Johnson & Johnson

March 5,2021 at 3:30 am approximately I woke up trembling severely ( entire body ) and intense internal spasms :, high fever : could not grab or hold bottle of water ; tried to get up and and could not stand trembling so bad : I covered up and it lasted till 7:30 am. Now bad headache and back ache

Onset approximately 12 hours p vaccination. Low grade temp. 99.4 ° (normal baseline 97.3) Chills (mild to moderate) Headache (mild to moderate) Neuralgia (mild to moderate) Tinnitus (moderate) Muscle aches (moderate) Site tenderness (mild) Cough (intermittent)

Severe headache, very tired, muscle aches,fever, short periods of dizziness, several hours of the feeling of pressure on my chest which then was replaced by significant burning sensation, bottoms of both feet were very painful and a wrist that i broke a couple of years ago and a knee which has caused pain in the past were very, very painful.

Immediate pain after injection in arm at injection site with some pain moving up in the neck muscle and lower arm. After 24 hours the pain increased and moved into shoulder and neck pain increased. No redness in injection site but muscle pain increased and continued into day three.

Fever for 40 hours, chills, uncontrollable shaking for more than 3 hours, severe nausea for 36 hours, nausea continues now but at a much less severe amount, swollen glands around head and in right arm pit for more than 40 hours, pain in right eye started within 10 minutes of shot and continues now, pain in ankles started about 8 hours after shot and continues now but is becoming much more bearable, joints of toes and joints of a few fingers were painful for about 24 hours, sore arm started about 3 hours after shot and continues now, overall muscle aches started about 8 hours after shot - became much worse within 12-14 hours after shot and became less severe after 30 hours. Overall I felt as if I had a terrible case of the flu. It was very intense. I was unable to sleep the first night due to the severity of symptoms. The second night I sweated a tremendous amount and my fever broke. I am still not over all of my symptoms but I am feeling better.

Approximately 6 hours after receiving the injection, chills began. Then headache, low grade fever, neck ache. Then nausea and vomiting. I couldn't keep anything down. About 24 hours after the side effects began, I started to feel better.

About 5pm after I began feeling achy and fatigued. The next day after I developed the tingly, pins and needles sensation that came and went in both legs, my face, arms and both hand area which I am still experiening today but not as frequent as it was when it began. When it happens its not always in the same spots and doesnt occurs at the same times its as if it alternates and now I also get a hot sensation at the top of my ears periodically which doesnt last very long but it does occur

initial and prolonged swelling with itching and hardness at the injection site which has escalated RT shoulder ache.

Fatigue (10 hours post), headache (3+ days) , severe pain under right armpit (10 hours post--lasting 2 days), dull pain under right arm 3+days, chills 36 hours post vaccine

Six hours after vaccine, extreme muscle aches; splitting, nauseating headache across the forehead. All symptoms resolved 30-36 hours post vaccine

fever to 100.4, headache, neck pain for 10 hrs then 3 days later developed fever 100.6 and abd pain, diarrhea,

Headache and neck stiffness within 15 minutes of vaccine and lasted for a couple days. The days after vaccine I had extreme tiredness and felt like I had a bad cold with a lot of coughing and shortness of breath. I was coughing up a lot of mucus. The cold like symptoms are still ongoing, 2 weeks after the vaccine, but are less extreme. 8 days after the vaccine I started to have pain at the injection site. My upper hurt if I touched it. Twelve days after the vaccine my upper arm hurts if I raise my arm and if I shake my inhalers to use them. This seems like a muscle pain from the injection site to my shoulder.

Around 13 hours later 7AM didn't sleep well. Woke up with dull headache and back of neck muscle aches. This lasted all day and evening. Today 3/26/21 I woke up feeling much better, dull headache pretty much gone. That was all that I had for side affects.

SWOLLEN LEFT ARMPIT (Swelling, Swelling) PAIN IN LEFT ARMPIT (Armpit pain, Axillary pain) This spontaneous report received from a patient concerned a 60 year old female. The patient's weight was 192 pounds, and height was 161 centimeters. The patient's concurrent conditions included hypertension, diabetes mellitus, gerd, and lexapro allergy, and other pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 04-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: Mammogram (NR: not provided) unknown. On 04-MAR-2021, the patient experienced swollen left armpit and pain in left armpit Patient reported that after covid vaccination in left arm she developed a swollen left armpit and pain in left armpit. Patient had to go to urgent care. The action taken with covid-19 vaccine as26.cov2.s was not applicable. The patient had not recovered from swollen left armpit, and pain in left armpit. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20210313453. Additional information was received from patient on 12/Mar/2021. The following information was updated and incorporated into the case narrative: Patient information (age, age group, weight, height) added, Patient medical history and lab details added.

Started 6 hours after injection and lasted 24 hours that included - Chills, Nausea, Muscle & Joint aches, Severe headache, Fatigue. I didn't take any course of action other than rest and sleep.

Approximately 12 hours after receiving the vaccine I experienced severe chills and couldn't get warm. I didn't take my temperature. The chills lasted approximately 5-6 hours. The day after receiving the vaccine I experienced fatigue and minor muscle aches.

Swollen lymph nodes in neck, stiff and painful neck, headache,fever,chills, Excessive fatigue x 9 days and to present

Fever of 100 for 2 days, muscle pain, chills 1.5 days after shot. swelling and painful arm from shoulder to elbow, bruise a quarter large at injection site for 5 days. Lymph nodes swollen along left clavicle and under arm. Felt fluish. Severe fatigue beginning in evening first day thru morning of 2nd day after shot.

7 hours from vaccine, my heart started palpitating and I started feeling sick. I got in my car to go home from a friends house and started severe chills and called Doctor for fear of heart attack. They told me to go to ER. I continued driving home. Chills got worse. I got in shower with heater on and chills persisted. Drank coconut water and heart palpitations resided. Got in bed and fever spiked to 102 and every bone was inflamed in pain. Nyquil did nothing. After a few hours of severe and unbearable pain I called ER. Headed over to ER at 3:00 a.m. and sat in parking lot. Fever broke at 3:00 a.m. which was hour 14 after vaccine. Other than severe nausea, pain calmed down. Drove home with Tylenol. Took 1,000 mg and finally rested at 4:00 a.m. Woke up at 8:00 a.m. with nausea but pain gone. 24 hours from vaccine, most of the reaction gone. 48 hours out body normal but pain in injection site.

Felt hot within a few minutes after the vaccine, then passed out. The NP on site said she was unable to find a pulse so did 10 chest compressions before I woke up. Called the rescue squad who did an EKG on route to Hospital and once I was in the ER another EKG was performed along with blood work and chest X-ray. Entry was noted as allergic reaction but diagnosis was noted as Vasovagal Syncope, Adult. EKG?s performed along with labs were normal. I have pulled muscles, tendons and ligaments from the chest compressions which were questionable but since that day have experienced tingling in upper body and arms and have felt bad. Went back to my Primary Care Doctor for follow up on March 29 for another EKG. Have had panic attacks from the situation and per Doctor will take 2 months for my chest, muscles, tendons and ligaments to heal. Hard to determine if the way I have felt is from the vaccine or what transacted when I fainted. Today which is April 9, I still feel weak, normally I am very energetic. Just wanted to report as when I saw the news that others had some situations thought best to let you know.

Severe joint pain (like arthritis) in all joints. It is not going away after12 days. Also, severe nerve pain in left side of body. This has never happened to me before.

FEVER; MUSCLE PAIN; FATIGUE; This spontaneous report received from a patient concerned a 60 year old female. 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: 1805025, expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced muscle pain. On MAR-2021, the subject experienced fatigue. On 21-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 38.2 C. On 26-MAR-2021, Laboratory data included: COVID-19 PCR test negative (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, muscle pain and fatigue was not reported. This report was non-serious.

extreme fatigue mild headache muscle pains nausea and vomiting chills taste confusion loss of appetite eye focus issues dizziness brain fog low grade fever sores on tongue lip blisters (Important to note: still experiencing severe blisters on my lips) low energy and fatigue continues day to day

The second day after the shot I was really tired. I also had a strange sensation on my face. A couple of weeks after I started to have insomnia. I kept waking up scared. I started to have a flare up of my Arthritis. I still have feelings of tiredness, headaches and my back has been really flared up. I have a disability with my spine being crooked. The pain has been a lot worse than normal. I have been visiting the Chiropractor frequently three weeks after my shot. I did not have as much back pain before the vaccine.

Patient reports shortness of breath, fevers, chills, diffuse myalgias along with right-sided back and chest pain since receiving the COVID vaccine. Symptoms began a few hours after receiving the vaccine. She reports localized pain to the injection site but denies redness or swelling. She reports she had fevers for 2 to 3 days, highest being of 101. She presented to the ED on 4/10/21 because of worsening shortness of breath with mild cough and pain in her back. This is exertional along with pleuritic. She reports she has overall improved from the myalgias but is generally not feeling well and continues to have dyspnea.

Mild pain and redness at injection site. General wide-spread muscle soreness and fatigue after 12 hours and continuing into second and third day. Symptoms consistent with very mild flu vaccine reaction or very mild case of flu. Symptoms lessening on third day after vaccine with some continued muscle fatigue, particularly after activity.

Extreme chills where my body would not stop shaking, sweats, muscle aches, nausea, bad headache, tired. Took 2 Tylenol every 4-6 hours to help the headache. It lasted until Sunday morning. My nose felt stuffy when I woke up Sunday morning at which time there was blood in my nose. The rest of the day it was clear but a small amount appeared Monday morning as well. Both sides of my temples are sore to the touch as if they were bruised. Other than that and being weak the other symptoms are gone.

Day 1 40min in... intense, in-tense....fiery, pain radiates from-injection. Up neck, across shoulders and down back. In.tense. Fiery. Pain. Just over 1hr very intense bone ache. Not muscle. Bone. Ache. Stop for lunch and find extreme bone ache across collarbone. Intense pain. Like i thought I broke collarbone. On walking in, to order lunch, dizzy and blurred vision. Had to sit awhile to dissipate. 1.5 hrs in Finish eating and spend time breathing thru pain. Vision clear, on my way back to work. Intense pain continues adding, now, itchy across shoulders. Through afternoon increased fatigue and itch. Little better at 4hrs. Day 2 utter fatigue. Want to. S.l.e.e.p. Pain now replaces the burn. Every. Where; ache. Ache. Ache. Day3 fatigue on waking. Pain is now in all joints. Knees hips excruciating. Manage 3hrs household tasks before the fatigue sets in to stop. Awake but still pain in joints. Not ache; pain. Hard to move. Spend afternoon cooking and resting. Soooo exhausted. Day 4-2wks arm still sore and swollen and warm to touch. cannot bear weight in left arm. Cannot use arm to drive. swelling down day 15 still cannot bear weight in left arm. pain continues along pathway of injected drug. burn sensation. now day 17 still cannot bear weight in left arm. If I do I get sudden weakness in arm and pain in back of shoulder.

Within first hour: pain at vaccination site, headache and left neck/shoulder ache, worser headache, numbness and tingling on left side of face and jaw (sort of like novocaine?) spreading down left arm, increasing severity of headache, nausea, tiredness. Throughout pm: chills, body aches, decreasing numbness on left side face/arm, increased fatigue. Took 2 acetamenaphen extra strength Throughout night: severe chills, headache, body and muscular pain. Day 2: frequent and severe chills; mild fever (100.8); severe headache, severe joint, muscle, and body aches (like flu), nausea, severe fatigue. Day 3(today): much fewer chills, decreased nausea, some fatigue, increased pain in back along spine and down legs, cont tylenol xs

Severe vein pain around ankle/lower calf and knee pain, and some swelling. Severe cramping in both legs.

Severe to moderate headache, fever (unknown first night and feverish feeling since), large joint and abdominal pain, very fatigued, thirsty, increasingly redness and tenderness at 8njection site and surrounding area over the past 2 days.

3/22/21: Vaccine administered 4:45 pm. Burning sensation on arms and legs began about 2 hrs later. Achy and feeling cold about 2 hrs after that. Then headache, shaking, muscles quivering, fever, weakness, some itchy spots, increased urination throughout next several hours. Fitbit showed elevated heart rate for several hours. 3/23/21: Nausea and vomiting. Could not keep water down. Very weak/shaky. That night, went to ED. Treated for dehydration and allergic reaction. 3/24/21: Able to tolerate clear liquids. Still weak. 3/26/21: Woke up with rash on both legs (small bumps, not itchy). Added bread to diet. Still weak. 3/29/21: Low grade fever, strong pain in right side of lower back.

headache, left body stiffness and pain, left sided weakness (sensation of body drooping). Strong flu-like symptoms

The patient had burning sensations and increased urination symptoms consistent with a possible urinary tract infection prior to the vaccination that took place on 2 April 2021. A urinary culture was negative on 31 March 2021. A few days after the vaccination, the burning pain and urgency subsided but was replaced by increasing lower abdominal pressure and pain. The patient will see a doctor on 14 April 2021. Other effects observed following the vaccination on 2 April 2021 include: headaches, muscle pain, injection site arm pain, sore throat. These effects resolved within 24 hours after the vaccination with exception of the sore throat which is ongoing.

Headache, neck soreness, Itchy all over, fever, and dizziness. Patient stated the headache started around 1:00pm on 4/12/21 and the itchy all over started about 4:00pm. All other symptoms started later that afternoon. Patient called to report this issue and stated he fever is now gone and so is it itchy all over feeling but the sore neck and dizziness are still present.

Approximately 24 hours after the administration of the vaccine the patient experienced a fever of 110.6, and left work and remained out for 24 hours. The patient proceeded to experience GI symptoms which presented as diarrhea for 10 days post vaccination. The fever resolved after 24 hours. The patient experienced pain in joints, this has continue and not yet resolved, the patient has made an appoint with their primary physician to address the matter. The patient is currently taking ibuprofen to treat the pain.

At time of injection:Burning and pain at injection site 11 hours later:Fever of 101, nausea, stomach pain, chills and other flu-like symptoms Appx. 8-10 days later: terrible deep /aching cramp-like pain in upper left arm. Limited range of motion due to pain. Sporadic head aches-unusual for me as i do not hget headaches unless it's sinus which this isn't.

Ears plugged. Then at 8:45 pm started severe back pain. (Lasted 3 weeks). Headaches off and on. Tired/fatigue.

Starting the 10th, patient has had bad headache, severe muscle pains more than usual, SOB more than normal and severe fatigue. She thought it would go away but the symptoms got worse with each day. No fever. She had been taking Ibuprofen and Tylenol around the clock. Symptoms had not improved Also had been nauseated since Monday 4-12-21. The site was sore and her arm felt heavy and she could hardly lift it.

One week after shot experienced left sided chest pain2/10 progressed to burning in left axils. Fatigue heaviness in bilateral arms and legs. Cold feet. Persistent dull left temporal headache. Felt dizzy and lightheaded in addition on 4/7 went to ER

April 13: Diarrhea, nausea in morning. Fever of 100 at 4 pm, muscle aches. Fever morning of April 14 with Diarrhea, fever gone by 3 pm.

SWOLLEN LEGS AND FEET; ACHES AND PAIN IN NECK; LEGS FELTS TIGHT; FEET FELTS TIGHT; ACHES AND PAIN IN HIPS; ACHES AND PAIN IN ARMS; EXHAUSTED DAY AND NIGHT; This spontaneous report received from a patient via a company representative concerned a 60 year old female. 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 MAR-2021 for prophylactic vaccination. The batch number was not reported and it has been requested. No concomitant medications were reported. On APR-2021, the subject experienced swollen legs and feet. On APR-2021, the subject experienced aches and pains in neck. On APR-2021, the subject experienced legs feel tight. On APR-2021, the subject experienced feet feels tight. On APR-2021, the subject experienced aches and pains in hips. On APR-2021, the subject experienced aches and pains in arms. On APR-2021, the subject experienced exhausted day and night. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the exhausted day and night, aches and pains in hips, swollen legs and feet, aches and pains in arms, aches and pains in neck, legs feel tight and feet feels tight was not reported. This report was non-serious.

My vision had 5-7 water bubbles that appeared with blood-stained edges. They would move as I looked at things for about 10 minutes. Was on a walk and went home and sat in a chair. 4 hours after injection my neck and upper back was killing me. I have had a previous injury from a car wreck 40 hears ago. I slept in the chair that night and the next days on a heating pad. My back felt like a horse kicked me. The next day my eyelids were too heavy to lift for about the duration of a movie. I could not fall a sleep, but could not lift my eyelids. I had vaccination on Friday night. I could not stand any sunlight until Sunday. My sinuses were killing me and the back of the head. On Sunday afternoon I could eat chicken broth and drank lots of water. By Sunday night, I felt fine and ran 5 miles on the treadmill. Feel great now.

initial symptoms- rash, itching, elevated BP, headache, ankle swelling ultrasound on 4/6/2021 - bilateral DVT CBC low platelets - 16 thousand CT chest - moderate burden PE Pt. was hospitalized

Patient's daughter called on her behalf to translate from Spanish. She reported that her mother was having "flu-like" symptoms approximately 3 weeks after receiving the J&J vaccine. She also mentioned that she was having a headache in the back of her head and neck which are known to be possible indication of a cerebral venous sinus thrombosis which has been rarely associated with the J&J vaccine. I advised the daughter to take the mother to the emergency department for further evaluation and she agreed that she would take her right away.

BONE ACHE; BODY ACHES; VERY HIGH FEVER; CRAMPS IN CALVES/LEG CRAMPS MOSTLY INSTEP AND CALVES; MIGRAINE TYPE HEADACHE LIKE STEAK THROUGH THE HEAD; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroid, and seasonal allergy. 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 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced migraine type headache like steak through the head. On 06-APR-2021, the subject experienced cramps in calves/leg cramps mostly instep and calves. On 06-APR-2021 03:00, the subject experienced bone ache. On 06-APR-2021 03:00, the subject experienced body aches. On 06-APR-2021 03:00, the subject experienced very high fever. Laboratory data included: Body temperature (NR: not provided) 101.5 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bone ache, and very high fever on 06-APR-2021, and migraine type headache like steak through the head, cramps in calves/leg cramps mostly instep and calves, and body aches on 07-APR-2021. This report was non-serious.

Felt some irritation near the upper middle of my back my spouse checked it out and it is hard to see.What I can see and my spouse is a 7x7 inch bumps spread across area.Some pain not much itching .I'm postive it's a reaction to shot first time iv ever had this happen.Im very healthy good skin no new products in used.Im feel like it's a reaction.Keeping Close eye on it.Useing hydrocortisone cream at this time.Thank you .I was asked by My local Health Dept to Contact you.

FEELING WOOZY OR DIZZINESS; HEART RACING; FEELING VERY TIRED; HEADACHE; MUSCLE ACHE; ACHY ARM; This spontaneous report received from a patient concerned a 60 year old female. 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 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 achy arm. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced muscle ache. On 10-APR-2021, the subject experienced feeling very tired. On 11-APR-2021, the subject experienced heart racing. On 12-APR-2021, the subject experienced feeling woozy or dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achy arm, and muscle ache on 11-APR-2021, and feeling very tired on 12-APR-2021, and had not recovered from heart racing, feeling woozy or dizziness, and headache. This report was non-serious.

4/8/21- unable to walk with normal stride 4/9/21 severe pain in right hip making it difficult to walk or go up stairs 4/10/21 morning - unable to walk at all. Called my doctor, who after discussion, prescribed 5 days of prednisone for severe inflammatory response 4/11/21 able to walk again and complete course of steroid. 4/16/21 some inflammation in joints and hip persists.

All symptoms for up to 10 days after vaccination: pain at injection site; muscle aches around neck/shoulders; chills; malaise; stuffy nose/sinus problems; blood while blowing nose; all over body aches; excessive sneezing; watery eyes; brain fog; tongue/gum swelling; shortness of breath; throat tightening; acne; fleeting stomach pain; sore sternum.

FEELING WEAK; MUSCLE ACHE; FEVER (101.4 F); FLU-LIKE SYMPTOMS; ACHY BODY; PAIN IN ARM; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced flu-like symptoms. On 08-APR-2021, the subject experienced achy body. On 08-APR-2021, the subject experienced pain in arm. On 08-APR-2021, the subject experienced fever (101.4 f). Laboratory data included: Body temperature (NR: not provided) 101.4 F. On 09-APR-2021, the subject experienced feeling weak. On 09-APR-2021, the subject experienced muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever (101.4 f) on 09-APR-2021, had not recovered from pain in arm, flu-like symptoms, achy body, and feeling weak, and the outcome of muscle ache was not reported. This report was non-serious.

SORE KNEE; SORE THUMB; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's past medical history included breast cancer, mastectomy, chemotherapy, and radiation, and concurrent conditions included arthritis, cigarette smoker, abstains from alcohol, and chest tightness, and other pre-existing medical conditions included patient received injection for her arthritis in her back last month. The patient experienced drug allergy when treated with codeine, and paracetamol for drug used for unknown indication. 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 12-APR-2021 18:30 for an unspecified indication. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced sore knee, and sore thumb. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore knee, and sore thumb. This report was non-serious.

I took 1 Benandryl about 1 hour before the injection of the vaccine prior to leaving my home. My son took me as I would anticipate some type of reaction given my history. J&J was the one my doctor recommended in hopes that I could handle the response better and only need 1 dose. I had options to get pfizer or moderna, but my dr wanted J&J so I waited several weeks longer to get this one. Within 10 minutes of having the injection, my ears swelled up, and felt like I was on a bad plane and could not burst clear. Then my throat on left side, the same side I got the shot swelled. My face was full of red and rash and my son mentioned he was concerned how I looked. I told him my symptoms and then took another Benadryl before we left the store. I told the pharmacist that I was having a reaction, they wanted to call 911-I said please no. I am used to having reactions and would want to see if I can manage it with Benadryl at home. I came home and took my Alegra (as I take my alegra at night before bed to help with congestion). Going forward every 2-3 hours I would take another benadryl rotating the time frames and slept as much as possible. It took several hours for the swelling to subside, longer than I was used to. Over the next several days, I would have times when my ears, throat would swell, my face would be red and rashed, especially at night my face will get red, rash and ears and throat swell late at night. It waxes and wains depending on how I feel. After the main allergic reaction of 12-24 hours later, I stared with the COVID symptoms, fever, chills, body ache, the joints that I have trouble with hurt so much more (knee, foot, arms, hands) I was so thankful I did not catch COVID. I don't think I would have survived. On Friday, March 19, 2021 was the first day I started to feel better except for the late night episodes of allergic reaction. I take Alegra or when needed Benadryl. It seems to lower my swelling response.

SWELLING ON THE SIDE OF LEFT NECK; DIFFICULTY SWALLOWING; HANDS AND FEET FREEZING FOR A LONG TIME; CHILLS AND SHIVERING; SUSPECTED FEVER; HEADACHE; NAUSEA DRY HEAVES; DEHYDRATED; THIRSTY; QUATER SIZE KNOT IN LYMPH GLAND AND SWELLING; FAST HEART BEAT; THROAT TIGHTNESS; ACHYNESS JOINT PAIN; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight was 190 pounds, and height was 155.44 centimeters. The patient's past medical history included covid-19 infection, and concurrent conditions included alcohol use, non smoker, allergy to animal, dust allergy, ragweed allergy, mold allergy, asthma, copd, joint pain, joint swelling, fibromyalgia, osteoarthritis, and drug allergy to tenormin somac metrogel amoxicillin, and other pre-existing medical conditions included the patient had no illness at time of vaccination. the patient had no past history of similar events. the patient had no pre-existing acute illness in 30 days prior to vaccination. the patient had no hospitalization in last 30 days prior to vaccination. the patient had no family history of any disease or allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072 expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. Concomitant medications included ascorbic acid/ergocalciferol/folic acid/nicotinamide/panthenol/retinol/riboflavin/thiamine hydrochloride for drug used for unknown indication, budesonide/formoterol fumarate for drug used for unknown indication, and for drug used for unknown indication. On 30-DEC-2020, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On MAR-2021, the subject experienced dehydrated. On MAR-2021, the subject experienced thirsty. On MAR-2021, the subject experienced quarter size knot in lymph gland and swelling. On MAR-2021, the subject experienced fast heart beat. On MAR-2021, the subject experienced throat tightness. On MAR-2021, the subject experienced achyness joint pain. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced nausea dry heaves. On 17-MAR-2021, the subject experienced suspected fever. Laboratory data included: Body temperature (NR: not provided) 99.4 deg. On an unspecified date, the subject experienced swelling on the side of left neck, difficulty swallowing, hands and feet freezing for a long time, and chills and shivering. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills and shivering, headache, nausea dry heaves, dehydrated, thirsty, achyness joint pain, fast heart beat, and throat tightness, had not recovered from quater size knot in lymph gland and swelling, and the outcome of swelling on the side of left neck, difficulty swallowing, hands and feet freezing for a long time and suspected fever was not reported. This report was non-serious. Additional information was received from patient on 16- APR-2021. The following information was updated and incorporated into the case narrative: Patient age group, medical history(alcohol use, non smoker, allergy to animal, dust allergy, ragweed allergy, mold allergy, asthma, COPD, joint pain, joint swelling, fibromyalgia, osteoarthritis, and drug allergy to tenormin somac metrogel amoxicillin), events( chills and shivering, headache, nausea dry heaves, dehydrated, thirsty, achyness joint pain, fast heart beat, and throat tightness, quarter size knot in lymph gland and swelling), outcome updated, causality; Sender's Comments: This case was non serious

Rapid heartbeat 24 hours severe stomach pain two weeks muscle and joint pain two weeks extreme high blood pressure two weeks. Extreme fatigue two weeks. The vaccine triggered an auto immune response. It triggered a flareup in my body and I was very ill for several weeks. Because of my severe stomach pain and blood pressure soaring my doctor ordered a CAT scan and blood work up. I am now three weeks post vaccine and my body seems to be calming down my blood pressure has returned to normal and the stomach pain has stopped. The extreme fatigue muscle and joint pain is still present but much better.

HIGH BLOOD PRESSURE; PULSE PRESSURE OF 106; FEELING OF FLUSH; DELTOID/SHOULDER SITE SORENESS; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included no-smoker, and non-alcoholic, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting, the patient had no known allergies and the patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the patient experienced feeling of flush (she stated that it felt like a heat coming through), high blood pressure of 103/101 (units unknown) and pulse pressure 106 (units unknown). She also experienced the deltoid/shoulder site soreness which lasted for 1 to 2 days. On an unspecified date she went to emergency room, she had blood pressure 240/140: high (units unknown) and pulse pressure (units unknown). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from deltoid/shoulder site soreness on 13-APR-2021, was recovering from feeling of flush, had not recovered from high blood pressure, and the outcome of pulse pressure of 106 was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0; 20210430543-covid-19 vaccine ad26.cov2. s-High blood pressure 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.

HIGHER LEVEL OF PAIN (EXTREME PAIN) IN THE SHOULDER AND IN UPPER ARM; LACK OF MOBILITY IN THE SHOULDER AND THE UPPER ARM OF THE INJECTED SITE; FROZEN SHOULDER; HIGHER LEVEL OF PAIN (EXTREME PAIN) AT THE LOCATION OF INJECTION; SORE ARM; LITTLE FATIGUE; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included immune thrombocytopenic purpura, 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: 1805022, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced sore arm. On 01-APR-2021, the subject experienced little fatigue. On 24-APR-2021, the subject experienced higher level of pain (extreme pain) in the shoulder and in upper arm. On 24-APR-2021, the subject experienced lack of mobility in the shoulder and the upper arm of the injected site. On 24-APR-2021, the subject experienced frozen shoulder. On 24-APR-2021, the subject experienced higher level of pain (extreme pain) at the location of injection. Laboratory data (dates unspecified) included: Platelet count (NR: not provided) Platelet count before the vaccination was 40. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little fatigue on 03-APR-2021, and had not recovered from sore arm, higher level of pain (extreme pain) at the location of injection, lack of mobility in the shoulder and the upper arm of the injected site, higher level of pain (extreme pain) in the shoulder and in upper arm, and frozen shoulder. This report was non-serious.

On and off symptoms include: light headedness, light weakness/tingle on the underside of my left arm, on and off achey weakness in right hand too. It started on day 12, 13, 15 (up to two weeks after vaccination). Symptoms went away and returned at night on April 27 and throughout the day on April 28, 2021. I was borne with mitral valve prolapse (no work/life restrictions) and wondered if the vaccine has any connection to the mitral valve prolapse.

LEG SWOLLEN; CANNOT PUT PRESSURE ON FOOT, WALKS ON TIP TOES; TENDERNESS ON OUTSIDE OF LEFT LEG; PAINFUL KNEE/LEG; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included blood pressure abnormal, knee disorder, and hand arthritis. 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 30-MAR-2021 for prophylactic vaccination. Concomitant medications included methotrexate for hand arthritis, and acetylsalicylic acid. On 10-APR-2021, the subject experienced leg swollen. On 10-APR-2021, the subject experienced cannot put pressure on foot, walks on tip toes. On 10-APR-2021, the subject experienced tenderness on outside of left leg. On 10-APR-2021, the subject experienced painful knee/leg. On 14-APR-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) No blood clots. On 20-APR-2021, Laboratory data included: Blood test (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tenderness on outside of left leg, painful knee/leg, leg swollen, and cannot put pressure on foot, walks on tip toes. This report was non-serious.

Janssen COVID-19 Vaccine EUA 24 hours of SEVERE pain in every muscle and especially neck, eyes, head, face, jaw. Also fever, nausea, vomiting, inability to sleep, intense tiredness. After 24 hours, all symptoms continued but were milder for 2 more days. Couldn't eat at all for 3-4 days.

Patient experienced extensive joint pain. She stated the doctor diagnosed her with inflammation on the left bone marrow. She now has stress fracture in the right foot.

Migraine headache for a week, had a MRI of the brain to rule out blood clots. A torn rotor cuff that happened 10 years ago that was a no issue, became very painful and inflamed to the point of needing a Cortisone shot and MRI to see what is going on.

I felt fine after the vaccine and I took a walk. Three hours later I got a massive headache. I was nauseous with vomiting and diarrhea. I felt like had bubbles going up my spine when I was lying down about a week after the vaccine. The nausea and vomiting went on for ten hours. After five weeks my arm is still a little slow I still have headaches intermittently, and sometimes daily.

4/6/2021 vaccination. Within an hour, I had hives .5", and spread to smaller all over body. I had a hard time breathing. I was fine for the first 15 minutes. I started to get itchy, neck started to hurt. My head was all broken out. All down my legs. An hour or 2 later is when it started to itch really bad. Burning going down my arm. I went to work and worked rest of the day, hard time breathing. I had major stomach ache. I couldn't eat. The HA kicked in and had asthma attack. Fever started; 102. Stomach cramps. HA was severe for quite a while. Seven days later, I called my doctor. 4/13/2021 Saw PCM; Pneumonia and sinus infection. Put on upper respiratory medication; Sefedna. *Migraine for 12 days, became a HA for almost a whole month. 102 FEVER lasted 7 days vomiting for 2.5 weeks body aches, chills, teeth chattering; first 2 days extreme fatigue 4/12 or 4/19 (?); COVID + *still experiencing muscle and joint pain *felt like breathing bleach whole time

Janssen COVOD-19 Vaccine EUA. I had a fever, terrible headache, muscle aches, tired, chills, soreness in upper abdomen and not being able to take a very deep breath. These lasted for a little over 24 hours, but I still have some tenderness in upper abdomen and cannot take a deep breath.

Fatigue, HA and migraine, neck pain, body aches, diarrhea that have lasted 4 days. Pt has taken Tylenol, Meloxicam, and Sumatriptan with mild improvement after medication but HA returns later. Diarrhea has improved. No improvement in body aches or fatigue

I woke up Wednesday and I felt like I was hit by a train. I felt like a wet dish rag hanging on the sink. Everything hurt, even taking a step, I just felt bad, tired like the flu but no respiratory issues. By the 14th I started getting short of breath, couldn't walk without SOB, my legs started to swell, joints were sore, I felt tired. Went to the doctor and my blood pressure was high, I was prescribed medication for my blood pressure and fluid pills. It hurt just to brush against the skin on my calf. An ultrasound revealed 4 blood clots in my left calf. Went to the ER at . Hospital in and sent to hematologist Dr. and there were no findings.

HIGH BLOOD PRESSURE; HIGH PULSE RATE; BODY ACHE; BACK ACHE; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 60 year old female. 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: 1816027, and batch number: 1816027 expiry: UNKNOWN) dose was not reported, administered on 17-MAY-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 17-MAY-2021, the subject experienced headache. On 17-MAY-2021, the subject experienced fever. Laboratory data included: Blood pressure (NR: not provided) 103/69, 102/68, and Pulse rate (NR: not provided) High. On 17-MAY-2021 14:00, the subject experienced high blood pressure. On 17-MAY-2021 14:00, the subject experienced high pulse rate. On 17-MAY-2021 14:00, the subject experienced body ache. On 17-MAY-2021 14:00, the subject experienced back ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, high blood pressure, high pulse rate, fever, body ache, and back ache. This report was non-serious.

I am filling out this report today because I received a follow up call from the website because I had reported loss work, loss of job, loss of activity and visits to doctors. I received the vaccine on March 12, 2021, I started having arm and shoulders symptoms the day after getting the vaccine but did not feel well that first night while trying to sleep. The symptoms worsened every day, I am in week 11 post vaccination. I have had 22 medical appointments with 3 to PCP, 13 to Physical Therapy who diagnosed left bicep tendinitis and shoulder impingement many weeks ago, 4 to acupuncture, and 1 to xray. This Thursday I finally get an MRI. I lost my job on week 7 after the vaccine, I can barely use my left arm, I live alone, I am exhausted and spend much time chasing a diagnosis or help in resolving this issue. I reported to website every time the link was sent to me. I called the Pharmacy on Day 3 and called Janssen hotline on Day 3 to report a reaction. I wrote to my doctor on Day 5 to say something was not right. By the next day I had an injection site reaction, very hard swelling in my arm, a dark red jagged surface reaction at the injection site now there is a divot there. Feeling very unwell, aches and pains, no fever. I had bad abdominal cramps that night after the injection, diarrhea for days, arm pain with swelling, joint pain in shoulder, knee, and fingers, and a rash across my back, I had to continue to work, typing fast 9 to 10 hours a day, I am a self-employed contractor doing tax technical support and the pain in my arm grew worse daily, I was in tears trying to work. Sitting to type, to read, to drive is the worse. I can dictate into my devices but not rapidly enough for the level of my work. The worse pain in my arm and shoulder is less by avoiding typing and driving but the injury is still there. The pain is constant even without movement.

POSSIBLE SMALL STROKE; POSSIBLE TRANSIENT ISCHAEMIC ATTACK (TIA); SUPER DIZZY; THROWING UP; COULD NOT OPEN EYES; WIERDLY AND EXCEEDINGLY THIRSTY; COULD NOT WALK; NUMBNESS IN LEFT ARM; COULD NOT STAND; HEAVINESS IN LEFT ARM; NAUSEOUS; HEADACHE; FELT LIKE HAD CHILLS LIKE ONE GETS FROM THE FLU; This spontaneous report received from a patient concerned a 60 year old White, Not Hispanic or Latino female. The patient's weight was 175 pounds, and height was 65 inches. The patient's concurrent conditions included slightly elevated blood pressure, alcohol user socially and on weekends, non smoker, and penicillin allergy since childhood. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, expiry: UNKNOWN) dose was not reported, 1 total, administered on 08-MAR-2021 for prophylactic vaccination. Concomitant medications included valsartan for elevated blood pressure, acetylsalicylic acid, and furosemide. On 10-MAR-2021, the patient felt like having chills like getting from the flu, for couple of hours might be, a headache for several days, might be for 3 days. For that the patient took some Advil 200 mg every 6 hours for the first couple of days. Then that passed and felt fine. On 24-APR-2021, around 04:00 in the morning the patient woke up and felt weirdly thirsty, exceedingly thirsty and super dizzy, nauseous thought was having a heart attack and heaviness and numbness in left arm but could still move the arm, however could not walk and could not open eyes until was in hospital. As a treatment Aspirin was given to the patient by husband. The patient was throwing up, could not stand. About 05:30 went to the hospital and ran many tests. Ruled out brain bleed, heart attack, anything cardiac did a CAT scan; bloodwork found that the patient was low in potassium and it was determined that the patient either had a small stroke or a TIA that dissipated on its own. The patient saw her cardiologist and wore a Holter monitor for 10 days. The patient also has an appointment with a neurologist coming up in June and having another CAT scan. Also seeing a vascular neurologist. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from possible small stroke, possible transient ischaemic attack (TIA), super dizzy, could not open eyes, wierdly and exceedingly thirsty, could not walk, throwing up, numbness in left arm, could not stand, heaviness in left arm, and nauseous on 2021, felt like had chills like one gets from the flu on 10-MAR-2021, and headache on MAR-2021. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: covid-19 vaccine ad26.cov2.s-Possible small stroke, Possible transient ischaemic attack , super dizzy, could not open eyes, wierdly and exceedingly thirsty, could not walk, throwing up, numbness in left arm, could not stand, heaviness in left arm. These events are considered unassessable. The events 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 events. covid-19 vaccine ad26.cov2.s-Nauseous. This event is labeled per RSI and is therefore considered potentially related.

Arm hurt as soon as I got the injection. The next day and every since. I have headaches. Awful neck pain,weakness,tired, coughing, pain in back. Using Tylenol doesn't help much..I will feel fine for a day then it comes back

Site: Pain at Injection Site-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Tinnitus-Medium, Additional Details: The patient reported left shoulder pain that radiated up her neck, with tinnitus in the left ear and chest tightness that has not resolved since getting the vaccine

I noticed a large lump, it started as a rush that was itchy and painful. I had some joint and muscle pain. The lump is still there and painful. I did have diarreha and fatigue.

When I received the shot I had no reaction at all not even a sore arm. Within a few days I started getting terrible pains in the calves of my legs. Then a few days later I got a purple line on my right calf that was painful. The next day I had 3 big yellow spots on the same leg. They went away in 2 days which I thought was odd. Next day I got a very large bruise at the vaccine location. After that I started with pains in all of my joints. Ever since then I have been having pains in all my joints. The pain level is not going away and has been getting worse

ABDOMINAL CRAMPING; EXTREME CHILLS; SHOULDER PAIN IN BOTH SHOULDERS; REALLY BAD HEADACHE; This spontaneous report received from a patient concerned a 60 year old female. 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: 042A21A expiry: UNKNOWN) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUN-2021, the subject experienced abdominal cramping. On 02-JUN-2021, the subject experienced extreme chills. On 02-JUN-2021, the subject experienced shoulder pain in both shoulders. On 02-JUN-2021, the subject experienced really bad headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from abdominal cramping, and had not recovered from extreme chills, really bad headache, and shoulder pain in both shoulders. This report was non-serious.

PAINFUL RASH ON RIGHT ARM AND HAND, LEFT ARM, LEGS, HEAD,BACK,FACE; WEAKNESS; HEADACHE SO BAD LIKE A MIGRAINE; FEVER; MUSCLE ACHE; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight was 189 pounds, and height was 64 inches. The patient's concurrent conditions included cancer, thyroid and other pre-existing medical conditions included patient receives steroid knee injection, left knee only every 3 months. 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 21-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included anastrozole for cancer, ibuprofen for drug used for unknown indication, and paracetamol for drug used for unknown indication. On 22-MAR-2021, the subject experienced weakness. On 22-MAR-2021, the subject experienced headache so bad like a migraine. On 22-MAR-2021, the subject experienced fever. On 22-MAR-2021, the subject experienced muscle ache. On 04-APR-2021, the subject experienced painful rash on right arm and hand, left arm, legs, head, back, face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from weakness, and fever on 26-MAR-2021, and headache so bad like a migraine, and muscle ache on 25-MAR-2021, and was recovering from painful rash on right arm and hand, left arm, legs, head, back, face. This report was non-serious.

I had leg pain, lymph nodes were swollen on the left side, pain down the right arm and tingling in my fingers, dizzy spells, back and head pain.

I had a flare up of rheumatoid arthritis. I haven't been able to use my body to its full potential. My right arm is affected. The more I try to do the more my body will start to hurt.

Right Hand and Arm feels tingling numbness ichy and major weakness. At times feels as though hand and arm are asleep. Lost functionality in hand at times.

LIGHTHEADEDNESS/DIZZINESS; MUSCLE CRAMPS/CRAMPING IN ARMS AND LEGS; ABDOMINAL PAIN (DESCRIBED AS LABOUR PAIN)/ STOMACH MUSCLES SORENESS; FELT WARM WITH NO FEVER; BURPING; DIFFICULTY IN SLEEPING; CHILLS; SORE ARM PAIN; BACK PAIN; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's past medical history included bronchitis, and concurrent conditions included diabetes, and bipolar disorder. The patient experienced drug allergy-rash when treated with sulfamethoxazole/trimethoprim. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: FC 202A21A expiry: 07-AUG-2021) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-JUN-2021, the subject experienced back pain. On 07-JUN-2021, the subject experienced sore arm pain. On 16-JUN-2021, the subject experienced muscle cramps/cramping in arms and legs. On 16-JUN-2021, the subject experienced abdominal pain (described as labour pain) / stomach muscles soreness. On 16-JUN-2021, the subject experienced felt warm with no fever. On 16-JUN-2021, the subject experienced burping. On 16-JUN-2021, the subject experienced difficulty in sleeping. On 16-JUN-2021, the subject experienced chills. On 17-JUN-2021, the subject experienced lightheadedness/dizziness. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle cramps/cramping in arms and legs, abdominal pain (described as labour pain)/ stomach muscles soreness, and difficulty in sleeping on 16-JUN-2021, and back pain, burping, chills, and sore arm pain on 17-JUN-2021, and had not recovered from lightheadedness/dizziness, and felt warm with no fever. This report was non-serious.

Get tire extremely fast when walking daily Shortness of breath daily Swollen ankles daily Headaches every morning when I wake up Pressure in left eye often Body was cold the night of the vaccine

patient presented to ER with myalgias/arthralgias, flu like symptoms including fever, congestion, sore throat. Pt had COVID vax 6/9. In ER, noted to have leukocytosis of 36k with neutrophil predominance. Admitted and no infectious source identified. COVID negative on 6/22. Pt transferred to higher level of care due to concern for hematologic malignancy. All tests unremarkable so far. Ferritin was > 11k. Pt case reviewed by rheumatology who suggested adult onset Still's disease which could be vaccine related. Starting Anakinra asap in effort to see improvement

Patient states that arm has been sore to use since receiving the vaccine; NO redness, rash, warmth to touch or lump or swelling; she states it is sore upon waking in the morning and the stiffness lesses slightly as the day progresses but is sore all day sometimes she has issues gripping & moving arm front to back but not as much soreness raising arm upwards; she was advised by her prescriber to have pharmacy report

Normal side effects at first. 72 hours after shot extreme pain in joints. Pain resolved everywhere but forearms, wrists, and hands. Currently, blood pooling in thumb joints, tenderness in wrists and fingers, stiffness in hands wrists, and forearms. Heat and sense of hardness in veins. Veins sticking out in forearms and thumbs. 13 weeks since vaccination. Primary Care physician unresponsive. Limited use of hands. Psychological despair setting in.

BLOODY STOOL; INFLAMED BURSA OF LEFT HIP, RADIATING TOWARDS SPINE; ARTHRALGIA; MYALGIA; SLIGHTLY LOW KIDNEY FUNCTION; FATIGUE; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroidism. The patient had no known allergies. The patient was previously treated with cortisone in shoulder joint. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, 1 total, administered on 16-MAR-2021 on right arm for prophylactic vaccination. Concomitant medications included ascorbic acid, calcium, chondroitin sulfate/glucosamine hydrochloride, colecalciferol, levothyroxine sodium, and magnesium. In the morning of 17-MAR-2021, the patient felt some fatigue, stayed in bed until noon and fatigue disappeared in the afternoon. On 07-APR-2021, the patient started experiencing pain and soreness in hamstring, behind knees and in hips. The pain and soreness gradually progressed upwards towards spine. The symptoms were worse in the morning and evening, with the period between noon and 8 PM saw some improvement. Since pain and soreness started, the patient had been taking painkillers like candy, Tylenol (paracetamol), Advil (ibuprofen) and Aleve (naproxen sodium) and had no effect on symptoms. On 21-APR-2021, the patient had some bloody stool and saw primary care physician that week. The blood tests, bone density and thyroid function were done. Only finding of note was slightly low kidney function and diagnosis of myalgia and arthralgia. The patient was told to discontinue painkiller use. On 12-JUN-2021, the patient saw orthopedist, was diagnosed with inflamed bursa on the left hip, radiating towards spine and was prescribed a 5 days tapering course of prednisone. The symptoms disappeared starting on the second day of prednisone. The symptoms reappeared with same severity 2 days after stopping prednisone (19-JUN-2021). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bloody stool on 21-APR-2021, and fatigue on 17-MAR-2021, had not recovered from inflamed bursa of left hip, radiating towards spine, myalgia, and arthralgia, and the outcome of slightly low kidney function was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210660357-covid-19 vaccine ad26.cov2.s- bloody stool, slightly low kidney function. 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).

Within the first 6 days after taking the vaccine a bump appeared on the right thumb. Chronic pain increased, right shoulder, wrist and elbow sore. Has a cough currently.

FEELING WARM AND COLD; SEVERE CHILLS(EXTREME COLD); FEVER; MUSCLES PAIN; HEADACHE; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight was not reported and height was 66 inches. 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: 1808978, 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 feeling warm and cold. On 25-MAR-2021, the subject experienced severe chills (extreme cold). On 25-MAR-2021, the subject experienced fever. On 25-MAR-2021, the subject experienced muscles pain. On 25-MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 103 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling warm and cold, severe chills(extreme cold), fever, muscles pain, and headache on 26-MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210663913.

4 months of new arm, shoulder and hand pain following vaccination with swelling and redness for 1month. Entire shoulder girdle burns and aches. Strong inflammatory reaction started on first night with many varied reaction symptoms for 10 days. Arm and shoulder pain remained and got worse daily for months, I now have nerve damage, weakness and loss of function. MRI showed damage, tendonitis, tears and much more, pain was severe for first 7 weeks, then I lost my job, I could no longer type for 10 hours a day. The pain progressed to pronounced weakness and poor coordination. Difficult to sleep for 4 months now. A steroid injection given for chemical bursitis by an orthopedic doctor did not help. Physical therapy, acupuncture and a home TENS unit have helped, progress of injury healing and nerve enervation is very slow. High medical costs. Symptoms are similar to Parsonage Turner syndrome, but two doctors said shot was given incorrectly, low and too deep, so possible SIRVA, or both. I progressively worsened for 4 months, now I am in slow recovery but I fear it will go on for years. This has affected all areas of my life. It has been difficult to get medical care and to care for myself. I live alone, there are so many things I can no longer do. I was self-employed, now I have no income and have lost full use of my left arm.

Immediately arm felt heavy but went away later. 5 to 7 days later covered with bumps and became nonstop itching, bruise easy

Strong headache and neck paon after two weeks of vaccination. Burning eyes. Leg pain. Difficulty to focus. Mind foggy. Tested for antibodoes for covid and vaccone resulted negatives after one month of vacconation and then again after 3 monthz. However had high autoinmune response. Headache and neck pain continued. Had N mri and neurologiat evaliation but nothing founf. Headaxhe continued and leg pain and stiffness also. Now also continuous ringing in my ears abd hot ears. Veins in my arm are unusually darker abd more visiblw.

The patient was given the Janssen Covid vaccine on 7/1/21 and she called in on 7/15/21 to report her adverse event. She said she had been having awful shoulder pain ever since receiving the vaccine and it continued to get worse. She went to see her Doctor on 7/15/21 and received and x-ray and prescriptions for oral steroids and an NSAID gel. She said her Doctor diagnosed her with a vaccine related shoulder injury. The results of the x-ray are unknown as of now and the medication was just started today. I told her I would be filling out reports on the incident and that I would check back with her in a few days to see if the medication was helping.

The injection was given into the shoulder joint rather than the deltoid muscle. This has resulted in an inflammatory process that has caused pain and injury to my left shoulder (e.g., tendons, ligaments, bursae, nerves). I now have persistent shoulder and upper arm pain, weakness, and limited range of motion that has worsened in the two weeks following the injection. I am dealing with chronic shoulder and upper arm pain, and am unable to carry out daily activities that were not an issue prior to vaccination. When the symptoms did not subside, I sought medical treatment from my primary care provider on July 15, 2021.

LEFT EYE COVERED WITH VASELINE MUCOUS; DOUBLE VISION; FOGGY VISION/ EYE GLASSES DON'T WORK AS WELL FOR LEFT EYE; MUSCLE SPASMS; WATER RETENTION; DISCOMFORT; CRACKLES IN LUNG; SLEEP FOR LONGER THAN 2 TO 3 HOURS; WEIGHT GAIN; RIGHT FORE ARM BRUISE; BACK PAIN AND PRESSURE; BACK FREEZING UP; PAIN AT THE DIAPHRAGM; FELT SLEEPY; FELT REALLY HOT IN NECK; HEART BEATING REALLY FAST; FELT REALLY WEIRD; SWOLLEN AND RED FACE/ PUFFING UP LITTLE BIT; TROUBLE BREATHING; UNWELL FEELING (GROSS AND CRAPPY); ALLERGIC REACTION; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight was 150 pounds, and height was 64 inches. The patient's concurrent conditions included alcohol user, and non-smoker, and other pre-existing medical conditions included caller stated that she does not have any chronic medical conditions. she takes 2-2.5 mg ativan daily, she stated this is half of the dose she was on 1 year ago. Patient had no any drug abuse/ illicit drug use. The patient experienced drug allergy when treated with medroxyprogesterone acetate. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022, and expiry: UNKNOWN) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. Concomitant medications included diazepam, ketorolac tromethamine, and paracetamol. On 27-MAY-2021, the subject experienced felt sleepy. On 27-MAY-2021, the subject experienced felt really hot in neck. On 27-MAY-2021, the subject experienced heart beating really fast. On 27-MAY-2021, the subject experienced felt really weird. On 27-MAY-2021, the subject experienced swollen and red face/ puffing up little bit. On 27-MAY-2021, the subject experienced trouble breathing. On 27-MAY-2021, the subject experienced unwell feeling (gross and crappy). On 27-MAY-2021, the subject experienced allergic reaction. On 10-JUN-2021, the subject experienced back pain and pressure. On 10-JUN-2021, the subject experienced back freezing up. On 10-JUN-2021, the subject experienced pain at the diaphragm. Laboratory data included: CT scan (NR: not provided) Normal, Chest X-ray (NR: not provided) Normal, Laboratory test abnormal (NR: not provided) unknown, and Pain scale (NR: not provided) 9/10. On 08-JUL-2021, the subject experienced right fore arm bruise. On 09-JUL-2021, Laboratory data included: Spine X-ray (NR: not provided) could not find anything in the series. On an unspecified date, the subject experienced left eye covered with vaseline mucous, double vision, foggy vision/ eye glasses don't work as well for left eye, muscle spasms, water retention, discomfort, crackles in lung, sleep for longer than 2 to 3 hours, and weight gain. Laboratory data (dates unspecified) included: Pain scale (NR: not provided) 8-10/10, and Water retention (NR: not provided) gained 25 pounds. Treatment medications (dates unspecified) included: lorazepam, succinate sodium, methylprednisolone, methocarbamol, naproxen sodium, and methylprednisolone sodium succinate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen and red face/ puffing up little bit, and trouble breathing on 27-MAY-2021, and left eye covered with vaseline mucous, double vision, and foggy vision/ eye glasses don't work as well for left eye, had not recovered from back pain and pressure, back freezing up, pain at the diaphragm, right fore arm bruise, water retention, and weight gain, and the outcome of felt sleepy, felt really hot in neck, heart beating really fast, felt really weird, unwell feeling (gross and crappy), crackles in lung, sleep for longer than 2 to 3 hours, allergic reaction, muscle spasms and discomfort was not reported. This report was non-serious.

CHEST X-RAY; ELECTROCARDIOGRAM; NUMBNESS IN RIGHT ARM; TINGLING IN RIGHT ARM; COMPUTERISED TOMOGRAM; ULTRASOUND SCAN ABNORMAL; HYPERTENSION; SKIN SENSITISATION; ARTHRALGIA; PAIN; FATIGUE; PERIPHERAL SWELLING; DEEP VEIN THROMBOSIS; PULMONARY EMBOLISM; GAIT DISTURBANCE; FEELING ABNORMAL; DYSPNOEA; INFLUENZA LIKE ILLNESS; MALAISE; This spontaneous report received from a patient via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (ID: 1331063) concerned a 60-year-old female. The patient's height, and weight were not reported. The patient's past medical history included degenerative disc disease (neck surgery (four discs repaired), and knee replacement, and concurrent conditions included fibromyalgia, and arthritis. The patient had no known allergy and current illness at the time of vaccination. The patient received covid-19 vaccine ad26.cov2. s (suspension for injection, route of admin not reported, batch number: 1802072, and expiry: UNKNOWN) dose was not reported, 1 total administered on 08-MAR-2021 15:00 at right arm for prophylactic vaccination. Concomitant medications included diclofenac, ibuprofen, oxycodone hydrochloride/paracetamol. The patient woke up and felt like she was hit by a train (feeling abnormal) and felt crappy for next 3-5 days, everything was hurting (malaise), even taking a step. She experienced gait disturbance, patient felt bad, tired like the flu (influenza like illness) but does not had respiratory issues. On 12-MAR-2021, she had dyspnea. Patient started symptoms shortness of breath, could not walk without SOB (Shortness of Breath), her legs started to swell (Peripheral swelling/edema), joints were sore/pain (arthralgia), she felt tired (fatigue). On 23-MAR-2021, she visited doctor with high blood pressure (hypertension) and edema, she was prescribed medication for blood pressure and fluid pills (unspecified). Four days later, her legs were swollen bigger, and the PCP switched the medication. It hurt to brush against the skin on her calf (skin sensitization). The patient was diagnosed 4 blood clots (thrombosis) in left calf by ultrasound scan. She ended up in the emergency room the following day, and Computerized tomogram scans were performed and they found pulmonary embolisms in the lower lobes of both lungs. The patient was also diagnosed with electrocardiogram, computerized tomogram, Blood test and chest x-ray. Laboratory data included: Computerized tomogram (NR: not provided) pulmonary embolisms in the lower lobes of both lungs, and Ultrasound scan (NR: not provided) 4 clot on left calf (abnormal). She has been taking Xarelto ever since. In JUN-2021, she said that she began feeling tingling numbness in her right arm, from her elbow to her fingertips. It tingles most of the day and wakes her up at night. Patient was on blood thinners. Laboratory data (dates unspecified) included: Blood test (NR: not provided) unspecified, Chest X-ray (NR: not provided) Not reported, and Electrocardiogram (NR: not provided) not reported. Treatment medications (dates unspecified) included: rivaroxaban. The action taken with covid-19 vaccine ad26.cov2. s was not applicable. The patient recovered from feeling abnormal, had not recovered from deep vein thrombosis, skin sensitization, peripheral swelling, pain, malaise, influenza like illness, hypertension, gait disturbance, fatigue, dyspnea, arthralgia, chest x-ray, computerized tomogram, electrocardiogram, and ultrasound scan abnormal, and the outcome of pulmonary embolism, numbness in right arm and tingling in right arm was not reported. This report was serious (Other Medically Important Condition). This case is a duplicate of 20210538232. Additional information was received from patient on 13-JUL-2021. The following information was updated and incorporated into the case narrative: reporter details (first and last name, address, city, zip code, office, email address), Updated disease start date (degenerative disc disease and knee replacement), Events added (pulmonary embolism, numbness in right arm and tingling in right arm), updated event (thrombosis to deep vein thrombosis), Updated event onset date (deep vein thrombosis, ultrasound scan and computerized tomogram) updated lab dates(ultrasound scan and computerized tomogram), updated lab result(computerized tomogram), Added vaccination time and treatment drug(Xarelto) and vaccine facility details (vaccine facility name, city and military information) Upon review following information was amended: Removed partial date (2021) of event Electrocardiogram and lab test (chest x-ray, electrocardiogram and blood test). Additional information was received from patient on 13-JUL-2021. It was determined that (20210538232) was a duplicate of this case. All relevant information regarding this case will be submitted under (20210556305); Sender's Comments: V1-20210556305-Covid-19 vaccine ad26.cov2.s-PULMONARY EMBOLISM and DEEP VEIN THROMBOSIS. Follow-up received regarding Other Information: reporter details, disease start date, Events added, updated event (thrombosis to deep vein thrombosis), event onset date ,lab dates,lab result, vaccination time , treatment drug and vaccine facility details . 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). 20210556305-covid-19 vaccine ad26.cov2.s-Thrombosis, ultrasound scan abnormal. This events are considered unassessable. The events has a compatible/suggestive temporal relationship, are unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.

Sore upper left arm the day of vaccination. 20-26 hr after vaccination pain in left arm spread down to the elbow and unable to lift using that arm. trouble sleeping the evening of 7/21/21 due to pain in arm. Extreme fatigue beginning 3pm day after vaccination. Unable to do any physical activity for more than about 5 min. then had to rest. So tired had to go to bed for the day at 8pm when normal bed time is 10-11pm

I start to have muscle pain all over the body. it has been on going till now. It is hard for me to e even perform everyday activities.

-severe shaking / chills for 2 hours ...so much so that I could not get warm and my muscles hurt from shaking so much -headache, body ache , both 24 hours -soreness at sight of injection

3/9/21- chills muscle aches, joint pain, tired for about 4 hours 3/10/21-4:00 pm- chili?s, joint pain, aches, headache, fever-99.8

Janssen COVID-19 Vaccine EUA 3/11/2021 - 8pm very sore lymph nodes under armpits, sore chest muscles - sore all the way around my torse from one armpit to the other. Start getting the chills. Went to bed at 10pm. 3/12/2021 - 12am woke up with VERY Intense headache (forehead area and temples) - never had a headache this bad in my entire life, back of neck very sore, couldn't sleep, relax or focus. 3/12/2021 - 3am Diarrhea and nausea started, mouth very dry, tried to drink water but couldn't due to nausea, Headache still intense, haven't slept since midnight and couldn't relax or focus. In and out of bed, up and down stairs just didn't know what to do. 3/12/2021 - 7am diarrhea and nausea ended but still very intense headache. No sleep since midnight and just kept pacing , trying to sit, tried breathing learned in childbirth, but nothing was relieving the headache or letting me relax and sleep. Husband thought I looked like death. 3/12/2021 - 9:30am I finally broke down and took 2 Tylenol and was able to sleep for 2 hrs. 3/12/2021 - 11:30am body still ached and headache was now tolerable. Able to finally focus and relax. Symptoms were now tolerable as compared to 12am-9:30am, prior to taking Tylenol. 3/12/2021 - 5:00 pm beginning to feel better and eat a regular dinner. 3/13/2021 - 8:00 am woke up and felt 100% normal injection site was never sore or red, didn't have a fever

Approximately 12 hours after injection I experienced extreme body aches. Hands ached, hips ached, back aches, legs and feet ached. Hurt the balls of my feet when I walked. My eyes felt like they had sand paper in them. I did not run a fever but my body felt like I had. I had Flu B January of 2018, my syptoms after Janssen Shot were as severe as Flu B, but the duration was not as long! Approximately 24 hrs after injection I starting experiencing a headache, along with neck and shoulder aches. And I experienced fatigue for 3 days after injection along with the headache and neck, shoulder and back ache. On the fourth day following the injection I only feel tired. Aches, pains and headache are gone.

DOSE AT 12:50 PM, ABOUT 5 PM GOT VERY NAUSEAND LAID DOWN IN BED ABOUT 8:00 PM, WITHIN MINUTES BECAME VERY VERY COLD. WAS VIOLENTLY SHAKING FROM CHILLS, THEN VIOLENT SHAKING WITH MUSCLE TENSION FOR SEVERAL SECONDS THEN RELAXED FOR A FEW MINUTES THEN MORE TENSION. ALL OF THIS ALONG WITH THE CHILLS.I DO NOT KNOW HOW LONG THIS HAPPENED BEFORE I FELL ASLEEP. NEXT DAY WAS VERY TIRED, AND ACHED ALL OVER AND WAS WEAK.

Neck and back pain night of vaccine... then 30 hours later Heart Attack (Myocardial infarction); Treatment: blood thinners (TNK and Heparin), Stent in coronary artery. outcome: hospitalization 3 days and then recovery and fatigue ongoing...

Elevated blood pressure 230/170 for over 24 hours. Dry mouth, Feeling of unease. Chilled, Insomnia. Loss of appetite. Joint pain, Headache for 6 days.

Received vaccine on Wednesday 3/17/21 @ 1250pm, pretty painful going in my R deltoid. Started feeling very tired on Thursday 3/18/21 around 7pm. Woke on Friday 3/19/21 with fatigue and diarrhea with body aches. Woke Saturday 3/20/21 with fever 101.7. (During this duration to include today I have taken Tylenol rotating with Motrin every 2 hours, this never broke my fevers). Fever continues on and off with body aches, nausea, the worst headache I have ever experienced and pain in the base back of my neck L side. These symptoms have continued since Saturday. It is now Friday, 3/26/21. I will say that during waking hours 8am - 10pm on Wednesday 3/24/21 and Thursday 3/25/21 I had no symptoms except absolute fatigue. The fever returned on those two nights at around midnight with it breaking about 4 am, waking up in a pile of sweat.

teeth-chattering chills, excruciating headache, 101 fever, muscle aches, vertigo, diarrhea, fatigue, achy chest with tingly cough, brain fog

Dolor, inflammation, heat and hardening, to palpation, in the muscle area where the vaccine was given, about 5 cm of radius that appeared 3 days after the vaccination. There was no color change in the skin, neither difficulty to make movement of the arm in any direction. After a day and a half the symptoms disappeared. It was not necessary to take medication for the pain only the application of ice compress symptoms improved

RIB PAIN; VOMITING; HEADACHE; NAUSEA; INJECTION SITE PAIN; NIGHTMARES/VIVID DREAMS; FEELING COLD; FEELS AWFUL; INAPPROPRIATE ROUTE OF VACCINE ADMINISTRATION; OFF LABEL USE; ARM PAIN; CHILLS; FEVER; FATIGUE; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight was 175 pounds, and height was 161.29 centimeters. The patient's concurrent conditions included stroke, alcohol use 1-2 glasses per week, non smoker, depression, and sleeping problem. The patient experienced drug allergy when treated with povidone-iodine, and codeine for drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intravenous, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 09:30 in left arm for prophylactic vaccination. Concomitant medications included fluoxetine for depression, zolpidem for occasion sleeping problems, acetylsalicylic acid for stroke, and atorvastatin for stroke. On 12-MAR-2021, the subject experienced inappropriate route of vaccine administration. On 12-MAR-2021, the subject experienced off label use. On 12-MAR-2021, the subject experienced arm pain. On 12-MAR-2021, the subject experienced chills. On 12-MAR-2021, the subject experienced fever. On 12-MAR-2021, the subject experienced fatigue. On 12-MAR-2021 18:30, the subject experienced feels awful. On 12-MAR-2021 19:00, the subject experienced feeling cold. On 13-MAR-2021, the subject experienced nightmares/vivid dreams. On 13-MAR-2021, the subject experienced vomiting. On 13-MAR-2021, the subject experienced headache. On 13-MAR-2021, the subject experienced nausea. On 13-MAR-2021, the subject experienced injection site pain. On 14-MAR-2021, the subject experienced rib pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nightmares/vivid dreams, rib pain, vomiting, feels awful, feeling cold, arm pain, chills, fever, headache, nausea, injection site pain, and fatigue on 15-MAR-2021, and the outcome of off label use and inappropriate route of vaccine administration was not reported. This report was non-serious. Additional follow up information received on 26-Mar-2021.The following information was updated and incorporated into the case: age, medical history, demographics, concomitant medication, route of administration for suspect product, events (inappropriate route of vaccine administration and off label use) concomitant medications and outcome was updated.; Sender's Comments: V1: Medical assessment comment not required as per the standard procedure as the case is assessed as non-serious.

I was fine at first but after 11 hours, I began to get a bad headache within 30 minutes I also had nausea and severe pain all over my body to the point I did not want to move at all. Ibuprofen did not help. I was so tired, I could not move. It lasted through the night and would wake me up. I slept most of the next day until about 1:00pm. I finally began to feel better about 12 hours after it began and within 24 hours I was back to normal other that the sore shoulder.

By 6pm, I started feeling feverish, with chills, nausea, chest pains and abdominal pain. I also experienced headaches and my fever got up to 102.5. I went to the ER and they gave me fluids. I was told it was a reaction to the vaccine, but my paperwork said upper respiratory infection. My cough started out dry, I had SOB, weakness, fatigue, diarrhea and joint pain. My PCP put me on a steroid and an antibiotic Keflex (500mg, 3 times a day). I get lightheaded just walking around the house. I'm still experiencing SOB, fatigue and the cough. Today is the first day that I could get up an move around. I'm fine when I first wake up, but I eventually feel depleted.

Severe - Chills for 12 hours, horrible neck/back pain, hallucinated, whole body ached & felt like I couldn't move, extremely tired, shortness of breath for 1/2 day, no energy, rash, runny nose & sore throat, tingly sensation on extremities (still occurring), ringing/piercing sound in my ears, headaches. It has been over 3 weeks and I still don't feel energetic & like myself.

Started after falling asleep. Was woken up by profuse sweating and then sleeplessness. Went to work and felt muscle aches and weakness all over. Then major exhaustion with a bad headache.

CHILLS; ARM SORENESS; JOINT ACHE; LOW GRADE TEMPERATURE; SOME MUSCLE ACHE; SEVERE FATIGUE; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroidism, and hypocholesteremia. The patient experienced drug allergy when treated with metaxalone. 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 30-MAR-2021 around16:30 on right deltoid for prophylactic vaccination. Concomitant medications included ezetimibe/simvastatin for hypocholesteremia, and levothyroxine for hypothyroidism. On 30-MAR-2021, the subject experienced chills. On 30-MAR-2021, the subject experienced arm soreness. On 30-MAR-2021, the subject experienced joint ache. On 30-MAR-2021, the subject experienced low grade temperature. On 30-MAR-2021, the subject experienced some muscle ache. On 30-MAR-2021, the subject experienced severe fatigue. Laboratory data included: Body temperature (NR: not provided) 99.5-100.5. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, arm soreness, joint ache, low grade temperature, some muscle ache, and severe fatigue on 31-MAR-2021. This report was non-serious.

VOMITING; FEELS HOT; FEVER; DIARRHEA; COULDNT SLEEP; CHILLS; MUSCLE ACHES; NAUSEA; This spontaneous report received from a consumer concerned a 61 year old female. 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: 1808980, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced diarrhea. On 31-MAR-2021, the subject experienced could not sleep. On 31-MAR-2021, the subject experienced chills. On 31-MAR-2021, the subject experienced muscle aches. On 31-MAR-2021, the subject experienced nausea. On APR-2021, Laboratory data included: Body temperature (NR: not provided) under 100. On 01-APR-2021, the subject experienced vomiting. On 01-APR-2021, the subject experienced feels hot. On 01-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from vomiting, and nausea, had not recovered from muscle aches, chills, feels hot, and fever, and the outcome of diarrhea and could not sleep was not reported. This report was non-serious. Version created to amend previously reported information on 01-Apr-2021. Upon review the following information was amended: Event ranking updated and reporter type changed to consumer/ non health care professional from contact.

on March 25 I had intermittent severe shooting pain at vaccine site. It lasted about an hour. Vaccine site also felt very sore. Arm remained mildly sore but becoming slight more painful each day. with some tingling in fingers the following week. By April 10 muscle sore and painful to lift lift for shoulder adduction at 90 degrees.

I received the J & J covid vaccine this morning at 8:30 a.m. At approximately 4:30 p.m a dull headache, nausea and aches in my joints began. About 1/2 hour later I had a brief bout of chills then a fever set in. At 6 p.m. the fever was 100.0.

extreme pain on left side of face, throat, and neck. swelling in throat that caused fair amount of difficulty in breathing, talking and swallowing received epipen at urgent care on 04/09/2021 as the doctor felt I was having an allergic reaction to the covid vaccine and was told to go to the emergency room. was given IV of benedryl and pepcid. had a CT with contrast do to feeling of having something lodged in my throat. sent home with perscriptions for steroids and pepcid. still having symptoms though they are less severe

Onset next day Chills. Fever, body aches, joint pain, abdominal pain, left breast swelled to double the size

Severe headache lasting one day after the vaccine. On the second day @48 hrs strong underarm pain radiating down under left breast, alleviated with Aleve every 12 hrs, lasted for over 1 week @8-9 days, actual bruising underarm pit, and pain and bruising down to the wrist and fingers. Did not seek medical attention.

About 24-hours after getting the vaccination I started having pain and discomfort under my left arm. I got the vaccine in my left arm. Feels like a swollen lymph node. A little more than 48 hours after the vaccine I am now starting to feel a little bit of pain and discomfort in my right underarm area lymph nodes.

Felt crippled unable to walk excruciating pain (bone next to tailbone on left side) Shortness of breath Couldn't hold urine Felt perfectly fine until the morning of 3/20/21 (lasted 2 weeks-until I begged DR. to provide anti-inflammatory, 5% lidocaine patch to treat this, and I did not want continue to take my Percocet (from previous facture event) that the Dr. recommended.

Chills, muscle aches, fever of 102 for 6 hours from 2AM 3/9/2021-, fever of 101 and headache/ muscle aches afterwards to 2AM 3/10/21 -fever broke. Fatigue, muscle aches continued for 3 days. (maybe not associated with vaccine... but hip/leg pain flared and continues as well as sudden fainting and flare of diverticulitis (ER-CTscan 3/28/21)

Had injection on March 31, 2021. Very sore arm with soreness and stiffness in the neck for a few days. On April 8th woke up very dizzy, had to lay back down for a little bit. On April 10th woke up not being able to take a deep breath without a very bad pain in my back (it felt like my right lung) same issue the 11th, and 12th. This pain was not severe unless I took a deep breath. I was able to go about my daily activities. Today April 13th still a little tight in my lung but do not have the pain in my back that I had the last few days.

Shortness of breath, stomach issues, muscle aches and pain, headaches, rapid heart rate, nausea, vision problems.

Swelling, tenderness at site. Headache within 5 hours. Muscle aches. Abdominal cramping and back pain all within 5 days (3/10-3/14 )of vaccine.Passed out on 4/10/21 while walking, noted fatigue on 4/8 until 4/13.

On 4/6/21 morning, standing helping sick Dad to shower, I experienced dizzy spell and felt like I was leaning to the left side. Slow to regain balance. Lightheaded after for an hour or so. On 4/9/21 evening, while sitting, I felt my head fog up, my left eye spinning in the bottom, my left arm went numb and fingers tingled, left leg numb (1st episode). Lasted several minutes. Shortly after, I experienced another like the first, Tried to walk to the other room, felt like I was dragging my left leg and left arm. Lasted several minutes. Took baby asprin, Within the hour I had 2 more milder episodes. Reported to my doctor on Sunday. She is scheduling tests for me today.

Nothing very serious. Cold chills, mild headache, some back and muscle pain, fogginess. All side effects were completely gone within 30 hours after onset.

Symptoms started as a dull headache , chills and myalgia that progressed to an ocular migraine the next morning and continued for the next 5 days. on the third day of the migraine I saw my PCP and was give Toradol IM and Zofran for the nausea. this dulled the HA but it returned the next day and remained for 2 more days before decreasing to a dull HA again. I have had a dull HA off and on since then, not a constant HA as initially.

Right after shot, did not feel anything that morning till around 5pm I started to feel feverish, headache, tired. My arm never got sore or swollen. AFter 5pm till, the feverish feeling and hot cold got worse as time went by and I started shaking uncontrollably - pretty severe. I took Tylenol early hoping to stop the achy feverish and shaking but did not seem to help. THis went to till about 1am or 2am when I could finally lay down and try to sleep. The shaking had stopped. I did take more Tylenol and drank some herbal chamole type of hot tea. I could not sleep that night. Next day I was exhausted, body aches and still had some feverish feeling. By the way, took my temperature and it was normal. Then on Wednesday, I believe is when I had a huge episode of diarrhea (came on sudden). I kept calling and talking virtually to the doctor telling him all of what was going on. The next day I the feverish feeling and body aches and being tired kept happening - adding headache getting worse. I kept taking Tylenol. Seem to help some but did not take the pain away. EAch night , I could not sleep due to the headache. I started to feel better but then on the weekend, I had that headache and tired feeling. The headache was getting stronger and it circled my whole head and both shoulder and around my neck. It scared me because I felt at times that my throat was getting smaller. I could still swallow but it was so strange. I kept putting heat packs and ice packs and taking Tyelnol. I know that on Thursday or Friday the week, the doctor told me if I wanted to to go get tested for Covid and I did. I was tested negative on both the quick test and the other test that takes longer. I had that headache, sinus tension pressure for quite a few more days. Overall it took 7 days. I had to take off most of the week from my telework job because I could not function. I also did not eat much and drank lots of water during this time. It seem to go away and then about a week later, I got this painful diarrhea out of the blue and went to see an urgent care doctor. They tested me for blood, urine, and stool and they were negative. I was also having pain on my left side. Then it seem to go away after I was on the BRAT diet for a few more days. Then the diarrhea happened again the next week or so. This week, as of yesterday, I got a very strange throbbing pain in my left hand and not sure where that came from. It can be extreme at times. I tool Tyleonol but the pain is still there. Also, during this time and before the shot, I got a trigger finger issue on my right index finger. I don't think that has anything to do with the vaccine. Please note I have been told my doctors and I know this for a fact, my body is super sensitive to food, meds. I don't usually get the flu shot because of that. Today I am experiencing the left hand pain and now metal tasting in my mouth. I am about 5 weeks out from the vaccine. I wish I had never taken it. I pray nothing more will happen in my body If I have left anything off it is because I did not write this down when was happening. I really thought I was going to die one night because of the pressure I was having in my head, neck and shoulders. I have a little bit of a headache now and told my PT doctor that if I needed to know, I could get a brain or some kind of scan to see if I am hainvg any issues. I am going to bring this up to my virtual call today.

ZAPPING PAIN THROUGH LEGS AND SHOULDERS; CHILLS; LEGS BURNING AND ACHY; SORE JOINTS; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. 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: 202A21A, 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 zapping pain through legs and shoulders. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced legs burning and achy. On 08-APR-2021, the subject experienced sore joints. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, legs burning and achy, sore joints and zapping pain through legs and shoulders was not reported. This report was non-serious. This parent/child case is linked to 20210420242.

NECK SORE TO TOUCH; EXCRUCIATING BACK PAIN; COULD NOT LIE ON BACK AND ON SIDE; MILD BODY ACHES; BACK PAIN RADIATING TO ABDOMEN; CHILLS BECAME WORSE; HEADACHE; MILD TEMPERATURE; CAHRLIE HORSE IN NECK, SHOULDERS. AND LEGS; DIARRHEA; SLEEPY; STOMACH PAIN; LOSS OF APPETITE; FELT TIRED; DRY COUGH; COULD BARELY WALK; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included type 2 diabetes, non-alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and did not have 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: 1808609 expiry: UNKNOWN) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced could barely walk. On 2021, the subject experienced dry cough. On 28-MAR-2021, the subject experienced loss of appetite. On 28-MAR-2021, the subject experienced felt tired. On 29-MAR-2021, the subject experienced stomach pain. On 30-MAR-2021, the subject experienced sleepy. On 31-MAR-2021, the subject experienced diarrhea. On 31-MAR-2021, the subject experienced cahrlie horse in neck, shoulders; and legs. On APR-2021, the subject experienced mild body aches. On APR-2021, the subject experienced back pain radiating to abdomen. On APR-2021, the subject experienced chills became worse. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced mild temperature. On 01-APR-2021, the subject experienced excruciating back pain. On 01-APR-2021, the subject experienced could not lie on back and on side. On 02-APR-2021, the subject experienced neck sore to touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from excruciating back pain, and could not lie on back and on side on 08-APR-2021, and cahrlie horse in neck, shoulders. and legs on 01-APR-2021, was recovering from diarrhea, loss of appetite, neck sore to touch, and mild temperature, had not recovered from felt tired, sleepy, headache, mild body aches, stomach pain, and chills became worse, and the outcome of dry cough, back pain radiating to abdomen and could barely walk was not reported. This report was non-serious.

Progress Notes - Clinical MD at 4/15/2021 1:30 PM HPI: 61 year old female with IBS presents with concerns about adverse reactions to vaccine which she got on 3/19/21. Patient reports that she felt lightheaded after the vaccine when she was leaving. She got home and felt better but then that night woke up in a delirium which passed by the morning. She had some weakness in her extremities, brain fog, cold feeling, funny GI feeling and fatigue for 3 days and then was fine. Two weeks ago she started to feel that the circulation in her lower legs was cut off with sensation of blood pooling in her legs with associated numbness and tingling. She describes it as what you feel when a tourniquet is applied to your arm. No visible lower extremity swelling, redness and no pain. One week ago she felt like her right hand was not working well and then left hand too. She then felt pooling in her arms like the sensation in her legs.No swelling, redness or pain. She reports she did a hand stand and afterward felt pooling sensation in her lower abdomen which has since resolved but continues to have a prickling sensation that comes and goes. Last night while lying on her back she felt the pooling sensation in her chest and this morning throbbing in head and chest and neck. That is when she decided to come in and be seen. Patient denies severe headache, backache, abdominal pain, shortness of breath, bruises, unusual bleeding or rashes. Patient has not had a physical exam with blood work since 11/9/17.

SHAKING TO THE BONE; RADIATING MUSCLE PAIN; LOW GRADE FEVER; ARM BRUISED FROM INSIDE; DISCOMFORT UNPTO THE SHOULDER; STOMACH PAIN; ARM HURTS ALL THE TIME; LOSS OF ENERGY; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient was not pregnant at the time of reporting. 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 22-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced arm bruised from inside. On MAR-2021, the subject experienced discomfort up to the shoulder. On MAR-2021, the subject experienced stomach pain. On MAR-2021, the subject experienced arm hurts all the time. On MAR-2021, the subject experienced loss of energy. On 23-MAR-2021, the subject experienced shaking to the bone. On 23-MAR-2021, the subject experienced radiating muscle pain. On 23-MAR-2021, the subject experienced low grade fever. The patient recovered from arm bruised from inside, discomfort up to the shoulder, shaking to the bone, stomach pain, loss of energy, and low grade fever on MAR-2021, and had not recovered from arm hurts all the time, and radiating muscle pain. This report was non-serious.

CHILLS; LOSS OF APPETITE; DIZZINESS; TIREDNESS; MUSCLE ACHE; WEAKNESS; PAIN IN ARM; VOMITING; NAUSEA; FEVER; This spontaneous report received from a patient concerned a 61 year old female. 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: 1808982, 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 patient experienced nausea, fever. On 10-APR-2021 the patient experienced tiredness, weakness, muscle ache, vomiting, dizziness, pain in arm. On 11-APR-2021, the patient experienced loss of appetite and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting on 10-APR-2021, and dizziness on 11-APR-2021, was recovering from nausea, and pain in arm, and had not recovered from fever, weakness, muscle ache, loss of appetite, chills, and tiredness. This report was non-serious.

WEIGHT LOSS; HEADACHE; PAIN AT INJECTION SITE; FATIGUE; NAUSEA; LACK OF APPETITE; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's past medical history included brain aneurysm. 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 06-APR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid, and calcium carbonate. On 06-APR-2021, the subject experienced lack of appetite. On 06-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced pain at injection site. On 06-APR-2021, the subject experienced fatigue. On 06-APR-2021, the subject experienced nausea. On 12-APR-2021, the subject experienced weight loss. Laboratory data included: Weight (NR: not provided) lost 4 pounds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from weight loss on 13-APR-2021, and headache on 12-APR-2021, was recovering from fatigue, nausea, and lack of appetite, and had not recovered from pain at injection site. This report was non-serious.

Starting around midnight, my joints were extremely achy. I went to bed, but tossed and turned, even though I was very tired, but so sore. I got chills and fever, but didn't take my temperature. The next morning, took my temperature and it was 101. Ate a piece of coffee cake with some tea. Was very tired, so went back to bed. Was also a bit queasy, and not hungry for lunch, and had a mild headache. Slept most of the day, had chills and fever off and on, and joints very sore. I did eat dinner. The next day I was much better, but still had some soreness in my joints, one or two episodes of mild chills, was somewhat tired and lethargic. The next day I was more or less back to normal. I did take Tylenol at some point, but I can't remember if it was the afternoon of the first day of fever, or not until the next afternoon. I know I did take it again the next morning. All in all, it felt like a full-blown case of the flu, but was of short duration.

headache, light headedness, nausea, muscle aches, joint aches, lymph node swelling, fatigue, swelling at the injection site. All symptoms lasted about 48hrs. The swelling and bump at the injection sited lasted 1 week.

On 3/21/2021 I woke up with sudden bad left lower back pain that radiated down the lateral left thigh. It continued to get worse as the week wore on. I could not bend over, lie down or sit for very long without severe discomfort. I ended up seeing a chiropractor within the week who has been treating the problem over this past month. X rays were taken. I have been treating it with ice, ibuprofen, and aspirin.

"Pressure on the chest/ pinching feeling up to my back. My left arm goes numb on and off with a little pain. Headache and dizziness. Vaccine given in the right arm."

Sudden onset of bruise in left ring finger and on left foot, left of big toe, both appeared at once while eating lunch. Left ring finger went numb, white and cold, with bruise appearing on the middle digit. Other finger tips turned pink. Skin turned red onhands with tingling sentation. Right hand blood vessels came to the surface and began to swell at intersections. Skin on rt. hand looked whiter and dry. The sudden onset sent me to the emergency room, the condition began to fade in 3 hours, not completely. The same reaction occured the next day at 12 noon. I took a hot shower and the condition improved followed by extreme tiredness. *At the time of vaccination, & on both of these events I had a stiff neck/red skin.

LEFT GROIN PAIN RADIATING TO THE LEFT LEG/ HARD TO WALK; MUSCLE ACHES; NAUSEA; FATIGUE; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Concomitant medications included tramadol hydrochloride. On 10-APR-2021, the subject experienced left groin pain radiating to the left leg/ hard to walk. On 10-APR-2021, the subject experienced muscle aches. On 10-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle aches, nausea, and fatigue on 11-APR-2021, and had not recovered from left groin pain radiating to the left leg/ hard to walk. 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 states her joint pains were markedly worse the day after her vaccine dose, including new pain in the knees. Of note is that her rheumatoid arthritis has been worsening for the past 2 months since she stopped taking Xeljanz 3 months ago. (Her rheumatologist closed his practice and she was unable to establish with new one till 4/9/2021. Exam then showed now inflammatory changes in joints. Exam today by me also showed no inflammatory in joints, including knees. Labs ordered on 4/9 are just being drawn today.

Patient discribed mild headache immediately after. Patient experienced sore arm for about 10 days. Patient started experiencing pain all over a week after the injection. she describes it as a burning sensation though her nervous system and joint pain. Patient also experienced a brain fog a week after her injection. She states that she has trouble putting her thoughts to words. She still feel this reactions on your 17th day.

Fingers on left hand began tingling around 30 minutes or so after shot. While riding home in the car, both the numbness, heaviness feeling in my arm and the tingling worsened. Then a strong sensation went up the left side of my neck and into the left side of my face where my face started tingling. That was so powerful and unexpected it caused me to gasp and grab the side of my neck. My husband turned the car around and we returned to the hospital where they took the information and had me sit for a while checking back a few times. My arm, fingers, neck and face continued to feel numb and heavy with my face and fingers tingling. After no improvement and some escalation as it ebbed and flowed, I had an April 12 appointment with Dr at Medical Center. Some blood work was done afterwards. A PT appt. is set for April 29th. It has been more than two weeks now and unfortunately, the numbness, heaviness and tingling continue.

CHILLS; PAIN IN HANDS; HEADACHE; VERY TIRED; MUSCLE ACHES; PAIN IN ELBOW; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient did not have known allergies. 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 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced chills. On 13-MAR-2021, the subject experienced pain in hands. On 13-MAR-2021, the subject experienced headache. On 13-MAR-2021, the subject experienced very tired. On 13-MAR-2021, the subject experienced muscle aches. On 13-MAR-2021, the subject experienced pain in elbow. Treatment medications included: diphenhydramine hydrochloride, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 14-MAR-2021, was recovering from pain in hands, and pain in elbow, and had not recovered from very tired, muscle aches, and chills. This report was non-serious.

LOSS OF APETITE; TINNITUS RINGING IN EARS; HEADACHE; LEG PAIN; HEAVINESS; LOSS OF ENERGY; CHILLS; FEVER; TIRED; This spontaneous report received from a patient concerned a 61 year old female. 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: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced leg pain. On 06-MAR-2021, the subject experienced heaviness. On 06-MAR-2021, the subject experienced loss of energy. On 06-MAR-2021, the subject experienced chills. On 06-MAR-2021, the subject experienced fever. On 06-MAR-2021, the subject experienced tired. On 07-MAR-2021, the subject experienced tinnitus ringing in ears. On 07-MAR-2021, the subject experienced loss of apetite. On 07-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from leg pain, heaviness, and chills on 07-MAR-2021, and fever, and headache on 09-MAR-2021, was recovering from tinnitus ringing in ears, and had not recovered from tired, loss of apetite, and loss of energy. This report was non-serious.

Super Dizzy (2 days), nausea (4 days), tingling throughout body (5 days), fatigue (10 days), Severe body aches. Felt like every bone in my body was broken (4 days)

My knee was swollen, body ache and fatigue for 3 day couldn't go to work. Since I heard the vaccination was stopped on 4/12 I was concerned. I went to doctor was advised to take Tylenol.

UPPER SPINE WAS VERY TENDER; COLD SWEAT; COULD NOT STAND UP FROM FLOOR; SEVERE DIARRHEA; FELT LIKE SOMETHING HAPPENED; ARM PAIN; BURNING HEAT OFF BODY; BRUISING AT UPPER SPINE/YELLOW BRUISING DOWN LOWER LEFT LEG; SEVERE PAIN UP NECK AND DOWN BACK; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sensitive to antibiotics, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. 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 04-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-MAR-2021, the subject experienced bruising at upper spine/yellow bruising down lower left leg. On 04-MAR-2021, the subject experienced severe pain up neck and down back. On 04-MAR-2021 14:00, the subject experienced burning heat off body. On 05-MAR-2021, the subject experienced arm pain. On 07-MAR-2021, the subject experienced cold sweat. On 07-MAR-2021, the subject experienced could not stand up from floor. On 07-MAR-2021, the subject experienced severe diarrhea. On 07-MAR-2021, the subject experienced felt like something happened. On 19-MAR-2021, the subject experienced upper spine was very tender. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from upper spine was very tender, bruising at upper spine/yellow bruising down lower left leg, and severe pain up neck and down back on 07-APR-2021, burning heat off body on 04-MAR-2021, and cold sweat, could not stand up from floor, and severe diarrhea on 07-MAR-2021, and the outcome of arm pain and felt like something happened 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.

J&J on 4/12/2021- other details unknown Fatigue, significant, prevents daily activity Headache, Arthralgia

FIBROMYALGIA EXACERBATION; SORE GLANDS AT JAW LINE; FEELING LIKE CENTRAL NERVOUS SYSTEM ON FIRE; SPINAL CORD PAIN; VERTIGO; SORE ARM; NAUSEOUS; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included fibromyalgia, atrial fibrillation, and anxiety. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: (6 or 0)43A(2or Z)(Ior1)A) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced fibromyalgia exacerbation. On APR-2021, the subject experienced sore glands at jaw line. On APR-2021, the subject experienced feeling like central nervous system on fire. On APR-2021, the subject experienced spinal cord pain. On APR-2021, the subject experienced vertigo. On APR-2021, the subject experienced sore arm. On APR-2021, the subject experienced nauseous. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vertigo, sore arm, sore glands at jaw line, feeling like central nervous system on fire, spinal cord pain, fibromyalgia exacerbation and nauseous was not reported. This report was non-serious. The Product Complaint Number was 90000177550 The suspected product quality complaint has been confirmed to be confirmed no PQC was identified within the reported complaint reported. complaint is approved for void. based on the PQC evaluation/investigation performed.

RIGHT SHOULDER BLADE PAIN WHICH SPREAD TO NECK; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 205a21a, expiry: 23-JUN-2021) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-MAY-2021, the subject experienced right shoulder blade pain which spread to neck. The action taken with covid-19 vaccine was not applicable. The patient recovered from right shoulder blade pain which spread to neck on 05-MAY-2021. This report was non-serious.

That night, no chills or fever but uncontrollable shaking - 10 pm - 4 am in morning. Starting at 10, as well, body aches - run over by a truck type. My chest was burning like it was on fire - lungs felt like they were on fire. I woke up the next morning, with a little bit of body aches - I slept the entire next day pretty much (the 7th). On the 7th, I noticed that my heart was beating - fluttering- skipping- beating. My left left also swelled up and was red. I had PVCs with pulmonary embolism on that left leg in1996 - when I was doing the chemo. My left leg ached, burned and got red on the 7th. I was going to see the PCP the following week and I was still having issues with the heart but the leg was getting better. It can still swell, burn and get red quite a bit of night because I stand on my legs all day - but the amount of pain and swelling did go down over that week while I was waiting to see the doctor. I had an ultrasound on my leg. And a heart halter to monitor my heart for 24 hours. I do have PVCs. Stress from vaccine caused Herpes Outbreak - that was on the left inner thigh right next to genitals - bumps within four days of vaccine. Created more pain. Took Benadryl for pain - helps with the nerve pain - two days with. I took 3000 mg a day of Tylenol for three days after the vaccine. Have not recovered from the calf and heart symptoms.

My left foot felt very heavy then my left lower leg started to get numb. We all 911 by the time the ambulance came my left arm was getting numb. I was transported in helicopter to regional Hospital I was having a stroke

Patient with c/o significant bilateral hip pain. Has been doing some stretching and using machine at PT on her hips that makes it feel a lot better when she is there. Is trying to do the exercises at home, but pain is the worst when she gets up in the morning and after sitting at night watching TV. IT Bands present as tight on exam bilaterally.

Acute Inflammatory Demyelinating Polyneuropathy/Guillain-Barre Syndrome, 6-day in-patient hospital admission, IVIG for 5 days, outcome undetermined as yet. Initial symptoms include severe low back pain for a week followed by bilateral leg weakness and ascending paralysis.

PRESENCE IN LEFT LEG; BACK TENSION; FATIGUE; This spontaneous report received from a patient concerned a 61 year old female. 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: 207A21A expiry: 23-JUN-2021) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAY-2021, the subject experienced fatigue. On 12-MAY-2021, the subject experienced back tension. On 18-MAY-2021, the subject experienced presence in left leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from back tension, and fatigue, and had not recovered from presence in left leg. This report was non-serious.

pt says she started having constant pain from her left leg from the knee to her hip along with muscle spasms that she has had for the past 3 days. She is taking ibuprofen and muscle rub. Pt will contact a doctor if her symptoms get worse.

Insomnia, muscle aches and weakness. back pain, severe headaches, fatigue. Abnormal D-Dimer levels. Shortness of breath and chest pain.

Insomnia, muscle aches and weakness. Back pain, severe headaches, fatigue. Abnormal D-Dimer levels. Shortness of breathe and chest pain.

I start of feeling sick in the stomach, headache, muscle aches, feverish. By that night I had chills and the really bad nausea, that I had to sleep on the bathroom. The next day, I barely made it to the bed. I am very weak, still having a headache, body aches and feeling fatigue. The ringing in my ear has gotten worst than it was before.

5/07/2021 I had the shot and immediately I got dizzy when I stood up. That night I encountered fatigue, fever, muscle ache and sore throat. Fever lasted 2 days and fever lasted for 5 days. 5/10 the arm was sore and there was a 6x6? huge rash. 5/24- 5/26 I had a rash that I kept under control with Benadryl. 5/29 my saliva glands began to swell and that?s why I went to the Doctor. The Dr sent me to an ENT and Rheumatologist.

swelling and bruising at the wrist area of the shot arm (was wearing a watch, during injection and during the night)

BONES HURTING SEVERELY ALL OVER THE HIPS KNEES ANKLES RIBS ARMS AND BACK; TINGLING IN RIGHT ARM; NUMBNESS IN RIGHT ARM; BODY ACHES LIKE THE FLU; LIPS TINGLING BUT NOT SWOLLEN HAPPENED ONLY ONCE FOR HALF HOUR; SQUEEZING LIKE PRESSURE ON RIGHT ARM FELT LIKE RUBBER AROUND BANDS ARMS AND BLOCKING CIRCULATION; JOINT PAIN; HEADACHE ON RIGHT TOP SIDE OF HEAD; FEVER TEMP HIGHEST 104.1F TO RANGE OF 102F; MUSCLE PAIN; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient not tested positive for covid, not aware that has had covid before, ended up in emergency room last fall due to non covid virus. The patient experienced got sick like in vomiting when treated with hydromorphone hydrochloride, and morphine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown) dose was not reported, administered on 15-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-JUN-2021, the subject experienced bones hurting severely all over the hips knees ankles ribs arms and back. On 15-JUN-2021, the subject experienced tingling in right arm. On 15-JUN-2021, the subject experienced numbness in right arm. On 15-JUN-2021, the subject experienced body aches like the flu. On 15-JUN-2021, the subject experienced lips tingling but not swollen happened only once for half hour. On 15-JUN-2021, the subject experienced squeezing like pressure on right arm felt like rubber around bands arms and blocking circulation. On 15-JUN-2021, the subject experienced joint pain. On 15-JUN-2021, the subject experienced headache on right top side of head. On 15-JUN-2021, the subject experienced fever temp highest 104.1f to range of 102f. On 15-JUN-2021, the subject experienced muscle pain. Treatment medications (dates unspecified) included: naproxen sodium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lips tingling but not swollen happened only once for half hour on 15-JUN-2021, and was recovering from tingling in right arm, squeezing like pressure on right arm felt like rubber around bands arms and blocking circulation, numbness in right arm, fever temp highest 104.1f to range of 102f, body aches like the flu, headache on right top side of head, muscle pain, joint pain, and bones hurting severely all over the hips knees ankles ribs arms and back. This report was non-serious.

04-23-21 - Woke up super dizzy & was unable to get out of bed for about 30 mins after that I had to VERY carefully move around slowly for weeks after that (until mid June) I also had ringing in my ears for most of that time pretty severe at first & still present but better that when I was dizzy. I had not had this before & it is quite unnerving. I have been doing PT for the dizziness & it has pretty much subsided. I have also had pain (no rash or lymph discomfort or swelling) just muscular pain in my upper right arm. This started about a month after the vaccination. It is in the arm muscle NOT the bursa. It happens when I have not moved the arm for awhile & I reach for something, etc.. the pain is not severe but obvious (0 to 10 it is about a 4) & goes down to about a 1 after I move the arm around for 30 seconds or so. I have also had pain & a bit of weakness in my legs & a sharp pain in my left beast (not my chest - the upper left quadrant about 1" below my armpit & 3 inches in the breast tissue. It is a single sharp pain (0 to 10 = 7) and only stays for a few minutes.

25 June 11 pm: Entire body aching -- Up multiple times during the night, general muscle aching and fatigue, some confusion; migraine developed overnight. 26 June, 7 am: Out of bed, short walk, general myalgia, fatigue, migraine, had to lie down. 8:30 am: Slightly longer walk, felt slightly better, able to eat small amount after this. 9:30: Felt nauseated, migraine, fatigue, and myalgia worse. Noon: Brief walk outside, lay back down due to nausea, fatigue, myalgia. 2:30 pm: Nausea a bit better, ate apple, lay back down due to symptoms above. 5 pm: Migraine and nausea slightly better, fatigue and myalgia persist. 6:30 pm: Ate plain lettuce, extreme nausea, and tinnitus; vomited entire quantity; nausea improved. Remained prone rest of evening. 7:30 pm: Mild nausea persists, migraine improving, may be slight decrease in myalgia. 9 pm: To bed, slept well, definite improvement through night, some myalgia persists and occasional tinnitus. Able to drink water throughout.

Abdominal pain/cramping/diarrhea 2-3 days Some joint achiness off & on for several weeks. Severe right groin pain around May 12. Saw PCP. Xray showed chondrocalcinosis which I've never had before. Aleve, Volteran. Still achy but not severe. Muscle weakness, fatigue, double vision waxed & waned for several weeks & then just got worse. Saw neurologist May 21. (Doing so well I hadn't seen him for 3 years) Blood tests & brain MRI. Only abnormal was a seropositive AchR which I've always been seronegative. Doubled MTX & wants to do IVIg but insurance is denying at this time.

Day 1: Shot Friday about 530 PM. Waited 30 minutes+. VERY ITCHY skin within minute or more of injection. Skin itched all over, but no rash, no other symptoms. Took usual aspirin & Tylenol before bed. Also began probiotics and elderberry/zinc/C supplements recommended in Covid handout. That night: Slept on other arm, when rolled over in early AM, hurt to press on shot arm. Day 2: Woke up hay feverish - sinuses completely blocked but could breathe through mouth, so airway OK. Moderate headache, all over muscle aches. Took usual aspirin & Tylenol. Skin still itches all over. Took a Zyrtec. Sinuses cleared, muscles and head aches went from moderate to mild, skin itch also from moderate to mild. Took usual aspirin & Tylenol before bed. Day 3: Woke up with sinuses partially blocked and sneezing. Mild headache and muscle aches. Took usual aspirin & Tylenol, and when sinuses wouldn't clear on sitting up and blowing and kept sneezing, took another Zyrtec. Day 4: Sinuses draining so I'm going to try to do without Zyrtec. Body still very achy so taking usual aspirin & Tylenol. Day 5 and beyond: Symptoms gradually subsided without further Zyrtec. Higher than normal tiredness persisted longer than aches and hay fever symptoms. Overall, much milder reaction than I had to a flu vaccine many years earlier, so I'm pleased, but felt VAERS should have complete information.

I went to bed feeling fine but experienced chills, achy joints and headache until the next afternoon. That was fine, expected that. On about the 4 or 5th day. I thought I had full blown Covid. Had all the symptoms. As this progressed my fatigue was overwhelming. I lost my appetite, had a bad headache, joints and muscles ached, etc. No fever at this time though and breathing was ok. Texted Dr. and was told it was my immune system overreacting and he prescribed oral steroid to calm it down. My fatigue lasted for a good 3 weeks. This was as sick as I have ever been.

Sudden weakness in legs ... so much that had to sit or would fall down because they wouldn't hold me. This has happened several times over the past few weeks but I did not know what it was.

Patient said that she is experiencing extreme fatigue and chronic pain in her hip back neck. she can hardly walk. She stated that she falls asleep any where. She has a strange feeling in her chest. She is experiencing breathing complications. She has a hard time drinking water without choking. She stated that she has a high tolerance for pain, but this pain is unboreable. She stated that she was taking walks and now she can barely walk to her car without loosing her breathe.

Immediate strong pain from injection that dissipated after 10-15 minutes; next morning low grade fever and moderate headache and moderate muscle/joint/body aches. Most symptoms dissipated after 3-4 hours after taking Advil.

Weird feeling no my left neck. Stiff? Like something is pulling on it. The nurse practioner told me to wait a month, but it has not completely gone away yet.

CAN'T WALK AT TIMES; VERY UNSTEADY WHEN WALKING; STANDING ON ONE LEG IMPOSSIBLE; MUSCLE CONTRACTED AND WON'T LET GO; MUSCLE WEAKNESS; MUSCLE PAIN; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included arthritis in knees.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-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-APR-2021, the subject experienced can't walk at times. On 25-APR-2021, the subject experienced very unsteady when walking. On 25-APR-2021, the subject experienced standing on one leg impossible. On 25-APR-2021, the subject experienced muscle contracted and won't let go. On 25-APR-2021, the subject experienced muscle weakness. On 25-APR-2021, the subject experienced muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from can't walk at times, very unsteady when walking, standing on one leg impossible, muscle pain, muscle contracted and won't let go, and muscle weakness. This report was non-serious.

Minor chills 36 hours after shot with sever chills 6-8 pm evening of shot. Fatigue and joint aches 36 hours after shot. Slept much more then normal 12-36 hours after shot.

Fever, chills, dry sore throat, headache, body and joint pain, nausea starting 5 hours after vaccination and lasting at least 12 hours

Janssen COVID-19 Vaccine EUA. Gradual headache late afternoon, followed by neck ache, then muscle aches, Horrible chills and shakes, nausea and throwing up. Muscle aches continued throughout the night and into the morning. Left with some muscle aches, stuffy head today. Tylenol did not help in the evening, so switched to Advil at midnight and that started to help.

While waiting the 15 required minutes after the shot was administered..I experianced a headache and left jaw discomfort. Minor arm pain the first day, I expected that. Did my regular errands and was fine, a little tired. The next day, (Sunday)...I went to church, had a headache, arms aching like mad, arthritic symptoms , legs cramping, joint pain in elbows especially, were off the chain! I returned home and took immediately to the couch, where I had a low grade fever and stayed all day. I had no appetite, no energy to get up except to go to the bathroom.

8 hours after vaccination I got headache, fever (101), fatigue and body aches. Woke up in the middle of the night with headache and slight nausea. The next morning and through the day/ night had some joint pain and extremely tired.

Chills Fever of 101.8 Nausea Muscle Aches Fatigue Trouble Breathing Dizziness Symptoms gradually subsided over 24 hours. Used a rescue inhaler for the breathing troubles, took extra strength tylenol for the fever. Slept for 18 solid hours from 9pm on March 7th till 3 pm on March 8th - had been napping most of the day before 9pm.Fever and fatigue were the last symptoms to resolve.

Mild headache, mild muscle aches, light headedness. Regular aspirin taken about 11 hrs after onset were effective for the aches. Mild light headedness continued for about 12 more hrs.

Janssen Covid 19 Vaccine EAU - 3/14/21 -Headache, Fever (99.2) , joint aches, Took Ibuprofen X 400mg at 9AM. Had headache and felt tired and achy all day. At about 6:30PM took Ibuprofen 400mg, Awoke morning 3/15 with slight headache but nothing requiring medication. Feel that reaction is 99% resolved

Migraine type headache lasted most of day greater than 12 hours, slight fever 1 degree, chills, ache, lower back pain.

About a week after the vaccine, I came down with pain in my lower back which progressed to the front lower abdomen and two red spots showed up on my right lower back side.

As soon as I was injected I felt a burning sensation that went from the site up into my neck. Day 2, 7am I woke with a temperature of 102 degrees, Throughout the day I had fever, chills and arm injection site to neck continued to be painful, arm swollen and warm to touch with a lump about the size of a walnut, and lethargic. Day 3-4 symptoms continued same as day 2 with temperature decreasing to 100 degrees. Day 5 fever gone. Day 5 through today the injection site continues to be somewhat painful with some heat in the arm and lump has decreased to dime size. Called and spoke with doctors office this morning. Advised to treat with wet warm compress and Ibuprofen for discomfort. Call is worsen.

Starting midday Sunday ( one day after vaccine) I started feeling nauseous and about 2:00 I started throwing up. I threw up until about midnight for a total of 7 times. The night before I had difficulty sleeping. The next morning I felt nauseous again and threw up about 10:00 a.m. I started having diarrhea which has lasted through today (Thursday) and I had lost over 5 pounds in just 3 days and my weight is still over 5 pounds less today because it is difficult to eat much. Sunday I was feeling pain around my lest breast where I had had my mastectomy in June of 2006. That eased up the next day. Feeling stressed because I have bad tinnitus and was worried about a reaction.

Systemic: tooth sensitivity, could not eat or chew-Severe, Systemic: Joint Pain-Medium, Additional Details: 3/19/21: after work, patient came home and noticed itchy rashes on both ankles\r\n3/20/21: Overnight, patient experienced tooth sensitivity, uncomfortable and painful to chew/eat. 1 top and 1 bottom teeth affected more than the others. Experienced joint pain in hips, hands, and ankles. Patient had history of arthritis\r\n3/21/21: Joint pain continued. Rash on R ankle had a few tiny blisters\r\n3/22/21: Dentist appt where one tooth was extracted. amox & pain med started, rash and pain went away

First noticed as driving away my tinnitus was triggered. More serious adverse events started about 6-7 hrs after injection about 10:30pm with achy body and nausea. Progressed to Chills, achy body, sore muscles, nausea. Took Tylenol but persisted. By 10:00am next day (12 hours after began) symptoms lessened, but still persisting nearly 24 hours after injection.

Tendon inflammation starting in forearm, gradually moving up arm to injection site over 2 weeks time.

Fatique, Neck tightness, Chills, Fever 102.3, bone pain fingers/hands, shaking legs, unstable walking.

TINGLY ON THE RIGHT UPPER LIP; MILDEST ACHY JOINTS; NOT FEELING HUNGRY; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included latent TB, and concurrent conditions included diabetes, obese, and skin eczema, and other pre-existing medical conditions included patient had allergies to MRI dye. The patient was previously treated with immunoglobulin g human; and experienced allergy when treated with metronidazole. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown expiry date: unknown) dose was not reported, administered on 26-MAR-2021 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced not feeling hungry. On 27-MAR-2021, the subject experienced mildest achy joints. On 28-MAR-2021, the subject experienced tingly on the right upper lip. Laboratory data (dates unspecified) included: Lab test (NR: not provided) negative, 7 times tested. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingly on the right upper lip, and had not recovered from mildest achy joints, and not feeling hungry. This report was non-serious. T

Initial reaction was flu-like symptoms but more concerning reaction was a bad rash with red small bumps on the same side as the shot was given directly above my left breast that was severely itchy. This rash is just now starting to dissipate but still itches; I used OTC cortisone creme and Benedryl to address the itching. The other major effect involved my left arm. For a full week, the muscle in which the shot was given was extremely sore to the touch and the whole arm ached. I still cannot fully extend that arm above my head without it feeling like an aching weight. Lastly, I had a pain in the center of my back as a hard ache that one week later still has not fully dissipated. It appears to be going away, but has lingered longer than I would have expected.

Fatigue that worsened over 3 week period, weakness in legs, arms that progressed over that time, dizzy foggy brain that progressed, chest tightness/heaviness that became more frequent over time, ending in inability to stay active for normal activities, fever on & off - thought MS exacerbation - symptoms completely subsided by 4/7/21

Janssen COVID-19 Vaccine EUA Severe joint and muscle pain all over the body starting at 7:30 pm. Progressively worsening overnight. Overall weakness, cold shivers, severe palpitations with 136 heart rate in resting position. Initially decreased temperature and then increased temperature to 101. Tramadol for pain and diazepan for sleep taken at night. Felt better by the next day afternoon.

Began with muscles in legs aching, then a headache, body aches, feeling of being sick, chills. Started feeling better two days after shot, but still weak.

Really bad headache, nausea, dizziness, fever, achy all over, arm swollen even in arm pit and really sore,diarrhea

Six hours after the vaccine, I had the chills that quickly turned into UNCONTROLLABLE & SEVERE body shaking, a headache, SEVERE back and neck pain and elevated resting heart rate (96). I took 2.5mg of Ambian thinking that if I could just fall asleep, I would sleep it off. After an hour of non-stop symptoms, I fell asleep for about an hour only to wake up with the severe neck and back pain and headache still present. The body shaking had subsided. The next day, I was tired but fine.

Nausea, headache, stiff neck six hours later. Muscle pain, elevated blood pressure, severe ringing in ears occurred 15 hours (3am) after injection. Saw PCP on 3/25- prescribed blood pressure medication (never taken before) and referred to ENT. Saw ENT on 3/29 and 3/30. Prescribed high dose Prednisone for two weeks. Hearing test shows hearing loss in left ear. Received injection in left arm. Shrill high pitched ringing in both ears with no improvement. See Audiologist on 4/20 for hearing recheck to see if hearing has improved in left ear.

Extreme headache for 2 days. Worse than any migraine I?ve ever had. Severe pain in neck, shoulders and spine. My heart heart. Extreme nausea, vomiting and diarrhea. Extreme fatigue. Couldn?t move or eat for 2 days. Didn?t think I was going to recover. 3rd day feeling light headed and tired but feeling better.

03/08/2021 (Symptoms began 45 minutes after shot): sore arm down to fingers, stuffy nose, watery eyes, headache, light headed, slight balance issues, malaise, no appetite, slight nausea, tight chest, arm soreness down to fingers became worst & was accompanied by arm swelling which included the fingers, 2 hives, tingle around mouth & nose, asthma feeling progressed to shortness of breath upon exertion, slight face swelling, Temp 102, chills. 03/09/2021 same symptoms as 03/08/2021 but minus the hives & the addition of the following symptoms: Temp 101, shaking so bad from chills couldn't hold anything, runny nose & eyes, extreme fatigue, small chest pain, skin cold like had been in freezer, lips & fingers slightly purple. 03/10/2021 same symptoms as 03/08/2021 & 03/09/2021 but minus the hives, slight face swelling, servere chills, lips & fingers barely purple & the addition of the following symptoms: Temp 100. 03/11/2021 symptoms include: Temp 99.7, sore arm down to fingers, stuffy nose, watery eyes, headache, slight balance issues, malaise, no appetite, slight nausea, tight chest, shortness of breath upon exertion, runny nose & eyes, extreme fatigue, & small chest pain. 03/12/2021 symptoms include: Temp 98.7, sore arm down to fingers, slight headache, slight balance issues, malaise, no appetite, slight nausea, slight tight chest, shortness of breath upon exertion, runny nose & eyes, extreme fatigue. 03/13/2021 symptoms include: Temp 97.7 (my normal), sore arm down to fingers, malaise, no appetite, slight nausea, slight tight chest, slight shortness of breath upon exertion, runny nose & eyes, extreme fatigue. 03/14/2021 symptoms include: Temp 97.7 (my normal), sore arm down to fingers, malaise, slight appetite, slight nausea, slight tight chest, slight runny nose & eyes, extreme fatigue. 03/15/2021 symptoms include: Temp 97.7 (my normal), sore arm down to fingers, malaise, slight tight chest, slight runny nose & eyes, extreme fatigue. 03/15/2021- 04/10/2021 symptoms include: Temp 97.7 (my normal), fatigue & slight malaise at times.

A few hours after receiving the "Janssen COVID-19 Vaccine EUA" I started to experience the following side-effects: headache, fever, muscle aches, tired and weakness. I also felt a little dizzie. I monitored my temperature thoughout the night; I recorded at 7:54pm 99.7; 9:23pm 99.2; 10:45pm 99.8; and at 6:00 am on 4/9 my temperature was back to normal at 97.5. The muscle ache were gone and the headache was mild. I do still feel a little dizzie and weak.

This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included rheumatoid arthritis, 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: 042a21a, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced tiredness. On 01-APR-2021, the subject experienced subject could not lift things (strength loss). On 01-APR-2021, the subject experienced pain in arm. On 01-APR-2021, the subject experienced muscle ache. On 01-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on APR-2021, and had not recovered from muscle ache, pain in arm, patient could not lift things (strength loss), and tiredness. This report was non-serious.

Mild reaction the following day including fever, fatigue, pain in joints. No treatment and symptoms went away in a few hours. Tested positive for Covid 19 on March 19, 2021.

Swollen lymph nodes in groin (1 day)and underarms and under jaw (2 days), headache(2 days), loss of appetite (2 days), muscle aches(1 day), feeling very tired(1.5 days) Treated with acetaminophen and rest. Symptoms mostly resolved by end of 2nd day

Experienced all common symptoms as well as other I have not heard of. Mental fogginess began at 8 PM (8 hrs after shot) and lasted until late the next evening Chills began at 8:30 PM and continued until early Friday AM. There were also a few instances of hot flashes in between the chills. About 10 hours after the shot the following began: headache (I rarely get headaches), nausea, muscle aches - mostly my quadriceps, low back pain, pain in the back of my neck, general lethargic feeling. These all lasted into Thursday evening, except the low back pain, which lasted into Friday AM. I felt a dull pain in all my back teeth that lasted about a day and was intermittent. See page 2 for more.

Pain of lower extremities; SHORTNESS OF BREATH; WEAKNESS OF THE UPPER ARMS; WEAKNESS OF LEGS; Chills; Fever; VIBRATION SENSE ON BOTH LEGS; Chest tightness; STIFFNESS/TIGHTNESS OF LEGS; This spontaneous report received from a consumer concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies and no 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: 1805029 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced vibration sense on both legs. On 09-MAR-2021, the subject experienced chest tightness. On 09-MAR-2021, the subject experienced stiffness/tightness of legs. On 09-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.1 F. On 16-MAR-2021, the subject experienced weakness of legs. On 23-MAR-2021, the subject experienced weakness of the upper arms. On 04-APR-2021, the subject experienced shortness of breath. On an unspecified date, the subject experienced pain of lower extremities. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest tightness, chills, and fever on 10-MAR-2021, and had not recovered from vibration sense on both legs, shortness of breath, weakness of legs, weakness of the upper arms, stiffness/tightness of legs, and pain of lower extremities. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as Non serious.

2 hours after I received the vaccination, I came down with severe chills. My entire body was shaking and I could not get warm. I got extremely fatigued to the point that I could not get out of bed. I got a severe headache (and I get headaches a lot...this one lasted for almost 10 days). It seemed that every bone and muscle in my body began aching, from head to toes. My fever went up to almost 102. These symptoms continued for a course of four days, except the headache and fatigue (which lasted for approximately 6 days and the headache for 10 days). I alternated Tylenol, Advil and Alleve. They did not help hardly at all, unfortunately. 2 weeks later, I developed lymph node swelling in my right arm pit and alongside my right breast. Today, these lymph nodes are still swollen and are painful to the touch. I experienced pain at the injection site and if I touch it, it is still painful today, but does not ache like it did initially.

Feeling glooomy snd a little foggy in the head since day one. Tightness in my leggs thighs. Feeling warm not fever. Not as much on day 7

Swelling of the lymph nodes in the same arm of the injection for 3 days, used heating pad to sooth. Pain at the injection site for 2 days, used CBD oil around site of injection to sooth. headache, feeling very tired, muscle aches , chills and joint pain for 4 or 5 days. I took 2 Tylenol 325mg 2 different times. I already take Mobic for a slipped disc. Had just had a L3-L4 dorsal epidural steroid injection on 2/25/21. It negated the medicine. My sciatic leg pain is back in full force. I called my PCM for advice. They suggested I inform you.

Leg Pain: Bilateral; heavy and achy especially to lower legs. Having generalized weakness and lack of energy. Associated sx: sob with rest/exertion; worse with exertion and dry cough. Onset of sx over Easter weekend and continued without improvement. Reports she had her COVID19 Vaccine (J&J, March 20). Onset of sx approximately 15 days from J&J COVID vaccine. Further c/o increased edema to BLE. Usually wears her stockings but cannot tolerate them d/t pain. Reports family hx of CHF in mom. She further has a hx of varicose veins. Tx: labs and imaging - see below.

Sore arm at injection site and then a couple hours later started with fever, then red rash over top of body chest, arms rash felt like a burn, nausea, diarrhea, body aches all over, slight headache, tired- took tylenol ever four hours. Rash lasted until Sunday early evening, headache until Sunday morning, tired and aches lasted until Tuesday. Nausea and diarrhea on and off until Tuesday. Fever until Sunday afternoon. Pain in back rt side. About 1 hour after vaccine - chest tightness felt like asthma coming on, then it went away.

Initial reaction was noted on 8:00 PM 3/17. Jitteriness and fatigue on 3/17. Around 9:00 felt neck pain and it was hard to move her neck. The neck pain was severe 10/10. Still has problems with the neck. Her neck pain has improved but the pain is worse than it was before she had the vaccine.

Dizziness approx. 30 minutes after vaccination, spinning sensation 1hr after vaccination. Chills and shivering approx. 5 hrs after-- nausea-vomiting-102 fever, severe muscle, joint and headache. 5 1/2 hrs later. 36 hrs after shot side effects lessen. 72 hrs later weakness and fatigue. Day 4 these symptoms resolve. Five days after vaccine dizziness and muffled hearing in left ear which is unresolved.

CHILLS; FEVER; MUSCLE ACHES; FEELING TIRED; FEELING WEAK; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included lung transplant, and liver transplant, and concurrent conditions included hepatitis c. 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 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced muscle aches. On 08-APR-2021, the subject experienced feeling tired. On 08-APR-2021, the subject experienced feeling weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 09-APR-2021, and had not recovered from muscle aches, feeling tired, and feeling weak. This report was non-serious.

NAUSEA; HEADACHE; INJECTION SITE PAIN; BODY ACHE; ARM HURT; CHILLS; JOINT PAIN; MYALGIA; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 125 pounds, and height was 174 centimeters. The patient's concurrent conditions included no alcohol user, and non smoker. The patient experienced drug allergy when treated with tetracycline. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068 expiry: 25/MAY/2021) dose was not reported, administered on 10-MAR-2021 11:00 for prophylactic vaccination. Concomitant medications included ascorbic acid/calcium/minerals nos/retinol/tocopheryl acetate/vitamin b nos/vitamins nos/zinc for drug used for unknown indication, calcium carbonate/colecalciferol for drug used for unknown indication, vitamin c for drug used for unknown indication, alendronate sodium for osteoporosis, nebivolol hydrochloride for slow heart down, aloe vera, and chondroitin sulfate/collagen/glucosamine. On 10-MAR-2021, the subject experienced body ache. On 10-MAR-2021, the subject experienced arm hurt. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced joint pain. On 10-MAR-2021, the subject experienced myalgia. On 10-MAR-2021 15:00, the subject experienced nausea. On 10-MAR-2021 12:30, the subject experienced headache. On 10-MAR-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, arm hurt, chills, myalgia, nausea, joint pain, and injection site pain. and headache on 11-MAR-2021 This report was non-serious.

2 hours after receiving the vaccine, I grew exhausted and had to sleep into late evening and was chilled, had a fever of 101 and developed severe pain and inflammation on the top of my collar bone that was feverish and migrated toward my shoulder region on the same side as my vaccine. Ibuprofen would not help with the pain but helped with the fever. My mind told me that I had things to tend to the next day, but still was forced to sleep off and on for 2 more days. After a week and a half, not only did I have thirst, but also food didn't taste right and was metallic. This lasted for 2 days and finally my taste was restored. The exhaustion lasted off and on for 2 weeks and I just listened to my body. The pain and inflammation on my collar bone has subsided 4 days ago but still have pain in my shoulder when I sleep. On April 5 around 8:30 a.m. a nasty virus hit me out of the blue. I grew week and tired and had to go to bed. I slept all day until around 9:00 p.m. and woke to uncontrollable diarrhea and fainting spell while in the bathroom. I had abominable pain and nausea that last for a half hour and then I returned to bed. The next 2 days, I was week and exhausted but continued with my regular routine. My equilibrium is still affected from time to time.

STABBING PAIN IN STOMACH; NAUSEA; INJECTION SITE SORENESS; FEVER; LOSS OF 5-6 POUNDS; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, penicillin allergy, and keflex, tylenol and asprin allergy. The patient experienced difficulty in breathing when treated with hydrocodone bitartrate/paracetamol, and hives when treated with naproxen sodium, erythromycin, and swelling of the face when treated with magnesium sulfate. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: 21-JUN-2021) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced loss of 5-6 pounds. On 01-APR-2021, the subject experienced stabbing pain in stomach. On 01-APR-2021, the subject experienced nausea. On 01-APR-2021, the subject experienced injection site soreness. On 01-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site soreness, and fever on 03-APR-2021, had not recovered from nausea, and stabbing pain in stomach, and the outcome of loss of 5-6 pounds was not reported. This report was non-serious.

Frontal lobe headache to start within a few hrs of vaccine. Back of the head to lower neck headache 8 hrs after. Every tooth in my mouth started throbbing at around 11 hrs and continued for about 5 more hours. Also during that time, waves of nausea but no vomiting, also uncontrollable shivering but I wasn't cold and I wasn't hot but weird shivering. I did not take my temperature as I didn't feel like I had a fever. Around 13 hrs after a stabbing pain in front of thighs like hot pokers started and around 14 hrs thigh pain was still present but then the calves on both legs started to get the same stabbing pain. At around 24 hrs after - headache remained, pulsating teeth stopped, thigh pain stopped but calf pain remained. Headache remained off and on for several days. General brain fog also lasted for about 1 week. The calf pain comes and goes even after 2 weeks. Arm where shot was administered was very tender to the touch for the last 2 weeks. Lastly, I wouldn't say I had shortness of breath but at times I just felt like I needed to stop and force myself to take a very deep breath.

SPEECH PROBLEM/SLUTTER; LACK OF MEMORY (FORGET THINGS); WEIGHT LOSS; HIGH BLOOD PRESSURE 172/95 SOMETIMES 180; RASH ON HER FACE; CHILLS; PAIN IN RIGHT ARM AND RIGHT LEG; This spontaneous report received from a patient concerned a 62 year old female. 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: 1805020 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced speech problem/slutter, lack of memory (forget things), weight loss, high blood pressure 172/95 sometimes 180, rash on her face, chills, and pain in right arm and right leg. Laboratory data (dates unspecified) included: Blood pressure high (NR: not provided) BLOOD PRESSURE 172/95 SOMETIMES 180. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in right arm and right leg, weight loss, chills, lack of memory (forget things), speech problem/slutter, rash on her face, and high blood pressure 172/95 sometimes 180. This report was non-serious.

MUSCLE SPASMS; STIFF NECK; TIGHTNESS IN THROAT; MUSCLE TWITCHES; HEAVINESS IN LIMBS; LOW GRADE FEVER; ARM PAIN; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 62 year old female. 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, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced arm pain. On 07-APR-2021, the subject experienced injection site pain. On 08-APR-2021, the subject experienced stiff neck. On 08-APR-2021, the subject experienced tightness in throat. On 08-APR-2021, the subject experienced muscle twitches. On 08-APR-2021, the subject experienced heaviness in limbs. On 08-APR-2021, the subject experienced low grade fever. On 12-APR-2021, the subject experienced muscle spasms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stiff neck, and heaviness in limbs on 10-APR-2021, had not recovered from low grade fever, injection site pain, muscle spasms, arm pain, and muscle twitches, and the outcome of tightness in throat was not reported. This report was non-serious.

RAISED RED MARK IN THE AREA OF SHOT; AREA OF SHOT HURT; HEADACHE; TIREDNESS; PAIN IN THE NECK; BITTER TASTE IN THE MOUTH; NASAL DRIPPING; DRIPPING BACK OF THROAT; SWELLING OF TONGUE; SORENESS OF BODY; DIFFICULTY IN BREATHING; PAIN IN RIGHT ARM; CHILLS; SHOULDER HURT; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included hip surgery, and knee replacement, and concurrent conditions included atrial fibrillation, hypertension, diabetes, gastrooesophageal reflux disease, rheumatoid arthritis, multiple myleloma, egg allergy, non-smoker, and non alcohol user, and other pre-existing medical conditions included the patient did not had any drug abuse or illicit drug use. The patient experienced drug allergy when treated with diphenhydramine hydrochloride. 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 10:00 for prophylactic vaccination. Concomitant medications included apixaban for atrial fibrillation, metformin for diabetic, torasemide for diuretic, omeprazole for gastrooesophageal reflux disease, pantoprazole for gastrooesophageal reflux disease, amlodipine for hypertension, eplerenone for hypertension, sodium perborate monohydrate for hypokalemia, paracetamol for rheumatoid arthritis, atorvastatin, and ubidecarenone. On 08-APR-2021, the subject experienced pain in the neck. On 08-APR-2021, the subject experienced bitter taste in the mouth. On 08-APR-2021, the subject experienced nasal dripping. On 08-APR-2021, the subject experienced dripping back of throat. On 08-APR-2021, the subject experienced swelling of tongue. On 08-APR-2021, the subject experienced soreness of body. On 08-APR-2021, the subject experienced difficulty in breathing. On 08-APR-2021, the subject experienced pain in right arm. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced shoulder hurt. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced tiredness. On 12-APR-2021, the subject experienced raised red mark in the area of shot. On 12-APR-2021, the subject experienced area of shot hurt. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bitter taste in the mouth, nasal dripping, dripping back of throat, swelling of tongue, and difficulty in breathing on 08-APR-2021, and chills on 12-APR-2021, was recovering from raised red mark in the area of shot, and area of shot hurt, and had not recovered from headache, pain in the neck, pain in right arm, tiredness, shoulder hurt, and soreness of body. This report was non-serious.

HOT FLASH; NAUSEA; JOINT PAIN/JOINT BURNING; FOGGINESS; VOMITING; FACIAL REDNESS; METALLIC TASTE; APPETITE LOST; SWOLLEN TONGUE; PAIN TONGUE; PEELING TONGUE; ADVERSE REACTION; LOSS OF TASTE; This spontaneous report received from a patient concerned a 62 year old female. 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: 04DDZ1D expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced hot flash. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced joint pain/joint burning. On APR-2021, the subject experienced fogginess. On APR-2021, the subject experienced vomiting. On APR-2021, the subject experienced facial redness. On APR-2021, the subject experienced metallic taste. On APR-2021, the subject experienced appetite lost. On APR-2021, the subject experienced swollen tongue. On APR-2021, the subject experienced pain tongue. On APR-2021, the subject experienced peeling tongue. On APR-2021, the subject experienced adverse reaction. On APR-2021, the subject experienced loss of taste. The dose of covid-19 vaccine ad26.cov2.s was increased. The outcome of the hot flash, nausea, joint pain/joint burning, fogginess, vomiting, facial redness, metallic taste, appetite lost, swollen tongue, pain tongue, peeling tongue, adverse reaction and loss of taste was not reported. This report was non-serious.

ARMPIT SWELLING; ARMPIT PAIN; SORE ACROSS THE SHOULDER; This spontaneous report received from a patient concerned a 62 year old female. 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, and expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 (Vaccinated in left arm) for prophylactic vaccination. No concomitant medications were reported. On 28-MAR-2021, the subject experienced armpit swelling. On 28-MAR-2021, the subject experienced armpit pain. On 28-MAR-2021, the subject experienced sore across the shoulder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the armpit swelling, armpit pain and sore across the shoulder was not reported. This report was non-serious.

MIND FOGGY; SHORTNESS OF BREATH; HEART RACING; UNABLE TO MOVE AROUND; CHILL; FATIGUE; FEVER; MUSCLE PAIN; VERY RED VEINS ON RIGHT LEG LOWER PART/RED VEINS ON LEFT ARM LOWER PART BETWEEN WRIST AND ELBOW; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, and other pre-existing medical conditions included patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced very red veins on right leg lower part/red veins on left arm lower part between wrist and elbow. On 06-APR-2021, the subject experienced shortness of breath. On 06-APR-2021, the subject experienced heart racing. On 06-APR-2021, the subject experienced unable to move around. On 06-APR-2021, the subject experienced chill. On 06-APR-2021, the subject experienced fatigue. On 06-APR-2021, the subject experienced fever. On 06-APR-2021, the subject experienced muscle pain. Laboratory data included: Pulse rate (NR: not provided) 92 /min. On 16-APR-2021, the subject experienced mind foggy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chill, fatigue, fever, and muscle pain on 08-APR-2021, was recovering from shortness of breath, and unable to move around, and had not recovered from heart racing, mind foggy, and very red veins on right leg lower part/red veins on left arm lower part between wrist and elbow. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard operating procedures, as the case was assessed as non-serious.

The day after my J&J vaccine, I experienced left leg and knee pain with numbness sensation. I had a left knee replacement in September 2020. I experience numbness below and above my knee cap. I also experienced bad migraines , arm soreness at the injection site. I called my doctor and he gave me an appointment to see him and he did not think it was related to the vaccine but he was not sure since I do have history of rheumatoid arthritis. Today my left knee and leg still feel numb and I am taking my regular medications as instructed.

Patient was seen in my office by me on April 27th. She reports having left leg pain discomfort which started 3 days after receive Johnson and Johnson COVID vaccine. She denies swelling or any other associated symptoms. I ordered Venous Duplex which was done today and revealed b/l femoral DVT. Patient immediately started on Eliquis .

Guillain Barre Syndrome. Leg weakness one week following vaccine. Hospitalized. Treated with IVIG. Improved with leg weakness only sequela.

Exhaustion, weak balance, foggy brain within 24 hrs. of vaccination. Neck pain (right side) within 1st week.

My both hips started hurting approximately 24-48 hrs after vaccine. I have had pain , sharp and dull, in both my hips when I walk, and they feel stiff too. I have had to take Motrin ever since. I started taking glucosamine with joint shield ever since with some relief.

Janssen COVID-19 Vaccine EUA Extreme chills and quaking, despite 3 blankets and two heating pads, occasional jerks of my body -within 7 hours. Lasted 20 hours or more. Fatigue- unable to walk myself to bathroom within 8 hours, lasted two or more days. Very weak. VERY Severe Headache, including facial pain, neck pain, temple pain and eye sockets , stared 7 hrs, lasted two days Severe nausea, I actually thought of food poisoning (but it wasn't). Approx. onset 9 hours. Very painful body aches and muscle spasms throughout my body but especially my Back, underarms, legs, feet. Approx. onset 7 hours. lasted 48 to 60 hour Diabetic Ketoacidosis approx 30 hours after. Wasn't able to eat, blood sugar remained in the 150 to 180 area. Managed to eat 2 TBsp of applesauce to reduce ketones, (which worked) Fatigue unable to work until 5 days later.

VERY LOW TEMPERATURE; VERY LIGHT-HEADED; LIPS WERE COLD; MUSCLE SORENESS; CHILLS; HEADACHE; BODY ACHES /LITTLE SORE; FEELING WORSE; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 170 pounds, and height was not reported. The patient's concurrent conditions included depression. 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 06-MAY-2021 13:00 for prophylactic vaccination. Concomitant medications included bupropion hydrochloride for depression. On MAY-2021, the subject experienced body aches /little sore. On MAY-2021, the subject experienced feeling worse. On 06-MAY-2021, the subject experienced headache. On 07-MAY-2021, the subject experienced chills. On 07-MAY-2021, the subject experienced muscle soreness. On 08-MAY-2021, the subject experienced very low temperature. On 08-MAY-2021, the subject experienced very light-headed. On 08-MAY-2021, the subject experienced lips were cold. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 94 F. Treatment medications (dates unspecified) included: naproxen sodium, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, chills, muscle soreness, body aches /little sore, lips were cold, very low temperature, very light-headed and feeling worse was not reported. This report was non-serious.

Extreme muscle aches and joint pain throughout the entire body which started in the evening. I did not sleep well with the pain with not being able to lay on my sides as my arms would go numb and I hurt terribly the next day until the afternoon when I took two Advils.

I have MS and I was having some stomach issues and they said it wouldn't be a problem but I ended up in the hospital for 5 days then in rehab. I woke up about 2am after vaccine and when trying to go to bathroom my legs gave out and I hit the floor, we called EMS to get me up and I was really weak. My legs were gone the rest of the night and I couldn't stand my husband had to help me . On the 24th, we called the EMS to take me to the hospital and they sent me to rehab and I got out of there on the 28th to home but I do not have my strength back.

First I had the itching and I came home and took a Benadryl and it subsided. The next day, I woke up stiff as a board. Everything hurt. Like I remember having the flu - feeling you get when joints etc. hurts all over. I took Tylenol - maybe took 1000 mg twice in that day. I have fibromyalgia and this was over and above that. The third day, the injection site on arm really hurt. The fourth or fifth day, the cough started - first a little irritation and then I started coughing and rattling and I have had the cough ever since. I have seen my doctor four times in the last month to get medications that work. I had to go to the walk in (Urgent Care at the clinic on Weekends) this Saturday (5/15/2021) and get this new medication that seems to be working - it's a steroid - it's Levaquin . Although, yesterday, I still had that overall body hurt (I was in bed all day) - could have been side affect of medication but today (after two doses) seems to be better and I'm not coughing as much.

Old injuries are flaring up again. In 2010, I dropped a 45-pound Olympic weightlifting bar from overhead onto my foot and fractured 3 bones. That was treated and healed (cast and flexible cam walker). In 2013 I had surgery on my left wrist for Derkervains. That healed up just fine also. All of the sudden, both past injuries have flared up again. I had foot pain so bad that I couldn't walk for a day. An Xray shows no damage. Yesterday, my wrist has flared up and is very painful. I have not seen a doctor about that. My foot is improving. I think it will bounce back. I now suspect that my wrist will also improve. My hypothesis is that the vaccine has challenged my immune system enough that old injuries are flaring up and then calming back down again. It's very odd. I don't know if it's significant, but thought I should report it, in case my experience matters.

Starting 3/21/2021 Pain, right knee, thumb swelled, terrible joint pain, muscle pain, tendon pains in legs and arms, knee is still swollen. Severe fatigue. In physical therapy

Four weeks after the vaccine my knee buckled when I was just walking around my house. I then started to have pain in my knee. I went to the quick care clinic three days after. The professional told me it was just sprained. I was referred to an Orthopedic Specialist and he diagnosed the Baker's Cyst. I have been diagnosed with a Baker's Cyst. I have had my knee cap replaced in August of 2018 with no problems like tis since the replacement. I am scheduled to receive Physical Therapy to help with it. I was advised to lower my walking activity.

COMPUTERISED TOMOGRAM; ELECTROCARDIOGRAM; LABORATORY TEST; PULMONARY EMBOLISM; X-RAY; PAIN ON THE RIGHT-HAND SIDE UNDER MY RIBS; MYALGIA; ULTRASOUND SCAN; LUNG COLLAPSED; FLUID IN THE BOTTOM OF HER LUNG; This spontaneous report received from a patient via Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) and concerned a 62-year-old female patient. The patient's height, and weight were not reported. The patient's concurrent conditions included depression, and penicillin allergy. The patient had no current illness. The patient had no heart problems, no pulmonary problem and diabetes. The patient experienced drug allergy when treated with paracetamol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 206A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 11-APR-2021 to left arm for prophylactic vaccination. Concomitant medications included levomilnacipran hydrochloride for depression, and quetiapine fumarate for depression. On an unspecified date in APR/2021, little more than a week after single-dose coronavirus vaccine at hospital facility the patient felt general malaise and minor pain in her right side. The patient had shortness of breath, and she looked anxious and her heart rate was very fast. The vital signs were not stable. The physician suspected that patient had developed pulmonary embolism blood clots in her lungs. When combined with her vitals, the doctor knew it was an emergency. The patient also began to feel mildly ill. She was experienced general malaise, soreness on her right side, and while she was not struggling to breathe, it hurt when she took a deep breath, her right-hand side, like under her ribs, she felt some pain. It was not a bad pain, not enough to take anything for it but just noticed it. The symptoms seemed minor, and at the time. It was reported that by 21-APR-2021, she still was not feeling well and decided to make an appointment at the urgent care center. The patient visited emergency room or department/urgent care facility for treatment of the events. The patient soon learned she had developed blood clots (pulmonary embolism) in both lungs due to the vaccine, a doctor at the hospital told her. One of her lungs also had collapsed. She had developed blood clots in both lungs due to the vaccine, she was there for 10 hours (undergoing tests). The patient underwent a computerized tomography scan and an X-ray. They did everything and got the results of the CAT scan, with pulmonary embolism in both lungs. They immediately gave her some blood thinner and was as hospitalized (date unspecified). It was reported that she would spend five days in the hospital. According to the doctors this was from the vaccine. The patient was also experiencing the pain on the right-hand side and also started getting myalgia, muscle aches just in different parts of her body. The patient's legs also felt weird. So they rushed her down and gave a sonogram in her legs to check for deep vein thrombosis. The pain on her right side grew worse for a day or two, and she was treated with morphine. The doctors surmised the patient had fluid in the bottom of her lung, which her body eventually absorbed. The patient was still on a blood thinner and continued to recover. Laboratory data included: Heart rate (NR: not provided) very fast, and Sonogram (NR: not provided) Not provided. On an unspecified date in APR-2021, Laboratory data included: Computerised tomogram (NR: not provided) pulmonary embolisms in both lungs, Electrocardiogram (NR: not provided) Not provided, Laboratory test (NR: not provided) Not provided, Ultrasound scan (NR: not provided) Not provided, and X-ray (NR: not provided) Not provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pulmonary embolism, had not recovered from computerised tomogram, electrocardiogram, laboratory test, ultrasound scan, and x-ray, and the outcome of myalgia, fluid in the bottom of her lung, lung collapsed and pain on the right-hand side under my ribs was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). Additional information was received from company representative via social media on 18-MAY-2021. The following information was updated and incorporated into the case narrative: patient's city added, events added (pain on the right-hand side under my ribs, myalgia, lung collapsed, fluid in the bottom of her lung), CT scan result updated, lab data updated (Heart rate and Sonogram).; Sender's Comments: V1: The follow up information in this version updates Patient's city, events (pain on the right-hand side under my ribs, myalgia, lung collapsed, fluid in the bottom of her lung), CT scan result updated, lab data updated (Heart rate and Sonogram). The follow up information received in this version does not alter the causality of the previously reported events 20210514298-COVID-19 VACCINE AD26.COV2.S-fluid in the bottom of her lung, pain on the right-hand side under my ribs: These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events. 20210514298- COVID-19 VACCINE AD26.COV2.S-myalgia. This event is labeled per RSI and is therefore considered potentially related. 20210514298-COVID-19 VACCINE AD26.COV2.S-Pulmonary embolism, computerized tomogram, electrocardiogram ,laboratory test, ultrasound scan, X-Ray: These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.

Immediate reaction = headache 4 hour reaction = increasing fatigue, headache 12 hour reaction = headache, joint aches, fatigue, fever 101.4 24 hour reaction = headache, fever gone, excessive fatigue and joint and muscle aches 24-72 hour reaction = headache, excessive fatigue, joint and muscle aches, bloating with intestinal discomfort Day 5 - 96 hour - symptoms improved, mild fatigue and joint aches, mild headache, able to do daily activities Day 5 - 10 pm = fatigue, headache, and joint aches increased Day 5- 11 = extreme excessive fatigue, joint and muscle aches, bloating and intestinal discomfort, mild headache - unable to work or perform daily activities Day 11- 17 symptoms improved slightly to allow some resumption of daily activities, intestinal symptoms include alternating diarrhea with constipation, joint and muscle aches prevent any return to walking and exercise, minimal work tasks completed Day 17-22 Symptoms the same as week before - becoming chronic - visit to MD on April 29th. Day 23-47 Treated with combination of Zyrtek, Pepcid, and Probiotic due to sensitivity to steroids. Symptoms gradually improved Day 48 (May 22nd) - first full day of ability to resume normal activities, including walking 2 miles (previous to vaccine was running 3-4 miles 3-4 times a week)

Patient reported full body joint aching stating that she could barely move the night of her vaccination. The aching is slowly resolving.

It started with body aches, headache and sore arm at injection site. Left side -left leg started getting swollen - it started in middle on knee part - the swelling went down my leg to my ankle and up my leg; up my thigh . It was like there was fluid in my leg. There was no pain. It went like that for 1 1/2-2 months. Just had to let it run it's course. I was being treated for it and had tests run to test for blood clot. She prescribed 800 ibuprofen for it; that didn't work. That same day of the vaccine, I also broke out with a fever - 102. And fever blisters all over my mouth. I had those for about a week.

JOINT PAIN; SORE ARM; MUSCLE ACHES; HEADACHES; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included hit by a drunk driver when was 20, and concurrent conditions included osteoarthritis, and body aches. 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 03-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-JUN-2021, the subject experienced joint pain. On 03-JUN-2021, the subject experienced sore arm. On 03-JUN-2021, the subject experienced muscle aches. On 03-JUN-2021, the subject experienced headaches. On 03-JUN-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle aches, headaches, joint pain, and sore arm, and the outcome of injection site pain was not reported. This report was non-serious.

Patient received J and J covid vaccine on 3/7/21. She did not feel well for the next few days and had the following symptoms: headache, fatigue, nausea, body aches, loss of taste. She recovered after a few days and was doing well until 6/11/21. She began having the following symptoms: migraine headache, nausea, dizziness, loss of appetite, blurred vision, weakness, loss of taste, muscle weakness and joint pain. She went to ER on 6/13/21. They did a cat scan and ekg, both came back normal. They did not do a covid test. She then went to her regular Dr. on 6/15/21 and he gave her topiramate. He did not do a covid test. She was off work for a week and returned to work on 6/18/21. She is feeling better now and has worked for the last two days. She came to pharmacy and told me what was happening and she thinks that her symptoms are from the original J and J covid vaccine on 3/7/21 and she is worried that she may have recurring symptoms for the vaccine

Swelling, redness and soreness and a knot in vaccine site for a month. As of today I still have a knot under the injection site and soreness. Cannot sleep on that arm and some pain with active or not. Achy joints and fatigue.

Fever, Chills, Headache, Muscle pain, extreme fatigue for 8 days. Continued with chills and extremem fatigue for 8 more days

Pain and burning on L side (arm, shoulder, neck, face, ear, back), headaches, brain fog, anxiety, twitching, spasms, neuropathy in feet, low appetite, fatigue, weakness, tired eyes, blurry vision, heart palpitation when lying on either side at night, hypo thyroid

Right after you received the vaccine on 03/31/2021, it was painful, but I thought it was just a shot pain, put I thought it was extremely painful. On my drive home it kept hurting. Finally on 04/17/2021, I was concerned because that was the time the media was mentioning blood clots from the vaccine. Because my arm, my shoulder hurt, and under my arm still continued to hurt I went into the ER. The doctor did not feel any abnormality in my arm. Till this day I still feel soreness in your arm and shoulder and under my arm. I can't extend my arm or use my arm. I use it cautiously, if I use it. I have had 3 or 4 visits with my doctor and she put me on methylpred 4 mg/ triage pack. It helped somewhat with the pain, but I still had soreness. So she prescribed Methocarban 500 mg. I just took it for 3 days. and it upset my stomach and gave me diarrhea . Now I have an MRI that is scheduled, but I don't know when at this point. I have to see if my insurance will cover it. I'm still pursuing to see why my soreness is persisting.

On June 14 I woke up with dry and sore throat the next day ears, eyes,head and body ache started. I waited 4 days and didn?t feel any better decided to visit my Dr. She didn?t find any infection she still gave antibiotics just Incase after two sets of antibiotics and pain medication I still feel the same I am hurting all over and am extremely tired all the time I have sharp pain shooting from back of my neck to the bottom of my scalp and my shoulders. My legs are heavy and tired. Over all I don?t feel good at all. It has been a month and not much improvement. I tested negative for covid about two weeks ago.

headache, left side of face was numb, tingling, weak right leg. this was all within a few days of receiving vaccine. I am now 3 months in, and continue with facial numbness on both sides of face, and weakness in right leg. These symptoms come and go, but I have them frequently. I might be a few days between the symptoms, but they always come back.

Itching and soreness at injection site 03/07/2021 Arthritis pain worse than usual 03/07/2021 Nausea 03/07/2021 Fatigue 03/07/2021

Severe chills, body ,muscle, joint aches, fever and sweats. Some stomach cramping . These all lasted 7 hours. Next day still body aches, headache and fatigue.

In the evening I started to feel aches in my eyes and joints. I was having trouble falling asleep. I woke up every 2 hours. My heart bpm went up to 102 in the middle of the night. I know this because my fit bit was vibrating and encouraging me to keep exercising and I was just laying in bed trying to sleep. I finally got up around 2:30 in the morning and took 1 Aleve. I also took my temperature with a forehead type and it was 98.5, so no high fever. I took another Aleve around 7:00 in the morning. Now I am feeling fine. It's now 8:22 a.m. and I am working from home. I just wanted to report that the aches in joints and 102 bpm and unable to fall asleep were my side effects. I feel fine now. I will continue to take Aleve as needed. I have never been tested for Covid. I have never had any symptoms to warrant testing for covid. Since March 13, 2020 I have been fortunate to work for a company that has us all working from home. We are still working from home. i am 63 years old. I shop around 6 a.m. in the morning for groceries to avoid people. I do not go out. I have been very careful.

Day 1 - received injectionwithin a fe minutes of administration I noticed a slight lightheadness and feeling "off" within half hour slight nausea began and headache began within hour muscles aches began with joint pain. Above symptoms progressively worsened by midnight was in pain and could not sleep. no fever. took tylenol and only had moderate relief. Day 2 -entire day severe muscle and joint pain - worst headache of my life, severe nausea and chills - no fever. double vision and dizzy Day 3 - same as day 2 - in evening - around 7 pm headache lessened so that it was tolerable with tylenol - muscle aches jopint pain the same Day 4 - headache tolerable, was able to eat. muscle pain better but joint pain still sharp Day 5 - headache sporadic and better - fatigue and muscle pain would come and go, joint pain not as sharp, extreme fatigue Day 6 - extreme fatigue - other symptoms much better

My symptoms were muscle aches and pains, headache and nausea. it started about 10 hours after the injection and lasted about 36 hours. Thereafter I was just very tired for 24 hours. I took an Advil about 10 hours (around noon) after the headache set in, which lessened the headache.

6:20pm Chills with uncontrollable shaking, headache, muscle aches. Took 2 ibuprophen. Went to bed. Headache continued. 9:30pm Started having chills again along with headache and muscle aches. Took 2 Tylenol. Fell asleep. Woke around 11:30pm with a pulse of 112bpm (which normally would have been 58bpm) and a headache. Fell asleep. Woke around 6am with a headache. Got up around 11am. Still feel tired.

Starting at 0100 on 03/11/2021. Awoke with symptoms of fever with chills, headache, neck and back pain (moderate to severe), pain in what seemed the bones of the skull and mandible (moderate to severe), nausea and vomiting, unable to take fluids, unable to sleep besides 60 mins. 24 hrs post vaccine. Vomiting lasting 12 hours and nausea continued without ability to take fluids. Dr. prescribed Zolfan and after the first dosage, fluids were tolerated. Fever lasting less than 48 hours, muscle soreness was mild by 48 hrs and continues as mild at this point, 78 hrs hrs post vaccine.

5-6 hours after vaccine-mild muscle aches, temperature elevated but above 100. About 8 hours after injection, muscle ached and so was chilled but felt ok otherwise. FitBit alerted me that I was earning points for being in my ?active zone? even though I was just watching tv - resting heart rate is 66 (actively exercising, heart rate is usually less than 120) but it was 136+. HR stayed elevated ( Verified HR with pulse oximeter) while I was not doing anything. Took temperature (forehead thermometer) and it was 103F. Took Tylenol. Heart rate slowly went down after Tylenol kicked in and fever came down to 101. Heart rate stayed a little higher than normal and fever lasted 24 hours. By 48 hours, all was well.

Janssen COVID-19 Vaccine EUA Severe pain developed about 6 hours following injection in central region of upper back, and at lowest ribs. Moderate pain developed in mid-abdomen. Duration of pain 8-12 hours. Unusual fatigue developed about 6 hours following injection, duration of fatigue about 5 days.

At the time of injection I felt a pressure pain radiating diagonally downward toward my armpit. Where she injected me was very high up on my arm almost close to the top. The pain at injection site was quite sore for the first few days and then went away for the most part for a day or two but has now come back much worse. It hurts to lift my arm or move it and feels like I've lost strength to raise my arm. I am in constant pain now and my arm around the injection site is painful when I press down especially on the bony area.

March 13, 2021-1:30pm-Shot administered to right arm-it bled and the nurse had to apply pressure with an alcohol swab. It stopped immediately. 1:40-started feeling a tightness in the muscle in my neck under my right ear Stayed a few minutes longer than the required 15 to see if anything else presented. Mentioned it to the nurse and rep. The rep asked if I was nervous about getting the shot. When I said yes, he said it may just be that. Told me to contact my doctor with additional issues. 1:55-When leaving the parking lot, I felt my lips and nostril on the right side go numb-it felt like when Novocain is wearing off after a dentist visit. As the day progressed, the area under my ear and down my neck got more and more sensitive. My lips continued to feel numb. My injection site was tender and black and blue. When I went to bed at 9pm, I began experiencing lots of pain in my right lower jaw. I took a Tylenol but it didn't alleviate the pain. I called on-call doctor. Since I already had taken a Tylenol, he suggested an anti-inflammatory and warm moist compresses and to contact him again if things worsened. 3/14/21-7:00am-Upon awaking, my jaw pain was virtually gone but the whole area I had had the issue with was very tender to the touch. My lip still felt a bit numb. 3:25pm- It is now 26 hours since my vaccination. I still feel like I had trauma to the right side of my face and neck because it is sensitive to the touch. I also have a continued slight sensitivity of my lips on the right side. My glands on both sides of my neck now seem tender, as well. 3/15/21-3/17/21-I continue to have random pain/tenderness in the aforementioned areas. I also have an aura of tingling in my brain from time to time.

Pain at injection site persisted for ~1 hr; 3 hrs. post vaccine -> mild headache; 6 hrs. post vaccine -> serious migraine with myalgia focused on neck and upper back and chest muscles (muscle knots developed and could be felt) -> slight fever (0.6 degrees F above normal); 7 hrs post-vaccine -> serious chills that shook entire body and would not stop for 30 minutes (similar to the kind I had when I had hypothermia at age 18); 8 hrs post-vaccine -> nausea; I took tylenol then and within 45 minutes everything except headache, myalgia and muscle knots, and nausea went away. Vomited in middle of the night. Felt very drained and tired with myalgia all of the next two days. Majority of symptoms went away after that but I felt as if I was coming down with a cold for the next 7 days - today my nose has been running all day and I have a stuffed head (and I have not had a cold since November 2019). I had a covid test yesterday because I need to accompany my husband for a medical procedure on Friday - that was negative. I have seen no one, gone nowhere, and done nothing different since I received my vaccine than I had beforehand yet I am displaying symptoms normally associated with a cold although I have no fever.

Fatigue, aches, nausea, cotton mouth, headache, wheezing, loosing voice, and arms and legs feel heavy. Called doctor the next day (the 16th) for medical advise, was told to drink coffee and take tylenol due to aspirin allergy.

chills for approximately 12 hours, thru the night; back muscular pain for same amount of time. weak.

Approximately 3 hours after my injection I became very lethargic and my heart began to race. I had fever of 101 and became very weak and tired. I experienced nausea, pain in my upper back and my heart raced for approximately 10 hours. On Tuesday, March 16, 2021 I slept on and off for the entire day and continued to have a fever. My heart rate came down within 24 hours after my injection and the fever came down to normal 36 hours after the injection. I felt weakness for approximately 3 days after the injection. I am currently recovered from all symptoms as of March 22, 2021.

Just walked in the house from work. Sudden total numbness of left arm. Had hard time speaking, words were slow coming out and were slurred. After about 10 minutes the numbness gave way to weakness. The speech was improving but slurred slightly for another 20 minutes. Checked out by emt's and paramedics, then husband drove me to hospital.

Received the J+J Janssen vaccine on Sunday 3/14/21. On Friday 3/19/21 developed bilateral lower leg discomfort and red spots on outer part of shin. On Sunday 3/21/21 noted increase in swelling both feet and lower legs with pain and rash waist down. Patient went to ER for evaluation. Started on prednisone. Dx: Vasculitis On Monday 3/22/21 evaluated by PCP. Follow up blood work and office appointment in 8 to 10 days. Report to VEARS. Awaiting patient call back to complete form. On Wednesday 3/24/21 patient returned call. Reports joint aches, right side decreased swelling, left foot and hand remains slightly swollen. Purple skin discoloration remains on lower extremities but decreased pain. VEARS form submitted.

On 3-22 11 days after vaccination), patient presented with lower extremity weakness and uper extremity paresthesias

Slight soreness in right arm. Headache (which lasted 2 days), nausea, muscles aches, fatigue (which lasted 12 hours or so).

Saturday after shot: felt fine afterwards; no soreness in arm, no other effects. Sunday after shot: started feeling lightheaded/dizzy in the evening; headache Monday -- Friday: fatigue, muscle ache, lots of congestion (nose/lungs) and deep bronchial cough, intermittent headache, intermittent low grade fever -- unable to work. Saturday-today after shot: still fatigue but better; congestion better as well--still congested but cough is relieved (saline nasal rinse helped a lot); no headache; no fever

Severe chills, fever, headache, neck pain, bad taste in mouth, severe nausea, dry retching and abdominal pain. The severe nausea and abdominal pain continued for 1 1/2 days. I still have some nausea and intermittent abdominal pain.

Backache (moderate), stiffness in legs (moderate), cold chills with shaking (moderate), Headache (mild) Side effects gone by morning of 4/2/21. Note: legs are most affected by MS, though mild. Still ambulatory. Thinking legs were affected due to existing weakness from MS.

vaccine received April 1 in left arm. On April 2, after sitting normally while watching TV, I experienced severe pain in my left wrist joint, heaviness, along with limited range of motion due to pain. Massaging relieved some of the pain.

Area around injection site firm, red and tender and remains that way as of 04/04/2021. Also had joint pain and fatigue.

Severe headache, chills and fever, muscles aches, muscle spasms. Headache, chills and fever lasted until about 5am 4/2/2021. Muscle spasms lasted until about noon on 4/2/2021 and muscle aches lasted until about 7am 4/3/2021. Took Tylenol which didn't affect symptoms until the second dose.

She got the vaccine, had no reaction initially and then went home and was tired, slept for a couple of hours and felt good. When she went to bed had a fever under 101 degrees, and really bad headache and then muscle pain all the way down to her calves to the point that she was sick to her stomach. This continued throughout the night. This morning she is still having the chills, so believes she has a temperature, feels miserable. About 1:30 AM she took 2 Tylenol for her symptoms.

SORE NECK; This spontaneous report received from a patient concerned a 63 year old female. 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: 1805020, and expiry: UNKNOWN) dose was not reported, administered on left arm on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced sore neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore neck. This report was non-serious.

Head pounding My entire body muscles felt like I had been beat up. Blankets were difficult move stretching/ spasms were strong and long. Took two pain killers my low back felt so bad I wasn?t sure if I could walk to bed. Rough night still have a bad headache low back ~ hips hurts to bend over.

Patient's lips started to swell, itchy throat, back pain and stomachache, no fever, gave benadryl, called 911 after 30mins

RACING HEARTBEAT; DIZZY; CHILLS; WEAKNESS; HEADACHE; FEVER; MUSCLE ACHE; NAUSEA; FATIGUE; This spontaneous report received from a patient concerned a 63 year old female. 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, and batch number were not reported) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-APR-2021, the subject experienced racing heartbeat. On 01-APR-2021, the subject experienced dizzy. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced weakness. On 01-APR-2021, the subject experienced headache. On 01-APR-2021, the subject experienced fever. On 01-APR-2021, the subject experienced muscle ache. On 01-APR-2021, the subject experienced nausea. On 01-APR-2021, the subject experienced fatigue. Laboratory data included: Heartbeats increased (NR: not provided) 144 /min. Laboratory data (dates unspecified) included: Body mass index (NR: not provided) 21 BMI. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from racing heartbeat, weakness, fever, muscle ache, and nausea on 02-APR-2021, and headache on 03-APR-2021, was recovering from chills, and had not recovered from fatigue, and dizzy. This report was non-serious.

Worst headache of my 63 years, starting in the night, still bad (though controlled by Tylenol Extra Strength) until about noon later that day, then faint headache for another day AND fog-brain, strange forgetfulness, almost dementia-like (both parents have dementia). Other symptoms earlier than the headache were joint/bone aches like with the flu and lethargy. Brain fog still a worry 3 days later.

Dizzy ,nausea ,complete loss of consciousness, catatonic, eyes rolled back , rigid total body ,extreme low blood pressure for over 1/2 hour Immediately at vaccine time ... 24 hours later chills , bad headache, nausea vomiting

woken up by a severe pain in my heart area. Bad Headache shortly after receiving the shot. My Left eye won't stop twitching. Rash on upper chest, nausea, upper chest/lungs area feel like they have a slight burning feeling. Chills, Fever. muscle pain my body feels like a truck hit it.

BURNING SENSATION DURING URINATION; REALLY BAD TINNITUS; GENERAL MUSCLE ACHES; This spontaneous report received from a patient concerned a 63 year old female. 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 was not reported) dose was not reported, administered on 06-APR-2021 to Right Deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced really bad tinnitus. On APR-2021, the subject experienced general muscle aches. On 07-APR-2021, the subject experienced burning sensation during urination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from burning sensation during urination, and general muscle aches, and the outcome of really bad tinnitus was not reported. This report was non-serious.

SORE ARM; JOINT MUSCLE ACHE; HEADACHE; NAUSEA; DIARRHEA; DIZZINESS; This spontaneous report received from a patient concerned a 63-year-old female. 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 06-APR-2021 at 10:10 in left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021 10:25, the subject experienced dizziness. On 07-APR-2021, the subject experienced diarrhea. On 07-APR-2021, the subject experienced sore arm. On 07-APR-2021, the subject experienced joint muscle ache. On 07-APR-2021, the subject experienced headache. On 07-APR-2021, the subject experienced nausea. Treatment medications (dates unspecified) included: bismuth subsalicylate/calcium carbonate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 07-APR-2021, and had not recovered from headache, joint muscle ache, nausea, dizziness, and sore arm. This report was non-serious.

At 24 hours post-vaccination, I experienced Dizziness. Nausea. Increased Appetite. Muscle aches/pain. Then Fainted and was out for a few minutes. Then woke up on my own. Still experiencing fatigue and some nausea/dizziness and mild diarrhea. Did not get transported to hospital or recieve medical care.

LEFT SHOULDER PAIN; This spontaneous report received from a patient concerned a 63 year old female. 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 at left arm on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced left shoulder pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of left shoulder pain was not reported. This report was non-serious.

BAD PAIN ON RIGHT SIDE (TOWARDS THE BACK); SWOLLEN NOSTRILS (INSIDE); Shaking; HARD TO WALK; Fever; Nausea; Chills; JOINT PAIN (KNEES, ELBOWS, SHOULDERS, HIPS, FINGERS, ANKLES); HEADACHE THAT FELT LIKE A SLEDGE HAMMER; SORENESS AT INJECTION SITE; EXTREME THIRST; Loss of taste; LOSS OF APPETITE; SWOLLEN HANDS; Runny nose; EYES CRUST AROUND THE EDGES; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 09:00 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced extreme thirst. On 03-APR-2021, the subject experienced loss of taste. On 03-APR-2021, the subject experienced loss of appetite. On 03-APR-2021, the subject experienced swollen hands. On 03-APR-2021, the subject experienced runny nose. On 03-APR-2021, the subject experienced eyes crust around the edges. On 03-APR-2021, the subject experienced joint pain (knees, elbows, shoulders, hips, fingers, ankles). On 03-APR-2021, the subject experienced headache that felt like a sledge hammer. On 03-APR-2021, the subject experienced soreness at injection site. On 03-APR-2021 22:00, the subject experienced shaking. On 03-APR-2021 22:00, the subject experienced hard to walk. On 03-APR-2021 22:00, the subject experienced chills. On 03-APR-2021 22:00, the subject experienced fever. On 03-APR-2021 22:00, the subject experienced nausea. On 05-APR-2021, the subject experienced swollen nostrils (inside). On 05-APR-2021 14:00, the subject experienced bad pain on right side (towards the back). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from runny nose on 05-APR-2021, and bad pain on right side (towards the back) on 05-APR-2021 21:00, was recovering from hard to walk, joint pain (knees, elbows, shoulders, hips, fingers, ankles), and swollen hands, had not recovered from swollen nostrils (inside), and the outcome of shaking, chills, fever, nausea, extreme thirst, loss of taste, loss of appetite, headache that felt like a sledge hammer, soreness at injection site and eyes crust around the edges was not reported. This report was non-serious.

pt says that later in the evening after taking the vax she had a weird feeling moving from the left arm to the left shoulder then to the base of her neck. This was very uncomfortable for the first couple of weeks, especially around the base of her neck. The pain seemed to be worse when she is laying down. On 4/13/2021 over a month later she still has some soreness but is getting better. She has been taking ibuprofen for the pain.

BLURRED VISION, HEADACHE, CHILLES, SEVERE PAIN IN RIGHT ARM, SHOULDER AND BACK FOR DAYS. STILL HAVING BLURRED VISION AND LITTLE HEADACHES

myalgia and arthralgia that was new and began since vaccination (She can not say how many days after vaccination that it began.). Date reported to me was 4/13/21. Vaccination 3/8/21.

Patient states that on 4-10-21 she developed a severe pain in her right knee. Patient states that the pain radiates from her thigh to her knee and sometimes down her leg. Feels a tightness in her leg and knee, No noted swelling of discoloration of the area.

Approximately 3 weeks after getting the shot, I had really bad lower back pain and a fever of 100.2. The fever lasted one day and the back pain for about a week until it started feeling better. I also had pain on the left side of my stomach area and a rash under my breasts. Rash and stomach pain gone.

She reported on 4/15/21 that her left elbow started swelling and hurting a bit on 4/11/21. Then next day her neck started hurting. But it wasn't bothersome enough that she reported to her primary care doctor. By today, she reported that the symptoms mostly went away. We advised her to see her primary care doctor regarding her symptoms.

My symptoms started 03-18-2021 at 11am where I developed chills, was very sleepy that I slept 15 hours straight. I felt very fatigued and my eyes hurt so much and I could not keep them open. On 04-06-2021 I still was not feeling well. I started to have problems with my right side of my face, eyes and mouth which gradually got worse so I went to the hospital. At the hospital they checked me for stroke, performed lab work, did MRI and CT scans and the the doctors came back and said it was Bell's palsy. I again went to the hospital 04-11-2021 but this time due to GI issues with pain. On 04-14-2021 through 04-15-2021, I started to experience neck pain behind my right ear. At the hospital they had prescribed my prednisone 50mg, so I took half for my pain. I still have trouble sleeping and have lots of pain.

Patient advises that she has been experiencing lower back pain, leg painful and swelling on her right foot, a fogginess that "feels like I'm on a conveyor belt", depression, diarrhea and fatigue since receiving the vaccine. Patient also advises that she used to be able to walk her dogs 4 miles a day and now can barely walk them 20 min. Patient also states that the foot that is painful is also a blueish gray in color.

Extreme Diarrhea, Fever 103 degrees, Chills, Sweating, Muscle Weakness, Fatigue, Muscle Pain, Nausea, Uncontrollable Diarrhea, Incontiness, headache, injection site welt, swelling, shoulder pain, unable to lift arm due to shoulder. Lasted 72 hrs for most extreme symptoms: headache, ongoing fever, extreme weakness (unable to walk without help). Did not return to regular strength until 8 days after administration of vaccine. Liquid Diet, Bedrest (4 days), Pain medication, Tylenol

This spontaneous report received from a patient concerned a 63 year old female. 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: 203A217 expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 14:15 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced neck pain. On 08-APR-2021, the subject experienced flu symptoms. On 08-APR-2021, the subject experienced bad night. On 09-APR-2021, treatment medications included: ibuprofen. On 10-APR-2021, the subject experienced dizzy/ light headed. On 10-APR-2021, the subject experienced sweaty. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from neck pain on 10-APR-2021, and bad night on 09-APR-2021, and had not recovered from dizzy/ light headed, sweaty, and flu symptoms. This report was non-serious.

Knee joints, great pain/discomfort when sitting down/getting up, made it extremely difficult to even sit on a toilet

Within 4 hours and lasting at least 50 hours; Terrible headache, chills, vomiting, tightness in muscles of calves that moved also to shoulder and stomach, swollen fingers, chest tightness and heaviness, diarrhea. Constipation on 4th day lasting through today the 9th day. Fatigue lasted for 8 days. Chest tightness and heaviness lasted for 6 days. Finally feel somewhat normal on 9th day although tongue still heavily coated with white.

After receiving J&J vaccine on Friday, 3 days later I developed severe lower back ache that spread across and covered my entire lower back and hip area also. The muscle pain was so severe I had trouble sleeping and sitting but could stand pain free. This lasted about 3 days. I took Tylenol to help with the pain and used a heating pad also. After day 3 it was all over and I've been fine ever since!

In the morning I noticed a pinching feeling in my lower right leg. I called my doctor to check on this. She sent me for an ultrasound of the leg on 04/15/2021. During a follow-up visit she informed me that it was a superficial blood clot and set up a second ultrasound on 04/28/2021 for confirmation that it had cleared.

Date and time of adverse event: 24 March, 2021 3hrs after started arm sore, muscle lakes, fatigued, fever, shortness of breath. All symptoms resolved except shortness of breath, getting better. List all vaccines given on the date listed (including how vaccine was given and where (body site) vaccine was given: Patient states she started to experience symptoms 3 hours after she received her vaccine. Sore arm, muscle aches, fatigue, fever, shortness of breath. All symptoms resolved except shortness of breath which is continuing to improve. She is just calling to report her symptoms, so no one else will take this vaccine.

24 hours after the vaccine I developed a sharp pain on the inside of my left knee, slightly above the knee cap. There was a soft bump in that area. At work the next day I felt more sharp pains and bumps developing around my knees on both legs. The backs of my thighs were also beginning to burn. I contacted the hotline set up at my work for adverse reactions when I got home from work that night. They were concerned and had me call my doctor. My work is onboard an aircraft and she did not want me to fly again without an ultrasound. I had an ultrasound perform on my left leg and the thigh of my right leg. It was normal. Over the next week I would get stinging , painful bumps and used NSAIDS to help. Approximately six days after the shot the burning sensation on my thighs got worst. It spread for the back of my thighs to the front and then to the calves, arms and shoulders in that order, I started taking Benadryl to release the burning. I went to my doctor who sent me for another ultrasound and blood up. Three weeks after the injection the painful stinging bumps are still happening and the burning is on my legs, arms and shoulders. I am going back to the doctor today and talk about prescribing Gabapentin.

FATIGUE; FELT HORRIBLE; SKIN BURNING AND HURTS TO TOUCH/SKIN ON FIRE/PAINFUL SKIN; NAUSEA; CHILLS; DIARRHEA; VOMITTING; LEG HEAVINESS; LEG PAIN/INTERMITTENT PAIN IN HIPS, BACK, DOWN TO MY KNEES; WEAKNESS; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid infection, double lung pneumonia, leg pain, and leg heaviness, and concurrent conditions included arthritis, and fatigue, and other pre-existing medical conditions included patient second shingles shot begins in february. 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 19-MAR-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced leg heaviness. On 2021, the subject experienced leg pain/intermittent pain in hips, back, down to my knees. On 2021, the subject experienced weakness. On 19-MAR-2021, the subject experienced diarrhea. On 19-MAR-2021, the subject experienced vomitting. On 19-MAR-2021, the subject experienced chills. On 19-MAR-2021 16:00, the subject experienced nausea. On 19-MAR-2021 23:00, the subject experienced skin burning and hurts to touch/skin on fire/painful skin. On 20-MAR-2021, the subject experienced felt horrible. On 25-MAR-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) No clots found. On an unspecified date, the subject experienced fatigue. Treatment medications (dates unspecified) included: calcium chloride dihydrate/fructooligosaccharides/glucose/magnesium chloride hexahydrate/potassium chloride/sodium chloride/sodium lactate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomitting, and nausea on 20-MAR-2021, was recovering from diarrhea, had not recovered from chills, skin burning and hurts to touch/skin on fire/painful skin, leg pain/intermittent pain in hips, back, down to my knees, weakness, fatigue, and leg heaviness, and the outcome of felt horrible was not reported. This report was non-serious.; Sender's Comments: V1:Medical assessment comment not required as per standard procedure as case assessed as non-serious.

LACRIMATION; MUSCLE CRAMPS; JOINT ACHES; CHILLS; FEVER; HEADACHE; TIREDNESS AND FATIGUE; This spontaneous report received from a patient concerned a 63 year old female. 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 23-MAR-2021 at right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 23-MAR-2021, the subject experienced joint aches. On 23-MAR-2021, the subject experienced chills. On 23-MAR-2021, the subject experienced fever. On 23-MAR-2021, the subject experienced headache. On 23-MAR-2021, the subject experienced tiredness and fatigue. On 24-MAR-2021, the subject experienced lacrimation. On 24-MAR-2021, the subject experienced muscle cramps. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101.6 F, 100.6 F. Treatment medications (dates unspecified) included: magnesium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle cramps, and headache on 24-MAR-2021, was recovering from fever, and chills, and had not recovered from joint aches, tiredness and fatigue, and lacrimation. This report was non-serious.

got it April 10th First day fine, second-day urine dark, third-day fog and disoriented sensation in my head and double vision, and periods of weakness in hands (now coming and going), lack of appetite, extreme thirst, no fever, no vomiting, pains in my thighs and stomach, middle back pain, Hips, pelvis, 9th day: calves so painful and tight I could not get out of bed, figures swelled up to the point that I could not put on my finds, 10th day my calves are very painful (like the soreness that is felt after someone punches you) Especially right calf. The batch number is 206a21a if I can read it from my card.

LEGS FEELING COLD; BLOOD SUGAR LOWER THAN NORMAL; SHOULDER HEAVINESS; BACK PAIN; ARM PAIN AT INJECTION SITE; TIREDNESS; SLEEPINESS; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included type 2 diabetes., hypertension, and non smoker, and other pre-existing medical conditions included patient do not smoke. patient has type 2 diabetes for approximately 17 years. patient also has hypertension. The patient received metformin non-company (prolonged-release tablet, route of admin not reported, batch number: Unk) dose, frequency, and therapy dates were not reported for an unspecified indication. The batch number was not reported and has been requested. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. Concomitant medications included amlodipine, atorvastatin, glipizide, hydrochlorothiazide/triamterene, insulin glargine, losartan, and sitagliptin. On FEB-2021, Laboratory data included: Blood test (NR: not provided) Results not specified. On 06-MAR-2021, the subject experienced tiredness. On 06-MAR-2021, the subject experienced sleepiness. On 10-MAR-2021, the subject experienced arm pain at injection site. On 11-MAR-2021, the subject experienced blood sugar lower than normal. On 11-MAR-2021, the subject experienced shoulder heaviness. On 11-MAR-2021, the subject experienced back pain. On 11-MAR-2021 17:44, Laboratory data included: Blood glucose (NR: not provided) 97 (unit not specified). On 12-MAR-2021, the subject experienced legs feeling cold. On 12-MAR-2021 06:00, Laboratory data included: Blood glucose (NR: not provided) 166 (unit not specified). On 12-MAR-2021 16:00, Laboratory data included: Blood glucose (NR: not provided) 79 (unit not specified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with metformin non-company was not reported. The patient recovered from legs feeling cold on 12-MAR-2021, was recovering from arm pain at injection site, shoulder heaviness, and back pain, and had not recovered from blood sugar lower than normal, tiredness, and sleepiness. This report was non-serious.

63yr old female called into call center, stated she received J&J vaccine Friday 4/16 (external site; not with county), and today noticed swelling on her left calf, and 4/10pain above her left knee. Pt denied emergency symptoms at the time of call. Stated sunday night she felt her throat ""a little tight."" Drank water and felt better. Denied swelling of face, lip and throat at time of call. Pt denied SOB, pain/tenderness on calf, petechiae, new/easy bruising, abdominal cramping, backache or headache. Pt stated only other symptom she felt was on Friday 4/16 evening, a slight headache after the vaccine. did not experience any other symptoms. Pt Advised to call 911 or arrange for immediate transport to the closest ED. Pt verbalized understanding and agreed.

Fatigue and malaise within 3 hours; chills, nausea and vomiting after 11 hours; headache, muscle aches, weakness and nausea/vomiting for 24 hours after the vaccine.

1) Severe headache and delirious sleep and overall muscle achiness. Lasted for 36 hours approx. 2) Approx ten days later on April 19th, 2021, I awoke at night with severe left shoulder pain/deep ache. It came and went over the next week, but became more constant and severe. I couldn't sleep most nights without sleep meds, and even then it was for a few hours, and on my back. I couldn't sleep on either the good and especially not the bad shoulder. Via a phone call, my PCP suggested I begin treatment with Ibuprofen, 3-4 times per day. I took 2-3 Ibuprofen at a time. As of today, May 12, 2021, I am still taking Ibuprofen 3 times a day as I still cannot sleep on my bad (left) side. I didn't think this was related to the vaccine shot until my husband said that he also was having shoulder pain on the same side as the injection. His was milder and lasted about a week, but began about the same time as mine did.

ARM IS VERY SORE AT INJECTION SITE AS WELL AS PAIN TRAILING TO UPPER SHOULDER AND NECK. PAIN IS VERY INTENSE AND CONSTANT AFTER ONE MONTH OF INJECTION. I DONT KNOW WHAT KIND OF DOCTOR I NEED TO SEE FOR THIS. I FEEL THAT THE PERSON THAT ADMINISTERED THIS HIT A NERVE IN MY ARM,AS IT WAS VERY PAINFUL AT TIME OF ADMINISTRATION.

SOME DAYS SHE DID NOT USE HER LEFT ARM; LEFT ARM WEAK; JOINT PAIN; CHILLS; FATIGUE / TIRED; HEADACHE; FEVER 101F; MUSCLE PAIN; SHORTNESS OF BREATH; DRY COUGH; BRAIN FOG; ALL SHE DID WAS SLEEP FOR 2 WEEKS; RACING HEART RATE; DIZZINESS; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight was 150 pounds, and height was 175.26 centimeters. The patient's past medical history included covid-19 infection, and concurrent conditions included non-smoker, alcohol use, sulfonamide allergy, high blood lead level, and neurological problems, and other pre-existing medical conditions included the patient had no known allergies and no food allergy. the patient did not have any drug abuse/illicit drug use. The patient experienced drug allergy when treated with ciprofloxacin, clindamycin, erythromycin, and nortriptyline. 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 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced racing heart rate. On 06-MAR-2021, the subject experienced dizziness. On 09-MAR-2021, the subject experienced shortness of breath. On 09-MAR-2021, the subject experienced dry cough. On 09-MAR-2021, the subject experienced brain fog. On 09-MAR-2021, the subject experienced all she did was sleep for 2 weeks. On 09-MAR-2021, the subject experienced left arm weak. On 09-MAR-2021, the subject experienced joint pain. On 09-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced fatigue / tired. On 09-MAR-2021, the subject experienced headache. On 09-MAR-2021, the subject experienced fever 101f. On 09-MAR-2021, the subject experienced muscle pain. Laboratory data included: Body temperature (NR: not provided) 101 F. On an unspecified date, the subject experienced some days she did not use her left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from racing heart rate on 17-MAR-2021, dizziness on 04-APR-2021, and joint pain, chills, and fever 101 F on MAR-2021, was recovering from dry cough, fatigue / tired, headache, brain fog, left arm weak, and muscle pain, had not recovered from shortness of breath, and the outcome of all she did was sleep for 2 weeks and some days she did not use her left arm 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.

after her vaccination on 4/2/21, she was tired on 4/5/21. on 4/11, she was achy, had HA, sens to light, stomach, backache, nauseous, bilat sciatic pain, temp up to 102, fatigued, oxygen sat 92%. she had visual hallucinations. she went to ER on 4/15/21.

Pain in right arm and shoulder. Sometimes it radiates down arm into the elbow and wrist. It is not consistent. Sometimes it is very light, and other times it is very severe. I have also had a great deal of weakness in the right arm since the vaccination.

Fever (99.80), Nausea, Headache, Low back pain, Intestinal cramping x 36 hours; left arm pain around site of injection x 5 days.

I experienced usual side effects, fever and chills but the entire reason is that I have swelling and edema in both feet and ankles enough so to concern doctors. I went to clinic on 03-26-2021 for evaluation. They put me on 3 day steroids. I went back to First med which they put me on a 6 day course of medication of steroids. I then went to my podiatrist, of my right ankle, I was scanned for blood clots but no blood clots were found. My exams only identify swelling and edema. I can only take NSAID'S. I have to get up wait a few hours to move. My ankle swelling and edema nerve decreases and my feet hurt so bad when I apply pressure. I had an MRI done as well and I am very upset that they cant find why I can not walk without pain and swelling. My doctors at this point do not what to do for me and I would like some answers. To this day, I am still having swelling and edema to both of my feet and ankles.

SHORTNESS OF BREATH (WORSE UPON EXERTION); ELEVATED HEART RATE; DIZZINESS; CHEST PAIN; WEAKNESS; FEVER; MUSCLE ACHES; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, allergy to plavix, and compazine allergy. The patient was previously treated with for drug used for unknown indication; and experienced drug allergy when treated with amlodipine for drug used for unknown indication. 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 13-MAY-2021, the subject experienced shortness of breath (worse upon exertion). On 13-MAY-2021, the subject experienced elevated heart rate. On 13-MAY-2021, the subject experienced dizziness. On 13-MAY-2021, the subject experienced chest pain. On 13-MAY-2021, the subject experienced weakness. On 13-MAY-2021, the subject experienced fever. On 13-MAY-2021, the subject experienced muscle aches. On 13-MAY-2021, the subject experienced headache. On 13-MAY-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, muscle aches, and headache, and had not recovered from shortness of breath (worse upon exertion), elevated heart rate, dizziness, weakness, fatigue, and chest pain. This report was non-serious.

UPPER CHEST WAS BLACK AND BLUE; CHEST TENDER TO THE TOUCH; CHEST HAD LIKE BROKEN BLOOD VESSELS; CHEST WAS TIGHT; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's past medical history included veins burning, vomiting, redness, burning sensation, swelling, sick, faint, and anaphylactic reaction, and concurrent conditions included multiple sclerosis, non alcoholic, non smoker, sulfa allergy, and steroid allergy, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. Patient was not pregnant at the time of vaccination. Patient had red light therapy as well. The patient experienced drug allergy when treated with teriflunomide, influenza vaccine, interferon, prednisone, cimetidine, and glatiramer acetate. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. Concomitant medications included atorvastatin for drug used for unknown indication, losartan for drug used for unknown indication, and ibuprofen. On 28-APR-2021, the subject experienced chest was tight. On 14-MAY-2021, the subject experienced upper chest was black and blue. On 14-MAY-2021, the subject experienced chest tender to the touch. On 14-MAY-2021, the subject experienced chest had like broken blood vessels. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from upper chest was black and blue, chest was tight, chest tender to the touch, and chest had like broken blood vessels. 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.

Hemoptysis, flank pain, bilateral leg pain, headache. Found to have thrombocytopenia of 44, extensive bilateral PEs, and nonocclusive aortic thrombus. Treated with IVIG x 2 days and argatroban. Course is ongoing at ~48 hours since presentation.

ITCH IN LEGS AND ARM; LITTLE POLKA DOTS /FLUID-FILLED BLISTERS (RASH ON ARMS AND LEGS AND LITTLE BIT ON STOMACH); SHARP PAINS FROM SHOULDER TO THE ELBOW/ SORE ARM; SHARP PAIN DOWN TO WRIST/JOINT PAIN; FLUID LEAKING; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included supraventricular tachycardia, low blood pressure, and osteoporosis, and other pre-existing medical conditions included the patient had taken a natural hormone medication from a compounding pharmacy and also osteonutrients and unspecified medication for osteoporosis. The patient experienced drug allergy when treated with cyclobenzaprine hydrochloride, and tetanus vaccine for drug used for unknown indication, drug allergy when treated with clarithromycin, diazepam, and hydrocodone bitartrate/paracetamol. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808982, expiry: 23-JUN-2021) dose was not reported, administered on 13-MAY-2021 08:55 for prophylactic vaccination. Concomitant medications included atenolol for supraventricular tachycardia. On 13-MAY-2021, the subject experienced fluid leaking. On 13-MAY-2021, the subject experienced sharp pains from shoulder to the elbow/ sore arm. On 13-MAY-2021, the subject experienced sharp pain down to wrist/joint pain. On 14-MAY-2021, the subject experienced itch in legs and arm. On 14-MAY-2021, the subject experienced little polka dots /fluid-filled blisters (rash on arms and legs and little bit on stomach). Treatment medications (dates unspecified) included: calamine/glycerol/zinc oxide, ibuprofen, charcoal, activated, triamcinolone acetonide, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine was not applicable. The patient recovered from sharp pain down to wrist/joint pain on 14-MAY-2021, had not recovered from little polka dots /fluid-filled blisters (rash on arms and legs and little bit on stomach), and itch in legs and arm, and the outcome of fluid leaking and sharp pains from shoulder to the elbow/ sore arm was not reported. This report was non-serious.

Extreme high fever Chills Headache Muscle pain Weakness Short of breath Chest pain Rapid heart rate Fever and chills went away after 4 days, all other symptoms continue I have had pulmonary function testing, and more appointments scheduled

STOMACH PAIN; SWEAT; DIZZY; CHILLS; JOINT ACHES; FEVER; HEADACHES; MUSCLE ACHES; FATIGUE; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight was 140 pounds, and height was 60 inches. The patient's concurrent conditions included lupus, rheumatoid arthritis, diabetes, latex allergy, non alcoholic, and non smoker, and other pre-existing medical conditions included no drug abuse or illicit drug usage. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. Concomitant medications included hydromorphone for drug used for unknown indication. On 24-MAY-2021, the subject experienced sweat. On 24-MAY-2021, the subject experienced dizzy. On 24-MAY-2021, the subject experienced chills. On 24-MAY-2021, the subject experienced joint aches. On 24-MAY-2021, the subject experienced fever. On 24-MAY-2021, the subject experienced headaches. On 24-MAY-2021, the subject experienced muscle aches. On 24-MAY-2021, the subject experienced fatigue. On 25-MAY-2021, the subject experienced stomach pain. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) highest was101F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from fever, muscle aches, stomach pain, headaches, fatigue, chills, and sweat, and the outcome of joint aches and dizzy was not reported. This report was non-serious.

I had COVID like symptoms again. After that I was doing good for about two weeks, but I still had a stiff neck. I have had a stiff neck for about 6 weeks now. I have had steroid medication provide for me and I felt better this lasted for about two weeks. After this I have went back to the hospital because I have not been able to stand, or barely make a fist.

Pain in left shoulder blade, back, shoulders and chest, felt like weight on chest. Adjusted meditation to capsule from tablet, blander diet, stress test. Symptoms decreased.

Headache, dizziness, chills, fever, eye movement, nausea, chest pain, muscle weakness and pain, falls.

Pain and have limited range of motion in left arm shoulder. Findings supraspinatus and infraspinatus tendinosis and sub deltoid burial fluid.

patient reported she was fatigued after receiving the vaccine. She then began to have joint pain and she reports she was barely able to walk. She has an appt. with her MD Wednesday (joint specialist). She has been taking Advil 325mg PRN.

Neck pain left side of neck; ongoing tic upper left lip without pain. History of trigeminal neuralgia but rarely symptomatic for past 11 years.

Patient complained of burning sensation immediately after receiving vaccine and progressively worsening arm pain over the course of a few day after vaccine administration. Patient states arm pain did not resolve and was seen at provider's office 6/17/21 stating she has decreased range of motion to left arm and continues with left deltoid pain. X-ray of left shoulder and humerus were ordered along with physical therapy.

At 04:00 pm, excessive fatigue. I was taking my mom shopping and I had to stop and take her home. Just excessive fatigue. 3/26/ 21- I woke up at 01:00 am with chills; freezing and infrequent tremors. I had a bad headache. Body aches. 04:00 am started feeling nausea. I contacted Dr to see what I could take. Got a reply email that recommended not to take anything. I toughed it out and I was in bed all day. I finally ate at 05:00 pm that day for the first time. The nausea and chills subsided with the mild food. But headache and achy body persisted. On 3/27, mild headache and mild body aches - I was a 2 out of 10 for pain. It continued to get better. I have joint pain in the winter when it is cold but I don't have any of that when it's warm. But I'm having joint point this summer. Which is weird and not usual. My joints have never hurt in summer time and spring before but have been this year. My left shoulder is frozen out of the blue at the injection site. It hurts. Have been having foot pain. Shooting pain in my right heal. Communications via email to Dr and Dr said to do heat and ice and sent me exercises to do with feet and shoulder. The shoulder still hurts but it is slowly getting better. I have been seeing Naturopath for hormone/menopause and I have been taking the hormonal supplements a month before the shot.

Right after the vaccine - Really bad sore arm for at least a week. I did have chills and aches for maybe a day. My usual joint pain that I experience wasn't worse that usual but I had just gotten cortisone shots a month earlier (March) so it was possible that it was keeping it all under control. But now I've been experiencing pain in joints. My thumb joints are in a lot of pain, very difficult to do almost anything; my lower back is really inflamed - the bones there. Other joints - knees and other joints hurt too but mostly those joints. Had chiropractic care - sometimes that increase inflammation because I'm moving the joints and but also have gotten 7 laser treatments on those joints - which has helped. Another number to call regarding my joint pain history medical records- haven't seen him since March, though -Doctor - who did - - he's not listed as my doctor but he did the cortisone shot and was my doctor before.

About 5 days after the shot, I was still having a lot of fatigue, but I developed severe headaches, like someone was sticking a knife in my head, and I was having bouts of light headedness. I am a person who never has headaches. Because the issue of the blood clots came about with the J&J, I ended up, because of the severe headeaches had to have a brain MRI to rule out the blood clots. I did not have any. But the headaches were very much a problem and the light headedness. I had to leave area for the summer, and now came to another area. I still was not feeling right. The bad headaches subsided, but I was till getting the lightheadedness with a slight headache after almost every day. II also had a full blood panel done on April 8. It is showing my thyroid is low and now have to be on Thyroid medication. I just had full blood work done in March, and all my blood work was normal. I also have noticed that my arthritis in my hands is exacerbated. And sometimes my feet go numb when I am riding my horse. And in the morning, my arms and legs ache. My BP was a little elevated as well. I never have had high blood pressure. I am 63 years old and have always had great health. Since I had the covid shot, I have had nothing but problems. If I had to do it over again, I WOULD NOT have gotten the shot. I only got it because my daughter was having a baby and insisted even though I had the virus back in October.

Rushed to emergency room with severe, severe pain left shoulder, arm, hand, underarm breast, upper back and midback (left side). Given morphine and nausea and sent home. Still in pain. Rushed back to emergency room exactly a week later with same symptoms plus blisters and rash (still left side). Treated for symptoms of shingles, but no "classic" signs of shingles. Saw primary care doctor on 06/02/2021. Continued the treatment for shingles. Extremely limited function in left hand (holding, etc.) Future doctor visits schedule for August.

About 2 weeks after vaccination and still continuing, head and neck pain. Running up neck to the back of head all the way to the top of head in the back.

extreme shortness of breathe, irregular heartbeat, fatigue, loss of bladder control, shooting pains, muscle ache, tightness in chest

Symptoms from improperly administered vaccinations - known as SIRVA, for "shoulder injury related to vaccine administration'' - include chronic pain, limited range of motion, nerve damage, frozen shoulder (the inability to move the shoulder) . I received a COVID-19 vaccination (2nd dose as part of the Janssen study ).. When the nurse injected the needle into my arm it HURT. I started to leap off the table but she told be to stop and 2 nurses stepped forward to steady me. I told her it hurt extremely bad but she didn't withdraw the needle. Another nurse handed me a tissue to wipe the tears from my eyes. The injection hurt, more so than the usual injection. In the days that followed, the pain in my right shoulder worsened. Initially, I dismissed it as typical post-shot soreness. But it didn?t go away. Months later, it still hurts. The sports medicine doctor says I have excess fluid buildup in the bursa. He withdrew the fluid. I'm still going for physical therapy 3 times a week to get back range of motion and strength in my arm. I?m convinced this occurred because the nurse injected the vaccine too high on my arm. I had no symptoms before the shot, and pain has persisted since.

brain fog vision problems, extreme exhaustion weight gain all scar tissue from surgerys is swollen and painful blown up and very visible, ( face is distorted) tingling in hands and feet

Covid 19 Johnson and Johnson, first and only dose ( not found above) Fever, chills, muscle aches, headache and loose stool Symptoms onset approximately 12hrs after shot lasting 36 hours Treatment Acetaminophen No medical professional consulted

Janssen COVID-19 Vaccine EUA Injection site bruising, swelling, redness, burning General - headache, very very tired, bloating/puffiness, muscle aches, nausea, low grade fever, light dizziness Took ibuprofen and drank lots of water... cold compress on arm...rest when needed As of Wednesday morning, the reactions are lowering and slowing down. The site is still swollen some and bruised and red.

at injection, arm was not opperable, too weak to pick up coat or purse. After about 15 minutes the full use of arm was back. The muscle is still affected and strained after 6 days. I waited a half hour at the site and got into my car at 3:45. On the drive home within 30 minutes my face started to itch and turn red, then my mouth inside started to itch, then my eyes started to itch. After that my throat started to feel gravely, so I took 75 mgs of gel cap benedryl. This is what I feel and take upon getting stung by a bee. I also took my albuterol inhaller two puffs which I also always have on me because of my asthma. I was sleepy but had dinner and went to be. I did not feel that I had to take more benedryl during the night.

Severe headache, overwhelming fatigue, 102.7 temp, massive body ache, left armpit and breast extremely sore

Within 12 hours I became to have severe muscle aches and joint aches. All my joint felt hot, it was bad enough I wasn't able to sleep. I took Ibuprofen to help sleep. I slept most of Friday I has extreme fatigue. On Saturday I has muscle weakness and tingly in my hands, the muscle aches have gone away. I couldn't knit ot fine motor skills, It bothered me. I woke up on Sunday where I had extremes muscle weakness in both my legs. I called my PCP, they were surprised by how the reaction was delayed. They wanted me to get a test for the strength in my legs and sent me to the ER. I wen to the Er they tested for stroke, blood work, scans, they were worried about Guillain Barre Syndrome. I stayed there about 5 hours. Yesterday afternoon the tingly went away from my hands but my legs are still kinda goofy. The muscle in my forearm and thigh feel like my muscle are really sore, like they have been tense

Chills and fever as high as 101 started at 10:30 pm along with skin sensitivity and then deep pain in muscles, joints, & tissue throughout my body & very bad headache. Had mild nausea. Took Aleve for pain, was unable to sleep through the night. Pain better by next morning, mild fever continued until approx 5 pm the following day. Some headache pain lasted about 20 hours.

Extreme fatigue and muscle ache throughout body, fever, chills and shaking, intense headache. Vaccine was administered at 9:30 am. Symptoms began around 3:30 pm and lasted until approximately 5:00 am the next day.

deep sharp pain in the muscle where the shot was administered. along with slight fever and low energy.

Pain radiation from injection site down arm to elbow, extreme headache (migraine like), nausea staring 24 hours after injection, no solids only liquid.

Bad headache, muscle pain over entire body, chills ,then hot, 101.7 fever. I just slept a lot ,drank lots of water, everything but the muscle ache is gone

Headache, fever, bone and bodyaches. Inflamed red area at site of injectionwith itching, painful and hot to the touch started within 24 hours after injection. Still red inflamed hot and itchy as of day of report. Fever has resolved, bone and body ache diminished. No betterment as of yet at injection site

30 minutes after receiving the vaccine- -- hot flashes that lasted 8 hours. Right away after receiving the vaccine-- stiff neck on the left side which after a night's sleep, moved to my right side of neck. No big deal. Tired & 'drunk' after the vaccine which lasted until mid-afternoon the next day. No big deal. The worst of all happened at 3 1/2 days, a rash started in the evening, went to bed, woke up the next day with rash almost everywhere. Red, swollen, & itching like crazy. The next day- Sunday, along with Monday & Tues. was horrid. I am covered from my scalp to the tops of my feet, my crotch hurts, as do my breasts. Used Benadryl cream, aloe vera to no avail.

Severe shaking chills, headache, fever, muscle aches that lasted several hours. Taking Advil helped reduce symptoms. These symptoms are typical of those who have taken the J&J vaccine and in fact, if you read the actual stories of the side effects of people who took this vaccine, shared on sites, these symptoms are closer to 100% present rather than the far lower and untrue percentage revealed by the CDC. These symptoms need to be better tracked and people should be forewarned how COMMON these side effects are; they are not rare!

NO medical intervention required. For reporting purposes ONLY. Within about five minutes, throat swelled but not to the point of concern. Don't remember reactions to previous vaccines but not surprised considering allergies. Left side of face felt strange but didn't look any different when a selfie was taken. Sometime during the afternoon/evening, experienced a headache of short duration. Approximately six hours after shot, experienced chills and low grade fever. Simply went to sleep. Better the following morning, though very tired. Probably unelated rough itchy patch on RIGHT arm the day following vaccine. Went away with no treatment.

Pain in arm at injection site x 2 days Fatigue on day 2 Headache on day 2 Fever of 100 on day 2 Muscle soreness on day 2

tingling on left side of face, numbness in left arm, blurry vision. Evaluated by EMS-Refusal to transport.

6-1/2 hours later: Symptoms came on quickly. Hands and feet felt frozen, chills, severe shoulder joint and muscle pain. Immediately had to lay down and took Advil/Tylenol. Could feel the movement of joint pain from shoulders to elbow, hips to knees. Headache. Couldn't navigate stairs safely. In bed or on the couch for 24 hours until 6pm Friday 4/9/2021. Three of us from the same company had the Janssen Vac within a day of each other and all 3 of us had the same adverse reaction. To me, that is not mild symptoms when it debilitated me and kept me from going to work. Most family members have had Pfizer with two shots and had NO side effects.

About an hour or so after the shot, continuing until now, only 36 hours later: A general sense of feeling quite ill, headache, extreme fatigue, weakness and sleepiness, muscle aches over the past 36 hrs since the shot occurred. I have been in bed sleeping off and on feeling ill in waves. I feel less ill for hours at a time, during which I get up out of bed and function relatively normally. I felt completely fine (except for injection site achiness) until about an hour and a half after the shot, after which I went to sleep for several hours after which I felt better. The major symptom is the general feeling of 'being sick'.

Patient experienced numbness in peripheral extremities and lips, headache, hypertension, neck stiffness, tremor, and blurred vision

Vax received Saturday. Entire leg very sore on Sunday. Monday morning woke early with pain in the knee that was replaced. I was unable to straighten leg when lying in bed. I managed to stand up and walk it off, but with pain as severe as in January when knee was replaced. Leg continued to be sore, then Monday night I didn't have the same issue w/bending, but I did wake early with horrible stabbing pains in knee. I treated with Tylenol, Alprozalan & Ice.

2 weeks post inoculation developed burning sensation/tingling /pain from armpit to thumb; some tingling in thumb - sensation more like nerve pain vs muscle pain. After two days gradually improved. Muscle strength not affected, but movement in most directions elicited sharp pain coursing down arm. Gradually improving to pain over the deltoid near injection site; as of 19 days since initial pain motility much improved but still periodically throbs and sensitive to pressure and certain movements. No treatment except restricting use of arm and time. 10 hrs post inoculation developed chills, myalgia and headache. Chills and myalgia resolved in a few hours; an aspirin the next day resolved the headache. This reaction was not unexpected. Did not have pain at injection site until 2 weeks post injection.

Jansen COVID-19 Vaccine EUA. Weight gain of 8 pounds overnight (water retention), glucose levels over 300 for several hours, elevated blood pressure (160/111). Doctor prescribed water pills for weight gain. Patient continues to monitor glucose levels.

I was very tired, had major headache, muscle and joint pain & chills for 1 1/2 days. Afterwards, I was fine. Note: I called Dr.'s office to report my symptons to the nurse the day after my vaccine shot. I was not sure if it was due to new BP meds or vaccine shot. The nurse said it was hard to say. The nurse did increase my Lisinopril to 10MG 1/day per the doctors orders.

Nausea, headache that increased to monstrous proportions throughout day and lasted 3 days; severe joint and muscle pain., incoherent thinking process, fatigue, some dizziness. Presently have shortness of breath. Surprisingly, injection site only hurt the first day.

4/8/21: "Six and a half hours after my Janssen vaccine I had started shaking with severe chills. By 8 hours after my vaccine I had impaired coordination, extreme fatigue, and it was laborious to walk. Muscle aches and a blinding headache overnight added to my misery. This morning the headache was painful not blinding and the muscle aches not as intense. Had to return to bed right after eating soup, due to weakness. Chills abated by this morning. Speech slowed this morning while talking on the phone. Have spent the day in bed resting" 4/9/21: "Voice was back to normal by 8:30 pm last night. Slept well overnight - no chills or headache. Feeling stronger this morning - no headache!!! Arm still aches, but that is nothing c

4/8/21: "Six and a half hours after my J&J vaccine I had started shaking with severe chills. By 8 hours after my vaccine I had impaired coordination, extreme fatigue, and it was laborious to walk. Muscle aches and a blinding headache overnight added to my misery. This morning the headache was painful not blinding and the muscle aches not as intense. Had to return to bed right after eating soup, due to weakness. Chills abated by this morning. Speech slowed this morning while talking on the phone. Have spent the day in bed resting" 4/9/21: "Voice was back to normal by 8:30 pm last night. Slept well overnight - no chills or headache. Feeling stronger this morning - no headache!!! Arm still aches, but that is nothing c

I suddenly became very tired. Almost immediately thereafter I got the chills and was shivering. I had a fever of 100.4. I took a 500mg acetaminophen tablet to prevent my fever from climbing. I awoke the following morning with a headache and still a low-grade fever of 99. I was feeling fine about noon except for being tired. I continued to feel like I had low grade flu like symptoms. for the next couple of weeks. This could have been related to DST beginning which is always a challenge for me. About 10 days later, the muscle in my right arm where I received my shot started to ache. Perhaps it is because I slept on it wrong and that created the ache. Now 5 weeks later I still feel some muscle ache in my arm, especially when I lift it over my head.

Headache. Severe , burning, nerve pain in neck shoulders and both arms . Right arm swollen from elbow to wrists. Went to Dr. on 3-19-21 . Told to return in 3 days if not better. They said pulse was ok so prob not a clot. I had pain for two weeks but did not return. At end of two weeks swelling gone . Still some residual pain in right arm, but not constant.

Beginning 3/18/21: Initial headache. Fever greater than 103 F. Severe myalgias. Profound fatigue and lassitude. Drenching night sweats. E.R. visit followed by 5 day in patient hospitalization. Discharged from hospital approximately 3/9/21. Symptoms not yet resolved. Patient has persistent fatigue and severe occipital headaches.

3/30/2021: lost consciousness for hours at a time for 36 hours extreme pain in lower back and side 4/10/2021 extreme pain in lower back, down left leg, shin, top of left foot. Could not stand or walk or lift anything without enormous difficulty. Restricted movement. Pain in all joints throughout body. Ongoing.

I've had bad nerve pain in my injured leg and lower back which started above my knee and has now moved down my calf.. I've gone to PT and taken Gabapentin to help ease the pain. I've had it from April 7th through today(April 17th).

Note this is in reference to initial report filed 03/31/2021 - Received Janssen vaccine for COVI-19 in mid-March 2021. Over the next couple of days, became very ill, spent five days experiencing severe headache, disorientation, confusion, neck, shoulder, and back pain together with generalized arthralgias and myalgias. Around the 2nd week post-vaccination began to experience ?numbness and tingling? initially, affecting all fingers and toes; symptoms gradually evolved into ascending paresthesia affecting the upper and lower extremities. (worse in the upper extremities). Neurological symptoms are accompanied by painful electrical-like impulses running along my spine and elicited by flexing my neck (Lhermitte neurological phenomenon). Neurological signs and symptoms prompted me to go to the emergency room. Currently, I am under the care of a neurologist and undergoing extensive diagnostic workup. Present treatment: Glucocorticoids (tapering) and Gabapentin. Among the initial rule out diagnosis, were transverse myelitis, and Guillain Barre. Present preliminary r/o diagnosis: Post-vaccine immune reaction ? No definitive diagnosis yet.

Patient was vaccinated on 4/6/2021 and reports that on 4/16/2021, she started to experience joint pains and muscle pain in her arms and legs, feeling fatigued and could barely stand. She reported these on 4/19/21. I advised her to contact her PCP to get evaluated for the signs/symptoms that she is experiencing to rule out anything severe. She did not seem to understand and asked to speak with the manufacturer. She said that she would contact the manufacturer and walked away. When I attempted to contact her again today on 4/20/21, the phone number she provided to us has been disconnected and we have no means of reaching her at this point in time. I am hoping she heeded my advice and contacted her PCP to get evaluated.

A little over a week after the vaccine I begin feeling so tired because my back started feeling so weard and fatigued feeling. It was like my back was tired and the muscles were really tensed. Moving helped but while sitting is when the issue back hurt worse. I reached out to your Chiropractor on 3/31 who performed a few settings on my back to help with the tension but the pain went up and down during that time and seems as if the pain went away on it on.

April 2 -3 felt tired and achey and chills April 8 - 10 tingeling of face, left eye hurt. April 11 no energy, left eye watering, lips swelling April 13 more swelling of face - Night of 13 wanted to rip my face off!!! April 14 swelling of eyes, lips, cheeks, hives on face and eyes. Felt miserable Zoom call with Doctor put on Medrol dose pack, Allegra, AM Zyrtec,PM Pepcid AC, purchased Epinephrine, Benadryl during day April April 19 more hives on chest

BODY HURTING; LEGS DID NOT SUPPORT; FEELING TIRED; PAIN IN RIGHT SIDE CHEST; PROBLEM BREATHING; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and diabetes, 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: 201A21A, expiry: 23-JUN-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced problem breathing. On 10-APR-2021, the subject experienced pain in right side chest. On 17-APR-2021, the subject experienced body hurting. On 17-APR-2021, the subject experienced legs did not support. On 17-APR-2021, the subject experienced feeling tired. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling tired, body hurting, problem breathing, legs did not support, and pain in right side chest. This report was non-serious.

APPETITE LOST; SORE THROAT; ACHING JOINTS; MUSCLE PAIN; HEADACHE; INJECTION SITE PAIN; UNABLE TO SLEEP; ITCHY RASH; FEVER; FATIGUE; This spontaneous report received from a patient concerned a 64 year old female. 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, and batch number were not reported) dose was not reported, administered on 09-APR-2021 03:24 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced unable to sleep. On 09-APR-2021, the subject experienced itchy rash. On 09-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced fatigue. Laboratory data included: Fever (NR: not provided) 100 increase body temperature (units unspecified). On 10-APR-2021, the subject experienced sore throat. On 10-APR-2021, the subject experienced aching joints. On 10-APR-2021, the subject experienced muscle pain. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced injection site pain. On an unspecified date, the subject experienced appetite lost. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore throat, itchy rash, and fever, was recovering from muscle pain, headache, and injection site pain, had not recovered from fatigue, and the outcome of appetite lost, aching joints and unable to sleep was not reported. This report was non-serious.

CLOTS ON RIGHT LEG; HEADACHE; PRESSURE ON BOTH LEGS; PRESSURE ON HANDS; This spontaneous report received from a patient via a company representative concerned a 64 year old Hispanic or Latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure and diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, 1 total administered on 17-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the patient had experienced headache after vaccination. On 27-MAR-2021, the patient began to experience intermittent pain on right leg. On 30-MAR-2021, she experienced headache again and was still having leg pain; she visited the Emergency Room (ER) and was admitted on 30-MAR-2021. On 02-APR-2021, the patient experienced clots on right leg. On APR-2021, a catheter was placed in catheterization procedure and her right leg vein was unclogged of a clot. A second clot did not require removal because the vein had already unclogged itself after medication. The patient was administered unspecified anticoagulants. She was discharged on 5-APR-2021 and was prescribed ticagrelor which was then changed to clopidogrel. On 18-APR-2021, the patient experienced a headache again and feeling of pressure on legs and hands. Patient was advised to visit ER. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from clots on right leg and intermittent pain on right leg on 02-APR-2021, recovered with sequelae from headache on 19-MAR-2021, and had not recovered from pressure on both legs and pressure on hands. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: This 64 year-old Hispanic or Latino female with history of high blood pressure and diabetes was hospitalized for clots in her right leg 13 days after receiving the Janssen Covid-19 vaccine. Concomitant medications were not reported. On the day of her vaccination, she experienced a headache. Ten days later, she began to experience intermittent leg pain. Three days later (ie, 13 days post vaccination), she went to the emergency room (ER) and was admitted to the hospital. During the hospitalization, a clot was removed via catheterization and she was administered unspecified anticoagulants. A second clot resolved on its own without surgical intervention. After 6 days in the hospital, she was discharged with ticagrelor which was later changed to clopidogrel. She recovered from the clots. Thirteen days after discharge, she began to experience headache and "pressure" in both legs and hands. She was advised to go to the ER; no further information was provided. Based on the limited information, the relationship of the serious events with Janssen Covid-19 vaccine is considered indeterminant. Additional information is being sought.

2021-04-23 Patient presents to the ED with right-sided mid-back pain and shortness of breath starting 2021-04-22 evening. Pain is sharp and worsens with coughing and deep inspiration; she feels that she is taking shallow breaths. On ED presentation, no shortness of breath, chest pain, dizziness, fevers, dysuria, or abdominal pain. She does have reproducible pain on her right mid-back area. There is some mild diffuse tenderness in her abdomen, but reports that she always has a tender abdomen due to Crohn's disease. No peritoneal signs. No recent travel. Patient was found to have pulmonary embolism. Hematology/Oncology specialist was consulted and recommended initiation of argatroban for treatment of pulmonary embolism. Patient was admitted to inpatient.

SORE ARM, AT FIRST ATTRIBUTED TO muscle ache, but later realized it was very specific to injection site, and very intense pain. I was unable to sleep more than a few short spurts the entire night as the pain was so intense. I read online that Benadryl was to be used for the pain, as well as ice. Originally I had used heat, before finding the information online. Nothing seems to help at this point.

DIZZINESS WHEN SUPINE; KNEE PAIN; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's past medical history included left knee surgery - complete knee replacement, 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: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On OCT-2020, Laboratory data included: CAT scan (NR: not provided) unknown. On 12-APR-2021, the subject experienced knee pain. On 19-APR-2021, the subject experienced dizziness when supine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from knee pain on 28-APR-2021, and had not recovered from dizziness when supine. 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 initial symptoms were very minor and occurred the day after I received the vaccine: 99.5 degree fever and very mild headache. But several days later, both legs felt strangely weak from the calves to the feet. I also experienced occasional tingly feelings, pain, and often numbness. It was subtle at first but increased in intensity until April 21. I began to fear Guillain Barre syndrome. I scheduled a doctor's appointment for April 22, but the doctor's office cancelled and told me to go to the ER. At the ER bloodwork was done, which was normal. I was told to follow up with a neurologist if needed. It is now May 2 and my symptoms have slowly improved. It was frightening to have the symptoms for about a month. I was prepared to possibly feel unwell for several days, but expected neither my symptoms nor their duration.

Same day of vaccine around 3:30pm I started to shiver I showed a fever of 99 by 4:00pm I had incontrollable shaking with a fever 104.2 fever and sever headache. I had muscle pain on my back and neck. I had violent vomiting multiple times. I felt asleep and about 2 hours later I woke up and I had an SVT episode where my heart rate was beating was up to 200 by then the fever had gone down to 99. I called the nurse line.. they told me to call an ambulance. I called the ambulance they took me in they immediately put fluids they monitored me for 7 hours and they sent me home afterwards. I slept for 24 hours. Then on 4/27/2021 I had another SVT episode where my heart rate went up to 176 beats per minute. This lasted for 2.5 hours but I did not have to go to the the ER.

Patient experienced soreness stiffnes to left arm, chills and headaches x 3 days. Patient no longer has symptoms.

The day after the vaccine I got the usual symptoms for 36 hours. Four days after the vaccine I developed a slight cough. The cough got worse, and I had green sputum. After ten days I contacted my doctor and he prescribed antibiotics. It cleared up a little, but it was persisting. I was tested for Covid-19 and the test was negative. I had the cough for almost three weeks. I developed a weird bruise on my right forearm the size of a silver dollar. It was round and it took a couple of weeks to go away. My arthritis in my hands was also worse than normal for the three weeks.

I had oral surgery four days before the vaccine with laughing gas and Novocain which lasted four hours. The morning after the vaccine I felt lightheaded and weird. I had heart palpitations and I was queasy. I started to walk back to my bedroom. The next thing I knew I woke up on the floor after passing out. After that I felt like my body was crumpled and I was disoriented. I could barely walk but I made it to the couch, and I had bumps in the front and back of my head near my ear. I was in a lot of pain and I think I was in shock. My foot was painful, and I saw a foot doctor. I had a doctor?s appointment and they did an EKG and they sent me to a Neurologist. It has been seven weeks I still have dizziness and nausea and it is hard to focus. I also have pain in my knee and my right arm.

TIREDNESS; NECK PAIN; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's past medical history included right leg broken, and concurrent conditions included leg nerve ending pain, and right leg pain, and other pre-existing medical conditions included the patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: 23/JUN/2021) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced neck pain. On 07-MAY-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tiredness on MAY-2021, and had not recovered from neck pain. This report was non-serious.

Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Anxiety-Medium, Systemic: Hypertension-Medium, Systemic: Shakiness-Mild, Additional Details: Patient experienced high levels of apprehension and anxiety pre-administration. After 15 minute observation period, pt was visibly anxious and reported a "weird" feeling on her left side, local to administration and radiating from left shoulder. Pt BP was read as 173/109 and 5 minutes later 168/95. Pharmacist advised pt leave site due to perceived anxiety/worry, measure again in an hour, and report to ER/Urgent care if BP still above 120/80. RPh will follow up with pt following day.

HEART BEATING FAST; HEART "SKIPPING BEATS"; ACHING JOINTS/JOINTS HURTING; NAUSEATED; HURTING ALL OVER; DIZZY; COULDN'T SLEEP; STOMACH FELT "BLOWN UP"; NO APPETITE; HURTING "DOWN REAL LOW" IN ABDOMEN; HAD TO URINATE ALOT; SHAKINESS; ITCHING ARM; FATIGUE; WEAKNESS/NO ENERGY; SORE ARM; DID NOT FEEL WELL; CHILLS; BREASTS SORE; SEVERE HEADACHE/SORE SPOTS ON HEAD; UNDER ARMS SORE; SUSPECTED COVID; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included dental surgery, and left arm broken. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A and expiry: 23-JUN-2021) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced suspected covid. On MAY-2021, the subject experienced breasts sore. On MAY-2021, the subject experienced chills. On MAY-2021, the subject experienced did not feel well. On MAY-2021, the subject experienced sore spots on head. On MAY-2021, the subject experienced under arms sore. On 11-MAY-2021, the subject experienced shakiness. On 11-MAY-2021, the subject experienced itching arm. On 11-MAY-2021, the subject experienced weakness/no energy. On 11-MAY-2021, the subject experienced sore arm. On 11-MAY-2021, the subject experienced fatigue. On 11-MAY-2021, the subject experienced severe headache. On 12-MAY-2021, the subject experienced hurting all over. On 12-MAY-2021, the subject experienced dizzy. On 12-MAY-2021, the subject experienced couldn't sleep. On 12-MAY-2021, the subject experienced stomach felt "blown up". On 12-MAY-2021, the subject experienced no appetite. On 12-MAY-2021, the subject experienced hurting "down real low" in abdomen. On 12-MAY-2021, the subject experienced had to urinate alot. On 12-MAY-2021, the subject experienced aching joints/joints hurting. On 12-MAY-2021, the subject experienced nauseated. On 18-MAY-2021, the subject experienced heart beating fast. On 18-MAY-2021, the subject experienced heart "skipping beats". Treatment medications (dates unspecified) included: ibuprofen, naproxen sodium, and amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate. The action taken with covid-19 vaccine was not applicable. The outcome of the severe headache, shakiness, weakness/no energy, fatigue, sore arm, itching arm, did not feel well, hurting all over, hurting "down real low" in abdomen, nauseated, dizzy, chills, couldn't sleep, stomach felt "blown up", no appetite, had to urinate alot, heart beating fast, heart "skipping beats", breasts sore, aching joints/joints hurting, sore spots on head and suspected covid was not reported. This report was non-serious.

Complaint of cramping in legs on April 26. 2021. Resolved for a short period of time. Earlier in May 2021 Complaint of Left Flank pain with Radiating pain to Left Thigh. Appointment with Orthopod cancelled due to inability to drive with pain. On May 15, 2021 complaint of continued Left Flank Pain Radiating to to Left thigh with burning and discoloration. Unresponsive on May 16, 2021. Pronounced Dead at 1:52pm by County Coroner. Cause of death noted as CV. Nature of death :Natural This is being reported in case another patient complains of these same symptoms. There may or may not be a Correlation with this Death and The Jassen Covid-19 Vaccine

Pt given Janssen vaccine per ususal protcol and asked to wait in designated chairs for 15min. After about 7 mins pt came to counter saying she had a pain in her neck and her chest was tight. Pt instructed to sit down, was alert, talking and breathing on her own. 911 was then called so pt could be looked at. EMS arrived on scene and transported pt

I had symptoms of fatigue for a week. My arm hurt a lot where the injection was. I was given an anti-inflammatory medication 10mg for fourteen days. My arm and shoulder are still sore and its hard to cross over. I have limited range of motion. I had double hip replacement ten years ago but after getting the vaccine, pain started to arise in that area where I had the surgery. I have to go to physical therapy now because of this.

Patient became ill after J and J vaccine. She was seen in the ER on 5/1/21. C/o were temp > 100, headache, fatigue and myalgia. She presented to the ER on 5/2/21 with multiple complaints. Since that time she developed cellulitis, elevated LFTs and was seen by GI/hepatology. She developed peripheral edema and has been treated with diuretics. Her h/h dropped and hematology referral made. She did not receive the vaccine at this clinic.

SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; ELEVATED C-REACTIVE PROTEIN OF 54.4 POST VACCINE; HEADACHE; MUSCLE ACHES; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's past medical history included asplenia at 30 years due to idiopathic thrombocytopenic purpura, and concurrent conditions included polymyalgia rheumatic (2 years ago) and received steroids for treatment. The patient's immunity was not good since she was 60 years old. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) 1 total, dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included prednisone 10 milligram (since 2 years). On an unspecified date in 2021 (after vaccination), the patient experienced very mild effects which included headache, muscle aches and elevated C-reactive protein of 54.4 (unit not reported). On an unspecified date, the patient had antibody test for two times which was negative (suspected immunological vaccine failure). The patient's laboratory data included: C-reactive protein increased (NR: not provided) 54.4 (unit not reported), and SARS-CoV-2 antibody test (negative) no antibodies. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, muscle aches, elevated c-reactive protein of 54.4 post vaccine and suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 - 20210601375-covid-19 vaccine ad26.cov2.s-Suspected Immunological vaccine failure.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: SPECIAL SITUATIONS

For the past six weekends patient gets severe fever of coldness shaking and lies on a full length heating pad to warm up. Then experiences fever of hotness sweating and cannot cool down. Muscle aches, joint aches and hurts to touch the skin and exhaustion. The aches and fever last 4 - 6 hours and the next day all she can do is sleep.

SWOLLEN LYMPH NODES IN THE BACK OF NECK; STIFF KNEES; JOINT PAIN/KNEE WAS SORE; This spontaneous report received from a patient via (other manufacturer- Abbvie ) concerned a 64 year old female. 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, intramuscular, batch number was not reported) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose was not reported, 1 time every 1 week, therapy dates were not reported for moderate to severe chronic plaque psoriasis, and moderate to severe rheumatoid arthritis. Concomitant medications included methotrexate for drug used for unknown indication. On 2021, the subject experienced stiff knees. On 2021, the subject experienced joint pain/knee was sore. On 16-MAR-2021, the subject experienced swollen lymph nodes in the back of neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen lymph nodes in the back of neck on 2021, was recovering from joint pain/knee was sore, and the outcome of stiff knees was not reported. This report was non-serious.

Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Diagnosed with "costochondritis" by hospital-Severe

She got her vaccine on Tuesday, just felt a little bit tired and achy. She had a dentist APT on Thursday and they took her BP and it was very elevated, which she normally has a low BP. Said it was 210/109 and thought it was the machine and retook it and it was again elevated at 206/104 (approximate #'s). She has subsequently taken it at home and it was still elevated yesterday was 142/80, then again on left arm was 146/89. The most recent one this morning was 139/90. She is a retired nurse, and knew to take it on the opposite arm. The dentist informed her to monitor her blood pressure. She still has joint achiness from the vaccine and fatigue, not quite the pep that she had prior. She took a diuretic last night and rechecked her BP this morning so her readings are after the diuretic.

LEG SWELLING/SWELLING WENT UP LEG TO KNEE; ANKLE SWELLING; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and multiple hernias, and other pre-existing medical conditions included the patient had no appendix and gall bladder. The patient experienced drug allergy when treated with naproxen. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1821288 expiry: UNKNOWN) dose was not reported, administered on 05-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-JUN-2021, the subject experienced leg swelling/swelling went up leg to knee. On 07-JUN-2021, the subject experienced ankle swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from leg swelling/swelling went up leg to knee, and ankle swelling. This report was non-serious.

Gagging, coughing, nausea, back neck and abdomen pains, aching, tiredness, headache and running fever

I had a large preexisting sebaceous cyst in my left armpit that had never caused any problem before, but suddenly it became extremely inflamed, infected, and painful. I also had body aches. I went to Urgent Care on May 19 and was given Keflex, which didn't help, and again on May 24, and was given doxycycline. On May 28, I was able to pull part of the cyst out of the wound--it was right at the surface, poking through. Over the next few days, more pieces of the cyst came out--all shaped like pieces of a sack or a shell. After that, the pain went away and the wound began to heal. Today, I still have a very small part of the cyst remaining, which I plan to have surgically removed.

EXTREME FATIGUE; EXTREME MUSCLE PAIN; JOINT PAIN; PAIN IN SHOULDER; SWELLING IS WORSE IN RIGHT ARM; PAIN ALL OVER BODY MORE IN HANDS AND ELBOWS; NOT BEEN ABLE TO SLEEP; PAIN IS WORSE IN RIGHT ARM; This spontaneous report received from a patient concerned a 64 year old female. The patient's weight was 220 pounds, and height was 62 inches. The patient's concurrent conditions included fibromyalgia, bipolar polar i, hypothyroidism, reactive hypoglycemia, abstains from alcohol, non smoker, and preexisting hand pain, and other pre-existing medical conditions included the patient had known allergies antidepressant drug had agitation allergy and narcotics drug had itching allergy. the patient did not have any drug abuse/illicit drug use. the patient is taking eye drops for unknown indication. The patient was previously treated with risperidone for bipolar disorder; and experienced vomiting when treated with dexamethasone for drug used for unknown indication, and drug allergy when treated with erythromycin for drug used for unknown indication. 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 26-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included acarbose non-company for drug used for unknown indication, calcium citrate for drug used for unknown indication, colecalciferol for drug used for unknown indication, colestyramine for drug used for unknown indication, duloxetine hydrochloride for drug used for unknown indication, fluticasone furoate/vilanterol trifenatate for drug used for unknown indication, iron for drug used for unknown indication, lamotrigine for drug used for unknown indication, levothyroxine sodium for drug used for unknown indication, lithium non-company for drug used for unknown indication, melatonin for drug used for unknown indication, nortriptyline for drug used for unknown indication, pancreatin for drug used for unknown indication, phenytoin for drug used for unknown indication, tegretol non-company for drug used for unknown indication, vitamin b12 nos for drug used for unknown indication, vitamin c for drug used for unknown indication, oxycodone/paracetamol for pain, and vitamins nos. On JUN-2021, the subject experienced pain all over body more in hands and elbows. On JUN-2021, the subject experienced not been able to sleep. On JUN-2021, the subject experienced pain in shoulder. On JUN-2021, the subject experienced swelling is worse in right arm. On JUN-2021, the subject experienced pain is worse in right arm. On 10-JUN-2021, the subject experienced joint pain. On 10-JUN-2021, the subject experienced extreme muscle pain. Laboratory data included: Pain scale (NR: not provided) 7-8/10. On an unspecified date, the subject experienced extreme fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extreme fatigue, had not recovered from extreme muscle pain, swelling is worse in right arm, pain is worse in right arm, pain all over body more in hands and elbows, and joint pain, and the outcome of pain in shoulder and not been able to sleep was not reported. This report was non-serious.

On the same day I got the vaccine and the next day, I had fever, body aches, and malaise; I was in bed for 2 days. I had a lack of energy that was worse than it had been before the vaccine. On or about 4/14/2021, I woke up at about 2:00AM with chest pain, pain in the left shoulder and in the left side of the neck. The symptoms subsided after some time. I had low oxygen saturation levels; I knew this, because I used a pulse oximeter that had been used by my late husband. The low oxygen saturation levels have been ongoing ever since, and I have had periods of rapid heart rate and oxygen levels that are even lower than the low levels I have experienced since the vaccine. I have also had periods of chest pains at times, so my PCP referred me to both a pulmonologist and a cardiologist.

Almost immediately these symptoms appeared: Extremely achy joints, swollen index finger on right hand, feet and hands hurt, facial filler in right side of chin dissolved completely. Approximately two weeks after vaccine feet and lower legs have pins and needles feel with nerves tingling. This is a 24 hour a day problem and quite concerning. My joints pop and creak like they suddenly aged and have no lubrication. These are all NEW symptoms/issues. I?m concerned that this is a long term and/or permanent medical issue for me! I WOULD LIKE SOME ANSWERS!!!!!

J and J vaccine: 40 min. after shot, my lower lip began to tingle, then went numb, next my upper lip, next nose felt funny. chest felt tight, no wheezing. Was still at Clinic so I went to Urgent care. I used my albuterol inhaler, chest tightness resolved. Treated in UC with solumedrol, famoditine, 1 liter NaCl. My allergist had me on 2 Zytec, and 2 famoditine the day of shot. Went to urgent care 7/5 for neuropathy. Saw neurologist on 7/8/21. Today is 12 days after the vaccination. My peripheral neuropathy is so bad I can't work. I have constant pain in my shoulder girdle, lower back thighs, calves, feet, hands, and visceral. My PCP won't give my any pain meds, my pain is 8/10.

LITTLE BRUISES TO LEFT HAND AND ARM UNDER THE SKIN; TINGLING UP LEG TO THE KNEE LIKE PINS AND NEEDLES/TINGLING ALL UP AND DOWN LEFT LEG; HURTS AFTER A MINUTE OR TWO OF WALKING OR STANDING/IT ONLY HURT WHEN PUT PRESSURE ON LEG; HARD TO SLEEP AT NIGHT; PAIN IS BELOW KNEE ABOUT 3/4 OF WAY DOWN TO THE ANKLE, NOT QUITE ABLE TO PINPOINT EXACT LOCATION; PAIN IN LEFT THIGH; LOWER LEFT LEG PAIN; NERVE PAIN IN LEG ALL ON LEFT SIDE; LEFT HIP BECAME SORE; CYST IN LEFT ARMPIT; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no related medical history. patient feels normal, super good and fine. 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: 07-AUG-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced cyst in left armpit. On MAY-2021, the subject experienced left hip became sore. On 25-MAY-2021, the subject experienced nerve pain in leg all on left side. On 25-MAY-2021, the subject experienced lower left leg pain. On an unspecified date, the subject experienced little bruises to left hand and arm under the skin, tingling up leg to the knee like pins and needles/tingling all up and down left leg, hurts after a minute or two of walking or standing/it only hurt when put pressure on leg, hard to sleep at night, pain is below knee about 3/4 of way down to the ankle, not quite able to pinpoint exact location, and pain in left thigh. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cyst in left armpit on 14-APR-2021, and little bruises to left hand and arm under the skin, pain in left thigh, and left hip became sore, had not recovered from nerve pain in leg all on left side, and lower left leg pain, and the outcome of hard to sleep at night, tingling up leg to the knee like pins and needles/tingling all up and down left leg, hurts after a minute or two of walking or standing/it only hurt when put pressure on leg and pain is below knee about 3/4 of way down to the ankle, not quite able to pinpoint exact location 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 considered non serious.

FALLING MORE AND WALKS WITH A CANE DUE TO WEAKNESS; SORE MUSCLES; BODY ACHES; RUNNY NOSE; This spontaneous report received from a patient concerned a 64 year old female. The patient's weight was 200.2 pounds, and height was 65 inches. The patient's concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. patient does not remember the name of the blood pressure medication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204a21a, and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 29-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-JUN-2021, the subject experienced runny nose. On 02-JUL-2021, the subject experienced body aches. On 02-JUL-2021, the subject experienced sore muscles. On 06-JUL-2021, the subject experienced falling more and walks with a cane due to weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches, sore muscles, runny nose, and falling more and walks with a cane due to weakness. This report was non-serious.

Day after vaccine: chills so hard I had charlie horses; bones ached; nauseous and diarrhea In May, Telemed visits to Dr. sneezing, sore throat followed by coughing. wheezing, tightness of chest, shortness of breath, tired, nauseous. All COVID tests came back negative. Blood test - no antibodies, no COVID, Seeing a heart Dr. for continued shortness of breath and pressure on my chest. Had stress test and echo test.

Patient reported swelling to left wrist are, no itching or pain. Area looked puffy and feels boggy. Patient given 50 mg of Benadryl Po. After 30 minutes, swelling improved. Patient advised to take Benadryl 50 mg ever 6 hours x 24 hours. no driving while taking Benadryl. Follow up with nearest ER if symptoms worsen. Follow up in office for recheck in 48 hours

Bleeding and pain at injection site; Droopy left side of face, pain in upper left jaw, below left eye, upper left arm and left shoulder/neck; Transient headache and pain in left leg with ankle swelling.

On 3/7/2021 after I returned home, I ate broiled, skinless chicken, salad and small amount of corn at 5:00pm. I started having diarrhea about 5:30pm. Later in the evening around 8:30pm, I had more diarrhea. Around the same time I became very, very sleepy and had extreme fatigue. My right arm where I received the shot did not hurt and still does not hurt. Around 6:00pm, my left arm starting hurting in the same spot where I received the vaccine in the right arm. On the morning of 3/8/2021, I ate breakfast consisting of whole wheat bread and peanut butter and weak coffee (my usual breakfast) and had diarrhea again soon after eating. At 3:30pm, I ate broiled, skinless chicken, green beans and small amount of instant mashed potatoes. Around 5:00pm, I had diarrhea again. I have been drinking a great deal of water on both 3/7/2021 and 3/8/2021 as I normally do every day. At 6:30pm, I had more diarrhea. Soon after, I took two imodium gelcaps and hoping they will help the diarrhea. My left arm has become increasingly more sore and hurts in the muscle. No other symptoms.

Starting about 5 hours after injection, fatigue, followed by extreme headache, followed by chills and aches. Lasting about 24 hours, treated with extra strength tylenol. I couldn't sleep due to the chills, and muscle aches during the night so I slept most of the next day until late afternoon. Kept taking Tylenol through the day and evening. Felt ok the following day.

Shot at 2:00 pm. Chills at 7:00 pm. Violent shaking from the chills that hurt my back & chest. Headache sore throat, dizzy

4 hrs after injection experienced joint pain in wrists and hands, treated with Extra Strength Acetaminophen 10 hrs after injection experienced fever & chills, body aches, headache and continued joint pain in wrists and hands; treated with Extra Strength Acetaminophen throughout night 21 - 28 hrs after injection continued to have headache; treated with Extra Strength Acetaminophen

Began with violent shakes and chills. Migraine type headache developed, followed by nausea feeling, all over sore muscles. This lasted about 12 hours, then slowly started to subside. By second day, nausea gone, headache gone, but very light-headed. On third day, still very light-headed.

started during dinner, 6pm, hands and feet cold, chills continued and increasingly worse, shaking, muscle spasms, headache, temp 103, vomited, ache muscles. Tylenol had no notable affect. Next day 3/8/21 chills subsided, groggy, headache #7 on pain scale with light sensitivity. Tylenol little affect. A metal taste in my mouth, food didn't taste right. Next day 3/9/21 felt much better. Please note I had hydrated well previous to getting the vaccine.

Around 10-11 hours after the injection, I began to feel body aches and soreness around my neck and upper back. I started getting chilled but was very hot and feverish. I went to bed around 10:00pm and had extreme body aches, shaking with chills and had a fever. I took tylenol around 4am, when my temperature was 100.7. The fever and aches subsided by the time I got up around 7am, but I was tired all day. Took another tylenol around 1pm and started feeling normal, fine. No other issues.

On 3rd day after vaccination, pain began in left pectoral region on left side. Pain heals settled in intercostals of left rib cage. This has caused difficulty in taking a deep breath. No congestion, coughing, or vomiting. Just pain with inhalation. Pain can be palpated in ribs, level 6 and 7. Somewhat better today, March 17.

pt stated that after she took the covid vax her arm was red and hurting very badly. Later she felt nauseas, had muscle pain and headache. Temp was 100.4. She took 2 Tylenol and felt some better. By 3/17/2021 she began having more muscle pain in her arms and legs and her arm is still very sore. Pt states she will call her PCP for medical advice.

I was fine at first. The next morning, I woke up with a bad pain in the joint of my left shoulder. I waited a few days before I contacted my doctor. By the third day, I contacted my doctor (via phone) and she told me to take aspirin, Tylenol or ibuprofen. I didn't have any pain at the injection site. It got better progressively over the next few days.

I am a well-nourished (doctor-speak for chunky), 65-year old female in fairly good health. My main issue is severe rheumatoid arthritis, for which I take Humira (abdulimumab) by injection every two weeks. I?ve been taking this medication for years and it has managed my condition well. March 5 I received my (Janssen) vaccine and suffered no side effects, not even swelling or discomfort at the injection site. Piece of cake! March 11 I took my regular injection of Humira. Pain started in my ankles, wrists, elbows and knees, increasing through the evening. I developed a sore throat, but there were no other signs of allergic reaction. Pain increased, waking me through the night. March 12 Discomfort has increased severely. Can?t put weight on my right leg and the slightest movement of any part of my body causes searing pain, especially in right leg from mid-thigh to below the knee. I can?t lift the leg on its own; have to move it using my hands. Pain is a constant 10, and I?m crying like a baby. My left foot shows gout-like symptoms with heat, swelling and pain at the base of the toes. The entire foot is very tender to the touch. Taking Norco every six hours and using a cane. I?m not a wimp. I spent 10 years in the military, have had two total knee replacements, a reconstructed ankle and fought breast cancer twice. March 13 Pain has diminished, but is still localized in the ankles, knees, wrists and elbows. Taking ibuprofen instead of Norco, drinking a lot of liquids and icing swollen foot. The most intense discomfort evolved during the 24 hours following the Humira injection. I?m not a clinician, but it seems that the Humira didn?t react well to the introduction of the vaccine. It?s as if it was saying ?Sorry, this spot is already taken,? and decided to duke it out. I?m a bit concerned about the next dose of Humira, but the vaccine has supposedly done its work within two weeks.

At around 3:30 am patient or my mum sorry having chills shivering muscle aches her temperature was 102.5 took Tylenol and fell asleep around noon that day very confused swore she took Tylenol but didn?t bell and couldn?t get off the floor again very confused lethargic MS was called temperature noted to be 106 Greece Fahrenheit was taken to the hospital given three bags of fluids was given Tylenol even though patient was argumentative and said she took Tylenol continue to be confused and lethargic throughout the stay at the hospital upon leaving hospital at 8 pm temperature was 100.7 patient was able to walk

First day developed a headache, and a bad rash on my chest that was very itchy for 2 days, rash was visible for approx. 2 weeks. (took a picture), second day had flu like symptoms, headache turned into a migraine 24 hours after initial headache began. Had joint pain, slight cough and lower back ache as well as headache until Saturday morning 3/13/2021. Took Tylenol at home and got extra rest until all symptoms went away.

Fever, chills, whole body stretches, headache, joint pain, very tired, This will take a day or two to not feel tired. and a little heavy breathing.

Night of shot experienced fever of 101, nightmares and slurred speech. The following day experienced fatigue. By the second day post vaccination memory impairemt. By the third day post vaccination has gait unsteadiness and fell six times. The 4th day post vaccination left arm weakness and could not use arm. accompanied by slurred speech.

When needle came out I felt like my upper arm was filled with lead - very heavy feeling for about 8 minutes. About 2 hours later I felt very fatigued and slept for 2 hours. Woke up at 4:30 am next day (04/08/21) with a raging migraine, unbearable nausea and cold to the bone. Vomited 2 times in the day. After drinking some ginger beer at 3 pm the nausea was gone by 3:30 pm. Migraine gone by 7 pm and freezing cold feeling gone this morning (04/09/21).

^ hours after injection my arm was aching. Then Head ache set in by 7pm. pain with neck and head and fever progressed quickly. by 9pm it was 103.7 By 11:00pm my fever was 105.4. By midnight it was 105.9 I took Vicks NyQuil because it was the only pain med that had Tylenol in it. Fever reduced to 105.4 by 2:30 am fever was at 104.5 and I felt safe to try and sleep and not die. A nurse friend was telling me to go to the emergency room. I applied and Ice pack to my splitting headache and eyeballs felt like they were going to pop out. also Icepack to neck. ate a popsicle. I hydrated emencely before the shot and All day with the shot. I kept moving my arm and it was fine after a few hours. THE FEVER SITUATION WAS QUITE FEARFUL AND STRESSFULL. My throat felt a "little" tightening. I swallowed every few minutes to make sure it did not progress. I had Benadryl on hand just in case. I slept from 3:00am until 9:30 am. My morning fever was between 103.7 and 104.5 It was 102.4 at 3:00pm it is 8:45 pm and my temp is 202.2 now. head ache is at 50% of yesterday.

No Sx immediately after. Joint and bone pain starting 12 hours later with increasing fatigue. Temp low -96.2° with chills (normal is 97°). Slight headache and ringing in ears started about 2pm. I felt like temp was going up, but I don't usually get a temp over 98.8° even when ill. Fever at 100° by 5pm Sat. No "CoVid symp" Eg cough, SOB, GI, loss of smell. Increase fluids. Allergies to PEG in Acetaminophen otc, and NSAIDs. Non critical event at this time.

Burning pain, waves of body Chills, left side neck pain, headache, slight nausea. Had a Blood Pressure check immediately and temperature check (97.1), waited for a longer period at facility to make sure I was OK. blood pressure was extremely high at first reading (I've never had such a high reading in my entire life); blood pressure was within normal limits on second check (127/85), and I was well enough to leave. The chills come in waves, with continued slight nausea.

On April 7 (six days after the vaccine) my mother experience a sharp pain on her left arm, radiating to her neck, back and finally chest. We went to emergency department, and she had EKG, CT Scan, X-Rays, MRI and blood work and could not find anything. She was discharge but the pain didnt go away. She is still in pain but less than before.

Upon leaving the store, started to develop headache. Next morning, headache severe, neck pain, nauseated and very tired. Headache lessened by 2nd day, still very tired, neck pain and nauseated. Neck pain persists, very tired and still some nausea. Eating very little due to feeling of getting sick.

INDIGESTION; GENERALIZED JOINT PAIN; FEVER; RAISED RASH ON RIGHT LEG; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included osteoporosis, mitral valve prolapse, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced raised rash on right leg. On 06-APR-2021, the subject experienced fever. On 06-APR-2021 15:00, the subject experienced generalized joint pain. On 06-APR-2021 19:00, the subject experienced indigestion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 06-APR-2021, and had not recovered from indigestion, generalized joint pain, and raised rash on right leg. This report was non-serious.

left knee swollen: x-ray done on 3/15/21, showing nothing wrong, doppler test done on 3/19/21- no blood clots, MRI done on 4/14/21, waiting on results: shortness of breath started on 3/12/21 and lasted about 3 weeks.

Severe Joint and muscle aches, fever, chills, loss of appetite, night sweats, severe headache, extreme fatigue. Symptoms started 8 hours after injection and persisted for 3 days. Took Tylenol as needed for fever and pain. Extreme fatigue kept me immobilized for those 3 days.

Evening of Day 1, shaking chills, fever (100), headache. Went to bed at 9:00, woke at 3am with severe "swelling" I felt like my brain was too big for my skull, my entire face felt swollen. Joint aches, muscle aches, nausea. Nausea has been intermittent thru day 5. Headache continues but not as severe. I still wake up with it every day (this is now day 5). Diarrhea began on Day 3 (watery, every 1/2 hour for 4 hours). fever subsided and returned on Day 3 (100). no fever since but muscle aches, headache and joint aches continue.

POOR CIRCULATION (IN FINGERS, FOOT, ANKLES, ARMS); BLOTCHY RASH WHICH GOES UP THE ANKLE AND LEG ABOUT 2 INCHES; TINGLING DOWN LEFT ARM AND IN FINGERS; LEFT ARM AND FINGERS ARE NUMB; RIGHT ANKLE SWELLS AT NIGHT; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included parkinson's disease. 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, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced poor circulation (in fingers, foot, ankles, arms). On 26-MAR-2021, the subject experienced blotchy rash which goes up the ankle and leg about 2 inches. On 26-MAR-2021, the subject experienced tingling down left arm and in fingers. On 26-MAR-2021, the subject experienced left arm and fingers are numb. On 26-MAR-2021, the subject experienced right ankle swells at night. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from poor circulation (in fingers, foot, ankles, arms), blotchy rash which goes up the ankle and leg about 2 inches, tingling down left arm and in fingers, left arm and fingers are numb, and right ankle swells at night. This report was non-serious.

Janssen Covid-19 Vaccine EUA. Left arm muscle continues to be sore- not able to use arm for functionality- It has continued to be very sore- when I use the arm - it gets worse. I rely on ibuprofen but still pain is there.

Patient had slurred speech, headache, pain in the thigh muscles, bloody nose, lost strength in the arms, hands and legs, could not chew or swallow. She was diagnosed with Guillian Barre Syndrome and hospitalized from 04/04/2021-04/18/2021.

around 1 week before appt (4/16/21) started noticing pain in underside of right arm, gradually worsened and moved into axillae area and in to right chest wall.

On Sunday night, 04/11/2021 around 7:00pm, patient stated she started getting sick to her stomach. She complained of headaches and fatigue. At midnight she vomited, couldn't lay down and symptoms lasted all night. She complained of back pain too. she noticed blood in her urine with a clot of blood in it and had shortness of breath. She vomited twice. In contact by phone with her daughter at the time. Patient refused to go the the emergency room or call her physician. She has a cardiologist who is her primary care physician.

I currently have swelling in my hands, pain in my vaccinated arm, bone pain, a bump in my hand like thrombi, burning sensation in my stomach, taste of blood in my throat, leg and joint pain. After I was vaccinated.

MUSCLE ACHES; FEVER; RASH; HEADACHE; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included latex allergy, and ciprofloxacin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 11:00 for prophylactic vaccination. Concomitant medications included levothyroxine sodium. On APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced rash. On 10-APR-2021, the subject experienced muscle aches. On 10-APR-2021, the subject experienced fever. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rash on 11-APR-2021, and muscle aches, and fever on APR-2021, and had not recovered from headache. This report was non-serious.

LEFT RIB CAGE PAIN; MUSCLE TIGHTNESS; DIFFICULTY BREATHING; COUGH; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included autoimmune hepatitis. The patient experienced drug allergy when treated with erythromycin, and morphine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 13:50 on left arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced cough. On MAR-2021, the subject experienced difficulty breathing. On 14-MAR-2021, the subject experienced left rib cage pain. On 14-MAR-2021, the subject experienced muscle tightness. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from left rib cage pain, and difficulty breathing, and the outcome of cough and muscle tightness was not reported. This report was non-serious.

The injection site has become increasingly painful as time goes on. It feels l like my shoulder muscle is 'dying' if that makes sense. definite increasing weakness in my shoulder and arm , pain radiating out deep in the muscle right at the injection site ,

NUMBNESS IN HANDS, FINGERS AND FACE; CONGESTION; SORE THROAT; DIZZINESS; CHILLS; WEAKNESS; FEVER; FATIGUE; NAUSEA; HEADACHE; MUSCLE PAIN IN BACK; This spontaneous report received from a patient concerned a 65 year old female. 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, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced numbness in hands, fingers and face. On 09-MAR-2021, the subject experienced congestion. On 09-MAR-2021, the subject experienced sore throat. On 09-MAR-2021, the subject experienced dizziness. On 09-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced weakness. On 09-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced fatigue. On 09-MAR-2021, the subject experienced nausea. On 09-MAR-2021, the subject experienced headache. On 09-MAR-2021, the subject experienced muscle pain in back. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, chills, weakness, fever, and headache on 10-MAR-2021, and had not recovered from fatigue, nausea, muscle pain in back, numbness in hands, fingers and face, congestion, and sore throat. This report was non-serious.

About three weeks after getting the J & J vaccine, I began getting headaches, mostly on the top of my head. They have lasted a month. Within a week I went to the ER and had a battery of tests; The only thing that showed up is that I was dehydrated after several hours of not drinking water. Normally, I drink about 64 oz. of water a day. The pain sometimes radiated to my neck. An x-ray showed arthritis. I have had occasional nausea.

FELT LIKE LEGS WILL BUCKLE UNDER HER WHEN GOING TO RESTROOM; HIVES; ITCHING; INSOMNIA; DOES NOT FEEL HERSELF; ANXIETY; DRY MOUTH DESPITE DRINKING A LOT OF WATER AS DIRECTED; WEAKNESS; 24 HOUR FLU; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207a21a, and expiry: UNKNOWN) dose was not reported, administered on 05-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-MAY-2021, the subject experienced 24 hour flu. On 06-MAY-2021, the subject experienced dry mouth despite drinking a lot of water as directed. On 06-MAY-2021, the subject experienced weakness. On 07-MAY-2021, the subject experienced itching. On 07-MAY-2021, the subject experienced insomnia. On 07-MAY-2021, the subject experienced does not feel herself. On 07-MAY-2021, the subject experienced anxiety. On 07-MAY-2021, the subject experienced hives. On 08-MAY-2021, the subject experienced felt like legs will buckle under her when going to restroom. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from 24 hour flu on 08-MAY-2021, and insomnia, was recovering from hives, and felt like legs will buckle under her when going to restroom, and had not recovered from itching, anxiety, does not feel herself, dry mouth despite drinking a lot of water as directed, and weakness. This report was non-serious.

No problems the remainder of day of injection. Next morning upon awakening, I was very groggy and unable to stay awake. I slept 4 hours past my normal time for getting up. I had no balance and would stagger when standing. My entire body was in muscle and nerve pain. Even my skin hurt. I took 300 mg of Gabapentine which eased my pain. I continued to be off balance the remainder of the day, however, by the end of the day I was much better. I took several 1 hour naps throughout the day.

Patient Received the COVID Janssen vaccine on 3/9/2021. On 4/11/2021, the patient developed symptoms described as right lower leg weakness (leg "bowed" out, felt, like a "lead" foot). She also complained of right upper arm weakness. She was admitted on 4/12 and determined to have an acute CVA. Her symptoms quickly resolved. She was started on enoxaparin, ASA, and rosuvastatin and discharged on 4/13.

On the way home I had neurological symptoms, tongue and lip tingling, nauseated. The smell of Lysol spray made me not be able to breath. Made me dizzy and nauseous. It was like an LSD trip. It like being on a roller coaster, It continued all the way home. I could see all the timbers and bright green colors. Neck was stiff and it crawled up my head to my temples. It was like someone was holding my head. About 3 days later after vaccine my throat started to close and we headed to ER. I took turmeric and ginger to the ER as well as Benadryl. The symptoms subsided before we reached ER so I didn't seek care. I took vitamin E and fish oil 2X everyday after vaccine for 10 days following vaccine.

Right away, they were watching me because I felt like my throat was tightening up a little bit. My blood pressure sky rocketed. Then I was okay after awhile. They pharmacist said to take some Benadryl when I got home if I needed it. He knew I had taken Claritin D earlier. I was okay though. But the next morning, I was so exhausted I could barely get out of bed. The next day, I was still really tired. On Sunday morning, 10th, it hit me - I woke up at 04:00 in am. Nauseous; light-headed; gastro-intestinal issues; extremely ill. I called my brother in and was afraid to be by myself. I could barely move around to even get water or go to bathroom. I got through it somehow that day and on Monday I was just maybe a little but that isn't saying much - still severe. By Tuesday, I called the pharmacy - I was so light-headed I thought I was going to pass out and they told me to go to ER and someone took me and doctor said he was seeing a lot of this. Gave me IV fluids. It was difficult to stay hydrated - they gave me paperwork on what to drink to stay hydrated - Pedialyte - anything that had water in it. I drank Essentia Water, too. I couldn't stay hydrated and I was so light-headed (kept feeling like I was going to pass out) that I could have gone to ER again two days later. Doctor said take it easy - he said my body was busy making antibodies. That light-headedness for about a week - but I couldn't drive for two weeks because of it - was still so dehydrated. I had a strange sensation - like I was outside my body - I couldn't think straight. I was feeling pain in my back by my kidneys and went to my doctor.

SLIGHTLY HOT TO TOUCH AT INJECTION SITE; DELTOID MUSCLE TONE LOSS; SWELLING BELOW INJECTION SITE; PAIN AT THE INJECTION SITE, PAIN IN BELLY OF LEFT DELTOID, LEFT DELTOID PAIN AT THE TIME OF INJECTION; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included vascular necrosis of the hip, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1802068, and expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced pain at the injection site, pain in belly of left deltoid, left deltoid pain at the time of injection. On an unspecified date, the subject experienced slightly hot to touch at injection site, deltoid muscle tone loss, and swelling below injection site. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from pain at the injection site, pain in belly of left deltoid, left deltoid pain at the time of injection, slightly hot to touch at injection site, deltoid muscle tone loss, and swelling below injection site. This report was non-serious.

On April 1st through April 4th, it first started with extreme fatigue. On April 5th, my entire left side of my neck, shoulder, upper back, and arm became tight and racked with pain. My whole left arm had felt like pins and needles, which progressed to my fingertips. I went to the chiropractor on April 6th, 8th, and 10th. On April 12th, I went to Dr. and he prescribed me steroids and muscle relaxers. It took a month to feel like I was at 99% again, I still have tingling in my left hand.

Immediate extremely strong metallic taste in mouth. Tongue and lips a little puffy. Very inflamed lymph nodes in neck. Metallic taste went to gums, and I could feel the metal taste scallop across my teeth, from left to right. Felt a sweaty sensation on top of head, like I had a bowl on top of my head. Metallic taste started going down my throat. Soft palate swollen causing gagging due to uvula touching my tongue. Could feel the sensation on my head inching its way down my head. It stopped at the hairline above my ears, which made me think that I was getting in feeling in my hair follicles and not a sweaty sensation. Stayed 70 minutes at site. Metallic taste mostly gone. I was told to pick up some Benedryl. As soon as I took it I felt a strong pounding in my ears. When eating dinner I could feel a slight constriction while swallowing. The next morning the lymph nodes in my armpits were extremely sore. Neck lymph nodes stopped being sore Saturday, but are still a little swollen. Lymph nodes in arm pits were better on Sunday, but are still sore if pushed on.

feeling light headed, nausea, some coughing tightness in chest, some loose stool, lower back ache, weakness, lack of sleep the first night. ate chicken noodle soup, tylenol PM, slept, drank white tea with peppermint tea, sucked, on Ricola drops and EmergenC drops

1st 24 hours, the expected chills, fever, shakes, severe headache, muscle aches, N&V. After that, profound fatigue, disordered taste, nausea, for one week. After that, exhaustion continued, with any mild to moderate activity causing return of chills, nausea, and headache. This lasted over FOUR WEEKS and began to resolve only with naturopathic treatment.

I have had muscle aches and tiredness since I had Covid-19 in April of 2020. The symptoms have gotten worse since I got the vaccine. The muscle aches were unbearable and I had a fever for the first two days. The aches and pains are still present after three months and they come and go at the moment. I have a constant ache in my legs as well as tiredness. These symptoms were present since my Covid-19 but they are worse than they were before the vaccine.

Had soreness in all muscles . Throat felt full 6/26/2021. 6/27/21 inside mouth/gums sore and slight fever... 6/28/21 gums still sore on upper left mostly hard to eat. did

DISCOMFORT IN UNDERSIDE OF RIB; DISCOMFORT IN LEFT ARM; NAUSEA; HEADACHE; TINGLING DOWN TO FINGERNAILS; PULLED A MUSCLE IN BACK; DIZZINESS, LIGHTHEADEDNESS UPON STANDING; DRY MOUTH; ARM HURTS WHEN STRETCHED; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included narcolepsy, and cluster headache. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, expiry: UNKNOWN) dose was not reported, administered on 21-JUN-2021 for prophylactic vaccination. Concomitant medications included verapamil for cluster headache. On JUN-2021, the subject experienced tingling down to fingernails. On JUN-2021, the subject experienced pulled a muscle in back. On JUN-2021, the subject experienced dizziness, lightheadedness upon standing. On JUN-2021, the subject experienced dry mouth. On JUN-2021, the subject experienced arm hurts when stretched. On 21-JUN-2021, the subject experienced discomfort in underside of rib. On 21-JUN-2021, the subject experienced discomfort in left arm. On 21-JUN-2021, the subject experienced nausea. On 21-JUN-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the discomfort in left arm, dizziness, lightheadedness upon standing, dry mouth, nausea, headache, pulled a muscle in back, arm hurts when stretched, discomfort in underside of rib and tingling down to fingernails was not reported. This report was non-serious.

I had a slight ache where the needle was placed after I was given the shot. It was not severe. Next 10 days I did not have any symptoms. At the night of the 10th day, I had a little chill, fatigue and joint pain on the fingers and the toes. Next 14 days, My joint pain on the same area and fatigue continued about at the same rate from the 10th night. On the 15th day, my joint pain was almost gone, a little bit of tiredness remains, I would not call this fatigue anymore. On the 16th day, joint pain was gone. and after 30 minutes of nap, the tiredness is gone.

Two weeks after vaccination, developed fatigue, low platelets (30,000), pain in thorax (ribs - tenderness/pain bilaterally, variable location - worse with standing up, not related to breathing), shortness of breath - developed epistaxis.

Started w/ nauseau and diarhea, shaking and chills (even in hot climate), take ibuprofen and peptobismalevery three hours, dreams, weird fever dreams, left leg burning, lower teeth pain, joint pain in left hand (unusual). After two weeks burning dissapeared, everything else lasted only 4 days

Re-occurrence of Lyme symptoms that had been in remission - double vision, memory problems especially short-term memory, headache, back and neck pain, insomnia,

Taking a shower and starting having severe shortness of breath, got real weak and it lasted about 45 mins. Could barely walk. Went to the ER got admitted and they couldn't find anything. She had to walk with a walker, body and joint aches. Walks very slow now, balance is off and she get lightheaded

My temperature is usually 96 degrees, but I reached a fever of 98.8 on the morning of 4/10/2021. I felt foggy and very fatigued. Between 4/10 and 4/12, my fever reached 101.1. I had a dull headache and I had bone pain and joint pain; I felt like a walking skeleton. I felt like I could feel every joint connected to every bone. I was extremely sleepy and had no appetite. I was in a neurological fog. The days just went by, and I basically don't remember anything. I went to a cardiologist on 5/2/2021 and had a halter monitor put on; the results indicated an electrophysiological myopathy, second and third degree heart blockage, supraventricular tachycardia. The etiology to all of these is unknown. There was no afibrillation. I wore the monitor for 13 days.

June 14, I had the vaccine. June 25, I started having muscle aches, severe headache and sore throat. This continued through the next week along with being extremely tired. July 5, I went to the ER due to severe chest pains (I have NEVER had chest pains before). They sent me home that same day. By July 7th, I felt like my heart was seizing and went back to the ER this time also with shortness of breath and a fever. I was admitted on July 7th and discharge on July 9th, with diagnosis of Pericarditis--a SIDE EFFECT OF THE VACCINE. I am now currently on sick leave as I cannot work. I was told by medical staff to report this so that is what I am doing.

Janssen COVID-19 Vaccine EUA Approximately six hours after administration of the vaccine, patient experienced sever chills and dizziness. Unable to stop shaking, patient took temperature which registered at 95.4F and then 95.1F at 15 minutes. Patient donned flannel pants, thermal shirt, and oversized hooded sweatshirt and got in bed under flannel sheets, two doubled-over blankets, a bedspread, and quilt. A down-filled king-size pillow was placed on top of patient's torso and a space heater was turned on to highest setting. Patient reports heart seemed to be racing, but did not take BP. Unable to quell the chills, the patient continued to shake, developing very stiff shoulders, neck and back as a result. This continued until approximately 2 am. The next morning, patient's temperature was registering at 99.4F and pulse was 96, but patient did not report chills. General muscle aches and mild headache were noted. At time of this report, patient's temperature and pulse are normal (97.6F and 76 pulse).

11 am March 8 onset of fatigue, body aches, "brain fog" which increase over course of afternoon and persist rest of day/evening Body temperature climbs to 99.5 in late afternoon Focused pain in hip joints, left side neck and jaw Unable to work/pursue normal daily activities entire day of March 8 Symptoms resolve as of March 9, when temp returns to normal, fatigue and aches abate

Janssen eua Very slight dizziness afterwards, and then very heavy feeling in chest, hard to breathe about 45 minutes later, and then hives about an hour later. Next day very slight feeling in the injection area, muscle aches, still have heavy chest and breathing issues, but not as bad as yesterday. I took a Zyrtec tablet around 6:00 p.m. on 3/9/21. Also used CPAP during the night. Oops, forgot to add CPAP and Zyrtec to medication list, I use CPAP nightly and Zyrtec 1xd at night time. I also had a resting pulse of 111 with fast heartbeat. My blood pressure was 136/84, my oxygen was down to 93.

Experienced body aches (in joints mostly), chills, mild fever and sore throat. These symptoms came on around 12PM and lasted until bedtime, which was around 11PM. At 6PM, I took 2 tylenol (500 mg. Each) upon awakening the next day, I felt tired, but the chills and joint aches were gone . Most of today, (3/16), I have felt better, just more tired than usual.

Violent shaking and chills, 100.1 fever, muscle aches, headache, dry mouth, pain in arm, nausea but no vomiting

Pt felt swelling on the right side of her neck(has went down) felt soar head hurt when turning but also going away, a little on left side very slight, brain fog on Friday night still very slight, and fatigued (still occurring), headache on first night no longer occurring

Symptoms began little after ten hours of receiving vaccine. Symptoms included flu like symptoms of aches , joint pain and fatigue with fever up to 101 lasting 3 1/2 days. Fever broke SUnday night 14th, approx 9:00pm. Awoke Monday the 15th light headed and fatigued but aches and fever gone. Then approximately 5 pm on Monday the 15th started having chest pain, upper right side. By midnight I was being transferred to ER for the chest pains. Released Monday morning the 16th from ER Dx. Possible chest wall inflammation; Followed up with primary care office (not my regular Dr. but with Dr. Have been experiencing internal jittering; agitated cough, upper respiratory issues (but lungs are clear.) ever since I originally had Covid.

Body aches, headache, slight fever, fatigue lasting....... 24 hours 3 days after injection lower back ache started lasting about 36 hours

On Saturday 3/20/21, Patient developed a circular rash below injection site on left arm. She had swelling and pain from left shoulder to elbow and radiating pain up to neck and down to hand with numbness in hand. Patient said the rash lasted about 2-3 days. On 3/27/21, Patient went to ER due to pain and was given naproxen. She went back to ER on 3/29/21 due to continuing to have pain. She is to follow up with PCP this week.

Approximately 10 minutes into the patient's 15 minute after vaccine monitoring time, she reported redness of upper extremities bilaterally. Patient taken to emergency medical area of public health vaccine clinic where she then reported numbness/tingling to the lips, Patient started to experience a "funny feeling in legs/feet", hives on chest and lower extremities. Blood pressure was 226/139. IV established LAC 20 gauge with EMS/Fire called. Patient transported to Campus via EMS. Patient contacted on 04/02/2021 via phone to obtain patient's current status: patient stated she was kept in hospital ER for 6 hours, developed further rash to face and back,felt really cold/freezing, and had shortness of breath while at hospital. Patient states she was given pepcid, prednisone, benadryl while at hospital; had lab work-CBC w/ diff, CMP, chest x-ray, 12 lead EKG. Patient discharged home with prescriptions for an Epi-Pen, benadryl, prednisone and pepcid. Patient reports she has a raspy voice, itchiness, some chest tightness, throat feels "a little tight like you are starting to come down with something" and headache that started morning of 04/02/2021.

hit me about 7:30pm - very tired, pain in my joints and fever during the night. Slept for 13 hrs Sat night and 10 hrs Sun night. Right arm has some swelling

BOTH EYES WERE IRRITATED; BOTH EYES WERE RED; DIZZINESS; FELL AGAINST SINK; FEELING VERY BAD; HEADACHE RADIATING TO SHOULDER AND NECK; TEMPERATURE 101.4 F; MUSCLE ACHES TO BILATERAL BUTTOCKS AND BILATERAL THIGHS; LEFT ARM PAIN ALL THE WAY TO THE BACK OF THE SHOULDER; VERY BAD HEADACHE; NOSE SWELLING; LIP SWELLING; LEFT EYE SWELLING; FEELS NASAL PASSAGE CLOSED; LEFT EYE NOT OPENING COMPLETELY; LEFT EYE TEARING; This spontaneous report received from a patient concerned a 66 year old female. The patient's weight was 218 pounds, and height was 62 inches. The patient's past medical history included anaphylaxis (closed throat) to sulfa, and concurrent conditions included asthma, sulfa allergy, corn allergy, non-alcoholic, smoker, hypothyroidism, seasonal allergies, and allergy to pcn, and other pre-existing medical conditions included the patient have allergy to caines. the patient did not have any drug abuse/illicit drug use. The patient was previously treated with epinephrine for anaphylaxis (closed throat) to sulfa. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1805018 and expiry: unknown) dose was not reported, administered on left arm on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced left arm pain all the way to the back of the shoulder. On 24-MAR-2021, the subject experienced very bad headache. On 24-MAR-2021, the subject experienced nose swelling. On 24-MAR-2021, the subject experienced lip swelling. On 24-MAR-2021, the subject experienced left eye swelling. On 24-MAR-2021, the subject experienced left eye not opening completely. On 24-MAR-2021, the subject experienced left eye tearing. On 24-MAR-2021, the subject experienced feels nasal passage closed. On 25-MAR-2021, the subject experienced both eyes were irritated. On 25-MAR-2021, the subject experienced both eyes were red. On 25-MAR-2021, the subject experienced dizziness. On 25-MAR-2021, the subject experienced feeling very bad. On 25-MAR-2021, the subject experienced temperature 101.4 f. On 25-MAR-2021, the subject experienced muscle aches to bilateral buttocks and bilateral thighs. On 25-MAR-2021, the subject experienced fell against sink. On 25-MAR-2021, the subject experienced headache radiating to shoulder and neck. Laboratory data included: Body temperature (NR: not provided) 101.4 F. The action taken with covid-19 vaccine was not applicable. The patient was recovering from dizziness, had not recovered from nose swelling, lip swelling, temperature 101.4 f, left arm pain all the way to the back of the shoulder, very bad headache, left eye swelling, both eyes were irritated, left eye tearing, muscle aches to bilateral buttocks and bilateral thighs, both eyes were red, and left eye not opening completely, and the outcome of feeling very bad, feels nasal passage closed, fell against sink and headache radiating to shoulder and neck was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.

went to bed at 10, and was cold but that's normal. about 12am was getting colder and back hurt. went to couch with heating pad, was so terribly tired, little nauseous, went to bathroom 8times. got up at 6am with husband and crawled into bed and slept, didnt hear anything happening in the house, just slept. got up to couch again and heating pad, then bed again. freezing and warm and sweating head. at 12 noon finally 'woke' up and got up and sat on couch but didn't feel need to sleep as much. ate a little at 1pm, now am sweating like a fever broke, not cold anymore. headache yet, stiff neck, arm sore

My are has hurt since the shot, it hurts to lift my arm up and aches into the shoulder, have been nauscious and started vomiting on 4/11, have had a bad head ache. Body Ache all over. Feeling very weak.

Profuse sweating 14 minutes after injection, dizziness and nausea. overwhelmed my body and limbs. lasted 35 minutes before I could leave the store to get in my car. felt fatigue for first 1 hours. Then at 10 hour mark severe fatigue low grade fever 99.1. At 22 hour mark sever headache, spine ache neck ache, loss of appetite, heartburn,/GRD, fatigue,muscle fatigue, fever 99.9 controlled with Tylenol brain fog, Severity of these symptoms still persisting as of 72 hours after injection.

About 30 minutes after the vaccination (on the way home), I felt very faint and almost passed out. At the same time, my injection arm started burning. Also, I started experience a mild headache while on the way home which became VERY bad about an hour after the vaccination (at home). My head, neck and shoulders hurt so badly that I could not move and my vision was blurry; it was a searing type of pain. Then, I developed a fever which, at its highest temperature, was 101.6° along with overall achiness, malaise and severe fatigue,

PAIN AT RIGHT KNEE REPLACEMENT AND LEFT KNEE; This spontaneous report received from a patient concerned a 66 year old female. 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 01-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced pain at right knee replacement and left knee. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain at right knee replacement and left knee. This report was non-serious.

Reports of having symptoms of severe bilateral leg pain at night. Started Sunday 4/11/21 at 11:00 pm and reports pain was so severe it kept her awake for 4-5 hours on night of 4/11-4/12 and had the same leg cramps 4/12 night and 4/13 night, noting the last two episodes did not last as long. Currently report of having swelling to left knee, tenderness to bilateral knees and bilateral calves.

Felt leg pain, heavy legs, burning sensation. The symptoms were more acute for the first week, still having some symptoms but a little lighter.

The patient is a 66 y.o. female with past history of diabetes, GERD and HTN who presents to the Emergency Department with visual changes of the right eye and associated pain to the face and neck. Per interpretor, patient woke up feeling at baseline yesterday morning, when she had her COVID-19 vaccine. Yesterday around dinner time, she began having issues with vision in her right eye, causing her visual field in that eye to appear dark to her entire right eye. She told her husband that she thought she might have a hair or eyelash in her right eye and that she had an irritating pain radiating from her right eye to the right side of her face. Even after washing her eye with cold water, the sensation did not subside. At approximately 3-4 AM this morning, she also began to experience pain to the back of her head and neck bilaterally. This morning, the visual impairment improved from the entire visual field to now only just the inferior aspect of the right eye. However, she denies weakness to any of her extremities. Patient also denies chest pain, numbness, abdominal pain or nausea. She was seen at ophthalmology, at which Dr. diagnosed her with a right retinal branch arterial occlusion and decided to send her to SHE to be evaluated for the possibility of a CVA. She denies being on blood thinners or taking Aspirin. She denies any previous diagnosis of a CVA or TIA.

Woke up at 6 a.m., Friday April 2, feeling buzzing feeling in right arm, right leg, and feeling of swelling on right side of throat, rapid heart rate. Duration of feelings lasted for approx. 1 1/2 hours. In general felt strange. On April 13, developed bothersome headache, had to take tylenol to alleviate. On April 14, developed bothersone headache, had to take tylenol to alleviate. On April 15, developed bothersome headache, had to take tylenol to alleviate.

NO APPETITE; BAD FLU; JOINT ACHE; NAUSEA; This spontaneous report received from a patient concerned a 66 year old female. 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: UNKNOWN) dose was not reported, administered on 07-APR-2021 17:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced no appetite. On 08-APR-2021, the subject experienced bad flu. On 08-APR-2021, the subject experienced joint ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from no appetite, and joint ache on 09-APR-2021, and bad flu, and nausea on APR-2021. This report was non-serious.

FATIGUE/SLIGHTLY TIRED; FEVER; CHILLS; HEADACHE; LEG CRAMPS; TWITCHY MUSCLES; BACK ACHES; ACHES; THIRSTY; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and prolapsed mitral valve. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: 13-JUN-2021) dose was not reported, administered on 10-APR-2021 14:00 for prophylactic vaccination. Concomitant medications included levothyroxine for drug used for unknown indication, atenolol for high blood pressure, hydrochlorothiazide for high blood pressure, and acetylsalicylic acid. On APR-2021, Laboratory data included: Blood pressure (NR: not provided), and Fever (NR: not provided) 92.7 F. On 10-APR-2021, the subject experienced leg cramps. On 10-APR-2021, the subject experienced twitchy muscles. On 10-APR-2021, the subject experienced back aches. On 10-APR-2021, the subject experienced aches. On 10-APR-2021, the subject experienced thirsty. On 10-APR-2021, the subject experienced headache. Laboratory data included: Fever (NR: not provided) 103 F. On 10-APR-2021 17:00, the subject experienced chills. On 10-APR-2021 20:00, the subject experienced fever. On 10-APR-2021 23:00, the subject experienced fatigue/slightly tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from leg cramps, twitchy muscles, back aches, aches, thirsty, chills, fever, and headache on 11-APR-2021, and was recovering from fatigue/slightly tired. This report was non-serious.

CHILLS; TIRED; INJECTION SITE PAIN; HEADACHE; FEVER; PAIN; FELT MISERABLE; BACK HURTING; LIGHTHEADED; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included acid reflux, pollen allergy, alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug use and was healthy individual at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 09:00:00 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced pain. On 08-APR-2021, the subject experienced felt miserable. On 08-APR-2021, the subject experienced back hurting. On 08-APR-2021, the subject experienced lightheaded. On 08-APR-2021, the subject experienced tired. On 08-APR-2021, the subject experienced injection site pain. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.8 F. On 08-APR-2021 18:00, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lightheaded, chills, and headache on 08-APR-2021, and fever on 09-APR-2021, was recovering from felt miserable, and back hurting, and had not recovered from pain, tired, and injection site pain. This report was non-serious.

SMELLY URINE; CLOUDY URINE; ABDOMINAL CRAMPS; DIZZINESS; HEART RACING; FEELING COLD; BRAIN FOG; NECK SORE; SOUND IN HEAD/HUMMING NOISE IN HEAD; DID NOT FEEL HUNGRY; FORGETFULLNESS; SHAKING WITH COLD/TEETH CHATTER/CHILLS; SEVERE HEADACHE; FEVER; NAUSEA; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's past medical history included cholesterol, and concurrent conditions included hypertension, non-smoker, non- alcoholic, and sensitive to medications, and other pre-existing medical conditions included the patient had no drug abuse/illicit drug use. the patient had no known drug allergies. The patient was previously treated with hydrochlorothiazide/lisinopril for hypertension, vitamins nos for drug used for unknown indication, and atorvastatin for cholesterol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On DEC-2020, Laboratory data included: Blood test (NR: not provided) not reported. On 12-MAR-2021, the subject experienced heart racing. On 12-MAR-2021, the subject experienced feeling cold. On 12-MAR-2021, the subject experienced brain fog. On 12-MAR-2021, the subject experienced neck sore. On 12-MAR-2021, the subject experienced sound in head/humming noise in head. On 12-MAR-2021, the subject experienced did not feel hungry. On 12-MAR-2021, the subject experienced forgetfullness. On 12-MAR-2021, the subject experienced shaking with cold/teeth chatter/chills. On 12-MAR-2021, the subject experienced severe headache. On 12-MAR-2021, the subject experienced fever. On 12-MAR-2021, the subject experienced nausea. On 14-MAR-2021, the subject experienced dizziness. On 02-APR-2021, the subject experienced smelly urine. On 02-APR-2021, the subject experienced cloudy urine. On 02-APR-2021, the subject experienced abdominal cramps. Laboratory data (dates unspecified) included: Chest X-ray (NR: not provided) NEGATIVE, Computerised tomogram head (NR: not provided) NEGATIVE, Fibrin D dimer (NR: not provided) ELEVATED, and Head MRI (NR: not provided) NEGATIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling cold, and fever on 12-MAR-2021, and smelly urine, cloudy urine, and abdominal cramps on APR-2021, was recovering from neck sore, and had not recovered from heart racing, shaking with cold/teeth chatter/chills, severe headache, nausea, did not feel hungry, brain fog, sound in head/humming noise in head, dizziness, and forgetfullness. This report was non-serious.; Sender's Comments: : V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious

Middle back pain began on Friday, April 16th and has continued. It is now upper back/neck and shoulders as well.

Transcribed from hard copy filled out by Pt who was unable to download to submit---- 4/08 3am: drenched in sweat: VIOLANT headache: SEVERE all-over body aches lasting 24hours. 9am: drenching sweats, nausea, hypersensitivity, hperacusis, overwhelming fatigue, mild nausea. 4/10 : seas, flushing , shaky, lightheaded. 4/11: body tremors, sweats, chills, nausea, diarrhea,. 7pm: tinnitus: severe body aches-diazepam. 4/12: Tinnitus resolved: flushing, profuse diarrhea,: Imodium. 4/313: diarrhea. Polyuria about every 2 hours the entire 6 days, even when taking little to no fluids. No fevers-i never run a fever. When body aches subsided, severe post-op spine and associated leg pain vanished, has not returned.

HARD TIME BREATHING; SUSPECTED SINUS INFECTION; FELT BAD AND MISERABLE; LEFT ARM HURTS WHILE PRESSING INJECTION SITE; DIFFICULTY LIFTING LEFT ARM; MUSCLE ACHE; SEVERE INFLAMMATION ALL OVER THE BODY; PAIN EVERYWHERE; JOINT ACHE; TENDON ACHE; SLEPT FOR 6 HOURS THROUGHOUT THE DAY/SLEEPINESS; DRY COUGH; INJECTION SITE WAS RED; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergies, and other pre-existing medical conditions included patient has type-a blood group. 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 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced injection site was red. On 07-MAR-2021, the subject experienced severe inflammation all over the body. On 07-MAR-2021, the subject experienced pain everywhere. On 07-MAR-2021, the subject experienced tendon ache. On 07-MAR-2021, the subject experienced slept for 6 hours throughout the day/sleepiness. On 07-MAR-2021, the subject experienced dry cough. On 07-MAR-2021, the subject experienced joint ache. On 07-MAR-2021, the subject experienced muscle ache. On 07-APR-2021, the subject experienced difficulty lifting left arm. On 07-APR-2021, the subject experienced left arm hurts while pressing injection site. On an unspecified date, the subject experienced hard time breathing, suspected sinus infection, and felt bad and miserable. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Unknown, EKG (NR: not provided) Normal, Erythrocyte sedimentation rate (NR: not provided) indicated inflammation, and Fibrin D dimer (NR: not provided) indicated inflammation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slept for 6 hours throughout the day/sleepiness on 07-MAR-2021, had not recovered from severe inflammation all over the body, pain everywhere, joint ache, left arm hurts while pressing injection site, hard time breathing, dry cough, muscle ache, and tendon ache, and the outcome of difficulty lifting left arm, injection site was red, suspected sinus infection and felt bad and miserable 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.

The evening after the vaccine Developed severe abdominal pain and joint pains This lasted about a week Also developed mild rash and itch the day after the vaccine Had extreme fatigue for about a week The second morning developed what appeared to be swollen blood vessels in both forearms This lasted several hours and went away Went To dr and received fluids and vitamin iv

APPROXIMATELY 3 DAYS AFTER RECEIVING THE SHOT I BEGAN TO EXPERIENCE PAIN IN THE RIGHT SIDE OF MY NECK WHICH WORSENED AND EXTENDED DOWN INTO THE RIGHT SHOULDER BLADE AND THEN TO MY RIGHT ARM AND CONTINUED DOWN INTO MY RIGHT LEG. THE PAIN HAS CONTINUED FOR OVER ONE MOTH NOW.

CHILLS; BLOATING; ITCHING TO LEFT LOWER ARM/LEFT UPPER; SWOLLEN AND TENDERNESS TO LEFT AXILLA TOWARDS BREAST; ACHING IN NECK; NECK SWELLING; MASSIVE HEART ACHE; NAUSEA; FEVER 100.6 F; MASSIVE HEADACHE TO FRONTAL AND TEMPORAL LOBES; RINGING TO LEFT EAR/RIGHT EAR; This spontaneous report received from a patient concerned a 66 year old female. The patient's weight was 117 pounds, and height was 61 inches. The patient's past medical history included pain to arm, inflammation, swollen neck, and fever 102 f, and concurrent conditions included non-smoker, and non-alcohol user, and other pre-existing medical conditions included the patient has no history of drug abuse or drug illicit use. She had a history of severe immune reaction to the Pneumovax (pneumococcal vaccine polysacch 23V) in 2019 which caused excruciating pain to arm and inflammation with swollen neck with 102 F and had to call 911. Paramedics stated stable and not taken to the hospital. The patient also experienced drug allergy when ibuprofen, neomycin, and magnesium sulfate/potassium sulfate/sodium sulfate. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered to the left arm, on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the patient experienced ringing to left ear and right ear. On 01-APR-2021, the patient experienced massive heart ache, massive headache to frontal and temporal lobes, rapid heart rate, pain near sternum that radiated downward, sensation of pressure at breast level, neck swelling, aching in neck, gastrointestinal upset, solar plexus, nausea and fever 100.6 F. On the same day, the patient went to urgent care and was given Zofran 4 mg sublingual. They took the lab at the urgent care. On 01-APR-2021, the patient's laboratory data included: Absolute lymphocyte count (NR: not provided) 0.7 (units not provided), Blood glucose (NR: not provided) 106 mg/dL, Body temperature (NR: not provided) 100.6 F, Chest X-ray (NR: not provided) normal, Complete blood count (NR: not provided) normal, Electrocardiogram (NR: not provided) normal, Heart rate (NR: not provided) Rapid, Lymphocyte count (NR: not provided) 11 % (low), Neutrophils (NR: not provided) 81 % (high), and Troponin I (NR: not provided) normal. On 02-APR-2021, the patient experienced swollen and tenderness to left axilla towards breast. On 05-APR-2021, the patient experienced itching to left lower and upper arm. On 08-APR-2021, the patient experienced bloating, pain from gas and increased changing of bowel habits. On 18-APR-2021, the patient's headache reappeared. On 19-APR-2021, the patient experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ringing to left ear/right ear on 06-APR-2021, aching in neck, neck swelling, and nausea on 01-APR-2021, swollen and tenderness to left axilla towards breast, and itching to left lower arm/left upper on 05-APR-2021, chills on 20-APR-2021, and fever 100.6 f on 02-APR-2021, was recovering from massive headache to frontal and temporal lobes, had not recovered from bloating, and the outcome of massive heart ache was not reported. This report was serious (Other Medically Important Condition). Initial information was received on 20-APR-2021, with additional information obtained via telephone follow up from a patient on 21-APR-2021, the following information was updated and incorporated into the case: events added (Ringing to left ear and right ear).; Sender's Comments: V0 : -covid-19 vaccine ad26.cov2.s -Massive heart ache. 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.

Developed shakes, chills, alternating hot and cold flashes, fatigue, muscular aches starting at 11:45 pm. Has let up some - shakes have stopped. and am generally feeling better (4:00 pm).

Waited 30 minutes after shot at clinic, just sore in upper arm. About 45 min after vaccine in car, shooting pain in upper arm that went down my forearm, and up neck, stopped and then started up again... - lasted for about 10 min. thought I was having a heart attack, but it all subsided. My husband felt it was anxiety - Happened again when we got home on and off, we thought sore muscle - subsided. Wakes me up at night sometimes, happens occasionally during day, happens when golfing - asked a PA friend in heart department at hospital and she said it may take time to heal from vaccine bruising. Past 3 days got another cold virus and yesterday my vaccine site and forearm was killing me all day off and on, a couple of times up same side neck. Got me concerned enough today to call Tri-county who scheduled vaccine to see if anyone else had similar symptoms - told me to fill this form out. I was concerned it was a blood clot. Better today- dull pain off and on.

More severe: Low back pain starting 06:40 AM Thursday June 10, continuing into present. Made same-day appointment with clinic. Tests normal. Mild to moderate: Site soreness (no redness swelling) starting June 7 continuing to present (6.5 days at present).

That next day, the injection site pain was with me for over a month. I couldn't move my arm; felt like someone was jabbing me. I can finally touch my arm now without feeling pain. The brain fog - it feels like - in the front of my forehead right above my eyebrows - like there's something the size of orange that is just sitting there. It stops my thoughts and word processing. I was fine the day before the vaccine. That has not gone away. The doctor does not know what to do about the brain fog. I was having horrific full body muscle pain - especially in my legs. Like someone had put 20 lbs weight on each of my ankles. That is sort of resolved. But the fatigue - hasn't resolved. I always have a little bit of low level fatigue but this is worse - I have to have two naps a day now. Brain fog is the most troubling to me - hard to function - it's like instant Alzheimer's - my words are stuck in my mouth and I feel like I'm trying to think through a veil or fog.

Significant muscle and joint pain, particularly in legs, mostly in right but varies. Feelings of cramping right calf. Went to ER, ultrasound negative, bloodwork unremarkable, MD visit later, was told to reduce inflammation via diet and moderation of activity. Symptoms have continued until present and have affected ADLs

STRANGE FORMATION ON THE INNER UNDERSIDE OF ARM WHERE VACCINE WAS ADMINISTERED LEFT ARM THAT TURNED YELLOW; DIZZINESS; FOOT ACHE; MUSCLE ACHES UNDERNEATH LEFT ARM; NOT FEELING WELL SINCE RECEIVING THE VACCINE; FALL; FEELING WOBBLY; This spontaneous report received from a patient concerned a 66 year old female. 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: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced feeling wobbly. On MAY-2021, the subject experienced fall. On 14-MAY-2021, the subject experienced not feeling well since receiving the vaccine. On an unspecified date, the subject experienced strange formation on the inner underside of arm where vaccine was administered left arm that turned yellow, dizziness, foot ache, and muscle aches underneath left arm. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from strange formation on the inner underside of arm where vaccine was administered left arm that turned yellow, feeling wobbly, not feeling well since receiving the vaccine, and muscle aches underneath left arm, and the outcome of dizziness, foot ache and fall was not reported. This report was non-serious.

First 5 days-fever, pain joints muscles lightheaded Since to date- racing heart and pulse. Severe dizzy spells. Intense pain and tingling I n legs.

Instant headache and pain shooting down arm and side while being injected, sick feeling and light headed right as I was leaving the facility. Within 4 hours I was struggling to do anything. I was tired and felt and nauseated, light headed and felt like i was hit by a truck. The bottoms of my feet hurt and I had stabbing pains so bad in my knee joints I could barely walk without assistance. I felt very ill for about a week after the shot but the headaches continued constantly for over a month but aren't daily anymore even though I still have them, and the fatigue was getting worse and still is a problem to this day. Once I was feeling a bit better my right knee started to give out and my left knee was cracking. Since I got that vaccine on 3/6/21 I have had back to back problems. Below is a quick list of these things that have occurred by dates: 3/30/21 - Constant headaches since the vaccine and ear pain and throat issues. 4/16/21 - Right knee giving out on me that started shortly after vaccine and gotten worse. X-ray and physical therapy ordered. 4/22/21 - Shortness of breath, back pain, constant fatigue. Blood work that showed elevated D-dimer then chest x-ray and ct-scan ordered. 4/26/21 - Ultrasound for nodule found on ct-scan. 5/4/21 - Biopsy done of mediastinal mass. 5/11/21 - Physical done for surgery. 5/24/21 - Surgery to remove mediastinal mass, right side of thyroid, two parathyroids and lymph nodes. 6/1/21 - Follow-up for surgery. When I asked why this happened, the doctor said we may never know but the biopsy of the right thyroid nodule result showed thyroiditis, Autoimmune/Hashimoto's, and that my immune system attacked my thyroid. The doctor said she tested me for that in 9/20 and it was negative. 6/2/21 - Left knee pain. About 4 days after my surgery on 5/24 i turned towards the door and heard a loud pop in my left knee. It had been crackling since the vaccine but wasn't giving out like the right one. I couldn't walk on it at all and was using crutches. 6/9/21 - Mri on left knee showed medial and lateral meniscus tears. Referred to Ortho Dr. 6/28/21 - Test thyroid levels post op. TSH levels high. Referral to Endocrinologist. 6/30/21 - Left knee treatment, cortisone shot in knee for now to help with pain and inflammation so I can function and physical therapy. Since then my 4th toe on my right foot has been numb for almost two weeks. I am scheduled for numerous future physical therapy appointments and doctors appointments. Then to make matters worse I just heard 2 days ago that J&J is having more issues and mentioned autoimmune and wondered could that be what caused all of this? I regret getting that stupid J&J vaccine. I expected it to he the Pfizer because that is what was there 2 days before I got my shot. I told the person I didn't want it and she got someone in charge to talk me into it. I should have walked out of there and I am mad at myself for caving to this woman. If J&J says we need a booster I will refuse to take it. I don't know if the vaccine was what triggered all of this but I find it quite odd that all of this started almost immediately after I got that vaccine. Not only to me but also to my sister who got it at the same time. She fell within 30 minutes of getting that vaccine and 3 more times that day, and has had and is still having numerous problems that mimic mine, such as issues with her feet and legs. She struggles to walk and is having issues with her thyroid among other things that she wasn't having a problem with prior to the vaccine. This is just the short version of all I have been through. Any questions feel free to contact me.

Numbness of extremities, flu, loss of appetite, headache, sluggishness, joint pain, loss of coordination, and confusion.

WEAKNESS OF THE RIGHT ARM; OCCASIONAL PAIN OF THE SHOULDER DURING THE DAY WORSE AT NIGHT; FEVERISH; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hyperthyroidism. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 23-AUG-2021) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. Concomitant medications included levothyroxine for hyperthyroidism. On 11-APR-2021, the subject experienced feverish. Treatment medications included: paracetamol. On 25-APR-2021, the subject experienced occasional pain of the shoulder during the day worse at night. On 25-MAY-2021, the subject experienced weakness of the right arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feverish on 11-APR-2021, and had not recovered from occasional pain of the shoulder during the day worse at night, and weakness of the right arm. This report was non-serious.

Painful injection site right away And within 20 min very painful left side-shoulder blade, shoulder, then pain went into neck, then jaw, then ear- felt blocked up and numb, then to eye- vision off, light headed. Pharmacist observed for 30 minutes and suggested I go to urgent care. I thought I was ok but on way home, jaw and cheek area went numb and sharp pain at left base of skull to top of head with chest and underarm muscles sharp pains. Went to urgent care. BP, temp & oxygen ok. While observing me for 45 min, also had left leg cramps, and profuse sweating Gave me 2 prednisone tabs 20 mg. Watched for another 45 minutes. Went home. 7 hours after injection still had these symptoms. Next morning 7/16/21, cheeks flushed, moderate jaw pain, cheek numbness and ear/ hearing not right. As day went on, numbness became intermittent but jaw pain remained.

Overnight on the 6th - muscle aches, chills, fever, headache, weakness. Starting on Sunday morning the 7th - bad nausea all day with vomiting for 12 hours. Barely able to have an ice chip.

Woke up the next morning with a neck ache. It got worse as the day went on. Around 11:00 a.m. I developed a headache. Later in the day I had chills for about 3 hours. When I woke up the next morning my neck ache and chills were gone but I had a mild headache.

On 3-10-2021, Covid Vaccine administered IM L deltoid at 12:15 PM. At 12:25 PM Pharmacist was notified patient symptoms of head and face tingling and throat swelling. BP 165/90 pulse 68 at 12:28PM. Patient described s/sx rapidly developing and described severity as 10/10 with difficulty breathing. Epinephrine (Epipen) administered in R thigh at 12:30PM. By 12:34 patient described symptoms as already decreasing to a 7/10 severity. EMS arrived, assessed patient. Continued improvement with no residual effects. EMS dismissed patient to care of her husband without further follow up needed.

At the time of the injection neck and arm were painful-fingers tingled. At about 60 minutes became dizzy, headache, About 2 hours after injection body aches, nausea, feeling very tired, teeth began to ache, all over joint pain About 9 hours after injection - low grade fever (~100* F.) and chills

Fever, Chills, muscle ache tired in AM then extreme chills and muscle ache for 12 hours then fever for 24 hours

Severe pain on my right side under my arm and right half of chest. Went to the ER did CBC w/auto Diff, Comp Metabolic panel, DDimer, Quantitative,Lipene , Quantative, Lipase level, magnesium level, tropinin - 1, UA WITH MICROPSCOPIC and reflex criteria for urine culture Urine culture reflex criteria Rsdiology XR Chest 1 View Frontal EKG/ Cardiovadcular Electrocardiography 12 Lead

Fast heart beat (120 beats/minute) that started at about 8:00 pm on the day of the vaccine and lasted about 7 hours. My normal resting heart rate is about 62 beats per minute. Other mild side effects were some muscle aches and feeling very tired.

Severe pain in hips and lower back like passing a kidney stone, severe bone pain in chest area, could not sleep for 2 nights and then slept 12 straight hours, headache and blood pressure spike on 3/14 resulting in ER trip with bp at 204/100. Anxious and nervous with low appetite.

15-20 minutes after the injection, I started feeling a tightness in back of my throat; I broke out in cold sweat. I started getting dizzy and very whoozy. I felt my vision starting to close in. I thought I was going to pass out. I got the attention of the person across me to get an attendant and they brought me a chair with wheels. Two people got me up (and I'm not a big person) - they were worried I was going down and I was taken to exam room. They said I was white as a sheet. She checked my eyes and throat a few times and checked my blood pressure. It was lower than normal but she didn't seem really concerned about it - 104 over 60 something which is low for me. She gave me water to sip. She gave me very cold compresses to put on my forehead. They watched me pretty good. She had the epi-pen ready. She watched me and I sat in there and nurse came in a quite a few times to check me for about an hour. About an hour later the tightness went away and I started feeling myself again. We went home. I went to sleep. I woke up at night to go to bathroom and I was still a little woozy but I didn't fall. Next day, I just didn't feel well. My left arm was starting to hurt - was no swelling; it was a little red at injection site. It hurt just a little. I was woozy. My eyes couldn't focus as well. I felt out of it. I drank a lot of water and took a nap. Yesterday, I felt pretty decent but still woozy somewhat. I tried to run errands with my husband - just wasn't quite right. Today, much better but I'm not quite myself yet. Just a little wooziness - weird feeling. Yesterday, I did feel a soreness in the back of my right calf muscle. It wasn't warm to the touch or swollen. I don't have it anymore, it went away. It could have been a muscle thing from the first day of the vaccine when I got home and I got up and almost fell down. I do still have some achiness in joints. Especially in my knees - which isn't normal because they are replaced.

Vaccine was painful but then pain partially subsided, then came home and had chills, temp 96F. Went to bed and had muscle aches, pains and headache. Next morning felt flu like symptoms, malaise especially. Tried to work and could only work 3 hours. Arm remained sore. 14 days later still experiencing soreness in injection site (does not appear swollen), tender to the touch. If arm is lifted up then feels like it is "pulling on something."

On day 11 post shot I started to feel mildly nauseated. Next day nausea increased, as did muscle aches and pain - by early evening I had repeated bouts of uncontrollable vomiting and uncontrollable diarrhea [no cramps, no warning] that lasted most of the night. I did have a fever briefly - got all red and felt like I was on fire - but that passed pretty quickly while the rest continued. I had to stay up all night, any attempt to lie down triggered more vomiting. By 3 in the morning I was ?on empty? and by 6 am could lie down. Nausea took three more days to leave completely. Muscle pain is resolving, almost gone. I am resuming my meds [everything that went down before came right back up]. The only tummy pain was after hours of vomiting [muscle strain]. Today is the 25th and I?m still tired and a bit foggy but otherwise feel better. I had a call with my doctor about this and she said I should report it so that?s what I?m doing.

Extreme body and mind agitation, thought psychosos (first night after shot) Chest pains in left side (first night after shot) Pain spot inside of left elbow for 9 days Shortness of breath for first 2 days with intermittent recurrences for next 7 days Achy, dizzy, headache, fever, & fatigue starting evening after shot, lasting 2 days with intermittent recurrences for next 11+ days

The pain in the muscle is very painful 3 weeks post vaccine. I am using Tylenol and a heating pad and not obtaining any relief. I keep thinking every day will be better, but that is not happening.

Shortness of breath, hypertension, hypoxia, tachycardia, lips and fingers turn blue, high fever, rash, hives, joint pain, whole body aches, left lower leg burning, artery blockages, infection, weakness, dizziness, tunnel vision, sweating, headache, new onset atrial fibrillation with rvr All of the above symptoms first occurred 30 minutes after injection of vaccine The atrial fibrillation occurred 6 days after injection Left lower leg started burning 15 days after injection The artial blockages and thrombus 18 days after injection by medical diagnosis due to instantaneous shut off of blood to left leg

HEART PALPITATIONS; DIZZINESS; SHOULDER PAIN; HEADACHE; BODY ACHES; BACK PAIN; This spontaneous report received from a patient concerned a 67 year old female. 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 or 1808928 (unsure), and expiry: UNKNOWN) dose was not reported, administered on left arm on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced body aches. On 01-APR-2021, the subject experienced back pain. On 01-APR-2021, the subject experienced shoulder pain. On 01-APR-2021, the subject experienced headache. On 02-APR-2021, the subject experienced heart palpitations. On 02-APR-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, back pain, and shoulder pain, and had not recovered from headache, heart palpitations, and dizziness. This report was non-serious.

4/10/21 6pm side effects, feeling very tired, muscle pain & aches. Continued until 4/11/21 12:05pm, pain was gone, did drink a lot of water.

3/6/2021- received vaccination. 3/9/2021 didn?t feel good 3/12/2012 went to q clinic and got a Covid-19 test and flue test. Both negative and was sent home. 3/15/2021 Doctor sent me to get a x ray, diagnosis pneumonia. Symptoms: Fever, Headaches, rash under both breast, muscle aches, nausea, fatigue, loss of appetite As of 4/12 2021 I am still nauseated , and fatigued

About one week after my injection, I had severe cramping in left leg. On April 5th started with a couple of days with severe pain in tendons of right shoulder. The pain referred into the right neck and base of occiput. On April 7, 2021, I felt off then developed a severe, stabbing headache over my right eye referring back into the occiput. Was not steady on my feet. Did not eat dinner, went to bed. Felt tingling around my mouth, and my neck and shoulders were very tight. I debated about going to the hospital, but decided against it. Still have tightness on the right side of my neck into the occiput and right shoulder.

Initially 2 to 5 days just fatigue. Evening of March 26th unusual fatigue and lower back to middle back discomfort low pain level.

Strange odor a few minutes after injection, followed by bitter taste, then nausea and spaciness. Dizzyness, with vision looking 2D and flat by 15 minutes. Told Pharmacist, of spaciness who said stay as long as I wanted. Left at 30 minute point, still spacy and nauseous. Spaciness ended by an hour with nausea off and on. Chest pain - began around 7pm, continued to expand in area of chest, sharp stabbing pain later, pain from just above left elbow to hand and tingling of fingers, pain lower left leg and tingling of left foot. Irregular heart rate at different times. Checked into emergency room at 11:00. IV inserted, placed on continual heart and oxygen monitors, EKGs, chest X-rays (2), blood tests (3). Admitted to hospital sometime during the night. Given IV medications to counteract IV contrast allergy. These medications caused full body shakes, eyesight auras and extreme nausea with gagging. Heart CT taken with IV contrast. Discharged around 3:00 PM.

KNEE PAIN; LEG PAIN AND PAIN IN THIGHS; PAIN IN CALVES; EXHAUSTED; CHILLS; JOINT PAIN; MUSCLE PAIN; EXTREME FATIGUE; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and other pre-existing medical conditions included no health issues. 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 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced joint pain. On 08-APR-2021, the subject experienced muscle pain. On 08-APR-2021, the subject experienced extreme fatigue. On 08-APR-2021 19:00, the subject experienced exhausted. On 11-APR-2021, the subject experienced pain in calves. On 11-APR-2021, the subject experienced knee pain. On 11-APR-2021, the subject experienced leg pain and pain in thighs. On 12-APR-2021, treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 08-APR-2021, and extreme fatigue, and exhausted on 10-APR-2021, and had not recovered from muscle pain, knee pain, leg pain and pain in thighs, pain in calves, and joint pain. This report was non-serious.

2 days fever - 101 degrees, aches in joints similar to flu with headache. 3 weeks after injection blood vessels burst in left arm leaving lower arm/wrist with very large bruise or venous flood.

CHILLS; HEADACHES; MUSCLE ACHES; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included several well-controlled autoimmune issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the patient experienced chills. On 24-MAR-2021, the patient experienced headaches. On 24-MAR-2021, the patient experienced muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, headaches, and muscle aches on 25-MAR-2021. This report was non-serious.

101.2 fever for four days with weakness for two weeks - 14 days. Since then, I have had virus symptoms every four or five days, such as aching joints, lethargy, muscle pain, and nausea that lasts about 48 hours each time. Then it clears up and I feel better for a few days, then it comes back. I haven't felt well since the shot.

Injection site sore for about 5 days - then 5 days later shoulder became very sore and achy. Arm now aches continuously and is very weak. Mobility without pain is limited. Have not contacted my doctor yet - but will do so soon. No doctor visit planned yet. (Suspecting this is SIRVA????)

Janssen COVID-19 Vaccine EAU Fever of 99.0 degrees for 2 days. Weakness and tired. Sore arm and joints.

48 hours of severe chills, rigors, fevers, severe headache, severe joint pains in all joints, full body muscle aches, nausea, loss of appetite, severe fatigue. Tylenol and Advil prn. (Note: I had monoclonal antibody IV 2/5/21, was told to wait 90 days which I did. These symptoms are exactly why I got those antibodies. I am a retired Nurse Practitioner in Internal Medicine. Why is the CDC and government official NO recognizing and giving credit for natural antibodies. I've had covid 19, monoclonal antibodies, there is herd immunity, and yet you want EVERYONE to get vaccinated. Very poor judgement for the cdc and government official. You wonder why people don't trust both of them? What if I had died or had resulting health conditions because of what I just went thru? I will never trust either again and will recommend others NOT get the vaccine. We don't even know what permanent disability or damage may come from this.

5-3-2021: at 11:54 am got J&J Covid-19 vaccine at Pharmacy. No anaphylaxis or other severe reactions within first four hours. By 8:00 pm began feeling fatigued and generally warm. No nausea or vomiting. By 11:00 pm developed diffuse soreness of left deltoid at injection site, mild chilling, muscle aches, T 98.8. Then developed severe shaking chills and profuse sweating, generalized, systemic burning sensation, nausea, light-headedness. This reaction lasted through the night, about 8 hrs. I spent 5-4-2021 in bed, and started feeling a bit better by 7:00 pm. By the next day felt very weak, light-headed and tired, and a little short of breath with movement. By 5-8-2021 felt pretty much back to normal, but tired. Arm soreness resolved. Reported reaction to my MD.

SORE THROAT; SHORTNESS OF BREATH; MYALGIA; FATIGUE; HORRIFIC HEADACHE; HORRIBLE PAIN IN CHEST LIKE HEART ATTACK; BONE WRACKING DRY COUGH; METALLIC TASTE IN MOUTH; FELT DIZZY; FELT LIKE HIT BY DUMP TRUCK; BODYACHE; NOT FEELING WELL; AGITATED; URINATING A LOT; BILATERAL EARACHE; WAS TOO SICK; HEART RATE WENT UP TO MORE THAN 80 BPM; This spontaneous report received from a patient concerned a 67 year old female. The patient's weight was 66.7 kilograms, and height was not reported. The patient's past medical history included tachycardia, atrial fibrillation, left periorbital ecchymosis, dry eyes, trouble focusing, headache, nausea on right side of chest, felt like gas bubble and emesis, possible post concussion symptoms, voice hoarse/raspy voice, chronic laryngitis, flare up of hemorrhoid, constipated over a weekend, increased heart rate, nontoxic uninodular thyroid goiter, atherosclerosis of aorta, fatigue, papillary thyroid cancer, right thyroid lobectomy, deep vein thrombosis, gerd, melanoma of skin, dyspnea, deep vein thrombosis, sinus pain, tooth pain, treatment non compliance, pharyngitis, stroke, vertigo, and influenza like illness, and concurrent conditions included non-smoker, no alcohol use, asthma, cerebral palsy, qt prolonged, chest pain when tired, diabetes mellitus, chronic kidney disease stage 3, hypertension, congenital nystagmus, hearing loss, hypothyroidism, and diabetes, and other pre-existing medical conditions included the patient had no history of abuse or illicit drug usage. The patient was previously treated with phenoxymethylpenicillin, guaifenesin for sore throat, calcium carbonate, famotidine, simeticone, promethazine, cefalexin, diphtheria vaccine toxoid/pertussis vaccine acellular/tetanus vaccine toxoid for prophylactic vaccination, salbutamol, ciclesonide, and polymyxin for red eyes; and experienced drug allergy when treated with atenolol, ciprofloxacin, and erythromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: 21-JUN-2021) dose was not reported, administered on 04-APR-2021 11:15 for prophylactic vaccination. Concomitant medications included disopyramide phosphate. On 10-MAR-2014, Laboratory data included: Factor V Leiden mutation (NR: not provided) negative, and Prothrombin mutation G20210A (NR: not provided) HET Abnormal, coagulation. On APR-2021, the subject experienced heart rate went up to more than 80 bpm. On APR-2021, the subject experienced agitated. On APR-2021, the subject experienced urinating a lot. On APR-2021, the subject experienced bilateral earache. On APR-2021, the subject experienced was too sick. On APR-2021, the subject experienced bodyache. On APR-2021, the subject experienced not feeling well. On 04-APR-2021, the subject experienced metallic taste in mouth. On 04-APR-2021, the subject experienced felt dizzy. On 04-APR-2021, the subject experienced felt like hit by dump truck. On 05-APR-2021, the subject experienced horrible pain in chest like heart attack. On 05-APR-2021, the subject experienced bone wracking dry cough. On 05-APR-2021, the subject experienced horrific headache. On 09-APR-2021, the subject experienced fatigue. On 13-APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 20-APR-2021, the subject experienced sore throat. On 20-APR-2021, the subject experienced shortness of breath. On 20-APR-2021, the subject experienced myalgia. Laboratory data included: Anion gap (NR: not provided) 10 mEq/L, B-type natriuretic peptide (NR: not provided) 64 pg/dL, BUN (NR: not provided) 26 mg/dL, Blood pressure (NR: not provided) 214/91 mm Hg, Body temperature (NR: not provided) 97.8 F, CO2 (NR: not provided) 26 mEq/L, Chloride (NR: not provided) 102 mEq/L, Creatinine (NR: not provided) 0.92 mg/dL, Differential white blood cell count (NR: not provided) Normal, Glomerular filtration rate (NR: not provided) more than 60 mL/min, Glucose (NR: not provided) 328 mg/dL, Hematocrit (NR: not provided) 42.9 %, Hemoglobin (NR: not provided) 14.9 g/dL, Lab test (NR: not provided) Normal (no blood clots/thrombocytopenia), MCV (NR: not provided) 91 fL, Nucleated red cells (NR: not provided) 0 kilo per microliter, Oxygen saturation (NR: not provided) 98 %, Pain scale (NR: not provided) 1 (units unspecified), Platelet count (NR: not provided) 190 kilo per microliter, Potassium (NR: not provided) 4 mEq/L, Pulse rate (NR: not provided) 81 beats per minute, RBC count (NR: not provided) 4.73 million per microliter, Respiratory rate (NR: not provided) 18 (units unspecified), Sodium (NR: not provided) 138 mEq/L, Troponin I (NR: not provided) more than 0.02 ng/dL, WBC count (NR: not provided) 7.3 kilo per microliter, and X-ray (NR: not provided) Aortic atherosclerosis. Treatment medications included: hydralazine. On 20-APR-2021 17:34, Laboratory data included: Blood pressure (NR: not provided) 190/100 mm Hg, Body temperature (NR: not provided) 36.6 degree celsius, Glasgow coma scale (NR: not provided) Eye opening:4, Verbal response:5, Motor Response: 6, Total Coma Score:15, Oxygen saturation (NR: not provided) 97 %, Pulse rate (NR: not provided) 74 bpm, and Respiratory rate (NR: not provided) 16 (units unspecified). On 28-APR-2021, treatment medications included: prednisone. Additional treatment medications (dates unspecified) included: estradiol, levothyroxine, paracetamol, verapamil hydrochloride, salbutamol, diphenhydramine hydrochloride/lidocaine/nystatin, budesonide/formoterol, guaifenesin, benzonatate, chlorhexidine gluconate, ipratropium, aciclovir, fluticasone, montelukast, hydralazine hydrochloride, fluticasone propionate/salmeterol xinafoate, and famotidine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from metallic taste in mouth on 05-APR-2021, felt dizzy on 20-APR-2021, felt like hit by dump truck on 16-APR-2021, was too sick, and shortness of breath, and horrific headache on 19-APR-2021, had not recovered from bone wracking dry cough, horrible pain in chest like heart attack, sore throat, and bilateral earache, and the outcome of heart rate went up to more than 80 bpm, myalgia, not feeling well, fatigue, urinating a lot, agitated and bodyache was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non serious

Felt great @ post injection. 9pm took 2 Melatonin & drank small cup hot Sleepy Time tea.. Went to bed. At 11:30 pm still not asleep. Restless & uncomfortable. 1:40 am woke up with terrible whole body muscle aches, sore belly, flatulence, gas, migraine-like headache, C5 & C6 neck pain, occasional leg cramping. Felt like I had the flu. Got out of bed & sat in recliner with quilt over me. After a bit started feeling a little better. Went back to bed @ 3 am. Still had a rough time getting back to sleep. Very uncomfortable. Got up @ 5am. Still have intense total-body aches, neck pain, headache, fever 100.1 Drinking a lot of water. Took 2 / 500mg Acetaminophen

inflamed psoriatic arthritis, Very sore muscles , chills, rash, fatigue, stomach upset since march 10, 2021

Patient states she had unexplained swelling in her knees and legs. She was concerned about a possible clot so she went to the orthopedic doctor to be examined. They couldn't determine cause of swelling asked if she wanted a CAT scan she declined. Also stated sever pain at injection site that doesn't go away, tender to touch, limits mobility. I suggested she return to providers office and let them know she received Janssen COVID-19 vaccine and that additional test may be warranted.

Patient received vaccine on 6/19/21. She came into the pharmacy on 7/10/21 to ask about side effects she had been experiencing from the vaccine. She stated having severe pain in her arm at the injection site. I asked questions to determine the type of pain and when it occurred. She stated it started a week or two after the injection, there was localized swelling, tenderness, and difficulty with mobility. As I asked more questions she also mentioned swelling in her knee and leg and that she had gone to her orthopedic doctor to be checked out and they couldnt determine the cause. They asked if she wanted a scan done because she was concerned about a clot she declined. I asked if she told the provider she had recently recieved the J&J COVID-19 vaccine she said no. I suggested she return to the doctors office and let them know that as they may be more apt to do more thorough testing and examination to rule out possible clots.

Severe pain in the arm muscle, followed by 3 days of headache, fever and intense pain in the arm, shoulder and right hand with pain and swollen knuckles and fingers, up to the right lung. Immobility from pain, I took TYLENOL, the discomfort was passing but the pain in my arm remained. I put hot water every day and applied the arnica cream after bathing to reduce the pain that intensified at the end of June along with the shoulder. I went to the doctor, she prescribed ibuprofen 800. To withstand the pain and regain mobility. She order Physical Therapy I had 10 sessions with physical Therapy. It has improved but I still have pain in my arm although I still have not finished with the sessions.

LEFT ELBOW STIFFNESS; JOINT PAIN; LEFT ARM SORENESS AT INJECTION SITE; LEFT ELBOW MUSCLE PAIN; SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a 67 year old female. The patient's weight was 200.4 pounds, and height was 67.5 inches. The patient's concurrent conditions included asthma-like attacks, palpitations, anaphylaxis-like reactions, formaldehyde allergy, and cat dander allergy, and other pre-existing medical conditions included patient had a 98 squares test on her back & breathing test. Pin sticks on arm to check for other allergies. The patient experienced drug allergy when treated with nickel, and fluoxetine hydrochloride. 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 09-JUL-2021 for prophylactic vaccination. Concomitant medications included salbutamol for asthma-like attacks, epinephrine for palpitations, metoprolol for palpitations, and loratadine. On 21-JUN-2021, Laboratory data included: Imaging procedure (NR: not provided) Normal. On 09-JUL-2021, the subject experienced shortness of breath. On 11-JUL-2021, the subject experienced left elbow stiffness. On 11-JUL-2021, the subject experienced joint pain. On 11-JUL-2021, the subject experienced left arm soreness at injection site. On 11-JUL-2021, the subject experienced left elbow muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath on 09-JUL-2021, and left arm soreness at injection site on 12-JUL-2021, and had not recovered from left elbow stiffness, left elbow muscle pain, and joint pain. This report was non-serious.

EXCRUCIATING PAIN IN ALL JOINTS, WRISTS, ELBOWS AND KNEES AND THIS INTENSE PAIN WOKE UP THE CONSUMER FROM SLEEP, PAIN IN NECK AND DUE TO THIS PATIENT HAD A LOT OF DIFFICULTY GETTING OUT OF BED; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included erosive osteoarthritis, antibiotic allergy, egg allergy, mold allergy, chemicals (silver) allergy, non alcoholic, and non smoker, and other pre-existing medical conditions included the pain has subsided from its severity right after getting the vaccine, but still lingers. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, treatment medications included: paracetamol. On 20-MAY-2021, the subject experienced excruciating pain in all joints, wrists, elbows and knees and this intense pain woke up the consumer from sleep, pain in neck and due to this subject had a lot of difficulty getting out of bed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from excruciating pain in all joints, wrists, elbows and knees and this intense pain woke up the consumer from sleep, pain in neck and due to this patient had a lot of difficulty getting out of bed. This report was non-serious.

I?m a neonatal nurse practitioner, I have a high pain threshold . I had Covid in January 2021 I am a healthcare worker and did not seek medical treatment. This was not a normal reaction to a vaccine. Extreme headache Fever of 101° normal for me is 95.7- 97° Extreme joint pain, left hip still inflamed Sever chills, almost spasmodic, teeth chattering. Rigors Extreme Weakness Numb fingers and thumb on left hand Lymph node popped the size of a Cherry tomato

feeling very tired (within 25 min), headache (within 3 hrs) worsened over the next several hours, muscle aches (within 8 hrs) worsened in time, fever (@100 dgs) with chills (within 8hrs), runny nose, watery eyes and dry mouth (within 8hrs), sinus pain (dry) and loss of appetite Called advice line @ 7am on 3/7/21 to see if I could take Ibuprophen (yes) and that helped. All side effects subsided in @ 36 hours.

Jansen COVID-19 Vaccine EUA I received the vaccination on 3/12/2021, about 8:30AM, at Fairgrounds. I needed the J&J vaccine, one Moderna or Pfizer as I have a history of anaphylaxis. County Public Health received about 200 does of the J&J and 800 of Moderna and Pfizer. I waited at the vaccine site about 40 minutes after the vaccine. I went home, ate, read, and became unusually sleepy so took a nap. I woke up about 2:00PM and noticed my lips and tongue were swollen, and sore. I took 2 Benadryl. The Benadryl seems to have worked as expected. I will take 2 more when I go to bed, about 11:00. I'm unusually sleepy, and my joints ache. Overall, however, I think I am experiencing a very mild reaction and I'm thankful for the vaccine. I sent my doctor a message through the patient portal, telling him of the reaction. His office is closed so he will get the message on Monday.

On MON evening after the shot, at 11:00pm I experience severe chills that lasted for hours. Tuesday morning I awoke with a bad headache and had body aches all day as well as tendonitis- like pain in both lower arms. I felt somewhat better on WED but I did notice that my compression sleeve on my right arm (lymphedema arm) felt more snug than usual. That night I had severe chills and fever of 101. I slept until 11:45am on THU and felt aches all over. Very fatigued. Went back to sleep from 2:00pm until 6:00pm. Temp was down to 99.8. When I woke and removed my compression garment, my arm was red and swollen, also rash-like bumps, and was very warm to the touch. FRI morning it looked worse, so I contacted my lymphedema specialist and then my PCP. This is NOT a good situation for anyone who has lymphedema and will necessitate months of treatment.

16 days after 1st vaccine, woke up to fever and chills, muscle weakness, fatigue, raging headache, occasional sweats, which lasted off and on for 10 days. Did not lose taste or smell, but coffee tasted horrible.

HYPOCHROMIA; HIGH WHITE BLOOD CELLS; DVT WITH INFLAMMATION AND SWELLING OF RIGHT LOWER LEG; RUNNY NOSE; BILATERAL WATERY EYES; LEFT ARM TENDERNESS POST IMMUNIZATION; URINARY TRACT INFECTION; LOWER BACK PAIN; This spontaneous report received from a patient concerned a 68-year-old female. The patient's height, and weight were not reported. The patient's concurrent conditions included baker's cyst, and reflux sympathetic dystrophy. The patient experienced drug allergy when treated with gabapentin, and prednisone, drug intolerance when treated with codeine, and ibuprofen. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, expiry: UNKNOWN) once a total dose was not reported, administered on 10-MAR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced urinary tract infection. On MAR-2021, the subject experienced lower back pain. On 10-MAR-2021, the subject experienced left arm tenderness post immunization. On 11-MAR-2021, the subject experienced runny nose. On 11-MAR-2021, the subject experienced bilateral watery eyes. On 14-MAR-2021, the subject experienced deep vein thrombosis with inflammation and swelling of right lower leg. On 23-MAR-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) confirmed DVT right lower leg, Urinalysis (NR: not provided) Unknown, and White blood cell count high (NR: not provided) 10.35 increased and was previously 9.23 not reported. Treatment medications included: ciprofloxacin for urinary tract infection. On 24-MAR-2021, the subject experienced hypochromia. On 24-MAR-2021, the subject experienced high white blood cells. Additional treatment medications (dates unspecified) included: rivaroxaban for deep vein thrombosis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from runny nose, and bilateral watery eyes on 12-MAR-2021, and left arm tenderness post immunization on 11-MAR-2021, had not recovered from deep vein thrombosis with inflammation and swelling of right lower leg, high white blood cells, and hypochromia, and the outcome of urinary tract infection and lower back pain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210348648-Covid-19 vaccine ad26.cov2.s-Deep vein thrombosis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

She is on Hospice for her COPD. After she received the shot her leg and shoulder pain/ache increased to an 8/10 (usually a 2-4/10) and was constant when it usually is intermittent. Her breathing is worse and she is maxing out her inhalers and needing many more doses of her rescue morphine than usual (usually 2.4 ml of 20mg/ml Roxanol used in a week and last week was 7.5ml). She has not been taking it for the pain for fear of med interactions. She has increased her Tylenol use from 500mg qd to 3000mg qd. Her tremors are worse and she is taking her propranolol for tremors 20mg BID instead of her usual 10mg BID. Her body sweats have gone from 1 time a week to 1-2 times a day. No fevers noted.

3/29/21 ER HPI: 68 y.o. female who presents with 3 day history of left anterior chest pain. The pain radiates into her back. Pain has been constant and severe at times. It has no relieving or exacerbating factors. Patient denies fever chills cough dyspnea diaphoresis nausea or vomiting. She denies prior similar history. Patient has taken nothing for the pain 4/2/21 ER presentation - flexed to clinic 4/2/21 Clinic HPI: 68 y.o. female who presents today for suspected shingles vs laceration that is infection on her L posterior back. She was seen in the ER for anterior chest wall pain on 03/29 which had started 3 days prior and then saw Dr. again yesterday for follow-up. He gave her a steroid shot and treated her with oral prednisone. In the ER, patient had elevated D-dimer but this was thought to be from her renal insufficiency. She had no other symptoms that suggested pulmonary embolism. No CT angiography of chest was done due to renal insufficiency.The rest of her workup was negative. Rash broke out the day she saw Dr. but didn't mention it to him at that visit. There was no rash on her anterior chest wall where she was hurting at the time.

I'm not sure this is even a "reportable event"! I have had mild tinnitus for several years, generally not noticeable except in extremely quiet settings. But 2 days after receiving J&J vaccine - (the day on which I felt the most "fatigued" and experienced some muscle aches, which responded well to ibuprofen) - I awoke with several episodes of loud ringing in my ears. From that time until now, my continuous tinnitus is much louder than it had been. I keep hoping it will subside! It's more frustrating and annoying than anything else. No pain or discomfort. For this reason I have held off seeking medical treatment. It seems like more than a coincidence to me, so I felt I should probably at least try to report it.

4/08/2021 @1200 - diarrhea, tired, weak. At 1700, extreme muscle achiness. At 2300, severe headache, temp 102° F, chills, sore mucous membranes in mouth, tachycardia (110-120/min), Respiratory expiratory wheezes. Took Tylenol extended release 650mg po. Drank grape juice & 7up. Diarrhea twice during night (4/09/2021) 0100 - 0600. Very sick. By 0700 on 4/09/2021 symptoms slightly better. Still had temp of 100 °F, O2 Saturation 94%, Took Tylenol every 6 hrs x 3 daily on 4/09/2021 thru 4/11/2021. Didn't feel better til 4/11/2021.

I had Covid Dec. 24, 2020. Tge very next day it felt like I had Covid all over again. Chills, tired. 100.8 temperature, headache, body and arms ache and backache. This was the very next day. I felt sick all day and went to bed. Not fun.

All tendons and muscles throughout entire body aches. Gradually getting worse each day. Face has irritating itching like I was allergic to medication.

BONE PAIN; HARD TO SLEEP; BAD FLU; BOTH SIDES OF THE BACK HURT; SHAKING; HARD TO BREATH IN MIDDLE OF THE NIGHT; BOWL MOVEMENT WAS VERY GROSS AND SMELLY; PAIN IN HIP; MUSCLE SORENESS; SLIGHT HEADACHE; FEVER; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's past medical history included blood thinner, and stroke, and concurrent conditions included grass allergy, tree allergy, and yellow paint allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced bone pain. On 08-APR-2021, the subject experienced hard to sleep. On 08-APR-2021, the subject experienced bad flu. On 08-APR-2021, the subject experienced both sides of the back hurt. On 08-APR-2021, the subject experienced shaking. On 08-APR-2021, the subject experienced hard to breath in middle of the night. On 08-APR-2021, the subject experienced bowl movement was very gross and smelly. On 08-APR-2021, the subject experienced pain in hip. On 08-APR-2021, the subject experienced muscle soreness. On 08-APR-2021, the subject experienced slight headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight headache on 09-APR-2021, and fever, was recovering from muscle soreness, bone pain, bad flu, both sides of the back hurt, pain in hip, and hard to breath in middle of the night, had not recovered from shaking, and bowl movement was very gross and smelly, and the outcome of hard to sleep was not reported. This report was non-serious.

shoulder and neck tightness and soreness, tiredness lasting to the present date, weak arms, tingling in hands, poorer short term memory and speech, pain below directly below lower sternum

Within first 12 hours, felt very tired, leg, back and shoulder muscles ached. Experienced on and off chills, low grade fever. Bad headache, dizziness and light headedness. All symptoms lasted 4 days. I handled this at home without medical intervention.

Pain at injection site, 16 days. Dizziness. Fever. Chills. Muscle ache 72 hours. Depression. Suicidal Ideation. 4 days. Excessive Fatigue 15 days.

I have had constant headaches all week that do not go away even with ibuprofen. I also have numbness in my face and legs and last night during sleep my arm was numb and I was not laying on it. When I went to bed last night I had severe back pain. This has not gone away even with pain relievers.

Injection site felt like a heavy material was injected. Started feeling ill shortly after. Slept fitfully with fever chills, next day body aches. 16 days later still have a constant headache, and stiffness in my neck.

BODY ACHES / PAIN; SHAKES / SHAKING; SHIVERING; HEADACHE; NOT FEELING WELL / FEELING OFF; SHOULDERS GOT TIGHT; LOWER BACK ACHE; ACHE IN HIP; LEGS HURT/ SORENESS IN ARM; FEVER / TEMPERATURE; This spontaneous report received from a patient concerned a 68 year old female. The patient's weight was 99 pounds, and height was 66 inches. The patient's concurrent conditions included penicillin allergy, asthma, and trigeminal neuralgia, and other pre-existing medical conditions included type o positive blood. The patient was previously treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, administered on 10-MAR-2021 10:00 to left arm for prophylactic vaccination. Concomitant medications included gabapentin for trigeminal neuralgia, ergocalciferol, and vitamin b12 nos. On 10-MAR-2021, the subject experienced shoulders got tight. On 10-MAR-2021, the subject experienced lower back ache. On 10-MAR-2021, the subject experienced ache in hip. On 10-MAR-2021, the subject experienced legs hurt/ soreness in arm. On 10-MAR-2021, the subject experienced fever / temperature. On 10-MAR-2021 10:00, Laboratory data included: Body temperature (NR: not provided) 102.6 F. On 10-MAR-2021 16:00, the subject experienced not feeling well / feeling off. On 10-MAR-2021 18:00, the subject experienced shakes / shaking. On 10-MAR-2021 18:00, the subject experienced shivering. On 10-MAR-2021 18:00, the subject experienced headache. On 10-MAR-2021 18:30, the subject experienced body aches / pain. On 11-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 97.2 F. On 11-MAR-2021 01:00, Laboratory data included: Body temperature (NR: not provided) 102.3 F. On 11-MAR-2021 05:00, Laboratory data included: Body temperature (NR: not provided) 101.6F F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shakes / shaking, and shivering on 10-MAR-2021, body aches / pain, not feeling well / feeling off, and fever / temperature on 11-MAR-2021, and headache on 11-MAR-2021 10:00, was recovering from ache in hip, lower back ache, and legs hurt/ soreness in arm, and the outcome of shoulders got tight was not reported. This report was non-serious.

Day 1 Sneezing dry no mucous Day2 Cough dry no mucus Day 3 settled in bones -ache particularly old injury...neck, ribs, spine, hips

Patient's caregiver reported that the patient (wife) had swelling of the lips, and swelling of the ankles.

Fever 103.2 degree, headache, stiff neck. Started 10 pm 04/28/2021. Temp reduced to 101.8 degree with Tylenol 500mg. Dose repeated every 4hrs (4 doses total). ALL symptoms resolved by 2 pm 04/29/2021.

(1) Approximately one month after vaccine, swelling in the muscle behind my left leg. I went to my Primary Care doctor, he examined my leg and immediately sent me to hospital ER because he was concerned that it might be a blood clot. They performed an ultrasound, but the results were negative and showed no signs of any blood clots. (2) Approximately three weeks after vaccine, I developed stiffness on the left side of my body in my arm, thigh and hip area. The stiffness was intense, uncomfortable and bothersome enough for me to take Tylenol for the pain the next 5 days and it lasted for about a week.

PAINFUL NECK; SORE FROM HEAD TO TOE; BURNING DURING INJECTION; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included autoimmune disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and batch number: 1808982 expiry: 23-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced burning during injection. On 09-APR-2021, the subject experienced sore from head to toe. On 24-APR-2021, the subject experienced painful neck. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore from head to toe on 10-APR-2021, and burning during injection on 08-APR-2021, and had not recovered from painful neck. This report was non-serious.

Patient reported knee pain at the end of march 3/28/2021 she was seen by a doctor on 4/14 and thought to have arthritis prescribed NSAIDS. Patient had no history of arthritis or chronic prescription use or chronic health conditions. She was referred to an orthopedic and when no arthritis was found she was referred to ER to check for a blood clot on 5/10/2021. Patient was diagnosed with a DVT on 5/10/2021 with no previous history of clots or other risk factors known.

Severe headaches started March 12, 2021 and lasted for over a month and a half, every day. Affected eyesight of left eye, Swelling in both legs, ankles and feet fore a week. Now every once in a while the sharp headache reoccurs and lasts for a few minutes. Mainly up the back left side of my head, up to the top of the head. Swelling has not occurred again.

SINUS INFECTION; JOINT ACHING ON BOTH FEET AND ANKLES; LUMP ON INJECTION SITE; SORE INJECTION ARM; REDNESS AT INJECTION SITE; REALLY ROUGH LOWER BACK PAIN; HEADACHE; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient has no known allergies and also has no covid in past and not tested positive for covid. 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 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-MAY-2021, the subject experienced headache. On 15-MAY-2021, the subject experienced really rough lower back pain. On 17-MAY-2021, the subject experienced lump on injection site. On 17-MAY-2021, the subject experienced sore injection arm. On 17-MAY-2021, the subject experienced redness at injection site. On 18-MAY-2021, the subject experienced joint aching on both feet and ankles. On an unspecified date, the subject experienced sinus infection. Treatment medications (dates unspecified) included: amoxicillin trihydrate/clavulanate potassium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from really rough lower back pain on 16-MAY-2021, and was recovering from sore injection arm, lump on injection site, redness at injection site, joint aching on both feet and ankles, headache, and sinus infection. This report was non-serious.

FALL/SHE FELL OVER AGAIN; UPON DISCHARGE WENT HOME WITH WALKER/SENT HER HOME WITH A WALKER; HAVING TROUBLE WITH HER DAILY LIFE; RED POLKADOTS ON HANDS; DRY SKIN; SOMETHING IN THROAT/RASPY THROAT; LEGS COLLAPSED; HER LEGS TURNED TO RUBBER; SAT DOWN HARD ON HER RIGHT ASS; HIT HEAD ON THE PAVEMENT; IT HURT; GOT UP DURING THE NIGHT; This spontaneous report received from a patient concerned a 68 year old other race female. The patient's height, and weight were not reported. The patient's past medical history included has broken 3 bones in the top of the foot, stroke, and shattered her shoulders and arm, and concurrent conditions included seizure, hydrochlorothiazide allergy, and penicillin allergy. The patient taking blood pressure pills and pills for seizures (unspecified). The patient received Covid-19 (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) 1 total dose, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the patient hurts. Then the patient went home; and went to store for picked up some groceries. On the way back to car the patient's legs turned to rubber and she sat down. Her legs collapsed and sat on ass hit head on the pavement. On 25-MAR-2021 the patient got up during the night and same things happened again and she fell over again and spent the night on the floor and admitted to hospital (dates unspecified) for 4 days and the patient received blood thinner shots (unspecified) in her stomach. The patient discharged from hospital (dates unspecified) with walker. On an unspecified dates the patient had all kinds of tests and all came back normal. On an unknown date the patient having trouble with her daily life. The patient had a physical therapy and occupational therapy for a month. On 30-MAR-2021, the patient experienced dry skin and something in throat/raspy throat. On an unknown date the patient had red polkadots on hands. The action taken with covid-19 vaccine was not applicable. On an unknown date the patient was recovered from fall/she fell over again, and not recovered from dry skin, and something in throat/raspy throat and the outcome for and the outcome of red polkadots on hands, her legs turned to rubber, sat down hard on her right ass, legs collapsed, hit head on the pavement, got up during the night, it hurt, upon discharge went home with walker/sent her home with a walker and having trouble with her daily life was not reported This report was serious (Hospitalization Caused / Prolonged). FALL/SHE FELL OVER AGAIN. 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).

Initially on vaccine evening 3/19/21 mild sore arm, mild brain fog, following day03/20/2021 headache, tired, second day post vaccine 03/21/2021 no noticeable symptoms . 03/17/2021 first notation of headache,, 03/18/2021 headache continued all day ,03/19,2021 notation of headache setting in early evening , 03/20/2021 notation of tiredness all day accompanied by headache and achy everywhere-joints-muscles. Days following had notation of mild headache/body aches. 04/01/2021-8:30am Extremely Dizzy upon getting out of bed, Strong Panic attack-symptoms subsided with am medications, and reappeared about 11:00am. Strong Panic attack, very dizzy, neck stiff,muscle tightness in shoulders, sysmptoms continued off and on

I had no pain at injection spot but I did have a severe headache shortly after injection and had to lay down at home and was in pain for six hours. I also experienced fatigue. I got out of bed in the evening and ate dinner. Then I returned to bed due to fatigue and severe nerve pain, joint pain, and all-over body pain. The second day I still felt lousy. The third day I felt OK.

Patient is a 69 year old female who was admitted on 5/27/2021 for CEREBRAL VENOUS SINUS THROMBOSIS. Patient is a 69 year old female "who lives at home with husband. Patient with a h/o DM2, hyperlipidemia, epilepsy followed by Dr. neurology outpatient, hypertension. Patient on keppra and tegretol with some episodes of partial seizures, sensitive to being off medications. Patient was in usual state of health until today. Daughter noticed around 6 PM patient was confused, altered, dizzy, not able to walk, and had left arm weakness. The patient's sister had a stroke in the past and they were concerned for this and so brought her in for evaluation when she didn't improve. Daughter thinks patient might have started having symptoms around 1 PM. Daughter reports patient was not taking her aspirin, and they never picked up the lisinopril that was prescribed for blood pressure in the past. She did have the J&J covid vaccine 6 weeks ago.

Stroke occurred 4 days after shot administered. Blacked out, right arm limp and of no use. 2 pm 5/17/21. 911 called transported to hospital and then transported/admitted to another hospital. CAT scan and MRI test done. Test show right side of head had stroke, and heart has damage.

Weakness that started in extremity (legs) and spread to all extremities over a 3 to 4 week period. Patient has received medical care, but has not returned to her previous normal, prior to vaccination date.

WOKE UP IN THE MIDDLE OF THE NIGHT HURTING ALL OVER (BODY PAIN); MORE TOTAL BODY JERKING; SORE JAW (PAINFUL TO OPEN MOUTH); TREMOR; JOINT PAINS FROM ARTHRITIS WORSENED; HEADACHE; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and back surgery, and concurrent conditions included osteoarthritis of all major joints, and benign essential tremor.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 23A21A, expiry: UNKNOWN) dose was not reported, administered on 11-JUN-2021 for prophylactic vaccination. Concomitant medications included paracetamol for pain. On 11-JUN-2021, the subject experienced headache. On 12-JUN-2021, the subject experienced woke up in the middle of the night hurting all over (body pain). On 12-JUN-2021, the subject experienced more total body jerking. On 12-JUN-2021, the subject experienced sore jaw (painful to open mouth). On 12-JUN-2021, the subject experienced tremor. On 12-JUN-2021, the subject experienced joint pains from arthritis worsened. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from woke up in the middle of the night hurting all over (body pain), sore jaw (painful to open mouth), headache, joint pains from arthritis worsened, more total body jerking, and tremor. This report was non-serious.

Vaccinated in March, began having some mild shortness of breath and fatigue around mid April which she attributed to allergies. Fatigue and shortness of breath continued to worsen and she began having some lower extremity edema. She saw her family physician at the time, Dr., who did an EKG in the office which was normal, and recommended that she follow up with Cardiology. In May the shortness of breath and fatigue worsened and she began having pain between her shoulder blades. She saw the Dr. He did a cardiolyte stress test which was reported as negative, and an echo which showed a mild pericardial effusion and they recommended a

(1) Swelling behind left knee- approximately 1 month after vaccine (2) Pain inside left thigh and leg area - recurring since taking vaccine, nothing done, just noted (3) Wake up with stiffness in left side of neck approximately 2 times per week- recurring approximately 1 month after taking vaccine (4) Developed a dry cough - present and recurring everyday, approximately 1 month after vaccine (5) Severe insomnia noted after taking vaccine - developed approximately 2 months following vaccine (5) Severe lack of energy and body tiredness

The patient had her vaccine on 6/10 and then on 6/11 began to experience tingling throughout her legs and feet. She also complained of swelling in the feet in the mornings and shuffling gait. She also noticed joint pain and cramping in the legs. She still has these symptoms at this time.

As soon as I got the vaccine I started with a cough 30 hours later developed a fever chills headache and it one point to it we?re not too three days muscle aches severely cold and now I have so I said my mouth five days later violent diarrhea five days later still sores

Nausea for 24 hours, threw up overnight. Headache for 24 hours. Some swollen glands. Excessive aching around hips.

Fatigue and fever of 99.9. Major side effect was muscle aches in lower to mid back to the point that I was doubled over and could not straighten up for several days. Legs were like jelly as well.

Slight pain at injection site. Moderate headache. Severe chills with chattering teeth and body shaking. Severe fatigue. Moderate muscle aches. Nausea. Racing, pounding heart. Rate measured at 100 bpm. Continued for approximately 12 hours. Overall weakness. Slight dizziness at height of symptoms.

On day 9 felt both sides of neck tender under ear by jaw line. Upon palpation both sides painful however left side more. Paid no attention to it except on day 10 because pain still felt with left side more painful. No lump or bump felt just very sensitive and painful upon palpation. Left side more painful when palpated. It seems to be going away slowly. Did not put this on my daily report because I chalked this up to being maybe a cold or something coming on. After thinking about this symptom I realized it is slowly going away and as an R.N. contributed to it now as a side effect. Below I put "No" regarding recovery because the pain is still there however not as bad. It seems to be going away slowly. Hoping it will be gone in a few more days.

Six hours after the shot I began to shake. I was not cold and my temp was only 99 degrees. The shaking turned into uncontrollable jerking of my shoulders, torso and thighs. The jerking lasted 3 hours. My family became concerned and said I looked like I was convulsing. We were making plans to go to the ER when it started to calm down. I had no control over my body. I finally stood up and my body felt like I was made of led. Headache, slight fever, and weakness persisted until 48 hours post shot.

My teeth started to hurt before I even got home. This usually means a sinus headache is coming. The next day I had a sinus headache, chills, was very fatigued, and was achy. I had a knee replacement in December and that knee ached so much I could barely stand on it. The next day I was fine.

COUGH; CHEST CONGESTION; TIRED; MUSCLE ACHES; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's past medical history included fall and concurrent conditions included high blood pressure, seasonal allergies and bleed on the brain. The patient experienced drug allergy when treated with ciprofloxacin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. Concomitant medications included metoprolol tartrate for blood pressure. On 13-MAR-2021, the subject experienced cough. On 13-MAR-2021, the subject experienced chest congestion. On 13-MAR-2021, the subject experienced tired. On 13-MAR-2021, the subject experienced muscle aches. On 25-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 97.2 Unit Not Reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cough, chest congestion, tired, and muscle aches. 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.

LEFT WRIST DROP, LEFT FINGER ABDUCTOR WEAKNESS, LEFT FINGER EXTENSOR WEAKNESS, LEFT ELBOW EXTENSOR WEAKNESS. NO ASSOCIATED PAIN.

NECK WAS PAINFUL; EARS WERE PAINFUL; BAD CASE OF THE FLU; DIFFICULT TO SLEEP; FEELS AWFUL; BODY ACHE; LETHARGIC; SEVERE CHILLS; PAINFUL JOINTS; HEAD WAS PAINFUL; PAINFUL MUSCLE; NAUSEA; FATIGUE; LOW GRADE FEVER; This spontaneous report received from a patient concerned a 69 year old female. The patient's weight was 140 (pound), and height was 167.64 (centimeter). The patient's concurrent conditions included shellfish allergy, alcohlic, artheriosclerosis, cholesterol, non smoker, and contrast dye allergy, and other pre-existing medical conditions included the patient did not have any history of drug abuse. The patient experienced mild adverse events when treated with influenza vaccine for prophylactic vaccination. 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, 1 total, administered on 10-MAR-2021 10:00 on right arm for prophylactic vaccination. Batch number was not reported and has been requested. Concomitant medications included rosuvastatin for cholesterol, ascorbic acid, colecalciferol, fish oil, magnesium, sambucus nigra, and zinc. On 10-MAR-2021, the subject experienced neck was painful. On 10-MAR-2021, the subject experienced ears were painful. On 10-MAR-2021, the subject experienced bad case of the flu. On 10-MAR-2021, the subject experienced difficult to sleep. On 10-MAR-2021, the subject experienced feels awful. On 10-MAR-2021, the subject experienced body ache. On 10-MAR-2021, the subject experienced lethargic. On 10-MAR-2021, the subject experienced severe chills. On 10-MAR-2021, the subject experienced painful joints. On 10-MAR-2021, the subject experienced head was painful. On 10-MAR-2021, the subject experienced painful muscle. On 10-MAR-2021, the subject experienced nausea. On 10-MAR-2021, the subject experienced fatigue. On 10-MAR-2021, the subject experienced low grade fever. On 11-MAR-2021, Laboratory data included: Body temperature (NR: not provided) low grade fever of 100. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ears were painful, bad case of the flu, feels awful, body ache, head was painful, nausea, and low grade fever on 13-MAR-2021, and severe chills, and fatigue on MAR-2021, had not recovered from lethargic, and the outcome of neck was painful, painful joints, painful muscle and difficult to sleep was not reported. This report was non-serious.

CHILLS; SEVERE JOINT PAIN ESPECIALLY IN THE KNEES; HEADACHE; NAUSEA; FATIGUE; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included pulmonary embolus, and other pre-existing medical conditions included patient had not pregnant at the time of reporting. patient had extensive allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. Concomitant medications included warfarin for pulmonary embolus. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced severe joint pain especially in the knees. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced nausea. 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 chills, headache, nausea, and fatigue on 10-APR-2021, and was recovering from severe joint pain especially in the knees. This report was non-serious.

Took Covid shot March 6 (J&J). Since then has felt fatigued and achy. No fever but has had joint pains. Feels SOB with walking. Feels it is worse since the shot. Having pain in the back of the neck, and her hands and knees are swollen (but not red or hot). Feels this is worse than it was before. Taking furosemide but swelling not going away. Taking spironolactone and potassium. Takes furosemide 4 days a week. No N, V, but has had diarrhea since taking vaccine. She says her husband has had very similar symptoms.

SWOLLEN LYMPH NODES (LYMPH NODES BLEW UP LIKE GRAPEFRUITS ); UNABLE TO PUT ARMS DOWN; PAIN UNDER HER ARMS ( PAIN UNDER HER ARMPITS); This spontaneous report received from a patient concerned a 69 year old female. 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: 1808980, expiry: 20-JUN-2021) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, the subject experienced pain under her arms (pain under her armpits). On 31-MAR-2021, the subject experienced swollen lymph nodes (lymph nodes blew up like grapefruits ). On 31-MAR-2021, the subject experienced unable to put arms down. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen lymph nodes (lymph nodes blew up like grapefruits), unable to put arms down, and pain under her arms (pain under her armpits). This report was non-serious. Sender's Comments: V0: Medical assessment comments not required as per the standard procedure as the case is assessed as non serious.

Severe pain in left arm (not at injection site) - on side near breast, also severe pain in neck and left shoulder, but more severe in my back (left side below shoulder). Pain was only in arm on 4/3, 4, 5 & 6. Then reoccurred in arm, neck, shoulder and back on 4/15/21. Been taking 600mg Ibuprofen 4/18, 19 & 20. Can't take anymore since it bothers my stomach.

I was sent to table 6. A young woman there started to swab my shoulder / very top of my arm. I told her to stop- I could see my friend at the other end of the table getting an injection 3 inches below the shoulder. Told the woman not to give me the injection so high. She said it had to go into the muscle. Told her there was just skin and bones that high and no muscle. She said she knew what she was doing. And gave me the injection. My arm and shoulder hurt immediately. Really hurt. I should have talked to someone in charge about her. A nurse watching us for 15 min said that pain at that point was normal. It has been almost 6 weeks and the pain is so bad that it wakes me up. Pain pills, Tylenol, Advil do not work. Please help me find a way to get rid of this pain. I did take a photo of the injection site later that day as the pain was still there. Went to my doctor and she said to give it more time. That was 2 weeks ago. This is a true story. I hope that you can help me get rid of the pain.

24 hours after vaccine patient had body aches, fever, chills which lasted 36 hours and then went away completely. Then on 3/18/21 patient developed bilateral hip pain, knee pain, ankle pain. Treated with prednisone 40 mg, taper by 10 mg every three days

MUSCLE PAIN; This spontaneous report received from a parent concerned a 69 year old female. 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 17-MAR-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of muscle pain was not reported. This report was non-serious.

April 15- late morning. Numbness right arm and hand and left arm. Loss of feeling in arm and hand. Difficult to raise arms, heaviness. Lasted less than 30 minutes. April 16- late morning. Left leg/foot very heavy, couldn?t walk. Lasted less than 15 minutes. 4:00 pm. Numbness again in left leg. Lasted less than 15 minutes. 5:00pm. Numbness in left arm and thumb and first finger. Lasted less than 15 minutes.

FOGGY FEELING IN HEAD; BURNING IN THE HEART MUSCLE; EVERY BONE WAS HURT; HEADACHE; CHILLS; FEVER; SWOLLEN HEART MUSCLE; CHEST PAIN; URINE COLORING YELLOW ORANGE; BODY ACHE; VOICE WAS HOARSE; This spontaneous report received from a patient concerned a 69 year old female. 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: UNKNOWN) dose was not reported, administered on 06-APR-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced voice was hoarse. On APR-2021, the subject experienced body ache. On 07-APR-2021, the subject experienced swollen heart muscle. On 07-APR-2021, the subject experienced chest pain. On 07-APR-2021, the subject experienced urine coloring yellow orange. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced foggy feeling in head. On 08-APR-2021, the subject experienced burning in the heart muscle. On 08-APR-2021, the subject experienced every bone was hurt. On 08-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain, foggy feeling in head, voice was hoarse, fever, chills, and headache on 11-APR-2021, burning in the heart muscle, and every bone was hurt on 09-APR-2021, urine coloring yellow orange on 10-APR-2021, and body ache on APR-2021, and was recovering from swollen heart muscle. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.

ARTHRITIS; PAIN IN HIP; COUGHING BLOOD; BLEEDING NOSE; CHEST PAIN; DIARRHEA; LOST APPETITE; WORSENED PERSPIRATION; LOST 100LBS; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin. The patient was previously treated with sulfur for drug used for unknown indication, codeine for drug used for unknown indication, and morphine for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 08:00 for prophylactic vaccination. Concomitant medications included warfarin sodium for drug used for unknown indication. On APR-2021, the subject experienced lost appetite. On APR-2021, the subject experienced worsened perspiration. On APR-2021, the subject experienced lost 100lbs. On 07-APR-2021, the subject experienced diarrhea. On 08-APR-2021, the subject experienced chest pain. On 09-APR-2021, the subject experienced coughing blood. On 09-APR-2021, the subject experienced bleeding nose. On 10-APR-2021, the subject experienced pain in hip. On 11-APR-2021, the subject experienced arthritis. Laboratory data (dates unspecified) included: COVID-19 virus test negative (NR: not provided) negative (units unspecified). Treatment medications (dates unspecified) included: ketorolac, and prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 08-APR-2021, chest pain on 09-APR-2021, coughing blood, and bleeding nose on 10-APR-2021, and pain in hip on 11-APR-2021, had not recovered from lost appetite, and worsened perspiration, and the outcome of arthritis and lost 100lbs was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious

CLIENT REPORTS THAT 4-5 DAYS AGO SHE STARTED HAVING EXTREME FATIGUE, AND RIGHT NECK, SHOULDER, PAIN THAT IS POUNDING AND REQUIRES TYLENOL PO Q 3 HOURS. ICE HELPS A LITTLE BUT ONCE MEDICATION WEARS OFF SHE HAD SEVERE PAIN IN THESE AREAS. IT STOPS AT THE LOCATION OF THE SHOT ON HER RIGHT SIDE/ARM.

TIGHTNESS IN HAMSTRINGS; BUTT PAIN; PAIN IN THIGHS AND CALVES AND ARM; GREAT DIFFICULTY IN MOVING; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's past medical history included polio, and concurrent conditions included arthritis in the arms, and other pre-existing medical conditions included the patient had no known allergies. The patient was previously treated with abaloparatide. 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 06-MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced great difficulty in moving. On 15-MAR-2021, the subject experienced tightness in hamstrings. On 15-MAR-2021, the subject experienced butt pain. On 15-MAR-2021, the subject experienced pain in thighs and calves and arm. Laboratory data (dates unspecified) included: Diagnostic ultrasound (NR: not provided) no blood clots, not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tightness in hamstrings, pain in thighs and calves and arm, and butt pain, and the outcome of great difficulty in moving was not reported. This report was non-serious. This case, from the same reporter is linked to 20210509287.

Heavy legs approximately 3 hrs after vaccine taken ,heart beating fast. The heavy legs went away after few days but for the next several weeks heavy legs came back & continues more frequently up to now. I went to see my doctor, on May 10, 2021,.,

ROLLING ACHE IN CHEST; FEELS LIKE FLU; STIFFNESS OF NECK; JAW GETTING READY LOCK AND FEELS OUT OF ALIGNMENT; LOW BLOOD PRESSURE/LOWER THAN NORMAL BLOOD PRESSURE; ACHINESS IN FINGERS FOR LONG TIME; ACHINESS IN SHOULDER ANKLE AND KNEE FOR LONG TIME; NECK PAIN; GLANDS SWOLLEN; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's past medical history included temporomandibular disorder, and irritable bowel syndrome, and concurrent conditions included sulfonamide allergy, non alcoholic, non smoker, and controlled high blood pressure. The patient was previously treated with for drug used for unknown indication; and experienced drug allergy when treated with chlorpromazine for drug used for unknown indication. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-APR-2021, the subject experienced glands swollen. On 30-APR-2021, the subject experienced neck pain. On 01-MAY-2021, the subject experienced achiness in fingers for long time. On 01-MAY-2021, the subject experienced achiness in shoulder ankle and knee for long time. On 02-MAY-2021, the subject experienced low blood pressure/lower than normal blood pressure. Laboratory data included: Blood pressure (NR: not provided) 112/65, 126/71, 124/84, 120/82, 138/72. On 06-MAY-2021, the subject experienced jaw getting ready lock and feels out of alignment. On an unspecified date, the subject experienced rolling ache in chest, feels like flu, and stiffness of neck. The action taken with covid-19 vaccine was not applicable. The patient was recovering from glands swollen, and neck pain, had not recovered from jaw getting ready lock and feels out of alignment, achiness in fingers for long time, and achiness in shoulder ankle and knee for long time, and the outcome of low blood pressure/lower than normal blood pressure, feels like flu, stiffness of neck and rolling ache in chest was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.

The nest morning when I woke up I felt like I had been hit by a truck. Every part of my body ached. Took monumental effort to get out of bed. Had a headache, felt just terrible. Stayed in bed for the day. It got better over the next several days so I could function. The joint pain got a little better but never really went away. Many of my joints still ache, wrists, fingers, ankles, not hurting enough to keep me in bed. But enough to feel different from before I had the shot. Was afraid to go to the doctor because there was a high rate of COVID in her immediate area so I was concerned about going to a hospital or something.

pressure on center of chest...fever....muscle aches....sweating....lack of appetite....fatigue.....sleep problems lasted 4 nights and days

FLU SYMPTOMS; ACHING BONES; HEADACHE; INTERMITTENT SWEATING; PAIN AND SORENESS IN THE LEFT ARM AT INJECTION SITE; REDNESS IN LEFT ARM AT INJECTION SITE; This spontaneous report received from a patient concerned a 69 year old female. The patient's weight was 214 pounds, and height was 65 inches. The patient's past medical history included lumpectomy of right breast, radiation therapy, and colon resection, and concurrent conditions included breast cancer, non-insulin-dependent diabetes mellitus, asthmatic, second hand smoke, chronic obstructive pulmonary disease, neuropathy, iodine allergy, sulfa allergy, non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. the patient had no history of drug abuse or illicit drug usage. the patient cannot take certain antibiotics because it upsets stomach. The patient experienced bad reaction with colon when treated with prednisone for drug used for unknown indication, and ministroke when treated with midazolam hydrochloride, and blood pressure problems and headache when treated with celecoxib, stomach upset when treated with erythromycin, and blood pressure increased when treated with salbutamol. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 7808980 expiry: UNKNOWN) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced intermittent sweating. On MAY-2021, the subject experienced pain and soreness in the left arm at injection site. On MAY-2021, the subject experienced redness in left arm at injection site. On 13-MAY-2021, the subject experienced flu symptoms. On 13-MAY-2021, the subject experienced aching bones. On 13-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from pain and soreness in the left arm at injection site, and the outcome of flu symptoms, aching bones, headache, redness in left arm at injection site and intermittent sweating was not reported. This report was non-serious.

Pain, pain, pain, and blisters, itchy and soreness. I went to the Clinic ER because I was in so much pain in my chest and back and they kept me over night and ran test. I was sent home and returned in a couple of days cause I was still in pain and was diagnosed with Shingles.

6/5/21 NO SYMPTOMS RIGHT AFTER SHOT, NO SORENESS. 6/13/21 SHE STARTED TO FEEL MUSCLE ACHE ON RIGHT FOOT, COULDN'T WALK. DR AWARE OF THIS SYMPTOMS AND DR THINKS IT MAY HAVE BEEN CAUSED BY HER MEDICATIONS. DR STOPPED FENOFIBRATE AND LOWERED DOSE ON ATORVASTATIN. ALSO DOING LAB TESTS

Cramping began in right leg off & on over 6wk period. Not thinking much of it just older I guessed. Then on June 6th my calf locked up & could barely walk. Later in evening my toes & foot went numb & cold & no feeling. Called Ambulance to take me to Hospital. 6 days of treatment. Many injections & needles.

I woke up thinking I had a bad cramp on left side, above the heart. Didn't go away! Called on call Dr, was told I had costochondritis. No reason could be found. Two weeks later, saw my Dr. Again, no reason found. Just happens is the basic thought. For me, I would like to add, when I received the shot, I felt I HAD TO BE IN RAPPORT with everyone...my husband made the appointment for the shot. I felt "out of choice, no self governance " over my body. I had wanted to wait, until I was ready, perhaps another week or two. Being in rapport hurts the connective tissue. I betrayed myself. I cannot blame the vaccine, only myself for not listening and waiting until I felt 100% capable of handling the vaccine within my body. 13 hours after I had the vaccine, I became ill. My bowels also have been slow to regain their true rhythm. Again I blame me for rejecting the vaccine!!!! I am only reporting this, because I believe a study about connective tissue and rapport, along with the willingness of someone to receive the vaccine would be interesting for someone to study. I ache, still, from the costochondritis. I take that ache as a reminder, and my responsibility to be more at peace with my choices. Thank you for listening, feels good to express myself.

My arm muscle was soar after the shot and the muscle continues to be soar four months later. I heard a news story about this situation this morning thus I am reporting my experience now.

PT RECEIVED VACCINE ON 6/9/2021. PT STATES THAT SHE DEVELOPED A STIFF NECK ON 6/20/21 AFTER DRIVING SEVERAL HOURS TO HER VACATION DESTINATION. SHE HAD TO TAKE NSAIDS AND USE A HEATING PAD OVER THE COURSE OF 2 & 1/2 WEEKS TO GET IT TO RESOLVE. STIFF NECK OCCURRED ON THE SAME SIDE AS INJECTION SITE.

7:30pm unusual restlessness in both legs; by 8:30pm dull constant pain increased, legs were weak, knees wobbly, hands shaking. Pain in legs became intense; I could not sit on the toilet. Went to emergency room of Hospital at 9pm; no medications given. Pain calmed by 10pm, but sensation in legs returned at 11pm and continued until discharge at 1:15am on 3/6. Took Tylenol PM at home for moderate pain in legs and went to bed. Awakened next morning to no pain, had breakfast and went back to bed until noon. Feeling fine since that time.

11.5 hours after vaccine I began to vomit and continued for 48 hours with dry heaves. Only drank water then vomited . Ate 1/2 cut of chicken soup and vomited it up. Constant chills. Back ached so bad I couldn't sleep first 24 hours. Still feel week 3 days later, however able to eat and drink with no nausea 1200 noon on 03/08/21. No health issues, no medications.

High fever, headache, muscle pain, neck pain, dizziness, tremors starting with in 7 hours of injection lasting all night and next day

Ten hours after vaccination into my left arm, my right arm, right leg, and right hip bones felt as if they were being crushed. I finally fell asleep for an hour or two, then awaken just in time to make it to the bathroom where I sat on the toilet ALL night having severe diarrhea and vomiting into a container on my lap. I would fall asleep, then wake up, on the toilet, very sick. The vomiting ended after that first night, but the diarrhea has persisted. It is getting better, though. (It has been 72 hours since the shot.) I had a headache, my left arm ached, I was nauseous, and feverish until about 8 a.m., today, when my fever broke. I still feel like I have a low-grade flu, which I have not had in over 40 years. And, I still have some diarrhea. I am sipping Coke and can eat some Cheerios, with milk and banana, but that is all that I want to attempt.

Chills, high fever (102) first and second nights. Tylenol helped. Fever broke around 2 am second night. Starting Mar 18, muscle aches in back.

Starting at 11:30pm started feeling queezy; then got chilled. The chills turned into shivering & body shaking & teeth chattering. Neck muscles & jaw muscles hurt. Dressed in polar fleece jammies, socks, flannel bed-sheets, two heavy duvets & couldn't get warm nor stop the shaking. Tried standing to walk it off but legs were like jelly. Tried bio-feedback to relax & stop the shivering but it just continued in wave after wave. My chest tingled and my heart felt like it was working hard. It subsided around 4:30a.m. The next day felt 'punk' muscles still jelly like & jaw really ached from chattering. The 2nd day was fine.

BREATHING GOT WORST; ANKLES SWELLING; HANDS SWELLING; SORE THROAT; TONGUE SORE; FEVER; This spontaneous report received from a patient concerned an elderly female. The patient's height, and weight were not reported. The patient's past medical history included heart attack, and concurrent conditions included copd, bad heart, and pneumonia, and other pre-existing medical conditions included the patient had no history of allergy to vaccine, drug, or food and no past history of similar event.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced ankles swelling. On MAR-2021, the subject experienced hands swelling. On MAR-2021, the subject experienced sore throat. On MAR-2021, the subject experienced tongue sore. On MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 F, and Investigation (NR: not provided) UNKNOWN. On 29-MAR-2021, the subject experienced breathing got worst. Laboratory data included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from breathing got worst, and the outcome of sore throat, ankles swelling, hands swelling, tongue sore and fever was not reported. This report was non-serious.; Sender's Comments: V1: Medical assessment comment not required as per the standard operating procedure as the case is assessed as non-serious.

I had the Johnson and Johnson one shot vaccination on March 15, 2021 and Initially had no adverse reactions .. However , 18 days after my vaccination, around April 2, 2021, began to have deep muscle pain radiating around the injection site, which was in my upper right arm, in the muscle at the top of my arm.. It was SO painful, the pain was deep in the muscle but not painful to external touch., that I had to take Tylenol for three days. Today is April 7, 2021, and the deep muscle pain is barely noticeable, but once in awhile, I will still get a jab of pain..

Severe muscle pain throughout body, legs and arms weak to the point of not being able to walk or get to the bathroom, chest pain, severe head/face pain, dizziness/vertigo, chills, fever, vomiting. Was so bad that I thought about calling 911. 15 hours later - muscle pain remains, head exploding pain, dizzy.

Head ache, ringing in the ears, Arthritis in the hands, Numbness in right finger, stiffness in body, feeling cold and feeling agitated.

METALLIC TASTE; SORE ARM; PAIN IN SHOULDER; HEADACHE; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included breathing issues, milk allergy, sulfa drug allergy, and hoarseness of voice, and other pre-existing medical conditions included the patient is not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Non-company suspect drugs included: clarithromycin ( batch number: UNKNOWN expiry: UNKNOWN, form of admin, route of admin, and were not reported) 500 mg, 2 times every 1 day, therapy dates were not reported for an unspecified indication. No concomitant medications were reported. On 09-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced metallic taste. On 11-APR-2021, the subject experienced sore arm. On 11-APR-2021, the subject experienced pain in shoulder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from metallic taste, sore arm, headache, and pain in shoulder. This report was non-serious.

Body aches started Saturday evening. Ran a temperature of 101 to 102.5 for 4 days. She had lower back pain "ovary pain" she describes worse than labor pains

Five minutes after getting injection, I noticed a tightening and tingling in my throat, mouth, trachea; sharp sudden onset headache; racing pulse 100 beats per minute; blood pressure 154/100. Because of the headache, I had the pharmacist take my BP. Upper palate was scratchy and irritated. Took 25 milligram tablet of Benedryl. Throat getting tighter but no shortness of breath. At 4:00 BP was 164/104, pulse still 100. At 4:00 took another 25 mg of Benedryl. BP remained high. Stayed for an hour. Turned down epi-pen because her breathing was fine. 5:15 BP still 164/104. Left site and started feeling itchy-- eyelids, lip, scalp. 7:00 BP had come down. 148/94, pulse 88; headache persisted. Took 650 mg of aspirin. 9:00 headache had lessened and BP was 138/80, pulse was 84. By 10:00, moderate headache. Slept. Woke up at 12:00 am with muscle pain in right leg. 3:30 am woke with bad headache, chilled, slight fever (99.6), rash on right trunk and upper abdomen. Took two more aspirin for headache. 8:00 am 130/76, normal temp, hives.

MUSCLE ACHES; INJECTION SITE SORENESS; INJECTION SITE REDNESS; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, high blood pressure, no alcohol use, and non-smoker, and other pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 206A21 expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced injection site soreness. On 11-APR-2021, the subject experienced injection site redness. On an unspecified date, the subject experienced muscle aches. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) High. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle aches, and was recovering from injection site soreness, and injection site redness. This report was non-serious.

Submandibular lymphadenopathy, severe bilateral temporomandibular joint pain started 4/19/2021. Patient went to urgent care and received cephalexin without improvement. Patient saw me 4/27/2021 and we are trying pain control with naproxen and hydrocodone?acetaminophen as needed for pain. Labs below were drawn.

My skin became very sensitive to touch 4-5 days ago, then I noticed some pain in my left leg like muscle overuse, then I woke up yesterday and found a rash. Dr. said its Shingles and said it is likely due to the vaccine.

BLACK TOE; STUBBED HER RIGHT SMALL TOE; SEVERE HEADACHE; CHEST PRESSURE; CHEST PAIN; SORE ARM; NECK PAIN; MUSCLE ACHES; EXTREME TIREDNESS; SHORTNESS OF BREATH; HEAVY AND TIRED EYE; MULTIPLE BRUISE; BLURRED VISION IN LEFT EYE; FUNNY EYES; COUGHING; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 in march 2020, and concurrent conditions included migraine on the right or left side of her head, and sinus problem. he 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 08-APR-2021 for prophylactic vaccination. Concomitant medications included mecobalamin. On APR-2021, the subject experienced shortness of breath. On APR-2021, the subject experienced heavy and tired eye. On APR-2021, the subject experienced multiple bruise. On APR-2021, the subject experienced blurred vision in left eye. On APR-2021, the subject experienced funny eyes. On APR-2021, the subject experienced coughing. On APR-2021, the subject experienced neck pain. On APR-2021, the subject experienced muscle aches. On APR-2021, the subject experienced extreme tiredness. Laboratory data included: Platelet count (NR: not provided) Normal. On 08-APR-2021, the subject experienced sore arm. On 10-APR-2021, the subject experienced chest pressure. On 10-APR-2021, the subject experienced chest pain. On 14-APR-2021, the subject experienced stubbed her right small toe. On 14-APR-2021, the subject experienced severe headache. On 15-APR-2021, the subject experienced black toe. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pressure, and chest pain on 11-APR-2021, and heavy and tired eye, blurred vision in left eye, funny eyes, coughing, black toe, stubbed her right small toe, sore arm, severe headache, muscle aches, and extreme tiredness on APR-2021, had not recovered from multiple bruise, and the outcome of shortness of breath and neck pain was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.

First, the injection was far more painful than anticipated (and it bled down my arm). My arm immediately ached intensely. Approximately 10 minutes after injection, I began to sweat profusely, followed by intensifying extreme lightheadedness. I could not stand, or lift my head, as I would have definitely passed out. My shoulders and neck became extremely painful, as if ?frozen?, also preventing me from lifting my head. After about 35 minutes I very gradually began to recover. It was about an hour before I began to move around normally. Pharmacy and store staff debated calling the paramedics, but I refused. FYI, I had not been especially anxious about the vaccine, and I have never experienced such a reaction to anything in my life. It was a traumatic experience I would not wish to repeat.

First night had chills, very slight nausea and low grade fever (99.3) the next two days. On the morning of April 7th I woke up with a swollen lip. Throughout the day the swelling continued on the left side of face, then on bottom of right foot and later on top of both feet. Went to emergency room and was treated for hives. Over the next five days, the hives kept moving around, the right side of face, and then to upper lip. I followed up with my Primary Care Doctor, who did extensive allergy testing. All came back negative. I felt that it was a result of my body reacting to the vaccine. In addition, I was feeling weak muscles and joints that kept moving around.

Headache - I had some neck pain. I don't remember - I might have some dizziness - I put them on the v-safe check-ins. I had to be taken by ambulance to the hospital on 4/17/2021 - I thought I was having a stroke. They said that I had developed bells palsy on the right side of my face. They gave me medication to use for one week. The symptoms that I was having went away less than two weeks later. They told me that Bells Palsy symptoms could last two weeks to six months. It's gone right now - I don't see any symptoms of it. I did have a virtual appt appt with my doctor -

4/30/21: This patient comes in complaining of worsening low back pain. She has a history of severe degenerative disease in his had surgery. She was scheduled to see her neurosurgeon last year however it got canceled due to the COVID-19. Patient states she saw her neurologist on Tuesday and was given injections which significantly helped. She states that her pain has returned however. She has had no trauma. No footdrop. No difficulty with her bowel or bladder. Patient states she only uses Tylenol arthritis at home. 5/1/21:The patient is a 70-year-old female presenting to the emergency department for back pain. She has a history of chronic back pain and states that has been worsening. She was recently seen here for the same complaint. She currently rates her pain 10/10 intensity. She reports that she has chronic numbness and tingling of her bilateral arms/hands and legs/feet. She states that this is also worsening. She denies any changes in bowel or bladder function or perineal numbness. She states that she has been using a walker at home and that she has tried to make an appointment with her neurosurgeon who previously operated on her but that she has been unable to get through to their office. She reports that she only called 1 time on a Friday. She is taking Tylenol at home for her pain and reports minimal relief. She denies any fevers or associated concerns at this time. 5/2/21: This is actually her 3rd visit in less than a week with this complaint. She was seen 2 other times at a outside facility. She states that she had back surgery about 10 years ago at Beaumont. She states she was supposed to see her neurosurgeon last year but this did not occur secondary to COVID-19. Her primary care physician had referred her to a neurologist did some injections ahead some relief of her back pain for a week or 2 but this is since worsened. She states that over last several days she has had increasing numbness and tingling in her feet as well as increasing weakness of her lower extremities as well as some now some new incontinence of urine when she stands up. She today she also complains some chest pain she attributes more from just amount of pain he has from her back. She rates her back pain as a 10/10 intensity. She did have 1 episode of a week or 2 ago where she slipped down and fell on her knee but did not hit her back directly. She did not hit her head. She describes the chest discomfort in her upper abdomen lower chest area. She is nauseated but not vomiting here. She denies any exertional dyspnea or orthopnea prior to this. She has had no recent fever chills. 5/11/21: The patient is an 70 y old female admitted on 5/4/2021. The patient was originally seen by Neurology on 05/07/2021 when she presented with diffuse weakness. She has a history of hyperlipidemia, hypertension and diabetes. The patient at that time described the acute onset of weakness ascending from the feet, then involving the legs and arms also associated with sensory symptoms that started about 2 weeks prior to her presentation. She also had persistent neck and back pain radiating to her arm and legs limiting her ability to walk. On neurologic examination at that time the patient had absent deep tendon reflexes in the lower extremities and trace reflexes at the biceps. She had significant weakness in the lower extremities and mild weakness in the upper extremities. She also had a dysarthric speech. Given the patient's CSF analysis showing protein elevation to 266 with no pleocytosis, wbc's were only for, there was support for a clinical diagnosis of acute inflammatory demyelinating poly radicular neuropathy or such variant. The patient was started on plasmapheresis and has received her 2nd session of plasmapheresis on 05/09/2021. She will have a total of 5 sections, one every other day. The patient also has hyponatremia, this can be seen in about 5% of patients with Guillain-Barre syndrome, we also do see pseudohyponatremia but this is in patients that have received IVIG.

It seems I experienced every listed side effect, save for fatigue. That included fever, muscle aches, brain fog, nausea, gastrointestinal distress

3 weeks after shot, numbness and tingling in right hand 3 weeks after that speech problems, trouble swallowing, loss of use of hand, went to the ER on May 18 with a blood clot in brain causing stroke.

After receiving 2 doses of pfizer covid-19 vaccine. patient was directed by MD to get Janseen vaccine as well, due to not having immunity.

STIFFNESS IN THE NECK; HEADACHE; TIREDNESS; SORENESS IN THE INJECTION SITE (LEFT ARM); MUSCLE ACHE; This spontaneous report received from a consumer concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, non-alcohol user, and non-smoker, 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: 202A21A, expiry: 07-AUG-2021) dose was not reported, administered on 30-JUN-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 01-JUL-2021, the subject experienced stiffness in the neck. On 01-JUL-2021, the subject experienced headache. On 01-JUL-2021, the subject experienced tiredness. On 01-JUL-2021, the subject experienced soreness in the injection site (left arm). On 01-JUL-2021, the subject experienced muscle ache. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stiffness in the neck, headache, tiredness, soreness in the injection site (left arm), and muscle ache. This report was non-serious.

I have an auto-immune disease, which I checked on the vaccine form as immuno-compramised. Within a week after vaccine, experienced swollen ankles, muscle at joints pain, heart muscle pain. I already had Covid in Feb 2020, after the normal 2-3-week cold/sinus /coughing in bed watching tv, and was totally fine after. I only got the JnJ shot to go to an event in June requiring it, but wish I hadn't! My natural immunity was probably compromised by the vaccine. Being on Humira for previous 10 years (another mRNA-style maintenance drug), probably complicated/worsened my current post-vaccine symptoms. Humira website says the combo isn't tested yet.

Patient called to report on going arm pain, possible inflammation with involvement of rotator cuff. Patient has seen primary provider who suggested involvement of rotator cuff. Patient and provider are in monitoring mode to see if issue resolves.

HPI 70 y.o. female with pmh of HTN presenting w/aphasia and R sided facial and extremity weakness onset 15m prior to EMS activation. Per EMS, pt may be on anticoagulation, unk meds. LKW 15 minutes prior to activation pt began slurring her speech and spoused noted R facial droop and R sided weakness. Patient unable to provide history based aphasia however cannot yes or no to questions. Pt is no longer taking medications for BP. Patient positive of intracranial hemorrhage.

1. first day swelling and pain 2. queasy, headache for 2 weeks, 3. Blisters reoccurring, 4.Inflammation in joint escalated. 5. Severe Angina (7) times 6. Tendonitis in knee, shoulder, elbow 7. Pressure in Back and hips then spread.

PAIN IN THE RIGHT KNEE; INFECTION IN THE TOP RIGHT TOOTH/SHOOTING PAIN IN THE TOP RIGHT FRONT TOOTH; PAIN IN RIGHT ARM/FEELING OF A SPLINTER MOVING UP DOWN IN THE RIGHT SHOULDER/PAIN MORE IN THE CUFF AREA; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. the patient had no history of other life style changes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: 07-AUG-2021) dose was not reported, administered on 08-JUN-2021 for prophylactic vaccination. Concomitant medications included lisinopril. On 18-JUN-2021, the subject experienced pain in right arm/feeling of a splinter moving up down in the right shoulder/pain more in the cuff area. On 06-JUL-2021, the subject experienced infection in the top right tooth/shooting pain in the top right front tooth. On 12-JUL-2021, Laboratory data included: X-ray (NR: not provided) Tooth infection. On 19-JUL-2021, the subject experienced pain in the right knee. Treatment medications (dates unspecified) included: amoxicillin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in the right knee on 19-JUL-2021, and pain in right arm/feeling of a splinter moving up down in the right shoulder/pain more in the cuff area on 21-JUN-2021, and had not recovered from infection in the top right tooth/shooting pain in the top right front tooth. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non serious.

Woke up at 4AM on 03/05/2021 with shaking chills, feeling very cold, couldn't get warm. Shaking so bad I couldn't get whole sentences out. Body aches and stiffness, affected my walking. Did not take temperature at that time. Got back into bed with 2 blankets and a comforter and still couldn't sleep. Got up a 7AM - temp 102.2, shaking less but still feeling cold, body was hot to touch. I had a bad headache and body aches and stiffness were still there. I noticed at that time that I had a bright red flush on both cheeks and my nose that was hot to the touch. Took 600mg of Ibuprofen. Went back to bed feeling terrible. At 12 noon I got back up and temp was down to 99.7. Headache, body aches, stiffness, and "red flush" still on cheeks and nose. Went back to bed. Took more Ibuprofen at 7pm - temp was down to 98.7. Headache was better, body aches improved. Flushed hot face was still present. Went to sleep at 11:30PM and slept for 10 hours. Today, 03/06/21, all symptoms improved, no fever, redness of face is still present but less.

Pt describes feeling severe chills, fever of 101.4, inability to walk overnight, and delirium yesterday afternoon and overnight last night. She reports chills causing contortions, inability to walk, she stool up and fell down immediately, and hallucinations. She describes thinking she was using a computer when she was not.

After receiving the vaccine I got a sharp pain on head near neck, they had me to wait to make sure I was ok, then I woke up and my shoulder and arm is in pain, the muscle hurts when i try to move my arm, my temp is 99.7 and I'm extremely tired. I took Tylenol.

pt reports waking up the next morning with "amnesia" "didn't know where I was, forgetful, " numbness radiating down her vaccinated arm, neck soreness

Rapid heart rate that lasted through the night subsided in the morning, severe muscle aches and chills

NECK PAIN; ELBOW PAIN; HIGH BLOOD PRESSURE; LEFT ARM PAIN; SHOULDER PAIN; BODY ACHE; FATIGUE; This spontaneous report received from a patient concerned a 71 year old female. 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 12-MAR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, Laboratory data included: Blood pressure (NR: not provided) High. On 12-MAR-2021, the subject experienced body ache. On 12-MAR-2021, the subject experienced fatigue. On 13-MAR-2021, the subject experienced shoulder pain. On 15-MAR-2021, the subject experienced left arm pain. On 16-MAR-2021, the subject experienced high blood pressure. On 27-MAR-2021, treatment medications included: paracetamol. On 01-APR-2021, the subject experienced elbow pain. On an unspecified date, the subject experienced neck pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, and fatigue on 14-MAR-2021, was recovering from high blood pressure, had not recovered from shoulder pain, and left arm pain, and the outcome of neck pain and elbow pain was not reported. This report was non-serious.; Sender's Comments: V1: Medical assessment comment not required as per standard procedure as case assessed as non-serious.

I had ligament repair surgery on my right ankle on 01/06/2021. My recovery was going well. I was walking well without pain and was gaining balance and strength with physical therapy. I had almost no discomfort at the site of my surgery. Three days after having my J&J vaccination I woke up to a lot of discomfort in my right ankle, making it difficult for me to walk as I had been able to walk. I have struggled over the last six days to get back to the mobility I had prior to getting my J&J vaccination. I spoke with representative from my orthopedic surgeon?s office this morning who confirmed that I am most likely suffering from the side effects of the J&J vaccination, and she suggested that my lack of normal mobility will most likely last another week.

BODY ACHES; NAUSEOUS; MUSCLE ACHES IN BOTH ARMS; TIRED; CHILLS; This spontaneous report received from a patient concerned a 71 year old female. 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: 1805025 expiry: UNKNOWN) dose was not reported, 1 total, administered on 27-MAR-2021 13:00 on left arm for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021, the subject experienced chills. On 28-MAR-2021, the subject experienced body aches. On 28-MAR-2021, the subject experienced nauseous. On 28-MAR-2021, the subject experienced muscle aches in both arms. On 28-MAR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and chills on MAR-2021, and nauseous on 29-MAR-2021, and had not recovered from muscle aches in both arms, and tired. This report was non-serious.

Fatigue started 4/6/2021 then on 4/7/2021 upper right arm was very sore and hot to the touch. Soreness extended down arm and lasted most of the day on 4/7/2021. About 2pm I took 2 Tylenol and that started to minimize the ache, by bedtime my arm felt better.

Tues. eve., after the vaccine, I got the CHILLS that lasted all night long! I woke up (Wed.) with NAUSEA and took the "anti-nausea" pills that I had left over from when I had COVID (11 - 2020). My upper arm was now very sore, especially when I tried to lift it. I took my temp. and I had a FEVER (101). On Thurs., my temp. went down to 99.5 and the nausea was gone. Today (Fri.), I woke up with pain on my shoulder (over the injection site). I took Advil and iced it and it is now much better (this eve.). The only side effect I have now is the pain in my arm (mostly when I lift it). I am eating better and sleeping better now.

SORENESS IN ELBOW, WRIST AND KNUCKLES; SORENESS IN ARM, HAND AND FINGERS; INJECTION SITE SORENESS; DIFFICULTY USING HAND; SWOLLEN SHOULDER; INJECTION SITE BRUISING; This spontaneous report received from a patient concerned a 71 year old female. The patient's weight, height, and medical history were not reported. The patient received Tylenol unspecified (form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: 20-JUN-2021) dose was not reported, administered on 31-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 2021, the patient experienced injection site bruising. On 02-APR-2021, the patient experienced difficulty using hand. On 02-APR-2021, the patient experienced swollen shoulder. On 02-APR-2021, the patient experienced injection site soreness. On 03-APR-2021, the patient experienced soreness in arm, hand and fingers. On 04-APR-2021, the patient experienced soreness in elbow, wrist and knuckles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with Tylenol unspecified was not reported. The patient had not recovered from injection site soreness, difficulty using hand, swollen shoulder, injection site bruising, soreness in elbow, wrist and knuckles, and soreness in arm, hand and fingers. This report was non-serious.

First 24 hours: Fever of 99.9; chills, sweats, spasms of muscles throughout body, extreme pain with muscle spasm, and muscle weakness. I could not go up and down steps as my legs would not hold me. Headache. Week 2 to present. Fatigue, I have to nap every day and I sleep 8 hours or more at night. Diarrhea, despite taking OTC medications to control. Dehydration and dizziness. I am now 4 weeks since my shot on March 4th and I continue to have these symptoms. I went to see my doctor and all lab tests are normal. There is no other diagnose reason for my continued symptoms. I wish I waited to get either the Pfizer shot or Moderna as I have not heard of these extreme and prolonged side effects from those shots.

Pt complained of tinging, heaviness in tongue. No drooling. No CP has some shortness of breath. No wheezing. Pulse ox 96% on RA. HR-78/min Lungs were clear. Pt given Benaydryl 25mg 1 tab by mouth. Pt given solumedrol 40mg IM pt showed improvement in signs and symptoms. BP 120/80

After vaccine I noticed I was having a horrible time sleeping, then I started having joint inflammation 10 days later. I was I excruciating down my legs, I had big knots on my as well. Days 12-14 the pain kept me up because it was bad. By day 15 I had extreme pain, water retention and I had to take something for pain. On 4/4 I had nausea and last Wednesday I was nauseated and started running a temperature and felt like the flu and chills. I went to get a covid test because of the way I was feeling and it came back negative.

Taste in mouth. Could feel in lungs. Eyes watering. Teeth chattering. Could not walk at first. When could walk needed help of two person to sit in observation area. After about 40 minuets was able to walk. Felt like my heart was bouncing at times. Legs were very weak. Headache the next day and nausea. My legs and balance are still off but I?m much better. Notified md office on April 12, and 13th by phone and was told if not better by next Monday to call back then by the nurse that I did not need to be seen at this time.

The left arm where the shot was given was only sore for a short time, but my right are began to ache the next day. It seems to be in the muscle between the elbow and shoulder. I can use my arm, but grasping items and raising them above my shoulder are very painful (like holding my hair dryer and raising it to dry my hair). I have debated with myself about reporting this, but with the current concern with the Johnson and Johnson - one shot, I thought maybe I should report it.

Fever, chills, muscle aches, rapid heart rate, pain in rib cage, pain at injection site Lasted for about 48 hours

Calling with questions /concerns-said she had to get vaccine because of recent dx/tx for breast cancer. She said received vaccine on 3/13- then on 3/16 she was seen for one of her breast cancer therapy sessions- they have been treating her for lymphedema - she said she has been going for breast cancer in July- no chemo just radiation- surgery of breast with removal of seven surrounding lymph nodes. She was advised to wear a compression bra- on 3/16 and ever since then her left side of neck has been sore- thought it was likely related to compression bra not fitting correctly b/c too tight & was professionally fitted on her- the straps seem very tight over the collar bone area that was damaged/irritated by the radiation she received on that side up through Oct 2020 for cancer. Now when she saw story today in news she got concerned could the neck soreness really be from a blood clot? She as been going the week for tightness in neck to physical therapy which started yesterday for lymphedema. Again her radiation ended Oct 2020 but she has had persistent swelling in breast & fluid in lymph nodes on the left side. She still has pain in on collar bone- on same side of radiation- blisters, sore, red. As well as this new compression bra having two tight straps on each side. Her COVID vaccine shot in right arm but left side where breast surgery was She went on 3/16 for consultation on breast lymphadema - that was when told her to wear tighter bra for compression on 3/16. She is going today to be fitted for new one that is not so tight. She is approx. 4 weeks post vaccination & post when started wearing that tighter bone- maybe three inches from where had radiation injury is located.

Patient with questions /concerns-said she had to get vaccine because of recent dx/tx for breast cancer. She said received vaccine on 3/13- then on 3/16 she was seen for one of her breast cancer therapy sessions- they have been treating her for lymphedema - she said she has been going for breast cancer in July- no chemo just radiation- surgery of breast with removal of seven surrounding lymph nodes. She was advised to wear a compression bra- on 3/16 and ever since then her left side of neck has been sore- thought it was likely related to compression bra not fitting correctly b/c too tight & was professionally fitted on her- the straps seem very tight over the collar bone area that was damaged/irritated by the radiation she received on that side up through Oct 2020 for cancer. Now when she saw story today in news she got concerned could the neck soreness really be from a blood clot? She as been going the week for tightness in neck to physical therapy which started yesterday for lymphedema. Again her radiation ended Oct 2020 but she has had persistent swelling in breast & fluid in lymph nodes on the left side. She still has pain in on collar bone- on same side of radiation- blisters, sore, red. As well as this new compression bra having two tight straps on each side. Her COVID vaccine shot in right arm but left side where breast surgery was She went on 3/16 for consultation on breast lymphadema - that was when told her to wear tighter bra for compression on 3/16. She is going today to be fitted for new one that is not so tight. She is approx. 4 weeks post vaccination & post when started wearing that tighter bone- maybe three inches from where had radiation injury is located.

Extreme fatigue, dizzy, foggy brain, disoriented, nausea, congestion, joints aching, extreme neck and shoulder pain on the left side . Feels like the Cortizone shot that I normally get for my joints stopped working once I got the J&J shot Shoulder doctor said the shoulder pain was caused from the shot being given to high in my arm

Patient presented 3-4 weeks after receiving the Janssen COVID vaccine with right MCA stroke with mass effect, mild midline shift and right MCA thrombus. Carotid ultrasound showed thrombosis of the right common and internal carotid arteries and right carotid siphon. She was found down, last seen normal 2 days prior to admission. She was not a candidate for tPA given the delayed presentation and unlikely to benefit from thrombus extraction. She was treated with aspirin and atorvastatin and treated for rhabdomyolysis. Patient is currently still admitted to the hospital but transitioning to comfort focused care.

Pain in hands, middle finger joint issue, forearms hurting, both shoulders and neck pain, ankle pain and shin pain? seemed like most major joints? most of these bilateral. No treatment yet. Diagnosed with polyarthralgia.

I started to have a heavy feeling in my right arm. On the fourth day it became worse, and my arm was really stiff and heavy. I was taking Advil and it didn?t help much. I went to the doctor on the sixth day. The NP thought it was a pinched nerve because it was my whole arm from the neck down. On the tenth day it started to affect my other arm which was the side that I got the shot in. I had no strength in my arms and my husband had to help me dress. It was almost two weeks after the shot I went back to the doctor. I was prescribed Meloxicam and an Arthritis cream and it did not help. Blood work did not show any definitive problem. Gabapentin and Advil did help a little. Three weeks after the shot the pain started to move to my legs as well. for one week. The pain is not as bad but now it is in my arms all the way into my neck and shoulders. It has been seven weeks since the shot and now the pain is still in my right arm and into my neck and shoulder blade. I still have good range of motion right now.

Chills, 102 fever, back pain lasted about 15 hours Then over the next week or two bumps the size of a mosquito bite on various parts of the body-gone after another week

PAIN IN NECK; JOINT PAIN/ MIDDLE FINGER JOINT PAIN; PAIN IN BOTH CHINS,SHOULDER, FOREARMS AND HANDS; PAIN IN BOTH ANKLES; HEADACHE; This spontaneous report received from a patient via a company representative concerned a 71 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included chin pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: 23-JUN-2021) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced pain in neck. On 2021, the subject experienced joint pain/ middle finger joint pain. On 2021, the subject experienced pain in both chins, shoulder, forearms and hands. On 2021, the subject experienced pain in both ankles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from joint pain/ middle finger joint pain, pain in neck, pain in both ankles, pain in both chins, shoulder, forearms and hands, and headache. This report was non-serious.

Nausea, chills, fatigue, body aches with unusual and extreme upper back pain. Took Aleve. Too tired and hurting too much to move.

Starting -4/12/2021 - initial symptoms cycled through over the first four weeks. Fever, chills, aches, pains, shooting pain in ears (first 9 days); uncontrollable shaking, erratic heart beat (April 17, 18); severe head and neck ache (lasted 2 days), resting pulse 100, head cold, diarrhea, cough, fatigue, weakness, chest tightness, pneumonia (X-ray on 04/30/2021), premature heart beat (EKG on 05/17/2021). As of 05/21/2021, still have heart beat irregularities, weakness, and fatigue.

I am diabetic so symtoms are like low blood sugar..I PASS OUT, SWEAT, COLD, DIZZY, MUSCLE PAINS, CONFUSED, VERY SLEEPY, PAIN IN EUSTACHIAN TUBE , HEADACHE, TOE PAIN,

First 2 days after shot both knees ached, could hardly walk, third day pain gone, then on 18th all heck broke loose at 1:10 am, I had uncontrollable diarreah with velocity vomiting at EXACT same time. I was chilled to the bone with temp that ran between 95.4 to 96, The chills quit on the 20th. Diarreah has been on going since the 18th, haven't held food or water for 6 days, goes right through me. I went to ER today, my blood pressure going in was 179/99 and after 2 bags of IV Fluid blood pressure was 122/68

Muscle aches and pains Some severe Calf pain, tired still, chills still, The pains keep changing to different parts

BODY ACHE; RASH; HEADACHE; FATIGUE; MUSCLE ACHE; This spontaneous report received from a patient concerned a 71 year old female. 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: 1808986, and batch number: 1808986 expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAY-2021, the subject experienced body ache. On 26-MAY-2021, the subject experienced rash. On 26-MAY-2021, the subject experienced headache. On 26-MAY-2021, the subject experienced fatigue. On 26-MAY-2021, the subject experienced muscle ache. The action taken with covid-19 vaccine was not applicable. The patient recovered from body ache, fatigue, and muscle ache on 27-MAY-2021, and headache on 26-MAY-2021, and had not recovered from rash. This report was non-serious.

GOT UP LIMPING A LITTLE BIT SORE TO THE TOUCH; RIGHT HIP BOTHERING/ SORENESS; LEFT LEG SWELLING,PARTICULARLY AROUND AND ABOVE THE ANKLE BY 4 INCHES; 3-4 EPISODES OF DIARRHEA PER DAY/ LOOSE STOOL THAT HAS BEEN BOTH LIQUID AND SEMI FORMED/ STOOLS ARE NORMAL COLOR; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's past medical history included leg injury, and darker skin discoloration, and concurrent conditions included asthma allergies, kiwi allergy, and reflux, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 2028A21A expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. Concomitant medications included bismuth subsalicylate. On 27-MAY-2021, the subject experienced 3-4 episodes of diarrhea per day/ loose stool that has been both liquid and semi formed/ stools are normal color. On 29-MAY-2021, the subject experienced left leg swelling, particularly around and above the ankle by 4 inches. On 30-MAY-2021, the subject experienced got up limping a little bit sore to the touch. On 30-MAY-2021, the subject experienced right hip bothering/ soreness. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from left leg swelling,particularly around and above the ankle by 4 inches, right hip bothering/ soreness, and 3-4 episodes of diarrhea per day/ loose stool that has been both liquid and semi formed/ stools are normal color, and the outcome of got up limping a little bit sore to the touch was not reported. This report was non-serious.

Two weeks after the vaccine on March 29,2021 all day that day right arm was stiff and felt like every nerve in her body was in pain. stated she felt like somebody was ripping her arm off it. Tried taking extra strength acetaminophen but it still didn't work. Range of motion with moving her arm didn't bother her at all it was just pain in her arm.

Increasing tenderness at injection site, small hard spot and new shoulder joint pain 7 days after injection. Shoulder pain increasing daily.

periodic neck stiffness, leg cramps, some rapid heart rate,memory loss, continual itching on torso and head, not energy and sleepiness after a good nights sleep, low energy. I am afraid of long term results. Wish I had not received it

Pain along side for 2 days (shooting pain along ribs). Broke out with blisters 2 days after the pain started. Spot approximately as big as an egg on left back. Small strip 1'' x 1/4'' under left breast.

Janssen COVID-19 Vaccine EUA Ten weeks ago I had A LOT of nasal mucous draining into my mouth during the night, couldn?t breathe, coughing. This went on for 4 days, so I went to the GP, took a COVID and Strep Test, both negative. I had and still have: a very difficult time swallowing any food or drinking water because I have a very irritated throat when I breathe, with throat pain going from the bottom of my neck up to my ear (earache). I?ve lost 7lbs. over the last ten weeks, 5?5? 93lbs. GP suggested an ENT. ENT did an XR Esophagram, CT Sinuses Fusion wo contrast and a CT neck soft tissue w contrast/creat. Everything OK. Sending me on to a swallow therapist on June 30th.

shot given 3-5-21 3-7-21 at 2:00 am was woken up by bad muscle and joint pains. But I was freezing. I had the chills very badly I sleep with an electric blanket, but I had not had chills in years. I was very sore and cold, but did not do anything until 4:00am. I went and got an expired prescription of oxycontin. I took 2 and went back to bed. I woke up at 6 and was fine. So it lasted maybe 4 hours.

Extreme lower back pain and shortness of breath. Breathing exercises for lungs and over the counter acetaminophen for body aches Outcome symptoms still the same.

Very severe muscle aches, headache, and shivering within hrs after receiving vaccine. Lasted all night into today. Dizzy and needed help walking. Seemed very extreme for a vaccine reaction. Starting to feel a little better but I am loaded up with Tylenol and Advil.

A day after the vaccine pt developed flue like symptoms, severe chills, headache, muscle ache, runny nose, nasal congestion. On 3/17/21 pt developed a hive on the right cheek, then on 3/19/21 pt developed hives all over body, went to hospital, was seen in ED sent home, hives continued beame so itchy all over her body, pt went back to hosp, admitted on 3/21/21, discharged on 3/22/21. Pt was given Prednisone. Pt took Benadryl at home which did not help.

Patient reported fevers as high as 105 at rehab and myalgias along with weakness, She was subsequently admitted to the hospital for these symptoms.

On Wednesday, March 10, 2021,I started having muscle pain throughout my left and right legs. Things and calves were like walking on raw nerve ends. I had all types of tests, x-rays, MRI?s and dr. visits to try to find the cause. This pain continued through March 31, until I was finally given a prescription for a steroid by my internist who believed this pain was being caused by the Johnson & Johnson covid 19 vaccination because of the time frame between the vaccine I was given and when the symptoms began. The pain while on steroids has disappeared. I am, as of this date, on the third day of a seven day course of the steroid medication. The pain subsided on day two of the medication.

Had a very intense right earache that lasted for about 30 minutes, with some neck pain. This disappeared after 30 minutes entirely.

ER 3/17 HPI: 72 y.o. female who presents with generalized weakness and not feeling well. Patient states that she had her 1st dose of COVID-19 vaccine about a week ago and since then has not felt well. She denies fever or chills, she denies any arthralgias or myalgias, she has had some nausea and vomiting but none in the last couple of days. There has been no diarrhea. There have been no urinary symptoms. 3/22/21 Inpt Admission hpi 72 y.o. female who presents with shortness of breath and hemoptysis. Patient has known history of COPD and also has a history of squamous cell carcinoma of the lung that is in remission. Patient reports she has noticed increasing shortness of breath for the past several weeks. She states the got worse around the noon time today. Patient reports she began having some hemoptysis today. Patient denies any chest pain or palpitations. Patient denies any fevers or chills. Patient denies any sinus congestion or nasal drainage. Patient denies any headaches, myalgias, or loss of sense of taste and smell. Patient does report a 4 day history of intermittent diarrhea. She denies any nausea or vomiting. Patient has had COVID-19 vaccination. Of note, patient's family reports she has lost 10 lb in the past 30 days. 3/30/21 Deceased

Chills that kept me from sleeping, muscle aches and pains, lowgrade (100 degrees) fever, lack of energy, sleepiness

HEADACHE; PAIN IN THE HEEL; FEVER; PAIN AT INJECTION SITE; FELLING UNCOORDINATED; PAIN RADIATING TO THE NECK; DIZZY; SHOOTING PAIN IN EAR; PAIN IN THE ANKLE; MUSCLE PAIN; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included osteo-arthritis, fibromyalgia, kidney stone, penicillin allergy, ibuprofen allergy, corticosteroid allergy and erythromycin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 14:00 at left arm for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced dizzy. On 2021, the subject experienced shooting pain in ear. On 2021, the subject experienced pain in the ankle. On 2021, the subject experienced muscle pain. Treatment medications included: acetylsalicylic acid. On 25-MAR-2021, the subject experienced felling uncoordinated. On 25-MAR-2021, the subject experienced pain radiating to the neck. On 25-MAR-2021, the subject experienced pain at injection site. On 25-MAR-2021 20:00, the subject experienced fever. On 31-MAR-2021, the subject experienced pain in the heel. On 02-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy, felling uncoordinated, and fever, had not recovered from headache, and the outcome of pain at injection site, pain in the heel, pain in the ankle, muscle pain, shooting pain in ear and pain radiating to the neck was not reported. This report was non-serious.

Low grade fever for 24 hours; Achy joints 3 days; lack of energy 5 days; gastrointestinal symptons, first 24 hrs extreme diarrhea & gas; 2 days later after eating extreme diarrhea gas & severe stomach cramps lasting 12 hours; 5 days later loose stools and slight nausa with some gas after eating meal. This is day 5 feeling better but not 100% yet.

April 8, 2021 had Janssen shot. April 9 to today date I have been Nausea , severe muscle aches, chill, fever, very tired.

Low grade fever for 24 hours; Achy joints 3 days; lack of energy 5 days; gastrointestinal symptons, first 24 hrs extreme diarrhea & gas; 2 days later after eating extreme diarrhea gas & severe stomach cramps lasting 12 hours; 5 days later loose stools and slight nausea with some gas after eating meal. This is day 5 feeling better but not 100% yet. Additional Information: April 14, 2021 At 5 pm on day 5 again started watery diarrhea and stomach cramps. Bowel movement was water just like a colon prep clean out for colonoscopy. Day 6 diarrhea stopped but stomach still queasy and mild cramping. This is day 8 and still stomach issues after eating. Queasy and mild cramping.

JOINT PAIN; FATIGUE; INJECTION SITE PAIN; CHILLS; FEVER; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, high blood pressure, and allergy. 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 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced injection site pain. On 11-APR-2021, the subject experienced joint pain. On 11-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 06-APR-2021, and fever on 08-APR-2021, and had not recovered from fatigue, injection site pain, and joint pain. This report was non-serious.

GIANT HIVES/HIVES STARTED; SEVERE CHILLS; MUSCLE ACHES; NAUSEA; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a 72 year old female. The patient's weight was 127 (pound), and height was 147.32 centimeters. The patient's concurrent conditions included sulpha allergy, latex allergy, heart disease, blood pressure, non-alcohol use, non-smoker, and cervical headaches, and other pre-existing medical conditions included the patient had no history of drug abuse. The patient was not pregnant at the time of vaccination. The patient did not have acute illness 30 days prior to vaccination and did not have history of any disease or allergy to vaccine or food. The patient did not have significant family history of diseases or hospitalizations. The patient was not breast feeding. The patient experienced drug allergy when treated with iodine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported,1 total administered on 12-MAR-2021 10:00 to right arm for prophylactic vaccination. Concomitant medications included butalbital/caffeine/codeine phosphate/paracetamol for cervical headaches. On 12-MAR-2021, the patient experienced severe chills, muscle aches, nausea, fatigue, headache and itching. On 16-MAR-2021, the patient hives started and on 18-MAR-2021, the patient experienced dizzy spells. She also had upper body hives several hours later and had severe itching and shortness of breath. On 19-MAR-2021, the patient visited the ER. On 20-MAR-2021, the patient had rash all over the body, had giant hives and also experienced swelling and difficulty swallowing. The patient was hospitalized on 21-MAR-2021. Unspecified lab tests were performed for the patient. The patient received unspecified prescriptions to treat the skin eruptions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from giant hives/hives started, and the outcome of severe chills, headache, muscle aches, fatigue and nausea was not reported. This report was serious (Hospitalization Caused / Prolonged). Additional information was received from patient on 06-APR-2021. The following information was updated and incorporated in to the case narrative: reporter details (physicians details added), patient demographic details (DOB, age, age group, height, weight, pregnancy information, date of admission and age at the time of vaccination), concurrent condition added (heart disease, blood pressure, sulpha allergy, latex allergy, abstains from alcohol, non-smoker, and cervical headaches), events added (severe chills, muscle aches, nausea, fatigue, headache, giant hives), no. of days hospitalized added for all the events (no information), other AE characteristics added (events giant hives/hives started), hospital address added for all the events, products added (Iodine and Fioricet with codeine), seriousness criteria added for all event (Hospitalization Caused / Prolonged). Upon review following information was amended (removed the event normal side effect and severe skin eruptions).; Sender's Comments: V1: This version is created to update regarding patient's demographic details, concurrent conditions, events added - severe chills, muscle aches, nausea, fatigue, headache, giant hives, dizzy spells and difficulty swallowing), other AE characteristics added (events giant hives/hives started and dizzy spells), products added, seriousness criteria added for event giant hives and difficulty swallowing (Hospitalization Caused / Prolonged) 20210351080-COVID-19 VACCINE AD26.COV2.S-giant hives. Follow-up received regarding Clinical Details. 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). 20210351080-COVID-19 VACCINE AD26.COV2.S-severe chills, muscle ache, nausea, fatigue, headache. Follow-up received regarding Clinical Details. This event(s) is labeled and is therefore considered potentially related.

DIZZINESS; BODY ACHE; CHILLS; HEADACHE; FEVER; PAIN RADIATED TO THE BACK; STINGING SENSATION; FELT TERRIBLE; This spontaneous report received from a patient concerned a female of unspecified age. 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: 25-MAY-2021) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced stinging sensation. On 17-MAR-2021, the subject experienced felt terrible. On 17-MAR-2021, the subject experienced pain radiated to the back. On 18-MAR-2021, the subject experienced dizziness. On 18-MAR-2021, the subject experienced body ache. On 18-MAR-2021, the subject experienced chills. On 18-MAR-2021, the subject experienced headache. On 18-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stinging sensation on 23-MAR-2021, and felt terrible, dizziness, body ache, pain radiated to the back, chills, headache, and fever. This report was non-serious.

Pt in previously good health received J&J vaccine 04/09 and felt well until 04/21 when she developed lower extremity weakness and incoordination which became progressively worse and was accompanied by slurred speech on the afternoon of 04/22. The pt's husband helped her into bed and she apparently died during the night of 04/22-04/23.

~36 hours after vaccine had expected reaction (site reaction, pain, fatigue, fever). One week later experienced repeated site inflammation and pain; new muscle pain across back, and sore, tender to the touch skin around breast and up to collar bone, body aches and fatigue. Resolved and arm pain restarted again 1 week later(4/22/21) (took 2000 mg of Tylenol without effect). when speaking with patient on 4/23/21 arm pain currently the only symptom.

PAIN NEAR THE EAR AND UNDER THE CHIN; CANNOT SLEEP; FEELS SWOLLEN; PAIN IN SHOULDER; This spontaneous report received from a patient concerned a 72 year old female. 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: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced pain near the ear and under the chin. On 25-MAR-2021, the subject experienced cannot sleep. On 25-MAR-2021, the subject experienced feels swollen. On 25-MAR-2021, the subject experienced pain in shoulder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in shoulder, cannot sleep, pain near the ear and under the chin, and feels swollen. This report was non-serious.

BUMPS; ACHE; ITCHING; RASH; HIVES; SORE MUSCLES; TIRED; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic.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 03-APR-2021 for prophylactic vaccination. Concomitant medications included lorazepam for diabetes, and metformin for diabetes. On APR-2021, the subject experienced bumps. On APR-2021, the subject experienced ache. On APR-2021, the subject experienced itching. On APR-2021, the subject experienced rash. On APR-2021, the subject experienced hives. On APR-2021, the subject experienced sore muscles. On APR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from itching, rash, hives, ache, sore muscles, tired, and bumps. This report was non-serious.

Mild nausea ongoing, migraine, exhaustion ongoing, off balance mentally and physically, mild vertigo intermittent, low back pain intermittent, both mild and severe,

ALL JOINTS ACHE; MUSCLE ACHE; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure. 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 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced all joints ache. On MAY-2021, the subject experienced muscle ache. Treatment medications (dates unspecified) included: tramadol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle ache and all joints ache was not reported. This report was non-serious.

DYING FROM PAIN; FEVER 99-100.8 F AS IF GOT THE SHOT AGAIN; CHILLS AGAIN; SEVERE PAIN IN THE LEFT LEG FROM HIP TO KNEE, THE WHOLE LEFT SIDE; FUNCTIONABLE DURING THE DAY BUT NOT AT NIGHT; CAN NOT SLEEP AT NIGHT; BOTH LEGS HURT AT GROIN; CRIES FROM THE SEVER PAIN; INCREASE IN THE BLOOD PRESSURE; DEHYDRATION WHICH MADE HER VERY THIRSTY; FELT BURNING IN THE RIGHT ARM WHILE GETTING THE SHOT; SWOLLEN FACE; SEVER CHILLS; FELT EXHAUSTED; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's past medical history included hip implant. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: 09-JUN-2021) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: Blood pressure measurement (NR: not provided) increased, COVID-19 virus test (NR: not provided) negative, Hip X-ray (NR: not provided) normal, and Investigation (NR: not provided) Negative. On 31-MAR-2021, the subject experienced increase in the blood pressure. On 31-MAR-2021, the subject experienced dehydration which made her very thirsty. On 31-MAR-2021, the subject experienced felt burning in the right arm while getting the shot. On 31-MAR-2021, the subject experienced swollen face. On 31-MAR-2021, the subject experienced sever chills. On 31-MAR-2021, the subject experienced felt exhausted. On 14-APR-2021, the subject experienced functionable during the day but not at night. On 14-APR-2021, the subject experienced can not sleep at night. On 14-APR-2021, the subject experienced both legs hurt at groin. On 14-APR-2021, the subject experienced cries from the sever pain. On 14-APR-2021, the subject experienced severe pain in the left leg from hip to knee, the whole left side. On 16-MAY-2021, the subject experienced fever 99-100.8 f as if got the shot again. On 16-MAY-2021, the subject experienced chills again. On an unspecified date, the subject experienced dying from pain. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from increase in the blood pressure, and dehydration which made her very thirsty on 05-APR-2021, felt burning in the right arm while getting the shot on 2021, swollen face, sever chills, and felt exhausted on 14-APR-2021, and fever 99-100.8 f as if got the shot again, and chills again on 21-MAY-2021, had not recovered from severe pain in the left leg from hip to knee, the whole left side, functionable during the day but not at night, can not sleep at night, and cries from the sever pain, and the outcome of both legs hurt at groin and dying from pain was not reported. This report was non-serious.

I have had Rheumatoid for about 10 years and I am 73 yrs old. I have been on Methatrextrate and Enbrel 50 mg once a week for about 8 yrs. I was I guess what the doctors call in remission until I had a Johnson and Johnson Covid vaccine on April 2, 2021. Guess I should start with the side effects from the vaccine...2 days after receiving it I was very fatigued for 2 days then on day 7 my collar bone started to hurt, thinking I had slept wrong I just ignored it. On day 8 my lymph nodes under the arm that I had the shot started to feel swollen. After checking I did not feel any lumps but if it was still there the next day I was going to call my doctor. My niece and 2 of her friends were discussing it and all three had the same reaction (all had Modena) I started reading more on line regarding this and saw that it was just a side effect. Well 10 days after shot my hands and knees started to hurt by one month the pain was terrible. After going to both my primary doctor on May 24th and my RA doctor a week later and having had all the blood work done. My RA doctor stated all my bloodwork was fine and she believes that the Covid vaccine was causing the Enbrel not to preform like it should. All I could find in was one regarding a man with RA taking Enbrel and after having a Covid vaccine having the same issue. My doctor told me to try the Enbrel for another 2 weeks and if not better she no found one lady that takes infusions for her Rheumatoid and had flare ups also after her Covid Vaccination. There is also a man in his 50?s that went there the same thing. He was on Enbrel and had to end up with steroid shots. would try me on Humira. Well I read that didn't work either on the man I mention below. I am hesitant to change from Enbrel to Humira as I have had great success with Enbrel. Also I have Can you shed some light on why this is happening and have you had anyone else report this?

SWOLLEN KNEES; LOOSE JOINTS; CHARLEY HORSE; HIGH FEVER (3 DEGREES OVER NORMAL); SEVERE FATIGUE; MUSCLE SPASMS; SEVERE MUSCLE CRAMPS; DIFFICULTY WALKING/BARELY MOBILE; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient has no medical history. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 180898L (or a 2 for last digit)) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced muscle spasms. On 06-APR-2021, the subject experienced severe muscle cramps. On 06-APR-2021, the subject experienced difficulty walking/barely mobile. On 06-APR-2021, the subject experienced charley horse. On 06-APR-2021, the subject experienced high fever (3 degrees over normal). On 06-APR-2021, the subject experienced severe fatigue. On 12-MAY-2021, the subject experienced swollen knees. On 12-MAY-2021, the subject experienced loose joints. On 04-JUN-2021, Laboratory data included: Blood test (NR: not provided) No blood clots detected., and X-ray (NR: not provided) No diagnosis. The action taken with covid-19 vaccine was not applicable. The patient recovered from high fever (3 degrees over normal), and severe fatigue on 14-APR-2021, and had not recovered from muscle spasms, severe muscle cramps, difficulty walking/barely mobile, swollen knees, loose joints, and charley horse. This report was non-serious.

Pt had her J and J vaccine on 5/18/21. now hospitalized from home on 6/15 with a few days of chest pain and admitted with sepsis, UTI, dense rll pneumonia and new svt/tachycardia/NSTEMI, syncope, rhabdomyolysis. her hospital course was very protracted due to recurrent tachycarida/svt and she was eventually discharged to rehab on 6/23/21.

Pt noticed increased weakness in legs after receiving COVID vaccine. Had been walking steadily. Now unsteady with walking, feeling like legs will buckle. Pt referred for home PT.

BACK PAIN WHICH HAS RADIATED TO THE LEGS; LEGS FEEL LIKE THEY ARE SLEEPING; This spontaneous report received from a consumer concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy, and other pre-existing medical conditions included the patient is not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802012, and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAY-2021, the subject experienced back pain which has radiated to the legs. On 10-MAY-2021, the subject experienced legs feel like they are sleeping. Treatment medications (dates unspecified) included: gabapentin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from back pain which has radiated to the legs, and legs feel like they are sleeping. This report was non-serious.

3/6 vaccination. 6PM HA, neck pain, body aches, chills, fatigue; 12:AM woke up with increased HR. HR was too fast; up to 178-200. 911 called by husband. A fib with rapid pulse, convert with IV medicines. Low potassium and magnesium levels. Nitro administer by husband before EMS arrived; had gone down by time ambulance arrived by was irregular. Kept me in observation floor. *still not feeling 100%; fatigue, high HR

Shot administered 3/9/2021; side effects started 3/11/2021. Patient states she had chills, muscle pain/spasms. Mostly in her legs. Her feet still hurt and she states her walking ability has declined. 3/14/2021 she states she has had improvement consistently, but is still feeling her walking ability is back to where it was.

I received vaccine at 2:00 PM on 3/10//2021. I was tired afterwards. By 11:00 that same night I felt nauseous, has a headache and every joint and muscle in my body was painful. I could not sleep or get into a position where I was comfortable. The pain level was a 10. I took Tylenol in the middle of the night but it did not help. In the morning I was unable to contact my physician's nurse so I called the 24 hour Nurse Line. The nurse took all my information and told me that I could take Ibuprofen. I took 400 mg. and found a lot of relief from that. I still had some symptoms for the next few days. By 3/14/21 I felt fine. Now today I have a stuffy nose which could be an allergy to something else. I don't know yet.

2-3 days after vaccine patient experienced lightheadedness 18 days after the vaccine patient experienced muscle aches 19 days after patient experienced neuropathy of hands and feet

All my teeth began to ache and progressively get worse to the point I wanted to pull the out. At the same time it felt like my head (in notch immediately forward of middle of ear to ear) was in a tightening vise. Then I got hot and cold but not severely. Same for dizziness, very mild. I was nasusseous and not able to eat. I had random muscles pains , none lasting more than a few minutes in any one place. Odd thing was that I felt no discomfort at sight of injection. Next day I felt just as bad but at 8:30pm I felt like throwing up (after having 2 teaspons of vegetarian vegetable soup). However, I only had dry heaves. I live by myself and started to get scared. I called my daughter and took a Tylenol at 9pm. Within 10 minutes the feeling of a vise and my aching teeth felt significantly better. but stil very fatigued. Next day, today, I feel much better but still a little foggy headed. I can eat. I can function normally, thank heavens. If I had to take another shot now, I wouldn't. Not even sure I'll take a booster when it comes out . It was very scarey.

NECK AND JAW ACHING; LEFT ARM ACHE; HEADACHE; DIARRHEA; FEELING HOT AND COLD FEVER; TINGLING FINGERS; JOINT ACHES; CHILLS; This spontaneous report received from a patient concerned a 73 year old female. The patient's weight was 175 pounds, and height was 60 inches. The patient's concurrent conditions included non-alcoholic, and non-smoker, and other pre-existing medical conditions included patient had no know allergies and 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: 201A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced diarrhea. On 07-APR-2021, the subject experienced feeling hot and cold fever. On 07-APR-2021, the subject experienced tingling fingers. On 07-APR-2021, the subject experienced joint aches. On 07-APR-2021, the subject experienced chills. On 07-APR-2021 17:00, the subject experienced left arm ache. On 07-APR-2021 17:00, the subject experienced headache. On 07-APR-2021 21:00, the subject experienced neck and jaw aching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, neck and jaw aching, and tingling fingers on 08-APR-2021, was recovering from left arm ache, and had not recovered from headache, joint aches, chills, and feeling hot and cold fever. This report was non-serious.

Patient called clinic 4/14/2021 stating the day after she received the vaccine she had chills, fatigue, extreme pain, pain in the lower back all the way to feet, and discomfort in hands and feet.

DIARRHEA; NO APPETITE; CHILLS; JOINT HURTING; FEVER; ACHES; FLU LIKE SYMPTOMS; SHORTNESS OF BREATH; DIZZINESS; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic obstructive pulmonary disease, severe bronchitis, arthritis, bad back, and drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808978 expiry: 13-JUN-2021) dose was not reported, administered on 06-APR-2021 11:30 for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 104 F. On 07-APR-2021, the subject experienced aches. On 07-APR-2021, the subject experienced flu like symptoms. On 07-APR-2021, the subject experienced shortness of breath. On 07-APR-2021, the subject experienced dizziness. On 07-APR-2021, the subject experienced no appetite. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced joint hurting. On 07-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced diarrhea. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches, shortness of breath, diarrhea, no appetite, and joint hurting on 12-APR-2021, flu like symptoms, dizziness, and chills on 11-APR-2021, and fever on 10-APR-2021. This report was non-serious.

night of 4-7-2021 102 degrees F fever, chills, extreme shaking 4-8-2021 - 4-9-2021 102-103 F fever, body ache/pain, muscles and bones, especially hips, upper legs, lower back 4-10-2021 afternoon, extreme nausea, took prescription suppository, Promethazine 25 mg sup,, seemed better on 4-11-2021, 4-11-2021 and 4-12-2021 improved, but had bloating and some stomach pain, was on a light diet 4-13-2021 abdominal bloating during the day, then had diarrhea in the evening, then, 4-14-2021 had extreme watery diarrhea, stayed on liquid and then light diet, fatigue for a couple of days, then improved

Severe pain in left thigh groin & knee area. Went to ER, confirmed blood clot. Sent home w/blood thinners - Xarelto

This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included wasp sting, and non-smoker, and other pre-existing medical conditions included unknown. The patient was previously treated with varicella zoster vaccine rge (cho) for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) .5 ml, administered on AUG-2020 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2020, Laboratory data included: Antibody test (NR: not provided) antibodies present. On AUG-2020, the subject experienced flu. On AUG-2020, the subject experienced shivers. On AUG-2020, the subject experienced rib cage ache. On AUG-2020, the subject experienced felt lousy. On AUG-2020, the subject experienced muscle aches. On AUG-2020, the subject experienced stung at arm. On AUG-2020, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu, shivers, rib cage ache, felt lousy, muscle aches, and stung at arm on AUG-2020, and had not recovered from fatigue. Product Quality Complaint number:90000173522 This report was non-serious. The suspected product quality complaint has been confirmed to be voided (did not meet pqc criteria)- , this report does not contain any indication of a pqc but only mentions pure ae's which are outside of the scope of quality investigation. Based on the PQC evaluation/investigation performed.

LEFT SHOULDER PAIN; FELT TIRED; PAIN IN BOTH OF LEGS AND CALF; PAIN AT INJECTION SITE; BRUISE ON HIP; FELL OVER A BOX; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's past medical history included shoulder surgery, and concurrent conditions included type ii diabetes, lupus, and cholesterol issues. 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 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced bruise on hip. On APR-2021, the subject experienced fell over a box. On 05-APR-2021, the subject experienced pain in both of legs and calf. On 05-APR-2021, the subject experienced pain at injection site. On 06-APR-2021, the subject experienced left shoulder pain. On 06-APR-2021, the subject experienced felt tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain at injection site on 06-APR-2021, and felt tired on 07-APR-2021, had not recovered from left shoulder pain, pain in both of legs and calf, and bruise on hip, and the outcome of fell over a box was not reported. This report was non-serious.

BLOOD PRESSURE STARTED INCREASING; MUSCLE ACHES IN SHOULDERS, NECK AND LEGS; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. the patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with cefalexin, and codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: Blood pressure (NR: not provided) 146/87 mmHg. On 01-APR-2021, the subject experienced muscle aches in shoulders, neck and legs. On 15-APR-2021, the subject experienced blood pressure started increasing. On 30-APR-2021, Laboratory data included: Blood pressure (NR: not provided) 165/96 mmHg. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 120/80 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle aches in shoulders, neck and legs on 22-APR-2021, and had not recovered from blood pressure started increasing. This report was non-serious.

All over body stiffness, muscle aches,hard to walk, couldn't raise arms up, weakness and fatigue. First we tried nsaids, then steroids, took various tests including Covid test. I was negative. All this took about 2 months. May 4 was last steroid pill. Nsaids had no good effect. Steroids helped quite a bit, but not totally. The day after the last steroid pill, all the aches, pains, everything came back.

Injection site, arm muscles are weak, headaches, fatigues, muscle aches and nausea. Intestinal pain, cramps, severe pain in left leg from heel to hip-joint; hands, arms and shoulders joint pain; feet joints, continued sleepiness and drowsiness. Patient has not died yet.

The vaccine made my arthritis in my knees, and hips worst after two weeks. My Doctor order an EKG done because of the swelling in my feet related to my heart and kidneys. My hips and knees continued to ache whenever I stand up (still an issue).

I started having headaches everyday that increased in intensity throughout the day and felt really sick. It hurt all over, but mainly in the back. I waited to call the doctor because I have seasonal allergies. My head would feel really tingling on the outside, I started experiencing a high pitched screaming sound in my ears and I felt foggy/off, along with memory issues. So after a month, I decided to call my doctor and we had a video call. She ordered an MRI, which hasn't been done yet. I had a CBC count done in the middle of April and it was normal. The headaches are getting better and I'm getting them about once a week versus daily. However, I did have a really bad headache yesterday that I would say was over a 10 on the pain scale, but it's better today.

UNEXPLAINED SEVERE, CUTTING, HOT, DEEP, INTERNAL-TORNADO LIKE PAIN TO LEFT SHOULDER; EXTREME FATIGUE AND UNABLE TO CARE FOR MYSELF/3 VERY STRANGE EPISODES WHICH LEFT HER VERY DRAINED; FEEL WEAK; DIZZY/OFF BALANCE; HURT ALL OVER/INCREASE IN NECK AND BACK PAIN; TEETH CHATTERING; This spontaneous report received from a patient concerned a 73 year old female. The patient's weight was 220 pounds, and height was 67 inches. The patient's past medical history included right shoulder arthroscopy, and weakness, and concurrent conditions included chronic pain homebound patient with scoliosis, bone spurs, spine curvature /abnormalities, abnormal muscles, degenerative disc disease, penicillin allergy, non alcoholic, non smoker, and sick w/ scoliosis at age 16, and other pre-existing medical conditions included the patient had allergies and no drug abuse or illicit drug usage.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-JUN-2021 for prophylactic vaccination. Concomitant medications included hydromorphone hydrochloride, and oxycodone. On 11-JUN-2021, the subject experienced dizzy/off balance. On 11-JUN-2021, the subject experienced hurt all over/increase in neck and back pain. On 11-JUN-2021, the subject experienced teeth chattering. On 11-JUN-2021, the subject experienced feel weak. On 13-JUN-2021, the subject experienced unexplained severe, cutting, hot, deep, internal-tornado like pain to left shoulder. On 13-JUN-2021, the subject experienced extreme fatigue and unable to care for myself/3 very strange episodes which left her very drained. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from feel weak, teeth chattering, dizzy/off balance, hurt all over/increase in neck and back pain, unexplained severe, cutting, hot, deep, internal-tornado like pain to left shoulder, and extreme fatigue and unable to care for myself/3 very strange episodes which left her very drained. This report was non-serious.

LEFT HAND STIFFNESS; LEFT HAND SORENESS AND FINGERTIP PAIN; LEFT AND RIGHT ARMPIT PAIN; LEFT HAND AND FOOT CRAMPING; INTERMITTENT HEAD ACHES; PAIN BEHIND BOTH EAR; SWELLING IN BOTH ARMPIT, BEHIND BOTH EAR; WATERY EYES; DRIPPY NOSE; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to mold.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286 expiry: 06-SEP-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 watery eyes. On 15-MAY-2021, the subject experienced drippy nose. On 17-MAY-2021, the subject experienced pain behind both ear. On 17-MAY-2021, the subject experienced swelling in both armpit, behind both ear. On 17-MAY-2021, the subject experienced intermittent head aches. On 19-MAY-2021, the subject experienced left hand and foot cramping. On 23-MAY-2021, the subject experienced left and right armpit pain. On 30-MAY-2021, the subject experienced left hand stiffness. On 30-MAY-2021, the subject experienced left hand soreness and fingertip pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from watery eyes, and drippy nose on 16-MAY-2021, and left hand and foot cramping on 30-MAY-2021, and had not recovered from left hand soreness and fingertip pain, left hand stiffness, pain behind both ear, swelling in both armpit, behind both ear, intermittent head aches, and left and right armpit pain. This report was non-serious.

Brain Seizures Stop Dead on movement Extreme Muscular Pain Extreme Bronchitis with green sputum Lame leg on left side Red Cell Count was low

LOW PLATELET COUNT; LIVER ENZYMES HIGH; BODY ACHES; JOINT ACHES; SEVERE NAUSEA; HORRIBLE HEADACHE; This spontaneous report received from a patient (who is a Healthcare professional) concerned a 73 year old, female. 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: 043A21A expiry: UNKNOWN) dose was not reported, 1 total, administered to the left arm on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified day, the patient had a horrible headache for 4 weeks and went into the hospital and did bloodwork. She stated that her platelet count went down to 69,000 and liver enzymes were high. She also had a head computerized tomography (CT) scan done as well as went to the eye doctor. Two weeks later the patient went and had another platelet count done and it went up to low normal. She wondered if a month after the vaccine, it was possible to have the side effects. She also stated that she had severe nausea along with the headaches. She also had joint aches as well as body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from low platelet count, and the outcome of liver enzymes high, horrible headache, severe nausea, joint aches and body aches was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210651622-covid-19 vaccine ad26.cov2.S-Low platelet count. 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.

The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 09-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced tiredness. On JUN-2021, the subject experienced fatigue. On JUN-2021, the subject experienced lack of energy. On 12-JUN-2021, the subject experienced headache. On 12-JUN-2021, the subject experienced soreness in right arm at injection site. On 12-JUN-2021, the subject experienced pain in the muscle in upper arm. On 16-JUN-2021, the subject experienced dark red blood in left eye. On 20-JUN-2021, the subject experienced slight blurred vision in left eye. On 20-JUN-2021, the subject experienced sleeping more than usual. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, dark red blood in left eye, tiredness, slight blurred vision in left eye, fatigue, lack of energy, sleeping more than usual, soreness in right arm at injection site and pain in the muscle in upper arm was not reported. This report was non-serious.

KIDNEY STONE; WEAKNESS IN BOTH LEGS, LOWER BACK AND PELVIC AREA; MORE FATIGUE/TIRED; MORE WEAKNESS; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's past medical history included right hip replacement, and concurrent conditions included hypertension, penicillin allergy, and sulfur allergy, weakness and fatigue. 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, 1 total, administered on 27-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On 2020, Laboratory data included: Arthroscopy (NR: not provided) Not reported. The patient stated that she had been experiencing more weakness and fatigue than usual since Apr-2021 three weeks after taking vaccine. Further, the patient reported that in APR-2021, the pain intensified along with the weakness in both legs, pelvic area, and lower back 2-3 weeks after vaccination. On 20-MAY-2021, she went to emergency room for kidney stone. The patient was referred to pain specialist and stated that she felt about the same and wanted her leg to work. The patient was tired and fatigued. Laboratory data included: CAT scan (NR: not provided) Kidney stone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from more fatigue/tired, weakness in both legs, lower back and pelvic area, and more weakness, and the outcome of kidney stone was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210727924-Ccovid-19 vaccine ad26.cov2.s-kidney stone. 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.