Johnson & Johnson

I woke up with hives over my arms and chest. My left eye was nearly swollen shut and my hands were swollen and in a lot of pain. Whole body is very itchy and sensitive to touch. I took sudafed because it is all I had available at the time.

Fever developed only hours after receiving vaccination. Spiked at 103.5 at 10pm on 4/1. Down to 101 the morning of 4/2. Aches are also present

Janssen COVID-19 Vaccine EUA I received the Janssen vaccine in my upper-left arm at 3:00 PM on April 5, 2021, at a public health clinic (I think that's the proper term for the site) established in a mall. After about ten minutes, during the scheduled waiting period, I began to feel lightheaded; I can best compare the feeling to that of being tipsy after a glass or two of wine. I waited another twenty minutes at the site to see if the feeling worsened, and when it didn't, I left without telling anyone how I felt. During the drive home, however, I continued to feel lightheaded during the drive home and worried that it might be affecting my driving. After I got home without incident, the feeling persisted for a few hours and ceased that evening. Since then, I have experienced nothing but what I think are standard post-vaccination symptoms (fatigue, muscle aches, slight brain fog, swollen lymph nodes?not unlike the sensations of recovering from a modest cold). I nevertheless want to report the lightheadedness because it appears (based on news reports) that it is an unusual reaction to the vaccine. I want to make sure that my experience is recorded, even though I do not believe that I require further medical attention.

Existing facial dermal filler (restylane) became inflamed and sensitive. Swelling lasted throughout the day and had mostly resolved by the same evening with ibuprofen, while still tender to the touch. No medical attention was sought as I determined it was a non-emergency.

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

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

Initially seen on 5/30 for pharyngitis x6 days, swollen uvula, LE edema. Given dose of dexamethasone. Seen again on 6/3 for >1 week LE edema, fatigue, penile and scrotal edema. Labs showed H/H and platelets slightly elevated. TSH also very high. Went to outside ED on 6/5 and had negative DVT U/S. Seen again on 6/9 at our clinic with significant facial edema, increased uvula swelling, changes in voice quality, abdominal bloating, and persistent LE edema. Given prednisone course and referred back to ED for airway evaluation and further evaluation/mgmt.

After 14 hours of receiving the vaccine, I woke up shivering with chills around 2:30AM. Fell back asleep and woke up with a horrible headache and migraine (primarily behind my eyes). Entire body ached and had a fever of 100.5. This lasted the entire next day after receiving the vaccine. The second day, the headache subsided but my neck and lymph nodes were swollen and very sore.

body aches/fatigue for 24 hours followed by generalized abdominal pain, diarrhea without blood, nausea, vomiting, diaphoresis, dizziness. at evaluation had benign abdominal exam and was clinically stable with normal VS. symptoms started early morning of 4-11-21, day of medical evaluation 4-15-21

Apr 8th: 10:30AM - Vaccination -Mild Fatigue, Body Aches Apr 9th: Vaccine Symptoms -Fatigue, Body Ache, Mild Fever Apr 10th-12th: No Issues Apr 13: Urticaria all over body, started from morning Apr 14-15th: Full Body Urticaria, Acidity, Uncomfortable feeling, Feels like lump in throat Prednisone Medrol Dosepak 5mg/Triamcinolone Acetonide No symptoms during prednisone dosage, itchiness started to appear at 10mg/5mg dosage Apr 20th-23rd: Symptoms Recurred, now including small swelling in fingers and toes Apr 24th-29th: 2nd medrol dosepak prednisone, all symptoms subside. Itchniness appeared in 10mg/5mg dose Apr 30th: Hives Returned, Acidity, Lump in Throat

Patient admitted to the hospital on 5/10/2021 with bilateral facial nerve palsies, followed by numbness and tingling of both arms and legs. Symptoms starting to resolve.

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

Since my shot I have not been able to feel muscles all over my body. There is little to know sensation unless I press as hard as I can. Lymphnodes have been in pain and swollen since the first or second day after the shot. Headaches on and off for a month now. And my anxiety has been like I'm in fight or flight mode all of my waking moments. Even when I'm falling asleep. I will wake up with panic attacks. My muscles can't take talking on the phone for longer than 5 minutes before I have to switch to my other arm because the previous arm is "dead" in the muscles and couldn't do it any longer. Blood pressure was in the 180-190's / the high 80's and sometimes even 90 being my bottom BP number. It has since gone down because of meditation.

had an allergic reaction - resulted in severe swelling in area around right arm/abdomen - caused difficulty breathing - symptoms were improved by use of benadryl / ibuprofen / tylenol

Within 24H had rash breakout on back, occasional nausea, fatigue, headache. Most resolved by 48 hours, but then had very swollen lymph nodes and sore joints. By 72 hours only fatigue remained.

Fever, chills, sweating, fatigue, muscle aches, swelling in neck, cough Ongoing as of 24 hours later

One week after receiving the vaccine I woke up on 5/21 with a mild rash. As the day went on the rash progressed and swelling of lips and uvula occurred around 5pm. I was taken to an urgent care who transferred me to a hospital via rescue. I spent the night at the hospital receiving multiple epi pen injections, and fluids. I was discharged 5/22 with a dose of prednisone. I was fatigued all day. On 5/23 I woke up to swollen eyes and lips and covered in hives again. I went to the ER where I was given steroids and fluids again. The hives went down but did not go away. One 5/24 I took multiple doses of Benadryl and dose of prednisone and in the evening time the hives progressed. Today 5/25 I woke up with swollen lips and checks and hives. I went to my doctors office to be evaluated.

lymph nodes started swelling in a few hours. Woke up in middle of night with 100.3 degree fever, aches, chills, congestion, and congestion related headache

Immediate arm soreness after injection, followed by swollen lymph nodes around 1 hour after injection. Approximately 8 hours after injection, patient experience intense chills and fever over 101 degrees F. Fever lasted for 5 hours, and then broke before bed. Next day, the patient was sore and weak.

Discomfort in throat due to swollen lymph nodes. Additionally, swollen lymph nodes under left armpit.

MINUTES AFTER SHE ADMINISTERED JANSSEN'S COVID-19 VACCINE TO PATIENT. HE FAINTED AND FELL OFF HIS CHAIR. SHE SAID HE CAME TO ALMOST IMMEDIATELY AND SHE HELPED HIM BACK IN THE CHAIR, OFFERING HIM WATER AND A BANANA. HE STAYED SEATED WHILE SHE MONITORED HIS BLOOD PRESSURE, CHECKED FOR PALENESS, AND SWEATING FOR 30 MINUTES. THEN HIS GIRLFRIEND/FRIEND DROVE HIM HOME.

Guillan Barre Syndrome. Hospitalized. IVIG 5 day treatment. 5 day treatment Plasma Ferisis transfusions. Numb Feet- Leg Paralysis- Numb Hands

I got the vaccine at 2pm. At 12am when I was asleep, I woke up shaking, crying, screaming, I couldn't breathe, I was very cold and hot at the same time. I was sweating too much. My wife at home tried to calm down, I took my blood pressure and it was 170-160. As a result of this we went to the hospital where they admitted me for more than 4 hours, while they controlled my tension and fever. The next day a large swelling appeared under my left arm, a gland or I don't know what it will be, but it is a very large swelling

Fever beginning at 7 pm of 101-102 F, racing heart beat, headache, swollen temples, insomnia due to racing heart beat, chills, fatigue

-Severe Headache (lasted from 4/29-5/11) -Swollen Lymphnodes (lasted from 4/30-5/4) -Fatigue (ongoing)

After shot, pain/soreness at injection site lasting up to 1 week after shot. Same night around 11:00pm vaccine symptoms include: fever/chills, headache, diarrhea lasting up to 10hrs. Reduced with aspirin. 9-13 days later increase in nightly symptoms including: Headache, stomach pains (upper stomach) Rashes/hive like bumps itching on body spreading to different parts each night ( 3-17-21, rash/swelling on both feet including white bumps that mostly went away with Benadryl (Diphenhydramine) and aspirin), ( 3-18-21, Rash spread to throat and face over night, numbness in upper lip mostly went away with Benadryl (Diphenhydramine) and aspirin), (3-18-21 rash moved to lower back left side, itchiness and sore throat.

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

around noon - legs went numb and weak - couldnt walk around 1 - took 2 tylonol and had sharp pains up and down the spine around 2 - face lips jaw were swollen around 4 - rashes on neck and back and welts on arms around 5 - went to emergency room around 6 - doc claims hes allergic to tylonol customer does not believe him and things dont make sense - pain in legs comes and goes

Body aches, joint pain, sore throat, fever, vomiting diarrhea, chest pain, starting several days before admission. Possible acute myopericarditis

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

Headaches for 3 weeks after shot. Unknown if possible side effect but swelling in quads off and on weeks after and recur monthly switching sides, and increased lower body mainly leg injuries all within the same time, calf strain, tearing of quad muscles, plantar pain on both sides, long lasting swelling in those regions too that require medication.

15min after receiving the vaccine I felt chills on the right side of my body and muscle soreness in arm spreading up to right side of neck. 10hrs after receiving the vaccine I developed a headache that lasted for 72hrs and wasn't relieved by Tylenol. I began running a fever of 101F, muscle and joint aches, chills, sweating that soaked by bedding that lasted for 48hrs. Four days after the injection, I noticed my legs from knee down were swollen for 36hrs. I also experienced by heartbeat racing for 48hrs that began 10hrs after the injection.

Patient received COVID 19 vaccine through work at the company in the location on 05/05/2021. 14:45. Said he didn't feel "right" immediately. Waited the 15 minutes without sxs of allergic reaction and went home. On arrival home felt dizzy and laid down. Had initial ED visit that night and again on morning of 05/09/2021. Full body hives, itching, facial swelling, throat swelling.

5/23/2021-Pt received J&J vaccine at pharmacy today approx one hour prior to arriving to the ER, passed out after receiving the vaccine in the room at the pharmacy. Pharmacist was in the room with pt and he had no injuries/did not fall. After leaving pharmacy he passed out again in the car and was shaking per pts wife, then started vomiting. He arrived to the ER c/o feeling 'like crap." vitals with normal bp, temp, RR , hr 69. given 1 Liter normal saline. he was observed in the ER and discharged home to recover.

Patient was given the vaccine at 10:40am. He was being monitored and at 10:53am, stood up and immediately passed out falling face first. He came about immediately and refused medical attention but has a large swollen area on his forehead.

Beginning on May 29, 2021, symptoms began with persistent headache and numbness in legs and feet. By June 2, 2021, severe pain in legs, arms, abdomen with throbbing headache, barely able to stand up or walk. Went to emergency room evening of June 2, 2021, but was released with suspected viral infection and was told symptoms should subside. Symptoms got worse, with the addition of full facial paralysis and revisited same emergency room on June 6, 2021. Admitted to hospital and diagnosed with Guillian-Barre Syndrome. Spent six days in hospital receiving IGIV treatment over five nights. Released on June 12, 2021 with severe upper body weakness, limited leg weakness, constant headaches, Bell's palsy and deteriorated vision. After two weeks of recovery, including doctor's visits and physical therapy, still weakness in limbs and Bell's palsy with deteriorated vision.

STOMACH PAIN; DIARRHEA; BURNING FEELING IN STOMACH; HEADACHE; FATIGUE; MILD REDDISH BRUISE ON RIGHT HAND; RIGHT CALF A LITTLE SWOLLEN VERY MINUTE; This spontaneous report received from a patient concerned a 31 year old male. The patient's height, and weight were not reported. The patient's past medical history included previous gastric issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821288, and expiry: UNKNOWN) dose was not reported, administered on 05-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On JUL-2021, the subject experienced right calf a little swollen very minute. On 06-JUL-2021, the subject experienced mild reddish bruise on right hand. On 06-JUL-2021, the subject experienced fatigue. On 07-JUL-2021, the subject experienced stomach pain. On 07-JUL-2021, the subject experienced diarrhea. On 07-JUL-2021, the subject experienced burning feeling in stomach. On 07-JUL-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from mild reddish bruise on right hand, and fatigue, and had not recovered from right calf a little swollen very minute, stomach pain, diarrhea, burning feeling in stomach, and headache. This report was non-serious.

It was a fully body rash the developed over the course of 24 hours. The night before I noticed a bit of itching an a bump that seemed like a bug bite. The following morning I had many such bumps in clusters on my neck and arm (and a few more bumps on my legs). At the time I thought I had bed bugs. By about 6 PM, I had more bumps and many of them had spread and turned into welts. There were bumps and rashes on all limbs, my neck and redness on my chest and back, The itchiness was severe. While not extremely painful, it was extremely uncomfortable and seemed like it would be hard to sleep or do anything. Around 9 PM I took Allegra to try and alleviate symptoms. I also used hydrocortison cream and calamine lotion all over my body to reduce symptoms of itching. By around 11 PM, I the rash was spreading into my face in the form of some bumps and redness. I visited the ER after consultation with a nurse over the phone, who said that anaphylactic shock could be a possibility and that it would be best to go in. At the ER, I was treated with 50 mg diphenhydrAMINE , 20 mg famotidine , 10 mg dexAMETHasone. I was given a prescription for dexAMETHasone and instructed to take a refill in 3 days if I still had symptoms. I was discharged a couple hours later. I did not need to refill the dexAMETHasone as the sympoms subsided and was almost unnoticeable by day 3 (and completely gone by day 4).

One minute after vaccination patient began to develop urticaria on his upper anterior chest. Patient complained of dry mouth and throat and "not feeling well". Patient was given 50mg of PO benadryl. Rash on chest resolved but swelling began in face around eyes, and blanchable redness developed on forehead and patient complained of itching scalp and nausea. 24 mg of methylprednisolone and 8mg of Zofran was administered. Patient maintaining a normotensive state throughout events, hr in the 70s and oxygen saturation 96%. at 0910 patient had returned a normal state, no signs of swelling or difficulty breathing. Fire team was called for evaluation and patient was observed for one hour. No return of symptoms.

RIGHT LEG BRUISING ON HAMSTRING; SWOLLEN AREA ABOVE THE ANKLE; TENDER TO TOUCH; RIGHT LEG PAIN IN HAMSTRING; ACHEYNESS/MUSCULAR TYPE ACHEYNESS IN HIS ONE LEG OR ARM; MILD FATIGUE; This spontaneous report received from a patient concerned a 31 year old male. The patient's weight was 140 pounds, and height was 70 inches. The patient's concurrent conditions included alcohol use, non-smoker, and penicillin (hives) allergy, and other pre-existing medical conditions included the patient had no medical 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, and batch number: 1821286 expiry: UNKNOWN) dose was not reported, administered on 03-JUL-2021 09:00 for prophylactic vaccination. No concomitant medications were reported. On JUL-2021, the subject experienced swollen area above the ankle. On JUL-2021, the subject experienced tender to touch. On JUL-2021, the subject experienced right leg pain in hamstring. On JUL-2021, the subject experienced acheyness/muscular type acheyness in his one leg or arm. On JUL-2021, the subject experienced mild fatigue. On 21-JUL-2021, the subject experienced right leg bruising on hamstring. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from acheyness/muscular type acheyness in his one leg or arm, and mild fatigue on JUL-2021, and had not recovered from right leg pain in hamstring, right leg bruising on hamstring, swollen area above the ankle, and tender to touch. This report was non-serious.

Patient complained of swelling to the pectoral area that spread towards the arm pit. No pain or redness. Patient is using ice packs and Ibuprofen to treat.

4/7/21 symptpoms began tired & aches. Nighttime severe swelling of face, lips & throat. Gave Benedryl 4/8/21 Visit Urgent Care, swelling slightly less, slight rash appears on arms & body. They gave a Cortisone injection & continue Benedryl. 4/9/21 Visit to PCP Doctor, swelling much less, rash became defined circles & trail lines over arms, knees & upper body. He determined allergic reaction to Covid Shot due to no exposure to other new factors. Determined the rash to be "Erytthema Multiforme". Give Allergra allergy medication. 4/10/21 swelling gone, rash only slightly visable, still some body aches. 4/12/21 swelling, rash gone, pretty much back to normal. This whole event began one week after shot.

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

On 03-04-2021 I started to experience respiratory problems, my nose was clogged up with mucus, had some difficulty breathing and was having like an asthma attack. I do not suffer from asthma prior to this vaccine. I experienced headaches, fatigue, congestion, my ears were plugged and I also developed a rash on my arms and I also noticed a lymph node in my neck that I did not have prior to the vaccine. When I went to see my doctor my symptoms were not as prominent and the lymph node in my neck is decreasing in size.

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

Pt received the vaccination at approximately 4:25pm on 6/21/2021. Pharmacist went over potential side effects before administration. Pharmacist administered the vaccine, filled out his paperwork, and then stood up. Pt stood up. Pharmacist started to ask him to wait in the pharmacy waiting area for 15 minutes so we could make sure that he did not have a reaction. Before the pharmacist could finish, the Patient started to sway. He leaned against the wall, started to bend over, hit his head on the wall, and passed out. The pharmacist called for help from the other staff. Pt's legs were lifted up so that his feet were resting on the chair. He had hit the bridge of his nose against the wall/side of door. His nose was swelling up, turning black and blue, and was starting to bleed. After about 15 seconds, the patient came around. He was able to answer questions coherently. He stated that he did not need an ambulance. Pharmacist retrieved a couple of ice packs for him and put his coat under his head. Patient remained lying down for approximately 30 minutes before he stood up. When he stood up, he did not sway and seemed stable. Pt declined the pharmacy staff to contact someone to drive him home.

I gained about 30lbs went from 155- 185 (weight increased about 5-10lbs every 2 weeks) body muscle mass grew? shoulders, back chest, quads etc grew, do have fat but it looks like I bulked up when I haven't worked out since COVID. Prior COVID, I went to martial arts 4 times a week and went to the gym 4-5 times a week still. My awareness was not good, hand dexterity was not as high, concentrating was not easy for long, high blood pressure, pre diabetic now, fatty liver, gallbladder stones/sludge, have high wbc count, rbc count high, high alt/ast range is 44-88-116-222, skin sensititivty, could only stay awake for 6 hours at a time. BTold to introduce coffee to help liver/ keep taking baby aspirin/ put back on Dexilant 60mg. When working out, I go to sleep within an hour of running 1 mile, weight lifting gets me extremely tired now, now its not as bad, can work out longer. In may, all my allergies disappeared, now they are back but in first month I was no longer allergic to fruits. This is new and started in June, pimples on skull and ears, voice is normal now, may have grown taller, leg shins hurt when touched. Skin still very sensitive, awake longer now but when I work out I still get tired where I have to stop, sit, or nap.

The day after my vaccination my shoulder was sore at the injection site. As the day went on my inner right armpit really became swollen and uncomfortable.

4/15/21 woke up with severe pain in left upper thigh. Fatigue and headache began a few hours later. Needed to leave work. Early evening a rash developed in the left thigh and left foot swollen size of balloon and bright red. Went to the ER 10:30PM, admitted from ER on 4/16/21 for possible deep vein thrombosis and cellulitis of left leg. Shortly after admission, unable to obtain venous access, central line inserted for IV fluids and IV vancomycin and Zosyn. Foot swelling increased up to below knee with bright red skin color. No open wound noted on extremity. Ultrasound did not find a thrombosis but enlarged lymph nodes. 6 days later leg still swollen and red, repeat doppler ultrasound negative, but report stated could not compress to complete test due to severe swelling. He was also tachycardic and hypertensive during admission. Infectious disease doctor consulted and confirmed severe cellulitis but it was written in discharge summary the covid vaccine can not be ruled out as a cause of the infection and admission. Lasix was initiated to decrease swelling in lower extremity. He was on SQ heparin 3 times a day during the admission. He was discharged on Doxycycline and Augmentin. After discharge saw primary care physician who palpated large lymph nodes in neck. Mild headache persists. Ultrasound of neck to be completed on 4/27/21. Started on Tizanidine for pain.

I started to have an allergic reaction to my face after my vaccine. I noticed it at night that my face was getting swollen. I went to an unspecified hospital where they performed lab work, administered steroid injection and also gave me Benadryl. My symptoms started to resolve or so i thought but by the next morning when I woke up, my face was more swollen and I again went to the unspecified hospital where lab work was performed and my symptoms lasted for one week.

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

Patient developed pain in the left lower leg about 8 days post vaccine, progressively worsening over time, with associated swelling and spread of discomfort to the thigh. Presented to urgent care on 5/23/2021 and was felt to have findings suspicious for deep vein thrombosis. See item 19 for details on test results.

Syncopal event approximately 1 minute after vaccine was administered. Woke up on floor to EMS. Sustained bump on left forehead with persisting headache but no follow-up care sought.

hives, angioedema (other s/s fever/bodyaches/HA) improved in 2 days. Started on 3/27. By the time pt called much improved.

Patient's mother called to report a new fever 3 weeks post-vaccination. Fever reported was 102.6. Patient also experiencing muscle spasms in his mid to upper back as well as a swollen lymph node in his leg.

It has been 25 days since I took the AZ vaccine. Below are the side effects and significant blood test results: Day25: INR 1.29, CRP 4.8 Day 20 INR 1.05 In addition, I have been having an ongoing 37.3 fever since day 15 which goes back to normal 36.5 at night. Moreover i have been having light bruising on the arms and fee without any physical impact. my blood vessels / veins on hands, arms and legs are inflamed and cleary visible. i have been also having a feeling of tiredness and fatigue. Please advise on what I should do. Regards

progressive lower leg weakness, numbness is lower chest, abdomen, pelvis, lower extremities, started on day after vaccination received assessment by neurologist consistent with clinical diagnosis of Guillain-Barre Syndrome

Major symptoms, roughly 20 hours after vaccination, 10-15 minutes after waking, while walking and standing: - Extreme pain in right hip joint. Pain is sharp, stabbing, burning. Pain radiates down leg, and right foot numb and tingly - Overheating - Lightheadedness, blurred vision, confusion - Fainting or loss of consciousness, falling to ground Timeline of events: 2021-04-08 13:00 Injected with Johnson & Johnson 13:00 - 13:15 Very slight nausea 13:15 - 22:00 Very slight nausea and fatigue 22:30 Lymph nodes in neck feel swollen, ears feel slightly clogged (typical early cold symptoms) 23:30 Insomnia and chills 2021-04-09 00:00 - 07:30 Insomnia, poor sleep, and cycles of chills and overheating while trying to sleep or sleeping. Stronger nausea than before 07:30 Wake up, knees feel slightly weak when walking 07:35 - 07:40 While walking inside a market. Right hip joint begins to hurt with sharp, stabbing, hot pain. The pain radiates down right thigh. Right foot begins to feel numb and tingle. This pain increased over 5 minutes, to excruciating levels, with right leg feeling numb, and sharp stabbing tingles in right foot. Difficult to walk normally 07:40 - 07:45 Pain becomes overbearing, and market counter used for support. Begin to feel light headed. Begin to feel hot, and begin to overheat within ~2 minutes. Walk outside market (outside temperature 32 - 40F) to cool down. Lean on car hood for support, and become increasingly lightheaded. Vision becomes blurry. Stumble and fall onto face. Regain consciousness after unknown time, groggy and with blurred vision, lightheaded feeling. Attempt to stand and fall again onto face. Regain consciousness after unknown time. No longer feeling extremely hot. After roughly 1 minute, regain clear vision and lucidity. Pain in hip and leg completely subsided 07:45 - 09:00 Driven to hospital. Treated by hospital staff for laceration in forehead requiring 7 sutures. EKG reports normal. Concussion check negative. 09:00 - 00:00 Occasional nausea, fatigue, weakness (same as weak cold) 2021-04-10 11:00 While walking and standing in line. Right hip joint begins to hurt, with pain radiating down right thigh. Right foot begins to feel numb and tingle. Begin to feel warm. Hip Pain remains at manageable level, and walking normally is easy. Hip pain is roughly 1/3 of pain of 2021-04-09. 2021-04-11 07:30 - 11:00 Occasional slight pain in right hip and left hip joints. Hip pain is sharp and burning, and roughly 1/10 of pain from 2021-04-09.

Left arm remains swollen 1 week after vaccine. It feels like a large gold ball is in the arm. Very sore to touch.

MARCH 9: BODY ACHES AND HEADACHE, SLEEPLESSNESS. CONTINUED OFF AND ON OVER FOLLOWING DAYS. MARCH 18: BLOOD PRESSURE AND PULSE WERE TOO HIGH TO DONATE PLASMA MARCH 21: DIDN'T FEEL NORMAL, GASTROINTESTINAL ISSUES, FATIGUE, SLEEPLESSNESS, ABDOMINAL PAIN, RAPID WEIGHT LOSS, LOSS OF APPETITE MARCH 26: URINE STARTED DARKENING TO ORANGE COLOR DESPITE STAYING HYDRATED, FEVER, MALAISE. APRIL 1: WENT TO DONATE PLASMA AT BIOTEST PLASMA CENTER AND NOTICED BLOOD PLASMA WAS AN ODD COLOR. APRIL 4: EMERGENCY ROOM PRESENTED WITH ABDOMINAL PAIN, JAUNDICE, WHITE/LIGHT COLORED STOOL. BLOODWORK, ULTRASOUNDS, CT'S WERE DONE AND SHOWED INFLAMMATION IN LIVER/GALLBLADDER/GI TRACT. HIGH BILIRUBIN. APRIL 5: COLONOSCOPY PERFORMED. DIAGNOSIS: ULCERATIVE COLITIS. ERCP PERFORMED WITH LIVER BIOPSIES. DIAGNOSIS: COMMON BILE DUCT BLOCKAGE WITH CHOLECYSTITIS AND HEPATITIS. STENT WAS PLACED. POSSIBLE PRIMARY SCLEROSING CHOLANGITIS- DEPENDING ON BIOPSY RESULTS. APRIL 6: CHOLECYSTECTOMY, MORE LIVER BIOPSIES TAKEN. APRIL 7: LIVER BIOPSY RESULTS/DIAGNOSES: OVERLAP SYNDROME OF AUTOIMMUNE HEPATITIS & PRIMARY SCLEROSING CHOLANGITIS. PLACED ON PREDNISONE. AWAITING APPROVAL FOR REMICADE INFUSIONS WITH POSSIBLE NEED FOR LIVER TRANSPLANT IN THE FUTURE AS PSC PROGRESSES. AS OF APRIL 18: JAUNDICE STILL PRESENT, BILIRUBIN NOT DECREASING. BEING REFERRED TO MEDICAL CENTER FOR FURTHER OBSERVATION AND TREATMENT.

TWO LUMPS ON LEFT SIDE OF NECK; ITCHINESS; PAIN; FATIGUE; FELT FEVER; CHILLS; MILD MUSCLE ACHES; This spontaneous report received from a patient concerned a 35 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: 21-JUNE-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced mild muscle aches. On 10-APR-2021, the subject experienced felt fever. Treatment medications included: paracetamol. On 11-APR-2021, the subject experienced fatigue. On 13-APR-2021, the subject experienced two lumps on left side of neck. On 13-APR-2021, the subject experienced itchiness. On 13-APR-2021, the subject experienced pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, mild muscle aches, and felt fever on 11-APR-2021, and fatigue on 13-APR-2021, had not recovered from two lumps on left side of neck, and the outcome of pain and itchiness was not reported. This report was non-serious.

After take it , there are some herpes coming out around the right eye. I visit at urgent care and the MD provide the prescription. Sulfamethoxazole, acyclovir & trifluridine ophthalmic solution 1% eye drop. Also, the skin is itchy with small red bumps. So far the symptoms of itchy skin is stronger than before.

35 Y/O MALE WITH NO SIGNIFICANT PMH PRESENTED TO EMERGENCY ROOM WITH ACUTE DIFFICULTY WITH MOUTH MOVEMENTS STARTING 18 DAYS AFTER JNJ COVID VACCINE. REPORTS DIFFICULTY WHISPERING, SMILING, PREVENTING LIQUIDS FROM LEAKING WHILE EATING. PATIENT IS UNABLE TO WRINKLE FOREHEAD, HAS SIGNFICANT WEAKNESS OF EYE CLOSURE WITH INCOMPLETE EYE CLOSURE ON BOTH EYES. NEUROLOGY DIAGNOSED PATIENT WITH BILATERAL PERIPHERAL FACIAL NERVE PALSY THAT IS LIKELY DUE TO GUILLAIN-BARRE SYNDROME VARIANT.

Severe headache, weakness, sudden loss of energy, drowsiness, blurred vision, loss of balance. The day of vaccination, it was mainly the severe headache and some swelling in my face. Mainly along my jaw line and gums. Day 2 all of the other effects I mentioned above hit me when I woke up and persisted until today. Still feeling some of it, mainly a slight headache, some loss of balance and I still get hot and start sweating at random times for no obvious reason.

The night after receiving the vaccine I started to develop a fever and headache. It lasted 3 days for the fever. On Tuesday I felt something different in my body. On Thursday I went to see an Optometrist. While there he found that there was something going on in my eyes. He noticed there was blood clot in the back of my right eye. I did go to the ER because of the blood clot. At the ER I had a CT scan and bloodwork completed. I was told that everything looked normal and I was told to go to a different hospital. I was transferred to Medical Center. While I was there they performed an MRI, CAT scan and Lumbar function test. I was told that everything looked fine from the neurology point of view. I need to follow up with an Ophthalmologist. I have gone completely blind in my right eye and my left eye is not clear anymore. On 05/20 I had an appointment with the ophthalmologist. There was something wrong with my optic nerve as well. There was a test performed 05/21. I went back to the doctor on 05/26 he said that the reports he received are not making sense to him. My next f/u appointment with Dr. is 06/09 because the doctor asked to have2 weeks to read through my hospital reports. I saw a different doctor instead on 05/27, Dr. , and he said that this can happen from the vaccine. He said that there is a swelling and I need to see a different doctor about my retina. I was told that I need to see another physician. I saw Dr. . on 05/27 and he said that there are fluids there, but no one can confirm that this is because of the vaccine. He gave me the option to take prednisone 10mg and I feel that it is working, but it is very slow. It was moved to 3x per day. I can see objects now even though it's still not clear. I have a f/u with Dr. 06/03.

Patient recieved Johnson & Johnson on 6/8/2021. Developed muscle aches with facial swelling on 6/11/2021. Came to urgent care on 6/28/2021. Evaluated by doctor . Sent home in stable condition.

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

Johnson & Johnson Vaccine on Saturday, April 10, 2021 - 1 p.m. 11 p.m.: Sharp pain inside of L thigh Sweats, Chills, escalating fever All night, fever increasing to 103 High blood pressure 160/130 Sweats Lymph nodes very swollen No sleep overnight Sunday, April 11, 2021 Aches and pains both legs Fever continued through Sunday 100F Migraine started at daybreak, lasted all day (Lots of Tylenol and Advil, alternating) Arm with shot started to hurt Few hours of sleep was interrupted again by inside thigh sharp pain in L leg Monday, April 12, 2021 Running fever 100 Blood pressure high Arm started to show rash in the evening Woken up with sharp pain in L leg. Caused limp all day Monday. Fever broke Monday evening. Tues., April 13, 2021 Sharp pain in L leg Leg felt hot Called physician, no return call Called pharmasist, told me to go to ER due to J&J Blood clot potential issue and my symptoms Went to the ER, long wait to get an ultrasound on L leg to make sure blood flow normal Released Didn't sleep well. Continued to have leg pain took advil to get rest Wednesday - Thursday, April 14-15, 2021 Felt sore on leg, went about my day normally Was in Bed at 11 p.m. Friday, April 16, 2021 Was woken by sharp pain under L armpit 1 a.m. and left arm hurt/sore Took Tylenol and Heartburn meds had trouble falling back asleep Fell asleep 4 a.m. Woke up 8:30 a.m. with sharp pain under armpit still Blood pressure 145/112, ten minutes later 145/108 Called my physician again and they told me to drop everything and goto a different ER to get an angiogram done - The first ER did almost nothing that needed to be done according to the physician.

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

36 Y male patient from another country with a past medical history significant for mild HTN (on 2.5 mg amlodipine) who was in his usual state of health until approximately 4/17/21 when he developed acute onset left volar forearm tingling sensation. He had received the Johnson & Johnson vaccine on 4/2/21 in his left arm and states that he did not experience any noticeable reactions after vaccination. He also recalls having had sustained a minor superficial scrape on his left volar forearm by a trash can lid when he had taken out garbage, which occurred very shortly before the onset of this tingling sensation. The tingling sensation then progressively worsened and became more diffuse across most of his body. He then developed fevers up to 102 at home, chills, neck pain, headache, and pain in all extremities (primarily arms but also in his legs). He initially went to the Health Care ED on 4/28/21. He was afebrile at the time and his vital signs at that time were unremarkable with the exception of elevated diastolic blood pressures (90-104 mm Hg). WBC 10.1 with normal differential, electrolytes and liver enzymes within normal limits. Influenza, RSV, and SARS-CoV-2 PCR were negative. Urinalysis showed few bacteria but no WBCs. Chest x-ray was clear. Blood cultures were drawn and patient was then discharged. Patient returned to the ED on 4/29/21 and reported fever to 102-103 d F, chills, nausea, weakness, body aches, and bilateral foot paraesthesias. He was afebrile (98.8) and his vital signs were within normal limits. His WBC was slightly elevated to 12.2 with a normal differential. His ESR was 11, CRP 1.5, CMP within normal limits. He was noted to have urinary retention and a foley was placed and he was given tamsulosin. Patient then returned to the ED again the following day, on 4/30/21, with worsening generalized pain and weakness and difficulty walking. ED course: temperature 101, heart rate 100s-110s, BP 140s-160s/70s-90s, RR low 20s, SaO2 high 90s. Labs remarkable for WBC 13.1 with 82.4% N, ESR 7, CRP 5.9, lactic acid 2.6, RF 10, urinalysis unremarkable, HIV antigen/antibody negative. Several imaging studies were performed. MRI T spine showed "Extensive cord signal abnormality in the cervical and thoracic cord as detailed above, with associated expansion of the cord (most pronounced in the cervical cord). Differential includes acute transverse myelitis, demyelination, infection (HIV, syphilis, other viruses)/parainfectious phenomenon, subacute combined degeneration, and inflammatory etiologies. An underlying mass or masses are not excluded but less likely given extensive multifocal patchy involvement. Recommend postcontrast imaging at this time for further workup. Consider brain MR as well to assess for systemic white matter disease." A lumbar puncture was attempted in the ED but was unable to be performed. Patient was given empiric IV ceftriaxone 1 g q24h and admitted to the hospitalist service. He was evaluated by neurology and was started on Solumedrol 1000 mg for acute transverse myelitis. 5/1/21 MRI brain showed "Multifocal patchy white matter signal changes, predominantly in the subcortical white matter, also present in the bilateral thalami and bilateral middle cerebellar peduncle, and redemonstration of extensive cervical cord signal abnormality and expansion. No associated restricted diffusion or enhancement. Broad differential, but given pattern of involvement findings are most concerning for ADEM (acute disseminated encephalomyelitis), other considerations include other demyelinating processes, toxic-metabolic pathology, or potentially atypical viral infection." Patient was given methylprednisolone for ADEM with transverse myelitis and clinically improved. He was hospitalized from 4/30/21 until being discharged to home in a wheelchair on 5/6/21.

Swelling of fingers and feet the next day after receiving the vaccine. It has been over 2 weeks and I still have swelling of my fingertips, hands, and feet. I also have excessive dryness on both hands and feet. My fingers feel like they are secreateing sticky moisture. Fingers feel sticky like they have glue on them.

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

I had swelling of the face, and cold sore on my lips, did have a hard time the first day after 40 minute swelling of throat

Pt admitted to the ICU on 3/22/21 w/ pleuritic chest pain and shock requiring vasopressors. At time of admission pt had been taking antibiotics for an upper respiratory infection for 3 days. Echo Lv 40-45% upon admission. Pt was determined to have myopericarditis. On 3/24/21 pt was transferred to the cardiac intermediate unit. Endocrine consulted while in the cardiac intermediate unit to control his elevated blood sugars- endocrine team unable to determine if blood sugar is type 1 or type 2. on 3/27/21 pt went into respiratory distress required bipap & high flow nasal cannula and had a fever. Pulmonary consulted at this time- determined to be related to pulmonary edema and not a PE positive for pleural effusion. ID has been negative up to this point. 4/9/21 pt transferred to internal medicine service for work up for fever of unknown origin and continued management. Rheumatology consulted for leukocytosis, anemia, and elevated IgG. Ruled out connective tissue disease, stills disease, and vasculitis. Histoplasma was borderline positive pt has had recent bat exposure. Bone marrow biopsy done on 4/13/2021, ruled out HLH. Bronch done 4/15 to assess for TB, histoplasma, negative results so far. As of 4/15 no recommendations from ID and patient continues to look weaker/fatigued and spikes fever.

red bump from injection itchy at injection almost passed out at the gym this morning was dizzy and need to sit for a moment on the floor

Shingles outbreak on left side of face/ head beginning ~ 5 weeks after Janssen Covid vaccine (fever, inflammation, blisters, rash, swelling, nerve pain, headache, occular complications)

After receiving the J&J Covid vaccine I was awake all night with fever and chills, which I understand is completely normal. However the next day my upper lip and lower nose swole up in an allergic reaction. I took Benadryl and went to sleep and by the time I work up it had subsided. Two days after that incident I woke up (this morning) and my left cheek was swollen from another allergic reaction. During this time I had not eaten or taken anything out of the ordinary.

This spontaneous report received from a patient concerned a 37 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 the patient had no known drug 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: 206A21A, and expiry: 07-AUG-2021) dose was not reported, administered on 14-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-JUN-2021, the subject experienced flushing in face. On 15-JUN-2021, the subject experienced tiredness. On 15-JUN-2021, the subject experienced headache. On 16-JUN-2021, the subject experienced swelling occurring at both sides of eyes temple regions. On 16-JUN-2021, the subject experienced muscle tightening at corners of mastoids. Treatment medications (dates unspecified) included: ibuprofen. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flushing in face on 14-JUN-2021, and tiredness on 16-JUN-2021, was recovering from headache, and had not recovered from swelling occurring at both sides of eyes temple regions, and muscle tightening at corners of mastoids. This report was non-serious.

Headache, arm and shoulder pain- 06/24/21 4pm Fever, chills, body aches- 06/24/21 11pm Lumps under right underarm- 06/26/21 8am Lumps under left underarm - 06/28/21 8am

About 9 hours after receiving the vaccine I began developing flu-like symptoms, which quickly escalated. Within a couple of hours I developed a very high fever (which peaked at 104.1 and hovered around 102-103), body-wracking cold chills, extreme lethargy and body aches. The only thing that kept my fever down was 1,000mg of Tylenol every 6 hours, with a cold compress on my head. The symptoms were less severe but still substantial by the following day. On the second night after receiving the vaccine (Monday the 8th) I had nightsweats, but then woke up on the morning of Tuesday the 9th feeling almost completely back to normal. The only other strange thing to happen was waking up today on Thursday the 11th with a giant fever blister on my lip, which I suppose could be attributed to an immune system in temporary disarray or overdrive. I am still very grateful for the vaccine and would do it again, but it was very scary that first night on Sunday the 7th. I don't remember the last time I felt that sick.

Vaccine 3/8/21 at 4:00 PM.Headache and fever 3 hours post vaccine. The following day had diarrhea and vomiting. Then presented to ER on 3/10/21 with lactic acidosis, & leukocytosis. Hospitalized for 24 hours 3/10/21 to 3/11/21.

allergic reaction. Rash, itchy to BLE and BUEs x 2 days with swelling; pt reports mainly in joint areas, getting worse today and spreading; received J&J vaccine on 10MAR21. Rash with redness and itchiness to BUEs/BLEs; no pain; patent airway. MDM: Pt does not have anaphylaxis. The temporal relationship to COVID vaccine is suspicious. Will treat as allergic reaction. F/u and return precautions discussed.

4/5 (Day of vaccine)- slight headache. 4/6- worsening fever, chills, flu- like symptoms, excruciating headache. 4/7: resolving symptoms, but small (grape sized) lump under Right Axilla. 4/8- Lump size of an apple. Contacted the facility. In for examination (internal medicine) (infectious disease): Reactive lymphadenitis. soft, moveable, non-tender, not red/inflamed. recommended ice and tylenol as needed and to contact clinic of not resolving within a week.

3/28/21 started to have jaw pain. 4/2/21 a lump started to form in neck. 4/3/21 lump in the neck and evening broke out with lesions on the left side of forehead, nose and temple. Went to ER for evaluation, CT scan with contrast. CT confirmed lump was swelling of lymphoid. ER thought maybe shingles, but it crosses over slightly over to the right with lesions.They determined maybe a virus and follow up with a dermatologist. 4/4/21 lesions now on left eye lid. ER visit again to ensure eye is ok, the ER dr. believes its shingles. 4/5/21 visit to dermatology and swab of lesions on face taken (still waiting on results). Dermatology believes some kind of herpes, but not sure. Went to Eye specialist to ensure eye does not have virus on same day. Eye dr believes shingles. Virus is not in the eye, but on left eyelid.

4/1 pt complained of not feeling well after Janssen vaccine. Patient had a syncopal episode while at monitoring tent, patient was trying to lay down on medical bay cot but ended up falling back and passing out. Pt was clammy and pale. Heart rate 42, spO2 99%. Pt oriented to self but not time or place. EMT arrive to further evaluate patient, BP 90/60. heart-rate 55, respirations 18. Patient refused to go to hospital, felt well enough to go back to work. Charge nurse followed up with patient later that day, patient was still at work and said he felt a lot better. One week later pt reached out on 4/8/2021 to inform on potential side effects. On the night of 4/7/2021 he began to develop hives/rash, and itchiness around the neck and legs. Next morning 4/8/2021 rash had worsened and pt had also developed swelling in the face and wrists. Pt was brought to urgent care where he was treated with prednisone. Pt was prescribed 20mg prednisone tablet twice a day. Charge nurse from day of vaccine followed up with patient, he will continue to take prednisone as prescribed and will follow up with allergist. Pt claims the itchiness is less, as well as, the swelling. Appreciates the follow-up phone-call and claims to feel better, will update us if any changes.

Rashes all over different parts of the body causing severe itchiness and some swelling. Randomly appears in places and disappears after two or so hours.

Confusion, very tired, joint aches, at first. On Tuesday April 13, my husband woke up in pain to his left leg. The left leg had a painful softball sized hard lump on inside of knee and a little bigger than a golf ball hard lump on his calf. Had no treatment until April 18th

SWOLLEN FACE; BAD RASH ALL OVER BODY; PASSED OUT; This spontaneous report received from a patient concerned a 38 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, intramuscular, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on left arm on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the patient passed out and had no symptoms until seven days. On 07-APR-2021, the patient experienced pretty bad rash. On 08-APR-2021, the patient experienced swollen face and rash all over body which made him to visit an urgency clinic where he was prescribed with prednisone for rash. The patient visited doctor or healthcare professional office for events passed out, swollen face, and bad rash all over body and emergency room or department or urgent care for events swollen face, and bad rash all over body. It was reported that, the medication had not eradicated the symptoms but only calmed them down. According to the patient, if he had stop taking the medications the symptoms would go back to the same intensity as before. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passed out on 01-APR-2021, and had not recovered from swollen face, and bad rash all over body. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210422310-covid-19 vaccine ad26.cov2.s -Passed out. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

Within about 5 seconds of receiving the vaccination my arm felt extremely sore; approximately 30 minutes later it felt like the neck swelled up and I developed a headache; the next morning I had a severe headache, nausea, fever, chills, pain in my neck, and severe muscle aches that lasted for approximately 2 days; during that time I could not sleep or eat; my stomach felt off for about 10 days; the headache improved but lasted approximately 2 weeks; the swelling in my neck seems to have improved but has not gone away completely

PATIENT REPORT MODERATE RASH AND SWOLLOWEN BUMP ON NECK. I ADVICED PATIENT TO TAKE IBUPROFEN AND BENADRYL. I RECHECKED AFTER 2 HOURS AND PATIENT HAD IMPROVED IN SYMPTOMS

9 hrs after injection - chills and mild headache. Took ibuprofen and slept. 20 hrs after injection - extremely minor chills. Took ibuprofen and symptoms faded without returning. 44 hrs after injection - swelling under left arm (likely swollen lymph nodes) which is in close proximity to the site of the injection (left arm) Now: 96 hrs after injection - swelling under arm remains persistent without worsening or subsiding. Does not impede use of arm.

Extreme right sided neck pain. Still present and most problematic around occipital lymph node on the right side behind ear

I developed a very itchy rash on my back, hands, feet, arms and what felt like everywhere. The just today stopped. The rash lasted about 8-10 days I would say. It got worse over the course of a week and then started getting better. Someone suggested I take an anti-inflammatory, because my hands were swelling and it was difficult to work at the computer. That seemed to help immediately or it could've just started to go away on its own. Regardless, I've kept the twice daily naproxen for the past 4 days and things seem to be all better now. My wife suggested I report my reaction. The small red bumps were scattered mostly on my back, feet and hands. They looked very similar to shingles but without the big red splotches only the small red bumps. As they were forming they appeared to be sun blisters and then turned bright red. Extremely itchy and kept me up scratching at night and scratching all day.

Right eye twitch, right side of face swelling, pressure right side of face, shingles like rash up left side of torso. The rash lasted a week the face swelling and twitching non stop since about day 7 and has not let up

Hives, swelling in lips, face, metallic taste in mouth. Continuing even after ER visit at 4 am Wednesday morning and taking meds to control reaction

DIZZINESS; SLEEPY; BODY ACHES; SWELLING IN THE LEFT ARM AND LEFT FOOT; VOMITING; FEVER; This spontaneous report received from a patient concerned a 39 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808978,expiry: unknown) dose was not reported, administered on 05-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-JUN-2021, the subject experienced swelling in the left arm and left foot. On 05-JUN-2021, the subject experienced vomiting. On 05-JUN-2021, the subject experienced fever. On 06-JUN-2021, the subject experienced sleepy. On 06-JUN-2021, the subject experienced body aches. On 07-JUN-2021, the subject experienced dizziness. The action taken with covid-19 vaccine was not applicable. The patient recovered from vomiting, and fever on 06-JUN-2021, was recovering from body aches, and had not recovered from sleepy, swelling in the left arm and left foot, and dizziness. This report was non-serious.

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

Janssen Lot #043A21A COVID-19 vaccine administered Tuesday July 13, 2021 at 12:15pm. Wednesday July 14, 2021 - quarter sized spontaneous bruising to bilateral calves Thursday July 15, 2021 - dollar sized spontaneous bruising to bilateral calves; petechial rash noted to bilateral ankles and calves Friday July 16, 2021 - continued bilateral calf bruising; petechial rash spread from ankles to mid thigh bilaterally and bilateral shoulders and back Saturday July 17, 2021 - patient presented to urgent care and referred directly to Emergency Department; platelets found to be 7,000; bilateral lower extremity ultrasound negative for thrombi; admitted to Hospital Sunday July 18, 2021 - platelets improved to 29,000; patient discharged to home for outpatient follow-up of new diagnosis of Immune Thrombocytopenia Purpura Tuesday July 20, 2021 - outpatient lab (see medical tests and laboratory results) - platelets 198,000 Friday July 23, 2021 - outpatient lab (see medical tests and laboratory results) - platelets 264,000 Monday July 26, 2021 - outpatient lab (see medical tests and laboratory results); platelets 45,000 initiated 40mg daily oral Prednisone