience dyspnea and atrial fibrillation.

Wakening up around 3AM. Check BP.. always around 151/95. Taking 20mg of Lisinopril AM and PM.. still high with head ache. this morning a little better 140/88. Just took an aspirin to see if it helps. i have not been taking Aspirin with Xarelto.

73 year old male with PMHx of AFib, CAD, and HTN who presents with c/o dyspnea that started 4/6/21. Patient states it got to the point where he could not walk in his house without severe dyspnea. States he was diagnosed with COVID-19 one week prior. Per chart review he was in our ER 4/3/21 and diagnosed with COVID-19. At the time he was 95% on room air. His only other symptom has been diarrhea. He states he received the Johnson and Johnson vaccine one month ago. He denies any dizziness, chest pain, abdominal pain, n/v, weakness, or numbness. In ER patient was hypoxic and improved only with BiPAP. Per chart review patient had cardiac arrest on 11/2020 for 17 minutes. He has a significant cardiac history consisting of stemi, fem-pop bypass surgery, PVD, CABG x4, AFib post ablation 2017, V-tach. He was started on therapy with steroids, anticoagulation, and Remdesivir. He failed to improve and had increasing oxygen requirements. He was eventually intubated. Due to failure to improve patient was made DNR and eventually expired.

Chest pains within a week then went to ER two weeks later where they did an ECG and saw that something didn't look right, since they were limited with what they could do, they transferred him to the Hospital where then they did more test to find out he had 3 clogged arteries, one being at 95% clogged. Ended up being diagnosed with Coronary artery disease and ended up having open heart surgery, ended up being hospitalized for a week then went to short term rehab for two weeks.

Father received vaccine on May 13, 2021. Complained of migraine headaches, feeling tired, and generally unwell. Migraines became more persistent. Father died on June 16, 2021 at home. Coughed up blood and vomited around time of death.

Two weeks to the day, high fever up to 103.5 for a week; tired slept for about a week, shaky, no appetite. Could barely function.

4/6/12 ER HPI: 74 y.o. male who presents with complaint of shortness of breath that is worse after eating for 3 weeks. Patient said he had received a his copied vaccine 3 weeks ago. No cough, no chest pain, no abdominal pain nausea vomiting, no palpitations and no fever or chills Shortness of Breath: Started 3 weeks ago and getting worse. Received covid vaccine 3 weeks ago and started then. No cough. Dyspnea on exertion. No fever. Early am he has had runny noses. No inhalers or nebs. Not smoker

My father received his shot on March 13, 2021. He drove to move home and on March 28th started having his right arm go numb but did not tell us. He asked to go the ER March 29th at 6:45am saying his chest hurt and was having a hard time breathing, this has happened before since having Covid in September. I called 911 after he became dizzy and could not walk. While at the ER suffered a massive stroke that paralyzed him from his nose down over a course of 3 days. His brain stem was affected and he lost the ability to swallow. After being on a ventilator for 72 hours he was removed from it and died less then 30 mins later from drowning in his own saliva on April 1, 2021.

Massive heart attack due to blood clot. Heart Cath putting in a stint with over night stay in hospital

Patient noticed blotches on both legs approximately 6 to 7 days after vaccine was administered. On 03/30/2021, patient fell to ground, unable to get up. Patient was taken by ambulance to Hospital emergency room. Scans revealed patient had multiple blood clots and was operated on. Later in the stay, patient developed widespread hematomas in groin, stomach, rear, and both legs. Patient was released from hospital on 4/8/2021.

I am submitting this report because of symptom onset relative to vaccination date, and because I have not experienced this cluster of symptoms before. My wife and I received the same lot number of the J&J vaccine on Saturday, March 13. We both had slight fatigue that evening and into the following day and she has had no further symptoms. On Tuesday, March 16, I had a mild ache around injection site with no further symptoms until Saturday, March 27 when I experienced a brief episode of lightheadedness. (CONTINUED BELOW)

13th of April. I had a blood clot in my hand. My index finger on my left hand was numb and black and blue all around the knuckle area and into my hand area. I went to my primary care - I went to the acute center there. She said the hand was cold and could see the black and blue. They put me on Plavix for 30 days and I haven't had any reoccurrence of that. I think it was the 21st, I couldn't sleep all night, I had a kidney stone - the pain was so bad I got nauseous - around my back and side and in my front. I didn't have a fever. I went to the doctor office and they checked urine - and said there was blood in the urine. I was prescribed - Tamsulosin HCL. They thought I had passed most of it by the time I got there.

Patient received covid-19 vaccine in left arm on March 9th. He alerted health care provider of left arm swelling on April 19th that started 4-5 days prior. There was no redness or warmth, reported as non pitting left arm swelling. Venous duplex revealed Left upper extremity DVT predominately effecting subclavian and axillary vein.

Progressively worse headaches culminating in seizure, unconsciousness, and subdural hematoma requiring helicoptering to the ER and brain surgery to drain the hematoma.

Approximately two weeks after vaccination I noticed his left foot and leg swelling. Patient advised me that he needed to go to the hospital because he was not feeling well and his oxygen level was low. We called 911 and was taken to the hospital. After at the hospital I advised a male nurse that I was concerned about his leg being swollen cause he had been given the Jansen Covid vaccine and I was concerned about blood clots. Everyday I would tell someone in the hospital (never saw a doctor I could talk to) about his swollen leg but did not really get anyone interested. Before he was moved to a Veteran?s State Home, I overheard someone saying they were going to give him his anticoagulant. I?m filing this report in case the swollen leg was a result of blood clots due to the vaccine.

74 y.o. male presented to the ER with complaints of right elbow pain and swelling. The nursing home did call the office yesterday requesting for x-ray of the right elbow. Bed x-ray did show an impression of: Unremarkable limited view left elbow without evidence definite fracture or dislocation this was read by the radiologist. Patient did have CT scan right elbow today showed an impression of: Diffuse soft tissue edema prominence subcutaneous soft tissue gas along the dorsum forearm proximally, in no acute pathology or CT evidence of acute osteomyelitis, no vascular pathology. It is noted that patient has swelling, redness pain, and erythema to the right elbow. Upon examination the patient does grimace pain movement of the right level. Patient does have a large pocket of fluid noted to the right medial epicondyle region and to the medial right upper forearm. Skin is hot to touch, but patient's pulses were noted at 2+ 2+, and CMS is less than 3 sec. Patient did also have lab work a white blood count noted of 5 point, hemoglobin is 10.4, hematocrit was 31, platelet count is 201. BMP showed a nonfasting glucose of 107, sodium was 135, calcium 8 1, and his GFR is 84. Patient's sed rate is elevated at 45. Patient's lactic acid noted at 0 4. Patient did also have blood culture in the emergency room and that result is pending. Patient's procalcitonin level is noted at less than 0.00. The patient was started on vancomycin 1 g IV piggyback every 12 hr. Patient was admitted to medical inpatient as it deemed that he will need longer than a 2 midnight stay for monitoring and IV piggyback antibiotics.

Patient developed shortness of breath with bilateral pulmonary emboli. He was hospitalized on 6/3/21 to 6/4/21 and was discharged home on blood-thinning medication.

Patient developed a lower extremity DVT approximately 2 weeks after receiving the J&J COVID-19 Vaccine. Patient was treated and discharged from our facility on apixaban.

Blood Clot leg/broke off went to lung Blood thinner Very weak tired cough Emergency room 4/72021 hospital two days 372021-3/9/2021

Initial Complaint of Constipation, admitted for altered mental status, respiratory failure, HTN, hypothyroidism. Information pulled from Report

10 mins after vaccine the pt passed out. We were able to get him back but he passed out 2 more times. His BP was 80/61. EMS was contacted and the pt was monitored and recovered in about 20mins. The pt refused additional medical attention and was released. I contacted the pt Friday night and again on Sat. Pt stated he was feeling fine and would follow up with his MD.

He complained Fever and after that shortness of breath, and when I tried to see a Doctor he suddenly collapse and died

Patient collapsed & died 48 hrs. after receiving vaccine. He was shopping at local CVS store & collapsed without warning. Two nurses on scene at Clinic performed CPR immediately & applied AED. EMS arrived within 5 min. There was never a heart rhythm & after 35 min. of CPR was DOA at hospital ER. He had gone to the gym earlier at 7am & was having a normal day. He had not mentioned any complaints of not feeling well.

Patient seen in clinic on 04/07/21 reporting 2 weeks of right leg swelling and calf pain. Vascular ultrasound on 04/07/21 showed blood clots in legs. Lovenox injections started 04/07/21. Warfarin started 04/08/21.

4/7/21 patient presents to ED with severe left arm pain and neck pain, dopplar shows occlusive thrombus in left cephalic vein 4/9/21 patient goes in to cardiac arrest; found to have an INR>10 and concern for life-threatening bleed that required treatment with KCentra; intubated and sedated; liver shock, heart failure with reduced ejections fraction; troponin elevation 4/13/21: patient extubated; patient's wife informs Dr. that patient was vaccinated on 3/31 with Jansen product after seeing news reports regarding adverse events 4/16/21 patient expected to be moved out of CCU to medical floor

patient had massive intracerebral hemorrhage 3 days after vaccination. family claims patient was doing well until vaccination. there is a suspicion that patient might have had sinus venous thrombosis that lead to the the ICH.

Deep Vein Thrombosis right leg. Five days after being vaccinated I began to notice swelling in my right leg from my knee through my ankle-foot area. There was an associated increase in pain in the knee. I tried to shake it off hoping that the swelling and pain would go away, but I finally relented to the concerns of my family and sought care on the 6th of April at the emergency room because my doctor refused an in-person appointment. The emergency room physician prescribed Eliquis which I have been taking. The swelling seems to have leveled off, but my right leg still appears to be twice the size of my left leg

Beginning about 10 days after vaccination, the patient noticed pain in his arm and he started ?not feeling so great.? Over several days, this pain began to radiate and involve muscle and bone aches. He continued to feel ill to what he described as the worst symptoms on Monday, April 26th, which included severe pain, high blood pressure (211/113 documented by the ER), symptoms similar to cardiac event. The patient was seen by Emergency Department who did not find a diagnosis, but gave the patient medication to lower blood pressure and referred further treatment to his Primary Care Provider. Blood pressure mediation was taken to lower his blood pressure and clonidine 0.1mg was prescribed by his PCP because of elevated BP (over 150/90). The patient was also instructed to take Advil for pain and was referred to get an X-ray with follow up in 2 weeks on 5/13.

BULGING FEET VEINS; HEADACHES; TIREDNESS; This spontaneous report received from a consumer concerned a 75 year old male. The patient's height, and weight were not reported. The patient's past medical history included back surgeries, and left elevated diaphragm, and concurrent conditions included prostate cancer, and diabetes, and other pre-existing medical conditions included does the patient have any allergies? :: yes provide details of the allergies :: codeine. The patient experienced drug allergy when treated with codeine. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAY-2021, the subject experienced tiredness. On 11-MAY-2021, the subject experienced bulging feet veins. On 11-MAY-2021, the subject experienced headaches. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from headaches, and bulging feet veins, and the outcome of tiredness was not reported. This report was non-serious.

Patient received 1 dose of Janssen vaccine at pharmacy on 5/25/21. Patient visited hospital emergency department on 5/28/21 after experiencing new a syncopal episode with abdominal pain and vomiting, then acute left-sided chest and arm pain after with new atrial fibrillation diagnosis which was managed. Patient revisited same ED later on 6/1/21 for significant fatigue/weakness and diagnosed with STEMI.

New / re-onset of asthma, dyspnea and tachycardia with minimal exertion, cough (persistent for 12 weeks, starting the night Pt received the vaccine and not resolving until early/mid-June). Pt had a remote h/o asthma as a child but had not had any flare-ups since he was 12 years old. He is a never-smoker and does not have COPD.