Johnson & Johnson

Patient received J&J covid vaccine on 4/7/2021. Patient presented to the ED on 5/3 for right arm swelling with redness. Patient was found to have proximal right upper extremity DVT extending to right subclavian vein along with bilateral PE in the ED. The provider noted the patient had no risk factors other than receiving the vaccine, requested a hematology/oncology consult for evaluation hypercoagulable , patient started on bivalirudin while HIT work-up completed plan to transfer to oral anticoagulation upon discharge.

SUSPECTED URETHRAL MUCOSITIS; CLOT; PENIS TIP GOT RED; PENIS PAIN; SAW ANGELS AND DEMONS IN BED; TERRIBLE MALAISE; HEADACHE; FEVER 40 DEGREE; This spontaneous report received from a patient concerned a 26-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: 204A21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 02-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-MAY-2021 at night, the patient experienced some symptoms after vaccination including Fever of 40 degrees Celsius, headache, and a terrible malaise. The patient also reported seeing angels and demons in bed; Also, the patient noticed that the penis tip got red and experienced pain. On 05-MAY-2021, the patient continued with the symptoms, and it seemed as if a clot was generated. On 06-MAY-2021, the patient had an appointment with general physician who informed that he never saw an adverse reaction like this after vaccination and that it could be a urethral mucositis. On 10-May-2021, the patient would have an appointment with the urologist to inform the symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever 40 degree Celsius, saw angels and demons in bed, headache, terrible malaise, penis tip got red, penis pain, clot and urethral mucositis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20210513944-covid-19 vaccine ad26.cov2.s -thrombosis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

BLOOD CLOTS INTO THE LUNGS; BLOOD CLOTS ON RIGHT ARM AND SHOULDER; FLU LIKE SYMPTOMS; DISCOLORATION ON THE RIGHT ARM AND IT TURNS BLUE; SWOLLEN RIGHT ARM; This spontaneous report received from a patient concerned a 26 year old. 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: 207A21A, and expiry: UNKNOWN) dose was not reported, 1 total dose administered on 07-APR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, two days later after getting the vaccine patient had experienced flu like symptoms. After 3 weeks, patient had discoloration on the right arm and it turned blue and swollen. On 03-MAY-2021, the patient was hospitalized. Patient was administered through the emergency care on 05-MAY-2021. Then the patient got transferred to the floor. Blood clots were formed on arm, shoulder, and into the lungs. At that moment patient had shortness of breath. Patient was hospitalized for 5 days and discharged on 07-MAY-2021. Treatment medications (dates unspecified) included: apixaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swollen right arm, had not recovered from discoloration on the right arm and it turns blue, blood clots into the lungs, and blood clots on right arm and shoulder, and the outcome of flu like symptoms was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210554390-covid-19 vaccine ad26.cov2.s- blood clots into the lungs, and blood clots on right arm and shoulder. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.

PATIENT'S MOTHER REPORTED TO PHARMACY THAT PATIENT DIED 6 DAYS AFTER RECEIVING THE JANSSEN COVID 19 VACCINE.

Preexisting Conditions: None given prior Vaccination; 10:33 observed 'scissoring', seizure activity, falls out of chair, hits head, generalized tonic clonic x 30secs Post Vaccination and seizure, Attendee reports he is hung over, didn't rehydrate, nor eaten breakfast. No Seizure history prior to this event. Left with EMS to ER

pt with an new onset single episode of tonic-clonic seizure on 4/9 (3 weeks after vaccination) that lasted 60-90 seconds. patient with no predisposing trauma, no recreational or illicit drug use or alcohol use, no history of seizure disorder or family history of seizure disorder. pt with postictal state lasting 10-15 minutes. Patient went to ER following episode and treated with Ativan. Patient with no reports of seizure like activity or episodes since the event.

Diffuse urticarial rash involving right axilla and over bilateral shoulders, developed intense chest pressure and squeezing, heart racing and when those symptoms resolved pt. became very weak. Of note pt. stated was lightheaded for 15 mins after receiving the vaccine

Extensive RLE and DVT, Xarelto initiated on 4/7/21 revealed the clinical finding. Patient in good condition.

ED NOTE is as follows...from 4/21/21 @ 21:47 a 28 y.o. male who to the emergency room with reports of a headache for the last 48 hours. He reports this as being one of the worst headaches he has ever had. He was seen at urgent care and given Toradol, Zofran and Benadryl and still rates his pain an 8 out of 10. He does feel pressure behind his eyes. And reports vomiting in the parking lot at urgent care. He denies abdominal pain back pain, neck pain, shortness of breath, chest pain, numbness or tingling or any other worsening concerns. Reports that he did receive a recent Johnson & Johnson vaccination. Patient states he does vape. He occasionally drinks alcohol he denies any illicit drugs. Patient denies any head trauma. Diagnosis management comments: This is a 28-year-old male arrives to the emergency room with reported migraine headache for the last 48 hours. He did report that he was go to urgent care in which he received a migraine cocktail of Zofran, Benadryl and Toradol. Patient reported that his headache was not resolved so urgent care sent him on for further evaluation. Patient upon arrival had a negative neurological exam however he did report that he had pressure behind his eyes. Was unable to see any papilledema on funduscopic exam. Check patient's pressures bilaterally and they were 21 and 18. Patient did report to me that this was the worst headache of his life. I did administer IV fluids here as well as Tylenol and morphine. Patient did report some improvement. Patient did report in his past medical history had a recent Johnson & Johnson vaccination. A CBC and CMP was obtained. Did have thrombocytopenia with a count of 66. Since my exam was PERRL with normal extraocular movements. He had no eye redness or eye pain. Of low concerns for any iritis or uveitis. Patient's patient CT of his head did show a abnormal CT that had a dense appearing superior sagittal sinus that was representing a venous thrombosis. Radiologist did recommend a MRI MRV. An MRI and MRV was ordered. Patient MRI MRv did show findings are consistent with a venous thrombosis involving the right jugular right transverse sinus and superior sagittal sinus there is also a patchy edematous change within the subcortical white matter areas bilaterally and symmetrically. There was no CVA. With patient's reported migraine headache. Reported blurred vision, low platelets, recent vaccination I do believe patient has vaccine induced thrombotic thrombocytopenia. With this finding I did converse with my overseeing physician Calls were made out to neurology and then a call out did prefer to have patient started on IVIG at 1 g/kg daily for 2 days and blood thinner Xarelto 15 mg p.o. twice daily. These orders were initiated. Internal med services was consulted and with conversations of family, internal med services out possible transfer that an interventionalists could be available if patient needed it. Report was given at 2100 upon my end of shift.

Shortness of breath, chest tightness, pain in shoulder, neck, and lower back. Symptoms started on 6/22/2021. Went to ER on 6/24/2021. Diagnosed with pulmonary embolism (multiple clot in left lung). Labs and imagining done, now on medication.

This was a J&J vaccine but I didn't see that as a choice in the drop down. My son passed away on June 5 2021. He had severe nausea

I had extreme chest pain on the 24th of March. It really hurt to breathe and it felt like I had pressure on my chest. I went to the Emergency room and they did a chest x-ray and a Covid-19 both of which were negative. I went home and I returned to the ER because the chest pain became worse. The chest X-Ray the second day showed I had pneumonia. I was told that it could have been from the Covid-19 in December or if was community acquired. I was prescribed with antibiotics and discharged. I still feel some chest pain after about a week and I have already finished the full course of antibiotics. I've seen my Primary Care physician, my cardiologist and my Pulmonologist.

29yom with no significant medical history was diagnosed by CT with acute pulmonary embolism involving the branch vessel in the right lower lobe 14 days after receiving Johnson & Johnson vaccine. Symptoms of right pleuritic pain began 4 days prior to the diagnosis. Initiated therapy on oral anticoagulants.

Patient with PMH of Aspergers, ADD and obesity brought to ED in status epilepticus. Headaches and nausea/vomiting started day of vaccine and progressively worsened. Was observed to have 2-3 seizures before arriving to ED (possibly over a 2 hour period) on 5/18. Found to have Superior sagittal sinus thrombosis and thrombocyctopneia with elevated D-Dimer and PF4 and low fibrinogen. Patient suffered irreverisible brain injury. Decision made with family to withdraw care

Patient developed intermittent right-sided pleuritic chest pain about 10 days following vaccination as well as lower leg pain. Patient started taking aspirin and stopped smoking and pain in leg resolved but still had intermittent chest pain. Last couple weeks patient stopped taking aspirin and started smoking again and 2 days ago noticed an increase in pleuritic chest pain that brought him to the emergency department.

Patient received the Janssen COVID -19 Vaccine at the end of a work day on Tuesday March 16, the next day before noon he was experiencing fever, headache and pain in the upper left side of his chest to the side by his left Axillary. He came home at 1:00 pm. Had a headache all evening, fever of 100 and the pain in his upper left side of his chest. At around 12:25 went downstairs to take an Aleve for his head ache, and pain. His pain was so severe in the left upper side that he could not even raise his arm. It was severe pain. He managed to take one pill and collapsed falling on the kitchen floor. We heard the commotion and found him unconscious and unresponsive, we called 9-1-1 and he started to have a Grand Mal Seizure. He has never had a seizure in his life.

I received the vaccine on Wednesday, April 7th. I was told I had an anaphylactic reaction at the time of injection: I started sweating upon receiving the vaccine, my blood pressure dropped, and I almost passed out. I was monitored for 30 mins before being sent home. Other than some fatigue, I was fine the rest of the day. On Thursday, April 8th, I was tired but felt fine otherwise. Friday and Saturday, April 9th and 10th, I felt like I was back to normal and even did some light exercise. On Sunday morning, April 10th, the left side of my body (side of injection) went numb, I had extreme vertigo, shortness of breath, and blotches that appeared in random places. It didn't look like hives, but rather looked like strips of red. I didn't feel like I was having an allergic reaction, but something did not feel right. I consider myself a pretty healthy guy with a healthy lifestyle. I did not feel the need to go to the ER quite yet, but I did have a friend come over to monitor me. My friend did some acupuncture which helped resolve the numbness and dizziness and some of the blotches, and also mentioned concerns regarding blood circulation and potential clotting issues she thought I was having.

Deep vein thrombosis (DVT) of axillary vein of upper right extremity, sub clavain vein and pulmonary embolism of right and left lung. Treated with injected Lovenox.

Sore arm, headache x 2 days. Severe myalgias and Rhabdomyolysis developed after 5-6 days. Briefly, 30 yo gentleman h/o bipolar disorder, opioid use disrder (on methadone), nicotine use disorder (vaping), recent Janssen COVID vaccination (about 1 week ago) who was admitted with a few hours of myalgias and dark urine, notable recent moderate exercise and over-ingestion of gabapentin. For Rhabdomyolysis: 4/16/2021: CPK peak 95,694; AST peak 779, ALT peak 282, Cr 1.0, Plt 279 Treated with aggressive IV hydration with improvement.

Severe headaches after four days. Continued mogranes to this date ( 14 days). Pain in right eye. Numbness and tingling throughout body. Waking up at 1 AM with 110 bpm heart rate. Easy bruising. Blood spots

BLOOD CLOT FROM NOSE; TEMPORARILY UNABLE TO WALK, RICKETY KNEES; BURNING LEG PAIN; JOINT PAIN/ SHOULDER PAIN; SHOULDER FEEL TIGHT; This spontaneous report received from a patient concerned a 30 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included cigarette smoker (occasional pot; rarely). The patient's grandfather died from blot clot under knee (thrombosis). The patient had no history of bloody nose. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on left arm on 28-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021 (two days after vaccination) the patient experienced really bad burning leg pain for few days and his joints in shoulder and knees were affected two days after vaccination and he could not walk (temporarily unable to walk). The patient also experienced rickety knees. On the same day, the patient blew out a huge blood clot from his nose. On 2021, the patient's shoulder felt tight. At the time of this report, the patient's knees and shoulders were still feeling tight like there was hardly any cartilage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood clot from nose, and temporarily unable to walk, rickety knees, was recovering from joint pain/ shoulder pain, and the outcome of burning leg pain and shoulder feel tight was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-Covid-19 vaccine ad26.cov2.s-blood clot from nose. 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

pt developed symptoms of left leg swelling on 4/22/21 with increased pain and fullness in lower leg. found at ER on unspecified date to have a acute DVT, started on Xarelto, and fu in clinic on later unspecified date - with cbc normal, cmp normal goal of 3months of AC and hematology consultation

About 12 days following vaccination, patient developed chest pain and shortness of breath. He went to the ED and was found to have multiple bilateral pulmonary emboli with signs of right heart strain. It is not clear if the vaccine was the cause of the embolism, but there are no other provoking factors that could be identified. He has been started on anticoagulants with improvement in symptoms, but he has persistent dyspnea with exertion.

a 31 year old man who received the COVID-19 vaccine on March 27, 2021 in the Public Health Department parking lot. Upon arrival and check in, the patient declined any comorbidities and health history but did state that he was nervous. After administration of the vaccine by NP, the patient lowered himself to the ground, from a sitting position, and had a 60 second tonic clonic seizure. Seizure precautions such as turning the patient on his side, supporting his head, and calling EMS were taken during the seizure. After 60 seconds, the patient came to and asked what happened. PPHD staff oriented the patient to what had happened, to which he proceeded to say ?oh that is normal for me when I get anxious.? With the help of PPHD staff and his wife, the patient was brought to a sitting position and given a granola bar and water to his request. According to clinic lead RN, ?his skin was normal in appearance for race, ethnicity, and age. He was mildly diaphoretic. He verbalized feelings of anxiety and worry surrounding the vaccine.? As EMS arrived on the scene and began assessing vital signs the patients anxiety appeared to increase; he became less verbal, closed his eyes, and his breathing pattern became shallow. The patient then had a second seizure at this time lasting approximately 25 seconds. When the patient came to he immediately verbalized, ?I?m good, I?m good, I?m fine?. He was slow to respond to verbal cues, but persistently refused transport to the local acute care hospital for further evaluation. He rested on the ground in supine position for approximately 25 minutes, with his partner and EMS at his side. Upon further evaluation of the patient and his wife, it was determined that the patient has a history of seizure activities when he is nervous and that he was ?expecting? this to happen. The patient continued to decline medical care and transportation to the hospital. The patient left in medically stable condition with his wife operating the vehicle.

Patient was in attendance at the JANSSEN vaccination clinic on 4/9/21. After vaccination while he was in the observation area, PT experienced a syncopal episode and hit his head on the window sill next to where he was sitting. Staff responded and assessed PT and decided to initiate a MET call. There was concern that the patient may have experienced a seizure. Patient was taken to the Emergency Department. Patient was ultimately admitted on 4/9/21 with new onset of a. fib. He was discharged on 4/11/21. While hospitalized, the patient received IV cardizem

10 after I received the Janssen Covid-19 vaccine, I admitted myself to the emergency room with severe chest pain and very difficult time breathing. They ran CT scans and found multiple blood clots in both lungs, pulmonary embolism. They put me on blood thinners and transferred me to another hospital. There they monitored me for a couple days and released me with a prescription for blood thinners.

Patient received vaccine through pharmacy at employer vaccination event. Presented to clinic on 04/13/2021 and noted to have imaging confirmed "There is occlusive superficial clot starting the upper lateral right thigh and extending distally through the mid to distal lateral calf. This appears to be within a superficial varicosity. Findings are consistent with extensive superficial thrombophlebitis of a varicose vein of the right lower extremity."

The afternoon after I got the shot I went for a jog. When I returned, I got intense chills and a fever of 103 degrees along with some flu like symptoms. I had a slight headache. Ibuprofen helped but the next day I had similar symptoms, but they went away by the end of the day. On the third day I felt a little better, so I went for a run. I had some shortness of breath and it was difficult to breathe when I was running. I normally run 4 miles daily. The shortness of breath was present for a week after that and also started to happen intermittently even at rest. One week after the shot I saw a doctor and they did some testing but did not find anything definitive. Six weeks after the shot I went to the ER and they diagnosed with Thrombocytopenia. At this point it has been seven weeks the shortness of breath has improved, and I haven't experienced it for a few days.

RUE DVT in brachial vein at site of injection. Patient complained of RUE pain and swelling on 4/28. That evening the team ordered a RUE venous duplex. The venous duplex noted a DVT in the proximal aspect of one of the two brachial veins. He was vaccinated during an inpatient psychiatric hospitalization. He was evaluated by the medical team on 4/29 and noted to be in stable condition. On discharge he was prescribed xarelto 15 mg BID with food for 21 days with instruction to follow up with PCP in 1-2 weeks. After 21 days of therapy plan was to switch to xarelto 20 mg daily with food until 7/22/21 for a total of 3 months of therapy. The adverse event did not prolong his hospitalization.

Received the J&J vaccine in May 20. Started experiencing leg muscle and back pain June 1, 2021. Progressively got worse over the following weeks. On June 15 I woke up with a new pain in my leg. Went to urgent care and had a D-Dimer test that came out very high. I was sent to ER where they discovered one clot in each leg and two in my lungs via ultra sound and ct scan. I was immediately hooked up to herapin blood thinner through an IV. I was released the following afternoon with Eliquis blood thinner tablets.

Client received his J&J vaccine and immediately afterwards he had a seizure-tonic clonic. Seizure lasted about 40 seconds, he was immediately evaluated by the paramedics on site. BP laying down was 117/74 p62 and later 116/82 p66. Client indicates that has a history of passing out when he gets his blood drawn. 911 was called and Medic arrived, client was transported to the hospital for further evaluation.

General muscle ache Dizziness Chills Very severe headache blew out my nostrils this morning and clotted blood came out

Covid-19 vaccine JJ: 32 y.o. male w/ no PMH presenting 2 weeks after receiving his Johnson & Johnson COVID vaccine after having severe L calf pain found to have thrombocytopenia. From H&P on 4/21, Patient reports that he had both fevers and aches after his vaccine (4/8/2021). Several days later developed low back pain radiating into his left leg which he initially attributed to sciatica. However, several days later, he went for a 6 mile hike, and felt that his left leg was hurting more. He went to PCP, where he received a blood test and was found to have a platelet count in the low 60s. This was initially thought to be a lab error, but he noticed that his left leg was swollen, somewhat red, and appeared that his blood vessels were swollen. This swelling resolves when he is lying down, and is worsened when he is standing. He received an US to r/o DVT, which was negative. However, after his repeat platelet count demonstrated thrombocytopenia, he was sent to the ED. He denies any recent leg trauma, though he has broken his leg before nearly 15 years ago. He denies weakness or issues going to the bathroom. Denies chest pain or shortness of breath. Denies chills, fevers, but did wake up last 2 nights drenched in sweat. He also reports a petechial rash on his legs. As of 4/22, medical team suspects Vaccine-induced thrombocytopenic purpura (VITT). VITT requires 1) thrombocytopenia, 2) documented clot, 3) positive PF4 Ab, and 4) recent AstraZeneca or J&J vaccine. He meets criteria 1, 3, and 4. He has clinical signs of DVT but does not have a documented clot. Patient has L calf tenderness and prominent pooling of blood and vein engorgement of the L leg when he stands up. Possible that he had a DVT or multiple that cleared and now he has post-thrombotic syndrome. This is consistent with the pooling of blood with gravity and relief of symptoms with elevation. As he has had 2 negative US for DVT, unlikely that he has an unresolved DVT. abdominal and head CT are neg for thrombosis.

Syncopal episode with spontaneous recovery. Second syncopal episode associated with 15 seconds of asystole on cardiac monitor.

Culminated in myocardial infarction. Chest pains started next day and leg pains. By April 23, I had severe chest pains and had to see medical at work. On April 30, 2021 was at emergency department for heart attack symptoms. Was transferred for myocardial infarction. Test results show myocardial infarction, coronary spontaneous arterial dissection, and blood clot.

Heart attack - Sudden onset chest pressure, shortness of breath, bilateral arm numbness. Found to have clot in LAD requiring stent. No cardiac risk factors.

Anaphylaxis including full body urticaria and pruritis, coughing, and bronchial constriction. Immediately took Benadryl and albuterol which helped improve symptoms over about an hour. I had COVID infection about six months ago and recovered without incident from that.

On the morning of Monday April 19, 2021, 1 1/2 days from receiving the Johnson & Johnson shot, I walked upstairs after coming down for breakfast and felt something off with my heart and I felt my heartbeat and noticed that I was in AFib. My heart had an irregular heart beat. I was taken by ambulance to the hospital where they had to shock my heart to get it back to a normal rhythm. They were able to get it back to a normal rhythm with one shock. Since then I have still noticed more heart palpitations, but have been alright since. I am a healthy 32 year old (now 33), with no health issues.

Triggered a grand maul seizure, with hot and cold chills and a slight fever. Patient is doing much better this morning.

Severe shaking. Admitted to ED for 180/90 blood pressure and rapid heartbeat (>120). Screened for potential pulmonary embolism and blood clots

Severe thrombocytopenia (Platlet Count of 18) HPI: 33 y.o. male with no PMH coming in now w/ progressive thrombocytopenia to 18. He received the J&J covid vaccine on 4/8 and felt well afterwards. Last Friday (4/16) he began to experience constitutional symptoms (fever to 100.4, chills, night sweats feeling drenched, decreased appetite) so decided to get his labs drawn as an outpatient for further evaluation. Symptoms progressed until Tuesday, when they began to subside slightly. At that point, his labs resulted and were notable for thrombocytopenia. He got his labs redrawn the day before admission and it was noted that his thrombocytopenia was worsening, so he was directed to the ED for further evaluation. Patient seen by hematology, started on dexamethasone 40 mg PO daily as well as IVIG treatment x2. MRV of brain without evidence of dural venous sinus thrombosis ***PATIENT CURRENTLY HOSPITALIZED***

After one week I suffered a TIA and have to be hospitalized From April 11 to April 15. After I was discharged I went back to the hospital April 18 with a second TIA. I was hospitalized from the 18 to the 21. Both times at same facility.

PT REPORTED TO ED WITH C/O SOB/DYSPNEA, CHEST PAIN, PROBLEMS WITH INSPIRATION AND FATIQUE-TACHYCARDIA HR 119- BILATERAL LEG PAIN SINCE 4/26/21

Patient received vaccine in a drive up clinic and was waiting in his car during the 15 minute observation time. 10 minutes after the vaccine, he became lightheaded and alerted for medical attention. When we arrived at his car he was having tonic clonic seizure like activity which lasted about 20 seconds. Patient was reclined in his car seat, VS taken and stable. Oriented x4 but described feeling light headed, tingling in left arm and lips, and diaphoresis. EMS arrived and assumed care. Extended observation showed improving vital signs, and resolution of described symptoms. Patient was released from EMS care and was transported to the ER by a friend for further eval.

I received the vaccine on 4/2/21. I started feeling tightness, soreness and throbbing pain in my right calf on 4/28/21. On 5/4/21 the pain was unbearable and there was swelling in my calf/ankle. On 5/5/21 I got an ultrasound that confirmed I have a DVT blood clot in my right calf and I got blood work done that confirmed everything was normal with my health (liver function, platelet counts...). I was prescribed Xarelto 15mg and began taking Xarelto on 5/8/21.

BLOOD CLOT IN LOWER CALF MUSCLES IN RIGHT LEG (DVT); NAUSEA (AFTER VACCINATION); EXTREMELY BAD HEADACHES; MUSCLES ACHES; BODY ACHE; LEG PAIN; This spontaneous report received from a patient concerned a 33 year old hispanic or latino male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: 21-JUN-2021) dose was not reported, 1 total administered on 02-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the patient experienced post vaccine nausea, extremely bad headaches, muscles aches. On 28-APR-2021, the patient experienced blood clot in lower calf muscles in right leg DVT (deep vein thrombosis). At around 2 weeks ago on 28-Apr-2021 or 29-Apr-2021, he started to feel throbbing pain and tightness in calf area. On an unspecified date in APR-2021, the patient experienced body aches specially in leg, back and arms and felt like it was a strain calf muscles or achilles pain, tightness in calf. At around 1-May-2021 to 2-May-2021, he felt the pain was extremely worse although he did not have any trauma and he did not run that may have caused a muscles strain. He went to emergent care on 5-May-2021, as he does not have a medical insurance. The doctor ordered an ultrasound as the pain he was experiencing was unlikely due to muscles strains as he did not do anything that may have caused it. On same day, laboratory data included: blood test (NR: not provided) all results are normal and diagnostic ultrasound showed DVT in lower right calf muscles in right leg. It was reported that, he was asked if he reporting those side effect to Janssen would affect him by anyway if he want to proceed into any legal action against Janssen as he experienced a blood clot. he was also asking if Janssen can provide him for the cost. On 08-May-2021, treatment medications included rivaroxaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea (after vaccination), extremely bad headaches, and muscles aches, had not recovered from blood clot in lower calf muscles in right leg (DVT), and the outcome of body ache and leg pain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210515729 -Covid-19 vaccine ad26.cov2.s-BLOOD CLOT IN LOWER CALF MUSCLES IN RIGHT LEG (DVT). 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 developed pain in the left lower leg about 8 days post vaccine, progressively worsening over time, with associated swelling and spread of discomfort to the thigh. Presented to urgent care on 5/23/2021 and was felt to have findings suspicious for deep vein thrombosis. See item 19 for details on test results.

I have blood clots in my left leg and some that have spread to my lungs. Pain started on May 19th shortly after waking up. At this time I can put no weight on my left leg. I went to an urgent care on May 23rd. I received an ultrasound and CT Scan.

I started to have blood coming out of my butt in the morning a week after the shot. The blood was enough to fill up my toilet but it only happens in the morning when I first wake up.

blood clot in left leg, cramping and soreness, tender to the touch. currently taking Eliquis for the next 6 months

Became extremely weak and sick for 3 days after the shot. Had a grand mall seizure 19 days after vaccine. Also had a really bad headache and lost vision in my left eye for nearly 8 hours about 2 weeks after the seizure. Have had dizziness and been feeling week for nearly 2 months after vaccine and still cannot manage to get rid of the constant headaches and loss of thought due to these side effects.

Presented 7/24/21 to the hospital with recurrent seizure and declining mental status after persistent headache for the several previous days. On imaging found to have extensive dural venous sinus thrombosis with hemorrhage. Treated with anticoagulation, anti-seizure medications, invasive mechanical ventilation, and transferred to alternate hospital for consideration of endovascular treatment.

Felt nauseous and out of breathe right away. Fainted and hit head on pavement within 15 minutes of shot. Admitted into ER with concussion and found bleeding in brain within 3 hours of shot.

Exact date and time of COVID vaccination unknown. Patient presented to Medical Center on 04/02/21 with left sided weakness and slurred speech. He reports receiving the COVID19 Janssen vaccine 15 days prior. Details of vaccination beyond patient report are unknown. Diagnosed with acute left cerebellar stroke, status post TPA on 04/02/2021. Extensive workup in hospital negative and unremarkable, including TEE, and hypercoagulable state so far negative. Follow up with hematologist as outpatient underway to evaluate for any possible coagulation disorders.

Diagnosed at ER with a transient ischemic attack. Right side went numb, struggled to speak and right side of face drooped

BLOOD CLOTS IN LEFT LUNG; TIRED; FEVERISH; This spontaneous report received from a consumer concerned a 34 year old male. The patient's weight was 175 pounds, height was 67 inches and Body mass index (NR: not provided) 27.4. The patient's concurrent conditions included non smoker, no personal or family history of clotting disorders and no recent trauma or travel. The patient was active and ran for 30 mins every day. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 043AZ1A or 043A21A) frequency one total, dose was not reported, administered on 05-APR-2021 at 10:15 hours in left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-APR-2021 in the evening, the patient experienced "normal side effects", specifically tiredness and fever (temperature was not taken) and he took 2 Advil and went to bed. On 06-APR-2021 in the morning, he felt back to his normal baseline. On an unspecified date of APR-2021 (08-APR-2021 or 09-APR-2021), he felt pain and tightness in his chest and difficulty breathing. He noticed that he had to work harder to do his daily run. On 13-APR-2021, when the symptoms did not improve, he went to the emergency room. The patient had blood was taken (results not reported). A computerised tomography (CT) scan showed 2 blood clots in the left lung and duplex scans of both legs did not reveal a clot. A chest x-ray was done but results not provided. The patient's COVID-19 test was negative, and he was admitted to the hospital and treated with intravenous heparin. It was reported that no oxygen was given. On 14-APR-2021, he was discharged with Eliquis which he should continue for 6 months. On 16-APR-2021, the chest pain was gone, and his breathing was better in the morning but still difficult later in the day. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired, and feverish, and was recovering from blood clots in left lung. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: This 34 year-old overweight male (BMI 27.4) was hospitalized for 2 blood clots in his left lung 8 days after receiving vaccination with Janssen Covid-19 vaccine. He had no chronic medical conditions, was a nonsmoker, no personal or family history of clotting disorders, no recent trauma or travel, and exercised every day. On the evening of his vaccination, he felt tired and fever (temperature not taken) and took 2 ibuprofen and went to bed. The following morning, he felt back to normal. Two or three days later, he felt pain/tightness in his chest and difficulty breathing; he found it more difficult to perform his daily exercise. Eight days after vaccination, when his symptoms did not improve, he went to the emergency department where a CT scan showed 2 blood clots in his left lung. Covid-19 testing and duplex scans of his legs were negative. Blood tests were performed but results were unknown. He was hospitalized for 1 night, treated with IV heparin, and discharged the following day with apixaban. As of the time of this report, the chest pain had resolved and breathing was improved in the morning but still difficult later in the day. Based on the limited information (e.g. absence of blood test results), the relationship with Janssen Covid-19 vaccine is considered indeterminant.

Started experiencing extreme chest pains (stabbing feeling) between my lower right breast and upper rib cage on Saturday afternoon, especially when trying to take a big inhale. I went to the emergency room the next day after pain meds (ibprofen) did not help, and they did an EKG and X-Ray and they said it was a muscle strain. I went home and alternated between 3000 MGs of Tylenol every 24 hours, 2400 MGs of Ibuprofen, 8 hours of 4% lidocaine patch and then off for 8 hours + and a heating pad when the patch was off. The pain in my chest got worse and worse on Mon and Tue (started having spasms in the chest that caused extreme sharp shooting pain down my back up into my head) so went back into the ER Tues night. They

Went into Afib at 3:00AM on 4-21-21. 911 was called. Diltiazem was administered IV. ER performed EKG and CT. I received Eliquis, Diltiazem and Lovenox. Released from ER at 9:00am still in Afib. Referred to cardiologist.

He had a stroke 25 days after getting the vaccine, before the stroke he was in a general state on not feeling good. He was also feeling bad a couple of days after the vaccine. After the stroke he is now paralyzed on his right side. He was in the hospital for over two weeks and is now in physical therapy to regain strength on his right side.

Chest pain developed 12 hours following administration . Presented to hospital on 4/13/21 diagnosed with pulmonary embolus.

Patient experienced extended episode of syncope and temporary discontinuation of respiration approximately 8 minutes after vaccination.

J&J vaccine 3/5/2021 COVID Positive 3/29/21 3/29/21: COVID positive. This is a 35-year-old male with complex past medical history including bilateral lung transplant and renal transplant performed several years ago. He both of them and regarding his transplant management. He is on immunosuppressive medications. He is here today out of concern for exposure to COVID. He was vaccinated with Johnson Johnson vaccine on 3/4. He is here cause overnight he started developed fever headache sore throat muscle aches. If continued through today. He was test in the outpatient setting but the results have not yet returned. He is here today with continued symptoms. He is well-appearing on exam but mildly tachycardic, low-grade temperature here no significant increased work of breathing no conversational dyspnea lungs are clear heart is regular but tachycardic without murmur he has no signs or symptoms of DVT currently. His chest x-ray shows all isolated left lower lobe infiltrate. His labs are unremarkable with normal renal function, normal electrolytes but is rapid COVID test is positive. Given his immunosuppressive status in infiltrate seen on x-ray initially recommended admission for observation even though he is not initially on any supplemental oxygen is work of breathing is quite comfortable. I was able to discuss with his transplant surgeon In addition I talked to admitting physician who then discussed with pulmonology here . In their opinion the best management for the patient would be to provide him with the monoclonal antibody treatment but this can only be performed in the outpatient setting given he has no increased work of breathing no supple ox requirement currently that he is stable for discharge. He has a pulse monitor at home will also enroll him in a COVID home program. Pulmonology will call him for follow-up tomorrow. When I discussed with they currently do not have any beds available at the hospital for transport. The patient does not want to go to an outside facility that has a transplant team other than the risks of. Ultimately the patient would like to go home. I will add doxycycline for bacterial possibility of his pneumonia seen on x-ray today. He also had very strict return precautions. He understands likely had a possibility of worsening symptoms understands to return immediately if any new or worsening symptoms or no improvement. Patient was given the monoclonal antibody treatment in the ER after ordered by Dr.. He will ultimately be discharged with very close follow-up.

Patient walked over to the post vaccine waiting area and fainted falling face forward hitting his head onto the concrete. Rph went to to patient, he started to shake and open his eyes. Paramedic was near and came over to aid patient. Patient's head was bleeding. Medic radioed out to the ambulance and they came in with a stretcher. Patient was alert

I went to the clinic and they diagnosed me with a possible stroke which was caused by the vaccine. I will be needing to receive a MRI next week. Also for the last 24 hours I have not been able to control the motion of my left eye.

THROMBOCYTOPENIA; This spontaneous report received from a patient concerned a 35 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) 1 total, dose was not reported, administered on 15-JUN-2021 12:00 PM for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 20-JUN-2021 at 21:30, the patient had a bruise with a radius of 15 centimeters on forearm and not on the site of vaccination. On an unspecified date, the patient had thrombocytopenia. The patient visited emergency room for a blood test, but he was in the category of normal thrombocytopenia and thrombosis-related levels. At the time of this report, the patient's thrombocytopenia trend was being monitored by taking blood tests every day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of thrombocytopenia was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210649091 - Covid-19 vaccine ad26.cov2.s- thrombocytopenia. 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.

Patient developed severe bilateral pneumonia with respiratory failure requiring ICU Admission. SARS CoV-2 RNA, RT- PCR tested positive

On April 19th, 16 days after vaccine administered, massive headaches began that left me bed ridden for roughly 2 weeks to a month afterwards. Severe headaches lasted all day with no breaks. Only relief I would have would be from laying down with head in a certain position. A month after initial symptoms, the pain started to subside, but very slowly, taking several more weeks to calm down and to feel reduction in pain. Pressure would also set in around brain when pain was becoming less. Several tests had been done after symptoms began which included: Bloodwork Lipid CT Scan without contrast CT Scan with contrast MRI without contrast On June 15th, I was notified by my Neurologist that the MRI, which had been performed on June 10th, had showed a mild stroke had recently occurred. I am now on blood pressure medication, as well as aspirin 81, reduce the likelihood of another stroke.

after vaccination patient had classic anaphylactix reaction, fainting, dizziness, hypotention 90/60,sweating , feelinf hot, wide spread redness

Patient experienced a tonic clonic seizure less than 24 hours after receiving vaccine. He has a history of epilepsy which is well controlled and no seizure activity in over a year. Seizure started at approximately 10:00am and lasted 5 minutes or so... Pulse and breathing were lost for 2 minutes while CPR was started. EMT arrived and did a full work up. Patient woke up and was in a postictal state for an hour or so. ECG, BP, pulse, were all fine when patient was released from EMTs care to wife to go home.

I woke up 4am on April 6th 2021 to pee and I noticed blood after my pee. There was no blood in my pee or discoloration however I had to clean my penis tip with a tissue and noticed a blood cloth came out while I was wiping. This concerns me but that was the only time I saw blood, there was none afterward nor has it occur since then.

36 year old male with hx of hypertension , asthma, schizophrenia . he recieved Janssen vaccine on 4/6/2021. he started to fell unwell on 4/14 and on 4/15 he was found by his father unresponsive then sent to the hospital. Pt was diagnosed with massive pulmonary embolism, severe shock, acute renal failure ,Diabetic ketoacidosis , hyperglycemic hyperosmolar nonketotic coma, acute respiratory failure, patient expried from massive pulmonary embolism within 48 hours after admission.

This information is second hand, I have not been in contact with next of kin- I am reporting this because I don't know if anyone else including a medical examiner or his PCP would know that he was recently vaccinated. I was told that this patient was feeling sick for a couple of weeks. A friend visited him within the last couple days and he had a migraine headache. When they went to check on him today they found him deceased in his chair. Further investigation would be needed.

Patient went to the hospital Monday. He received the Janssen single-dose Covid vaccine on Thursday, April 8 and by Saturday, April 10 he was starting to develop fairly significant peripheral edema without any breathing difficulties. This persisted and was worse by Monday, April 13 EKG showed global nonspecific T-wave abnormalities and ST segment changes so I had him sent to the ER. As it turned out he had a pancytopenia (mostly neutropenia and thrombocytopenia) so he was admitted to the hospital. This seemed to resolve pretty much on its own and so they attributed everything to his hepatitis C. Indeed his LFTs are elevated in the 300 range and imaging showed hepatosplenomegaly. they also did a bone marrow biopsy for which there are no results yet

Received J+J Covid vaccine on 4/3/21. Admitted on 4/19. Per admission note: Patient is a 36YO male with a history of HFrEF s/p heartware 12/17/14, ICM with embolic MI, CAD, chronic driveline infection, HTN, HLD, DM type II, SVT, obesity, gout who was sent to the hospital for bilateral PEs. Patient called our OP line on 04/17 complaining of fever of 102 and chills. He was instructed to go to local lab and get labs done. They drew basic labs as well as blood cultures. On Sunday, the patient reported his fever was gone and he felt better. Today, he was feeling SOB and presented to his PCP. They ordered a CTA which reportedly showed bilateral PEs. They sent him to the local ED who transferred him here. Of note, his INR has been supratherapeutic for several weeks and pharmacy has been adjusting his warfarin dosing. The patient tested COVID negative prior to transfer. The vaccine lot number information is not accessible to this reporter.

DEATH; This spontaneous report received from a patient concerned a 36 year old male. The patient's weight, height, and medical history were not reported. As per reporter patient was healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported, per procedure no follow up will be requested for this case. No concomitant medications were reported. The reported stated that presence of antibodies should be tested before taking the vaccine and taking the vaccine with covid antibodies present can kill. The patient died on an unspecified date with unknown cause of death after vaccination. 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).; Sender's Comments: V0: 20210428954 -covid-19 vaccine ad26.cov2.s -Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH

Patient states he had no soreness to his left arm. Patient states he got a blood clot. He went to the doctor and his doctor told him that the blood clot he had was not related to the vaccine.

Patient developed DVT and pulmonary embolism 3 weeks after the vaccine was given. Patient had no other risk factors.

He is a 37-year-old active male with no significant medical history. One week ago, on Friday, March 26, he received the Johnson and Johnson vaccine for Covid 19. That day he felt fine. The following day he had some muscle aches. Sunday he states he had some slight shortness of breath, only for that day. Then he had some fever and chills feeling. That resolved. The only symptoms that persisted was his muscle aching and tightness. Then yesterday, the day of his presentation to the ER, he noted some bilateral lower extremity edema which prompted his visit. He is feeling mostly fine except a bit of muscle tightness. BNP was 154. Chest x-ray showed pneumonitis. He received antibiotics. Echocardiogram was completed showing preliminary findings of small to moderate pericardial effusion and trace aortic insufficiency. Will treat with colchicine and ibuprofen.

Patient developed left leg pain 5 days after the vaccine, with tightness behind the knee, and then soon developed swelling. As pain improved he did not seek attention until today, 4/14/2021 and was found to have a severe large fully extensive and occlusive femoral DVT L leg.

Blood clots in the Liver and Kidney also Pulmonary Embolism. went to ER was admitted and spent 6 days there. was put on Heparin as well as antibiotics. currently on Warfarin to maintain proper blood INR numbers.

SHORTLY AFTER RECEIVING VACCINE (APPROXIMATELY 1/2 MINUTE) PATIENT FAINTED. HE SLOWLY SLID OUT OF CHAIR AND I (PHARMACIST) CAUGHT HIM GOING DOWN AND HE LANDED ON HIS LEFT SIDE, ALMOST FACE DOWN. I SHOUTED OUT HIS NAME SEVERAL TIMES, ROLLED HIM ON HIS BACK, AND CHECKED FOR BREATHING. NO BREATH SOUNDS OR CHEST RISING, COULD NOT FIND A PULSE, AND THEN HIS EYES ROLLED UP AND BACK. A STORE CUSTOMER CALLED 911 AND I BEGAN COMPRESSIONS. AT COUNT 20 HE BEGAN TO MOVE AND TRIED TO TALK. STOPPED COMPRESSIONS, AND ROLLED PATIENT ON HIS LEFT SIDE. I WAS ABOUT TO CHECK BLOOD PRESSURE WHEN PARAMEDICS WALKED IN AND TOOK OVER. PARAMEDICS CHECKED VITALS, TEMPERATURE, BLOOD GLUCOSE AND RAN EKG. THEY SAID THEY COULD NOT SHARE RESULTSWITH ME, BUT STATED PATIENT REFUSED TO GO TO THE ER/HOSPITAL. AFTER ABOUT 30 MINUTES PATIENT WALKED OUT OF THE STORE ON HIS OWN.

Received vaccine on 6/5/21, next morning at 7:00 am mother heard a loud noise and found PT face down lying half way in bathtub unresponsive, attempted to lift him observing his eyes were rolled back in head, was unconscious for approximately 1 min trying to lift him out, then he blacked out a second time hitting bathtub a second time. Lifted him out and placed on floor, he was unresponsive - called 911, he came to slightly after 3 minutes. Ambulance took him to ER and we stayed all day receiving fluids and chest XR (clear). We were discharged in the afternoon with the doctor saying he has a syncopy episode. At 4:00 PM PT was going to the bathroom and he stated he didn't feel good. I stood in front of him because he turned white and eye rolled up into his head and he blacked out and stopped breathing for approximately 2 minutes while I got him on floor and gave CPR. Called 911 and he began breathing again . Back in ambulance to hospital and we stayed in hospital for 2 days.

Mild side effects in the hours after the injection (headache, sore throat, muscle aches, chills). Mild enough to not need any medications. At 1:30am, I woke up needing to urinate. I went into the bathroom and lost consciousness, finding myself with one hand in the toilet and one on the side. I felt nauseous and thought I would vomit, but didn't and believe I lost consciousness again. I was able to make it to the sink to try to wash my hands, and I fell down on my knees. I knew I was bleeding somewhere but didn't know from where (my right pinky was cut on an item in the bathroom when I fell). My wife made it to me, and I lost consciousness a couple more times while talking with her. I laid on the bathroom floor for a

Adverse effect: Experienced Atrial fibrillation. (chronic) Treatment: Emergency room visit and was given a cardioversion to bring heart back into normal sinus rhythm. Outcome: Still experiencing episodes of irregular heartbeat and seeking treatment from doctors and hospitals. Adverse effect: Balance and coordination problems (chronic) Treatment: Neurologist appointment Outcome: Taking medication for basilar migraine Adverse effect: Restless legs Treatment: None Outcome: None

Developed pain in right calf and hamstring. No improvement over the next few days. Went to Vein specialist and they performed an ultrasound. A blood clot was found in my right calf.

On April 8, 2021, I received the J&J vaccine. Initially, I only had the chills and body aches. Then, on Monday April 12, 2021, I went to the gym where I worked out. When I came home and after showering, I returned a phone call shortly after 8 P.M. While speaking on the phone, I could tell after a few minutes of talking something was off, and then all of a sudden, the words stopped coming out. After a few more seconds, I was trying to yell upstairs to my wife for help. I sounded like a goat while trying to yell that word. I then snapped out of it, and was able to speak clearly and normal again. I told my wife and called back my friend. My friend said I sounded like I was getting sick when I had the attack. The next morning I went to the hospital. I was diagnosed with a Transient Ischemic Attack "TIA."

Left posterior leg/knee pain started on 4/26. DVT left leg diagnosed via ultrasound, started on Xarelto

ED notes: 39 y.o. male with no significant medical history brought by EMS for dysarthria, RT arm weakness, and RT facial droop beginning at 2:05pm today. Sx acute onset, severe, constant, and have not occurred previously. Pt was driving just prior to symptom onset when he called his mother stating he did not feel well at 2:05pm. Upon arriving home, mother noticed he was dysarthric and called 911. EMS noted facial droop, arm weakness, dysarthria, and gaze palsy and transported him to the hospital. Initial glucose by EMS 110. Pt denies headache, recent head trauma, history of brain hemorrhages or prior stroke. PMH: None, PSH: None, Allergies: NKDA, Tobacco: Denies, ETOH: Social, Drugs: Denies Pt AAOx3, bib from home for weakness and facial droop. Stroke alert called en route. As per report, pt was driving home at 2 pm when he started to feel ""weird"". Pt called his wife and was able to drive himself home. Upon arrival at his house he ""collapsed"" on the couch and his wife noticed right-sided facial droop and weakness, more prominent on the right side. Upon arrival to ED pt appears pale and weak. R sided facial droop and right arm and right leg weakness noted. Dr. at bedside. Stroke alert called in ED. Hr noted to be in the 40s. As per wife, pt is an athlete 5/4/21 Critical Care Notes: Neurology- No hx of neurological disease but does have family history of blood clotting disorder in maternal uncles and cousins (factor 2 and factor 5 but unclear specific diagnosis)- Patient presented with R sided weakness, R facial droop, dysarthria, double vision, R CN 6 palsy; no prior history of similar events- CT brain negative for acute abnormaility - CTA brain/perfusion showed no significant stenosis, occlusion, aneurysm, no perfusion abnormality- MRI brain showed small acute ischemic infarct in ventromedial L thalamus and chronic bilateral cerebellar lacunar infarcts- Patient showing improvement in symptoms s/p tPA- Repeat CT showed new mild hypoattenuation suggesting evolving acute infarction with no bleed, herniation, mass effect, or midline shift- Echo with bubble study revealed patient PFO, No DVT on LE US- Lipid profile WNL, tox screen neg, RPR neg- Neuro checks per unit protocol- Check ANCA, Anti cardiolipin, anti thrombin III, antiphospholipid Ab, Factor V Leiden, Protein C and S, ANA, FTA, A1c; Dr. (H/O) consulted- ESR elevated- DAPT per neuro- DSA with NIR today Cardiology- Hx of sinus bradycardia: Patient is athletic, works out regularly. Had previous cardiac evaluation with no significant findings- EKG showing borderline 1st degree AV block- Troponin neg- BP well controlled - MAP goal >65mmHg- 2D echo with bubble study revealed patent PFO, No DVT on LE US Heme/Onc- CBC unremarkable - No active bleeding- Transfuse if Hgb < 7- DVT prophylaxis SCDs, patient ambulatory- No DVT on LE US- Workup as above for blood clotting disorders given stroke in otherwise young healthy patient with family history of clotting disorders- H/O consulted, pending eval 5/9/21 Neurology Note: Overall neurological assessment remains stable and unchanged overnight. Double vision on the right eye stable, improving as per patient's report. Will recommend to continue with DAPT as ordered. Follow up with neurology as an outpatient in 2-4 weeks. Follow up with Cardio as well. Ok to discharge patient home as per Neurolgy standpoint. 1. Left ventromedial thalamic CVA. 2. PFO - S/P closure 5/7/2021. 3. Congenital hypoplastic left VA, basilar trunk. 4. Remote cerebellar lacunar infarcts. 5. Family history of Factor V Leiden, factor II. PLAN: 1. Ok to discharge patient home as per neurology standpoint. 2. Continue ASA 81 mg and Plavix 75 mg Daily. 3. Follow up with neurology as an outpatient in 2- 4 weeks. 4. Follow up with Cardio as per their recommendations. 5. Medical management as per IM.

description from patient: 1.. On Wed, Apr 28, I got the JnJ vaccine. Other than fatigue the following day no major issues. 2. On Sat, May 1, I had an afib episode in the morning. Reset to sinus rhythm the next morning around 2:30am. I spoke with you during the episode. 3. On Mon, May 3, I had brain fog. I?m usually tired after an afib episode. But this seemed different. I?ve never experienced something like this before. But I chalked it out to the after effects of the afib and moved on. 4. On Fri, May 7, I started having the stiffness in my right calf. I checked in with you that weekend to make sure it wasn?t a clot. After we spoke I think we ruled out a clot. 5. In addition, I?ve developed some added symptoms since then: (i) Sweaty feet. (ii) Pins and needles sensation in feet. (iii) Tightness in the arch of the right foot. (iv) Feet and hands feel sensitive to cold. (v) Burning sensation in feet and left hand. (vi) Mild headache mostly felt in the left temple. (vii) A pulling feeling on the left side of the face. (viii) A feeling that if I close my eyes, I may faint.

Pt presenting with symptoms consistent with acute stroke within 24hr after receiving vaccine. Pt has hx of prior strokes before.

Patient suffered a hemorrhagic stroke (brain bleed) in the right deep brain structures with significant brain swelling and build up of cerebral spinal fluid requiring drainage. Patient's confusion and motor function have been improving and the bleeding has not worsened.

More than 30 days after receiving the Janssen vaccine, I tested positive for COVID-19. Symptoms began as runny nose, sneezing, and sinus pressure/burning on April 6, 2021. Tested for COVID-19 on April 11, 2021 (nasal swab, PCR test) after a family member tested positive. Symptoms worsened on April 12, 2021, including shortness of breath, chest pain, complete loss of taste and smell. Sought treatment for breathing difficulty at ER on April 13, 2021 (Vidant Medical Center and was instructed to rest at home. Sought treatment for breathing difficulty at PCP on April 14, 2021 ( Medical Center) and prescribed Prednisone. Symptoms worsened on April 15, 2021, including shortness of breath, chest pain, numbness in face/arms/legs, dizziness, loss of balance, memory and speaking difficulty, near fainting. Sought treatment at ER on April 15, 2021 (Vidant Medical Center, Greenville, NC). Held for three days, treated with Remdesivir (3 doses) and supplemental oxygen. Discharged from hospital on April 18, 2021. Symptoms did not improve following discharge. Sought treatment for ongoing symptoms at ER on April 21, 2021, instructed to rest at home. Symptoms continued to worsen on April 24, 2021, including shortness of breath, chest pain, numbness in face/arms/legs, dizziness, loss of balance, memory and speaking difficulty, near fainting, and slurred/incoherent speech. Sought treatment at ER on April 15, 2021, admitted to hospital on April 25, 2021 diagnosed with probable TIA. Treated with Optiflow high-flow oxygen therapy, nebulizer, and steroids. Received a variety of tests and scans of head, neck, spine, chest, heart; none showed signs of any serious cardiac, vascular, or neurological problems. Transferred to in-patient rehabilitation on May 1, 2021 for physical and occupational therapy. Discharged from in-patient rehabilitation on May 6, 2021. Prescribed out-patient physical and occupational therapy to resolve remaining dizziness, balance, and endurance deficits.

patient stated he went to the hospital for blood clots. Says he went in last Tuesday or Wednesday for heavy breathing. Normal activity was making him very tired. Had COVID infection in March. The doctors cannot determine what other cause could have led to him having blood clots. Patient was released yesterday from being in since last Tuesday or Wednesday. Patient says he's having nose bleeds starting today. He was on the blood thinner shots but not sure of the name. Now he is on the pills (Eliquis) from pharmacy instead of the shot.

didn't have any at the time. had flu-like symptoms and area hurt then had a stroke about a month later

ANGIOGRAM PULMONARY ABNORMAL; SCAN WITH CONTRAST ABNORMAL; SARS-COV-2 TEST POSITIVE; FULL BLOOD COUNT NORMAL; SARS-COV-2 ANTIBODY TEST NEGATIVE; ANGIOGRAM; ANGIOGRAM PULMONARY; BLOOD GASES; BLOOD MAGNESIUM; BLOOD PHOSPHORUS; BLOOD THYROID STIMULATING HORMONE; CHEST X-RAY; COMPUTERISED TOMOGRAM; COMPUTERISED TOMOGRAM HEAD; COMPUTERISED TOMOGRAM THORAX; ECHOCARDIOGRAM; ELECTROCARDIOGRAM; ELECTROENCEPHALOGRAM; FIBRIN D DIMER; GLOMERULAR FILTRATION RATE; GLYCOSYLATED HAEMOGLOBIN; MAGNETIC RESONANCE IMAGING HEAD; MAGNETIC RESONANCE IMAGING SPINAL; METABOLIC FUNCTION TEST; SCAN WITH CONTRAST; TROPONIN; LIPIDS; PULMONARY EMBOLISM; TRANSIENT ISCHAEMIC ATTACK; AGEUSIA; AMNESIA; ANOSMIA; BALANCE DISORDER; CHEST PAIN; COVID-19; DIZZINESS; DYSARTHRIA; DYSPNOEA; EXPOSURE TO SARS-COV-2; PRESYNCOPE; RHINORRHOEA; SNEEZING; PARANASAL SINUS DISCOMFORT; HYPOAESTHESIA; SPEECH DISORDER; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient via a Regulatory Authority, VAERS (Vaccine Adverse Event Reporting System) (VAERS ID 1347147), concerned a 38 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high cholesterol. The patient had no known allergies. The patient had no current illness at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070 expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 03-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the patient experienced pulmonary embolism, ageusia, amnesia, anosmia, balance disorder, chest pain, dysarthria, dyspnoea, paranasal sinus discomfort, presyncope, rhinorrhoea, scan with contrast abnormal, sneezing, speech disorder, dizziness, hypoaesthesia, angiogram, angiogram pulmonary, angiogram pulmonary abnormal, blood gases, blood magnesium, blood phosphorus, blood thyroid stimulating hormone, chest x-ray, computerised tomogram, computerised tomogram head, computerised tomogram thorax, echocardiogram, electrocardiogram, electroencephalogram, exposure to sars-cov-2, fibrin D dimer, full blood count normal, glomerular filtration rate, glycosylated haemoglobin, lipids, magnetic resonance imaging head, magnetic resonance imaging spinal, metabolic function test, sars-cov-2 antibody test negative, sars-cov-2 test positive and troponin. More than 30 days after receiving the Janssen vaccine (on 06-APR-2021) the patient tested positive for COVID-19 (Confirmed COVID-19 Infection) and was confirmed Clinical Vaccination Failure, the patient experienced symptoms runny nose, sneezing, and sinus pressure/burning. Laboratory data included: Angiogram (NR: not provided) Not reported, Angiogram pulmonary (NR: not provided) Not reported, Angiogram pulmonary (NR: not provided) Abnormal, Blood gases (NR: not provided) Not reported, Blood magnesium (NR: not provided) Not reported, Blood phosphorus (NR: not provided) Not reported, Blood thyroid stimulating hormone (NR: not provided) Not reported, Chest X-ray (NR: not provided) Not reported, Computerised tomogram (NR: not provided) Not reported, Computerised tomogram head (NR: not provided) Not reported, Computerised tomogram thorax (NR: not provided) Not reported, Echocardiogram (NR: not provided) Not reported, Electrocardiogram (NR: not provided) Not reported, Electroencephalogram (NR: not provided) Not reported, Fibrin D dimer (NR: not provided) Not reported, Full blood count (NR: not provided) Normal, Glomerular filtration rate (NR: not provided) Not reported, Glycosylated haemoglobin (NR: not provided) Not reported, Lipids (NR: not provided) Not reported, Magnetic resonance imaging head (NR: not provided) Not reported, Magnetic resonance imaging spinal (NR: not provided) Not reported, Metabolic function test (NR: not provided) Not reported, SARS-CoV-2 antibody test (NR: not provided) Negative, SARS-CoV-2 test (NR: not provided) Positive, Scan with contrast (NR: not provided) Abnormal, Covid-19 virus test (NR: not provided) Positive and Troponin (NR: not provided) Not reported. On 11-APR-2021 tested for COVID-19 (nasal swab, PCR test) after a family member tested positive (confirmed covid-19 infection). Laboratory data included: SARS-CoV-2 PCR test (NR: not provided) Positive. On 13-APR-2021, Laboratory data included: Basic metabolic panel (NR: not provided) Not reported, CBC (NR: not provided) Not reported, and EKG (electrocardiogram) was normal. On 12-APR-2021 symptoms worsened including shortness of breath, chest pain, complete loss of taste and smell. On 13-APR-2021 the patient received sought treatment for breathing difficulty at ER (emergency room) and was instructed to rest at home. On 14-APR-2021 the patient received sought treatment for breathing difficulty at PCP (primary care physician) medical center and was prescribed prednisone. On 15-APR-2021 symptoms worsened including shortness of breath, chest pain, numbness in face/arms/legs, dizziness, loss of balance, memory and speaking difficulty, near fainting and patient received sought treatment at emergency room. The patient was held in hospital for three days and was treated with remdesivir (3 doses) and supplemental oxygen. Laboratory data included: CBC (complete blood count) Not reported, Chest X-ray (NR: not provided) Not reported, Comprehensive metabolic panel (NR: not provided) Not reported, EKG (electrocardiogram) Normal, Magnesium (NR: not provided) Not reported, Phosphorus (NR: not provided) Not reported, SARS-CoV-2 IgG antibody test (NR: not provided) Negative, TSH (thyroid stimulating hormone) Not reported, Troponin I (NR: not provided) Not reported, and Urine analysis (NR: not provided) Not reported. On 16-APR-2021, Laboratory data included: Basic metabolic panel (NR: not provided) Not reported, CBC (complete blood count) Not reported, Computerised tomogram scan (NR: not provided) Not reported, Computerised tomogram thorax (NR: not provided) Not reported, Echocardiogram (NR: not provided) Not reported, HbA1C (Glycated hemoglobin) Not reported, Lipids (NR: not provided) Not reported, Magnesium (NR: not provided) Not reported, Phosphorus (NR: not provided) Not reported, Troponin I (NR: not provided) Not reported, and Vitamin D (NR: not provided) Not reported. On 17-APR-2021, Laboratory data included: Comprehensive metabolic panel (NR: not provided) Not reported, and Fibrin D dimer (NR: not provided) Not reported. On 18-APR-2021 the patient was discharged from hospital. The patient reports that the symptoms did not improve following discharge. On 18-APR-2021, Laboratory data included: Comprehensive metabolic panel (NR: not provided) Not reported. On 21-APR-2021, the patient undergone sought treatment for ongoing symptoms and was instructed to rest at home. Laboratory data included: Basic metabolic panel (NR: not provided) Not reported, CBC (complete blood count) Not reported, Chest X-ray (NR: not provided) Not reported, Computerised tomogram thorax was found to be pulmonary embolism with contrast, EKG (electrocardiogram) Not reported, Estimated glomerular filtration rate (NR: not provided) Not reported, and Troponin I (NR: not provided) Not reported. On 24-APR-2021 the patient reports that the symptoms were continued to worsen including shortness of breath, chest pain, numbness in face/arms/legs, dizziness, loss of balance, memory and speaking difficulty, near fainting, and slurred/incoherent speech. Laboratory data included: Arterial blood gases (NR: not provided) Not reported, Chest X-ray (NR: not provided) Not reported, Comprehensive metabolic panel (NR: not provided) Not reported, Computerised tomogram head (NR: not provided) Not reported, EKG (electrocardiogram) Not reported, SARS-CoV-2 IgG antibody test (NR: not provided) Positive, and Troponin I (NR: not provided) Not reported. On 25-APR-2021 the patient received sought treatment at emergency room and admitted to hospital on the same day again, patient was diagnosed with probable TIA (transient ischaemic attack) and was treated with Optiflow high-flow oxygen therapy, nebulizer, and steroids. Laboratory data included: CBC (complete blood count) Not reported, Comprehensive metabolic panel (NR: not provided) Not reported, Computerised tomogram head (NR: not provided) Not reported, Computerised tomogram neck (NR: not provided) Not reported, Computerised tomogram thorax (NR: not provided) Not reported, Echocardiogram (NR: not provided) Not reported, HbA1C (Glycated hemoglobin) Not reported, Magnetic resonance imaging brain (NR: not provided) Not reported, Magnesium (NR: not provided) Not reported, and Phosphorus (NR: not provided) Not reported. On 26-APR-2021, Laboratory data included: CBC (complete blood count) Not reported, and Lipids (NR: not provided) Not reported. On 27-APR-2021, Laboratory data included: CBC (NR: not provided) Not reported, and electroencephalogram (EEG) (NR: not provided) Not reported. On 28-APR-2021, Laboratory data included: Basic metabolic panel (NR: not provided) Not reported, CBC (complete blood count) Not reported, Fibrin D dimer (NR: not provided) Not reported, Magnesium (NR: not provided) Not reported, Magnetic resonance imaging spinal (NR: not provided) Not reported, Magnetic resonance imaging thoracic (NR: not provided) Not reported, Phosphorus (NR: not provided) Not reported, and SARS-CoV-2 IgG antibody test (NR: not provided) Positive. On 30-APR-2021, Laboratory data included: CBC (NR: not provided) Not reported, and SARS-CoV-2 PCR test (NR: not provided) Positive. On 01-MAY-2021 The patient was transferred to in-patient rehabilitation for physical and occupational therapy, Laboratory data included: CBC (complete blood count) Not reported, Magnesium (NR: not provided) Not reported, and Phosphorus (NR: not provided) Not reported. On 03-MAY-2021, Laboratory data included: CBC (complete blood count) Not reported, Magnesium (NR: not provided) Not reported, and Phosphorus (NR: not provided) Not reported. On 06-MAY-2021 patient was discharged from in-patient rehabilitation and was prescribed with out-patient physical and occupational therapy to resolve remaining dizziness, balance, and endurance deficits. The patient was hospitalized for 16 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ageusia, amnesia, angiogram pulmonary abnormal, anosmia, balance disorder, blood gases, chest pain, dysarthria, dyspnoea, paranasal sinus discomfort, presyncope, pulmonary embolism, rhinorrhoea, scan with contrast abnormal, sneezing, speech disorder, transient ischaemic attack, blood magnesium, blood phosphorus, blood thyroid stimulating hormone, chest x-ray, computerised tomogram, computerised tomogram head, computerised tomogram thorax, covid-19, dizziness, echocardiogram, electrocardiogram, electroencephalogram, exposure to sars-cov-2, fibrin d dimer, full blood count normal, glomerular filtration rate, glycosylated haemoglobin, hypoaesthesia, lipids, magnetic resonance imaging head, magnetic resonance imaging spinal, metabolic function test, sars-cov-2 antibody test negative, sars-cov-2 test positive, troponin, angiogram, angiogram pulmonary, and scan with contrast, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). The case is associated with Product Quality Complaint number: 90000181966. The suspected product quality complaint has been confirmed to be not confirmed. The reported allegation was not confirmed and the root cause was determined to be not manufacturing related, based on the PQC evaluation/investigation performed. Additional information was received from Central Complaint Vigilance on 21-JUN-2021. The following information was updated and incorporated into the case narrative: Product complaint investigation result was added.; Sender's Comments: V1. The follow-up information in this version updates Product complaint investigation result. This updated information does not alter causality of previously reported events. 20210609990 -covid-19 vaccine ad26.cov2.s - Pulmonary embolism , transient ischaemic attack, Ageusia, amnesia, angiogram pulmonary abnormal, angiogram pulmonary , anosmia, balance disorder, blood gases, chest pain,dysarthria, dyspnoea, paranasal sinus discomfort, presyncope, rhinorrhoea, scan with contrast abnormal, sneezing, speech disorder, blood magnesium, blood phosphorus, blood thyroid stimulating hormone, chest x-ray, computerised tomogram, computerised tomogram head, computerised tomogram thorax, covid-19, dizziness, echocardiogram, electrocardiogram, electroencephalogram, exposure to sars-cov-2, fibrin d dimer, full blood count normal, glomerular filtration rate, glycosylated haemoglobin, hypoaesthesia, lipids, magnetic resonance imaging head, magnetic resonance imaging spinal, metabolic function test, sars-cov-2 antibody test negative, sars-cov-2 test positive, troponin, and angiogram. 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). 20210609990-covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS

PATIENT ALERTED US ON 6-18-21 THAT EXACTLY 2 WEEKS AFTER HIS VACCINE HE WNET TO THE DOCTOR FOR SHOULDER PAIN AND HAD A SUPERFICIAL BLOOD CLOT. THEY PERFORMED AN MRI AND DETERMINED BLOOD WAS STILL FLOWING SO THEY DETERMINED NO TREATMENT WAS NECESSARY

Patient has a long history of seizures. He has seizures on a daily basis. He lives with his family, who are his primary caregivers, they family provides all of his activities of daily living. Patient received vaccine on Friday morning, feeling well throughout the day according to the father. Went to bed, during the night in bed he had seizures which is typical for him, and during the episode the father noticed that he had stopped breathing. called 911 who came to the house and the patient died in the house. I do not believe he went to the hospital.

I developed leg pain in my right leg 2 weeks after vaccination. A week later, I went to the hospital and they confirmed "Acute deep vein thrombosis) DVT of calf muscle vein of right lower extremity" and at least one additional superficial clot. I was prescribed blood thinners apixaban (Eliquis) and was discharged. I'd previously had a clot in the same leg in 2009.

Patient at gym working out and had a seizure, when 9-1-1 crews arrived patient was post-ictal, while treating the patient he had another seizure, during transport patient went into cardiac arrest, crews provided ACLS care and transported patient to hospital for treatment. Resuscitation efforts were terminated by physician in emergency room.

DEATH; This spontaneous report received from a consumer concerned a 39 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. Patient was healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) frequency 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. Reporter stated that the patient took the vaccine and then died 3 days later (date unspecified). Reporter did not have any further information to provide. On an unspecified date, the patient died from unknown cause of death. It was unknown whether autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20210611846-COVID-19 VACCINE AD26.COV2.S-Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH

Night of the vaccination had a fever of 102., body aches, chills and fatigue one night tired for a couple of days then three weeks later three weeks after vaccination had a fever body aches, chills, fatigue lasted 9 days, 3rd short ness of breath, 5th day head aches,6th blistered and body swelling, face swelling lips, neck and antiphallic type. A week into the symptoms Tele visit was told to take Benadryl next day, Emergency room a week into the symptoms, after taking Benadryl and was not seeing relief. Right wrist blister and both arms and legs was swollen feet and ankle was swelling and over the weekend the swelling. 5lbs of water swelling. Cold sweats through the symptoms.

Initial chest pain 1 month after vaccine, pain returned with increased severity June 19th resulting in ER visit. Pulmonary embolisms have caused some permanent lung damage. Patient is currently taking Xarelto. Minor symptoms remain.

Second episode of atrial fibrillation since receiving Janssen COVID-19 vaccine. I had a heart rate of 180 BPM and again needed to be cardioverted.

A third episode of intense atrial fibrillation. I have been hospitalized twice for this condition since receiving the vaccine. This incident lasted for 2.5 hours but resolved at home.