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.

Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Nausea-Medium, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Patient complained of nausea/dizziness followed by blurry vision. He felt like he was going to black out. I took his vitals at 11:43 am and his BP measured 78/53 with a pulse of 45. He was also sweating profusely. The paramedics came within a 5 min time frame and patient was stabilized within 10-15 minutes later.

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.

Approximately 5-10 after vaccination, pt began to feel lightheaded, became diaphoretic and pale and felt like he was going to pass out. Pt was lowered to the floor and placed in trendelenburg position. Vitals stable. Pt reported fingers feeling number. EMS was called and pt was evaluated and released. Pt remained at clinic being monitored until he was completely back to baseline.

Patient is a 26 y.o. male who received the Janssen Covid-19 Vaccine, Ad26.COV2.S (PF) 0.5 mL IM Susp, Lot 1805020 on 3/12/2021. Vaccine administered at 1610 and reaction was immediate. The patient experienced the following reaction(s) during the immediate observation: pt presented chills and shivering upon administration of vaccination. Brief altered mental status and decrease in HR. Staff talked pt through symptoms. PT stated "I pass out after hang a shot." Also informed staff that he is a runner. 1621 VS- 100/62, P-56, R-99, noted pale, shivers, clammy hands and cold 1627 VS P-61, O2-100% 1629- BP 104/64 and shivers improving 1635- Stood patient up and moved him to chair in post vaccination area 1637 VS 102/64, P-61, O2 sat- 100%, R-22 1652- P-50, O2-99% 1659- P-47-56, O2 sat 100%, BP- 122/62- good color, shivers resolved HR Increased to 56. Pt is now stable and ambulating. Patient was treated/managed as follows: assessed vitals until wnl, wrapped patient and covered, cool damp cloth, offered therapeutic communication, cool water, and stayed with patient until he was able to ambulate. Left vaccination site accompanied by mother @ 1720. Patient given educational material regarding vaccine and advised to continue to self-monitor per the agency guidance. Education patient on how to seek primary provider or additional medical management if symptoms return.

Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Severe, Systemic: Visual Changes/Disturbances-Medium, Additional Details: Patient has history of fainting with IVs but never to vaccinations. He said he gets stomach aches with sugar derivatives. First BP taken was 107/93 with a low pulse. 5 minutes later it was 165/93 pulse 99. We called the paramedics and they came within 5 to 10 minutes. Patient stabilized after.

I received the vaccine at 4:20 PM on Friday (3/12). I had no adverse effects until after I fell asleep. I woke up at 2:00 AM with a fever, body aches, headache, and severe nausea. I proceeded to vomit until 6:00 AM. The following day (3/13) included mild headache, mild body aches, and slight nausea. By Sunday (3/14), all negative symptoms had gone away.

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.

Went most of the day with no symptoms. Performed a High Intensity Workout around 7pm for an hour, and ate shortly after. Took a hot shower and relaxed before bed time around 10pm started to have a headache. By 10:45 when I went to sleep it was an intense headache. Under the covers my body was incredibly hot, without covers I was freezing cold. I woke up around midnight in a sweat and again around 2:30am when I called in sick to work. I then sat in my bathroom for 30 minutes, threw up once, and then feeling much better (Still had an intense headache) I drank some water and fell back asleep in my room. Today is the second day, I have a small headache, have not eaten all day, and slept most of the afternoon. I highly recommend not working out the same day of getting the vaccine, I didn't think to ask about that when I received it. I doubt I would have had this problem if I rested instead.

Quick onset of nausea, stood up and hearing was lost and felt ready to faint, drank a Gatorade and water and sat on the ground. Hearing came back after 5 minutes, but moderate body shakes began and lasted an hour. Got very cold feeling and began to feel fever like. Took acetaminophen and covered up with blankets and drank water. Took a couple hour nap and woke up sweating with terrible migraine and light body shakes. Fell asleep for a few more hours and woke up not feeling feverish, but migraine and body aches. 22 hours after onset I have a light headache and body aches and am mostly feeling recovered.

Immediately after standing up experienced ringing in the ears and faintness. Was helped back to nurse who laid me for 15 minutes for observation. When I laid down I became very flush and sweaty. Then at 12am experienced fever of 101, body aches, and sharp stabbing chest pain which has lasted 18 hours so far.

NAUSEA, BLURRED VISION, SWEATING, FELT LIKE PASSING OUT - SUSPECTED PANIC ATTACK - PATIENT FELT NORMAL AFTER 20-30 MIN

Patient stated they felt "lightheaded, clammy and sweaty". BP was 72/48, HR was 44, and O2 sat was 99%. Started about 10 minutes after receiving vaccination. No interventions needed and no transport. Recovered on own and was able to walk out of clinic.

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.

Nausea and vomiting within 5 minutes of receiving the vaccine Chills about 7 hours after receiving vaccine Fatigue throughout the following day after receiving the vaccine

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

Starting last week I had cold symptoms, massive headaches, and this week I no longer can smell or taste. I got a covid test to ensure i did not get sick in the meantime but it came back negative..

Initial symptoms of visual impairment, later diagnosed as visual snow, occurred on Sunday 3/28 along with a headache. Assumed it was a migraine, but after it continued on Monday 3/29 I called advise nurse and scheduled exams for my eyes. The eye doctor confirmed it seems to be experiencing symptoms of visual snow. My vision is currently still looks like static. It has not gone away. Google search showed potential side effect of astrazeca vaccine in their report so am assuming it is also a side effect of the Johnson and Johnson vaccine as this occurred as a result of receiving it. I never had this before.

around 10 pm started with chills and fatigue with a sore injection location. Around 11:30 pm he got light headed and passed out for 4 seconds. After awaking he doesn't remember the last 5 minutes. He laid down to go to sleep and was consistently hot and then cold. He does have a history of night terrors but they have remained dormant for about 2.5 years. Around 12 am he started having one of the worst night terrors I've seen. The following morning, April 2nd 2021, he was feeling incredibly sore and the injection spot was tender. He said "it feels like I got hit by a truck." Seems to be doing okay otherwise now.

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.

About 5 minutes after administering vaccine I found patient sitting in chair experiencing a seizure and was unresponsive for a couple of minutes. Patient was pale and had perfuse sweating. After a couple of minutes patient was able to speak and was coherent. We called paramedics and they checked hi out in ambulance. Patient was released and was ok

After taking the vaccine on March 19,2021 that same day he had a fever of 105. 8 days after the vaccine was inserted in his arm in March 27, 2021 he got a seziure and was rushed to the hospital. Today April 5 2021 he got another sezuire and was taken to the hospital.

I have started to feel symptoms of intense shivers and a headache that has gotten progressively worse through the night.

Nausea after about 1 minute, fainting, low blood pressure lasting 15 minutes, cold chills lasting ~1 hour. Fever over 103F recorded ~11 hours after injection.

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

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.

Janssen COVID-19 Vaccine EUA When I went to bed, I had chills that lasted until I fell asleep. I woke up around 3AM, I no longer had chills, but I had a migraine that lasted about an hour until I fell back asleep. When I woke up I'm the morning, I still had a slight headache.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional Details: After administration of vaccine, patient was still seated in the waiting area. I went back and checked on him after 5mins of waiting, then came back to the pharmacy. But heard a big bang shortly after. Some how, he had fallen out of his chair and bumped his head and neck on an end camp. He seemed a little confused, when I ran over, but was awake, a little sweaty and nauseated. EMS was called. They transported him to ER to have his head checked, since he bumped it.

Pt is a 26 yo M with a documented allergy to Amoxicillin (rxn: Rash; severity: Not Specified; since 01/19/2018). On 04/08/21, pt presented to clinic for immunization. At 0834, pt was administered COVID-19 J&J (Janssen) Vaccine 0.5 mL in left deltoid (Lot #207A21A; Exp: 6/23/2021; NDC #59676-580-15). After injection, pt became diaphoretic and dizzy. Pt reported similar reaction with blood draws. Pt was placed in supine position, given water and ice packs were applied to his neck. Pt evaluated by MD with no new orders given. After 10 minutes of observation, pt reported symptom resolution and return to baseline. Vitals assessed as BP: 126/81, P: 77, O2 sats: 97%. Pt discharged in stable condition.

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.

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.

As soon as I go the shot I didnt have any severe symptoms, but as I drove (20 min) to reach my home. After reaching my home even after few hours also I didnt have any symptoms. But before I went to sleep (around 12:30 am ), i started to have mild pain near the vaccination sight. Even during my sleep i felt okay, but as soon as I woke up (around 09:00 am) i felt mild symptoms on pain, as I started attending to my regular activties right after 10:00 am, i started to feel severe chills, fever, body pains, lazyness, moderate headache and severe pain at vaccination site. Again I had some food and slept due to severe body pains and even through the sleep also I had severe body pains, fever, nausea and lazyness. As I woke up after my evening nap of 3 hours, i woke up at 6:00 pm and felt chills, body pains., fever and nausea.

Started experiencing fever/chills and headache around 7:00pm the same day. Now (the next morning) I am still experiencing chills, mild headache and body aches.

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.

Difficulty breathing (short and shallow breathes), vomiting, increased heart rate, nausea, dizziness, numbness in extremities, headache and weakness and tiredness. Symptoms arose approximately 8 hours after vaccination (between midnight and 1 AM, 4/9/21) and persisted until approximately 5 AM, coinciding with sleeplessness. Throughout the entirety of the next day nausea, headache, and weakness persisted. After 36 hours, mostly bedridden, and 12 hours of sleep the following night symptoms have dissipated as of 10 AM 4/10/21.

Flu like symptoms, SEVERE muscle cramps. Loss of feeling in limbs. Headache and nausea. Lightheaded. Chills and shaking.

Patient fainted from sitting position and hit forehead. Had symptoms of nausea, HA, and laid down for 15 minutes. Drank OJ, ate chips upon sitting and laid back down due to dizziness. Patient sat up, vomited, and continued symptoms of headache. Stayed in observation for an hour and felt better enough to go home with friend. Recommended patient visit medical provider if no improvement or worsening of symptoms.

Flu like symptoms next day. Hives beginning next day starting on injection arm, and spreading to entire body over the course of the next week. Largest is approximately 6"x3", about 1-2 dozen quarter sized on arms and legs, many more approximately dime sized or smaller covering rest of body.

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

While at recovery pt complained of dizziness, became pale and diaphoretic. Immediately sat pt on floor( refused to elevate feet). leaned against wall with ice pack to back of neck , water for hydration. no LOC no SOB no N/V. VS taken 130/72, HR 98 reg strong, resp 16 reg non labored, SopO2 97% Pt stated this happened before with tetanus shot a long time ago. Monitored 30 minutes. Provided reassurance pt stated I feel fine now. OKd to exit

Approximately 7 hours after vaccination, chills, fatigue, and body aches began. Two hours later, nausea and vomiting and a fever started and continued off and on for eight hours. Fever broke the following morning and vomiting ceased. Back to feeling healthy approx. 24 hours after vaccination. Did not use any medicine, drank adult Pedialyte to replenish fluids.

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.

J&J vaccinated @1030 today. HA, chills, fever and bodyache started @1600. Took tylenol 325mg po x4. Denies difficult breathing, chest pain or cough. History: pt here for fever of 104F at home since 1600. Had J&J COVID vaccine in the morning today. Has body ache, headache, light sensitivity, slight nausea. Denies any symptoms before vaccine and denies vomit/diarrhea, rash, cough, runny nose, ear pain, recent illness/injury, recent sick contact, recent procedure, prior co-morbidities. Took 4 tylenol pills at around 1830. Ibuprofen or NSAIDs make pt's throat swell up.

Janssen COVID-19 Vaccine EUA. When I was going to bed, I had very bad chills, leg cramps, shortness of breath, and a pounding headache. my vision was a little blurry at times too.

Symptoms: cool, pale, diaphoretic, Vitals: 110/70, RR 16 pulse 88 O2 96% Intervention/treatment: assessed vitals, gave patient juice & water Passenger switched to driver side to drive patient home

Within 12 hours of injection: Body aches, fever, severe chills ( convulsions ), headache, nausea, threw up three times, passed out.

Arm pain immediately after the shot. 3:45 PM. Headache, eye soreness, sinus pain - 11:30 PM. Chills and shakes - 2:30 AM. Sweats - 4 AM. Continued tiredness throughout the day.

The patient was nervous prior to vaccine and had a needle phobia. About 5 minutes post-vaccine, the patient stated he was not feeling well and feeling warm and sweaty. The pharmacy staff provided the patient with water and an ice pack. The patient stated he was feeling faint. The patient fainted for about 20 seconds and then became conscious again. The patient didn't have any injuries and didn't fall down. The patient was okay and he laid down and elevated his feet on a chair. He then stated that he has severe needle phobia and has fainted several times in the past with vaccine administration and blood draws. He had experienced this in the past. He was still slightly faint and requested that he be checked out. The EMT arrived and they took his vitals and checked him. By the time the EMT arrived, he was beginning to feel better and had sat up and drinking water. There were no further issues. The EMT stated he was good to head home. We followed up with patient and the patient was feeling good with no further issues.

Severe convulsions, harsh chills, 102 fever, sweating, and migraine headache around 9 hours after vaccination. I have had a strange and non-stop headache ever since that day, and my entire body feels like I had went to the gym and did hardcore aerobics. Those are the main two symptoms I still have as of now. I am afraid my body is being set up for a blood clot.

I felt aching on my entire upper left arm all the way to shoulder. Had a minor fever midnight which make sleeping difficult. Fever stopped on 4/10/ 21 evening. Ache stopped on 4/12/21. I consumed 4 panadol pill in total, 2 on 4/9/21 midnight, 2 on 4/10/21 morning

nausea & dizziness; clammy, diaphoretic; pallor; TX - mask removal / air flow; increased air condition; car seat recline; cool cloth to forehead; emotional support; after 15 mins, returned to upright position after symptoms much improved - no further dizziness; given water; 1625-assisted to passenger seat by 2 . Wife drove off observation lot.

Patient received Janssen( Johnson and Johnson ) Covid vaccine on Friday 4/9/2021. Patient attended work that evening . Mother reports patient complained of feeling dizzy weak fatigued and generally not well when got home that evening at 10pm . Redness pain and swelling noted ot injection site on left arm noted at that time also. Nausea and vomiting began on saturday 4/10/2021. Nausea vomiting dizziness malaise fatigue continued through Tuesday 4/13/2021. Redness and swelling and pain to injections arm. Consulted verbally with family practice physician on Monday 4/12/2021 Benadryl and anti nausea medications used with some improvement . Injection arm visually inspected non-visit . patient missed work and school Saturday 4/10/2021 through Tuesday 4/13/2021 . report received on Thursday 4/15/2021 that patient's nausea vomiting has resolved but continues with dizziness headache and injection site with redness, swelling . Swelling has not increased but has not decreased

I received the J&J vaccine at 10:00am on March 18, 2021 at the Community Center. By about 5:00pm, I started to feel minor flu-like symptoms, but as the night progressed it got significantly worse. Around 8-9pm, I was bedridden with the worst chills/shaking I've ever experienced in my life. Around 9:30-10:00pm, I was filling water at my sink and projectile vomitted multiple times into the sink and could not make it to the bathroom. Subsequently, I ate a bagel and drank lots of water, knowing my vomitting could make me dehydrated. Throughout the night, I was awake and shaking, and drank and filled my water bottle repeatedly. At 8:00am, I was filling my water, and without my knowledge of awareness, fainted on my kitchen floor, dropping the Brita filter and likely hitting my head. My roommate heard the commotion and saw me passed out in our kitchen. He tried to wake me up and I phased in, but then subsequently phased out again 20-30 seconds later as I was trying to stand and likely hit my head again. My roommate eventually got me over to our couch and called EMTs. Upon their arrival, EMTs checked my pulse, which was fine, and saw an open laceration on the back of my head, so they took me to Hospital to access the Trauma Center. On the way, I threw up repeatedly and was very lightheaded. Upon my arrival at Hospital, I was checked for any neck bone breaks, given an IV, a CT scan, an EKG, and staples were placed in the back of my head to heal the laceration. After my release, I was bedridden for 2-3 days and required a daily nap during work (1-2) hours for the next 1 1/2 to 2 weeks. For a while, everything was fine, but recently during the first two weeks of April, it has become apparent that my head is foggy and reacts to changes in the weather, which leads me to believe that I likely banged my head pretty good when I fainted those two times.

BLUE NAILS; CHILLS; FEVER; HEADACHE; SORENESS ON INJECTION SITE; This spontaneous report received from a patient via a company representative concerned a 26 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced blue nails. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced soreness on injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blue nails on 09-APR-2021, and had not recovered from fever, chills, headache, and soreness on injection site. This report was non-serious.

BLOOD SUGAR WAS 9; BLOOD PRESSURE 132/95; NAUSEA; PAIN IN BACK OF HEAD; DIZZINESS; LOSS OF CONSCIOUSNESS; This spontaneous report received from a physician concerned a 26 year old male. The patient's weight was 245 pounds, and height was 172.7 centimeters. The patient had no known allergies and had no chronic medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: 202A21A and expiry: unknown) dose was not reported, 1 total, administered on left deltoid on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the patient complained of dizziness, nausea and pain in back of his head. Once the nurse arrived at the cell, the patient was on the floor with loss of consciousness. He was placed on a stretcher following which he regained consciousness. His vitals signs (unspecified) were stable, blood sugar was 9 (unit not provided), blood pressure was 132/95 (unit not provided) and respiratory rate was at 18 (unit not provided) (NR: not provided for all tests). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of consciousness on APR-2021, had not recovered from dizziness, nausea, and pain in back of head, and the outcome of blood sugar was 9 and blood pressure 132/95 was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210420193- Covid-19 vaccine ad26.cov2.s-loss of consciousness. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

LOW DIASTOLIC PRESSURE OF 40; LIGHT HEADED; SWEATING; 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 received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 041A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 10-APR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the patient experienced low diastolic pressure of 40, light headed and sweating. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from low diastolic pressure of 40, and had not recovered from light headed, and sweating. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210420610-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Blood pressure diastolic low. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

SORE ARM; NAUSEA; FEVER; CHILLS; FATIGUE; HEADACHE; 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 asthma, mental health, penicillin allergy, and sulfa allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018 expiry: UNKNOWN) .5 ml, administered on 05-MAR-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, the subject experienced sore arm. On 05-MAR-2021, the subject experienced nausea. On 05-MAR-2021, the subject experienced fever. On 05-MAR-2021, the subject experienced chills. On 05-MAR-2021, the subject experienced fatigue. On 05-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea, chills, and fatigue on 06-MAR-2021, was recovering from fever, and had not recovered from sore arm, and headache. This report was non-serious.

Initial adverse reaction was a headache and impaired vision. My vision has continued to be impaired with it being similar to static and has caused headaches. After research I saw AstraZeneca had this in their files as a possible side effect. I understand it is different but made with similar technology so it may or may not be true for J&J vaccine, but this has continued for almost a month so I am concerned.

Started with pain in the abdomen and chest after sinusitis Flammable throat started The phlegm has already drained everything I had. Without sinusitis Only fever and sore throat Fever. sweating all night yet I'm using medicine for those sintomas

THE PATIENT STARTED SWEATING WITH SHAKES FOR A FEW MINUTES THEN STARTED FILLING COLD HE STATED IT FELT LIKE SEIZURE NOT SURE IF THAT'S WHAT HE HAD. HE STATED HIS CHEST FELT TIGHT. HIS EYE MAY HAVE ROLLED BACK NOT SURE AFTER A FEW MINUTES(5-10 MINUTES) HE STARTED FILLING BETTER WE CALLED 911 AND THEY CAME WITHIN 5-10 MINUTES HE WAS OBSERVED FOR A WHILE HE SAT ON THE CHAIR TILL BETTER AND WENT TO ER FOR FURTHER OBSERVATION

The patient wanted to go to the restroom after getting the vaccine. He said he felt a little nauseous and had a slight headache but felt ok to walk to the bathroom. After returning from the bathroom, the patient informed he gotten a little dizzy in the bathroom and passed out. His head was bleeding. Patient informed his head was hurting at hit sit, feeling nauseous, vision a bit blurry and did throw up a bit. He was able to state his name, address, DOB, and was cognizant. There was no signs of SOB or allergic reaction. The EMS was called and it was detected his BP was a little low. Patient did feel a little better but it was advised to go to the hospital to make sure he did not have a concussion. Patient was then escorted by EMS to the hospital.

Patient got vaccine and sat down for observation. He reports that after 1 minute, he was shakey, sleepy, and very tired. Then he felt like he fell asleep until the person checking him called at him. He had some vision and hearing impairment at the beginning, then after 10 minutes he was better. His arm was hot, he was sweating, his skin was turning white color. His mom came (she was shopping) and said the patient is usually an anxious person, so it was overwhelming to be at department store and getting the shot. After another 10 minutes, he was drinking water, his senses were back, he was fine.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient had a syncope event shortly after receiving Janssen Covid vaccine. Patient put feet up and laid back for additional 10 minutes after initial 15 minute observation. BP and Pulse were not significant (176/79 and 79). Patient recovered after 25 minutes and went home.

itchy skin on belly. Approximate 10 red dots which are similar to the reaction of Mystique bite. It appears after fever at 37.9C.

Patient became weak and fell to the floor. Patient felt lightheaded and was sweating profusely. We monitored his blood pressure and it was 104/65 with a pulse of 45. The patient never lost conciousness. We monitored his BP and HR over the next 30 minutes and it eventually went back to normal of 134/86 with HR of 57.

26y/o AD male J&J vaccine yesterday, today has Mild HA, but body feels heavy as if he is wearing his kevlar and full kit. denies NVD,

Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Shakiness-Mild, Systemic: Vomiting-Medium, Additional Details: patient fell in the ground a few min after he received vaccine and he started sweating. pt felt better after he vomited and refused to go to the hospital

7 May 2021 0900 hours - Vaccine received 0945 hours - Mild paresthesia experienced throughout left side of body (arm, leg, back, shoulder, neck) 1100 hours - Onset of mild headache 1630 hours - Experienced fatigue and lightheadedness 1800 hours - fever of approximately 103 degrees, chills, shivering, body aches, and moderate headache 1900 hours - Individual's face and extremities became cold and discolored: hands and lips of purple hue. Individual also experienced muscle spasms and cramping in back and legs. 1800 - 2300 hours - Aforementioned symptoms persisted in cyclical fashion. At one brief point, individual experienced dull pain in testes. 2300 hours - Continued fever with nausea, painful headache, and body aches. Individual unable to sleep due to headache. 7 May 2021-8 May 2021 2300 - 1100 hours - Aforementioned symptoms persisted. 1100 hours - Fever and headache subsided, but body aches persisted. Individual did not treat symptoms with OTC medication

Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Patient went unresponsive approximately 30 seconds after vaccine administration, was unresponsive for a total of 30 seconds, his neck and face were flush, pupils were dilated and his eyes wandered. He woke up confused.

Presented to urgent care on 4/10/21 with cough and sore throat for about 2 days. Symptoms worsened and he presented to the emergency department on 4/11/21. He was found to by COVID-19 positive at that time and was admitted to hospital for further management. He was discharged from hospital on 4/19/21.

- a 26 yo male, received a Janssen vaccine at approximately 1:30pm on 5/9/21 - Prior to administration, I asked patient if he had any issue with vaccines prior and he stated no. His consent form did not indicate medication allergies or a history or reactions. - Less than 5 minutes after administration, the patients friend, who also received a vaccine, stated that he was having a seizure - I instructed her (pharmacy technician) to call 911. - I observed the patient laying on his side by the wall in the pharmacy waiting area; he was conscious with eyes open. I did not observe him seizing. He did have a red spot on his forehead where his head hit the wall. He was also sweating. His friend stated that he seized for less than 5 seconds. - I gave the patient a frozen water bottle for his head and a room temperature water bottle. - The patient stated he did not want to pay for an ambulance which I relayed to her . - The EMT did arrive anyway and checked on the patient. - The patient and his friend left the store together, without EMT support or transfer. - The EMT team did not communicate with me prior to leaving the store.

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.

SUSPECTED URETHRAL MUCOSITIS; CLOT; PENIS TIP GOT RED; PENIS PAIN; SAW ANGELS AND DEMONS IN BED; TERRIBLE MALAISE; HEADACHE; FEVER 40 DEGREE; 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 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, 1 total, administered on 02-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-MAY-2021 at night, the patient experienced some symptoms after vaccination including Fever of 40 degrees Celsius, headache, and a terrible malaise. The patient also reported seeing angels and demons in bed; Also, the patient noticed that the penis tip got red and experienced pain. On 05-MAY-2021, the patient continued with the symptoms, and it seemed as if a clot was generated. On 06-MAY-2021, the patient had an appointment with general physician who informed that he never saw an adverse reaction like this after vaccination and that it could be a urethral mucositis. On 10-May-2021, the patient would have an appointment with the urologist to inform the symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever 40 degree Celsius, saw angels and demons in bed, headache, terrible malaise, penis tip got red, penis pain, clot and urethral mucositis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20210513944-covid-19 vaccine ad26.cov2.s -thrombosis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Pt got J&J vaccine around 1:25pm. After shot administered, while talking to me, patient suddenly slumped over into my arms and eyes rolled back and lost consciousness for about 10 seconds and he was making some gurgling noise. Some excretions came out of his nose and he came to and was able to lie on floor to elevate his feet, but still was very dizzy. First responders showed up and his vitals were WNLs, but pt continued to look pale and struggle to come to upright position for another 15-20 min. Pt's friend showed up to pick him up and he was able to walk out to the car without issue.

PALPITATIONS; HEADACHE; FEVER 102 F; 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 received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAY-2021, the subject experienced palpitations. On 14-MAY-2021, the subject experienced headache. On 14-MAY-2021, the subject experienced fever 102 f. Laboratory data included: Body temperature (NR: not provided) 102 F. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, fever 102 f, and palpitations. This report was non-serious.

I woke up in the middle of the night experiencing severe chills and shaking, my body was cold to the touch and I was unable to get warm. This lasted for several hours until finally fading away at around 12:30-1:00 PM on the same day (May 20th, 2021), at which point I developed a mild fever. I was unable to find any report of this side effect of severe chills/shaking on the vaccine's pamphlet that I got.

About 11 hours following injection experienced body aches, chills, and overall run down feeling. I took 400mg of Ibuprofen every 4 hours starting 4 hours after symptoms on set and was fine 6 hours after first dose.

Received shot and waited for the 15 minutes as required, feeling no good with no symptoms. While driving home after leaving the pharmacy, I started experiencing light headed ness and dizziness. This eventually turned into tunnel vision which I thought was going to result in me fainting. This led me to start pulling over, but then the tunnel vision went away. During my short 10 minute drive home, this happened to me twice. After getting home, I had about 3 similar episodes during which similar light headedness happened. These all felt like they were getting close to fainting, and at one point while walking up the stairs in my house I could not stand. All of these symptoms started approximately 20 minutes after leaving the store, and then took place in a 20-30 minute timespan. Roughly 4-5 episodes in total, including the drive home and short time spent at home. No issues after lightheadedness stopped, besides feeling tired. I do not have a history of anxiety attacks due to needles. Donated blood and plasma in college, and have recieved many vaccines and never had this happen.

patient reports fever, chills, diarrhea that started yesterday. states was vaccinated yesterday J&J vaccine. was called today by someone stating was in contact with someone that tested positive.

DIARRHEA; UPSET STOMACH; FATIGUE; WORST NAUSEA EVER; 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 pre-existing medical conditions included patient took gatorade.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 23-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced worst nausea ever. On 25-MAY-2021, the subject experienced diarrhea. On 25-MAY-2021, the subject experienced upset stomach. On 25-MAY-2021, the subject experienced fatigue. Treatment medications included: bismuth subsalicylate, and paracetamol. The action taken with covid-19 vaccine was not applicable. The outcome of the worst nausea ever, diarrhea, fatigue and upset stomach was not reported. This report was non-serious.

I got fever, severe pain in the body from the tip of the head to the toes, without exception. All this for 4 days. In this same period snot and gag, throat felt a bit clogged and I did force myself to breathe the first day. Headache, tiredness, a little diarrhea only for 2 days.

few minutes after the patient had the vaccine, he felt dizzy, start sweating, his face and lips looked pale. we gave him water and snack, then he felt fine. this just last 5 minures.

chill, hot flashes day of vaccine and during the first night, extreme headache for the first week , fatigue for at least 2 months, nausea, dizziness for the first day, mild headaches lasted for at least 2 months since vaccination

5 MINUTES AFTER GETTING THE VACCINATION, PATIENT FAINTED WHILE SITTING IN THE CHAIR AND WAS GASPING FOR AIR FOR A FEW SECONDS BUT CAME TO RIGHT AWAYS AND SEEMED ALERT. PATIENT REPORTED EXTREME NAUSEA AND WAS SWEATING PROFUSELY. EMS was contacted and patient was taken to the hospital. A lot of tests were ran and it was concluded that patient vasovagled and was released from the hospital.

Medical evaluator reports: profuse sweating, delayed response, near syncopal. EMS reports: Pt feeling dizzy with Blurred vision after receiving shot.

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

15:50pm ?patient was injected Janssen-J&J COVID-19 vaccine to Lt. deltoid muscle ? 25gauge-1? safety syringe used w/o difficulty. Side effects/adverse reactions explained to client, verbal acknowledgement and consent obtained. Written consent signed prior to injection. 16:20pm ? Patient was carried to clinic area by 3 fellow patient. He presented obtunded, grey pallor, face noted to be profusely diaphoretic with gasping attempts at respiration. P-110. Unable to respond to verbal commands, unable to speak or open eyes. Brisk taps to his face and calling his name elicited a slight optic response by visible attempt to open his eyes. At this time, he was observed to grimace, grab his throat and jerk himself upright, proceeded to projectile vomit a moderate amount of clear fluid. Immediately slumped off chair and was limp and non-responsive to commands. EpiPen Auto Inject administered-0.15mg Epinephrine to Lt. anterior quadriceps. Pulse-126, gasping during respiratory attempts. Skin frigid to touch. 16:22pm- B/P-150/101- P-58 per portable wrist B/P monitor. Respirations -22-rapid and shallow, appearing to hyperventilate. He attempted, but unable to follow instructions for calming and deeper breaths at this time. Fellow seamen and the 2nd Officer, carried him to the ship ?hospital? area accompanied by me RN, monitoring continued. Patient responded rapidly to administered Epinephrine. 16:23pm-B/P-148/108-P-68-per monitor-R-20 - Responsive to name, LOC x3, visible muscle twitching and tremors. Remains diaphoretic, pallid, and skin is cold to touch. Speech is slurred and weak, client continues to be lethargic and slow to verbal responses. C/O of ?bad HA?. 16:30pm- two-500mg Paracetamol tablets PO with H20 administered by 2nd Officer for increasing HA pain per patient request. Lights dimmed in room. Clear soup and a coke ordered for patient due to suspected hypoglycemia based on reported pt. hx of limited caloric intake in the past 12 hours. Attempting to locate a glucose meter on ship at this time. 16:38pm ? B/P-139/87-P-69-per monitor-R-20- C/O severe HA and feeling weak. C/O muscles twitching in extremities. Visible twitching noted. Reassurance provided. 16:43pm- B/P-139/87-P-69-R-20 ? Pt. fed clear broth soup and 12oz Coke PO without difficulty. Resting quietly. Appears to be tired, with continued slow responses to questions and weak speech. Pt. continues to be concerned about his exaggerated leg muscle twitching. Reassurance provided and informed of effects of epinephrine. 16:52pm ? B/P-133/86-P-65-per monitor-R-18- Personnel informed of need to transport by EMS to the Hospital for extended monitoring and evaluation by Physician per CDC adverse response to COVID-19 vaccination Protocol. Report given to personnel ? Technical Superintendent- who began transport requests through EMS services. Report to RN Supervisor. 17:07pm- B/P-126/83-P-85 per monitor-R-18- Monitoring pt. at BS. VSS. C/O severe HA and feeling ?weird?. Exhibiting pain with HA despite previous Paracetamol PO by squeezing his head and stating it hurts. Continues to be pale, mucus membranes pale, lower extremity muscle twitching is annoying him. Patient states he is feeling better after receiving food and liquids. OX3. Assisted to BR by fellow patient. Pt. reports urination w/o difficulty. 17:20pm ? Report given to EMS personnel. Transported from ship. Assisted Ambulatory by EMS and fellow personnel to stretcher at gangplank, and into ambulance.

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

Soon after administration, patient got hot, sweaty, and had tunnel vision/ blurry vision. Checked blood pressure and was 54/40. Called EMS for support. Patient was light headed and shaky, would respond to questions and commands but a bit slow. Eyes seemed to be rolled back in head, but never lost consciousness. 2nd BP check was 94/62. EMS arrived at 11:25, patient began feeling a bit better at 11:30. paramedics arrived at 11:34. Patient moved to ambulance for observation until picked up to return home. Was not transported to the hospital. Checked in on patient at about 4:30 and was feeling well.

BODYACHES; CHILLS; FEVER; This spontaneous report received from a patient concerned a 26 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid/caffeine/paracetamol/salicylamide. On 30-MAY-2021, the subject experienced bodyaches. On 30-MAY-2021, the subject experienced chills. On 30-MAY-2021, the subject experienced fever. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from fever, chills, and bodyaches. This report was non-serious.

Patient recieved Covid vaccination from our intern and 10 seconds later reported feeling dizzy and unwell. Pt sat down immediately in consult room but then fainted and fell out of the chair and landed face first on the floor and experienced seizing motions. Patient was out for 30 seconds to a 1 minute. The patient came to and reported feeling better, wanted to sit up and wanted water. A water bottle was provided for the patient. 911/paramedics were called and 3-5 minutes later the patient fainted with seizing motions again but was supported and did not fall out of chair again. shortly after the second fall, paramedics arrived and took over. patient ate 4.5 hours prior to vaccination and also reported never fainting before after or while getting a vaccine.

Status post receiving J&J on left deltoid. Patient stated he has a fear of blood prior to receiving the vaccine. Patient went to the observation area and was noted to have a syncopal episode witnessed by RN. Patient was noted to be pale and diaphoretic. Patient was lowered to the ground by two (2) RNs. RN held c-spine while lowering patient to the floor. He was nonresponsive for approximately 30 seconds. No injuries were noted. After being lowered to the ground in supine position, patient was A/Ox4. Vital signs were assessed as follows: O2 was 98%. HR was 65. Temperature was 98.1. BP was 116/75. Respirations were 16. Patient stated he has a history of a similar incident that happened 7 years ago when he cut his finger he "passed out." EMS was called at 1425 and arrived at 1430 and assisted him into a chair. Upon checking his blood sugar, patient immediately had a second syncopal episode/LOC while EMS was on scene. Patient was again lowered to the ground in supine position. EMS performed a 12 lead EKG and transferred him to a stretcher. Patient A/O x4 prior to EMS departure. EMS left with the patient at 1445.

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.

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

Was lightheaded, hot and sweaty, tingly and numb left and right arms. Had him sit down and gave him some cold water. Called 911. They came and evaluated him. Said he was okay to go.

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.

CHILLS; SORE LEFT ARM; HIGH FEVER 103.9 F; HEADACHE; 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 non-smoker, and alcohol user, and other pre-existing medical conditions included the patient had no known drug allergies. no drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A expiry: 07-AUG-2021) dose was not reported, administered on 12-JUN-2021 for prophylactic vaccination. Concomitant medications included paracetamol/ dextromethorphan hbr /guaifenesin / pseudoephedrine hcl for fever. On 12-JUN-2021, the subject experienced chills. On 12-JUN-2021, the subject experienced sore left arm. On 12-JUN-2021, the subject experienced high fever 103.9 f. On 12-JUN-2021, the subject experienced headache. 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 had not recovered from high fever 103.9 f, headache, chills, and sore left arm. This report was non-serious.

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 non-smoker, and non-alcoholic, and other pre-existing medical conditions included the patient had no known allergies and 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: 1808986, and expiry: 15-JUNE-2021) dose was not reported, administered on 15-JUNE-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-JUNE-2021, the subject experienced tired/feeling drained. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tired/feeling drained. This report was non-serious.

patient received Janssen vaccine around 10:37am . After receiving the vaccine, patient is sitting on the chair and waiting for observation. After a couple minutes later, he fainted and fell off the chair and laid on the floor. He was sweeting but alert. Patient stay in the pharmacy for about 30-40 minutes for observation . He was fine after all

The patient calmly walked out to seating area and sat down after receiving vaccine. The patient did state that he "did not like needles". After a few minutes the patient went pale, started sweating, then lost consciousness for about a minute. During that time patient was unresponsive. No vitals were taken. I ran to get an Epipen and by the time I came back the patient was alert and responsive albeit a little shaky. Patient was given water, a small Cliff bar, and an orange soda. After about half an hour, the patient stated he was fine and left.

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.

Woke up with pounding and searing headache, extremely cold with chills, got a blanket, had to decide between being extremely cold and shaking or being super hot and sweating it out. Decided to sweat it out. Would get very light headed upon standing and was continuously nauseous. Woke my mom up at around 4am after fighting the illness all night and she made me tea to rehydrate and eventually I was able to keep down advil and the headache subsided. Felt ALOT like the side effects I had after getting a lumbar puncture.

This was the Johnson and Johnson shot I received. Normal symptoms of tiredness, soreness occurred immediately. Within 3 days I developed chronic stomach pain and GI problems. Bloody stool has been going on now for 3 months. I weigh 145 lbs and have lost 40 lbs. currently at 105 lbs. Doctors haven't been able to diagnose my situation even after several blood tests, colonoscopies and biopsy's. I was a perfectly healthy 26 year old with no family issues of GI problems or other complications. I now can barely stand for a few minutes at a time. Doctors think I have either Chrons, or Ulcerative Colitis, but the biopsy's are inconclusive.

Fatigue, chills, slight fever headache- within first 24 hours Nodule felt on right temple area- 8 days after vaccine Headaches on both temples- 8 days after vaccine Slight blurry vision left eye- 1-2 weeks after vaccine Headaches left temple- 2-4 weeks after vaccine Left sided chest pain with difficulty taking deep breath lasting 2-3 days- 3 weeks after vaccine

Patient felt lightheaded after vaccine. Noted excessive sweating. Initial vitals BP: 90/60, HR: 49, Sp02: 97% R: 18. Second set of vital signs BP: 110/61, HR: 51, Sp02: 98%, R: 18 and T: 98.7. EMS was called when vitals did not improve and patient was transported to a local medical facility at 10:10am.

Pt. tol vaccine well and was moved to observation room. He was given water and apple juice--both of which he quickly finished. Appx. 3 minutes after vaccination, pt reported feeling dizzy. 1 minute later, became diaphoretic and reported losing his vision. CNP was called in and pt. was moved to a lying position in our recuperation area. As he was being lowered, pt fainted. After 5 seconds, he became cogent and said he felt fine. Cool cloths were applied. He remained lying for about 20 minutes before sitting in a chair for another 10-15 minutes. He finished 2 bottles of water and 2 boxes of juice in this time period. Pt. left with friend feeling better. He was instructed to continue drinking water.

ACHY; FEVER; This spontaneous report received from a parent concerned a 26 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included brain tumor, and allergy to tree nuts. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821281, and expiry: UNKNOWN) dose was not reported, administered on 14-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-JUL-2021, the subject experienced achy. On 14-JUL-2021, the subject experienced fever. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and achy. This report was non-serious. This case, from the same reporter is linked to 20210738675.

patient didn't feel well a few minutes after his shot and then he passed out. 911 was called and patient was evaluated by the EMT. I know they did check his ekg and blood sugar which all came back ok. patient denied going to the hospital and a friend came and picked him up

Fever onset (100F) along with chills uncontrollable shivering and teeth chattering around 8 PM. Around 5 Am, fever had hit 103F and body temperature (measured by an Oura ring) recorded average body temperature increase of +5.6F while sleeping compared to baseline. Fever remained intermittently throughout the next day, as well as headache, sore throat, chills.

-Muscles Spasms (lasted about 15 minutes) -Fever -Chills (including chattering teeth) -Diarrhea -Vomiting -Sore Throat -Headache -Fatigue -Stomachache -Loss of appetite -Shortness of breath

I got the shot at 5:30 pm. Starting early the next morning (around 3 or 4am), I began to experience intense fever and headache. I got up to get Advil and had a seizure. I have epilepsy, and had not missed a dose of my medication. My last seizure before this was 2 years ago. After recovering, taking Advil, taking a shower, and going back to sleep for about 4 more hours, I woke up feeling fine.

101.7 F fever, nausia, tiredness, runny nose, headache the night and day after the vaccine, that went away after 48 hours.

approx 10 hours after shot, he felt chills, body aches and then sudden onset of nausea and then woke up next to his desk. uncertain length of time of LOC. next day feeling tired and achy but better

After receiving the Johnson & Johnson vaccination at approx 0855 the patient told the vaccinating nurse that he was "feeling dizzy." Pt then fainted and was lowered to the floor and positioned on his side; he was pale and diaphoretic initially but resolved before he was sat up. He then opened his eyes and stated that he was "feeling ok." Patient then confirmed that he has fainted twice before while receiving bloodwork or vaccines. Pt refused emergency services. Pt advised to call 911 or seek medical attention for any concerns after leaving facility. Pt verbalized understanding. Pt vital signs are as follows BP 136/58, R 18, P 84, O2 sats 98% on room air. Pt alert and denies any pain or discomfort. Denies any further concerns. Pt left facility at 0900.

1000 vaccine recieved and pain started after he felt a pop, (instructed him this was the vanish shield needle most likely) followed by numbness and tingling. When he walked to chair become dizzy and light headed. 1005 reported issues to recovery staff. b/p 132/78, p-99, 02 sat 97%ra, r-18. 1019 cont to be dizzy and light headed, tingling wrist down, pain is gone @ this time. 1023 starting to get sleepy per report. 1045 c/o of vision alterations, blurry vision. B/P 152/80, p-99,02 sat 96%ra, r-18. 1100 b/p 140/86, p-99, r-18, 02 sat 97%. Reports cont to feel the same. 1105 Site lead instructed pt to call MD, go to urgent care or we could call EMS. Pt and significant other opted to drive via their car to urgent care.

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.

Janssen COVID-19 Vaccine EUA Symptoms started with a minor headache approximately 10 hours after receiving vaccine; I had dismissed it as a result of too much time in front of a computer screen. The next morning I was nauseous, head was hurting, and then started to develop chills at about 10am.

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.

Woke up with severe fever and cold chills, only at night time after sleeping for several hours. Body ache to go along with that symptom. Taking an acetaminophen remedied these symptoms.

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.

Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Seizure-Mild

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

Fever, measured at 99.5 at around 7:30 AM on 4/7/21 and 100.4 at around 2:00 PM, low grade headaches throughout morning.

Fever, chills, headache and extremely tired. Slept for 18 hours after vaccination. Feel much better now.

vaccine reaction. PT reports HA. bodyaches, diarrhea and 1 episode of vomiting this morning. denies fever. reports received JJ vaccine yesterday. command requested medical evaluation. Patient is experiencing the normal side effects of this vaccine. Quarters for 24 hours given. RTC precautions given.

Dizziness, fatigue, light-headedness, aches, dull pains throughout body, and difficulty composing thoughts

After patient received the vaccine he stated he felt dizzy. pharmacist that administered the dose watched him and asked if he felt like he needed to lay down. said he did not feel like he needed to lay down but then stated he was starting to have a headache and left arm was feeling numb (this was the arm dose administered in). kept monitoring him and after about 20 minutes stated he was beginning to feel itchy. asked him if he was having shortness of breathe to which he responded no. After a few more minutes he was still itchy and gave him 50mg of liquid benadryl. This was at 531pm. He stated his symptoms were about the same and checked his bp 163-99 hr 88. continued to monitor him til about 600pm. By this time patient was able to walk around, no longer lighted headed, and numbness had resided.

At 0940, RRT was called for a 27 y/o M with complaints of dizziness with diaphoresis. Vitals: BP ? 128/84, HR ? 78, RR ? 18. Vaccinated on the L arm at 0929. No PMH, NKA, only took a Multivitamin today. Head-to-toe assessment completed. He did not eat for the day yet. The vaccination staff encouraged him to eat prior to receiving the vaccination but client declined. During monitoring period, client?s condition improved. Client stated he was okay to drive home and did not feel dizzy anymore. Client was not diaphoretic anymore. Client was educated that if he feels worse at any time, he can call 911 or go to the nearest hospital. Patient departed vaccination clinic at 1000 in stable condition, ambulatory, with breathing even and unlabored.

Approximately 5 minutes after vaccine patient felt lightheaded. Pharmacist immediately checked on patient who was beginning to become incoherent. He had a mild seizure and ems was called. Patient was sweating and pale. He remained onsite with EMS and later left with a family memeber.

Janssen COVID-19 Vaccine EUA About two to five minutes after taking the vaccine, I began to feel as if I was going to pass out. I collapsed twice, but never went unconscious. My arm was very sore, and I was very weak and dizzy and clammy. I got only a little better as the night went on. Today, I have had flu-like symptoms and my body aches very much. I hadn?t seen a lot symptoms involving nearly immediately passing out, so I thought I should report my side effects.

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.

About 8 hours later, patient developed a fever around 101.8 degrees. Currently taking ibuprofen and Nyquil for treatment.

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

Nausea, vomiting, headache, body aches, fever and chills. Treated with ES Tylenol 500mg -2 tabs. Ondansetron ODT 5mg tables. 1 liter NS intravenously. Urine specific gravity 1.030 at admission to clinic. Observation 4 hours. Fever resolved, headache and body aches resolved, nausea resolved. Repeat urine SG at discharge 1.005. Ambulatory out of clinic.

Apart from headaches and general nausea I began to shake uncontrollably around 5pm which lasted about 15 min. Then later in the evening it happened again but this time it was hard to breathe because everything in my body was so tight. This lasted until I got into the shower with the temperature set as hot as I could.

Immediately following injection the patient stated he was going to pass out. He lost consciousness for approximately 30 seconds. He was confused and disoriented for a few minutes. Radial pulse was present and regular at 66, O2 sat was 96% on room air, BP was 118/77. Skin was warm and diaphoretic. He was monitored for 30 minutes in Observation area. He refused offer of EMS transport, When he left the clinic he was alert and oriented with no complaints.

Started with mild headache around 7:00PM, increasing in severity through the night. Chills/feverish beginning 8:00PM Severe chills/vomiting 11:00 PM Woke following morning with headache Symptoms resolved by 11:00AM following day

102 degree fever, headache, dizziness, aches, and lethargy from +8hrs to +24hrs after vaccine administration.

At approximately 11:00 PM, 13 hours after receiving the vaccine, I began to feel cold and have chills. I also experienced achiness at this time. This progressively worsened throughout the night, resulting in my struggling to sleep, until about 4:00 am, when I noticed that I did not feel the feverish coldness symptoms as intensely. From this point on however, I experienced a substantial headache, coming and going all morning. Until now (12:45 PM) when I still feel a slight headache.

FEELING WORSE; FEVER; FATIGUE; PAIN AT INJECTION SITE; SHIVERING; SORE ALL OVER; This spontaneous report received from a patient concerned a 27 year old male. The patient's weight was 72 kilograms, and height was 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: Unk) dose was not reported, administered on 31-MAR-2021 at 13:30 on left deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-APR-2021, the subject experienced sore all over. On 01-APR-2021, the subject experienced shivering. On 01-APR-2021, the subject experienced fatigue. On 01-APR-2021, the subject experienced pain at injection site. On 01-APR-2021 07:00, the subject experienced feeling worse. On 01-APR-2021 07:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling worse, and the outcome of fever, shivering, fatigue, pain at injection site and sore all over was not reported. This report was non-serious.

NOT an adverse event, just strong reaction. Fatigue/Body aches started 1-2 hours after vaccination. Fever started 6 hours after injection and rose to 103.4 F (at height). Stayed above 102 F for about 8 hours. Accompanied by chills, nausea, headache, and night sweats. Following day (14 hours after injection), fever subsided and side effects consisted only of body aches, soreness, and fatigue

Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: Shortly after vaccine was administered, patient lost consciousness

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

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

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.

Chills, aches, fever, stomach pain, diarrhea, headache. Treated with rest and ibuprofen. Lasted less than 12 hours

Slight chills in the afternoon - Lasted 2-4 hours. Began at 4:30 pm. No fever Extreme fatigue - Lasted 12-18 hours. Began at 4:30 pm Difficulty Sleeping - body aches and hot flashes. Also had odd dreams of trying to solve a problem related to the vaccine.

Difficulty breathing. Fatigue. Intense pain all over. Fever. Extreme chills. Involuntary shaking. Headache. Dizziness. Lose of strength. Loss of appetite.

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

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.

After the initial 15 min wait period I was feeling fine, so i left the pharmacy. About 5-10 min later my heart rate became very fast very quickly and it became more difficult to breathe. I was driving home at the time, had to pull over and wait a few minutes until the event subsided. I debated contacting medical help, but i began recovering and was able to continue driving. Since the event i have been feeling slightly fatigued and i have a slight feverish feeling, but in general have been able to rest and have not had a repeat occurrence. I received no medical attention or treatment.

6-7 hours after receiving, I got a headache, and became very tired & achey all over. I took ibuprofen & acetaminophen and felt reasonably better for a few hours. Then later that night (12-18 hours after vaccine) I became much sicker and was unable to sleep. I had a low fever, upset stomach, severe chills (couldn't stop shaking/shivering for over an hour) body aches, and an extremely bad headache. I continued to use ibuprofen and acetaminophen but even combined they weren't nearly enough to relieve my symptoms. Late into the night around 3-4am (15-16 hours after vaccine) nausea became the worst side effect, surpassing the headache. I eventually vomited around 4am, after which point the symptoms became more bearable and I managed to sleep a couple hours. Thursday/Friday (two days after vaccine) I still felt very weak, achey, and tired and had to call out of work both days. I was never again in the severe discomfort I experienced Wednesday night/Thursday morning, but I still felt a little tired, achey, and mildly sour stomach on days 3 &4 (Saturday/Sunday). Monday morning I felt similarly tired & achey, but I do feel essentially back to normal Monday night.

At approx 1am following my vaccination I experienced extreme chills/shivers, confusion, slurred speech, nausea, headache, dizziness, inability to stand and a fever of 103.2F The symptoms continued after sunrise, however, they were less severe. Today (4/12/21) I am still experiencing headaches and feel extreme exhaustion and fatigue. I have not been able to work a full day since the day of vaccination

High fever (over 101 degrees F) with Advil starting at 11:30pm on 4/9/21 (less than 12 hours after injection), which subsided by the following morning. Hives and itchiness all around front and back torso, shoulders, and neck starting at 10:45am on Sunday 4/11/21 (47 hours after injection), which began clearing up the following morning after taking Allerclear on 4/11/21 at 11pm. Itchiness has remained, but hives are no longer present.

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.

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

Severe headache, weakness while standing, low grade fever, nausea, and heavy sweats and chills. Treatment: Rest Outcomes: Still weak from the adverse event. Left work early on 04-13-2021 due to some motion sensory illness (nausea like symptoms with an elevated temperature).

Severe headache, shortness of breath, stomach ache, diarrhea, minor leg pain, moderate all-body soreness. Symptoms have abated except for headache and shortness of breath. These have only reduced in severity.

Feels Faint/sweaty. Did NOT lose conscious. Some neuropathy in arms and legs. Pulse 65, BP 102/59 Observed 30 min. Paramedics consulted. All symptoms resolved <30 mins.

Presented with 27 YO male, seated in a chair S/P receiving Johnson and Johnson COVID-19 vaccine. PT started to feel dizzy and started to become diaphoretic. PT does not speak English, upon translator?s arrival they advised this writer that PT was feeling dizzy, and short of breath. PT visibly diaphoretic and his skin color changing from normal to pale. PT pulse weak and thready, and PT hypotensive at 76/P. PT administered 50mg of Benadryl IM in his right deltoid, successful. PT pulse no longer palpable in the radial so PT placed in a supine position on the floor and PT legs elevated to a Trendelenburg position for his hypotension. PT administered 1mg Epinephrine 1:1,000 IM in the left deltoid, successful. Ambulance called for transport of the PT to the nearest hospital. PT blood pressure slowly starting to stabilize at 90/56. PT SPO2 reading 98% on room air with respirations 18 and regular with clear lung sounds. PT no longer having Shortness of breath or dizziness. PT no longer sweating and he is beginning to stabilize. Radial pulse palpable again and strong and regular at a rate of 76 bpm. PT blood pressure reading 110/76. Upon fire department arrival determined that the PT was stable enough to sit upright in the chair again. PT was assisted off the floor and to a seated position in a chair. PT vitals after seated position for 5-7 min, BP 120/82, pulse 86 strong and regular, RR 20 and clear equal bilateral lung sounds. PT has no other complaints at this time. PT has no allergies to medication, PT has a pollen allergy that he takes over the counter allergy medicines for. PT has no past medical history. Upon arrival of ambulance PT care relinquished to EMS with full report, PT care relinquished without incident or injury.

Fever temp reaching height of 102.2F, extreme light headedness/mild vertigo, incredibly high heart rate, quickened breathing (no shortness of breath), body temp of extremities quickly changing, strong shivering, nausea. Mostly more severe instances of known side affects/symptoms.

Fever / headache started at 4 to 5pm and lasted for 24-36 hours. Highest temperature was 102.5. Fever reduced with Advil and sat around 100 for remainder of the time period. Headache was immense. Extremely weak / couldn't get out of bed.

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.

FEELING COLD; BODY ACHES; FEVER ABOVE 100 F; This spontaneous report received from a consumer concerned a 27 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no medical history and no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 21-JUN-2021) dose was not reported, administered on 07-APR-2021 to Right Arm for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced feeling cold. On 07-APR-2021, the subject experienced body aches. On 07-APR-2021, the subject experienced fever above 100 f. Laboratory data included: Body temperature (NR: not provided) above 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever above 100 f, feeling cold, and body aches. This report was non-serious.

Dizziness with HA with intermittent mid-sternal burning CP x 3 days; room is spinning; CP lasts few seconds, nothing makes/worse better; Denies any CP at this time; non-radiating; 325mg Tylenol at 0515. CHIEF COMPLAINT & HPI: 27 yo M with fatigue, bodyaches, chills, headache, and gastritis after covid vaccine on tuesday. no numbness or weakness. Pt endorses peripheral vertigo. no nausea/vomiting. no anginal chest pain. no cough/SOB.

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

I gave the vaccine around 6:20pm after counseling on possible adverse reactions and going over the patient's questions. I then asked them to wait 15min. Within 5-10mins the patient got up and came back to our counter saying he thinks he's having a reaction. I pulled him back into our vaccination area and had him sit down and explain what he was feeling to me. He looked pale and told me he felt dizzy, sweaty, shaky, & nauseous. He wanted me to grab him a bag incase he puked. I grabbed a bag as well as water and Benadryl. I asked if he was having any issues breathing or if it felt like his tongue was swollen at all. He said no issues breathing and tongue felt fine. He started to feel better within about 10-15 minutes after onset. He did not puke and his color returned. I had him wait an additional 10-15 minutes after that to make sure we were recovered. I asked him if there was anything else going on and he mentioned that he hadn't slept well the night before and that he had barely eaten today. He also mentioned he can get anxiety. I told him all of those factors could certainly contribute to what he just experienced but that I would be reporting this on to be safe.

migraine, fevers, body aches x 2 days after receiving J&J vaccine on 13Apr21; states max temp 100 at home; reports taking tylenol at home with minimal relief; last dose yesterday around 1200; denies any vision changes.

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

BODY ACHES; CHILLS; FATIGUE; INJECTION SITE PAIN; NAUSEA; This spontaneous report received from a patient concerned a 27 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: 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 body aches. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fatigue. On 10-APR-2021, the subject experienced injection site pain. On 10-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fatigue, had not recovered from injection site pain, chills, and body aches, and the outcome of nausea was not reported. This report was non-serious.

Johnson & Johnson Janssen COVID-19 Vaccine EUA Since 4/11/2021 I have had reoccurring headaches which are persistent. Minor vertigo, nausea, light sensitivity have accompanied each headache series. In healthy condition, rarely ever have headaches. Have had more headaches in the past week than I've had in many years combined. No treatment outside of consuming adequate hydration

SEVERE SINUS HEADACHE; FEVER; FATIGUE; This spontaneous report received from a consumer concerned a 27 year old male. The patient's weight, height and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced severe sinus headache. Treatment medications (dates unspecified) included: paracetamol, pseudoephedrine hydrochloride and guaifenesin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever and fatigue on 11-APR-2021 and had not recovered from severe sinus headache. This report was non-serious.

High grade fever, multi hour severe migraine, light sensitivity, sharp abdominal pain, confusion, coordination/balance problems and severe flu like symptoms. Treatment was self administered and comprised fluids and bed rest.

HANGOVER; CHILLS (SHAKING); FEVER; HEADACHE; NAUSEA; This spontaneous report received from a parent concerned a 27 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, non-smoker, high cholesterol, low vitamin d, seasonal allergy, and walnut allergy, and other pre-existing medical conditions included the patient had no drug abuse. the patient had no history of hospitalization in last 30 days with cause and no family history of any disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 18:30 for prophylactic vaccination. Concomitant medications included cetirizine hydrochloride for allergy, ascorbic acid/biotin/calcium pantothenate/calcium phosphate dibasic/cyanocobalamin/ferrous fumarate/folic acid/magnesium oxide/manganese sulfate/nicotinamide/potassium sulfate/pyridoxine hydrochloride/riboflavin/thiamine mononitrate/tocopheryl acid succinate/zinc sulfate for general health, and ergocalciferol for low vitamin d. On 21-MAR-2021, the subject experienced hangover. On 21-MAR-2021, the subject experienced chills (shaking). On 21-MAR-2021, the subject experienced fever. On 21-MAR-2021, the subject experienced headache. On 21-MAR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 103 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 23-MAR-2021, had not recovered from headache, nausea, and hangover, and the outcome of chills (shaking) was not reported. This report was non-serious. This case, from the same reporter is linked to 20210341912.

Woke up about 7 hours after receiving vaccine with violent shaking or shivering almost like a seizure except was alert and oriented and could hold conversation. Every part of body was shaking so hard the whole bed was moving. Lasted about a full hour. Was ready to go to hospital when the shaking died down to flu-like shakes which lasted on and off for the next 24 hours. Felt incredibly sick and exhausted for next three days.

PASSED OUT; FALL OVER; COLD; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 27 year old white, not Hispanic or Latino 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: 203A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 10-APR-2021 at 16:00 to left arm for prophylactic vaccination. No concomitant medications were reported. It was reported that day after vaccination on 11-APR-2021 in early morning, the patient had chills and fever. The patient went down to get some unspecified medications and he passed out for roughly 5 minutes and fell over. The patient had headache at the time of this report. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passed out, cold, chills, and fever on 11-APR-2021, had not recovered from headache, and the outcome of fall over was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210421495 - covid-19 vaccine ad26.cov2.s- Passed out. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

FEVER; DIARRHEA; This spontaneous report received from a patient concerned a 27 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802072, and batch number: 1802072 expiry: 14-MAR-2021) dose was not reported, administered on 13-MAR-2021 for covid-19 virus prevention. No concomitant medications were reported. On MAR-2021, the subject experienced diarrhea. On 13-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and diarrhea. This report was non-serious.

12 hours after vaccination, had a fever, chills, increased heart rate (roughly 50 bpm higher than normal), headache, pain in chest. This lasted roughly 12 hours through the night and into the morning

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

Approximately eight hours after injection, sweeping to severe fatigue began to onset along with severe headache and moderate to severe chills, along with other "flu-like" symptoms, including symptoms of fever but no recorded fever. Lasted through the night and hindered sleep without the help of OTC sleep medication. After 8 hours of overnight sleep, woke up next day feeling better, but still had a terrible headache and a great deal of fatigue. Considered visiting a walk-in clinic or the ER at least four times throughout this timeframe. Symptoms lessened with time with a bad headache and lingering fatigue being the most consistent 24 to 36 hours after the initial injection time. Now May 3 at 1:00pm, several days after, most symptoms have subsided except for some lingering fatigue which still is present.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Severe, Additional Details: IMMEDIATELY UPON INJECT THE PT FAINTED. I GOT HIM ON THE FLOOR AND ELEVATED HIS FEET. CHECKED HIS PULSE AND BREATHING. GAVE HIM WATER. HIS MOTHER KEPT CALLING HIS NAME. WHEN HE SAID HE WAS FINE. HE SAT DOWN THEN FAINTED AGAIN. 911 WAS CALLED. EMT ARRIVED AND TOOK CARE OF HIM. HIS MOTHER DROVE HIM HOME. MOTHER STATED HE DOES THIS EVERY TIME HE GETS A SHOT

FEVER; HEADACHE; This spontaneous report received from a patient concerned a 27 year old male. The patient's height, and weight were not reported. The patient's past medical history included runny nose, and sneezing, and concurrent conditions included seasonal allergies, consume alcohol, and non smoker. The patient experienced upset stomach when treated with ibuprofen, and oxycodone/paracetamol. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On JAN-2021, Laboratory data included: COVID-19 virus test (NR: not provided) negative. On APR-2021, Laboratory data included: Body temperature (NR: not provided) 100 to 101 degrees Fahrenheit. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 100 to 101 degrees Fahrenheit. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from fever, and headache. This report was non-serious.

On day 1 (April 15) of noticing my body was very off after the vaccine I had Leg pain and severe headaches, I say severe because though I rarely get headaches and stay hydrated I could tell this headache really hurt and lasted the full day and several days after (something I have never had happen to me) Also on April 15, I had leg pain, If I took a step off a few inches curb or stair step I felt sharp pain shoot up my leg. On April 16th I still had the headaches and leg pain , but also while driving I began loosing my vision and started to pass out/faint. I Pulled over and waited at least a half hour. during that time I. noticed I couldn't type or read anything on my phone as I was trying to reach a friend to help me. eventually after time had passed I was able to drive myself to a friends where I thought the best thing would be to sleep it off. the headaches and leg pain lasted a couple more days and I thought it was going to go away, but it is now May 5th and today and last couple days the leg pain feels more like someone has been punching my left leg. five had chest pain and headaches return. I do not have medical insurance and have avoided going to the hospital or primary care because I am afraid. today the pain is so irritating and sore I wish I could escape my body.

27yo male vaccinated with Janssen covid vaccine. Within minutes of standing up from vaccination in the vaccine booth, stated he was dizzy. I sat him down immediately, he was having trouble staying awake eyes glossing over, speech very slow. I turned to push the door open into the main pharmacy to call for help and have them dial 911, grabbed epinephrine and ammonia salts as well. When I turned back he had slumped in his chair. As I took the step back towards him, he spontaneously started to sit up and speak. Was diaphoretic, still slow speech eyes glossy. I supported him as best I could. His HR was 42, i lifted his legs up unto to a chair in quazi trandelenburg position. He stated that made him feel alot better. I stayed with him until EMTS arrived. He got himself onto they stretcher and they took him out of the store.

Patient received vaccination. While he was sitting for 15 minute post-observation he notified us that he was feeling dizzy. He also became pale and started sweating. We had patient put his head between his knees, gave him some water, and a cool, moist towel. After a few minutes patient felt much better and got his color back. He never fainted or lost consciousness.

DIZZY, SYNCOPE, DIAPHORETIC, PALE, BS: 62, ATE SMALL MEAL EARLY AM,SEEN BY PARAMEDICS, VSS, PROVIDED GATORADE AND FOOD, SX IMPROVED, REFUSED TRANSPORT, AMA SIGNED.

I got a fever 10 hours after receiving the vaccine. It went away temporarily after taking Tylenol. It came back a few times over the following 36 hours.

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

FELT FAINT, DIAPHORETIC, PALE, SYNCOPE FOR 15 SEC, WOKE UP, PROVIDED DRINK AND SNACK, SYMPTOMS RESOLVED, REFUSED TRANSPORT.

Hives or Redness on upper center of chest and red flushed looking cheeks. Claims throat may have been slightly scratchy. Administered Diphenhydramine 50mg and observed for an additional 30 minutes. This resolved after the diphenhydramine dose and they were able to leave and return home.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: patient is able to recovered after sitting down for 15-20 minutes

Janssen COVID-19 vaccine EUA Woke up around 4:00 am - 4:30 am with a mild head ache with minor pressure around where the nose bridge intersects the eyebrows. Along with some minor nausea.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Tinnitus-Medium

CHEST COLD; FEELING SICK; FEVER; PRESSURE IN CHEST; COUGHING ON AND OFF; DIZZINESS; NOT FEELING GREAT; SORE ARM; This spontaneous report received from a consumer concerned a 27 year old white, hispanic or latino 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, expiry: 23/JUN/2021) dose was not reported,1 total administered administered on 03-MAY-2021, 17:00 for prophylactic vaccination. No concomitant medications were reported. On 03-MAY-2021, after 30 to 50 minutes of vaccination, the patient started feeling not sober, dizzy, not feeling great and sore arm. On 04-MAY-2021, (Tuesday), the patient woke up feeling really sick, feeling feverish then felt better during the afternoon (around 5 pm). The patient felt like he had a chest cold, he was clearing his throat more often, feels a kind of pressure in his chest (but no shortness of breath) and was coughing on and off. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, feeling sick, and fever on 04-MAY-2021, had not recovered from cough, and pressure in chest, and the outcome of sore arm, chest cold and feeling bad was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210509097 (same reporter).; Sender's Comments: V0;20210509350-covid-19 vaccine ad26.cov2.s-Chest Cold. 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).

I was feeling fine drove hope happy about getting the vaccine. When I got home after 20 mins exp uncontrollable shivering and teeth chattering(appeared comial). I took an Advil went to sleep, got back up middle of the night with 103 fever, high heart rate, full body, sweats sustained for the better part of next day. I continued to rotate Advil and Tylenol for high grade fever lasted 1 day and low grade day after.I was wearing Fitbit 105 beats per min abnormal I'm usually 50 beats per min. I contacted my doctor dint go in due to Covid regulations was advised to continue monitoring heart rate.

About 8 minutes after injection, patient comes to consultation window to ask question unrelated to vaccine. Upon walking away, he gets light-headed and starts to fall. He half catches himself on immunization booth nearby. He sits in chair in booth. I check on him. He says he is ok. He is a little pale and sweating a little. A few minutes later he says he is fine and wants to leave. he agrees to stay longer. A little later after other store team members have checked on him, I check on him again. He says he is fine and then leaves.

Felt dizzy and light headed after vaccine. Did not want to take BP due to increasing anxiety. Anxiety before the vaccination. Stayed in store for 30 minutes. I called the patient back at 5:00pm; he stated he was felling fine minus some fatigue.

patient stated he was feeling dizzy a few minutes after shot. Patient had remained in immunization booth due to potential for issue. Patient continued to feel dizzy, and was asked to lie down with feet elevated. The dizziness began to get better and receded a few minutes later. Patient stated dizziness was gone but had some feeling of heat and sweating for a few minutes after. Patient was moved to waiting area a few minutes later and remained for 15 minutes, with no additional symptoms.

Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Additional Details: First BP reading was 108/49 pulse 45 at 4:08pm and second reading was 122/77 pulse 76. Patient experienced profused sweating, dizziness, and hypotension. After hydrating and laying down he gradually felt better.

The evening of the shot, I felt a wave of chills through my body. I felt a sore throat begin. I felt light headed and nausea. By the time I went to bed, my body was extremely sensitive. Entering my bed was painful due to the cold sheets, the cold was contrasted by the occasional heat flash. The night was full of body aches, hot and cold flashes, and loads of sweating. I woke up with a headache and body soreness. That was the worst of it. Spent the remainder of the day resting in bed. Notes: I rarely get sick, maybe like this once every few years. I probably could have drank more water to flush out my system following the shot.

After injection, patient jolted and eyes fluttered. He seemed to be having a seizure like reaction. He then slumped to side and head hit side of wall since we had chair with side rails positioned against wall. He lost conscious for maybe 30 seconds and then eyes opened. I asked if he was OK and the first thing he asked for was water. He said he felt light headed and dizzy. I had my intern who was working grab him water from the deli and had him sit and rest. He started sweating and asked for paper towels. I grabbed him a couple of towels so he can wipe his face. I continued to check on him while doing my work. He seemed fine after that. After 30 minutes, I checked his blood pressure. It read 100/63. I continued to monitor him and he left after that. He did have friend with him the entire time who helped him.

5 min after shot. Warming sensation spread from arm across my entire body. Felt nauseous and blacked out. Passed out face first on the floor. No fear of needles. I have records of getting previous flu vaccines without passing out. I have been experiencing hot flashes, nausea and fatigue for 6 days now.

Covid symptoms started 5/20/21 with body aches, headache, slight cough and fever. Tested positive 5/25/21 due to symptoms continuing. His symptoms are getting better, he is taking some pain meds to help with fever and the body aches. He has no underlying health conditions and wasn't seen at the hospital for covid-19. Vaccinated 4/8/21 with J&J.

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.

At approximately 6:47pm we gave a Janssen COVID vaccine to the patient. After a few minutes the patient became noticeably sweaty with pallor. I talked with him and he said he was dizzy as well. He stated that it is due to anxiety. I checked his blood pressure and it was 124/94 with a pulse of 83. We gave him a cold pack to use on his wrists and neck. We watched the patient for any worsening of symptoms. After a while the patient stated he now felt fine with no symptoms and left with no issues.

Patient stood up and walked over to register and said he didn't feel so well. I came around the pharmacy and he was fainting as I got to him. Technician called paramedics, store manager was called and when I asked him his name and if he knew where he was he said yes. We sat him up per his request. When he was well enough we sat him on a chair, I took his blood pressure and we got him water. He was on the phone with his dad who is a physician and dad said it sounded like a syncope and asked we give him gator aid. Paramedics arrived and they took his vitals and ran some tests.

HEADACHE; TIREDNESS; INJECTION SITE PAIN; This spontaneous report received from a patient via a company representative concerned a 27 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 204A21A) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced headache, tiredness, and injection site pain. The action taken with covid-19 vaccine was not applicable. The outcome of the headache, tiredness and injection site pain was not reported. This report was non-serious.

SEIZURE; DIAPHORESIS; PALE; NAUSEOUS; This spontaneous report received from a patient concerned a 27 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included patient had no known drug allergies and patient had no drug abuse or illicit drug usage. Patient had no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: 31-OCT-2021) frequency 1 total, dose was not reported, administered to left arm on 03-JUN-2021 at 14:37 p.m. for prophylactic vaccination. No concomitant medications were reported. On 03-JUN-2021, events occurred within 3 minutes post-vaccination- seizure, diaphoresis. After seizure-like activity, patient was nauseated and pale. The reporter began cool compress, BP monitoring (Blood pressure measurement) result not reported, called EMS (emergency medical services), and gave water and snacks. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from seizure, diaphoresis, pale, and nauseous on 03-JUN-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210607494-Covid-19 vaccine ad26.cov2.s-Seizure. 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).

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.

About 10 minutes after vaccination the patient began profusely sweating. He then feel to the floor from the chair during his observation period. 911 was contacted and the patient attended to. Help arrived and they ran a few tests, he was conscious, and gave the clear. After sometime he began to feel better and remained in the store for additional time after the paramedics left. It was recommended he call a ride to drive him home. He spoke with the pharmacy staff said he felt well and was meeting his ride outside and left.

Patient was given the Janssen (Covid-19) Vaccine. While he was in the Post Vaccine area after getting the vaccine he became nauseous and vomited. He began to sweat and said he needed to use the bathroom (bowel movement). He was given water and observed for a while. Then we went to the bathroom. Upon returning he said he felt a lot better. He was observed for a few more minutes and allowed to go home.

SHAKING; CAN NOT STAND; DIZZY; SWEATING; HOT AND COLD; PAIN ALL IN BODY; This spontaneous report received from a patient concerned a 27 year old male. The patient's weight was 200 pounds, and height was not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 04-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-JUN-2021, the subject experienced shaking. On 05-JUN-2021, the subject experienced can not stand. On 05-JUN-2021, the subject experienced dizzy. On 05-JUN-2021, the subject experienced sweating. On 05-JUN-2021, the subject experienced hot and cold. On 05-JUN-2021, the subject experienced pain all in body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shaking, can not stand, dizzy, sweating, hot and cold, and pain all in body. This report was non-serious.

"Pt w/ PMH Depression, Anxiety. No PSH. Current Medications: Zoloft. NKDA At approximately 1400, pt in observation, post-vaccination of Johnson and Johnson (received at 1353), was brought to triage area by TRN, d/t complaints of sweating and dizziness. Pt denied experiencing any other abnormal sxs. On-site NP and clinic lead ANM notified. On-site NP provided further eval with pt. V/S taken at 1405: BP - 101/47, HR - 81, RR - 18, T - 97.8 V/S taken at 1408: BP - 111/66. HR - 74, RR - 20 Fluids encouraged and given. Pt placed on recliner chair. Per NP, after additional 15 min observation (and if pt is stable), pt is okay to be released from vaccination site. Pt expressed improvement to sxs, stable gait, AxOx4. Pt stable to go home."

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.

PT received the Janssen covid vaccination, after about 5 mins the pt fainted and then regained consciousness. Pt had hit his face on the floor, 911 was called to the pharmacy. 911 indicated not to give anything to the pt to eat or drink. Event occurred around 12:50/12:55. When EMS arrived a few minutes later and pt blood pressure was 125/81 , pt was feeling lightheaded and sweating profusely. Patient was also given an ice pack for his face, EMS took the pt to medical facility for further follow up

I experienced a weird taste in my mouth shortly after the shot and the day was fine I just felt kind of drained and that night is when it started I was puking my eyes were watering my throat hurt and I couldn?t hardly sleep the next day I?ve experienced a lot of body aches

Patient was very dehydrated, lost consciousness a few times, lowered blood pressure. Blood pressure was taken, medical respondence was contacted, and they came and took care of the patient.

SEIZURE; PASSED OUT; POSTURE CONTRACTED; DIAPHORETIC/ SUPER SWEATY; CONFUSED; AFRAID; IT WAS LIKE A DREAM; This spontaneous report received from a pharmacist concerned a 27 year old male. The patient's height, and weight were not reported. The patient's past medical history included chest burning, and concurrent conditions included seasonal allergy and non-alcoholic user and other pre-existing medical conditions included no previous medical history or conditions, no family history of seizures/epilepsy, no illness at the time of vaccination, no past history of similar event, no history of allergy to vaccine, drug, or food, no family history of any disease (relevant to vaccination) or allergy, no other suspected causes including co-administered vaccine(s)/risk factors. The patient had no drug abuse or brain surgery. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular and batch number: 1808609 expiry: unknown) dose was not reported, 1 total administered on JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On unspecified date in JUN-2021, Reporter stated that the patient had his head backwards, the patient posture contracted, passed out in the observe area, which was tight and small area. Reported did not see that patient fall to ground. Reporter assumes that patient must have had a fall to get from the chair to the ground when she was able to see. Reporter stated that the seizure was about 15 seconds, eyes rolled back, blank stare, eyeballs twitching, full blown seizure. Reporter stated that when patient came back, he was super sweaty, diaphoretic, and only remembers that his chest was burning prior to vaccine. Reporter mentioned that patient did not know that he passed out. Reporter stated that patient said it was like a dream and do not know how long he was out and stated that he just said his chest was burning. Reporter mentioned that the guy was afraid and did not know what happened. Patient was confused upon waking up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from seizure, passed out and it was like a dream and the outcome of posture contracted, diaphoretic/super sweaty, confused and afraid was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210667371-Covid 19 vaccine-Seizure, Passed out. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

COVID-19 INFECTION; COUGH; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 27 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and non-smoker, and other pre-existing medical conditions included no relevant medical history and no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 041A21A and expiry: UNKNOWN) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-JUN-2021, the subject experienced cough. On 07-JUN-2021, the subject experienced fever. On 07-JUN-2021, the subject experienced headache. On 11-JUN-2021, Laboratory data included: COVID-19 (NR: not provided) Positive. On 12-JUN-2021, the subject experienced covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from covid-19 infection on 28-JUN-2021, cough on JUN-2021, fever on 10-JUN-2021, and headache on 12-JUN-2021. This report was non-serious.

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

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.

A few of days after the shot I had gotten a rash on my back. After about a month and a half went to doctors and was put on prednisone. The medicine had almost gone away and now is back stronger. My back was very sore almost 3 months later with rash worse. Just took my last dosage and the rash is very sore and very red. I also have felt tired and ache.

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

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

Fatigue, fever, minor nausea for over 24 hours. Vaccine occured Saturday at 11:30AM and beginning of symptoms were noticeable around 10 am the following day (Sunday).

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

Fever (101.8), body aches, chills onset about 8 hours after injection. Treated successfully with nsaid

developed fever 100 F at midnight and fever of 102.5 F at 4 am. Assoc with body aches, HA and decrease sense of taste and smell

Broke into cold sweats when I went to the bathroom. Went back and sat in the chair and blacked out. Eyes rolled into the back of my head. Stiffened up and rolled out of the chair. Then I slowly came out of the black out.

fever, headache, chills, body aches, burning eyes followed by nausea and burning chest when taking deep breaths

Fever, fatigue, headache All symptoms began about 9-10 hours after receiving the vaccine. Treated with acetaminophen. Symptoms lasted throughout the day after receiving the vaccine and subsided by 2 days after receiving the vaccine.

No immediate side effects after shot. 8 hours after shot, had fever that reached 103 degrees F, with chills and nausea. Felt "cloudy" in thoughts and couldn't focus or complete any tasks. Was not able to sleep at all that night. Around 8 AM the following day the fever reduced to 101, but cough started and felt fatigued. Fever dropped to 99 by the evening, but cough and fatigue persisted. Fever completely gone on Friday 3/12/21, but cough and fatigue are still present as of 3/15/21. Current cough is inconsistent (few times an hour) and fatigue is better than previous but still present.

Received vaccine at 0900. At 2100, chills, body aches. At 2300, itching left elbow that progressed. Seen at 0600 next day and diagnosed with hives. No anaphylaxis. However, as precaution he was given epi, solumedrol iv, and Benadryl po. Patient discharged to room. He is in setting overseas.

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".

07:40 patient reported to mother that he was "lightheaded and dim vision" then mother witnessed syncope. Nurse assessed patient LOC but breathing was recorded at approximately 1 minute with pallor, cool, and clammy skin. ED was notified of patient transport. Vitals were obtained BP - unobtainable, HR - 44 faint and thready, Resp -10. Patient regained consciousness and informed nurse that he had "white coat syndrome and history of fainting with blood drawn and doctor visits" he apologized for not notifying nurse prior to vaccination. 07:43 patient has second witnessed syncopal episode after reporting "dim vision", patient was lowered to floor with assistance from 3 nurses and bystanders. Vitals obtained - BP - 117/76, HR - 46 Resp - 12. LOC lasted 30 seconds, patient was pallor, skin was cool and clammy. Patient regained consciousness and was alert and oriented x 3. 07:48 patient was assisted to sitting position and then assisted to W/C and escorted to the ED with a nurse, CNA and family for examination and further treatment. Upon leaving patient had pink color, skin was warm, but diaphoretic. Pt entered ED at 07:55 VS BP - 141/83 MAP - 102 HR - 66 RR- 20 SPO2- 96% Temp - 97.9. Pt was observed in ED for an hour and was provided food and liquids after report of not eating or drinking since previous night.

I started to get uncontrollable shakes the night of my vaccine for 10-15 minutes. I had chills for about an hour afterwards and a sleepless night. The next morning I woke up with a headache and was achy/sore throughout my body. While I was eating I passed out without any signs. I was unconscious and do not remember the episode. Once I was alert, I felt nauseas and was heading to the restroom when I passed out again and was unconscious. I do not remember the episodes. There were no signs of passing out before I did either time.

PATIENT WAS SITTING IN OBSERVATION AREA WHEN HE BECAME DIAPHORETIC AND PALLOR, STATED HE FELT HOT AND FLUSHED. PT WAS FAINT BUT DID NOT LOOSE CONSCIOUSNESS. HOWEVER PATIENT WAS LOWERED TO THE GROUND, CLOTHES LOOSED. PT WAS MONITORED FOR AN ADDITIONAL 30 MINUTES WHERE SYMPTOMS RESOLVED PATIENT WAS THEN RELEASED HOME TO SELF CARE

Following administration of covid vaccine client stated he did not "feel well" He complained of being "light headed" Blood pressure 118/63 pulse 62 and oxygen saturation 97%. Reaction started 5 minutes after administration. Second Blood pressure in 5 minutes 118/72 Pulse 70 with oxygen saturation 100%. Client was reclined for a short time. Client released when symptoms resolved.

Headache, diarrhea, tingling in legs, tingling in arm of shot, Arm site where injection was red, warm, raised and got larger since vaccine. Arm pain and redness, warmth, raised continued still. All other symptoms gone

Patient was in at 1711 presenting diaphoretic and light headed. Patient has known hx of seasonal allergies and a hx of passing out with blood draws. Stats were 93% SP02, BP 101/58 lying, 54 HR. Vitals at 1719 were 113/70, 86 again lying. patient by 1723 was drinking and eating at bedside. released into care of significant other at 1730 returning normal.

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.

The patient felt hot and sweaty and was afraid of passing out. He was placed on the floor and his blood pressure was fine . His symptoms resolved after a few minutes. I observed the patient for 30 minutes and he had no further problems.

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.

Body aches, chills, fatigue, fever (up to 102F). Symptoms started approx 6 hours after injection, peak fever measured ~9 hours after injection. OTC acetaminophen administered. Symptoms persisted into next day, although less severe (~100F). Fever cleared the following day, ~40 hours after injection.

PATIENT HAD TINGELING IN VACCINATED ARM, THEN HE LOST CONSCIOUSNESS BRIEFLY, BLOOD PRESSURE WAS ELEVATED BRIEFLY , SWEATING, PALE , 911 WAS CALLED AND HE WAS TAKEN VIA AMBULENCE TO ER FOR EVALUATION

Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: patient fained and regained consciousness very quickly. patient refused 911. Nurse and pharmacist checked on patient periodically. pt was under monitoring for 30 minutes and reported feeling well after drinking orange juice and some crackers.

2am, 36 hours after shot. Nausea, then vomiting and heavy sweating. Lasted for 1.5 hours, light nausea persists.

Starting around 8 hours after shot: flu-like symptoms - extreme chills, headache, 100F fever, significant body aches, loss of appetite, mild diarrhea, mild nausea; moderate injection site pain Most symptoms were resolved within 48 hours of shot, with some lingering injection site pain and mild upset stomach

Headache, diarrhea, fever 102 - 5 days after receiving vaccine, body aches, loss of sense of smell, L arm pain, fatigue, cough, congestion

?Janssen COVID-19 Vaccine EUA" About 3 minutes after administration was experiencing lightheadedness, dizziness, and blurred vision. Turned very pale and heart rate dropped to 47. About 8 hours after administration body aches and body temperature began to rise.

Janssen COVID-19 Vaccine EUA Shivers and a low grade fever developed at nighttime (around 11 pm), followed by headache. Acetaminophen (500 mg) taken at 4 am. Symptoms subsided by 11 am.

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.

approximately 15 minutes after vaccination patient had elevated blood pressure, pulse,. He appeared very flushed, pale and sweating profusely. He was complaining of chest tightness, dizziness, ringing in ears, nausea. Continued to monitor blood pressure and pulse, after approximately 5-10 minutes heart rate, pulse and appearance back to normal. Patient stated at this point he was feeling back to normal.

The patient had symptoms of light-headedness, diaphoresis, and was pale approximately 8 minutes after administration. No signs or symptoms of anaphylaxis were identified so the patient was observed and monitored. The patient then became unconscious for approximately 10-15 seconds with small jerking movements identified during this time. 911 was called and the patient was monitored until EMS arrived. Epinephrine was prepared and ready during this whole time but was not administered because the patient didn't show symptoms of anaphylaxis (trouble breathing or talking, trouble swallowing, hives, flushing etc). The time from vaccine administration to EMS arrival was approximately 20-25 minutes. The patient was able to talk and communicate clearly the entire time except during the brief unconscious period.

Fever, Cold Sweats, Chills, Shivering, Whole Body Ache, Headache. Onset about 8-10 hours after vaccine dose. Back to full health in about 48 hours.

Initial symptoms included fatigue, chills, fever, mild aches (quad, hip flexor), and mild headache. Required additional clothing due to chills without improved symptoms. Fever progressed to highest at 104 degrees. Required additional effort for moving in bed and short household distances. Progressed to extreme fatigue, mild nausea, and extreme dyspnea ("very deliberate breathing" "I felt like if I didn't concentrate on my breathing I would just stop breathing"). Noticed increased restlessness and increased discomfort. Took 400 mg ibuprofen and after ~30 minutes there was a gradual decrease in symptoms, particularly fever and dyspnea. Symptoms resolved after taking ibuprofen. 24 hours following initial symptoms onset, noted to have fever (101 degrees), achiness return, face was flush, and transient chills/sweats.

Janssen COVID-19 Vaccine EUA Strong headache 7 hrs after shot; lasting over 24 hours Fever 9 hrs after shot; lasting 18 hours Brief nausea lasting 3 hrs upon waking up the next day Aches lasting 12 hrs upon waking up the next day

HD received report of a vaccine recipient experiencing significant side effects after receiving Janssen vaccine. Health department spoke with patient on 4/9/2021 at 11:20AM. Patient reported generalized body aches starting on 3/22/2021 at 11:00PM. On 3/23/2021 at 12:00AM patient reported emesis that resolved after 30 minutes, chills, and a fever. Tmax, measured orally by patient, was 106F on 3/23/2021 at 2:00AM. Patient's wife called the Emergency Department, who advised patient to take tylenol and advil and to come into emergency department if temperature did not start coming down. Oral temperature by 3AM was 104F and was 100F by 8AM on 3/23/2021. Patient reported that all side effects resolved by 3/24/2021.

- 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

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

On 04/07/21, 28 yo presented to clinic for immunization. Pt's documented allergies include codeine (rxn: rash; severity: low) since 02/06/2018. Pt had no previously documented encounters. Pt was seen at another institution on 02/06/18 for Generalized Anxiety Disorder and was prescribed sertraline 25 mg PO daily. Unknown if pt continues on this medication. On 04/07/21 at 1141, pt was administered COVID-19 J&J (Janssen) Vaccine 0.5 mL in left deltoid (Lot #043A21A; Exp: 6/21/2021; NDC #59676-580-15). Immediately after injection, pt became lightheaded, dizzy, diaphoretic and "felt like his vision was closing in". Vitals assessed at 1145 were BP: 94/55, P: 42, O2 sats: 98%. Pt placed in Trendelenburg position with vitals BP: 116/75, HR: 43, O2 sats: 98%. Pt denied any chest pain, shortness of breath, throat swelling, skin itching or hives. Pt reported no previous reactions to vaccines and no h/o anaphylaxis. Pt did report a similar event during a previous blood draw. Pt remained in Trendelenburg x 10 minutes. At 1159, pt was repositioned to sitting with BP: 120/80, HR: 48. Pt reported a low baseline HR. After a total observation of ~20 minutes, pt was reassessed by MD and permitted to leave. Event noted as "Symptoms are most consistent with a vasovagal reaction after J&J Covid vaccine."

Patient vaccinated by nurse and nurse reported patients eyes rolled back, patient appeared diaphoretic and pale Patient seen by medical team, vitals were stable, patient provided water and stated symptoms resolved Patient refused medical transport and signed AMA form

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 .

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)

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.

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

Chills and full body ache started a few hours after vaccine and lasted until 00:00. Vomiting began at 23:30 and lasted until 00:15 with very little expelled, having eaten a large meal at roughly 18:00. After vomiting, chills were replaced with sweating and feeling very hot, starting to wane after 02:30. Fever of 99.1 observed. Body aches and headache continue to present, though lessened. Dizziness throughout Friday the 9th while drinking plenty of fluids.

Severe chills, shaking, dizziness, fever (102.4 F), soreness. Started about 6-8 hours after vaccination and lasted for roughly 36 hours.

Fatigue, aches over body, severe chills. Symptoms started about 5-6 hours after vaccination and were severe after 8-9 hours. Less intense symptoms the following day. Treated with Tylenol and Motrin for aches and chills which help with pain, but symptoms would return after medicine wore off

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

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

Headache and chills started over night. Heavy fatigue, weak and achy in the morning. Dizzy spells come and go. Nauseous but no vomiting.

Patient had not eaten breakfast or lunch, experienced sweating and dizziness. BP 101/58 HR 69 and 5 minutes later BP 102/55 HR73. Given water, apple juice, and crackers. Patient released in stable condition

5pm felt warm, temp at 99.3. clingy behavior. Gave one advil, settled down. Advil relieved his behavior. Ate dinner, off balance afterwards, fell asleep..possible seizure activity occurred 6pm. I increased his klonopin by .5mg. To monitor.

Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Nausea-Mild, Systemic: Visual Changes/Disturbances-Mild

Patient was extremely anxious prior to receiving COVID vaccine. After 30 minutes of administration, vomiting occurred. Dry heaving followed. Did not have an allergic reaction. Did not need to call 9-1-1. Just worked himself up so much about it. Sent him home as I didn't want him to complete his shift while vomiting. Was having chills and wasn't sure how long they were going to last. Left him to go home with girlfriend. Went out front to wait for his ride and get some fresh air. Exchanged numbers so I could keep in contact with him. Knows to contact EMS if symptoms worsen.

about 5 minutes after vaccine, patient became pale, hot, sweaty, nauseous and lightheaded. He vomited once.

Fever, Chills, Body Aches, and Fatigue began about 7 hours after the vaccination and lasted for a period of about 36 hours. Used Tylenol and ibuprofen to reduce fever and help relieve body aches.

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.

Patient has felt Extreme nausea, mild to moderate sweating, gittery feeling and blurred vision for about 2-3 minutes.

At 4:15 pm the Covid-Janssen vaccine was given to the left deltoid and the patient was told to sit down for 15 minutes. When the patient got up after 2-3 minutes, patient became disorientated, sat down, and shortly fainted thereafter. The patient was brought into a nearby room, away from a busy thoroughfare and laid down. The patient regained consciousness soon after. Symptoms included: sweaty, palpitations and low blood pressure. After resting for 15-30 minutes he was able to walk out.

LEFT SIDE FACE PAIN; BLISTERS ON THE FACE; FEVER; This spontaneous report received from a consumer concerned a 28-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: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 in left deltoid for prophylactic vaccination. Concomitant medications included benzylpenicillin. On 03-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 38 C. On 05-APR-2021, the subject experienced left side face pain. On 05-APR-2021, the subject experienced blisters on the face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 04-APR-2021, and had not recovered from left side face pain, and blisters on the face. This report was non-serious.

- Woke up in the middle of the night following the day of my shot, approximately 14 hours after injection, to the shivers. Whole body shaking, almost feverish, but without running a temperature. - Severe fatigue the entire two days following the injection. Slept for 21 hours beginning on noon the day following the shot until 9am the following day. - Mental haziness/fogginess three days after injection. Felt as if I was buzzed without having consumed any alcohol.

10 hours after injection; began to get a headache. Which was when I went to lay down early for bed. Strong chills and sweats. Dizziness and chills for most of the night. Began feeling better in the morning and back to normal by Monday.

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)

Extreme fever 6 hours following the shot. Fatigue lasted roughly 48 hours. Then Sunday 4/11, 5 days after receiving the shot, I've experienced shortness of breath. It felt like someone was sitting on my chest. This restriction has loosened since but still causes discomfort.

Janssen COVID-19 Vaccine EUA led to Nausea, severe headache, severe pain throughout entire body (legs, back, neck, head), vomiting for 12 hours. I took Tylenol and Migraine Medication but both were to no avail.

Slight rash at injection site noticed later on in the same day as injection. The rash grew and was tender when noticed on Satuday 4/10 more then 48 hours after injection. Arm is still sore as of 4/13.Headache began on Monday 4/13 and is persistent throughout day.

Chills that started 12 hours after shot but resolved within a few hours. Bad headache that started the following day, but has persisted for 7 days straight with OTC medicine (advil and tylenol) not doing much to stop symptom

Severe headache - lasting for 24 hours starting at 3:30pm Nausea - lasting for 2 hours starting at 3:30pm on 3/10/2021 Chills - lasting for 4 hours starting around 7pm on 3/10/2021 Low-grade fever - lasting for 4 hours starting around 7pm on 3/10/2020 Soreness - effecting entire body and lasting for 24 hours starting at 3:30pm on 3/10/2020

Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: while observing the patient after administering the vaccine, he temporarily fainted. He came to immediately and felt better within the following 5 minutes.

Jansen COVID-19 Vaccine EUA On 04/12/2021 at 11:30pm (5 days after I was originally vaccinated), I started to itch inside of the crooks of both of my arms were starting to itch. After a few minutes of not scratching the crooks of my arms, I had noticed that both crooks of my arms were still red. I then took off my shirt and realized that I had an extensive rash with hives all over my trunk. I also had a sudden onset of nasal congestion and sneezing during this same time period. I took Benadryl and Pepsid on that same night and then saw my primary care doctor the following morning. My primary care doctor diagnosed my rash/hives as a probable result. I was instructed to continue with the Benadryl and Pepsid and watch for any changes.

FEVER; This spontaneous report received from a patient concerned a 28 year old. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 14:48:00 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, Laboratory data included: Body temperature (NR: not provided) 101-102, 101.5 F. On 08-APR-2021 22:00, the subject experienced fever. On 08-APR-2021 23:00, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever. This report was non-serious.

blood transport vessel in left thigh throbbing for a few hours upon waking in the morning, very sore legs. The rest of the symptoms are considered normal for the covid 19 vaccine and they included fever, headache, fatigue, bodily aches, occasional recurring chills and injection site soreness.

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.

The patient is a 28 y.o. male who presents to the Emergency Department with left sided body aches and 6/10 head pain that began approximately two weeks ago following the administration of the Johnson and Johnson COVID-19 vaccine. The patient is present with a chaperone at bedside who helps provide history and translates for the patient. Since the administration of the vaccine the patient states he's been experiencing these symptoms. The patient reports that he began experiencing his symptoms approximately 30 minutes following the vaccine administration and have worsened since onset. He reports that he took oral Tylenol yesterday with minimal relief. The patient states that movement and exertion exacerbate his symptoms and reports that he was not able to attend work today secondary to his pain. The patient denies any associated symptoms of fever, chills, nausea, vomiting, diarrhea, constipation, or any visual changes.

TEMPERATURE GOING UP TO 100.7; This spontaneous report received from a consumer concerned a 28 year old male. The patient's height, and weight were not reported. The patient's past medical history included possible covid-19 infection, and concurrent conditions included depression. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Concomitant medications included mirtazapine for depression. On APR-2021, the subject experienced temperature going up to 100.7. Laboratory data included: Body temperature (NR: not provided) 100.7 F, 100.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from temperature going up to 100.7. This report was non-serious.

BLOOD IN URINE; FEELING BAD; BODY ACHES; CHILLS; EXHAUSTED; This spontaneous report received from a patient concerned a 28 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included iga nephropathy, non-smoker, and non alcoholic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced blood in urine. On 11-APR-2021, the subject experienced feeling bad. On 11-APR-2021, the subject experienced body aches. On 11-APR-2021, the subject experienced chills. On 11-APR-2021, the subject experienced exhausted. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood in urine on 13-APR-2021, and chills, was recovering from feeling bad, and had not recovered from body aches, and exhausted. This report was non-serious.

fever, body aches, and headache on 04/11/2020. was instructed to take tylenol and to apply cold compress. patient was instructed to seek medical attention if the symptoms got worse.

SEVERE STOMACH ACHE; BODY ACHE; VOMITING; SORE THROAT; HEADACHE; NAUSEA; FEVER; This spontaneous report received from a patient concerned a 19 year old male. The patient's height, and weight were not reported. The patient's past medical history included mycosis fungoides, and concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested for this case. No concomitant medications were reported. On 10-APR-2021, the subject experienced severe stomach ache. On 10-APR-2021, the subject experienced body ache. On 10-APR-2021, the subject experienced vomiting. On 10-APR-2021, the subject experienced sore throat. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe stomach ache, body ache, nausea, vomiting, sore throat, headache, and fever. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.

NYSTAGMUS; VERTIGO, NAUSEA, VOMITING AND DIZZINESS; FLU-LIKE SYMPTOMS; This spontaneous report received from a consumer concerned a 28 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, alcohol user, non-smoker, and no known allergies. The patient was previously treated with levocetirizine dihydrochloride for seasonal allergies, and budesonide for seasonal allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 16:30 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: dimenhydrinate. On 16-MAR-2021, the subject experienced flu-like symptoms. On 17-MAR-2021, the subject experienced nystagmus. On 17-MAR-2021, the subject experienced vertigo, nausea, vomiting and dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms on 17-MAR-2021, and had not recovered from vertigo, nausea, vomiting and dizziness, and nystagmus. 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

Starting at 2am had the worst fever, shivers/shakes, headache, aches, and felt weak. Shaking/shivering uncontrollably all night. Tylenol helped but when it wore off I recorded a high 103-low 104 degree fever. Tylenol and a bath helped bring it down, rest of day just headache and weakness, sweating. By 4pm next day started feeling a bit more normal. The night/morning of was the worst fever/sickness I can remember feeling.

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

Patient became very dizzy, lightheaded, lost balance, sweating. emergency services was contacted and was evalualted by EMS. EMS left scene, patient felt completely recovered after waiting in the store for 45 mins and left facility . Patient mentioned after the incident that this has occured with other vaccines. Patient did not indicate this history prior to covid vaccine adminsitration or episode

Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium

Systemic: Throat felt itchy, but he never had any swelling.-Medium, Systemic: Shakiness-Mild, Additional Details: Pt waited 15 minutes, left. Then felt throat tingling and tightness on his drive home. Came back to the pharmacy, drank some water, we opted to give him loratadine instead of benadryl since he had a 2+ hour back home. He stayed in the pharmacy for another hour and was able to drink water and eat a snack with no issues and wanted to continue on his trek home. He called us when he arrived home and was feeling fine.

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.

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.

After getting vaccine and during the 15 minute wait, he became light-headed and started sweating profusely. He became pale and lips were white. Helped to lie down on matt, with feet in chair, and cool cloth applied to neck. Blood pressure was 100/64 and pulse was 64. After about 2 minutes, he said he felt better than when he first came in. I asked him if he had ever had this happen before and he said yes when he had blood drawn a few years ago. He was helped to sit up in a chair. He no longer had any light-headedness and his color was returning to normal. His lips were now pink. He was given a granola bar and water to drink. After staying for 20 minutes longer he left. He was called the next day by me and he said he had not had any light-headedness after he left.

approximately 10 minutes after the innoculatioin the patient was sitting and talking with me and thenjust drooped his head down andwas unresponsive. I shook him and said his name while my coworker called 911.A retired nurse assisted me . As patient was coming to he tried to stand up and appeared to be convulsing, so we sat him back in the chair. He then wasa responsive but sweating profusely. We got him to the floor andput cold compresses on forehead and neck and waited for 911 to arrive. They released him to his girlfriend to bring him home.

Pt got J&J COVID vaccine around 5:15pm, a few minutes into observation time, he told RX tech that he wasn't feeling so well so she suggested he move into the counseling room to lie down. As he got up to move he became lightheaded and had to squad down. We then instructed him to lie down and elevated his feet. We gave him some apple juice and water and he said he felt better after drinking the beverages. He was responsive and alert the entire time, and pharmacist continue to converse with pt until he no longer lightheaded. Pharmacist then asked pt to transition to sitting, continued that observation for 5 more minutes. At around 5:35pm the pt. was able to stand without issue and the pharmacist walked him to his car without further issue.

Unable to climb stairs, walk or stand up. Nausea. Fever. Shaking. Headache. Diarrhea. Starting about 12 hours after vaccination. Most severe symptoms cleared in 24 hours, but did not feel 100% for 3 days. Missed 1 day of work. Slept 18 of the 24 hours.

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Visual Changes/Disturbances-Medium

Almost immediately after injection was given, patient complained of chest pain, light-headedness and sweating. He admitted to a previous history with past vaccinations although inconsistently. Chest pain resolved, per patient. Patient transported by wheelchair to paramedic area with brief loss of consciousness, spontaneously resolved. Patient able to transfer from wheelchair to cot, reporting improvement when lying down. Paramedic and EMT monitored vitals, paramedic advised transport to hospital to rule out cardiac event, patient consented. Tranported to Hospital

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

Headache and fever of 99.1 F. Tylenol 500 mg two tablets taken twice in a 12 hour period. Luke warm showers taken, as well cool towel compress. Fever reduced

Headache, Fever, body ache, hot and cold flashes Employee receive 1 dose of Johnson and Johnson Covid-19 vaccine on 16 March21 and developed symptoms on 17March21 at 0100. Currently employee is stable at home of record and advised to seek medial attention if symptoms become life threating. Informed employee to call supervisor of any intended absences.

Diarrhea, headache, stomachache, bilateral lower leg pain, temp of 103- all symptoms started the following day after vaccine.

Starting feeling dizzy, then extreme chills/shakes, followed by low grade fever. Fever broke during sleep, and pain in left arm.

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.

Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Additional Details: After about 5 minutes after pt recieved COVID shot, he wasn't normal. He said he had lightheadness and chills and tingling. A few minutes later he went to the bathroom to vomit. Person called paramedic because pt didn't seem well and pt said he needed medical attention. Paramedic came about 5-8 minutes. Pt left a few minutes after paramedic left.

Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Additional Details: After about 5 minutes after patient recieved COVID shot, he wasn't normal. He said he had lightheadness and chills and tingling. A few minutes later he went to the bathroom to vomit. Paramedic called because patient didn't seem well and patient said he needed medical attention. Paramedic came about 5-8 minutes. Patient left a few minutes after paramedic left.

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.

5 minutes after initial injection I became increasingly lightheaded, nauseous, dizzy, disoriented, and fatigued. 10 minutes after initial injection I experienced a short fainting event in passenger seat of vehicle. Immediately after regaining composure I began sweating profusely and became very pale/flushed color in face at which point I exited the vehicle and flagged EMS to assist me. EMS monitored blood pressure and blood saturation before releasing me on my own recognizance approximately 25 minutes later. Tingling sensation felt in left arm after fainting approximately 10 minuets after initial injection. Next 48 hours after injection I experienced severe body chills, body aches, headache, nausea, loss of appetite, and night sweats. 72 hours after injection I am close to fully recovered but still experience fatigue and night sweats.

Patient approached the RN, and stated that he thought he was going to pass out. The patient's knees buckled and he sank to the floor. (witnessed fall) The patient did not hit his head on the floor. At 105 the Patient was moved to the recovery area where he was laid on the floor and his feet were raised onto a chair. Patient was diaphoretic BP 116/74 pulse 70 oxygen 99% on room air. Around 1210 the patient sat up on the floor and complained of dizziness and nausea. Patient was placed back into a lying position and BP recorded at 140/90. At 1230 the patient was sitting on the floor and nausea and dizziness had subsided. At 1245 the patient was placed in a wheelchair and assisted to the car and the girlfriend drove him back home. BP recorded at 116/70 upon leaving the vaccination clinic.

Approximately 3 minutes following administration of vaccine, the skin on the patients face, arms, and legs turned red and the patient began to sweat profusely. The patient reported that he was feeling dizzy and had blurred vision. The patient did not report any shortness of breath or swelling of the face, throat, or lips. Physical assessment confirmed patients report of no swelling of the face, throat, or lips. The patient was treated with an ice pack to the back of the neck and was advised to place his head between his legs. The pharmacy student remained with the patient for 30 minutes after the reaction occurred. During the 30 minutes, the patient reported that his dizziness and blurred vision were improving and he was no longer sweating. Physical assessment of the injection site found that there was no redness, swelling, or rash developing. After 30 minutes had elapsed since the reaction, the patient reported that he was no longer dizzy, experiencing blurred vision, or sweating. Assessment of the injection site at this point was the same as above with no redness, swelling, or rash occurring. At this point, the patient was cleared to leave the pharmacy and was advised to go home and rest for the night and not perform any strenuous activity.

c/o of severe nausea and dizziness. pale and diaphoretic. patient assisted to exam room - able to ambulate independently. pt worked night shift in a factory had not slept or eaten prior. vital signs with in normal limits. pt wearing multiple layers of clothing - hoodie and long sleeve shirt removed pt remained in flannel pants and shirt. ice pack provided , water, juice, and food. returned to baseline. denies any s/s of sob, itchiness or tightness in chest. color returned and no longer diaphoretic. reports feeling "normal again". pt monitored an additional 30 mins VS repeated and spouse was present and accompanied them home. informed to take hoodie back off and keep hydrating. pt left facility in stable condition w/ written instructions on when to call for help and what is an emergency.

Patient reported sudden vision impairment, started palpating and had profuse sweating with shortness of breath; patient was administered one dose of Epipen; 911 initiated per protocol. By the time ambulance arrived, patient was already feeling better; for safety and evaluation , they took him to emergency.

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.

fever, chills, syncope, unconscious. starting 5-10mins after vaccine received. s/s experienced for about 30min following vaccination emergency services contacted

DIARRHEA; FOGGY FEELING; BEING UNABLE TO FOCUS; COLD AND HOT SWEATS; FINGER NUMBNESS WHICH COMES AND GOES; FEELING DEHYDRATED; BODY WEAK/CAN ONLY LAY IN BED; HEADACHE; SORE IN RIGHT ARM AT INJECTION SITE; This spontaneous report received from a patient concerned a 28 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no change in lifestyle. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 07-AUG-2021) dose was not reported, administered on 15-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, treatment medications included: paracetamol. On 15-JUN-2021, the subject experienced diarrhea. On 15-JUN-2021, the subject experienced foggy feeling. On 15-JUN-2021, the subject experienced being unable to focus. On 15-JUN-2021, the subject experienced cold and hot sweats. On 15-JUN-2021, the subject experienced finger numbness which comes and goes. On 15-JUN-2021, the subject experienced feeling dehydrated. On 15-JUN-2021, the subject experienced body weak/can only lay in bed. On 15-JUN-2021, the subject experienced headache. On 15-JUN-2021, the subject experienced sore in right arm at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body weak/can only lay in bed, headache, diarrhea, foggy feeling, cold and hot sweats, sore in right arm at injection site, finger numbness which comes and goes, feeling dehydrated, and being unable to focus. This report was non-serious.

Ten minutes after the shot the patient became shaky, light headed, dizzy, was nauseated, and was sweating. after 45 minutes patient felt better and went home.

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.

Patient complaint of Body aches, nausea, headache, and sore arm. Patient was given Tylenol 650 mg TID PRN for pain X 7 days.

CHILLS; FEELING COLD; FEELING TIRED; 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: 1808982, expiry: UNKNOWN) dose was not reported, administered on 25-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-JUN-2021, the subject experienced chills. On 25-JUN-2021, the subject experienced feeling cold. On 25-JUN-2021, the subject experienced feeling tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, feeling cold, and feeling tired. This report was non-serious. This case, from the same reporter is linked to

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.

- Extreme body aches on lower back and thighs/glutes. Could not walk and legs started to cramp for 2 days. - Face and skin began to turn yellowish in hue (Jaundice) -Extreme dizziness and feeling of euphoria where I could not stand -High Fever over 102.5 degrees.

1616- Patient received injection and immediately fell forward from chair and struck plastic chair with right forehead while falling to floor. Staff called for help. 1617- Patient lying on side, not responding to voice or tactile stimulation for 30-60 seconds. Patient spontaneously opened eyes, sat up, and asked 'where...what'. Pulse ox placed on patient HR 50, O2 sat 99% on RA. Code team arrived. BP 86/45 HR 50. Patient pale, diaphoretic. MD advised lowering head between knees. COld pack placed on back of neck. Pt offered juice, patient drinking juice. Patient with small closed laceration above right eyebrow. 1620 HR decreased to 48. This NP advised patient to lay down, feet elevated. Band-aid placed on laceration. MAE, Ice pack placed on forehead. Patient reports mild pain on forehead that increases when pressure placed on forehead. 1622- A&O x4, pale. BP 109/67 HR 58, O2 sat 100%. Patient consented to notifying spouse of his condition. Staff member sent outside to notify spouse. 1627- A&Ox 4, skin pink, BP 114/75, HR 54, 02 sat 98%.. Patient offered more juice. Denies dizziness, reports mild HA. Dsg to forehead clean, dry and intact. Spouse and children at patients side. Patient interacting. Spouse reports patient "didn't eat much and was very nervous". 1632- A&Ox4, skin pink, dry. BP 119/79, HR 55, O2 sat 100%.. Discussed plan with patient to gradually have patient sit up and that we advise following up at urgent care today. Worked with staff to find urgent care. Spouse states she will drive patient. 1634- A&Ox4, skin pink, warm, and dry. Patient sitting up. BP 120/76, HR 61, O2 sat 98%. Patient denies dizziness, or nausea. Reports MIld HA and forehead pain. 1640- A&Ox4 skin pink, warm, and dry. Patient sitting up. BP 108/73, HR 65, O2 sat 98%. 1646 HR 62. Patient denies dizziness, or nausea. Reports MIld HA and forehead pain. Patient wanting to stand up. Patient assisted to feet, denies dizziness, gait steady. Standing BP 123/70, HR 54, O2 sat 99%. 1650- transported via wc to private vehicle. Patient ambulated and seated in car without c/o. Address for Urgent Care provided to patient's spouse. Patient and spouse state understanding of recommendation for further follow up at urgent care.

Site: Pain at Injection Site-Mild, Additional Details: Pt received vaccine at 4:02 pm, started to feel faint at 405 pm( became pale and diaphoretic per). Called for NP help from in next room. Provided pt with ice packs. BP 100/62. Provided coca cola after patient stated he had not eaten since morning. Patient started to get color in face. BP re-check at 4:22 pm was 110/80. Pt was able to ambulate to waiting room at 4:35 pm. Pt & mom left waiting room feeling better at 5 :05pm

ITCHINESS WITH BURNING SENSATION; WORSE RASH ON ARMS, LEGS, CHEST, NECK, BACK AND ALL OVER BODY; FEVER; This spontaneous report received from a patient concerned a 28 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and 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: 1808982, expiry: UNKNOWN) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUL-2021, the subject experienced fever. On 10-JUL-2021, the subject experienced worse rash on arms, legs, chest, neck, back and all over body. Treatment medications included: paracetamol. On 12-JUL-2021, the subject experienced itchiness with burning sensation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 10-JUL-2021, and had not recovered from worse rash on arms, legs, chest, neck, back and all over body, and itchiness with burning sensation. This report was non-serious.

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.

increased glucose levels, treated with insulin. Patient suspected DKA and went to E.R. Patient experienced vomiting and dehydration

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.

patient developed sore throat, headache, and new loss of taste / smell on 07/14/21. He tested positive for COVID on 07/18/21.

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.

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

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

vasovagal syncope or seizure? After receiving the drive-through vaccine, we drove into a parking space to sit and make sure I was ok. Within 5-10 minutes, I was sitting in the car and sending a text and with no warning whatsoever mid-text lost consciousness, profuse sweating, wheezing, lost color in my skin, was making unintelligible noises, and eventually woke up about a minute later but couldn't speak or comprehend those speaking to me (according to my wife who was terrified). I was not nervous, stressed, or scared of receiving a vaccine. I regained the ability to speak about a minute later and my wife had summoned the staff on the scene who instructed me to lie back and breathe without a mask. I drank some liquids. A nurse was called over and offered to take my vital signs but I decided I felt ok enough not to. Eventually my normal skin color and came back and sweating stopped after about 5 minutes. We sat for a few extra minutes and once I felt it was past me, my wife drove us home.

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

Fever and restlessness for about two hours, followed by low-grade headache, and body ache, generally feeling tired.

Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Mild, Additional Details: Patient alerted me that he was feeling unwell, he started hyperventilating, sweating, shaking, experiencing tingling and numbness throughout his body. Patient was dizziness. He received an epinephrine shot in which he then layed on the floor and started calming down. Paramedics came and checked him out and found him to be alert and well. Patient left store fully recoverd and consulted to go to emergency room if he had any symptoms of an analyphylatic reacction.

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.

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 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.

Moderate Pain at injection site, severe headache, chills, all over body aches, low grade fever, nausea, vomiting

I got the vaccine roughly at 6:10pm on 3/15. I was fine when I went to bed around 10pm. I woke up around 1am on 3/16 with fever/chills/body ache/headaches. Fever was around 103 degrees F at it's peak and stayed at or above 100 degrees from about 1am until about 5 or 6pm on 3/15. I took tylonel during this time. I also experienced diarrhea and loss of appetite during the day; random periods of feeling nauseous. I seemed to be dehydrated but drank a normal amount of water the day before. It felt like I had the flu, but I don't think I've felt this sick since I was a kid. It was terrible. I felt incredibly tired on Tuesday but couldn't fall asleep. 3/17--woke up today feeling mostly fine minus a bit of lingering soreness and feeling very tired still.

Fever of 100 degrees accompanied by chills started approximately 7.5 hours after administration and persisted until through going to bed. Cleared up by the morning

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

12 hours after my shot I developed a severe headache and fever of 102. This persisted for about 7 hours. Then the fever decreased to about 100.5 for the next 24 hours. After my fever broke, however, I developed a chest cough with some phlegm. This feels like bronchitis and my doctor has prescribed azithromycin. I also feel rolling fatigue, which comes on randomly. The cough and fatigue has persisted so far for 6 days. In addition, though I do not have a fever most of the day, on some nights my fever spikes (last night, reaching 102 for a short period of time while trying to sleep). It has been 8 days since my injection. I have very little appetite (though I can smell and taste fine).

Monitored for 30 minutes after injection, no symptoms, released back to housing (cell). Approximately one hour later, presented to Health Care Unit with c/o itching, nasal congestion, watery eyes, lightheadedness, nausea, "hard time breathing". Very anxious. Administered 50 mg Benadryl IM without any relief. Patient was sent to local emergency department as precaution. Given epi SQ and additional Benadryl in the emergency department

Temperature steady at 101, body aches, severe headache, fatigue, body chills, sweats, feeling hot, and feeling dehydrated.

NKA from patient. Patient in at 1553 and out at 1608. Hx of chronic rhinitis and asthma. Patient presented with vitals of 163/105, HR 67, SP02 94% (sitting). VS at check out were 145/88, HR 64. Patient reported with hunger, flushed, diaphoretic, and pale. there was no SOB or dizziness reported. Patient provided juice and snack. Patient returned to normal and released.

Janssen COVID-19 Vaccine EUA was given at 11am and symptoms began around 9pm. Mild fever, tiredness, achiness, nausea, and headache were the worst between 9pm and 11am the next day. Beyond the first 24 hours, mild nausea and tiredness have persisted for the first week after vaccine was administered.

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

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.

I had extreme chest pain on the 24th of March. It really hurt to breathe and it felt like I had pressure on my chest. I went to the Emergency room and they did a chest x-ray and a Covid-19 both of which were negative. I went home and I returned to the ER because the chest pain became worse. The chest X-Ray the second day showed I had pneumonia. I was told that it could have been from the Covid-19 in December or if was community acquired. I was prescribed with antibiotics and discharged. I still feel some chest pain after about a week and I have already finished the full course of antibiotics. I've seen my Primary Care physician, my cardiologist and my Pulmonologist.

12 hours later I began to suffer from shaking, fever, chills, nausea. This continued off and on for about 14 hours. I used Advil around 10am and it broke my fever.

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

Weakness began at approximately 10:00. Chills and Fever over the course of the night measured at 100.2. Major fatigue the following day. Slight nausea on 4/3 Body aches persistent through 4/4 Headache on 4/3, persisted to 4/4. Symptoms drastically improve with ibuprofen (Advil), though return after approximately 6 hours. No fever on 4/4.

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.

UPON RECEIVING THE IMMUNIZATION, PATIENT REPORTED FEELING LIGHT HEADED. HE WAS GIVEN WATER AND REMAINED SEATED. AFTER A COUPLE MINUTES HE BEGAN TO PERSPIRE AND WAS PALE. ROUGHLY 5-7 MINUTES AFTER RECEIVING THE VACCINE, THE PAINTED FAINTED AND DID NOT RESPOND TO HIS NAME FOR 90 SECONDS. HE DID ALSO HAVE SOME BRIEF SHAKING MOVEMENTS OF HIS ARMS. UPON WAKING UP, THE PATIENT REMAINED SWEATY AND PALE. HE WAS ASSESSED IN THE PHARMACY (LOCATED IN A HOSPITAL) BY AN EMERGENCY ROOM PHYSICIAN AND WAS CLEARED TO LEAVE WHEN HE WAS COMFORTABLE.

mostl likely vasovagal syncope. patient fainted and woke up very quickly disoriented. was sweaty for about 10 minutes. He was given reeses candy bar and water and monitored for an additional 15 minutes after his beginning time. was released about 40 minutes after his vaccine/reaction.

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

Felt fatigue 6 hours after shot and went to sleep for two hours. I started running a temp of 102 10 hours after shot. I started throwing up about 12 hours after shot until about sixteen hours after shot. I had hot and cold chills and would wake up with night sweats for about 40 hours after shot. Had a pounding headache also for about 24 hours after shot. Was thirsty for about 12 to 16 hours just couldn?t drink due to having to throw up. Still have hot and cold chills and feel weak and have no appetite now 45 hours after the shot. Only been able to eat soup since the shot.

Fatigue and lightheadedness 2 hrs after vaccination for two days Fever onset 8 hours after vaccination, peaking at 104F lasting 14 hours Chills onset 8 hours after vaccination lasting 18 hours Headache onset 24 hours after vaccination lasting one day

On the night of the vaccine: Fever of 101.5. and headache(6/10). Morning after vaccine: Fever 100.5, headache (6/10), pallor, diaphoretic, nausea. Stood up and then passed out for approximately 2 minutes, hitting his head on the wall. Regained consciousness on his own.

Within 5 minutes of administration, patient began to experience some nausea and alerted pharmacy staff. The pharmacist gave patient trash can and began monitoring patient condition. Patient stated has anxiety and has experienced this before. Patient was pale at this time. After 10 minutes from vaccination, patient began to get sweaty. pharmacist gave patient an ice pack for forehead and helped patient to the floor. Patient sat on floor and remained conscious. After several minutes on the floor. patient's color returned and he stated was feeling much better. Patient returned to his chair at this time (about 15 mins post vaccination). Patients condition continued to improve from there on. Patient waited at the pharamcy for 30 more minutes to ensure syncope event had past and no other issues arose. Patient left after 45 minutes stating they feel normal.

It started with a headache approximately 8 hours after the shot. Then quickly was followed with a fever and chills. This continued until approximately 24 hours after the shot. When it turned back into just a headache. Which is ongoing. (32 hours after shot)

Symptoms similar to days of positive COVID-19 but in 'fast-forward': intense chills/shivering (12:30-2AM), low-grade fever of 99.5-101.1 (3-6AM), moderate fever of 102.1 (7 AM) broke around 9-10AM. Followed by intense headache/migraine, photosensitivity, difficulty sleeping, and mild nausea (until 12PM). Headache finished around 230 PM. Loss of appetite all day. Still not feeling well at time of submission. Treating with Tylenol and forcing fluids.

At approximately 4 pm, I gave the patient a Janssen covid-19 vaccination. I asked the patient to sit for 15 minutes for observation. About 10 minutes later I was notified someone wasn't doing well. I went to the patient and he was hunched down and looked pale and he stated he was very dizzy. I asked him if he had trouble breathing and he stated he had not. He appeared like he was about to pass out, I was asking him questions about his state and he wasn't being coherent. I told him I was going to give an EpiPen and call 911. I gave him the EpiPen in his outer thigh. EMS came 5 minutes later. A few hours later I got a call from a close by asking if I had given him a Benadryl because he was feeling drowsy. I asked his status and the nurse stated he was doing fine.

SLIGHT DIFFICULTY IN BREATHING; DRY COUGH; CHEST TIGHTNESS; ALMOST UNRESPONSIVE AT DINNER TABLE; HIGH LEVEL OF FATIGUE AND SLEPT ALL DAY; NAUSEA; HEADACHE; SLIGHT NUMBNESS TO FACE; This spontaneous report received from a parent concerned a 29 year old male. The patient's height, and weight were not reported. The patient's past medical history included surgery to left foot at late adolescent, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 11:00 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced slight numbness to face. On 30-MAR-2021, the subject experienced slight difficulty in breathing. On 30-MAR-2021, the subject experienced dry cough. On 30-MAR-2021, the subject experienced chest tightness. On 30-MAR-2021, the subject experienced almost unresponsive at dinner table. On 30-MAR-2021, the subject experienced high level of fatigue and slept all day. On 30-MAR-2021, the subject experienced nausea. On 30-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from high level of fatigue and slept all day, dry cough, nausea, headache, chest tightness, slight difficulty in breathing, and almost unresponsive at dinner table, and the outcome of slight numbness to face was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.

Cold chills, hot flashes, night sweats, headache, dizziness, 105.6 F fever the following night/day and a 102.0 F fever the second day. Light headedness the third day with no fever

vaccine reactions,headache,body ache. PT presents with bodyaches, HA and chills x 0300. denies n/v/d. reports received JJ vaccine yesterday.

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.

High fever reaching 103.8° F. Between 7pm and 12am, my fever ranged from 100-103.8° F Elevated resting heart rate of 90-130 beats per minute. My normal is 62-75 bpm. While I was sleeping, my heart rate ranged from 93-113 bpm (according to Apple Watch). Extreme headache Inability to sleep Chills and shakes Extreme fatigue Light headed and unable to speak clearly I don?t know if this was life threatening; I know it was likely my immune system responding but these side effects were extreme. I almost called an ambulance. I?ve never felt pain like that before in my head. My heart felt like it was racing all night and my brain felt like it was going to expand out of my skull. The head pain, heart rate, and rapid breathing was keeping me up. I tried to sleep 7pm?12am which was the worst of it. By the middle of the night, it seemed that the fever subsided and my resting heart rate was more in the 90-100 range (still 15-30% high). The next day, I have a moderate headache that feels like after pain from the night before. Fever subsided. Heart rate is slightly high at 80-100 bpm. I managed to sleep in the whole morning. I had to take off from work today in order to rest.

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.

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

Headache almost immediately, chest tightness starting maybe 2 hours later and persisting until present time, roughly 30 hours post-vaccine.

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.

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

Patient fainted from sitting on chair, felt nauseous, dizzy, and lightheaded 5 minutes after receiving vaccine. Felt dizzy for an additional 15 minutes and laid supine. Patient drank juice, ate a salty snack, and sat up. Continued to feel lightheaded, laid down for additional 15 minutes. Patient vomited, complains of headache and nausea. Symptoms continued for an additional 45 minutes before patient felt comfortable to leave with friend.

Day after had 101 temperature, headache, vomiting, soar throat, runny nose and body felt like glass. 4 days after and still fill pretty sixk

First night after vaccine: could not sleep due to significant pain in my arm and constantly feeling too hot and then too cold, in addition to night sweats. Day 1: could not walk (had to crawl to move around), extreme fatigue, dizziness, hallucinations, exceptionally poor motor skills, no real memory of anything I did that day, brain "mush" to where I could not understand words spoken to me, extreme arm pain persisted Day 2: slept 14 hours and took a 4 hour nap that day, able to walk but could not use stairs, fatigue, dizziness, poor motor skills, no memory of what I did this day, brain "mush" persists, extreme arm pain persists Day 3: slept 12 hours and took a 5 hour nap, able to walk but not use stairs, fatigue, dizziness, poor motor skills, memory improves but still poor, brain "mush" persists, extreme arm pain persists Day 4: slept in again long at night and had a long nap, able to use stairs again but very slowly, fatigue, dizziness, poor motor skills, memory improves but the ability to recall past experiences and recall words remain poor, arm pain persists Day 5: slept in again long at night and had a long nap, able to use stairs again but very slowly, fatigue, dizziness, poor motor skills, memory improves but the ability to recall past experiences and recall words remain poor, arm pain persists Day 6: slept in again lost at night but no longer napping, ability to use stairs finally improves, fatigue, dizziness, poor motor skills, memory improves but the ability to recall past experiences and recall words remain poor, arm pain persists I could not drive a car until 8 days after the vaccine due to poor motor skills. To this day (one month later) by ability to recall memories and recall words remains poor. I have troubles forming sentences because words don't come to me. To this day I cannot recall anything that happened days 1-3 after the vaccine. I was able to write this report because my partner made me take notes on how I felt. Prior to the vaccine I never had an issue with memory recall. My physical reactions cleared during the second week after the vaccine. However, the mental reactions still stubbornly persist.

7 hours after the shot I experienced headache and a weird skin discomfort feeling, I took Tylenol. 12am I woke up with violent shaking and clenching with no fever. Took Tylenol again. 2am woke up without the shakes but severe body pain. 7am another headache bad body aches took more Tylenol. Everyone i feel like I?m getting better I feel worse again. I feel like everything is coming back again.

Flushed, Sweating, decrease drastically in HR, and almost passing out. Treatment with icepack on nape of neck, cold water and frequent HR checks with observation. Time allotted for patient to return to normal state was 34 minutes.

615pm went to sleep, 9pm woke up with headache that was moderate to severe, chills and racing heart later on my blood pressure went up to hypertension levels..my temp was 103.8, the back of my shot arm was ice cold, took 1 ibuprofen, 909pm 102.4 temp took 2nd ibuprofen, BP 155/82 @ 1059pm, 129/78@11pm. Racing heart between 121-111@1058pm. 99% oxygen. 1201pm 2 Tylenol rapid release, 101.2 temp heart racing 108-109, symptoms unchanged, 1232am 142/86, 100.8 temp 99% oxygen Symptoms mild. 122/83, 101-102 heart still racing melatonin taken..100.1 temp, 1:52 am 94-95 , 99.2 temp, 6:24 sleeping 70-71 heart rate 96.1 temp

Complained of fatigue. Monitored for an additional 45 minutes while waiting for his girlfriend to arrive to drive him home. B/P 128/72, P-88, R-20, SaO2- 98%.

High fever, chills, delirium, heavy body aches, head aches, nausea -- all felt as if he got COVID again (unknown if acutally had COVID, a theory from being heavily sick for a few days early last year).

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.

12 hours after receiving JNJ vaccine, experienced fever, chills, headache, sore throat, body aches (these symptoms resolved after 24 hours). 24 hours after, experienced hives on both arms, upper back and hips. Hives eventually were limited to only arms after 3 days. 7 days after experiencing on and off hives, I took an antihistamine until hives disappeared for longer than 24 hours. Hives were not itchy, but large and warm to the touch. No single hive lasted for more than 24 hours. They disappear and reappear randomly on my arms. Specially over veins. It has been over a month since my vaccine and I?m still experiencing these hives that appear and disappear at random. I?ve documented each hive outbreak with photos and currently undergoing blood tests trying to learn more about this issue.

PATIENT STATES HE HAD COVID TWICE LAST YEAR AND THE VACCINE HAS BEEN WORSE. STARTING 2 HOURS AFTER VACCINATION HE HAD CHILLS, INTOLERABLE BODY ACHES, NAUSEA, VOMITING, FEVER. THEY LASTED 48 HOURS. BODY ACHES ARE STILL OCCURING 96 HOURS LATER. FEVER BROKE WITH TYLENOL. PATIENTS POA (HIS AUNT) CONCERNED ABOUT BLOOD CLOT.

The patient was found lying on the floor face down at 2:40am. He was responsive and able to sit up. Reported dizziness and chills. Was visibly shaking while staff were talking with him. Was sent to the ER for evaluation.

Pt stated severe body aches to where he could hardly get out of bed, nausea, vomiting, headache and chills. Pt stated he never went to the doctors and has been off work but is feeling recovered and about to return to work.

Pt reported severe fatigue over the past week, noting new onset of bilateral facial weakness 2 days ago (Sunday), progressively worsening. All symptoms started bilaterally at the same time. Diagnosed with Cranial nerve VII palsy. Received IVIG x 2 days with no improvement. At follow-up visit 2 weeks later, pt reported 80% improvement in symptoms.

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.

Patient developed severe bloody nose 5 days after administration of vaccine. It did eventually stop on it's own. He also had moderate headache and cold sx starting 5 days after vaccination.

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.

Presented with 28 YO male, seated in a chair S/P receiving the Johnson and Johnson COVID-19 vaccine. PT states he was feeling dizzy with shortness of breath. PT was given a bottle of water by RN for hydration. PT skin color starting to change from normal to a pale and PT started to become diaphoretic. Ambulance notified for transport to the closest facility. PT pulse 70 and strong and regular, BP 100/60 and respirations 20 strong and regular. PT denies any medical history or allergies at this time. No other interventions performed with PT due to ambulance arrival and PT care relinquished to EMS with full report, PT care relinquished without incident or injury.

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.

7 PM (4.5 hours after J & J shot) - Chills begin, both calf muscle in legs starting to shake. I move to my bed. 7:30 PM - In bed, dressed in sweatshirt, wool socks, etc., a a couple blankets wrapped around me, space heater turned to 80 degrees, shaking uncontrollably from being so cold (mostly hands and feet), mild headache begins in middle back of head. 8:00 PM - still freezing, temperature was at 98.7. most of body is aching 9:00 PM - chills and body ache starting to slow down, temperature at 100.3 9:30 PM - still have chills, space heater still on and i was still wrapped in a bunch of clothing/blankets. temp at 100.5 and i drank 6 oz water. 10 PM - chills going away, heat/blankets/clothing still on, temp at 101. body aches mostly only in left and right calf. Rest of night until around 4 A.M. was me tossing and turning being restless. My heart rate was ~130 BPM throughout the entire night according to my smart watch. I was checking my temperature constantly with an infrared thermometer and it was between 101-102.5. I probably drank ~24 oz of water throughout the night. It felt like each time i fell asleep, i would wake up no more than 30 min later and each time i woke up it felt like i had been asleep for 5 hours. At a few moments it felt like i was hallucinating seeing little boxes around my head.. At no point during the episode did i take any advil/tyenol/etc. Only drank water. Woke up around noon the next day, I felt extremely groggy, still had a headache and my temperature was back to ~98. I ate for the first time that day around 1 P.M. and had a few advil which helped with my headache.

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

12 hours after vaccine injection, experienced a 103.2 degree fever, sweating (lost 3 lbs in one day) and extreme body aches (unable to sleep due to pain) 24 - 36 hrs after vaccine injection experienced extreme chills & body aches. 96 hrs after vaccine injection, still had a 100.6 degree fever and migraine like headache and developed a rash all over my body that lasted for 48 hours and was only subdued by taking Benedryl.

Fever, aches, pain started 6 hours after vaccination. Unable to sleep for the first night. Temperature was over 102 all night. Fever did not respond to ibuprofen or acetaminophen. Fever ended after 24 hours.

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

MIGRAINE; VOMITING; HEAVY CHILLS; FEVER OF 102.6; This spontaneous report received from a patient concerned a 29 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included 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 use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 042A21A expiry: 21-JUN-2021) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced migraine. On 03-APR-2021, the subject experienced vomiting. On 03-APR-2021, the subject experienced heavy chills. On 03-APR-2021, the subject experienced fever of 102.6. Laboratory data included: Body temperature (NR: not provided) 102.6 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraine, vomiting, heavy chills, and fever of 102.6 on 05-APR-2021. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.

I started having constant headache with slight breathlessness 5 days later. The breathlessness is better now but the headache is still there on the 8th day after vaccination.

Dizziness within 1 hour nasua fever of 104. Body aches, body chills, after 2 hours . The nasua and fever got so bad I had to pull over and dial 911 for an ambulance .

CHILLS; HIGH FEVER; NAUSEA; VERY TIRED; This spontaneous report received from a consumer 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: unkown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced high fever. On 09-APR-2021, the subject experienced nausea. On 09-APR-2021, the subject experienced very tired. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102.7 F, 103.2 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the high fever, chills, nausea and very tired was not reported. This report was non-serious.

Mild headache and dehydration from approximately 10 PM on 04/11/21 until approximately 4 PM on 04/12/21

Patient experienced epistaxis the morning after the vaccine, and has continued to have mild-moderate headaches. To note, patient?s baseline is typically: - Roughly 1 nosebleed every ~4 years - Mild headaches 2-3 times per week

Janssen COVID-19 Vaccine EUA Body rash covering torso and leg appeared morning of 4/12, subsided roughly 12-14 hours later. Also had mild fever first night (4/11) after injection; persisted 4/12 and had completely subsided by morning of 4/13.

HEART RATE OF 111-121; BLOOD PRESSURE OF 155/81; O2 SATURATION OF 99 %; CHILLS; HEADACHE; FEVER SPIKED 103.8; 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 seasonal allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced heart rate of 111-121. On 09-APR-2021, the subject experienced blood pressure of 155/81. On 09-APR-2021, the subject experienced o2 saturation of 99 %. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced fever spiked 103.8. Laboratory data included: Blood pressure (NR: not provided) 155/81 (unit not provided), 129/78 (unit not provided), Body temperature (NR: not provided) 101.8 to 102.8 (unit not provided), 103.8 (unit not provided), Heart rate (NR: not provided) 111-121 (unit not provided), and O2 saturation (NR: not provided) 99 %. On 09-APR-2021 21:00, treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever spiked 103.8, and the outcome of chills, headache, heart rate of 111-121, blood pressure of 155/81 and o2 saturation of 99 % was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.

SHORTNESS OF BREATH; EYES BURNING; EXTREME FATIGUE; HEADACHE (PRESSURE IN FOREHEAD) FOR THREE DAYS; TROUBLE LOOKING AT THINGS FOR A LONG TIME/PATIENT COULD NOT OPEN HIS EYES; 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: Unk) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced trouble looking at things for a long time/subject could not open his eyes. On 07-APR-2021, the subject experienced shortness of breath. On 07-APR-2021, the subject experienced eyes burning. On 07-APR-2021, the subject experienced extreme fatigue. On 07-APR-2021, the subject experienced headache (pressure in forehead) for three days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from eyes burning on APR-2021, had not recovered from extreme fatigue, shortness of breath, and headache (pressure in forehead) for three days, and the outcome of trouble looking at things for a long time/patient could not open his eyes was not reported. This report was non-serious.

The night following my vaccination I ended up with a fever of over 100 degrees Fahrenheit and also suffered from a severe headache and sore throat. The fever and headache subsided after 24 hours, but the sore throat and ulcers on my gum line remained for the next 3-4 days. 9 days after I had gotten the vaccine, I started suffering from what I thought was a significant MS relapse. The left side of my face went numb and started drooping, my legs went completely numb, and my vision went blurry.

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.

CHILLS; FEVER; LOST MY VISION; CLOSE TO FAINT; PALENESS; DIZZINESS; UNABLE TO STAND; SWEATING; LOSS OF ENERGY IN LEGS/BODY WEAKNESS; This spontaneous report received from a patient concerned a 29 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included iodine allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced lost my vision. On 09-APR-2021, the subject experienced close to faint. On 09-APR-2021, the subject experienced paleness. On 09-APR-2021, the subject experienced dizziness. On 09-APR-2021, the subject experienced unable to stand. On 09-APR-2021, the subject experienced sweating. On 09-APR-2021, the subject experienced loss of energy in legs/body weakness. On 10-APR-2021 14:00, the subject experienced chills. On 10-APR-2021 14:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lost my vision, close to faint, paleness, dizziness, unable to stand, sweating, and loss of energy in legs/body weakness on 09-APR-2021, and fever on 14-APR-2021, and was recovering from chills. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.

DEHYDRATION; PASSED OUT TWICE; COULDN'T SLEEP; VERY UNCOMFORTABLE; SUPER BAD CHILLS; REALLY, REALLY TIREDNESS; This spontaneous report received from a patient concerned a 29 year old white and not hispanic or latino male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021, 1 total at left arm for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, patient experienced super bad chills for 7 to 8 hours after the vaccine for 10 minutes, subsided and got again 24 hours later, but not as bad as night before, could not sleep it was very uncomfortable. On 16-MAR-2021, patient also felt really tired. On 17-MAR-2021, the patient experienced passed out twice back to back in about 10 minutes of each other and on same day patient went to emergency room. On 19-MAR-2021, the patient experienced dehydration. Patient had never tested for COVID-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passed out twice on 18-MAR-2021, couldn't sleep, and super bad chills on 17-MAR-2021, dehydration on 2021, and really, really tiredness on 20-MAR-2021, and the outcome of very uncomfortable was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210454256-Covid-19 vaccine ad26.cov2.s-PASSED OUT TWICE. 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).

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Seizure-Severe, Systemic: Shakiness-Severe, Systemic: Tachycardia-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Severe

Upon arrival, patient noted laying down on floor with feet elevated. Patient noted pale, sweaty and clammy. Patient awake, alert and oriented x3. Patient states that he started feeling light headed immediately after receiving his vaccine. Bp 143/95 P 70 T 97.7 O2 99% on room air and Blood glucose 114. Patient states that he had breakfast around 8am and fruit as a snack at 1030am. Vitals reassessed Bp 137/88 P 80. Patient states that he is feeling much better. Patient able to sit up without feeling dizzy or weak. Bp 126/91 Hr 83 Patient had granola bar and water. Patient had to rest an additional 30mins. will continue to monitor O2 remains @99% on room air. Patient states that he feels great. Vitals reassessed Bp 130/80 Hr 78 O2 99% on room air. Patient left facility in stable condition.

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

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

Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: PATIENT FAINTED AFTER RECEIVING VACCINE AND INJURED THEIR CHIN, PATIENT WAS SITTING DOWN AND WAS ABLE TO FEEL BETTER AFTER GIVEN WATER AND REST ON BENCH

Pt states he has pressure behind the tear by temple, has been feeling nauseas, and has tinging in arm.

Janssen COVID-19 Vaccine EUA Had typical reaction for 2 nights after shot (Severe headache, chills, fever, muscle cramps, etc), but chills, headache and nausea persisted. Currently (6 days after vaccine) I have feeling of pressure in head above left ear. Pressure accompanied by slight headache, dizziness, feeling flush, stomach pain, and tingling in right hand. These symptoms haven't changed over last 4 days, and most pronounced is head pressure, dizziness, and general disorientation. Haven't taken medication, just getting good rest and hydration, but symptoms aren't lessening.

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.

Patient received vaccine at around 11am. After waiting around for a few minutes he stated he was light headed. I went over to observe and gave patient some water. He was starting to sweat and turned very pale. 1 minute later he passed out. I brought him to the floor from his chair and he starting shaking and 'seizing" for about 10-15 seconds. We used pressure on his chest to try to "snap" him out of it. After about 15 seconds of "seizing,not breathing normally and his left arm completely locked up" he came to and did not know where he was for about 2-3 minutes. After about that time he started to realize where he was and recognized his wife who was assisting. EMS was called and arrived shortly, He was lucid and knew where he was and started to feel normal again. EMS checked his vitals and they were normal. Patient refused to go to hospital and EMS released him to his wife. I checked on patient 4 hours later and he had no ill effects and stated he felt just like he did before receiving the vaccination.

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

Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: pt sat down after receiving vaccine and felt faint within the next minute, slouched over in the chair and woke up on his back on the floor. pharmacist reported pt was sweating but alert immediately after this incident. pharmacist assisted pt and pt ambulated into clinic with assistance and was supine for 10 minutes and sitting for 10 additional minutes. BP 118/76, pulse 79, spo2 98% and heart rhythm regular. pt ambulated out of clinic without problems, all symptoms resolved.

Patient with PMH of Aspergers, ADD and obesity brought to ED in status epilepticus. Headaches and nausea/vomiting started day of vaccine and progressively worsened. Was observed to have 2-3 seizures before arriving to ED (possibly over a 2 hour period) on 5/18. Found to have Superior sagittal sinus thrombosis and thrombocyctopneia with elevated D-Dimer and PF4 and low fibrinogen. Patient suffered irreverisible brain injury. Decision made with family to withdraw care

LAYING ON THE FLOOR WHEN NURSE ENTERED POD. PATIENT REPORTED DIZZINESS, HEADACHE, NURSE NOTED DIAPHORESIS.

@ 0950 pt c/o of dizziness, nausea, lethergy, diaphoretic . Pt was provided cold compresses that were applied to the axillia and nape of the neck. Pt was able to rest his head down on a table. Pt declined oral hydration. @ 1000 Pt's partner encouraged him to stand up and go back to his appartment. Our clinical staff encouraged the pt to remain seated and remain in the clinic area until he was able to walk independently. Pt declined and was able to rise from the chair independently and ambulate with assistance from his partner. Pt was able to communicate during the entire event. no LOC was observed. The patient left the clinic area 1005.

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.

Systemic: see comments below-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium, Additional Details: patient became faint, sweating, with decreased vision. He sat down on a chair, heart rate in 52-57/min, BP 100/56, rr 20, O2 sat 100%. Took about 10 minutes to fully recover, and all sympotms resolved, HR returned to 61-67/min. He declines EMS, says he will follow- up with PCP regarding drop of heart rate. His girlfriend picked him up and he went home.

ARM WAS LITTLE HURTING; HEADACHE; This spontaneous report received from a patient concerned a 29 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAY-2021, the subject experienced arm was little hurting. On 25-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from arm was little hurting, and headache. This report was non-serious.

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.

Overall I am a very healthy guy, rarely get sick, and when I do quickly recover. I got a cold just about 2 months after receiving my COVID vaccine. After about a week of having the cold I developed bronchitis (confirmed via chest X-ray). I highly suspect that the COVID vaccine may be causing my immune system to overact to my cold causing this bronchitis. Again I have never had bronchitis in my life and I have always been healthy. Although impossible to prove this link, CDC please take this report seriously as my wife also has bronchitis right now and research what this is doing to our immune systems. Thank you.

Patient reported headache and stomach ache to family doctor. Patient has appointment with doctor on 6/7/21. Patient stated that adverse effect started one week after vaccination.

patient had not eaten all morning and was dehydrated ( we were told this after the fact) . patient received vaccine and was fine upon immediately receiving vaccine. patient stood up and headed out the door of vaccination room in good spirits. Once patient got outside of the door to waiting area , patient began to feel dizzy and sat down in the chair. Patient began to sweat and show signs of impaired vision (spots) and discomfort. Pharmacist immediately ran to get the patient soda and a bag of chips to get patient's blood sugar up. patient immediately began to perk up. patient later stated he had not ate all day leading us to assume low blood sugar and abrupt movement was the cause of his dizziness.

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.

March 11: fever, headache, pain fatigue, arms turned bright red for about 10 minutes March 12:fever, headache, fatigue, nausea March 13:fever, pain, fatigue March 14:fever, pain, chills, fatigue, nausea, vomiting March 15: fever, chills, headache, tinnitus March 16: fever March 17: March 18: fever March 19: fever March 24: fever March 25: fever Last week or so: chest pains, really high heart rate

Sudden increase in PVCs; have noticed them once or twice before, but increased to 1/4-7 beats. Noticed first at 11:00am, and continued at the mentioned interval until the present moment. Headache present as of June 14 PM.

Pt received JJ vaccination, and subsequently moved to the patient monitoring area. Approximately 2 minutes after waiting in the monitoring area pt states he experienced flushing, dizziness and clamminess then ?passed? out for approximately 20 seconds while in a seated position. Syncope was witness by patients girlfriend. RN didn?t witness pt syncope, but noted patient laying in the seat then immediately alerted me. Pt was recovering in a seated position when I arrived, with noted pt w/ diaphoresis with no associated respiratory distress. While I was collecting pts history said he didn?t want to talk about it anymore in an attempt to calm himself down, approximately 2-3 minutes later I witnessed pt have another syncopal episode which lasted 15-20 seconds while in seated position. Pt regained consciousness and I had an employee help me move pt to the floor for recovery. Pt displayed no signs of respiratory distress, denied chest pain and headache. Pt states syncope is his typical response after vaccinations or blood draws, last occurrence was 8 months ago during a blood draw. Pt states these syncopal episodes initially started in childhood and has gotten worse as he has gotten older, pts father also experiences these episodes. Pt declined EMS several times. Pt was monitored for 41 minutes, vitals taken twice while pt was in recovery on the floor, vitals were stable. I had pt lay supine on the floor for approximately 15 mins post syncopal episode. After recovering for 15 mins I had patient sit upright on the floor, reassessed him and repeated vitals which were stable, pt reported feeling well. After approximately 10 mins pt was helped up into a seat, vitals were stable and patient reported feeling well and having no complaints. I had pt stand and repeated vitals which continued to be stable and pt reported no complaints. Pt drove to the vaccination site in a rental care which he states he will leave parked close to vaccination site and initially states he?d walk. I recommended pt and girlfriend take a free ride home which the agreed to do. I personally walked the patient up the stairs which pt was able to do with no problem and no reported complaints. Pt was given strict ER precautions and given resources for primary care also. Pt stable at the time of discharge. Pt declined follow up. Pt stable at the time of discharge. Pt accompanied by with girlfriend, who will get pt home via ride.

Approx 10 mins after receiving vaccination, the patients significant other reported that the patient was not feeling well. Pharmacist checked on the patient who reported loss of vision and a feeling of dizziness. Pharmacist contacted 911 and EMS came in to evaluate patient. Patient refused transport to the Emergency Department, reported feeling better after EMS evaluation, and left store under own power.

Swelling of Tongue and headache after receiving the vaccine, patient was given Benadryl 50mg PO BID x 3days and Prednisone 60 mg PO daily x 3 days

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.

CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; SINUS PRESSURE HEADACHE; This spontaneous report received from a parent concerned a 29 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included none reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown expiry UNKNOWN) frequency 1 total dose was not reported, administered at right arm on 15-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-JUL-2021, at night the patient started experiencing symptoms until next morning on 06-Jul-2021 the patient had sinus pressure headache, mild sore throat, some body aches, cough, chills, fever. On 07-JUL-2021, the patient experienced more severe sore throat, increased body aches, loss of taste. It was reported that he did not actually take his temperature but felt that he had fever. On 08-JUL-2021, Laboratory data included: COVID-19 PCR test and patient experienced confirmed covid-19 infection and confirmed clinical vaccination failure. On 09-JUL-2021 he received his positive results. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sinus pressure headache, and the outcome of confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210722832-COVID-19 VACCINE AD26.COV2.S-Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

First day- arm pain body ache Second day-Fever spiking to 100.2f full body aches, fatigue, arm pain, lethargic, Third day- fever broke early morning, fatigue and aches all over Treatment included Nyquil, Tylenol, DayQuil, lots of rest and fluids

LOSS OF TASTE; LOSS OF SMELL; EYES ARE BURNING; ARMS ARE VERY SORE; EXTREME TIREDNESS; FEVER; MASSIVE HEADACHES; ARMS ARE VERY COLD; SHORTNESS OF BREATH; CHEST PAIN; BODY IS VERY HOT; This spontaneous report received from a patient concerned a 29 year old male. The patient's height, and weight were not reported. The patient's past medical history included had a surgery on the finger, and other pre-existing medical conditions included the patient had no known allergies. The patient was previously treated with paracetamol for surgery on the finger. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 20-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-JUL-2021, the subject experienced shortness of breath. On 21-JUL-2021, the subject experienced chest pain. On 21-JUL-2021, the subject experienced body is very hot. On 21-JUL-2021, the subject experienced arms are very cold. On 21-JUL-2021, the subject experienced eyes are burning. On 21-JUL-2021, the subject experienced arms are very sore. On 21-JUL-2021, the subject experienced extreme tiredness. On 21-JUL-2021, the subject experienced fever. On 21-JUL-2021, the subject experienced massive headaches. On 22-JUL-2021, the subject experienced loss of taste. On 22-JUL-2021, the subject experienced loss of smell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, chest pain, body is very hot, arms are very cold, eyes are burning, extreme tiredness, fever, and massive headaches on 21-JUL-2021, was recovering from arms are very sore, and had not recovered from loss of taste, and loss of smell. This report was non-serious.

PAINFUL RED BUMPS ON LEGS AND ARMS STARTED OFF SMALL AND THEN GETTING LARGER AS NICKEL TO QUARTER SIZED; INJECTION SITE REDNESS; FEVER; INJECTION SITE ITCHINESS; This spontaneous report received from a patient concerned a 29 year old male. The patient's height, and weight were not reported. The patient's past medical history included not taking any medications no medical diagnosis, and other pre-existing medical conditions included the patient was not taking any concomitant medications at the time of this report. The patient had no medical diagnosis. 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: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUL-2021, the subject experienced injection site itchiness. On 09-JUL-2021, the subject experienced injection site redness. On 09-JUL-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.8 F. On 19-JUL-2021, the subject experienced painful red bumps on legs and arms started off small and then getting larger as nickel to quarter sized. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site itchiness, injection site redness on 16-JUL-2021, and fever on 11-JUL-2021, and had not recovered from painful red bumps on legs and arms started off small and then getting larger as nickel to quarter sized. This report was non-serious.

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

Patient is a 29 y.o. male who presents to the ED with an adverse reaction of the Covid vaccine. The patient received the Johnson & Johnson vaccine yesterday. Today he is nauseous with some vomiting. He has widespread body aches. He had a subjective fever at home. He took Tylenol prior to coming here.

Went to bed after getting my shot at 11:00 PM on 3/7/2021, feeling no symptoms. Woke up at 5:10 AM the next day on 3/8/2021 feeling tired, sore, and a little nauseous, with a headache. These symptoms are very similar to how my COVID symptoms were in early October 2020

5:02p - reaction time; Blood sugar - 169; O2=94; HR 57; BP 110/68; Pt complains dizziness, sweats, no SOB

Injection Site soreness, chills and fever about 12 hours after receiving Vaccine, slight headache the following morning .

I had a feverish episodes, low grade fever of 100.1 degrees Fahrenheit at the highest with some body aches, headache and mild soreness at the injection site. This took place about 5-10 hours after injection and last for about 24 hours.

Fever to 101F for about 15 hours, site pain for about 24 hours, headache for about 15 hours, shortness of breath ongoing, took 400mg ibuprofen every four hours

Seven hours after receiving the shot, I started to have severe chills. This carried on for about three hours. During the night, I started to have a fever. The highest I measured the fever was at 101. Into the next day, the fever lingered and I was sore. I had a headache that had extreme sinus pressure by my temples. Into the second day and there are no signs of a fever or chills, but there is a light headache.

Fever of 101.4 F, migraine headache. Treated with sleep rest and ibuprofen and hydration of fluids. 17 hours from initial symptoms, fever broke. Temperature normal at 98.6 twelve hours after initial symptoms.

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 .

Towards the evening of the same day as receipt of the vaccine, I began to experience a growing fever, aches, and headache. By the time 11pm came around I was in a full blown fever which lasted until around 5:30 am the next day. The fever was reduced through the taking of two Acetaminophen pills. Throughout the night, I was unable to sleep due to intense headache pain, I felt exhausted and couldn?t move. I had a fever around 102 degrees Fahrenheit at its peak and maintaining usually around 101.4 degrees. I was nauseous and experienced emotional instability. The adverse affects lasted until the morning with some affects such as the headaches and nausea still currently lingering on to present time (10:48am).

Headache lasting at least 12 days (time of appointment scheduled) w/ sensation of "foggy" vision day after vaccine (that resolved after that). Headache is improving, but not resolved at day 12, and was "excruciating" day after he received.

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

Fever, chills, aches, pains, stomach cramping, fatigue The chills, aches, and stomach cramping were the worst of it. Side effects lasted for 48 hours

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

Patient got dizzy around 5 minutes after dose; and began shaking a bit 1 minute later and staring into distance. Sweaty, continued dizziness. responsive at 1 minute after side effects began. Patient drank some water as able, and reported ears were ringing. Ambulance was called and reported all vitals looked good and patient likely experience syncopal event rather than seizure.

Patient received the Janssen COVID -19 Vaccine at the end of a work day on Tuesday March 16, the next day before noon he was experiencing fever, headache and pain in the upper left side of his chest to the side by his left Axillary. He came home at 1:00 pm. Had a headache all evening, fever of 100 and the pain in his upper left side of his chest. At around 12:25 went downstairs to take an Aleve for his head ache, and pain. His pain was so severe in the left upper side that he could not even raise his arm. It was severe pain. He managed to take one pill and collapsed falling on the kitchen floor. We heard the commotion and found him unconscious and unresponsive, we called 9-1-1 and he started to have a Grand Mal Seizure. He has never had a seizure in his life.

Patient complained of chills, nausea and dizziness. Temperature obtained was 102.0. No other symptoms.

Mild Injection site pain, Moderate fatigue, light nausea, and moderate hot and cold flashes; onset about 5 hours after injection. The injection site pain and fatigue will hopefully be cured by getting a good sleep tonight; nausea was offset by Tums. The temperature flashes are still occurring 9 hours after injection and do not seem to be getting worse any more; hands and feet cannot warm up and neck and forehead are hot (no thermostat to look at temperature).

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.

Dizziness occurring 10 minutes after vaccine given Fainting occurring 10 minutes after vaccine given Headache occurring 30 minutes after vaccine given Nausea occurring 30 minutes after vaccine given Vomiting occurring 1 hour after vaccine given

Initial soreness at injection site in right arm, which largely faded within four hours of vaccination; Ongoing as of this writing since 11:30 a.m. on 03/30/2021: mild stomach nausea (started at 11:30 a.m. and still going at 02:00 p.m.; vague chest pain (feels mild and seems like what I would expect from anxiety or drinking too much caffeine--of which I have not consumed), which started at about 01:15 p.m. and still going at 02:00 p.m.; a brief headache that lasted about 20 minutes from 01:00-01:20 p.m.; and a few times I had trouble mentally and visually focusing on my work (I do not mean my vision was blurry, just that I felt somewhat distracted). No treatment sought at this time.

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.

April 1: Started to shiver between 6:00 and 7:00PM. Temperature rapidly increased from 99.2 to above 101. Peaked at 102.9 around 8:15PM, then hovered between 102.0-102.7 until 2:30AM. Starting at 7:45PM, I took acetaminophen and kept a washcloth with cold shower water on my neck. I also drank a lot of water and some Powerade and orange juice. April 2: I continued to take acetaminophen every 6 hours. Temperature stayed between 100 and 102 until noon, then between 98.9 and 99.5 until evening.

About 8 hrs after injection while at work I started to notice a dry sore throat and that I was kind of feverish. 5 hrs later when getting ready for bed I got chills that lasted almost an hour as I attempted to warm up. Upon waking up next morning felt very lethargic while still being sore in the arm and very feverish. That lasted all day, feel much better this morning but retained a persistent cough

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.

CPT administered Janssen COVID-19 vaccine to the pt 4/5. While sitting in the pharmacy area for his 15 minute observation period, he fainted. He said that he was texting on his phone and the next thing he knew, he was on the ground with people around him asking if he was ok. He stated that he was very sweaty, nauseous, and a little dizzy. We called a code white, provided the pt with a cold compress and elevated his feet. Pt did not want us to call 911. Pt did not have PCP and has not been to a doctor in about 5 years. He said he was very nervous getting the shot and is afraid of needles so that may have contributed. Pt stayed in the pharmacy area for about 45 minutes until he started to feel better and his mom came to get him. I tried calling pt again at 7:10pm to check in, but there was no answer and I could not leave a voicemail due to mailbox being full.

About 10-15 minutes following vaccination, patient turned very pale, was sweating, and feeling lightheaded and dizzy. (Patient mentioned he had a great fear of needles prior to vaccine administration) A nearby ARNP took his blood pressure and he read very low..he was advised to lay down and elevate his feet to improve his blood pressure. He felt better. 911 was called and fire department was dispatched just in case. Fire department came and assessed his vitals. Patient started feeling better and was eventually able to sit up. He sat for a few more minutes before he left the store.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Within 15 minutes after vaccine, patient was light headed and sweating. Had patient lay down and gave him Sprite to drink at his request. Sypmtoms resolved within a few minutes. Patient was monitored for an additional 20 minutes and felt fine.

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

1:22 AM: chest pain, abdominal cramps, chills, difficulty breathing, hyperpnea, bilateral upper extremity trembling VS: pulse 112, respirations 22, temperature 37.0 Celsius, BP 156/103, O2 sat 99% on room air has history of deep vein thrombosis, pulmonary embolism 1:30 AM sent to emergency room via ambulance 4:00 AM report from emergency room: patient is stable and reported feeling better and breathing easier shortly after arriving to ER. Patient received 500cc NS bolus IV. Labs findings unremarkable. INR 2.0, PT 21.3, PTT 31. Last taken VS -BP 127/71, P109, R20, O2 93%RA. Patient will be discharging with Dx: reaction to COVID vaccine.

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.

Pt reported general weakness and headache at 1120. Vitals were 136/90 bp, 90 hr, and 97% O2 room air. Pt reported no itchiness or hives. Pt stated not eating much in the morning. Pt given water and orange juice . Pt advised to stay for further observation. Vitals reassessed at 1146. BP 142/96, 87 hr, and 97% O2 room air. Patient stated his headache was gone and he felt itchiness in left and right arms. At approx. 1150, patient given diphenhydramine oral solution 50 mg. Patient advised to stay for 30 minutes. Patient declined and stated he wanted to leave. Patient ordered a ride and left facility with steady gait and unlabored breathing at approx. 1200.

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.

100-101 fever starting 04/06/21 still present on 04/06/08 NyQuil helps for a while but then the fever comes back

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.

High Fever (103 F), Headache, Chills, Body Pain. Fever went away after 1 day but other symptoms lasting over 5 days

During 15 minute monitoring- this RN performed her routine check. The patient had approximately 12 minutes remaining on his timer, indicating that he had received his vaccine in the last 3-4 minutes. He stated that he was feeling lightheaded. This RN and clinic staff secured the vehicle- shutting off the truck and removing the keys. We reclined his seat back and applied a cold compress on his forehead. At this time, the patient presented with diaphoresis and increased pallor. O2 sat 98% on RA, B/P 130/60, pulse 118. Had patient drink approximately 240 cc of cold water. Patient driving his company truck. Employer notified. Employer to send staff to drive the patient and the truck back to his home/work siteContinued to monitor patient for the next 30 minutes. At the end of monitoring- color had returned to his face, diaphoresis had ceased, and he stated the he felt "much better". Patient assisted to the passenger side of the vehicle with assist x 2. Gait steady. Patient drank an additional 240 cc of cold water. Patient encourage to continue to hydrate, and to contact his physician with any concerns- 911 with any emergent concerns.

Immediately after vaccination, while still in vaccination chair, patient became diaphoretic and said he was going to pass out. Patient was given juice and peanut butter crackers. Patient stayed in observation 30 minutes, stated feeling better. Patient left fairgrounds.

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.

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.

LETHARGY; BODY ACHES; DRY IRRITATED THROAT; CHILLS; HEADACHE; FEVER; NAUSEA; ARM PAIN; 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:1808609, and expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 to right deltoid for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the patient experienced arm pain. On 31-MAR-2021, the patient experienced nausea. On 01-APR-2021, the patient experienced lethargy. On 01-APR-2021, the patient experienced body aches. On 01-APR-2021, the patient experienced dry irritated throat. On 01-APR-2021, the patient experienced chills. On 01-APR-2021, the patient experienced headache. On 01-APR-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lethargy, headache, body aches, fever, dry irritated throat, chills, arm pain, and nausea. This report was non-serious.

woke up on Saturday with a headache, slight dizziness and nausea with a fever of 99.4. I took 2 Ibuprofen and the fever and other symptoms seemed to leave for the next 6 and a half hours until the headache came back. I took more Ibuprofen and the headache went away again.

Patient was feeling faint, had shallow breath, headache, and nausea. Patient was given a snack (at 10:51) and patient started feeling less sick and headache was gone by 10:56. Patient was given water (at 10:58) and started to feel more alert.

Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: sweating-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Severe, Systemic: Weakness-Medium, Additional Details: the person failed to tell us about that what happening to him when he taking any injectios.

Patient received the vaccine and started walking around the store to wait for the 15 mins required, He report feeling light headed and was sweating so he came back. I sat him down and gave him water and orange juice to drink. Within 10 mins he stated he was fine and his BP was 100/48 before he left.

Dizziness, nausea, abdominal pain, pain and swelling at site of injection, full body muscle aches, headaches, fever, chills, and brain fog.

38,9 centigrade fever, lots of shaking, headache, very very tired and ache with slight pain on right arm

Patient reported feeling a little dizzy and nauseated after being vaccinated with girlfriend Patient soon after had syncopal episode Patient appeared clammy and pale and diaphoretic Patient seen by medical team Blood pressure 91/45 and heart rate 61 Patient provided water and repeat BP was 109/61 Patient refused medical transport and signed ama form but will have girlfriend drive him to hospital

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chills-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Hypotension-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium, Additional Details: pt's blood pressure 77/43, threw up

I developed extreme body aches and chills along with an extreme fever, and it progressed throughout the night until I was delirious. I fainted once trying to take medication (ibeprofen) in the bathroom. I never measured the fever because I was delirious and could hardly move due to pain. I have never felt so sick in my life and I am a healthy 30 year old with no other health issues. I am feeling better this morning but have lingering symptoms of chills and aches. I am reporting this because the intensity of the reaction seemed overwhelmingly extreme and scary for someone of my health and age.

High fever, nausea, dizziness, fatigue, sore throat, headache Symptoms lasted 2 days Sore throat and fatigue lasted 5 days

After being screened to enter the healthcare facility and completing the intake screening for COVID vaccine, patient received the Janssen COVID vaccine at approximately 11:00am. Several minutes later while sitting in the observation area, patient stated that he felt like throwing up and that he had a headache. He said he just started feeling tired. He denied any shortness of breath, swelling in his mouth or throat, or rashes. He stated he had not eaten breakfast in the morning. When his vital signs were checked, his blood pressure was 149/94 and heart rate was 90. He was alert and oriented. He was transported to the facility urgent care for further assessment and observation. In urgent care, he appeared to become more lethargic, although his vital signs remained stable. 911 was called. While waiting for the ambulance, staff spoke to the patient's brother (who had been waiting outside for patient). Patient's brother stated that patient had a fever and stomachache the night before, and that patient had a recent surgery and had not completed his post-op antibiotic course. Patient's brother stated that he came to clinic anyways for the vaccine appointment because he wanted to get the COVID vaccine so that he could return to work (as required by his employer). Patient was transported to Hospital. Per nurse report, he was released from the emergency room after a brief observation period.

Pt reported not feeling well in less than 5 minutes after shot. Initially he was sweating, followed by dizziness. In few seconds, he started convulsing. I administer Epi-pen 0.3 mg, 1 adult dose in his left thigh. His convulsion stopped at very moment, paramedics took over from there. His vitals were checked and monitored by paramedics for few minutes. He did not require hospitalization at this moment, however advise to seek medical attention if he feels something abnormal. He was able to walk himself to his car, where his family member drove him to home.

Patient felt a reaction on his tongue that presented as tingling and his throat was hurting. He used liquid Benadryl and then felt completely fine.

Vaccine was administered Wednesday 4/7/21 at 8:00am, 24 hours later, woke up with a sore throat. By Friday 4/16 pain in the throat reached a level 10. unable to talk, open mouth, or swallow without being in severe pain. 4/16 made an appointment at clinic because the pain was unbearable. did a strep test and COVID test. Results: strep test: NEGATIVE COVID test: POSITIVE pain in throat continued to increase with all of the same symptoms as previously stated previously. started on amoxicillin 4/11 for infection in his thorat

PAINFUL ARM; COLD CHILLS; 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 pre-existing medical conditions included no medical history.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced painful arm. On 06-APR-2021, the subject experienced cold chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from painful arm, and cold chills. 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.

time course given as time after shot (i.e. "at 6 hrs" means 6 hours after I received the vaccine) at 6 hrs: mild headache, fatigue at 10 hrs: moderate headache, chills, fatigue at 15 hrs: moderate/severe headache, chills, fatigue, fever at 22 hrs: headache, fatigue at 28 hrs: mild headache, mild fatigue

Immediately after injection: pain and soreness around injection site. Starting about 3-4 hours later: impaired coordination. The next morning: severe dehydration, disorientation, loss of balance, very low energy, headache, body aches, inability to remain standing or sitting, difficulty walking, fever, feeling hot and cold, sweating and shivering intermittently and sometimes both at the same time, impaired mental focus, worsened pain and soreness around the injection site, nightmares. Slept the majority of the day, rising only to eat and drink lots of water. Symptoms abated throughout the day. By about 7pm, I was able to sit up enough to play some video games. The second morning: most symptoms gone or almost unnoticeable. Hot/cold flashes, impaired coordination and low energy continue, but improving. Attempted to go out for my usual 2-mile jog after work, but only made it about one block walking before becoming both too cold and too tired to continue. The third day, afternoon: completed my usual 2-mile route, at a walk, with frequent stops to rest. No noticeable symptoms from the 4th day after injection, onwards.

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

Runny nose, sore throat, headache, tiredness starting April 9th around 7pm. Symptoms are still occurring today (April 13th), but are getting better.

Janssen Covid-19 Vaccine EUA First 12 hours after the shot I experienced headaches, body aches, and chills. Within the next 24 hours all of these symptoms increased severely, and around 5pm on 4/11/21 I experienced a seizure that resulted in me being taken to the ER.

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

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.

A week after getting my vaccine, I got a very strange and strong headache on the left side of my head that persisted for the whole day. It was strange enough that I made a note to call my doctor if it persisted, but the headache was gone the day after.

Woke up Monday morning at 2AM with severe abdominal pain. Had a strong headache over the weekend as well.

Patient c/o dizziness, palpitations, SOB. VS within normal limits blood pressure 100/60, pulse 71, 97-99% Oxygen saturation. Diaphoretic, responsive with GCS 15. Denies existing health conditions, medications, or allergies. Given 1 bottle of water. Patient asked to walk with nurse. After walking 15-20 feet, patient said "whoa" and nurse grabbed patient and lowered him to the ground. Patient was placed supine and bag placed behind his head. Nurse unable to palpate carotid pulse and patient completely unresponsive. Nurse instructed to call 911 at this time. Patient positioned for CPR and opened his eyes. Stated "I fell asleep while I was walking." Patient instructed to lie still and informed 911 had been called. At this time, RN positioned patient's legs upward to increase blood flow to chest and head. This nurse repeated blood pressure at this time 96/62. Nurse obtained heartrate 71-75 and oxygen saturation 98%. Denied pain. Stated he used a push mower in his yard this morning. Patient diaphoretic and chilled. Assisted into seated position to drink orange sports drink and a second bottle of water. Upon EMS arrival approximately 4 minutes after call, paramedics examined patient and took over his care. They measured a blood glucose level of 134. Nurses assisted patient into ambulance for paramedics to run an EKG. Patient later returned to his personal vehicle and remained on site for about an hour. He called his brother-in-law to assist him home. Nurses on site checked on patient every 10-15 minutes until his family member arrived.

Dizzy/sweaty. Has not eaten today. Glucose tab administered with water. SXS improved. No further intervention needed. Declines any allergy.

H/A,vomiting,diarrhea. PT presents with chills, n/v, diarrhea and bodyaches x 0100. received JJ vaccine yesterday. has not yet taken tylenol/motrin.

So my right eye was swollen and had hives under my eyebrow and inside of my nose on both sides and on my mustache above my mouth. I had a headache. My throat was hurting.

Fever for 2 days and I?m having fatigue feeling everyday till my vaccine date sometimes little shortness of breath. Have leg pain. These feelings and pains occur different days. Just took Tylenol no other medicines so far.

I woke up in a very heavy sweat and got up to use the bathroom. I felt unsteady. After washing my hands, I turned to the towel and vaguely remember falling to the floor. When I came to, I was too weak to get up. I laid there for 5 minutes before struggling to sit. After some time I was able to weakly return to bed and drank some rehydration tablets. My best guess was I had been drinking water but not replenishing my electrolytes.

About 8 hours after receiving my shot (11 pm 4/8/2021) I started experiencing chills and low fever. 12 hours after the shot (3 am 4/9/2021), I had a temperature of 102 degrees F, took 1 Tylenol and experienced difficulty sleeping. 16 hours after the shot (7 am) I awoke with a headache followed by mild nausea (8 am). Over the course of the day, the fever and all other symptoms gradually subsided. By the morning of the next day (4/10/2021) I was completely back to normal and feeling healthy again.

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.

Fatigue, slight fever, chills same day and next. Itchy arm starting around 5 days after with on and off pain.

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.

Extreme chills and high fever starting approximately 12 hours following vaccination. 14 hours after vaccination had high fever, profuse sweating, leading to heart palpitations and two syncope episodes resulting in hospitalization. CT scan and xrays, ekg and blood tests, all normal, sent home on fluids. 76 hours after vaccination presented axatia, slurred speech, confusion, dizziness, resulting in rehospitalization. MRI, EEG, EKG, blood, and urine tests all completed and normal. Sent home on steroid.

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.

COLLAPSED TO FLOOR; BLOOD PRESSURE 88/40; SWEATING; HEADACHE; NAUSEAOUS; This spontaneous report received from a health care professional 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, intramuscular and batch number: 043A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 08-APR-2021 at 11:20 to left arm for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021 at 11:30, the patient felt nauseous and stood up and collapsed to the floor. The patient did not lose consciousness. Emergency medical services was called for the patient. At 11:30, blood pressure was found 88/40. The patient was sweating and experiencing headache. The oxygen saturation was normal. On 08-APR-2021 at 11:50, the blood pressure became normal. The patient was monitored for another 20 minutes and was allowed to leave. On 08-APR-2021, Laboratory data included: Oxygen saturation (NR: not provided) Normal, at 11:30, Laboratory data included: Blood pressure (NR: not provided) 88/40. On 08-APR-2021 11:50, Laboratory data included: Blood pressure (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood pressure 88/40 on 08-APR-2021 11:50 and the outcome of nauseous, collapsed to floor, sweating and headache was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210421741- covid-19 vaccine ad26.cov2.s-Collapsed to floor, blood pressure 88/40. 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).

Seizure - I have never had a seizure before and there is no history of epilepsy in my family. I had the Janssen vaccine shot at around 5PM on Thursday and felt mostly fine on Friday. I had typical shot symptoms (tired and soreness near injection sight). On Friday night around 10:00, I was standing talking to one of my friends in the living room when I had a blackout seizure without any warning. The seizure only lasted about 30-45 seconds, and then I became conscious again. It took me about 5-10 minutes to become completely aware and able to stand up. I have never had a seizure before and have not had one since then. Later the following week, I did have a couple of hours where I felt extremely dizzy and lightheaded, but it went away without another seizure. This is also not typical for me.

Client was leaving the parking lot post vaccination waiting period when he felt lightheaded. Wife indicates that client passed out twice in the car. Client reports feeling dizzy and hot and he looks pale and sweaty. His BP is 60/40. Client does not have any other medical history and is not taking any medications currently. He is allergic to sulfa. EMS on site evaluated client and was determined that 911 needed to be called. EMS responded and client was transported to the hospital.

FEVER; WEAKNESS; DIZZINESS; DIFFICULTY BREATHING; VOMITING; HEART RATE INCREASED; 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 concurrent conditions included renal insufficiency. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 and expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. The patient vaccinated on left arm at approx 13:45 -14:15. No concomitant medications were reported. On 15-MAR-2021, the subject experienced vomiting. On 15-MAR-2021, the subject experienced heart rate increased. On 15-MAR-2021 04:30, the subject experienced dizziness. On 15-MAR-2021 04:30, the subject experienced weakness. On 15-MAR-2021 04:30, the subject experienced difficulty breathing. On 17-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.5 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and had not recovered from dizziness, weakness, difficulty breathing, vomiting, and heart rate increased. This report was non-serious.

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

SENSE OF SMELL DECREASED FROM NORMAL; SENSE OF TASTE DECREASED; LINGERING AFTERTASTE AND AFTER SMELL SENSATION; CHILLS; FEVER; HEADACHE; 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 non-smoker, and alcohol use (2 per week), and other pre-existing medical conditions included the patient had no known allergies. the patient did not have any drug abuse/illicit drug use. The patient experienced ulcerative colitis when treated with adalimumab for ulcerative colitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced headache. On 10-MAR-2021, the subject experienced sense of smell decreased from normal. On 10-MAR-2021, the subject experienced sense of taste decreased. On 10-MAR-2021, the subject experienced lingering aftertaste and after smell sensation. On 26-APR-2021, Laboratory data included: Comprehensive metabolic panel (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fever, and headache on 10-MAR-2021, and had not recovered from sense of smell decreased from normal, sense of taste decreased, and lingering aftertaste and after smell sensation. This report was non-serious.

Severe headaches after four days. Continued mogranes to this date ( 14 days). Pain in right eye. Numbness and tingling throughout body. Waking up at 1 AM with 110 bpm heart rate. Easy bruising. Blood spots

Patient raised hand and noted to be pale. Was asked if okay and noted that eyes rolled back and became diaphoretic . Paramedics called. Patients legs lifted and ammonia applied. Patients color started improving and patient started speaking. Patient stated " I want to lay down". Patient was taken by paramedics on stretcher

MILD COLD SYMPTOMS; SORE ARM; WEAKNESS; FATIGUE; THIRD STAGE HBP; 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: unknown, expiry-unknown) dose was not reported, 1 total administered on 06-MAR-2021 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. After the vaccine administration he felt "kind of weak and tired" and had mild cold symptoms and his arm was little sore With weakness on 06-MAR-2021, patient visited to the dentist to get a cleaning, they took his vital signs in the office, and were not able to do a cleaning because the blood pressure was very high (196/150). They waited 10 minutes and took the Blood Pressure again, still 196/150. he always had low BP. then bought a blood pressure monitor and it was continuously very high and even higher than at the dentist.due to this patient scheduled a doctor appointment on 3/25 physician took Blood pressure and prescribed some lab test. He had another appointment on 4/1,that time blood work was good everything functioning well, physician not understand why the BP was so high. patient told he received vaccine recently. On 25-MAR-2021 He was diagnosed with stage 3 High Blood Pressure, then physician put him on blood pressure medication. he also report works out every day ,very healthy and never had medical condition before, never took any medication ,No family history of HBP or heart condition Laboratory data included: Blood pressure (NR: not provided) 196/150. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from third stage high blood pressure, and the outcome of sore arm, mild cold symptoms, weakness and fatigue was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210441025.; Sender's Comments: V0-20210436063-covid-19 vaccine ad26.cov2.s-Third stage high blood pressure. 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).

4/27 11pm started to feel cold chills and aches, Sore at injection site 4/28 2am fever started, aches increased, Sore at injection site 4/28 7am fever of 101.9, nausia, stomach aches, cold sweats, body aches, Sore at injection site 4/28 noon 98.9 temp, stomach aches and "queezy" feeling, Sore at injection site 4/48 9pm stomach ache, and queezy, Sore at injection site 4/29 stomach ache continues with queezy feeling. tmep is 98.8, Sore at injection site Question 20 is answered on this area I am currently writing it with the stomach ache and sore at injection site. (is marked no since my fever is gone)

Waves of exhaustion for 5-6 days and discomfort at injection site for 6 days following injection. When the exhaustion would hit, starting the day after injection, I was too weak to go up and down stairs. It seemed significant and was more than normal tiredness, and I ended up needing to take a half day at work four days after vaccination. On the sixth day after vaccination, I was feeling well again and discomfort at the injection site had subsided as well. It was the worst the day after getting vaccinated, which was to be expected. I did not expect it to last so long.

During the observation period, pt was seen trying to take off his jacket, and proceeded to pass out and fall out of his chair. Pharmacist rushed to help him up and he complained of feeling very hot and sweating profusely. He did not have any swelling/itching of throat/facial area. Patient was provided cold water, and told to remain seated. Pt was asked questions such as name, what day it is, to establish if patient was alert and oriented. Patient complained of experiencing tunnel vision while passing out. He proceeded to pass out once more, while seated, this time the pharmacist was able to support him in his chair. After the water and rest, patient said he felt much better and his girlfriend came to escort him home. He stayed for about 30 minutes before leaving and staff made sure he was feeling alright.

30-second syncopal episode and urinary incontinence while seated--3 minutes after injection. Did not fall or hit head. Regained consciousness without intervention. BP, pulse and respirations wnl. Positive for diaphoresis. Negative for swelling and shortness of breath. Recovered in 20 minutes and was able to leave clinic site. Provided water and cookies. Employer activated their emergency response system.

About 5 minutes after receiving the vaccine patient approached the pharmacy and said he wasn't feeling well. I asked him if he would like some water and he accepted. He returned to the chair in front of the pharmacy and sipped on the water. He looked like he was pale and breathing more slowly. I went out front to check on him and his breathing appeared labored, he was sweating profusely and he said he felt lightheaded and his hands were tingling. I told him to relax and take some breaths. His hands were very shaky and I took him BP (94/61 and HR 54). At this point I had my technician call 911. Between the time the paramedics arrived he went unresponsive for approx 20-30 seconds. I yelled his name and slapped his leg. No response. I checked for a pulse and if he was breathing. He did have a pulse and was breathing. After coming to the paramedics arrived and took him to the hospital for evalution.

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.

Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Shakiness-Severe, Systemic: Weakness-Severe

Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe

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.

Headache that does not respond to tylenol. Still have a headache 36 hours later. Fever lasting several hours starting at 11PM 5/7 and coming and going a few hours at a time on 5/8. Body aches and chills all day 5/8. Chills. excessive sweating but no fever morning of 5/9.

SWOLLEN TESTICLES TO 3 TIMES THEIR NORMAL SIZE; SWEATS; CHILLS OR TEETH CHATTERING; FEVER; This spontaneous report received from a health care professional concerned a 30 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and other pre-existing medical conditions included the patient did not have known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: 13-JUN-2021) dose was not reported, administered on 05-MAY-2021 11:38 for prophylactic vaccination. Concomitant medications included testosterone. On 05-MAY-2021, the subject experienced sweats. On 05-MAY-2021, the subject experienced chills or teeth chattering. On 05-MAY-2021, the subject experienced fever. On 06-MAY-2021, the subject experienced swollen testicles to 3 times their normal size. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills or teeth chattering, fever, sweats, and swollen testicles to 3 times their normal size. This report was non-serious.

Friday, I received the shot at 3:30pm. I got home around 5:00pm and I started to not feel not feel well at all around 8:00pm. I woke up Saturday feeling dizzy and weak just like the night before. Saturday evening I let my dog out and when I turned around to go inside I fainted and feel on my face.

Sudden crash/exhaustion (within an hour), full body soreness(several hours later), further symptoms pending(if any)

LOST OF CONSCIOUSNESS WITHIN MINUTES OF VACCINATION; SWEATING; HIGH BP 214/157 WITH "LO" PULSE; REMAINED BREATHING THE ENTIRE TIME WHILE WAITING FOR 911; GIVEN COLD COMPRESS TO THE NECK; REGAINED CONSCIOUSNESS BEFORE EMT'S ARRIVE AND COHERENT

Symptoms began on 05/01/21 with fever, rapid heart rate, headache, chest pains, disorientation, nauseous and dizzy spells. I have kept a log of symptoms of when they occur, the time they occur and what the symptom is.

PT WAS SEATED, WAITING FOR 15 MINUTE MONITORING PERIOD POST VACCINE ADMINISTRATION. FELT DIZZY. REMAINED SEATED BUT PASSED OUT FOR A FEW SECONDS. CALLED 911. CAME TO, WAS ABLE TO TALK AND BREATHE BUT WAS SWEATY AND DIZZY AND PALE. SAT ON FLOOR SO HE WOULDN'T SLIDE OFF CHAIR IN CASE HAPPENED AGAIN. PARAMEDICS CAME, MONITORED BP, BLOOD SUGAR, EKG. HE HAD LOW BP BUT IT CAME BACK TO NORMAL IN FEW MINUTES. PARAMEDICS DETERMINED HE WAS OK TO GO HOME, DIDN'T NEED TO GO TO HOSPITAL

I woke up in the middle of night to use the bathroom and I don't remember what I was feeling, but I kept telling my self to just finish peeing and I woke up on the ground, I was pretty out of it, it took a couple minutes to get out of it I had a couple of buries, I felt stages of light headed for a few days it felt like I was giving blood. The next day I felt off, I didn't think I was safe to drive, I did feel better but still off and on Tuesday I felt drained.

Light headedness, dizziness immediately upon injection body aches, chills, headache following 48 hours

PATIENT GOT VERY DIZZY AND LIGHTHEADED AFTER VACCINE. ALSO STARTED SWEATING PROFUSELY. GAVE ORANGE JUICE AND WATER. SYMPTOMS RESOLVED AFTER A FEW MINUTES.

pt felt faint, blanking out, pale color to face, seemed unresponsive at one point, he stated he was not feeling good and that he needed help. I sat pt down, lifted his legs onto a chair, got alcohol for pt to smell, got water for pt to sip, got a fan to circulate air around him, removed his mask and called 911. rescue came and pt left on his own. after 10 minutes pt was feeling better and color and responses confirmed he was better.

The night/next morning after receiving the vaccine I was awoken by a racing heart rate that I measured at a resting heart rate of 200 bpm. After 5 minutes of trying to assess what was happening, I recognized that my heart rate was not slowing down. I woke my wife because I was worried and had difficulty breathing. It continued to be in the 180-190's, I called an ambulance. On the way to the hospital my resting heart rate was 180. After I got to the hospital they ran blood work, a CT scan and a chest x-ray. I was in the hospital until 10 am. My heart rate steadily fell to about 110 beats per minute after 9 hours in the hospital. They released me because my tests had come back normal. Upon being released, I came home, had lots of fluids and rest. After 1 week, my heart rate went back up to 160's. My chest started to feel tight again and I had difficulty breathing again. I called my PCP emergency number and they advised me to go back to the ER at 10 am on 05/15/2021. They did another EKG, a D-Dimer and I received saline. My heart rate dropped to 120 and they released me. I was given an all clear from all tests performed. Sunday-Wed that week, I had a slightly elevated resting heart rate, have had difficulty getting a full breath, general stomach pains and I had felt fatigued. Thurs-Sat, my resting heart rate returned to normal (60 bpm) minimal difficulty breathing, but continued pressure in my abdomen and chest. Saturday I fell asleep because I was having a migraine. I woke up at 10 pm and the cycle started again. My heart rate went back up into the 160's. I called the emergency line for my PCP and was told to go back to the ER (05/22/2021). They performed a chest x-ray, an EKG and some blood work. My resting heart rate went to 90 bpm around 3 am and was sent back home. The rest of Sunday, I had difficulty getting a full breath and my resting heart was higher than usual. I had an echocardiogram on Wednesday and it came back normal. I wore a heart monitor for 24 hours, but I have not received the results yet from my doctor. I have never experienced any sort of cardiac episode in my life.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Medium

DIFFICULTY SWALLOWING; WAKE UP ALMOST EVERY HOUR; CONFIRMED COVID-19 INFECTION; CONFIRMED CLINICAL VACCINATION FAILURE; LETHARGY; SORENESS ON THE INJECTION SITE; This spontaneous report received from a patient concerned a 30 year old male. The patient's weight was 170 pounds, and height was 175 centimeters. The patient's concurrent conditions included Tourette's syndrome, seasonal allergy, penicillin allergy, non alcoholic, and cigarette smoker, and other pre-existing medical conditions included no drug abuse and illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, and expiry: 01-FEB-2023) dose was not reported, frequency 1 total, administered on right deltoid 07-APR-2021 for prophylactic vaccination. Concomitant medications included clonazepam for Tourette's syndrome. On 07-APR-2021, the patient experienced soreness on the injection site which lasted for 2 weeks. He also experienced lethargy. Then on the last week of APR-2021, he developed throat pain, cough and high grade fever. His chest was hurt really bad and he felt as if his lungs was on fire. He was also coughing really hard that woke him up every hour. The fever lasted of a day and the rest of symptoms lasted for 3 days. He did not performed COVID test because he just thought the symptoms were just allergic reaction. Then, on the 24-MAY-2021, he started to develop the same symptoms that he had before. It was started as a pain on the throat, he thought it was just an allergy because he had a seasonal allergy. He had a difficulty swallowing which developed into cough. His chest hurt so bad that he felt as if his chest and lungs were on fire. He described his coughing associated with burning sensation that caused him to wake up almost every hour. He also noted that after vaccinated he still followed social distancing and wearing mask protocol. His HCP did not prescribe any medication for COVID-19 infection, but he was taking Tylenol, increased his fluid intake and started using a nasal spray. On 28-MAY-2021, Laboratory data included: COVID-19 virus test positive (NR: not provided) Positive., Fever (NR: not provided) 102 F and the patient had confirmed covid-19 infection, confirmed clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lethargy, and soreness on the injection site on 21-APR-2021, had not recovered from difficulty swallowing, confirmed covid-19 infection, and wake up almost every hour, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210557859-Covid-19 vaccine ad26.cov2.s - CONFIRMED COVID-19 INFECTION and CONFIRMED CLINICAL VACCINATION FAILURE . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

did not eat/drink this AM, patient reported he has a lot of anxiety with needles, received vaccine in drive thru clinic, when arrived to observation area began feeling shaky, diaphoretic, vomiting, was seen and evaluated by paramedic, after 10 minutes reported symptoms had resolved, was accompanied by father and girl friend, was observed in observation area for 30 minutes, given juice and water, did not want to go to the ER, was driven home by dad

Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium, Additional Details: Patient felt dizzy, lightheaded and then began seeing spots and proceeded to faint about 5 minutes after receiving vaccine. He attributes it to getting worked up just before vaccine.

Daily headache that started 3 days after vaccination. Patient self treated with daily Tylenol 500mg Q8H for 2 weeks. No concerning neurological findings on exam. Discussed addressing stress patient reported and sleep disturbance patient reported.

1140 Medical Technologist from HCF calling to report that a patient who received the J&J covid vaccine in March now tests positive for Covid 19. Patient started having a cough and shortness of breath on June 1st. Arrived at the hospital June 4th. Diagnosis : Covid pneumonia. Patient is improving on 3 liters of oxygen via nasal cannula. Meds: albuteral, decadron, apap , zofran, Remdesivir . Patient has history of being overweight , diabetic , and hypertensive.

Shortly after administering vaccine, patient nearly fainted. Patient was sweating, pale, and BP was low. Patient advised he was nervous and only had a smoothie for breakfast. Gave patient water and protein bar. Monitored patients symptom and BP which normalized shortly after consuming water/food. Let patient leave after 30 minutes post incident after confirming patient had been feeling okay 15 minutes.

Two days after vaccine, flue like symptoms. Third morning couldn't hear out of left ear. Few days it cleared up but now has ringing in left ear and worse ringing in the right ear. Now gets a rash when skin is exposed to the sun. Still very fatigued since the vaccine and has been sleeping 10 to 12 hours a night.

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

Chronic headache. Tension, pressure in back of head and scalp. 24/7 head tension for 23 days and on going. Occasional lightheaded symptoms and dizziness. OTC medication has minimal effect.

BP 115/64 (BP Location: RA-RIGHT ARM, BP Patient Position: LYING, Cuff Size: Standard Adult) | Pulse 52 | Resp 16 | SpO2 100% Location of event Vaccine Center Description of Event: Pt reported not feeling ok. Was sitting in chair and began to slump back into chair. Reports having blacked out for a moment. Interventions: Transferred to gurney, given water, juice, assessed, vitals taken. Medications administered: None Response to interventions and/or medications given: Improvement to baseline Disposition:Home Treatment

I experienced normal side effects. Aches, fever, headache, chills, fever for about 5 days. They subsided, but I still don?t have an appetite, and I keep coughing up mucous, some with what looks like blood streaks, like a blood vessel, and blood spots when I blow my nose. And my lungs feel heavy. And it?s almost impossible to breathe deeply with coughing. Although I can go a few hours without coughing. The blood is very rare but it has happened several times in the past 4-5 days. It could have to do with my vaping, but it isn?t normal, only since being vaccined.

I had a cough and congestion in my lungs. An ongoing cough and an ongoing congestion for a few weeks. I noticed the cough and congestion on 06/07/2021. I still have it now, it's just lingering, and it's not as severe as it was.

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.

DISCOMFORT; ACHY HERE AND THERE; FEVER; SWOLLEN ARM AT THE AREA OF VACCINATION; REDNESS AT THE SITE OF THE INJECTION; HEADACHE HERE AND THERE; 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 stroke, and covid-19, and concurrent conditions included immunocompromised, and low immunoglobulin g (igg). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: 07-AUG-2021) dose was not reported, administered on 06-JUL-2021 for prophylactic vaccination. Concomitant medications included immunoglobulin human normal for low igg. On FEB-2021, Laboratory data included COVID-19 virus test positive (NR: not provided) Positive. On 06-JUL-2021, the subject experienced discomfort. On 06-JUL-2021, the subject experienced achy here and there. On 06-JUL-2021, the subject experienced fever. On 06-JUL-2021, the subject experienced swollen arm at the area of vaccination. On 06-JUL-2021, the subject experienced redness at the site of the injection. On 06-JUL-2021, the subject experienced headache here and there. On 14-JUL-2021, treatment medications included paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, swollen arm at the area of vaccination, discomfort, redness at the site of the injection, headache here and there, and achy here and there. This report was non-serious.

APPROXIMATELY 10 MINUTES AFTER THE VACCINE WAS ADMINISTERED TO THE PATIENT, THE PATIENT BEGAN SWEATING AND FEELING LIGHTHEADED/DIZZY AND WAS THIRSTY AND APPEARED PALE IN COLOR. THE PATIENT WAS GIVEN 50MG OF LIQUID DIPHENHYDRAMINE BY MOUTH AND BEGAN TO HAVE IMPROVEMENT IN SYMPTOMS APPROXIMATELY 5 MINUTES LATER. THE PATIENT WAS OBSERVED FOR 30 MINUTES AFTER, AND WAS GIVEN WATER TO SIP.

Woke up March 9th and had trouble breathing. Fell well short of getting full breaths, chest hurt. Took aspirin and slept for 6 hours. Felt about the same through the evening. Next day, still having trouble getting full breaths but less pain.

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

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.

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

Fever over 100F about 12 hours after injection, lasting about 12 hours, after subsiding, arms and neck broke out in a hives-like rash (but does not itch). I?ve taken some Excedrine, Ibuprofen, and Benadryl... I occasionally had idiopathic allergic reactions as child, and this seems moderate to me - my breathing is fine, my stomach doesn?t have the rash (my back does a little...) I?m not certain this is cause for concern, but if a handful of other people react similarly, that might be useful information. I don?t feel like I?ve had direct contact with anything that would cause this sort of reaction - & the few environmental allergies I have rarely react this strongly even when I am directly exposed...

About 9-10 hours after receiving vaccine at 8:15am - chills, body aches, and headache. Fever peaked at 101.4 around 8-9 pm. Tylenol was able to reduce fever. Woke up twice in the middle of the night dripping in sweat. Next morning (3/14) all symptoms were gone.

Vaccine given at approximately 11:10. Patient states "light headed". Noted to be diaphoretic and pale. Vitals taken. Patient placed on floor with 2 assist. Dr. on site. Patient recovered quickly with color (skin) improvement. He was moved by wheelchair and brought to the clinic's first aid room. Patients vitals obtained and within normal limits. No further issues noted. Patient left clinic for home in the care of his wife.

Temperature suddenly went from normal to 102, developed body aches and pains. Fever Lasted about 5 hours, body aches lasted a few days.

I had my Johnson and Johnson vaccine around 10:30am and felt fine throughout the day. Went to work, had a 40 min workout, and had dinner with friends (had one drink and a cigarette) . I was in bed by 9pm and with in a few min started to get chills. By 9:30pm I was in sweating, shaking, headache, and had extreme body aches. I struggled to get out of bed to use the restroom, any movement was painful. I didn't get much sleep due to the body aches. By 8am my symptoms began to fade. I felt fatigued and had a headache by noon.

Fatigue 2-3 hours after vaccination. Sweating/elevated heart rate about 11 hours after vaccine. Severe Headache 11 hours after vaccination.

Hours after the administration of the covid vaccine inmate reported chills and body aches. Ibuprofen and Tylenol was given to treat symptoms. Next morning, inmate had no other complaints, symptoms had resolved.

Patient became diaphoretic and light headed following vaccine. Skin pale and Bp 108/60 with pulse 68. No respiratory distress noted. Patient transported to cot via wheelchair where they were monitored for 60 minutes. Bp improved to 118/60 before leaving.

Janssen COVID-19 Vacccine EUA was administered on March 19th, and I had head ache and fever that night, and was unable to sleep. By the end of the following day (March 20, 2021) my side effects were essentially gone. I felt normal until Wednesday (March 24, 2021) afternoon where the same symptoms returned but were more pronounced (i.e. worse headache). I am writing this Saturday March 27, 2021 and am still having headaches, sensitive skin, and a mild fever.

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.

Fainting, dizziness, blurred vision, sweating, feeling clammy, blood pressure dropping and sugar dropping.

Had high fever of 104.6 night of vaccine with extreme fatigue and chills. Next morning collapsed due to lack of blood to the brain due to dehydration. Doctor said it was a side effect of the side effect (fever) not directly from vaccine. Fully recovered within 48 hours

Leg fatigue (felt like I had run a half marathon) first in the evening. Severe headache began overnight and lasted until 24 hours from injection. Treated with Tylenol, 2 pills, every 6 hours

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

Pt presents with syncopal episode 5 minutes post vaccination of 1 dose Janssen vaccine to left deltoid. Pt was in his vehicle when he started to feel lightheaded and had +LOC. His girlfriend who was sitting next to him states that he was unconscious for about 15 seconds before regaining consciousness. He had no head injury or other trauma. On immediate evaluation he is conscious and endorses diaphoresis and lightheadedness. He states that he has had similar episodes of syncope in the past following vaccinations. He denies medical problems, medications, or any Hx of allergies. Pt denies swelling of the face, throat tightness, difficulty swallowing, itching of the skin, SOB, CP, nausea or vomiting. Following evaluation by EMS, Pt refused medical transport and signed out AMA. Pt felt improved and was driven home by his girlfriend.

Patient was talking to a friend about five minutes after receiving the vaccine and suddenly passed out and fell to the floor. He was awake again in about a minute. The patient was sweating, pale and a little disoriented for a couple minutes but started improving steadily until he was feeling his normal self again. The EMS was called but the patient declined being taken to the hospital as he felt much better by the time they arrived.

Fever, skin pain nausea. Very low blood pressure. The fever last for 6 hours and the episode of blood pressure was in the next morning.

I got vaccinated on Friday. That night, I had chills and a headache, but this went away by Sunday morning. On Monday, I woke up and I was too dizzy to walk. The initial dizziness subsided but I'm still having balance issues as of Wednesday night. A doctor prescribed meclizine which didn't help.

As expected from any vaccine I've received, I have a sore arm that is lasting over 3 days (again, this is expected). What I wasn't quite expecting: -Fever at 101 for 48 hours -Extreme fatigue for 48 hours -Alternating chills and hot flashes/sweating for 48 hours -Quite strong aches and pains (hurt to lay down, sit, stand, just existing hurt) for 48 hours -Headache for 48 hours -Itchy/sore throat around the 24 hour mark, lasting to the 36 hour mark from time of injection Treatment: I took 400 mg of Ibuprofen around the 12 hour mark from vaccination (about 5 hours after fever spiked at 101--fever rose no higher than 101). I continued 400 mg of Ibuprofen the next morning and once more that same evening (two does of 400 mg Ibuprofen). Each of those doses brought fever down to around 99 for about 4 hours, and I felt considerably better (though definitely still quite sick--just not contained-to-lying-in-bed sick). I took 200 mg of Ibuprofen around the 36 hour mark, and that was it. Fever then back to normal range (approx 98) and feeling 95%-100% recovered all day. Obviously none of those are life-threatening, but they sure knocked me out. Definitely way worse than the "mild" symptoms advertised. I'm definitely not complaining, as I'm overjoyed to now be vaccinated, and I'm so grateful for the scientific community, the CDC, and you people reading this right now for all your work in making it happen, and doing it as safely as possible. Thank you!

Felt achy at work day after vaccine; took Advil. Later that day felt worse, went to bed and 2 hours later woke up in a pool of sweat. Repeated every 2.5 hours throughout the night. Total 10.5 hours. Lost 2 pounds. Diarrhea on night 2. Janssen COVID-19 Vaccine EUA

Fever, headache, body aches, light headedness and nausea causing me to pass out while trying to walk to the bathroom. Upon standing up from the laying down position, I got lightheaded, started profusely sweating, became nauseous and ultimately lost consciousness. When I regained my consciousness, there was a loud ringing in my ears and my hands were numb. I took some Tylenol, laid down and it subsided shortly after. I did not experience any symptoms as severe as this at any point again.

4/6/21: 1:30PM - Sweating profusely 1 hour after shot, fatigue/fogginess lasting 48 hours. 8:30PM - 99.8°F fever + chills lasting through the night, preventing me from sleeping until 4:30AM. 4/7/21: 6:45AM - fever & chills subside upon waking up. Headache, fatigue, fogginess, and lightheadedness last the entire day. Fell into deep sleep @ 10:30PM. 4/8/21: 9:15AM - woke up sweating but otherwise fine. 11AM - sweating, chills, and shaking returned for 1 hour and have since subsided. Now - I think I?m back to normal.

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

achiness and fatigue followed by chest pain/pressure and extreme shortness of breath. Pt also experiencing urinary retention and pain when urinating

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 received the vaccine and fainted shortly thereafter. He became very sweaty and came to in a couple of minutes. Paramedics attended to him and deemed it necessary to take him to Medical Center for further evaluation due to irregular heart rate.

Client woke up at 1am the night of the vaccination with Chills, Fever, chronic vomiting. This continued for the next 36 hrs. Took Phenergan on hand to stop vomiting at 5pm second day. Continues now with mild headache and chest congestion.

Fever greater than 103 Dry heaving Diarrhea Extreme headache Chills Sweats Extreme fatigue Dizziness Blurred vision Lethargic

I received the vaccine as 1 shot to my left arm. I felt fine until about 530pm and then I started getting body aches, head aches, and severe chills. I could not sleep at all throughout the night my body was extremely temperature sensitive. I was hot and then cold, hot and then cold. The symptoms went away after 24 hours and now I'm fine. It was a horrible night of discomfort and pain.

Weakness, Dizziness, server headache, chest pain, Blood pressure went down to 90/52 . I'm going to see primary care physician Monday.

Flu symptoms. Body ache. Chills. Fever. Starting at 8pm 8 hrs after shot. By 9am. Symptoms were gone

BITTER TASTE ON MOUTH (CHEMICAL TASTE); AN INTERMITTENT SENSE OF CHEMICAL SMELL; 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 patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-APR-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 03-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102 F. On 05-APR-2021, the subject experienced bitter taste on mouth (chemical taste). On 05-APR-2021, the subject experienced an intermittent sense of chemical smell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and had not recovered from bitter taste on mouth (chemical taste), and an intermittent sense of chemical smell. This report was non-serious.

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

Experienced sudden onset of extreme fatigue at 8pm, followed shortly by chills and an extremely high fever that lasted until around 5am the following morning. Also experienced terrible headache and was extremely disoriented throughout the night. The following day the fever and chills had subsided, but was still very fatigued and the headache lasted until the evening. All symptoms had subsided by the morning of Friday 4/9.

Patient stood up quickly from waiting area and fell back into chair. Patient diaphoretic and dizzy. Patient lay prone on stretcher with legs elevated. VSS at O2 sat 99%, HR 66, BP 140/80. Patient reports he had not eaten since previous day at 6pm, given snack bar and 2 oranges. Patient remained in waiting area for 30 minutes and stated he felt recovered when leaving facility.

experienced chills, and body aches starting at 6-7 hours post injection. He also experienced a fever. His fever spiked to 103.9 at 11:43pm, dropped to 103.7 at 1:20am and dropped further to 102.5 at 1:47am. By morning, 8:30am his temperature had returned to normal at 98.3F.took extra-strength Tylenol around 8pm and again at 4am. I (his wife) put a fresh cold compress on his forehead every 5-15minutes from 11:40 through 1am.

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.

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.

Patient received I IM injection of Johnson and Johnson vaccine. Patient went pale in the skin and felt lightheaded and unwell. Nurse supported patient and laid patient down on the cot next to table. Emergency response / Code Green on site vital signs stable patient recovering. Five minutes post incident patient walked to observation no immediate life threatening signs or symptoms. Patient refused additional medical support and transport.

Janssen Covid-19 Vaccine EAU I experienced chills, high fever, nausea, and vomiting Starting about 10 hours after the vaccination and lasting about 4 hours. After vomiting twice around 13 hours post vaccination my symptoms began to significantly improve. I experienced fatigue and minor stomach irritation the following day. My symptoms were completely gone within 48 hours.

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.

I had a fever of 101.6, including severe chills and severe body aches. These symptoms started the evening of the vaccination (4/8/21) and ended two days later (4/10/21).

Immediate and lasting arm pain through day 4 Extreme Fatigue resulting in inability to do job for 3 days after Cold flashes for about 2 hours the day after Headache still lasting Motion sickness/Dizziness/Lightheadedness - comes and goes, still exists

4/8/2021 - light headed, dizzy, vomiting, body aches, fever, headache, vivid dreams (upon waking and throughout day) 4/9/2021 - light headed, vivid dreams 4/10/2021 - light headed and felt like about to pass out (3pm), vivid dreams 4/11/2021 - diarrhea, vivid dreams 4/12/2021 - Skin rash/welts, diarrhea

Patient fell to the floor 7 minutes after receiving the vaccine. He was monitored and placed on his side then back to facilitate breathing. The patient was unresponsive for 10 seconds and unable to respond to commands. The patient regained consciousness after 10 seconds and was responsive to commands. Initial assessment identified a small abrasion to his left sagittal head with a complaint of a headache. Patient was placed in a sitting position with monitored vitals identified as stable. He denied neck/back pain, numbness or extremity tingling. Vital signs remained stable and patient refused treatment or transport to another facility.

Chills, fever, sweating, fatigue and insomnia started within a few hours of vaccine and resolved within roughly 24 hours. Tinnitus started within a few hours of vaccine and is unresolved one week later.

PATIENT FELT DIZZY POST VACCINATION, WAS SWEATING.FELT WEAK. NO LOSS OF CONCIOUSNESS. INTERVENTION: FELT BETTER AFTER PUTTING ON SUPINE POSITION WITH FEET ELEVATED

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.

Patient called on 4/9/21 asking about whether side effects from Janssen vaccine should still be present since he had the vaccine on 4/7/21. Patient said he had fever within 24 hours of the vaccine and was feeling miserable (severe fatigue, chills, fever, nausea, headaches). He said he was feeling slightly better than the first 24 hours but still feeling really bad. He has been taking Advil which has help slightly. I advised him to monitor symptoms and to call dr if symptoms get worst and to keep us posted. I called patient today to follow up with patient and he said that he was not feeling that much better. He did have a virtual visit with his doctor and was prescribed azithromycin, prednisone, and an inhaler. Patient has been on medication for a couple of days. He will continue meds and call us if things do not improve

Flu-like symptoms for 48 hours started 18 hours after injection Headache, fever, body aches, nausea, cough, low energy

Headache about 12 days following injection, reduced with pain and migraine medication but not yet fully gone.

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.

HIVES RASH; VERTIGO; FLU LIKE SYMPTOMS; FATIGUE; 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 concurrent conditions included anxiety, and non smoker. The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 at 11:50 AM for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced fatigue. On 03-APR-2021, the subject experienced flu like symptoms. On 06-APR-2021, the subject experienced vertigo. On 09-APR-2021 23:30, the subject experienced hives rash. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms on 05-APR-2021, vertigo on 07-APR-2021, and fatigue on 09-APR-2021, and had not recovered from hives rash. This report was non-serious.

Received the shot in left shoulder. Was browsing phone for about 30 seconds to a minute. Felt a rising sensation in the esophagus. Felt as though nausea was impending. Sensation rose into skull in "crawling waves". Skull felt heavy. Interpreted the sensation as disorientation. Asked pharmacist if dizziness was normal with the vaccine. Woke up a few seconds later picking myself up off the floor.

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; 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.

I feel severe headache yesterday and today i took Tylenol and i felt better today again same time headache start and i feel like little dizzy, sharp pain in my legs between ankle and knee,

My wife and I were driving home and while I was driving I started experiencing a pain in my chest and started experiencing a shortness of breath. We pulled of the freeway and I walked around for a few minutes trying to catch my breath but I was unable to. My wife started to drive and I as I sat in the passenger seat I started getting the chills and all the muscles in my body were shaking. When we got to town I told my wife we needed to go to the ER because I was not feeling well. That is where they did some tests and hooked me up to an IV.

Headache and tired for three days after shot. Then 14 days after shot I got a migraine. 15 days after shot I broke out in petechiae. Went to the hospital and had blood platelet count of 1,000. Receiving steroids and IV IG. At risk of fatal internal bleeding.

The afternoon after I got the shot I went for a jog. When I returned, I got intense chills and a fever of 103 degrees along with some flu like symptoms. I had a slight headache. Ibuprofen helped but the next day I had similar symptoms, but they went away by the end of the day. On the third day I felt a little better, so I went for a run. I had some shortness of breath and it was difficult to breathe when I was running. I normally run 4 miles daily. The shortness of breath was present for a week after that and also started to happen intermittently even at rest. One week after the shot I saw a doctor and they did some testing but did not find anything definitive. Six weeks after the shot I went to the ER and they diagnosed with Thrombocytopenia. At this point it has been seven weeks the shortness of breath has improved, and I haven't experienced it for a few days.

Got J&J vaccine at our clinic on 4/9/21. Notes that several hours later he developed HA and hives over his abdomen. Sx got worse overnight, and by the next morning he noticed additional sx of tongue numbness/tingling, so went to the ER. ER diagnosed him with allergic reaction and discharged him with a short course of steroids and Rx for Banophen. He notes that the symptoms returned again on 4/24/21, and again this morning 4/28/21. Went back to ER on 4/24, got more steroids and sx went away. This morning bought OTC Benadryl and sx went away when he took 50-100mg.

DIZZY; CRYSTALS IN THE EAR CREATING IMBALANCE PROBLEMS; NUMB HEAD; RHINORRHEA; NASAL DISCHARGE; INJECTION SITE PAIN; FEVER; NAUSEA; 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 concurrent conditions included non-smoker, and alcohol use, and other 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 and batch number: 205A21A expiry: 23-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced dizzy. On APR-2021, the subject experienced crystals in the ear creating imbalance problems. On APR-2021, the subject experienced numb head. On APR-2021, the subject experienced rhinorrhea. On APR-2021, the subject experienced nasal discharge. On APR-2021, the subject experienced injection site pain. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced nausea. Laboratory data included: Blood test (NR: not provided) came out to be clear., and COVID-19 (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain, and fever, had not recovered from nausea, dizzy, crystals in the ear creating imbalance problems, and rhinorrhea, and the outcome of numb head and nasal discharge was not reported. This report was non-serious.

Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium, Additional Details: Vitals : BP 130/87 HR 69 BS 103. EMT arrived to evaluate pt. Pt refused hospital care. Pharmacy had pt wait 30 minutes before leaving. EMT confirmed pt ok to stand, walk, drive, and state date/location/president.

At about 7:30 after taking a shower, I started shivering. I thought it was just because the house was chilly, but I couldn't stop. I did not check if I had a fever, but it felt like I did. I had body aches, nausea, and I vomited a couple of times. By about 10:30-11 I felt a lot better.

10 minutes after the patient recieved the vaccine, he felt dizzy, noxious, and sweatting for about 30 min

dizzy, sweating, clammy skin, light headed about 5 minutes after getting vaccine, lasted less than 10 min, he got a ride home just to be safe

Pt scheduled appointment for and received correct J&J Covid Vaccine that was requested. There were no issues with processing nor provision. PT advised RPH that he had a problem with needles and experienced low blood pressure every time he was vaccinated or had blood drawn in the past but had done better the last time and did not want to miss out on getting the vaccine. RPH was prepared and patient was cared for properly. Pt arrived at 1244 hrs and was provided vaccine at 1247 hours. Patient was fine for about 1 minute and then reported he was having trouble. Pt remained seated in booth in chair with room to get to floor if needed. RPH remained with patient, brought his significant other into the booth to help calm the patient as he was alert and orientated and continued to improve while removed mask and fanned with papers (pt stated the fanning was helping). Pt was improving slowly and moving/trying different positions as he felt he was improving. At approx 1325 hrs pt knew he needed to lie down and moved himself to floor with the assistance of his significant other and associate (did not fall nor did head impact the floor at any time). Code White was called. PT remained alert and orientated and was talking and stated that this was really helping. Code Team arrived and pt was continuously monitored until he gradually returned to his feet and was able to leave under his own power. Pt refused medical attention and refused Ambulance - never lost consciousness so no EMT was called. Pt's significant other was able to drive them home. Event concluded at approximate 1345hrs.

Shortly after the administering the vaccine the person tensed up and became unresponsive. He appeared to be having a seizure. I was able to get the patient to the floor and he became responsive. He said he "was ok". We had contacted EMS. We had the patient lie flat until the EMT's arrived. He was very sweaty and tired but he insisted he was fine. He refused to go to the ER and he was able to get a ride home.

after about 5-6 minutes, he started feeling weird, then started to get pale and sweating, didn't pass out but did vomit. took a ride to er with the ambulance, came back to let me know he was ok and thank me.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Medium, Additional Details: administered vaccine at 1:17pm, after a few minutes, CC of dizziness, feeling light headed and began to sweat. Pt sat with feet elevated and applied cold compress, BP was 106/69 with pulse of 71. pt remained seated for approx 20min and felt better, was able to get up from seat and walk out. did not seek any medical advise.

"Patient who had recently been vaccinated approached me and stated that he did not feel well." "Complaining of weakness and dizziness after COVID Vaccine." "Pale and notably diaphoretic" "Vital signs assessed and found to be bradycardia and hypotensive in seated position. EKG completed and transport to medical facility via medic ambulance." 11:43 BP 90/31, HR48 (weak, regular), RR 16 normal and SpO2 98% room air. 11:46 BP 86/39, HR52, SpO2 98% 11:55 BP 125/68, HR73, SpO2 100% 12lead performed to show brady-sinus with no indications of heartblock. IV fluids, 100mL LR via 20g in LAC.

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.

imeediately after vaccination, patient lost conciousness, had a period of muscular jerks similar to seizure, for about 30 seconds. After that, could respond (had no memory) but was generally not lucid for another 90 seconds. At that point, the patient could respond, wanted to lie down, started sweating profusely, and after about 5-10 minutes was generally recovered. Patient stated that they have had previous issues while giving blood.

Twenty-four hours after the vaccine I got fever, chills and body aches. Three days after the vaccine I had irritation in my right eye. The next day my eye was more irritated, and it was uncomfortable. I had a telehealth visit and they gave me antibiotic drops. I was diagnosed by an optometrist on the five days after the vaccine with the Shingles virus. The Shingles are still present on my eye after three weeks and I am taking steroids for that.