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.

Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient remembered sitting down in a chair for observation, then slumped forward while on his phone. He did not remember falling over and was alert and oriented right away. Emergency services were called as he sustained an injury during his fall.

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.

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.

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.

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

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.

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

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.

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.

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.

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

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

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.

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.

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.

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.

According to vaccinating nurse, a few minutes after vaccination patient experienced a short (less than one minute) generalized seizure. She was able to lower him to the ground and patient did not hit his head or suffer fall. Two EMTs were on site and attended to patient. 911 was called and patient evaluated by medics. Blood sugar and vital signs within normal limits. Patient' s father also came to the scene. Patient and father refused transport to the local hospital. Father stated they will go directly to the local emergency room for evaluation.

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.

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

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.

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.

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

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.

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.

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

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.

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.

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.

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

Was observed for at least 15 minutes. Arrived at home and had a seizure, was rushed to the hospital. Mother claimed patient is in ICU.

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.

Systemic: Seizure-Severe, Additional Details: within 5 minutes after administration, he collapsed, lost conciousness and had a seizure which lasted 30-40 seconds. we protected his head and laid him flat on ground and called 9-1-1. he maintained breathing and pulse throughout. when EMTs arrived he walked out with them for further evaluation.

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,

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

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

I asked the patient how he felt after the injection and he said that he felt a little lightheaded and nauseous. He said he had a little too much to drink last night because his buddies were moving West. I asked him to lay on the floor but he refused. He said, "I just want to sit for a while". Within minutes the patient turned pale and started twitching. I asked another pharmacist to help to move him to the ground. 911 was called while patient was on the ground lying sideways because I was afraid that he may choke on his vomit. In a few minutes, patient sat up and asked for a bucket to throw up in. The Fire department came and took his blood pressure (BP120/?) and asked him some questions. They his blood pressure was good and advised him not to drive home. They helped him to get back on the chair. He stayed in the vaccination booth for us to keep an eye out until his friend showed up to take him home (30 minutes later). We had a male associate escort him out because he said he was still nauseous.

2:05pm Post vaccination witnessed client pass out for about 30 sec., then becomes conscious responding to verbal / tactile stimuli w/ full orientation. During transport to medical monitoring witnessed another unconscious episode x 30 sec, noted color pale, skin cool/ clammy, again becomes conscious verbalizing and responding appropriately to questions. Vital assessment: BP 122/44 P85 O2 sat 99%RA; Upon several attempts to sit up during medical monitoring reports increased dizziness, remains aaox3 at this time. Plan for transport to ER for further evaluation/ treatment, for unresolved vasovagal episodes.

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.

Administered vaccine in left arm at 11:46 AM . about 11:48 patient said he felt lightheaded. I got up to get patient a Gatorade and he began to snore. I realized he had passed out . I held his arm and said his name he immediately jerked awake and did not know where he was or what he was doing. He drank some Gatorade and ate a couple of chocolate kisses. He began to have cold sweats that lasted a few minutes. I sat with him in counseling room for 15 minutes and then he sat in waiting room until he felt better. He did not feel that he needed further attention or medical assistance.

- 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.

Shortly after (4 days) receiving the vaccine I began to experience leg pain and minor cramping, in addition to mild general pain. This continued for about 1 week. I still have occasional pain, particularly in the legs, made worse by exercise (lighter exercise than would normally cause pan). I have also been experiencing hypertension that, to my knowledge, did not exist prior to receiving the vaccine. This has persisted since first measured 5 days after the vaccine until today, more than a month after receiving it.

Patients wife called to voice concern over excessive pain in patients arm and concern over shot placement

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.

BACK PAIN; PAIN IN BOTH LEGS; BODY PAIN; ANXIOUS; This spontaneous report received from a patient concerned a 26 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and cigarette smoker. The patient experienced drug allergy when treated with codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 16:00 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced anxious. On 14-MAY-2021, the subject experienced body pain. On 15-MAY-2021, the subject experienced back pain. On 15-MAY-2021, the subject experienced pain in both legs. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body pain, pain in both legs, and back pain, and the outcome of anxious was not reported. This report was non-serious.

Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient was very nervous/anxious upon arrival. Shortly after the vaccine was given he became unresponsive and unconcious. 911 was called. Patient became responsive minutes later. Patient became unconcious for a second time while EMT was present. Patient was taken to the hospital.

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

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.

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.

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.

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.

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.

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.

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.

06/22/2021 @ 1000 Patient was given J&J vaccine. 1010: Patient had seizure under a min. Patient was placed on side lying position and safety measures 1015: VS WNL 102/72 68 HR. Patient was still confused but alert. 1025: Patient was transferred by EMS. Injection site was free from itching, redness, patient denies any respiratory problems, or history of seizures.

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.

Preexisting Conditions: None given prior Vaccination; 10:33 observed 'scissoring', seizure activity, falls out of chair, hits head, generalized tonic clonic x 30secs Post Vaccination and seizure, Attendee reports he is hung over, didn't rehydrate, nor eaten breakfast. No Seizure history prior to this event. Left with EMS to ER

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.

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

Patient has a history of dizziness with shots, so they elected to get the Johnson and Johnson shot so that they would only need one shot. Patient received the vaccine in the counseling area, and the shot itself went as usual. About 15-45 seconds after the shot the patient stated that they began to feel dizzy. The patient then tried to lower himself to the floor. As soon as he started, he lost consciousness and fell forward out of his chair. He got some carpet burn in the area surrounding his eye. About a dime sized area above and a quarter sized area below. His head also mildly bumped against the wall. As soon as he passed out, 911 was called as a precaution. He was responsive within the minute, stating he was fine. He lost consciousness soon after for about 30 seconds before becoming responsive again. He was able to hold a conversation upon awakening. Patient states this is normal for him to experience. He has some discomfort with the carpet burns but reported no pain from bumping the top of the head. We offered some Neosporin for the carpet burns but patient stated that medication smells can sometimes make him dizzy, so we did not use any. We did provide him with some bandages for the area. I advised him to wash the area with soap and water at home. We kept him in the pharmacy for a half hour keeping conversation with him to make sure he was all right. He was able to stand on his own without issue after 25 minutes, he did not have any issues with dizziness at this point. After the wait and with patient being back to baseline, they wanted to get home and proceeded to go home. Before they left, I did verify that he was not the one driving home. Ii advised them to seek any medical attention if he has any further such issues. Patient came back after about 45 minutes asking what to use to clean wound. I recommended Neosporin, we did provide patient with both Neosporin and rubbing alcohol.

-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.

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.

Within 5 minutes of receiving the vaccine, patient stared to feel warm, and clammy. He was assessed by EMS in the Observation Areas. He was assessed by EMS. He did have low BP. Initial was 114/77, and lowest was 58/38. No dizziness or loss of consciousness.

PATIENT HAD A SEIZURE ABOUT 45 MINUTES AFTER GETTIN THE VACCINE. PATIENT'S EYES ROLLED BACK AND STARTED FOAMING AT THE MOUTH. PATIENT HAD BEEN SEIZURE-FREE FOR 3 YEARS PRIOR TO GETTING THE VACCINE.

Pt received the Janssen Covid-19 vaccine. Pt started to feel numbness and tingling in his left hand (vaccinated arm) 15 minutes following the immunization. Pt stated that he felt fine other than his left hand experiencing numbness and tingling, specifically in his fingertips. Pt had no other adverse symptoms. I asked the pt to remain seated for an additional 15 minutes. He stated that he was ok but I convinced him to remain in his seat so we could continue to evaluate him. After a total of 45 minutes of evaluation, pt stated that the feeling of numbness and tingling was gone. Once again, I verified with the pt that he was feeling ok, with no additional adverse feeling or symptoms. Pt stated that he felt fine now and only felt a little soreness at the injection site.

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.

Single Dose Janssen - one minute after injection - lightheadedness - inability to focus/concentrate - ringing in both ears -,tingling in hands/feet. Time now is approx 25 minutes post vaccine and he is feeling mostly better

Bells Palsy, diagnosed by Medical Center. Treatment: Valacyclovir for 7 days, Prednisone for 12 days.

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.

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.

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.

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.

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.

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.

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

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

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

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.

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.

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.

vasovagal episode / syncope with subsequent fall to ground, striking head. lightheaded, clammy, loss of vision prior to episode. Brought to Emergency Department, discharged to home in stable condition within 5 hours.

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

Patient has reported having an issue with fainting with vaccines in the past and patient requested to be given immunization while sitting on the floor. Patient was given a cold compress for his wrists before the vaccine was given. Approximately 1 minute post vaccine, patient reported feeling dizziness and feeling warm. Patient was given a cold compress for the back of the neck and the wrists. Patient did not lose consciousness but did report dizziness. Patient was able to hold conversation and reported feeling better after about 5 minutes. Patient was monitored for an additional 15 minutes and reported feeling normal before he left.

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.

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).

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.

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

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.

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.

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.

patient with seizure disorder, within 10 minutes patient had a seizure with typical presentation for this patient.

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.

pt with an new onset single episode of tonic-clonic seizure on 4/9 (3 weeks after vaccination) that lasted 60-90 seconds. patient with no predisposing trauma, no recreational or illicit drug use or alcohol use, no history of seizure disorder or family history of seizure disorder. pt with postictal state lasting 10-15 minutes. Patient went to ER following episode and treated with Ativan. Patient with no reports of seizure like activity or episodes since the event.

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.

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.

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.

NOT FEELING TOO AWARE; DIZZY; TINGLING AT INJECTION SITE; WEAKNESS ALL OVER BODY; 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 traumatic brain injury. 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 29-MAR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 29-MAR-2021, the subject experienced not feeling too aware. On 29-MAR-2021, the subject experienced dizzy. On 29-MAR-2021, the subject experienced tingling at injection site. On 29-MAR-2021, the subject experienced weakness all over body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling at injection site, and weakness all over body on 2021, and had not recovered from not feeling too aware, and dizzy. This report was non-serious.

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.

Systemic: Seizure-Mild, Additional Details: before the shot, patient said he gets nervous and cautioned that he might get lightheaded. after the shot, he started having a seizure. full body contractions in a wave-like pattern from the bottom up. seizure lasted 20 seconds. we offered to call ambulance, but patient refused. he stayed in the store for 30 minutes, when he left he said he felt fine. no previous history of seizures.

Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Medium, Additional Details: this patient has had similar events with all vaccines administered in the past. he has even had a similar event at work recently due to a cut on his hand.

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

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.

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

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

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

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

Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Additional Details: Patient fainted and had seizures like symptoms along with cramps. Patient fainted for less than a minute. Was breathing and talking soon afterwards. 911 was called.

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).

Patient felt nausea and could not breath so he stood up and took a breath. When he stood up he lost consciousness and fell. Patient hit his fore head and started having a seizure. The seizure lasted about 1-2 minutes before he regained consciousness. Patient was taken away by the EMS

patient took vaccine went over to post vaccination area and fainted. Patient immediately woke up in cold sweats. Sat for 30 minutes and felt better.

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.

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.

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.

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.

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

Developed Bell?s Palsy 3 1/2 weeks after vaccination. Developed peripheral neuropathy hands/feet 4 weeks after Hypertensive crisis (No Hx of high BP)

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

Patient was nervous before getting vaccine. Within a few minutes after getting injection, he became very pale and clammy and asked for cold liquid. He consented to receive a Juicey Juice juice box and sat down with some cold wet napkins on his neck. He said he felt like passing out and we led him into our vaccine room where he lay on the floor for about 5 minutes. He then wanted to sit up. He felt much better and sat in our waiting room again for 10 more minutes. He left without further incident, having never lost consciousness.

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.

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.

On June 19, 2021 I woke up around 6:00 a.m. having extreme chest pains. I went to the Emergency Room to be treated. They did an EKG, blood work, and an ultrasound of my heart. My EKG was negative for a heart attack, but my blood work was positive because of my Troponins were elevated. They gave me some aspirin and the chest pain went away. I was admitted into the hospital where I stayed until the end of the day on June 21, 2021. On June 20, 2021 they continued to watch my vitals, took tons of blood for blood cultures and for pretty much every virus you can get along with urine samples as well. All of the test for any virus and the blood cultures were negative. The urinalysis and urine culture were negative as well. Once all test came back negative, the cardiologist ordered a Heart cath. The heart cath was performed on June 21, 2021 and there was no blockage in any of my arteries and everything was clear so I was discharged that afternoon from the hospital. I was diagnosed with Myocarditis or Pericarditis. The doctor prescribed me 25MG Captopril to take 3 times daily and 25 MG Metoprolol Tartrate to take 2 times daily. I have only experienced any other affects a few times since being released which was a burning sensation in my check. I spoke with the doctor and they told me it could be indigestion or heart burn.

Patient complained of dizziness following vaccination. Patient was placed in a supine position with legs elevated. Patient also complained of some numbness in left arm and feeling a little hot. Patient's blood pressure was checked several times and reported initially at 89/79 and finally 100/66. Wife reports patient usually have blood pressure readings in the lower range. Patient also reports having a vasovagal event following vaccinations. Patient was observed for about 20 minutes. Reported feeling fine and left pharmacy.

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).

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

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

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.

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

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.

chest pain. Chest Pain since 0900, started while at rest, radiating across chest lasting a couple minutes, describes as aching, deep breath makes it worse, reports feeling warm; reports CP at this time; alleve taken around 0915.

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".

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

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

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.

pt was extremely anxious about getting the vaccine. pt was fine during the administration. 5 minutes after pt sat in the observation area he felt light headed and clammy . we eased him down to the floor before he passed out. We them put ice packs around his neck and hand. he came too and after resting for 15 minutes in a supine postion he had some water and seemed to feel better and left on his on accord.

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.

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.

Employee came at 1:30 to get vaccinated. Three to five minutes after administering the Johnson & Johnson vaccine, I asked the patient if he is feeling ok because he seemed nervous and sweaty. He responnded "yes, but I have a mental anxiety from vaccines, needls, doctors". one minute later he started complaining of pain in his left arm and feeling weak. . He then asked to sit on the floor and said that he can hardly breath, and lost vision. I administered Epipen injection to his left thigh while the store director was calling 911. He then complained about not being able to move his hand fingers. The ambulance came and took him to the ER. later in the day, his manager said that he spoke to hid family and they told him that he has been having anxiety from doctors, needls, and shots ever since he was little. He is feeling better now and the hospital will keep him for tomorrow.

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

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

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.

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.

Patient had a witnessed seizure while in observation area. Patient seizure activity lasted approximately 15 seconds. Patient became conscious, alert, and oriented, within 5 minutes of seizure activity starting.

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 .

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

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

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.

C/O lightheaded, dizzy Had brief <5 second nonresponsive to speech episode. Arousal with Ammonia inhalant Pt went home

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

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.

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

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

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

Dizziness, hot, light headed, no SOB, no hives, no throat tightness, similar symptoms when blood drawn, PB 131/70, HR 60, PO2 95%. Allowed to rest, cool cloth to forehead. snack/drink denied.

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

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.

Patient states they have partial facial paralysis (right side of the face) that started Sunday, April 11th in the morning. No other signs or symptoms. Breathing is normal, no rash, only reports paralysis of face. Patient has not reached out to a physician yet, so we recommended to see a doctor immediately and call us back with update.

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

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.

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)

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.

entered clinic with red bull energy drink, spouse reported Patient drank a soda earlier, skin appeared pale, reported he did not do well with vaccines as a child in the past, still wanted to proceed with vaccine. Had seizure for 2 mins, family reported past history of fainting. EMS attended, responded to questions appropriately, fainted a second time, monitored, pt was released home with spouse

- 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.

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.

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.

ED NOTE is as follows...from 4/21/21 @ 21:47 a 28 y.o. male who to the emergency room with reports of a headache for the last 48 hours. He reports this as being one of the worst headaches he has ever had. He was seen at urgent care and given Toradol, Zofran and Benadryl and still rates his pain an 8 out of 10. He does feel pressure behind his eyes. And reports vomiting in the parking lot at urgent care. He denies abdominal pain back pain, neck pain, shortness of breath, chest pain, numbness or tingling or any other worsening concerns. Reports that he did receive a recent Johnson & Johnson vaccination. Patient states he does vape. He occasionally drinks alcohol he denies any illicit drugs. Patient denies any head trauma. Diagnosis management comments: This is a 28-year-old male arrives to the emergency room with reported migraine headache for the last 48 hours. He did report that he was go to urgent care in which he received a migraine cocktail of Zofran, Benadryl and Toradol. Patient reported that his headache was not resolved so urgent care sent him on for further evaluation. Patient upon arrival had a negative neurological exam however he did report that he had pressure behind his eyes. Was unable to see any papilledema on funduscopic exam. Check patient's pressures bilaterally and they were 21 and 18. Patient did report to me that this was the worst headache of his life. I did administer IV fluids here as well as Tylenol and morphine. Patient did report some improvement. Patient did report in his past medical history had a recent Johnson & Johnson vaccination. A CBC and CMP was obtained. Did have thrombocytopenia with a count of 66. Since my exam was PERRL with normal extraocular movements. He had no eye redness or eye pain. Of low concerns for any iritis or uveitis. Patient's patient CT of his head did show a abnormal CT that had a dense appearing superior sagittal sinus that was representing a venous thrombosis. Radiologist did recommend a MRI MRV. An MRI and MRV was ordered. Patient MRI MRv did show findings are consistent with a venous thrombosis involving the right jugular right transverse sinus and superior sagittal sinus there is also a patchy edematous change within the subcortical white matter areas bilaterally and symmetrically. There was no CVA. With patient's reported migraine headache. Reported blurred vision, low platelets, recent vaccination I do believe patient has vaccine induced thrombotic thrombocytopenia. With this finding I did converse with my overseeing physician Calls were made out to neurology and then a call out did prefer to have patient started on IVIG at 1 g/kg daily for 2 days and blood thinner Xarelto 15 mg p.o. twice daily. These orders were initiated. Internal med services was consulted and with conversations of family, internal med services out possible transfer that an interventionalists could be available if patient needed it. Report was given at 2100 upon my end of shift.

Recieved the vaccine and the following morning around 5am had a seizure which lasted for about 20 minutes. Was transported by ambulance to medical center and recieved care until he was stable and able to go home, but told to follow up with his neurologist as soon as possible. The neurologist saw him within 2 weeks and increased the dosage of his Vimpat and has ordered for him to have a 3 day EEG as soon as possible.

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.

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

Patient returned to site 30 mins after observation as he felt short of breath, difficulty swallowing and dry throat. Patient was evaluated by RN and EMS. No swelling noted. Vital signs obtained. Patient hydrated and was closely monitored. Patient was also evaluated by PA and PA. Patient was then had some complaints of left arm tingling. Patient provided with water to hydrate. Patient felt better after 30 mins. Patient instructed to contact PCP if any worsens Symptoms or if any medical emergency to call 911 or to ER. Patient also advised to report any symptoms using the VAERs online on card.

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.

FAST HEARTBEAT; FEELING FAINT; TWITCHING IN INJECTION SITE ARM; FELT LIKE GETTING DRUNK; ARM FELT NUMB; FEELING LIKE FLUID IS GOING INTO ARM RANDOMLY; PHANTOM INJECTION SITE ARM PAIN; STUMBLED A BIT; LEGS BUCKLED; This spontaneous report received from a patient concerned a 28 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced fast heartbeat. On MAR-2021, the subject experienced feeling faint. On MAR-2021, the subject experienced twitching in injection site arm. On MAR-2021, the subject experienced felt like getting drunk. On MAR-2021, the subject experienced arm felt numb. On MAR-2021, the subject experienced feeling like fluid is going into arm randomly. On MAR-2021, the subject experienced phantom injection site arm pain. On MAR-2021, the subject experienced stumbled a bit. On MAR-2021, the subject experienced legs buckled. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt like getting drunk on MAR-2021, had not recovered from phantom injection site arm pain, twitching in injection site arm, fast heartbeat, legs buckled, feeling faint, and feeling like fluid is going into arm randomly, and the outcome of arm felt numb and stumbled a bit was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.

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.

Patient fainted after vaccine. and felt numbness in cheeks. 911 was called. Patient came to in 45-60 seconds and no longer complained of any breathing issues or of feeling faint. Vitals were WNL. 911 was cancelled and patient was advised to see primary physcian for follow up.

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

Pt received janssen vaccine, within 5 minutes pt was seated in waiting area and fainted very briefly and fell to the ground. Fell slowly and did not hit head. 911 was called. With the help of pt's mother, pt placed on his side, appeared pale, slow to response, generalized weakness. Within 1 to 2 minutes pt become more responsive, was placed on his back and raised his feet up on a chair. An ice pack was applied to pt's forehead and was monitored until EMTs arrived and care was transitioned to paramedics. Pt was assessed and taken with paramedics to be evaluated.

Pt received IM vaccination and was told to wait up front in store. Noticed patient seizing in his chair less than 5 minutes after the shot. He was lowered to the floor and placed on his side. Total seizure was about 30 seconds. Pt came around and had no previous history of seizures.

Pt reported "pins and needles" in chest and veins, itching, nausea, and feeling hot. Administered 20 mL of 12.5mg diphenhydramine 15-20 minutes post-admin. Pt reported he continued to feel worse, then vomited 5-10 minutes after administration of diphenhydramine. Checked BP after pt vomited, 160/100. He reports that his BP is usually not high. Advised for HR representative to call EMS. Update from HR representative states that pt reported swelling of throat upon arrival to hospital, but appears to be "settling down".

Patient started feeling very dizzy and nauseous and warm upon receipt of the vaccine. He denied any shortness of breath or swelling. There was no rash or redness present. After 30 minutes and a glass of water he felt fine.

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.

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

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

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

Patient was sitting for 15 minute observation period when he started convulsing and fainted. He again started convulsing and then he came to, was nauseas and dizzy and pale.

ABOUT 10 SECONDS AFTER TIME OF INJECTION, PATIENT LOST CONSCIOUNSESS AND PASSED OUT AND SLUMPED OVER. AFTER ABOUT 20 SECONDS, HE CAME REGAINED CONSCIOUSNESS AND WAS SHAKING FOR ABOUT 3 SECONDS OR SO. PATIENT WAS VISIBLY NERVOUS AND CLAMY TO THE TOUCH. PATIENT WAS ABLE TO COMMUNICATE WITH US WHILE EMS WAS CHECKING VITAL SIGNS.

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.

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.

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.

Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Hypotension-Mild, Additional Details: Pt was sitting on chair in the observation area and he fell over hitting his head on the side panel. Pt got up immediately and sat back on the chair. Pt was pale but allert and responsive. After drinking some water and extended observation time, pt was able to walk away. EMT was called but pt refused service.

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.

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.

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

- 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.

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

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

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.

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.

Patient began to feel cold and clammy, and lose color in his skin. He temporarily lost consciousness for about 2 minutes. I monitored his pulse and respiration and he began to feel better after about 5 minutes. He remained seated for 10 more minutes and left under his own power.

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

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

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

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

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.

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.

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.

Patient was in store for 15 minute monitoring after dose, he states he was anxious and pacing back and forth then he felt faint/dizzy and fell over in the store. Pharmacist and staff ran over to help patient and called 911, initially had him sit up on the floor after 2-3 minutes he was comfortable enough to sit in a chair. Patient was given water he stated he still felt a little dizzy and was very anxious stated his arm hurt from falling down.

Resident of recovery home was found convulsing in bed the evening following vaccination. An ambulance was called. Resident stayed in hospital overnight and discharged.

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.

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.

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

The patient had an observed seizure. Patient was asleep when convulsions were observed by roommate; hospital staff alerted and seizure activity observed by nursing staff and medical students. Tonic clonic movements lasted approximately one minute, spontaneously resolved, then patient entered post-ictal state, and recovered approximately 5 minutes later. Vital signs were taken (WNL) and patient observed until return to being stable. Patient did have a history of seizure occurrence and was on anti-epileptic medication, which he was compliant with. Patient was stable and seizure free for at least the previous six months per hospital records. Medications reviewed and levetiracetam dose was increased to 1,000mg PO

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.

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

hot and nauseated. patient was evaluated and vitals were taken. all were within normal range. patient stated he has anxiety. patient laid down and was evaluated for the remainder of his 15 min. patient stated he felt find after his 15 min and went home

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

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.

Nausea and arm pain at first. Then throughout the day could not keep down food or water without vomiting. Last vomit was around 5pm. The next morning, was able to keep down fluids and food. Arm still partially painful.

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.

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.

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.

Patient had symptoms of vasovagal syncope 10 - 30 seconds after receiving the shot. Felt dizzy, hot, and passed out. EMS was called and patient stayed an hour on site and received water. Patients girlfriend reported this had happened before with other vaccines.

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.

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.

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.

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.

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.

Bad muscle cramp on left calf while running on Monday morning - pain has persisted since, although pain has subsided since Monday.

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.

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.

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.

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.

Patient passed out during 15 minute wait time and began to have a seizure after receiving the J&J vaccine. Seizure last about 5-10 seconds. Pt was turned to his side and remained in the same position until EMS arrived. He was conscious after the seizure and was responding and speaking full sentences. EMS was on the line until they arrived in person. Medical EMS personnel were called and responded. They advised pt had a history of seizures. Pt refused to go to the hospital with EMS. EMS cleared pt to continue regular activities. Event time approximately 3:00-3:20pm.

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.

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

At 1809, patient returned to vaccination site as passenger of personal vehicle with complaint of tingling sensation throughout his body that lasted for about 5 minutes. Patient denied loss of consciousness. Patient had received Janssen vaccination to his left deltoid at 17:56. Patient had reported history of feeling near syncope to vaccinations. Patient?s level of consciousness, stroke scale, and vital signs were assessed. Patient was offered a call for emergency services on his behalf but patient denied emergency services. Patient stated that a mild tingling sensation continued on his left arm but that he did not feel any more tingling throughout his body at 18:10. At 18:14 patient stated that he wanted to continue to monitor himself at home and he was encouraged to call for emergency services if symptoms continued or worsened. Patient left as passenger of personal vehicle at 18:18 while his friend was driver of their vehicle.

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

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.

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

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.

about 15 minutes after receiving the vaccine, the person that accompanied the patient yelled for help. She states his eyes rolled back and then slumped over and arms flailed a few times. The patient didn't know it had happened. He stated he felt dizzy and looked pale. We gave him a water bottle and after a few minutes he felt better.

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.

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

The patient received the COVID-19/Janssen vaccine at 12:33pm. Approximately, 5 minutes after receiving it, the stated that he was feeling dizzy and had ringing in his ears. I had him lie down with his knees elevated. He stated that he felt better in the supine position. I attempted to take his blood pressure, but was unable to get a reading after two tries. After a few minutes, he stated that he no longer had any ringing in his ears, but felt some numbness in his arms. His fingers were cold and I had a difficult time finding his pulse. While he was resting, he stated that he had anxiety to needles and "white coat" syndrome. He felt that he was okay to sit up, so he did without any adverse reactions. He drank some water and stated that feeling was returning to his arm. I asked if he had eaten anything this morning and was told, just a cup of coffee. We speculated that low blood sugar could have possibly compounded the situation. At approximately 12:55pm, he felt well enough to leave. I had him contact his mother who was in the store to accompany him out at around 1:00pm.

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.

Patient reports feeling tightness in chest immediately after vaccine on 5/26/21, and 2 days later experienced feeling an internal burning sensation without a fever. Patient went to emergency room on 5/26/21 and was discharged with no conclusive diagnosis.

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.

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.

Patient developed intermittent right-sided pleuritic chest pain about 10 days following vaccination as well as lower leg pain. Patient started taking aspirin and stopped smoking and pain in leg resolved but still had intermittent chest pain. Last couple weeks patient stopped taking aspirin and started smoking again and 2 days ago noticed an increase in pleuritic chest pain that brought him to the emergency department.

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

19yo Male client had a seizure witnessed by observation nurse after receiving Janssen vaccine. Seizure lasted 4-5 seconds. Client alert and oriented post seizure and reported dizziness. BP 90/64 then 110/78 Client reported not eating for over 24hrs No EMS called Client ambulatory with family upon leave

Paramedic stated that patient blacked out for 30 seconds and stated that patient was blankly staring ahead unresponsive. Patient states he has no past medical history except mole removal. EMS was called and took vitals on patient. BP 102/67. HR 72. O2 SAT 100%. Patient was the driver but brought a friend. Patient switched places with friend and had friend drive him home.

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.

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

Pt received his single vaccination of Janssen, and fainted while waiting in waiting area after receiving his vaccination. Pt says he has a needle phobia, and was hesitant to get the vaccine. He had a muffin to eat earlier in the day, and nothing since. The tech, called me when she saw him fall. when I saw him, he was standing up. He sat back on his chair. I got his to rest with his head lowered. He appeared to be dizzy and cold and clammy. When I took his Blood Pressure, it was 95/46. He had a 1 cm cut below his right eyebrow. He did not want to go for stitches, because he hates needles. After resting up for about 30 minutes, he told me that he felt better, then left.

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.

Patient was administered the shot and shortly after started experiencing a shaking episode (not a seizure) and hot flashes.

Shortly after patient received vaccination, I was flagged by spouse as patient became nonresponsive and experienced acute loss of consciousness. No fall or external trauma. Consciousness regained however patient was A&O x 2/3 with pallor and incoherent speech. EMT was contacted and pt was assessed. Pt declined transport to hospital and was further monitored in pharmacy prior to departure.

Pt experienced vasovagal syncope 5 minutes after receiving the Janssen Covid 19 vaccine. Pt became cool, pale, and clammy, and lost consciousness briefly. During this time, pt was breathing (moving adequate tidal volume) and maintained a radial pulse. Pt regained consciousness about 1 minute later, and vital signs were obtained. Pt had a heart rate of 56, breathing at 16 times a minute, moving adequate tidal volume with clear lung sounds. Pt was satting at 96% on room air, and when asked questions appeared fully oriented to person, place, time, and event. Pt had a blood pressure if 124/82, and pupils were 2 (L) and 3 (R) mm, and fully reactive to light. Pt states his pupils are irregular in size

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.

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

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 .

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.

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).

Patient received vaccine, returned to playing cards, attempted to ambulate 10-15minutes later and fell to floor with seizure like contracting activity. duration of event 5-10 minutes. Medical attention received patient sent to hospital. Patient returned same day.

After receiving the Janssen Covid 19 vaccine, I proceeded to the waiting area and was instructed to wait 15 minutes before leaving the facility. Approximately 5 minutes after receiving the injection, I started to feel faint, lightheaded, nausea, and clammy. I informed a member of the staff and several medical personnel came to assist. They laid me down on a cot and checked my vitals. I started to feel better after laying down. The staff took my blood pressure and heart rate readings, which were relatively normal. But after sitting me up and taking my vitals again, my blood pressure and heart rate spiked. I was taken to Hospital in an ambulance; however, after waiting in the ER waiting room for about 2.5 hours, I left without seeing a doctor. During those 2.5 hours my original symptoms did not return, so I elected to leave.

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

Patient given 0.5ml dose of covid-19 vaccine by Janssen. Patient stated was scared of needles. He immediately stated he thought he was going to pass out. Patient passed for approximately 30 seconds and jerked/like a seizure then came back but still felt dizzy, passed out again and jerked came back but still felt bad, Patient stated he did not feel right was hot wanted to lie down on floor. 911 was called made patient comfortable until EMT's arrived and patient was taken to ambulance and released.

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.

the nerves in my Teeth and Jaw are hurting. The pain comes in waves. It is keeping me up at night. I average about 3 hours of sleep every night.

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

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.

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

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.

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.

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.

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.

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.

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

Systemic: Fainting / Unresponsive-Mild, Additional Details: patient was given J and J \r\nCOVID vaccine. patient was seated when patient fainted. patient came to right away and was instructed to lay flat and elevate feet. patient started fo feel better. bp 100/80. Pt was monitored for 30min. Further BP was also 100/80. Pt was instructed to take it easy tonight and leave early from target shift and to seek medical care if any further fainting or symptoms.

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

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

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

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.

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.

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

2 days after receiving the vaccine my right great toe started hurting. I went to the doctor 10 days after symptoms first appeared, and he said it was inflamed but didn't understand the cause. He thinks possible tendon or nerve inflammation. He has started me on an NSAID but symptoms haven't improved

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.

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.

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.

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.

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

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

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.

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

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

Friday night, Got a migraine and I had it all Saturday to night. I felt nauseous that night. It went away on Sunday. The following Saturday, I had a migraine and it lasted a full eight days - hanging out in my left eye (it was all in that eye - when I moved that eye from left to right, I would feel it) . I had taken Tylenol and ibuprofen but it didn't do anything. Some days it was intense and some days it was in the background. I did see and talk to a someone at my doctor's office - over video chat (on April 15th - that was day eight of migraine) and she told me to start taking Tylenol that night and I've been taking it one time in the morning since that day and it hasn't come back. I think the migraine went away on it's own. I haven't had a migraine ever in my entire life so it was very unsettling.

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.

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.

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.

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).

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

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

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.

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)

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.

A few minutes after vaccine was administered, patient moved to the waiting room and we heard a bang from the waiting area. We looked over to see patient slumped over and seizing. My technician called 911 and I put a cool compress on his neck and he started to come to. The seizure stopped but the patient was still feeling lousy. I had him lay down with his knees elevated until the EMT's arrived

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

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.

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

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.

Patient had exited the vaccination tent and began to feel "weak" and turned and ran into the vaccination tent. In f=doing so he ran into an employee that was scanning people out of the tent. Once inside the tent a medic came to his aid and assisted him to the ground. The med crew and doctor came to immediate aid and patient was placed on the stretcher and care rendered. Patient was transferred to the observation tent and observed until he decided he would leave on his own. The employee that was bumped into was asked if she was ok and she confirmed she was fine.

Roughly 5-10 minutes after receiving the vaccine, patient fainted and began seizing for about 30 seconds. 911 was called, but patient came too and denied ambulance. Patient then vomited a couple minutes after. Patient reported he had not eaten anything and he was given orange juice and water. Patient waited another 30 minutes and reported feeling better. denied any further medical treatment.

After 45 minutes to 0100 hours, numbness in side of face opposite from injection site. Persistent for 1-2 days. Pain in jaw when chewing. After 18-24 hours, tremor in hands worse than prior to vaccination. Can not raise glass of water to mouth without a significant tremor. The greater the weight of the item being lifted, the more significant the shaking of my hand

Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient regained consciousness in about 20 seconds after lying him on his back with leg elevated.

Patient felt weak and collapsed for 1 second, patient felt better quickly. Called 911 and paramedics checked vitals and left after five minutes. Patient stayed for 10 more minutes and felt fine and left.

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

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

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.

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

30y M w/no PMH s/p COVID-19 J&J vaccine <5min exhibited syncopal episode while seated, resulting in ground level fall from chair witnessed by relative associated w/prodrome of mild flushing and upward nystagmus, but w/no significant head trauma. On exam noted to be contracted in extension, nonverbal and with fixed gaze which resolved w/in 1-2min with nl return of mental status. Pt's knees were slowly bent and the spine lightly placed in flexion, with slow transition to chair and finally legs elevated; no further complaints/events encountered.

Patient reported in his consent form and verbally that he has a prior history of Vasovagal Syncope, but is manageable and definitely wanted to get his Covid 19 Vaccine at the pharmacy. Patient received his vaccine on his right arm, remained seated in his chair. A few seconds later, he decided to lie down on the floor, removed his mask and started taking deep breaths with his eyes closed. About 3 minutes later, his eyes got dilated, skin started flushing red, started with mild seizure like twitching and patient became unresponsive. So I quick put some ice cold water (from his water bottle) on his face, patted his cheek, put an ice pack on his face and neck and while I was asking his father (who was with him) to call 911, the patient regained consciousness and said he was okay. He continued to put the ice pack on his neck and forehead and in a few minutes the flushing stopped, in about 5 to 8 minutes, patient was able to sit up, lean back against the wall, take a few sips of water and the eat a granola bar. Patient then proceeded to wait in our waiting area for another 15 minutes and then decided to leave , since he was feeling much better.

Body aches/soreness, migraine, shortness of breath. Patient felt like he had COVID again for 12hrs (he had COVID previously, and all the symptoms from the vaccine were the same).

after about 10 minutes patient went weak and muscles went into tetani for a brief time .911 was called .Patient recovered well in a sitting position bu then some minutes later p[resented with syncopy. He was placed on floor with legs raised and did recover some time later. The para medics put up a drip and took him away . Patient does not return my calls to find out status

Patient had seizures for an unknown time and urinated in his seat. Pharmacy is next to an urgent care so the doctor from urgent care checked him in to make sure vitals were stable. Unknown outcome.

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.

Immediately upon administering the vaccine, the patient loss consciousness. I was able to catch him. He was unresponsive for approximately 5 minutes. His eyes rolled back in his head and he made seizure like motions. By the time EMS arrived he was responsive.

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

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

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.

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

a 31 year old man who received the COVID-19 vaccine on March 27, 2021 in the Public Health Department parking lot. Upon arrival and check in, the patient declined any comorbidities and health history but did state that he was nervous. After administration of the vaccine by NP, the patient lowered himself to the ground, from a sitting position, and had a 60 second tonic clonic seizure. Seizure precautions such as turning the patient on his side, supporting his head, and calling EMS were taken during the seizure. After 60 seconds, the patient came to and asked what happened. PPHD staff oriented the patient to what had happened, to which he proceeded to say ?oh that is normal for me when I get anxious.? With the help of PPHD staff and his wife, the patient was brought to a sitting position and given a granola bar and water to his request. According to clinic lead RN, ?his skin was normal in appearance for race, ethnicity, and age. He was mildly diaphoretic. He verbalized feelings of anxiety and worry surrounding the vaccine.? As EMS arrived on the scene and began assessing vital signs the patients anxiety appeared to increase; he became less verbal, closed his eyes, and his breathing pattern became shallow. The patient then had a second seizure at this time lasting approximately 25 seconds. When the patient came to he immediately verbalized, ?I?m good, I?m good, I?m fine?. He was slow to respond to verbal cues, but persistently refused transport to the local acute care hospital for further evaluation. He rested on the ground in supine position for approximately 25 minutes, with his partner and EMS at his side. Upon further evaluation of the patient and his wife, it was determined that the patient has a history of seizure activities when he is nervous and that he was ?expecting? this to happen. The patient continued to decline medical care and transportation to the hospital. The patient left in medically stable condition with his wife operating the vehicle.

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

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!

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

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.

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

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.

SORE ARM; This spontaneous report received from a patient concerned a 31 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: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.

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

Patient passed out in sitting position 5 minutes after receiving vaccine, opened ammonia salts at 1:40pm, but patient became unresponsive by 1:48, administered EpiPen in right thigh. EMS contacted - HR of 54, BP too low to calculate. MD/hospital referral.

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

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

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 had instant numbness and cold feeling in the arm that received the shot. Patient was asked to wait 30 minutes post-vaccination for monitoring. Patient said the feeling had not gotten worse in that time period, and was released. Patient was asked to sign up for V-Safe to report his side effects. Patient was told to monitor their arm, and if it got worse to contact their doctor/health care provider or go to an emergency room if necessary. Patient has reported no new symptoms, and his arm has been getting much better over the past few days, but still has a slight bit of numbness.

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.

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

COLD AND HOT FLASHES; NOT THINKING WELL; This spontaneous report received from a parent concerned a 31 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 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, the subject experienced cold and hot flashes. On 08-APR-2021, the subject experienced not thinking well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cold and hot flashes, and not thinking well. 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.

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

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.

Rashes and hives on my hands, then feet then legs exactly 1 week after my vaccination. Itching started on the back of my hands and then progressed to the tops of my feet and rose up my legs, I took 2 Benadryl and went to urgent care. The Benadryl started working within a half hour of taking it. The itching started as o laid in bed where the only food or liquid I consumed before getting out of bed was a bottled water. The doctor stated that I may be allergic to the pba?s in the water bottle. I have never been allergic to this before I was given this vaccine. Intense itching and hives have been occurring ever since that day and without taking Claritin or Benadryl daily the itching and hives takes over my whole body. I fear I could go into anaphylaxis if I do not take this medication. I have cut out several different foods and different liquids including bottled water and have fasted yet still am getting a allergic reaction. I saw my family dr and he said it?s likely due to the Johnson and Johnson covid 19 vaccine and I believe that to be true. Other symptoms include facial flushing and upset stomach

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.

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

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.

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

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.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild

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.

Mother states approx. 2 days after receiving vaccine patient had following symptoms similar to his sister that received vaccine on 5/2/21: Bell' Palsy type of symptoms: disfigured mouth pulled to right and one side of eyelid raise/and other side drooping. Mother states his getting a little better. Unable to talk to him/left msg.

I started having a headache that became stronger. On Wednesday 3/16 I also woke up shaking and with a fever, so I decided to see my doctor. After speaking with him, he said that was a normal reaction to the vaccine and to monitor the symptoms and if they worsen or don't go away to see him again. They went away after a day or two.

Approximately 10 minutes after receiving the Janssen vaccine the patient walked up to the pharmacy counter and asked a technician if it was normal to feel clammy after the vaccine. Immediately after the patient passed out.

Patient started feeling lightheaded about 2- 3 mins of vaccine administration. Patient moved from the chair to the floor because he felt like he was going to pass out. Patient passed out for about 30 seconds, slight twitching during episode and then came through. He was a bit disoriented but alert, we had him stick around until his wife came and picked him up.

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

Patient felt warm and did not feel well. The pharmacy staff gave the patient a bottle water and ice pack. After 30 min, the symptoms significantly decreased and the patient felt fine.

Flu like symptoms, fatigue, mild fever, arm soreness, headache. But mostly a large rash all over my torso front and back, arms and legs

DIZZY, PASSED OUT IN HIS SEAT, MOVED TO COT, REMAINED UNRESPONSIVE FOR 30-45 SECS, INCONTINENT OF URINE. EMS CAME, BP 137/72, HR 56, PROVIDED GATORADE AND SNACKS, SYMPTOMS RESOLVED, REFUSED TRANSPORT.

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

Immediately after the patient received the Janssen Covid-19 vaccine, the patient closed his eyes and became unresponsive for less than 10 seconds. Patient then opened his eyes and was conscious again. Patient stated that he always has this type of reaction every time he receives a vaccine. He did not disclose this information because he did not think it would happen since he had not received any vaccines for the last 3 year.s.

Janssen COVID-19 Vaccine EUA Between 6-7 hours after receiving the vaccination I started to feel increasingly cold. After putting on a sweater and trying to stay warm I also started to get sore. Around 8-9 hours after vaccination I decided to go to sleep to hopefully sleep of the symptoms. I was extremely cold and sore, but attempted to sleep. Around 12 hours after the shot the fever broke and I was sweating. After that I slept much better and woke up the next morning feeling fine. No further issues.

3 days later I started having sever shooting and stabbing pain on the entire left side of my face that would not go away. The pain started in my teeth, jaw, temple, eye and ear. The next day I went to the dentist thinking it was my wisdom teeth, they checked my teeth, did ex rays and checked for infection but found nothing. Went to my primary care flight doc and she was un sure what was going on. Then I went to the Emergency room and I was diagnosed with Trigeminal Neuralgia of the face.

Roughly 4 mins after receiving vaccine, patient stated left arm (vaccinated arm) was numb and hand was "locked up", pt stated he could not move his left hand. Patient's vitals were taken and were ok (BP: 130/92 and HR: 72). Patient waited for approximately 20 to 30 minutes and said he felt fine when he left. Patient was informed he should call PCP to tell them about the reaction ASAP to determine if he should go in for further testing.

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

Patient and his girlfriend came in for a COVID vaccine and received it in our vaccination room. Patient was consulted on possible side effects of the vaccine and was instructed to wait for 15 minutes before leaving the area. - A couple minutes after receiving the vaccine we heard the patients girlfriend cry out for help. - We went to assist the patient immediately and the patient was slumped over on his side with his girlfriend holding him up. - Patient did not hit the floor or hit any part of his body. - We asked the patient if he was ok, and he was disoriented and looked pale. - The girlfriend told us that he has fainted in the past after getting suck with needles. - Patient started to come to and said he was hot. We gave him Pedialyte to drink and aimed the fan on him. - I asked the patient a series of questions to determine what his condition was. - Patient did not feel any allergic reaction coming on, did not have difficulty breathing, did not feel tightness in his throat area. - Patient stated that he felt hot, and felt his blood pressure drop, and was light headed. - Patient was instructed to sit and stay in the area and we would observe him before he could leave the area. - Patient was within visual sight and every few minutes we would check on him to see if he was feeling better. - Overtime patient's color started to return to normal, patient became more responsive to conversation, and no longer complained of being hot or light headed. - After about 20 minutes or so, patient said he was felling much better and was ready to leave the area and get lunch in the food court. - Patient and his girlfriend was instructed to report back if was feeling lightheaded or faint before leaving the store.

Pt got J&J vaccine yesterday around 0900. and woke up w/ swelling of lower lip. No issues with breathing, chest pain. Denies pain but discomfort. c/o slight headache

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

Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: fell on forehead after fainting-Mild, Additional Details: pt fainted and fell on his forehead causing his forehead to bleed

Patient (myself) experienced lightheadedness, blurred/starry vision, clammy palms, intense cold sweat and almost fainted approximately 10-15 minutes after receiving Janssen COVID19 vaccine injection. I was provided a small bag of cookies and a bottle of water while sitting in a chair. These symptoms manifested a second time approximately 10 minutes after the first on-set and I was laid on the floor with feet elevated.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Patient reported hx of previous fainting with other vaccines and within 2 minutes of receiving this vaccine if fainted and quickly came to. We continued to monitor him for 30 additional minutes with no further complications.

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

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

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

Within 2 minutes of the vaccination, the patient became unresponsive and seized, also exhibiting some facial redness and sweating. Within a minute of that reaction, the patient was alert and oriented x4. He noted that he felt dizzy but was not aware of the events that had transpired.

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

2 minutes after injection, proceeded to completely black out- the nurse at the time described it as if I was gasping for air, in somewhat of a convulsion. She then proceeded to administer to use an epi-pen, which in turn immediately relieved my symptoms. Paramedics were called, vitals were checked - was eventually able to leave the facility and return home.

LOST MY TASTE BUDS A LITTLE BIT CINNAMON STICKS PUT IN MOUTH BUT COULD NOT TASTE IT AT ALL; BODY ACHES OCCURRING HERE AND THERE THEY COME AND GO; LEFT ARM SORE/ACHES IN LEGS; TEMPERATURE OF 101.9-102.1; FELT HOT; FEELS UNDER THE WEATHER; This spontaneous report received from a patient concerned a 31 year old male. The patient's weight was 180 pounds, and height was 67 inches. The patient's concurrent conditions included non-smoker, and alcohol user, and other pre-existing medical conditions included the patient had no known allergies, no drug abuse or illicit drug usage and no past medical history not with covid or anything like that.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 07-AUG-2021) dose was not reported, administered on 30-JUN-2021 18:00 for prophylactic vaccination. Concomitant medications included ibuprofen, paracetamol, tramadol, and venlafaxine. On 30-JUN-2021, the subject experienced felt hot. On 30-JUN-2021, the subject experienced feels under the weather. On 30-JUN-2021, the subject experienced temperature of 101.9-102.1. Laboratory data included: Body temperature (NR: not provided) 101.9-102.1. On an unspecified date, the subject experienced lost my taste buds a little bit cinnamon sticks put in mouth but could not taste it at all, body aches occurring here and there they come and go, and left arm sore/aches in legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left arm sore/aches in legs, and body aches occurring here and there they come and go, and the outcome of temperature of 101.9-102.1, feels under the weather, lost my taste buds a little bit cinnamon sticks put in mouth but could not taste it at all and felt hot was not reported. This report was non-serious.

Patient felt lightheaded, dizzy, clammy, cold. Described a feel like passing out. Rescue arrived on scene and had patient taken for medical care. EKG was abnormal for a possible precursor of heart block.

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

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

Same day of receiving the vaccination woke up with chills, fever, nauseous, tingling feeling in the index finger. Next day body was in pain, no appetite, dehydration, soreness at injection site.

After the vaccination was given the patient got up to ask for a tissue. When he approached the pharmacy counter he mentioned he felt hot then he stated he was getting dizzy. His body went limp forward and the pharmacist got behind him while a chair was brought behind him to sit down. He sat down and was given water and an ice pack for the back of his neck. He stated he felt better and thought it was just because he got up too fast. EMT was called because his fiance also had a similar reaction but her blood pressure dropped. The patient walked out with EMT services and declined further assistance.

The vaccine was administered to the patient at approximately 1135am. A few minutes after the vaccine was administered, the patient started feeling faint, dizzy, and sweaty (patient was sitting in a chair at the time). He also experienced some tingling in his hands and feet (like they were falling asleep). The patient laid down on his back on floor. The patient said he did not want 911 called. The patient started feeling better after laying down. The patient's blood pressure and heart rate were checked at 1150am (while still lying down) - blood pressure was 115/68, heart rate was 69. The patient said he had something similar happen once before when getting a Meningococcal vaccine. When feeling well enough, we had the patient sit up on the ground. The patient sat on the ground for a few minutes to acclimate, and then stood up and sat in a chair. The patient reported he was feeling better and continued resting in the chair. The patient reaffirmed he did not want us to call 911 or a family member to come be with him. The patient left the pharmacy around 1215pm after reporting that he was feeling better.

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

Immediately after immunization administered, pt became unresponsive. Remained conscious entire time, but very light headed. Pt was warm, sweating, clammy. After 5min, epinephrine was administered. Pt became more conscious after 5-10min of epinephrine dose. Pt. stayed in immunization area for approximately 70min after event. Wife contacted. Wife arrived 60min later. Pt left under wife care. Pt did not drive home. Pt was given water, and a soft drink after 30min. Contacted pt early evening. Pt reported feeling fine. No further symptoms.

After receiving Janssen covid vaccine at 10:45, patient reported feeling lightheaded and weak at 10:47am. Patient lowered to the ground safely, alert and oriented, state has Hx Vasovagal response s/p vaccine injections and blood draws. Patient alert throughout the episode, laying flat on the ground with leg elevated, initial B/P 88/60 HR 50, R 18, O2 sats 98-99% ra. Orange juice and cookies provided to patient, ate and drank and stated felt better. Repeat VS: B/P 92/64 HR 65 R 18 O2 98-99%.Dr at the patient site, patient observed for 30 minute- patient felt he's at his baseline and d/c home, no distress noted. Re-evaluated by Dr, BP on/dc 102/72.

Patient with a history of vasovagal reactions first experienced shakiness and diaphoresis and thenhad a brief (<30 seconds) loss of consciousness but without loss of postural tone about 2-3 minutes after the injection. BP-148/82 P-86 O2- 99% Monitored, offered fluids, recovered fully and was discharged home.

Approximately 5 minutes after receiving the injection, I became dizzy and lightheaded. My eyesight became blurry and my hearing very "tinny". I felt nausea and thought I was going to throw up. I sat down in a chair and was given a granola bar and some water. After about 3 or 4 minutes the majority of these seemed to fade, but I still felt slightly "off". Approximately 9pm that evening I felt very fatigued, so I went to bed. At approximately midnight, I woke up shivering, extremely cold, and sweating. Around 2am I had a fever of 102.3. I took some Tylenol to try to bring my fever down, which seemed to help. Around 9am the next morning my fever was gone, though I still felt extremely fatigued. Later that evening, after several naps, I started to feel a little better. Most of these adverse events were resolved by 28 hours after injection. I had arm soreness at the injection sight that felt like having been punched in the arm for about a week after the injection.

After receiving my Johnson and Johnson COVID vaccine I experienced a lack of motor function in my throat. Approximately 40 minutes after having received the shot, I lost the ability swallow. A tingling sensation took the back of my throat and eventually felt as though it moved into my head. The whole experience lasted a couple of minutes. Since that time all other symptoms have been normal, sore, slight fever, etc.

At around 6:30 in the afternoon, I felt sick to my stomach. I didn't know if I had to throw up or have diarrhea. At around 8 pm I couldn't do anything but lay in bed. I had high flashs and cold flashes every 30 mins. I was laying in bed with a hoodie and sweat pants on and could not stop shaking from being cold. Then 30 mins later I was so hot I had to take everything off. It kept going on like that till the next morning. I just now started to feel better around 10 am the next day.

Vasovagal reaction. Lightheadedness, pale, clammy. Resolved with lying down in passenger seat, elevating legs, juice/water/crackers, and additional monitoring time Advised to go to ED if symptoms arise later in the day or call PCP

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

Extreme chills, hot flashes, feverish without a temperature, small amount of vomit, nausea, confusion

My vision has been affected. Starting 4 days after the shot, I had discomfort while driving. I was wearing contacts and had my prescription renewed 2 days before my vaccination so I don't think my contacts are the issue. I The discomfort feels like my eyes are having trouble focusing even though I can see fine. It's as if my eye muscles are strained. It also feels like I've been trying to look at something very close to my eyes for a long time even though I haven't. I'm not certain, but I think the discomfort is on top or behind my eyeballs. My optometrist told me to stop wearing contacts for 2 weeks and that's helped but I still have slight discomfort still, especially when driving or having to focus on near and far objects.

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

Patient felt anxious about the vaccination and afterwards felt dizzy/faint, and warm. We had him sit down put an ice pack on his neck, and had him drink some juice. After about 10 minutes he felt much better.

Patient endorsed unilateral eye twitching with subsequent development of generalized unilateral facial droop. Seen by provider the evening of 1April2021 where he was diagnosed with Bells Palsy.

Migraine, dizziness, vomited, fever of about(101.7), extensive sweating and elevated heart rate. Lasted for 6 hours.

Patient recieved vaccine and was moved to observation area. Patient suddenly lost conciousness and fell from chair to the ground. Pt regained conciousness within 30 seconds. Patient was alert and orient upon regaining conciousness. Patient verbalized he was having no trouble breathing and vitals were taken. Patient vital signs were within normal ranges. Patient verbalized that his left arm hurt and fingers were numb on that side. Patient was taken to urgent care clinic and evaluated by physician. Patient signed an AMA form and was released from hospital. Patient encouraged to follow up with primary care doctor.

Rash all over the body that causes itching more intensely on the legs, arms, and hands; Inflammation of the lips and loss of sensation in the lips, and inflammation of the hands.

Began running a fever and experiencing cold chills after about 6 hours of receiving injection. Fever lasted about 12 hours. Once fever and chills subsided a migraine came on. Migraine lasted about 4 hours.

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

Patient had an episode of fainting about 10 mins after vaccine administration. after regaining consciousness he had rolling eyes and seizure and 2nd episode of fainting. The fainting episodes were for few seconds (30-45 sec). Patients feet were elevated and paramedics were called. while waiting for the paramedics we had patient drink water and orange juice as he was on diet and had taken only 300 calories per patient. Used cold compress on his face and neck, patient was comprehending well afterwards. paramedics arrived and examined the patients vital and asked if he would like to go to the hospital even though patient seemed fine. Patient denied going to the hospital and paramedics left afterwards. patient waited for 30 minutes afterwards and then left. we called the patient later and he was doing fine.

Patient recieved dose at 3:32pm and went to sit out front for the 15 minutes at 3:36pm another patient that was waiting thier 15min came to get us because he noticed he was turning white. I went to check on him and he was yellowish in color and barely able to speak to me. I asked another pharmacist to get me a cold pack and water. By the time we got the cold pack and water, he was not speaking, but eyes were open. I called 911 and the other pharmacist fanned him and placed the cold pack on his head and neck. He started talking within minutes and we waited for ambulance to come just to check him out. He was ablet to verify his name and where he was and EMSA came at 3:50pm. He left to their truck and said he was okay just felt shaky and clammy, but he could hear everyone talking to him.

Patient felt dizzy and vomited after the shot he felt hot and was sweating . Patient got shot at 14.40 and he started feeling dizzy at 14.45. After he vomited he started feeling better and he sat down for 5 to 10 minutes then he left. Per patient he was feeling good.

Approx 5 minutes post-immunization patient reported momentarily blacking out and dizziness. Patient was instructed to sit back down and was given a cold compress to apply to back of neck. Patient reported visual disturbances and shortness of breath. Patient was instructed to lay down with his feet elevated. Patient reported some numbness in left arm and hand (arm that vaccine was received in). Patient remained laying down with feet elevated for approx 10 minutes until he began to feel better. Patient then moved to sitting position on chair, with feet resting on second chair, where he remained until he began to feel back to normal. Patient was monitored for additional 15 minutes before patient left. Patient was feeling normal when he left the pharmacy area.

102 Fever 32 Hours/Continued Dizziness Tired Light Headed Nausea Chills for 12 Hours Followed by Sweating Overall weakness Confusion.

2-3 Minutes after receiving the vaccine, the patient was seated in the waiting area for his 15 minute wait time. We heard a crash and the yell of his wife and 3 children. Found the patient laying on his back on the ground. Patient was breathing, but non responsive to tapping and shouting. 911 was called. Patient regained consciousness after about 15-30 seconds. He complained of being hot, thirsty, having to go to the bathroom and feeling out of it. He appeared pale. We did record a BP of 95/57. He remained conscious until EMT's arrived. He was attended to and taken to the ER by emergency personal.

Systemic: Tasting iron in mouth-Mild, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Numbness at injection site

Fever, headache, severe chills, uncontrollable tremors. Had difficulty walking or controlling violent shaking. After ~1 hour took a ibuprofen which reduced fever and shaking enough to fall asleep. In morning was achy, tired, and headache. Mid afternoon had mostly recovered.

April 9 Morning: woke up with a mild headache. April 9 Afternoon (12 pm): feeling fatigued and headache grew worse. Plus chills. April 9 (5pm): feeling very cold and tired (worse than noon) April 9 (11:30pm): This time was the most severe for me in respect to side effects. I believe my headache woke me up. The headache was so bad that my eyes hurt as well (swollen almost). I think my fever broke. I felt very ?heavy? all over. The main concern was that around midnight I was having sharp pains on the right side of my body, near where my Liver is located. That was one effect that I did not read about. The sharp pains happened once every few minutes. I considered going to the ER but wasn?t sure. I ended up just changing my shirt, got some water, and went back to bed. April 10: My appetite was not normal, I ate but very little. The sharp pain on my right side went away but I had a minor headache for the rest of the day.

Started with slight tingling feeling in my fingers. Then I became tired and starting shivering aggressively. Then got the chills pretty bad as I laid down to go to bed. Became really sore all over. Couldn?t stay asleep for more than an hour. Later in the night I started sweating and felt really hot. Also became quite thirsty. During the entire night I also had horrible dreams. After about 5am things started improving. Had some light sensitivity in the morning for a shot bit. By noon I was almost back to 100%

Pt became dizzy, diaphoretic, and warm. Pt was rehydrated by PO fluids and felt better, and wanted to go home. Pt was stable when he left

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

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

The night of, I went to bed and woke up around 1:00 AM suddenly feeling very cold and shivering, under a blanket in a 73 degree room. I soon after experienced my body (especially my core) seize up for 5-6 seconds at a time for at least one or two minutes. Next day, headache and fatigue.

Client received his J&J vaccine and immediately afterwards he had a seizure-tonic clonic. Seizure lasted about 40 seconds, he was immediately evaluated by the paramedics on site. BP laying down was 117/74 p62 and later 116/82 p66. Client indicates that has a history of passing out when he gets his blood drawn. 911 was called and Medic arrived, client was transported to the hospital for further evaluation.

Woke up with severe chills for about an hour. For the next 1-2 hours I had muscle spasms followed by a 104 degree fever which did not let up until 1pm. This was followed by a headache and bad body aches which did not stop for another 24 hours.

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

Nausea (24 hours), chills (24 hours), sore throat (1.5 weeks, ongoing), thick bloody mucus (1.5 weeks, ongoing), dry cough (1.5 weeks, ongoing), loss of voice (1.5 weeks, ongoing)

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

Was sitting in chair, fell over. Hit head on cement floor. Seized for 35 seconds. Eyes rolled in to back of head and foaming at the mouth. Awakened suddenly to confusion. Escorted off floor to wheelchair. Reoriented.

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

TIGHTNESS IN THE CHEST; MIGRAINE HEADACHES WHEN STANDS UP FROM BED; PAIN IN THE ARM; This spontaneous report received from a consumer concerned a 32 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced tightness in the chest. On APR-2021, the subject experienced migraine headaches when stands up from bed. On APR-2021, the subject experienced pain in the arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in the arm, tightness in the chest and migraine headaches when stands up from bed was not reported. This report was non-serious.

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

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

0 mins: Discomfort in arm flowing from injection site to the rest of the body 2-4 mins: Light-headedness 5-10 mins: About 2 minutes after sitting down at the 30-min waiting area, I began to feel more light-headed while checking my phone, though I don't remember it, I fainted and hit my head on the gym floor ~15 mins: I am awake and feel extremely foggy and have low blood-pressure and heart rate ~25 mins: I am told to sit back up in the chair ~26 mins: I start feeling light-headed again and lose consciousness again and am told that I had a seizure for 20 seconds before coming back again

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

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

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

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

FEELING LETHARGIC; HAVEN'T BEEN FEELING GOOD EVER SINCE; OCCASIONAL SHORT FEVER MILD; SEVERE NAUSEA; STOMACH UPSET EVERY TIME WHEN EATING AND FASTING; BRAIN FOG; BLOATING AFTER EATING; DISCOMFORT; This spontaneous report received from a patient concerned a 32 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-APR-2021, the subject experienced stomach upset every time when eating and fasting. On 11-APR-2021, the subject experienced brain fog. On 11-APR-2021, the subject experienced bloating after eating. On 11-APR-2021, the subject experienced severe nausea. On 11-APR-2021, the subject experienced discomfort. On 11-APR-2021, the subject experienced haven't been feeling good ever since. On 11-APR-2021, the subject experienced occasional short fever mild. On 12-APR-2021, the subject experienced feeling lethargic. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from occasional short fever mild, and had not recovered from stomach upset every time when eating and fasting, discomfort, severe nausea, brain fog, bloating after eating, feeling lethargic, and haven't been feeling good ever since. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not needed as per standard procedure since case is assessed as non-serious.

Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypertension-Severe, Systemic: Nausea-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Severe, Additional Details: Within 10 minutes of administration patient became very overheated and passed out. I provided and ice pack and cold water to help revive the patient. I monitored the blood pressure which was elevated at 126/93 at the time of the event. I monitored him as he revived and his blood pressure came down to 110/68 then normalized at 118/81. He reported feeling nauseas before he lost consciousness. Conciousness was lost for a matter of seconds. Patient also reported numbness/tingling in both arms.

pt mentioned prior reaction history of seizures but hasn't happened in a long time. Felt anxious when getting vaccine and motioned he thinks he might be having an anxiety attack before shaking. I was near patient when seizure started was able to guide him off chair slowly onto ground to try to protect head but head was slightly bumped on the ground; only lasted 2 to 5 seconds but pt felt fine after awakening and asked how long seizure went on for. Denied EMS services and after 30 minutes of rest with cold water and an ice pack patient felt better and left store.

2nd time submitting this because first submission said error; doing another report just in case. Patient got vaccine and said felt anxious then started having a seizure for 2-5 seconds pt said they had history of this prior but has been a while. I was near patient and able to slightly guide patient down but head did slightly hit floor. Patient woke up and said they were fine . Had patient stay an extra 30 minutes and gave ice pack and water and left the store after ensure they felt fine.

Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium

Culminated in myocardial infarction. Chest pains started next day and leg pains. By April 23, I had severe chest pains and had to see medical at work. On April 30, 2021 was at emergency department for heart attack symptoms. Was transferred for myocardial infarction. Test results show myocardial infarction, coronary spontaneous arterial dissection, and blood clot.

After receiving vaccine patient was about to sit in observation chair, he started seizing and fainting. Hit his nose and had nose bleed. He was having panic attack due to injection. Called 911. We made him comfortable and then in 5 minutes he started to faint. Ex-Ems was next to him, he started asking him questions and make sure he was awake. Within 5 minutes EMS arrived and they took over, checked all his vitals and found out patient did not eat or drink for whole day and had phobia with needles. Patient refused to go to hospital. Per EMS recommendation patient had drink and a bagel. Patient's relative came and took him home.

Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional Details: Patient came to pharmacy for Covid vaccine. He said he once fainted after giving blood and has a fear of needles. He was given his vaccine and after 10 minutes he felt nauseated and fainted. The patient awoke within 30 seconds but then vomited. EMS was called to make sure the pt was okay. After another 30 minutes of rest the patient was able to leave the pharmacy.

Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Medium, Systemic: Tingling of Lips and Tongue-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium

Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: Shortly after vaccination, the patient became lethargic and slow to respond. Immunizing technician immediately called the RPh over to assess the patient. RPh instructed technician to grab blood pressure (BP) cuff and bottled water. BP did not register on cuff, the patient's pulse was 54. After a brief unresponsive episode, the patient became responsive & drank water. Then became sweaty and unresponsive 2 more times. RPh monitored for 30 minutes and will check in on 5/8/2021.

After receiving the Janssen vaccine at 3:30pm, patient started filling dizzy and lightheaded. He was clammy to the touch and was sweating profusely. Vitals were checked and blood pressure/pulse were normal. Ice was applied to patient's wrist and neck. Patient was till complaining he was not feeling well and was sweating. Pharmacist had patient lie down on the floor. Paramedics were called to the scene. They also checked his vitals and they were good. Patient refused to go to hospital and stated that he was feeling better. Everything happened right after the patient received the vaccine. It was not a delayed reaction.

Approximately 8 hours after injection I began experiencing extreme fatigue. This was soon followed by uncontrollable shaking and chills. As this progressed I began to experience extreme aching pains all over my body, a headache, and dizziness. I fell asleep somewhere around 11pm or 2 hours after on set of symptoms. I awoke multiple times in the night to body aches and a head splitting migraine. During the night the chills and shaking turned into a fever and sweating. At 6am the next day I forced myself to take some painkillers and hydrate. The body aches had started to recede at that point but the migraine was extremely painful and It was nearly impossible to open my eyes with a hypersensitivity to light. I slept on-and-off through the next morning and nearly all symptoms stopped by 1pm on May 8 or 24 hours after the injection.

Site: Pain at Injection Site-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: pt fainted-Medium, Systemic: Flushed / Sweating-Medium

Roughly three hours after getting the shot I was very cold and developed a fever of 102.8. I vomited that night. I took an ibuprofen to help reduce the fever then slept. For the next six days I had an on again and off again low grade fever and was nauseas most of the time. Sometime during those 6 days I developed intermitted tingling in my left hand, primarily by index finger. This continues to today happening roughly once a day. On rare occasion my right had will do the same thing but that is far less often. I never had tingling in either hand prior to my vaccine. I also developed heartburn occurring roughly 1-2 times a day. Prior to the vaccine I rarely (1-2 times a year) had heartburn and I have not changed anything about my diet or lifestyle since my vaccine. Occasionally my head feels "foggy" as well and this began sometime after the vaccine but I can't recall exactly when it started. It's not a headache, more of a slight lightheaded, dull feeling. I had none of these symptoms with any regularity until I was administered the vaccine.

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

Patient began sweating profusely approximately 10 minutes after his vaccine. He went to his parent's car and asked his father to turn on the air conditioning as he was hot. he then passed out in the back seat of the car. His mother came inside and asked for assistance. I grabbed an epi-pen and ran outside to the car. Patient was breathing and had a pulse rate of 64. He aroused shortly after I began asking him if he could hear me and asked if he could tell me his name. He was pale (notably his lips were quite pale) and confused. He could not say his name but could nod appropriately to questions when asked. We immediately called EMS for assistance. They arrived within 4-5 minutes and transported the patient to hospital.

Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: patient became unresponsive/faiting while sitting in the chair.

Patient received a Johnson & Johnson vaccine today. Shortly afterwards while waiting in pharmacy area, we were alerted that the patient was unresponsive by his wife. Immediately responded to patient. Code white called and management responded. Tried to get him to wake up, he opened his eyes but immediately closed them again. I attempted to keep him alert and eyes open. This proceeded to go on for several minutes. Ice packs were placed on neck and wrists. Feet elevated. Once patient was alert and oriented, water was provided and patient was instructed to take small sips. Patient was kept in pharmacy area for additional 15 minutes once he was back to normal. Patient stated that when he passed out, he felt tired, couldn't see or hear.

Patient fainted after vaccination while he was seated during the 15 minute observation window. Patient quickly recovered (less than 1 minute) but was feeling cold and clammy. Patient was given water to rehydrate and stay seated for observation; Pt did not require EMS to be called as he recovered quickly on his own. Patient left with his friends when he recovered. A follow-up phone call to the patient was made a few hours after vaccination and patient was doing well. Patient instructed to rest up and contact MD if needed.

Patient family shouted to nurse , upon nurse arrival patient was already unconscious and ammonia quickly placed under the patient nose . Patient was stuffed and started having sudden body and limb jerks movement that involved the arms, head and neck. Shortly after patient regained consciousness follow by a small period of confusion . Paramedic arrives at the scene and patient was placed on the lateral position ,oxygen was provided and continued to be monitored by the paramedic.

Site: Pain at Injection Site-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Weakness-Medium

Patient felt light headed and weak, EMS called, patient recovered within 5 minutes. Will keep in observation for 20 more minutes.

Heart attack - Sudden onset chest pressure, shortness of breath, bilateral arm numbness. Found to have clot in LAD requiring stent. No cardiac risk factors.

Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe

NUMBING IN THE FACE; DIZZINESS; CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 32 year old male. The patient's height, and weight were not reported. The patient's past medical history included ulcerative colitis, and concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included the patient did not have no known drug allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203A21A, and batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAY-2021, the subject experienced chills. On 18-MAY-2021, the subject experienced headache. On 18-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 F. On 19-MAY-2021, the subject experienced numbing in the face. On 19-MAY-2021, the subject experienced dizziness. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine was not applicable. The patient was recovering from chills, headache, and fever, and had not recovered from dizziness, and numbing in the face. This report was non-serious.

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

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

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

Patient had rapid heart beat that occurred on and off of approximately 10-15 minute intervals over the course of 40 minutes. His face also felt warm at the temple area. His blood pressure was elevated when taken by EMT services but pulse was normal. EMT was called and he was given the option to go to the hospital which he did as precaution.

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

PATIENT RECEIVED J&J COVID VACCINE AT 11:15AM ON 5/29/21. WHILE WAITING FOR 15 MINUTES PERIOD AFTER VACCINATION, HE WAS FAINTING AND SAT DOWN ON THE FLOOR IN FRONT OF PHARMACY AT 11:20AM. PATIENT WAS SHAKING. HIS BODY TEMPERTURE TURNED COLD. HIS SKIN TURNED PALE.

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

APPROXIMATELY 4 MINUTES AFTER ADMINISTRATION, PATIENT REQUESTED TO LAY ON THE FLOOR DUE TO DIZZINESS AND BEING HOT. I ACCOMPIONED HIM TO THE FLOOR, AS PATIENT LAYED DOWN, HE LOST CONSIOUSNESS, EYES ROLLED TO BACK OF HEAD,SWEATING AND UNRESPONSIVE TO MY VOICE OR TOUCH. DEEP SNORE. 60-90 SECONDS, LIFTED HEAD, THEN SLIGHTLY BUMPED BACK OF HIS HEAD. AS PATIENT WOKE UP, HE ASKED WHAT HAPPENED. INSISTED AND REPEATED HE WAS ALRIGHT. I KEPT HIM ON THE FLOOR FOR APPROXIMATLY 7 MINUTES UNTIL FIRST RESPONDERS ARRIVED. THEY SAT HIM IN THE CHAIR, ASKED SEVERAL QUESTIONS AND TOOK VITAL SIGNS, AND EXAMINED BACK OF HEAD. HE SIGNED OFF WITH THE AMBULANCE ATTENDANTS AND REFUSED TO GO WITH THEM. HIS MOTHER ARRIVED AND STAYED WITH HIM FOR ANOTHER 7-10MINUTES. PATIENT LEFT WITH FAMILY MEMBER, SIGNED OFF AT THE REGISTER .

Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient stated he has history of vasovagal syncope. EMS was called. Patient was fine after 30 minutes

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

Patient started to experience nausea/vomiting soon after getting the vaccine, then started convulsing and having seizure-like symptoms.

seizure reaction within 5 minutes of receiving vaccine. dry heaving, unresponsive, seizure, numbness in both arms, confusion, headache for 24+ hours.

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

Patient said since the day he got the vaccination he has had severe pain in the arm. He has full range of motion but he is in severe pain every day when he lifts his arm. He has to stretch, take OTC pain medication and will be consulting his doctor for further treatment.

Patient appeared to have a vasovagal response after having the vaccine. He became nauseous and clammy and pale. He began to seize and passed out. EMT evaluated him and found his vitals were stable, as well as, his blood sugar. He felt better and refused transport for further evaluation. No other incidents occurred.

Patient received the vaccine and felt fine. Within a minute patient began to have a seizure which lasted roughly 30 seconds. Patient stated had not had a history of seizures before receiving vaccination. Also, patient stated no medical conditions to date.

Patient called around 6:50pm on 7/28/21 saying that his left arm has been numb since getting the shot, which he received on 7/24/21. Per patient 10 hours after getting the vaccine he woke up to pain (rated 6-7/10) in both arms which he described as feeling very sore and aching, not burning or tingling or sharp. The pain has continued and has decreased to a 4/10 but is now only in the arm that the vaccine was administered in. When asking patient if he experienced any other symptoms I should be aware of he mentioned that he felt very dizzy and unbalanced and that it started several hours after getting the vaccine and still hasn't gone away. Did not mention any other symptoms. Told patient to be seen or to contact his primary care provider but as of now am unsure if patient did or will follow through and be seen.

15 minutes after vaccine received, patient reports feeling hot and dizzy. Patient denies respiratory distress. Patient advised to follow up with primary care provider and to call 911 if symptoms persist or experience respiratory distress. Patient instructed to take Acetaminophen/Ibuprofen, to have food/fluid, and to rest. Pt able to hydrate with water. Patient ambulatory and reports symptoms resolved after 30 minutes. Patient reports able to return to work. Patient declined transportation to hospital for further evaluation. BP 118/78, HR 64.

Client begin to feel numbness and tingling to right hand and fingers shortly after receiving vaccine. While being assessed by this nurse, client experienced syncope episode for approximately 10 seconds and was immediately alert and oriented to self, person, place and time after syncope episode. Client became clammy and diaphoretic. 911 was called and client was assisted to triage area for further assessment. BP 164/96, HR 74. Client was cleared per EMT, able to walk out of clinic withou assistance and drive self home.

Shaking fever and chills all night, waking up every two hours freezing cold despite lots of clothing and blankets. Woke up today feeling slightly better but still have a slight fever today, chills, and naesuea. Super lethargic and monitoring my condition daily.

Patient is a 33 y/o male c/o having dizziness and nausea while he is sitting after 5 minutes of getting vaccine. vitals BP 100/60 HR 66 Oxygen sat 95 pain 0/10 resp. 18 Clamy to touch. Negative for shortness of breath, throat swelling, facial swelling, negative for rash. Negative for numbness or tingling of lips or throat. Vasovagal synciope Reasurrance given. Monitor. Patient standing walking around after 30 mintues. Refuses to call parents reports he feels much better.

Pain in injection site and hand, with little difficulty to breathe. that night start feel chili, wake up with fatigue, body ache, headache and fever at 102 degree.

I received the shot around 11AM on the 11th. By 5PM that evening I was beginning to have a headache and chills. I drove home from work and by 6PM I had severe chills, I was shaking so bad I could barely fill a cup of water and take ibuprofen, the water was sloshing out of the cup. I had a fever of 102 and spend the rest of the evening in bed, shaking. By around 10 PM the severe chills had subsided and my fever was 101. I did not sleep much during the night due to a headache and alternating chills/sweating. This morning it is 7 AM and my temperature is 99.5 and I am beginning to feel more normal. I took advil at first and then tylenol every 4 hours during the night.

Jansen COVID-19 Vaccine EUA Approximately 12 hours after receiving the vaccine, I began having headache, body aches, and cold chills. 24 hours after receiving injection, most symptoms have gone away, with only a slight headache remaining and soreness at the injection site.

I started to feel light headed and a bit dizzy around 8:00 PM on the day of vaccination. The symptoms progressed to feeling week and having a chill by 10:00 PM. I woke several time during the night feeling hot and uncomfortable. By the time I woke up at 6:30 AM the following morning those symptoms had gone. I had a bad headache in the morning and took acetaminophen which helped alleviate the headache. I have felt a bit weak and tired through the day.

muscle "spasm" L arm injection site, then gassiness / indigestion. Symptoms dissipated with fresh air, emotional support, sips of water. Left parking lot after 15 mins additional wait time.

Fever first day and a half. 6 Days after vaccine body has broken out into a rash all over. Woke up on 3/18 and rash was gone. Around 2:30pm on 3/18 , rash came back all over body. Doesn't itch but it does burn.

Numbness in left arm and face, overheating, fainting, Medical personal fist on site noticed shaking due to Seizure.

Pt reported tingling, swelling in lips and tingling in arm 32min post vaccine. Administered epi 0.3mg and 50mg IM Benadryl and called 911. Pt transported to local ER awake, alert and breathing on his own. Called ER 5 hours later. Pt continued to be observed. No more epi had been administered.

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

Started with shaking chills, aches then low grade fever (100.5 even after taking 600 mg ibuprofen the morning after vaccination) and extreme fatigue. Symptoms resolved after 36 hours.

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

patient felt hot and clammy. nauseated. watched patient and he improved. no longer nauseated and feeling better

Patient became distressed within 1 minute of injection. Became sweaty and hot. Pulse became elevated to 120 bpm. After 20 minutes all symptoms returned to baseline.

Fever, chills, body aches, headache, fatigue, pain in arm, pain in stomach, all occurring ~ 12 hours after vaccine.

Triggered a grand maul seizure, with hot and cold chills and a slight fever. Patient is doing much better this morning.

Around 7:00 pm on the day of the shot (about six hours after receiving the vaccine), I began to feel feverish and cramping. I took 600 mg of Tylenol as mentioned by the pharmacist for those that are feel side effects. Around 1:00 am, I woke up shivering with a 104.5 fever and nausea. I took another 600 mg of Tylenol, which brought the fever down to 100.5 for the six hours. I also threw-up around 2:00 .

It was a drive thru shot facility. They gave me a shot in my left arm and asked me to pull around to park. I parked my vehicle and didn?t feel well so I switched seats with my girl friend. As soon as I got into the passenger seat I was out. She said My eyes rolled back in my head and I started shaking and eyes at this point she said where going up down and side to side . She ran for help and after about 1-2 minutes I woke up. I thought I passed out so I instantly put my feet on the dash of my car and the pharmacist gave me water and chocolate milk. He then checked my heart rate it seemed good and after 20 minutes he let us go home.

Around 1730: Patient was found unresponsive in the bathroom by a patron who alerted PHN. Patient was unresponsive, breathing, and had a pulse. 911 was called for EMS and further medical staff came and patient's head and neck was stabilized. Patient woke up and was A&Ox1, to self. EMS then arrived and transported patient to local emergency department.

Injection +8 hours: strong headache, full body sensitivity, body fatigue, flush neck and face, full body chills, full body shivering. +9 hours: hands pale, thumb capillary refill L: no refill, R: 6 seconds. HR98 +10 hours: Temp: 101.4, thumb capillary refill L:2 R:2. Eyes bloodshot, headache over eyes/temples +11 hours: Temp 102.5, HR 109, SpO2 95 +12 hours: full body chills transition to full body slight flush/damp. Headache pulsing behind/above eyes and temples. +18 hours: Temp 100.2, HR 87, SpO2 99, headache continues.

1. Fever, approximately 100 to 101 degrees F, starting about 8 hours after injection and lasting at least 12 hours. Treated with multiple doses of OTC pain killers. 2. Body aches, starting approximately 8 hours after receiving vaccine and lasting approximately 24 hours. 3. Insomnia. Inability to sleep and/or stay asleep for 2 nights following vaccine. On day two I woke up at 3:30 AM feeling a normal energy level and never fell back to sleep, compared to a normal wake up time of 6:30 AM. 4. Mild arm soreness lasting about 1 week.

Severe shaking. Admitted to ED for 180/90 blood pressure and rapid heartbeat (>120). Screened for potential pulmonary embolism and blood clots

1) Mild nausea within a few hours and lasting for 24 hours 2) mild headache within a few hours and lasting for 24 hours 3) significant fatigue within a few hours and lasting for 24 hours 4) flushed face within a few hours and lasting for 12 hours 5) severe chills from hours 8-10 6) severe overheating and sweating from hours 10-20 7) moderate body aches within a few hours and lasting for 24 hours

For at least 20 hours: Fatigue, woozy/clouded head, slow to process thoughts, fever ranging from 99.5 F - 101 F, lack of appetite Frequently during the above 20 hours: "tingly" nerves across body, "swimming" sensation when turning head with delay in focusing, headache For hours 16-18 after vaccination: runny nose

After administration of Janssen vaccine 0.5mL, pt reported arm was hurting and he began moving arm. CMA noticed that continued to shake arm after 5 minutes but patient was alert and oriented x 3. CMA thought the way he was shaking his arm seemed irregular so she advised pt he would be taken to an observation area for further observation. Half way to the observation area, pt reported to CMA that he was seeing spots and felt like he was going to get sick. CMA called for help. Patient experienced a syncopal event just as he made it to the chair. Several staff was helping to support patient. Legs were lifted to another chair. Patient was not responsive for a short time, very diaphoretic, breathing regular and unlabored. Patients eyes then rolled upward toward the ceiling and patient's entire body began shaking uncontrollably while staff managed to keep patient from falling to floor from the chair. Once patient was conscious, he was able to state his name but reported he was very confused and could not think clearly. He was able to sit upright. In the meantime while patient was shaking uncontrollably, staff sought urgent care provider to come and see patient. Patient was then taken over to the urgent care side of the building to evaluate and treat patient.

Sever fever near 103, sever chills, severe headache, pain and aches throughout body, loss of strength , severely tired

Right arm became very sore the following day and remained extremely sore for about five days after receiving the first and final dose of the J&J vaccine. On the day following the injection, I began developing a headache. I didn't think twice about it until the headache didn't go away on the second day, the third, the fourth, but finally the fifth day it seemed to subside. The intensity was severe and was concerning due to how long it lasted. I had simply assumed that it was normal side effects. Yesterday on Monday, 04/12/2021, I developed severe and sharp pains in my stomach/abdomen that actually put me in bed all day.

No reactions until 12:30am when I awoke with severe chills/shaking and freezing. Lasted about an hour. Woke up every 2 hours. Severe headache & muscle aches. Took maximum dosage of ibuprofen and tylenol. I was very tired the next 2 days.

33yr old patient with unknown PMH and allergies, presented to office for COVID-19 injection on 4/10. CMA administered JANSSEN COVID19 VACC (LOT # 207A21A, exp 6/23/21) IM to patient's right deltoid at 0841. Immediately following injection, patient's arm began to shake which continued past 5min. Patient endorsed seeing black spots, then nausea. Patient denied shortness of breath, difficulty swallowing, chest pain or other symptoms. Patient noted to be pale, diaphoretic, and fainted upon sitting down. Reporter observed patient shaking. Patient admitted to urgent care for further follow up. At 0904, BP 136/82, HR 79, 98% RA. At 0947, BP 93/61. Patient given NS 500mL bolus IV. At 1025, patient denied dizziness, weakne At 1025, patient denied dizziness, weakness, or nausea. Patient changed to sitting position with mild nausea. VS remained stable. At 1035, patient ambulating without issues. Patient discharged home in stable condition. Patient noted he had not eaten prior to injection. Urgent care provider indicated per physical exam consistent with vasovagal reaction to vaccine. POC = 142, given crackers and water x 2.

Patient in clinic for sick call. Pt having random bruising and pain in his LE patient does have limp favoring his rt leg. Pt reports having random bruising ever since he received the Johnson and Johnson vaccine. states that he has been having headaches and pain in his feet. Pt reports head aches started about 3 days ago. Pt does report history of family members having clotting issues. Tem 97.8, B/P 105/75, P88, resp 16

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

After 6 hours got chills and full-body soreness, went to bed, woke up with fever dreams, couldn't stand, felt fine lying down (except for headache) but profuse sweat and weakness (collapsed to floor) when standing. The next day felt much better.

PATIENT SAID THAT VACCINE BURNED AFTER ADMINISTRATION. HE GOT REALLY HOT AND NEEDED TO REMOVE HIS MASK TO BREATH. I ESCORTED HIM TO A SEAT NEXT TO HIS WIFE AND HE FAINTED. HE REGAINED CONCIOUSNESS AFTER 1 MINUTE. GOT HIM A COLD CLOTH FOR HIS HEAD AND A GLASS OF WATER. ABOUT 15-20 MINUTES LATER HE FAINTED AGAIN. HE REGAINED CONCIOUSNESS AFTER 30 SECONDS. EMS FINALLY ARRIVED AFTER 2 CALLS TO THEM. EMS CHECKED HIS VITALS AND PREFORMED AN EXAMINATION. HE DECLINED TO BE TAKEN TO THE HOSPITAL. AFTER ABOUT 2HRS HE LEFT ON HIS OWN POWER

Noticed headache bottom left back of head before bed. Woke up at 2:30am with right leg fully asleep. Attempted to wake leg up, lost equilibrium, stumbled, lost hearing, couldn't put words together to tell wife what was going on and ended up on the floor to regain composure. Had difficulty putting on clothes to go to hospital. Went to ER, had severe diarrhea there, they did blood work and EKG, sent me home saying maybe I feinted. Had high blood pressure at ER, 150/86. Felt weak and 'off' sense the event, felt tightness in chest and odd limb pain past 72 hours. Woke up at 3:30am on 4/15 with left arm asleep, went back to bed fine. Never had these symptoms before.

I am experiences pain in both my legs, in the calf musscle of both legs and palpatations int he calf muscle.

SEVERE CHILLS; BEING INCREDIBLY HOT; GENERAL LIGHT HEADEDNESS; THIRSTY ALL NIGHT; URINATED (PEED) A LOT AT NIGHT; PAINFULLY CHAPPED LIPS; TIREDNESS; HORRIFIC HEADACHE; MAYBE SLEPT FOR 4 HOURS; This spontaneous report received from a patient concerned a 33 year old male. The patient's height, and weight were not reported. The patient's concurrent condition included obesity. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular) .5 ml, administered on 07-MAR-2021, around 11:30 am for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the patient experienced maybe slept for 4 hours. On 07-MAR-2021, the patient experienced severe chills. On 07-MAR-2021, the subject experienced being incredibly hot. On 07-MAR-2021, the subject experienced general light headedness. On 07-MAR-2021, the subject experienced thirsty all night. On 07-MAR-2021, the subject experienced urinated (reported as 'peed') a lot at night. On 07-MAR-2021, the subject experienced painfully chapped lips. On 07-MAR-2021, the subject experienced tiredness. On 07-MAR-2021, the subject experienced horrific headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tiredness, severe chills, horrific headache, general light headedness, and being incredibly hot, and the outcome of thirsty all night, painfully chapped lips, urinated (peed) a lot at night and maybe slept for 4 hours was not reported. This report was non-serious.

I received the vaccine Saturday 4/10/21 at 9 am. By 8 pm of the same day I had fever, chills, headache and body aches. For about 30 minutes I saw a white spot on the peripheral view of my left eye. By Monday, I felt dizzy and bottom right part of my chest hurt when taking deep breaths. The dizziness and chest pain lasted all week, still feel feel it today 4-18. My doctors office told me vertigo was a common side effect. On Thursday 4-15 every time I bent down and tried to get up, my right leg hurt as if I had exercised. At the moment I haven?t gone into work since Monday 4/12 since my job requires a lot of physical work. I have mostly been home resting but don?t feel ready to go back to work. If someone calls can it be a Spanish speaking person please.

Within maybe 20-30 minutes of vaccination, I noticed a small dull pain in my right calf; I disregarded and walked back to the car. This pain has reduced over the last week, but is still vaguely present. 5-6 hours after vaccination, headache and strong sinus-headache. Laid down to rest. I woke up around 20-30 minutes later with full body tremors and muscle spasms. Muscle spasms particularly violent in my back, feeling similar to if someone was involuntarily using one of those muscle-stimulator elecrode pad systems on me; could feel each individual muscle tensing and releasing at random. Tremors and spasms persisted and then diminished over the next 4-5 hours. 99.7F fever was recorded. Chills, fever, nightsweats, and repeated sleepless rest/waking every 30-40 minutes until the next day. Headache was still strong and present at 4am, took 600mg ibuprofen and continued hydrating. Headache, general soreness, and fever persisted for ~3 days, but manageable with hydration and rest. On day 3 a rash appeared on both my knees/innerthigh just above the knee. Likely not hives, subdermal red speckles that appeared at night; close to 4mm in diameter, skin was warm to the touch and very itchy. Most of the rash was gone by morning, and the itching and warmth was completely gone. I have noticed a very similar rash appear on my front left collar/shoulder area just this morning, but no itch/warmth. Outcomes: Muscle spasms/tremors subsided within a day. Fever/headache subsided within 3 days Knee/Thigh rash gone. More similar rash just appeared on upper left shoulder/collar. Upper calf dull pain still present, but only barely "It feels a bit off" would be the best description.

Patient reports having severe upper thigh pain that started 4/20/2021. Patient stated that there have been no other symptoms at this time. Patient was advised to go to the emergency room immediately to get further evaluation. Patient verbalized agreement and stated that he would go to the nearest ER right away.

Patient reports having a sharp pain in the upper thigh following exercise. The pain was the most intense the day it happened. Patient stated " It feels like a pulled muscle". Patient stated that it only hurts when he moves a certain way. Call was transfered to a provider for further assessment. Provider advised that the patient continues to have the pain or if the pain worsens to call 911 or go to the nearest emergency room. Patient also educated on other signs and syptoms to look out for and when to seek medical attention.

Severe thrombocytopenia (Platlet Count of 18) HPI: 33 y.o. male with no PMH coming in now w/ progressive thrombocytopenia to 18. He received the J&J covid vaccine on 4/8 and felt well afterwards. Last Friday (4/16) he began to experience constitutional symptoms (fever to 100.4, chills, night sweats feeling drenched, decreased appetite) so decided to get his labs drawn as an outpatient for further evaluation. Symptoms progressed until Tuesday, when they began to subside slightly. At that point, his labs resulted and were notable for thrombocytopenia. He got his labs redrawn the day before admission and it was noted that his thrombocytopenia was worsening, so he was directed to the ED for further evaluation. Patient seen by hematology, started on dexamethasone 40 mg PO daily as well as IVIG treatment x2. MRV of brain without evidence of dural venous sinus thrombosis ***PATIENT CURRENTLY HOSPITALIZED***

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

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

Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: patient was dripping sweat, very pale. blood pressure never dropped below 120/100 per OMRON meter, pulse stayed around 60. he was given water and recovered in about 5 minutes. He stayed for 30 minutes further observation, then left feeling very normal

PT REPORTED TO ED WITH C/O SOB/DYSPNEA, CHEST PAIN, PROBLEMS WITH INSPIRATION AND FATIQUE-TACHYCARDIA HR 119- BILATERAL LEG PAIN SINCE 4/26/21

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

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

Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: called 911 but patient recovered before paramedix arrived

Site: Pain at Injection Site-Medium, Systemic: Chills-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Fever-Medium, Additional Details: Wife of patient had called the pharmacy hours after patient had recieved his J&J vaccine to inform us of this symptoms a few hours when arrving at home. He experienced fainting, chills, fever, and pain and took a tylenol and symptoms started to subside and has been currently been resting in bed. Wife says they will continue to take tylenol around the clock if needed and will seek medical attention is symptoms worsen.

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

After 12 h, i feel cold with low fever, mild sweating during sleep, they lasted for two nights. diarrhea started 1:30 am on day 2, with 3 times of water stools in total on day 2.

TINGLING IN CHEEK (ONE SIDE); This spontaneous report received from a pharmacist concerned a 33 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A expiry: 23-JUN-2021) dose was not reported, administered on 03-MAY-2021 14:50 for prophylactic vaccination. No concomitant medications were reported. On 03-MAY-2021, the subject experienced tingling in cheek (one side). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling in cheek (one side). This report was non-serious.

COULD NOT SLEEP AS TOSSING AND TURNING ALL NIGHT; BODY ACHES; BODY SHAKING; CHILLS AND SHIVERING; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 33 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. 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-MAY-2021 16:10 for prophylactic vaccination. No concomitant medications were reported. On 03-MAY-2021 23:30, the subject experienced could not sleep as tossing and turning all night. On 03-MAY-2021 23:30, the subject experienced body aches. On 03-MAY-2021 23:30, the subject experienced body shaking. On 03-MAY-2021 23:30, the subject experienced chills and shivering. On 03-MAY-2021 23:30, the subject experienced headache. On 03-MAY-2021 23:30, the subject experienced fever. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not sleep as tossing and turning all night, body shaking, and chills and shivering on 04-MAY-2021, and had not recovered from fever, body aches, and headache. This report was non-serious.

Patient received vaccine in a drive up clinic and was waiting in his car during the 15 minute observation time. 10 minutes after the vaccine, he became lightheaded and alerted for medical attention. When we arrived at his car he was having tonic clonic seizure like activity which lasted about 20 seconds. Patient was reclined in his car seat, VS taken and stable. Oriented x4 but described feeling light headed, tingling in left arm and lips, and diaphoresis. EMS arrived and assumed care. Extended observation showed improving vital signs, and resolution of described symptoms. Patient was released from EMS care and was transported to the ER by a friend for further eval.

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

A few minutes after patient was vaccinated he started to feel clampy , cold sweat,feel like fainting " feeling of thing starting to close in" but alert and in a sitting position. He was talking the entire time. A few minutes later he said he starts to feel better.

About 2 minutes after vaccination patient was feeling light headed, pale, sweaty, clampy. It lasted about a minute or 2 then he stated that he was starting to feel better. He stayed in the store about 30 minutes ( or until he was comfortable leaving on his own).

Systemic: Chills-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Medium, Systemic: Seizure-Severe

Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild

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

Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Medium, Additional Details: he was fainted right after the shot. my tech called 911 and i stayed with him. after 1 minute he was responding but still needed medical attention. i waited with him until paramedics come.

BODY TEMPERATURE OF 79 DEGREES F; MENTALLY CONFUSED; CRAMPING UP; DIZZY; CHILLS; This spontaneous report received from a consumer concerned a 33 year old male of an unknown ethnicity and race. 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 and expiry: Unknown) dose was not reported, 1 total administered on 08-MAY-2021 on right arm for prophylactic vaccination. No concomitant medications were reported. On 08-MAY-2021 (after vaccination), patient experienced chills, fever at 102.5 degrees F, cramping up and dizzy. It was reported that patient at the first had body temperature of 79 degrees F and later had 103 degrees F body temperature. On the same day, the patient was mentally confused, did not remember that had been married for five years. At the time of reporting the patient was being taken to the emergency room. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, body temperature of 79 degrees F, cramping up, dizzy, and mentally confused. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210516895-COVID-19 VACCINE AD26.COV2.S-Body Temperature of 79 Degrees F. 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).

Extreme swelling at vaccine site, red spot - after 10 days, still some swelling Nausea, headache, general discomfort (felt like I was hit by a truck) - about 5 days, lessening each day Treatment with acetaminophen

Patient told me before I gave him a shot, he sometimes faints. Patient leaned back in the chair just in case he faints. I gave him the shot then after a few minutes, he said he was going to prop his leg up on the chair. After a few minutes later, he told he was going to lay on the floor just in case he faints. Patient had a seizure for less than 1 minute. Afterwards, the patient told me he sometimes get seizures especially after vaccination, when he bumps his elbow, or once when he got his ear cleaned. He had test in the past to determine root cause but doctor do not know why he had seizure. He said he did not want his girl friend to come in because he didnt want her to freak out just in case he had a seizure. I observed patient for full 30 minutes to make sure he was well to leave and his girl friend took him home. I did not know about his seizure history and he did not indicate it on the vaccine form.

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

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

Right sided facial droop and inability to speak. Symptoms began 20 hours after vaccine administration and were only partially resolved five hours afterwards.

Arm pain has not gone away, still have pain when moving my arm up over my head and frequently wake up from the arm pain when moving around asleep in bed.

I experience pain in my left leg I also had fever and was in bed all day .On 04/11/2021 called my Dr. and he informed me to take IB profrin. Pain in my leg was completely gone in 10 days.

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

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

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

GIVEN INJECTION AROUND 12:50 pm, patient moved to waiting area, patient passed out around 12:55 and hit head on floor. Pt was conscious quicky, was sweaty, hot, dizzy before passing out. Applied cold rag to neck, fanned pt, eventually moved to chair. Asked if he needed ambulance, he refused. Feeling better within about 15 minutes and patient wanted to leave.

Patient received vaccine and went out and sat down in chair. I was back in IMZ room wiping it down when fellow associate knocked on door and said patient was having a seizure. I rushed out to check on him. He remain seated and I just made sure he didn't fall out of chair. It lasted about 10 seconds while I was there then pt regained control of himself. Tech called 911 and alerted store management. Asst Mgr arrived and stayed with him until paramedics came to check him out.

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

After 5 mins of getting the vaccine, pt had a syncope and/or seizure episode. Pt's eyes started to roll back and was only showing the white. His hands were flinching into fist and pt was unresponsive. This lasted about 20-30 secs. We called ED and got the operator on the phone. When we started to give the operator information, pt starts waking up. Pt's mom didn't want the ambulance to come since pt is now awake so we told the operator everything is fine now and hung up. Pt's forehead was sweaty and facial color was very pale. We gave pt some water to drink and asked pt to continue to sit there and relax. Pt has no idea of what happened he said he just remember one moment talking to his mom and the next moment she was holding him up. Pt sat there for a total of about 1 hour and he said he was fine so they left. We informed mom and pt to please go the UC or ER for follow up but they declined. They said they will have him rest and hopefully things will be OK soon. I checked his Blood pressure x 2 and both times they were good at around 128/87. Gave mom my pharmacy business card to call with any further questions or concerns

Pt fainted in the observation area by the pharmacy. He was pale and trembling. We called 911 and the paramedics checked his BP, Blood sugar, and heart function. Everything was normal and paramedics let his wife pick him up and take him home. I spoke to pt around 8:15pm on 6/24 and he said he was feeling fine

blood clot in left leg, cramping and soreness, tender to the touch. currently taking Eliquis for the next 6 months

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

Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Shakiness-Mild, Additional Details: patient had vasovagal episode @ 3 minutes after receiving Janssen vaccine. Has a history of vasovagal with blood draw and injection.

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

Patient received dose of Janssen Covid vaccine in right deltoid. He chose the right arm because his left upper arm is fully tattoed. Patient sat for about 5 minutes and then he got up and fell forward on our counter in the waiting room. After about a minute he got up and sat on the bench for a few minutes. We discovered him after about 10 minutes lying sideways on the bench. First BP reading was 86/63mmHg and patient was clammy and sweating. His major complaint was fatigue. He took a sip of soda and ate a peanut butter cup. EMS arrived his BP had gone up to 120/68 mmHg. Oxygen levels were normal but patient refused to allow EMS to check his blood glucose.

Vaccine was administered at approximately 5:57 P.M. At approximately 6:00 P.M., patient's companion alerted pharmacist that patient appeared to be unresponsive. Patient was slumped forward and momentarily unresponsive to verbal queues. Patient quickly (within seconds) became oriented and stated he felt hot and sweaty. Pharmacist called 911. Patient denied difficulty breathing and reported no swelling or difficulty swallowing. EMTs arrived within 10 minutes. EMTs determined that patient most likely experienced vasovagal syncopal episode. Patient was allowed to leave on his own accord by EMTs with instructions to seek medical attention if difficulty breathing developed. Duration of entire case was approximately 25 minutes.

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

Numbness and tingling in left leg within 15 minutes of receiving shot. Symptoms continue to persist up until now (July 13 and on-going)

Became extremely weak and sick for 3 days after the shot. Had a grand mall seizure 19 days after vaccine. Also had a really bad headache and lost vision in my left eye for nearly 8 hours about 2 weeks after the seizure. Have had dizziness and been feeling week for nearly 2 months after vaccine and still cannot manage to get rid of the constant headaches and loss of thought due to these side effects.

Cold sweats, headache, body aches, nausea and relative flu like symptoms that lasted for about a day and a half.

Presented 7/24/21 to the hospital with recurrent seizure and declining mental status after persistent headache for the several previous days. On imaging found to have extensive dural venous sinus thrombosis with hemorrhage. Treated with anticoagulation, anti-seizure medications, invasive mechanical ventilation, and transferred to alternate hospital for consideration of endovascular treatment.

Within 12 hours of receiving the vaccine, around 2-3am, I began getting chills that lasted a couple of house. I had a temperature of 99.5 but immediately came down. In the early morning (the next day since receiving the vaccine), I felt nauseous followed by a headache. I also felt dizzy, but that immediately subsided. All of the mentioned side effects have subsided. My arm has been sore since receiving the vaccine but the pain has relatively minimized over time.

102.7 Fever, felt completely freezing, significant body aches, so tired it was hard to open my eyes. Took Tylenol Extra Strength and put ice on forhead Hour later fever came down to 101.7 Body kept switching between sweating and freezing entire night 24 hours later at 7:30AM the next day, i was still very tired, sweating, but fever was gone. 48 hours later - i'm still a bit foggy and have a light cough

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

Janssen COVID-19 Vaccine EUA 34 y.o. male with GERD who presents with syncope and question of PEA arrest. He went for COVID 19 J&J vaccine on 3/13/2021. A few minutes after getting the vaccine he started feeling nauseated. His lips became gray. He went unresponsive and was taken out of the car. He had agonal respirations. He had 90 seconds of chest compressions and returned to his normal state of health. He was seen in ED where labs were remarkable for mild hyperkalemia (serum potassium 5.5). Given worrisome syncope, chest compression he was admitted for observation. He did well overnight, No arrhythmias of telemetry and was discharged with Holter monitor.

Severe anxiety, nervousness, panic feeling, pacing, shaking, aches, chills, irritability, headache. Unable to function mentally due to severe irritability. Experiencing similar symptoms to when actually tested positive for COVID 19 in March of 2020.

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

Pt had J and J vaccine at outside facility on 3/14. by 3/14 evening, had fever, sweats, bodyaches which he thought was vaccine related since 3/15, some ST w/ dry cough, fatigue, sweats overnight some mild sob when laying down by 3/18: Headaches, fatigue, SOB

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

Patient reported feeling flush of heat. patient SP02 98%, 88 pulse, 125/97. patient recovered without intervention and left for home.

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

Around 8 hours after the vaccine, I started to feel very cold. At around 16 hours I measured a temperature of 100.13 deg. F. Also a slight headache, and soreness near the injection site.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Feeling faint, on the verge of fainting-Mild, Systemic: Flushed / Sweating-Mild

3/31/21 4:30pm - received vaccine - got a sore arm quickly after 11:00ishPM- started getting the chills and shakes and couldn?t get warm. 4/1/21 3:00am- fever spiked to 104.5 -Chills, severe body aches and nausea began and stayed all day 5:00pm- fever returned of 101 9:00pm- vomiting began for 10 minutes Chills, shakes, body aches and nausea still remain.

Rapid heart rate 138bpm- 3:20 am. Stayed elevated all night Uncontrollable shacking- 12:30 am. Lasted 10-15 mins

First 10 minutes directly after administration: arm pain, dizziness, nausea. Felt like I was going to pass out for about 5 minutes. Felt basically normal by the time I left the facility and my arm has not been hurting since. Approx 8:00 PM onset of headache, progressively worsening thru ~11:00 PM and plateauing. Headache was less by ~8:00 AM, and took Ibuprophin at 9:00 AM to further alleviate. Approx 9:30-10:00 PM onset of chills and shivering, progressively worsening thru ~11:30 PM. Chills lasted through the night, but shivering stopped around 12:00 AM after turning the heat up and putting on more clothing, beanie, and blankets. Fatigue is ongoing (as of now, ~22.5 hours after administration), but may be a result of poor sleep due to the chills overnight.

Soreness at injection site, body aches, nausea, chills, feeling hot, foggy minded, unable to concentrate or form words, instability while standing/walking, irritability

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

Felt nauseous and out of breathe right away. Fainted and hit head on pavement within 15 minutes of shot. Admitted into ER with concussion and found bleeding in brain within 3 hours of shot.

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

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

patient developed seizure 5 to 6 minutes after vaccine administration . 911 was called and patient was taking to the hospital

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

Approximately 15 minutes after vaccination, patient?s wife said he wasn?t feeling well. I found him sitting up right but not very respondent. Said he was blacking out, he couldn?t see well. He was barely audible and sweating. 911 was called at 11:17am. Before EMS arrived he started to feel better and was conversing but waited for EMS. They arrived about 10 minutes later. He had a couple sips of water He was checked out. He said he hadn?t eaten all day and had never had a vaccine before. He walked out on his own with his wife

Injections site pain and bruising, diarrhea, severe headache, tires, fatigue, muscle cramping shooting pain, nausea, slight fever.

After vaccination, patient appeared to be slouched over in chair in observation area. Two bystanders approached him and held him to prevent him from falling from his chair. Patient was diaphoretic and eyes half-closed. Attempt was made to arouse patient by talking to him and rubbing chest. His head and body moved erratically for approx. 3 seconds. Patient was lowered to the floor. Nurse continued speaking to patient and rubbing his chest. He then opened his eyes and was startled. Patient abruptly sat up and said, ?what happened and where is my phone?? The nurse reassured him he was being taken care of and she asked if he knew where he was? Patient replied, ?I have no idea.? A paramedic approached and asked the patient if he knew his name. The patient correctly replied. The patient had no recollection of what had taken place, but did know where he was. Patient was then evaluated by the paramedics. All tests performed were normal and patient refused to be transported to hospital. Patient was driven home by his wife. Follow up phone call to patient yesterday evening with no answer. Follow up phone call to wife (listed as emergency contact), 4/7 at approx. 6 pm. Per wife, patient experiencing fatigue and still very pale. She said he just wasn?t himself. Patient was concerned that they did not know what to expect a week or two from now. I advised patient that if she had concerns, she needed to have patient evaluated in ER.

34 YO MALE WAS COMPLAINING OF HIS LEFT ARM AND SIDE OF HIS FACE STARTED TO FEEL NUMB AFTER GETTING IS COVID 19 VACINATION. PT DENIED CHEST PAIN, SOB, N/V/D, HEAD NECK AND BACK PAIN, BLURRED VISION, DIZZINESS. PT HAD A PATENT AIRWAY WITH EQUAL CHEST RISE AND FALL. PT HAD NO NOTED SWELLING TO THE LEFT SIDE OF HIS FACE AND HAD FULL PMS AND ROM TO THE LEFT ARM. PT HAD NO OTHER NOTED DCAPBTLS, HEENT WAS UNREMARKABLE. PT VIATLS WERE TAKEN AND RECORDED. PT OFFERED TRANSPORT TO THE LOCAL HOSPITAL FOR FUTHER EVALUATION. PT REFUSED

dizzy, lightheaded, numbness and tingling in left/right hand and legs. Evaluated by EMS-Refusal to transport.

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

Fatigue (36 hours), Chills (8pm 4/8/21 to 12pm 4/9/21), weakness (48 hours), soreness in injection site (all day 4/10/21)

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

Patient received vaccine on 4.9.21. Patient responded to symptoms survey on 4.12.21. Stated that he had severe side effects including dizziness / weakness; also stated that he was unable to move for 48 hours; had intense diarrhea and had hallucinations. (reported not within first 4 hours - unsure on timeframe) - did not seek any medical care per electronic chart review.

Pt fainted immediately after injection, regained consciousness after about 15 seconds. Reported feeling uneasy and weak for 20-30 minutes following injection. Provided supportive care with water. Pt was able to leave on his own after about 45 minutes.

Immediate numbness of arm/hand. Burning pain, sweating, freezing and cotton mouth feeling within 10 minutes of injection Injection site was at top of humerus bone area

Began with cramping/convulsing of my left thigh, then my right and within a split second all the muscles in my body were convulsing for about 3-5 minutes. I had a headache and small tremors following that episode. Tylenol helped but side effects did not dissipate until the following morning 3/11 at 10AM. Fresh air helped also.

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

4/9/21 5:00 PM- back of head headache started, Took Tylenol. 6:00 PM worse headache ever had started vomiting. 7:00 PM headache and vomiting continued layed on bathroom floor could not get up cold and sweating. 11:00 PM made it to my bed and was freezing, shivering and sweating until approx. 8:00AM 4/10/21.

Exact date and time of COVID vaccination unknown. Patient presented to Medical Center on 04/02/21 with left sided weakness and slurred speech. He reports receiving the COVID19 Janssen vaccine 15 days prior. Details of vaccination beyond patient report are unknown. Diagnosed with acute left cerebellar stroke, status post TPA on 04/02/2021. Extensive workup in hospital negative and unremarkable, including TEE, and hypercoagulable state so far negative. Follow up with hematologist as outpatient underway to evaluate for any possible coagulation disorders.

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

dizzy, could not walk, talk, hear anything, popped blood vessel in eye. slurred speech We have ordered blood work and a ct scan.

Diagnosed at ER with a transient ischemic attack. Right side went numb, struggled to speak and right side of face drooped

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

After patient received vaccine they reported they felt "off", said there was tingling and burning sensation down arm. After 5 minutes patient said they still felt off, 10 minutes no change, 15 minutes patient said they felt hot and their throat was dry, offered antihistamine (Benadryl) and asked if the patient could have someone pick them up, the called their physician on base and they physician stated for the patient to come in for observation. Patient refused Benadryl but arranged for a family friend pick him up at my request because I did not feel comfortable releasing the patient without observation. 45 minutes later the patient was picked up and they went to their physician to be observed. Called patient at 7pm to check in and they stated they "felt better but still off".

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

Sore arm muscle for over a week. Couldn?t raise arm without pain. Rest and heat helped. The other issue was development of mouth ulcers about 4 days after vaccination. Multiple mouth ulcers on bottom lip and gum (about 4-5) developed and spontaneously resolved within about 3 days.

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

BURNING SENSATION ALL OVER BODY; RED EYES; HOT EYES; BODY ACHE; HEADACHE; NAUSEA; This spontaneous report received from a consumer concerned a 34 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A218, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced burning sensation all over body. On 08-APR-2021, the subject experienced red eyes. On 08-APR-2021, the subject experienced hot eyes. On 08-APR-2021, the subject experienced body ache. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from burning sensation all over body, headache, red eyes, body ache, nausea, and hot eyes. This report was non-serious.

About 7 hours after the shot, nausea, fever, chills, fatigue, and headache were all present along with minor injection site soreness. These symptoms lasted through the night and were still present the following evening. The chills were no longer present by midnight and the fever was starting to break. An pain in the foot also started at the same time and continues to exist as of this report.

PECULIAR BROWN VOMITING; WEIRD FEELINGS/FELT LOUSY; ACHES; CHILLS; SORE ARM; HEADACHE; FEVER; This spontaneous report received from a parent concerned a 34 year old male. The patient's height, and weight were not reported. The patient's past medical history included kawasaki's syndrome, and concurrent conditions included stomach issues, migraine headache, allergic to bee stings, allergic to dog hair, alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no illicit drug usage. 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 12-APR-2021 15:30 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced aches. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced sore arm. On 12-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.6 F, 99 F. Treatment medications included: paracetamol. On 13-APR-2021, the subject experienced weird feelings/felt lousy. On 13-APR-2021 07:30, the subject experienced peculiar brown vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, fever, peculiar brown vomiting, aches, chills, sore arm, and weird feelings/felt lousy. This report was non-serious.

T+ 4 to 6 hours: mild fever, fatigue. T+ 1 days: mild fever continues, hot flashes begin, mostly at night interrupting sleep. T+ 2 days - 7 days: fever subsides, hot flashes increase in intensity significantly, continuing to interfere with sleep. Other possible androgenic symptoms begin to arise: change in body odor, sex drive, motivations, appetite. T+ 7 days till current: previous symptoms of days 2-7 continue, extremely gradual onset headache begins one night. Making sure to rule out hydration and electrolyte imbalance expecting headache to be gone in the morning after sleep, I found that it was only worse and that an interpolation of the two pain points from when I went to sleep and woke up would have created a almost imperceptibly gradual but linear increase between the two points. The headache was of a type I had never had before, located in the center of my head just barely dorsal to the spinal insertion. It felt deeper than any headache I had had before which usually occur in the frontal lobe/neocortex zone. I do not regularly suffer headaches getting maybe a couple per year. Once I recognized androgenic involvement and the headache were continuing I took myself to the ER where I was evaluated and despite presenting with continuous hypertension and the symptoms mentioned above, I could not get them to perform a estrogen test and they let me leave with hypertension without any investigation. I'm returning today to their urgent care facility to try again to get my estrogen levels checked. I had left a message on the phone line of VAERS prior to the original ER visit but had not heard back from anyone so I felt it was prudent to file a written report here.

Janssen COVID-19 Vaccine EUA About six hours after receiving the vaccine, I felt a sudden lack of energy followed by uncontrollable shivering. I developed a low-grade fever that persisted for three days. I treated the symptoms with over-the-counter medications. I did not see a doctor. The symptoms went away on the fourth day after receiving the shot.

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

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

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

Developed facial paralysis (Bell's Palsy) nineteen days after receiving the vaccination. Diagnosing neurologist attributed the condition to an autoimmune response triggered by the vaccine.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Additional Details: immediately after vaccination patient became dizzy, started sweating, was flushed and naseaus. rested for about 40 minutes and felt better

Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Additional Details: Pt received shot, went to monitoring area, sat, leaned to right and passed out, pharmacist ran out, made sounds like gasping for breath/eyes rolled back/not responsive but breathing, asked tech to call 911, had bystander help lower to ground, pt regained consciousness, mother came around and said he has a history of doing this/phobia of vaccines, no one informed us

Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Additional Details: Patient received vaccine, went out to sit on chair in waiting area. Leaned over and passed out, pharmacist ran out to patient, bystander helped lower patient to ground, all the while the patient was breathing very heavily, sounded seizure like or that he was gasping for breath. Asked tech to call 911. While being lowered to ground patient regained consciousness. Mother came around the corner and stated patient has history of reacting this way to vaccines, neither pt nor mom told us this before.

After my J&J vaccine, I experienced fever, chills and a left sore arm and those symptoms resolved in 24 hours. On 04-06-2021 I experienced headaches on and off and on 04-07-2021, I had light headiness, an air-filled pressure sensation to my eyes, forehead, more like a sinus headache. On 04-14-2021, I went to see my PCP due to my headaches continuing, the doctor ran complete blood panel test were performed along with a D-dimmer test to rule out blood clots and he told me to take Advil as pain medication. My D-dimmer test was normal. I noticed when bending down my headaches became worse. On 04-20-2021, an MRI of the brain was performed. On 05-01-2021, I experienced muscle body aches, fever and continued with headaches. I went to a walk-in clinic, where a Covid-19 test was performed and it was negative. I started taking antibiotics and the fever and muscle bode aches started to go away. I still have to this day headaches and an air-filled pressure sensation around my eyes and eyebrows. As of today, my headaches are consistent, and they come and go.

Around the time stated in form I began feeling slightly flushed in the face, general fatigue, as well as a slight headache.

Patient was advised to remain in observation area for 30 minutes due to history of breathing difficulty with sulfa antibiotics in past. Shortly after being vaccinated the patient presented to our service window stating he did not feel well and was immediately escorted by the pharmacist to our administration area to have a seat. He stated he felt light headed, flushed (though not visibly), felt like his heart was racing, and was not having diffuculty breathing but felt like he couldn't catch his breath and stated he thought he was having a panic attack. He had stated before vaccination that he had not had a vaccine since his routing childhood schedule, his whole family had already had doses, and he had been putting it off because he was nervous. He insisted he needed some fresh air several times and was escorted outside by the pharmacist (with emergency supplies and a cell phone and within shouting distance of the pharmacy) for continued obsevation and was given water when requested. After a few minutes he stated he felt much better and the symptoms had resoved. He was directly observed outside per his request for the remainder of his waiting period and had no further symptoms. He was instructed to call the pharmacy right away if he had any additional symptoms after leaving.

Patient experienced light headedness, dizziness and passed out for about 2-3 seconds. Minor convulsions during unconsciousness.

Site: Pain at Injection Site-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild

4/5/21 - Shot 4/6/21 - flu like symptoms 4/6/21 - persistent headaches & pains in body start (pains vary - some shooting some persistent) 4/9/21 - primary care does D-Dimer Test (result 1.46) 4/10/21 - primary send me to ER 4/10/21 - ER does blood work & EKG, all fine. Checks out AMA w/o CT scan. 4/17/21 - Bruise appears between eyes and above nose w/o any trauma event. 4/17/21 - checks back into ER. Blood work fine, CT scan fine. 4/18/21 - headaches and body pain continue to persist (most notable body pain is almost a numbness feeling in legs and arms at joints) 5/11/21 - headaches have subsided partly but numbness body pain persist.

Patient was complaining of being light headed, sweaty, and he stated his arms were feeling numb and that he could not feel his legs. We laid him on the floor and he started to shiver and said he was cold. We monitored his pulse and contacted emergency services. An ambulance came at 10:45 AM and they asked which vaccine he was given and took over care of the patient. We gave the paramedic the EUA facts sheet for the Johnson & Johnson vaccine and they took the patient.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium

Injection site: pain/tenderness General side effects: Nausea, weakness (full body), nearly fainting multiple times, headache, some confusion, dehydration, some difficulty breathing, tired even with rest, low fever

Patient warned of previous vaso-vagal syncope. Patient was placed in supine position for vaccine administration and about 1 min afterward became anxious and passed out. He was unconscious for 10 sec and awoke, sweaty, weak. He was not confused, did not seize or lose bowel/bladder continince.

Following morning I woke up with a head ache. (Scale 1-10) about 2. ... Was feeling nauseated (Scale 1-10) 2-3.. also was feeling exhausted as in no energy... ( Scale 1-10) 3-4

While waiting for 15-mins monitoring after getting Johnson&Johnson covid vaccine, he fainted and fell off the chair. Pharmacy staff rushed to his aid and he regained consciousness within a minute. He said he was feeling flushed and dizzy. He said he was having too much anxiety and has had fainting issue with vaccinations/MRI in the past. His blood pressure was low with high heart rate. We called 911 and paramedics came immediately. He was still unstable so the paramedics took him for further evaluation

Patient felt very warm after receiving Janssen vaccine. Patient was given an ice pack and a bottle of water. Patient quickly began to feel better. Pharmacist checked in with patient every few minutes. Patient sat in pharmacy area for a total of 30 minutes and felt totally back to normal when he left.

Patient was in waiting room immediately following vaccine and got up to briskly walk to restroom, at which time patient reports feeling very hot (~2 minutes after vaccine administration) and went to bathroom to get cold water. Patient came back to waiting area and sat down and then vomited in the chair. Pharmacist walked over to patient to ask how they were feeling and offered water. Patient reported that they remember feeling very hot and getting up to splash water on face. Patient stated "oh wow, I must have gotten sick" indicating they had no recollection of that. The patient reported feeling fine following the episode and stayed in the waiting room for 30 minutes. Patient was advised to go to urgent care to be checked for further evaluation.

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

Patient received vaccine at approximately 10:55a.m. and started reacting at 10:57a.m. Patient stated that he started to feel like he was blacking out, alerted staff at the vaccination site. When staff got to patient he was incoherent and having body movements similar to a seizure, when staff spoke to patient he immediately responded as other staff went to get epi. Pulse was racing, breathing was normal, and patient able to communicate. Epi not administered, as soon as epi arrived to patient and 911 called at 10:58a.m. patient was talking normal, responding to questions, heart rate was returning. Staff stayed with patient to wait for EMS to arrive, police officer arrived pulse ox reading was 99% saturation, and heart rate of 59bpm. Applied oxygen with non-rebreather to help stabilize. Patient continued to improve, vision blurriness was the last symptom to fully return. Patient evaluated by EMS staff and released shortly after.

UNRESPONSIVE; DIFFICULTY BREATHING; DIAPHORETIC; BLOOD PRESSURE 70/34; LOW HEART RATE; This spontaneous report received from a patient concerned a 34 year old white and not Hispanic or Latino male. The patient's weight was 134 pounds, and height was 69 inches. The patient's concurrent conditions included alcoholic, and non smoker. The patient had no known drug allergies and had no past medical history. 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: 207A21A expiry: 23-JUN-2021) dose was not reported, 1 total, administered on 26-MAY-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 26-MAY-2021, after administration, the patient had a somewhat severe reaction with difficulty breathing and went unresponsive. The patient did not remember much. The Emergency Medical Services (EMS) were called and the pharmacist gave an epi pen shot to the patient. The patient was diaphoretic and unresponsive when they arrived. The EMS slowly monitored the patient and as epi kicked in and the patient came back to life. The patient's blood pressure was 70/34, and that, along with it his heart rate, started to rise. The whole process lasted 45 minutes. The EMS wanted to take him to hospital, but the patient refused. On 26-MAY-2021, Laboratory data included: Blood pressure (NR: not provided) 70/34 mmHg, and Heart rate (NR: not provided) low. Treatment medications included: epinephrine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from unresponsive on 26-MAY-2021, and the outcome of difficulty breathing, diaphoretic, blood pressure 70/34 and low heart rate was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210607523-COVID-19 VACCINE AD26.COV2.S-Unresponsive, difficulty breathing, diaphoretic, blood pressure 70/34, low heart rate. 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).

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

Tremors, sweating, severe headache, vision flashes, pain in arm, fatigue, confusion, reduced consciousness, fainting, loss of balance, unable to ambulate or communicate, adrenal crisis, started in morning, treated at home with oral steroids for Addison's disease, doubled dosages for the next few days, pain and headache lasted beyond these symptoms.

At 02:00 am, my leg hurt really bad. Thought it was a blood clot. It's not a muscle weakness in my leg; numbness in my foot and pain in my leg (right leg). Primary care doctor - had me take Oral Steroids and that didn't help. I'm taking Gabapentin - it does help with the pain when I do take it - but I can't drive with it so to go to work I can't take it.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Severe, Systemic: Shakiness-Medium, Systemic: Weakness-Medium, Additional Details: Patient found unresponsive to physical stimuli, staring up at ceiling, clammy pale skin, hypotensive (80/40), and Heart rate 49. EMS activated. Epinephrine given in Left thigh, patient responded. HR increased to 62bpm and Blood pressure 142/72 and 130/80. Patient stable and refused to leave store with EMS. Patient signed refusal to be transported via EMS and notified of importance of monitoring after Epinephrine administration. Patient verbalized understanding.

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

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