Johnson & Johnson

PAIN IN THE TERMINAL END OF SPINAL CORD; SWELLING OF THE RIGHT PELVIC LYMPH NODE; This spontaneous report received from a patient concerned a 76 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, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, the subject experienced swelling of the right pelvic lymph node. On 06-APR-2021, the subject experienced pain in the terminal end of spinal cord. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in the terminal end of spinal cord on APR-2021, and had not recovered from swelling of the right pelvic lymph node. This report was non-serious.

SWOLLEN LEFT LEG, NO PAIN, NOTHING ELSE JUST BIG, REAL TIGHT, FELLS HARD, NOT HOT TO TOUCH; This spontaneous report received from a patient concerned a 76 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 204azia, and expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced swollen left leg, no pain, nothing else just big, real tight, fells hard, not hot to touch. The action taken with covid-19 vaccine was not applicable. The outcome of swollen left leg, no pain, nothing else just big, real tight, fells hard, not hot to touch was not reported. This report was non-serious.

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

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

TENDERNESS; LOSS OF APPETITE; PROFUSE SWEATING; BACK TIGHTENING; MUSCLE SPASM; SWELLING; BACK SORENESS; LACK OF SLEEP; HIP SORENESS; TIREDNESS; NAUSEOUS; FEVER; This spontaneous report received from a patient concerned a 78 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included disabled. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced tenderness. On MAY-2021, the subject experienced loss of appetite. On MAY-2021, the subject experienced profuse sweating. On MAY-2021, the subject experienced back tightening. On MAY-2021, the subject experienced muscle spasm. On MAY-2021, the subject experienced swelling. On MAY-2021, the subject experienced back soreness. On MAY-2021, the subject experienced lack of sleep. On MAY-2021, the subject experienced hip soreness. On MAY-2021, the subject experienced tiredness. On MAY-2021, the subject experienced nauseous. On MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 98.4 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tenderness, loss of appetite, tiredness, profuse sweating, fever, hip soreness, nauseous, back tightening, muscle spasm, swelling, back soreness and lack of sleep was not reported. This report was non-serious.

The patient developed paresthesias and weakness in the legs approximately 2 weeks after the vaccine. After the thorough work-up he was diagnosed with Guillain-Barré syndrome. He was treated with IVIG and has had some improvement.

Symtoms were first noticed on Tuesday June 8th about two oclock in the afternoon when I noticed a slight burning sensation on my right shoulder. I had presumed this to be sunburn. The next day I noticed a few blisters and additional discomfort and subsequently applied OTC lotion. As the days progressed it looked as though it was poison-ivy as opposed to sunburn. Again applied OTC medications to relieve the pain. By Monday, June 14th, the situation had progressed in severity, necessitating a visit to the emergency room. I was examened by DR. who diagnoeded the problem as 'shingles', not poison-ivy. He subsequetly dianosed taking ValACYclovir for seven-days then recommended that I follow-up with a Primary Care Provider in seven-days. The valACHclovir helped stop the spread of the problem, but did't do much to relieve the discomfort. The following Tuesday, June 22nd I met with Dr. of the Health Clinic adjacent to the hospital. After vitals were all taken, we had a question and answer session where it was determined that nothing else could be done for Me except for the shingles to 'run their course'. Retuning home I continued to administer OTC lotions and sprays to help reduce some of the burning sensations experienced around the face, ear, neck, and shoulder which was becoming more severe. After several days of not being able to sleep or get any relief from the 'burning and stinging', I decided it was necessary to get a second opinion. I then notified another hospital, that I would be arriving for an examination that afternoon, July 12th. at approximately 2pm. Upon arrival and completion of completion of all vital signs by medical staff, I was met with a doctor. Upon examination and understanding the symptoms experienced, she prescribed 'Gabapentin' to help reduce the 'burning sensations' and 'Prednisone' to help reduce the 'skin rash and swelling'. Returning home and starting the prescribed meds, I did notice some immediate relief from the Gabapentin, which for the first time in more than a week or so, I was able to get a nights sleep. I didn't notice any changes taking the prednisone and had to presume that it helped stop the spead of the rash from going further. As I prepare this overview, it is now July 18th and once again experiencing severe pain and tighening of muscles around the face, neck and shoulder. Pain feels like 'stinging needles', 'miniture electical shocks' that course thru from above the ear, down thru the face neck and over to the chin-throat' area. Pain lasts but a brief second, but very painfull, making sleep impossible. Touching any area on the right side of my body from the scalp, across the face and neck down to my shoulder, back and collar bone result in extreme 'burning sensations'. I have a 12:45 pm appointmet at the hospital on Tuesday July 20th to meet with Dr. who will become my Primary Care Provider. I can only hope that we're able to come-up with some solution that will easy the severity of the 'stinging sensations and burning' that will allow me to sleep and get beck to resuming nornal activity. Up until this event, I had been an actrive, healthy, 78yo man who had never been sick nor been to a Dr. in over 20 years, which I contribute to the clean, healthy environment here. In summary, it is my firm belief that in view of recent media reports about the Guillian-Barr symtoms which affect the nerves and muscles, it is the result of having received the Johnson&Johnson vaccine that contributed to the onset of my developing shingles. Because I had not had the Shingles vaccine at any time, it might be advisable for those that are beyond a certain age who have not had the shingles vaccine NOT get the Johnson&Johnson vaccine if other alternatives are available.

Urticaria and angioedema with nausea/vomiting 48 hours after vaccination. Symptoms persisted responded to treatment but came back 6 days later and required further treatment with steroids.

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

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

Patient with history of myasthenia gravis with multiple prior myasthenic crises requiring IVIG and one requiring intubation experienced myasthenia gravis exacerbation with no apparent trigger that began two weeks after receiving J&J vaccine. Daughters noticed he was having progressive difficulty swallowing, slurred speech, and generalized weakness. O2 sats were also noted to be lower than normal with pulse oximeter at home (92% compared to baseline of 95%). On day of admission patient had a mechanical fall while carrying a tray with his walker. Hypoxic to 88% on arrival. Labs notable for leukocytosis (13.68), hyponatremia to 127 and negative infectious workup. CTH with chronic microvascular changes and global atrophy but negative for acute process. He was admitted and continued on prednisone 5mg daily (outpatient regimen). Patient was started on a three day course of IVIG on 5/3/21 due to concern for myasthenia exacerbation with subsequent improvement.

Swollen right hand and inflamed and painful index tendon sheath. Swollen right foot and painful large toe

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

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

Patient received the 1 dose J&J vaccine on 3/25/2021. Patient reports on 3/27/2021 swelling and pain and redness in LLE. Of note, patient has a hx of PE (1995) and afib, and is not on a blood thinner per cardiologist. Patient presented to ED on 4/8/2021 and u/s r/u DVT. Patient contacted physician's office on 4/19/2021 with continuation of symptoms. Unsure if this is truly an ADE as patient reports the pain/swelling/redness occurred during a walk.

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

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

Patient had diarrhea that started about half a day after the vaccine was received (7/22/21). He presented to the emergency department 7/24/21 with chief complaint of diarrhea and bilateral lower extremity weakness.

Swollen shoulder, pain in shoulder in line with the injection site. Tiredness, fever for two nights.

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

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

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

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

As soon as I started to inject vaccine into arm patient arm started to swell and get a welt at injection sight. I finished injecting vaccine but by the time I finished the welt was about 1.5 inches in diameter and about a 1/4 inch thick. Notified provider and he looked at it and stated it was a local reaction and stated to patient to watch it and put ice on it when he got home. He also told patient if he had any other side effects to come in to clinic or go to ER.

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

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

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

WORSENED GUILLAIN BARRE SYNDROME; PAIN IN FOREARMS; SWOLLEN LEGS AND FEET; FALLING AND IMBALANCE; This spontaneous report was received from a patient and concerned an 87 year old male. The patient's height and weight were not reported. The patient's concurrent conditions included Guillain Barre syndrome, alcohol intake red wine sometimes, non smoker, and no known allergies. Patient had no drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020) dose was not reported, administered on 16-MAR-2021 to his right arm for prophylactic vaccination. There were no concomitant medications. On an unspecified date, the patient experienced worsened Guillain Barre syndrome. In APR-2021, the patient was falling and had imbalance. In MAY-2021, the patient experienced swollen legs and feet. In JUN-2021, the patient experienced pain in forearms. Patient uses a walker to walk inside his home: " I have to walk beside the wall, otherwise I will fall on the floor and I have difficulty to getup" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen legs and feet, pain in forearms, worsened guillain barre syndrome, and falling and imbalance. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This spontaneous report received from a consumer concerns an 87-year-old male, with concurrent Guillain Barre syndrome (GBS) who was reported to have "worsened" GBS after an unspecified duration of receiving the Janssen Covid-19 vaccine. The worsening was described as falling and had imbalance; swelling of hands and feet; pain in forearms. No treatment reported; the events have not resolved. The information available precludes a complete and meaningful assessment. Based on the information available, and the clinical picture of concurrent GBS could represent the normal progression of the illness. However, a relationship with Janssen Covid-19 vaccine cannot be ruled out and thus the relationship is considered indeterminate.

Onset of extreme fatigue, diarrhea, and then swelling, pain, redness, heat, and hardness of the Left Leg and Ankle. Sharp pain in the leg and ankle developed over the next months with swelling, becoming severe enough to see an Orthopedist on June 15, and then a visit to the primary Dr. on June 22. EKG, Blood including d-dimer, and Chest xray done same day, then a Sonogram done on June 23. No signs of blood clot, but leg issues and diarrhea continue, with skin breakdown occuring at the ankle. Placed on Prednisone 10Mg x 5 days, Lasix 40mg x 30days, Klor-Con MEG 10mg x 30 days, Keflex 500mg x 10 days, Mupirocin 2%.skin cream 3x day. Some improvement of the diarrhea since this time, but leg continues to be swollen, red, painful, and hard.