Johnson & Johnson

Immediate burning in both arms. Unable to hold a pencil to fill out card after receiving vaccine. Weakness in upper extremities. Tingling, pain and numbness in both arms, red streaks appeared on the left arm going further up on to the shoulder, the were visible and painful for about 90 mins. Sweating. Nausea. Blurred vision. Loss of consciousness. Headache behind the eyes.

Friday night at about 10ish I suddenly got a terrible migraine, shaking uncontrollably, and my body have stiff. I tried going to bed at 11pm, but couldn't fall asleep. I got up sometime around 2am and I still had all of these along with extreme nausea. Check my temperature, it was 101.4 F. Got more blankets and tried to get some sleep, but took a while due to the migraine. At 7:30am, the shaking was gone and the migraine was not as bad, but I still had a temperature of 99.1 F and nausea. After calling my boss and mother, I went back to sleep. Stayed in bed until about 1:45pm Saturday. By then, the migraine was manageable and nausea was not as bad, though still had a temperature of 99.9 F. Took a shower and took 2 pills of ibuprofen.

Fever of 100.4 Degrees F. Muscle Swelling/Inflammation throughout body. Fatigue. Vertigo/Dizziness. 3/9 (31 Hours from Vaccination time) Fatigue and inflammation exist throughout body but temperature has normalized to 98.5 Degrees F.

Patient noted weakness in both hands while finishing 15min post-observation time, felt it was abnormal. EMS onsite support provided 100mg diphenhydramine HCL (40mL) PO. Patient/EMS contacted provider, who recommended he be evaluated at ER. Patient was transported to ER for evaluation. Upon following up with local hospital, P.A. noted symptoms did not reflect a vaccine reaction in her opinion and patient was discharged. Patient stopped by several days later to pick up vaccine card and noted was much recovered.

vaccine reaction. Recieved Jansen COVAX Monday, since has had bodyaches, HA, "feels foggy", runny nose. requesting quarters to rest. 26 yo M, no known chronic medical conditions, p/w malaise, frontal HA, myalgias, mildly runny nose, occasional dry cough that started 12h after receiving J&J COVID vaccine on Monday. No changes to sx since initial onset. Came to ED for quarters. No SOB, CP, LH, n/v/d, abd pain, dysuria, hematuria, or any other sx.

about 6 hours after injection, i started getting chills and extreme fatigue. this lasted throughout the night with mild fever peaking at 100.8 F. muscle aches, fatigue, and persistent dizziness continued the following day. most symptoms resolved by the 36hr point.

Janssen COVID-19 Vaccine EUA Muscle pain from lower back down. Lasted 24 hours. Started 7-8 hours after shot. Hurt to walk and sit. Chills. Started 7-8 hours after shot. Lasted 3 hours. Headache. Started 7-8 hours after shot. Headache still going strong 3 days later. Arm pain. Started right away and is still painful after 3 days. Tiredness. Started 7-8 hours after shot. Lasted 2 days.

Headache, high fever, fast heartbeat, fatigue, muscle soreness in legs and elbows, dizziness, inability to sleep

Worst chills I?ve ever had during first night. Muscle soreness at injection site. Fever. Fatigue. Slight cough and tight lungs.

Chills and overheating, exhaustion, muscles aches, headaches. It began 7 hours after the shot, rendering me bedridden, and continued until I woke up the next morning.

Muscle pain, headache, chills, and fatigue. Started at 10am on Friday morning, lasted all through Friday, and by Saturday morning I felt back to normal.

Starting about 8 hours after the shot and for about 12 hours thereafter: fever, insomnia, fatigue, mild delirium, and aches/soreness. One instance of vomiting during this period. Symptoms gradually lessened after about 12 hours (around 8:30 am on April 2), and by that evening, or about 24 hours after onset, were entirely gone except for fatigue, which was itself gone by the morning of April 3.

patient presented with Covid vaccination related complications. Onset sx around 2-3 pm yesterday after J&J strain given. One dose. Pt noticeably very nervous, admits blurred vision and lower lumbar/spine feelin on "fire".

Patient came in for vaccine. After vaccination, I had patient sit in a chair in case of any adverse reactions. About 5 minutes after vaccination, another patient came over and said that was not feeling well. When going out to patient I noticed he was very pale and sweating. The patient then proceeded to pass out. I was able to hold the patients head and the other customer was able to hold his shoulders to make sure he did not fall out of the chair. The patient then got very stiff and proceeded to push back in his chair, after about 10 seconds he relaxed. The patient was passed out for about 3 mins, during that time I was able to remove his mask and hold his head. After gaining consciousness, I was able to make sure he was ok. We were able to give him some water and he stated he felt better. I asked the patient to stay for another half hour to monitor. After giving the patient another bottle of water, and having him sit he was able to get up and leave.

12 hours after receiving injection, was asleep and awoken with whole body shaking severely. Temperature was 102F, smashing headache, join pain in armpits, elbows, knees, lower back, right side of neck very sore. Very nauseous. Symptoms lasted for 6-8 hours after onset. Lethargy for 24 hour period following first symptoms

Main adverse event being that starting with injection I have had shoulder pain at injection sight. I can not lift my are up past 90 degrees without pain and discomfort. as of right now that pain has been constant. 12 hours after injection started having a low grade fever, fever went away 6 hours after it started.

Only minor chills before bed, 11pm. Muscle aches, felt as tightness in IT bands, made remaining asleep difficult. Got up to use the bathroom around 5am. Upon finishing peeing while standing, I lost consciousness, falling. As a result of the fall, I fractured my cheek bone, cut open my ear, later requiring three stitches, and was concussed, resulting in a loss of memory. I was nonresponsive when my fiance found me immediately following the crash, and was rushed to the hospital via ambulance. Upon arrival to the hospital, my fever was found to be 102 F. As a result of the fall, I have a cheek bone fracture, three stiches in my ear, and a concussion.

Terrible chills, fever of 101, extreme fatigue, significant joint pain, splitting headache and nausea and inability to sleep peacefully for 36 hours

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

Patient passed out after sitting about 5 minutes after the vaccine. He went stiff and out for less than 30 to 45 seconds. He came to and was alert and talking. EMTs arrived and he passed out again and started vomiting. They did take him in the ambulance.

I took the vaccine around 4pm in 9th of April, it was ok that day , then i slept at 12am and i woke up shaking after 3 hours having sever chills and fever , after that the other day i had really bad fever and muscle pain , the severity was 8/10 , I couldn?t do anything that day .. but the interesting thing that i have CIA and it?s under control by taking loratidine everyday , but since i took the vaccine my rashes flared up , i got lip swelling, rashes all over my body regardless of taking loratidine as usual , and it?s getting worse at night time now since i took the vaccine.

SEVERE BACK PAIN; This spontaneous report received from a consumer concerned a 26 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 29-APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 2021, the subject experienced severe back pain. The action taken with covid-19 vaccine was not applicable. The outcome of severe back pain was not reported. This report was non-serious.

HANDS WERE FREEZING; SORE BODY; HEADACHE; FEVER; PAIN IN THE MUSCLES; This spontaneous report received from a patient concerned a 26 year old male. The patient's weight, height, and medical history were not reported. The patient was previously treated with quetiapine fumarate. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203AZ1(A/I), and expiry: 23-JUN-2021) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAY-2021, the subject experienced hands were freezing. On 12-MAY-2021, the subject experienced sore body. On 12-MAY-2021, the subject experienced headache. On 12-MAY-2021, the subject experienced fever. On 12-MAY-2021, the subject experienced pain in the muscles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hands were freezing on 12-MAY-2021, and had not recovered from headache, fever, pain in the muscles, and sore body. This report was non-serious.

2:01P PT RECEIVED VACCINE. 2:02P PT MOVED TO LOBBY AND SAT AT BP MACHINE. STATED HE FELT DIZZY AND LOST CONSCIOUSNESS AND FELL TO THE FLOOR. REGAINED CONSCIOUSNESS BY 2:04P ASKING WHAT HAPPENED, STATED HIS WRIST HURTS. ACKNOWLEDGED HE ALWAYS FAINTS WITH VACCINES/NEEDLES. BY 2:08PM PT REPORTED FEELING BACK TO BASELINE BESIDES HIS WRIST. EMS ARRIVED BY 2:18PM. WHEN GETTING HIM TO SIT UP HE FELT DIZZY AGAIN AND LIED BACK DOWN. WAS ABLE TO SIT THEN STAND BY 2:25PM. DUE TO THE DIZZINESS AND FAINT FEELING LASTING GREATER THAN 10 MINS, EMS RECOMMENDED AMBULENCE TRANSPORT TO HOSPITAL. PATIENT REFUSED STATING HE FELT EXACTLY AS HE HAD IN THE PAST WHEN HE HAD FAINTED PREVIOUSLY FROM VACCINES. NO REDNESS/ITCHING/SWELLING/PAIN AT SITE OF INJECTION. DECLINED TRANSPORTATION TO HOSPITAL. ONLY COMPLAINT WAS WRIST PAIN WHICH WAS A RESULT OF FALLING.

BACK PAIN; PAIN IN BOTH LEGS; BODY PAIN; ANXIOUS; This spontaneous report received from a patient concerned a 26 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and cigarette smoker. The patient experienced drug allergy when treated with codeine. 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 14-MAY-2021 16:00 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced anxious. On 14-MAY-2021, the subject experienced body pain. On 15-MAY-2021, the subject experienced back pain. On 15-MAY-2021, the subject experienced pain in both legs. 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 body pain, pain in both legs, and back pain, and the outcome of anxious was not reported. This report was non-serious.

Regular symptoms from the shot, EXTREME back pain (lower) headache, felt cold and exhausted, on first day. The second day I had blurry vision and all those symptoms so I went to doctor. They said I was having a reaction and also gave me Toradol for the back pain. I started to feel better symptom wise but the following day I started to poop blood. That only happened for one day then went away after a day. But I?ve had one or two more bloody stools since then. The ER said that it?s likely from the Toradol but to keep an eye on it. I have had 2 episodes since but it?s been random. Haven?t taken any more ibuprofen at all, was told to take omeprazole for a month and see how my body recovers

Night of I got the regular fever and chills. I then went to sleep and woke up with a throbbing migraine and my legs were so sore I wanted to cut them off. I could barely walk they were so tight. I have now been getting bruising on my legs. I don't know if it is due to the shot though. I shaved my legs and I usually get some bruising after that. My arms have been slightly tense and sore as well. I have reasons outside of the shot to believe that it may not be the vaccine, but I thought I should report it.

Patient was seated for 10 minutes post vaccination, then suddenly turned pale and passed out. Patientas laying on floor on his stomach with seizure-like muscle contractions for a minute, then stood up abruptly. Patient was seated in chair again and reported feeling unwell, woozy and nauseous. EMS was called and evaluated patient. Patient declined further medical treatment or transport to hospital.

States 1-2 weeks after taking the Jansen vaccine he began having pain in the bilateral elbows, knees and ankles. Seen 5-28-21 given acetaminophen BID x 3 days.. 6-11-21 Ordered Ibuprofen 600mg BID x 10 days. 6-15-21 given Kenalog 40mg IM. 6-16-21: ordered Prednisone 20mg daily x 6 days.

Day of-Within 5 minutes I went unconscious. I was sweating profusely and my vision began blurring I could feel my heart rate and had haggard breathing. After I came by to I had extreme light sensitivity and nausea. After 1 week-Still experience fever, chills, muscle ache, headaches, nausea, fatigue, winded easily, and hot flashes. 2 weeks- Still experience excessive fatigue, nausea, hot flashes, persistent mild to moderate headaches with occasional overwhelming migraine, light-headed, dizzy, loss of coordination and balance. 3 weeks-Same as 2 weeks out.

7/9/21 only - Sharp excruciating neck and back muscle pain requiring pain medication (one dose of Aleve) Onset within 48 hours (beginning 7/10/21): Hives Itching Diarrhea Respiratory/chest pain Difficulty breathing/chest tightness Dizziness/lightheadedness Anxiety attacks High blood pressure As of 7/17/21 I presented to the emergency room 3 times with acute anxiety from difficulty breathing. Per doctors recommendation, began taking maximum dose of over-the-counter Benadryl, symptoms did not subside. On my 3rd trip to the Emergency Room I was prescribed Prednisone (40mg daily) and continue taking 75-100mg Benadryl daily when symptoms worsen to manage the discomfort and sleep.

elevated temperature of 99.3, some shivering soreness through upper back, shoulders, and neck with a bit of stiffness all mild

Nausea, body/joint aches, headache. All symptoms began approximately 7:30 PM on the same day of the vaccination and lasted approximately 24 hours. Symptoms were at their peak at approximately 12:30 AM - 3:00 AM on 3/14.

By 10 am I felt like I was hung over, by noon I had muscle aches and chills. 8am the next day I felt 70% better still back headache 2 days later 100% better

This is to the best of my ability. I took notes, but they started after my symptoms were bad. This starts at about 12:40pm. It should also be noted that I have been feeling symptoms of either mono or IBD for over a year now (I got diagnosed around the same time and it's difficult to discern what is causing my feelings of general fatigue and headaches, however I haven't experienced muscle fatigue, per se). 0-3 hours: mildly sore arm at injection site only (happened immediately) 3-5 hours: headache, slight nausea, slight muscle fatigue 5+ hours: strong headache, severe muscle fatigue, nausea, chills, fever of 102.6 Started taking notes at the time they occurred, I will note when symptoms went away. 4:38am- 102.0 fever, chills stop (However, I was buried under blankets) 9:00am- 101.6 fever, loss of appetite... muscle fatigue and headache improve but are still present 7:56pm- 100.4 fever, other symptoms remain Next day (in general) Muscle fatigue is virtually gone, fever is gone, headache is present, slight nausea (when eating anything other than small amounts of white rice) and loss of appetite still remain

104.5 degree fever, chills and shaking, all started suddenly 7 hours after vaccination (around 10pm on 3/26). Fever was attenuated with extra strength Tylenol. Fever came back the following day with a max temperature of 101.5 (1pm on 3/27). Took Tylenol again and the temperature returned to normal (99.1). Temperature rose to 100.2 the following day (2pm on 3/28) and returned to normal (98.6) after Tylenol. Throughout all of these events, there was stiffness in the upper arm where the vaccine was injected.

Chest pains and shortness of breath started within an hour from vaccination. 3 hours after shot dizziness and chills began. The following day symptoms progressed and lasted all day. Severe dizziness, blurred vision, muscle aches, headaches, chills , shortness of breath, chest pains, sore throat, cough, fatigue, fever(up to 102.5).

Woke up at 12:00am today with headache, lots of discomfort (especially in stomach), and for the most part could only fall back asleep for short intervals while being awake most of the night. At around 2:30am, could barely walk into the front room. Just very slowly and painfully. Ended up in such a state that I absentmindedly urinated onnthe bathroom floor while pulling pant leg up to scratch an itch while urinating in toilet. Laying on back caused butt and thighs to hurt significantly more. Same for stomach. Getting up from and laying down on my floor mattress was and still is difficult. Later into the morning at around 6:40am, had to crawl slowly on hands and knees to get back in the front room. By around 8am, I could walk around without it being unbearable. Just slow-ish. Ate breakfast, so stomach is more uncomfortable than in pain. Can lay on it without too much problem, but butt is still hurting. Stretching legs forward caused some pain. Possible fever.

Muscle soreness at site and throughout body particular in opposite shoulder, neck, lower back, buttocks, hamstrings, and feet. Chills but no fever. Temperature taken twice was ~98 degrees Fahrenheit. General fatigue and lethargy.

Client seen face down on floor. At first, client seemed like he could be convulsing so 911 was called immediately. 2 PHNs and one safety officer came to be with the client and assess. Client suddenly woke up after being on the ground for approximately 5-10 seconds. Client was awake and able to talk. Client?s legs were elevated on a chair. Per safety officer, client hit left forehead on ground. Dr. came over to assess the client. Vital signs taken. BP=152/71, HR=72, 99=O2. Client explained that he had yogurt and honey along with coffee that morning for breakfast. Client explained that he has feeling lightheaded at first when walking back to observation area, he sat down, and then he suddenly woke up on the ground. Client did not want offered ice pack for his forehead. Dr. gave the OK to cancel EMS after assessment of client. Client given juice, fruit strips, and water. Client moved carefully to chair with armrests and seen sitting with roommate, which he came to the clinic with. Rechecked client again around 1045. BP=127/79, HR=68, and O2=98%. Client said his head was feeling OK, but neck felt like it was tweaked but said a hot shower would likely help. Client said he did not need an ice pack. Dr. reassessed the client saying he was good to go. Before client left, he was given additional fruit strips and juice. Client walked out of clinic with roommate.

Started getting muscle soreness 8 hours after injection, which got worse and worse for 3 hours, then slowly subsided. Got chills 10 hours after injection, which subsided within 5 hours. Had a fever 12 hours after injection, slept it off. Headache after waking up next day

Side effects started at 630pm same day of vaccine Started with muscle aches, then severe chills and fever of 101°F. At 5am the following day a fainting spell occured after awakening in severe hot flash with fever of 100°F. Lost consciousness for about a minute. Continued with chills and fever for about another 3 hours. Awoke next day with headache for about 2 hours then felt better and continued on normal. Treated with tylenol

4/8 4:35-4:50pm: Immediate pain in arm and slight dizziness within the 15-minute observation window. 11:30pm: Onset of uncontrollable full-body tremors (rigors) and body chills with nausea. 101 degree fever. 4/9 1:30am: Nausea worsenes, uncontrollable vomiting. Headache and body aches. Fever persists. Symptoms continue into the morning hours. 4:00pm: At this point the fever subsides but headache and joint pain remain. Major fatigue sets in. This continues into the night. 4/10: Headache and body aches for most of the day. Fatigue persists. 4/11 (today): Feeling better but still fatigued.

Diziness, Sweating, Visual disturbance, Heavy arm, Pale, Hearing disturbance (hearing voices), Nauseated

102 degree fever within 6 hours of getting the vaccine with sever muscle fatigue. Wasn?t feeling better for 3 days.

1 pill of acetaminophen was taken around 5 PM for arm and lower back soreness. Shivering, chills, radiating pain behind eyes started around 11 PM. Patient was kept warm and rested. May have developed fever throughout the night. Was given acetaminophen around 3 AM for headache. Adverse symptoms had ceased. Patient is now fatigued.

Sore arm around injection site that has spread into the shoulder. Started shortly after receiving vaccine and is still persistent Itchy around injection site, started 1 day after and is still persistent General Fatigue lasted for the day of and the next day. Nausea and sweating started 10 minutes after injection that lasted about 2 minutes.

Around 6 pm the same day I received the J&J shot I started to feel chilly and a little nausea. I went for a walk for about 40 mins started to feel worse. I had body aches throughout my back and chest and in both arms, was freezing. Tried to eat dinner but couldn?t, too much pain and increased nausea. Tried to lay down, but began having a fast heartbeat and fast/some difficulty breathing. The pain in my chest was the worst pain I?ve ever felt. Continued feeling horrible with a fever of 100.7, nausea, headache pains throughout chest back and arms, freezing, and my arms and legs felt like they were becoming numb. Could not stand, very dizzy, tried to sleep through it. I threw up around 11 and did so a couple more times after that. Was finally able to sleep and woke up feeling much better. Arm is still sore at the injection point.

04/08 15min after injection, got breath difficulty that lasts for 1hr 04/09 Intense fatigue, muscle ache and dizziness whole day 04/10 Symptoms cease to exist 04/12 Early in the morning: Left arm and hand numbness with ache , head numbness; Noon: getting better; Evening: left leg and feet numbness, face and head numbness; Night: head numbness and nausea, left arm and hand numbness 04/13 Head numbness, left arm and hand numbness, left leg numbness

Chills, Muscle aches throughout my body, Elevated Heartrate (~115bpm while laying down trying to sleep-recorded on fitbit), could not sleep due to symptoms persisting through the night. Took tylenol in the morning and symptoms faded soon after. Took another dose of tylenol in the afternoon when symptoms seemed to be returning. Symptoms did not return afterwards

as per my PCP, tendinitis in left upper arm due to the vaccine. Currently undergoing anti-inflammatory naproxen for two weeks and will see how it is after.

Patient presents with chills and nausea without vomiting x 0230. Patient received J&J vaccine yesterday at 1630. Reports he took Tylenol at 0230. Patient also reports feeling achy to back but believes because he had ACFT yesterday.

Systemic: Dizziness / Lightheadness-Mild, Systemic: other-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Mild, Additional Details: Transient lasting about 10 minutes then was able to leave on his own

Janssen COVID-19 Vaccine EUA: patient presents to clinic with shoulder pain that started when vaccine administered. Patient reports the immunization hurt a lot more than it usually does when patient receives a vaccine. The following day arm and shoulder continued to hurt. After a few days the muscle became less painful but the pain in the shoulder continued and was deeper as if it was in the shoulder joint itself. Over five weeks later the pain is still sharp within the shoulder with reaching up or across. Patient reports no pain without movement. No numbness, tingling, redness, swelling, bruising, fever, chills, recent injury, or weakness documented. Ibuprofen was not helpful. Patient administered steroid injection during visit and follow-up with physical therapy arranged. Patient reports mild pain relief after injection.

After like two weeks, before going to bed, I started having SOB and then a full-on chaotic panic attack. Chest pain, stomach was visually twisted and hurt, felt like I had a knot in my throat and full on anxiety. It took about a week for it to start going away after one Urgent Care visit, two ER visits, and a PC visit who prescribed me with clonazepan and Prozac. When I took both of them two weeks later, my symptoms and pain finally got better, but I am still having SOB, a little fatigue, my joints hurt once in a while, digestive problems, weird chest feeling. At least the heart pains went away.

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

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

Patient called pharmacy on 07/06/2021 around 550 pm to report that he is experiencing side effects from the Janssen shot he recieved on 07/03/2021. He said he started to experience side effects the following day after shot (7/4/2021 - specific time unknown) and they have not improved. He said he is experiencing muscle pain and muscle spasms in his neck, back and arms. Also experiencing shortness of breath, nausea and chest pain. I instructed patient to seek immediate medical care. He said he was going to go to ER.

An extreme fever that hit 103 and lasted for about 24 hours after my vaccine. I had full body muscle pains for about 2 days and strange pains in the left side of my body, and left femoral artery felt clogged for several days after vaccine. Even 2 weeks after the vaccine I am breaking into sweats very easily

Muscle pain for several days after then stomach problems(not diagnosed gas problem) since culminating in my trip to the ER and immediate surgery to remove my gallbladder on June 29. Stomach problems are not fully resolved as of yet.

6/25/21 Received vaccine. 6/26/21 Started feeling sick, unwell. Patient stated he almost fell over. EMT's at game stated it was because his immune system was working in overdrive trying to create immunity to pneumovax and Covid. On 6/27/21 in am, Patient went to hospital because his shoulder hurt. He was given some medication cocktail by hospital and went home same day. On 6/27/21 in pm the redness in his arm started and got worse and he started sweating really bad. On 6/28/21 He started feeling better, but went to the clinic due to the rash. They gave him cephalexin 500 mg 1tid, but he only took it once or twice a day and didn't finish the course. MD drew a line around rash and told him if rash expands beyond line, to come back in due to possible blood clot. On 6/29/21 patient stated he felt better. 7/9/21 Patient states he has recovered.

No more than 60 seconds or so after vaccine was administered, patient stopped responding verbally then his head tilted backwards (seemed to be vasovagal response). Held patient's head upright so that he did not hit his head on wall and applied ice pack to the back of his neck. Patient twitched, sneezed, then muscles tensed and then relaxed. He came to not 45 seconds after initially losing consciousness. Patient was very pale and sweaty. He asked for water and sat for 5 minutes or so. Patient said he was then feeling a bit lightheaded so we gave some orange juice. 5 more minutes passed and he said he was feeling much better. Patient described feeling very dizzy and not being able to hear clearly before losing consciousness

Began with weakness in extremities around 7:00PM. By 9:00 PM lost feeling in legs. This lasted for about 12 hours to one day.

About two weeks after the shot I started noticing the following symptoms: Dizziness/lightheadedness, brain fog, loss of balance, ears ringing, pressure behind the top my nose, neck pain/tightness running up to my head, nausea,

Muscle aches in armpits began a few hours after receiving the dose. Within 8 hours of dose, a mild fever and chills began (around 100 degrees F). I attempted to take a bath to soothe aches but it did not help, and instead tried to go to sleep at 8:30 pm. A slight red rash appeared on chest and arms around this time. I was woken up at 10:30 pm feeling disoriented and hot, with a fever of 104.5 degrees F. My wife noticed slurring of words and that I seemed unstable and confused, and symptoms were severe enough we considered going to the emergency room. I experienced ringing in my ears and a severe headache. I took 2 extra strength Tylenol, put a cold cloth on forehead, and drank fluids to fall back asleep. Fever dropped to around 102 but continued throughout the night. I woke up at 6:30 am and took two more Tylenol. The severe headache continued and I vomited twice. I attempted to take a shower and rinse off, and continue to rest. Fever is reduced to 99 degrees F with help of Tylenol.

Frequent urination Insomnia ( unrelated to frequent urination) Feelings of severe dehydration Muscle ache Headache

Cold chills, shivering, muscle & body soreness, chest congestion, coughing, migraine, sweating, fever, exhaustion.. Treatment: water and pedialyte. Time course: several hours into the next morning

Muscle weakness, dizziness, nausea and vomiting beginning 7 hours after administration and continuing to occur 36 hours later at the time this form is completed.

At 10 pm I started to experience some moderate body aches. By 1 am, I was in so much pain I could not sleep and started to develop a fever. I drank a ton of fluids, used OTC treatments (Ibuprofen and Motrin) but nothing alleviated the pain. By 10 am I had a sustained fever over 100 degrees. I was in so much pain I was crying in bed. By 3 pm my fever reached 102 degrees. I had to go to the emergency room for IV drip and medication because I couldn't drink enough water to stay hydrated. Once given IV, my temperature plummeted. When the medication they administered wore off, my body started experiencing mild to moderate pains again. Body aches and soreness all over- my muscles feel like they are being squeezed from the inside. I am still feeling a lot of fatigue and pain but it is random and comes and goes along with "hot flashes".

03/30/21 09:35 AM - Vaccine administrated 05:00 PM - Uncontrollable shaking/shivering and dizzy 06:00 PM - Uncontrollable shaking/shivering, very dizzy, fever of 101 07:00 PM - Uncontrollable shaking/shivering, less dizzy but still, fever 102.5 08:00 PM - Shaking stopped, dizziness stopped, chills started, fever 103.5, nausea, very sore muscles in legs and lower back 09:00 PM - Chills, fever 103.9, worse nausea and vomited once, very sore muscles in legs and lower back, headache begins 03/31/21 08:00 AM - Chills gone, fever 101, nausea worse, headache much worse, sore muscles in legs and lower back 10:00 AM - Fever 101, nausea and vomiting, headache very bad, sore muscles in legs and lower back 10:30 AM - Took Imitrex (sumatriptan succinate) for the headache and fell asleep 2:00 PM - Fever gone, nausea and vomiting better, headache better, back and legs muscles feel better, arm soreness starts 04/01/21 - Light headache persists and arm soreness. All other side effects subsided.

TIREDNESS; MUSCLE ACHES; SORE THROAT; NASAL CONGESTION; CHEST CONGESTION; BODY ACHES; MILD FEVER OF 99.3; HEADACHE; This spontaneous report received from a patient concerned a 28 year old male. The patient's weight was 160 pounds, and height was 180.34 centimeters. The patient's pre-existing medical conditions included the patient had no allergies and no family history of disease relevant to vaccination. the patient had no illness at the time of vaccination or no history of similar event. the patient had no adverse event after any previous vaccinations. the patient reported to have no pre-existing acute illness 30 days prior to vaccination and no history of hospitalization in last 30 days. 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-MAR-2021 at right 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 sore throat. On MAR-2021, the subject experienced nasal congestion. On MAR-2021, the subject experienced chest congestion. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced mild fever of 99.3. On MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 99.3 F. On 08-MAR-2021, the subject experienced tiredness. On 08-MAR-2021, the subject experienced muscle aches. On 19-MAR-2021, Laboratory data included: COVID-19 antigen test (NR: not provided) Positive, and COVID-19 molecular test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tiredness, and muscle aches, and the outcome of sore throat, headache, mild fever of 99.3, nasal congestion, chest congestion and body aches was not reported. This report was non-serious. This case was associated with product quality complaint number : 90000173743 The suspected product quality complaint has been confirmed to be void (confirmed no pqc was identified within the reported complaint reported) based on the PQC evaluation/investigation performed.; Sender's Comments: V2: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.

Immediately after shot I felt a slightly elevated heart beat and 5 minutes later I blacked out and tensed up according to a witness. My back was also sore from whatever happened while unconscious. I never had an adverse effect with a vaccine before. After I came around I felt tingling in my arms and hands for 5-10 minutes. Back pain subsided shortly after. No other side effects

Patient received Janssen Covid-19 vaccination today at approximately 6:20pm. At 6:35, he said he had left arm weakness (arm he received vaccine in), fatigue, was dizzy, and felt "off". Patient did not lose consciousness and refused an ice pack. BP checked at 6:38pm (170/98, pulse 105). Patient stated his blood pressure usually runs high. I offered him an ice pack a second time, but he said there was no need and he felt better. BP checked again 6:52pm (152/101, pulse 99). I recommended that since his blood pressure is usually this high, he should follow up with his primary doctor regarding blood pressure as he may need some medication to assist in lowering it. He said ok. He left the pharmacy area at 7:02pm and said he was fine to leave, he did not want to remain any longer.

Nausea , diahrea , fatigue , muscle fatigue , high fever , extreme back ache in lower back caused me to collapse to the ground when walking . Could not get up. Had to have help to get up lost all ability to move . Sick for a week extremely bad did not go to work could not afford to go to dr I don?t have insurance . I am still weak and not well .

Approximately 7 hours after the shot, Patient started shaking, mild shakes at first but then the shaking became more violent, I helped him lay down in bed as he was not able to control the shaking and his legs became stiff. I was monitoring his temperature and he did not have a fever. I was massaging his hands and legs, this went on for 45 minutes to 1 hour. When the shaking subsided, the fever started, at this point I gave him Tylenol and continued to monitor his temperature. He is better this morning.

I (the patient) experienced severe symptoms about 10 hours after receiving the vaccine. The serious symptoms lasted for 24 hours after receiving the vaccine: Serious Symptoms: -Intense Chills/Hot flashes -Rapid heart rate (90bpm) -Difficulty breathing -Joint and muscle pain -Headache -Nausea/Diarhea -Dizziness -Unable to sleep Moderate symptoms lasted for 48hrs after receiving the vaccine: -headache -Muscle and Joint pain -Chills

Severe chills which result in violent shivering, On-and-off fever, severe joint and muscle pain, headache, hives on left side of face, tenderness at injection site, sleeplessness (though that could also be a result of not being able to sleep due to the symptoms I'm experiencing)

Extremely high fever; slight hallucinations Unable to get out of bed Severe shaking Severe pain in muscles and bones, unable to walk Severe migraine

- Fever for approximately 6 hours - Chills, headache, fatigue, nausea, loss of appetite, muscle aches for 24 hours - Soreness at site of injection for 72 hours

Headache, fever 104 degrees, body and joint aches & pain. Nausea, Chills, diarrhea, painful urination, throat swelling, light touching of torso is very painful.

These may be symptoms of the vaccine- and I'm not sure this is necessarily considered an AE (I am filling this form myself)- but I believed it to be relevant data: -Severe Nausea -Fever of 101 F -Severe chills/shivering -Extreme Fatigue: muscle stiffness/soreness left me bed ridden for 16-24 hours and time off work -High resting heart rate (normally 45-55- RHR of 68 on night after vaccine) -Soreness in arm

These were the symptoms I was feeling: - Arm pain - Chills - Fever - Headache - Muscle Spasms - Rigidity - Facial Numbness - Chest Pain Treatment: - Went to emergency room after facial numbness and chest pain. Muscles in both arms were extremely tight and no control of my fingers as it was painful to extend them beyond a fist. Could barely walk and stand for more than 20 seconds as well. - Took tylenol and benadryl before going to hospital but had little to no effect. - Arrived at the hospital at 9:30 with severe pain throughout my body and the effects subsided by 12:30am.

In case of starting the vaccination at 11:45am it went fine and once again I have have no medicine allergies. My adverse effects were the following throwing up, pain in the upper Portion of my neck and slight pain in my chest , and fever with chills grandually getting worse throughout the day. By 9:00pm - midnight I couldn?t even sleep or close my eyes to sleep because the pain was unbarring that I had to call my family for mental support. I eventually fell asleep because of exhaustion, and Sunday I couldn?t even get out of bed my body was so worn out from the shot and the night. I stayed home all day and slept . I still have pains in my neck and coughing becomes my issue.

First night (Day 1): severe chills, headache, arm & shoulder pain, nausea (Day 2) First day after vaccine (took one Advil the night before): extreme fatigue, arm pain, mild headache Days 3-5: headache, fatigue, heartburn, mild stomach pain Days 5-7: severe abdominal pain, headache, gas & bloating, mild diarrhoea, nausea Day 7-9 (current): headache (very mild but continuous non-stop / does not feel like a common headache), mild drowsiness (feel like I am a little dizzy BUT WITHOUT actually being dizzy or feeling like I will loose my balance or anything similar), mild chills (after having some cold cereal for instance)

RAPID HEART RATE FOR 6-8HRS; DIFFICULTY BREATHING; HOT FLASHES; MUSCLE AND JOINT PAIN; UNABLE TO SLEEP; DIZZINESS; DIARRHEA; INTENSE CHILLS; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a 28 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced rapid heart rate for 6-8hrs. On 2021, the subject experienced difficulty breathing. On 2021, the subject experienced hot flashes. On 2021, the subject experienced muscle and joint pain. On 2021, the subject experienced unable to sleep. On 2021, the subject experienced dizziness. On 2021, the subject experienced diarrhea. On 2021, the subject experienced intense chills. On 2021, the subject experienced nausea. On 2021, the subject experienced headache. Laboratory data included: Heart rate (NR: not provided) 90bpm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rapid heart rate for 6-8hrs, difficulty breathing, hot flashes, muscle and joint pain, unable to sleep, dizziness, diarrhea, intense chills, nausea, and headache on 2021. This report was non-serious.

Fever, chills, fatigue, muscle aches, headache, a little sore at injection point on arm. No medication taken. Took approximately 36 hours for adverse effects to subside.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: pt experienced syncopal episode in store, resolved and left after 30 minute stay

Fever, headache, full body aches, muscle and joint. Onset 12 hours post-vaccination. Lasted approximately 12 hours. Took 2 Advil to alleviate symptoms.

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

A few hours after vaccination the fever started and muscle aches/chills also began. Around 10:00 P.M., pain in the right calf started and light pain in the left side of the chest with shortness of breath. Patient went to the ER and was hospitalized for 1 day.

FAST HEARTBEAT; FEELING FAINT; TWITCHING IN INJECTION SITE ARM; FELT LIKE GETTING DRUNK; ARM FELT NUMB; FEELING LIKE FLUID IS GOING INTO ARM RANDOMLY; PHANTOM INJECTION SITE ARM PAIN; STUMBLED A BIT; LEGS BUCKLED; This spontaneous report received from a patient concerned a 28 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 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 fast heartbeat. On MAR-2021, the subject experienced feeling faint. On MAR-2021, the subject experienced twitching in injection site arm. On MAR-2021, the subject experienced felt like getting drunk. On MAR-2021, the subject experienced arm felt numb. On MAR-2021, the subject experienced feeling like fluid is going into arm randomly. On MAR-2021, the subject experienced phantom injection site arm pain. On MAR-2021, the subject experienced stumbled a bit. On MAR-2021, the subject experienced legs buckled. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt like getting drunk on MAR-2021, had not recovered from phantom injection site arm pain, twitching in injection site arm, fast heartbeat, legs buckled, feeling faint, and feeling like fluid is going into arm randomly, and the outcome of arm felt numb and stumbled a bit 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.

Pt present with c/c of headache, chills, and muscle aches x 5 days after getting the covid vaccine. The pt has been taking Tylenol and ibuprofen but state states it has not helped with the symptoms. Pt last took ibuprofen at approx 0900.

Rapid onset of severe back pain. Limited mobility. Treatment of chiropractic adjustments and deep tissue massages.

TIGHTNESS AND CRAMPING IN LEFT LEG AND RIGHT ARM; CONFUSED; GROGGY; TIGHTNESS AND CRAMPING IN LEFT LEG AND RIGHT ARM; TIRED; UPSET STOMACH; HEADACHE; MUSCLE ACHES; SHARP PAIN IN LEFT ARM; SORE ARM; NAUSEA; This spontaneous report received from a patient concerned a 28 year old male. The patient's weight was 205 pounds, and height was 73 inches. The patient's concurrent conditions included irritable bowel syndrome, alcohol user, cigarette smoker, and depression, and other pre-existing medical conditions included patient had no know allergy and no drug abuse or illicit drug usage. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced nausea. On 27-MAY-2021, the subject experienced sharp pain in left arm. On 27-MAY-2021, the subject experienced sore arm. On 30-MAY-2021, the subject experienced upset stomach. On 30-MAY-2021, the subject experienced headache. On 30-MAY-2021, the subject experienced muscle aches. On 31-MAY-2021, the subject experienced tightness and cramping in left leg and right arm. On 31-MAY-2021, the subject experienced confused. On 31-MAY-2021, the subject experienced groggy. On 31-MAY-2021, the subject experienced tightness and cramping in left leg and right arm. On 31-MAY-2021, the subject experienced tired. Treatment medications (dates unspecified) included: calcium chloride/glucose/magnesium chloride/potassium chloride/sodium chloride/sodium lactate, and ondansetron. The action taken with covid-19 vaccine was not applicable. The patient recovered from sharp pain in left arm on 27-MAY-2021, had not recovered from sore arm, upset stomach, headache, muscle aches, tightness and cramping in left leg and right arm, tired, confused, groggy, and tightness and cramping in left leg and right arm, and the outcome of nausea was not reported. This report was non-serious.

Patient was overwhelmingly nervous about needles. After injection, he felt faint, he became unresponsive, his head fell back and he was sliding down the chair. In moments he came to, and wanted to lie on floor, we moved him to the floor. Paramedics were called. He was pale and sweating on the floor. He stated his neck was stiff and face was tingling. Paramedics came and evaluated him. The patient chose not to go to the hospital. This was approximately over a 30 minute period.

ANKLES SWELLING; ANKLES REDNESS; IN PAIN AND HURTS TO WALK; This spontaneous report received from a consumer concerned a 28 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 05-JUN-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced in pain and hurts to walk. On 05-JUN-2021, the subject experienced ankles swelling. On 05-JUN-2021, the subject experienced ankles redness. 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 ankles swelling, and ankles redness, and the outcome of in pain and hurts to walk was not reported. This report was non-serious.

Client reports immediately after getting does that his left arm from the injection site down feels "heavy". At 4:04PM Vitals are taken by PHNs pulse 77, blood pressure: 130/80 and oxygen: 97%, . Client reports sensory and motor are intact. No other symptoms reported. At 4:06pm client reports arm is feeling better. At 4:09PM oxygen is 98%, pulse: 72 and blood pressure 122/86 and still feeling heaviness in arm. At 4:14pm, client reports that arm sensation of "heaviness" has resolved. Oxygen: 99%, pulse:76 and blood pressure: 122/82. At 4:19pm vitals oxygen:98%, pulse:77 and blood pressure 110/88 no symptoms at this time. At 4:24pm no symptoms reported and vitals: oxygen:98%, pulse:76 and blood pressure:120/82. At 4:30pm PHN gave ER precautions. oxygen 98%, pulse: 79 and blood pressure: 128/90. Client reports he has no primary care provider and will be returning to his country tonight. No symptoms reported. At 4:33pm last set of vitals: blood pressure:120/86, pulse:79 and oxygen 99%. Client left the facility unassisted at 4:35pm.

Shivering even when it was really warm Sensitive skin to touch Sweating profusely I went from freezing to overheating out of nowhere Puking Dizziness Pounding headache in back of head for about 10 hours Body aches muscular Felt like my hip bones up my spine and neck were hurting I finally was able to take exedrin and after an hour I was able to relax a little. Enough to fall asleep for a couple hours. 2 hours after I got the shot I started feeling effects. I didn?t sleep until 0400 in the morning because I was in so much pain. Today I have a headache and my body is sore but I feel a lot better. If I didn?t live so far away from my friends or coworkers I would have gone to the hospital. I was too weak and sick to use my phone.

Chills (Intermittent) Fever (Intermittent) Loss of Appetite (Constant) Dehydration (Intermittent) Muscle Ache (Intermittent) Coughing (Rarely) Lethargy (Constant) Symptoms began occurring 2 hours after receiving the vaccine and have yet to subside. No further medical treatment has been provided.

Shortness of breath, chest tightness, pain in shoulder, neck, and lower back. Symptoms started on 6/22/2021. Went to ER on 6/24/2021. Diagnosed with pulmonary embolism (multiple clot in left lung). Labs and imagining done, now on medication.

Pt. states received vaccine 05/01/2021 shortly after 05/06/2021 started experiencing symptoms of fever, muscle/joint pain, pressure headaches, dizziness, fatigue, and nauseous. No physician's visit noted. Still experiencing symptoms on/off. Plans to visit a local physician if symptoms persist.

Janssen COVID-19 Vaccine EUA Bruising and soreness around injection site, low-grade fever (~100.25 degrees Fahrenheit), muscle aches mostly along posterior chain from shoulders/neck to legs, sleeplessness, mild headache behind eyes. Symptoms first appeared approximately 12 hours after injection. Patient self-treated with 400 mg of Ibuprofen at approximately 9:00 AM on 7/8/21, roughly 19 hours after injection. Symptoms were minimized.

Light headedness, fever, muscle aches, headache. Began approximately 12 hours after dose was administered. Prevented returning to work or any strenuous physical activity?have not waned noticeably now 34 hours after vaccination.

Patient felt hot, fainted, and fell out of chair. He regained consciousness and was helped up while EMS arrived. The patient was assessed and given water and a snack. He informed the pharmacist on duty that his neck and head were a little sore from the fall but that he was feeling better.. After speaking to EMS he stayed for about 20 minutes then left.

Pretty quickly after the shot (that evening) I felt a tingling/prickling in my finger tips and I swore down in my toes. I developed a few sickness symptoms the next day but definitely felt much better about 48 hours later. What I really want to say now is that I still feel like I notice very minor tingling in my fingers (mainly left arm) but sometimes down in legs or right forearm. Additionally, my upper left arm where the injection was sometimes feels stiff or strange. It isn't pain, but its more like a nuisance.

Chills woke me up at 5am, kept me up for at least an hour. Headache, pain in eyes, fever continued through the day. Muscle pain in back significantly worse than previous days

Muscle soreness and fatigue. Starting at around 6:00 last night and continuing into today. Took Tylenol to reduce pain and soreness.

First three days 102 fever, legs were in so much pain I could not walk or get up. The fourth and fifth day my lips and face would become tingly/numb and my left arm would get weak and I would feel a little disoriented, my sleep has been pretty disturbed. It felt like I was having a stroke. I did not have a stroke, I continue to occasionally feel the above symptoms, a little less potent than they were, they might be going away, I can't tell. I will be calling my doctor if it continues.

At 6:00 PM 3/12 I began to feel slightly dizzy. It did not effect my ability to stand or move around very much, but my head did feel strange and if I turned to quickly I would need a second to gather myself. However, it was not severe enough to force me to sit or lay down. By 7:00-7:30 I began to feel hot and uncomfortable and I took my temperature at 7:30 and I was running a low grade fever at 99.8 degrees F. I began to feel very fatigued and was in bed by 9:00 PM. I woke up feeling fine and my temperature at 7:00 AM 3/13 is 97.8 degrees F. My only possible side effect this morning (3/12 as I write this) is that I am mildly stiff, mostly in my left arm, neck, and back (the side of the injection site). Despite the mild fever I did not feel any nausea, nor did I have difficulty breathing. Overall the side effects were mild but uncomfortable.

At 9pm (3-13) I began feeling sore and cold with some shivering. Couldn't get warm in bed, continued to shake harder. Slept until 11:15pm and woke up to violent shivering, pounding headache, full body aches, sore skin, achey joints, nausea, swelling tongue and throat. Took 1 dose of nyquil and then tossed and turned all night, very little sleep, symptoms persisted into the next day, but shivering stopped in the night. By morning (3-14) registered a fever of 100.3 which persisted most of the day along with remaining lessening symptoms. By evening I was still very sore, bad headache, and very lethargic/fatigued. Next morning (3-15) low temp of 97.1 degrees, headache, fatigue, lightheaded. Still feel headachy and tired.

6 hours after injection, I began feeling muscle pain and chills, 8 hours after, these symptoms worsened, 11.5 hours after I had a fever and more intense symptoms with a max recorded fever of 102°F and intense cold sweats. This lasted for about 12 hours and I woke up with a slight fever which then subsided. Later the following day I felt fine again. Essentially, when the symptoms were most intense, I felt like I did when I contracted Covid in March of 2020

I have had Pain and soreness throughout the entire left side of my body.. and very sore left side kidney area pain. the pain runs from the side up through my arm and into my neck

03/24/2021 - Mild sore throat in the evening. 03/25/2021 - Moderate sore throat, moderate fatigue and muscular pain. 03/26/2021 - Mild sore throat and mild fatigue. 03/27/2021 - Moderate sore throat, moderate fatigue and muscular pain. Low grade fever of 99.1F. 03/28/2021 - Moderate sore throat, mild ear pain, eye pain/pressure. Fever spiked to 102.4F during the night. 03/29/2021 - Severe inflammation of the right side tonsils, severe ear pain, severe eye pain/pressure, fever of 101.9F. Consulted a doctor on MD Live who felt it might still be a reaction to the vaccine and prescribed Ibuprofen 600mg to manage symptoms. 03/30/2021 - Extremely severe inflammation of the right side tonsils, severe ear pain, severe eye pain/pressure, low grade fever of 99.5F. 03/31/2021 - Symptoms same as 03/30/2021. Consulted a doctor at the local Urgent care clinic. Prescribed amoxicillin-clavulanate and predniSONE.

Janssen COVID-19 Vaccine EUA - Severe chills. - Fever symptoms. - Headache. - Muscle Ache. - Tiredness.

Fever and muscle aches, Sleeplessness related to previously stated; 800 mg ibuprofen, approximately 6 hours post beginning, symptoms appear to have passed after 12 hours.

Muscle ache, back and neck pain, fatigue and dehydration. Side effects started 10hrs after vaccine shot and lasted for around 20hrs

Woke up at 1:30 AM with sudden severe panic attack with heart rate at 160+, acute panic symtpoms including elevated heart rate & blood pressure lasted about 6 hours, ongoing anxiety throughout the next 24 hours treated with proscribed benzodiazepines. 102 degree fever without medication, 99 with steady usage of over the counter ibuprofen. Violent shaking and chills, severe muscle aches, extreme fatigue, couldn't walk up stairs without assistance. Sporadic dizzy spells, similar to the "Brain zaps" of SSRI withdrawal. Began to subside 36 hours post injection, with lingering symptoms still present 52 hours post injection.

once the person recieved the vaccine within a minute he felt dizzy, dry mouth, blurred vision, kept sweating he asked for water but he lost control of his muscle and the water spilled on his pants. We called 911, then after about 6 minutes he felt ok even before 911 arrived.

Fever, fatigue, generalized muscle soreness, loss of appetite - treatment included tylenol, rest, and hydration.

Injection: local sore left arm Injection + 1 hr : arm sore subsided Injection + 9 hr : body temperature rose to 99.8, light level of chill Injection + 10 hr: temperature rose to 100.4, light level of chill and fatigue over torso Injection + 21 hr: temperature came down to 99.5, light fatigue persisted, light level of right knee joint pain emerged Injection + 24 hr: temperature dropped to 99.1, fatigue and joint pain subsided Injection + 27 hr: temperature dropped to 98.8, no discomfort Blood pressure and pulse normal throughout

Fainted/fell unconscious in chair immediately after injection. Out for 20 seconds or so. Reportedly stiff as a board and twitchy. No significant history of fainting.

muscle aches at injection site muscle aches upper back/shoulders About 18 hours after injection 101 degree fever for approximately 4 hours General weakness/lack of energy but not extensive enough to actually hinder basic activities

Horribly severe headache. Incredible muscular pain and body aches, severe dehydration, extreme chills , and a high fever. I have never been so ill in my entire life. All of these symptom started out mild, but grew more severe into the night. The duration was about 8-9 hours.

Consumer (self) inoculated at 3:50PM at site. At 9:00PM on same day, consumer experienced onset of chills. At 10:00 PM, consumer vomited periodically until 12:00 AM. Consumer was unable to drink any liquids (water) without immediately vomiting. Chills stopped at 12:00AM. After chills stopped, consumer experienced fever, headache, fatigue, night sweats, and myalgia throughout body. Consumer did not record body temperature. At 6:30AM, consumer took two 650mg acetaminophen oral tablets for the indication of fever, headache, and myalgia. Fever stopped at 7:30AM. Headache, myalgia, fatigue are lessened but still present at time of writing (10:40 AM). Consumer was unable to sleep the entire night due to intensity of adverse events. Consumer consents to necessary follow-up via email.

All times in format HH:MM:SS after injection T+00:05:00: Heaviness, weakness in left arm. Gradually cessated over four hours. T+08:00:00: Interrupted sleep; insomnia lasting four hours; visual disturbances (flashing lights, geometric patterns). Ceased within 2 hours. T+18:00:00: Fever of ~1.5 degree F above normal; injection site reaction (soreness); weakness; fatigue; chills; all symptoms ?flu-like?. Slowly resolved over next 18 hours.

Severe headache, chills, body aches - Legs & Arms starting the evening of the vaccine. All symptoms proceeded for the first 2 days following. Chills stopped after 2nd day. Severe headache, and body aches - Legs & Arms proceeded into 3rd day. Body aches - Legs & Arms stopped after the 3rd day. The severe headache continued throughout the rest of the week 5-6 days. During days 5 & 6 I noticed new symptoms- a feeling pressure/constriction in my hands/wrists. In addition, I noticed (2) bloody stools over days 5 & 6 - 1 each day in the morning. Both symptoms seemed to have gone away after day 6. However, pressure/constriction in my hands/wrists and headaches has been noticeable intermitately since. No distinct or identified activities or food-related timing during or causing the onset of the pressure/constriction in my hands/wrists or headaches symptoms thus far.

After approximately 12 hours of receiving the vaccine shot my entire body ached. Every muscle in my body was tight, making it difficult to move. I also experienced a strong headache behind the eyes, and difficulty urinating.

I received the Janssen COVID-19 Vaccine EUA at roughly 2:15pm on Sunday 4/11/21. I waited at the vaccination site for 30 minutes and did not have any adverse effects. I went through the rest of my day without any adverse effects. I went to bed at 9:00pm. I woke up at 11:00pm with body aches and chills. I could not stop shivering. I then became very warm. I alternated between freezing/shivering and burning up all night. I felt very sore and my muscles hurt. It was primarily my upper body that hurt, not my lower body. My arms, torso, back, and neck hurt to move. I was very sensitive to everything I touched. It felt uncomfortable to touch the blankets in my bed or the water when I washed my hands. It did not hurt to do that, it just felt sensitive and uncomfortable. Around 5:00am I got a terrible headache. It felt like my head was made out of a lead ball. It hurt to move lift my head. My face hurt and felt like I had pressure. This lasted all day for Monday 4/12/21. After 5:00pm I slowly started to feel better. My body aches went away. I still had a headache, but it was far less severe. It is approximately 7:00am on 4/13/21 as I am filling this out. I still have a minor but persisting headache. My left arm is sore at the injection site. I am feeling much better than I was.

Headache: 4.5 days - current Nasal Congestion: 4.5 days - current Fatigue: 4 days Sensitive Skin: 2 days Nausea: 8 hours Muscle soreness: 1 day

Complete body/muscle lock up - Was rendered useless on hallway floor for 15 minutes while my body locked up with muscle spasms Extreme Migraine morning after - Continues to be an issue as the days go on - Not getting worse, but each day is a headache Extreme Muscle pain from left collar bone area to the left ear Minor/Medium pain behind my eyes every so often Shortness of breath at times with no strenuous activity prior

LEG PULLING; BODY ACHE; CHILLS; FEVER; This spontaneous report received from a patient concerned a 29 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) Results pending. On 09-APR-2021, the subject experienced leg pulling. On 09-APR-2021, the subject experienced body ache. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, chills, and fever on 11-APR-2021, and had not recovered from leg pulling. This report was non-serious.

I started feeling fatigue and soreness in both of my legs and arms about a 5 after the vaccine. At day 7 I started to feel sharp, cramps, tingly sensation and numbness in different parts of my legs, arms feet and hands. I also had headaches and felt dizzy. Headaches went away by day 15, but the pain, tingly sensation and fatigue in my arms and legs still remain (tomorrow it?s going to be a month since I got my shot). It gets significantly worse when I walk and I feel very fatigued after walking for about 30 minutes. The pin has also appeared less frequently on other parts of my body, like my heart, my neck and around my rib area. Over the last two weeks my legs have also been getting itchy.

On 5/19/2021: Fever of unknown temp beginning at 8pm. Fever caused inability to sleep. Fever broke around 4am. Extreme fatigue and muscle aches that caused inability to work. Began at about noon and continued through midnight. On 5/20/2021: Severe bone/joint pain in the shoulders that caused inability to sleep beginning about 9pm. Pain unmitigated by 800mg ibuprofen and topical analgesic. Minimal relief from icing the area. Pain not in the muscle. Extreme tenderness when pushing on shoulder blades. Minimal tenderness to muscle around shoulder blade. Pain subsided around 4am. Soreness and minimal pain on morning of 5/21/2021.

29-year-old male chief complaint of fevers chills body aches and back pain after Johnson & Johnson vaccine. On arrival vital signs stable. On exam patient with no meningismus no focal neurologic deficits. Suspect vaccine reaction. Counseled patient on taking supportive medications and follow up with primary care physician. Patient in agreement with plan.

Almost immediately after receiving the vaccine pt went rigid and was unresponsive. He came to within a minute. He was very panicked and stated he thought it was a dream. He was extremely pale and very sweaty. We gave him some water and an ice pack to cool down. We checked his blood pressure. He then lied down on the floor and we elevated his feet. He then stated he could not move his hands and his lips were tingly. We then gave him some liquid benadryl and continued checking his blood pressure and called EMS. They arrived and he left with them. I tried contacting him later without success. Will try again tomorrow.

Gastrointestinal issues including severe nausea, diarrhea, and loose stools. Difficulty eating due to tightness of stomach and feeling full after only a few bites. Sharp chest pains, including racing heartbeat and pressure which induces coughing. Various sharp body pains, mostly in the chest and torso. Uncontrollable shaking, and a buzzing electric feeling throughout body. Flashing in eyes when closed. Head feels heavy with constant vertigo and brain fog. Muscle spasms all over and twitching in left index finger. Insomnia due to listed issues. Nystagmus and feeling of eyes vibrating.

FEELS LIKE PULSING SENSATION AND BLOOD IS NOT CIRCULATING PROPERLY; DISCOMFORT IN ARM AND LEG; This spontaneous report received from a consumer concerned a 29 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and non -smoker, and other pre-existing medical conditions included patient has no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204AZIA, and expiry: UNKNOWN) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAY-2021, the subject experienced discomfort in arm and leg. On 07-JUN-2021, the subject experienced feels like pulsing sensation and blood is not circulating properly. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from discomfort in arm and leg, and feels like pulsing sensation and blood is not circulating properly. This report was non-serious.

Sharp pain to back and abdomen that comes in cycles without warning or trigger. Individual has difficulty getting out of bed and talking due to the pain level.

Patient was seated in the passenger seat of the car. We talked for a few minutes prior to administration and I actually administered a vaccine to the person in the driver's seat first. I walked over to give his shot and he then tells me he "doesn't do well with vaccines." He later told me he felt sick to his stomach after getting the shot and had a metallic smell similar to a bloody nose. About 1 minute after administering his vaccine, the patient's head went back, his muscles went very stiff, and he appeared to convulse. We called 9-1-1. His mom was sitting in the back seat and placed an ice cube on the back of his neck which seems to have pulled him out of it. During the episode, he reports "blacking out" without orientation to time or place. After the episode, he was dizzy and lightheaded for a few minutes. Soon there after he was jovial. I took his BP and HR about 5 minutes later BP 100/62 and HR 48. Paramedics also took vitals which were a bit higher than these. He reported having a small cereal bar for breakfast and 2 cups of coffee.

Patient said that he experienced extreme dizziness. When he stood up he had a headache and could not walk. Patient stated that his hand locked up and it was painful to move. He went to bed and when he woke up he was fine. Patient stated that this happened 44 days after taking the vaccination. Patient stated that he started this was a one time occurrence and that it happened around 8pm.

Over night and into next day. Body aches, headache, no energy, nausea, sore arm, amplification of lower back pain, discomfort.

Fever, headache, fatigue/tiredness, chills, and body aches occurred after falling asleep for the night on the day the vaccine was administered. Fever, headache, and chills were gone 24 hours after receiving the vaccine. Tiredness, fatigue, and general weakness persisted for several days. Chronic Back pain has become more intense and still present to a significant degree .

101 Deg F Fever, Sore Arm, Muscle Aches and chills. Fever, Muscle Aches and Chills lasted for roughly 24 hours from symptom onset.

Received vaccin on 3/24 3:00pm, started experiencing severe fever and chills on 3/24 from 10:00pm to 2:00am. Fever broke around 2:30am. Had fatigue, headache, and extreme body ache through 8:30 pm on 3/25. Residual full body muscle soreness and headache through 3/26 at 12pm.

Patient received vaccine and reported approximately 5 minutes later that he needed help. Within just a few seconds following him calling for help he was not able to talk and his eyes had rolled into the back of his head. His body was rigid but he did not lose consciousness. A technician called 911. He was sweating profusely so his jacket was removed and a cold rag applied to his head. He finally came to after approximately 1-2 minutes and reported that he was feeling very dizzy. His blood pressure was 118/80 and temperature was 98.5 degrees Fahrenheit. He was examined by an EMT, and they found a very similar blood pressure. Patient reported feeling much better and was fine to go home. Treatment occurred over a 15 minute window.

Shortly after, I began to feel "woozy" and a bit "out of it" mentally. Mostly fatigued but didn't limit my ability to do normal activity things. Around 10:30pm that night, I got a 100.3 degree F fever, aggressive chills, and a headache. Woke up around 11:30 and the fever had broken (due to taking a Tylenol before bed). Day after vaccine, heaviness in left arm (injection arm). General fatigue and headache. Most prevalent symptom was achy body.

03/11/2021 3:05 pm Patient observed in chair pale with stiffened body and eyes rolling on back of head. Patient initially unresponsive V/S 97.2 20,71, 96/50, O2 sat@ 98% on room air. Blood glucose monitored @ 105 mg 1d1. 911 called patient responsive to verbal and tactile stimulation. Legs elevate, patient stated that he only ate breakfast for the day water and snacks offered and consumed. BP rechecked 80/50 Legs remains elevated. Awaiting for 911 to arrive close monitored is in progress. 3:20 pm The Fire Department arrives and assesses the patient. 3:30 pm BP 110/70 Patient awake and verbally responsive. Patient lift facility with rescue via stretcher en route to the hospital.

COVID-19 Vaccine EUA Approximately 12 hours after injection woke up in middle of night with fever and chills. The next morning a moderate headache and minor muscle soreness presented. Ibuprofen reduced headache and soreness.

04/06/2021 11:30 soreness in left arm 13:00 tingling in left fingers 18:00 99.9 degrees F 20:00 101.1 F 21:00 102.1 F 22:30 101.7 F 04/07/2021 12;26 101.8 degrees F 1:34 101.5 F 9:00 99.0 F 11:00 99.0 F soreness, cramping in left calf 04/08/2021 soreness in right shoulder

Joints began feeling achy and body felt tired within a few hours of vaccination. About 10 hours later body began to feel warm and then within an hour began uncontrollable shivers and aching in testicles followed shortly after by a throbbing headache and pain behind eyeballs. I put on extra clothing and jumped into bed as symptoms persisted. Later in the night I began sweating profusely and removed the clothing. The headache and pain behind the eyes persisted. I also began feeling nauseous and almost vomited when I went to the bathroom. My body was so tired and achy I could barely move. I tried to wake up for work but my headache and pain behind the eyes was so bad I went back to bed for another four hours. I did not have any appetite for the rest of the day. My headache subsided that afternoon and I went for a walk that night and my body still felt incredibly tired and achy. The pain behind my eyes persisted. The following day I felt somewhat better and could work. That night I went for a jog and my body felt extremely heavy, my joints ached, and I could not catch my breath. My symptoms continued to improve but I have had no sex drive for a week.

Systemic: Dizziness / Lightheadness-Severe, Systemic: Weakness-Severe, Additional Details: DIZZINESS AND LEGS \"FELT LIKE JELLY\". RESOLVED AFTER AND HOUR OR SO.

Fever to 103, rigors, chills, diaphoresis, severe muscle aches and cramping throughout body for 36 hours beginning about 8 hours after vaccine administered. L arm pain and cramping at injection location for 6 days following vaccine administration.

Fever, muscle ache, headache starting about 6 hours after vaccination, worst symptoms at about 12th hours since vaccination, symptoms starting to clear at about 20th hour.

I had received the Janessen vaccine around 3:30pm. Around 1 am I woke up to shivering and chills. My head felt extremely pressurized inside. My eyes felt like they were being pushed out of their sockets. My body hurt. It hurt to move. My neck , knees, ankles and back were in shooting dull pain. It took everything I had to stand up. I couldn't get to sleep. I had a fever. I started to shiver. My thought raced. It began to hurt to breath. My lower chest is sore on the inside where the lungs meets the rib cage. I could not to go class or do any work. Was easily one of the worst nights of my life.

Severe body aches, chills, and lethargy for two days following injection. Soreness and bruising at injection site. Non-injected shoulder joint pain with rotational movement since 1 day after vaccine. Has not stopped.

About 2 hours after the vaccine until 6:00 pm the symptoms were slowly increasing in intensity (chills, 101.2 fever, fogginess, sinus pressure, muscle soreness, headache, sweating). This continued until I took theraflu around 10:00 pm and then mild symptoms persisted.

BODY ACHES; JOINT ACHES; CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 30 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 06-APR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced body aches. On APR-2021, the subject experienced joint aches. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body aches, joint aches, fever, headache and chills was not reported. This report was non-serious.

On day of: after 8 hours, intense chills of body. Muscle aches from shivering due to chills. Lasted about 4-6 hours, with no residual effects the next day. 7 days after administration: rashes all over body, including both arms, legs, and sides. Rashes were prominent and itchy during the morning, and slowly got better over the day. Daily Claritin was taken in morning.

Patient complained of right lower leg pain with shortness of breath and headache starting on 04/12. He was seen in the medical office for complaints along with malaise, fatigue and muscle pain. Patient was diagnosed with acute vital syndrome

the next morning (4/9/21) i had a very bad headache and my lower bad hurt so bad i could barely move, extremely tired. slept most of the day. this continued until Monday. Monday my back was better and headache was better but very tired. Starting Monday night and continuing currently my chest has a sharp pain and i lose my breathe very quickly doing any kind of strenuous activity. Headache and fatigue have continued since then also.

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

Sore arm, headache x 2 days. Severe myalgias and Rhabdomyolysis developed after 5-6 days. Briefly, 30 yo gentleman h/o bipolar disorder, opioid use disrder (on methadone), nicotine use disorder (vaping), recent Janssen COVID vaccination (about 1 week ago) who was admitted with a few hours of myalgias and dark urine, notable recent moderate exercise and over-ingestion of gabapentin. For Rhabdomyolysis: 4/16/2021: CPK peak 95,694; AST peak 779, ALT peak 282, Cr 1.0, Plt 279 Treated with aggressive IV hydration with improvement.

LOWER BACK PAIN; WEAKNESS; FEVER 99-100; This spontaneous report received from a consumer concerned a 30 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced lower back pain. On 13-APR-2021, the subject experienced weakness. On 13-APR-2021, the subject experienced fever 99-100. Laboratory data included: Body temperature (NR: not provided) 99-100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever 99-100, and weakness, and the outcome of lower back pain was not reported. This report was non-serious.

Bruises on my right leg. Possible blood clot. Right leg has noticeable pain when bending and feels heavier/ different compared to my left leg.

Patient presented to ED with lower extremity weakness and pain, severe pins and needles sensation. No DVT seen on ultrasound so sent home with prednisone. Patient returned to the ED two days later with 8/10 pain that has spread to his spine/lower back, feet numbness and cramps, and calf pain. Patient was unable to raise his legs off the bed or curl his toes.

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

BLOOD CLOT FROM NOSE; TEMPORARILY UNABLE TO WALK, RICKETY KNEES; BURNING LEG PAIN; JOINT PAIN/ SHOULDER PAIN; SHOULDER FEEL TIGHT; This spontaneous report received from a patient concerned a 30 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included cigarette smoker (occasional pot; rarely). The patient's grandfather died from blot clot under knee (thrombosis). The patient had no history of bloody nose. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on left arm on 28-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021 (two days after vaccination) the patient experienced really bad burning leg pain for few days and his joints in shoulder and knees were affected two days after vaccination and he could not walk (temporarily unable to walk). The patient also experienced rickety knees. On the same day, the patient blew out a huge blood clot from his nose. On 2021, the patient's shoulder felt tight. At the time of this report, the patient's knees and shoulders were still feeling tight like there was hardly any cartilage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood clot from nose, and temporarily unable to walk, rickety knees, was recovering from joint pain/ shoulder pain, and the outcome of burning leg pain and shoulder feel tight was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-Covid-19 vaccine ad26.cov2.s-blood clot from nose. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY

Substantial back pain after 3-4 drinks, as well as a medium grade fever (102). Patients should be warned of this.

Within 24 hrs of shot had expected chills and muscle aches. Then within a week of shot began to develop mild tingling and/or squeezing sensation primarily in arms/hands. Comes and goes throughout the day and has appeared daily since within a week of the shot. Occasionally the same feeling is felt in feet, but primarily/regularly felt in arms. Not overly painful, but noticeable.

At approximately 7:15 pm on 5/7/21 administered a COVID19 (Janssen) vaccine to the patient. Immediately the patient began to complain of feeling "sick" and slumping forward in chair. immediately lowered patient to the ground and placed in a supine position. Called 911 and waited outside for EMS to arrive. Patient remained conscious and pulse was noted as strong but breathing was shallow and rapid. Pt was encouraged to focus on breathing but began to complain of muscle tightness in the hands and back. at approximately 7:25 EMS arrived and were able to calm patient using breathing exercises. EMS attributed the incident to an panic disorder which was reported to have occurred once before approximately 10 years prior when receiving a flu vaccine. The patient denied ambulatory care to the hospital for further evaluation.

SWOLLEN ANKLES; ICE COLD FEET; TYPICAL SIGNS AND SYMPTOM; This spontaneous report received from a parent concerned a 30 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included postural orthostatic tachycardia syndrome (POTS). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced typical signs and symptom. On 27-MAY-2021, the subject experienced swollen ankles. On 27-MAY-2021, the subject experienced ice cold feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the swollen ankles, ice cold feet and typical signs and symptom was not reported. This report was non-serious.

About 2 minutes after administering the vaccine to the patient, the patients fiance notice that the patient began to roll his eyes and slump over. Upon accessing the patient I notice that the patient was unresponsive to my calls, at which point I motion for my technician to call for emergency; then I proceeded to try to move the patient from the chair to the floor with the aid of his fiance. The patient became responsive a second before we go him to the floor and he seemed responsive and was breathing pretty well. The patient was unresponsive for about 35 second at which point his eyes were rolled backwards, his head was sweating profusely as well as his muscles seemed to become very rigid. Thankfully within 5 minutes emergency personal was at the scene and they took his blood pressure and heart rate with both values being on the lower end. The patient objected to going to the hospital, at which point they offered to roll him outside for him to get fresh air and observes him before leaving with his fiance

Headache, fever, chills, migraine, nausea, vomiting, stomach cramps, muscle ache, muscle spasms... got vaccine at 10:00 am-symptoms appeared around 6:00 pm with tiredness/uncomfortableness/achyness... ramped around over the next few hours, becoming severe around 10:00 pm. At about 11:00 pm, Ambulance was dispatched and patient was brought to ER at 11:30 pm under the care of doctor. Patient received 1000 mL IV fluid plus Zofran, Reglan, IV Tylenol and Toradol over the course of 4-5 hours. Patient was then released around 5:00 am on the morning of 3/22. Patient felt much better and was stable and improved.

Delayed slowed down time nauseous heart racing chest pains muscle aches joint pains anxiety stress none functional went to a urgent care and hospital no help CT scans x rays shakes fevers at night going on almost 2 weeks unable to work keep focus body shuts down

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

3/7/21 - The day of the vaccination, minimal adverse side effects encountered. Minor soreness at the injection site, as well as general tiredness. 3/8/21 - Day after vaccination - mild soreness in arm, shoulder. Tiredness. 3/9/21 - Day - moderate soreness and pain experienced in the injection arm, shoulder, and back. Body aches, chest aches. Occasional waves of discomfort, similar to nausea but without stomach discomfort. Overall tiredness. Occasional mild headaches. No noticeable fever. Total 1000mg paracetamol taken throughout the day. 3/9/21 - Night - unable to sleep soundly due to moderate pain and aches in upper body, lots of discomfort. 1 dose of Nyquil liquid taken to reduce pain and aid sleep. 3/10/21 - Most pain has gone away, just some mild soreness remains. Still some overall tiredness. 3/11/21 - Side effects appear to have subsided by this day.

Injection was around noon, felt fine until dinnertime At around 5pm I started feeling a little groggy, lack of appetite By 7 pm I was experiencing moderate chills and shakes and tingling fingers and tongue, shakes subsided around 830p 9pm I went to sleep, 11pm woke up disoriented having been tossing and turning, elevated heart rate (approx 120 bpm) and temp (101.5) which lasted until around 12:30 am Resolved with symptoms of pressure headache until mid morning, made it difficult to sleep Treatment was ice and water, cold compress, hot shower, then in the morning two tylenol Day2 only effects seem to be those lingering from the night before (tired from lack of sleep, muscle soreness from shakes) The main fear was the high heart rate which was only listed in my side effects packet as something to look out for shortly after the injection as sign of an allergy, not something that would come on later

March 8: 6pm: chills, body muscle aches, headache 7pm: fatigue had to lie down 11pm: fewer chills, a little spine pain (maybe caused by inflammation?) March 9: Noon: Only sore throat, which went away after drinking and eating

Janseen COVID-19 Vaccine EUA headache, feeling very tired, muscle aches, nausea and fever. Onset started about 8 hrs after vaccine and subsided about 12 hours later leaving slight headache and muscle pains.

Muscle aches in lower legs 11pm 4/1/2021 ? 11pm 4/2/2021 Strong chills intermittently 11pm 4/1/2021 ? 11pm 4/2/2021 Headache 8am 4/2/2021 ? 12pm 4/2/2021 Loss of appetite / nausea 8am 4/2/2021 ? 10pm 4/2/2021

high fever, chills, shaking, severe headache, body aches, joint pain; all symptoms started roughly 7 hours after the injection, peaked roughly 14 hours after the injection, and have since receded to some physical soreness and a mild headache, 2 days after the injection

I received the vaccine at 9:00am on Wednesday. By 5:00pm I had a severe fever, chills, fatigue, muscle aches and pains including my joints feeling like they were on fire, and the worst headache of my life. Today, Friday, I have no voice as it's made my voice very hoarse.

103 degree fever, chills, muscle aches, headache. Most symptoms went away after a few hours. Headache stayed a full day or so.

patient fainted right after he was give his vaccine, he seemed very stiff. It took 2 minutes for hi to regain conscious. he mentioned that he sometimes faints when he gets injected by a needle. he was observed for 30 minutes offered water, and left the pharmacy in good shape

STIFF MUSCLE; STIFF JOINTS; SORE BODY; FEVER; This spontaneous report received from a patient concerned a 31 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A,expiry: UNKNOWN) dose was not reported, in left arm administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, Laboratory data included: Body temperature (NR: not provided) 101 F. On 04-APR-2021, the subject experienced fever. On 04-APR-2021, the subject experienced stiff muscle. On 04-APR-2021, the subject experienced stiff joints. On 04-APR-2021, the subject experienced sore body. Treatment medications (dates unspecified) included: naproxen sodium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, stiff muscle, and stiff joints on 05-APR-2021, and sore body on 06-APR-2021. This report was non-serious.

Janssen COVID-19 Vaccine EUA Two hours post vaccination I felt very tired. Symptom resolved in 5 hours. Twenty hours post vaccination I developed a fever of 100.6, chills, muscle aches, headache, weakness and dizziness. Took 400mg ibuprofen at onset; symptoms resolved in three hours.

About 7 hours after vaccination, muscle aches, chills, fever, nausea. Lasted for around 12 hours. Took Tylenol as treatment, helped lessen the symptoms.

12 hours after receiving the vaccine I started experiencing muscle and body aches, fever of 101.3, chills, hot/cold flashes, loss of appetite, the arm was sore and sensitive to the touch for 4 days straight, a really bad headache 24 hours after injection.

SORE ARM; TIREDNESS; SHIVERING; MUSCLE ACHINESS; SHAKING; CYCLING BETWEEN FEELING VERY HOT AND VERY COLD; TINGLING; INAPPROPRIATE ROUTE OF VACCINATION; This spontaneous report received from a patient concerned a 31 year old male. The patient's weight was 138 pounds, and height was 167 centimeters. The patient's concurrent conditions included non-alcoholic, non-smoker, asthma, and tmj, and other pre-existing medical conditions included patient have no known allergies and had no history of drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intravenous, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 13:00 for prophylactic vaccination. Concomitant medications included cyclobenzaprine for tmj, fish oil for tmj, lactobacillus reuteri for tmj, and vitamins nos for tmj. On 06-APR-2021, the subject experienced inappropriate route of vaccination. On 06-APR-2021 22:00, the subject experienced shaking. On 06-APR-2021 22:00, the subject experienced cycling between feeling very hot and very cold. On 06-APR-2021 22:00, the subject experienced tingling. On 06-APR-2021 22:00, the subject experienced shivering. On 06-APR-2021 22:00, the subject experienced muscle achiness. Treatment medications included: paracetamol. On 07-APR-2021, the subject experienced tiredness. On 07-APR-2021 04:00, treatment medications included: paracetamol. On 07-APR-2021 10:00, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking, cycling between feeling very hot and very cold, tingling, sore arm, shivering, muscle achiness, and tiredness on 08-APR-2021, and the outcome of inappropriate route of vaccination was not reported. This report was non-serious. This case, from the same reporter is linked to 20210413992. Additional information was received agency Follow Up on 09/Apr/2021.The following information was updated and incorporated into case narrative: Reporter details, Patient demographics, medical history, events (tingling and tiredness added),Event stop date added for all events, Event Outcome updated for all events, Concomitant products Cyclobenzaprine, multivitamin, fish oil, probiotic. added, Product Lot number added.

9 hours after receiving the vaccine, around 5:00 PM on 3/21/2021, I experienced a fever, nausea, headache, soreness in muscles/joints, and chills. The next morning, these symptoms had all gone away. A couple of days after the vaccination, I believe on 3/23/2021, I began experiencing unexplained back pain and shortness of breath. This pain was severe at time and I still have a dull pain in my back as of today, 4/15/2021.

FLANK PAIN; BACK PAIN; CHILLS; INJECTION SITE SORENESS; FEVER; MUSCLE ACHES AND SORENESS; HEADACHE; This spontaneous report received from a patient concerned a 31 year old male. The patient's weight was 97.4 pounds, and height was 61 inches. The patient's concurrent conditions included abstains from alcohol, and non smoker, and other pre-existing medical conditions included patient had no known allergies. 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: 041A21A, expiry: 21-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 flank pain. On 08-APR-2021, the subject experienced back pain. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced injection site soreness. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced muscle aches and soreness. 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 chills, and fever on 09-APR-2021, was recovering from injection site soreness, muscle aches and soreness, back pain, and flank pain, and the outcome of headache was not reported. This report was non-serious.

NECK PAIN; RIGHT ARM PAIN; This spontaneous report received from a parent concerned a 31 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included patient have no known allergies, 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: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced neck pain. On 11-APR-2021, the subject experienced right arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from neck pain, and right arm pain. This report was non-serious.

NECK PAIN; TROUBLE IN MOVING; TINGLING SENSATION; SORENESS IN RIGHT ARM; CHILLS; WEAKNESS; FEVER; DIZZINESS; FEELING ACHY; FEELING FREEZING; DIARRHEA (3 LOOSE BOWEL MOVEMENT); This spontaneous report received from a patient concerned a 31 year old male. The patient's weight was 180 pounds, and height was 182 centimeters. The patient's concurrent conditions included non-smoker, and abstains from alcohol, and other pre-existing medical conditions included the patient had no known allergies and no drug abuse/ illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced dizziness. On 10-APR-2021, the subject experienced feeling achy. On 10-APR-2021, the subject experienced feeling freezing. On 10-APR-2021, the subject experienced diarrhea (3 loose bowel movement). On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced weakness. On 10-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100 F. On 13-APR-2021, the subject experienced neck pain. On 13-APR-2021, the subject experienced trouble in moving. On 13-APR-2021, the subject experienced tingling sensation. On 13-APR-2021, the subject experienced soreness in right arm. Laboratory data (dates unspecified) included: Pain scale (NR: not provided) 7/10. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling freezing, diarrhea (3 loose bowel movement), chills, and fever on 12-APR-2021, had not recovered from feeling achy, dizziness, weakness, neck pain, and soreness in right arm, and the outcome of tingling sensation and trouble in moving was not reported. This report was non-serious.

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

PERICARDITIS; MYALGIA; This spontaneous report received from a physician concerned a 31 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included cigarette smoker, and other pre-existing medical conditions included the patient had no known allergies and no known medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) with unspecified dose 1 total, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021 the patient had experienced fever, myalgia. On 20-APR-2021 the patient diagnosed with pericarditis, chest discomfort and was hospitalized, patient had reported these symptoms to health care professional. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pericarditis, fever, chest discomfort, and myalgia. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210448217-COVID-19 VACCINE AD26.COV2.S-Pericarditis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

The day of the vaccine I had full body aches which went away. Three days after the vaccine I started to get soreness in my upper back, the left side of neck stretching to the left shoulder and down my left arm. It feels like a muscle pain it is on a 5-6 on the pain scale. The pain is worse about midday and in the afternoon and early evening. I have tried Tylenol and I was prescribed some Muscle Relaxants which I haven't tried yet. I have had a couple of occasions of pain on the right side but not much. I have been referred to PT and Massage Therapy. It has been there now for four weeks and the pain is still the same and happening daily.

At 23:15 (7 hours after the dose) I started to get cold while under my blankets trying to sleep. My teeth began chattering as I started to shiver. I got up out of bed to put on a sweater. With each step I took towards the sweater my body started to fully shiver and contract. After about 4 or 5 steps I could no longer move and I fell over. I started having full body spasms and full contractions. I felt like I pulled every muscle in my body trying to relax and fight the contractions. It felt like I was being tasered for about 10-15 minutes. Once I had the strength to grab my sweater I slipped it on. As my body warmed up these contraction subsided. By 01:00 (9 hours after dose) my body temperature had spiked. I didn't have a thermometer to check my temperature but I wouldn't be surprised if I spiked a fever. I placed a wet cloth on the back of my neck, forehead and chest to cool down. At 06:00 (14 hours after dose) I took a cold shower to further drop my body's temperature. It felt like a full body sun burn where you just radiate heat. I was hot everywhere. At 08:00 (16 hours after dose) I took three (3) 500mg ibuprofen to help fight a nagging headache. I did not have much appetite for food. I regularly eat breakfast in the morning (bowl of cereal). From 09:00 to 12:00 (17-20 hours after dose) I felt groggy. Did not seem or act like myself. Was very tired from the lack of sleep the night prior. Seemed very fatigued. Around 13:00 (21 hours after dose) I took a 45-60 minute nap. Woke up feeling much better. I would say most / if not all symptoms subsided after 22-24 hours.

Headache Fever Muscle pains Fatigue All appeared simultaneously, and reasonably strongly. Went to bed, fever-sweat, body aches, head pains stayed strong for 6 hours, began to subside. After 14 hours from initial symptoms, body aches subsided, mild fever, mild headache persisted and remained. After 20 hours from initial symptoms only a verymild headache persisted. After 30 hours all symptoms were gone.

Horrendous chills, terrible back and joint pain, uncontrollable shivering and muscle spasms, intense nightsweats, fever, extreme headache, Soreness in chest/heart area. All 1000x worse than Covid which I had in December. Would have gone to the hospital if I didn?t know I had the vaccine.

I began having strange heart palpitations in the late afternoon, 5 days after receiving the vaccine. On the morning of the 6th day, I had an elevated heart rate, chest tightness and shortness of breath. It was difficult to have a conversation without having to constantly stop to take a deep breath, to ?catch up.? My lungs felt like they had substantially less capacity with a deep breath than before the symptoms presented. I had extreme fatigue, joint and muscle pain. On the 7th day, I woke up with the same symptoms, and decided to go back to bed due to continues extreme fatigue. After waking up, I felt somewhat better, until later in the evening, when all the aforementioned symptoms came back. The following morning (8th day) I felt much better, and decided to go on a mountain bike ride to see how my heart and breathing felt. I noticed some decreased cardiovascular performance, but not as bad as the previous days. Later that evening, the shortness of breath and elevated heart rate came back. On the 9th day, the elevated heart rate was noticeably better, and the shortness of breath was still present, but not as bad as before. My blood pressure remained elevated and I have been unable to get it below 135/80 range. Same issues on the 10th day. Today, on the 11th day, I attempted to go run and found that my cardiovascular conditioning was the worst I have ever experienced in my life, without exaggeration. I had difficulty with a pace and duration that I would normally complete with ease before being vaccinated. I had to cut it short, as I was having difficulty breathing and my lungs were burning. I hope that these symptoms subside and are not permanent. I was hesitant to get the vaccine for a very long time, but decided to do it based of off removal of the mask mandates for vaccinated personnel. If I could go back knowing I would feel this way, I would never have allowed this vaccine to be injected in my body. I am a healthy, athletic 31 year old male, and now I feel like I am in the worst shape of my life. I feel awful.

Starting approximately 12 hours after injection and lasting 12 hours: Headache Stuffy nose Aching muscles and joints (especially strong in old injuries from over year ago: broken leg and sprained wrist) Cold chills Fever and sweats Nausea Feeling faint Insomnia Fatigue (lasting from April 11th to present May 25)

ARM SORNESS AND REDNESS AROUND INJECTION AREA, FOLLOWED BY FEVER, CHILLS, HEADACHE, MUSCLE AND JOINT PAIN ABOUT 6 HOURS AFTER RECIEVING VACCINATION. SYMPTOMS LASTED ABOUT 3 DAYS.

FLANK PAIN; INABILITY TO FALL ASLEEP; HEADACHE; NAUSEA; INABILITY TO URINATE; CONSTIPATION; This spontaneous report received from a patient concerned a 31-year-old male. The patient's height, and weight were not reported. The patient's past medical history included back pain due to car accident a year ago, and dislocated disc in lower back and neck. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, RA10630, expiry: unknown) dose was not reported, 1 total administered on 19-MAY-2021 for prophylactic vaccination to left deltoid. No concomitant medications were reported. On 19-MAY-2021, for the first week, patient could not sleep at all and had a headache and nausea for about 3-4 days. Then it got better. As per patient, it was easier to sleep at the time of reporting, but still a little harder to fall asleep. Patient reported that he was having constipation and urinations issues since getting the vaccine. It was not painful to go to the bathroom but it took a while. Consumer woke up on 31-MAY-2021, and had excruciating pain in the back, flank area. It was hurting when he tried to move anyway to the left and if he used to touch it. He felt like he wants to scream. Consumer did consult with his PHP regarding the inability to fall asleep and problems with constipation. He was given some sleep medications and advised to take cranberry juice. HCP (health care professional) was not aware of the flank pain that consumer had that day. He was advised to call PHP or go to urgent care to determine cause of pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and nausea on MAY-2021, was recovering from inability to fall asleep, and had not recovered from constipation, flank pain, and inability to urinate. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210557948-COVID-19 VACCINE AD26.COV2.S - inability to urinate. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY

I got my Covid vaccine on Wednesday, 5/5/21. That night I experienced the typical side effects (Chills, Aches, Pains, Soreness in the injection site on my right arm). By Thursday afternoon I was feeling significantly better. However, on Friday evening I started to feel a tightness and pressure in my chest and left arm and neck. The chest pain felt like I was having a heart attack but my heart rate was mostly normal. I felt shortness of breath where I couldn't get a good deep breath in and I was also nauseous and had no appetite. At times I felt lightheaded and weak. These symptoms continued over the next couple days. On Monday 5/10/21 I decided to got to the ER to get checkout since I was still having chest pains and tightness. They ran a series of tests and concluded that I was just experiencing typical aches and pains from the vaccine. My symptoms continued for another full week and at times the shortness of breath and chest pains felt really severe. By the following week I was starting to feel a little better on and off. I got my appetite back and and I was able to start exercising again. After about 2 full weeks after receiving the vaccine most of chest pain and pressure + shortness of breath has disappeared and I feel better.

On Saturday, I woke up to my right arm - at injection site area - was itching. I woke up to numerous nose bleeds. I'm not prone to nose bleeds. Also - consistent since Saturday, Diarrhea; muscles aches; fatigue; vomiting. Problems with keeping liquid and food down now - just started a couple of days ago. Dr called me on Friday -I was doing okay; On Monday - he called again and I wasn't doing well. Have spoken to my doctor each day. And now (since two days ago) it feels like my skin is tearing apart and burning and that the inside of my bones are on fire. At the same time, I couldn't keep food and liquid down anymore. Autonomic immune system is in fight response since Saturday. Haven't been able to get out of bed for last two days. Diarrhea has worsened. - Have been taking Zofran - nausea med for the last two days. To subdue the vomiting. Have a new medication that I am starting today to subdue the diarrhea - can't remember what it's called. Trying to make sure it doesn't go into an autonomic crisis. Only Telemed visits so far - video appts. Have had several fevers doing this time - currently at 100 but went up to 103. I have gone to low grade too and means I have not been doing well at all - on Saturday to Sunday. (Went to high grade - Mon, Tuesday, Wednesday).

Immediate side effects: Heavy brain fog, odd soreness all over my body in my muscles/vascular system (sore neck, wrists, lower back), I felt a pressure in my heart like it had swollen or something, ringing in ears, muscle twitching like I had just gotten off of a long run. Ejaculation was yellow for about a week with a different texture than normal texture (which is back to normal seemingly now). Longer side effects: Overall it took about 2 weeks before I felt back to normal. Lingering issues are some slight inter-muscular pains that didn't exist before.

Received the J&J vaccine in May 20. Started experiencing leg muscle and back pain June 1, 2021. Progressively got worse over the following weeks. On June 15 I woke up with a new pain in my leg. Went to urgent care and had a D-Dimer test that came out very high. I was sent to ER where they discovered one clot in each leg and two in my lungs via ultra sound and ct scan. I was immediately hooked up to herapin blood thinner through an IV. I was released the following afternoon with Eliquis blood thinner tablets.

Received the shot Wednesday 05/05/21 in the afternoon. Flu like symptoms Thursday. Which subsided after 24 hours. On Friday 05/07/21 I had severe joint and muscle pains. To the point where I could not make a fist with either hand. The pain in my joints and muscles would not be the same each day. Some days it was hands and elbow. Then it was knee and a hand or a foot and a hand. This lasted for 4 weeks. There were times where the pain on the bottom of my feet was so bad I could not walk on them. Pain in my hands to where I could not use them to pick up a cup or open a door. The pain subsided for a week or so until tonight 06/17/21 when my left wrist and fingers are sore with a slight pain.

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

Initial symptoms were normal (chills, fever, fatigue) and stopped in a day. Over next few weeks, began having tingles all over both legs, including a burning/throbbing sensation in my calves. I also noticed any physical exertion could lead to extreme light-headedness where I felt like I was going to pass out. This stopped within a few days. By week 3, I began having pretty significant (and constant 24x7) joint pain in both knees, making it difficult to walk. I have never had issues with my joints before and am healthy / active / young. I did not change anything about my routine or life, and my doctor agreed it was likely from the vaccine so I am reporting it here. The joints in my fingers also become painful if I spend too much time typing or on the phone. It's now 2 months of this joint pain and really hoping for some relief soon. Please contact me or my doctor if you have any thoughts or updates!

I started getting really itchy in my extremities I thought I had mosquito bites from the night before I was outside. I also noticed the tips of my pointer and middle finger on my left hand felt numb. The numbness has gone away but my hands and legs still feel weak, people are saying that I have been walking funny. The itching wouldn?t stop and areas after I scratched 30 minutes or so later had what looked like dried puss. This has been happening for almost 2 weeks and it?s happening all over my extremities. The itchiness is there as soon as I wake up, it goes away and comes back periodically. When I take my pants off it happens to my knees. I have scratched open flesh all over my body little scabs everywhere. I know it?s not poison ivy or anything like that because it comes and goes and I know it?s not hives.

Began having widespread muscle fasciculations on 4/5/21. These continue presently. Areas of fasciculations: feet, calves, thighs, ribs, pecs, neck, hands, arms, jaw, buttocks, knees. Other symptoms similar to Benign Fasciculations Syndrome (BSF) also present: fatigue, exercise intolerance, stiffness, soreness.

Symptom onset 7/19/2021 with cough, runny nose, muscle aches, sore throat, nasal congestion, fever, headache & fatigue. Called nurse triage line and COVID-19 test ordered which resulted as positive.

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

Woke up in middle of night with headache. Thought maybe tired from getting up early but have had fatigue and muscle aches (lower back, arms, ankles, head, chest). Been tired through the day...not so bad that I was unable to work. Took Tylenol and that helped lower the body aches...but only lasted 4-6 hours.

Initial: 12 hours following - fever, chills, nausea, diarrhea, dizziness Following (since vaccination): extreme dizziness, eye pressure and blurry vision, tingling in scalp and face, back pain, hearing loss, and tinnitus

Woke up to aches and muscle pain, developed 101 degree fever & chills lasting through the night. Fever broke around 6 AM following morning, woke up drenched in sweat after very turbulent sleep.

48 Hours after severe headache, muscle and joint aches low grade fever. Chest pressure and throat tightness occurred, cough associated and phlegm, low energy and upper back pain. Symptoms increasing gradually. Spouse is not experiencing same symptoms after 24 hours

Generalized myalgias. Fever. Malaise. Fatigue. Note: I did have and recovered from COVID-19 infection in December 2020.

Severe headache and fever lasted about 12 hours. Max fever was 102.7 until otc acetaminophen was taken. Moderate symptoms continued to the next day and was unable to work or manage daily routine. Other moderate/mild symptoms included chills, joint and body pains.

Janssen COVID-19 Vaccine EUA Left arm soreness (including extreme finger and elbow joint pain) all first 36+ hours Low grade fever after 24 hours (lasting about 3 hours) Full body aches on and off for first 36 hours, worst at 24 hour mark Nausea at 36 hour mark Treatment: rest, hydration, some Tylenol at 24 hour mark, pepto for nausea at 36 hour mark

allergic reaction. Patient reports blurry eyesight, headache, fever, feels like he cant think clearly, patient reports balance has been off, and back pain x 6 hours. Received J&J vaccine at 1800 last night. Denies vomiting and diarrhea.History: pt had J&J COVID-19 vaccine yesterday evening and here with headache, lack of balance (but able to walk), blurry vision with loss of peripheral vision, fever, back pain, some nausea, here for eval. Says he was in his usual state of health before vaccination and no recent sick contact or COVID-19 hotspot visit. No prior co-morbidities and denies recent illness/injury, use of any meds.

Mild/moderate fatigue, muscle aches, brain fog developed 12 hours post-injection, sustained for 4 days post-vaccination and persisting/increasing. Moderate headache for 24-36 hours post-vaccination. All treated with OTC dosages of ibuprofen. Injection site soreness to touch developed 36-48 hours post-injection and sustained at 4 days.

Heart racing/pounding, fatigue, muscle soreness, slight shortness of breath, chills lasting for six hours

Within 6 hours after shot severe chills, shaking, fever, nausea, vomiting, fever, sweating, muscle pains, joint pains. Symptoms last all night, were 90% gone within 24 hours after injection.

I typically faint when getting shots or blood drawn. I did faint about 10 seconds after the initial shot injection. I was conscious throughout but was not able to speak clearly or control my body even though I could hear everything going on around me. After 30 minutes, I was feeling back to normal. The remainder of the day I felt drowsy and a little out of it. At 12:15am I began to get severe chills and shakes. This lasted throughout the night but was the worst from about 12:15-1:00am. I woke up at 4am with a fever and sweating. My entire body was stiff and in pain with aches specifically in my arms and legs. Very sore pain in my left deltoid where the shot was injected and is still slightly sensitive. It felt like my veins were stiff and in pain and it hurt to move. I had what I can describe as flu like symptoms (i.e. my teeth hurt, my body ached, fever, shakes, body stiffness and overall tiredness and weakness). These all lasted until about 6:30am at the worst and were relieved over the next few hours. I started to feel back to normal around 3pm later that day. That was April 11th. Last night, April 12th, I had trouble sleeping because my left arm was in pain from my elbow to fingers. It was a lingering pain that went away by this morning and is mostly gone now (morning April 13th).

General muscle ache Dizziness Chills Very severe headache blew out my nostrils this morning and clotted blood came out

Immediate loss of consciousness. I lost color in my face (pale white) I experienced chills and cold. My hands were shaking for about 4 hours following. From the fall, I developed right shoulder pain, right hip pain, jaw pain, right eye pain, right chest pain, right back pain, and a black eye. All symptoms have lasted a week.A I also had fever for about a day, along with generally feeling weak/unwell.A I

About 15 minutes after the injection I felt light headed and my chronic back pain was completely gone. Around 5 hours after injection I was overcome with extreme lethargy and had to sleep. 8 hours after injection I woke up very nauseous and could not stop salivating, however I never puked. I woke up again 18 hours after injection and felt nauseous and my chronic back pain had returned. I also had a weird throbbing pain in the right side of my neck and in the lower left side of my left leg. All symptoms were gone by ~36 hours after the injection.

(URGENT) MULTIPLE - severe, sharp shooting pain up from left side of neck to upper chest. - Lasted 3 weeks and still will come every now and then. - 2 day neck stiffness (normal) - complete immune system break down: Lost partial taste in tongue, developed oral thrush that was resistant to diflucan and nystatin. - 2 day stint with allergies (Sneezing, stuffy nose, no yellow mucus or fever) - Periodic headaches - swelling of tongue - fatigue lasted weeks. - easily bruising or bleeding under skin after getting minor scratches. Never healed properly (As in disappear) -glossy watery, red eyes with swollen nasolacrimal duct (inside pink corner of eye. Puffy and red.)

I opted for the J&J variant and received it on Monday at 1:00 PM, mere hours before they pulled distribution of it on the national level. I started feeling flu like fatigue, body aches, and a headache 8 hours post injection. I ran a 101+ fever Monday night and got less than 4 hours sleep due to fever and fairly intense muscle aches. On Tuesday morning the headache, fever and muscle aches persisted till the late evening accompanied by general fatigue. By 9:00 on Tuesday night I was feeling significant improvement and slept well Tuesday night with minor night sweats on and off. Wednesday morning I felt 80% back to normal. No fever, minor headache only evident when standing up quickly or sudden head movement, and continued muscles aches body wide specifically in the neck and chest as well as injection site muscle soreness. These symptoms continue to persist into Thursday at the same or perhaps slightly elevated levels. Friday 4/15 symptoms persist with generalized soreness, fatigue, headache, injection site soreness. Not his typical self.

I got out of work went home, started having sharp pains in my chest, and on my arm, I got worried nothing like this has happened before with the chest pain, I was already having back pain, shortness of breath, and headaches

I experienced a sudden onset of symptoms approximately 7 hours post-vaccination. Symptoms started with severe chills, elevated heart rate, fever (~102), and progressed into muscle and joint soreness, severe migraine with sensitivity to light, and strong fatigue, coupled with insomnia. The symptoms were severe enough that I considered going to the hospital, but ultimately did not. Fever, chills, and elevated heart rate subsided by the next morning (~12 hours after onset), but muscle soreness, migraine, and fatigue lasted for another 12-24 hours, along with a loss of appetite. I am an otherwise healthy, male adult with no outstanding medical conditions whatsoever. This was one of the most severe immune responses I have ever had, including actual illnesses. I have received other vaccinations in the past and never had any response nearly as severe. I was significantly concerned for my overall health during the height of the vaccine response, and I wanted to report this to ensure that is aware of these types of responses, and can help prepare others by informing them adequately of the types of responses to expect from the vaccine. This response very much took me by surprise in terms of severity -- I had to call out of work at a critical time.

This is a comprehensive neurological evaluation for a very pleasant right handed 32 year old gentleman who denies any past medical history who presents to the hospital with several day progressive visual changes and facial weakness. Patient reports he noted on Saturday that he had somewhat of a headache, he does get headaches from time to time in particular while looking at screens the television, he did have some associated blurring of his vision as well. This was not the worst headache of his life. He had no other associated symptoms. He went to bed on Saturday, he awoke on Sunday and went out to eat and noted that he couldn't form his mouth around the utensil, his face and lips and mouth felt weak. He still did have an intermittent headache and perhaps some neck pain as well at this point. His vision was still blurry. He denies any recent trauma, no car accident no whiplash no falls. He did go to an outside facility where a CT brain was performed and was normal he was told. He has noted yesterday that he could not close his eyes unless he did it manually, also he notes the way his voice sounds is different to him. He has not appreciated any weakness of his arms or legs. He is able to lift up his head off the bed without trouble. He does not think he has a hard time swallowing or breathing per se however he does describe that he is more "aware" of his breathing. He describes paresthesias of his face and around his mouth. No recent URI or diarrheal/GI illness, he did receive the Johnson & Johnson COVID -19 vaccine March 31st. Seen and evaluated in the ED with ed staff. He does report he recently ran a virtual type marathon over the course of 16 days. Clinical context and exam most consistent with that of GBS type variant (?Miller Fisher). Treated with IVIG. Symptoms improved after 1 dose. 4 more doses pending.

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

BODY ACHES; HEADACHE; NAUSEA; LOW GRADE FEVER; MUSCLE ACHE; BURNING AT INJECTION SITE; LEFT ARM SORENESS AT INJECTION SITE; This spontaneous report received from a patient concerned a 32 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. gatorade since symptoms appeared with minimal improvement.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1085022, and batch number: 1085022) dose was not reported, administered on 19-MAR-2021 07:15 for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99.9 F. On 19-MAR-2021 07:15, the subject experienced burning at injection site. On 19-MAR-2021 07:15, the subject experienced left arm soreness at injection site. On 19-MAR-2021 15:30, the subject experienced body aches. On 19-MAR-2021 15:30, the subject experienced headache. On 19-MAR-2021 15:30, the subject experienced nausea. On 19-MAR-2021 15:30, the subject experienced low grade fever. On 19-MAR-2021 15:30, the subject experienced muscle ache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning at injection site on 19-MAR-2021, and had not recovered from headache, body aches, nausea, low grade fever, left arm soreness at injection site, and muscle ache. This report was non-serious.

Patient had standard side effects (fever, fatigue, muscle soreness) day 1 and 2 after vaccination. Starting approx. 3 days after vaccination, patient started noticing altered smell and taste, which has gotten worse in the 14 days since vaccination. Patient also has fatigue and has been experiencing weakness since vaccination. These symptoms are identical to the symptoms the patient had with COVID (starting ~3 weeks after contracting COVID and lasting over a month). The patient contracted COVID in December 2020 and had fully recovered prior to vaccination. Recrudescence of symptoms appears to be due to immunological response to the vaccine.

Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Visual Changes/Disturbances-Mild, Systemic: Weakness-Mild, Additional Details: Numbness, tingling in hands/ mouth/ tongue. History of similar reactions with other vaccinations per patient. Patient has a phobia with needles.

I felt faint and dizzy, as though I was about to faint. I was unable to think clearly. After arriving at the ER, my symptoms graduated to achy muscles, pounding headache, neck aching, odd throat sensation, etc.

Day of vaccination: Pain/soreness at injection site and nearby arm muscles. Took acetaminophen day of vaccination, which helped, and soreness has lessened over time, but still lingers. Morning after vaccination: Muscle aches, chills, feverish. Took acetaminophen every 6 hours and it helped somewhat, particularly in the morning, but was less effective as the day went on. Next day: felt mostly better from feverish symptoms. Pain/tenderness in arm has continued but lessened over time.

Heavy body pain and stiffness, fatigue and malaise for 2 weeks after receiving vaccine. One month later broke out into a shingles rash on left side. Still recovering from shingles outbreak

Patient received 0.5ml of Janssen in right deltoid on 5/16/21. He experienced side effects (fever, chills and joint pain) starting that night at 8pm. He reports that his knees hurt so bad that he could not walk. He is treating with tylenol and ibuprofen and side effects have improved

6 days after receiving the vaccine I began to feel I'll. My arms were numb, I was sweating profusely, and was having a bad headache while at work. Suddenly I began to get tunnel vision and felt as if I was about to pass out. I was transported via ambulance to Medical Center where I was given IV and medication to treat vertigo and massive head pain/migraine. Since that day I have continually dealt with severe neck and head pain leading to migraines causing visual issues (auras and blind spots), vertigo, and nauseau.

Two days after receiving the vaccine, I woke up and could not walk due to pain in my left leg. My knee could not be extended, retracted, or left hanging. My left knee was swollen to the size of a softball and add immense pain on top and to the left but not under. There were no trauma related incidences, no working out nor was there anything out of the norm that happened . Since Tuesday, I have also had terrible headaches, fever and chills.

I was diagnosed with Transverse Spinal Myelitis at ER in town on April 27th. I had been suffering from sever back and neck pain for over a week. I reported to the ER due to the inability to void my bladder. I had full back, neck, and Brain MRI?s after being admitted to the hospital and neurologist Dr. made the diagnosis of Transverse Spinal Myelitis. I spent 3 days in the hospital and received 5 IV steroid treatments to treat my condition.

7 minutes after the injection of my Janssen injection for COVID-19, a heat enveloped my body from deep in my chest and I went pale (according to the objective findings of my nurse) and I began to feel lightheaded and almost became syncopal. I was asked to remain there for 30-minutes, and began to feel better shortly thereafter. The next several days, the lightheadedness came and went in waves, which became stronger and stronger. Two days post-injection, I developed severe joint pain where I'd otherwise previously had none - for instance, my low back ached with 7/10 pain which only went away after the first week. I had thoracic spinal pain which radiated to my chest, and by day 3 I was having serial panic attacks (which I don't have), such that I visited the local emergency department to rule out sinister cardiorespiratory sequelae. I was discharged with a ddx of GERD, though I do not believe this to be true. Since then, I have largely recovered, however the lightheaded spells have dissipated only a little but are largely still plaguing me. Thankfully, the panic attacks have decreased to the point of almost being gone altogether.

At around 4 am when he came to bed, he lay down and started convulsing. It was like he had an extreme chill but his body was so tensed up and he could not control his muscles or his breathing. He kept convulsing and was unable to control it for about 20 minutes. He asked if he was having a seizure but he was cognitively aware with no trouble speaking and so I told him it was not. His muscles hurt but I assume that was from the prolonged tensing of them. Later that afternoon he complained that his whole body was sore- arm, back, etc. He also has a headache and sore throat. Things to note- he has been running low on sleep (about 3-4 hours a night) for about 5 days leading up to the vaccine date.

Headache, severe muscle aches and cramping, difficulty breathing. Effects lasted 6 days before subsiding.

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

About 8 hours after the shot extreme fatigue set in. And anywhere between 10-12 hours an extreme fever that included prolific sweats and chill throughout the night. This is in addition to muscle ache and a headache in multiple spots of my head. Even to this morning I have a little part in the back of my head that?ll feel uncomfortable from time to time

About 4 weeks after my J&J vaccine I noticed blurred vision along with (what I can best describe as) ?neon colored eye floaters?; followed by an intense headache that lead to violent vomiting; after that day stopped; but headache, muscle ache (at base of skull and neck /shoulder area), mental fog / inability to focus, mild to intense vertigo all continue to today. A week after chest pain started occurring.

6 or 7 hours after getting the shot I started to feel a little sore and achy all over my body, it felt like I had the flu for 12 hours. The muscle achiness has persisted and has gotten worse over time. The first day it was my whole body, the next day it was less. Then my legs and arms were really tired. If I lift my arm to get a cup it feels really heavy. I do not feel tired but my legs have gotten worse, it constantly feels like they are really achy and tired. Mainly in my knees. I went to the doctor about 3-4 weeks after my vaccine, so early May and they told me to rest for 6 weeks and come back and if that persisted they recommended me to go to the orthopedic surgeon. He did an x-ray in both knees and prescribed me medication.

High fever approx 8:00pm 102.8 degrees. Severe chills, muscle aches, moderate headache. Fatigue, dizziness and confusion. All side effects approx 6:00pm to 8:00pm when started. Still continuing at current time of 10:12pm times.

Chills, muscle aches, diarrhea, fatigue,headache, joint pain, congestion, sneezing. Flu like symptoms.

I first felt the usual dead arm feeling and then that quickly progressed into a full-blown hot flash/feverish feeling accompanied by a splitting headache that I had last all of last night. Now I still have a minor headache and a dead arm after taking Tylenol (Rapid Release). I also felt very weak and fatigued all night with a dry mouth and plugged up sinus. Felt like I was going to be knocked out for 24 hours. I can hardly do these basic task on my work laptop.

Janssen COVID-19 Vaccine EUA First day after getting the shot I got a feeling of being very tired throughout the day I did not feel like to do anything. Also my arm was very very sore. Even moving it slightly a bit would hurt. The second day is when things got way worse I could not really sleep that well throughout the night because I noticed I had body aches in my legs and my back. Throughout that day I also felt like I had a fever in the morning I took my temperature and had a 100 fever. At night time I took my temperature and it went up to 102, with still a bad headache, chills, and body aches throughout my legs mostly. I also felt some palpitations. When I went to bed I was sweating very prefusively all night that I had to change my shirt. On the third day I felt a lot better, still with a slight headache no fever, and still feeling like im sweating on and off.

Janssen COVID-19 Vaccine Received vaccine at 1330CST, general soreness around injection site. Around bed time (2200) chills and sore hips, continued soreness in arm. Next morning, woke up at 0700 with significant body ache, fever of 100.2. Significant fatigue. Fever resolved by 1200, took 600mg ibuprofen. Body ache persists throughout the day. I?ve had COVID, side effects of vaccine more drastic than Covid was for me.

Extreme fatigue for over 72 hours. Headache for 24 hours. Muscle pain for 72 hours. Fever of 100.4 for 24 hours. Pain, redness, and swelling at injection site for over 72 hours. Fatigue and injection site pain still not gone.

COVID-19 Vaccine EUA About 12 hours after injection of vaccine I started to get a head ache; and about 16 hours after injection I started to get full body aches (mostly muscle) especially at injection site. Body aches lasted a full 24 hours after they started,

Saturday, 10 Apr 2021, 01:00AM MT: Woke up with substantial upper back pain and slight nausea. Took Alieve + hot 30min shower with water directed at upper back. Went to sleep at 04:00AM MT same morning. Sunday, 11 Apr 2021: Woke up with some degree of conjunctivitis (pink eye) in right eye. Eye was red and experienced pain due to sensitivity to light. No water or other discharge. Additionally, upper back discomfort still experienced. However, such went away with Tylenol. Monday, 12 Apr 2021: Some form of conjunctivitis continued in right eye. However, light sensitivity lessened greatly; eye minority affected by sunlight and no longer affected by indoor bright house lights. No water or other discharge. No back pain. Tuesday, 13 Apr 2021: Right eye is getting better. Eye is still somewhat red. No more pain due to light sensitivity. No water or other discharge. No back pain.

Fatigue and arm soreness starting approximately 6 hours after vaccination. Fatigue lasted approximately 26 hours. Severe headache, intermittent fever, chills, skin sensitivity to touch along with joint pains and lack of appetite increased in severity peaking at 24-36 hours after injection. Approximately 38 hours after injection, symptoms began to subside. 800mg of ibuprofen followed by 2 excedrine migraine were taken during the period 24-30 hours post injection.

As soon as I woke up, I read the Janssen pause news from my bed. I got up to go to the bathroom and upon finishing, I felt my heart rate skyrocket and felt faint. I immediately went back to the bed where I lost consciousness. My wife said my eyes were open and my body was rigid. I came too within a minute of that and was breathing heavy and sweating and very fatigued. My wife had called 911 as I was coming back to consciousness. The EMTs checked my vitals and all was normal. They asked if I wanted to go to the hospital, and I said no. My back was extremely sore all day, and I developed small red spots around my eyes. I went to my doctor later that day and told them about it. They took my blood for tests, which I have not heard back about, and they did not conclude anything, but did set me up with an appointment for an MRI of my head, given my past history.

He got the vaccine, he's been having fever but did not take it and feels he is still running fever. He is having pain in his left shoulder on the backside and has heartburn. He did take some Ibuprofen yesterday, but nothing else, not even for the fever. No problems with the area around the injection site.

Experienced, numbness and tingling in left arm that progressed into general pain in Joints. After 2 weeks pain occurred in left chest area and was diagnosed on 4/27/2021 as Pluerisy. Treatment with Methylprednisolone and rest.

BRAIN FOG; CANT FOCUS; COULD NOT SLEEP; NUMBNESS AT THE BASE OF THE SKULL; SEVERE HEADACHE; BODY GETTING HOT; BODY ACHES; LEG PAIN; BODY FATIGUE; MUSCLE PAIN; NAUSEA; PALPITATIONS; FAST HEART RATE; This spontaneous report received from a patient concerned a 33 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination.The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced fast heart rate. On APR-2021, the subject experienced palpitations. On APR-2021, the subject experienced body aches. On APR-2021, the subject experienced leg pain. On APR-2021, the subject experienced body fatigue. On APR-2021, the subject experienced muscle pain. On APR-2021, the subject experienced nausea. Laboratory data included: Diagnostic ultrasound (NR: not provided) Negative, Not reported, Headache (NR: not provided) 6-7/10 pain level, Leg pain (NR: not provided) 9/10 pain level, 7-8/10 pain level, and MRI (NR: not provided) NORMAL. On 06-APR-2021, the subject experienced body getting hot. On 08-APR-2021, the subject experienced brain fog. On 08-APR-2021, the subject experienced cant focus. On 08-APR-2021, the subject experienced could not sleep. On 08-APR-2021, the subject experienced numbness at the base of the skull. On 08-APR-2021, the subject experienced severe headache. On 13-APR-2021, Laboratory data included: Blood test (NR: not provided) NORMAL, CT scan (NR: not provided) NORMAL, and ECG (NR: not provided) NORMAL. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body getting hot on 08-APR-2021, and fast heart rate, had not recovered from severe headache, brain fog, cant focus, nausea, body aches, leg pain, muscle pain, body fatigue, numbness at the base of the skull, and could not sleep, and the outcome of palpitations was not reported. This report was non-serious.

Patient presented w/ loss of consciousness on 4/26. Initial workup negative. Pt then had a witnessed seizure requiring intubation for airway protection. After extubation on 4/29, patient was noted to have profound leg weakness out of proportion to brief intubation. Infectious and neurologic workup negative for transverse myelitis. Thought to be possibly auto-immune Guillain-Barre like peripheral neuropathy. Started on plasma exchange with immediate good response.

4/8 got vaccine. Then on 4/20 patient developed myalgias in back, legs, and jaw and headaches, tingling in hands, normal strength. Then on 4/25 developed Bells palsy treated with prednisone and valcyclovir for possible meningitis (no LP). Full body pain particularly in LE persisted even though Bells palsy resolved. He then developed confusion and intrusive thoughts, as well as urinary retention. He was direct admitted to our hospital. Neuro exam was notable for diffuse myalgias and 1+ patellar reflexes bilaterally. Patient was treated with gabapentin for neuropathic pain control, urinary hesitancy improved, no strength deficits. Lumbar MRI showed cauda equina enhancement consistent with ascending infectious or inflammatory process like GBM.

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

BLOOD CLOT IN LOWER CALF MUSCLES IN RIGHT LEG (DVT); NAUSEA (AFTER VACCINATION); EXTREMELY BAD HEADACHES; MUSCLES ACHES; BODY ACHE; LEG PAIN; This spontaneous report received from a patient concerned a 33 year old hispanic or latino male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: 21-JUN-2021) dose was not reported, 1 total administered on 02-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the patient experienced post vaccine nausea, extremely bad headaches, muscles aches. On 28-APR-2021, the patient experienced blood clot in lower calf muscles in right leg DVT (deep vein thrombosis). At around 2 weeks ago on 28-Apr-2021 or 29-Apr-2021, he started to feel throbbing pain and tightness in calf area. On an unspecified date in APR-2021, the patient experienced body aches specially in leg, back and arms and felt like it was a strain calf muscles or achilles pain, tightness in calf. At around 1-May-2021 to 2-May-2021, he felt the pain was extremely worse although he did not have any trauma and he did not run that may have caused a muscles strain. He went to emergent care on 5-May-2021, as he does not have a medical insurance. The doctor ordered an ultrasound as the pain he was experiencing was unlikely due to muscles strains as he did not do anything that may have caused it. On same day, laboratory data included: blood test (NR: not provided) all results are normal and diagnostic ultrasound showed DVT in lower right calf muscles in right leg. It was reported that, he was asked if he reporting those side effect to Janssen would affect him by anyway if he want to proceed into any legal action against Janssen as he experienced a blood clot. he was also asking if Janssen can provide him for the cost. On 08-May-2021, treatment medications included rivaroxaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea (after vaccination), extremely bad headaches, and muscles aches, had not recovered from blood clot in lower calf muscles in right leg (DVT), and the outcome of body ache and leg pain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210515729 -Covid-19 vaccine ad26.cov2.s-BLOOD CLOT IN LOWER CALF MUSCLES IN RIGHT LEG (DVT). 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).

Low grade fever, fatigue around 4pm. 630pm fever 103.2 degrees F. Tylenol 1000mg administered. 930pm- temp 104.9?600mg ibuprofen administered. 9:45pm tmax 106.6 & cold therapy to bring down temp. Fever broke between midnight 5/18 (100.2-Tylenol 1000mg again) and 2am (98.7). 330am- 600mg ibuprofen again for muscle aches. During febrile state, fever accompanied with chills and muscle aches. 9am 5/18? afebrile, fatigue, slight muscle aching & headache. No nausea, vomiting or diarrhea noted.

BACK PAIN; NUMBNESS IN BACK AND ARMS; CHILLS FEELING HOT AND THEN COLD; This spontaneous report received from a patient concerned a 33 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included post traumatic stress disorder, chest pain (heart and lungs problems), and body pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAY-2021, the subject experienced back pain. On 20-MAY-2021, the subject experienced numbness in back and arms. On 20-MAY-2021, the subject experienced chills feeling hot and then cold. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills feeling hot and then cold, back pain, and numbness in back and arms. This report was non-serious.

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

I woke up the next morning with an extreme headache that would not resolve for the entire day despite taking migraine medication. I felt achy and tired as well. The next day 5/29 I had extreme nausea, muscle pain, chills, shortness of breath/tiredness and a flare up of psoriatic arthritis and psoriasis activity as well as diarrhea. Today 6/1 I have a flare in PSA symptoms and diarrhea still.

COLD SWEAT; MIGRAINE HEADACHES; ARM SORE 5-6 HOURS; LEGS HURTING AFTER JANITORIAL WORK; CHILLS; BODY TEMPERATURE; This spontaneous report received from a patient concerned a 33 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced cold sweat. On MAY-2021, the subject experienced migraine headaches. On MAY-2021, the subject experienced arm sore 5-6 hours. On MAY-2021, the subject experienced legs hurting after work. On MAY-2021, the subject experienced chills. On MAY-2021, the subject experienced body temperature. Treatment medications included: paracetamol. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold sweat, migraine headaches, arm sore 5-6 hours, legs hurting after work, chills, and body temperature on 29-MAY-2021. This report was non-serious.

Started feeling tightness in my left arm and left side. Then, eventually, I had muscle spasms on my left side. They had to issue 2 CC of lidocaine in my left shoulder. My muscles were so painful that I couldn't drive or stand any type of vibrating sensations, and I was issued muscle relaxers My left arm will go numb frequently and I have trouble moving it. For a while, I couldn't sit up straight or work because of my arm. My blood pressure has also shot up significantly and is often over what is healthy for me

The first 15 minutes after the shot, I felt weak and a little dizzy. An hour later, I felt dizzier and my resting heartbeat was up to 75 bpm. My heart was racing and tingling, it felt like chills inside of my body. I became weaker and my heart jumped to 90 bpm. I became pale, disoriented, and my jaw tightened. I had no respiratory issues but I had a little troubling swallowing. I met with a Teladoc doctor who said that if I didn't get better by 6pm, to go to the ER. At 5:20, things calmed down and the reaction stopped. I felt very tired.

PRESSURE PAIN FROM THE LEFT CROWN OF THE HEAD; SWELLING NEAR THE LEFT EYE; PRESSURE IN THE LEFT EAR CANNEL; SOFT TISSUE SWELLING AROUND THE CROWN/SOFT TISSUE LUMPS OR SWELLING/NEW BUMPS ON HEAD; PRESSURE PAIN IN THE LEFT EYE NEAR THE BROW; SINUS PRESSURE; SORENESS IN HEAD; SORENESS IN BACK OF NECK; SORENESS IN INJECTION SIRE; SORENESS IN THE LEFT ARM; This spontaneous report received from a patient concerned a 33 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. takes blood pressure medications when necessary. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 14-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-JUN-2021, the subject experienced soreness in the left arm. On 14-JUN-2021, the subject experienced soreness in injection sire. On 15-JUN-2021, the subject experienced soreness in back of neck. On 15-JUN-2021, the subject experienced soreness in head. On 17-JUN-2021, the subject experienced pressure pain from the left crown of the head. On 17-JUN-2021, the subject experienced swelling near the left eye. On 17-JUN-2021, the subject experienced pressure in the left ear cannel. On 17-JUN-2021, the subject experienced soft tissue swelling around the crown/soft tissue lumps or swelling/new bumps on head. On 17-JUN-2021, the subject experienced pressure pain in the left eye near the brow. On 17-JUN-2021, the subject experienced sinus pressure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness in the left arm, and soreness in injection sire on 16-JUN-2021, and had not recovered from soreness in back of neck, pressure pain from the left crown of the head, swelling near the left eye, pressure in the left ear cannel, soft tissue swelling around the crown/soft tissue lumps or swelling/new bumps on head, pressure pain in the left eye near the brow, soreness in head, and sinus pressure. This report was non-serious.

103.5 Fever, chills, convulsions, nerve pain radiating into elbow, hand and left pinky and ring fingers, numbness and tingling in left pinky and ring fingers, vomiting, chest tightness and mild asthmatic reaction, joint pain, muscle soreness.

After 1:00 pm the day, I started warming up. I felt like I was getting sick. Had a little fever and joint aches. My knees and all my joints were hurting. And that happened until the end of the night and the next day there was nothing, I felt okay. I am having a really bad cold now. It started last Tuesday. A little sneezing, runny nose and dry cough and now it's a lot of mucous and feeling tired in general. Me and my partner also got it at the same time and had the same Johnson and Johnson at the same time. I talked to Kaiser (e-visit) and they told me to start using Cold and Flu - and prescribed an antibiotic - Doxycycline Monohydrate - 100 mg for 7 days - 2 caps per day. It's the worst cold that I've had - it's a really, really bad cold. Never had one this bad before. I'm still not 100%. I still have dry cough, mucous and a little tired.

I have had a feeling of "Pins and Needles" in both my upper arms and upper legs everytime I go to move either limb after it has been resting. The pins and needles could also be described as a burning sensation. I am also experiencing muscle soreness at night, The feeling has not gone away and does not appear to be getting better after 3+ weeks.

Several minutes after vaccines patient became light headed, he then passed out for several minutes and became very stiff. When patient came to he was disoriented (didn't know where he was or who I was). Patient felt nauseous. Patients blood pressure was 81/50. Patient was taken to ED for further evaluation.

Tested positive for covid 19. Muscle and body aches, fever, chills, headache etc. Moderate symptoms and took off work for a week.

Fever 102.2 degrees on the night of vaccine. Chills, muscle aches especially in the lower body. Cold showers, cold compress, Tylenol and ibuprofen. After 6 hours, symptoms subsided.

Fever (101 degree), headache, muscle aches, chills. Treated with tylenol and rest. So far it seems to be helping.

After 12 hours I got mild fever , body ache severe weakness pain in my joints all over body and lower back buttocks area , head ache ,

2 hours after receiving the vaccine I began to feel hot and cold flashes and a flush feeling as if I was going to faint. I went to the emergency room. The ER doctor did blood work, took my blood pressure (a little high at first) and EKG. Doctor said everything appeared to be fine. After I left the hospital I started feeling mild shortness of breath and tightness in my chest which has not stopped as of this writing. I also have moderate pain in the upper middle part of my back by the vertebrate.

Tingling sensation in left arm that radiated from injection site to hand, onset immediately after injection and lasted approximately 2 hours. Additionally, member noted left sided inguinal pain; onset several hours after the injection. Pain described as an constant ache that lasted for 2 - 3 days. Member presented to medical department approximately 3 days after vaccination out of concern symptoms might be related to vaccination. Physical exam normal. Symptoms resolved on own without intervention.

starting on 3/27/2021: right arm slightly sore at injection site. Lethargy/mental fogginess. Joint aches, especially in the low back/hip region. Hypersensitive skin, especially to the thoracic region. Slight pressure in head, not bad like a headache, but still present.

Oral fever, 101.8 +8hrs Muscle and body tightness and soreness +8hrs Chills 5-6hrs Headache +8hrs Home treatment ongoing

Patient called on 3/29/2021 at around 2:00pm stating he is experiencing the symptoms he experienced on 3/20/21 after receiving Janssen Covid vaccine. The symptoms included: cold sweats, nausea, fever, headache, and muscle aches. He had all of these symptoms right away after receiving the vaccine, it went away and then symptoms came back 1 week later 3/29/21. Per patient, the symptoms are manageable and does not need medical doctor attention. Advised patient if symptoms persists or come back again, he should contact his medical doctor to be seen. Also told patient to call us if symptoms does not go away or come back as well for us to report again. Told patient there is a 2 weeks time frame for immunity to kick in so symptoms could happen again. Recommended Tylenol for fever and pain as home self treatment in the meantime.

Severe muscle aches and chills, headache, and joint pain starting a six hours from injection, peaking at 13 hours after injection. Symptoms subsided by 24 hours after injection.

Chills, fever, heady, weakness, joint pain, nausea, body aches and fatigue. I drank Tylenol every 6 hours and drank lots of water for around 48 hours after symptoms started. Most of the symptoms went away after the 36-48 hour mark after starting. It?s been currently almost a week after the vaccine and still feel some joint, back pain and a light headache.

Sore Arm, Sore Joints (knuckles of hand), Chills, Fever, Aches, Headache, Fatigue, Muscle Weakness. Worst at 12 hours 1st evening - slowly getting better over next 24 hours with rest.

Fatigue, fever, chills, body aches, headache, joint pain in elbows, wrists, hands, and fingers, cold sweats.

Initial night - headache, muscle aches, nausea, arm soreness, and fever. Intense shivering as well as feeling both too hot and too cold. Near inability to sleep. Second day - headache, muscle aches, weakness, fatigue, nausea, arm soreness, fever (101.3 oral), and elevated heart rate (resting pulse of 120 - my normal is 80-90). Sensitivity to temperature but milder than the previous night. Was able to sleep through the night. Third day - most symptoms have subsided or are mild. Mild headache.

4/5/2021 8 p.m. feeling lethargic, body discomfort 4/6/2021 3 a.m. having trouble sleeping, shoulders and neck are feeling stuff, feeling hopeless. I've only been able to sleep in small increments. 1 p.m. still feeling lethargic, was able to sleep, however woke up covered in sweat. 4/6/2021 2 a.m. Was awoken due to excessive sweating. Was able to get back to sleep without to too much effort.

Minutes after receiving the injection (4pm) my blood pressure dropped and I lost consciousness. I recovered well enough to drive home within 15 minutes afterwards. That night (10pm) I began shivering, which escalated to periods of convulsions, to which a mouth guard was needed to prevent chipping teeth and/or biting my tongue. There was no fever present, and to subside the uncontrollable shivering I sat in a very hot shower until motor functions gradually returned. Periods of headaches, joint pains and sweating ensued for the remainder of the night. There were no other symptoms in the following days.

Slight fatigue, headache, body aches, particularly in legs, similar to influenza. Very subtle though. Soreness upon waking as well. Injection site has no issues, just very light twinge when arm is raised.

muscle aches and pains starting the day after injection, severe for the first 2 days getting better on the 3rd day

Post vaccination reports feeling lightheaded w/ no additional symptoms or complaints; medical monitoring w/ vital assessment: BP 138/79 P89 O2 sat 98% RA; rest w/ symptom resolve, released home w/ self.

Approximately 6 hours after receiving the vaccine, I started feeling feverish and having body aches. Over night, I woke up with a low grade fever, severe body aches, and a severe headache. Those three symptoms lasted throughout the day, 4/8. I woke up at approximately 7:15am on 4/9, and my symptoms were mostly gone, with some lingering muscle soreness. Today, 4/10, I am feeling nearly 100% again

Fever (6-7 hours), chills (8-9 hours), body aches in lower back and extremities (9-10 hours), and headache (15+ hours)

Muscle aches and severe shaking due to chills reported 8 hours after injection, fever of 102 and mild nausea reported 12 hours after injection, continued fever and muscle aches from 12 hours - 30 hours after injection, ocular pain and tenderness reported 30 hours after injection along with continued muscle aches

Fever of 101 for a few hours, severe aches and pains all over and especially in joints, severe headache, mild vertigo / dizziness, severe chills, difficulty breathing.

Patient active-duty military on deployment at time of vaccination. Patient to return to later this week. Dr. and I remains on deployment and are best reached via e-mail or above phone number. 34 y/o active-duty male received the Jannsen COVID 19 vaccination on 29-Mar-2021. He describes expected symptoms of fatigue and body aches overnight, but reports development of melena the next morning, 30-Mar. On 31-Mar-2021, he developed nausea/vomiting and persistent diarrhea/ melena. He presented for care after an episode of syncope with extreme pallor and hypotension (BP 70s/40s). Hypotension and pallor resolved with 2L NS bolus and patient felt well and was dispositioned to quarters without further workup. On the night of 01-Apr, patient had a recurrent episode of syncope with recurrent hypotension. He was transferred to the ED and found to have a Hgb 5.0 secondary to GI bleeding due x3 peptic ulcers in different stages of healing. He received x4 units PRBCs and started on a proton-pump inhibitor. He continues omeprazole and iron supplementation. Hgb is now stable at 11.6. H. pylori pending. He will follow-up with GI physician. Of note, patient has had a voluntary weight loss of 30 pounds over the past x3 months. He has aggressive supplement use as above and reports exercising twice daily.

fatigue, weakness, malaise, n/v, joint pain, chills, diarrhea, anorexia. Treated with ondansetron and NS 1L.

SLOWING DOWN; ARM WEAKNESS; FEVER; FATIGUE; ARM TINGLING; PALE HANDS; HOT FLASHES; DROOPY EYES; LOW BLOOD PRESSURE; This spontaneous report received from a patient concerned a 34 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-APR-2021 13:30 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, the subject experienced arm tingling. On 07-APR-2021, the subject experienced pale hands. On 07-APR-2021, the subject experienced hot flashes. On 07-APR-2021, the subject experienced droopy eyes. On 07-APR-2021, the subject experienced low blood pressure. On 07-APR-2021, the subject experienced arm weakness. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced fatigue. On 07-APR-2021 20:30, the subject experienced slowing down. Laboratory data included: Body temperature (NR: not provided) 103.9 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm tingling on 07-APR-2021 19:30, and arm weakness, had not recovered from fever, fatigue, hot flashes, and droopy eyes, and the outcome of pale hands, low blood pressure and slowing down was not reported. This report was non-serious.

severe joint pain and tiredness starting 12 hours post vac. lasted 12 hours. extreme headache 14 hours post vac, lasting 10 hours. i noticed during my lunch bathroom break that i had ruptured blood vessles on my eye lids and skin surrounding the eyes. all symptoms cleared after 14 hours duration. no additional ruptured vessles. occasional dizzyness, i maintained full function during the day, i forced myself to work because i had a critical heath and safety audit vital to our manufacturing site that could not be changed and i had no backup. it was a miserable struggle, i think the average person would have slept all day. i took ibuprofen 600mg in the afternoon and asprin 325mg around 10am. drank fluids

I felt extreme fatigue and general malaise at 14:30. I took a Vicodin for my chronic back pain and lost consciousness at 15:00. I Went to bed and woke up at 16:25. 30 min later I slept again for about 90 min. Then I woke up and walked outside for some fresh air and got this extreme ice pick pain in the left side of my head for a few seconds. Then a few seconds later again. Now it just nags a bit behind my left eye and it feels a bit off in the left side of my brain. Bright lights hurt a bit. My back pain and Sciatica is also a lot higher than normal.

Could feel thickness of shot move down my arm and within 20 seconds I could feel it enter my heart. The second it entered my heart my face became numb. I was lightheaded within 5 minutes and that lasted about 30 more minutes of dizziness/lightheadedness. My left ear started ringing as soon the the lightheaded feeling started subsiding. About 2 hours later I had a small muscle cramp in my neck and the ringing stopped. My face was numb until about 2am.

SEEN ON 4/16/2021 WITH PROVIDER WITH THE FOLLOWING COMPLAINTS: Pt here for left sided low back pain; he gets it in different spots. Sharp - left mid back , left low back, left hip and left thigh. Does not radiate to foot. Does not cause paraesthesias, numbness, weakness or tingling. No problems urinating, dysuria. The pain started after janssen vaccine along with low grade fever; lasted for 2 days then went away for over 1 week. In fact he drove and hiked 10 miles as well w/o any recurrence of pain. He notes pain restarted 2 days ago. Massage and heat help. Exercising does not worsen. Pain for past 2 days is at a 2 level. No hx of back pain or arthritis. He does have hx of renal stones and cystitis but was cleared last year by his urologist. He has not drunk enough water today and would like to do his cbc on 4/22. He denies any heaches, vision changes, abd pain or leg pain. Most of the time his pain is low back area. It was more intense in the 2 days after vaccine. No hx of blood clots. No chest pain or SOB. No injuries to back. Pain is the same as post vaccine though milder. He denies straining his muscle. No easy bruising or bleeding. kidney stones feel much differently.

Started experiencing extreme chest pains (stabbing feeling) between my lower right breast and upper rib cage on Saturday afternoon, especially when trying to take a big inhale. I went to the emergency room the next day after pain meds (ibprofen) did not help, and they did an EKG and X-Ray and they said it was a muscle strain. I went home and alternated between 3000 MGs of Tylenol every 24 hours, 2400 MGs of Ibuprofen, 8 hours of 4% lidocaine patch and then off for 8 hours + and a heating pad when the patch was off. The pain in my chest got worse and worse on Mon and Tue (started having spasms in the chest that caused extreme sharp shooting pain down my back up into my head) so went back into the ER Tues night. They

moderate/severe headache starting 3/27/2021 evening and going to 3/29/2021. Some relief with tylenol. Muscle aches starting 3/27/2021 evening and going to 3/29/2021. Some relief with tylenol. Chills 3/27/21- resolved on own during the night. Fatigue starting 3/27/2021 evening and going to 3/29/2021.

BONE PAIN; HEADACHE; This spontaneous report received from a patient concerned a 34 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced bone pain. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and bone pain was not reported. This report was non-serious. This case, from the same reporter is linked to 20210459729 and 20210459703.

Severe muscle soreness fatigue started around 7:00. At around 8:30 or 9 I started to get a severe headache and fever. Symptoms lasted through the night. At 4:00am I had a 100.8 fever and by 8:30am my fever was down to 99. I took Advil at 4:00am and 9:00am. Headache was much less severe but lasted throughout the day. Muscle soreness and fatigue were also mostly gone by 8:30am.

Muscle aches, ocular pressure behind the eyes, chills, fever, soreness, gas and bloating, frequent urination, dizziness, faintness, difficulty moving, head ache, subocciptal pressure / muscle tightness, nausea.

WOKE UP ON sUNDAY WITH EXCRUCIATING BACK PAIN, TOOK IBUPROFEN, DIDN'T WORK, MONDAY PAIN WAS LOWER AND WAS EASIER TO CONTROL WITH IBUPROFEN. TUESDAY MOST OF PAIN HAD GONE AWAY, BUT NUMBNESS IS VERY PRONOUNCED AND HAS NOT CHANGED SINCE TUESDAY (6/1/21). NUMBNESS ON BACK SIDE OF THIGH AND RIGHT SIDE OF CALF AND RIGHT HALF OF FOOT ON RIGHT LEG

Rec'd vaccine at 1500, reaction started at 1505- pt observed to be stiff posture, eyes rolled to back of head and unconscious. Pt transferred to a gurney and heard to be wheezing. Epi x1 given and 911 was called. Pt became arousable after a few minutes as ambulance arrived. Pt breathing improved and able to answer simple questions. Transferred to nearest hospital.

Severe raised burning itching rash, severe headache, vision blurred, very tired fatigue, joint muscle pain, throat pain, mental fog slowness,severe pain at surgery site, increased tremor, pain in chest, itching keeps waking me up

started with a headache, then the muscle fatigue set in and i was so tired i could barely get up. fever got to 101.7 fever reducer meds were taken once before trying to go to sleep. woke up in morning feeling much better, a little bit of muscle ache still but fever is down to 99.3

Muscle Aches, EXTREME kidney pain (I'm going to drink cranberry juice after work, Hopefully that will help)

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

Chills, fever, headache, fatigue. Muscle weakness and eye pain within 24 hours Continued headache with fatigue and eye pain. New symptoms include back pain, dizziness, Numbing and tingling of arms, legs, and faces within 72 hours

Fatigue, muscle soreness, body aches, and hives. Hives were only thing treated, went to ER because it was all over entire body. was given steroids and Benadryl. after follow up was given an additional steroid shot.

Tested Positive for Covid19 on 07/08/2021. Suspected Delta Variant Had Covid19 Symptoms, including headache, body pains, Severe lower back pain, Loss of smell, Low oxygen levels (83%), persistent cough, fatigue- Lasted 10days Recovered, but persistent cough, mild headaches and mild fatigue

Nothing for the first two hours; malaise and fatigue from hours 2-8 post-vaccination, with a return to vibrancy around 1500 local time. Around 1700, fatigue returned. Took a 3 mile walk between 1700-1800. Consumed two beers @ 7% ABV between 1800-1845. Around 1830 began feeling tingling, chills and muscle and joint pain which continues. The pain is similar to DOMS that occurs after a robust workout; did not have a robust workout today. I'm fully functional, able to eat and able to otherwise function, so the symptoms are manageable.

High fever for 2 days -topped out at 104, muscle aches and pain, Chest pain and mild breathing issues, and extremely tired

JANSSEN COVID-19 VACCINE EUA 12PM Sore deltoid left side up the neck BY 2PM lightheadedness, dizziness, nausea, headache, fatigue BY 4PM Dry cough and chills, BY 6PM Muscle soreness on the entire left side of body By 10PM 101 fever, aching in every joint of body, trouble breathing By 2AM hot and feverish. All symptoms continued through Sunday, many abating by Monday. However, I am still fatigued, coughing, lightheaded, dizzy, and nauseous since then to even now 3/19/2021. Headache comes and goes and slight difficulties in breathing from the normal. COVID rapid result test came back Negative today from facility.

Fever of 100.6f Extreme full body muscle pain. Headache Shortness of breath. Shivering Labored breathing Chest pain Unable to eat or drink. Symptoms lasted from 10:30pm till 9 am the next morning. Extremely painful experience. Able to drink and eat again at 5pm 4/2/21

High fever (101.8 degrees F) in evening on the day of vaccination. Severe chills leading to difficult to control teeth chattering. Muscle weakness. Nausea & vomiting. Symptoms felt very similar to flu. Slept for ~11 hours, and was largely recovered in the morning (mild headache & tiredness remains the next day)

Headaches, fever, fatigue, muscle aches. Fever lasted from ~7hrs after receiving vaccine to ~13 hrs. Fatigue lasted from 7-40hrs after administration. Took ibuprofen for fever 13hrs after administration.

102.4F which lasted past 24hrs, gradually lowering without any fever reducing medications. Ended after about 36hrs+ Extreme back pain Extreme Head ache mild nausea when on an empty stomach

Slight pain at injection site at moment of injection, but then no pain after for the remainder of the day. Felt slight body aches at bedtime (11PM). Slept poorly all night due to body pains. Woke to muscle aches and slight join pains, which worsened throughout the day. Low grade temperature appeared at noon the day after the shot, and stayed into the night. Headache began around 5PM and got worse. Tylenol helped at 7PM. Slept from 7:30PM to 7:30AM. Felt back to normal by morning.

About 6/7 hours after the vaccination, I experienced fairly violent chills/shakes and the beginnings of a headache. I went to bed and woke some hours later with a 101-102-degree fever and muscle/joint aches (at the injection site on my left arm and throughout my body; I especially thought the joint aches in my legs and hands). Now, about 27 hours after the vaccination, my fever has reduced to 99 degrees, my chills/shakes are gone, and my headache is mostly gone. The primary symptoms I have are the remaining sight fever, continued joint/muscle aches (mostly in my legs) and fatigue.

I received vaccine about 4:00 PM. I felt fine until I went to bed about 10:30 P.M. I got extremely teeth chattering cold and could not get warm and began to have a small headache. I awoke about 2:30 A.M. and was extremely hot. I went downstairs to bathroom and the next thing I know my wife is shaking me to wake me up laying on the floor. My wife said she heard me fall and discovered me in the bathroom floor. She woke me up and I stood up and exited the bathroom and collapsed in the hallway. My wife awoke me again and I didn't know what occurred. My wife called 911 and EMS responded and assessed my condition. I explained everything that occurred and that I had my J&J vaccine hours earlier. My vitals were taken and my condition was evaluated. I had a bad headache that felt like my head was in a vise and my knees and chins hurting a bit from the fall I was fine. I just did not recall collapsing either time and I was distraught when my wife woke me both times. That's what I was informed by my wife. I don't recall anything after urinating to being woken up by my wife and I was on laying on the hallway floor and my wife was on the phone with 911.

High fever, chills and shaking, body aches, nausea, pain in all joints and extremities. This lasted for approximately 5 hours.

Severe joint stiffness and pain, mild relief with Aleve. Severe Headache/ Migraine, so far with Aleve, Tylenol and Hydrocodene, no relief. Cold compress over the eyes seems to help with comfort but pain remains. Considering ER visit.

Severe fever. Chills. Nausea. Dizzy. Confusion. Weak fever high of 105.3, stiff neck and super high liver blood count.

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

8 pm chills and tremors started. Alternated throughout the night with chills/ fever and sweating. Severe muscle ache and headache. Lasted about 12 hours.

Fever of 101 by that evening, treated with Tylenol. 99 by the next morning. Severe body/joint ache. Headache. Severe Diarrhea. Difficulty breathing, treated with Albuterol inhaler. Still experiencing body aches and diarrhea 46 hours after vaccination.

Woke up 8 am 4/11 headache and body achs. When I got moving my headach turned more migraine body achs were every joint/ muscle hurt, once I sat down after morning routines I found myself with the dead sweats. I was shivering and clammy sweating continuously. Symptoms subsided about 5pm

Patient stood for count in the prison and blacked out. Fell and lost conciousness for approximately 2 seconds. Reported since "this am" he had been experiencing weakness, joint aches, hot flashes, and nausea. Reports he is dizzy. BP 108/64, HR 84, RR 16, O2 sat 96% room air. Was given tylenol and advised to rest.

10 April 2021: 14:00 J&J Covid-19 vaccine. No issues whatsoever throughout day, neither muscle soreness at injection point, nor fatigue etc. 11 April 2021: Woke having had headache and left shoulder/neck muscle soreness affect sleep. Woke ~09:00. Headache became worse, & minor chills. Had breakfast (toast w/Vegemite). Drank lots of water. Through day, felt worse (notably headache, fatigue). Had lunch ~12:30 (salad and jerkey), but quickly felt unwell with it. Interrupted phone call at ~13:45 to go to bathroom, feeling nauseous Felt a bit dizzy, having to stabilize my walking around apartment a couple times, but mostly feeling mentally foggy/unclear. Struggled with some sentences on phone calls.

MYALGIA THROUGHOUT BODY; FEVER; POUNDING HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 35 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known allergies zero co-morbidities. 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 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced myalgia, fever, pounding headache, and nausea. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100.3. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the myalgia, fever, pounding headache and nausea was not reported. This report was non-serious.

Severe chest pain started a and led to externally heavy chest feeling, currently in hospital. Evening of vaccine very weak and muscle aches. Within days extreme chest pain, weakness, heavy ness in chest.constant pain and breathing problems

To whom it may concern, the evening of the shot and the days that followed I had a high fever, chills, was sweating a lot, pain in my muscles, legs, etc. This all passed, and it wasn?t until yesterday 4-17-21 that I began to experience bizarre symptoms (not congruent to the above). My left arm is extremely tingly, almost as if it?s asleep. As of this evening (4/18/21 around 7:30 PM), I am also experiencing this tingly sensation on the left of my face as well. It feels like pins and needles, and is very bizarre. I?m extremely confident in saying it?s in direct correlation to the shot. Please advise.

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

JOINT PAIN; HEAVY MUSCLE ACHES; This spontaneous report received from a patient concerned a 35 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 13-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced joint pain. On 13-APR-2021, the subject experienced heavy muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heavy muscle aches, and joint pain. This report was non-serious.

Pt received first and only dose of Janssen J&J COVID vaccine on 4/5/2021. 2 weeks later, patient would have been considered to reach full immunity. On 4/21/2021, pt went to the ED with symptoms of COVID and tested positive via SARS-CoV-2 PCR. Pt was not ill enough to be admitted. "Symptoms include nonproductive cough, pleuritic chest pain, shortness of breath, arthralgias, myalgias, fever, vomiting, diarrhea."

TWO LUMPS ON LEFT SIDE OF NECK; ITCHINESS; PAIN; FATIGUE; FELT FEVER; CHILLS; MILD MUSCLE ACHES; This spontaneous report received from a patient concerned a 35 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: 21-JUNE-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced mild muscle aches. On 10-APR-2021, the subject experienced felt fever. Treatment medications included: paracetamol. On 11-APR-2021, the subject experienced fatigue. On 13-APR-2021, the subject experienced two lumps on left side of neck. On 13-APR-2021, the subject experienced itchiness. On 13-APR-2021, the subject experienced pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, mild muscle aches, and felt fever on 11-APR-2021, and fatigue on 13-APR-2021, had not recovered from two lumps on left side of neck, and the outcome of pain and itchiness was not reported. This report was non-serious.

SKIN PEELING BETWEEN INSIDES OF FINGERS OF RIGHT HAND; HEADACHES; NAUSEA; BLURRY VISION; SORENESS OF KIDNEY/LOWER BACK AREA; MASSIVE BODY ACHES; DIZZINESS UPON STANDING (HYPOTENSION); CHEST TIGHTNESS; FOGGINESS; FATIGUE; This spontaneous report received from a patient concerned a 35 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included no known drug 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: 1808982 expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: Pain scale (NR: not provided) 5-6 out of 10. On 09-APR-2021, the subject experienced fogginess. On 09-APR-2021, the subject experienced fatigue. On 10-APR-2021, the subject experienced blurry vision. On 10-APR-2021, the subject experienced soreness of kidney/lower back area. On 10-APR-2021, the subject experienced massive body aches. On 10-APR-2021, the subject experienced dizziness upon standing (hypotension). On 10-APR-2021, the subject experienced chest tightness. On 10-APR-2021, the subject experienced headaches. On 10-APR-2021, the subject experienced nausea. On 13-APR-2021, the subject experienced skin peeling between insides of fingers of right hand. 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 fogginess, blurry vision, fatigue, massive body aches, dizziness upon standing (hypotension), headaches, nausea, chest tightness, skin peeling between insides of fingers of right hand, and soreness of kidney/lower back area. 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 vaccine 3/5/2021 COVID Positive 3/29/21 3/29/21: COVID positive. This is a 35-year-old male with complex past medical history including bilateral lung transplant and renal transplant performed several years ago. He both of them and regarding his transplant management. He is on immunosuppressive medications. He is here today out of concern for exposure to COVID. He was vaccinated with Johnson Johnson vaccine on 3/4. He is here cause overnight he started developed fever headache sore throat muscle aches. If continued through today. He was test in the outpatient setting but the results have not yet returned. He is here today with continued symptoms. He is well-appearing on exam but mildly tachycardic, low-grade temperature here no significant increased work of breathing no conversational dyspnea lungs are clear heart is regular but tachycardic without murmur he has no signs or symptoms of DVT currently. His chest x-ray shows all isolated left lower lobe infiltrate. His labs are unremarkable with normal renal function, normal electrolytes but is rapid COVID test is positive. Given his immunosuppressive status in infiltrate seen on x-ray initially recommended admission for observation even though he is not initially on any supplemental oxygen is work of breathing is quite comfortable. I was able to discuss with his transplant surgeon In addition I talked to admitting physician who then discussed with pulmonology here . In their opinion the best management for the patient would be to provide him with the monoclonal antibody treatment but this can only be performed in the outpatient setting given he has no increased work of breathing no supple ox requirement currently that he is stable for discharge. He has a pulse monitor at home will also enroll him in a COVID home program. Pulmonology will call him for follow-up tomorrow. When I discussed with they currently do not have any beds available at the hospital for transport. The patient does not want to go to an outside facility that has a transplant team other than the risks of. Ultimately the patient would like to go home. I will add doxycycline for bacterial possibility of his pneumonia seen on x-ray today. He also had very strict return precautions. He understands likely had a possibility of worsening symptoms understands to return immediately if any new or worsening symptoms or no improvement. Patient was given the monoclonal antibody treatment in the ER after ordered by Dr.. He will ultimately be discharged with very close follow-up.

HEADACHE; FEVER; TIREDNESS; MUSCLE ACHE; This spontaneous report received from a parent concerned a 35 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, 1 total, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, the subject experienced headache. On 21-MAR-2021, the subject experienced fever. On 21-MAR-2021, the subject experienced tiredness. On 21-MAR-2021, the subject experienced muscle ache. Laboratory data included: Body temperature (NR: not provided) 100 degrees F. 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 headache, fever, tiredness, and muscle ache. This report was non-serious.

SEVERE NAUSEA; MYALGIA OF LOWER EXTREMITIES; FEVER; DROWSINESS; DIARRHEA ALL DAY; LOSS OF APPETITE (ATE BREAKFAST AND LUNCH, THEN NOTHING ELSE); HIVES WHICH WERE SHORT-LIVED; DEAD ARM FEELING; HEADACHE; This spontaneous report received from a patient concerned a 35 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy. 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 in left arm on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced dead arm feeling. On MAR-2021, the subject experienced diarrhea all day. On MAR-2021, the subject experienced loss of appetite (ate breakfast and lunch, then nothing else). On MAR-2021, the subject experienced hives which were short-lived. On MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 98.9 F. On 19-MAR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) negative. On 20-MAR-2021 17:00, the subject experienced drowsiness. On 20-MAR-2021 21:00, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 F. On 21-MAR-2021, the subject experienced severe nausea. On 21-MAR-2021, the subject experienced myalgia of lower extremities. On 21-MAR-2021 05:00, Laboratory data included: Body temperature (NR: not provided) 103.5 F. On 21-MAR-2021 16:00, treatment medications included: paracetamol. Additional treatment medications (dates unspecified) included: dextromethorphan hydrobromide/doxylamine succinate/ephedrine sulfate/ethanol/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, was recovering from myalgia of lower extremities, and headache, and the outcome of drowsiness, severe nausea, hives which were short-lived, dead arm feeling, diarrhea all day and loss of appetite (ate breakfast and lunch, then nothing else) 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.

History: pt got J&J COVID-19 vaccine on 4/5 and the next day, pt developed left-sided headache and body ache, like as if having a cold, per pt, and gradually the headache got better every day but it didn't go away completely, now steady for a week w/o daily improvement, bilateral, but also with left neck pain with certain rotation of neck, with vague intermittent bilateral blurry vision and bilateral intermittent non-pulsatile tinnitus (says pt heard some gobbled unclear noise during meeting thru the speaker earlier), w/o paresthesia/weakness in limbs, here for eval. Sometimes, pt has felt dizzy when standing up. Denies use of any meds currently and denies prior history of headaches, prior concussion/head injury.

Shoulder joint pain when lifting arm above my chest. It is too painful to continue lifting my arm above my head. Pain is persisting after 2 weeks.

He seemed to be stiff (arms out stiff) and was not coherent sitting in the chair. We called out his name and he came to. Acknowledged us. He broke out in a sweat all over is body and said both arms were tingling. We set him in the back room and gave him a old pack and water. We took his blood pressure and heart rate. It was 100/76 and 57 bpm. Waited 10 minutes and it was 107/78 with a heart rate of 56 bpm. He said he was a runner and this was normal for him. Also give him a candy. After about 40 minutes he said he was feeling good and had a ride home.

8 hours after injection felt tired 10-12 hours after injection I had extreme chills that caused me to tremble, fingers and toes felt very cold, elevated resting heart rate as high as 115 bpm, body aches all over which got worse throughout the night. 12 hours after injection I went to bed. Chills and body aches continued. I didn?t feel like I could get warm. Slept on and off throughout the night. Woke up 16 hours after injection and chills were gone and had night sweats. Still really achy all over. Woke up 20 hours after injection and still had body aches and felt groggy. Body aches turned into joint aches and still continue 48 hours after injection. Minor injection site pain started approximately 36 hours after injection.

CHEST PAIN; MUSCLE WEAKNESS; CHILLS; FATIGUE; FOGGY HEADED; WAS UNABLE TO SLEEP; FEVER; This spontaneous report received from a patient concerned a 35 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 29-APR-2021 09:50 for prophylactic vaccination. No concomitant medications were reported. On 29-APR-2021, the subject experienced foggy headed. On 29-APR-2021, the subject experienced was unable to sleep. On 29-APR-2021, the subject experienced fever. Treatment medications included: paracetamol. On 29-APR-2021 17:00, the subject experienced muscle weakness. On 29-APR-2021 17:00, the subject experienced chills. On 29-APR-2021 17:00, the subject experienced fatigue. On 30-APR-2021, Laboratory data included: Body temperature (NR: not provided) 99.6 F. On 04-MAY-2021, the subject experienced chest pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from muscle weakness, fatigue, and chest pain, had not recovered from foggy headed, and fever, and the outcome of was unable to sleep and chills was not reported. This report was non-serious.

During the evening around 6pm after I started developing symptoms consistent with the flu. Fever reached 104 around 8pm. Uncontrollable chills also were present. A severe headache followed. I took fever reducing meds immediately. Confusion and trouble breathing happened during the fever and chills period. An attempt to go to the hospital was unsuccessful because I lost consciousness while attempting to find phone/car keys. After I woke up, I felt less confused and could catch my breath, so I decided to take more fever reducing meds and see how I felt in a few hours - this was around 11pm. Around midnight my fever broke and the chills stopped, but the headache was at the worst it's been. The headache lasted the entire next day as well. I wanted to go to the doctor, but was physically unable to and had no one to alert. I do feel better today. I have some weak headaches that come and go, along with muscle aches, but I feel that they are minor enough.

Five days days after the vaccine I pain in my chest and all the way around my back on left side. The pain was intermittent and it seemed to move. I went to the the emergency room and they did some tests and the results were normal. I have been taking some Tylenol and it helped a little. It has been four weeks and I still get the pain intermittently for a couple of hours every day and it is mostly in my back. It is a little less frequent but not much better.

DIFFICULTY IN BREATHING; WENT FROM CHILLS TO HOT; SLIGHT FEVER; NAUSEOUS; LEFT DELTIOD INJECTION SITE PAIN; FATIGUE; HEADAHES; MUSCLE ACHES; LIGHTHEADED; LEFT SIDE WAS ACHING; DRY COUGH; LEFT MUSCLE TIGHTNESS; ALL JOINTS ALL OVER BODY WAS HURTING; CHILLS; This spontaneous report received from a patient concerned a 35 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included gastro issues, and hypothyroid, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 (suspension for injection, route of admin not reported, and batch number: 1805020 expiry: 25-MAY-2021) dose was not reported, administered on 13-MAR-2021 at 09:30 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced left muscle tightness. On 13-MAR-2021, the subject experienced left deltiod injection site pain. On 13-MAR-2021, the subject experienced muscle aches. On 13-MAR-2021 14:00, the subject experienced lightheaded. On 13-MAR-2021 14:00, the subject experienced nauseous. On 13-MAR-2021 14:00, the subject experienced fatigue. On 13-MAR-2021 16:00, the subject experienced chills. On 13-MAR-2021 16:00, the subject experienced headahes. On 13-MAR-2021 18:00, the subject experienced left side was aching. On 13-MAR-2021 18:00, the subject experienced dry cough. On 13-MAR-2021 18:00, the subject experienced all joints all over body was hurting. On 14-MAR-2021, Laboratory data included: Body temperature 100.1 deg. On 14-MAR-2021 02:00, the subject experienced went from chills to hot. On 14-MAR-2021 02:00, the subject experienced slight fever. On 14-MAR-2021 10:00, the subject experienced difficulty in breathing. The action taken with covid-19 vaccine was not applicable. The patient recovered from chills, and slight fever on 14-MAR-2021, was recovering from left side was aching, went from chills to hot, difficulty in breathing, and muscle aches, had not recovered from fatigue, lightheaded, nauseous, dry cough, and headahes, and the outcome of left deltiod injection site pain, all joints all over body was hurting and left muscle tightness was not reported. This report was non-serious.

4/3 vaccination. Six hours later, slight fever. Horrible body aches, HA. Aches lasted for a couple days. Nausea lasted almost till presently. Week after, started to experience increase stomach pain. 'Empty stomach feeling'; hurt, sharp pain, if drank liquids it was sharp pains between lower chest and above belly button, like ulcer. Tele health - prescribed anti-acid medications; no relief, not immediate. Second week, hard eating solids. The ulcer pain started really hurting. Only really eating milk, bread, very bland foods. Saturday, I woke up legs were numb. Thru the day, my lower back hurt more and more. The pain interchanged between the back pain and leg numbness; sciatica. MRI of lower back; neg. *Stomach still not 100%; still tender *I have been getting better but not watching what I eat, not eating normal things. I have lost 6-7lbs. *I have appt with PCP for opinion and get referred as my stomach is still tender, sore.

Reporting a symptomatic positive COVID swab after the Janssen J & J vaccine administration on 3/18/21. Description of symptoms Loss of taste and smell Congested Cough Sore throat Shortness of breath-states he feels like he cannot draw out a full breath and feels short of breath even at rest Muscle fatigue

Patient initially reported symptoms of body aches to jail officer at 10:00 and requested ice pack. Jail nurse provided details of symptoms at 12:15 am 5/20/21 as the following report from officer "He (jail officer) said he had the following symptoms: severe body pain, muscles felt like they were burning, confusion, severe headache. Officers noted lip swelling, weakness, and confusion. They had to help him walk. According to ED notes he was given Benadryl, Ibuprofen and a bag of fluids. They (ED) did a CBD and Metabolic/Electrolyte Panel."

HALLUCINATION; NUMBNESS ON THE RIGHT SIDE OF BODY; UNABLE TO SPEAK; HEADACHE; CONDITION WORSENING EVERYDAY; UNABLE TO EAT; LOSING WEIGHT; SLEPT FOR 3 CONSECUTIVE DAYS; WORDS SPEAKING DOES NOT MAKE SENSE; FELT VERY TIRED; This spontaneous report received from a consumer concerned a 35 year old male of unspecified race and ethnicity. The patient's weight was 72 kilograms, and height was 70 inches. The patient's concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies and no history of drug abuse or illicit drug usage. The patient was healthy and did not have any medical issue before getting vaccinated. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, 1 total administered to right deltoid (arm) on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-APR-2021, 2 weeks post vaccination, the patient experienced numbness on the right side of body, hallucination, unable to speak and headache. The patient was hospitalized on 22-APR-2021. Laboratory data included: CT scan (NR: not provided) small spot in brain, negative for stroke and any other condition, and MRI (NR: not provided) small spot in brain, negative for stroke and any other condition. The duration of hospitalization was 1 day. On an unspecified date in 2021,while at home the patient slept for 3 consecutive days (excessive sleep) and complained to feel very tired. Therefore after 4 days, the patient went to the hospital again, since the doctor could not find anything, he was sent back to home again and was given the following treatment medications included: Clopidogrel, ethyl Loflazepate, and Etoricoxib. Per reporter until this day the numbness is not completely gone but is mild, the patient can speak but the words that he says does not make sense (slurred speech). The patient complained of losing weight, was unable to eat and the condition was getting worse everyday. Laboratory data included: Weight (NR: not provided) loosing weight. The patient's family would like to take him to a country for a second opinion or further check up but could not cross the border due to the pandemic. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from unable to speak, and numbness on the right side of body, had not recovered from felt very tired, unable to eat, headache, hallucination, losing weight, words speaking does not make sense, and condition worsening everyday, and the outcome of slept for 3 consecutive days was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210544637-Covid-19 vaccine ad26.cov2.s-Hallucinations. Numbness on right side of body ,Unable to speak. 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. 20210544637-covid-19 vaccine ad26.cov2.s-Headache. This event is labeled per RSI and is therefore considered potentially related.

Coughing congestion,nose,chest ears runny nosy stuffy nose sore throat body pain fatigue muscle aches 5/26/21 - now

Pain in left shoulder muscle has not subsided after 3 weeks of receiving shot. Pain killers do not help.

Symptoms started ~10 minutes after injection. I began to feel dizzy. I felt very warm and began to sweat profusely. My vision got cloudy. I was given water. The pharmacist measured my blood pressure, and I believe he said I was 70 over 50. I began to feel like I was about to pass out, so I laid down and gradually began to improve. I began to feel very cold instead of very warm. About thirty minutes later, I felt well enough to leave the pharmacy. After a couple hours, I began to experience what I think are more typical symptoms - stiffness and pain in the arm which received the shot, and chills. The next day, I experienced sore wrists, shins, and lower back; fatigue; headache; and hot & cold flashes with uncontrollable shivering or sweating at times. These symptoms were alleviated about 42 hours after the injection, except for persisting mild pain in the arm had which received the shot.

03/23/2021 awoke with felt pulled shoulder, heat, pain on the backside of a pull shoulder like a knot and had shoulder issue of pulled shoulder to severe pain still had function of arm but still had use of arm. Had difficult time sleeping and had pain presented at the injection site and the top of the arm. It took a day for the pain to change from the shoulder to the injection site to the top of the arm. 9/10 for pain for three weeks starting not able to use the left arm and inflammation of the was restricting the nerve and pain. Lack of sleep for three weeks do no sleep and shoulder, neck, torso, and ribs, not able to sit down. Not able to user the left arm with daily test that required the use of the left arm. Week three doctor for appt. early April No imaging, observation and range of motion, flexibility and strength evaluation then they prescribed the Gabapentin because of lack of sleeping . Went to a Dr. a week later for the doctor did the same test and pain evaluation was wanting to do imaging. Same the timeframe of the J &J being pulled from market and they did not want to image just increased the dosage Gabapentin. Symptoms that he had did not show side effects of blood clotting.

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

Soreness at injection site for 3 hours. Pain in upper arm/shoulder joint started a few hours after injection, and is diminishing into Day 2. Pain in various joints is very noticeable by 9:00am the day after injection. Left hip joint pain up to a 6/10 on pain scale. Also pain in right hip, knees, and right shoulder, not to exceed a 4 or 5 on pain scale. Also at 9:00am on Day 2, headache is quite noticeable and persisting through Day 2. I rarely get headaches normally.

felt like I had the flu a day after but went away then the Tingling fingers, Tingling/ numb feet, legs giving out, eyes contantly watering all started 3 weeks after shot

Shoulder around injection site still has pain. Usually the pain is behind the or at the side of the injection site. The pain comes and goes and it is noticeable. I still have full range and use of my shoulder. However, after four months of having the shot, it is strange how the pain/soreness is still there. My doctor said either to have physical therapy or to try to self therapy which I choose to do.

Went to bed around 10 pm. Woke up at 11:30 with moderate to severe chills and 100 degree fever. Added blankets and clothes. Took Tylenol. Drank water. Chills subsided. At 12:45am temp was 100.4 degrees F. Woke up at 6am. Temp was 98.2. Took Advil at 6am to help with muscle aches from the chills.

Severe chills and shaking, fever ranging from 99-101.7 F, muscle aches, joint aches, headache lasting from 1 am - 11 pm 3/6 (day after injection). Acetaminophen every 8 hours, beginning at 3 am; ibuprofen every 8 hours beginning at 4 pm. Felt some general weakness on Sunday.

Beginning the evening of the vaccine pt spiked a fever, experienced migraine-like symptoms and excessive joint pain in the hips. That evening sleep was irregular with waves of chills and excessive sweating. The following day a headache continued until about 12pm and then the body seemed to go back to normal. Two days after the initial vaccine there has remained consistent muscle weakness in OS (left) knee and numbness in OS leg from the knee down. There is also infrequent dizziness. Both symptoms are becoming more regular.

Headache, Myalgia, Fever, NauseaVomiting, temp 99-100 per patient Narrative: Patient states symptoms started about 2am 3/17/21 and are no resolving although still feeling fatigue. Other Relevant History:

Chills; headache; joint pains; muscle and body aches; fatigue/extremely weak (had to be helped to sit up); nausea; slight fever (~99.8 F); racing heart rate (93, normal resting for me is ~60); heavy breathing, though no difficulty breathing.

102.2 degree fever. Tremors and shaking for hours and hours. Insomnia. Diarrhea. Nerve pain. Joint swelling. Loss of taste

Violent chills happened while working on computer. Laid on heat pad to assist in bed. Chills lasted about 20 minutes. Parasthesia happened immediately. Myalgia in legs happened immediately. No fever at this time. Woke in morning with no fever, but muscle aches, malaise, lethargy, parasthesia were all present. Spent entire day in bed napping occasionally. Measured temperature in evening at 100.7F. Painful stomach pain happened in evening. Patient never gets acid pain or similar so this was very abnormal. Antacid helped but stomach pain continued all evening at a lesser degree. When going to bed most symptoms had subsided. Still some parasthesia and Myalgia. Woke up on 4/9 feeling much better after lots of sleep. No fever or other symptoms on morning of 4/9.

Nausea, tiredness, muscle aches, chills, headache. Lasted for 24 hours. Did not take temperature. Tylenol helped.

Dizzyness, high-grade fever, breathing issues, muscle and joint pain, chills, night sweats, nausea. No treatment other than trying to sleep and hope it goes away in the morning. This morning I feel very dizzy, still have a headache, and still have a fever.

Fever, muscle aches, fatigue, headache, burning while urinating. After 2 weeks of a fever which would have 100 degrees and peak at 102 I went to the doctor on 3/29 and was diagnosed with a kidney infection. I was prescribed cipro 2x day for 10 days.

While exercising on the morning of 4/11, received a sudden, severe headache on the left side of my head. It started in my neck, moved up through my skull, and ended above my left eye. The feeling gradually improved with time, stretching, and acetaminophen. For more than 24 hours, a mild feeling persisted. On 4/13, the left side of my neck is still stiff and my left eye has a light throbbing.

10 hours after injection: chills, aches, sweats, trouble sleeping. Following day: fatigue, muscle aches, headache near top of head. Symptoms subsided about 24 hours after.

On the evening of 4/8/2021 at around 8 pm I began experiencing an upset stomach (felt like I might throw up) and then shaking in my stomach started and I got a lot of chills and a headache. Then I spiked a very high fever and sweat like crazy. I was shaking like crazy and had to call a doctor on call twice. I had full body pain and was very sleepy. The fever and chills lasted a bit over 2 days but unfortunately the pain in my body had not gone away. Currently (4/14/2021) I have pain in all my joints and my neck and back and I noticed a rash around my right knee. I have felt very tired. I have felt some mild shortness of breath, which may be seasonal allergies (discussed with a nurse earlier, my oxygen levels are 98 percent today, so I am breathing fine, but there is a sensation of shortness of breath) . I have consulted my primary care office about the above and they are speaking to the doctor. I am trying to limit my exposure to any hospital setting until the 14 days (2 weeks) is up from the vaccine. Hopefully these symptoms will go away soon and hopefully none are related to a blood clot issue. We'll see if my doctor or you guys may recommend a future platelet test?

Two days following vaccination I started having tingling in my feet. Often it felt like pins and needles, and eventually more like a burning sensation. My understanding is generally we would refer to this as neuropathy. It comes and goes in my hands as well. I've had some significant leg pain in my hip off and on, and a couple of headaches, but the consistent for more than two weeks has been the neuropathy issue and it is not going away.

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

Fatigue, general body aches, vomiting within 24-36 hours. Ongoing body aches and pain in joints, especially left elbow joint, for 10 days after injection

I have been having pain in my legs above and below my knees. I have pulsating pains under my left armpit and arm. Have been having headaches everyday that are worse first thing after waking up. Feels like I have a head cold (runny/stuffy nose, cough, sore throat) for the past 4 days that seems to be getting worse.

Sweaty immediately after shot. No big deal. Now about 10 days after shot, still very fatigued and head foggy. The main issue is back pain. Spine pain. The top half of my spine has discomfort at its best and mild/modern pain the rest of the time. It's constant. At times my spine feels cold and tingly. Then my entire core gets cold and tingly. I've never had back pain or injured my back. This pain is directly related to the vaccine and my experience seems to be outside the norm of side effects subsiding after a couple days.

EXCRUCIATING LOWER BACK PAIN; HOT AND COLD FLASHES; TIRED; HEADACHE; This spontaneous report received from a patient concerned a 36 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced hot and cold flashes. On 08-APR-2021, the subject experienced tired. On 08-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced excruciating lower back pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hot and cold flashes, tired, and headache on APR-2021, and had not recovered from excruciating lower back pain. This report was non-serious.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: this may be duplicate: pt recieved shot 2:10pm at 2:15 complained of profuse sweating and blurred vision, asked for cup of water and turned on fan for patient, no other symptoms except for say felt the med injected to arm, at 2:39pm bp was taken and was 118/74 with 70 pulse, pt remained seated for additional 15mins, total 30 min observation time at 2:41 pm took 2nd bp reading was 129/79 pulse of 72, pt doesnt have pcp and Advised to have urgent care thats 24 hrs on speed dial in case

Headache, chills, feeling very tired, muscle aches, nausea. Woke up shaking very hard and couldn't breathe much, was able to get breathing under control and stop the shaking.

For 2 days, typical arm soreness, flu-like symptoms with significant muscle pain and general weakness and malaise. However, on the 5th day, EXTREME abdominal pain, left side. Pain level up to 9. Incapacitating. Two visits to urgent care. This was in March before any info came out about adverse blood clot events for the J&J vaccine, so the doctors were not really interested at the time that I had just gotten my shot. They gave me antibiotics, thinking it may be diverticulitis (diagnosis based on symptoms only - no diagnostics - it was the doctor's "best guess"). Pain did not subside, only got worse. 4 days later I could barely move, abdominal pain was extreme. Went back to clinic and they did a PET scan to check for diverticulitis. There was none; PET scan revealed nothing out of the ordinary. So they told me they had no idea what it was and sent me home. PET scan reading by the doctor notes specifically that blood/vascular was not able to be observed because no contrast or dyes were used. Bottom line was over 10 days of extreme abdominal pain 5 days after receiving the shot. I've never experienced anything like that before.

Patient developed cranial nerve 7 palsy, facial numbness, and non descript visual changes. Was treated with prednisone for Bell's palsy. Also developed joint pain

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

8PM - Night of receiving Vaccine - Slight back pain - Took 800mg Ibuprofen Next Day 2 AM - Woke up with severe Muscle spasms in middle back area - Bad Pain for 15-20 minutes - Took more ibuprofen 6 AM - Woke up with severe Muscle spasms in middle back area - Bad Pain for 15-20 minutes - Took more ibuprofen Next Day 6 AM - Woke up with severe Muscle spasms in middle back area - Bad Pain for 15-20 minutes - Took more ibuprofen Every Morning - Next 3 weeks (ongoing) Back Pain around 5:30 am each morning (Mild discomfort)

Later that eveing around 10pm I developed muscle pains and chills. A headache came about 2 hrs after and a little later I developed a fever and the headache went from light to mild. Throughout the night I could not sleep because the headache had gotten so severe and I had uncontrollable chills and shakes and a fever. 3/6 I did start around the clock Tylenol which did reduce the fever and make the headache less as intense but for about 2 days the headache so bad with pressure associated it felt as if my eyes were going to bulge out of my head. By day 3 I woke up feeling better but was in a fog which lasted the remainer of that day and by day 4 all symptoms had subsided

Extremely Severe Headache, Fever, Body Ache during the first 24 hours after vaccine injection. Extreme mental fog during 24-48 hours after vaccine injection. After initial 48 hours after vaccine injection, experienced tightness in chest with a slight bias to left side. Also still experiencing very faint feeling of headache since injection. This seems to cause slight mental fog and has remained as of writing this 2 weeks after injection. At 72 hours after injection, tightness or pressure moved across entire upper chest collar area, and down left arm and up left side of head behind left ear and into the back of the head, and then finally to the top of the head. Pressure/Tightness discomfort seems to effect left hand nerves... effecting typing on keyboard with left hand fingers. Pressing on left and right collar bone pectoral areas exacerbates irritation. Adverse symptoms after initial 48 hour period have remained the mostly same for almost 2 weeks period.

FLARE UP ON HIS LOWER BACK/SEVERE LOWER BACK PAIN,LEFT LUMBAR SIDE; LEGS HURTING; FELT QUITE TIRED; This spontaneous report received from a patient concerned a 36 year old male. The patient's weight was 85 kilograms, and height was 186 centimeters. The patient's concurrent conditions included non smoker, 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: 07-AUG-2021) dose was not reported, administered on 22-JUN-2021 15:14 for prophylactic vaccination. No concomitant medications were reported. On 23-JUN-2021, the subject experienced flare up on his lower back/severe lower back pain, left lumbar side. On 23-JUN-2021, the subject experienced legs hurting. On 23-JUN-2021, the subject experienced felt quite tired. Treatment medications included: naproxen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flare up on his lower back/severe lower back pain, left lumbar side, felt quite tired, and legs hurting. This report was non-serious.

Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Joint Pain-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: patient stated he is experiencing severe arm pain from the moment he received the vaccine til now. recieved on 05/03/21. stated he has limited arm movement but has not been seen by a doctor. Recommdened on the call today to go follow up with md and see if its nerve pain/damage. I stated to patient it could also be a clot that is causing pain so need to follow up with MD. Pt acknowledged and and will make an appt asap. I told patient I am starting a safety report and we will followup soon.

Restless nights, excruciating pain in hip and knees, elevated blood pressure(169/114), right side of face numb, entered the emergency room several times back and forth but no overnight stay

FEELING OF ALMOST PASSING OUT; ROEMHELD SYNDROME; ANHEDONIA; WEIGHT LOSS AROUND 10 POUNDS/ LOST 40 POUNDS; SEVERE GAS; DIARRHEA; LIGHT ASTHMA; This spontaneous report received from a patient concerned a 36 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included childhood asthma, caffeine allergy, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with prednisone. 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 on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced light asthma. On 29-MAR-2021, the subject experienced anhedonia. On 29-MAR-2021, the subject experienced weight loss around 10 pounds/ lost 40 pounds. On 29-MAR-2021, the subject experienced severe gas. On 29-MAR-2021, the subject experienced diarrhea. On 18-MAY-2021, the subject experienced roemheld syndrome. On an unspecified date, the subject experienced feeling of almost passing out. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Not reported, Cardiovascular evaluation (NR: not provided) Not reported, Helicobacter pylori infection (NR: not provided) Negative, and Psychiatric evaluation (NR: not provided) Not reported. Treatment medications (dates unspecified) included: macrogol 3350, and omeprazole. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from anhedonia on 05-APR-2021, and light asthma on 25-MAR-2021, had not recovered from diarrhea, roemheld syndrome, severe gas, and weight loss around 10 pounds/ lost 40 pounds, and the outcome of feeling of almost passing out was not reported. This report was non-serious.

Very dry/sore throat, intermittent lose of voice, low-grade fever, body shivering/chills, pressure/tension headache, hard spot at injection site, joint pain/stiffness, ringing of ears; all for around 40 hours and slowly clearing up. *Tylenol, ibuprofen, cold/flu meds had minimal effect.

I started to feel extreme fatigue around noon the day after but what I found very concerning is I lost probably 80-90% of the strength in my arms. I couldn't palm a ball i had for the kids which i normally can easily. I had chills and nausea as well. I can't really remember much from that day and it feels like a big blur. I woke up the next day feeling very irritable with brain fog. Today its gotten better and I am hoping tomorrow I will be back to normal.

Janssen COVID-19 Vaccine EUA Muscle and joint aches, headache, Fever 100 degrees, lethargic, trouble sleeping

Fever, Chills, Muscle Aches, Pounding headache, Fatigue, Malaise, Joint pain, stuffy nose, shortness of breathe, chest feel heavy, injections site pain (not red or swollen), sinus congestion, inner ear ache.

Got the vaccine around 10:30am, felt ok until around 7:30pm, when I started feeling some nausea and dizziness and weakness. Then progressed to severe shaking chills, fevers, headaches, tingling/electric shock feeling in back of head/neck, muscle aches, mild joint pain, eye discomfort associated with the headaches, poor appetite at first, trouble sleeping, and fatigue; all of which required doses of Tylenol and ibuprofen and cold packs. Symptoms lasted all night and fever broke overnight after finally falling asleep. The next day (3/17) took some more Tylenol and ibuprofen, but the fever and chills subsided. The other symptoms mostly resolved except was still quite tired and felt weak. Also, had cold sweats all day on 3/17. By around 3/18 most all of the symptoms resolved. Also, had mild soreness at vaccination site throughout. I?m a physician. If I wasn?t a physician I may have sought medical attention.

Very sore shoulder immediately after shot, still present 2 days later. Chills and fever started at 7:00 that night, achy joints around 9:00pm, elevated heart rate started around midnight, coupled with headache. Unable to sleep much at all due to elevated heart rate. Tylenol removed the headache, fever broke around 1:00am the same night, all other symptoms were gone by 10:00 am the day after the vaccine

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

Loss of consciousness about 5 minutes following vaccine administration. Muscles contracted with arching. As patient regained consciousness he still had vision loss. Complained of nausea for about 24 hours but no vomiting. Dizziness and headache persistent for about 36 hours. Patient with severe fatigue for about 24 hours and gradually improving over next 48 hours.

Chills from 2100-2400 5APR Elevated resting heart rate (160bpm) 2300-0700 6APR Joint pain in every joint 2300 5APR-1700 7APR Swelling and pain at injection site 5APR-9APR

Fever, muscle pain, joint stiffness, joint pain, headache, nausea, light headedness, tingling in my hands and legs.

Patient developed left leg pain 5 days after the vaccine, with tightness behind the knee, and then soon developed swelling. As pain improved he did not seek attention until today, 4/14/2021 and was found to have a severe large fully extensive and occlusive femoral DVT L leg.

Patient reports that within 2 hours of receiving Janssen vaccine, started with migraine-symptoms and dizziness; he had to stay out from work the next next day due to fatigue/dizziness/headaches/myalgias. Started with shortness of breath and asthma exacerbation symptoms on 4/1/21; saw PCP, on 4/2/21 for shortness of breath and asthma/allergy-like symptoms. He also reports that since the time of his vaccine his BP has been running slightly high around 140/85 and headaches have continued off and on. He was started on Budenoside inhaler by PCP and prednisone (patient does not recall dose). Came to see me at on-site clinic on 4/13/21 for continued headaches and concerns to blood pressure elevation persistence

Sudden onset of extreme chills, shivering uncontrollably until approximately 5am. This was accompanied by a severe headache and sore muscles. By about 10am the shivering/chills had subsided enough to be able to get out of bed and get Tylenol for the headache. This helped get some sleep. At about 1pm was the first time I checked my temperature and it read 102 orally. By this point the sore muscles had mostly subsided, but the headache and fever persisted until almost 11pm on the dot. The fever dropped from 102 to normal in under an hour.

Headache, chills, muscle aches, fatigue starting about 10 hours after vaccine was administered and lasting about 24 hours. After that, chills went away and headache improved. Muscle aches/fatigue continued for another 3-4 days.

Patient experienced extreme fatigue and severe muscle aches, starting the second day after receiving vaccine and it lasted up to this date.

KIDNEY INFLAMMATION (RENAL DISORDER); LUNGS FILLED WITH FLUID; PANCREATIC PAIN; KIDNEY INFECTION; LEG PAIN; KIDNEY FAILURE; CAN'T MOVE; SEVERE BACK PAIN; KIDNEY PAIN; LOSS OF VOICE; This spontaneous report received from a patient concerned a 37 year old male. The patient's weight, height, and medical history were not reported. The patient received two weeks ago covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, 1 total administered on 22-MAR-2021 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 22-MAR-2021, the patient experienced kidney failure, can't move, severe back pain, kidney pain, loss of voice, leg pain. The patient didn't feel right and lied down and woke up with severe back pain. The left side of patient body was in excruciating pain and he was unable to walk. On 05-APR-2021, the patient experienced kidney infection and pancreatic pain. On an unspecified date, the patient experienced lungs filled with fluid and kidney inflammation (renal disorder). He addressed that his lungs were filled with fluid and he lost his voice which was later improved in few days. The patient required urgent/emergency care visit, for events back pain, kidney pain, leg pain, can't move, loss of voice, kidney failure, and kidney infection. The patient was experiencing as if he was dying and failure in kidney and not be able to understand to compensate the situation. The patient family was concerned about him and due to vaccine he was not able to work or to do anything. Considering severity he was asking for the compensation for the vaccine effect on him. The patient asked for a call back as he was not able to talk and he was on bus so could have got disconnected. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of voice on 24-MAR-2021, had not recovered from back pain, kidney pain, leg pain, can't move, kidney failure, and pancreatic pain, and the outcome of lungs filled with fluid and kidney inflammation (renal disorder) and kidney infection was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: v0 This spontaneous report involves a 37-year-old male patient who experienced kidney failure, can't move, severe back pain, kidney pain, loss of voice, leg pain the same day the Janssen COVID-19 Vaccine Ad26.COV2 had administered. The patient didn't feel right and lied down and woke up with severe back pain. The left side of patient body was in excruciating pain and he was unable to walk. Apporxiamtelly two weeks later he had kidney infection and pancreatic pain. On an unspecified date, the patient experienced lungs filled with fluid and kidney inflammation. Medical history, concomitant medications, and details of the events were not reported. This case has insufficient information to make a meaningful medical assessment. The case will be assessed further when additional information is received.

DIFFICULTY BREATHING; MENTAL CHANGES; RAPID HEART BEAT; FULL BODY PAIN; FEELING OF LEAD IN VEINS TOE NAILS TO HEAD; ANXIETY; BRAIN ZAPS; FEELING OF HEAT IN BRAIN; SEVERE PAIN; LEG PAIN; LEG FALLING ASLEEP; FEELING OF CHANGES IN NERVOUS SYSTEM; FEELING SPACEY; PALPITATIONS; DIFFICULTY SLEEPING; BURNING IN CHEST; LIGHTHEADED; FEELING LIKE GOING TO PASS OUT; PANIC ATTACK; EXTREME BONE PAIN; SUFFOCATING; SUFFERING AND TORTURE; FOOT FALLING ASLEEP; POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME; This spontaneous report received from a patient concerned a 37 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, non alcoholic user, and postural orthostatic tachycardia syndrome, and other pre-existing medical conditions included the patient had illicit drug use as a teenage. the patient was homeless from age of 14 to 22. the patient was sober as of 26-mar-2006, past 15 years was sober. 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: 1805029, and batch number: 1805029 expiry: 25-MAY-2021) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: CT scan (NR: not provided) not reported, Contrast media reaction (NR: not provided) not reported, Diagnostic ultrasound (NR: not provided) not reported, Echocardiogram (NR: not provided) not reported, Fibrin D dimer abnormal (NR: not provided) not reported, and Heart rate (NR: not provided) Increased. On MAR-2021, the subject experienced difficulty breathing. On MAR-2021, the subject experienced mental changes. On MAR-2021, the subject experienced rapid heart beat. On MAR-2021, the subject experienced full body pain. On MAR-2021, the subject experienced feeling of lead in veins toe nails to head. On MAR-2021, the subject experienced anxiety. On MAR-2021, the subject experienced brain zaps. On MAR-2021, the subject experienced feeling of heat in brain. On MAR-2021, the subject experienced severe pain. On MAR-2021, the subject experienced leg pain. On MAR-2021, the subject experienced leg falling asleep. On MAR-2021, the subject experienced feeling of changes in nervous system. On MAR-2021, the subject experienced feeling spacey. On MAR-2021, the subject experienced palpitations. On MAR-2021, the subject experienced difficulty sleeping. On MAR-2021, the subject experienced burning in chest. On MAR-2021, the subject experienced lightheaded. On MAR-2021, the subject experienced feeling like going to pass out. On MAR-2021, the subject experienced panic attack. On MAR-2021, the subject experienced extreme bone pain. On MAR-2021, the subject experienced suffocating. On MAR-2021, the subject experienced suffering and torture. On MAR-2021, the subject experienced foot falling asleep. On MAR-2021, the subject experienced postural orthostatic tachycardia syndrome. On APR-2021, Laboratory data included: Stress test (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rapid heart beat, difficulty breathing, full body pain, feeling of lead in veins toe nails to head, anxiety, brain zaps, feeling of heat in brain, severe pain, leg pain, leg falling asleep, feeling of changes in nervous system, feeling spacey, palpitations, difficulty sleeping, burning in chest, mental changes, extreme bone pain, suffocating, and suffering and torture, and the outcome of lightheaded, feeling like going to pass out, panic attack, foot falling asleep and postural orthostatic tachycardia syndrome was not reported. 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.

Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Mild, Systemic: Weakness-Medium, Additional Details: Patient fainted 2 minutes after dose administration followed by full body contraction which lasted 30 seconds. Patient indicated post-incident he had a needle phobia and had previously fainted during blood drawing appointments

SUSPECTED SINUS INFECTION; TIGHTNESS OF NECK; BODY SPASMS; UNABLE TO SLEEP; SEVERE PRESSURE HEADACHE; DIFFICULTY CONCENTRATING; LIGHT HEADEDNESS; PAIN AROUND LEFT EYE; TIGHTNESS OF FACE; NUMBNESS OF FACE AND NECK; This spontaneous report received from a patient concerned a 37 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, and other pre-existing medical conditions included the patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced numbness of face and neck. On 12-APR-2021, the subject experienced severe pressure headache. On 12-APR-2021, the subject experienced difficulty concentrating. On 12-APR-2021, the subject experienced light headedness. On 12-APR-2021, the subject experienced pain around left eye. On 12-APR-2021, the subject experienced tightness of face. On 30-APR-2021, the subject experienced body spasms. On 30-APR-2021, the subject experienced unable to sleep. On 30-APR-2021, the subject experienced tightness of neck. On 04-MAY-2021, Laboratory data included: CT scan (NR: not provided) CLEAR. On an unspecified date, the subject experienced suspected sinus infection. Treatment medications (dates unspecified) included: amoxicillin trihydrate, naproxen, azithromycin, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe pressure headache, difficulty concentrating, light headedness, body spasms, unable to sleep, numbness of face and neck, tightness of neck, pain around left eye, and tightness of face, and the outcome of suspected sinus infection was not reported. This report was non-serious.

HEAD PRESSURE; HEART PALPITATIONS; FEELING OF A RUSH TO THE HEAD AFTER EATING; DRY EYES; RINGING IN THE EARS; MYALGIA; GI ISSUES LIKE BUBBLING STOMACH; FATIGUE; STIFFNESS IN THE NECK/ MUSCLE TIGHTNESS IN THE JAW; DROOPING RIGHT EYE LID; CHEST PRESSURE; ANXIETY; DIZZINESS AFTER GOING FOR A WALK; HEADACHE; This spontaneous report received from a patient concerned a 37 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced dizziness after going for a walk. On 2021, the subject experienced anxiety. On 2021, the subject experienced headache. On APR-2021, the subject experienced drooping right eye lid. On APR-2021, the subject experienced chest pressure. On APR-2021, the subject experienced stiffness in the neck/ muscle tightness in the jaw. Laboratory data included: Blood test (NR: not provided) NOT REPORTED. On 07-APR-2021, the subject experienced fatigue. On 08-APR-2021, the subject experienced gi issues like bubbling stomach. On 09-APR-2021, the subject experienced myalgia. On 18-APR-2021, Laboratory data included: Blood test (NR: not provided) did not find any specific signs causing his symptoms, and CT scan (NR: not provided) did not find any specific signs causing his symptoms. On 25-APR-2021, the subject experienced ringing in the ears. On 26-APR-2021, Laboratory data included: Blood test (NR: not provided) also found nothing unusual. On an unspecified date, the subject experienced head pressure, heart palpitations, feeling of a rush to the head after eating, and dry eyes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from gi issues like bubbling stomach, feeling of a rush to the head after eating, and dizziness after going for a walk, had not recovered from fatigue, myalgia, head pressure, heart palpitations, chest pressure, anxiety, and ringing in the ears, and the outcome of dry eyes, stiffness in the neck/ muscle tightness in the jaw, drooping right eye lid and headache was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious.

Patient in chair sitting position at time of vaccination, minutes later fell out of chair face forward and on carpet floor lying on left side breathing hard. Patient had rug burns on face. Patient lost consciousness for about 1 to 1 and a half minute patient snapped back immediately and slowly came back to being oriented. EMS arrived to check over patient, patient was nauseated and vomited. Patient complained of neck discomfort, EMS pressed on patients neck and EMS felt it was muscle related. Patient refused additional service from EMS. EMS advised patient to seek additional services from hospital if symptoms worsen.

This spontaneous report received from a patient concerned a 37 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no known drug allergies, no history of drug abuse or illicit drug use. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 07-AUG-2021) dose was not reported, administered on 14-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-JUN-2021, the subject experienced flushing in face. On 15-JUN-2021, the subject experienced tiredness. On 15-JUN-2021, the subject experienced headache. On 16-JUN-2021, the subject experienced swelling occurring at both sides of eyes temple regions. On 16-JUN-2021, the subject experienced muscle tightening at corners of mastoids. Treatment medications (dates unspecified) included: ibuprofen. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flushing in face on 14-JUN-2021, and tiredness on 16-JUN-2021, was recovering from headache, and had not recovered from swelling occurring at both sides of eyes temple regions, and muscle tightening at corners of mastoids. This report was non-serious.

Left muscle is very sore months after shot. The pain did not start until 1 month after the shot. It is impossible to use arm to lift heavy items and the pain sometimes cause me to be unable to do my normal jobs.

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

Full body convulsions, completely locking up the body, eased over time. Fever. Nausea. Extreme muscle weakness and headaches.

PAIN AS FEELING LIKE A BUBBLE OF FLUID; PAIN FEELS LIKE A DEEP, SOFT TISSUE INJURY; INJECTION SITE SWOLLEN; PRESSURE UNDER THE MUSCLE; INJECTION SITE ARM PAIN AND TENDER; SPACEY; This spontaneous report received from a patient concerned a 37 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: UNKNOWN) dose was not reported, administered on 01-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JUL-2021, the subject experienced spacey. On 01-JUL-2021, the subject experienced injection site arm pain and tender. On 16-JUL-2021, the subject experienced pain as feeling like a bubble of fluid. On 16-JUL-2021, the subject experienced pain feels like a deep, soft tissue injury. On 16-JUL-2021, the subject experienced injection site swollen. On 16-JUL-2021, the subject experienced pressure under the muscle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from spacey on 01-JUL-2021, and had not recovered from injection site arm pain and tender, pain as feeling like a bubble of fluid, injection site swollen, pressure under the muscle, and pain feels like a deep, soft tissue injury. This report was non-serious.

No symptoms within first 2 hours of vaccination. At about 2 hours, became extremely sensitive to light and sound, severe headache/migraine (pain 7/10) to left side, and heavily fatigued. No discomfort at injection site. Temp 99.1°F, muscle pain, weakness, stiffness approx 5 hrs after injection. OTC Tylenol (700mg) taken around 7 hrs after injection with no relief of symptoms. Unable to stay awake, slept approx 12 hours from 21:30 on 03/08/2021 until 09:30 on morning of 03/09/2021. All symptoms still active, headache improved slightly (5/10) but muscle stiffness, muscle pain, and fatigue worse. Nausea and mild abdominal pain/cramping around noon. Fever of 101.2°F at 13:00 on 03/09/2021, 100.0°F at 16:00, and down to 99.1 at 20:00.

No initial adverse reaction to vaccine and negligible localized pain at injection site. Sudden onset chills, severe tremors, and muscle spasm beginning +12h after vaccine administration, lasting ~2 hours followed by high fever (peak 103.6F), treated with acetaminophen OTC. Persistent fever (>100F) until +18h after vaccine administration. Fatigue, headache, muscle soreness persisting +24h after administration.

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

after 10 hours since the shot i experience extreme fatigue. then very painful muscle aches in my lower back and legs. as well as my rib cage and neck. uncontrollable shakes and chills. no fever. it lasted 24 hours. after that time i am still experiencing fatigue and nausea throughout the day. i am improving since the start of my symptoms.

Gout flare within hours of receiving the vaccine. No gout flare in 6-8 years. No other changes in diet or lifestyle in recent weeks.

Shot at 9 am 4/2/2021 Back pain: 6pm 4/2/2021 Chills and body aches 7 pm Fever 9 pm( lasted about 12 hours) Body aches for the next 36 hours Arm pain and bruising

Mild side effects in the hours after the injection (headache, sore throat, muscle aches, chills). Mild enough to not need any medications. At 1:30am, I woke up needing to urinate. I went into the bathroom and lost consciousness, finding myself with one hand in the toilet and one on the side. I felt nauseous and thought I would vomit, but didn't and believe I lost consciousness again. I was able to make it to the sink to try to wash my hands, and I fell down on my knees. I knew I was bleeding somewhere but didn't know from where (my right pinky was cut on an item in the bathroom when I fell). My wife made it to me, and I lost consciousness a couple more times while talking with her. I laid on the bathroom floor for a

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

38 y/o M with syncope 3-4 minutes after receiving Janssen vaccine at 12:54pm. Patient with loss of consciousness for 1-2 minutes with some rigidity to body. Patient placed in supine position with legs raised. RN administered smelling salts at 1:00 pm and patient regained consciousness slowly. 4 sets of vital signs taken between 1:07pm and 1;18pm. Emergency Medical Services called at 1:12pm. Patient denies prior history of allergies, denies current medication or medical conditions. Patient reports not eating or drinking prior to vaccine administration time. Last set of vital signs taken at 1:18pm showed blood pressure and heart rate within normal range. Paramedics took over assessment at 1:19pm, patient refused to go to hospital for further evaluation and left facility on his own. Patient with steady gait and ambulated on his own. Recommend follow up with Primary care physician.

The evening after I received my vaccine I became very cold and couldn't get warm, to the point of shivering very hard, while at the same time having a fever of 102 F (about 9:30 pm). The house was 68 F, and I bundled up with thermal underwear, fleece pajamas, a robe, and two extra blankets, but I couldn't stop feeling cold. My body was painfully sore the rest of the night; this may have been a reaction from shivering so hard and wearing my muscles out. Later that night, I woke up in a sweat (maybe 11:30pm) and had to strip out of my clothes down to my underwear, and I couldn't stop feeling warm. I slept the rest of the night on top of the covers, and woke up very frequently, probably every half hour. Each time I woke, I drank half a glass of water (about 6 oz). The next day my fever was gone and I felt normal temperature wise, but my muscles were all very sore. I had flu-like symptoms for about a week, a little bit less each day. It was probably a full week later until I felt normal.

Severe cramping in right abdominal area. Couldn?t lay down. Severe muscle soreness. Kidney punch providing reaction. Neck and shoulder soreness and cramping.

Severe joint pain and fever with chills the second day after the vaccine. Also I developed a headache that has been persistent since the date I stated onset of the symptoms, I still have the headache which is worse some days than others.

Hi I was vaccinated Thursday April 8th 2021 at approximately 9:15am. I kept a log so I could share my experience with my friends and family. After vaccination I was fine for a few hours but I randomly got a case of watery eyes that would last about 15 minutes and then clear up. This happened 4 times over a 9 hour period. Around 9 hours after vaccination I started to feel like I had a cold and my skin all over my body ached to touch and my heart started racing. I felt sunburned and nauseous and went to bed. 13 hours exactly after vaccination I was hit hard with intense chills to the point of teeth chattering and full body shivering. 15 hours after injection I woke up intensely hot and I had a massive headache, full body pain, a tickle deep in my lungs that made me cough, nausea, and a fever of 101. I also was having extreme heart palpitations. I have a laser thermometer and I discovered my fever was 101.5 at my forehead but my neck and chest were 103. I took ibuprofen and kept patting myself with cold wet wash cloths to combat the fever. At this point I debated going to the hospital. I had intense fatigue and I was too weak to move but too sick to sleep. This level of fever and symptoms went on for about a day and a half. Since my vaccination I am still fatigued, I get winded very easily, something small like feeding my dog makes me break out in a sweat, and I need to lay down. I am still weak and fatigued but not to the same level as before and it changes every day. I have a sore throat, headaches, occasionally my body will twitch in random places, fever will pop up and go away, I cough gag and get very weak under any physical stress. I did not have injection site pain out of the ordinary until 48 hours after injection and it felt like a shotgun blast to the arm.. I did have very unusual joint pain from the start. I was injected in my upper left arm, but my lower right ankle was painful and my left wrist... I am a 38 year old male with treated hypertension, obesity and sleep apnea. My mother who is 65 was vaccinated at the same time as myself and her symptoms were slow onset and much milder than mine but she too has headaches, upset stomach, fatigue, watery eyes, fever, chills, twitches, injection pain, etc.

At 4:30 AM approximate 36 hours after vaccine, constant shooting pain and nerve pain in right arm, upper back/neck area on right side, pain and nerve pain spreading down in to right forearm. As of now, approximately one week after onset, very little change

Jansen COVID-19 Chills, fever, dizziness, lasting till 6am and again at 9:30. General muscle soreness.

Left-sided face numbness and tingling in tongue approx. 12 hours after receiving the shot Extreme fatigue, back pain/kidney pain, joint pain, extreme pain in both feet, vertigo, ringing in ears, stiff neck, back pain, heaviness in legs, difficulty sleeping, brain-zaps (forget my thoughts)

Pt felt lightheaded, dizzy about 5 minutes after his vaccine, LOC with some stiffness and tremors during brief episode. Pt was then positioned lying down, monitored for 30 mins, vitals nl, continued to have lightheadedness, tingling in extremities, intermittent hot/cold. Pt agreed to be transferred to ER after incomplete recovery after 30 mins.

JOINT PAIN; TOTAL MYALGIA; FATIGUE; This spontaneous report received from a patient via a company representative concerned a 38 year old male. The patient's height, and weight were not reported. The patient's past medical history included tested positive for covid-19 in 1-NOV-2020, and concurrent conditions included cigarette smoker, and other pre-existing medical conditions included the patient did not have any known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041AZ1A, 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 joint pain. On 07-APR-2021, the subject experienced total myalgia. On 07-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from total myalgia, joint pain, and fatigue. This report was non-serious.

SLIGHT DIFFICULTY IN BREATHING; CHILLS; FATIGUE; HEADACHE; INTERMITTENT FEVER; MUSCLE PAIN (BACK AND JOINT PAIN); This spontaneous report received from a patient concerned a 38 year old. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced slight difficulty in breathing. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fatigue. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced intermittent fever. On 10-APR-2021, the subject experienced muscle pain (back and joint pain). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight difficulty in breathing, chills, fatigue, headache, and intermittent fever on 11-APR-2021, and had not recovered from muscle pain (back and joint pain). This report was non-serious.

Left work early because Chills, sweating Fever, Headache, Muscle and body aches, Fatigue, Shortness of breath, Fast heartbeat, Blood pressure 150/86/98 at 4:10pm on April 11. Cyclobenzaprine 10mg at 5pm and slept under multiple blankets because I was cold and sweating. Woke up the next day fine just a sore arm.

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

BLOTCHY RASH ON THE TRUNK (STOMACH TO CHEST); RASH ON UPPER INSIDE THIGHS (BOTH SIDE); RASH FROM ELBOW TO WRIST (BOTH SIDES); SHOULDER PAIN (DULL); This spontaneous report received from a patient concerned a 38 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known drug allergies. 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 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced shoulder pain (dull). On 18-APR-2021, the subject experienced blotchy rash on the trunk (stomach to chest). On 18-APR-2021, the subject experienced rash on upper inside thighs (both side). On 18-APR-2021, the subject experienced rash from elbow to wrist (both sides). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shoulder pain (dull) on 12-APR-2021, and had not recovered from blotchy rash on the trunk (stomach to chest), rash from elbow to wrist (both sides), and rash on upper inside thighs (both side). This report was non-serious.

After receiving the vaccine, about 12:30am on 03/28/21 I felt a chills, shaky muscles around my neck/shoulders..the room temperature was at 80F but I felt cold like 35F. The next morning, I felt very tired walking up stairs from the basement to my room on the 2nd floor..barely made it to the 2nd floor, felt like my body hitting a wall/ no energy to lift my legs up. I made to my bedroom but felt very dizzy, using my hands holding myself up on my desk and realized I might faint any seconds..my vision was bright and blurry. I slowly moved myself to a bed and laid down for a while. Later that day in the late afternoon, my muscles were sore (legs, thighs, back) I could not walk more than 10-15 steps which I needed rest. These conditions lasted me for 6 days since receiving the vaccine and felt better on the 7th day. Currently I'm ok.

Chills, Muscle Spasms, Shortness of Breath, Fever, Sweating, Joint Pain, Muscle Aches, Severe Headache. Symptoms resolved within 24hrs except headache and fatigue. Headaches continue and new symptoms have emerged. Acute severe head pain, dizziness, mental confusion, difficulty speaking and visual affects of stars, dark spots and difficulty focusing.

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

Left posterior leg/knee pain started on 4/26. DVT left leg diagnosed via ultrasound, started on Xarelto

Symptoms: Fever, tiredness, body aches, joint pain, soreness around eyes, and soreness at injection site. Symptoms started approximately around 7:00 P.M. , which is approximately six hours after receiving the vaccination.

2 weeks of intense nausea, confusion, foggy, fatigue, motion sickness, headache, arm numbing, heart burn, short of breath, neck pain, shoulder pain. Neck pain and shoulder pain remain at 4 weeks post vaccine. Pain level 9 on a 1-10 scale.

ED notes: 39 y.o. male with no significant medical history brought by EMS for dysarthria, RT arm weakness, and RT facial droop beginning at 2:05pm today. Sx acute onset, severe, constant, and have not occurred previously. Pt was driving just prior to symptom onset when he called his mother stating he did not feel well at 2:05pm. Upon arriving home, mother noticed he was dysarthric and called 911. EMS noted facial droop, arm weakness, dysarthria, and gaze palsy and transported him to the hospital. Initial glucose by EMS 110. Pt denies headache, recent head trauma, history of brain hemorrhages or prior stroke. PMH: None, PSH: None, Allergies: NKDA, Tobacco: Denies, ETOH: Social, Drugs: Denies Pt AAOx3, bib from home for weakness and facial droop. Stroke alert called en route. As per report, pt was driving home at 2 pm when he started to feel ""weird"". Pt called his wife and was able to drive himself home. Upon arrival at his house he ""collapsed"" on the couch and his wife noticed right-sided facial droop and weakness, more prominent on the right side. Upon arrival to ED pt appears pale and weak. R sided facial droop and right arm and right leg weakness noted. Dr. at bedside. Stroke alert called in ED. Hr noted to be in the 40s. As per wife, pt is an athlete 5/4/21 Critical Care Notes: Neurology- No hx of neurological disease but does have family history of blood clotting disorder in maternal uncles and cousins (factor 2 and factor 5 but unclear specific diagnosis)- Patient presented with R sided weakness, R facial droop, dysarthria, double vision, R CN 6 palsy; no prior history of similar events- CT brain negative for acute abnormaility - CTA brain/perfusion showed no significant stenosis, occlusion, aneurysm, no perfusion abnormality- MRI brain showed small acute ischemic infarct in ventromedial L thalamus and chronic bilateral cerebellar lacunar infarcts- Patient showing improvement in symptoms s/p tPA- Repeat CT showed new mild hypoattenuation suggesting evolving acute infarction with no bleed, herniation, mass effect, or midline shift- Echo with bubble study revealed patient PFO, No DVT on LE US- Lipid profile WNL, tox screen neg, RPR neg- Neuro checks per unit protocol- Check ANCA, Anti cardiolipin, anti thrombin III, antiphospholipid Ab, Factor V Leiden, Protein C and S, ANA, FTA, A1c; Dr. (H/O) consulted- ESR elevated- DAPT per neuro- DSA with NIR today Cardiology- Hx of sinus bradycardia: Patient is athletic, works out regularly. Had previous cardiac evaluation with no significant findings- EKG showing borderline 1st degree AV block- Troponin neg- BP well controlled - MAP goal >65mmHg- 2D echo with bubble study revealed patent PFO, No DVT on LE US Heme/Onc- CBC unremarkable - No active bleeding- Transfuse if Hgb < 7- DVT prophylaxis SCDs, patient ambulatory- No DVT on LE US- Workup as above for blood clotting disorders given stroke in otherwise young healthy patient with family history of clotting disorders- H/O consulted, pending eval 5/9/21 Neurology Note: Overall neurological assessment remains stable and unchanged overnight. Double vision on the right eye stable, improving as per patient's report. Will recommend to continue with DAPT as ordered. Follow up with neurology as an outpatient in 2-4 weeks. Follow up with Cardio as well. Ok to discharge patient home as per Neurolgy standpoint. 1. Left ventromedial thalamic CVA. 2. PFO - S/P closure 5/7/2021. 3. Congenital hypoplastic left VA, basilar trunk. 4. Remote cerebellar lacunar infarcts. 5. Family history of Factor V Leiden, factor II. PLAN: 1. Ok to discharge patient home as per neurology standpoint. 2. Continue ASA 81 mg and Plavix 75 mg Daily. 3. Follow up with neurology as an outpatient in 2- 4 weeks. 4. Follow up with Cardio as per their recommendations. 5. Medical management as per IM.

FLARE UP OF RA; This spontaneous report received from a health care professional via concerned a 38 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, frequency once total, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the patient experienced flare up of Rheumatoid Arthritis (RA). Patient stated that physician told that flare up of RA caused by COVID vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of flare up of RA was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210512871-covid-19 vaccine ad26.cov2.s-Flare up of rheumatoid arthritis. 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).

description from patient: 1.. On Wed, Apr 28, I got the JnJ vaccine. Other than fatigue the following day no major issues. 2. On Sat, May 1, I had an afib episode in the morning. Reset to sinus rhythm the next morning around 2:30am. I spoke with you during the episode. 3. On Mon, May 3, I had brain fog. I?m usually tired after an afib episode. But this seemed different. I?ve never experienced something like this before. But I chalked it out to the after effects of the afib and moved on. 4. On Fri, May 7, I started having the stiffness in my right calf. I checked in with you that weekend to make sure it wasn?t a clot. After we spoke I think we ruled out a clot. 5. In addition, I?ve developed some added symptoms since then: (i) Sweaty feet. (ii) Pins and needles sensation in feet. (iii) Tightness in the arch of the right foot. (iv) Feet and hands feel sensitive to cold. (v) Burning sensation in feet and left hand. (vi) Mild headache mostly felt in the left temple. (vii) A pulling feeling on the left side of the face. (viii) A feeling that if I close my eyes, I may faint.

Awoke two days after with severely swollen, stiff, and painful knees. Practically impossible to bend. Other minor unusual sore spots, base of left index finger, we're tolerable, but I am having trouble standing, sitting, and walking because of the extreme state of my knees! No history of arthritis, but every appearance of sudden onset!

Ever since the shot, that night - severe chills, fever. A week later, I went to ER - I was still having short term memory loss, chest pain and body aches and joint pains I have been scheduled for a Rheumatologist; Neurologist. I'm still taking prednisone until I can get to the Rheumatologist. As long as I'm on the prednisone, I'm all right but as soon as I come off it I get symptoms back of pressure in my head, all my joints start hurting and have short term memory loss.

PATIENT CALLED TO REPORT PROLONGED SIDE EFFECTS FROM VACCINE. EXTREME FATIGUE, MUSCLE ACHES, NECK AND UPPER BACK/SHOULDER PAIN SINCE RECIEVING THE VACCINE. MILD HEADACHE AND OCCASSIONAL DIZZINESS.

pt says after he took the vaccine he felt like his bones and muscles got heavy like he was walking in water and had fever. He is very tired and wants to sleep all of the time. He gets dizzy and disoriented and has diarhea. He has body aches and pains, feels like his muscles are swollen and feels like he is wearing weights when he moves and completely fatigued.

Pain and swelling at the injection location. Extreme tiredness, headache, muscle pain/soreness, chills and intermittent (minimal) nausea. Felt like my body was working harder than normal, with slight tightness in my chest.

I work as a security officer for a multi-story office building. About a week after receiving the vaccine I began having a pain in my hip. Normally, my job requires me to walk between 2-4 miles per shift, and I?ve never had problems doing so. But since the vaccine I?ve only been able to walk for about 30 minutes before needing to sit and rest; the pain becomes unbearable. It doesn?t feel like a backache. It feels like a sharp stabbing sensation in my hip/thigh joint when I'm standing or walking. OTC aspirin and IB have had no effect and the problem hasn?t subdued. A dull pain is always there, even at home and when I'm sleeping, but it becomes a major issue at work because of the constant walking. I?m unsure if it?s vaccine related.

PATIENT ALERTED US ON 6-18-21 THAT EXACTLY 2 WEEKS AFTER HIS VACCINE HE WNET TO THE DOCTOR FOR SHOULDER PAIN AND HAD A SUPERFICIAL BLOOD CLOT. THEY PERFORMED AN MRI AND DETERMINED BLOOD WAS STILL FLOWING SO THEY DETERMINED NO TREATMENT WAS NECESSARY

Pt called health system call center c/o vaccine side effects. Verified pt with 2 identifiers. Proceed the screening questions of covid vaccine side effects. Noted no emergency s/sx. Pt stated pt got covid vaccine J&J 5/13/2021 at VSC and then Headache, body aches, joint pain, sore throat, chills, cough, sore throat, fever started from Monday 5/17/2021. Pt is taking tylenol and ibuprofen for the symptoms. Pt scheduled urgent care provider 5/21/2021 for consultations. Pt made aware. Pt is educated covid vaccine side effects. Pt agreed and verbalized understanding.

Arms and legs tingling, pins and needles as if they have fallen asleep and this was perpetual, slight numbness, weakness in grip. The feeling of tendonitis only not just in tendons. Every time I move I feel pins and needles through muscles and tightness in joints. This lasted for about three weeks and has declined by about 70% since. I still feel it now localized to elbows, wrists, inner and back of legs with the occasional spams and shaky feeling in my hands. Throughout the day my fingers will randomly shake. It's not enough to effect motor control loss or precision, but it's enough for me to notice and feel happening and is extremely unsettling.

Patient reported to the pharmacy the following morning complaining of the following symptoms: knee pain, insomnia, chills, and increased heart rate. Counseled the patient on potential reactions and how the chills may be due to a low grade fever, insomnia/HR due to anxiety about potential side effects. Patient asked about the ability to get paid time off while recuperating from the vaccination, he was referred to the HR department. Patient reports that he called Vsafe and VAERS. He was going to talk to personnel at the end of the conversation at the pharmacy.

Muscle pain aches, particularly in back and legs. Fatigued. Chills. Strong headache. Dehydration. Symptoms began to subside by the next morning and with acetaminophen.

Immediate numbness in right hand and right shoulder, followed by pain in hand and shoulder. Facial pressure, fever, body aches, headache lasting 24 hours.

Evening of vaccination: fatigue, sensation of feeling hot Day after vaccination, AM: mildly sore arm at injection site, sore joints elsewhere, continuing fatigue Day after vaccination, PM: continuing fatigue

Chest fluttering Dizzy/nauseous/fatigued 1st day Fever/chills/tension headache 2nd day Mild chest tightness 3rd and 4th day Sweaty/clammy hands and feet every day since vaccine Waking up sweaty every night Mild left ear Tinnitus 4th day Forehead Neck/throat/chest/stomach warm no fever 3rd and 4th day Some loose stool 4th day, vertigo Imbalanced feeling chest quivering elevated heart rate 4th day constipation 5th day and insomnia along with severe vertigo when lying flat severe tension headaches mild hearing imbalance and popping both ears 6th day mild tension headaches with pressure on head, stomach burn, heartburn weak legs vertigo 7th day mild tension headaches with pressure on head, stomach burn, heartburn weak legs vertigo 8th day pressure on head, stomach burn, heartburn weak legs vertigo 9th day

Felt a little hit after shot and was asked to stay 30 minutes cause was a little red and heart rate was a little elevated. The following 2 days had a 103 fever shivers muscle pain and fog in head 4 days later still don't feel 100 percent

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

8:00pm april 6 2021 body aches and headache. April 7 10:00pm chills and fever of 101.3 f. Tylenol helped fever but returned a couple of hours later. Body aches and joint pain accompanied with fatigue and weakness and overall not feeling well. April 9 woke up at 5:00am and my whole body felt as if i had done hard labor all day making any activity uncomfortable and painful

about 8 hours post shot, I had uncontrollable shivering and head to toe aches and muscle stiffness as well as a moderate headache. 24 hours post shot, Shivers were gone body ache and headache persists with cold sweats (sweats lasted for about 3-4 hours) 32 hour post shot to now still pretty achy, mostly left arm (where I got the shot), back (mostly left side) and both hands. The achiness is fading (in line to how I've felt after Tetanus shots in the past).

Within a few minutes of receiving the vaccination I lost consciousness. It was a drive-through vaccination clinic by the Health department. My vehicle rolled into a cement and metal bar/side of the building's exit at a slow speed. The EMS at the scene stated that my heartbeat was irregular, varying between bradycardia and tachycardia. When they checked my blood pressure inside the ambulance they stated it was very low. About 15-20 minutes later I tried to sit up and was still unstable and unable to keep myself upright without assistance. I was then taken by ambulance to the nearest hospital's emergency department. Nothing notable or unusual was found when I was checked out there. Within a couple hours I felt well enough to go home. Once home I had a headache, fatigue, mild dizziness, and nausea with physical activity. The following day I had a headache, muscle aches, pain at the injection site, and nausea with extended physical activity. Today I have pain in the arm where I received the vaccine and a mild headache.

10 hours after my shot I had moderate to severe chills with pains that moved around my body. Pain would go from deep pain in my leg, to hands, to feet. Not ache like the flu, but piercing pain. Head ache as well. This first round lasted for 1 hour and 36 minutes. Then, a break for almost two hours. Following that break, the next 12 hours i was achy throughout my body, headache that would come and go and very fatigued. I was only able to get out of bed for roughly 2 hours during that 12 hour stretch. Following this I ended up getting a fever later that night that lasted for about 2 hours (100.5 at the highest). Since that night I have had pain daily throughout my body. They are quick, sometime sharp pains in my head, and various muscles throughout my body. I have also had deep pains as well that have come and go in random muscles in my body.

5:30PM on Saturday 4/10/21 began chills and slight headache. Arm very sore. 7:00PM fever was 101, chills and headache worsening 9:00PM fever was 102.1, chills, massive headache and bones of legs hurt. 11:00PM fever was 102.7, all same symptoms except now whole body hurt and very cold. 4/11/2021 12:00AM fever was 102.9, all same symptoms, started Tylenol 2:00AM fever was 103.1, all same symptoms 4:00AM fever was 102.9, woke up nauseous 5:30AM fever was 102.7, threw up. 6:00AM fever was 102.9. Took more Tylenol 10:00AM fever was 101.1. Was able to sleep for 4 hours 12:00PM fever was 100.5. Took Advil (2) for headache. 5:00PM fever was 98.3. Took more Advil (2)- headache was still pounding. 9:30 PM fever was 101.5. Chills returned. Went back to Tylenol. 4/12/2021 1:00AM fever was 98.9. Chills were gone. Felt better. 7:00AM fever was 98.3. 9:30AM Feeling foggy. Left work to come back home. 9:45AM fever was 99.5. Took Tylenol. Head still hurting but manageable. 11:00AM fever was 101.1. Headache returning. 1:00PM fever was 100.9. Same general weakness. 3:00 PM fever was 101.4. Took Tylenol. 6:00 PM fever was 99.5. 9:00 PM fever was 99.0 11:00 PM fever was 98.2 4/13/2021 Slept through the night. Stopped taking medicine. 8:30AM fever was 98.6 11:00AM fever was 98.8 As of right now, I feel better outside of just general weakness from previous fever. At injection site is still extremely sore and today has developed to look a bit infected. It is itchy and sore to touch.

Fatigue, dizziness, chills, back/neck/muscle pain, fever 100F, headache, night sweats, starting after 6-8 hours, lasting 36 hours; still some lingering headache

4/10/21 - I took 4 low dose Bayer aspirin about 11:45 AM on 4/10/21. I received the Janseen COVID19 vaccine about 12:45 PM on 4/10/21. I cleared the 15 minute monitor period at 1:05 PM. About 8:00 PM on 4/10/21 I felt slight chills and left wrist was achy. About 9:00 PM on 4/10/21 chills persisted and I felt fatigued. About 9:45 PM on 4/10/21 I felt more body aches and took 4 low dose Bayer aspirin at 81 mg. About 10:15 PM I had a temp of 100.4 F and body chills. 4/11/21 - About 2:35 AM I had a body temp of 101.6 F with body chills and night sweats. About 11:25 AM body temp decreased to 99.9 F and had a headache. I took another dose of 4 low dose Bayer aspirin. I slept a total of about 3 hours from 10 PM on 4/10 to 10 AM on 4/11. About 9:00 PM body temp was 99.6 F. 4/12/21 - About 8:30 AM body temp was 97.9 and slept more than 5 hours with light to moderate night sweats. Experienced injection site pain from 4/10/21 to 4/13/21.

Fever, severe chills/violent shivering, extreme fatigue, loss of appetite, diarrhea, muscle/body aches, prolonged pain at injection site

BONE PAIN; HEADACHE; This spontaneous report received from a consumer concerned a 39 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced bone pain. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bone pain and headache was not reported. This report was non-serious. This case, from the same reporter is linked to 20210459724 and 20210459703.

Three days and continuing since onset Fevers of above 100(Tylenol sometimes controls fever) 2 every 6 hours Muscle aches Extreme fatigue Dizziness Shivering /hot and cold flashes Loss of strength Mental confusion Coughing Shallow breathing Loss of taste and smell Loss of appetite Nausea Sensitive skin(pins and needles)

Janssen Covid-19 Vaccine EUA. Symptoms started about 4-5 hours after injection. Headache and overall tiredness started on the first day. By the next morning 5/5/21, I was experiencing Muscle soreness, Joint pain, Headache. By the next evening, 24 hours after injection I was experiencing Extreme Muscle soreness and Joint pain, Piercing headaches, Fever, overall weakness and exhaustion. These symptoms continued on 5/6. By 5/7 the severity of the symptoms had lessened, But I continue to experience headaches, Muscle fatigue and weakness, and overall tiredness and an inability to feel well rested after sleep.

Pain in back, legs, shoulder and neck with ascending neurological symptoms, hypothesized as Guillain-Barre Syndrome. Still undergoing tests and physical therapy.

day followimg shot: i awoke to extreme pain in all muscles and joints, profuse sweating, blurred vision, headache just behind my eyes muscle/joint pain lasted approx 24 hours; ibuprofen offered some relief. sweating lasted 3 days and resulted in dehydration to the point where my kidneys ached; i drank as much water as i could but my urine remained dark headaches/blurry vision lasted 2 days 5 days after the shot, the soles of my feet began to feel itchy, and the itchiness has been ongoing even up to now (7 days after shot) 7 days after shot, itchiness has also begun affecting the palms of my hands

injection given into left deltoid, within 5 minutes, patient complained of syncope, then became flaccid. He never lost consciousness and kept talking to immunizer. we applied a cold compress to neck and gave water and accompanied patient until he departed the store

He has s had severe pain in left shoulder that radiates pain up into his neck, causing some headaches and seeing black spots. He cannot put his arm behind him, raise it up very high, and interferes with everyday living which is causing a lot of frustration and depression! It's been about 5 weeks and has taken Advil & Tylenol with no relief; feels the same pain & lack of mobility each day with no improvement.

Since june 10th I had experience a headache non stop every day, it feels like my head is really heavy and my neck is contracted, I had gone to the doctor, recommend a HEAD TAC but everything is ok, also I have been taken tylenol everyday for the headache. It is unbeareble this pain.

After shot experienced joint pain, left arm and next day work for two hours tired, weak, left early, second day felt sleepy again and chest pain and pounding heart. Third day came to work felt tired went to emergency room EKG. Fourth day sit down felt drowsy heart complications.

Neurological symptoms, nerve tingling, numbness, headache, neck and shoulder pain, pain in right leg first reported on 4/13/21

PATIENT PASSED OUT MOMENTARILY FOR NO MORE THAN 30 SECONDS WITHIN 5 MINUTES OF RECEIVING VACCINE DOSE. PATIENT SELF-REPORTED FEELING ONSET RIGHT BEFORE SYNCOPE OCCURRED. HE SLUMPED BACK IN HIS CHAIR (DID NOT FALL) AND ARMS DROPPED TO HIS SIDES. DURING SYNCOPE PATIENT HAD SHALLOW AND QUICK BREATHING AND TURNED PALE FOR ABOUT 15-20 SECONDS. BREATHING THEN NORMALIZED FOR 10 SECONDS AND PATIENT REGAINED SOME COLOR TO COMPLEXION. PATIENT FINALLY WOKE UP FEELING SLIGHTLY NAUSEOUS, DIAPHORETIC, AND STILL SLIGHTLY PALE. HE WAS PROVIDED WATER AND A GLUCOSE TABLET AND VITALS WERE TAKEN. HE DECLINED PARAMEDICS OR ANY EMERGENCY ASSISTANCE, AND LEFT THE FACILITY ON HIS OWN.