Johnson & Johnson

Site: Swelling at Injection Site-Mild, Additional Details: After giving the vaccination, patient developed immediate reaction at injection site: warmth, swelling at the site. He did bleed a little and after putting on the bandaid, I went to grab an ice pack and I started applying the icepack to the site. Checked on patient every 5 minutes. Even did a follow up call to him an hour later and he told me he was doing okay. No more warmth in the area, some pain but the swelling had gone down substantially. I suggested to continue to monitor, apply icepack

seconds after administration patient started losing consciousness. he stated he previously experienced vasovagal syncope after flu shots. he went in and out consciousness several times over the next 5 minutes. he lost color in face and eyes closed when head dropped. his body was stabilized and kept alert with verbal and physical tests. cold compress was applied behind neck and BP monitor placed on arm. he had normal BP/pulse. skin color gradually improved as well as mental acuity. patient could stand after approx 10m and was observed for additional 30m. his phone was used to call his wife and someone came to assist getting home. said felt fine after full observation time and seemed to have made full recovery.

Patient received Janssen vaccine at 4pm and began having itchiness and redness at injection site at 4:10pm. At 4:23 patient was given an ice pack to apply to the area and 50mg of benadryl PO. Patient did not have SOB. At 4:28pm rash was still spreading to underarm and chest. Discussed possible future use of epinephrine due to history of anaphylaxis to spider bite, but patient had no SOB and emergency services was called at 4:34pm to assess patient. EMS arrived at 4:50pm and determined patient to be stable. Patient was given another 50mg Benadryl dose to take with him and instructions to call EMS if symptoms worsened.

Body aches around 6 hours after injection. Headache and fever shortly thereafter. Fever reached 102. Fever resulting in shivering with multiple layers of clothing. These symptoms lasted through the evening. Headache, fatigue and injection site stiffness and pain lasted for multiple days.

Chills, headache, bodyaches, nausea, and tiredness started overnight on 3/19 and lasted throughout Saturday. Woke up fine on Sunday, March 20th. The injection site was also sore for 2 days after vaccination, but is better now too. I did have Covid-19 in August of 2020.

During the day that I was administered the vaccine I had pain in my arm (area in where I was vaccinated). The next day, I woke up with general pain in the body, pain in the arm where the vaccine was injected and it swelled up a little the skin under the eyes (hives). As the day goes by, the pain in the arm has diminished, as well as the hives in the eyes.

Severe sharp pain at injections site started 2 weeks after shot. Shot site was very high in shoulder suspected SIRVA

Patient reported at 1210 with hx of allergy to PCN (reaction hives), cephalosporins. Patient reported flushed, L side of face warm, 0 dizziness, 0 lightheadedness, 0 CP, 0 SOB, PMH-0. Hx of feeling warm with injections. Water was provided to patient, snack was as well but declined. VS initially were 173/104, 102, 98% Sp02, R 16 unlabored. Repeated after water and assessment at 135/90. Patient left at 1226.

Experienced moderate debilitating flu symptoms day after vaccination and recovered the following day. Over one week later (3/25) developed skin sensitivity on the neck which later spread to back, torso, and legs. Skin sensitivity persists still one week after onset, is a severe chafing feeling when skin comes into contact with clothing. No rash or any visual signs. Along with the skin sensitivity, mild to moderate chills from day to day as well as muscle fatigue and upper/lower back pain. Symptoms varied in severity day to day; used ibuprofen and it seemed to offer limited, temporary relief. Concurrent with second onset of symptoms, noticed gradual abdominal inflammation and developed sensation similar to UTI but urine dip and lab test results were all normal. Doctor concluded immune reaction to vaccine as no other allergies or changes in routine as well as no prior medical history of any of these symptoms. Prescribed daily prednisone for three days to calm immune response; after one day symptoms were greatly improved. Abdominal inflammation has improved and UTI sensation improved. Still experiencing slight chills and skin sensitivity unchanged.

Started with itch on left inner thigh that turned in several raised bumps that resembled hives. After about an hour, it went away. Several hours later, I started having the same reaction on the sides of my torso, under my arms to my waist line. I had a virtual doctor visit that evening where the doctor prescribed Prednisone 20mg for 5 days and Benadryl. Saturday, April 3rd, took second dose of Prednisone and continued Benadryl every 4 hours. Symptoms were better in the late morning and early afternoon then started getting worse. Started getting the hives on my arms, legs, and started spreading to my neck, back of my scalp, and onto my face. It got worse at the night progressed and I went to a 24 hours urgent care at 2am on Sunday, April 4th. The doctor checked me out and noting the severe case, increased my prescription to 60mg Prednisone, decreasing 10mg every day, and Famotidine 20mg daily, Clairitin in the morning, and Benadryl at night. Taking the 60mg of Prednisone on April 4th has drastically reduced the symptoms. I will continue the regime to determine if the issue goes away completely.

CHILLS; FEVER; BURNING SKIN; HOT FLASHES/FEELING HOT; FATIGUE; This spontaneous report received from a patient concerned a 40 year old male. The patient's weight was 77.1 kilograms, and height was 175.26 centimeters. The patient's concurrent conditions included seasonal allergy, alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. The patient was previously treated with diphtheria vaccine toxoid/pertussis vaccine acellular/ toxoid for prophylactic vaccination; and experienced reactions to vaccines when treated with diphtheria vaccine toxoid/pertussis vaccine acellular/tetanus vaccine toxoid, and tetanus vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808609 expiry: 09-JUN-2021) dose was not reported, administered on 19-MAR-2021 14:00 in the right arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced hot flashes/feeling hot. On MAR-2021, the subject experienced fatigue. On 19-MAR-2021, the subject experienced burning skin. On 19-MAR-2021 22:00, the subject experienced chills. On 19-MAR-2021 22:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning skin, hot flashes/feeling hot, chills, fever, and fatigue on 20-MAR-2021. This report was non-serious. Additional information was received from the patient on 30-MAR-2021. Following information was updated into the case: other identification numbers added, patient's contact details added (address, city, zip code, email address and phone number), patient demographics added (age ,age group, gender, height, and weight), concurrent condition added ( seasonal allergy, non-smoker, alcoholic), event added (fatigue and hot flashes/feeling hot), past reaction added( reactions to vaccines), suspect drug route of administration added ((intramuscular), vaccination time added, past drug added (Tetanus and TDAP) and due diligence updated.

Site: Bruising at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Severe, Additional Details: vasovagel reaction pt layed down on floor with legs elevated for 30 min felt better and coloring came back to skin and he was released, tried to call at 5 pm after clinic to follow up to see how feeling no answer on above phone number

Approximately 5 minutes after the patient received his vaccination, he rested his head on the wall behind him in the chair he was being observed in and passed out and turned white. His wife began slapping his face and screaming his name and the observer called for me. I arrived within seconds and assisted his wife in moving him from the floor to the chair. Within seconds of getting his head to the ground safely, he came back to and was very sweaty, red in the face. He stayed on the ground laying down, and then sitting for approximately 25 minutes. During that time, he told us that he had previously passed out during 3 procedures done at doctors offices. We got him an ice pack and a orange pop as he was complaining of being hot and having only eaten a granola bar all day. He was able to get up to a chair and sat there for an additional 5 minutes, before he was able to walk out on his own accord. I have spoken with the patient twice since, once last evening and once today and he reports he feels great now besides the expected body aches from the vaccination.

Body aches, headache, weakness in the receiving arm and hand, feels like the injection site is on fire (very painful 7 on the pain scale), my phantom pain is going nuts in my missing left forearm and hand (very painful too 7 on the pain scale)

Patient was vaccinated at a pharmacy around 9AM in the morning. An hour later, he was driving on a highway, had a syncopal event and was involved in a single-vehicle MVC where his vehicle struck a guardrail and rolled twice. Patient was brought to the ED at Hospital where he was evaluated by me in the ED. Patient had a normal mental status (GCS 15) and was alert and oriented on exam. He did have some bruising to his forehead from the airbag. Patient denies feeling ill or lightheaded after receiving the vaccine and reports the syncopal event came on very suddenly.

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.

Rash on both arms, started the next day, still there a week later. no treatment Sore throat, next day still happening. Nausea started next day. went away two days after Fatigue. day after and went away after that.

Starting from 04/07/21, Sudden waist and back pain, cannot straighten up the body. When straighten up the body feels breathing difficulties . After 3-4 days there?s a continuous pain in both thigh and the calf, and red marks are spawning on the legs.

Client returned to the clinic with c/o flushing and feeling very hot, numb, tingly lips, itching on the face. Benadryl 50 mg PO given. Patient added some of the previous c/o after the initial communication. Improvement after 15 minutes. Client remained with the Facility HCP.

Pain in chest and back began on Wednesday 4/14. What started out feeling like an uncomfortable pulled muscle in my back/chest area on Wednesday escalated rapidly to very sharp stabbing pains in my chest and back by Thursday afternoon 4/15. After discussing my symptoms with the office of my PCP Thursday afternoon, I was told to go to the Emergency Room for evaluation. I checked into the ER at approx 6pm that Thursday evening on 4/15. While there I underwent a blood test, EKG and a chest Xray. Upon evaluating the results of each test the Dr on assignment stated that there were no problems with major organs but could not diagnose. Small red marks began developing on the right side of my chest that same day and progressively expanded in quantity across the right side of my chest and back. A follow-up visit with my PCP was completed on Tuesday 4/20 and the diagnosis of Shingles was confirmed. Pain has not subsided and has only gotten worse as of 4/21. Prescription treatments began the evening of 4/20.

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.

The evening of the vaccination I began experiencing tingling at the site of the shot, then this extended through the night to chest pains and tightness in the chest. That continued through the night and into the following day. The following day and lasting until present (4/27/2021) I have continued to experience tingling at night, extending to my arm and fingers, random very sharp pains in my chest, and some feeling of strong heart throbbing. This subsides during the day-time (when I'm upright versus lying down) but all of these symptoms return during the evening. These are all things I never experienced prior to the vaccine. Also, I have tested regularly for COVID-19 since my companyconducts covid-19 testing and I have not been infected with COVID-19 at any point during the past year. The continuation of these symptoms is concerning. There have been at least two instances where the sharp pains in my chest were much more intense than the other chest pains I have felt since the vaccine.

BRUISE AT THE INJECTION SITE; SORE AT THE INJECTION SITE WHEN PUSHED; This spontaneous report received from a patient concerned a 40 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: UNKNOWN) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 26-APR-2021, the subject experienced bruise at the injection site. On 26-APR-2021, the subject experienced sore when pushed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bruise at the injection site, and sore when pushed. This report was non-serious.

My face went numb for several hours a day and a half after injection. I also had extreme fatigue, headaches, and pain and swelling at the injection site for 7+ days.

patient complained of pinching at the site left arm deltoid and pressure to the chest area which lasted for 1 minute. Vital signs taken and EKG done. Sinus rhythm on EKG result. Patient discharged home.

Patient within a few minutes indicated he felt dizzy and sweaty. I sat him down within minutes his eyes rolled back and he lost consciousness. He bagan to make gurgling noises as if trouble breathing. His color was grey and he was sweating profusely. 911 was called by a technician and I gave one dose of Epinephrine 0.3 mg into lateral right thigh at approx. 9:40 am. Within this period of time he began seizing. He regained consciousness prior to EMT's arriving and was brought to the hospital.

After about 13 days I developed a bald spot on the left side of my head. It appears the hair follicles are dead. It has been over a month since this first appeared with no evidence that it is getting better.

STOMACH HURT; VOMITING /THREW UP BROWN LIQUID; CAN'T EAT OR DRINK ANYTHING; FEELING COLD; BODY CHILLS; WEAKNESS; LEFT ARM PAIN; HEADACHE; NAUSEA; 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 penicillin allergy, non smoker, and non alcoholic. The patient experienced drug allergy when treated with amoxicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 21-MAY-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 21-MAY-2021, the subject experienced stomach hurt. On 21-MAY-2021, the subject experienced vomiting /threw up brown liquid. On 21-MAY-2021, the subject experienced can't eat or drink anything. On 21-MAY-2021, the subject experienced feeling cold. On 21-MAY-2021, the subject experienced body chills. On 21-MAY-2021, the subject experienced weakness. On 21-MAY-2021, the subject experienced left arm pain. On 21-MAY-2021, the subject experienced headache. On 21-MAY-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting /threw up brown liquid, left arm pain, and nausea on 21-MAY-2021, had not recovered from headache, body chills, stomach hurt, weakness, and feeling cold, and the outcome of can't eat or drink anything was not reported. This report was non-serious.

Headache, fatigue, muscle ache (mainly in back), joint ache (legs), soreness at injection site. All of these started within 6 hours of having been vaccinated. Alternating ibuprofen and acetaminophen provided good relief for muscle/joint ache. This also reduced the severity of the headache, but did not relieve it. Headache, muscle ache, and joint ache resolved by 40 hours post-vaccination. Mild fatigue/tiring more easily gradually improved over the next 48 hours. I took one day of sick leave from my job to rest.

Patient received COVID-19 vaccine. After approximately ten minutes of sitting in the waiting area, patient began feeling ill. As he was walking up to the drop-off window to tell staff how he was feeling, he fainted and hit the back of his head on the ground. Patient was unresponsive so 911 was called. Patient was extremely pale, hot, and clammy, but slowly started to regain responsiveness. Patient reported blacking out. While waiting for paramedics, two cold ice packs were applied to the patient's head and neck. Paramedics arrived and assessed the patient. They released him from their care as free to go. Patient sat down outside the pharmacy for approximately ten more minutes. Once he decided he was feeling better, he walked around outside the pharmacy until he felt okay to leave. Prior to leaving, patient reported he was feeling better and appeared to be in good spirits. He also reported having fasting labs drawn 45 minutes prior to receiving the vaccine, as well as low blood pressure at his doctor's office. He confirmed ability to drive. Patient left the pharmacy approximately 45 minutes after receiving the vaccine.

Had Janssen Covid 19 vaccine 5/3/21 on 5/12/21 Urticaria started face Dermatographic Urticara dx on 5/13 Just diagnosed.

After 3 weeks, small rashes along the arms, minor coughing, occasional breathlessness, and mild diarrhea began appearing. Currently about 4 days of these symptoms. The week immediately after the injection, only minor itching about the body and nothing else. This might all just be a delayed response, but I'd like to note this occurred.

Developed petechial rash to bilateral lower extremities, scattered petechiae to bilateral upper extremities 3 weeks after vaccination. Denies all other medical complaints.

Pt was vaccinated without issue. Pt advised to sit for 15 mins. After being in observation area for 5 mins, pt stood up and immediately fainted and fell to the floor hitting head on floor. Pt had some bleeding from small laceration on head. 9:50am VS BP 130/80, P 60. Rescue called and was brought to ED for evaluation since he hit his head.

INSOMNIA (COULD NOT SLEEP FOR THREE TO FOUR NIGHTS); COUGH; BODY ACHE; SORE THROAT; FEVER; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 40 year old male. The patient's weight was 169 pounds, and height was 66 inches. The patient's concurrent conditions included alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies, no drug abuse or illicit drug usage and no pertinent medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A, expiry: 07-AUG-2021) dose was not reported, administered on 08-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-JUL-2021, the subject experienced injection site pain. On 11-JUL-2021, the subject experienced sore throat. On 11-JUL-2021, the subject experienced cough. On 11-JUL-2021, the subject experienced body ache. On 11-JUL-2021, the subject experienced fever. On 15-JUL-2021, the subject experienced insomnia (could not sleep for three to four nights). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on 09-JUL-2021, and fever on 14-JUL-2021, was recovering from body ache, and insomnia (could not sleep for three to four nights), and had not recovered from cough, and sore throat. This report was non-serious.

Chills, fever over 102.1 for 5 hours, extreme burning sensation in stomach, cramps in stomach for over 24 hours. Extreme fatigue for over 24 hours. Pain, soreness, and raised area at injection site.

Rash development 4x4 inch on back of neck and shoulder base, small 2 inch section of left side, abdominal region, upper left chest base of neck 2x2 inch section and small bumps 3 inches below bellybutton( no growth there). Taking Benadryl 4hr. And using topical hydrocortisone cream.

Metallic taste in mouth - 5 min after injection Ringing ears - 45 min after injection Pain at injection site - immediate after injection

Neck pain, back pain, fatigue, weakness, muscle soreness in back, injection shot pain, headache, out of sorts - all lasted from 3-4 hours after shot for approximately 48-72 hours

Getting blisters all over body including in mouth, very similar to , if not, chickenpox. A big bluster on the injection site. Taking Valacyclovir/Valtrex

At 12:05 am client came to the staff office treatment facility stating he feels sick and has been throwing up. He stated he had the Johnson & Johnson vaccine Tuesday 4/6/21 in the morning and around 6 pm on Tuesday he started to feel sick. The staff took his temperature and it was 100.9 degrees. The client was dry heaving and red in the face and having cold sweats. Staff monitored him while 911 was called and paramedics showed up within 10 minutes. The Program Manager was notified and the client was given instructions for when going to the hospital.

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

Itchy burning hives covering my entire body 12-36 hours after being vaccinated. Between those hours I took benadryl and used cortisone cream, which helped slightly. I went to e.r.in the night as advised by my doctor, where I received a steroid, some benadryl and pepcid. I woke up the next morning feeling much better with little to no signs of hives

Hives start forming 12 hours after receiving vaccine. When I woke up in the morning my body was covered in hives. I went to e.r. in the night as advised by my doctor. They gave me a oral steroid, a pepcid and some benadryl, also gave me prescriptions. When I woke up the next morning hives had mostly gone away, but returned later that evening due to not picking up prescription from pharmacy. I have it now and am taking them. I still get itchy and have some burning but it's very minor and a little more tolerable with the medications.

Headache and shooting kidney pain two hours after injection. By that evening, I had severe chills and shivered all night. The next day, the kidney pain turned into a constant ache. Headache worsened. Severe joint pain. Arm/injection site was horribly sore. By 5:00PM I had a 101.2 fever. That (Thursday/next night) evening, I felt much better. Friday morning, I woke up feeling completely normal with only minor pain at injection site.

Raised, red rash (hives?) periodically appearing all over body. Very itchy, not painful. Individual flare ups subside after several hours if not itched or irritated. First noticed 8 days after vaccination. Continue to appear on day 13 (today) but less frequent.

I had an itchy raised red rash that started between my shoulder blades on my back, and over the course of about 4 hours spread around my ribcage to the center of my chest. Took Pepcid and Zyrtec, which caused rash to abate. It returned very mildly for a few more days then subsided completely. For reference, the only other time in my life that I ever had any kind of rash was immediately after leaving the hospital in late 2019 after I suffered serious respiratory complications due to an oddly severe non-flu mystery virus that knocked out my sense of taste and smell, made me sick as a dog, and nearly killed me. At the time it was thought that my rash may have been an allergic reaction to the Ceftin I was taking, but given what we know today, I'm not so sure.

Injection Friday. No issues Friday, Saturday, or Sunday other than slight pain at the injection site and slight body aches on Sunday. Monday morning at approximately 0230 i woke up to what i can only describe as lightning pains in my legs. It was a very intense pain shooting from my upper thighs to my knees and slightly bending around to the top of my calves on the outside of the leg. Monday all day i did not feel well. Had a dull pain in center of chest, and my left arm from the shoulder blade to the elbow had what i can only describe as a slight warm sensation. I was also very "foggy" and light headed. On Tuesday the pain in my chest worsened. My left arm kept going numb (and still does today 04.21.2021), my jaw hurt, i was light headed and again very foggy. On Wednesday it was the same thing and I called the VA and they told me to come to the ER for evaluation.

4-12-21 Patient reported to sick call with soreness under right arm. Not relieved by cool compresses or hydrocortisone cr. came to clinic for c/o allergy to possibly wool blanket- Wool test performed 4-22 wool test negative, but several zosters noted. Dx Shingles- started on Acyclovir

I developed a rash a week after the dose. Went to urgent care and diagnosed allergic reaction. Gave me Prednisone 20mg tablet 3 tablets by mouth daily for 3 days and reacting correctly

ITCHING ON LEGS,CHEST,BACK; RASH ON SEVERAL PARTS OF THE BODY; This spontaneous report received from a patient concerned a 41 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced itching on legs, chest, back. On 15-MAR-2021, the subject experienced rash on several parts of the body. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itching on legs, chest, back, and rash on several parts of the body. This report was non-serious.

My patient experienced diffuse urticaria and throat swelling. He was seen in the ER, given IV steroids and released as his symptoms improved after 2 days. He was discharged on Decadron and Benedryl.

INTERNAL ITCHINESS; MILD CHILLS; FATIGUE; This spontaneous report received from a consumer concerned a 41 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, 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 fatigue. On 23-APR-2021, the subject experienced internal itchiness. On 23-APR-2021, the subject experienced mild chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue on 11-APR-2021, and was recovering from internal itchiness, and mild chills. This report was non-serious.

Approximately 8 minutes post-vaccination patient started to feel dizzy. Patient then got out of his chair to come tell the pharmacist (myself), during which time I witnessed him starting to sway and attempted to approach the patient. Before I could make it to the patient he passed out and fell to the floor, his bottom hit the floor first followed by his torso. I told the intern to call 911 and stayed with the patient. He never stop breathing and a pulse was always present. He attempted to get up moments after falling and I requested he stay on the ground. After a couple minutes he felt slightly better and I assisted him into a chair. At this point the paramedics arrived and took over patient care while I described

ABOUT 2 MINUTES AFTER VACCINATION PATIENT SAID HE WAS FEELING WARMTH TO HIS FACE , SWEATY , DIFFICULTY BREATHING STILL ALERT. CALLED 911 AND I TOLD HIM THAT I WAS GOING TO GIVE HIM AN EPIPEN. A FEW MINUTES AFTER THE EPIPEN HE SAID HE WAS FEELING BETTER.

Patient was given the vaccine. After sitting in a chair for a few minutes post vaccination, he said he felt dizzy and then fell over and hit the floor face first but had blacked out and did not remember fainting or passing out. He was bleeding because he had hit his face and his lip was split and his tooth was chipped. He also continued to be very dizzy, was extremely pale, and was sweating profusely. The EMT arrived about 20 minutes later and took him to the emergency room.

Felt severe burning/stinging pain in injection site upon injection. Left pinky and ring finger were pretty numb shortly thereafter for about a day or two. Numbness still comes and goes, but not as bad as after the initial injection. After about day 2 started to have severe pain in joint of left shoulder along with impingement, popping. Uncomfortable to sleep on left shoulder as it starts to hurt and "feels" as if it will pop out. Range of motion seems pretty normal, but still getting some pain, popping, and impingement with certain movements/actions throughout the day. I believe it to be SIRVA.

Strong headache at back of head and body aches from about 10 hours after vaccination until about 28 hours after vaccination. Body ache cleared up and headache lessened but off and on present since (now 17 days). I don't normally get headaches. Head has felt cloudy as well. About 4 days after vaccination I had itchy red bumps on my left arm between elbow and wrist for an hour or two then that cleared up. The next day I had the same itchy red bumps on the right arm, also clearing up on its own after a couple of hours. Day 7 or 8 after vaccination I had the same thing on my left leg between knee and ankle. The next day it was on both legs. Always clearing up within a few hours.

5/21/21 10:00pm shortness breath, chest pain, shoulder pain, jaw pain, metallic taste, fatigue ?mini heart attack? symptoms 5/26-5/27 trouble breathing, fatigue, light headed 5/29 pain in left arm 5/30 night - second ?mini heart attack? symptoms General fatigue, hard to breath, overall feeling bad 6/2 - bruise on arm and lump Extreme headache, fatigue, chest pain, arm pain Emergency room visit = blood clots

The first three days were normal expected side effects, such as fatigue, headaches, and so forth. I felt better after two days. Then on the 6th day, I suddenly broke out in hives, starting with a reaction at the injection site on my right deltoid. The hives continued to progress and get worse over the next few days and started welting. My legs and arms were covered in hives. I became dyspneic which was relieved by using albuterol. Hives reduced from antihistamines. For three days the hives would appear systemically with skin sensations of burning and itching.

Moderate soreness at site of injection. Headache Mild fever (99-99.6) Body wide muscle ache Skin touch sensitivity Tiredness Treated with 2 tablets of Extra strength Tylenol

(Janssen COVID-19 vaccine EUA) Day of vaccine - soreness in shoulder at the site of the injection. Day 2 - continuing soreness of shoulder, along with general aches, chills, and sleepiness. Day 3 - continuing soreness in shoulder, but no aches, chills, or sleepiness. Began feeling nauseous, but still had appetite. Day 4 - continuing soreness in shoulder, as well as nausea, but both are somewhat diminished.

12 hours post vaccine injection I had a slight fever. Fever lasted until 20 hours post injection. When measured, my temperature was 100.1. 36 hours post vaccine, I started itching and at 50 hours post vaccine the itching has turned to hives. As of right now, 51.5 hours post vaccine i still have hives.

I had the vaccine at 4:00 PM. I woke up at 12:05 AM with severe chills that turned into uncontrollable shaking for the next hour and twenty minutes. The shaking stopped at that time and my temperature went from 101.1 to 102.5. My skin was warm and I began to be very clammy. Around 3:45 AM, the fever broke and I was down to 99.5. I?ve subsequently had muscle aches and the feeling of being fatigued.

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.

got the shot on wed 3-17-21. Got flu like symptoms on Thursday and Friday the following days. On Saturday felt better but developed a rash all over my body. On my arms, back, neck, head, chest, legs, feet, waist. It started on Saturday the 3rd day after the vaccine and currently still have it. It calms down during the day and activates at night just before bed around 8pm.

aches and chills lasting approximately 24 hours; alleviated with Tylenol and Motrin soreness at injection site lasting 5 days to 6 days

Brain Fog /confusion since shot.. Arm (left) the shot was administered is still lacking in strength (just holding a cell phone wears it out). 2 weeks to the date, after the shot, I experienced extreme pain in all joints in left arm ( elbow, wrist, finger joints) The pain extruded to the middle of my rib cage from the left side. Shot site still mildly sore.. Brain fog still continues.

KNOT ON LEFT ARM; OFF LABEL USE; INAPPROPRIATE ROUTE OF VACCINATION; INCREASED BP; INCREASED HEART RATE; DIZZINESS SUNDAY AND MONDAY; PAIN IN ARM; DONT FEEL WELL; SOME NAUSEA; TINGLING OF HAND; This spontaneous report received from a patient concerned a 42 year old male. The patient's weight was 239 (unit unspecified), and height was 5 (unit unspecified). The patient's concurrent conditions included allergy, thyroid, sinus infection, elevated growth hormone, non-alcoholic, and non-smoker, and other pre-existing medical conditions included the patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intravenous, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on left deltoid on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced tingling of hand. On 27-MAR-2021, the subject experienced off label use. On 27-MAR-2021, the subject experienced inappropriate route of vaccination. On 27-MAR-2021, the subject experienced increased blood pressure. On 27-MAR-2021, the subject experienced increased heart rate. On 27-MAR-2021, the subject experienced dizziness Sunday and Monday. On 27-MAR-2021, the subject experienced pain in arm. On 27-MAR-2021, the subject experienced don't feel well. On 27-MAR-2021, the subject experienced some nausea. On 28-MAR-2021, the subject experienced knot on left arm. Laboratory data (dates unspecified) included: EKG (NR: not provided) clear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness Sunday and Monday, and had not recovered from knot on left arm, tingling of hand, pain in arm, some nausea, increased blood pressure, increased heart rate, don't feel well, inappropriate route of vaccination, and off label use. This report was non-serious.; Sender's Comments: V1: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.

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.

Started with a mild rash on my neck, shoulders, head and inner thighs. After about 30 minutes of noticing that I started getting tremors for about 30-45 minutes in my legs. All symptoms started at 7:15pm cst amd lasted until 9pm cst. No symptoms after that.

My initial symptoms were light swelling a region around the shoulder of my injection arm and excessive sweating in the armpit on my injection arm side. Following this, symptoms similar to being on a hallucinogenic gradually manifested over the next several hours, including euphoria, a persistent urge to grind teeth, and some mild-to-moderate visual and physical effects. Following the date of the injection, the primary symptom has been a bruise/cramp hybrid pain in the upper arm of the injection site that is gradually receding (but still ongoing), along with random light bouts of nausea and headaches, random light pains throughout my injection arm, and occurrences of coldness in my injection arm (lasts about an hour)

Large lump/knot in the injection area after the 'student' administered the vaccine by pinching my skin and fat then injecting at a 45-degree angle that caused excessive bleeding on my arm. The lump/knot is painful and I am concerned about my blood possibly clotting.

About 2-4 hours after shot husband had body aches and was sleepy. 12-14 hours post vaccination husbands vision would go blurry for about 10-20 seconds, happened about a dozen times over the course of the next 5-6 hours then stopped. At 30ish hours post vaccine woke up drenched in sweat, all bedding had to be washed, but said he felt better aside from mild Muscle pain/body aches that remained for about 48 hours from initial time of injection but was about return to work without issue on Wednesday. Still has mild soreness at injection site on Thursday 4/15.

This spontaneous report received from a patient concerned a 42 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, 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: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced dizziness. On 11-APR-2021, the subject experienced body aching. On 11-APR-2021, the subject experienced chills. On 11-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced nausea. On 11-APR-2021, the subject experienced pain at injection site. Laboratory data included: Body temperature (NR: not provided) 101.2 F. On 12-APR-2021, Laboratory data included: Body temperature (NR: not provided) 99.9 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and pain at injection site, and had not recovered from dizziness, headache, body aching, chills, and nausea. This report was non-serious.

I normally have Psoriasis that had been under control and mostly under control before I got the shot. I started to notice a new rash about two days after the shot. My Psoriasis would normally show up as white patches, but these are red bumps. They are more like little red bumps. They are on my arms, sides and hips. They are a little itchy especially on my back They are still are still there, but they don?t seem to be getting any worse.

Leg pain, Back pain , Developed shingles 5-6 days after the leg and back pain started. (April 11-12th.)

Severe full body rash roughly 36 hours after vaccination. Took Benadryl 48 hours after rash started which resolved the rash. Minor recurrence of rash in patches across body persisting for the past two weeks. Additional symptoms 12 hours after vaccination: heartburn, fever, chills, headache, tiredness . All resolved within 48 hours of vaccination and haven?t returned.

On 4/10 I started feeling tired with muscle aches. A few days later my skin started to hurt. Clothing was uncomfortable when it moved across my skin. Those symptoms lasted about a week. Then as they started to lessen I had some back pain (Sciatic) and a sore throat. Also the muscles behind my eyes were slightly painful and bright lights were uncomfortable. Then about 4/21 most of the symptoms reduced and I was feeling close to normal. Then on 4/22 I was brushing my teeth and noticed that I couldn?t spit water like normal. I called my GP doc and she recommended I head to the ER. After thinking about it I also remember on 4/21 while drinking something I had some water squirt out of my lips. At the time I thought I was just being clumsy but in hindsight the muscle weakness in my face started on 4/20. I checked into the ER on 4/22. When I checked into the hospital my facial weakness was very difficult to notice. By the evening of 4/22 it was noticeable if I tried to ?show my teeth? or make a big smile. By the morning of 4/23 it was very noticeable. The morning of 4/24 I couldn?t move my lips, nose or eyebrows. My tongue, jaw and throat were not impacted at all. I was started on plasmapheresis on 4/24. I had another treatment on 4/25. I noticed facial weakness was very slightly recovering the evening of 4/25. By 4/27 my facial weakness is still healing with noticeable improvement day to day.

THE PATIENT RECEIVED JANSSEN COVID 19 VACCINE IN THE LEFT ARM. I RECOMMENDED TO SIT FOR 15 MINUTES TO OBSERVE THE PATIENT. PATIENT REQUESTED TO USE THE BATHROOM IN THE PHARMACY RIGHT AFTER VACCINE. PATIENT CAME BACK FROM THE BATHROOM SAYING THAT HE FAINTED AND FELL IN THE BATHROOM AND SLASH OPEN THE LEFT SIDE OF HIS CHEEK WAS BLEEDING A LOT AND HE FELT DIZZY AND NAUSEA. HE FAINTED THE SECOND TIME ON THE FLOOR. 911 WAS CALLED PROMPTLY. POLICE AND AMBULANCE CAME TO GO TO THE HOSPITAL.

5 hours later. Terrible Headache, so bad could not sleep the entire night. Chills, aches, small fever. 10 Days later. Rash and bumps all over both arms, neck and upper back

Could not get air into lungs, made sugar get out of control, had a seizure and turned purple, passing out , ambulance had to come get me from vehicle and take me to emergency room in the hospital, kept me there for about 6 hours then released me to go home, went to my Doctor next day and he immediately sent me to hospital. I was checked for Blood Cloth due to the signs being there along with other tests I am home however I still do not feel well.

I had general soreness and stiffness. I took a bath before I went to bed because I noticed a fever. I had a fever of 103 F. I also realized I lost my motor skills. I was not able to do normal functions. Around 3:00am I experienced shakiness, and I experienced the worst headache in my life. I also have bumps that have appeared on my face. My right arm where I did not receive the shot I saw bruises down my arm. April 25,2021 is when I was in the hospital my blood pressure dropped and my pulse because very low. My blood pressure has been very high since I have gotten the vaccine.

Presented to ER with subacute malaise and worsening bruising area receiving Johnson & Johnson COVID vaccine 11 days ago, found to have microangiopathic hemolytic anemia and thrombocytopenia, concerning for TTP. He was transferred to Hospital as a direct admit to initiate plasmapheresis. Patient outcome tentative.

Currently presents a bruise with pain when touched in the area where the vaccine was placed. A little headache in the temple area.

limb pain starting in injection area on left upper forearm to right fore arm. limb pain occasionally flairs up and has remained persistant for a few days.

DULL CONTINUOUS SORENESS AT THE SITE OF THE INJECTION; This spontaneous report received from a patient via a company representative concerned a 42 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: 23-JUN-2021) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAY-2021, the subject experienced dull continuous soreness at the site of the injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dull continuous soreness at the site of the injection. This report was non-serious.

Symptoms of extreme skin pain on extremities (Hands, Feet, Knees, Face) upon being exposed to cooler temperatures. Symptoms of extreme pain upon being brushed against or scratched causing feelings of being cut on skin. Symptoms started approximately 2 weeks after receiving COVID19 Vaccination- Johnson and Johnson.

In the beginning, my feet and hands had poor circulation and became discolored, cold, and painful (like Reynaud's syndrome). I was able to get the circulation going by exercising. This lasted for a couple of weeks. I had cold sweats and chest discomfort, which I thought were symptoms of WPW. I went to the cardiologist. An EKG was done and I was put on a 2-week halter monitor. Everything checked out as not being a heart issue. Blood tests were done, and the results were normal. After the cold hands symptom, I developed palmar erythema. I also developed a lot of abdominal pain. I became really gassy, and my bowel movements became a light yellow. I had frequent urination. My weight dropped from 191 to 180, and I lost my appetite completely; the appetite loss happened for a week and a half. I had to force myself to eat. My hunger is now back, and I currently weigh 187. The gassiness, yellow stools, abdominal pains, and the frequent have all largely subsided. The stools are now a normal color. The palmar erythema is still present, though.

Patient reports feeling hot and warm all over body. Reported itching on palms of hands, nurse noticed sizable welts. Patient contacted his PCP and PCP recommended giving patient 2 doses of Benadryl. Patient was given 2 doses of Benadryl per PCP request and reported feeling better.

Puss shooting out after 10 days from date of vaccination. Wound infected, redness around injection site.

Began as headaches (4/4/21), progressed to strange skin sensations painful and hot to touch (4/6/21). This then progressed to numbness in lower body (4/12/21), the numbness then became weakness and inability to walk (4/26/21). I was then hospitalized 5/5/21 and had many, many tests. Ultimately I have been diagnosed with neurosarcoidosis and am currently undergoing treatment.

Janssen COVID-19 Vaccine EUA Nasty chills and fever started 10 to 12 hours after vaccination and continued through the night. By 24 hours after the shot, things improved. 24 to 48 hours better -- no chills/fever-- but still general fatigue. "less than 100%". 48+ still not fully recovered. Arm muscle still sore at injection site. Suspect will be better largely by tomorrow.

Had a sudden onset fever which reached 103 the evening of the injection. There was muscle soreness, fatigue, my pulse was above 80 all night and reached 100 during the peak of the fever. By the next morning, the fever had dropped to 100, fatigue remained and a slight headache appeared. The headache was gone by noon, the fatigue remained all day. The evening after the injection, a slight fever returned and then stopped. Two days after the injection, there were no further averse reactions other than slight soreness in the injection site. I am no longer fatigued and feel fine. Hope this information helps.

Date: 3/23/2021 Problem: fainted Notes: Pt was being observed post Janssen COVID Vaccine when the nurse observed pt fall onto the floor from his chair. This nurse began to take VS- BP 144/77 P74 O2 100% T 98.6 RR 18 BS 105. Pt did hit head when falling to floor but answered all questions appropriately. Pt states he is afraid of needles and this has happened to him previously as well. 911 called by head nurse. Pt able to move all extremities. This nurse stayed with pt until EMTs arrived. Pt alert and oriented x4. Redness noted to left cheek, no bleeding noted. PERLA. EMT found no signs of distress and pt refused to be transported to hospital. This nurse notified pt that he would need someone to take him home. Wife arrived to take pt. Pt showed no signs of acute distress and left with wife.

Date: 3/23/2021 Problem: fainted Notes: Pt was being observed post Janssen COVID Vaccine when the nurse observed pt fall onto the floor from his chair. This nurse began to take VS- BP 144/77 P74 O2 100% T 98.6 RR 18 BS 105. Pt did hit head when falling to floor but answered all questions appropriately. Pt states he is afraid of needles and this has happened to him previously as well. 911 called by head nurse. Pt able to move all extremities. This nurse stayed with pt until EMTs arrived. Pt alert and oriented x4. Redness noted to left cheek, no bleeding noted. EMT found no signs of distress and pt refused to be transported to hospital. This nurse notified pt that he would need someone to take him home. Wife arrived to take pt. Pt showed no signs of acute distress aand left with wife.

Patient is a 43-year-old, male with a history of fear of needles. At 2:39 pm, the patient received a dose of the Janssen vaccine, (lot number 1808980, expires on 06/20/2021) on right deltoid, given by RN. Immediately following the vaccination at 2:40 pm, Patient reportedly slumped his head forward in his seat and was caught by RN, sustaining zero physical bodily injuries. The patient was unconscious for approximately 2 seconds. EMT'S responded immediately at 2:40 pm and took the patient's vitals. At 2:40 pm, the patients vitals were: 117 systolic BP and HR 89 (EMT unable to hear the diastolic BP due to environmental noise). The patient appeared diaphoretic, pale, with warm, clammy hands and a weak radial pulse. The patient was given a water and tolerated intake of water. The patient was assisted by EMT to a anti-gravity chair at 2:43pm. The patient was observed to have a steady gait and reporting no dizziness. At 2:44 pm, the patient's vitals were: HR 54 and 110 systolic BP (EMT unable to hear the diastolic BP due to environmental noise). At 2:50, the patient had a strong, bounding radial pulse with a HR of 70 BPM and 115 systolic BP (EMT unable to hear the diastolic BP due to environmental noise). At 2:55 pm, the patient's vitals were: HR 75 BPM and 115 systolic BP (EMT unable to hear the diastolic BP due to environmental noise). At this time the patient reports feeling "better". At 3:00 pm the patient's vitals were: HR 81 BPM and 118 systolic BP (EMT unable to hear the diastolic BP due to environmental noise). At 3:05 pm the patient's vitals were: HR 77 BPM and 120 systolic BP (EMT unable to hear the diastolic BP due to environmental noise). At 3:10 pm the patient's vitals were: HR 74 BPM and 118 systolic BP (EMT unable to hear the diastolic BP due to environmental noise). At 3:15 pm, the patient was assisted up from anti-gravity chair. The patient had a steady and balanced gait. The patient denied any additional dizziness, lightheadedness, or nausea. EMT provided patient with education related to when to call his HCP (i.e. dizziness, itching of throat). The patient reported he was "ok to drive home" and left to the parking lot at 3:15 pm.

Numbness and weird feeling in left arm (injected in left arm) started like 8pm got worse. Also still felt awful comes and goes cold and feverish again. Felt good a day and a half. Then bad again but was at work. Woke up 2am with pain in chest and arm felt numbness and very strange and pain in chest - which did subside but almost called 911. Will go to urgent cate today to get checked out. Took BP at home and it was normal/ took an aspirin at 2am as well/

sharp pain in arm starting approximately 5 minutes after injection, lasting about 5 minutes. dull ache in arm at injection site for four days after injection. flu-like symptoms including body ache, tiredness, weakness, fatigue, loss of appetite & general malaise starting approximately 24 hours after injection, lasting about 12 hours.

Hives started appearing days later and have not eaten anything different than the week before and have not changed shampoo, body wash, deodorant, etc or taken any medication

The day of the vaccination 5 hours after receiving the vaccine I started to get bruises the size of my hand on my left leg then I kept getting more on the upper part in the leg and in the buttock I take photos to have the record then I started to feel dizzy that I couldn't walk and I was going to faint, I had to call the rescue to come to my house because I felt very bad I could not move then I went to the emergency room to the hospital with the same symptoms I couldn't move it seemed that if I get up I was going to faint, I was under observation the bruises did not continue to appear, but I have been left with nervous tic symptoms in the left eye and in the left arm I have involuntary reflexes in the muscles of the left arm

Shingles outbreak. Rash started to appear on 4/4/21. Patient has had shingles one time in the past. The rash appeared in that same location.

INJECTION SITE PAIN; SWELLING AT INJECTION SITE; This spontaneous report received from a patient concerned a 43 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included unspecified allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 in right arm for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, the subject experienced injection site pain. On 23-MAR-2021, the subject experienced swelling at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from injection site pain, and had not recovered from swelling at injection site. This report was non-serious.

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

I thought I was going to get the first shot of the Moderna vaccine, it wasn't until the needle was in my arm that I was told I had received the Janssen vaccine. At approximately 4:46pm I developed a strong pain at the injection site. At approximately 8pm I began to run a fever and feel extremely fatigued. My back and all my joints started to ache, I was sweating but also freezing cold. I had a dull, throbbing pain in my testes. I had pain in my scalp, my eyebrows, my ear lobes, my fingernails, my toes and toenails, the soles of my feet hurt. Least of all I also had a headache. I took 500mg Ibuprofen for the pain. Now, almost 48 hours later I still have a low grade fever, still have considerable pain at the injection site, still have a headache. The remaining symptoms dissipated on 5/2/21 at about 12pm. Took another 500mg Ibuprofen for breakfast, but otherwise have had no appetite since receiving the vaccine.

Approximately four weeks after receiving the shot I came down with symptoms related to Shingles and was diagnosed with such five days later. Unsure if there is causation but I thought it was worth reporting because other than receiving the covid vaccine I have had no changes or health issues or anything else that would indicate a change in my immunity status that could have resulted in this onset. I am a bit on the young side to be experiencing Shingles so thought it was worth reporting.

PAIN IN STOMACH; SWEATS; REDNESS ON BODY LOOKS LIKE SKIN IS DISCOLORED; CHILLS; FEVER; NAUSEA; BODY PAIN; MIGRAINE; EVERY BEAT OF HEART HURTS; HYPERVENTILATION; COULD NOT GET A FULL BREATH; PASSED OUT'; FINGERS WENT NUMB; GOT A CHARLIE HORSE ON LEG; EVERY SINGLE JOINT AND ANKLES HURTS FOR NO REASON; This spontaneous report received from a patient concerned a 43 year old male. The patient's weight was 135 pounds, and height was 66 inches. No past medical history or concurrent conditions were reported. The patient's concurrent conditions included migraine 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, 1 total to right deltoid on 19-MAY-2021 around 10 am for prophylactic vaccination. No concomitant medications were reported. On 19-MAY-2021, around 7 pm patient started experiencing side effects. After 1 hour of shot patient had his heart hurt at every beats, hyperventilation. It lasted for 1 -2 hours. The patient also had fever, chills, nausea, sweats and had not taken any medication, as he was afraid of another side effects, had redness on his body which looked like skin was discolored and was like hives. The patient also had body pain appeared suddenly. The patient also had pain in stomach which felt like nastiest gas cramp patient had ever and it was continuous like a rock blocking in stomach, he did not know if it is pain or gas but was hurting. Patient had migraine which lasted long time and was continuous than he ever had. The patient was fine as he was speaking at the time of reporting. On MAY-2021 (dates unspecified) the patient experienced Charlie on his leg (muscle spasm) for which he stood up and didn't do anything on leg, he was passed out and fingers went numb, felt every single joint and ankle hurt with sharp pain like a stuffed knife (intermittent pain for 3-5 minutes).He could not get a full breath of air, and was breathing really fast. Then patient tried to slow down breathing as he didn't want to be hyperventilated but it happened. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body pain, hyperventilation, migraine, pain in stomach, chills, fever, nausea, and sweats, and the outcome of passed out, could not get a full breath, redness on body looks like skin is discolored, got a charlie horse on leg, every single joint and ankles hurts for no reason, fingers went numb and every beat of heart hurts was not reported. This report was serious (Other Medically Important Condition); Sender's Comments: V0: 20210540430-COVID-19 VACCINE AD26.COV2.S --Every beat of heart hurts, Passed out. 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 admitted to hospital with a platelet count = 0. Patient presented with fatigue, mouth sores and body rash and extensive bruising. Patient also tested positive for COVID 19.

Woke up the next morning feeling sore at shot site and as the day progressed my body started to ache all over. For the next 2 days after this, I will alternate between having the chills and having intense sweats. On Friday 06/25/2021, I woke up to my chest hurting , I could not catch my breath, it felt like I had a very heavy weight on my chest . I went to the emergency room which is a part of the Hospital. After the initial tests the physician told me with 99% certainty that I had had a heart attack. Soon after this they rushed me by ambulance from hospital to hospital which is about 20 miles or so. They rushed me in and completed an arteriogram within minutes of arriving at the hospital. They confirmed with this test that is was not a heart attack and after several more test, the doctor that I had developed Myocarditis due to the vaccine shot. The admitted me into the hospital on 06/25/2021 for observation and to run more test until I was stable enough to go home. I stayed in the hospital for 1 evening and was discharged on 06/26/2021 at about 1:00 or 2:00 that afternoon. The doctor prescribed several medications for me to take for my heart for the next foreseeable future. On 06/30/2021 I had a visit to my new cardiologist in which he ran several test and stating that I was looking better, but he had ordered an MRI to take place on 07/06/2021 at Hospital. I have a follow up visit for my cardiologist slated for 07/19/2021 in which I will find out more information.

pt has h/o htn and take 4 different meds. he has taken all of his meds today . pt received his covid vaccine on 03/13/2021 in the left shoulder and he woke up this morning with pain in the left shoulder radiating down his arm and it originates at the site of the vaccine. pt denies substernal chest pain , dyspnea , doe. he has h/o elevated blood pressures at the level seen today (180/100) when he has poor sleep and he had poor sleep last night due to pain at injection site. no CAD hx. pain is not changed with walking but will be worsened by moving his left arm. PE: a+ox3, in moderate pain left arm: injection site clean and intact. left arm is neurovascularly intact. no bony deformity of the shoulder lung: normal respiratory status, cv rrr no mgr Signed on 3/14/2021 at 11:54am

3/12 4:30 pm started with frequent liquid diarrhea for the next 3 days but on 3/13 at about 9pm broke out in full body hives, very red and became flushed and hot

puritis in arms and legs. given 50 mg of benedryl and improvement started prior to discharge from vaccination site

PT ARRIVED VIA POV WITH WIFE DUE TO COMPLAINING OF HAVING JOHNSON AND JOHNSON VACCINE REACTION THAT HE RECEIVED YESTERDAY AT 1130 AM. PT VOICED HE WAS NOT ABLE TO SLEEP MUCH, HAD FEVER, CHILLS; WOKE UP WITH SWOLLEN UPPER LIP, RASH OVER HIS UPPER EXTREMITIES; RASH AND WHELPS SEEN TO HIS RIGHT RIB REGION-MODERATE AMOUNTS. PT ALSO VOICED, FEELING ITCHING ALL OVER HIS BODY. DENIED OTHER SYMPTOMS. PT IS STABLE. ER PROVIDER NOTIFIED. TX: FAMOTIDINE, BENADRYL, SOLU-MEDROL, DECADRON.

Rapid onset of nausea and dizzy / lightheaded feeling shortly after standing up from chair within 2 minutes after vaccination. Immediately sat back down to place my head between my knees, and completely blacked out, fallout out of the chair and hitting my head and knee on the floor and nearby fixtures. Regained consciousness on floor about 30 seconds after fainting and immediately felt much better. Pharmacy staff were on hand and promptly called 911, instructed me not to move and took my pulse and monitored me until EMS arrived within 5-10 minutes. Vital signs normal including BP 120/90, 100% o2 levels, normal blood sugar and EKG. EMS assisted in getting me back to seated position and monitored for another 10-15 minutes. Declined transport and had family member drive me home where I rested for a few hours and woke up feeling fine. Very minor bruising / bump on head with no lasting sign of concussion or other trauma. 24+ hours post vaccine no other notable vaccine reactions aside from sore arm / muscles on injection site.

SYNCOPE/PASSED OUT FOR A COUPLE OF HOURS; SEVERELY DEHYDRATED; FLU; INJECTION SITE WAS SORE; This spontaneous report received from a pharmacist concerned a 44 year old 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, and expiry: 06-JUN-2021) dose was not reported, frequency 1 total administered on 02-APR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the patient was severely dehydrated a couple of hours after receiving the vaccine, syncope/passed out for a couple of hours (unsure how long), and injection site was sore. On same day, it felt like the patient had the flu, which was described as chills, fever and the patient's throat being sore at the same time. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from syncope/passed out for a couple of hours, severely dehydrated, injection site was sore, and felt like patient had the flu on 04-APR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;20210411188-covid-19 vaccine ad26.cov2. s-syncope/passed out, severely dehydrated. 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).

CHILLS; JOINT PAIN; SENSITIVITY AT THE INJECTION SITE; MUSCLE ACHES; HEADACHE; FEVER UP TO 101 FAHRENHEIT; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included pernicious anemia, non smoker, and ketosis, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 10:00 for prophylactic vaccination. Concomitant medications included cyanocobalamin for pernicious anemia. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced joint pain. On 08-APR-2021, the subject experienced sensitivity at the injection site. On 08-APR-2021, the subject experienced muscle aches. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced fever up to 101 fahrenheit .Laboratory data included: Body temperature (NR: not provided) 98 F, 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, joint pain, muscle aches, headache, and fever up to 101 fahrenheit ,on 10-APR-2021, and had not recovered from sensitivity at the injection site. This report was non-serious.

Blood Clot and bruising on lower backside of leg, I noticed leg Pain (just uncomfortable) in the right leg at the location of clot. A time frame in relationship to the time of shot is unkown. Estimated within 24 hours. Bruising appeared morning of 04/14/21, PCP recommended in person visit. I went to urgent care, they had me drive to emergency Room at local hospital. Evaluation, blood testing and imaging concluded a blood clot in the lower right leg. Blod thinners was prescribed Eliquia 5 mg, discharged same day. It may be possible the hospital had submitted this form on my behalf.

Got COVID (Janssen) vaccine shot on April 6th at noon. Felt fine Tuesday and went to bed as normal. Woke up April 7th at 7AM with sharp pains in my left shoulder (same side as shot) and slight shortness of breath, and slight chest pain in the left quadrant of my torso (same side as shot). Proceeded to take Advil and seemed to help a bit. Minor aches/pains and shortness of breath throughout the day until about 8PM. At this time shoulder chest pain became more severe, and breathing became very strained, short, and painful. Pain and breathing kept getting worse and at midnight on Wednesday night thought I was having a heart attack due to extreme chest pain, couldn't breath, lightheaded, dizzy, tingly extremities. My wife drove me to ER at 12:30 AM Thursday.

Received shot at 9:20 am. Came home and went to bed. Woke up at 3pm and felt worn out. Then about 5:30pm I got super uncomfortable and then my skin got hypersensitive. To the point I couldn't even touch it. Then I felt like I had a fever but when I checked I did not. Went to bed at 8pm still with the hypersensitive skin. Could not get comfortable to sleep but when i eventually fell asleep I slept for 10 hours. Thats about 5 more than I normally do. The next day the hypersensitive skin was gone just felt a little wore out.

At injection muscle spasmed, nurse stated never seen that before. Within 1-2 hours had runny nose and felt stuffed up, thought it could be allergies or something and didn?t really attribute to vaccine. 4-5 hours after injection felt something across the top of my brain ... felt as though something had been stuck in a blood vessel and became unstuck allowing blood to shoot through. Was certainly freaked out by this, but was at an event and head of the ER department of the local hospital was also attending - so figured I had quicker access to medical care there if needed, than at home. 30-60 minutes later congestion completely cleared up. 9-12 hours after vaccination had extreme chills. Day after vaccination had pain below the injection site... injection was 2? above pain. Also neck pain. Day 2-8 since vaccination, on/off muscle pain or injection site pain. Today, day 9, have muscle pain in wrist of injection arm.

Diarrhea-like soft stool 2.5 hours after inoculation; fatigue and general malaise for more than 36 hours after inoculation; sore left arm for more than 36 hours and soreness at the injection site.

Allergic reaction, swollen lips, numb skin on face, itching all over body, scratching hives, blisters

RED SPOT UNDER SKIN; BODY ACHES; HEADACHE; PAIN IN ARM; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported. The patient's past medical history included hematomas, and concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included patient had no known allergies and drug abuse and drug illicit use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 205A21A expiry: 23-JUN-2021) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) Negative. On 30-APR-2021, the subject experienced pain in arm. On 01-MAY-2021, the subject experienced body aches. On 01-MAY-2021, the subject experienced headache. On 02-MAY-2021, the subject experienced red spot under skin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and headache on 02-MAY-2021, and pain in arm on 01-MAY-2021, and was recovering from red spot under skin. This report was non-serious.

Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Within a few minutes, pt began to sweat/feel light headed/dizzy/ringing in the ears. Pt stated he felt like he was going to pass out. Pt reported no symptoms related to anaphylaxis. Pt did not lose consciousness and symptoms started improving within 10 minutes. Pt then noticed blurry vision which resolved. Pt's BP was checked: 120/90, pulse WNL. Pt. was feeling fine but per PCP guidance, went to ER for a follow up when I followed up via phone. Reported no further issues after leaving pharmacy

METALLIC TASTE IN MOUTH; FACE WAS RED; FLUSHING ON FACE; RIGHT LEG PAIN DESCRIBED AS DULL ACHE; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included gout. The patient could not take statins because they cause muscle pain but not an allergic reaction. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 205A21A) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAY-2021, the subject experienced metallic taste in mouth. On 10-MAY-2021, the subject experienced face was red. On 10-MAY-2021, the subject experienced flushing on face. On 10-MAY-2021, the subject experienced right leg pain described as dull ache. The action taken with covid-19 vaccine was not applicable. The patient recovered from face was red, and flushing on face on 10-MAY-2021, and was recovering from metallic taste in mouth, and right leg pain described as dull ache. This report was non-serious.

Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash Generalized-Mild

It started with a pain around my spine and it proceeded through my hand. I thought it was a muscle strain. I had blotches in the crevice area of my arm.

Allergic reaction started on 5/30/21 (4 days after receiving the vaccine) - rash on left arm and abdomen, shallow breathing/wheezing a few hours after the rash developed. Patient went to the ED and the rash resolved by 6/1/21.

Initial reaction day after vaccination - 4/1/2021 site reaction with swelling, erythema, and warmth; generalized reaction - flu-like symptoms - all resolved within a few days. 6/6/2021 - uncertain if related to vaccine - patient reported chest pain as thought he thought he was having a heart attack. Went to hospital. Dx with pulmonary emboli and DVTs. Transferred from (Name) Hospital to (Name) Hospital to ICU. As of 6/7/2021, patient reports he has been moved from the ICU to a regular room, no on oral anticoagulants. Patient has not yet been discharged at the time of report submission.

Fainted twice after receiving the vaccine. First time 5 days after receding the vaccine, the second time about 6 weeks later. First time I was dehydrated, and fainted at the gym while exercising. The second time I fainted while walking the dog. Both times I broke out in hives, the second time more severely (all over my body). Both times I fell, hit head head and had to get stitches or staples.

About 30 hours after vaccination, patient noticed a sunburn type redness all over his body. Rash was apparent face, neck, chest, stomach, arm, legs, and tops of feet. Rash was warm, but not itchy. Rash was not raised. Resembles a sunburn

Cold chills, cough, muscle aches, swelling at injection site, dizziness, body aches, headache, fatigue

Patient came to clinic for left shoulder pain on 7/29/21 that he reports began immediately with injection of COVID-19 vaccine on 4/11/21. Pain progressively got worse over the next few days and has stayed the same since. Worse with lifting and exam consistent with tenderness at insertion of biceps tendon. Concern for SIRVA (shoulder injury related to vaccine administration.)

Allergic skin reaction/break out at the site of the injection on outside of the arm and continuing under the arm down the arm. Bumpy itchy and redness.

Severe chills, fever, and whole body muscle ache. Symptoms began approximately 8 hours after injection and continued at a high level for 12 hours (overnight). Muscle aches and skin sensitivity continued into the day following but chills and fever subsided completely.

Rash on left foot, both arms and hands. Slight dizziness at times. Slight Fever has been noticed a few times, then went away. Headaches on the first day after, but not on the second day. Treatment was heat pack for head, ice packs for rashes to decrease swelling. Also took ibuprofen

Really bad hurting in chest pain, swollen lips and a headache. Had to go to ER. Forgot to mention the vaccine shot. They finally decided it was an allergic reaction. Gave a steroid shot and Benadryl. Sent home on steroids for 5 days. The next day had rash and itching. The next day it was worse looked like lace pattern rash over most of his body and really bad itching. Like this through the 20th then he took Claritin and put on anti -itch cream. The next day the rash had mostly cleared but still a little itchy. Today the 22 I have had a really bad headache.

Full body hives/rash. Began 8 days after injection, covered 70% of his body in rash that was itchy and painful. When the rash cleared up after 3 days of using benadryl and famotidine, it left scabs and small pimples and peeling skin behind.

Mach 24 1700-1730 feeling odd with some joint pain in knees. Injection shot pain normal as most injuections. 1900 achy 2000 chills started 2100 fever of 99.8 March 25 0015 sweaty and hot fever of 102.5 entire body aches, joint pains knees and arms. Musclar aches all over felt slight nausea 0700 aches continued fever down 100.2, fatigued slept most of the day. Injection site tender. Drank water ate toast. 1300 fever subsided 98.6 (my normal is 98.2) Took motrin for aches. Rest of day and night slightly achy stiff joints fatigued. March 26 Still achy and stiff. No fever. Took Motrin. By midday had more energy and able to get around and walk. Noticed taking deep breaths was hard to do with out slight pain. Was gone by the 28th.

GROGGY; HEADACHE PRETTY MUCH THROUGHOUT THE DAY; SORENESS AT INJECTION SITE; This spontaneous report received from a patient concerned a 45 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: 1808609, expiry: UNKNOWN) dose was not reported, administered on left arm on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced groggy. On 26-MAR-2021, the subject experienced headache pretty much throughout the day. On 26-MAR-2021, the subject experienced soreness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from groggy, headache pretty much throughout the day, and soreness at injection site. This report was non-serious.

Onset Thursday, 4/08/21 at 03:00 am: Fever, Chills, Severe Body Aches and Joint Pain, Exhaustion. 09:00 am to 1:50 pm: Slept with profuse sweating. Friday 4/09/21 at 12 midnight: Fever with ears red and burning. Applied wet cold towels on body. Vomited once, followed by dry heaves. 10: 00 am Nauseous. Checked temperature with ear thermometer- afebrile. Checked oxygen saturation with pulse oximeter- 96% HR 35. Checked pulse manually with a range of 39-44 and irregular.

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.

Pt presents to the clinic c/o itchy, red rash located on arms, back, chest, head since approx. 0500 this morning.

Woke up with eyes swollen almost shut, red rash all around eyes. Blurry vision, eyes feel like they are on fire. Skin on eye lids are peeling. Fever and chills

SHARP HAND PAIN; SWOLLEN INJECTION SITE; FATIGUE; INJECTION SITE PAIN; BODY ACHES; 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 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: 206a21a, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced swollen injection site. On 08-APR-2021, the subject experienced fatigue. On 08-APR-2021, the subject experienced injection site pain. On 10-APR-2021, the subject experienced sharp hand pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen injection site on APR-2021, and injection site pain on 08-APR-2021, was recovering from body aches, had not recovered from fatigue, and the outcome of sharp hand pain was not reported. This report was non-serious.

One week later I have an itchy rash on my feet and legs that goes away after a while. Past 3 mornings now.

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 past medical history included covid-19 test positive. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced unable to go work. Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 06-APR-2021, the subject experienced warm throughout right arm at injection site. On 06-APR-2021, the subject experienced severe headache. On 08-APR-2021, the subject experienced stomach/abdominal pain. On 08-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach/abdominal pain, and warm throughout right arm at injection site on APR-2021, had not recovered from severe headache, and fatigue, and the outcome of unable to go work was not reported. This report was non-serious.

HYPOTHERMIA; LOSS OF TASTE; ARM WAS LIKE ROCK SOLID; RASH ON LEFT ARM AND WENT ALL OVER THE BODY; HURTING ARM; WEAKNESS; FEVER; FLUCTUATING BLOOD GLUCOSE LEVEL; LIGHT HEADED; DIARRHEA; 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 past medical history included sinus surgery, and spine surgery, and concurrent conditions included type 2 diabetes mellitus, allergy to pecan walnut, allergic to pollen, allergic to lobster/oyster, allergic to molds, allergic to dust, and allergic to cat hair. The patient experienced drug allergy when treated with doxycycline. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 05-APR-2021 16:00 to left arm for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, within 1-2 hours after getting vaccinated the patient experienced a rash on left arm where he got the vaccine and it went all over the body. On the same day, his temperature was 95.1 F On 05-APR-2021, he also experienced weakness that lasted for a week. His arm was hurting and was like rock solid for almost ten days. The patient was feeling light headed that started on the same day of vaccination and could be due to low glucose level. The patient had diarrhea that started the same day as vaccination and was still ongoing. The patient's blood glucose was going up and down since the vaccination. On 05-APR-2021 at 23:05, his blood glucose level was 249 mg/dl. On 05-APR-2021 around midnight the patient had a fever of 101.9F. The patient experienced fever for first three days after vaccination, for which he took Tylenol for three days as directed by his physician. The patient took Tylenol 500 mg for every four hours total he took 5 pills on day one. The next day he took 3 pills of Tylenol 500 mg. On 06-APR-2021 at 8:00, his blood glucose level was 349 mg/dl and then he took his medication and it went down to 169 mg/dl. The patient stated that since vaccination his blood glucose has been unstable and the blood glucose readings are between 47 to 389 mg/dl. On 06-APR-2021, his temperature reading was 94.3 F. The patient also experienced loss of taste on the day after vaccination which has resolved now. His taste came back about a week or 10 days. The patient was not sure if the loss of taste is due to his allergy or the vaccine. On 07-APR-2021, the patient's temperature was 99.7 F. On 07-APR-2021, he took 500 mg every 6 hours. The patient took Tylenol for only three days and fever stopped after three days. On 07-APR-2021 the patient experienced hypothermia of 94.3 F. On 18-APR-2021 at 6:30, his glucose level was 95 mg/dl. The patient said that he had such unstable blood glucose readings only when he had an infection going on. On Friday the patient was going to see his endocrinologist. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hypothermia, loss of taste, arm was like rock solid, hurting arm, and weakness on APR-2021, and fever on 07-APR-2021, had not recovered from diarrhea, and fluctuating blood glucose level, and the outcome of rash on left arm and went all over the body and light headed was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210438172- COVID-19 VACCINE AD26.COV2.S- Hypothermia, Fluctuating blood glucose level. 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.

12 hours after vaccine, 100.4 fever, chills, body aches. Fever broke after about 18 hours. General pain on injection arm, continuing through this day. General pain/discomfort in upper left arm and shoulder/back area.

RASH ON BOTH ARMS (GOTTEN A LITTLE BIGGER); ARM ITCHING; RASH ON BOTH ARMS (ARM CREASES IN THE FRONT AND IT IS OVAL SIZE AND ABOUT 3 INCHES LONG); This spontaneous report received from a patient concerned a 45 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: 202A21A expiry: 23-JUN-2021) dose was not reported, administered on 01-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-MAY-2021, the subject experienced arm itching. On 02-MAY-2021, the subject experienced rash on both arms (arm creases in the front and it is oval size and about 3 inches long). Treatment medications included: cortisone. On 03-MAY-2021, the subject experienced rash on both arms (gotten a little bigger). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on both arms (arm creases in the front and it is oval size and about 3 inches long), arm itching, and rash on both arms (gotten a little bigger). This report was non-serious.

Started in the middle of night- awoke to my arm I got injected in being completely numb. Moved my arm around, got circulation and feeling back went back to sleep. Then the next day all day my back was sore and all my joints felt sore including my ankles, wrist, neck, knuckles, elbows, knees. Just soreness - NO FLU LIKE SYMPTOMS - but sorness all over. I left message with Doc's office. Next day my joints felt better but I awoke with splitting headache. Took aspire and all improved.

Pain on side of torso of mid abdomem near lower last rib starting on Saturday, 5/8. Felt like a side stitch similar to a long run but much more intense. Pain steadily increased as to Monday, 5/17, in the AM went to urgent care. They misdiagnosed and said I must have twisted wrong. Went to primary care phisician Wednesday, 5/18, and was diagnosed with, Shingles, Herpes Zoster. Prescribed anti-viral Valacyclovir 1000mg 3x daily, Naproxen 500Mb 2x daily and lidocaine cream as needed.

TWO BIG KNOTS ON SHOULDER; INJECTION SITE SORENESS; This spontaneous report received from a patient concerned a 45 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: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JUN-2021, the subject experienced injection site soreness. On 02-JUN-2021, the subject experienced two big knots on shoulder. The action taken with covid-19 vaccine was not applicable. The patient recovered from injection site soreness on 01-JUN-2021, and had not recovered from two big knots on shoulder. This report was non-serious.

TEETH PAIN; JAW-LINE ON FIRE; RING-WORM LIKE RASH AROUND INJECTION SITE; FEVER; SEVERE 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 familial mediterranean fever (genetic variant). 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, administered on 06-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-JUN-2021, the subject experienced ring-worm like rash around injection site. On 06-JUN-2021, the subject experienced fever. On 06-JUN-2021, the subject experienced severe headache. On 07-JUN-2021, the subject experienced teeth pain. On 07-JUN-2021, the subject experienced jaw-line on fire. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, severe headache, ring-worm like rash around injection site, jaw-line on fire and teeth pain was not reported. This report was non-serious.

Shingles - symptoms - Went to Urgent Care - they diagnosed with Shingles. They prescribed a medicine. It took about 10-15 days to help with the symptoms.

Attendee with history of fainting with needles. was given his single shot while sitting. Had declined offer to go to cot, Staff observed Attendee's color changed after Initially attempted to stand up, observed and told to remain sitting. Given ICEPacks, Monitored, reports tingly cold hands Transitioned to lying down. declines EMS and medications, Symptoms resolve after WIfe arrives, transitioned to standing, D/c to wife /daughter/ car to home.

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

Within about 5 hours of the vaccine, started to feel skin sensitivity all over my body. It felt like every pore on my body was open and hyper sensitive to touch. My scalp was very sensitive to touch and there was a strange sensation when my clothes touched my body- I've never been hyper sensitive like this before. Within about 12 hours, developed a fever, chills and inability to get warm. Symptoms persisted for about 36 hours.

Sore and swollen at the shot site. 24 hours after shot I experienced chills, and a bad headache that lasted all day off and on even with use of Motrin. Headache went away but still had chills and a low grade fever next day. Was really tired and fatigued for 48 hours sore hips and aching joints. Now 3 days after just a swollen itchy shot site.

Body shaking and aches 5 hours after vaccine, fever started 6 hours after vaccine, along with headache and inability to sleep, fever lasted for almost 36 hours, nausea which led to vomiting 16-17 hours after vaccine, vomiting off and on for the next 8 hours, 3 days later and still have headache and some dizziness and brain fog and some moments of nausea, day 2 had some itching on legs, day 3 and still don?t feel back to normal

Started itching 4 days after receiving vaccine. Broke out with rash in patches all over body. Feet , legs, arms and back itch. Symptoms haven't worsened or subsided in 3 hours.

body rash, but the reason I'm letting you know is b/c it came about 5 days after my shot. It was not bad at all, like mild poison ivy, and was gone after 24 hours and 6 Benadryl pills (the max over 24 hours the pill recommends).

Redness around left eye developed into severe rash spread all over body. Intense itching and discomfort. All started to occur 3/16 and progressively got worse and continued to spread. 1st dx was shingles (2nd time having it?2018) treated with prednisone and then dx contact dermatitis steroid shot and antihistamines then diflucan and went to Derm gave another steroid shot and antibiotic?all since 3/16 still progressing

immediately felt tingling in left arm (like ben gay), then after about 10 min felt go into neck and and cheek. A little light headed. At 15 minutes asked nurse if normal. Then started sweating. left hand turned purple. Dont really remember anything else. Went unconscious. Remember them yelling Code something and Cardiac arrest. Taken to ER. Think they may have said anaphalatic shock. I think they gave me epinepherine. Had paralysis in left hand when i woke up for a few minutes. Blood work and EKG were normal. Went home within a couple of hours. Light-headed two days later still. Saw doctor two days after. Blood pressure is high. Little bit of fatigue and brain fog.

I received the J&J shot after work on Friday around 5:30 p.m.. Around 3 a.m. Saturday morning, I woke up with a fever and chills. My head was hot. My body was cold. I had a pretty severe headache as well. My body ached all over. Muscle and joint pain. I took Tylenol, but it didn't seem to do much. I spent all day Saturday in bed or on the couch. I ran a fever of 100.9 to 101.6 all day Saturday. My body ached making it hard to go up or down stairs. I was weak feeling and I was exhausted just going to refrigerator to get juice or water. Not much of an appetite all day. Also, arm was sore and bruised at the shot location. That was the least of my issues. Today is Sunday and I am feeling better now. I feel like the worst is absolutely behind me, but I felt so terrible yesterday, I thought I should report my issues.

Pain at injection site, woke up next morning with double vision. With both eyes open, dizziness, loss of depth perception

day after, was severe nausea, body aches, low grade fever. headache. 2nd day I was fine, about a week later I had a relapse without the nausea. I have felt off ever since, low grade fever comes and goes 99-100 degrees. My skin feels constantly hot and has become extremely sensitive, scratching my head is painful. I am more shakey in my hands than normal, my head is foggy and cant concentrate at times, insomnia. Which is essential for my work. My heartbeat is rapid at times but my blood pressure isn't up. All of my bloodwork looked fine except for weak anemia which is new for me. the last thing is a rash appeared on my feet and legs but doesn't itch and I started getting shooting pains in my legs, this is new, started about a week ago.

3AM woke up with high fever, headache, muscle ache from shoulders up. Treated with Tylenol to reduce fever, symptoms continued through the day. 2PM discovered large patch of hives on back from right shoulder to waist approximately 4 inches wide at the top and narrowing to 1 inch wide at the bottom. Treated with my go-to allergic reaction kit: Xyzal, Benadryl, Prednisone, and Pepcid. Hives started fading after 1 hour and were mostly gone within 3 hours, followed by 12 hours of sleep.

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

24 hours after the vaccination the patient developed a delayed allergic reaction in the vaccination site (right upper arm). He developed 3 serous filled bulla with the largest measuring 5cm by 2.5cm with surrounding erythema and tenderness to palpation in the area. This was associated with headache, diaphoresis, shortness of breath, substernal chest discomfort, and sensation of throat itching. By 72 hours the bulla had popped and the patient's the only remaining symptom was right upper arm pain.

FEVER; MUSCLE ACHES (SHOULDERS UP); HEADACHE; LARGE PATCH OF HIVES (SHOULDERS TO WAIST); This spontaneous report received from a patient concerned a 46 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: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced muscle aches (shoulders up). On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced large patch of hives (shoulders to waist). Treatment medications (dates unspecified) included: prednisone, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, muscle aches (shoulders up), and headache on APR-2021, and large patch of hives (shoulders to waist) on 11-APR-2021. This report was non-serious.

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

Patient had no symptoms for 3 weeks. Then he developed an abscess at the injection site. It was red and swollen with a hard nodule under the skin. Pus came out from abscess at home with no intervention; patient sought follow up with PCP a few days later. Area was still swollen with a visible scab at injection site. Patient is spanish-speaking only.

He was in his usual state of excellent health until yesterday. He noticed a small blister over his left upper gum. This burst and was clearly filled with blood. Over the ensuing 24 hours, he has had multiple such blisters and came to the Emergency Room for fear of a reaction to the COVID vaccine that he had had 13 days ago. This was Johnson and Johnson. He had no major reactions to it. On coming to the Emergency Room today, he noticed significant petechiae forming over the lower extremities as well as scattered petechiae forming elsewhere. He presented to the Emergency Room and there was noted to have a CBC showing hematocrit of 51, 4000 platelets, and a white count of 7.7 with an unremarkable differential. INR is 1.1. D-dimer was 0.33. Chemistries were limited, but were within normal limits.

BLISTERS ON RIGHT ARM BETWEEN ELBOW AND SHOULDER; SHORTNESS OF BREATH; BLURRED VISION; ITCHING ALL OVER ESPECIALLY IN RIGHT ARM; FEVER OF 101 F; TIREDNESS; SCAR ON ARM THAT WAS 4 INCHES LONG AND 2 INCHES WIDE; This spontaneous report received from a patient concerned a 46 year old male. The patient's weight was 225 pounds, and height was 66 inches. The patient's past medical history included umbilical hernia, and covid-19, and concurrent conditions included high cholesterol, non-smoker, and social alcohol drinker, and other pre-existing medical conditions included the patient had no known allergies. 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 admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. Concomitant medications included atorvastatin calcium for high cholesterol. On APR-2021, treatment medications included: diphenhydramine hydrochloride, oxygen, and paracetamol. Also given unspecified cream for right arm. He wanted help with the scar on arm that was 4 inches long and 2 inches wide. On 12-APR-2021, the patient experienced tiredness. On 13-APR-2021, the Patient experienced blisters on right arm between elbow and shoulder, shortness of breath, blurred vision an itching all over especially in right arm. On 13-APR-2021, the patient experienced fever of 101 F. Laboratory data included: Body temperature (NR: not provided) 101 F. On an unspecified date, the patient experienced scar on arm that was 4 inches long and 2 inches wide. The patient was hospitalized for 2 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blisters on right arm between elbow and shoulder, shortness of breath, blurred vision, itching all over especially in right arm, tiredness, and fever of 101 F on 14-APR-2021, and the outcome of scar on arm that was 4 inches long and 2 inches wide was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210435619-COVID-19 VACCINE AD26.COV2.S-blisters on right arm between elbow and shoulder, shortness of breath, blurred vision, itching all over especially in right arm. 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). 20210435619-COVID-19 VACCINE AD26.COV2.S-tiredness, fever of 101 F. This event(s) is labeled and is therefore considered potentially related.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Additional Details: Patient fainted after receiving vaccine, he tipped forward in his chair and hit his head on counter in front of him. 2 minor laceration on forehead and cut upper lip. Pt unconscious for less than 1 minute. Blood pressure taken about 5 minutes later and was 65/40. 911 was called and paramedics arrive on scene. Care was transferred to them

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

Localized rash to right shoulder (injection in right deltoid) and a slight increase in lower back pain since day after injection

Patient fainted post vaccination. Patient was seated in our post vaccine area in a chair with arms. Within a few minutes patient collapsed into the floor, was hot/sweating and a little disoriented. Patient regained consciousness, applied wet compress and tested in a seated position with head down. Began feeling better. Patient provided with a bottle of water. Patient remained on our site for another 30 minutes until felt better and stable.

I experienced a bit of soreness to my left arm, my arm felt a little bit warm to touch. I also felt tired and some fever on the second day. The pain went away in 3-4 days.

Had the following events: muscle & joint pain, persistent tiredness for 4 days following the shot. On the 3rd day following the shot I started sneezing regularly and having a stuffy head & runny nose. This lasted about 4 days. After the sneezing started to subside I started experiencing a nasty head cold which then traveled to my chest and lasted for about 5 days. Was coughing all day long. Once those symptoms started to subside, about 2 and a half weeks after the shot, I broke out in a body rash which I'm still dealing with today and seems to be getting a little worse. I'm currently at a dermatologist in the waiting room filling out this report. The rash is very itchy & at times a tad painful.

Shingles in throat. Vertigo, dizziness, half of head numb. Disoriented, Throat and ear pain, eye pressure on face and in eye, tinnitus, tired. Most symptoms since April 12th. Took two doses of antiviral because I got sores in my throat twice three to four weeks apart. Vertigo, dizziness, disoriented persists.

random body rashes from my feet to my neck for 15 days now. None on the genitals. Itchy and skin welts without even touching it. I've changed my diet, changed detergents, stopped taking all vitamins, nothing helps. they come and go all day and night. On 7/13/21 between 3pm-10pm my whole head went tingly, itchy, and semi-numb, including when I flossed my teeth.

Patient was a healthy 46 y/o male with no significant medical history. He was taking no medications. He received the J&J vaccine on 04/06/2021. On 04/28/2021 he had a fall from probable syncope. He sustained a laceration to his forehead. He was sent to Hospital for evaluation. He had CTs of head and neck, which were unremarkable. A drug screen was negative. Both before and after his return he was having issues with his speech. He seemed to understand words but when he tried to respond, his speech was garbled . He was observed in the infirmary. There was slight improvement in speech. He returned to his block. Because of persistent issues with speech he had an MRI of his brain on 06/03/2021. This showed a left middle cerebral infarct which appeared as a late subacute/early chronic infarct. While an outpatient workup was being scheduled, he had another episode of witnessed syncope. This was on 06/14/2021. An MRI at hospital showed a larger infarct than seen on 06/03/2021. He was hospitalized for 3 days. No cause for the CVA was found during this hospitalization. He has continued with speech symptoms and is starting speech therapy in the near future. In summary, this I/M was in a normal state of health with no risk factors for vascular disease. Two weeks after receiving the J&J vaccine, he had a CVA which may have extended on 06/14/2021. After multiple tests, no reason was found for the CVA to occur. It is certainly possible that the CVA was related to his COVID-19 J&J vaccine.

Shingles on left side of face. It's a mild case, but pain and extreme sensitivity to touch, numbness in some areas, fluid-filled blisters that break open and crust over, itching.

Chills/shivering (at normal room temperature), Muscle & Joint aches, headache, soreness at injection site. Symptoms (except soreness at injection site) remained for 12 hours after onset. Soreness at injection site reduced to very mild after 48 hours

total body pruritic started about 6 hours after administration: per pt, started from feet, then spread to legs, lower back, sides, then forearms. he took two Benadryl and it subsided while he slept (so exact duration unknown). he did use a dose of sildenafil the night prior to getting the vaccine.

Woke up with intense arm pain at injection site on 15th day after vaccine. Radiated down arm , subsided after approximately 30 minutes. Deep tissue, burning pain. Remained only slightly sore remainder of day. Had not experienced arm pain at injection site since day 3 previously.

soreness at injection site, body aches, fever starting about 8 hours after injection and resolved the following evening, about 30 hours after injection

Patient received the vaccine. Immunizing tech stated: the patient seemed fine at the time of the shot. After administration of the shot the patient began to bleed out of injection site (like normal). The immunizing tech swabbed the area with cotton and placed a Band-Aid on the patient then stepped back into the pharmacy to grab another band aid while the patient remained at the immunization chair. The tech applied another band aid and told the patient to wait 15 minutes after the immunization and directed him to a waiting chair. The tech came back into the pharmacy and was cleaning the immunization basket when the patient's wife yelled for help. At this point I went out to the patient. Another tech called 911, another grabbed a nearby EpiPen. The immunizing tech grabbed the e-kit while I was out with the patient while he was unresponsive. Patient was unresponsive and slouched in chair. His wife and I supported the neck of the patient and laid him on the floor. I checked pulse and breathing to which both were present. Patient was still unresponsive and making strange movements. Pulse and breathing remained present and then the patient became responsive relatively quickly. At this point patient responsive and answering questions and moving fine. He asked if he had passed out then stated, he had a phobia of needles and said he felt nauseated. (wife previously stated he had a fear of injections). Soon after the ambulance showed up and I told the paramedics the above story. After a few more minutes I checked in with the paramedics and they said the patient was doing fine. Lastly, he was taken out of store with paramedics.

1 hr after shot (tuesday 0831 hrs), right bicep was twitching. Next morning (wedenesday 0700 hrs) pain an redness in Right shoulder. Most importantly pain in the spine from middle to lower back.. (Thursday 0510 hrs) while brushing teeth, a sharp pain put me to my knees.. 1200 hrs pain was still there... Went to urgent care.. Doctor said it was back spasms.. Said he didn't know if it was related to the vaccine. Then also said nobody knows. I have not worked out nor have I lifted anything heavy in 2 weeks prior to receiving the covid vaccine.

When injected after about 60 seconds semi severe achy-burning feeling in my arm that subsided in a few minutes. After 15 minutes slight tingling/numbness on the tip of my tongue and slight tingling in the upper lips of my mouth. I was not worried. I took 1 Benadryl and 2 Ibuprofen (400 ml) at that time for symptoms. I took additional 1 Benadryl and 4 Ibuprofen about 6 hours later as a precaution. Day 2 after about 36 hours I had slight soreness, and some sweating as I slept the 2nd night. Treated with 4 ibuprofen. Also I woke up with a feeling of uneasiness in the middle of the night on the 2nd night. Day three, just a general feeling of tiredness. Day 4 and 5 still slight ache in the injection sight if pressure is applied. Other than that I feel normal as of day 5.

Rash with hives on both arms and legs....parts of neck and top of shoulders. Dr prescribed Prednisone, Cetirizine, and Cimetidine

102 fever for 48 hours beginning 5 hours after injection. Stiff neck for 3 days beginning 24 hours after injection. Rash on back, chest, and feet with itching and redness beginning 13 days after injection

04/09, ~11:15 a.m.: Received injection in left arm, released at 11:30 a.m. 04/09, ~1:00 p.m.: Mild headache, dizziness and fatigue, mild pain in left arm 04/09, ~7 p.m.: Moderate headache, dizziness and fatigue, mild nausea, spasms in muscle around injection site/itching/redness 04/09, ~8 p.m.: Went to bed and slept 04/10, ~2 a.m.: Awoke with severe headache, fatigue and dizziness, chills/fever, moderate nausea, sleeplessness, moderate pain in arm, moderate joint and muscle pain all over body 04/10, ~3 a.m.: Symptoms progressed to include delirium and hallucinations, rapid heart rate, itching in extremities, neuropathy and hyperesthesia 04/10, ~8 a.m.: Symptoms began reversing in order of occurrence over next 36 hours, starting with delirium and hallucinations; unable to concentrate or function properly 04/12: Lingering mild dizziness and headache, fatigue

Pt got the Janssen (Johnson and Johnson) vaccine on 4/3/2021, and today on 4/13/2021 he reported to us that he had a systematic rash though out his body. We saw rashes on his arm and torso. He also reported bumps on his torso and arms as well.

Mild Soreness at injection site, Sore,Achy muscles across upper back and shoulders. No Treatment required.

Hives itching burning and with intermittent pain extremely painful like large needles stabbing. Right Chest and right back close to injection site. About 10-15 hives

skin rash with red, raised bumps. Initially at ankles, then thigh, next day on arms, belly. Lasted one full day. Treated with hydrocortizone cream, then with benadryl. Three adult doses of benadryl were taken until resolution

The day after injection: severe flu-like symptoms (high fever, body aches all over (former injury sites), headache. Symptoms subsided after 24 hrs. The following days featured muscle cramps all over my body, brought on by exercise. Calves cramped the most with the left calf being injured from cramps. Upper shoulders and neck muscles seized. 'Hot spots' on my torso. Skin very sensitive to touch on side and back. Sleeping a lot more than usual. Fatigue has lasted a week. A week later and muscles are feeling somewhat better. Skin still very sensitive. Still more tired than usual. Still avoiding exercise until muscles feel 100%.

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

Went to the dentist on 4/17/21 for routine cleaning. My gums became sore the next day. Today is 4/21, 4 days later and my gums are still sore. Normal gum soreness for me after a cleaning goes away by the next day when I wake up. On Sunday 4/18, I was working on the car and bruised my arm/wrist in a couple of places. That evening the locations bruised up really good and was tender. Today the areas are still tender and have dark bruising patterns. I generally do not bruise like this, and frankly was surprised bruises even appeared. Yes, I did bang my arm on the car a couple of times, but no where hard enough to receive this kind of bruising. I do not think this is an issue for me -- more of "just dealing with the inconvenience," but am curious if this is some sort of side effect from the vaccine. I could not find any information online related to "easily bruises" at all.

RIGHT SHIN PAIN; ANXIETY; DIFFICULTY CONCENTRATING; HEAD FELLS FUZZY; POTENTIAL SHINGLES; SEVERE LEG PAIN IN RIGHT LEG/RIGHT THIGH PAIN; RIGHT HIP PAIN/RIGHT ANKLE PAIN; LOWER AND MID BACK PAIN; SENSATION IN HEAD AND NECK; 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 concurrent conditions included inflammation, blood pressure, abstains from alcohol, and smoker (1 pack/day or a little less), and other pre-existing medical conditions included the patient had no known allergies and there was no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: 13/JUN/2021) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. Concomitant medications included chlortalidone for blood pressure high, and ibuprofen for inflammation. On 26-MAR-2021, the subject experienced sensation in head and neck. On 27-MAR-2021, the subject experienced right hip pain/right ankle pain. On 27-MAR-2021, the subject experienced lower and mid back pain. On an unspecified date, the subject experienced right shin pain, anxiety, difficulty concentrating, head fells fuzzy, potential shingles, and severe leg pain in right leg/right thigh pain. Laboratory data (dates unspecified) included: Platelet count (NR: not provided) 271 (units unspecified). Treatment medications (dates unspecified) included: cefalexin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe leg pain in right leg/right thigh pain, right shin pain, difficulty concentrating, head fells fuzzy, and lower and mid back pain, and the outcome of sensation in head and neck, right hip pain/right ankle pain, anxiety and potential shingles 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.

My full list of symptoms were: Pins and needle feeling as well as hypersensitivity all over my skin that originated in my lower legs but traveled up my body to include my entire legs, hips, and arms. It was more severe on the left side of my body which is the side I received the vaccine. I did not notice it on my head, face, and upper torso. I had full muscle control but I did have problems with my bladder and bowels. I'm not sure if I could not control them or did not feel them because the sensitivity was high in my hip area but I could not control them fully. No treatment was administered except to wait and see. Three days later and I am improving but not fully recovered yet.

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

Eczema flare up has continued since injection and is spreading up to my upper legs above my knees. Eczema has always only affected the area around my calves and shin.

CHILLS; MUSCLE ACHES; NAUSEA; SORENESS AT INJECTION SITE; HEADACHES; This spontaneous report received from a patient concerned a 47 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 16-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAY-2021, the subject experienced chills. On 17-MAY-2021, the subject experienced muscle aches. On 17-MAY-2021, the subject experienced nausea. On 17-MAY-2021, the subject experienced soreness at injection site. On 17-MAY-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and nausea on 17-MAY-2021, was recovering from muscle aches, and soreness at injection site, and had not recovered from headaches. This report was non-serious.

RESTLESS SLEEP; FELT COLD; INJECTION SITE SORENESS; TIRED; LOW GRADE FEVER; This spontaneous report received from a patient concerned a 47 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: 203A21A, and batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2021, the subject experienced restless sleep. On 15-MAY-2021, the subject experienced felt cold. On 15-MAY-2021, the subject experienced injection site soreness. On 15-MAY-2021, the subject experienced tired. On 15-MAY-2021, the subject experienced low grade fever. Laboratory data included: Body temperature (NR: not provided) 99.4 (unit unspecified). On 16-MAY-2021, Laboratory data included: Body temperature (NR: not provided) normal. The action taken with covid-19 vaccine was not applicable. The patient recovered from restless sleep, felt cold, and low grade fever on 16-MAY-2021, injection site soreness on 19-MAY-2021, and tired on 17-MAY-2021. This report was non-serious.

Covid-19 Janssen vaccination administered on 5/24/2021 at approximately 1230. At approximately 1247 patient noted to have flat red rash to left side of neck moving towards chest and same rash on left antecubital space. Patient reported feeling hot. Diphenhydramine 50mg IM administered. Patient reported feeling short of breath, epi-pen 0.3mg IM administered. Respirations at 16 per minute, lungs clear to auscultation. Noted bilateral flat rash to underarms, improved with removing clothing from area. Patient symptoms improved. At approximately 1330 patient reported starting to feel short of breath. Patient self administered albuterol inhaler, two puffs. Lung sounds per auscultated expiratory wheezing bilateral upper posterior lobes and right middle lobe, no stridor. Post inhaler lung sounds very faint expiratory wheezing upper posterior lobe, right middle lobe cleared. At approximately 1400 noted rash to bilateral underarms started to return, rash to left side of neck started to raise, noted dermatography to bilateral sides. EMS activated. Perioral edema noted, patient reported starting to feel short of breath, epi-pen 0.3mg IM administered, oxygen at 2L per NC applied. Ambulance on prison grounds at approximately 1412, left grounds at approximately 1429 to Emergency Room for a higher level of care. Treatment at ER not available. Discharged from ER on same date at 2246. On 5/25/2021 at approximately 0215 patient reported pain in jaw, neck and chest. EKG obtained, normal EKG. Follow up scheduled with medical provider.

The first day I noticed a burning rash on the back of my leg, that lasted for about a few days until the pain was unbearable. Blisters started to appear and spreading. Nerve pains started to occur throughout the body that resulted into going to the clinic and was diagnosed with Shingles. The doctor prescribed a 7 day anti-viral prescription that helped with the pain, after taking it the pain went away a few days later. After taking the medication as prescribed I did recover from my symptoms.

The morning of May 30th, experienced hives all over torso and legs, as well as swollen lips. As of this report (6/1/21), still dealing with bouts of on and off hives and alternating areas swelling in lips and eyes. Currently treating symptoms with Benadryl which is helping to moderate symptoms. However, symptoms are still present.

Shot was painless the first. Next day was severe enough to limit movement for the next 2 days. Eventually shoulder pain s as me shooting pain down my arms. 3 weeks later noticing pain in all my joints, especially shoulder that was injected and my knees and hips. 4 weeks later all pain persists and the site of injection still is sore.

Approximately 12 hours after getting the vaccine, I began shivering uncontrollably for about an hour and felt hot (like a fever) at the same time. I also ached all over. I took 2 Tylenol and was able to fall back asleep. I woke up sweaty, but the chills and fever were gone. I?m now just stiff, with some mild pain at the injection site.

Redness and itching at injection site Severe joint pain in neck, shoulder, hipd, knees, ankles for 36 hours

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

Mild reactions including breathing heavy, throat felt swollen while trying to sleep, slight dizziness, some rashes(similar to big mosquito bites). All reactions are mild.

Chills lasted for about 16 hours Fever in the middle of the night Muscle pain in injection arm (current) Pain in arm pit of injection arm (current) Headache lasted about 24 hours

pain at injection site, fatigue on the 23rd. Extreme fatigue on the 24th. Only mild pain at injection site on 25th. No other reactions

Soreness at injection site. Headache and body aches and fatigue. I had Covid and still have antibodies so I think this made my reaction worse than others.

rapid heart rate, excessive sweating, chills, muscle aches, pain all over body, chest pain. Weakness, brain fog, out of sorts, flu like symptoms, break outs on face, trouble breathing. These conditions have lasted over 5 days so far.

Full body sweats, migraine for 2 days, threw up 4 times, shakes, pain at injection site/shoulder/chest, extreme fatigue, body aches

At night time, felt my face getting hot and felt as if I had a fever. 4 days later, developed itchy rash under the armpits, and sides, lower stomach inner thigh near groin.

Patient immediately experienced soreness on the site of inoculation. Patient had headache for 3 days accompanied by extreme fatigue/tiredness and was lethargic. Patient also was sweating a lot at night.

Ongoing, beginning two days after injection. In addition to injection site/arm soreness, began to experience a constant tightness (cramp-like) within the left side of torso, like the muscles around heart or lung is cramping. Unable to take a full inhale of breath without discomfort/pain.

Sunday morning, 4/11/21, had severe itching in hands/feet that was improved by deep massage and hot water. Also had hives on flanks that moved up sides. Initially took Benadryl 1 tab twice and then in evening took 2 tabs d/t worsening symptoms. Next day had similar symptoms but hives also on trunk that traveled up to neck and jawline. Denies airway involvement or s/sx of blood clots.

The following morning I felt mild flu like symptoms and very low energy. While at working my right upper ankle/ lower knee became extremely sore for no reason. A mild headache and upper respiratory irritation also occurred. My right arm at injection point was extremely sore. I figured it was a immune response and didn?t get too worried. These symptoms have persisted. Hopefully will subside soon

Sore arm, redness, swelling, hot to touch, itches when touched when the patient reported the symptoms on 4/17/21

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.

Shingles. On the evening of the vaccine, he had a low grade fever and chills (from approximately 7 pm to 1 am). Two days later, he developed shingles. They started as a red rash spot in the middle of his back, approximately the size of 2 quarters, 2 days after the vaccine. On the 3rd day, the red rash was apparent along the right side of his midsection. Blisters started to appear on day 4. He phoned his doctor and provided photos for a virtual patient visit, and the doctor diagnosed shingles. The area affected is both itchy and painful. The doctor prescribed Valocyclovir. After taking the medication for 3 days, the blisters started to dry out and scab. The itching and pain are still present but reduced from their peak.

TIGHT BURNING FEELING IN UPPER RIGHT BACK AND RIGHT ELBOW; CRIPPLING CONSTANT PAIN; MUSCLE WEAKNESS TO THE RIGHT ARM; TIGHTNESS ON UPPER RIGHT SIDE ON BACK NEAR RIGHT SHOULDER; INJECTION SITE PAIN; INITIAL BURN WHEN VACCINATED; DISCOMFORT; DID NOT SLEEP WELL AT NIGHT; 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 concurrent conditions included shellfish allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 12:30 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced discomfort. On MAR-2021, the subject experienced did not sleep well at night. On 11-MAR-2021, the subject experienced muscle weakness to the right arm. On 11-MAR-2021, the subject experienced injection site pain. On 11-MAR-2021, the subject experienced tight burning feeling in upper right back and right elbow. On 11-MAR-2021, the subject experienced crippling constant pain. On 11-MAR-2021, the subject experienced tightness on upper right side on back near right shoulder. On 11-MAR-2021, the subject experienced initial burn when vaccinated. Treatment medications (dates unspecified) included: ibuprofen, naproxen, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on 12-MAR-2021, was recovering from tight burning feeling in upper right back and right elbow, crippling constant pain, did not sleep well at night, discomfort, initial burn when vaccinated, and tightness on upper right side on back near right shoulder, and had not recovered from muscle weakness to the right arm. This report was non-serious. Additional information was received on 19/Mar/2021. The following information was updated and incorporated into the case narrative. Reporter details added, patient information (date of birth, sex, ethnic origin, race) added. patient allergy details, batch number of suspect, site of administration, Vaccine facility details, events: injection site pain and muscle weakness to the right arm were added.; Sender's Comments: V1:Medical assessment comments not required as per the standard procedure as the case is considered non serious.

on 4/9/21 around 8pm extreme cold chills , headache , body aches fever all night , flu like feeling for 3 days body ache and little sleep , consistent headaches . Had out patient knee surgery on 4/14 . Continues nasty headaches and body aches after . on saturday 4/17 bad headaches all night , bones in upperbody and skin hurt , from waist up felt like i had sunburn including on top of head , little sleep again . Went to Emergency room on 4/18 am . Tested for blood clot in leg and was negative , they gave me something for headaches and i was dehydrated , tongue was white and continues to wake up everyday white and feeling like dehydration , continues head aches from front to back with some continues neck pain in back . Havent slept more than 2 hours at a time . wake up with headache everyday and at night headaches are bad . i drink plenty of fluids all day , should not be feeling dehydrated . its now 15 days since vaccine and have no answers , i need to be able to sleep to do my job , vaccine was a mistake

SHORTNESS OF BREATH; CHEST PINCHING; FAST HEART BEAT; RASHES HAD REDNESS; RASHES AS ITCHY; RASHES ON CHEST AND BACK AS PAINFUL; EASILY GOT TIRED; FELT HEART WAS CONGESTED; COUGH; LITTLE BIT OF HEADACHE; This spontaneous report received from a patient concerned a 48 year old male. The patient's weight was 150 pounds, and height was 170 centimeters. The patient's past medical history included low platelet, and bypass surgery, and concurrent conditions included rashes allergy, non drinker, and non-smoker, 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, intramuscular, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for low platelet. On 31-MAR-2021, the subject experienced little bit of headache. On APR-2021, the subject experienced felt heart was congested. On APR-2021, the subject experienced cough. On 12-APR-2021, the subject experienced shortness of breath. On 12-APR-2021, the subject experienced chest pinching. On 12-APR-2021, the subject experienced fast heart beat. On 12-APR-2021, the subject experienced rashes had redness. On 12-APR-2021, the subject experienced rashes as itchy. On 12-APR-2021, the subject experienced rashes on chest and back as painful. On 12-APR-2021, the subject experienced easily got tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little bit of headache on 01-APR-2021, had not recovered from shortness of breath, chest pinching, fast heart beat, rashes on chest and back as painful, easily got tired, rashes as itchy, and rashes had redness, and the outcome of felt heart was congested and cough 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.

Since my J&J vaccine, I have limited mobility on my left shoulder, at the injection site, still sore and can not lift my left arm to full extent.

LEFT EYE WITH BLOOD SPOT IN THE EYEBALL; PAIN IN THE CENTRAL PART OF THE CHEST; DIFFICULTY BREATHING WHEN DOING ACTIVITIES; HEADACHE; LEFT ARM PAIN WHERE SHOT WAS ADMINISTERED; COULDNT SLEEP THE DAY OF THE VACCINE; BODY TREMBLING; This spontaneous report received from a 48-year-old, male patient The patient's weight was 184 pounds, and height was 74 inches. The patient's past medical history included gallbladder removal. The patient was non-smoker, social drinker (only in holidays mostly), and the patient had no known allergies. The patient did not have any 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: 207A21A and expiry: 23-JUN-2021) dose was not reported, 1 total administered on 14-MAY-2021 around 13:15 to left arm for prophylactic vaccination. No concomitant medications were reported. On 14-MAY-2021, the patient experienced left arm pain where shot was administered, body trembling and couldn't sleep on the day of vaccine. On 17-MAY-2021, the patient experienced headache which had diminished, but suddenly they were like stabbing, left eye with blood spot in the eyeball and pain in the central part of the chest, which on occasions varies from right to left with breathing difficulty when doing activities. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body trembling, couldn't sleep, and left arm pain where shot was administered on 18-MAY-2021, was recovering from headache, and left eye with blood spot in the eyeball, and had not recovered from pain in the central part of the chest, and difficulty breathing when doing activities. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 : 20210555889-COVID-19 VACCINE AD26.COV2.S -Left eye with blood spot in the eye ball. 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 72 hours of receiving the vaccine, I began experiencing itchiness in random locations on my body. However, it was intermittent and not too severe - initially. The itchy rash would pop up and subside, until Weds May 26th. In the middle of that night (5/26) I awoke with the most severe itching and discomfort that I've ever experienced, and it was in spots across my arms, legs, abdomen, inner thighs, underarms, soles of feet, wrists, and elsewhere. The next morning (Thursday 5/27) I began calling dermatology offices and clinics hoping to secure a Doctor's appointment ASAP to get a diagnosis and hopefully some relief. I was able to secure an appointment at Immediate Care for later that morning. At that time I received a steroid shot in my arm, and began a cycle of Prednisone to address the rash. It persisted and was very uncomfortable for the following three days, but thankfully began to subside due to the steroids by Monday 5/31. I would like to stress that I've had no known allergies in my life, and that this was the most extreme rash and itching I've ever experienced. If I had it to do over again, I would not get the vaccine.

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.

SKIN ABRADED; AWAKE LAST NIGHT BECAUSE OF INTENSE ITCHING; ITCHING OF KNEECAP, QUAD, LOWER QUAD ON BOTH LEGS, BOTH SIDES OF HIP NEAR PELVIC BONE, BICEP, LOWER ABDOMEN; REDNESS OF KNEECAP, QUAD, LOWER QUAD ON BOTH LEGS, BOTH SIDES OF HIP NEAR PELVIC BONE, BICEP, LOWER ABDOMEN; This spontaneous report received from a patient concerned a 48 year old male. The patient's weight was 178 pounds, and height was 69 inches. The patient's concurrent conditions included alcohol user, non smoker, and eczema, and other pre-existing medical conditions included the patient had no known allergy. The patient was normally healthy, had no medical conditions. The patient took no medications. The patient did not have any history of drug abuse or illicit drug use. The patient took vitamin b for men. The patient was previously treated with alprazolam, and zinc. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 04-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-JUN-2021, the subject experienced itching of kneecap, quad, lower quad on both legs, both sides of hip near pelvic bone, bicep, lower abdomen. On 12-JUN-2021, the subject experienced redness of kneecap, quad, lower quad on both legs, both sides of hip near pelvic bone, bicep, lower abdomen. On an unspecified date, the subject experienced skin abraded, and awake last night because of intense itching. Treatment medications (dates unspecified) included: cortisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itching of kneecap, quad, lower quad on both legs, both sides of hip near pelvic bone, bicep, lower abdomen, and redness of kneecap, quad, lower quad on both legs, both sides of hip near pelvic bone, bicep, lower abdomen, and the outcome of skin abraded and awake last night because of intense itching was not reported. This report was non-serious.

SHORTNESS OF BREATH; UNABLE TO WALK; BRUISE IN THE STOMACH; HEADACHE; ARM PAIN; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 09041738 expiry: UNKNOWN) dose was not reported, administered on 16-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-JUN-2021, the subject experienced arm pain. On 19-JUN-2021, the subject experienced headache. On JUL-2021, the subject experienced bruise in the stomach. On an unspecified date, the subject experienced shortness of breath, and unable to walk. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, had not recovered from arm pain, bruise in the stomach, and shortness of breath, and the outcome of unable to walk was not reported. This report was non-serious.

OCCASIONAL CRAMPING SPECIFICALLY IN THE CALF MUSCLES/ LEGS - SYMPTOMS OF CRAMPING; LEGS-NUMBNESS; FEELING OF LEGS TIREDNESS; LEGS-WEAKNESS; WARM FEELING BUT NO FEVER - TEMP 99.0F; GENERALIZED BODY ACHES (NO SPECIFIC LOCATION OF PAIN); INJECTION SITE MINOR PAIN/ NO RASH OR MUSCLE PAIN; 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 concurrent conditions included alcohol use, seasonal allergies, and non smoker, and other pre-existing medical conditions included patient does not have medical history and not taking prescribed medications .the patient does not have history of illicit drug abuse. patient does not experienced headache, fever, nausea. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 10-JUL-2021 for prophylactic vaccination. Concomitant medications included ibuprofen for drug used for unknown indication. On 10-JUL-2021, the subject experienced warm feeling but no fever - temp 99.0f. On 10-JUL-2021, the subject experienced generalized body aches (no specific location of pain). On 10-JUL-2021, the subject experienced injection site minor pain/ no rash or muscle pain. Laboratory data included: Body temperature (NR: not provided) 99.0 F. On 15-JUL-2021, the subject experienced occasional cramping specifically in the calf muscles/ legs - symptoms of cramping. On 15-JUL-2021, the subject experienced legs-numbness. On 15-JUL-2021, the subject experienced feeling of legs tiredness. On 15-JUL-2021, the subject experienced legs-weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from warm feeling but no fever - temp 99.0f, generalized body aches (no specific location of pain), and injection site minor pain/ no rash or muscle pain on 11-JUL-2021, and had not recovered from occasional cramping specifically in the calf muscles/ legs - symptoms of cramping, legs-numbness, feeling of legs tiredness, and legs-weakness. This report was non-serious.

Patient experienced hives on face/neck after first Moderna dose in Feb, treated w/ benadryl at that time, lasted several hours, no mouth/throat swelling. Patient was scheduled for his 2nd Moderna dose at clinic. Given his reaction to moderna previously he was sent to outpatient pharmacy to get Janssen (J&J) vaccine. After the Janssen Covid vaccine was administered patient immediately began feeling red, hot, and itchy. Was given benadryl 25mg/5ml oral dose x2 after being monitored for 30 min. Told patient if symptoms got worse or persisted to come back to hospital. After monitoring patient he felt safe to go home and had no visible signs of reaction after 30 min. Called patient to follow up 24 hours later and he stated he felt a "little itchy" that evening and had flu like symptoms when he woke up in the morning (achy, chills) but the itching went away last night.

Around 14APR2021 noticed small rash on top of right hand, used cortisone cream to treat it, did not help 24APR2021 I went to urgent care for a rash that spread to my biceps, I saw Dr., prescribed prednisone for 5 days 2x a day, but the rash never cleared; 03MAY2021 I saw Dr., because the rash spread from biceps to the back of my elbows, he prescribed me Mometasone cream. This helped a little, but I quickly ran out of the cream,. I communicated through patient portal online to Dr., they prescribed more Mometasone cream. The cream seemed to help but the rash kept spreading. 11MAY2021 I went to see Dr., the rash spread all over my arms, with slight signs on my body. I was feeling fatigue because I was not able to sleep. I remember Dr. mentioning a possibility of an allergic reaction to the Johnson & Johnson vaccine, because I never really had a history of allergies. My body was rejecting something though, prescribed prednisone for 9 days. Rash still spreading. 24MAY2021 the rash was all over my body.. arms, legs, torso, it had a sensation of heat, stinging, and intense itching...could not get in to my doctor until the next day...I called in sick to work. 25MAY2021 I went to see Dr. He put me on medical from 24MAY2021 through 07JUN2021 and recommended to see Dermatology for diagnoses and testing. 26MAY2021 I went to Dermatology to see DR. She said it looked like Chronic Urtacaria, but needed to take a biopsy from my skin to confirm she also ordered a blood test. I was instructed to take two over the counter medications. XYZAL and ALLEGRA, and prescription Montelukast 4 Xyzal 2Allegra and 1 Montelukast a day totaling 7 pills, 02JUN2021 I Had my blood drawn. 07JUN2021 I went to Dermatology to see Dr. I had the stitches removed from my arm. My rash was better but still present continued medication; 10JUN2021 I went to Hospital ER, for severe muscle cramps and dehydration...was later released; 10JUN2021 after discharge from the ER, I went to see Dr. at my doctor office. I told him I feel overmedicated and have depression and was having severe leg cramps and could not sleep, he told me to immediately stop taking the MONTELUKAST medication. 28JUN2021 dermatology called me and said my blood test result from my 02JUN2021 blood draw was STREP positive. I was instructed to take AMOXICILLIN 2x a day for 10 days the rash was slowly subsiding, and by 05JUL2021, I was happy to see the rash was gone from my skin, 07JUN2021 I finished AMOXICILLIN; Dr. told me to start up meds again if rash were to return.

Received COVID Vaccine on 03/14/2021. Pt had body aches and fatigue but on 03/17/2021 started with itching, pain on lips, forehead and waist line. Patient has lesions and significant pain consistent with shingles.

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

9 hours after shoot woke up feeling very poorly and feverish. Went to take Tylenol and passed out. Came to with wife shaking my arm. Suffered trauma to noise and back during fall as a result of passing out including laceration from hitting face on counter. After coming to sever body shakes. Temperature was taken twice and recorded 92.5 and 93.0. Blood pressure and pulse after moving to couch to lie sit down was normal. Next day couldn't do much and was very tired. By second day I was recovered but sealing with injuries from the fall.

Soreness in the vaccinated arm, persistent swelling through course of week. Likely delayed allergic response.

Patient mentioned he had a small itchy rash along part of his shoulder, along with pain near the injection site. The pain comes and goes even after 20 days since the vaccination, the rash is still present. Pharmacist encouraged patient to contact primary health care and have them examine him and see if they need to administer corticosteroids for the rash.

headache on day 2 with low energy and felt lethargic Also felt hot all night like I couldn?t cool off. Woke up with rash all over body. Mostly around neck and right chest/armpit area. Also speed to arms and legs but to a lesser degree.

Patient received Johnson&Johnson COVID vaccine in the afternoon on 3/31/21. Patient reported having right arm pain, diaphoresis, chills, nausea, and muscle aches/pain in upper leg/lower back at 5:30am the following morning. Patient took 2 tablets of 500mg naproxen in the morning and in the afternoon. Symptoms did not resolve and patient had to leave work early. Upon getting home patient took 2 tablets of 650mg tylenol and symptoms resolved within 48 hours. On 4/3/21 patient reported mild to severe pain in heel of left foot. The following day the patient went to WellNow urgent care to get his heel examined. During examination provider noticed patient's lesions and patient stated more lesions have appeared since getting the vaccine. 1 on his stomach, 1 on the dorsum of his left foot, 1 on his back, 1 on his left elbow, in between his toes of his left foot, and in between the fingers of his right hand. Patient stated that these lesions cause a burning sensation and can become itchy. Patient was sent to Hopsital ED as provider at urgent care was concerned patient may have purpura. Patient was seen and discharged on 4/4/21 from the ED. The heel pain was determined to be plantar fascitis which was treated with at home exercises with a heel cup. The patient was given clotrimazole for his lesions. The patient had a follow-up visit with his primary care provider at hospital on 4/6/21 in which he explained the clotrimazole only made his lesions worse. Patient was referred to follow up with dermatology on 4/8/21. Primary care provider believes progression of the lesions since getting the vaccine leads to concern of an underlying autoimmune exacerbated by vaccine.

12-15hrs after injection, general fatigue, loss of appetite, and minor aches treated effectively with IBU, APAP, and sleep. The second morning, itching sensation on forearms with ~6 minor welts forming on right fore arm. 18month prior, had a sever exposure to poision oak treated with high dose prednisone. Forearms were very red, welts, and itchy. Itchy sensation occurs occasionally with exposure to hot shower water, but only transient. Post vaccine, much more severe itching sensation with formation of small (<2mm) hives. Fatigue had subsided by this time.

JUST A BIG KNOT IN ARM AT INJECTION SITE; DIARRHOEA; EXTREME LETHARGY; EXTREME FATIGUE; NAUSEA; FEVER/LOW GRADE FEVER; EXTREME ABDOMINAL PAIN 12HRS AFTER INJECTION; UPPER GASTROINTESTINAL GAS; BLOATING; CHILLS AND SHAKING VERY STRONGLY; VOMITING; This spontaneous report received from a patient concerned a 49 year old male. The patient's weight was 260 (unit not reported) and height was 73 inches. The patient's concurrent conditions included non alcohol user, non smoker, type 2 diabetes, hypertension, and pain, and other pre-existing medical conditions included patient had no history of allergy to vaccine, drug, or food. patient had no drug abuse. the patient had no family history of any disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805020 expiry: 25-MAY-2021) dose was not reported, administered on left arm on 26-MAR-2021 10:01 for prophylactic vaccination. Concomitant medications included atorvastatin for cholesterol, dapagliflozin propanediol monohydrate for diabetes mellitus, metformin for diabetes mellitus, amlodipine for hypertension, atenolol for hypertension, irbesartan for hypertension, and capsaicin/menthol for pain. On 26-MAR-2021, the subject experienced extreme abdominal pain 12hrs after injection. On 26-MAR-2021, the subject experienced upper gastrointestinal gas. On 26-MAR-2021, the subject experienced bloating. On 26-MAR-2021, the subject experienced vomiting. On 26-MAR-2021, the subject experienced chills and shaking very strongly. On 26-MAR-2021, the subject experienced nausea. On 26-MAR-2021, the subject experienced fever/low grade fever. Laboratory data included: Body temperature (NR: not provided) 100 (unit not specified). On 27-MAR-2021, the subject experienced extreme lethargy. On 27-MAR-2021, the subject experienced extreme fatigue. On 28-MAR-2021, the subject experienced diarrhoea. On 29-MAR-2021, the subject experienced just a big knot in arm at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extreme abdominal pain 12hrs after injection, upper gastrointestinal gas, bloating, extreme fatigue, and nausea on 30-MAR-2021, vomiting, chills and shaking very strongly, and fever/low grade fever on 26-MAR-2021, and diarrhoea on 28-MAR-2021, and the outcome of extreme lethargy and just a big knot in arm at injection site was not reported. This report was non-serious.

Flushed at first. Extreme fatigue for two days. Rash on chest which is most visible after showering. Rash seems to be lessening with each passing day.

initially patient had fever, mild headache, fatigure x1 day and on day 2 he had flat rash on entire torso, lower back, bilateral arms

Pain started in buttocks; then numbness in legs, then progressed up back to mid back pain, then to neck fullness and tightness, pain on both sides of neck, jaw and chin, feeling of something popping in neck and then Bell's Palsy of right side of face, difficulty speaking, eating, numbness of tongue; right eyelid unable to close, more pain on both sides of neck and back of head; cold and hot sensations on limbs today and no improvement of facial paralysis; hearing cricket noises in right ear at times, burning pain in patches of face.

Day after vaccination started getting bruises appearing. Day 1 and 3 got red circular shaped rashes with pale centers. Got another bruise on day 4. Wen tto ER where bloodwork was done. Normal 1 week after vaccination hives started. Day 9 skin feels like it is burning in the sun.

INJECTION SITE PAIN; HEADACHE; TIREDNESS; SORE TO TOUCH; 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 past medical history included stroke, and concurrent conditions included high blood pressure, and other pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022) .5 ml, administered on 05-MAR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced injection site pain. On 06-MAR-2021, the subject experienced headache. On 06-MAR-2021, the subject experienced tiredness. On 06-MAR-2021, the subject experienced sore to touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain, headache, tiredness, and sore to touch. This report was non-serious.

BRUISE ON LEFT ARM; This spontaneous report received from a patient concerned a 49 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-APR-2021, the subject experienced bruise on left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bruise on left arm. This report was non-serious.

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.

Patient seen at medical facility 4/6/2021 with headache, fatigue, lower extremity petechial rash, unexplained bruising, small amount of blood in stool. CBC ordered 4/6/2021 and obtained on 4/8/2021. Platelet count was 4 x 10^9/L. Patient admitted to hospital. Hematology/Oncology consult obtained. Patient diagnosed with Immune Thrombocytopenia Purpura (ITP). 4/9/2021 Given 1g/kg IVIG and 125mg IV methylprednisolone. Platelets increased to 15 x 10^9/L. 4/10/2021 Given 1g/kg IVIG and 125mg IV methylprednisolone, platelets increased to 81 x 10^9/L. Patient discharged on oral prednisone with Hematology/Oncology outpatient follow-up. Patient advised to stop Goodies Powder for Headache. 4/13/2021 patient returned to hospital emergency department with generalized weakness. His platelets were rechecked and were 277 x 10^9/L. D-Dimer was undetectable at <0.27. Patient was discharged home from the emergency department.

SORE; RASH ALL OVER THE BODY; SHIVERING; FEVER; TIREDNESS; 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 graves disease, abstains from alcohol, and non-smoker, and other pre-existing medical conditions included patient had no known allergies. no drug abuse/ illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-APR-2021, the subject experienced sore. On 14-APR-2021, the subject experienced rash all over the body. On 14-APR-2021, the subject experienced shivering. On 14-APR-2021, the subject experienced fever. On 14-APR-2021, the subject experienced tiredness. Treatment medications (dates unspecified) included: methylprednisolone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore, rash all over the body, shivering, fever, and tiredness on 14-APR-2021. This report was non-serious.

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.

Tinnitus and diminished hearing in the left ear only 5 minutes post injection. Pain at injection site lasting 1 week. Anxiety prior to receiving vaccine and post lasting 1 hour. Fatigue, body aches starting 5 hours post injection. Chills starting 12 hours post injection and lasting 2 hours. Headache lasting 24-36 hours. Elevated temp at 98.4, normally 97.4

Rash/hives developed on left inside forearm, then right forearm same day. Rash/hives appears on upper arms and wrists after a couple days. Rash developed in the groin /genital area after one week then along the belt line a bottom after about a week and a half. After two weeks rash/hives started on legs. After 2 1/2 weeks rash stared on the fingers. After over 3 weeks and 3 days (today), rash continues, but is not as itchy on the arms.

He got the vaccine, He felt as if he was breathing shallow on the bus to get to work, within 15 minutes of the vaccine. He came home and collapsed due to the fatigue which is not normal for him. About 12 hours later his throat got scratchy, achy but doable. He went to work and had to leave early due to flu-like symptoms, felt feverish. Really bad aches now, and his breathing and heart rate are elevated right now. Achy-like headaches. He did take some Ibuprofen 800 mg and seems to be helping. He has had the typical soreness of getting the vaccine in the left shoulder, but otherwise ok. He also has a stuffy nose, scratchy throat and his eyes are a little red and glassy. He was directly exposed to somebody for 25 hours that was positive for COVID, but nobody else in the car got COVID in January.

Itchy rash on both arms. Started after vaccination and has not yet resolved. Itching relieved from oral benadryl.

HIVES; 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 allergic to seashells. The patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, Laboratory data included: Allergy test (NR: not provided) Allergic to tomatoes, peanuts, pecans, and grass. On 03-MAY-2021, the subject experienced hives. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hives was not reported. This report was non-serious.

EYESIGHT IS A LITTLE BLURRY; BLEEDING GUMS WHEN BRUSHING TEETH; LIKE A BLISTER; PAIN IN LEG; 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 high blood pressure, and other pre-existing medical conditions included the patient was healthy and fit. The patient experienced drug allergy when treated with codeine. 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 prevention of covid-19 vaccine. No concomitant medications were reported. On APR-2021, the subject experienced like a blister. On APR-2021, the subject experienced pain in leg. On an unspecified date, the subject experienced eyesight is a little blurry, and bleeding gums when brushing teeth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in leg, eyesight is a little blurry, bleeding gums when brushing teeth, and like a blister. This report was non-serious.

49M with PMH significant for anxiety and depression; unmedicated due to lack of health insurance presenting with vasovagal syncope 15 minutes after Janssen vaccine administration in left arm. Pt reported feeling nervous prior to vaccine administration with remote history of fainting one time due to needle phobia, pt was offered to prophylactically lie down in a cot to receive the vaccine, he refused. Pt stated that he began feeling flushed and sweaty when he lost consciousness falling from a seated position, hitting his face and head. Pt was lying in prone position unconscious for 10-15 seconds, EMS was notified and pt was turned using C-spine precautions and transferred to stretcher. Pt was placed in trendelenberg,

Upon waking the morning after my vaccine, I experienced arthralgia, mainly in the knees, myalgia, injection site pain, head heaviness, palpitations/premature ventricular contractions, and general tiredness/malaise. All AEs lasted the entire day until I went to sleep at 10:30 PM, and all were resolved upon waking the following morning at 7:00 AM.

Fatigue, body ache, chills, headache. Chills starting Monday night/Tue morning while trying to sleep. Restless through night, then very tired Tue. Took Tue off from work and spent at home. All largely better by Tues evening. Wed morning, left arm still tender at injection site, but nothing serious.

About 8 hours after the vaccine shot, I started to experience joint aches, then strong chills where I could not get warm, then a splitting headache. Then the injection spot hurt badly, These symptoms lasted for approximately 36 hours

I got a knot and soreness in my arm directly below the injection site that began immediately after the shot and lasted for one day. 24 hours after the vaccine, I began a low grade fever and general fatigue that lasted for several hours. The next morning, I felt fine.

Syncope, clammy/sweaty/grey skin, loss of bodily function and non-responsive for 1 minute, with O2 sat dropped to 91% after event. Onset approximately 2 minutes following injection.

About 20 hours after injection, I had mild flu-like symptoms, including headache and muscle ache, lasting about 12 hours. But about 5 days after my injection (5 days + 5 hours, actually), I experienced a bewildering all-over rash that freaked me out. It started as itching around my elbows and ankles -- it felt like mosquito bites and sunburn together -- and spread to wrist and knee areas. The rash climbed by legs and arms. I applied coat after coat of Benadryl, which seemed to help. The rash would disappear and move somewhere else. I had it on my left foot, but then that resolved, only to find it on my right foot. After about 3 hours, it had spread to my stomach, the bridge of my nose, and my cheeks. It started to calm down around midnight. I woke up at 6:00 am (12 hours after onset) with extremely itchy hands. At 8:00 am (14 hours after onset), it had mostly disappeared except for patches on my back, and my wrists still itch. I'm hoping it goes away later today! It was crazy!

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

On Day 3 started a Rash on the back and has spread to other areas of the body. Severity is not bad, Itchy

Day after vaccination (18/MAR/2021)--fatigue, body aches, chills. Physically felt as if temperature was elevated--but when measured, no temperature elevation was found. Symptoms lasted entire day, were gone the following day. Two days after vaccination (19/MAR/2021)--injection site soreness. Note that site was not at all sore on either date of injection (17/MAR/2021), or day after. Soreness lasted approximately two days.

First, pain around the injection site; it appeared within a few hours after the injection, but it was bearable. Then, after about 23 hours after the injection, bad headache (especially around the eyes - which also caused light sensitivity) and general malaise. Shortly thereafter, low-grade fever (99.5 F) and significant muscle pain, all over the body. The most worrisome side effect was the last one, which appeared during the second night after the injection (about 32-33 hours after the injection): extremely fast heartbeat / racing heart. I did not use any treatments for these side effects.

Injection site swelling and extreme soreness Fatigue Stomach cramping Nauseous Chills Muscle aches Migrane

Immediately on injection felt severe pain in arm - the pain radiated downward but at time of typing this report patient states pain is lightening up and remains only at injection site.

Felt a slight numbness is throat, possible slight swelling in throat- felt this 20 minutes after shot and it lasted about 30 minutes.... 30 minutes after the shot my face turned red and my ears were very red, almost purple , and hot. This lasted for several hours after... At 11:30pm, almost 7 hours after the shot, I started to feel lousy. I started to get body aches and chills. Within 30 minutes they were fairly intense body aches and chills, shaking. At 1:00am I started to feel nauseas . At 1:30 am I started dry heaving. At approximately 2:30 I threw up twice, and the dry heaving and nausea lasting until 4am , when I took an anti nausea pill. I finally fell asleep at 430am. I woke up at 8am and felt tired, and no longer nauseated.

5 days post vaccination I experienced sudden onset of generalized hives associated with itchiness. After use of benadryl the hives became more red, less raised, and resembled a confluent measles rash. From association with hives I experienced ear pruritus, sore throat, nausea. And fatigue. Hydrocortisone creme was used on the rash.

Chills, mild fever, joint aches, skin sensitivity. Fatigue but difficulty sleeping. Similar to onset of flu, but milder.

Injection sight pain Chills Muscle Aches - day 2 Headache - Day 2 and 3 Fatigue - Day 1,2,3+ Coughing Lung pain Shortness of Breath Chest Pain

I received the J&J vaccine on 3/24, and by that evening I had a headache, and my tinnitus was louder than normal. I had mild barely perceptible tinnitus prior to the vaccine. I would normally never notice it during the day, but lying down and going to sleep in a quiet room I would hear it. Constant high pitch but not loud, in the background more. I always run a fan in my bedroom so that I have some white noise and don't hear it. I had the flu like headache from the vaccine for two days and then it slowly started to subside into the weekend. I was tired as well from the immune response. Five days out, I get out of the shower in the morning, and go to put underarm deodorant on, and notice my left armpit is all bright red. I check my right armpit, just as red.. Took photos of the red armpits and shared with some family and friends, as I read on the Internet that there were all kinds of crazy side effects that were possible. The red skin like rash is one of them, although my armpits never itched or burned. I could feel that they were warmer than normal, that was it. It was the 2nd day after my red armpits that my tinnitus ratcheted up to the current level that I am really unhappy with. The red armpits went away within 48 hours, never did anything about the redness, just didn't put underarm deodorant on until it passed. Sadly, the Tinnitus has remained and it is at a level that is distracting and persistent.

Patient developed an itchy rash on his back on Thursday evening to Friday. He is currently treating it with hydrocortisone cream. I advised him to monitor the rash and also take benadryl to reduce inflammation. Will follow up with patient.

SWOLLEN EYES; RED EYES; RASH AROUND BOTH EYES; This spontaneous report received from a patient concerned a 50 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, administered on 31-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced swollen eyes. On APR-2021, the subject experienced red eyes. On APR-2021, the subject experienced rash around both eyes. Treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rash around both eyes, swollen eyes and red eyes was not reported. This report was non-serious.

Hives starting 11 April; resolved temporarily with a single dose of benadryl; then recurred the following day.

Headache, Dizziness, Pain in the arm where the vaccine, these three the first 3 days. Right now arm pain and headache.

Hives (all over body) Spent the day outside on a high-pollen-count day. At 6PM noticed itchy/tingly and upon inspection noticed hives all over body. I have had Hives at least once before while on high-dose (400-600mg) ibuprofin, but never from allergies. Not certain this is related to J&J shot, but doctor said it wouldn't hurt to report. Next day stayed indoors. Hives are less common, but still present.

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

Patient called Monday and stated the morning 2 days after his vaccine he woke up with a rash all over his body. I tried to call the patient to see how he was doing on Wednesday but did not get a call back.

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.

Persisted for three days: Arm soreness Headaches Body Aches Tiredness/fatigue These faded and on 4/7/2020, liver began to feel enlarged for two days. This was followed by UTI; pain in kidneys and groin; rigidity, discoloration, and extreme swelling in right testicle; inability to urinate; 100-degree fever. Remains on antibiotic (Keflex 500mg 4/pd) and Flomax. Testicle rigidity & some swelling remain.

Achy; No appetite; Mild dizziness; Feeling flushed; Soreness at the vaccine site; Fever; MILD JOINT PAIN; Chills; 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 liver disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN expiry: UNKNOWN) 0.5 ml, administered on 05-MAR-2021 10:45 for prophylactic vaccination. The batch number was not provided and has been requested. No concomitant medications were reported. On 05-MAR-2021, the subject experienced mild joint pain. On 05-MAR-2021, the subject experienced chills. On 05-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.4 F. On 05-MAR-2021 11:00, the subject experienced mild dizziness. On 05-MAR-2021 11:00, the subject experienced feeling flushed. On 05-MAR-2021 11:00, the subject experienced soreness at the vaccine site. On 06-MAR-2021, the subject experienced achy. On 06-MAR-2021, the subject experienced no appetite. On 07-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99.6-99.8 (high fever). On 08-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 98.8 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from mild joint pain, and fever, had not recovered from soreness at the vaccine site, and the outcome of mild dizziness, feeling flushed, chills, achy and no appetite was not reported. This report was non-serious.

Dear, Since i got my shot Covid19 (Janssen) I have muscle pain on my arm whre I received the vaccine. Please let me know what i have to do. Must i go to do a consultation and where. Thank you. Sincerely

NAUSEA; DIARRHEA; TIRED; LUMP ON INJECTION SITE; This spontaneous report received from a patient concerned a 50 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: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced lump on injection site. On 13-APR-2021, the subject experienced tired. On 14-APR-2021, the subject experienced diarrhea. On an unspecified date, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lump on injection site on 26-APR-2021, nausea, and tired on 19-APR-2021, and had not recovered from diarrhea. This report was non-serious.

I started having random hives all over my body with severe itching about a month after the vaccine. It made me highly uncomfortable to where I was unable to go outside. I never had hives before. These were very unusual and happened at random times, at night, in the morning, when outside, in the afternoon at home. There was no common theme to these. I had to shower multiple times a day to get some relief but was short-lived.

Symptoms began at 10:30 pm on the day of the vaccine, fever, chills, pain throughout the body and at the site of the vaccine, headache and a lot of exhaustion. The fever is continuous and still does not subside, it is being controlled with tylenol. Headache and exhaustion continue.

?Janssen COVID-19 Vaccine EUA? Severe shoulder pain at injection site in muscle and joint that has worsened over time. Currently unable to sleep because of pain.

LUMP IN ELBOW; CHILLS; JOINT PAIN; 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 alcohol user, and cigarette smoker, and other pre-existing medical conditions included patient had no known allergies or 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: 1816022 expiry: 01-JUL-2021) dose was not reported, administered on 16-MAY-2021 for prophylactic vaccination. Concomitant medications included diphenhydramine. On 16-MAY-2021, the subject experienced lump in elbow. On 16-MAY-2021, the subject experienced chills. On 16-MAY-2021, the subject experienced joint pain. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 17-MAY-2021, was recovering from joint pain, and had not recovered from lump in elbow. This report was non-serious.

throat swelling shut, called ambulance, took Benadryl. Currently nausea, burning lower stomach, severe lethargy, hot skin,

Development of Blisters on tips of fingers. Started within 12 hours of receiving the vaccine. Still present today 6/7/21 . Not limiting his activities

It's been more than a month since I got my Janssen shot. My left arm's injection area is sometimes red and itchy. At the same location, I have 6 other TB shots. I am not sure if they have reactions between Janssen and TB shots. Also, the red itchy area has expanded toward my neck and upper back area.

Arm Where injection site occurred has lingering pain that will not abate. No reason for pain no movement. But nerve just keeps acting up and going crazy. May not be related but it is at the injection site

FATIGUE; BODY ACHES; LOWER BACK PAIN ON LEFT SIDE/BACK PAIN; PAIN IN HIS WHOLE UPPER ARM (SHOULDER TO ELBOW) OF THE INJECTION SITE/LEFT ARM SORENESS; COLD CHILLS; INJECTION SITE PAIN; 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 headaches, blood pressure abnormal, iodine allergy, non-alcohol user, and non-smoker.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. Concomitant medications included losartan for blood pressure abnormal, and verapamil for headaches. On 13-APR-2021, the subject experienced body aches. On 13-APR-2021, the subject experienced lower back pain on left side/back pain. On 13-APR-2021, the subject experienced pain in his whole upper arm (shoulder to elbow) of the injection site/left arm soreness. On 13-APR-2021, the subject experienced cold chills. On 13-APR-2021, the subject experienced injection site pain. On 05-JUN-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and cold chills on 15-APR-2021, lower back pain on left side/back pain, and fatigue on 06-JUN-2021, and injection site pain on APR-2021, and had not recovered from pain in his whole upper arm (shoulder to elbow) of the injection site/left arm soreness. This report was non-serious.

2 days after shot, numbness/weakness in left leg and pins and needles in left hand. Upper arm pain where injection given. Neck pain. Seems to be autoimmune reaction. Hospitalized for 2 nights, seeing neurologist, having physical therapy for leg and neck

Within two weeks of vaccination: energy level down, muscle ache, diarrhea, congestion, extra gas (intestinal). Ongoing: extra gas (intestinal); cold flashes that course quickly through body; tingling in arms, hands (like a buzz or very fine pins and needles); irritability; itchiness (upper body, face and head); numbness on front of tongue; stiff finger joints; brain fog; quick onset of fatigue; sudden faint feeling; feeling of weakness in muscles; bruise on right upper arm which remained for a couple weeks; apparent reduced allergen/pollen resistance. Also, it seems I may now be having novel allergic reactions to peanuts. I had long consumed peanuts and peanut butter without incident before taking the vaccine.

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.

Chills, Fever (101.0), Achy, Sore muscles, Stiffness, injection site pain, mental fuzziness, Headache

Injection site: pain, redness of the skin and swelling. In general: headache, feeling very tired, muscle aches, fever and chills. Duration: approx. 24 hrs

2 hours after vaccination I noticed left arm started hurting . Went to bed at my usual time and woke up at 2:00 am with the chills I could not get warm late that night around 5:00 am I started having joint pain and fatigue with a headache and hot skin. I had taken my temperature and it was 100.7. I tried to wait out symptoms but I seem to bee get worse throughout the morning. Around 10:00 am I was in terrible pain and my body hurt all over. I once again took my temperature and it had gone up to 101.9. I had to call of work because I was so ?out of it?. I started taking Tylenol ever 4 hrs for my fever and I was trying to hydrate. My temperature slowly went down but still had body pain. I then started thank ibuprofen to help. Later that night around 9:00 pm my temperature was 99. The next day I called off work for fatigue and body pain. Today my temperature is normal and I?m starting to feel like my self again

The first day at night woke up with night sweats and fatigue. Second-day headache and have a rash on the upper front part of my body and the upper part of my body on my back.

Fatigue that lasted for 15 hours. General muscle and joint aches for about 12 hours. Minor Injection site pain that lasted for 2 days.

Sore arm at injection site immediately after and still after 24 hours post-injection. Overall feeling of malaise, fatigue, slight chills, body aches, joint pain from about 8 hours post-vaccination continuing to 24 hours post-vaccination. Slight cough and chest congestion, feel warm but no fever (36.6 C).

Petechiae on both legs and feet swelling, pain, redness, and warmness to the injection site(left arm)

Day 1: injection site soreness Day 2: Extreme fatigue, muscle soreness, aches, fevers, chills, dizziness, nausea Day 3: Extreme fatigue, muscle and joint soreness, aches, fevers, chills, dizziness, nausea Day 4: moderate fatigue, chills, fever spikes, dizziness

ARM SORE; RUN DOWN; INJECTION SITE PAIN; FATIGUE; LOW GRADE HEADACHE; ACNE ON FACE, BACK AND THIGH; This spontaneous report received from a patient concerned a 51 year old male. The patient's weight was 235 pounds, and height was 65 inches. The patient's past medical history included skin boils, and pimples, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 at right Arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced acne on face, back and thigh. On 21-MAR-2021, the subject experienced arm sore. On 21-MAR-2021, the subject experienced run down. On 21-MAR-2021, the subject experienced injection site pain. On 21-MAR-2021, the subject experienced fatigue. On 21-MAR-2021, the subject experienced low grade headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm sore, run down, injection site pain, fatigue, and low grade headache on 23-MAR-2021, and had not recovered from acne on face, back and thigh. This report was non-serious.

PAIN ON THE INJECTION SITE; DIARRHEA; FATIGUE; NAUSEA; This spontaneous report received from a patient concerned a 51-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: 1808978,and expiry: 13-JUN-2021) dose was not reported, administered on 25-MAR-2021 in right deltoid for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced diarrhea. On MAR-2021, the subject experienced fatigue. On MAR-2021, the subject experienced nausea. Treatment medications included: Ibuprofen. On 25-MAR-2021, the subject experienced pain on the injection site. The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The patient recovered from pain on the injection site on 26-MAR-2021, and had not recovered from fatigue, diarrhea, and nausea. 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.

Janssen COVID-19 Vaccine EUA - bright red rash on top of both feet, on toes and sides of feet - looked like gives - rash appeared on evening of shot, April 1, about 4 - 5 hours after injection. Rash increasingly got worse until Saturday, 4-3-21. Then, started fading and eventually going away.

1) Bruise on right shoulder (opposite shoulder from injection) 2) Nosebleed - lasted approximate 5 mins, 2 Kleenexes, only once 3) Bruise on left leg (large ~ 2 inches in diameter, white center)

Starting 96 hours after vaccination: extreme stabbing pain in left deltoid (injection site). Soon, this was accompanied by dull but severe pain in left shoulder and upper left back (top of scapula and around collar bone), extending to base of neck. This pain lasted 2 weeks, and was severe enough to prevent patient from sitting or standing for more than a few minutes at a time, especially during the first week of pain. Painkillers (Acetaminophen or NSAIDs) or muscle relaxants (cyclobenzaprine) did not help alleviate the pain. The pain started on March 17, and finally eased up on April 2 (the vaccination was on March 13). There is still some pain and stiffness in the left arm (currently in the biceps), but it is no longer severe. By the way, in addition to the above symptoms starting at 96 hours, there were the usual expected systemic symptoms immediately after the vaccination (starting at 6 hours and ending at 36 hours): light fever, mild body ache, fatigue and mild local pain at injection site.

On March 26, 2021 the right side of my head felt like I had chills. The sensation grew to the right side of my face where it felt like splinters were under the skin. By Sunday night, March 28,, 2021 bumps appeared on my face and scalp. On March 29, 2021 the doctor diagnosed me with Herpes zoster without complication.

Beginning 16 hours after injection, fever/chills followed by headache and flu-like symptoms for approximately 18 hours Today, 6 days after injection, itchy rash on both thighs, upper arms and torso front/back

Pain to right leg (hip to foot) started at 7:30pm on 4/7/2020 and continued to worsen until medication ordered on 4/12/2020. Also developed rash to right shin on 4/10. Several "knots" to arms, neck, and back.

irregular flat rash on the arms, the chest, and the back, with delineated borders in different shapes, mostly snake-like.

I started with rashes (red) on both ankles. then near arm pits. They I started with very itchy eyes which turned to Pink Eye. Addtionally I got very congested, trouble breathing, phelm production. Tired or fatigued. Got back enough and went to the doctor and receive a steroid shot, and eye drops. I am still have issues still.

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.

Pain at site of shot. Hot flashes, chills. Before bed got real hot from waste up. Muscle spasms. twitchs at shot site. Light headed, dizzy, shortness of breath. Shot should have been 2nd dose of pfizer. Pharmacist called the next day and told me to remove Janssen sticker from covid shot record card and said to write in pfizer info.

DIARRHEA; INJECTION SITE REACTION; EYE PAIN; TEETH PAIN; CHILLS; TIREDNESS; HEADACHE; GENERALISED ACHING; This spontaneous report received from a patient concerned a 51 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: 202A21A and expiry: 23-JUN-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced generalised aching. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced tiredness. On 09-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced eye pain. On 10-APR-2021, the subject experienced teeth pain. On 14-APR-2021, the subject experienced injection site reaction. On 14-APR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from generalised aching, and chills on 11-APR-2021, was recovering from tiredness, had not recovered from headache, injection site reaction, eye pain, and teeth pain, and the outcome of diarrhea was not reported. This report was non-serious.

R sided paresthesias started at 8pm on 4/24/21 and worsened to entire R side of body on 4/25/21 am. He was evaluated and admitted to the hospital 4/25/21 and found to have left thalamic stroke. No weakness in arm noted but some R hand dysmetria along with decreased sensation.

BOTH EYES HAVING PRESSURE-TYPE PAIN, NOW LOCALIZED TO LEFT EYE; HEADACHE; INJECTION SITE PAIN SPREAD IN LEFT ARM; BODY ACHES; CHILLS; This spontaneous report received from a consumer concerned a 51 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes ii, insomnia, neuropathy, tinnitus, vertigo, acne, chronic back pain (bulging discs), seasonal nut allergies, anxiety, smoker, non alcohol user, depression, hearing loss, and cholesterol.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: not reported) dose was not reported, administered on 08-APR-2021 12:00 for prophylactic vaccination. Concomitant medications included atorvastatin for cholesterol, bupropion, lamotrigine, metformin hydrochloride, montelukast, and sertraline. On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced chills. On 08-APR-2021 12:00, the subject experienced injection site pain spread in left arm. On 08-APR-2021 15:00, the subject experienced headache. On 09-APR-2021, the subject experienced both eyes having pressure-type pain, now localized to left eye. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site pain spread in left arm, body aches, chills, headache, and both eyes having pressure-type pain, now localized to left eye. This report was non-serious.

Received Johnson & Johnson vaccine on April 1st. Had fever for one day (after 20 hours and lasted less than a day). Took Tylenol 2 doses in 6 hour interval. After a week or so, small red dots (few) under the skin appeared in my fore arms. Subsequently after another week or so, I noticed large number of red dots in my legs. Checked with my primary care physician on 4/28/21 and she ordered blood tests. Blood test report (CBC With Differential/Platelet; Comp. Metabolic Panel (14)) came back and my doctor said, no abnormalities were there. She also tested/checked my lungs, presence of fever (no fever), oxygen saturation - max present. She thought this seems like 'Petrichiae'. She recommended I see a dermatologist. Meanwhile, today (5/2/2021), I noticed another large cluster of red dots on my left arm.

He is currently hopsitalized for lack of blood flow to 2 of his fingertips. It started with his right ring finger tuned white and extremely painful, then turned purple.. Then over the next week or 2 it started in pinky finger. The ring finger is now numb at times, and sometimes it tingles. The pinky finger is still very painful. He is hospitalized for this condition as they are performing tests to try to figure out the cause. The hospital isnt saying its the vaccine, but we just wanted to let you know about his symptoms. In case it does have something to do with the vaccine.

The injection site is still sore to the touch and tight feeling. I?ve never had any vaccine sore more than a day or two. It?s now been almost 2 months. Otherwise I feel fine. No other side effects.

ITCHY RED RAISED, SPLOTCHY RASH ON LOWER POSTERIOR REGION BACK SIDE OF BOTH THIGHS, BUTTOCKS AND LOWER BACK; 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 concurrent conditions included alcohol consumption, and non-smoker, and other pre-existing medical conditions included the patient had no known drug allergies. the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine(suspension for injection, route of admin not reported, batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAY-2021, the subject experienced itchy red raised, splotchy rash on lower posterior region back side of both thighs, buttocks and lower back. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from itchy red raised, splotchy rash on lower posterior region back side of both thighs, buttocks and lower back. This report was non-serious.

Immediately after injection patient had a raised lump of about 1 inch, no redness, around injection site. Localized reaction, no other symptoms.

Hives (urticaria) appearing intermittently around feet, legs, hands, and trunk over the course of 5 days.

Presented with 1 month of nausea and occasional vomiting for the past 4 weeks since receiving J&J vaccine with acute worsening 2-3 days prior to admission with multiple episodes of emesis daily. Patient has history of GERD and cataracts. Complaint of lethargy and itchiness for the last month. Patient sought treatment at ER and was admitted. Wife noticed jaundice on morning of admission. Found to have transaminitis and hyperbilirubinemia on admission with some improvement after IV fluids. Patient admitted to hospital for 4 days. Note: Patient had been treated for Hep B infection for 6 months in 2007 with tenofovir

Patient received their vaccine on 6/17 and had no complaints of adverse effects. The patient was found unconscious at some point between 6/17-6/18. They appeared jaundice and had low BP. They were airlifted to the hospital and died on 6/18/21.

Approximately 3 minutes after he received J&J vaccine he passed out while sitting in a chair. He hit his head on the wall next to the chair. Staff immediately supported him and he stayed in the chair. He regained consciousness within a few seconds. A cot was brought to him, he was assisted by staff and laid on the cot, cool cloth applied to his forehead. Within 8 minutes he was feeling better, sitting up on the cot, drinking water. He did report that he has previously passed out at the sight of blood, and there was a small amount of blood at the injection site. We observed him for another 25 minutes and he returned to baseline, stated he was feeling fine. He went home with his step Dad, who had given him a ride to the clinic. I called the patient 2 hours later to check on him. Step Dad reported he was outside and unavailable, but that he has been feeling fine since leaving the clinic.

Pain in deltoid muscle around point of injection starting about a week after injection and persisting.

Noticed Petechiae, bruising and blood blisters in mouth 6/15/21. Went to urgent care and had CBC done and platelets were at 2,000 and was instructed to go to ER. Got second opinion from primary care physician an instructed to go to ER. Went to ER on 6/15/21 and was immediately admitted to hospital. Began steroid IV treatment and had completed blood profile done. Underwent bone marrow biopsy and abdominal ultrasound 6/18/21 - all normal. Was given platelet infusion and human immune globulin infusions. Release from hospital on 6/21/21 with platelet count at 32,000. Continued steroid treatment and regular CBC tests. Platelet count dropped to 6,000 on 7/2/21 and was readmitted to hospital. Given steroid infusions and began 1 of 4 Bitruxan treatments. Released from hospital on 7/5/21. Continuing steroid treatment and Bitruxan treatments with regular CBC tests. Outcome to be determined

After the initial injection site pain, I have experienced constant intramuscular pain at the site and adjacent areas in the muscle upon movement or use. Something as simple as flexion or extension causes a sharp pain in that area. I initially put that off to the trauma of the injection itself, but now four months later with no improvement, I can only conclude that the injection caused more than normal injection trauma. I am also experiencing numbness and tingling in the whole arm after periods of immobility (such as sleeping). Getting up in the morning, that arm is moderately sore, and I experience particular pain around the injection site. There has been no injury to that arm or that muscle group. I have no pre-existing injuries or conditions that would have a bearing on this pain. I have not sought medical attention, as I feel certain that there is not enough known about this vaccine to reliably come up with a treatment plan.

SEVERE ITCHING; RED WHELPS ON LEGS,THIGH AND STOMACH; FATIGUE; INJECTION SITE SORENESS; INJECTION SITE RED; INJECTION SITE SWOLLEN; LIGHTHEADNESS; 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 concurrent conditions included hypertension, diabetes type 2, penicillin allergy, non alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug usage. The patient experienced drug allergy when treated with amoxicillin, sulfamethoxazole/trimethoprim, ciprofloxacin, erythromycin, and pravastatin. 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-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-JUL-2021, the subject experienced lightheadness. On 06-JUL-2021, the subject experienced fatigue. On 06-JUL-2021, the subject experienced injection site soreness. On 06-JUL-2021, the subject experienced injection site red. On 06-JUL-2021, the subject experienced injection site swollen. On 15-JUL-2021, the subject experienced severe itching. On 15-JUL-2021, the subject experienced red whelps on legs, thigh and stomach. Treatment medications included: calamine, and cortisone. On 17-JUL-2021, treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lightheadness, and fatigue on 07-JUL-2021, severe itching, and red whelps on legs,thigh and stomach on 16-JUL-2021, and injection site soreness, injection site red, and injection site swollen on 10-JUL-2021. This report was non-serious.

headache, low-grade fever (100), malaise, followed within a couple of days by upper respiratory symptoms (pruritus/congestion, croup cough), went to family doc on Monday, July 26 for Decadron shot and treatment of symptoms (tested positive for COVID-19). Symptoms improving, lost taste/smell July 27.

Minor pain around shot area. Around 5 pm 3/8 started to have cold chills which became annoying to the point my teeth were chattering. after maybe 3 hours the chills subsided and then i started feeling hot. very achy and tired at this point in time. all day 3/9 very achy and tired feeling awoke on 3/10 to almost normal feeling but after walking and going out in public became tired. evening of 3/10 safely say i am almost 100% .

At approximately 1 AM I woke up to chills and sweats. Had a fever of approximately 102°F, body achiness from head to toe a severe headache, slight cough and general muscle fatigue. Slight pain at injection site.

Hives on lower back, sides of torso, under both arms pits/shoulders, inner thighs, and behind the knees. Itchy and becoming painful on third day of symptom.

Initial symptoms began with pain at the injection site and generalized fatigue. This developed into soft tissue pain in proximity of the large and small joints which could be elicited further on palpation. I had eye pain (left more severe than the right) which could be further elicited on palpation, headache, dizziness, chills, and an inability to feel warm. There was also significant skin sensitivity over the trunk, scalp, and upper extremities and more in the left arm than the right. The symptoms persisted over the second day albeit at less severity. Presently on the third day, I am experiencing continued eye pain, mainly in the left eye and mild dizziness.

Rash face/both arms/back, pain joints including ankles right hip and lower back, pain at injection site, mild headache,

began 24 hours after injection. Hot to touch round, red rash with a knot under skin. Chills with body temp of 98.6F. Body aches and could not get out of bed for 2 days. Chest tightness and trouble breathing.

Headache, 20 hours, onset after 10 hours Injection Site Pain, 72 hours, onset after 10 hours Injection Site Itch, onset after 72 hours

Patient began feeling arm tingling, throat tingling, and had redness to arm and chest. Patient denies shortness of breath but has a severe history of allergic reactions that he did not communicate to provider prior to vaccine administration.

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

Rash is growing on legs and arms. It has gotten progressively worst in the last 3 hours. I have taken Benadryl, but have no relief yet.

fever and chills; skin sensitivity; joint aches; lethargy starting approximately 6-hours after injection; effects are slightly ebbing 24-hours after injection (18-hours after onset of effects)

Injection site pain, spreading throughout arm on same day as shot. Next day increased site pain, minor to mederate light headedness with vertigo that lasted severel hours. General fatigue with fever of 99.9 most of day. By 04/09 only experiancing decresed arm pain with minor fatigue.

Broke out in hives that started in my feet, then made it's way up my legs and to my arms. I took Benadryl for sleep that night. The next day I was fine until about 6PM again, then hives started in my feet. I took Benadryl right away and it seemed to mitigate the hives. The next day There were a couple of sites on my chest, but I took nothing and they didn't get any worse.

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

Skin rashes in various places: arm, belly, arm pit, groin area. Not too itchy so does not cause major discomfort or requiring medical treatment Started occurring an hour after shot. Gradually getting better. Still have some rashes on day 3 after the shot. Hopefully will be gone in the next several days.

Had very cold chill starting about 6:30 pm, about 1:15 am starting to feel better, but arm was still sore and the injection site. soreness site stayed sore for about another 3 to 4 days, but total top arm around site still sore and aching. Arm is hard to lift up at some times and weak to lift anything up sometimes. Arm feels week for about 2 to 3 days and then starts to fill better. Then after a day of the soreness or no weakness in the arm, it starts back hurting again. It now getting worse at night time and sometimes during the day. Some days it hurts so bad that I can't even move it. I don't bother to tell my wife, because it just last for about a 2 to 3 hours. I have been to my doctor yet. But if it keeps bothering me I will make an appointment to see him. It just my arm and hand be very weak to use at sometimes every other day.

High temperature (104-105), muscle and joint cramping. This occurred the night of the 30th. Temperature started to decrease over the next two days so did the cramping. Then starting on 4/5 I started to experience pain in the back of my head along with the sensation of heat/burning. This was accompanied by a stiff neck. This pain and stiffness persists to today. Medication prescribed by my doctor lessens the discomfort but has not rid me of the issue.

Arm immediately swelled up with the injection. Became a hard painful lump. Stayed swollen and hot for several days. The bruise is still visible 18 days after vaccination. Created a large bruise 3-4 inches in circumference.

BRUISE ON UPPER RIGHT SIDE OF CHEST; This spontaneous report received from a consumer concerned a 52 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: 041A21A, and batch number: 041A21A expiry: 21-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced bruise on upper right side of chest. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bruise on upper right side of chest. This report was non-serious.

SKIN PEELING; SKIN BLISTER; RASH UNDER BREAST; HEADACHE; STOMACH PAIN; DIARRHEA; COUGH; BODY ACHES; FEVER; 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 concurrent conditions included sulfa allergy, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 21-JUN-2021) dose was not reported, administered on 10-APR-2021 12:30 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced cough. On 10-APR-2021, the subject experienced body aches. On 10-APR-2021, the subject experienced fever. Laboratory data included: Fever (NR: not provided) 100.7 F. Treatment medications included: guaifenesin, and paracetamol. On 11-APR-2021, the subject experienced stomach pain. On 11-APR-2021, the subject experienced diarrhea. On 11-APR-2021, the subject experienced headache. On 14-APR-2021, the subject experienced skin peeling. On 14-APR-2021, the subject experienced skin blister. On 14-APR-2021, the subject experienced rash under breast. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, cough, body aches, headache, stomach pain, and diarrhea, and had not recovered from rash under breast, skin peeling, and skin blister. This report was non-serious.

Hives/body rash on left side of body, neck, and face. Hives/rash also under right arm and groin area.

Rash on arm, then bad headaches, real bad headaches, When driving this last Monday. I would pass out at the wheel. At least 4 times I jumped the median. Got lost in a nearby neighborhood. Once I figured out what was going on I went straight home.

Immediately after the injection patient felt a pressure like and felt a ball on the back of his head left side that resolved within a day. Within a week from vaccine patient started having a headache on and off with feeling of like his brain is swelling on the left side. Within another week patient experienced abdominal pain and chest pressure. went to a hospital CT abdomen was negative. On 4/28 patient had a severe headache followed by numbness to left face and left facial droop. 911 was called patient was code stroke in ED.

Patient experienced bruising in the 2 weeks following vaccine with critical platelets of 8. No history of thrombocytopenia prior to receiving the vaccine

WAS TOLD THAT IT WAS THE ONE AND DONE AND IT WAS THE JANSSEN VACCINE, BUT LOT # IS MODERNA: He got the vaccine, had no reactions at all for 2 weeks. Then on Friday, 4/23/21 he woke up early with pain in his left arm near the area of the injection and the back of his arm and to his shoulder like he was hit with a bat. It did not move the next day and went to his PCP on Tuesday and referenced Ortho and could not find any doctor and his pain was getting worse. He went to the ER on Wednesday, had a bad experience. Went back on Friday 4/30/21 and nothing was done for his shoulder and needs to see somebody regarding his arm. The arm is painful and painful to move in all directions. They did not do anything for him in the ER, actually made it worse. The ER said that they could not do an MRI as he needed a referral from an orthopedist for that. They wanted to check him for his heart, and they would not listen to him.

ON LOWER LEFT ARM, PATIENT STARTED HAVING WELTS ALL OVER ARM. NO ITCHING, NO ISSUES BREATHING, NO PAIN. STARTED AFTER ABOUT AN HOUR AFTER ADMINISTRATION OF VACCINE. OFFERED TO CALL PARAMEDICS, AND OFFERED BENADRYL, PATIENT DECLINE. INFLAMMATION OF WELTS STARTED SUBSIDING, SO PATIENT DECIDED TO LEAVE WITH NO TREATMENT ACCEPTED.

Pt had "tingling" on his throat. Bilateral rash on arms. Elevated B/P 170's. Nausea and vomiting Pt was given 25mg Benadryl. Pts b/p lowered. Nausea and vomiting resolved.

SHINGLES RASH (ACHES AROUND ABDOMEN AND CHEST AND HAD WELTS/BUMPS ALL ON RIGHT SIDE FROM ARMPIT AND ALL THE WAY DOWN TO PALM AND WRIST AND RIGHT SIDE ABDOMEN, CHEST BACK AND LOWER BACK); This spontaneous report received from a patient concerned a 52 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 and batch number: 204A21A expiry: 23/JUN/2021) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAY-2021, the subject experienced shingles rash (aches around abdomen and chest and had welts/bumps all on right side from armpit and all the way down to palm and wrist and right side abdomen, chest back and lower back). Treatment medications (dates unspecified) included: valaciclovir. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from shingles rash (aches around abdomen and chest and had welts/bumps all on right side from armpit and all the way down to palm and wrist and right side abdomen, chest back and lower back). This report was non-serious.

LOW PLATLET COUNT; BLACK AND BLUES; This spontaneous report received from a consumer concerned a 52 year old male. The patient's weight was 194 pounds, and height was 180.34 centimeters. The patient's concurrent conditions included non smoker, and other pre-existing medical conditions included blood work clean in september 2020,no drug allergies. The patient did not had any illness at the time of vaccination, no similar event in the past. He never had any adverse event in past for vaccination. The patient did not had family history of any disease or allergy. The patient did not had medical history of blood clots, heart disease. 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 12-APR-2021 for prophylactic vaccination on left arm. Concomitant medications included doxycycline for drug used for unknown indication. On APR-2021,he noticed black and blues appearing randomly all over his body for no reason whatsoever. They continued to worsen until he went to primacy doctor who did blood work on 29-APR-2021. On 1-MAY-2021 doctor called about blood work to said that he had dangerously low platelet count and to make sure he did not fall and hurt himself. He was instructed to go to the emergency room where they were waiting for him. He was admitted that day. He was treated with steroids for two days with no response, 2 day plasma treatment with minimal response. On May 7-MAY-2021 he was discharged from hospital and was told to continue Doxycycline 2 weeks treatment course. He later had more blood work and the levels have radically dropped again. He had an appointment with a Hematologist/Oncologist specialist on Friday 12-MAY-2021., Laboratory data included: Blood test (NR: not provided) low platelet count. Laboratory data (dates unspecified) included: Blood test (NR: not provided) levels dropped. Treatment medications (dates unspecified) included: plasma, Steroids. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from low platelet count, and black and blues. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210536558.; Sender's Comments: V0: 20210535373-covid-19 vaccine ad26.cov2.s-low platelet count. 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).

Was doing well with just some minor joint pain, then a couple of days ago I could not stop itching. Wife looked a day later after my complaints and saw tiny red bump clusters. Some were on my back, shoulder, buttocks and the itching was also spread out; on the head, foot, wrist, and groin region. She found no dots there. I did not contact my primary yet. Cortisone cream and antihistamine pill today are what I took.

Shortly after the injection my left shoulder (site of injection) remained sore/painful. The pain is a sharp, almost nerve like pain. I have a limited range of motion now and turning my arm, reaching for something can cause the sharp pain to occur. It will go away after about 10 seconds.

Patient received the J&J vaccine on 6/7 around noon. Patient first started noticing redness, soreness, swelling, heat around the injection site on Tuesday noon and it continued on till Thursday evening around 5 pm (which is when the patient informed us). Patient also mentioned that the symptoms were getting bette

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.

On 06-06-2021- I developed shingles in my body and also have excessive sweats. To this day I continue to experience these symptoms.

Patient presented to the pharmacy today 06/26/21 with a rash that started about 4 days after the vaccine was administered which was on 06/08/21. He also says that he has some radiating pain that wakes him up at night on the same arm and his arm feels hot. I recommended diphenhydramine at night to help him with the rash.

Pt. states 04/09/2021 @ 8:30am started experiencing symptoms from injection site (paralysis), numbness in the face (Left) droop 30mins-45mins, 05/18/2021 numbness in the face/difficulty speaking 2-3hrs, 06/12/2021 again numbness in the face05/20/2021 diagnosed with male Breast Cancer. Breast tissue removed. 06/27/2021 severe facial droop, whole numbness left-side of body, Admitted for observation. 06/28/2021 discharged TIA. Currently experiencing numbness.

1) immediate pain 1/2 through injection - fully dissipated within 5 minutes. Felt great all day. 2) Fever conditions (chills, body aches) about 10 hours later and pain in both shoulders that evening (difficulty sleeping). Next day feeling lethargic due to rough night`sleeping (?) and/or body's response to vaccine

I was very fatigued. I could not even eat anything because of how tired I was until 8 pm. I also had a pounding headache. I felt like I had the chills. I thought I had a fever but when I checked, it was 98.7. My left arm was very sore in that area. The next day I felt a lot better and the soreness in my arm was a lot less.

Swelling and pain at injection site Itchy and. irritated skin tingling and numbness through body fatigue in both legs and back restlessness

PATIENT REPORTS ITCHING ON LEGS ON WEDNESDAY NIGHT (~11PM). PATIENT WOKE THE NEXT MORNING AND NOTICE HIVES OVER HIS BODY.

After my vaccine, I developed itchiness sensation to my calves. One week later I developed red bumps the size of a dime. I went to see m PCP who prescribed a cortisone cream along with steroids. My red bumps are still present but slowly going away.

Patient was given one dose J+J vaccine about 8 minutes after injection- he felt weak and slumped a bit in his chair. In addition to this he felt pain in Right Pectoral Muscle. Patient was noticed with pale and diaphoretic appearance but within few minutes felt better with increased ventilation and cold compress.

After getting the shot on Friday at 6:00 pm. I did not have any issues with the shoulder. Sunday evening around 11pm I have started to have shoulder pain. The pain is around the area of the injection. The pain is generally in the deltoid muscle and has spread some to the bicep muscle as well. Uncertain if this is common to the injection process but it caused concern as its onset had been over 48 hours post injection.

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.

Janssen COVID-19 Vaccine EUA. Yellow rash appeared in center of chest. About 6 cm above bottom of sternum. Size is approximately 5 cm x 7 cm. Appearance is light yellow with tint of green and orange. No tenderness in or around the area. No blistering, flaking or other skin abnormalities. Appears to be just discoloration of the skin. No prior experience with symptoms of this type anywhere on body. Discoloration was noticed day after the vaccination when I stepped out of the shower and looked in the mirror. Size, shape, color have remained consistent for past 4 days.

Patient received vaccine on 4/7/21, noticed pain near inject site a few days after administration. On 4/12/21 he noticed a large bruise spanning from the injection site in his deltoid down and around to his bicep.

Patient felt fine first week after vaccine. On the second week, developed itching to arms and legs. On the third week, developed swelling to upper and/or lower lips that happened off and on 4 times. Self treated with Benadryl. Patient thought might be related to vaccine.

On 3/26/21, I got the vaccine. 2 days later, I started general itchiness. 2 days after that, starting at upper torso red spots began to show and then the red raised spots continued to go all over the body, I began taking OTC benadryl. On 4/2/21, I saw my family MD who instructed me to continue taking benadryl OTC & gave a prescription for topical steroid. On 4/9/21, I saw my family MD for the continued itchy whole body rash who asked me to continue taking OTC benadryl and the prescription topical steroid, he was hesitant to start something else that might interfere with the vaccine's course. I am to follow up with my family MD 4/16/21 with the thought that enough time will have passed to give something else..

vaccine given on 3/30/2021-no pain till 4/6/2021- on 4/6/2021 patient started having pain in left arm after lifting something one week after injection. 4/7/2021 states that pain radiates from the injection site to the back of the arm when he rises his arm to shoulder level-- arm feels weak after carrying something pain level 8/10 when he lifts his arm. No pain otherwise.

Diffuse rash, starting the day after vaccination. Itching only. No swelling, difficulty breathing. Antihistamines prescribed.

Janssen COVID-19 Vaccine EUA Injection site pain; muscle stiffness; joint pain in shoulders, elbows, knuckles, hips, knees; severe headache; nasua; fatigue; low grade fever

Lost his vaccine card would not give him a new one. He got his vaccine, had burning sensation immediately after the needle was pulled out. About 5-10 minutes later he started sweating, and seemed to have calmed down and felt OK. He was observed for 30 minutes there and went for observation for another 30 minutes. He went to another doctors office and at about 15:00 started feeling light headed and weak. He drove back home, picked up some stuff at a grocery store, and outside the grocery store in 80 degree heat he felt the need to put on a jacket as he had the chills. he went home, went to bed feeling bad, his shoulder was still burning where he got hte vaccin.e He had a little bit of site pain, applied topical and the pain went away. He woke up the next morning feeling really bad, felt like a major flu, his head felt like it was going to explode, but no problem with sinuses, no cough, no sneezing. His eyes were watering from the pain, and chills on and off. He had to change his sheets a couple of times due to sweating. He then developed a fever of 99 degrees at about 18:00 that night, and about 19:00 he went to 102 when he checked it. After that it went to 103, and about 15 minutes after that it was 104, and then higher at 104.+. He took some vodka, honey and lemon juice and took an alcohol bath and the fever had not broken yet. He called the clinic and they told him to call 9-1- 1 and to go to the ER. He went to the ER at about 10:00, gave him fluids, did a chest x-ray and released him about midnight. He apparently disoriented and tried to walk off and didn't remember this. They took him back to the gate and called his son. He went home, took another bath and woke up in sweat and was in bed for the entire weekend. He got up Monday morning, 4/13/21 feeling a little bit better and went to see his doctor, who does not believe he was having any side effects and that the information that is being reported is true. He is still feeling a little weak and still fatigued and on bedrest. He was taking Advil besides his regular medicines every 6 hours with 500 mg of Tylenol for the intense pain as every joint in his body ached, and the worst headache he had ever had, as well as the high fevers. His fever subsided on Saturday morning, and still had some sweats following that. Did have hot/cold flashes on Saturday and Sunday. He was given a COVID test in the ER and he was negative, but did not give him any other information regarding his lab work.

About a week after the vaccine, I developed raised red welts on my right pectoral and on the right side of my back (on and near the scapula). Dermatologist said they are shingles. I have never had shingles before. They are painful, itchy.

BELL'S PALSY; NUMBNESS IN ARMS, LEGS, LOWER ABDOMEN AND BUTTLOCKS; ITCHING THROUGHOUT; TINGLING IN ARM, LEGS, FEET AND HAND; This spontaneous report received from a patient concerned a 53 year old male. The patient's weight was 240 (unit unspecified), and height was 182.88 centimeters. The patient's concurrent conditions included hypertension, and other pre-existing medical conditions included patient had family history of any disease (relevant to vaccination) or allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, the patient experienced bell's palsy, numbness in arms, legs, lower abdomen and buttlocks, itching throughout, tingling in arm, legs, feet and hand. Laboratory data (dates unspecified) included: Blood test (NR: not provided) nothing out of range, CT scan (NR: not provided) negative, Chest X-ray (NR: not provided) negative, and Urinalysis (NR: not provided) nothing out of range. Treatment medications (dates unspecified) included: hydrochlorothiazide/lisinopril. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from itching throughout on 23-MAR-2021, was recovering from numbness in arms, legs, lower abdomen and buttlocks, and tingling in arm, legs, feet and hand and bell's palsy. This report was serious (Other Medically Important Condition). Additional information was received from patient on 31/03/2021. The following information was updated and incorporated into the case narrative: Reporter (HCP), Patient demographics (Gender, weight, height, Concomitant condition), Event (Bell's Palsy), Lab Test : CT Scan (Head and Torso), Blood work, Urinalysis, Chest X-ray- negative, Suspect product: (Route of administration), drug used to treat AE (Lisinopril) was added.; Sender's Comments: V1: Additional information received in this version is regarding patient demographics, serious event Bell's palsy, lab test, medical history of the patient. This information changes the seriousness of the case from V0 nonserious to V1 serious. 20210357779-Covid-19 vaccine ad26.cov2.s-Bell's palsy. 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).

just 24 hrs. after receiving shot developed fever of around 102 and chills. Fever kept going through the second night, developed several small itchy bumps on body, and also developed pain in lower abdomen. On the third day went to an urgent clinic because of lower abdomen pain and felt as though my diverticulitis had started. Was prescribed antibiotics, Flagyl and Cipro, for the diverticulitis. Fever broke that night I believe.

SORE THROAT; SORE ENTIRE UPPER BACK; RIGHT SHOULDER SORE; HEADACHE; SORE NECK; LEFT SHOULDER INJECTION SITE PAIN; ROOF OF MOUTH TENDER; EAR ACHE; RIGHT KNEE AND SHIN BONE PAIN; SORENESS FROM LEFT SIDE TO LEFT WRIST; FLUSHED; 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 concurrent conditions included severe allergies to grass, severe allergies to cat, and severe allergies to bees. 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 08-APR-2021 08:50 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, the subject experienced sore neck. On 08-APR-2021, the subject experienced roof of mouth tender. On 08-APR-2021, the subject experienced ear ache. On 08-APR-2021, the subject experienced right knee and shin bone pain. On 08-APR-2021, the subject experienced soreness from left side to left wrist. On 08-APR-2021, the subject experienced flushed. On 08-APR-2021, the subject experienced left shoulder injection site pain. On 10-APR-2021, the subject experienced sore entire upper back. On 10-APR-2021, the subject experienced sore throat. On 10-APR-2021, the subject experienced right shoulder sore. On 10-APR-2021, the subject experienced headache. Laboratory data on 08-Apr-2021 included: Body temperature (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore neck, sore entire upper back, roof of mouth tender, ear ache, sore throat, and headache on 12-APR-2021, and flushed on 08-APR-2021, and had not recovered from right knee and shin bone pain, left shoulder injection site pain, right shoulder sore, and soreness from left side to left wrist. This report was non-serious.

PURPLISH BRUISE ON FOREARM; 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 past medical history included heart surgery, and concurrent conditions included alcoholic, and non-smoker, 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: 1805025, and batch number: 1805025 expiry: 25-MAY-2021) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid. On 08-MAR-2021, the subject experienced purplish bruise on forearm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from purplish bruise on forearm on MAR-2021. This report was non-serious.

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

This spontaneous report received from a patient concerned a 53 year old male. The patient's weight was 185 pounds, and height was 67 inches. The patient's concurrent conditions included hiv, non alcohol user, and smoker, and other pre-existing medical conditions included the patient did not have any drug abuse/illicit drug use. The patient experienced drug allergy when treated with acetylsalicylic acid. 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 18-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, Laboratory data included: Urine analysis (NR: not provided) WNL. On 20-MAR-2021, the subject experienced skin rash. On 20-MAR-2021, the subject experienced extreme fatigue. Laboratory data (dates unspecified) included: Blood test (NR: not provided) WNL. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from extreme fatigue, and skin rash. This report was non-serious.

POSSIBLE THROMBOCYTOPENIA; RASH FROM KNEE TO FEET /SPOTTY RED DOTS ON LEG; SLEEPINESS; NECK ACHE; TIREDNESS; MUSCLE ACHE; HEADACHE; This spontaneous self-report concerned a 53 year old male patient. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the patient received the vaccine, waited at facility for 15 minutes, and everything was okay. On 17-APR-2021, the patient experienced neck ache, muscle ache and felt a sense of tiredness, headache, sleepiness, which he treated with Aleve (naproxen sodium). He also noticed his feet had a rash from his knee to feet, and according to his sister (who is a healthcare professional) it looked like small micro-embolisms (thrombocytopenia). The patient went to his physician who said the spotty red dots could be petechiae caused by thrombocytopenia. As recommended by his primary care physician, the patient has an appointment for lab work, including platelet counts, on 20-APR-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, tiredness, neck ache, rash from knee to feet (red dots), muscle ache, and possible thrombocytopenia, and the outcome of sleepiness was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This 53-year-old male patient was found to have petechiae-like rash on his knees to feet, that according to attending physician could be caused by thrombocytopenia, 2 days after receiving Janssen COVID-19 vaccine for the prevention of symptomatic SARS-CoV-2 virus infection. The patient underwent laboratory procedure including platelet count (results not reported). The patient complained of neck ache, muscle ache and felt a sense of tiredness, headache, sleepiness that he treated with Aleve (naproxen sodium) on the day the petechiae-like rash appeared. No other details reported. The information available precludes a complete and meaningful assessment. However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded. Additional information as requested.

Sunday after injection, had a low-grade fever and slept half the day. A couple days later I noticed a bump on my neck which I thought was an ingrown hair or bug bite. One week later I had the same low grade fever and the 'bump had expanded across my neck and shoulders. Made it in to the doctor a couple days later and was diagnosed with Shingles. There were no other life stressors that could have caused it, life was good. Now, three weeks later, the pain has diminished but still present. Nerve sensitivity remains.

That evening - 04:30 pm, I started feeling body aches and pains and fatigue. The aches getting worse in the night. Felt feverish but didn't have a fever overnight. The next day the same - general aches and pains and fatigue. Early afternoon, I took Tylenol and at night time I had headache and I took Tylenol again that evening (about 11:00P). Next morning, just fatigue - no more aches. Site of vaccination was more sore than initially. I had a sort of sinus headache - left side of face and head. My wife noticed I had bags under my eyes - very odd bags under eyes. I took Sudafed. Inside of my left nostril was aching. Tuesday morning, the bags weren't there but I got bad acne on the same nostril - my left nostril. It was like - I was worried that the acne was cystic (very deep - through the nose). I haven't gotten acne in a long time. I had the sinus headache and acne which lasted two to three days. I tried nasal saline - on that Wednesday and Thursday. The acne lasted into the next week - subsided beginning on the 12th or 13th. The bagginess in eyes had been gone by end of the 5th. Headaches didn't persist after the 7th or 8th or so. Had trouble getting a doctor appt because they didn't know what doctor to send me to.

CUT HIMSELF WHILE SHAVING; CHEST RASH; SHAKING; HEADACHE; LETHARGIC; ACHEY; This spontaneous report received from a consumer concerned a 53 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included epilepsy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 04-MAR-2021 to left arm for prophylactic vaccination. Concomitant medications included lamotrigine for epilepsy, and levetiracetam for epilepsy. On 04-MAR-2021, the subject experienced lethargic. On 04-MAR-2021, the subject experienced achey. On 04-MAR-2021, the subject experienced headache. On 05-MAR-2021, the subject experienced shaking. On 10-MAR-2021, the subject experienced chest rash. On 16-APR-2021, the subject experienced cut himself while shaving. Treatment medications (dates unspecified) included: loratadine, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cut himself while shaving on APR-2021, chest rash on 13-MAR-2021, and headache on MAR-2021, and the outcome of lethargic, achey and shaking was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment was not required as per standard procedure as case assessed as non-serious.

BOWELS UPSET AND YELLOW SLIME COMING OUT SINCE DAY OF SHOT; BURNING IN ARM; SEVERE PAIN IN ARM AT INJECTION SITE; PSORIASIS; NECK PAIN; BRUISE HAVING THE SIZE OF 50 CENT PIECE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic, severe gastroparesis, internal tremors, and psoriasis, and other pre-existing medical conditions included unknown. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203a21a, expiry: UNKNOWN) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. Concomitant medications included adalimumab for psoriasis, ixekizumab for psoriasis, risankizumab for psoriasis, and ustekinumab for psoriasis. On MAY-2021, the subject experienced neck pain. On MAY-2021, the subject experienced bruise having the size of 50 cent piece. On MAY-2021, the subject experienced psoriasis. On 10-MAY-2021, the subject experienced bowels upset and yellow slime coming out since day of shot. On 10-MAY-2021, the subject experienced burning in arm. On 10-MAY-2021, the subject experienced severe pain in arm at injection site. The action taken with covid-19 vaccine was not applicable. The patient was recovering from bowels upset and yellow slime coming out since day of shot, had not recovered from severe pain in arm at injection site, and burning in arm, and the outcome of psoriasis, neck pain and bruise having the size of 50 cent piece was not reported. This report was non-serious.

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.

Massive headache for 8 days. I believe it was encephalitis. Dizziness, fatigue, nausea, terrible neck pain, pain allover skull. Completely out of it. Disoriented, Fever, rash, missed work. Now I have a purple spot on my inside of left leg, found this morning 6/14/21 7:30 am.

About 4 weeks following vaccination, patient had pain and swelling on the posterior aspect of the L-knee. He could barely flex the knee, and it became discolored initially dark blue and then yellow which extended halfway up the posterior thigh. HE was evaluated by various physicians. Ultimately was diagnosed with hematoma that was aspirated - described as old blood. Cultures were negative. Was feeling better afterwards, but noticed more pain in L-calf. Venous duplex ultrasounds showed no evidence of blood clots. Patient was referred to infectious diseases to evaluate possible ADE secondary to vaccination.

Received the Janssen vaccine on 6/3/2021 at clinc. Pt. noticed red spots to back of calves on 6/15/2021, 11 days after vaccination. 3 days after noticing the red spots he started to notice bruising to bilateral arms. No complaints of pain or itching. Has not gone to see primary care physician before reporting to today. Examined skin today. Multiple bruising to bilateral arms, wrist and left palm. Red spots noted to bilateral calves and back.

"rash covering the entire body" wife reported to pharmacy 7/21/21. Rash does not itch. Wife called doc. MD advised pt to take zyrtec. RPh could not reach patient 7/22/22 to see how he has responded

I had no noticed issues for about 18 hours after the injection Tuesday evening. Sometime early Wednesday afternoon I began to experience body aches, a low-grade fever, and extreme tiredness. I slept most of the rest of the day and night and felt better when I woke up Thursday morning, well enough to go about a normal day. It is now late Thursday afternoon and I am still a little tired and mildly achy with no fever but otherwise much improved. One other thing to report, initially there was no pain or tenderness to the injection site but that started changing about 24 hours after the injection. Now about 46 hours after injection the site has a constant noticeable soreness even if I am not moving my arm.

Skin felt extremely on fire, body chills and sweats , bad headaches, fatigue. Took pain relievers and rested. Over just about 24 hrs after injection.

Diarrhea started around 1 PM the day after the vaccine. Currently still occuring at almost 2 PM. Not sure if this should be reported or not. Someone told me we had to report instances. Injection site is still sore.

SEVERE RASH: large, unabated, red to dark red, raised welts. The initial rash started under arms covering from underarm to hip as circular patterns. Then spread into the back. Covered sides, back, neck, into scalp, upper arms, buttocks, knees (front and back), thighs. Rash appeared mostly as one large/connected reddish glob. Spread occurred within 2 hrs from initial onset at 8pm. SEVERE RASH Lasted 8 hrs and would lessen but then new lesser rash would appear and is still present to lesser degree. Rash itched and burned. Treated self with a Claritin pill and cortisone cream all over rash. Took a Benadryl tablet the following day. Rash decreased each day. Rash still present to a lesser degree on 3rd day after it started with the rash appearing more as reddish dots. **Pictures are available upon request**

I had a rash develop I might lower extremities from just below the knees to mid thigh. It happened around 4 p.m. I did not know if it was something that I had come in contact with outside so I took a shower and applied cortisone cream to the rash. Around 6 p.m. I developed a rash on the left side of my chest the rash continue to grow across my chest and my abdomen to both sides and my arms. Again applied cortisone cream. Around 9 p.m. I took antihistamines and went to bed in the morning the rash is gone. I'm only reporting this because I've only read where the rash is on the arm or the injection site where this one was on my lower extremities and my upper extremities chest an abdomen.

I just thought I should report two changes I have noticed in my body since being vaccinated, the first being about a dozen small pimples on my forehead, which is weird for me, but were evident for several days that week after the vaccine; and I have been very dizzy when I get up in the middle of the night to go to the bathroom, bumping into the wall, which is uncommon for me. I also teach at a community college and I noticed that I get dizzy when I turn to go to the board and sometimes have had to put my hand out to steady myself against the board before writing on it. Not major disruptions, but strange to me. I don't take much in the way of medications, ever. I might take an aspirin once in a while, but I don't take any regular meds or have any other health issues. Just wanted to put this on the record. Thank you.

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.

Fever (100.0-100.2); headache/foggy head; muscle aches; pain at injection site. Symptoms lasted 36-48 hours.

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.

About 18 hours after vaccination, I began to feel myalgias and burning skin while in the shower; I began to feel "hot" and very fatigued. Then my temperature went up to 101.9 degrees F, taken by an electronic touchless digital thermometer. Then, the L Deltoid vaccination site began to feel very sore. As the day went on, I felt increasingly fatigued and exhausted, and had trouble concentrating. I felt better the 2nd day after vaccination, but felt intermittent myalgias, increasing L Deltoid soreness, and hot and chilled at the end of the day. Today, I felt better in the morning, exceptfor persistent L deltoid soreness, and fatigue. This evening, I am feeling cold, tired, and myalgias again.

I had a small lump appear at or near the site of injection past the 2 week period. My arm was stiff and sore. My spouse massaged my shoulder and the lump seemed to disappear. Arm felt better. The next day the same thing happened. My spouse massaged my arm and it went away again. I haven't had any other issues beyond that. I'm not completely sure it is related to the vaccine. I was also in the hospital during this time for an unrelated health issue. I had an obstructed bowel that required surgery. My surgeon assured me that they did nothing to my left arm during the surgery and treatment of the bowel obstruction. After a few conversations with the medical staff and my spouse we thought that the arm issue may have been a side effect of the vaccine shot. That's why I'm submitting this to you now. So far I haven't experienced anything else at the injection site. My spouse also had the same vaccine at the same time as me. He hasn't experienced any of the same effects as I have.

Burning at injection site for several hours following shot. Slight headache 1-2 hrs after. Body aches & chills 16 hrs after injection. Symptoms subsided after taking advil dual action. 29 hrs after injection Symptoms returned stronger than previously. I slept about 6 hours. Symptoms still present but not as bad as earlier

RASH; This spontaneous report received from a consumer 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: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash. This report was non-serious.

Six days after being vaccinated I broke out with a rash on both arms (triceps area) and on the top of my feet. The rash kept moving to different parts of my body, my knees and thighs, my lower back, even the bottom of my feet in the palms of my hands. It kept moving from location to location for two full days (I started taking corticosteroids and antihistamines this AM, which help a lot)

Janssen COVID-19 Vaccine EUA Within the first minute after injection, I started to feel dizzy and I felt like I was having a hot flash. For a few minutes I continued to get warm and at about the 10 minute point I was taken to the waiting room where I got a drink of water. After drinking the water I felt much better and soon felt normal with the exception of discomfort at the injection site. (My left upper arm just below my shoulder) After six days now, I still feel fine overall however, if I message the injection site, I can still feel a little bit of discomfort.

Five days after receiving the vaccine, he started noticing spots on his back with severe itchiness - his doctor recommended Allegra which he took with some success - the spots pop up in different places everytime. He is now taking allergy medicine twice daily to keep the itching and red spots at bay. His itchiness is now at a "tolerable" level as long as he takes the allergy medicine.

uriticaria all over body, hands, palms, arms, torso, back, abdomen, itching, Small reddened diffuse bumps , mild R sided headache

BODY ACHES; EXCESSIVE FATIGUE/EXCEEDINGLY TIRED; FEVER; HEADACHES; PAIN AT INJECTION SITE; 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: 1805022, and expiry: unknown) dose was not reported, administered on 07-MAR-2021 (vaccinated at left arm) for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the subject experienced pain at injection site. On 08-MAR-2021, the subject experienced body aches. On 08-MAR-2021, the subject experienced excessive fatigue. On 08-MAR-2021, the subject experienced fever. On 08-MAR-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and fever on 09-MAR-2021, pain at injection site on 10-MAR-2021, and headaches on 14-MAR-2021, and had not recovered from excessive fatigue. This report was non-serious.

1 week post vaccine developed SOB and cough petechiae to bilateral lower and upper extremities and back

Within 3 days the skin on my palms and bottom of my feet started to peel off in thick sheets. There was not pain other than the underlying skin was tender. I have never had any peeling of skin in either location. There was some mild fatigue the day after the injection.

BRUISING AT INJECTION SITE; DARKER DISCOLORATION ON OUTSIDE AND A LIGHTER COLOR ON INSIDE OF BANDAGE; PAIN AT INJECTION SITE; 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 past medical history included arthritis, and smoker, and concurrent conditions included non-smoker, and other pre-existing medical conditions included the patient had no other bruises recently or petechia, chest pain, leg or abdominal pain, difficulty breathing, headache or blurred vision and no allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 23/JUN/2021) dose was not reported, administered on 27-APR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for arthritis. On 27-APR-2021, the subject experienced pain at injection site. On 29-APR-2021, the subject experienced bruising at injection site. On 29-APR-2021, the subject experienced darker discoloration on outside and a lighter color on inside of bandage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from bruising at injection site, had not recovered from pain at injection site, and the outcome of darker discoloration on outside and a lighter color on inside of bandage was not reported. This report was non-serious.

Abdominal rash with red patches covering 90% of abdomen appeared 48 hours after injection with no itching , applied topical otc hydrocortisone cream one time, skin clear at seven days.

Woke up incredibly sore. Muscle aches in my legs and arms. My left arm at the injection site feels like lead. Left side of my chest is sore. Pounding headache.

Patient received Janssen vaccine on 5/11/21 @ Pharmacy, noted 12 hours after the vaccine had headache, body aches, and chills. The on 5/17/21 woke with a head to tow rash. Went to ED and was treated with Prednisone and antihistamines. 5/19/21 noted chest and head congestion, shortness of breath and return of rash on his back only. Patient referred to see provider 5/19/21 to rule out covid infection and discuss the treatment of symptoms.

Chills starting in upper left quadrant of back and feeling of sunburn hypersensitivity starting on 5/13/21, Dailey spread across back then chest, then stomach and down legs. No rash no fever, then aches and pain feeling in same areas. Then spread sunburn feeling up neck to bask of skull with aching pains on both sides of neck. Scalp now painful to touch and have chills radiating through body when exposed to cold air. Skin hyper sensitive to shower (hot or cold)with pain like needles

I felt fine immediately after the shot and had no physical pain or discomfort other than mild soreness at the injection site. The next morning I woke up and noticed a loud ringing in both ears. That ringing has not diminished or gone away since then. When surrounded by loud ambient noise I don't notice it unless I concentrate on doing so. Otherwise, it is quite loud and constant.

INJECTION SITE PAIN; 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 non smoker, and alcohol user (in moderation), and other pre-existing medical conditions included the patient had no known allergies, no any drug abuse/illicit drug use. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-MAY-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from injection site pain. This report was non-serious.

103.5 degree F fever, severe chills, body aches, headache, intense pain at injection, nausea, fatigue

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.

Around 7:00 P.M. on March 12, 2021 approximately 9 hours after receiving the Jansen COVD-19 vaccine in my left arm. I developed extreme fatigue, muscle aches, skin hurt to the touch of anything including clothing, headache, and fever 101.5. I had to go to bed and was very weak. I took ibuprofen and Tylenol for the discomfort. I slept 14 hours and was able to get up at 11:00 A.M. on March 13, 2021. The soreness at the site of the injection is not problematic. There were other odd symptoms overnight I would awake with strange nerve like sensations tingling and itching that occurred on the bottom of the left foot, upper lip, and neck. I also had several episodes of restlessness that was so bad that I had to stand for a few minutes before being able to lay down again. The worst is the skin hurting and headache. I have also had a few dizzy episodes since getting out of bed this morning. It passes if I sit down or hold onto something. None of these symptoms are normal for me and I cannot remember having a reaction to any vaccinations that I have received in the past. I hope this helps with your study.

I have itchy red bumps on my lower legs and knees and on the tops of my feet I have red spots the size of silver dollars that are light red in the middle and dark red on the edges. annular demarcation. it's worse on my left foot. my legs feel much colder than the rest of me. I applied a steroid cream and it seems to be getting much better.

I took the shot at 10:50, first early side effects where mild burning sensation in the legs couple of hours after the vaccine, later pain in the legs in the afternoon. At night I had a mild fever, chills, body aches (everywhere) unbearable headache (still going on 24 hours after the shot), pain at the vaccination site (left shoulder, still strong after 24 hours), pain in the lungs (I sneezed a couple of times). I took Tylenol every 4 hours, but did not improve, only brought the fever down a bit. Today after 24 hours, I still have headache, muscular aches, and fatigue.

Janssen COVID-19 Vaccine EUA Fever of 101.3 for over 24 hrs. Only could control with Tylenol. Once I stopped, fever would spike up. Severe joint pain Headache Severe pain at injection site for 48 hours Burning eyes Uncomfortable urination

Janssen COVID-19 Vaccine EUA Prickly itchy rash appeared on thighs; discomfort waned after ~ 15 min. Similar rash appeared on arms, legs, & back after showering same day at ~ 5 pm. Again, discomfort waned after ~20 min. Rash appeared on thighs again this morning at ~ 7:30 am. Again, discomfort waned after ~20 min. I have not yet sought medical attention since symptoms have been intermittent rather than persistent since first appearing.

Relaxing watching TV wearing shorts and t-shirt, A/C on at 77, suddenly overtaken with extreme cold and body aches about 8:30pm. Sat outside in 85 degrees for awhile to try to warm up. About 9pm got in the walk-in shower and sat on bench super hot water. Got out of shower at 9:40pm my skin beet red mostly my chest. Still freezing and body aches. Put on sweatpants and long sleeve t-shirt. Now have A/C off and windows open, 82 degrees outside. My temp taken before I started this form was at 98.7. I ache all over and am freezing. Not shivering though. But have goosebumps on arms under sleeves. I am very uncomfortable. It is now 10:35pm.

Extreme left arm and shoulder neck pain and tightness within a week of shot and has persisted for over a month. Treated with Methocarbamol and Diclofenac Sodium. Within two and a half weeks of the shot, on March 23rd, sudden loss of peripheral vision in right eye. Doctor diagnosed as NAION, non-arthritic anterior ischemic optic neuropathy. Vision loss in one eye is blurred from varying angles and grayed out and is considered permanent. Eye problem caused pain down neck and jaw. Also, a rash developed over chest with symptoms similar to shingles.

Client vaccinated in left deltoid and experienced immediate pain shooting up to the shoulder and neck/head region. Patient applied ice pack to the left deltoid and felt better.

Full body hives started roughly about 20-22 hours after injection. Ended up covering body within the coming days. Saw doctor virtually and prescribed prednisone and two trips into the emergency room. ER administered epinephrine shot along with Benadryl, famotidine, and Ativan as the hives become in mouth and lips and swelling was occurring.

Patient developed pain in both knees and pain and swelling of calves about 36 hours after receiving the J&J COVID19 vaccine. His Allopurinol dose had been increased to 300 mg. daily a few days before that but no other change in health status. Now his left calf still feels a little swollen and he noticed a bruise there without history of trauma.

Fatigue for several days, very mild rash, followed by dizziness and disorientation/unsteadiness on day 8

PAIN IN INJECTION ARM; TIREDNESS; 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 allergic to bees, allergic to trees, and contrast allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: not reported) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced tiredness. On 05-MAR-2021, the subject experienced pain in injection arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in injection arm on 05-MAR-2021, and tiredness on 09-MAR-2021. This report was non-serious.

Janssen vaccine received by patient on 3/24/21, no immediate symptoms. As of 4/14/21 started having petechia and non-traumatic ecchymosis. PLT count of 2. Hospitalized for severe thrombocytopenia, thought to be ITP. Currently admitted as of 4/16/21, report made on day 1 of hospitalization.

Approximately a week after receiving the J&J injection I have experienced excessive itching in the areas of my abdomen, groin, inguinal and femoral lymph nodes. There are no rashes, sores, or other visible marks associated with the itching sensation.

SWOLLEN UPPER LIP; INJECTION SITE PAIN; 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: 201A21A, and batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 09:40 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced injection site pain. On 14-APR-2021, the subject experienced swollen upper lip. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swollen upper lip, and had not recovered from injection site pain. This report was non-serious..

ELEVATED HEART RATE; CHEST PAIN; FELT FAINT; BODY ACHES; STOMACH UPSET; DIARRHEA; FELT JITTERY; HEADACHE; NAUSEA; SORE ARM AT INJECTION SITE; This spontaneous report received from a patient concerned a 55 year old white male. The patient's height, and weight were not reported. The patient's past medical history included both knees replacement, both hips replacement, and heart attack, and concurrent conditions included heart problems, circulation problems, and cigarette smoker. 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, 1 total administered on 08-APR-2021 at 10:15 to left arm for prophylactic vaccination. Concomitant medications included warfarin (5mg) for blood thinner, atorvastatin (80mg), baclofen (10mg), furosemide (40mg, 1 to 2 daily), glyceryl trinitrate, losartan (25mg), midodrine (5mg), oxycodone hydrochloride/paracetamol, potassium, and promethazine (25mg). On 08-APR-2021, the patient had heart rate issue after 45 minutes of vaccine administration, while driving to home and went to sleep for 2 hours. The patient felt faint, body aches, stomach upset, diarrhea, headache, nausea, sore arm at injection site and felt jittery. He told vaccination provider that he was on a blood thinner (warfarin 5mg), and had heart and circulation problems. He also took lorazepam (1mg) as treatment for jitters, which was not helpful for it. His heart rate had been fluctuating down to low 70's and up to 100's since he received the vaccine. On 09-APR-2021, he called his nurse about heart rate and nurse advised him to visit to emergency room (ER) if he experience chest pains. On 10-Apr-2021 at 09:00, the patient visited emergency room due to worsening of the elevated heart rate, and chest pain. The patient felt like he had another heart attack. The patient was admitted to the cardiac floor and medicine was provided to stabilize the heart rate. The patient was hospitalized for 2 days and discharged on 11-APR-2021 with the improvement of heart rate on prescribed medicines and advised if heart rate passed 90 to 100 to went back or felt flutter. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt faint, body aches, stomach upset, diarrhea, nausea, and sore arm at injection site on 10-APR-2021, was recovering from elevated heart rate, had not recovered from headache, and felt jittery, and the outcome of chest pain was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: 20210420626-covid-19 vaccine ad26.cov2.s-Elevated heart rate, Chest pain. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE

7 days after my first shot into my left arm. my pointer finger turned white / purple and was tingling numb and cold. that would come and go and then about day 14 my middle finger experienced the same thing as my pointer got worse and more painful. , by day 20 my ring finger started to experience it but never as bad as the pointer and middle. I went to the DR at that time and it was presenting as Raynaud's. and i was prescribed amLODIPine (NORVASC). after a week of this seams not to help.

The patient received the Janssen vaccine lot #1808980 exp 06/20/2021 at0930am in the left arm. Patient has a history of asthma, high blood pressure, anxiety, and hearing voices. He takes lisinopril and zyprexa. He was in the hospital recently due to hearing voices but can not remember how long ago. He is living at a recuperative care shelter. Patient denied drug use, denies prior vaccine reactions, and said he was allergic to Geodon which makes him brake out in a rash. The patient was sitting in the observation area after receiving his vaccine. At 09:35am he said he had 8/10 "sharp chest pain" that started after receiving the vaccine. He was warm to touch, non diaphoretics, no dizziness or nausea, and color was appropriate for race. He was AOx4. BP 139/90, RR 18, HR 91 and regular per palpation, Spo2 95% and no respiratory distress noted. At 0935 the patient said the pain "went away" and said it was now a 0 out of 10. He said he has had that sharp pain the past and has seen a doctor but he doesn't know what causes it. Vitals were rechecked. BP 130/92, RR 18, SpO2 95%, HR94. Patient remained alert and oriented. Patient remained with RN in observation area until 10am and continued to deny pain or any other symptoms. At 10am patient stood up. He denied dizziness or pain and walked away with a steady gait. The patient was educated to see his primary care physician about the periodic chest pain. Patient says he smokes 1 pack of cigarettes per day.

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.

My deltoid will knot up (spasm) if I stretch or reach forward as to work on something or lift anything from an awkward position where that muscle needs to contract significantly. I have to lower my arm and massage it to try to get it to relax again. Symptoms developed within a week of the vax and are focused precisely at the injection site. Pain and intensity of the spasm depends on how quickly I back off but if I am holding something I can drop and can't back of fast enough it gets fairly intense.

I woke up and had a fever of 103. also had chills felt like I had covid. I couldn't walk on my right leg , my calve in my right leg was super red. I called my Doctor and he told me to take Tylenol. I felt better about 2 days later but my right calve was sore for a week.

NUMBNESS IN BOTH ARMS; TINGLING IN ARM; PAIN IN RIGHT ARM ALL THE WAY TO THE WRIST; INJECTION SITE SORE; HEADACHE; 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 car accident, and concurrent conditions included cataract, teeth problems, nerve condition, penicillin allergy, marijuana abuse, non-alcohol user, and cigarette smoker. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAY-2021, the subject experienced headache. On 30-MAY-2021, the subject experienced numbness in both arms. On 30-MAY-2021, the subject experienced tingling in arm. On 30-MAY-2021, the subject experienced pain in right arm all the way to the wrist. On 30-MAY-2021, the subject experienced injection site sore. The action taken with covid-19 vaccine was not applicable. The patient recovered from headache on MAY-2021, had not recovered from pain in right arm all the way to the wrist, tingling in arm, and numbness in both arms, and the outcome of injection site sore was not reported. This report was non-serious.

Day one was headache as expected and right arm pain. Day two I had bad headache (9) joint pain in my shoulder and hips, loud ringing ears. shortness of breathe, left lung pain. This repeated for three days so I tested by BP and found it to be 160/130. Past day 3 I started with adrenaline spikes where heart would race up and I felt like hulk and blood pressure spikes out of the random. 5/24/21, I saw my family doctor and since my BP was so random high and then low she did not want to give me meds since it could drops too low at time. For my difficulty breathing and lung pain she gave me an prescription inhaler. As of today I still have the ringing left ear, shoulder joint pain like a pin stuck in it and unable to raise over my head without using my left arm to support, high BP on average 140/132. 167/151, 126/89, 122/91,110/87, 126/84 are some examples. These at the lowest is 10+ point higher than my normal range of 120s over 70s. Headache continues but may be due to the higher than normal BP.

4 days after being inoculated, my skin began itching all over my body. It was not intense and not distracting, but very present. It continues to this day basically unchanged.

TIREDNESS; SKIN PAIN; 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 heart attack, and smoker, and concurrent conditions included type 2 diabetes mellitus, allergy to vodka, and immune to pain relievers.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821288 expiry: UNKNOWN) dose was not reported, administered on 10-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, Laboratory data included: Pain scale (NR: not provided) 3 on a 1-10 scale, 7 out of 10. On 10-JUN-2021, the subject experienced skin pain. On 12-JUN-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tiredness, and skin pain. This report was non-serious.

STOMACH PAINS; CHILLS WITH FREEZING SHIVERS; PAIN WHERE VACCINE WAS INJECTED; ENTIRE STOMACH FEELS BLOATED AND GASSY; 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 low testosterone, alcohol use, and non smoker, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: 07-AUG-2021) dose was not reported, administered on 23-JUN-2021 for prophylactic vaccination. Concomitant medications included testosterone for low testosterone. On JUN-2021, the subject experienced entire stomach feels bloated and gassy. On 23-JUN-2021, the subject experienced pain where vaccine was injected. On 25-JUN-2021, the subject experienced stomach pains. On 25-JUN-2021, the subject experienced chills with freezing shivers. Laboratory data (dates unspecified) included: Colonoscopy (NR: not provided) colon twisted. Treatment medications (dates unspecified) included: simeticone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills with freezing shivers, and had not recovered from stomach pains, pain where vaccine was injected, and entire stomach feels bloated and gassy. This report was non-serious.

Tingling and numbness in arm injection was given, lasts about 30 seconds and is intermittent. Patient compares it to a TENS device on low setting.

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).

Fever: onset ~7.5 hours post injection. Peaked at 101.8 °F ~13 hours post injection. Overall duration ~24 hours. Headache: accompanied fever Sore arm in vicinity of injection site: roughly same time as fever as well. Made it almost impossible to lie on my left side.

I started having very itchy feet and it gradually got hot and made it's way up my legs and on to my back and buttocks. I had extremely itchy, angry, red, hot raised skin rash. I have never had a rash like that. Luckily, I did not have any problem with breathing. I took a cool shower and took 2 Claritin. I also put Caladryl on my skin. This was 5 days and a couple of hours after taking the vaccine. It seem "Janssen COVID-19 Vaccine EUA"

woke up at 2:30 am with fever. Did not take it with thermometer but consistent with a 100.00' range no chills, sore injection site and shoulder joint in general including pec insertion. fevevr lasted for three hours, for fever took 2 ibuprofen 200mg and woke at 7am with no fever. Continued ibuprofen for rest of day every 4 hours, last doe at 5:30 pm. Shoulder and injection site pain lasted 3-4 days after

12 hours after injection, slight fever and chills, lasted for 12 hours. Slept. Skin rash (large red bumps) on neck, arms, legs, chest, face) started 18 hours after injection and lasted about 10 days. Used anti-itch cream and 50mg antihistamine at night.

Itchy rash from thighs to feet covering 30% of lower extremities. Improved after 2 oral Benadryls. no other complaints or symptoms.

Headaches, migraines, and tired after vaccine for 2 weeks. 14th day after vaccine noticed some red spots on leg that looked similar to a heat rash and over the next 24 hours entire legs were covered in red dots and feet were almost solid purple. On the morning of 16th day constant nose bleed and multiple blood blisters in mouth inside cheeks and all over tongue. Blood was coming from mouth. At that point legs were covered in dark red almost purple and spreading to chest, back, and arms.

Headache, 100 degree temp, aches, joint pain that includes neck, shoulders, knees, ankles and fingers. Cramps in legs. Skin sore to touch almost felt like sunburn. Gastrointestinal discomfort that included loose stools and gas. Frequent urination possibly due to water intake, but was unusual. Fever lasted about 24 hours. All symptoms starting to subside around the 24 hour mark.

Itching started in right arm and front of chest, redness. No hives or SOB. Offered water but patient refused benadryl. Stabilized and felt better afterwards.

4/11 Sunday afternoon fatigue and tired. 4/11 Sunday night into 4/12 Monday morning woke up with severe coughing, heart racing, and a rash. The rash was present on the right side of body, chest, arm, ribs. The rash was round bumps, raised, bright red, severe itching, and warm to touch. The rash and itching presented for 5 days. Tuesday severe headache and body aches present in addition to other symptoms. Heart racing continues still to this day 4/18.

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.

I began to feel numb around my mouth and nose. It spread to most of my face, then chest, then arms, mainly left arm and leg, then to both legs. General weird feeling / numbness, no pain. I had trouble with limb control, not bad, but enough to notice. Mainly left side, but noticeable on both sides. From the onset on face numbness to the chest leg spread was just a matter of a few, maybe 5 minutes. I looked at my face in the car mirror, and appeared to have facial control. I was driving to a relatives house, and it worried me. On the way, I also noticed a lump in my right neck, about the size of a pea. When I got to my relatives house I told them I thought I had a small stroke, but wasn't sure. The numbness lasted until the next day, then slowly went away. It took about 2 days before the numb twitchy feeling went away from my left eye/upper cheek area. The lump in my neck also went away. rubbing on it actually made the numbness slightly go away. I did not go to a hospital, or seek any treatment. I think I should have. I do believe that l had a small stroke / blood clot, and that it should be reported. I think I am OK now,

I have never had hives before but my wife says it seems just like it. I have these extremely itchy areas on my body. They never show up in the same area and leave no trace after itching stops. These itchy situations show up in random areas on my body lasting for about 15 mins two or three times a day.

BRUISING ON THIGHS AND BELOW GROIN AREA; This spontaneous report received from a patient concerned a 56 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, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced bruising on thighs and below groin area. 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 bruising on thighs and below groin area. 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.

SKIN BREAKDOWN (ON ARMS AND TORSO AREA AND LITTLE BIT REDNESS); LITTLE BIT OF REDNESS; This spontaneous report received from a patient concerned a 56 year old male. The patient's weight was 190 pounds, and height was 180 centimeters. The patient's concurrent conditions included alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies, had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced skin breakdown (on arms and torso area and little bit redness). On 13-APR-2021, the subject experienced little bit of redness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from skin breakdown (on arms and torso area and little bit redness), and the outcome of little bit of redness was not reported. This report was non-serious.

SWEATY; SWOLLEN LIP; CHILLS; TIRED; FEVERISH; ITCHY FOREARMS; FLU-LIKE SYMPTOMS; ACHEY; This spontaneous report received from a patient concerned a 56 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced itchy forearms. On APR-2021, the subject experienced flu-like symptoms. On APR-2021, the subject experienced achey. On APR-2021, the subject experienced tired. On APR-2021, the subject experienced feverish. On an unspecified date, the subject experienced sweaty, swollen lip, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu-like symptoms, tired, achey, feverish, sweaty, chills, swollen lip and itchy forearms was not reported. This report was non-serious.

CHILLS; FEVER; INJECTION SITE PAIN; 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 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: 1805029, and batch number: 1805029 expiry: 25/MAY/2021) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The patient vaccinated at right arm. No concomitant medications were reported. On 12-MAR-2021, the subject experienced injection site pain. On 16-MAR-2021, the subject experienced chills. On 16-MAR-2021, the subject experienced fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 98.6 F, 100.1 F. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on 14-MAR-2021, and had not recovered from fever, and chills. This report was non-serious.

1. The left eye was red for a couple of days. 2. Many red spots on the body like rashes. Still going on.

It is 22 days post vaccine and still having pain at the injection site. Pain and achiness when moving arm with certain activities or moving in certain directions such as taking off shirt

Severe and debilitating fatigue, body aches, headache, soreness at injection site. Symptoms laste 3 days

RASH ON LEFT FOREARM; This spontaneous report received from a patient concerned a 56 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: 204A21A, and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 01-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-MAY-2021, the subject experienced rash on left forearm. Treatment medications (dates unspecified) included: calamine/glycerol/zinc oxide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on left forearm. This report was non-serious.

Pain in the vaccination area began about 18 hours after injection. It has not abated in 3 weeks. General body aches - mostly in feet and in upper right arm, shoulder, and neck area (C1-down to mid-shoulder), fogginess of thought, and overall tiredness and lack of sharpness since about 2-3 days post injection.

DIARRHEA; REALLY BLOATED/STOMACH DISTENSION; BODY ACHES WORSENING FROM PREVIOUS LEVEL; ABDOMINAL PAIN; RASH ON THE FRONT OF THE RIGHT SHIN / RASH THAT GOES AROUND THE LEFT SHIN; POSSIBLE WORSENING OF PREVIOUS HEADACHES; This spontaneous report received from a patient concerned a 56 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included degenerative disc disorder, and rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 206A21A, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. Concomitant medications included golimumab for rheumatoid arthritis. On 21-MAY-2021, the subject experienced diarrhea. On 21-MAY-2021, the subject experienced really bloated/stomach distension. On 21-MAY-2021, the subject experienced body aches worsening from previous level. On 21-MAY-2021, the subject experienced abdominal pain. On 21-MAY-2021, the subject experienced rash on the front of the right shin / rash that goes around the left shin. On 21-MAY-2021, the subject experienced possible worsening of previous headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from diarrhea, really bloated/stomach distension, body aches worsening from previous level, possible worsening of previous headaches, rash on the front of the right shin / rash that goes around the left shin, and abdominal pain. This report was non-serious.

BODY TREMBLING AND SHAKES; FEELING ELECTROCUTED; TINGLING ALL OVER THE BODY; INSOMNIA; BARELY ABLE TO WALK; REDNESS IN THE FACE; HEART FEELING WEIRD; WHOLE BODY ACHES; EXTREME SORNESS OF LEGS; EXTREME WEAKNESS; HEADACHES; This spontaneous report received from a patient concerned a 56 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included there was no past medical history. the patient was overall healthy prior to the side effects after receiving the vaccine. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: 09-JUN-2021) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced body trembling and shakes. On APR-2021, the subject experienced feeling electrocuted. On APR-2021, the subject experienced tingling all over the body. On APR-2021, the subject experienced insomnia. On APR-2021, the subject experienced barely able to walk. On APR-2021, the subject experienced redness in the face. On APR-2021, the subject experienced heart feeling weird. On APR-2021, the subject experienced whole body aches. On APR-2021, the subject experienced extreme sorness of legs. On APR-2021, the subject experienced extreme weakness. On APR-2021, the subject experienced headaches. Laboratory data (dates unspecified) included: Scan (NR: not provided) No diagnosis, and X-ray (NR: not provided) No diagnosis. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from body trembling and shakes, tingling all over the body, insomnia, redness in the face, whole body aches, extreme sorness of legs, heart feeling weird, headaches, extreme weakness, and barely able to walk, and the outcome of feeling electrocuted was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious

Within 2 hours after the shot, my arm became sore and warm to the touch. Within 36 hours, this went away. no other bad effects. Then, around the first of May (about a month after the shot), the injection site became sore again. This also happened to my business partner who was vaccinated on the same day. He took the Moderna vaccination. The injection site is still sore on both of us, feeling like we have been knuckle punched in the arm all the time. I haven't done anything to injure my arm. I also have tendonitis in my groin, but don't particularly think that is related to the virus. I am just telling you so that if that is part of a larger pattern, you will have recorded it.

SWELLING OF TOUNGE, HIGH HEART RATE, BLURRED VISION, RINGING IN EARS, METAL TAISTE IN MOUTH, RED RASH ON HEAD AND CHEST. WAS TREATED AT THE EMERGENCY ROOM AND RELEASED.

FELT DIZZINESS; SORENESS IN RIGHT ARM; WEAKNESS IN RIGHT LEG AND RIGHT ARM / CAN'T PICK UP ANYTHING OVER 5 POUNDS; SORENESS AT INJECTION SITE TRAVELLED DOWN RIGHT ARM; NAUSEOUS; This spontaneous report received from a patient concerned a 56 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821281, and expiry: 06-SEP-2021) dose was not reported, administered on 01-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUL-2021, the subject experienced felt dizziness. On 02-JUL-2021, the subject experienced soreness in right arm. On 02-JUL-2021, the subject experienced weakness in right leg and right arm / can't pick up anything over 5 pounds. On 02-JUL-2021, the subject experienced soreness at injection site travelled down right arm. On 02-JUL-2021, the subject experienced nauseous. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt dizziness on 02-JUL-2021, and had not recovered from soreness at injection site travelled down right arm, nauseous, weakness in right leg and right arm / can't pick up anything over 5 pounds, and soreness in right arm. This report was non-serious.

Shingles (Herpes Zoster) symptoms began just over 24 hours following the administration of the vaccine. Initial symptoms were pain and numbness radiating from right hip / gluteal area down right leg. Pain/tingling/numbness spread across belly area in the following days. Patient remained unaware it could be shingles until June 1, 2021 when multiple patches of blisters appeared down lower right leg. Medical help sought the following day June 2, 2021. Acyclovir 800mg (5 times daily) was prescribed for 7 days. To date, some soreness remains at the initial site as well as some sensitivity across belly area.

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

Severe chills lasting a couple of hours entire body shakes, headache lasting 24 hours, fatigue lasting 24 hours, full body rash still in progress

12 hours post injection developed severe chills, HA, muscle pain and fever of 101.1 along with moderate injection site tenderness with slight itchy rash on arm. Took 500mg Tylenol and went to bed. Felt better in morning fever down to 98.8 with additional Tylenol taken at 0500 am before arising. Moderate fatigue.

pt c/o head and chest itchiness, Benadryl given @ 12:36. VSS 1300 pt stable, no itching. Pt discharged to home.

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

About a week after receiving the shot from the hospital, I starting having itching in my elbows then calves and inner thighs and back sides of my knees. It started as blotches in areas. The ones on my arms seemed to have gone away. We have confirmed I am using the same soap, same laundry detergent and same deodorant. It was the worst on 4/4/21. So I have started to bathe in epson salt each day and not only shower. 4/5/21 it was high on my thighs. Trying to minimize itching. I also tried to apply a 1% hydrocortisone anti itch cream the last last few days. The redness has been reduced today. I have pictures of it growing. I think getting better.

onset of hives all over the faces..converted to rashes all over the body in next two days with itching, chills and nightly low grade fever. lastly the red patches moved to the extremities with touch sensitivity and itching.

4/10 - after 4 hours, (14:00) felt hot and my face was in red color. Generally OK 4/11 - Generally felt hot, red face, and then around 16:00, arm and let joins started to ache and mild pain occurred. 4/12 - After having a dinner around 17:00, with in 30min, chest pain started at left chest. felt more like heart burn sensation. 19:00 pain stopped by drinking some hot tea. 22:00 took my meds, Brilinta, Carvedilol and Atorvastatin 23:30 chest pain came back instead of left side, in the center of chest. took some tums and drank some hot water 26:00 no more pain and was able to go sleep. 4/13 - 07:00 no pain but off and on with discomfort in the chest area from last night chest pain.

on 4/2 the day after the vaccine a large rash with hives developed around my neck I took benadryl 50mg and it subsided . Then on 4/4 (sunday) I went to sleep early around 8pm Wasnt feeling well. I woke up around 2 hours later I had a bad rash with hives in my groin, on my torso, again on my neck, scalp and palms of my hands. My hands were covered in hives. I took 125mg of Benadryl at 10pm and had a prednisone prescription at home similar to a medrol dose pak So I took 6 prednisone 5mg at 10pm and 5 prednisone 5mg early the next morning around 5am 4/5. I also added more benadryl around 2am (50mg) and 6am (50mg) By the morning tho the rash was very visible and still raised on my palms, neck and groin. I went to the doctor and he examined me and he felt in the absence of any other factors like new deodorant, shampoo , or new laundry soap that it was likely the vaccine. I finished a five day course of the steroid and im completely back to normal.

FEVER OF 101.4; CHILLS; SEVERE HEADACHE; ICHY RASH AT INJECTION SITE; SYMPTOMS OF RASH; SHAKING; This spontaneous report received from a consumer concerned a 57 year old male. The patient's weight was not reported and height was 73 inches. The patient's concurrent conditions included no alcohol use, and nonsmoker, and other pre-existing medical conditions included patient had no known drug allergies. patient had no drug abuse or illicit drug usage at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029, and batch number: 1805029 expiry: UNKNWON) .5 ml, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced fever of 101.4. On 09-MAR-2021, the subject experienced shaking and chills. On 09-MAR-2021, the subject experienced severe headache. On 09-MAR-2021, the subject experienced ichy rash at injection site. On 09-MAR-2021, the subject experienced symptoms of rash at injection site. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101.4. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever of 101.4, shaking and chills, severe headache, and ichy rash at injection site, and the outcome of symptoms of rash at injection site was not reported. This report was non-serious.

A few days after, a painful rash appeared near the injection site, below the site, in the elbow joint and upper left shoulder blade area.

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

BROKE OUT IN HIVES ALL OVER BODY; SORE ARM; This spontaneous report received from a patient concerned a 57 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: 1802070 expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, the subject experienced sore arm. On 25-MAR-2021, the subject experienced broke out in hives all over body. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 06-MAR-2021, and was recovering from broke out in hives all over body. This report was non-serious.

LEFT EYE TRAUMA/ CATARACT; RASH ALL OVER BODY ARM/ECZEMA; SHOULDER PAIN/SORENES/WOUND; BLOOD SUGAR ABNORMAL 319; URINATION PROBLEM; MALE GLAND (REALLY BIG) WAS SWOLLEN/ RED; FEELING OF PASSING; LIGHT HEADACHE; WEAKNESS; This spontaneous report received from a patient concerned a 57 years old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes (did not take any medication). Patient was assaulted before getting the Covid-19 vaccine and was cut in the neck and needed blood transfusion last OCT-2020. Patient got several vaccinations. Last vaccination he received was in 1980. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, 1 total administered on 08-APR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, 1 day after vaccination, patient experienced light headache, feeling of passing and weakness. On 11-APR-2021, after 2-3 days of vaccination, patient was suffering from urination problem which included swollen male gland/ redness (peeling of the skin /flesh is visible /getting worse) and pain during urination. He had pain upon pulling back his foreskin (he was not circumcised and never had such problems). On unspecified day, he had trouble in vision. He visited two doctors regarding the problem who stated that patient had left eye trauma (cataract). On unspecified date. he also had rashes all over the body (specifically arms) referred as eczema. On an unspecified date, he had shoulder pain/soreness/wound on both shoulders right as well left. Skin of the left shoulder was peeled and flesh was visible. He stated that peeling of the skin was moving towards the back of his shoulder and was getting worse. He had tattoos on his left and right shoulder/arm. As per patient, he was given a lot of shots in his right during his profession. Patient has abnormal blood sugar level. On 23-APR-2021, Laboratory data (dates unspecified) included: Blood sugar abnormal (NR: not provided) 319. Treatment medications (dates unspecified) included: bismuth subsalicylate and took 7 up to alleviate symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left eye trauma/ cataract, urination problem, rash all over body arm/eczema, weakness, feeling of passing, light headache, and male gland (really big) was swollen/ red, and the outcome of shoulder pain/sorenes/wound and blood sugar abnormal 319 was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 : 20210448488 - COVID-19 VACCINE AD26.COV2.S - left eye trauma / cataract . 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). 20210448488-COVID-19 VACCINE AD26.COV2.S-BLOOD SUGAR ABNORMAL 319 .This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE

HEADACHE; PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a 57 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: 041A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced pain at injection site. On 11-APR-2021, the subject experienced headache. On 26-APR-2021, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain at injection site on 12-APR-2021, and had not recovered from headache. This report was non-serious.

The day after the vaccine the patient developed a fever lasting one day, and a very pruritic rash over his trunk, arms/hands as well as a few lesions over his scalp and face. The rash persisted, and per the photos that he emailed to the office was maculopapular in nature. I instructed the patient to take cetirizine 10 mg twice daily, and within 4-5 days the rash had completely resolved.

Pt reports rash, hives, and itching that began shortly after receiving the vaccine. He also reports vomiting about once a week.

Moderate hives continuing to this day. On arms, legs, back, and stomach. I'd never had hives before and didn't know what they were. Of course there is no way to prove this is specifically a reaction to the vaccine.

History of Present Illness: Patient has a history of sinus problems. He was schedule for sinuplasty and had preoperative evaluation on 04/21/2021 with WBC 5.8, Hb 15.5, PLT 193,000. He had J&J covid vaccination on 04/27/2021. He underwent sinuplasty on 05/05/2021. Subsequent to his surgery he was having headache. He had some nasal discharge with blood. He took tramadol but had persistent pain. His symptoms were worsening up with some weakness of his right upper extremity. Was having generalized fatigue and weakness. He states he was getting short of breath with a flight of stairs. He had decreased appetite. He was given Vicodin for his headache with some improvement. He noted discoloration and bruising with pain pain in his left internal thigh area. Was noticing some changes in his vision but no loss of vision. He presented to the ED on 05/11/2021 and laboratory showed WBC 8.7 Hb15.2, PLT 6,000, segs 77%, lymphs 9%. He had no dark colored urine. INR 1.4 PTT 33, immature platelets 30.2. His bili was 2.1. He was treated with dexamethasone 40 mg. There is tiny focus of restricted diffusion in the both cerebellar hemispheres measuring up to 0.4 cm white matter left cerebellar hemisphere of left parietal junction measuring 0.5 cm compatible small lacunar infarcts. Chronic paranasal sinusitis. Patient described minimal blood with flushing his sinuses. Patient was ultimately transferred to Hospital after 3 days (on 5/11) for further acute care management given the multiple clots and bleeds associated with severe thrombocytopenia.

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

VACCINE WAS ADMINISTERED PRIOR TO PATIENT LOSING CONSCIOUSNESS. PATIENT REGAINED CONSCIOUSNESS AND REPORTED DIZZINESS AND BRUISING ON HEAD. 911 WAS CALLED, AND EMS ATTENDED TOPATIENT.

11 days after the vaccine I came down with a bad case shingles, It has been 8 weeks and I still haven't recovered, I couldn't eat for three days because I kept vomiting from the pain.

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)

PT STATES THAT HE HAS HAD ARM PAIN NOT JUST AT THE INJECTION SITE BUT HIS WHOLE ARM SINCE 2 DAYS AFTER BEING VACCINATED

Burning of underarm and left part of stomach. This went on for 1 week before my PCP. They took X-ray scans because of the stabbing pain. They came back negative and ran blood tests for internal bleeding. Then they scheduled an MRI which came back negative too. I got with a neurologist and they said I have nerve damage. This has been over the course of 3 months.

ELEVATED HEART RATE; DISCOMFORT SLEEPING ON THE LEFT SIDE; 4 EPISODES OF CAPILLARY BURSTING, 2 IN EACH EYE; CHRONIC DIARRHEA 2-3 TIMES DAY; RIGHT HAND/FINGERS JOINTS ACHY; SEVERE HEADACHE; INJECTION SITE SWELLING; This spontaneous report received from a patient concerned a 57 year old male. The patient's weight was 172 pounds, and height was 71 inches. The patient's past medical history included covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On OCT-2020, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On 12-MAY-2021, the subject experienced right hand/fingers joints achy. On 12-MAY-2021, the subject experienced severe headache. On 12-MAY-2021, the subject experienced injection site swelling. On 15-MAY-2021, the subject experienced chronic diarrhea 2-3 times day. On 19-MAY-2021, the subject experienced 4 episodes of capillary bursting, 2 in each eye. On an unspecified date, the subject experienced elevated heart rate, and discomfort sleeping on the left side. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from right hand/fingers joints achy, and injection site swelling on 15-MAY-2021, 4 episodes of capillary bursting, 2 in each eye on 29-MAY-2021, and severe headache on 12-JUN-2021, had not recovered from chronic diarrhea 2-3 times day, and the outcome of elevated heart rate and discomfort sleeping on the left side was not reported. This report was non-serious.

Long-term hives, known as chronic idiopathic uritcaria (CIU). Continues with no end in sight. Itching comes and goes, with reddish patches of raised skin on legs, arms and torso.

Vaccine on 6/7/2021...after about 1 to 2 weeks, tingling hands, swelled foot, some infrequent shortness of breath, some slurring of words, unusual stutter, abdominal pain, pressure in chest front to back, soreness at shot location, later - a very high blood glucose reading. 6/25/2021 - glucose reading of 225, HBA1c reading of 8.8%! Later diagnosed with LADA because of glucose readings, AND because lifestyle is vegan vegetarian and active workouts, AND no prior high glucose readings. subsequent tests for auto immune, negative.

Fatigue, stomach bloating, shortness of breath, nerve problem-shaking, rash, was provided antihistamine by healthcare professional.

Started with a fever - that began about 6 hrs after the injection. That lasted a little more than 24 hours, then went away. Last night - about 55 hrs after that vaccine, I have developed an itching rash over most of my body - I still have it as of this morning. Also, slight swelling of my lips

Broke out in hives in the middle of the night. All over my legs and arms. Very itchy but otherwise doesn?t seem like a problem.

Had nausea, body aches, chills and slight aches at injection site. Some diarrhea as well. Symptoms lasted for a few hours (except diarrhea which lasted a couple of days). All fine currently.

I exp headache and chills 2 days after vaccine. I broke out with Shingles on my abdomen on 3/13.The doctor told me Shingles would remain for several weeks.

Patient stated arms felt warm and then started to develop hives 2 to 3 minutes after receiving vaccine. Then stated arms, shoulder and back felt achy. Patient was given 50mg or Benadryl orally and monitored.

noticed rash/hive/red patches on upper left arm, about 2 inches away from the injection site, about 3 inches in diameter at 7 am on 4/10/21, not itchy, slight muscle ache in the injection area when the arm is moving. no treatment. about ~ 90% resolved at 10 pm on 4/11/2021.

Mild flu like symptoms with low-grade fever bodyaches chills and ongoing pain at the injection site persisting to date

Numbness in two fingers on left arm (ongoing for over one month after dose), rash on site of injection (ongoing for over one month)

Approximately a week after vaccine administration a rash developed on torso. Then on April 12, 2021 after working throughout the morning sitting in front of my computer, I took a lunch break. While preparing a meal, I felt discomfort in the left eye and it became very uncomfortable. When I checked in the mirror, I discovered my left eye was filling with blood. Upon seeing an eye doctor that same afternoon, the doctor explained that my left eye had ruptrued a large vessel and hemmoraged. However, the reason for the hemmorage could not determined because I was not under stress, had not lifted anything heavy, was not on blood thinner medication, was not constipated and have no underlying health condition.

This spontaneous report received from a patient concerned a 58 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: 180502D, and expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced didn't feel good. On 25-MAR-2021, the subject experienced tired. On 13-APR-2021, the subject experienced dizzy. On 13-APR-2021, the subject experienced pinched nerve. On 13-APR-2021, the subject experienced felt like hot fluid was running down the inside of his right arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy, pinched nerve, felt like hot fluid was running down the inside of his right arm, and didn't feel good on APR-2021, and tired on 28-MAR-2021. This report was non-serious.

Red spots all over my body, arms, legs, stomach, back, just a few the first week after, but has continued with more and more each week. 6 weeks after and I'm covered with red spots, and yes they itch as well, all over.

NECK PAIN; ARM PAIN; LEFT SIDE BODY PAIN; HEADACHE; 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 concurrent conditions included diabetes, blood pressure, non alcohol user, and non smoker, 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: 1808609, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On APR-2021, treatment medications included: ibuprofen, and paracetamol. On 13-APR-2021, the subject experienced neck pain. On 13-APR-2021, the subject experienced arm pain. On 13-APR-2021, the subject experienced left side body pain. On 13-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, neck pain, arm pain, and left side body pain. This report was non-serious.

RED ITCHY BURNING BUMPS SPREAD TO HANDS AND LEGS; RED ITCHY BURNING BUMPS ON STOMACH; This spontaneous report received from a patient concerned a 58 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: Unk) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-APR-2021, the subject experienced red itchy burning bumps on stomach. On 15-APR-2021, the subject experienced red itchy burning bumps spread to hands and legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from red itchy burning bumps on stomach, and red itchy burning bumps spread to hands and legs. This report was non-serious.

FELT LIKE SOMETHING ON CHEST; SKIN HOT; LITTLE BIT OF COUGH; FEELING HOT; CAN'T SLEEP AT NIGHT; DIZZY; BARELY COULD STAND; COULD BARELY WALK; PAINS IN BACK ESPECIALLY BACK UP NECK; CHILLS; VERY WEAK; FELT VERY HOT FEVERISH; NIGHT SWEATS; TIRED; This spontaneous report received from a patient concerned a 58 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: 1808609 expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced tired. Laboratory data included: Blood test (NR: not provided) everything was ok. On 24-MAR-2021, the subject experienced night sweats. On 24-MAR-2021, the subject experienced chills. On 24-MAR-2021, the subject experienced very weak. On 24-MAR-2021, the subject experienced felt very hot feverish. On 25-MAR-2021, the subject experienced dizzy. On 25-MAR-2021, the subject experienced barely could stand. On 25-MAR-2021, the subject experienced could barely walk. On 25-MAR-2021, the subject experienced pains in back especially back up neck. Treatment medications included: naproxen. On APR-2021, the subject experienced little bit of cough. On APR-2021, the subject experienced feeling hot. On APR-2021, the subject experienced can't sleep at night. On APR-2021, the subject experienced felt like something on chest. On APR-2021, the subject experienced skin hot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired on 2021, was recovering from pains in back especially back up neck, and felt very hot feverish, had not recovered from chills, and the outcome of night sweats, little bit of cough, dizzy, barely could stand, could barely walk, very weak, feeling hot, can't sleep at night, skin hot and felt like something on chest was not reported. This report was non-serious.

BLOOD CLOT IN UPPER THIGH; NO PULSE FROM KNEE DOWN ON RIGHT LEG; RINGING AND BUZZING IN EARS; PURPLE TOE; COULD NOT MOVE; FEELING CRAPPY; TIRED; NAUSEOUS; 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 concurrent conditions included Barrett's esophagus, and controlled high blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular batch number: 1805031, and expiry: unknown) dose was not reported, 1 total administered in left arm on 24-MAR-2021 for prophylactic vaccination. Concomitant medications included Nexium (esomeprazole sodium) for Barrett's esophagus, and lisinopril for high blood pressure. On 25-MAR-2021, the day after the vaccination, patient felt crappy and could not move, had tiredness and nauseous. After 10 to 12 days of vaccination on an unspecified date in APR-2021, the patient had ringing and buzzing in ears, pain in the bottom of feet on walking, and purple discoloration to front of the right toe. The patient had visited health care professional (HCP). The patient had undergone some tests and HCP identified no pulse from the knee down on his right leg and a blood clot in upper thigh. The patient had experienced pins and needles and buzzing on his leg. He has also has a ringing and a buzzing in his ears and the bottom of his feet hurt when he walked on them. The patient was scheduled for an appointment with cardiovascular surgeon on 28-APR-2021, prior to the visit the patient has to tested negative for COVID. The patient went to take test on 23-APR-2021 and results not yet received. Laboratory data included: Peripheral pulse absent (NR: not provided) no pulse from the knee down on right leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling crappy, tired, nauseous, no pulse from knee down on right leg, blood clot in upper thigh, ringing and buzzing in ears and could not move was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to.This spontaneous report received from a patient concerned a 58 year old male.; Sender's Comments: V0: This 58-year-old male patient was found to have blood clot in upper thigh with no pulse from the knee down 10 to 12 days after receiving COVID-19 VACCINE AD26.COV2.S for the prevention of symptomatic SARS-CoV-2 virus infection. Concurrent conditions include Barret's esophagus and "controlled" high blood pressure; concomitant medications includes Nexium and lisinopril. The symptoms reported were ringing and buzzing in ears, pain in the bottom of feet on walking, pins and needles and buzzing on his leg, and purple discoloration to front of the right toe that prompted consult with HCP, who advised the patient that there was no pulse from the knee down on his right leg and a blood clot in upper thigh. Prior COVID test was negative. No other details reported. The information available precludes a complete and meaningful assessment. However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded. Additional information was requested.

RIGHT ARM PAIN AROUND INJECTION SITE (PAIN LEVEL 8); 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 concurrent conditions included pacemaker stent in right artery, alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. The patient did not have any 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: 1805022 expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, Laboratory data included: Laboratory test (NR: not provided) unknown. On 27-MAR-2021, the subject experienced right arm pain around injection site (pain level 8). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from r arm pain around injection site (pain level 8). This report was non-serious.

DEPRESSIVE EPISODE; IRRITABLE; BODY ACHE; INSOMNIA; FEVER; HEADACHE; INJECTION SITE PAIN; TIRED; 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 granule storage platelet disorder, early-stage prostate cancer, itch, face peeled, and huge sunburn like reaction, and concurrent conditions included alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with morphine, and articaine hydrochloride/epinephrine bitartrate. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: 23-JUN-2021) dose was not reported, administered on 29-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-APR-2021, the subject experienced depressive episode. On 30-APR-2021, the subject experienced irritable. On 30-APR-2021, the subject experienced body ache. On 30-APR-2021, the subject experienced insomnia. On 30-APR-2021, the subject experienced fever. On 30-APR-2021, the subject experienced headache. On 30-APR-2021, the subject experienced injection site pain. On 30-APR-2021, the subject experienced tired. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99.5 F, running greater than 100 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache on 01-MAY-2021, and injection site pain on 02-MAY-2021, had not recovered from fever, headache, irritable, depressive episode, and insomnia, and the outcome of tired was not reported. This report was non-serious.

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.

At 12 hours after application: Headache, left lobe. At 24 hours of application: skin rashes, with some burning, but remains 4 days later. No other effect.

Injection site slightly stiff post injection. 06/12/2021 02:00pm. experiencing extreme vertigo symptoms. One hour later reclined for a 2 hour nap. Awoke feeling a small bit better. Upon arising experienced chills, body aches, fatigue and extreme "over the toilet nausea". BP slightly elevated

On Friday June 11 I woke up with itching hands; as the day went on the condition worsened; I applied Aveeno and Benadryl cream; Saturday June 12th I went to urgent care and received a Steroid shot which did help the rash and hives. On Sunday June 13th I noticed my hands starting to hurt ; by Monday the the pain was severe; I saw my family Dr on Tuesday June15th on he prescribed oral steroids. Wednesday the pain had moved to my shoulders and hands where it continues. The pain is not as severe but it still hurts to move my shoulder or to grip things with my hands.

PAIN AT INJECTION; This spontaneous report received from a patient concerned a 58 year old male. The patient's weight was 130 pounds, and height was 64 inches. The patient's concurrent conditions included non smoker, and no alcohol use, and other pre-existing medical conditions included the patient had no known allergies and had no history of drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 2018218, expiry: 23-JUN-2021) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. Concomitant medications included bnt 162 for prophylactic vaccination. On 20-MAY-2021, the subject experienced pain at injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain at injection on 20-MAY-2021. This report was non-serious.

PATIENT HAS SOME REDNESS ON THE ARM, SLIGHT RAISED AREA AT THE INJECTION SITE & COMPLAINS OF ITCHINESS.

Severe psoriasis symptoms. Itching. Rashes and hives on back, armpits, stomach, groin area, buttocks, wrist, legs, feet. Symptoms subsided after taking a total of 4 Benadryl tablets. Milder symptoms mostly on legs started to come back on the next day. Cleared up after taking 2 Benadryl tablets. No symptoms since. Typically suffer from mild psoriasis. Have never experience such a severe episode before.

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

patient reported that he first had flu like symptoms and his injection site looked like it may have had bruising. He then said after flu symptoms faded away he kept noticing his injection site first looked like a pea sized bruising it then kept increasing in size and is now about the size of Ping-Pong ball. He said its painful if he lays on it otherwise does not hurt but still keeps increasing in size with time and is not shrinking.

PATIENT GIVEN VACCINE AFTER ALL PROCEDURAL ITEMS WERE COMPLETED ANDWAS LEFT SEATED IN A CHAIR ASSIGNED FOR COVID 19 MONITORING . PATIENT STARTED SNORING/GURGLING AND I LOOKED OVER TO SEE IF PATIENT WAS CATUALLY SNORING . PATIENT WIFE CALLED HIM BY NAME HE DID NOT ASWER RIGHT AWAY, I RAN TO TO ATTEND TO HIM AND I NOTICE HE WAS PALE , SWEATLY AND CLAMY ALSO WARM TO TOUCH. I CALLED HIS NAME HE ASWERED I THEN TOOK HIS PULSE WHICH WAS NORMAL AND GAVE HIM SOME WATER TO SIP AND ALSO GAVE PATIENT A CANDY WITH MENTHOL THEN HE STARTED GAINING BACK COLOR . HE FELT WEAK BUT STARTED FELLING BETTER. HE SEEM TO HAVE DIZZY ,LIGHTED HEAD SPELLS RIGHT AFTER VACCINE WAS ADMINISTERED. I MONITORED PATIENT FOR 45 MINS HE WAS ABLE TO GET UP AND WALK AND SAID HE FELT BETTER. ITS SEEM LIKE IT WAS MORE OF A FAINTING SPELL BUT BECAUSE HE WAS SEATED AND BEING MONITORED HIS RECOVERY WAS GOOD. PATIENT GOT UUP AND WALK AROUND AFTER RECOVERY AND I TOKK HIS NUMBER SO THAT I CAN FOLLOWUP AFTER CLOSING

I'm not sure if this related to the vaccine, but I suspect it is. Starting about 10-14 days after receiving the vaccine (IM into my deltoid), I have been experiencing a regional (almost dermatomal) distribution itchiness and hypersensitivity in my left infrascapular and upper lateral back region. It's a superficial (dermal/epidermal) discomfort, not deep. I have observed NO associated rash or hives; nothing is visually evident. I am still experiencing this at day 19 post vaccine. I've not taken any medication, have not applied any topicals, etc.

Coldness, then slight chills, then chills with shivering, then extreme chills and shivering. No fever until 8 hours after shot. Skin extermely warm heart rate increased from 64 to 110 for over 6 hours.Chills started to reduce around 11 hours after shot Fever of 101.2 at 9 hours after shot Fever of 101.6 at 10 hours. Chills stopped and extereme hotness began. Fever and hotness slowly began reducing until 14 hours after dose. Fatgue set in.. note during chills also felt extreme hotnwss at same time in all parts of body

INJECTION SITE SORENESS; This spontaneous report received from a patient concerned a 59 year old male. The patient's weight was 200 pounds, and height was 182 centimeters. The patient's concurrent conditions included alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known allergies (food vaccine and drug). No history of drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 13:30 to right deltoid muscle for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced injection site soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site soreness on 11-MAR-2021. This report was non-serious. Additional information was received from reporter on follow up 23-MAR-2021 following information was amended into case: The patient details (height, weight, sex and age), concurrent conditions (alcohol use, non-smoker), vaccination time, route and vaccination site.

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.

Terrible rash with raised welts, coalescing over 25% of body within 6 hrs of vaccination (Sunday evening) . I took 75 mg Benadryl. Next day continued with Benadryl and visited the local urgent care clinic and was prescribed prednisone (40 mg). About 50% of body covered with about hives and coalescing welts. Medical clinic told to go to ER or a doctor if problem persisted. Telemed with doctor Monday continuing through today. Placed on 10 mg of loratadine/day and 60 mg of prednisone, for 5 days, rash and raised coalescing welts continue for 6 days and started dissipating on day 7. Tapering off prednisone, Prescribed epi-pen too if breathing issue developed (breathing problems did not occur.) Today is day 9 since vaccination. rash still present over 20% of body a welts still "pop up". I am still reacting to the vaccine

MILD PAIN IN LEFT LEG; RIGHT ARM WAS SORE WHERE HE GOT THE VACCINE; This spontaneous report received from a patient concerned a 59 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, had no bad medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 on right arm for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced right arm was sore where he got the vaccine. On 02-APR-2021, the subject experienced mild pain in left leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from mild pain in left leg, and right arm was sore where he got the vaccine. This report was non-serious.

Slight swelling right eye (left corner) small mole - swelled up no other affects surfaced about 1 hr after vaccine.

Went emergency after noticing one of my veins had turned red and was hardening. Vein pulsing in left leg. Emergency room doctor diagnosed "superficial thrombophlebitis." The pulsing in lower leg (calf) continues and in elbow and wrist joints. The pain is not an issue. I've been feeling a bit of but most of my discomfort has been anxiety about what's going to happen next and what are the throbbing. The vein is no longer red, is slightly hard, pain is a 1 on scale of 10. Doctors have not contacted me since the evening after I was seen and I reported to them I felt better than I did at the hospital.

FELT HUNGOVER; LOSS OF ENERGY/DIDN'T HAD GUMPTION TO DO ANYTHING; FELT-LIKE DRUNK/BUZZED; TROUBLE GOING BACK TO SLEEP; FEELING OF LIKE BEATEN UP/ FELT DEAD; TIREDNESS; INJECTION SITE BURNING; ARM SORENESS; This spontaneous report received from a patient concerned a 59 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: 1808978, and batch number: 1808978 expiry: 13-JUN-2021) dose was not reported, administered on 12-APR-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced injection site burning. On 12-APR-2021, the subject experienced arm soreness. On 13-APR-2021, the subject experienced trouble going back to sleep. On 13-APR-2021, the subject experienced feeling of like beaten up/ felt dead. On 13-APR-2021, the subject experienced tiredness. On 13-APR-2021 05:30, the subject experienced felt-like drunk/buzzed. On 15-APR-2021, the subject experienced felt hungover. On 15-APR-2021, the subject experienced loss of energy/didn't had gumption to do anything. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site burning, and arm soreness, had not recovered from tiredness, felt-like drunk/buzzed, felt hungover, loss of energy/didn't had gumption to do anything, and feeling of like beaten up/ felt dead, and the outcome of trouble going back to sleep was not reported. This report was non-serious.

ITCHY PATCH ON FEET/ ON SHINS/SIDE OF KNEES; PATCHY BURNING RASH ON LOWER BACK/TOP OF BUTTOCKS; SORE ARM; FATIGUE; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was very healthy, does not have skin, breathing problems and also not taking any medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced sore arm. On 12-APR-2021, the subject experienced fatigue. On 16-APR-2021, the subject experienced itchy patch on feet/ on shins/side of knees. On 16-APR-2021, the subject experienced patchy burning rash on lower back/top of buttocks. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, sore arm, patchy burning rash on lower back/top of buttocks, and itchy patch on feet/ on shins/side of knees. This report was non-serious.

I started seeing red blotches on my right arm and then it spread to both legs. I have eczema, so I thought that's what it was. I went to see my doctor, and she said it was a reaction to the vaccine. One of the nurses said the vaccine probably triggered my eczema and they have been seeing it a lot. She gave me a Vitamin D ointment and told me to use my eczema meds as well. It took a while to clear up, but it's better.

a severe pain in my left leg inside thigh. A bright red dot was there. My arch of my foot was burning and then the burning moved up my shin. Pain is not continuous, but moves to my calf and back to my thigh. I had a ultra sound done, my doctor told me I have a blood clot and put me on Eliquise on 4-21-21.

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.

10 days of almost constant muscle twitching below the injection site at the elbow area/ top of forearm. This uncontrollable muscle movement is almost constant. I have strong pain and fatigue if I use my arm. Additionally, the injection site bled and remains bruised after 10 days.

Itchiness starting in lower legs, arms, head, and back, started on Thursday, May 20, peaking on Saturday and Sunday, diminishing today, Monday, May 24. No related redness, splotches, or marks. No other symptoms related to shot.

My left arm/ shoulder is extremely sore since the shot on 4-1. 7 weeks ago. It does not seam to be improving as days go by.

THROAT SWELLING; BODY ACHES; STOMACH ACHES; CHILLS; DIZZY; SEVERE HEADACHE; FEVER; INJECTION SITE BLEEDING; MILD SHOULDER PAIN; INJECTION SITE "BUBBLED UP"; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's past medical history included many surgeries post traumatic car accident, and concurrent conditions included a lot of scar tissue on shoulder (at injection site), and high blood pressure.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A2114, and 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 injection site bleeding. On 18-MAY-2021, the subject experienced mild shoulder pain. On 18-MAY-2021, the subject experienced injection site "bubbled up". On 19-MAY-2021, the subject experienced dizzy. On 19-MAY-2021, the subject experienced throat swelling. On 19-MAY-2021, the subject experienced body aches. On 19-MAY-2021, the subject experienced stomach aches. On 19-MAY-2021, the subject experienced chills. On 19-MAY-2021, the subject experienced severe headache. On 19-MAY-2021, the subject experienced fever. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine was not applicable. The patient recovered from injection site bleeding, and injection site "bubbled up" on 18-MAY-2021, and mild shoulder pain, was recovering from severe headache, throat swelling, fever, chills, and body aches, had not recovered from dizzy, and the outcome of stomach aches was not reported. This report was non-serious.

I had diarrhea for 16 hours after the injection and loose stools for another 10 days after the injection. My left forearm became itchy a few minutes after receiving the injection in my left arm and I have developed a rash that has not gone away and my forearm remain itchy.

Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Joint Pain-Mild, Additional Details: Pt claimed that after 6 days after vaccination, his left arm is still sore when moved. He also claimed that he is limited mobility of his left arm due to the vaccine with out feeling some level of pain.

Developed dizziness , light sensitivity the next day last about 2 weeks. Soon after that I noticed a ringing in my ears that won?t go away.

Patient first displayed hives in a localized area just above the beltline. Within 6 hours, the hives spread across the patient's entire body from head to foot. Hives were itchy, burning and painful. Hives were evaluated by healthcare professionals and determined not to be shingles or some other known condition. The hives have waned through several courses of treatment, but still remain present.

Patient complaint of rash to arms and legs starting after receiving vaccination on 6/16/21. Patient seen at ER on 6/18/21. Labs unremarkable and treated with oral Benadryl, oral Pepcid, and oral Motrin. He was sent home with prescription for Benadryl and Pepcid and to f/u with PCP. He was seen by provider 6/22/21 and was given Triamcinolone Injection & order for Hydroxyzine for continued itching. Patient reported at that time that he thinks he has bed bugs and unsure if rash from that or vaccine. Seen on 6/28/21 seen again for rash on abdomen and forearms, started on Prednisone and Triamcinolone Acetonide Cream.

HYPERSENSITIVITY TO THE SUN; LIGHT RASHES ON ARM BILATERALLY; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and alcohol user, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. the patient did not have pertinent medical history. The patient experienced hypersensitivity when treated with erythromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced hypersensitivity to the sun. On JUN-2021, the subject experienced light rashes on arm bilaterally. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from light rashes on arm bilaterally, and hypersensitivity to the sun. This report was non-serious.

pain in the arm & shoulder joint where shot was given. Still feels like I have been punched, area hurts when the shot was given and the shoulder joint feels like it is pulled out of socket. date of shot 6/21/2021 and todays date 7/21/2021.

Swollen wrist, ankle, knee, and shoulder joints with intense pain at times. Still have soreness and pain at injection site..