Johnson & Johnson

swollen ankles and toes, toe swelling resolved after 3 days, patient still had some ankle swelling on day 4 but was muchimproved

SEVERE MUSCLE CRAMPING AND PAIN THROUGHOUT BODY. PROLONGED FEVER OF 102.9 DEGREES. SEVERE CHILLS AND BODY SHIVERS. EXTREME HEADACHE. ENLARGED AND PAINFUL LYMPH NODE ABOVE LEFT COLLARBONE

Injection administered on a Wednesday, by Saturday severe pain and inflammation on forearm below injection location. Not at injection- but on same arm. Forearm stayed swollen and stay in severe pain with no ability to grip. Feels like internal grinding at joints, muscle and wrist. Resting has minimized pain, but has not improved much since Saturday.

Pain developed early on and persisted till ~ 3 weeks remains persistent. Went to internist following tests Positive ANA, Elevated RO-SSA >200, Elevated sed rate, Elevated crp, change in hgb from 14.9 to 12.7, low iron, muscle pain, bilateral leg swelling, joint pain, tightness, rash on both legs, ankle up to knee over 3-4 days, at four weeks out continued pain, weakness, and swelling. Persistent soaking night sweats and low grade fever in the evenings. Purple rash on arms and legs with nodules. Referral made to rheumatologist for further work up.

Called Connections on 4/20/21. Pt c/o feeling swollen throat glands, hard to swallow, dry/sore throat, also random dizziness not constant, feeling body aches, tired, runny nose but pt denies sob, difficulty breathing, chest pain. Speech seems comfortable, AO X 3. Pt stated these sx started on 04/13/2021 after he got his Janssen(J&J) covid vaccine on 04/12/2021,he stated sx not getting better its getting more from then. This writer recommended pt to go to ED/call 911 for further evaluation and treatment. Pt took covid test yesterday awaiting for his result. Denies any past medical Hx

SWELLING IN SPINE; INCREASED HEART RATE WHICH GOT WORSE WITH PHYSICAL ACTIVITY; PAIN IN LOWER PART OF BOTH LEGS; TINGLING IN LOWER PART OF LEGS/TINGLING IN TOES; HEADACHE; This spontaneous report received from a patient concerned a 40 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included no known allergies, no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced headache. On 23-APR-2021, the subject experienced tingling in lower part of legs/tingling in toes. On 23-APR-2021, the subject experienced increased heart rate which got worse with physical activity. On 23-APR-2021, the subject experienced pain in lower part of both legs. On MAY-2021, Laboratory data included: Blood test (NR: not provided) Unspecified, MRI brain (NR: not provided) Unspecified, and Magnetic resonance imaging spinal (NR: not provided) Unspecified. On 03-MAY-2021, the subject experienced swelling in spine. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from increased heart rate which got worse with physical activity on 28-MAY-2021, and headache on 23-APR-2021, was recovering from pain in lower part of both legs, and tingling in lower part of legs/tingling in toes, and had not recovered from swelling in spine. This report was non-serious.

Severe Axillary Lymphadenapathy shown in left side, with pain radiating into back and chest. Slight Axillary Lymphadenapathy shown in right side, tender to touch. Moderate headache treated with ibuprofen.

Fever as high as 103.7, normal fever in 100-101.5 range, hot and cold flashes, sore arm and swelling in left hand, diarrhea, head aches

About seven (7) days post vaccine injection I began to experience pain and numbness in both arms, numbness and swelling in my lips and face area and a feeling of indigestion/heartburn. I presented to urgent care and subsequently the emergency room on 03.27.2021 with those symptoms and was treated and released. The following day, the symptoms continued, specifically the pain and numbness in the bi-lateral arms and additionally began to experience pain in the chest area and increased resting heart rate (125+ bpm). Again presented to emergency room on 03.28.2021, treated and released.

Background:41-year-old male reported that he awakened with right lower leg pain intermittently since approx. May 10 2021. Woke on June 10 with increased pain and swelling to RLE. He tried to "run it out" but the pain worsened. In the ER he was noted to have elevated D-Dimer- 1980, ESR of 27, labs otherwise normal. Ultrasound showed DVT. He was started on hydrocodone-APAP and Xarelto. Returned on 11 June with SOB. PE was confirmed. Admitted to ICU Note today states continued swelling and pain to RLE. Considering transfer to hospital for vascular consultation and further management.

Severe, ongoing pain in left anterior cervical lymph nodes. More than one week of pain - especially sensitive when touched or head is moved to the right.

Immediate(3-5 seconds) and rapid injection site swelling and redness, bleeding more than usual from a shot, dizziness, full body sweating, rapid heart rate, hives, as well as general body swelling that caused great difficulty in starting an IV. I did not have any significant issues with breathing. They treated me with a IV fluids, an intramuscular injection and IV injection of Benadryl and a steroid that I cannot recall the name of, I apologize.

Drop in blood pressure on the day of vaccination, hives and swollen face/eyes several days after the vaccine, headache and weakness for several days after injection. Resolved after about a week.

Patient reports extreme leg swelling on both legs occurring 30-45 minutes after vaccination (04/05/2021) and lasting 7 days. Patient reports shortness of breath which has not improved since vaccination date. Patient contacted PCP and was told to continue monitoring side effects,

Received vaccine 3.24.21. Had been incarcerated / in prison system until 4.7.21. Complex past medical history. 4.10.21: Went to ED on 4.10.21 - for hematuria. CHIEF COMPLAINT: BLOOD IN URINE (patient reports hematuria an hour prior to arrival along with spitting up a large clot (hemoptysis). denies rectal bleeding at this time. denies being on a blood thinner. c/o back pain starting a few hours ago. HX aortic aneurysm and scheduled to get surgery in a few weeks. )Urinalysis returned showing moderate amount of blood was 73 RBCs. Patient did not have frank hematuria on specimen. Patient's laboratory work otherwise remains unremarkable. Electrolytes within normal limits. Patient has a stable hemoglobin of 13.8. CT scan showed evidence of acute aortic dissection. There were scattered faint ground-glass opacities along the right upper lobe as well as left upper lobe. COVID-19 testing was added on after results. At this time I do not have a great explanation for the patient's hematuria. I did instructed to follow up with Urology for further evaluation of this. He is hemodynamically stable I do not believe further testing is warranted at this time. Return precautions were discussed including urinary retention, large volume bleeding or any other concerning symptoms. He voiced understanding of this and was discharged stable condition. He was provided a work note as he is on probation and it is for her of his hospitalization at this time. 4.13.21: Went to ED on 4.13.21: CHIEF COMPLAINT: LEG PAIN (pt c.o. right leg swelling/pain that started 3 days ago; had johnson&johnson vaccine on 3/24 and is concerned for blood clots; supposed to have surgery at the end of the month; recently seen for blood in urine; c.o. generalized body aches)42-year-old male presents with right calf pain and reported swelling. On presentation patient is well-appearing and nontoxic, afebrile, hypertensive 134/113 with otherwise normal vital signs. On exam, the patient has no swelling in the bilateral lower extremities, he does have very mild tenderness to palpation in the right posterior proximal calf just below the knee. Remainder of physical examination is otherwise unremarkable. Given history of blood clot and reported right calf pain, right lower extremity duplex venous ultrasound ordered to evaluate for DVT. EKG was obtained on arrival, and showed normal sinus rhythm with no evidence of ST segment elevated for depression, no dysrhythmia, no comparison when compared with prior EKG from July 2019. Right lower extremity ultrasound showed no evidence of DVT. I shared results of the workup with the patient and told him that there is no indication for further workup or treatment at this time. I recommended Tylenol or Motrin as needed for right leg pain. I recommended compression stockings as needed for right leg swelling. I encouraged him to follow up with all specialists physicians as previously scheduled and with his primary care physician as needed. Office visit 4.14.21: Subjective: a 42 yr.. male evaluated with a video visit on 4/14/2021 Currently he complains of headache, hot/cold flashes (no fever), nasal congestion, and Bilat ear pain. R leg is swollen. The symptoms have been present for 2 day(s). Was incarcerated - has been out for about week. He denies a history of chills and fevers He has tried acetaminophen, Flonase for his symptoms. Sick Contacts: none known History is provided by patient There is history of asthma or recurrent respiratory infections. Went to the ER yesterday and 4/10 Had his J&J vaccine: 3/24 COVID19: negative 4/10

1st Adverse Event 4/13/2021, Left posterior lower leg(calve) pain, lasted 2 days, no treatment 2nd Adverse Event 4/16/2021 Left posterior knee pain, pain is still present but pain level has decreased, no treatment 3rd Adverse Event 4/16/2021 Left supraclavicular tender and enlarged lymph node for 2 days, no longer tender but lymph node is currently slightly enlarged, no treatment.

Cold hands and feet, blood pooling in hands, blurred vision, loss of appetite, palpitations, excessive urination, and pain around left shoulder blade area of back.

11 days following the single shot I developed severe pain in my right calf muscle that felt like a charlie horse and on my leg from knee to my ankle felt a squeezing sensation like I was wearing a very tight sock that I couldn't take off. After a few days the pain subsided and the similar pain began in my left leg however not as severe. The pain would seemingly move around and come and go. Some days it was so bad I couldn't walk or balance. I believed I had a muscular issue. I then began having swelling on the top of my left foot and around the ankle of my left foot. After about a week, my right leg began to swell from the knee to ankle fairly significantly. New veins appeared on the front of my right leg and other veins on the back of my right leg began to bulge. Pain on both legs started to subside on the evening of 5/23, however swelling continued. On the evening of 5/25 I was experiencing severe squeezing sensation and bulging veins in my right leg.

GUILLIAN BARRE; This spontaneous report was received from a consumer (the patient's wife) and concerned a 42 year old male. The patient's weight was 170 pounds and his height was 76 inches. The patient was a non-smoker, a non-drinker, had no known allergies and no prior or underlying medical history or past medications. The patient received COVID-19 vaccine Ad26.CoV2.S (suspension for injection, route of admin not reported, batch number reported as unknown), dose not reported administered once in total to the left arm on 12-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAY-2021 (same day post-vaccination), the patient felt tired, but felt better on the second day (13-MAY-2021). On 14-MAY-2021, two days post vaccination, the patient went to work (works as a landscaper) where he fell over and twisted his ankle. This happened again later during the day and after a few days, he felt that his feet were not picking up (like Frankenstein syndrome). Patient could not move his toes and his feet felt sloppy like a drop foot. After 2 weeks, on 26-MAY-2021, the patient started experiencing tingling and numbness in his arms and had to wake up in the middle of the night to shake his arm. The patient's physician referred him to a neurologist, the neurologist thought that it could be a case of transverse myelitis and asked him to go to the emergency room (ER) immediately. At the ER, all his tests were run such as x-rays, magnetic resonance imaging (MRI), coronavirus disease (COVID-19) test, together with unspecified blood work and neurological tests, the results of which were not provided. The patient was diagnosed with Guillain-Barre syndrome and was hospitalized on 04-JUN-2021 where he was being treated with immunoglobulins (product unspecified) and was discharged on 08-JUN-2021 (duration of hospitalization: 5 days). On 17-JUN-2021 in the morning, patient fell in his garage. At the time of reporting, patient couldn't lift his toes. Patient was perfectly healthy prior to the shot. Patient was getting mentally affected as everything felt like labor and work seemed burdensome. At the time of the report, all his symptoms were ongoing. The action taken with COVID-19 vaccine Ad26.CoV2.S was not applicable. The patient had not recovered from Guillain-Barre syndrome. This report was serious (caused/prolonged hospitalization). This case, from the same reporter is linked to 20210637283.; Sender's Comments: V0: This spontaneous report received from the patient's wife concerns a 42-year-old male who was hospitalized for Guillain-Barre syndrome (GBS) 23 days after receiving Janssen Covid-19 vaccine. He does not smoke or drink alcohol, does not have underlying medical conditions, and was not taking concomitant medications. Two days post vaccination, he fell and injured his ankle twice while at work as a landscaper. After a few more days, he felt difficulty lifting his feet and could not move his toes. Fourteen days post-vaccination, tingling and numbness began in his arms, and he was referred to a neurologist who then referred him to the emergency room (ER) out of concern for possible transverse myelitis. At the ER, x-rays, MRI, Covid-19 tests, and other unspecified blood & neurologic tests were performed; results not reported. Twenty-three days post-vaccination, he was diagnosed with GBS and hospitalized. He was treated with immunoglobulins and was discharged 4 days later. Nine days after discharge, the patient fell in his garage and could not lift his toes. At the time of this report, the patient had not recovered. Information regarding potential etiologies of GBS is insufficient, and the occurrence of the events could represent background incidence of such events in the general population. Considering the temporal relationship, the events are assessed to have an indeterminate relationship with vaccination.

The first day after the vax was fine, but towards the end of the day I felt strange. Half way through the second day, my pancreatitis came back with a vengeance for about a month, along with whole body inflammation for about a week, resufacing of neuralgias and other pain also. The first week was the worst. The whole body inflammation went away after a week. But the pancreatitis flare up was worse than experienced before, and the amount of pain increased since the injection of the pancreas has increased by about 10 to 15 %, and has not returned to pre-vaccination levels. I am taking more tramadol than ever now. I WILL NEVER GET A COVID VACCINE AGAIN.

Was having normal side effects including headache, fever, muscle aches which started about 6 hours after injections. Roughly 14-16 hours after the injection (8:30-9am) started getting chest pain and slight shortness of breath. Called my PCP and they told me to go to the ER as the chest pain is not normal. At the ER they did an EKG which came back abnormal and I was rushed into a procedure to check my heart including a catheter, ultrasound, and a few more I will provide below. Outcome after all the test was inflammation which I asked if it could have been in other areas of my body but doctor said it was my chest. My C-Reactive Protein level was double the normal level. They put me on 3 medications, Ibuprofen, one for Gout and Prilosec.

Patient states he was doing well until 419 when he had abdominal pain. Patient says abdominal pain started in the middle of his belly and radiated to his back. Pain is worse when he tries to eat and 8 out of 10. Pain is sharp. Patient has not had pain like this before. Pain improved when not eating. Patient has had watery non-bloody diarrhea for the past 2 days. Patient denies any fevers or chills.

Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Right upper eyelid bruise-Mild, Additional Details: patient came and said he woke up with right upper eyelid bruise and not hurting. I advised him to monitor and if getting worse , he need to go to emergency or urgent care

TENDERNESS IN THE CHEST; LUNG INFLAMMATION; COUGHING; SORENESS; TROUBLE BREATHING; THROAT SWELLING; CHEST TIGHTNESS; GENERAL SWELLING; DETERIORATION; DID NOT FEEL WELL; TIRED/FATIGUE; This spontaneous report received from a patient concerned a 43 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1805020, and batch number: 1805020 expiry: 25-MAY-2021) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-APR-2021, the subject experienced tired/fatigue. On MAY-2021, the subject experienced deterioration. On MAY-2021, the subject experienced did not feel well. On 07-MAY-2021, the subject experienced soreness. On 07-MAY-2021, the subject experienced trouble breathing. On 07-MAY-2021, the subject experienced throat swelling. On 07-MAY-2021, the subject experienced chest tightness. On 07-MAY-2021, the subject experienced general swelling. On 07-MAY-2021, the subject experienced coughing. On 08-MAY-2021, the subject experienced tenderness in the chest. On 08-MAY-2021, the subject experienced lung inflammation. The action taken with covid-19 vaccine was not applicable. The patient was recovering from tired/fatigue, had not recovered from soreness, trouble breathing, throat swelling, chest tightness, general swelling, lung inflammation, and coughing, and the outcome of tenderness in the chest, did not feel well and deterioration was not reported. This report was non-serious.

Painful Arm, 4 days Fever 2 days Swollen lymph nodes in groin with tenderness, from day 7, currently ongoing.

Blood clot in superficial vein behind right knee as well as vertigo and nausea. Currently on 30mg/day of XARELTO blood thinner (I've been taking since diagnosis on 5/5/21). Will continue to take 20mg/day for the next 30 days. Background: I started to notice my right calf get tight and sore approximately ~3 weeks following my vaccination. I had been doing a lot of running and hill training so I assumed it was a muscle strain/aggravation. After approximately 1-2 weeks I noticed the tightness worsen and also noticed significant swelling around my lower calf/ankle. I went to the doctor on 5/4/21 and was given a D Dimer blood test which came back 1.27 mcg/mL FEU (over the recommended 0.5 mcg/mL). The next day I had an ultrasound of my right leg where they discovered the SVT clot behind my right knee in a superficial vein (but near a major/deep vein intersection). I was immediately prescribed XARELTO blood thinner - to be taken for ~51 days. ~21 days of 30mg/day (15mg twice/day) followed by ~30 days of 20mg/day 1x per day. The morning of 5/20/21 around 6:30am I started to feel nausea and vertigo after returning home from walking my dog. I finished a low-intensity exercise routine at my home and around ~7:15am my symptoms worsened. I went upstairs to my bedroom to lay down on my bed and the room started spinning. I then went to the bathroom and vomited clear fluid. I started feeling a little better after vomiting but was still slightly dizzy and light-headed. I made an appointment and went to the doctor around 10:30am. The doctor suggested doing further bloodwork and a CT scan of my head. Both tests came back normal. The doctor suggested the vertigo and nausea were inner ear related and that I should continue taking XARELTO and to also start wearing a compression sock (especially during exercise/activity).

Patient reported received his Johnson and Johnson COVID 19 vaccine 05/31/2021. Reported stated having generalized joint aches, HA and left axillary swelling. Reported symptoms stated 06/1/2021 at 8pm. patient reported did not take any medications for symptoms.

Patient developed mild case of Guillain Barre Syndrome 34 hours after injection of the Johnson and Johnson vaccine. Patient has severe extremity pains. The patient has a personal history of being diagnosed with Guillain-Barre after a yellow fever vaccination.

Pt had progressive shortness of breath/weakness and fatigue. CT scan did not show PE. CK level was 17000, inflammatory labs were mixed. Rheumatology consult concluded it was myositis related to COVID vaccine. admitted to hospital 4/27-4/30.

At first on April 23rd, my tongue felt like it was burned and tingling. By 4/26 I woke up with right side of face dropping, swollen, and paralyzed. Went to the ER and was diagnosed with Bells Palsy. ER doctor also performed CT scan which was normal. Was given prednisone and valacyclovir, instructed to protect and dress my eye. The right side of my neck under my ear is very swollen and tender. I have pain in the back of my neck on the right side. I had a follow up with PCP 5/05/21. She told me to use an eye ointment. It has been two weeks and my face is still paralyzed. Some of the swelling has gone down in my check.

Pt. received the vaccine at approximately 2:44pm. Before I could hand him his card, his hands began trembling and he looked pale. I asked how he was feeling. He reported feeling shaky, dizzy, and very hot. I asked him if he was having any difficulty breathing, had tightness in his throat/airways, or even felt a tingle. He said no. Noting the time, I asked if he had eaten lunch. I asked if he has ever felt this way before. He said he had when he gets a "hypoglycemic attack." While not diabetic nor on any medications, he said he will occasionally get very low blood sugar. He said he had not eaten since early that morning. Another employee brought some juice I requested. I again asked him about symptoms related to anaphylaxis, to which was not an indication of an anaphylactic reaction. I gave him the juice to sip. I asked him again about symptoms. Because he was still dizzy, I took his blood pressure/heart rate. His BP was 160/119 and heart rate 96bpm. His color became more gray over the next several minutes. He was still too dizzy to stand, felt hot, shaky, and now nauseous. He handed over the juice and was given a receptacle if he vomited. We suspected a vasovagal response, but was still symptomatic after 10 minutes. Meanwhile, the other pharmacist tried to call his doctor's office. We learned his doctor had moved away and he had not yet come in nor selected a new provider. We asked him if he felt he needed to be seen by a doctor. He said he did and agreed to us calling an ambulance. The ambulance arrived around 3:10. The EMTs took his BP. It had come down, but he could not stand up without his knees buckling. The EMTs got him on the stretcher and took him to the hospital.

3/21 - Felt like a sinus infection/Ear infection. Swollen lymph nodes. No congestion. 3/27 - Went to urgent care. Was given antibiotic/steroid to combat sinus/ear infection type symptoms. Tested neg. for strep. 3/29 - Went to PCP for continues pain in head and starting to have pain in lower back and down both legs. Some pain in arms too. 3/31 - Went to PCP for increased pain, weakness and numbness in legs and arms. Took blood for tests. COvid test 4/3 - Went to ER with intense pain/numbness/weakness/ restlessness in legs and some in arms/hands. Head still hurts too. More blood work, given Hydrocodone/Ibuprofin to help manage pain. 4/5 - Returned to PCP. Was given Gabapentin to help with the pain. Was referred to neurologist. 4/8 - Initial exam at neurologist. Plan to complete MRI and Nerve Conduction studies. 4/9 - Had MRI completed of brain and upper spinal cord.

FINGER TIPS GETTING HOT; FINGER TIPS GETTING NUMB; INSIDE OF LEFT ARM EXCRUCIATING PAIN; COULDN'T WALK DUE TO SWOLLEN ANKLES; COULDN'T WALK DUE TO SWOLLEN ANKLES; SHORTNESS OF BREATHE; HOT AND SWEATY; PAIN ALL OVER BODY; EXTREME CHILLS; REALLY COLD; HEADACHE; This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included headaches. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 12:30 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced shortness of breathe. On 11-APR-2021, the subject experienced hot and sweaty. On 11-APR-2021, the subject experienced pain all over body. On 11-APR-2021, the subject experienced couldn't walk due to swollen ankles. On 11-APR-2021, the subject experienced extreme chills. On 11-APR-2021, the subject experienced really cold. On 11-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced couldn't walk due to swollen ankles. On 16-APR-2021, the subject experienced finger tips getting hot. On 16-APR-2021, the subject experienced finger tips getting numb. On 16-APR-2021, the subject experienced inside of left arm excruciating pain. Treatment medications (dates unspecified) included: tramadol, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breathe on 11-APR-2021, and hot and sweaty, couldn't walk due to swollen ankles, couldn't walk due to swollen ankles, extreme chills, really cold, and headache on 12-APR-2021, was recovering from pain all over body, and had not recovered from inside of left arm excruciating pain, finger tips getting hot, and finger tips getting numb. This report was non-serious.

Patient does not remember most of the adverse event. Patient's partner reports that patient started feeling a tingling sensation on his left arm about 10 minutes after vaccination. Partner also reports that patient was hallucinating and sending her confusing text messages during his 15 minute observation period. The patient did not report feeling any adverse symptoms at the checkout station after his 15 minute observation period and before leaving the vaccination clinic. After patient returned home, his partner reports considerable swelling on his left arm, continued hallucinations and trying to dismiss her concerns. Subsequently, that same day, partner reports the patient had a severe migrane and began to lose feeling on his left arm and leg, at which point the patient also lost consciousness. Also at this point, the partner calls 911. After arrival of emergency personnel, the patient regains consciousness, but does not remember name and complains of continued pain on his arm. He is transported to hospital where he spends 3 nights and receives treatment and care for stroke symptoms. Patient reports that he does not remember much of anything 1.5 days after vaccination. After returning home from hospital, patient complains of memory lapses and begins seeing neurologist for minor seizures during his sleep. Wife reports that patient now lashes out and easily loses temper due to the fact that his memory is foggy.

Ten days after vaccination I had an allergic shellfish reaction to a frozen lobster product. Never happened before and I've had other Lobster on the east coast before. I also ate shrimp a few days prior to vaccination with no reaction. I have eaten other Lobster all my life with no reaction. My sinuses and throat closed up making it very difficult to breathe. I didn't know what was happening so I took decongestants and antihistamines then went to the doctor and got injected with a steroid immune suppressor. I now have epinephrine just in case it happens again.

Guillain Barre syndrome- symptoms of BLE numbness with ascending bulbar weakness developed 4/18 and diagnosed on 4/27

Tinnitus level 8/10. Bad swelling / inflammation. Brain fog. Diarrhea. Ear pain. Treated with large doses of Antronex with recommendation from Chiropractor. Antronex helped reduce swelling. Treated sinuses with Xlear nasal spray. Helped reduce swelling. Tinnitus still at level 4/10 after 9 days.

On 5/13/2021 patient developed a cough in the evening. Patient woke up not feeling well on 5/14/2021, and also had nausea and vomiting. Patient was driving a vehicle when he had a seizure. No prior history of seizures. Drifted off the road, no significant damage to vehicle. Patient post-ictal following seizure, seizure activity was witnessed by bystanders. CT brain showed small subdural hematoma. A CTA chest performed due to hypoxemia and tachycardia at Hospital showed Multifocal groundglass type nodular infiltrates throughout the right lung involving the upper lobe, middle lobe, and lower lobe, minimal left lower lobe patchy infiltrate, as well as patient's known thymoma. These multifocal groundglass infiltrates were not previously mentioned on a CT chest performed on 4/10/2021. Patient was transferred to this facility for evaluation by neurosurgery. Patient was mildly tachycardic, hypoxemic to 88% on room air, and tachypneic. Patient reported decreased sense of taste & smell for 1 month, which he attributed to his losartan use. A covid/flu/rsv PCR on 4/10/2021 was negative, and a viral respiratory pathogen panel with covid PCR was negative on 5/14/2021, as was an antigen & NAAT for COVID on 5/14/2021. Patient was treated with antibiotics and admitted for further management.

Complained of right lower leg pain and swelling, shortness of breath, sent to hospital for Ultrasound of right lower leg, Ultra sound was positive for a DVT. Was then sent to the Emergency room for evaluation and treat for DVT. Complained of Shortness of breath. CT Scan Angiogram completed and found to have bilateral Pulmonary Embolism

Superficial thrombophlebitis in left medial lower calf, along with edema in foot and ankle on same leg and pain in calf, foot, and ankle. No explicit treatment prescribed. Symptoms are ongoing as of 6/25/2021, but have reduced in intensity. The was the first blood clot I've ever experienced.

Near-syncope followed by mild pain in the upper left chest region. Prescribed 81mg Aspirin (daily), 10mg Atorvastatin Calcium (daily), 0.5mg Clonazepam (twice daily). No further episodes of near-syncope, but mild pain in the upper left chest region continues on occasion.

NUMB FACE INITIALLY, NUMBNESS DOWN BOTH LEGS. NO FEELING OF HOT OR COLD ON THIGHS, ARMS. LIPS CURRENTLY NUMB. ICY-HOT SENSATION WHEN WIND HITS BODY WHEN SWEATING. HANDS IN COLD WATER FEELS "ICE, ICE, ICE FREEZING COLD". HEAT FROM SUN IS SIGNIFICANTLY ENHANCED AS IF THE SKIN WERE BURNING

24 hours later had all the side effects and feels like my rectum is swollen, and ears are burning, belly is swollen, feels like I have the flu, I feel hot but don't have fever, and I started feeling better and it all came back at one week later, is this normal and will it pass. Lymph nodes hurt from back of head down shoulders, constipation, voice different, smells are different, taste is different, and skin feels half numb.

Blurred vision, sore body, stiff neck and swollen glands, size of a lemon. Flu like systems but no fever.

Headache and high fever next day. Symptoms subsided within 24 hours. Treated with Tylenol. 5 days after, itchy hives all over, treated with Benadryl and cortisone cream. Severe Leg and foot swelling (left leg). Treated with steriod regemin

Pain all over the body! Swelling in both feet ankles, fever, stomach pain, fatigue, chest pain and phlegm! Extreme tiredness, pain and swelling in the vaccinated arm, swollen of the shoulder of the vaccinated arm, severe headache

SWELLING ON HIS KNEES; JOINT PAIN; HORRIBLE CHILLS; FEVER OF 105.9 F; This spontaneous report received from a patient concerned a 46 year old male. The patient's weight was 135 pounds, and height was 173 centimeters. The patient's past medical history included marijuana use, and concurrent conditions included penicillin allergy, alcohol use, smoker, lactose intolerance, attention deficit hyperactivity disorder, and anxiety. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Concomitant medications included clonazepam for ADHD, and anxiety, and hopantenate calcium for ADHD, and anxiety. On APR-2021, treatment medications included: ibuprofen. On 06-APR-2021, the subject experienced swelling on his knees, joint pain, horrible chills, fever of 105.9 f. Laboratory data included: Body temperature (NR: not provided) 105.9 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from horrible chills on 10-APR-2021, and fever of 105.9 f on 09-APR-2021, and was recovering from joint pain, and swelling on his knees. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious

Janssen COVID-19 Vaccine EUA: two weeks after vaccination patient reported to an urgent care with right leg swelling and headache. Two days later patient presented an emergency department, diagnosed with left lower extremity deep vein thrombosis (DVT) and bilateral pulmonary emboli (PE). Transferred to current hosptial for management including anticoagulation with a direct thrombin inhibitor, intravenous immune globulin (IVIG), and additional laboratory testing.

HIGH BLOOD PRESSURE; BRAIN FOG; FATIGUE; ANAPHYLACTIC SHOCK; PARALYSIS IN LEFT HAND; LIGHTHEADED; This spontaneous report received from a patient concerned a 46 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included pre-diabetic, and other pre-existing medical conditions included the patient had no known drug or non-drug allergies. The patient had no illness 30 days prior to vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) 1 total dose was administered at left arm on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021 at 14:35, the patient immediately felt tingling in left arm (like ben gay) after vaccination, 10 minutes later he felt tingling in neck and cheek. His left hand turned purple. He became unconscious (he did not remember anything). He had cardiac arrest (patient remembers yelling code). He was taken to emergency room. He thought people in emergency room said anaphylactic shock and gave him epinephrine (patient was not sure). He had paralysis in left hand when he woke up for a few minutes. His blood test and Electrocardiogram were normal. He went home in couple of hours (on 31-MAR-2021). On 02-APR-2021 (two days later) he was light-headed, he went to his doctor. His blood pressure was high, he felt little bit of fatigue and brain fog. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lightheaded, anaphylactic shock, paralysis in left hand, high Blood pressure, fatigue, and brain fog. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210443005-covid-19 vaccine ad26.cov2.s- anaphylactic shock, paralysis in left hand. 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 with elevated hematocrit (though has other reasons for this) Asytmpomatic but found on lab testing

Site: Pain at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: patient was unresponsive for few seconds less than a min and came back 911 paramedics evaluated him and took to emergency for further evaluation

Transferred from Hospital on 4/1/21 for fever and altered mental status, suspecting adverse reaction from Janssen COVID vaccine given 3/30/21, symptom onset 3/31/21 morning. Sepsis with unknown source of infection: This is evidenced by leukopenia, tachycardia and fever. Acute metabolic encephalopathy, likely secondary to possible sepsis versus effects of COVID vaccine. Encephalitis and meningitis ruled out. Acute nontraumatic rhabdomyolysis: evidenced by elevated CK levels 1700 on admission, likely secondary to sepsis. Acute renal failure, hypothyroidism, transaminitis, elevated troponin likely associated with rhabdo. On sepsis protocol (vancomycin, meropenem and acyclovir) Disc

On 4/14/2021, right elbow started to hurt. This was a site of a removed gout-caused mass over a year ago. That subsided within a day. On 4/15/2021, left foot started to hurt. By 4/17/2021, the next to smallest toe and the large toe was swollen and very tender to any sort of touch. It was not warm. The pain was almost unbearable on 4/18/2021 and the suspicion that it might be gout was considered. On 4/19/2021, after a visit with his doctor, gout was confirmed as the likely cause of the pain/swelling. However, no blood tests were run to confirm. Treatment for gout was initiated.

Two days after receiving vaccine, patient developed acute swelling and tenderness in right lower extremity and diffuse whole body urticaria.

NUMBNESS IN LEFT ARM FROM SHOULDER DOWN TO FINDERS AND IN BOTH LEGS; SWOLLEN RIGHT FOOT 2X BIGGER; LOSS OF COORDINATION; HARD TO WALK; LITTLE FEVER; This spontaneous report received from a patient concerned a 47 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no history of diabetes except family history.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 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 little fever. On 15-APR-2021, the subject experienced numbness in left arm from shoulder down to finders and in both legs. On 15-APR-2021, the subject experienced swollen right foot 2x bigger. On 15-APR-2021, the subject experienced loss of coordination. On 15-APR-2021, the subject experienced hard to walk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little fever on 03-APR-2021, and had not recovered from numbness in left arm from shoulder down to finders and in both legs, swollen right foot 2x bigger, loss of coordination, and hard to walk. This report was non-serious.

4.3.21: soreness throughout body, fever 4.4.21: fingers turned blue 4.5.21: tongue swelled and turned bright red fingers mottled for 5 days intense body aches for 6 days 4.26.21: antecubital fossa hot, swollen and red, significant pain 4.27.21: pain extends down into forearm and red and streaked 4.30.21: pain continues

Patient developed presumptive Guillain-Barré syndrome after receiving the J&J vaccine outside of a hospital.

Increased pain and swelling in left arm - started within 12 hours and continued for 2 weeks Fever over 100 - started within 12 hours and continued for 1 month (fever between 100 and 102) Nausea - within 12 hours (continued for 1 month) Vomiting - within 24 hours (continued for 3 days) / then again 2 weeks out for 3 days) Migraine Headache - started within 12 hours and continued for 6 weeks (and on-going) Labored breathing - started within 12 hours and continued for 5 weeks (and on-going) Low oxygen - started within 36 hours and continued for 1 month) General muscle and body aches and pains (started within 24 hours and continued for 6 weeks (and on-going) Extreme exhaustion and lethargy (started within 6 hours and continued for 6 weeks (and on-going)

Blood clot which was diagnosed via ultrasound on my top left calf on 06/07/21. I began to experience swelling and pain on 06/03/21

severe lower back pain, radiating down left leg; legs became wobbly; lost balance; fell several times enroute to ER. Admitted to hospital. MRI x3. Diagnosis Guillain Barre syndrome; treated with IVIG & steroids x 1 week Transferred to Rehabilitation Institute. Dr. primary rehab doctor. Neurologists consultants.

Fever 101, severe aches, swelling of face, fast heartbeat, bad rash all over body, dizziness and weakness, headache

swelling and pain the day he was vaccinated and it has lasted for almost three weeks, it has gotten better but he hasn't fully recovered.

SWOLLEN ARMPIT; SORE ARM; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. The patient's 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, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced sore arm. On 07-APR-2021, the subject experienced swollen armpit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen armpit, and sore arm. 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.

L leg pain starting 4/15/2021, symptoms similar to superficial thrombus he has in the same leg in 2017 . No recent injury. J and J COVID 19 vaccine on 4/6/2021. Started on Eliquis on 4/16/2021. Improved but still having significant L medial thigh pain during follow up appt on 4/20/2021. Scheduled to be seen by PCP next on 5/10/2021.

Developed symptoms of pain, redness, swelling to left anterior shin on 4/13, symptoms worsening so presented to clinic for evaluation. Has multiple varicose veins in this area.

Patient evaluated in ED 04/26 for bilateral leg cramping, swelling that started just over a week prior. Reviewed records from that visit. Work up was significant for bilateral lower extremity DVTs and thrombocytopenia. Patient was started on Xarelto at that time. Patient does not have any significant risk factors for blood clots. He is not obese, denies tobacco use, recent procedures, recent travel, prolonged immobility, family history of bleeding or clotting disease, etc. He is up to date on cancer screenings based on age/family hx. He did receive the Johnson and Johnson vaccine on 04/07.

About three weeks ago began to experience swelling in lower right arm, above wrist (he had vaccine in left arm), fever, cough at nighttime and tingling to point of pain from right shoulder to elbow, and left little finger numb

RED MARKS ON ANKLE, FEET AND CALVES OF LEGS; SWOLLEN WRIST; SWOLLEN RIGHT FOREARM; SWELLING OF LEFT LEG CALF; PAIN; REACTION ON LEFT LEG WORSENED AND SPREAD TO RIGHT LEG AND INNER THIGHS; This spontaneous report received from a consumer concerned a 48 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, alcohol user (occasionally on weekend), and non smoker, and other pre-existing medical conditions included no drug abuse or illicit drug usage and no complaints of medical issues. The patient was previously treated with fexofenadine hydrochloride for seasonal allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced swollen wrist. On APR-2021, the subject experienced swollen right forearm. On APR-2021, the subject experienced swelling of left leg calf. On APR-2021, the subject experienced pain. On APR-2021, the subject experienced reaction on left leg worsened and spread to right leg and inner thighs. On 20-APR-2021, the subject experienced red marks on ankle, feet and calves of legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen wrist, swollen right forearm, swelling of left leg calf, and pain on APR-2021, had not recovered from reaction on left leg worsened and spread to right leg and inner thighs, and the outcome of red marks on ankle, feet and calves of legs was not reported. This report was non-serious.

BILATERAL LOWER EXTREMITY PAIN; MULTIPLE ACUTE BILATERAL PULMONARY EMBOLI; PLATELET COUNT DECREASED; DEEP VEIN THROMBOSIS; VACCINE INDUCED THROMBOTIC THROMBOCYTOPENIA; ULTRASOUND DOPPLER ABNORMAL; FULL BLOOD COUNT; METABOLIC FUNCTION TESTS; MUSCLE SPAMS; SWELLING; MILD HEADACHE; This spontaneous report was received from a health care professional via a Regulatory Authority and from literature: Vaccine-induced thrombotic thrombocytopenia following Ad26.COV2.S vaccine in a man presenting as acute venous thromboembolism. 2021 Jun 03;1-4., and concerned a 48 year old white male (not Hispanic or Latino). The patient's height, and weight were not reported. The patient's concurrent conditions included exercise induced asthma, and no tobacco use (both current and historically), and other pre-existing medical conditions included the patient had no known allergies. The patient was not obese, denied recent procedures, prolonged immobility, family history of bleeding or clotting disease, etc. The patient was up to date on cancer screenings based on age/family history. He was reported as being an unusually physically active and fit 48 year-old male who has enjoyed good health and exercised regularly. In 2019, his platelet count was 177 10*9/L. The patient reported flying out of town and back on 30-MAR-2021 and 04-APR-2021 respectively with the longest continuous flight lasting around 4 hours. The patient at age 48, received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 07-APR-2021 for prophylactic vaccination. Concomitant medications included finasteride, and salbutamol. On an unspecified date in APR-2021, the patient experienced mild headache. On 18-APR-2021, 11 days after receiving the vaccine, the patient experienced deep vein thrombosis, vaccine induced thrombotic thrombocytopenia; new pain in his big toe, bilateral leg cramping (muscle spasm), bilateral lower extremity pain, and swelling. The patient attributed soreness in the large muscle groups of his thighs to Peloton riding and exercise. The patient travelled again via airplane to an unspecified location 22-APR-2021 and 25-APR-2021 (both1 hr long flights). The patient administered Advil for the leg pain when he returned on an unspecified date. On an unspecified date he felt a leg vessel that "didn't seem right." On 26-APR-2021 the patient went to emergency department for evaluation presenting with leg pain and chest discomfort. He had normal vital signs and oxygen saturation. Additional laboratory results: Platelet count (NR 140-440 K/uL) 74; fibrinogen (NR 150-430 mg/dL) of 254; D-dimer (NR 0-499 ng/mL FEU) 15,109 ng/mL FEU; activated partial thromboplastin time (aPTT) (NR 25.1-36.5 s) 31.8. Venous duplex ultrasound of the lower extremities revealed non-occlusive DVT in the bilateral popliteal veins extending to the gastrocnemius veins, an occlusive DVT of the left posterior tibial vein, as well as occlusive superficial venous thrombosis in the bilateral saphenous veins. The patient was discharged from the emergency room on rivaroxaban 15 mg twice daily with two-day follow-up with his primary care physician. He had no known exposure to heparin before the onset of symptoms and no exposure during his emergency room visit. On 28-APR-2021 (also reported as the next day), the patient complained of a new onset of chest pain (pleuritic) and presented again to the emergency room. Chest CT showed presence of acute pulmonary embolism, with emboli present in segmental and more proximal arteries. He had already taken his rivaroxaban for the night (1800). The patient was hospitalized for further evaluation and work up. A peripheral smear showed thrombocytopenia without schistocytes. The hematology service was consulted, and a presumptive diagnosis of VITT (vaccine induced thrombotic thrombocytopenia) was made. His anti-PF4 enzyme-linked immunosorbent assay (ELISA) (LIFECODES PF4 IgG), performed on a sample collected prior to initiating IVIG therapy, demonstrated a strongly positive result of 3.323 optical density (OD) units (reference interval < 0.399), consistent with a diagnosis of VITT. The patient was immediately treated with 1 g/kg of intravenous immunoglobulins (IVIG) for 2 days, 1 mg/kg of prednisone, and switched from rivaroxaban to an intravenous argatroban infusion drip, during which he achieved therapeutic aPTT levels between 44 - 50 sec. The patient was also treated with apixaban. Other studies included: Magnetic resonance venography (MRV) and angiography (MRA) of the brain, performed due to symptoms of mild headaches, were unremarkable. Platelet factor 4 (NR: not provided) strong positive at 2.9 OD; Prothrombin mutation G20210A not detected, Red blood cell count (NR: 3.98 - 5.98) 5.07 M/ microliter, Red blood cell sedimentation rate (NR: not provided) Normal, SARS-CoV-2 test was negative, Serotonin release assay was positive, and WBC (NR: 3.2 - 10.6) 5.8 K/microliter. Anticardiolipin antibodies (NR: not provided) 5 GPL, Beta-2 glycoprotein 1 antibodies (NR: 0 - 20) 0 SGU, 5 SMU, Blood homocysteine (NR: not provided) 13.4 nml (normal), C-reactive protein (NR: not provided) 2.6, Cardiolipin immunoglobulin G (NR: 0 - 12) 6 MPL, Cell marker increased was positive, EKG (NR: not provided) Normal, Hematocrit (NR: 36.9 - 52.1) 42.2 %, Hemoglobin (NR: 2.5 - 18.0) 15.0 g/dL, Lupus anticoagulant (NR: not provided) not detected, MCHC (NR: 33.4 - 35.3) 35.5 g/dL, MCV (NR: 80.6 - 97.6) 83.2 fL. On an unspecified date the serotonin release assay was no longer positive. Within a week post-discharge, the patient developed recurrent thrombocytopenia, with a platelet count that down trended to 107 10*9/L His thrombocytopenia appeared to somewhat correlate with prednisone dose adjustments, suggesting an autoimmune-driven process, although it did not respond to repeat IVIG administration. Due to the normalized D-Dimer levels and negative SRA, it was assumed that there was no further ongoing platelet activation. The authors stated the patient had no prior risk factors for thrombosis other than the 2 recent 4-hour flights. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bilateral lower extremity pain, was recovering from deep vein thrombosis, vaccine induced thrombotic thrombocytopenia, platelet count decreased, swelling, full blood count, metabolic function tests, muscle spasms, ultrasound doppler abnormal, and multiple acute bilateral pulmonary emboli, and the outcome of mild headache was not reported. This report was serious (Hospitalization Caused / Prolonged). This case is a duplicate of 20210642952. Additional information was received from literature article on 19-JUN-2021. The following information was updated and incorporated into the case narrative: literature reference information, additional reporters, laboratory data, updated events. It has been determined that Manufacture Report Number 20210514958 is a duplicate of deleted case 20210642952. All relevant information from Manufacture Report Number 20210642952 will be reported in this case 20210514958.; Sender's Comments: V2: Follow up consisted of a literature citation, presenting this case as a case report. This does not change the previous assessment. This case obtained via VAERS (ID 1264060) concerns a 48-year-old White male who developed symptoms of bilateral lower extremity deep vein thromboses (DVT) and thrombocytopenia 11 days after receiving Janssen Covid-19 vaccine. Concurrent conditions included exercise induced asthma. Patient was not obese, did not smoke, denied recent procedures, family history of bleeding/clotting disease & was physically active. He was up to date on cancer screenings based on age/family history. He had taken two 1-hour long flights 15 days and 18 days post-vaccination. Concomitant medications included finasteride & salbutamol. After 1 week of bilateral leg cramping & swelling which began 11 days post-vaccination, he presented to emergency department (ED) where complete blood count showed platelets 74 k/uL, peripheral smear with giant platelets, and d-Dimer 15K. Venous duplex ultrasound showed nonocclusive DVT in the bilateral popliteal veins extending to the gastrocnemius veins, occlusive superficial vein thrombosis in the bilateral saphenous veins, and occlusive DVT of the left posterior tibial vein. He was started on rivaroxaban & was not hospitalized. Two days later, he developed new chest pain & returned to ED, where CT chest showed numerous bilateral pulmonary emboli. He was hospitalized; empiric treatment for vaccine-induced immune thrombotic thrombocytopenia was started: IVIG, steroids, & argatroban. Anti-PF4 resulted as OD=2.9 and 3.323 (strong positive), confirming diagnosis. The patient was recovering from the events. Based on evolving knowledge of Thrombosis with Thrombocytopenia Syndrome (TTS, per definition from Brighton Collaboration), low platelet count & temporal relationship to vaccination, the events are assessed to have a plausible relationship with vaccination.

About a month after receiving the J&J vaccine, I noticed a bump in the top of my left calf, which caused some discomfort and also noticed slight numbness in left foot / toes. Primary, Dr., sent me for ultrasound, which showed I had several blood clots in my leg. I have never had any blood clots before. Dr. referred me to Hematologist, Dr. She ran extensive blood tests and found no genetic predisposition for clots. She stated it was likely the vaccine that caused me to develop blood clots. I am now on blood thinners to try to dissolve them and may have to take them for life if the clots don't go away in the new few months. Follow up ultrasound scheduled 9/7/21.

Initial aches and chills that developed the evening of and subsided after 2 to 3 days. Then, on the 4th day, fingers on right hand started to swell. Has continued to improve but is still having some discomfort and stiffness in the right hand. Is now 2 weeks since initial injection.

Pruritic rash on extremities began 3/11/21 and on 3/14/21 developed lip and facial swelling on right side of face requiring trip to emergency room at hospital

swelling in right elbow (size of a gulf ball), with slight pain and a lot of black and blue around the elbow and up my forearm

6 hours after shot, body started shaking involuntarily for 3 hours. I was extremely cold, 3 layers of clothes and 3 layers of blankets. Unable to sleep all night. Got up 6 am, had major headache, swollen nodes in neck, all over body aches and still had chills. After 24 hours I may have been 50% to normal, after 48 hours approx 75%, 72 hours about 85%. Headache was gone unless cough or sneeze. On third day. I did not take any over the counter Medicine after the shot at all in fear of affecting the vaccine.

Janssen COVID-19 Vaccine EUA: patient presents to emergency department with altered mental status and confusion three days after being discharged from a different hospital for COVID-19 infection. In emergency department diagnosed with stroke, left ventricular thrombus, subacute anterior myocardial inferction with totally occluded mid LAD, and COVID-19 infection. Underwent cardiac catheterization and transferred to current facility for higher level of care and testing- currently remains hospitalized on anticoagulation and oxygen.

Swollen lymph nodes and abdominal pain from right him bone down to scrotum. Pain on 4/7 was such that i though i was suffering a hernia. Couldn't get out of car or move my right leg across my body. Could put right leg into pants leg. Hurt to bend over and do much of anything on 4/7. Initially thought pain was in testicle but doesn't hurt at all to the touch. Realized it more a swollen area in the groin between hip bone and scrotum. Nothing hurts to the touch at all in that area either which lead my to believe it was swollen lymph nodes. The Feeling is as if i got hit in the right groin and my testicle has been hit and discomfort is 8 inches above right testicle in my groin area. It has been improving every day since then, the more i walk the better it is. It only hurts when i sit now and it seems to aggravate it pretty well but once i start moving the pain goes away. It has been 9 days now and the i don't notice it all day until i come back to the office and sit at my desk and again it gets aggravated and the discomfort feels like my right testicle is near my appendix Since this all started my legs feel heavier in the calf and have little nerve sensations when i sit too, which concerns me about the blood clot possibility and so i have been emailing with my doctor. I am going to make appt for Monday 4/19

CHILLS; BURSITIS; BRUISING IN BLACK AND BLUE DISCOLOURATION AT RIGHT ELBOW; This spontaneous report received from a patient concerned a 49 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy. The patient experienced drug allergy when treated with ibuprofen. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 10:55 for prophylactic vaccination. Non-company suspect drugs included: prednisone (tablet, oral, batch number: Unknown) 50 mg, 1 time every 1 day, from 02-APR-2021 for bursitis. No concomitant medications were reported. On 01-APR-2021 15:55, the subject experienced bursitis. On 01-APR-2021 15:55, the subject experienced bruising in black and blue discoloration at right elbow. On 02-APR-2021 04:30, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and treatment with prednisone was withdrawn. The patient recovered from chills on 02-APR-2021, had not recovered from bruising in black and blue discoloration at right elbow, and the outcome of bursitis was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.

Immediately dizzy, nauseous and fatigue lasted 2 days. One week later (5/12) had severe allergic reaction including violent diarrhea with severe cramping and pain, and swollen lips, tongue, face, hands and feet. Acute swelling and diarrhea lasted 12 hours. Ongoing angioedema lasted 4 days and moved from mouth to face and hands and feet. No previous food allergies or allergic reactions.

ITCHY; FACE SWOLLEN; RASH ON ARMS, CHEST AND LEGS - LITTLE DOTS; This spontaneous report received from a patient concerned a 49 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included penicillin allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 to left deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-MAR-2021, the subject experienced rash on arms, chest and legs - little dots. On 18-MAR-2021, the subject experienced face swollen. Treatment medications included: diphenhydramine hydrochloride. On 19-MAR-2021, the subject experienced itchy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from rash on arms, chest and legs - little dots, and face swollen, and the outcome of itchy was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious.

Developed ascending paralysis, currently hospitalized and being worked up, but felt to be inflammatory with extensive spinal lesions and brain lesion.

While eating dinner, my lips and face around my mouth began to swell. They swelled to the point that it was very visible and became hard to enunciate due to the excessive swelling of the lips. The swelling lasted over 24 hours and did not respond to antihistamines.

I started having a lot of pain in my right leg. I could actually feel and see that my veins were swollen. It progressed and started moving around. I started having chest pain and headaches. I ended up at ER. They gave me pain meds and did a CT Scan and ultrasound, which were both clear. The next day, I was walking around and my hand and arm started hurting and then went numb. My right wrist was swollen to twice its size. I went to care and they told me to go back to the ER. They eventually did another ultrasound, but the swelling had gone down by then. A few hours later, my left arm started to swell and lasted for about 4 hours. From there, I had pain in my arms and legs for a few days after that, but then I was fine.

PNEUMONIA; MULTISYMPTOM INFLAMMATION SYNDROME; This spontaneous report received from a consumer concerned a 49 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included patient had no known drug allergies and not aware of previous medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, one total administered on 07-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. Consumer called to report patient developed multi-symptom inflammation syndrome after received the Janssen Covid-19 Vaccine and experienced pneumonia. Reporter was looked to get information regarding compensation for medical expenses after hospitalization. The patient was hospitalized on 23-May-2021 and discharged on 08-Jun-2021. The patient was hospitalized for 17 days. Laboratory data included: COVID-19 PCR test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pneumonia, and the outcome of multi symptom inflammation syndrome was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210621953-covid-19 vaccine ad26.cov2.s - Pneumonia, Multi symptom inflammation syndrome. 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).

Systemic: Allergic: Rash Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Body Aches Generalized-Mild, Additional Details: Patient experienced swelling of both hands, and a generalized blotch rash on arm, back, and ribs bilateraly

Janssen COVID-19 Vaccine EUA Swollen lymph node on collarbone on same side (left) as injection arm, lasting 10 days at time of report and continuing. Patient will seek medical consult if condition persists for more than 7 more days

Severe itchy rash/hives all over body. Particulary on both forearms, stomach, chest (nipple area), thighs. Also tenderness and slight swelling in under armpit area/gland with discoloration.

The outbreak of Herpes labialis on the lower lip. I did not have any outbreaks of Herpes labialis for more than 2 years before that.

A week and a half after taking the Janssen COVID shot I had a knot and pain come up in my lower back. After going to the chiropractor two times the knot and pain ended up in my right leg. I then went to Urgent Care where they diagnosed me with a large blood clot. They sent me to imaging and after scanning the area confirmed that there was a blood clot in my right leg. Urgent Care then set me up with a specialist.

MUSCLE WEAKNESS; NO ENERGY; TIRED; HEADACHE; LIGHT-HEADED; FACIAL SWELLING; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid- 19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 and expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021, the subject experienced facial swelling. On 29-MAR-2021, the subject experienced light-headed. On 29-MAR-2021, the subject experienced headache. On 30-MAR-2021, the subject experienced muscle weakness. On 30-MAR-2021, the subject experienced no energy. On 30-MAR-2021, the subject experienced tired. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from facial swelling on 02-APR-2021, was recovering from muscle weakness, and tired, and had not recovered from light-headed, headache, and no energy. This report was non-serious.

Soreness & lump in left lower thigh size of tic tac Swollen and sore left foot Diagnosed with ultrasound as superficial blood clot Heat applied and aspirin Still swollen

BLOOD CLOT IN LEG; SHORTNESS OF BREATH; HEART RATE INCREASED; GANGRENE IN TOE; RIGHT LEG SWOLLEN; RIGHT FOOT SWOLLEN; CHILLS; RUNNY NOSE; FEELING HOT; This spontaneous report received from a patient concerned a 50 year old male. The patient's height and weight were not reported. The patient's concurrent conditions included high blood pressure and diabetes. The patient received COVID-19 vaccine Ad26.CoV2.S (suspension for injection, route of administration not reported, batch number 1802070, expiry date unknown), dose not reported, 1 total administered on 19-APR-2021 for prophylactic vaccination on left arm. Concomitant medications included amlodipine besilate for drug used for unknown indication, empagliflozin for drug used for unknown indication, fenofibrate for drug used for unknown indication, insulin aspart for drug used for unknown indication, insulin glargine for drug used for unknown indication, losartan for drug used for unknown indication, and pioglitazone hydrochloride for drug used for unknown indication. On an unspecified date (reported as 22-MAR-2021; 28 days prior to vaccination), the patient experienced shortness of breath, heart rate increased, runny nose, chills and was hospitalized (date unspecified). He reported that on this past Saturday, 17-APR-2021 (2 days prior to vaccination), he went to the emergency room. He reported that his toenails were coming off, the skin on his toes was coming off, and he had swelling in his right foot and up his leg. He says there was no circulation going to his toe and he was diagnosed with having a blood clot in his right leg. He says he had surgery to open up the arteries in his leg, and also reported gangrene in his toe. The subject was discharged on 21-APR-2021. On 23-APR-2021, the patient experienced feeling hot. He also reported that he may need to have his right pinky (fifth) toe amputated because it has gangrene. He reported that he is going to go back to the hospital, to which he would seek medical attention if he was having issues. Treatment medications (dates unspecified) included paracetamol. When called back due to his vaccination dates being after event start dates, the patient said that his memory is not too good, so he 'had to take his time to remember the correct dates'. The action taken with COVID-19 vaccine Ad26.CoV2.S was not applicable. The patient was recovering from blood clot in leg, and had not recovered from runny nose, shortness of breath, heart rate increased, chills, feeling hot, gangrene in toe, right leg swollen, and right foot swollen. This report was serious (caused hospitalization).; Sender's Comments: V0: This 50-year-old hypertensive and diabetic male patient reported that he was feeling hot and may need to have his fifth toe amputated because it has gangrene 4 days after receiving COVID-19 VACCINE AD26.COV2.S for the prevention of symptomatic SARS-CoV-2 virus infection and 2 days after discharge form the hospital. The patient was hospitalized for shortness of breath, heart rate increased, runny nose, and chills 28 days prior to vaccination. The patient went to the emergency room 2 days prior to vaccination because his toenails/skin on his toes were coming off, swelling in his right foot and up his leg, gangrene in his toe; he reported that there was no circulation going to his toe and was diagnosed with having a blood clot in his right leg; the patient reported he had surgery to "open up" the arteries in his leg. Four days after vaccination, the patient felt hot and reported reported that he may need to have his right pinky (fifth) toe amputated because it has gangrene. The patient is taking paracetamol as treatment. No other details was reported. Based on the lack of temporal association, the causality is considered not related for the events blood clot in leg, shortness of breath, heart rate increased, right leg swelling, right foot swelling, chills, and runny nose. The information available regarding event gangrent of fifth toe and feeling hot 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.

Abdominal Pain - ended up being mild pancreatitis with elevated lipase to 423 on 4/17/21 that went to normal on 4/21/21 with value 49.

I WOKE UP SATURDAY MORNING WITH FLU LIKE SYMPTOMS (FREEZING ONE MOMENT THEN BURNING UP THE NEXT). THAT WENT ON UNTIL MONDAY AFTERNOON. SATURDAY MORNING I ALSO NOTICED MY LEFT LEG WAS SWOLLEN AND HAD A BLUEISH/REDDISH COLOR AND WAS THROBBING. FROM TIME TO TIME i WOULD EXPERIENCE A SHARP PAIN BEHIND MY KNEE AND THIGH. AFTER A WEEK THE SYMPTOMS DID NOT GO AWAY SO I WENT TO THE DOCTOR. HE ORDERED AN ULTRASOUND ON MY LEG. THAT SAME DAY I HAD THE ULTRASOUND WHERE THEY FOUND MULTIPLE BLOOD CLOTS IN MY LEFT LEG. DOCTOR IMMEDIATELY PUT ME ON ELIQUIS. THE DOSE FOR THE FIRST 2 WEEKS WAS 10MG TWICE A DAY (10 MG MORNING AROUND 8AM AND 10 MG AROUND 8 PM). AFTER 14 DAYS HE REDUCED MY DOSE TO 5 MG AM AND 5 MG PM.

On June 29, 2021 I got poked by a plant on my left hand, my vaccine was on my left arm, and the reaction was anaphylaxis. I have been poked by this plant before, and I never had a reaction. I had the ambulance and the whole bit come out. I was taken to the hospital and was put on 4 different IVs. I was in the hospital for like 4 or 6 hours. I haven't been hospital again but it happened again 7/06/2021, I had the anaphylaxis again, it was triggered on it's own. No thorns or anything. I took 2 doses of Benadryl. The second dose stopped it. I'm on over on medication, Benadryl, Prednisone, Pepcid, Meclizine (takes care of any dizziness), to keep the anaphylaxis shock from coming back. As soon as I stop taking the medication it probably would come back. I have one more week of medication left.

Acute back pain leading to numbness in both legs causing paralysis in both legs, facial paralysis, blurred and double vision, trouble urinating and having bowel movements. Has been diagnosed with GBS/ Miller-fisher disease.

developed a myelitis, presenting and paresthesias and leg weakness, responsive to high dose steroids.

From what I am being told and Google, my lymph nodes in the armpit are swollen. Quite scary to not know and not be able to reach anyone about it. Aches and pains are a discomfort to say the least, but add a tennis ball size swollen mass under your arm pit and you get concerned. You should have a 24/7 hotline or something or add this to your possible side effects at least.

swolling on face. Mild Facial Swelling, decreased sensation and pressure behind eyes x 2 weeks. Pt states he received J&J vaccine on 10MAR21 and developed symptoms next day; swelling has since decreased but decreased sensation and pressure remains. Decreased sensation to bil cheeks; airway intact; Pupils PEERL Bil; NAD; steady and balanced gait.

Developed DVT. Complains of calf pain and swelling starting evening of 4/8/2021, worsening over weekend. To walk in care on 4/13/2021. Dx DVT in left lower extremity. Ultrasound shows DVT in the proximal femoral vein through the portal vein. Physician notes indicate patient seen for "left leg soreness, tender to touch, protruding veins, redness, cramping in calf, radiating up to posterior thigh"

NUMB CHEEK; WARM LEFT EAR; RED LEFT EAR; SENSATION OF TINGLE ON LEFT SIDE OF THE FACE; LEFT EAR SWOLLEN; FACIAL MUSCLE SWOLLEN; PAIN AT THE INJECTION SITE; This spontaneous report received from a patient concerned a 51 year old male. The patient's weight was 220 pounds, and height was 187.96 centimeters. The patient's concurrent conditions included penicillin allergy, allergic reaction to bee stings, insect bites allergy, alcoholic, and non-smoker, and other pre-existing medical conditions included none and did not had any drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: 25-MAY-2021) dose was not reported, administered on 06-MAR-2021 13:42 for prophylactic vaccination. Concomitant medications included esomeprazole magnesium for acid reflux. On 06-MAR-2021, the subject experienced numb cheek. On 06-MAR-2021, the subject experienced warm left ear. On 06-MAR-2021, the subject experienced red left ear. On 06-MAR-2021, the subject experienced sensation of tingle on left side of the face. On 06-MAR-2021, the subject experienced left ear swollen. On 06-MAR-2021, the subject experienced facial muscle swollen. On 06-MAR-2021, the subject experienced pain at the injection site. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from left ear swollen, and facial muscle swollen, and had not recovered from numb cheek, warm left ear, pain at the injection site, red left ear, and sensation of tingle on left side of the face. This report was non-serious.

Patient presented on 4/21 with 2 weeks of generalized fatigue, abdominal pain, and weight loss with multiple lab derangements concerning for acute liver failure. Patient on 4/22 is tachycardic and change in mental status. Acute liver failure likely due alcoholic hepatitis. Cholestatic etiologies will be considered. Acetaminophen toxicity treated with acetylcysteine. Started on methylprednisolone 32 mg daily. RUQ: biliary sludge within gallbladder. No sonographic evidence of acute cholecystitis. Acute respiratory failure secondary to COVID pneumonia. Chest pain and elevated troponins. Alcohol withdrawal on treatment protocol. Sepsis and Community acquired pneumonia. Thrombocytopenia and elevated INR. Macrocytic anemia and AKI.

Patient states that he received Janssen Covid-19 vaccine on 3/31/2021 and was exposed to a covid-19 positive co-worker on 4/2/2021 and tested positive for Covid-19 on 4-10-2021. The patient came to the hospital emergency room via EMS on 4/21/2021 at 0912 complaining of shortness of breath. According to EMS the patient had an O2 saturation of 57% on room air and was place on CPAP, 15 liters, and transported to the ER.

SWOLLEN LYMPH GLANDS ON BOTH SIDES OF NECK; This spontaneous report received from a patient concerned a 51 year old male. 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: Unk) dose was not reported, administered on 11-MAR-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAR-2021, the subject experienced swollen lymph glands on both sides of neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen lymph glands on both sides of neck. This report was non-serious.

Exactly 11 days after receiving the J&J vaccine my husband developed leg pain in his right lower inner leg, he was taken to the hospital on 04/20/2021 which a ultrasound was completed but resulted no blood clots, no other labs or treatment was performed that day, the next day he developed severe diarrhea and flu like symptoms with continued leg pain and difficulty breathing, He was then rushed to the hospital by ambulance where he was suffering from very low BP 41/31 was the lowest, a line was placed and he was put on pressors to increase his BP. He was transferred to the hospital where he was diagnosed with a flesh eating bacteria in the right leg where the pain was at and Sepsis. He was taken to surgery to debride the right leg and was started on CVVHD because his new kidney was now failing, he eventually was started back on Hemodialysis and taken to surgery 2 more times where he cardiac arrested on the table in surgery and died. A private autopsy is being performed but the preliminary results shows he had multi-system organ failure, including his liver which was NEVER a problem in the past.

Patient had his Covid vaccine 5/10/21 upper left arm, then a week later he presented with puffy left arm. Staff attempted x 2 to assess his left arm. Patient refused both times. Staff observed that patient did have full range of motion with no complaints of pain or discomfort. Appt was set up to assess his left arm edema. Both times patient refused. Dr was made aware that patient still has some edema and that staff was unable to measure related to uncooperative nature of patient. Dr. feels it is an adverse reaction to his Covid-19 (Adenovirus) Vaccine. This is now listed on his Allergy list. Dr feels this edema will resolve itself.

gradual onset of paresthesias beginning exactly 14 days after vaccine administration. patient was then admitted to hospital on 5/22 when symptoms worsened and he was ultimately diagnosed with Guilliam Barre Syndrome.

Pt reports 2 days after vaccine having swelling in joints, hands, and facial area. Numbness/tingling in hands b/l. Reports still having numbness/tingling in hands as well as swelling in facial area

swelled immediately after the shot and was given 2 benadryl before leaving the drive through. Experiened chills, fever and was vomiting all night. Feeling tired and dizzy afterwards and ever since.

10 min after receiving vaccine patient became flushed, feels like arms are swollen and itching, nausea, and sweating. Patient went to ER and they noted tachycardia and diaphoresis

Lymph- there is 5-6 cm area of generalized swelling in the right axilla. There is a small area of petechiae below the swelling.

Was having flu like symptoms, then tested leg swelled up below right knee , now still swollen and bruising down leg

Patient with extensive PMH- rectal adenocarcinoma with colostomy, sacral ulcers, cardiomyopathy, from Nursing Home. Sent from nursing home due to persistent hypotension for 2 days which did not respond to IV fluids, sepsis since patient was tachycardic and hypotensive. Urinalysis positive, sepsis possibly due to urinary tract infection, patient also with bacteremia- gram-negative. Patient still hospitalized on antibiotics.

SWELLING ON BOTH LEGS AND THIGHS; This spontaneous report received from a pharmacist concerned a 52 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known medical condition. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced swelling on both legs and thighs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling on both legs and thighs. This report was non-serious.

LEFT FOOT SWELLING COMES AND GOES; LEFT FOOT SORENESS; LEFT FOOT FEELING HOT; This spontaneous report received from a patient concerned a 52 year old 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, intramuscular, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced left foot feeling hot. On 30-MAR-2021, the subject experienced left foot swelling comes and goes. On 30-MAR-2021, the subject experienced left foot soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left foot swelling comes and goes, and left foot soreness, and the outcome of left foot feeling hot was not reported. This report was non-serious.

104 fever first 3 days day 4/5 swollen arm now joint pain , elbows ,, wrists ,, fingers ,, ankles and toes

In March I had a pain in my left calf muscle that I could not identify with getting hit or injuring it in any way. I called Urgent care because i read and heard about problem with the J&J vaccine that it was giving people blood clots. Urgent care said there was no need to come in that there was very little reason to believe that it was a blood clot. Then in June I woke up to very severe pain in my left leg from my foot all the way to my thigh. It was hot, swollen and I could barely bend my knee. I went to Urgent Care and they sent me across the street to the Hospital for an ultra sound on my leg. Here are the result from the ultra sound. Real time color Doppler imaging and spectral analysis were performed during ultrasound evaluation of the left lower extremity is performed. There is persistent occlusive deep venous thrombosis within the mid to distal superficial femoral vein extending nonocclusive bleed to involve the popliteal vein and exclusively within the proximal popliteal and peroneal veins of the calf. The doctor put me on 3 week of taking a blood thinner twice a day and then will go down to taking one blood thinner once a day for 6 months. I also saw MD. Here are his notes from my Drs appt. Patient is seen today, 6/14/2021, to discuss management of left leg DVT. Patient presented to urgent care on 5/20/2021. He had noticed soreness in his left leg for a couple of days and then he awoke that day and the leg was swollen. The duplex scan showed that he had occlusive clot involving left superficial femoral vein extending through popliteal vein down to peroneal vein in the left calf. He was started on rivaroxaban 15 mg twice daily. He transitions to 20 mg rivaroxaban daily tomorrow. The leg soreness has eased slightly but the swelling has not improved. He did have a repeat duplex scan on 6/7/2021 which was unchanged. Thrombus persisted but was not worse. He has not had chest pain or breathing issues or dyspnea. He does recall that about 4 weeks earlier he had a muscle spasm sensation in the left calf. He had received a Johnson & Johnson Covid immunization in late February, 2021. He was aware of the public information about venous clotting in women who had received the J&J vaccine and was also aware that it involved cerebral veins. He called his provider and was asked questions about the leg and otherwise the answers were negative. So imaging was not obtained. The muscle spasm sensation did not recur. His family history is negative for clots in his personal history for clots is otherwise negative. He is a maintenance manager. He has not had lengthy travel recently. He also denies any trauma to the legs. He has a history of GERD from which she had developed iron deficiency anemia in June 2020. He had undergone EGD has a result. He also had a colonoscopy when he turned 50 years of age and had polyps removed and then had repeat colonoscopy 6 months later. This evaluation occurred with Dr. of gastroenterology. His colonoscopy was on 12/20/2018. One of the polyps was a hyperplastic polyp. The second was a tubulovillous adenoma with high-grade dysplasia/intramucosal adenocarcinoma, 2 cm size. Polyps were excised. Had repeat endoscopy on 7/10/2019 he had a hyperplastic polyp in his rectum. Also he had a PSA checked in summer 2020. It was 0.5. He is a smoker only of very infrequent cigars, perhaps every 6 to 8 months. PAST MEDICAL HISTORY: GERD Sigmoid colon polyps, resected December 2018 and June 2019 Left leg DVT, May 2021 Sleep apnea Iron deficiency anemia related to gastritis. Diagnosed June 2020, treated with oral iron ADHD History of depression MEDICATIONS: has a current medication list which includes the following prescription(s): amlodipine, escitalopram, esomeprazole, multivit-iron-fa-calcium-mins, prednisone, rivaroxaban, unknown home medication, and tadalafil. ALLERGIES: Patient has no known allergies. PAST SURGICAL HISTORY: Vasectomy 2 colonoscopies, first in December 2018 and second in July 2019 EGD on 2 occasions, first in March 2019 and second in June 2020 FAMILY HISTORY: Father died age 66. He had a pacemaker and was on blood thinners Mother died of a throat cancer. She was a heavy smoker. Died at age 60 1 brother and 1 sister are healthy SOCIAL HISTORY: Smokes cigars, perhaps twice a year. Never smoked cigarettes Alcohol use maybe 4 beers on the weekend Previously married and divorced 3 children, 2 daughters and 1 son ranging in age from 17 through 21 REVIEW OF SYSTEMS: Significant for persistent soreness in his left leg albeit easing over the last 3 days and persistent swelling in his left leg including dorsum of his foot General: Denies weight loss, no issues with energy, denies night sweats HEENT: No mouth or throat soreness, no issues with hearing, no tinnitus, no issues with taste No epistaxis Resp: Denies cough, exertional dyspnea, sputum production. Heart: No palpitations, no exertional chest pain, no lightheadeness or dizziness when standing Gi: No dysphagia. No heartburn, Denies nausea or vomitting. Bowels are regular, no diarrhea or constipation. Denies melena or hematochezia GU Denies hematuria. No dysuria. No incontinuence. Skin: No rash, no petechiae, no dryness. No itching or burning. Musculoskeletal: No bone pains, no joint pains or swelling. No localized weakness Neurologic: Denies headaches, no double vision, no weakness, no change in sensation Psychiatric: Good spirits, sleeping well, no anxiety, normal mood Endocrine: Denies heat or cold intolerance. Heme: No easy bruising PHYSICAL EXAMINATION: BP (!) 142/99 | Pulse 95 | Temp 97.6 °F (36.4 °C) | Resp 18 | Ht 6' 3" (1.905 m) | Wt 295 lb (133.8 kg) | SpO2 96% | BMI 36.87 kg/m² Appears alert, oriented, not in distress. Well developed Psychiatric: Patient is alert oriented ×4, good spirits, interacts appropriately He has swelling in his left leg DATA: CBC: .5/20/2021: WBC 7.49 X10^3/uL; Hemoglobin 14.8 g/dL; Hematocrit (calc.) 43.4 %; Neutrophil (%) 75.4 %; MCV 98.4 fL; Platelet 141 X10^3/uL* CMP: 4/22/2021: Bicarbonate (TCO2) 25 mmol/L; BUN/Creatinine 16; Calcium, total 9.0 mg/dL; AST (SGOT) 41 IU/L*; ALT (SGPT) 38 IU/L; Alkaline Phosphatase 62 IU/L; Bilirubin, Total 0.4 mg/dL; Protein, total 6.9 g/dL; Albumin 4.3 g/dL; Albumin / Globulin 1.7 5/20/2021: Sodium 142 mEq/L; Potassium 4.6 mEq/L; Chloride 103 mEq/L; BUN 13 mg/dL; Creatinine 1.2 mg/dL; Glucose 110 mg/dL*; Calcium, Ionized 1.17 mmol/L ASSESSMENT: 1. Left lower extremity DVT. Etiology unclear. No definite provocation. He did receive a Johnson & Johnson Covid vaccine in late February, 2021. He first noticed a muscle spasm sensation in left calf in mid April, 2021 and then had onset of soreness 2 days before his visit with swelling onset the day of his urgent care visit, 5/20/2021. Currently on rivaroxaban. Transitioning now to the 20 mg daily dose. Family history negative for DVT as is his personal history. PSA was unremarkable and summer 2020. Has had prior colonoscopy in December 2018 and June 2019. Did have finding of sigmoid colon polyps with atypia in 1 and possible noninvasive adenocarcinoma. Repeat scope showed hyperplastic polyp but no additional polyps. Has also had EGDs in March 2019 and June 2020 because of GERD and iron lack anemia. Non-smoker. I discussed with patient that we would usually treat him for 6 months with anticoagulation and then reassess to determine whether it is safe to discontinue therapy. But if he has ongoing swelling and soreness in his leg it would be difficult to stop treatment because we would lose one of our early indicators of recurrence of DVT. I also suggested that we should do a lab panel to assure that he does not have any underlying inherited or acquired abnormality that predispose to this clot, since we do not have any clear-cut causative etiology. (We discussed that the Covid immunization may have been his predisposition, but that existing data suggest that this is a risk factor in females and that most of the episodes were central nervous system venous clots.) PLAN: 1. So we will draw lab panel assessing acquired and inherited predispositions for hypercoagulability. And we will plan to see him back in a couple of months to reassess his status.

Started with Headache at 10pm (Right between eyes) Pain started spreading through entire body. 1020pm Hands itchy and swelling, chest tight 1020pm Took 2 Tylenol and two benadryl 1030pm Itchy hands and tight cheat subsided by 1130pm Headache and severe body aches throughout entire body continued through and did not get better until 04/08/21. Bed ridden for duration. No fever.

Started with swelling of Rt. lower leg with pain, pain went to Rt. and Lt. side of upper leg, had appointment with Fam. Doctor was sent to get Ultra sound of Rt. upper leg was then advised to go straight to emergency room, started on cores of blood thinners after a blood clot was found.

Patient describes right side of face became red/purplish and swollen roughly 3 days after vaccine. Symptoms were accompanied by sinus pressure on right side of face. Eye was also red and mildly itchy. Facial symptoms were accompanied by arm pain and tenderness. Symptoms resolved after roughly 3 days

facial swelling, facial drooping, complaints of left ear pain Emergency department visit diagnosed with Bell's palsy treated with valtrex prednisone

PAIN IN JOINTS; WEAKNESS IN ARMS; BUMPY RASH; SWELLING IN LEFT FOOT AND RIGHT FOOT; ITCHINESS THROUGHOUT BODY; SWELLING OF LEFT AND RIGHT KNEE; FLUCTUATING FEVER; NIGHT SWEATS; HEADACHE; SORE THROAT; UNABLE TO WALK; BREAKOUT ON BACK OF HEAD; This spontaneous report received from a consumer concerned a 53 year old male. The patient's weight was 90.71 kilograms, and height was 179.832 centimeters. The patient's pre-existing medical conditions included the patient had no coughing, no nasal conjunction and no upper respiratory symptoms. The patient experienced drug allergy when treated with morphine, and sickness when treated with Demerol (pethidine hydrochloride). The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. Concomitant medications included ascorbic acid, and cetirizine hydrochloride. On MAY-2021, the subject experienced breakout on back of head. On MAY-2021, the subject experienced sore throat. On MAY-2021, the subject experienced unable to walk. On 21-MAY-2021, the subject experienced night sweats. On 21-MAY-2021, the subject experienced headache. On 23-MAY-2021, the subject experienced swelling in left foot and right foot. On 23-MAY-2021, the subject experienced itchiness throughout body. On 23-MAY-2021, the subject experienced swelling of left and right knee. On 23-MAY-2021, the subject experienced bumpy rash. On 23-MAY-2021, the subject experienced fluctuating fever. Laboratory data included: Body temperature (NR: not provided) 97F to 101 F. On 24-MAY-2021, the subject experienced pain in joints. On 24-MAY-2021, the subject experienced weakness in arms. On 25-MAY-2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) Negative, and Recurrent urinary tract infection (NR: not provided) Negative. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, ibuprofen, and paracetamol. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from swelling in left foot and right foot, itchiness throughout body, fluctuating fever, and bumpy rash, and the outcome of headache, night sweats, weakness in arms, pain in joints, swelling of left and right knee, sore throat, unable to walk and breakout on back of head was not reported. This report was non-serious.

SWOLLEN GLANDS IN JAW; HEADACHE WAS AFFECTING BOTH SIDES OF THE HEAD; FATIGUE; This spontaneous report received from a patient concerned a 53 year old male. 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: E04AZ1A, expiry: UNKNOWN) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAY-2021, the subject experienced swollen glands in jaw. On 18-MAY-2021, the subject experienced headache was affecting both sides of the head. On 18-MAY-2021, the subject experienced fatigue. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache was affecting both sides of the head, fatigue, and swollen glands in jaw. This report was non-serious.

patient experienced a vasovagal type reaction within minutes of receiving vaccine. He fainted and bumped his head on the floor. He came to within seconds of fainting and had not realized he had fainted. An ice pack was given to the patient to hold to his left eyebrow bone (where he hit the ground) in order to reduce swelling. He was guided into a chair and observed for about 20 minutes when he wanted to leave the pharmacy. The patient felt well shortly after the fall. I checked in with him 2 hours later and he still felt well.

Patient reported pain and swelling in left leg 5 days after receiving the Janssen vaccine. Patient was seen in clinic for symptoms and was evaluated by PCP.

Patient arrived for COVID vaccine prior to working shift. He stated upon questioning having an anaphylactic reaction to seafood. We requested him to stay in observation for 30 minutes after vaccine administration. He agreed and vaccine was administered. After working approximately 3 hours later he returned to the pharmacy stating he felt out of breath. He didn't know if it was because of vaccine or CHF. Questioning him further, he said he felt a little swollen around neck. He was responsive. Administered 50mg of Benadryl. Instructed him to sit. He had a portable fan. After sitting down, he started to feel better. He remained at the pharmacy and called for transportation home, leaving approximately 1 hour later

Pt received the Johnson and Johnson covid vaccine on 4/1/21 at 1330 and started having body aches, rash, fatigue and angioedema on 4/2/21 at noon.

Placed follow up call to patient relative on 4/5/2021 at 1:04pm: reported that the patient is feeling much better today. All his ADE has subsided. Patient rcvd Janssen vaccine on 4/3/2021 at 11:15am in Right IM Deltoid, and at approx. at 7pm that same night patient experienced lightheadedness. The next day on 4/4/2021 patient had a fever, chills, rash on back and swelling on the face and lips. Patient relative reported that she gave the patient Mortin last night (4/4/2021) for his fever as recommended and his fever broke this morning. She also reported that she gave the patient Benadryl as recommended, and this helped cleared up the rash last night (4/4/2021). She reported no contact was made to patient's PCP regarding ADE experienced. Advised if she or the patient have additional information to contact the COVID-19 Information Line back.

Shortly after receiving the vaccination I started to experience chronic exhaustion, leg cramping and pain in my lower back right side, upper right thigh, behind my right knee and down into my right calf. I figured that the pain would go away but the pain increased and my leg started swelling and the pain increased making it very difficult for me to put my leg down on the ground and put pressure on my right leg.

Arm pain and swelling began immediately. Later in the evening on same day of shot, I began to experience nausea. Next morning pain, swelling and nausea persisted. Medium intensity body aches and headache began late morning. By mid afternoon body pain increased to the point that I was no longer able to function and needed to lie down. Took a 4 hour nap. Side effects persisted after waking up. At time of writing, 28hrs after vaccine, I am still feeling the side effect although less severe. Ibuprofen and Tylenol do seem to help.

Right Elbow pains within 7 hrs after shot. Next day elbow and right hand swollen and throbbing pain. still swollen and can not bend all the way 3 days later.

Unusual painful swelling of toes of left foot. (NOT entire leg or entire foot.) Pain like that after foot "falls asleep" then "wakes up." Symptoms started ~5 days after vaccination Took Ibuprophen for pain. Swelling faded after ~24 hours.

Pt rec'd vaccination to LUE on 4.9.21. Pt denies any trauma to LUE. Pt reports L wrist/hand pain, swelling, numbing, burning, tingling that started 4.13.2021 (Friday at around 1700 hrs). In our ED now, awaiting to be seen by our Hospitalist for possible admission to the hospital.

Left leg pain, swelling, and tingling. Patient was found to have DEEP VEIN THROMBOSIS of LEFT LOWER EXTREMITY - POPLITEAL VEIN.

SWELLING ON LEFT TOE; ARM HURT A LOT; VERY TIRED; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included blood pressure abnormal, and other pre-existing medical conditions included the patient did not have any known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. Concomitant medications included lisinopril for blood pressure abnormal, and blood thinner. On 06-APR-2021, the subject experienced arm hurt a lot. On 06-APR-2021, the subject experienced very tired. On 10-APR-2021, the subject experienced swelling on left toe. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling on left toe on 11-APR-2021, and arm hurt a lot, and very tired on 07-APR-2021. This report was non-serious.; Sender's Comments: v0-Medical assessment comment is not required as per standard operating procedures.

I had a J&J shot at 11am on March 23rd. I woke up at 12am with extreme chills and body aches including major pain around my groin. About a day later, I was fine but tired. Approximately 3 weeks later on April 9th, I had sharp pain in my lower back when I breathed in and my neck lympth nodes were swollen and sore. I am fine now and the only reason I am reporting this is to document symptoms for your research efforts. Thank you.

Patient presented to ED on 4/22/2021 with non-productive cough, mild shortness of breath x 10 days. Acute onset chest pain x 1 day. Chronic bilateral leg swelling, but worsening leg pain. Hx of DVT and PE, not on anti-coagulation.

I was admitted to the ER on 4/12/21 with dizziness, lightheadedness, vertigo, some auditory issues, shortness of breath, swelling/puffiness of legs and feet, unusual coldness in extremities, and some minor pain in chest. CT-Scan revealed DVT in left leg and PEs in both lungs. Was given two shots of heparin over a 24-hour period and then Xarelto 15mg (oral) the following day.

FEELING HORRIBLE; BLOOD CLOT; BODY ACHES; JOINT PAIN; SPAMS ALL OVER BODY; TOE SWELLING; KNEE SWELLING/ ANKLE SWELLING; This spontaneous report received from a patient concerned a 54 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: unknown) dose was not reported, 1 in total administered on 03-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. After getting the vaccine, the patient had immediate joint pain and body aches. He had spasms since day one. After two weeks, he developed swollen toe looked like a bunyon, then it moved up to the ankle then it moved up to the knee being swollen. The patient was sent to the imagining center. He had following imaging tests done, bilateral Lower extremity Doppler Exam. On 30-APR-2021, he was recommended to go to the emergency room (ER) and was admitted. He was diagnosed with blood clot and stayed overnight. He was prescribed on Xarelto (rivaroxaban) 15 mg twice a day (BID), titrating to 20 mg once a day. The patient was hospitalised for 2 days. He got another follow up on 14-MAY-2021, gave him another prescription for blood thinner to be on for two months. On 18-MAY-2021, he was given tramadol 7 pills for spams which had helped with his pain and currently patient was feeling horrible. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from joint pain, body aches, toe swelling, knee swelling/ ankle swelling, spams all over body, and blood clot, and the outcome of feeling horrible was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210540030- Covid-19 vaccine ad26.cov2.s- A 54 yearold male presents with Blood clot, Body aches, Toe swelling, Knee swellng /Ankle swelling, Spasms all over body, feeling horrible. 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). 20210540030- Covid-19 vaccine ad26.cov2.s-Joint pain. This event(s) is labeled per RSI and is therefore considered potentially related.

April 13 (I had been traveling before it and came back) and I was preparing for work and my foot hurt. I hobbled around that day and noticed my foot was swollen. The next morning, I went to Piedmont Hospital ER( on the 14th) - they gave me a starter dose of blood thinners and I was able to schedule appt with Dr. Shamm -my hematologist - Zeralto - was what she prescribed. Everything is "back to normal." But based on my health history - the doctor care will be ongoing and I'll continue to see this doctor for treatment.

Severe head ache30+ hrs started 5hrs after injection . abdominal cramping and musscel pain in leg and butt area.sever joint pain in lower back and hips and knees hands and feet.at 5 hrs of injection. Sore throat and inside if ckeeks and swellind of lower lip1 sat after injection. Joint pain in knees and lower back pain was severe and lasted 3 days. Numbness in fingers at 1 day - oresen confysen in thinkinj

Patient noticed swelling in lower left leg on 5/18 and called office on 5/25 with swelling and temperature change in left leg, he was sent to the emergency room.

About 8 hours after the vaccine at 2:30am I had a fever and bad sweats, back and stomach pain, diarreha, lost of bowel control, achy all over. Which prompt me to call for an ambulance. I went into the ER I had to get 3 bags of IV fluids for dehydration, anti-nausea medication, pain medication for back pain because I passed out and hurt my back and cut my face. I also had swollen in my left foot. I am still having fatigue feeling. I still don't have my energy levels back from before the adverse event.

After receiving , approx. next day, patient noted shortness of breath which worsened over the course of a few weeks. Right leg began to swell with some chest pain approx. 2 days before admission. He presented to ER, CT Chest Protocol showed multiple pulmonary thromboemboli, distal left and right main pulmonary arteries and several segmental branches. and had right heart strain. Venous Doppler of right leg revealed complete occlusion of multiple veins. He was admitted to hospital for anti-coagulation.

To begin, I have always been a healthy, middle-aged male, with no history at all of neurological problems. What follows is a comprehensive summary of all that happened to me shortly (7 days) after getting the Janssen COVID vaccine and the supporting documentation to support the diagnosis of my having developed Guillian-Barre' Syndrome (GBS) as a direct and obvious consequence of the vaccine. THURSDAY, 5/13/21: Received the J&J vaccine at 10:00 AM (LOT NUMBER 205A21A). FRIDAY - THURSDAY, 5/13 - 5/20/21: No obvious reaction to the vaccine, at all. FRIDAY, 5/21/21: During the day, I noticed deep-muscle pain/soreness in both shoulders (deltoid muscles) that increased throughout the day. It felt as if I had been doing heavy-weight presses with the resulting soreness. I attributed it to a delayed reaction from the vaccine (as I'd heard muscle pain, particularly in the shoulders, is a common reaction symptom), as I had no injury or other possible cause and chose to ignore it. It may have even started a day or two before Friday, but wasn't of such consequence as for me to recall it; the only vivid memory I have is the discomfort on Friday, 5/21/21. SATURDAY - SUNDAY, 5/22 - 5/23/21: I had continued shoulder pains, but ignored them because they were not acute and just attributed them to a short-term vaccine reaction. MONDAY, 5/24/21: In the evening, while sitting in the bleachers attending a sporting event, I noticed my buttocks was pretty sore. The bleachers are not normally comfortable, but this was a dull, serious ache across my entire buttocks. I didn't know to what to attribute it (not yet at that time associating it with the shoulder pain), so ignored it. In retrospect, I realized later that the soreness I was feeling at that time was similar to the shoulder pain and was the pain felt from a deep numbness across the buttocks, akin to when a body part (hand, foot, etc) "falls asleep" so deeply that it's numb, but is still very, very sore. Later that night, my upper back began to feel sore, from shoulder to shoulder, down to my mid-back. As the night progressed, this pain increased exponentially to a "Level 10", leaving me unable to sleep but in 15-minute increments, wandering the house to find a spot -- sofa, chair, floor, anywhere -- to give me some comfort to sleep; I slept 2 hours, total, that night. The pain across my back felt equivalent to someone beating me with a baseball bat all over my upper back -- it wasn't an acute, localized pain, but very deep and broad across the area. Normally, Aleve quickly resolves any pain issues I have, but overnight, it did nothing to reduce the pain. TUESDAY, 5/25/21: I began to piggyback Aleve and Extra Strength Tylenol, and that seemed to help abate a little of the most intense pain, but it was still painful and precluded sleep and much of my working. I think it was at this time that I began to notice the pain and numbness going beyond my buttocks, down the backs of my legs, and into my feet, leaving my feet (and toes, in particular) numb and tingling. I also began to notice a problem with balance and gross motor controls (stumbling when walking, nearly falling several times in the shower) -- all symptoms I have never experienced in any capacity. Additionally, I had considerable pain down the backs of my legs, leading me to feel as if my calves and hamstrings had been through a heavy workout the day before and desperately needed stretching -- however, any attempts to do so led to excruciating, stabbing pains in those muscles. I also noticed that the pain in my upper back was becoming more acute and localized in my cervical vertebrae area. Having taken care of a father who has had many back surgeries and suspecting I have my own degenerative cervical disc issues (I've had past neck pains), I began to believe that all the pain and numbness throughout my body might be due to a cervical issue (e.g., bulging disc, stenosis, etc), and so tried to treat the area as such, with hot shower, heating pad, better neck support, etc. I continued to piggyback the two pain meds that day, but the upper back and neck pain and numbness and gross motor issues came back in full that night, again leaving me no relief for sleep -- I could only doze in 15-minute increments and found no position or place to sleep that was comfortable; I was in tremendous pain 10) across my entire back and down my legs. By 2:00 AM, I knew there was going to be no relief, and I couldn't wait until the morning; I drove myself to the nearby ER, again still believing/expecting at the time that this was a spinal issue. In the ER, I was met by a PA who reviewed my situation, determined that cervical imaging was unnecessary, and prescribed Percocet. My blood pressure was recorded at 160/94. I was released after two hours and returned home. Despite the meds, I was still in considerable pain that night and found myself unable to sleep in more than 10- to 15-minute increments. WEDNESDAY, 5/26/21: During the day, the Percocet seemed to abate the pain, somewhat, although it tended to flare up much more at night during the prior 2 nights, anyway. However, I noticed I had an upset stomach by midday, and as the day progressed, the pain in my abdomen grew considerably. By the evening, the pain across my abdomen was unbearable, as bad as it was in my back and legs. Late in the evening, I researched Percocet and saw that abdominal pain and nausea are two prominent side effects. I stopped taking the pain medication immediately, knowing that my back pain would return in full through the night; again, I slept in 15-minute increments in considerable back and abdominal pain for a total of about 3 hours. It was also during the day Wednesday that I noticed considerably worse gross motor skills (e.g., walking, ascending/descending stairs, standing up straight, writing), balance, and increased numbness and tingling in my legs, feet, and hands. At one point, I tried to walk by my daughter in a hallway in the house, and in trying to go around her, I fell against the wall. She thought I was joking; I wasn't. It happened several more times that week. Also, this day or the next, I started noticing additional problems with urinating and defecating. It felt as though I had no control over my abdominal muscles, so could not strain or push when going to the bathroom. When trying to have a bowel movement -- and I knew needed to -- I felt as though I had no control to push; when urinating, I had no muscle support for pushing out the urine. THURSDAY, 5/27/21: Still believing these pain, numbness, and other neurological, problems to be related to cervical vertebrae/disc issues, I had an appointment with a spine orthopedist. He ordered cervical X-Rays and confirmed that I do have disc compression/degeneration, but not excessive and nothing that could explain the pain and numbness persisting all over my back, down to my hands, across my buttocks, and down my legs to my feet. The message: the cervical discs were not the problem. This is when I reconsidered all I had been through, tying back to the initial pain I felt in my shoulders the prior Friday. This is when I realized that my body had been reacting to the vaccine. Never before in my life had I had neurological problem. Never before had I experienced pain, numbness, and tingling across my entire body that way, so until that moment, I hadn't considered the vaccine to be a possible vector for all that was going on with me. The coincidence of these events was FAR too great to be anything but a causal relationship. The likelihood of these symptoms arising on their own is infinitesimal in comparison to a causal effect. The vaccine had triggered a serious and painful neurological response in my body. The orthopedist, knowing I had responded poorly to the Percocet, prescribed oxycodone. I took that pain medicine that day and into the evening, but once again, my stomach and abdomen began to bother me and the abdominal pain returned. Once again, I looked at the side effects of the medicine, and the first two I saw were stomach pain and nausea. I stopped taking the pain medicine immediately. That night, I slept a total of 2.5 hours. FRIDAY, 5/28/21: I was still in considerable pain, and that combined with very little sleep (and none of it good) for 4 days led me to having trouble thinking clearly. My wife insisted I needed to go back to the ER in the morning to see what could be going on. My blood pressure upon being seen was initially approximately 185/140, but what was finally recorded after a second test was 191/112. I waited to be seen for about 2 hours, but I finally met with the ER physician and described my history of problems that week, including my then-belief that this was a vaccine reaction. She ordered full bloodwork, chest X-Ray and CT scans (without contrast) of lumbar and thoracic spine and CT scan with contrast of chest/abdomen. Nothing strikingly abnormal was found in these scans, but doctors (ER physician and neurologist) noted bliteral weakness in lower and upper body. The doctors wanted to order MRIs, but I am unable to have an MRI due to a piece of metal in my left eye. The morphine I was administered helped reduce my pain and my blood pressure upon leaving had abated, somewhat (don't recall my final BP). Both doctors seemed not to believe that these symptoms could be the result of an adverse vaccine reaction, but they were unable to explain a cause. On my inquiry, at my friend's recommendation I ask to verify, the neurologist disagreed that these were symptoms of a presentation of Guillian-Barre' Syndrome (GBS). The ER doctor asked if I was interested in being admitted, but I felt some of my more extreme symptoms (blood pressure and pain -- thanks to the morphine) had abated sufficiently to allow me to leave. After 8 hours in the ER, I left and returned home. My numbness, tingling, some pain, balance, and motor skills issues persisted, but were blunted somewhat (probably from the morphine?). It was either this day or the next, that I was standing outside, and knowing I had problems walking and with balance, I decided to try to run a few steps to see how weak my legs were and bad my motor skills and balance were. Immediately, it was clear that things were worse than I had considered. I had very poor control of my legs -- they flew off to the sides, out of control, as I tried to step; I stumbled a couple times and almost fell; and I couldn't proceed in a straight line, veering off at an angle. I earnestly tried several times, with the same results each time. That night, while the pain was still there, it was tolerable enough that I was able to sleep for a total of about 5 hours. SATURDAY, 5/29/21: Early in the AM, I noticed I was unable to smile. Having a friend who had had Bell's Palsy, I recognized the signs immediately. The left side of my face sagged, I was unable to smile (left side of my mouth sagged), and I was unable to close my left eye. My wife took me to the ER, and we were met by the same ER physician who had seen me the day before. She was shocked about my return so soon after my prior visit. My blood pressure, on being admitted, was 151/102, but as with my other visits, asymptomatic other than the problems described before (pain, numbness, and tingling, in my back, arms, legs, and abdomen; gross motor movement; lack of coordination; and lack of clarity in thinking); no other signs of infection or illness. The Dr ordered a CT scan (without contrast) of my head and other bloodwork. Of note, the CK came back at 712 U/L. The CT scan came back normal. Again, I was administered morphine, which abated my pain and allowed me to relax. After 3 hours, I was released, with prescriptions for Amlodipine for the high blood pressure and Prednisone and Valtrex (Valacyclovir) for the Bell's Palsy. The morphine helped reduce my back and abdominal pain and give me some comfort, such that I could sleep another 5 hours that night, although all other symptoms persisted. SUNDAY - WEDNESDAY, 5/30/21 - 6/2/21: I continued to experience the numbness and tingling in my back (primarily), abdomen, legs/feet, and arms/hands, but my severe pain began to abate, such that I could sleep a bit more easily. I taped my eye shut at night, as my Bell's Palsy eyelid would not close fully, and it teared constantly. WEDNESDAY, 6/2/21: Not having a GP, I finally found an Internist to review my case and symptoms, but primarily to extend my meds (Blood Pressure and antiviral and steroid for the Bell's Palsy), as the ER doctor had only given me a 5-day prescription. The doctor review my situation and continued the meds. Having been prompted regularly by my friend to confirm a GBS diagnosis, I asked this doctor about a possible GBS-vaccine link and after a cursory review, he said he did not think so. THURSDAY, 6/3/21: With the weakness in my left eyelid, my desire to find a resolution to it, and my concerns about its effect on my vision, I had an appointment with my opthamologist, who recommended eye drops until the eye improved and instructed me to stop taping the eye shut. She noted no other problems with my vision. FRIDAY - MONDAY, 6/4/21 - 6/7/21: During this time, the medicines for my Bell's Palsy seemed to take effect, and the paralysis symptoms abated mostly (with some residual weakness in my left eyelid). I continued to experience the other neurological symptoms, however. TUESDAY, 6/8/21: Having been unable to get a timely appointment with a trusted neurologist, a friend with a contact at medical school head of neurology was able to get me an appointment with a neurology faculty member. I met with Dr. that afternoon, and he was the first to really listen to the symptoms I had and understand some of the possible triggers and consequences of them. I started the conversation explaining that I'm a reasonable, rational, and science-based person, an engineer by training and career, and that I firmly believed all the symptoms I was presenting were a direct consequence of my getting the vaccine. Additionally, at my friend's continued urging, I asked if these symptoms could point to a Guillian-Barre' diagnosis. He was at first skeptical of my proposition of the vaccine cause, but was quick to say he was glad I had raised the question of GBS, because he had that diagnosis in mind, as I discussed my symptoms. He believed that the symptoms I had and the way and speed with which they had progressed pointed to a likely GBS diagnosis. He scheduled a follow-on appointment to have an Electromyogram (EMG) and Nerve Conduction Study to assess the extent of the neurological damage and prognosis for resolution, as I am unable to get an MRI and he seemed to feel a lumbar puncture was unnecessary. FRIDAY, 6/11/21: I had my scheduled EMG and Nerve Conduction Study with Dr. The results showed some abnormal neuropathy, but mostly normal in my extremities and indicative of some recovery from symptoms. Although I still had considerable numbness, tingling, and some pain down my legs into my feet and down my arms into my hands, my most prevalent issues at that point were numbness and tingling across my entire upper back and abdomen, but the doctor indicated these tests don't identify issues very well, that they are better designed for testing neurological issues in the extremities. We agreed to reconvene over the phone in several weeks, unless problems worsened. TUESDAY, 6/29/21: During a follow-up appointment with the doctor, I indicated that some of my neurological issues were abating and that my blood pressure had returned to near-normal range. My energy was returning to a degree and my motor skills and balance and control had improved. However, I continued to have significant numbness and tingling across my back and abdomen, and of greater concern, I had increasing tingling and pain going down my left arm to my index finger when I stretched out my arm. This was a new symptom and increased in pain in frequency in the following days and raises the question of what other symptoms might arise. AS OF 7/8/21: CURRENT STATUS: I have continued numbness and tingling in my feet and hands and back and abdomen, although they are reduced from their earlier state. However, I have increased shooting pain in my left index finger when stretching out my left arm. Additionally, I have a mild increase in weakness in my left eyelid, after prior improvement from the Bell's Palsy. My dangerously high blood pressure at the early onset of these symptoms has returned to near-normal levels, although my GP continues to keep on blood pressure medicine (Amlodopine) for now. Finally, a lot of the issues I had thinking clearly and regularly making mental mistakes, all noticeable and commented on by my family, have lessened, although I still find myself making mental mistakes and forgetting information that would have been MUCH less likely prior to this adverse GBS event caused by the J&J vaccine.

TROUBLE GETTING UP; COULD NOT FEEL ANYTHING; BRUISED HIPS ARMS AND BUTTOCKS BRUISES HAD SWOLLEN TO BE SIZE OF A FOOTBALL ON RIGHT BUTTOCKS AND HIP AND FEW SMALLER BRUISES ON RIGHT SHOULDER; DISCOLORATION ON THE BRUISES/BRUISES WERE EXTREMELY DARK; FELT WEAK FROM WAIST DOWN; AS WERE WALKING BUCKLED OVER/ FELTS LEGS BUCKLED COMPLETELY; FELL TO FLOOR BUT DID NOT LOSE CONSCIOUSNESS; BRUISED HIPS ARMS BUTTOCKS; This spontaneous report received from a patient concerned a 54 year old male. The patient's weight was 245 pounds, and height was 76 inches. The patient's concurrent conditions included back issues, and spinal cord stimulator implant, and other 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: 1808978 expiry: UNKNOWN) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-JUN-2021, the subject experienced as were walking buckled over/ felts legs buckled completely. On 19-JUN-2021, the subject experienced fell to floor but did not lose consciousness. On 19-JUN-2021, the subject experienced bruised hips arms buttocks. On 19-JUN-2021, the subject experienced felt weak from waist down. On an unspecified date, the subject experienced trouble getting up, could not feel anything, bruised hips arms and buttocks bruises had swollen to be size of a football on right buttocks and hip and few smaller bruises on right shoulder, and discoloration on the bruises/bruises were extremely dark. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from as were walking buckled over/ felts legs buckled completely, fell to floor but did not lose consciousness, and felt weak from waist down on 19-JUN-2021, and bruised hips arms buttocks, and bruised hips arms and buttocks bruises had swollen to be size of a football on right buttocks and hip and few smaller bruises on right shoulder on 04-JUL-2021, was recovering from discoloration on the bruises/bruises were extremely dark, and the outcome of trouble getting up and could not feel anything was not reported. This report was non-serious.

Whole body inflammation water retention adding 1-2 lbs a week. Have gone from 210 lbs. to 222. Muscles aches, fatigue, Got blood and urine tests on June 7th. Trying to find cause for water retention, fatigue and lightheadedness. Doctor stopped losartan and prescribed a daily diuretic. The water retention persists and The body still feel stiff and sore. Especially in the morning.

in mid-June 2021 I started experiencing pain in my feet. They started swelling and feeling tingly... almost like they had fallen asleep. Minor tingling also started occurring in my hands. On certain days the discomfort in my feet was enough to limit my walking. I noticed on certain days my shoes fit tightly and my calfs were very tight with the ankles showing signs of swelling. The symptoms continue through the date of this filing...sometimes better/sometimes worse.

1. Swollen Lymph nodes on upper chest near shoulder (Left thoracic duct area) and left arm pit large enough to feel by hand, lasting approx 8 hours. 2. Stomach bloating accompanied by stomach discomfort / pain and severe diarrhea for 48+ hours. 3. Intermittent Dizziness and headaches lasting approx 24 hours. 4. left arm and finger joint stiffness, lasting approx 48 hours.

Patient called pharmacy Monday morning to report side effects of swollen lymph node under arm and fever of 101 degrees. Suggested patient call his primary care physician and told him I would report side effects.

Moderate left deltoid pain the day after vaccine - pain is persisting through today 4/8/21 - a month later. Olecranon Bursitis in left arm - same as vaccine - 4/2/21 - seen at ER and given IV antibiotics, then outpatient oral antibiotics

3-20-21: The day after the shot I had a miner swollen lymph node inner elbow area which went away. 4-18-21: Perfect health. No pain in left arm. 4-19-21 to 4-20-21 : Over 24 hours sudden increase of swollen lymph node of the inner elbow area of my left arm. Constant pain which increases sharply with arm movement. Unable to lift arm without high level pain. Can't put left arm through coat sleeve without assistance. No medical assistance yet, as this just occurred. Waiting this week to see if it gets better.

PANCREATITIS; This spontaneous report received from a patient concerned a 55-year-old not Hispanic/Latino white male. The patient's height, and weight were not reported. The patient's concurrent conditions included pancreatic cyst, and alcohol use. The patient had no known allergies and no history of 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: 1808982, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. The company is unable to perform follow-up to request batch/lot no. On approximately 09-APR-2021, at the night of Thursday/Friday (overnight), suddenly the patient experienced pancreatitis. It was reported that, on day of vaccination the patient was fine and drank 1/2 glass of wine in the evening after receiving vaccine and before he experienced pancreatitis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pancreatitis. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: -COVID-19 VACCINE AD26.COV2.S-Pancreatitis. 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.

Developed transient SOB on 4/16 that resolved on 4/18. Developed left leg pain and swelling on 4/19. LE ultrasound revealed extensive DVT. Does report a 4 hour plane ride 4 weeks ago.

On 4/15/21 client contacted public health office to report adverse effects of COVID Vaccines. Reports late afternoon on 4/6/21 he felt "heavy", had a HA, tired, nausea, body aches, high fever (did not take his fever), sweating, only drank water for 3 days, under arm swelling in the right arm. On 4/7/21 reports right shoulder and arm pain all the way down his arm to his hand began with tingling and sharp pain in his hand. On 4/12/21 he was tested for COVID and tested negative. Denies any rash, redness, or swelling at the site of the actual injection. On 4/15/21 was seen by MD for ongoing arm and shoulder pain.

Patient had weakness, chest discomfort, dizziness, weakness, moderate severity. same day of the vaccination. pt complained of left leg swelling.

Patient awoke on the morning of 4/14/21 and noted swelling of the lip/left facial region; swelling got worse throughout the day. Patient received epinephrine inhalation, famotidine IV, methylprednisolone IV, and diphenhydramine IV. Discharged 4/14/21.

Immediately after shot had fever and chills with flu symptoms for about 4-5 days after vaccination. On 3/22 went to urgent care for left elbow swelling which had never occured before in this joint visit deteremined was olecranon bursitis. The very next day began complaining about leg pain around 3/23 and by 3/26/2021 pain was unbearable in the leg and went to ER where patient was then admitted for DVT and pulmonary embolisms.

1 day after injection, headache + fever + elevated heart rate. This went away by the next day. 2 days after injection, swollen and sore lymph node left arm pit. Still there

Numbness in nose and upper lip shortly after receiving shot. Both arms pain and numbness and tingling. Back and neck pain. Arm swelling.

BLOOD CLOT IN LEFT LEG; DIFFICULTY SLEEPING; SOME LEG CRAMPS; SWELLING; This spontaneous report received from a patient concerned a 55 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, expiry date: unknown) dose, 1 total on an unknown date in APR-2021 (reported as about three weeks ago from the date of reporting) on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. Since an unknown date in APR-2021 (reported as about a week ago), the patient experienced swelling and some leg cramps. It was reported that nothing (swelling and leg cramps) was dramatic initially, however, they worsened. On 28-APR-2021 (reported as last night), the patient had difficulty in sleeping. On 29-APR-2021, the patient was diagnosed with blood clot in left leg by his doctor. At the time of report (reported as currently), the patient was in transport to a hospital for further evaluation. The patient further mentioned that he did not have possession of the vaccination card, but his wife had it and she would be arriving at hospital later. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot in left leg, swelling, and some leg cramps, and the outcome of difficulty sleeping was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: -COVID-19 VACCINE AD26.COV2.S-Blood Clot in leg. 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.

On March 28th, started noticing symptoms. There was pain in my entire right leg, shin swelling; calf- swelling and skin discoloration; and right foot - swelling. On 4/1, I went to Urgent Care where I was seen, evaluated and treated by Dr. She ordered blood tests and an ultrasound within 20 minutes. I had 4 blood clots in 3 veins in my right leg/DVT. My blood platelet value was 267 and the standard range is 130 to 400. They didn't consider it low, but it's still an issue. I was given an injection of Enoxaparin Sodium Injection--1 ml injection twice a day for 5 days, which was started in the ER. I then switched to Pradaxa 150mg pill twice a day. I took that until around the 6th of this month when I noticed my right leg had gotten worse. I was instructed to go back to the urgent care. Another ultrasound was ordered and it showed I still had the 4 blood clots in 3 veins that seems to have worsened, so the meds were not working. He consulted with a vascular surgeon and they put me back on the injection once a day, which I am currently still on. I was told to follow up with my PCP in two weeks and that appt is on Thursday with Dr.

Skin rash starting with intense itch, swelling, redness, vesicles turning into scaling, still ongoing after 4 weeks.

Weakness of lower extremities and arms that started around 5/26 and progressed over the next week until admission on 5/31. MRI brain and spine with diffuse enhancement and CSF with protein > 500. Started on PLEX for presumed Guillan Barre Syndrome. He is slowly improving after 4 sessions.

SHORTNESS OF BREATH (FEELING CONSTRICTED BUT NOT COMPLETE LOSS OF BREATH); LEFT NECK LYMPH NODE SWELLING (NOW DECREASED IN SIZE, STILL PALPABLE AND INFLAMED); FEELS HYPOSTATIC; LIGHT HEADED; FEELING BACKED UP; CLOUDINESS IN URINE; This spontaneous report received from a patient concerned a 55 year old male. The patient's height, and weight were not reported. The patient's past medical history included fever, tinnitus, and drug induced hypertension, and concurrent conditions included autoimmune disease -psoriatic arthritis, and other pre-existing medical conditions included the patient had experienced many adverse experiences with other vaccines/medications in the past. the patient had received steroids that resulted in bright pink torso and was aware about the steroid allergy. the patient thinks he had covid-19 back in december because he loss his sense of smell for 2 to 3 weeks. patient received a vaccine 10 years ago that gave him a fever for 10 days straight. The patient experienced hypertensive when treated with salbutamol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 04A21A, and expiry: 05/AUG/2021) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAY-2021, the subject experienced cloudiness in urine. On 21-MAY-2021, the subject experienced shortness of breath (feeling constricted but not complete loss of breath). On 21-MAY-2021, the subject experienced left neck lymph node swelling (now decreased in size, still palpable and inflamed). On 21-MAY-2021, the subject experienced feels hypostatic. On 21-MAY-2021, the subject experienced light headed. On 21-MAY-2021, the subject experienced feeling backed up. On 01-JUN-2021, Laboratory data included: Blood test (NR: not provided) all clear. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 111/63. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath (feeling constricted but not complete loss of breath), left neck lymph node swelling (now decreased in size, still palpable and inflamed), feels hypostatic, light headed, cloudiness in urine, and feeling backed up. This report was non-serious.

Adverse Events: Headache, Fever, Diarrhea, Nasal Congestion, Leg Pain, Weakness, Paralysis Dx. Guillain Barre Treatment: Immunoglobulin, Sodium Chloride 0.9%, Respiratory Bypass, Oxygen Outcomes: Patient actually in Intensive Care Unit at Hospital receiving treatment. Continue with oxygen by nasal cannula, whole body paralysis with urinary and feccal incontinence (foley and diaper). Symptoms begin since June 10,2021. Admission to Hospital on June 17, 2021 to present.

June 17-swelling of hands and arms, pain, tingling, burning sensations in arms and legs. Dizziness and fatigue.

GUILLEN BARRE SYNDROME; BELLS PALSY/FACE DROOPING; CHILLS; HEADACHES/EXCRUCIATING HEADACHES; FEVER; This spontaneous report was received from a consumer and concerned a 55 year old male. The patient's height and weight were not reported. The patient's concurrent conditions included drug allergy. Other relevant history included general good health and a marathon runner. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025, expiry: 09-JUL-2021) dose was not reported, administered on 17-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the patient experienced fever, chills and headaches. On 14-APR-2021, patient thought he had eaten something that had burned his lip. On 18-APR-2021, the patient experienced bells palsy/face drooping. His "lip going numb" then "face started drooping". He went to the emergency room. The doctors proceeded with an MRI and "all sorts of bloodwork." Patient also had "leg started to have twitching" and then started to have excruciating headaches ", "back started hurting on around the 22nd or 23rd of April" and "his legs and feet were numb" and "just couldn't get his utensils", "body weakness and headaches." He went to a neurologist and had a nerve conducting study and "it looked like it was GBS and chronic inflammatory." On 27-MAY-2021, Guillen Barre syndrome was diagnosed. Treatment medications included: ibuprofen, gabapentin, sodium chloride, paracetamol, naproxen, and plasma infusions to help with GBS. At the neurologist, the patient had 5 treatments of plasma. He was having reactions with the infusion including "light headedness or headaches." He was given saline and the doctors told him to "stay hydrated and also was suggested acetaminophen and ibuprofen." He was also having "extreme weakness" with the plasma therapy. The neurologist was looking into the diagnosis and determined as it "is a reaction to the vaccine". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of Guillen Barre syndrome was not reported. The patient recovered from Bells Palsy/face drooping on 23-APR-2021, and fever and chills on an unspecified date, and had not recovered from headaches/excruciating headaches. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210726629.; Sender's Comments: V0: This spontaneous report received from a consumer concerns a 55 year old male, who was noted to have bell's palsy and diagnosed with Guillain-Barre syndrome (GBS) 32 and 71 days, respectively, after receiving the Janssen Covid-19 vaccine. Patient's height and weight were not reported. The patient's past medical/surgical history, concurrent conditions and concomitant medications were not reported. Information on smoking history, illicit drug use and alcohol abuse were not provided. Patient has drug allergy, unspecified. Patient had fever, chills and headache one day after receiving the vaccine. Thirty-two (32) days post vaccine, the patient's face started to droop and was noted to have bells palsy. He sought consult at the emergency room and was worked up on. No results provided. Patient started experiencing twitching of his legs, excruciating headaches and back pains. Later, his legs and feet started to get numb, described as not being able to get his utensils. His body started to get weak and he still was experiencing headaches. He went to a neurologist and had a nerve conducting study. Seventy-one (71) days after receiving the vaccine, patient was diagnosed with Guillain-Barre Syndrome (GBS). Treatment medications included: ibuprofen, gabapentin, sodium chloride, paracetamol, naproxen, and plasma infusions. Information regarding other potential etiologies was insufficient, and the occurrence of Bells Palsy and GBS could represent background incidence of such events in the general population. Considering the temporal relationship, the event is assessed to have an indeterminate relationship with vaccination.

PAIN OF THE LEG AND ARMS; WEAKNESS OF LEGS AND ARMS; DIZZINESS/ FEELING LIGHT HEADEDNESS; TINGLING AND NUMBNESS OF THE LEG AND ARMS; BREATHING DIFFICULTY; TINGLING AND NUMBNESS OF THE LEG AND ARMS; REDNESS OF THE RIGHT HAND; DVT, BLOOD CLOT, IN THE LEFT LEG; SWELLING OF THE RIGHT HAND AND LOWER PART OF THE ARM/ LEFT ARM SWOLLEN; This spontaneous report received from a patient concerned a 55-year-old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 207A21A expiry: unknown) dose was not reported, one total administered on right arm on 09-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-JUN-2021, the patient woke up in morning and experienced swollen right hand and the lower part of his arm. On the same day in the evening, nurse (from country jail) gave antibiotic due to redness and swelling of the right hand. On 18-JUN-2021, the patient experienced feeling light headedness, dizziness, continue to feel worse, breathing difficulty, weakness of legs and arms and continue to feel worse throughout the weekend. On 21-Jun-2021 on the afternoon, he took the last dose of antibiotic and noticed swelling went down. On the same day in the evening, he was taken to the hospital emergency room (ER) from the jail due to continued pain and tingling of the arms and legs, swelling, and blood pressure spike. Lab work was done, unable to finish the computer tomography (CT) scan of the chest due to left arm intravenous (IV) line blew out and dye went to the left arm. He was discharged back to the jail and left arm was swollen but was fine the next morning (22-JUN-2021). On 22-JUN-2021, he again returned to the hospital ER to get a chest CT scan but unable to perform the chest CT scan due to unable to get an IV line started. Laboratory work done from the night before resulted elevation of the d-dimer. Ultrasound performed on both legs and deep vein thrombosis (DVT), blood clot, was found on the left leg and no blood clot on the right leg. ER health care professional (HCP) prescribed blood thinner Xarelto (rivaroxaban 15mg) the first 3 weeks and fourth week started 20mg. (He was on his nineteenth dose at the time of reporting). After discharged from the ER on 22-JUN-2021, he was discharged from the county jail due to the current medical conditions. On same day at 17.47, he went to the local ER near home due to same symptoms, swelling and tingling of the arms and legs. ER HCP reviewed the medical records from the prison and agreed with the diagnosis of DVT from the above hospital ER visits. On 25-JUN-2021, he went to see his primary physician. HCP reviewed the medical records and verified the DVT on his left leg. HCP ordered the chest CT scan, ultrasound of both arms, and more blood work. On 27-JUN-2021, CT scan of chest resulted negative finding. On 01-JUL-2021, ultrasound of the arms resulted negative as well. On 09-JUL-2021, follow-up visit with primary physician, confirmed DVT and requested him to continue Xarelto for 3 months. He ordered the spine x-ray due to the pain and tingling of the arms and legs to find out the cause. Primary HCP follow-up appointment scheduled for 17-SEP-2021, Comprehensive Metabolic Panel (CMP), D-dimer test, ultrasound of the left leg due to DVT, B-12 test for the numbness and tingling of the legs and arms ordered to be completed prior to the follow-up appointment on 17-SEP-2021. HCP ordered X-ray of the spine. Tingling and numbness of the arms and legs are still severe at the time of report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness/ feeling light headedness on 25-JUN-2021, was recovering from breathing difficulty, and had not recovered from DVT, blood clot, in the left leg, swelling of the right hand and lower part of the arm/ left arm swollen, weakness of legs and arms, tingling and numbness of the leg and arms, tingling and numbness of the leg and arms, redness of the right hand, and pain of the leg and arms. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210725185-covid-19 vaccine ad26.cov2.s-DVT, Blood clot, in the left leg. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

May 29, 2021 Kidney infection. Back pain, blood in urine. Hospitalized for three days treated with antibiotics. Continued antibiotics for three days after discharge.

Beginning on 3/19 he developed a progressive ascending numbness first in his toes, then progressing to include bilateral legs up to knees and bilateral arms up to mid forearm. He also had mild leg weakness bilaterally. He has absent reflexes. His lumbar puncture showed albuminocytologic dissociation. He was diagnosed with Guillan-Barre syndrome and is being treated with IVIG.

Presented with 2-3 weeks of fatigue and acute on chronic leg swelling (h/o chronic venous disease, phlebitis) 13 April; treated for dehydration and prescribed ASA. Tachycardia on exam, resolved with resuscitation. Asymptomatic 4 hours later, and expired overnight in his sleep. Found unresponsive in the morning, time of death 09:57.

1 week after receiving the vaccine, what I believe to be a gout flare started in my right foot. The joint of my big toe became very swollen and red, painful to the touch and the rest of the front part of my foot also became swollen. It was difficult to walk or even put pressure on it for 5 days and I treated it with ice, elevation and 600 mg ibuprofen 3X/day. Symptoms are starting to resolve , but the joint is still swollen and red, though the pain is subsiding. I am able to walk with a normal gait, though there is still stiffness and some pain.

Less than 1 mo following injection pt developed DVT RLE. He presented with rt foot/ankle pain 3/29. The pain improved then around 4/10 he developed significant pain/swelling to rt calf. Venous US confirmed DVT. Pt started on Eliquis. Pt has h/o superficial thrombosis, not h/o DVT.

Developed hemophagocytosis syndrome (hemophagocytic lymphohistiocytosis) resulting in hospitalization

My health was great before my vaccine. I was able to have a normal full day five days out of the first 60 without health issues. This week I haven't had one day where I haven't had something going on. I woke up day after vaccination and started feeling feverish, but going into bad chills, extreme headache, a different kind of headache than my migraines, abdominal had pain, heart rate and breathing, heart rate was elevated, breathing not normal, out of breath, deep pain right thigh at bone, did not bruise. I called cardiologist 03/25/2021, about thigh, thought it might be DVT, I followed up 03/29/2021 since I did not hear back, we spoke on the 30th, I had very high blood pressure, doc presumed I had a tress fracture of right thigh bone and that other things were related to my chronic intro viruses. I saw my infectious disease doctor on April 13th he said this could be a major conflict with either current viruses, meds taking in conjunction with vaccination. All of my major lymph nodes were inflamed. I do have non Hodgkin's lymphoma, but they told me it is slow growing. Visited ER on 04/14/2021. Dr met me there.

Fevers started on Wednesday evening, April 14th. Over the next three to four days, the fevers and chills continuously got worse. Patient experienced fatigue, congestion, headaches, sore throat, body aches, neck pain. Conducted a televisit on Sunday, April 18th, and then went into the doctor on Monday, April 19th. The day of the doctor appointment, the patient could not get out of bed and could not stand for longer than 15 minutes at a time before extreme fatigue set in. Blood tests were taken at the doctor, a Z-pack was prescribed. The evening of the 19th, the doctor called after hour to send patient to emergency room to be admitted to hospital. Patient went immediately to Medical Center at which point, the patient was admitted for the next 19 days. The patient was released from the hospital on Saturday, May 8th. While in the hospital, the patient saw almost every "category" of doctor possible. Patient experienced fevers every night for 15 days straight, and after release from the hospital and "fever free for 4-5 days, experienced fevers again for the next week. Doctors were unable for the first two and a half weeks of hospitalization to draw a conclusion about what was the cause of the sepsis (systemic). Patient received daily blood tests, MRIs, CAT scans, spinal tap, bone marrow biopsy, echocardiogram, etc. Patient spent the first two and a half weeks on an antibiotic, antifungal, and antiviral. The "final" diagnosis, which is still not confirmed, as histoplasmosis, which per the doctor would not have placed the patient in the hospital. Determined the fevers were officially "fevers of unknown origin" with a diagnosis of MIS-A and a vaccine contributing factor. Medication put patient in kidney failure and did not address the fevers (patient had fevers of 103+ for 25+ days in a row). On May 27th, doctors are conducing new fungal tests and patient is discontinuing antifungal medication because of severe liver damage. Patient was not and is not in a situation where histoplasmosis is a logical conclusion based on the patient's daily activities.

Diarrhea and soft/loose stools EVERY DAY since to this day! Leg swelling...mostly in right leg & foot. Trouble walking. Some unusual & day long blurred vision.

Symptoms:hives allergy to my right arm.swollen discolorment in my left arm.Four Emergency visit back to back pain.I was given Amoxicillin 500,Banophen25mg,Mapap500mg,Clindamycin 300mg,Sulfamethoxazole

After the injection on Friday 03/12 at 1:50 PM at facility, I started to get a slight temperature, Along with chills as well. This continue throughout the weekend. I remained at home and did not have any energy to go out and be around people. The next day, I also got diarrhea and was very dehydrated. Immediately, after I left the vaccine shot location, like within 5 minutes, I started to smell fish and my mouth tasted like salt for three days. I also had excruciating headaches that did not go away with advil. So I rested a lot and had no real big appetite what so ever!. Today, I am concerned that on my left side below my left clavicle, I feel a big bump what appears to be possibly a lymphatic swelling of node? I am concerned because I did not have this swelling before and do not know if it's a reaction to the vaccine. Pls contact me via phone, this is urgent. Thanks

Injection site reaction: pain, swelling General: headache, muscle aches Worse reaction: swollen left underarm lymph nodes

Numbness in extremities, paralysis full body. Pneumonia left lung. Now diagnosed with Guillain-Barre syndrome, due to reaction to covid-19 vaccine

Patient started complaining of extreme back pain and trouble walking within days after receiving the vaccine. His pain got increasingly worse. On the 23rd he had to be taken into the hospital in an ambulance. He said he felt as if his lower body was separated from his torso, and visible was having trouble walking. They prescribed him Valium, preformed an x-ray, and sent him home. On the 27th he was taken back to the hospital due to leg weakness, tingling in his hands and feet, and extreme pain. He was diagnosed with Guillain-Barre Syndrome. He passed away April 6, 2021 after spending 11 days in the hospital, and 6 days on a ventilator.

extreme body ache, fever 103 at 2 in the morning, swelling of the face, extreme chills, felt like I was freezing.. Start about 7:00 pm 4/10/2021lasted until 6:30 am 4/11/2021..fever has broke, but body ache still remains

Got J&J COVID vaccine on 4/10/21, at noon, in right arm. About 24 hours later suddenly felt dizzy which lasted a minute, but since then has felt dizzy and right leg has felt tight and swollen.

Extreme lower Extremity pain; like running a marathon; Red swollen lumps in legs; fever; chills and sweats This has been currently going on for 12 days with fever everyday up to 103

I was informed by CPT, that a patient who received the vaccine was in critical care and diagnosed with Guillian Barre Syndrome and is now on ventilator. Attempts to reach the DR or patient have been unsuccesful at this point but we will continue to try. I have no PMHx of the patient or current medications

Two blood clots in right leg below the knee, calf pain, swelling of lower leg and foot, painful to walk

GUILLAIN-BARRE SYNDROME; This spontaneous report received from a consumer concerned a 57 year old male of unspecified race and ethnicity. The patient's height and weight were not reported. The patient's past medical history included previous back injury, and concurrent conditions included alcohol intake 2-3 beers a day, and smoking 1-2 cigarettes per month, and no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, dose and vaccination site not reported, batch number: 1808607 or 1808609, expiry: UNKNOWN) administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-APR-2021, patient experienced pain and tingling sensation on his back but he still went to work. On 16-APR-2021, he did not go to work, tingling sensation started going on his hands. On 17-APR-2021, patient went to the emergency clinic, and was told the symptoms might be cause by herniated disc. On 19-APR- 2021, he went to fill out worker's compensation and was seen by his worker's comp doctor. X-ray was taken and showed some abnormality in the neck area. On 20-APR-2021, symptoms worsened and patient was paralyzed from the shoulder down. On 21-APR-2021, patient went to the hospital and was admitted. Magnetic resonance imaging (MRI) found nothing on patient's neck and showed old back injury, but per patient's doctor it should not cause the paralysis. Unspecified additional tests were done, and Guillain-Barre Syndrome was diagnosed. On 25-APR-2021, hospital physician ruled out other causes and confirmed that Guillain-Barre Syndrome (GBS) was caused by Janssen COVID vaccine. At the time of report, the patient was intubated at the hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from Guillain-Barre Syndrome. This report was serious (Life Threatening).; Sender's Comments: V0: 20210456333-covid-19 vaccine ad26.cov2.s-Guillain-Barre Syndrome . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

The evening of the shot I woke up with pain in my legs near my hips which lasted for a day. On 04/12/2021 my left leg was swollen and painful. I was already taking blood thinner. I went to the Emergency Room the next day and they found a blood clot in my leg. The Thrombosis was behind my left knee. My leg was swollen from the knee down and my ankle was very swollen. My Eliquis dosage has been increased from 2.5mg to 5mg twice daily. I did not have a repeat sonogram but my leg is no longer swollen.

3 weeks ago pt. felt numbness/ tingling in RLE, swelling in RLE has increased & 5 days ago pt. felt increased pain and tightness.

Initially I experienced severe headache, fatigue, fever, tight chest and short breath and swelling in my hands such that I couldn?t get my ring off. I am still experiencing varying degrees of headache and fatigue that is at times preventing my working.

Both feet swollen, right toe hurts, heels hurt. First few days was hard to walk. It is better now but still a little swollen and heels and right toe hurt

Severe itching behind right and left knee and left arm. Swelling of the left ankle and left arm. Skin erythema left arm and left and right calves Time for 7 days

Patients right leg swelled up from foot all the way to groin started 5-20-21 patient went to hospital 5-21-21. Also developed blisters all over the leg (front and back)

3 days after the vaccine, I felt pain in the left leg; I thought I had torn my angle/foot (I have not kicked anything nor made a wrong step, but there was a bit of pain: since I hike a lot in the City and the country, I could have slightly sprayed my ankle without really recalling it), but I have never had such swelling: I could put my finger in the foot from the ankle down and it would leave a 1/3rd of an inch depression in a puffed-up skin/subcutis. I am a pathologist myself and found it unnecessary to bother anyone with the trouble. So I took aspirin which controlled the swelling somewhat. It took a good 4 weeks for the swelling to fully subside, with a few occasional episodes of worsening. It is all good now.

Patient admitted with worsening numbness and weakness 2 weeks after vaccination; Neurology consulted and patient diagnosed with acute inflammatory demyelinating polyradiculoneuropathic form of Guillain-Barré syndrome and underwent plasmapharesis. Patient continued with progressive weakness difficulty with swallowing and choking on food as well as progressive loss of voice. Patient subsequently developed acute respiratory failure, transferred to critical care and was intubated.

3/24/21 ER HPI: 58 y.o. male who presents with shortness of breath, palpitations, chest pressure, and hemoptysis. Patient has known history of atrial fibrillation and coronary artery disease. Patient reports he was out in his yard approximately 1 hour ago this evening picking up some items when he bent over and started feeling palpitations. Patient states the palpitations caused a pressure in the center of his chest. He then became short of breath. He then states he got into a coughing fit and coughed up some blood. Patient states he knew something was not right so he told his wife to bring him to the ER. Currently here in ER patient continues to complain of palpitations and trash pressure. Patient currently gives his pain as 6/10. It is nonradiating. Patient reports shortness of breath but denies any lightheadedness, dizziness, nausea, vomiting, or diaphoresis. Of note, patient reports he has been having acid reflux and belching tonight. He states his wife had given him two Pepcid earlier.

Headache started 4:30 pm 4/8/21 - 6:00am4/10/21, body ache 3:30am 4/9/21 -10:00pm 4/9/21, very tired 3:30am 4/9/21 - 6:00am 4/10/21, slight pain swelling under both side of jaw and left armpit 3:30am 4/9/21 - 6:00am 4/10/21.

4/4/2021 - feeling off, somewhat run down /// 4/5/2021 - feeling more run down /// 4/6/2021 - exhibiting sore throat and swollen glands throughout the day then at 5:45 was eating cocktail shrimp when I lost function and control of my right arm as well as a slight problem with my gait. As soon as the event took place my sore throat and swollen glands stopped immediately. My wife took me to the hospital where I was entered into stroke protocol. I was subjected to a series of tests including: EKG, ECHO, Platelet Cnt, Lipid Panel w direst LDL reflex, Hemoglobin, MRI Brain w/o contrast, CTA Stroke Alert (head/neck), CT Stroke Alert Brain, ECG, Basic Metabolic Panel, CBC, Protime - INR, APTT, Troponin I, Covid19, Influenz Influenza A/B, RSV PCR, and POCT GLUCOSE. I was kept for observation and determined I had suffered a small stroke. Released from the hospital 4/7/2021.

Patient flew from city to city through another city on Tuesday 3/16/21. He had a reaction on the flight where he coughed for 1.5 hrs and was hot in the airplane. He could not go to work and was required to get Covid tested on 3/18. Still coughing and having trouble sleeping (laying down). Rapid Covid test negative on 3/18. PCR test results negative on 3/21 from hospital. He continued to grow weak and cough from 3/16-3/21. At 3am on 3/22 he called and said that his feet were 2X their size and having difficulty breathing. Taken to hospital via ambulance. When transfered to ER bed, Dr said that he lost pulse. They intubated and got his pulse back. Died at 5:15am. Autopsy said cardiac arrest. Dr said that they could not maintain a heart beat. He asked me if the patient had a history of blood clots? No he did not ever has a blood clot that I know of. He had a chest xray post mortem showing fluid in his lungs from low circulation of blood.

Severe Abdominal pain. CT scan and ultrasound revealed inflamed lymph nodes in abdominal cavity. Pain medicine prescribed. Pain is still present today, 04/25/21

Patient is a 58-year-old male with history of DM2 on insulin, bovine aortic valve replacement, nonischemic cardiomyopathy (unknown EF), hypertension, obesity, presented to Medical Center on 4/26/21 for left leg pain and swelling. Symptoms began about 2 days ago when he drove to visit some friends and started to " feel under the weather" hence drove back yesterday. He then had acute onset of left leg swelling and pain which prompted him to present to the ED. He was reportedly concerned about " having a clot" as he just received the Johnson & Johnson Covid vaccine this past week.

BLOOD CLOTS IN LUNGS; NUMBNESS IN HANDS AND FEET; SWELLING IN HANDS AND FEET; This spontaneous report received from a patient concerned a 58 year old white male. Initial information was processed along with the additional information received on 11-MAY-2021 The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no history of blood clots. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 207A21A expiry: UNKNOWN) dose was not reported, 1 total administered to right deltoid on 09-APR-2021 around 13:00 for prophylactic vaccination. No concomitant medications were reported. After receiving the vaccination on 09-APR-2021, the patient went home and slept for 6 hours. One week after vaccination, on 12-APR-2021 the patient experienced swelling in hands and feet. Two weeks after, on 19-APR-2021 the patient experienced numbness in hands and feet. On 21-APR-2021, the patient went to the emergency room (ER) and was given the tests, laboratory data included: Blood test (NR: not provided) unknown, CAT scan (NR: not provided) blood clots in lungs, and EKG (NR: not provided) unknown. The patient experienced blood clots in lungs and was hospitalized. On 22-APR-2021, laboratory data included: Sonogram (NR: not provided) results awaiting and will get records on wednesday. As of 22-APR-2021 the patient was started on blood thinner. Treatment medications included: apixaban (Eliquis) 2 a day. On an unspecified date in APR-2021 while in the hospital the patient was on oxygen (unspecified indication). The patient was discharged on 22-APR-2021 and the duration of hospitalization was 1 day. The patient was released with a prescription of Eliquis for 3 months. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling in hands and feet, numbness in hands and feet, and blood clots in lungs. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210518013 -COVID-19 VACCINE AD26.COV2.S- Blood Clots in lungs . 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).

Immediately after injection significant arm pain that resolved quickly. Approximately 36 hours after injection dizziness. 48 hours after injection neck and head pain on left side, arm soreness, and swollen lymph node on left side of throat. Minor pain in mouth and throat with fatigue and dizziness. Neck and head pain decreasing on day 3 with all other effects resolving but injection site is still fairly sore. Overall, I would say this was probably a normal response associated with my immune system reacting to the injection. I had the virus the first week of December 2020. I would classify my infection as moderate. I was sick with fever, chills and severe body aches and it lasted for 10-14 days.

Pain in left upper arm about 10 days after injection, shooting down arm to hand, reduced mobility of the arm, didn't improve for 3 weeks thus saw my own doctor. She referred to orthopaedic doctor. Saw him on 5/12/2021, he diagnosed adhesive capsulitis in left shoulder possibly caused or exacerbated by the swelling due to the vaccination in that same area. Revisit in 3 weeks after dr. visit. Taking ibuprofen to reduce inflammation.

BLOOD CLOT IN LUNG; BILATERAL FEET AND HAND NUMB; BILATERAL HANDS AND LEGS SWOLLEN; SLEPT FOR 6 HOURS AFTER SHOT; TIRED; This spontaneous report received from a patient concerned a 58 year old male. The patient's weight was 285 pounds, and height was 56 inches. The patient's concurrent conditions included high blood pressure, depression, diabetes, flea bites allergy, peanut allergy, alcohol consumer, non smoker, heart disorder, nerve pain, mood disorder, fluid retention and pain. He had no known drug allergies. He did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 23-JUN-2021) dose was not reported, 1 in total administered to right deltoid on 09-APR-2021 for prophylactic vaccination. Concomitant medications included hydralazine 25mg BID (twice a day) for blood pressure, metformin hydrochloride 500mg BID for diabetes, Baby Aspirin (acetylsalicylic acid) EC (enteric coated) for heart disorder, escitalopram 10mg daily for mood disorder, gabapentin 100mg TID for nerve pain, and celecoxib 200mg 1 tablet a day as needed for pain. olmesartan medoxomil 40mg daily for blood pressure, amlodipine besilate 10mg daily for blood pressure, furosemide 40mg daily for fluid retention, potassium chloride ER (extended release) 20 Meq TID (thrice a day) and metoprolol succinate ER 50mg daily for an unknown indication. On the same day vaccination, the patient slept for 6 hours after shot and was tired. On 16-APR-2021, the patient experienced bilateral hands and legs swollen. On 19-APR-2021, the patient had bilateral feet and hands numb. On 21-APR-2021, he went to the emergency room (ER) and was hospitalized. He had following test done. Covid-19 test and EKG (electrocardiogram) results not provided, sonagram of legs showed no blood clots, computerized tomography (CAT) scan found blood clots in lungs. He was put on IV fluids and oxygen. He had blood clots in lungs, he could not specify if both lungs had it. He was discharged the next day without oxygen. He was put on Eliquis (apixaban) 5mg BID for 3 months. He was hospitalized for a day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slept for 6 hours after shot, and tired on 09-APR-2021, had not recovered from bilateral hands and legs swollen, and bilateral feet and hand numb, and the outcome of blood clot in lung was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210554313- COVID-19 VACCINE AD26.COV2.S- blood clot in lung, bilateral hands and legs swollen and bilateral feet and hand numb. 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).

FELT LIGHT HEADED; DISORIENTED; SWELLING OF STOMACH; SWELLING OF ARMPITS; SWELLING OF HANDS; ANXIETY; FEELS LIKE VERTIGO; This spontaneous report received from a patient concerned a 58-year-old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19 (took 6-7 months to clear), and concurrent conditions included smoking, fatty liver, high triglycerides, dieting, and seasonal allergies. 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: 204A21A, and expiry: UNKNOWN) dose was not reported, administered, 1 total to left arm on 09-MAY-2021 for prophylactic vaccination. Concomitant medications included loratadine for seasonal allergies. On 09-MAY-2021, 30 minutes after vaccination the patient felt light-headed and disoriented and he drove to the hospital where he consulted in emergency room and did blood work, and did X-ray of heart and lungs. They put him on IV (intravenous). Patient was admitted for 4 hours and discharged. On 09-MAY-2021, the patient also experienced swelling in both hand, stomach and in his armpits. Since after discharge patient felt disorientated sometimes. The patient felt nervous and also felt like vertigo. Patient was completely disoriented and felt dizzy when he was walking (prior day of reporting). He still had swelling on hands and recovered from swelling on stomach and armpits. Patient felt anxious sometimes and could not walk and he mentioned it could be partly due to unemployment and overwhelming medical bills. The patient mentioned that he had covid-19 in OCT-2020 which was pretty bad that made him decided to take vaccine. He was worried how long these symptoms will persist at a time and unemployment added to his anxiety. He also mentioned about seeing doctors to rule out other rational other than the vaccine. Patient had lab test during his emergency room visit. Laboratory data included: Blood test (NR: not provided) as Not reported, and X-ray of heart and lungs (NR: not provided) as Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling of stomach, and swelling of armpits in MAY-2021, and had not recovered from felt light headed, disoriented, feels like vertigo, anxiety, and swelling of hands. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210556773 -Covid-19 vaccine ad26.cov2.s-Felt Light-headed, Disoriented. 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 V0: 20210556773 -Covid-19 vaccine ad26.cov2.s-Swelling of stomach, swelling of armpits, swelling of hands. 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).

BILATERAL SWOLLEN LEGS FROM HIP TO FEET; SWOLLEN TESTICLES; DIFFICULTY AMBULATING UPSTAIRS; DIFFICULTY PUTTING ON SHOES; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's past medical history included open heart surgery, and aortic aneurysm. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. Concomitant medications included furosemide for heart surgery. On 04-MAY-2021, the subject experienced bilateral swollen legs from hip to feet. On 04-MAY-2021, the subject experienced swollen testicles. On 04-MAY-2021, the subject experienced difficulty ambulating upstairs. On 04-MAY-2021, the subject experienced difficulty putting on shoes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bilateral swollen legs from hip to feet, swollen testicles, difficulty ambulating upstairs, and difficulty putting on shoes. This report was non-serious.

swelling of extremities, legs and feet and toes were swollen badly . eyes were blurry and constantly watering. hbp

(4/19) Began experiencing discomfort in right side (bottom of rib cage) when getting in/out of bed; no other symptoms. (4/30) Rapid fever onset with chills from 98.6 to 102.7 within four (4) hours; increased pain in right side; . Seen at urgent care: blood pressure normal; elevated heart rate (130); sub-normal SpO2; urinalysis negative; chest x-ray negative; COVID test negative. Referred to ER. (4/30) ER: increased pain; no coughing or symptoms beyond extreme chills/fever; two additional COVID tests negative; extremely high white cell count (25K), CT showed small pneumonia on right side. Treated with multiple antibiotics and released. (5/1-5/7) Continued elevated (99-100F) fever; occassional lethargy; no coughing or other symptoms. (5/8) Temperature normal; occassional lethargy; no coughing; increased pain on right side at night. ( through 7/10) increasing pain on right side; present constantly but worse at night; radiates front to back on right side below rib cage; no other symptoms. (5/12,6/23,7/1) Follow-up visits with PCP; additional chest x-ray negative; CT scheduled for 7/14.

Leg pain 24 hours later, fever pneumonia, congestive cardiac failure, dialysis access dysfunction, post vaccine fever, hyperkalemia, anemia, vomiting, weakness, hypoxia, hypervolemia; Pt rcvd J & J and next day seen in ER with leg pain, N, V, diarrhea and shortness of breath. Mult stool antigens neg. Lactic acid and WBC elevated. Initial fever resolved as did hyperkalemia and hypervolemia state after urgent dialysis.

Presented with generalized malaise, fever, chills on June 23. Had headache and cough on and off after receving vaccine. On July 8 admitted to hospital with rash concerning for erythema migrans. Positive Lyme IgM. Started doxycycline. Discharged 7/10. Came back on 7/11 with bilateral facial nerve palsy. noted to have severe back pain of unclear cause as well. Started on Ceftriaxone. Discharged again on 7/13. On 7/14 presented to oupatient ID clinic with increasing back pain and numbness on trunk and upper thighs. Sent back to hospital. CT head, MRI thoracic and lumbar spine normal. LP done normal cell count, mildly elevated protein on CSF. Increasing muscle weakness of extremities (proximal muscles of lower extremities first). Impression: Guillain Barre. Started on IVIG

Woke up overnight with a black eye, a pretty good shiner. No trauma to the eye area. I feel great. Face was slightly puffy in the AM.

Severe headache on first night, with chills and sweats. On first morning after inoculation, rashes covered genitalia, spreading to several places (silver-dollar-sized rashes elsewhere). On evening of day after inoculation, facial swelling, including eyes and lips. At no time was there any problem with swallowing or breathing. On advice of physician, began 50mg of antihistamine Benadryl at night, with daytime antihistamine during day.

A week after the patient had the vaccine he developed weakness with numbness in the lower extremities. Patient continued to get worse and was admitted on 04/03 with concerns for Guillain-Barré syndrome ( GBS). Patient is currently getting treatment for GBS.

I experienced and noticed swelling to my left side between my collar bone of my neck. I felt a lump upon palpation o my sub clavicular lymph node, left side of my neck. They told me to let it run my course and I have a follow up appointment in 6 weeks to monitor the lymph node. I still have a little lump, lymph node is smaller in size.

Patient had LLE swelling and pain, went to see PV provider the next day who recommended pt go to ER. Pt was diagnosed with nonocclusive SVT in the L short saphenous vein via ultrasound. Good prognosis, no CP or SOB.

10 days after the vaccine my perfectly healthy husband began developing terrible back pain and abdominal numbness, went to the ER, had a brain bleed and was daignosed with Guillain-Barre Syndrome. He has been in the hospital for a week. He is not being released yet.

No symptoms other than just a mild injection site pain. Didn't last long. On 5th of April I began to get: I had rigors (shaking, chills), sweats at night 3 or 4 times of night changes of bedding, acute Prostatitis and pain upon urination and pain from prostrate itself. fever spike as high as 102.2 and my blood cultures were positive for Staphauereus in my blood stream. Sepsis diagnosis. I was admitted to hospital on 7th April of Hospital I had a fever of 102. My prostate was enlarged to 131 grams and I was having difficulty urinating. The infection was Staphaureus Staphlicottis. I was initially treated at a walk-in clinic and they did a direct admit to the hospital for UT .and I stayed there for 7 days. They installed a PICC line for IV upper arm to vena cava up into my heart. I still have that in - for intravenous home infusions of antibiotic. Peripheral Inserted central Catheter. Up until Sunday, May 16, of this past week, I had extreme fatigue to the point of not being able to walk a normal amount for me - maybe 1/3 of the amount. I haven't been able to get back to my regular exercise. I was having headaches and brain fog and a lot of aches and pains throughout the body up until Sunday. Since then I have felt quite a bit better.

approximately 12 hours after receiving the vaccine, patient awoke with angioedema with tongue swelling, but no airway compromise. He was given Benadryl, famotidine, and 100mg steroids.