Johnson & Johnson

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.

Janssen COVID-19 Vaccine EUA .. Super sore for over 24 hours. Lost sense of smell and taste for a short period of time. Cotton mouth and wasn't dizzy but had a weird feeling in my head I never felt before.

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

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.

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

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

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.

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

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

Patient reported feeling anxious and sensation of vertigo Patient seen by medical team and refused medical transport and signed AMA form Patient stated symptoms improved

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.

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.

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

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

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

Patient experienced dizziness. Patient was a bit disoriented. Patient was observed and given some food (potato chips) and water. Symptoms resolved.

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.

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

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

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

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

The last two nights I have gone to bed with itchy legs on and around my ankles, shins, knees, wrists, and elbows. The itch has been so severe and uncontrollable I wake up in the night and cannot go back to sleep.

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.

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

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

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

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.

SUSPECTED URETHRAL MUCOSITIS; CLOT; PENIS TIP GOT RED; PENIS PAIN; SAW ANGELS AND DEMONS IN BED; TERRIBLE MALAISE; HEADACHE; FEVER 40 DEGREE; This spontaneous report received from a patient concerned a 26-year-old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 02-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-MAY-2021 at night, the patient experienced some symptoms after vaccination including Fever of 40 degrees Celsius, headache, and a terrible malaise. The patient also reported seeing angels and demons in bed; Also, the patient noticed that the penis tip got red and experienced pain. On 05-MAY-2021, the patient continued with the symptoms, and it seemed as if a clot was generated. On 06-MAY-2021, the patient had an appointment with general physician who informed that he never saw an adverse reaction like this after vaccination and that it could be a urethral mucositis. On 10-May-2021, the patient would have an appointment with the urologist to inform the symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever 40 degree Celsius, saw angels and demons in bed, headache, terrible malaise, penis tip got red, penis pain, clot and urethral mucositis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20210513944-covid-19 vaccine ad26.cov2.s -thrombosis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

PATIENT IS AFRAID OF NEEDLES, HE WAS ANXIOUS AT TIME OF VACCINATION. AFTER VACCINE WAS GIVEN, PHARMACIST TOLD PATIENT TO BE SEATED AND WAIT 15 MINUTES. ABOUT 10 MINUTES LATER, PHARMACY STAFF HEARD PATIENT SAYING 'GOING DOWN' HE WAS SLIDING DOWN THE CHAIR. PHARMACIST RUSHED OUT TO THE PATIENT AND SECURED AREAS AND HELD PATIENTS ARM AND SHOULDER MAKING SURE HE IS NOT HITTING ANYTHING WITH HIS HEAD. PHARMACIST ASKED ANOTHER PHARMACIST TO CALL 911 AND MANAGEMENT TO THE PHARMACY. ALSO CALLED PATIENTS FATHER TO COME IN FROM PARKING LOT, HE SPOKE TO PATIENT AND MADE SURE HE IS FINE AND AMBULANCE CREW CAME VERY QUICK AND CHECK ON PATIENT. PATIENT WAS AWAKE AT THE TIME, NO INJURIES. CREW TOOK HIM TO EMERGENCY ROOM FOR FURTHER EXAMINATION.

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.

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.

Pt w/o medical hx/drug allergies presents with syncope in observation area s/p J&J injection. Patient stood up with dizziness and loss consciousness with head injury on counter. (Estimated 10 Seconds KO). Upon arousal pt presents tachypnea, pin-point pupils, hand contractions, one episode of vomiting, loss of memory. Orientated to name/dob although does not know location or recollection of receiving vaccine. EMS called responding to seen. Initial VS: BP: 86/55, O2: 96%, HR 81. Paramedics responding on scene EKG/BS checked patient taken to . Pt stabilized and transported with AMR paramedics to .

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.

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.

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

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

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.

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

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.

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

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

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.

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.

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

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.

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.

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).

Tinnitus in both ears since day after vaccination. April 15 left ear tinnitus mostly subsided but right ear still noticable and preventing sleep.

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

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.

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

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

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.

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).

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

Systemic: Dizziness / Lightheadness-Mild, Additional Details: pt felt dizzy/like he was going ot faint after vaccine. sat with him for a few mins (held head between legs) and checked his vitals. all were good. pt was very anxious because he was diagnosed with afib recently and felt like his heart was being fast (vitals normal) - had us call an ambulance. they came and did vitals as well and more specific cardiac readings and everything was normal. they left and pt went home fine.

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

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

Approximately 1 minute after administering vaccine, patient asked for water with complaints of lightheadedness. As he walked up to pharmacy door for water, he collapsed to the ground. He went in and out of consciousness while laying on the ground for about ten minutes. He had no other complaints other than lightheadedness. He did not eat any food today. He said in the past he had fainted after getting a numbing injection for a dental procedure and believes it may be a similar reaction. The paramedics were called and evaluated him. His blood pressure and HR were within normal limits. He refused to be taken to the hospital for further evaluation.

patient had post vaccine reaction to the Janssen vaccine. he lost consciousness without warning, his upper extremities were fixed and postured towards his chest. He contracted. He was LOC for an estimate of 15 seconds duration. He reported feeling nothing preluding to the LOC. He was fearful and agitated upon arousal. EMS alerted and patient workup done by EMS. Unknown whether patient refuses or consented to Hospital Observation.

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.

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

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).

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

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

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

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

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

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.

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.

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.

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

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.

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

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

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

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

Client received injection at 1:26 and felt dizzy/faint and anxiety at 1:28. Client also reported muffled hearing. Client repported this reaction to previous injections.

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.

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

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

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

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

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

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

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.

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

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.

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.

I saw him through the window and patient was felling little dizzy so I step outside of pharmacy to patient waiting area and ask him how he was feeling . He couldn't speak English and had the sister translate to ask him how he was feeling and the sister said he was nervous and feeling dizzy . I checked his heart rate and berating, notice his heart rate was high . He was having a anxiety attack and palpitation . we called 911 and also I gave a bottle of water to him , he drank some water and started feeling better ,then ems came and they took over from there.

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

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

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.

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.

Three weeks post-vaccination, experienced constant vertigo/dizzyness along with "brain fog". Difficulty concentrating especially when using computer screen. Felt like being on a boat or a dock that is moving. Still experiencing these symptoms intermittently for the past 2 weeks.

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.

I started feeling intense chest pain a couple of days after vaccination. I went to the ER for the pain. Later I was referred to a cardiologist where they conducted additional testing. They found inflammation. I cant do any strenuous activity and they have to do further testing on my heart, which is interfering with my job. I'm still having the chest pain.

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

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

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

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.

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

pt received vaccine and went to waiting area. 5 minutes after in the waiting area, pt had a self reported panic attack/fainting spell. pt did not fully lose consciousness. pt has a history of panic attacks/fainting spells, especially with needle sticks. Paramedics assisted on scene but pt was not transported to hospital. pt left under his own power

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

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

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

Anxious following vaccine with vasovagal response but no syncope. Reclined in car seat with pulse of 67 Blood pressure of 92/49 and oxygen saturation of 97%. EMS and Dr on site. Client felt better quickly and was released. Advised to seek medical attention later if needed. Client stated understanding.

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

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.

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.

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

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

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

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

Patient presented himself for COVID19 Vaccine administration on 04/05/2021 at 4:10pm. Upon checking in for his appointment, he was provided with Conviva?s COVID19 vaccine screening and consent form in which he denied the following: ? Having allergies and reactions to any medication, foods, vaccines, or latex. ? Carrying an Epi-pen for emergency treatment of anaphylaxis. ? Having had a severe reaction to previous dose of this vaccine or to any of the ingredients of this vaccine. After the vaccine administration, patient was guided to the observation area for a 15-minute observatory period. At approximately 4:25 pm- patient, while in the observation area, expressed to the clinical staff member monitoring the area, that he felt lightheaded and needed to lay down, he leaned forward, and the clinical alert team was activated. Patient was lowered to the floor; a pillow was placed under his head and his feet were elevated. Vitals reported were taken in the presence of registered nurse while patient was laying on the floor. Vitals ? Glucose 97 ? Blood pressure 120/77 ? Oxygen saturation level 97% ? Pulse 72 Register nurse reports that patient was laying on the floor, alert, oriented to place, time and person. Patient never lost consciousness and within approximately 5-7 minutes he was sitting up, drinking water. At this time, patient was asked the following series of questions: ? How do you feel? As per patient, he was feeling nauseous, dizzy, and anxious. ? Are you allergic to any medications or have you had any allergic reactions to a vaccine? Patient denied having had a history of any adverse or allergic reaction to any medication or vaccines in the past. Several minutes later patient stated that he was feeling better and he was assisted to sit up. Patient stated that he was feeling fine, and able to drive. Patient was kept in the observation area an additional 15 minutes. At approximately 4:40 pm- After patient was considered stable by doctor, he was checked out. Patient was given phone numbers in case he had any clinical or general questions. At 6:00 pm- (Center Administration) called patient, he stated that he was still driving and felt fine. At 6:21 pm- Patient sent a text to Center Administrator, stating the had arrived home and was feeling fine.

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.

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

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.

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

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

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

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

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

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

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

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

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

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

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.

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.

5 minutes after receiving vaccine, patient stated he didn't feel so good. Lost color in face and then fainted. Pt layed on floor for 5 minutes. A wet cloth was placed in forehead. Pt came back to feeling better then sat up on floor for a few minutes then sat in chair. Pt drank a bottle of water and called his brother for a ride.

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

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.

Insomnia. Initially prescribed Temazepam after 3 days of no sleep on 4/28, then on 5/5 prescription switched to Doxepin and Lunesta. sleep problems persist and still taking Doxepin and Lunesta.

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

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

I asked the patient to take a sit for 15 minutes after administering COVID vaccine. Right around after 15 minutes, he came to the counsel window to let me know that he was not feeling good and he passed out. He became conscious right away as our staff members called his name to check if he was ok and called our store manager. We asked him if he was ok and gave him a bottle of water to drink. We asked him to call his family member to get a ride for the safety of the patient. I checked his status as he was waiting for a ride. After 30 minutes, he left our pharmacy with his family member. I called him for the follow up and left message to call us if he has any concerns.

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.

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.

10 minutes after receiving vaccine, patient felt nausea and a "body rush." Assisted patient to treatment room, layed down and took VS. Patient given water to drink, discharged from clinic 15 minutes later, NAD

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

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

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.

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

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.

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.

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

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

Patient came to the pharmacy to get COVID vaccination. After the vaccination he felt a bit anxious and slipped. He recovered in less than a minute and felt good after it. We took care of him. We observed him for more than 30 minutes. He felt really well after that minute. It was not a adverse reaction to the medication. He said he felt anxious with flu shot as well

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.

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

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

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

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.

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

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.

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

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.

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

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

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

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

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

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

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

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

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

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

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

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.

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

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.

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

Following vaccination patient reported feeling dizzy, lightheaded ,visual changes. Paramedic and writer evaluated patient. Patient is alert and oriented. Able to verbally respond to questions. VS = 138/68, 73, 17, 98% RA. Patient states he has a history of anxiety and low BP untreated. Patient states he believes this is an anxiety related event. Declined further medical evaluation offered by writer. Patient waited in monitoring area another 15 minutes with Paramedics on standby. Left vaccination site with friend.

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.

After receiving the vaccine, the patient had a mild panic attack. The patient has a history of panic attacks and the feeling on the vaccine in his arm is what started the attack. The patient laid down for a few minutes and calmed himself down. After about 5 minutes, he was able to sit back up again and was feeling better.

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.

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

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

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

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

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

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.

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

Client awoke with chest pain and visited local ER for suspect M.I. Transferred to Hospital for angioplasty, related to thrombosis in R) coronary artery. Treated for 3 days and released to home with 3 months of follow-up cardiac rehab. Scheduled to return back to work as an auto mechanic on 4/26/2021.

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

Patient received COVID 19 vaccine through work at the company in the location on 05/05/2021. 14:45. Said he didn't feel "right" immediately. Waited the 15 minutes without sxs of allergic reaction and went home. On arrival home felt dizzy and laid down. Had initial ED visit that night and again on morning of 05/09/2021. Full body hives, itching, facial swelling, throat swelling.

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.

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.

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

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

I was feeling nausea. I developed anxiety and depression. I got really dehydrated and I was light headed. I didn't eat for awhile. I had a brain fog. I was prescribed anxiety and depression medications.

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.

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.

within a minute patient felt nervous ..faint, two minutes later he started to sweat, but talkative and I took blood pressure at 1:32 it read 69/41 67 a few minutes later he looked less pale and his demeanor improved I re took the blood pressure at 1:38 and it read 112/85 91 he continued to improve and at 1:45 he stood up said he felt normal, stayed for a few more minutes then went home

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.

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.

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).

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.

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

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

S.L. STATED THAT HE WAS "NERVOUS" BEFORE VACCINE ADMINISTRATION. HE STATED THAT HE FELT "LIGHT-HEADED" ABOUT 2 MINUTES POST-VACCINE. HE PUT HIS FEET UP AND HAD SOME COLD WATER TO DRINK. ABOUT 2 MINUTES LATER, HE SAID HE FELT "NAUSEATED" AND PROCEEDED TO THROW UP IN THE PHARMACY. AFTER THROWING UP, HE STATED THAT HE FELT BETTER.

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

After vaccination, patient got very pale, nauseous, chills, and sweating. He felt as though he may pass out. We elevated his feet and had him remain seated for 15 minutes. After 15 minutes, patient felt better, but still shaky, We continued to monitor for 30 minutes.

32yrold patient with PMH including anxiety presented on 4/7/21 at office for J&J COVID 19 vaccine. Administered JANSSEN COVID19 VACC (LOT # 043A21A, exp 6/21/21) IM in patient's left deltoid at 1350. After receiving vaccine, patient felt lightheaded and sweaty. At 1358, BP 81/49, HR 37, 93% RA. Patient endorsed previous reactions during immunizations previously. Other symptoms denied and no history of anaphylaxis. Patient placed in Trendelenburg position with resolution of symptoms. BP while in Trendelenburg position, 1010/58, HR 66, 98% RA. Minutes later while in sitting position, VS remained stable and BP 125/89, HR 87. Provider assessed patient and noted vasovagal reaction following vaccination. No syncope. All symptoms resolved. Patient discharged home in stable condition.

Janssen COVID-19 Vaccine EUA Symptoms started after 6 hours. Developed fever (up to 102 F) which lasted at least 24 h varying from 99.8 to 102 F. Had bad chills, aches, nausea, and dizziness preventing any normal daily activities.

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

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

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

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%

On the first night after receiving the shot I woke up 1 hour after falling asleep with extreme chills. I had to get up and did not sleep again that night. I also experienced a slight difficulty in taking deep breaths. All of my muscles were sore and continue to be so 36 hours later, though that is improving. I did get normal sleep the following night.

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.

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.

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).

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.

BRUISES ON ARMS AND LEGS; LIGHT HEADED; LITTLE OFF; 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: 207a21a, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced light headed. On 09-APR-2021, the subject experienced little off. On 10-APR-2021, the subject experienced bruises on arms and legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bruises on arms and legs, and the outcome of light headed and little off 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.

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

PERIODIC PANIC; ANXIETY; FLU LIKE SYMPTOMS; 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: 1805029, and expiry: 25-MAY-2021) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced flu like symptoms. On 21-MAR-2021, the subject experienced periodic panic. On 21-MAR-2021, the subject experienced anxiety. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms on 19-MAR-2021, and had not recovered from anxiety, and periodic panic. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.

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

I felt like I got hit by a bus. I felt very off the next day and light headed. I know Covid is serious and I did the vaccine to protect others, but at my age I think Covid symptoms would have been easier to deal with. The extreme, and I am saying extreme, symptoms lasted for roughly 24 hours. They started 24 hours after the vaccine. I am significantly better now (8:24 am 6 minutes from the 48hr mark).

Can feel increased heart rate at times and harder beating. Started day of vaccine and has continued to today, nearly 2 months later. My watch has data on heart rate variability and has seen a statistically significant increase variability since the date of the shot. The feeling can come and go. It can persist for hours at a time in a noticeable At its worst it can stop me from an activity for up to a minute of intense heart rate and chest pounding feeling. Does not totally seem to be related to physical exertion.

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.

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.

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.

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.

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

32 yo M, no known chronic medical conditions, p/w FLS since getting the J&J vaccine yesterday. Sx are improving, but pt was feeling sick at work so his supervisor told him to come to ED for eval. Only sx pt currently has are severe fatigue, mild frontal HA, and mild nausea.

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.

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.

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 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

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

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.

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.

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

MEMORY LOSS; DISORIENTATION; EYE PAIN; FEELING WEIRD; FEVER; VERY INTENSE HEADACHES/ PRESSURE IN THE HEAD; 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 concurrent conditions included non smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no known drug allergies, drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 22-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAY-2021, the subject experienced memory loss. On 23-MAY-2021, the subject experienced disorientation. On 23-MAY-2021, the subject experienced eye pain. On 23-MAY-2021, the subject experienced feeling weird. On 23-MAY-2021, the subject experienced fever. On 23-MAY-2021, the subject experienced very intense headaches/ pressure in the head. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from eye pain, and fever on 24-MAY-2021, had not recovered from very intense headaches/ pressure in the head, disorientation, and memory loss, and the outcome of feeling weird was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.

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.

33 yo M with NKA, history of fainting in the past and anxiety about vaccines and needles was in the drive through clinic to receive COVID-19 Janssen vaccine on 3/12. After receiving the vaccine at 0943 (lot # 1802070) in right deltoid, the patient began to feel anxious. He had been or was watching EMS working with another patient who had experienced an ADR. He began to feel "floaty" and noted he was blinking uncontrollably. He reported some tunnel vision/blurred vision. He states he recalled a nurse rubbing on his chest and placing a cold pack on his neck and at this point he began to feel better. He states he was trying to "fight" the feeling and was tensing up his extremities but denied convulsions or any loss

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.

Woke up at 4:00 am restless. Could not sleep. Body aches. Flu like symptoms by 10:00 am that lasted all day. Bad headache in the afternoon. Went to sleep around 9:00 pm. Felt normal by the next morning.

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.

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

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

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

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.

DIFFICULTY SLEEPING; SHORTNESS OF BREATH; TIREDNESS; BODY ACHES; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 33 year old male. The patient's weight was 166 pounds, and height was 68 inches. The patient's concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included patient have no known drug allergies. the patient did not have any drug abuse, illicit drug use. patient did not had other medical history or medicines. patient reports fairly healthy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced injection site pain. On 14-MAR-2021, the subject experienced body aches. On 14-MAR-2021, the subject experienced tiredness. On 19-MAR-2021, the subject experienced shortness of breath. On 25-MAR-2021, the subject experienced difficulty sleeping. Laboratory data (dates unspecified) included: Body mass index (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and tiredness on 15-MAR-2021, and injection site pain on 13-MAR-2021, and had not recovered from shortness of breath, and difficulty sleeping. This report was non-serious

Pt received vaccine; then stated that he felt nauseated, dizzy, and had increased anxiety due to his fear of needles. While sitting in observation he passed out momentarily while sitting in his chair. He awoken quickly and was assisted to a wheelchair for one on one observation. Pt states this has happened before and he always quickly awakens. Water given. Pt observed for 30 minutes and left in stable condition.

Muscle soreness at injection site starting immediately after. Within 8 hours: headache, fever, chills, tiredness, and inability to sleep

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.

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.

Around 5-10 minutes after the injection, patient began to feel faint. Patient turned pale and diaphoretic and passed out. Patient was lethargic and confused when coming back. Patient then began to remember where he was and started to feel better for about 2 minutes. Patient then fainted again and was able to regain consciousness with tactile and verbal stimulation. Medics were called for the patient. Patient's blood pressure was 80/55. When medics arrived, the patient had started to feel better and refused ER treatment. Medics left patient without doing vitals or assessments. Patient stayed at the vaccine clinic for another hour and then left after feeling better.

Jansen COVID-19 Vaccine EUA Since vax on Friday April 9th: - extremely lightheaded, fuzzy, dizzy and disoriented, would describe similar to vertigo - fever on off, less frequent Sunday and Monday (today April 12) - racing heart (fri night after vax, resting heart rate over night at 70+, normal RHR 48) - anxiety

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

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.

The evening after getting the vaccine I developed a severe headache, fever, and rigors. Headache resolved within 24 hrs after which I was able to rest and recover, while having a low grade fever and minor fever on day 2 (48hrs). Total recovery took 3 days. The reason for reporting is that this headache was unusually severe and prevented me from sleeping, delaying recovery.

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

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.

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.

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.

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.

The Jannsen COVID vaccine shot was administered at 5pm on 4/9/21. No immediate symptoms occurred. At 2:30 am on 4/10, the patient awoke with malaise. This quickly progressed to chills and flu-like symptoms. Sleep was difficult for the rest of the night and slowly transgressed into a severe headache and fatigue. Surface forehead temperature was taking in the morning on 4/10/21 and registered 100 F. The patient took an ibuprofen and felt normal by mid afternoon on 4/10. No further effects have presented as of 4/21/21

Triggered mental and psychology strain, was exhausted from weekend meta. Caused a panic attack; treatment was self-administered and this was the outcome.

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.

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.

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

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.

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.

Initially fever to 103 and headache, then developed a Stye on left eye and pain around entire left orbit lasting severe days, and has subsequently had significant brain fog, misplacing items, forgetfulness, which had never experienced before and in absence of any mood problem and is still ongoing a month later

A few minutes after administration the patient went to leave the room where he got his vaccine. He stood up turned to ask another question about the vaccine and then fainted. He was out for about 15 seconds. He awoke disoriented and sweaty. I gave him water and some glucose tablets. He said he felt fine after that. i have called to follow with him and he says he fells fine

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).

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.

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

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

No treatment has been received. Anxiety with very elevated heart rate and shortness of breath. Almost like panic attacks. Those happen regularly that didn't happen before. The really bad one (episode) happened once. But I'm still getting them at a moderate level about 2 or 3 times a week. I went to ER other than that I've ridden it out when it happens. I went to ER on May 29th. I have scheduled a mental health therapist appt.

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

Whenever I drink anything with caffeine, I get dizzy. I've had caffeinated drinks my entire life, but since getting the shot, I have gotten dizzy every time I have consumed caffeine. I generally feel a lightheadedness at the top of my head, and it makes it difficult for me to concentrate or work at the computer. I also develop vertigo sometimes whenever I try to move around. Also, whenever I have this dizziness, my ears feel full and stopped up. The symptoms persist as long as the caffeine is in my system; once the caffeine leaves my body, the symptoms cease. I am scheduled to see my doctor about this on 7/30/2021.

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.

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.

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

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

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.

Patient reported to vaccinator before receiving vaccine that he normally passes out when he gets shots. After receiving shot, patient passed out for about 20 seconds and head fell back. Vaccinator called for assistance. Patient regained consciousness and stated, "I didn't even know where I was." Patient noted to be diaphoretic. He also had pulse rate of 42 and Bp of 98/48 which he reports as being normal for him as he is a runner. Patient stayed seated, vitals assessed, ice applied for sweating, and juice given. After 15 minutes, patient escorted in wheelchair to monitoring area where he remained in a cot for 20 minutes. Vitals reassessed with Bp 113/73 and pulse 49. Patient reported feeling well and able to ambulate steadily. Patient left at that time

patient was diaphoretic, fell to the floor from seated without hitting head, very anxious as reported by patient. Patient rested, declined intervention including water, juice, or snack. patient was stable upon leaving

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

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

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

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

Client felt light headed and dizzy approximately 3-5 minutes following vaccination. Loss of consciousness, fell from chair in observation area. Regained consciousness approximately 1 min. later. Assisted to cot with legs elevated. Vitals obtained by on-site EMS. Vitals: @ 1605 HR 53, Spo298%, BP 159/88 initially. Continued to monitor last vitals 143/80, HR 56, SPO2 98%. Client denies ongoing dizziness or feeling faint. Client able to sit, stand, and walk without symptoms. Client left site in stable condition.

3 minutes after vaccination was given patient stood up and requested juice then fell down and fainted. About 15 seconds later the patient came to. EMS was contacted. Patient had his vitals checked, blood sugar taken. Patient reported to EMS that he was feeling anxious. Patient was asked by EMS questions in relation to time and place. Patient refused to have EMS take him in to the hospital for further tests. Patient was instructed to have a family member come in to take him home and advised him not to drive. Upon a follow up call 30 hours later patient reported he was bruised on his left shoulder, left hip and he had a puncture wound to his Jaw due to his fall. He reported he went to urgent care for follow up. they told him stitches would not be necessary for the puncture wound to his Jaw.

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.

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.

Woke up at 2:00AM morning after vaccine with strong fever/chilling Felt very febrile for next two days (48hr) and had very achy body for 3 days after vaccine. Acute soreness at site of vaccination for about a week.

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".

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

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.

First day after shot was normal expectations as described to me. But, 7 days later I had another reaction. The symptoms were significantly worse. Much higher fever, chills, body aches, Light headache. But occasionally, that same light headache keeps coming back. It?s worrying me. Affecting my mental health. And I had panic attack today. I?m also unemployed and have no insurance. I wanna know if this is normal. Has it been reported by other ?

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.

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

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.

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 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.

After 5 minutes of patient getting the inmunization he felt lightheaded, dizzy, pale and nauseous. He was alert all the time and responding to our questions. His blood pressure was low 94/79. He mentioned he was fasting and spend long hours without food , including that he was anxious regarding the inmunization. He drank a sip of orange juice and we place him on the floor by his back and his feet elevated resting in a chair. After 15 minutes his blood pressure went to normal 126/87. He sit down for 30-35 minutes more. We offered to call 9-1-1 but he refused. I spoked with him by the phone 4 hours later and he responded he is good.

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.

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.

6/15/21 triage call: Patient called stating that for the past week he's been having some brain fog, pressure in his head and fatigue 6/16 /21 office visit: The patient has been dealing with pressure bilateral sides of the head over the past 12 days or so. No visual change. It is a pressure but not really a pain. No sinus pain. No difficulty with hearing, no tinnitus. No balance problems. He also is dealing with significant related fatigue. Fatigue is present all day. Brain fog. Difficult to concentrate. 6/23/21 triage call-MRI Brain Pending. Pressure in head Not Better 6/25/21 er 7/6/21 pressure in head

He had a stroke 25 days after getting the vaccine, before the stroke he was in a general state on not feeling good. He was also feeling bad a couple of days after the vaccine. After the stroke he is now paralyzed on his right side. He was in the hospital for over two weeks and is now in physical therapy to regain strength on his right side.

Immediate pain in the arm after the injection and it still hurts 4 days later. Every arm movement causes pain. About 8 hours after the injection, I could feel my heart rate rising. I tried to sleep and experienced disturbed sleep. At 3:00 am I woke up and felt terrible. I checked my blood pressure, and it was normal at 105/61, but my heart rate was 99. My resting heart rate is typically about 50. My heart rate doubling provided a terrible sensation. I could barely walk and shuffled around outside to get some fresh air. 3 hours later, my heart rate started coming back down but took a day to get back to normal. Even now, I have lost my appetite, am not eating much, and I just slept 16 hours. I have never experienced any vaccine such as this.

Just before bed, about a week after getting the vaccine, I started to itch on my feet and arms. I fell asleep and woke up at about 3 AM with incredibly itchy skin from the tops of my feet all the way up to my shoulders. It was so itchy and uncomfortable that it woke me up. I took 2 Benadryl and put some anti-itch lotion on, and was able to fall asleep. I woke up the next morning feeling groggy, but better. The itch has not returned at all in the week since this happened.

following vaccine client complained of feeling dizzy and nervous. Per Dr he was experiencing a vasovagal event with no syncope. Blood pressure initially 83/43 then within 5 minutes 129/65. Pulse 54 then 79. 02 saturation 100%. juice given x 2 then released once symptoms resolved. EMS on site also.

recieved jansen covid 19 shot on 3-18-21 11:56 am and felt fine the rest of the day then woke up that night around 1:30am throwing up alot,after about 20 mins in bathroom tried to lay back down and was shaking cause i had the chills after about 30 mins i had to throw up again laid back down with the chills fell back asleep. woke up friday morning to try to get ready for work i tried to eat a couple pieces toast and threw it back up and body aches and chills and throwing up i called into work and laid back down . i woke up at noon with body aches but as the day progressed i started to feel better went to bed . i woke up sat feeling good and continue to feel fine lasted total about 24 hrs.

Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient received covid vaccine - while in waiting area, fainted suddenly and hit his head (rug burn on forehead). Got up and felt fine. Called EMS who then took patient away. Patient was alert when taken away. Previously has fainted when he's gotten blood drawn.

Terrible body aches starting at 8pm on April 1st. Then had the chills. Was able to take ibuprofen and slept for a bit. Next morning April 2, got a migraine where it hurt to open my eyes. Had that for about 2 hours then got better. Also, I had trouble eating. I would take a small bite of crackers and feel like I was going to throw up. Took me a long time to eat a package of crackers and to drink 1 whole bottle of gatorade. I took more ibuprofen through the day and that helped. Around 5pm that night I was able to eat a little more and drink some with out feeling sick to my body. Around 9pm that night headache came back and I went to bed for the night. Today April 3 I feel a lot better. Body still aches a bit and feels like I?ve been sick for 2 days so will probably take today and tomorrow to fully recoup. No headache today. Just small aches and tired.

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

HPI: Patient is a 35 year old male who presents following administration of a single dose of J&J COVID19 vaccine in the left deltoid. Patient started to feel light headed and nauseous while walking to his car. About 20 minutes following vaccination, a vaccinator had walked passed his vehicle and noted that he was unconscious. Patient was still unconscious upon medical response team arrival and unresponsive to stimuli. Once the patient awoke about 30 seconds later, he continued to state that he was nauseated and ?did not feel good.? Patient was unaware that he had lost consciousness. He further disclosed that he had been working in the sun planting trees all day and had not consumed any food or beverage. He denied allergies to medication, food, and other vaccines. He relayed that he had passed out from vaccinations in the past as a child. He affirms lightheadedness and nausea. He denies chest pain, difficulty breathing, swelling of the face/lips/tongue/throat, skin rash/itching, cramping abdominal pain, and vomiting. Exam (update as needed): GEN: Upon arrival, patient unconscious and not responsive to stimuli HEAD: NCAT EYES: pupils unreactive and mydriatic ENT: Ears normal, Nose normal, OP normal, no evidence of angioedema NECK: Supple, without LAD. CV: RRR, no m/r/g, palpable strong radial pulse PULM: Clear to auscultation bilaterally, no accessory muscle use ABD: Soft, no tenderness. SKIN: Skin pale, cool, and clammy. No rashes. No erythema or edema of the injection site. MSK: FROM, MS 5/5 NEURO: Patient unconscious upon arrival. CN 2-12 grossly intact, no ataxia, gait steady Clinical Impression/Field Tx: Vasovagal syncope. EMS called immediately to respond to the site for further evaluation. Patient placed into a reclined position. Patient not displaying active signs or symptoms of anaphylaxis. Upon regaining consciousness, patient was alert and oriented x4. Once the patient demonstrated ability to control airway, he was given candy and water. EMS arrived and an EKG and BGL were performed, both of which were normal. Vital signs were stable. Instructed patient to consult their PCP regarding the post-vaccination reaction. Patient instructed to go to emergency department should they develop chest pain, difficulty breathing, swelling of the face/lips/mouth/tongue/throat, or cramping abdominal pain with nausea/vomiting, as these are signs of possible anaphylaxis that requires immediate intervention. Medications administered: None Disposition: FD EMS called to the scene for further evaluation. Patient elected to go home after evaluation by EMS.

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

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

At roughly 8 to 10 hours after injection I started developing a minor fever, fatigue, slight loss of appetite, lack of focus, chills and aches. Signs and symptoms continued to worsen throughout the night and next morning. Unable to sleep due to an increase in chills, fever progressed to 101.3F, developed a severe headache, aches were more prominent, same with fatigue. Loss of appetite went away. Started taking cold medication in the morning which either helped reduce the signs and symptoms or I had already experienced the apex of the adverse events. Fever was reduced, same with the aches and chills. Everything is fairly minor now, but the severe headache continued to to be present untill a second round of cold medication. Still fatigued when writing this at 9:30pm at night despite sleeping the majority of the day.

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

Chills began almost exactly 6 hours after the shot. Overnight I didn't sleep much at all with chills, fever, body ache and headache. The next day I had a very strong headache all day and couldn't get out of bed due to no energy, chills and body aches. Was in bed sleeping on and off until 4:00pm, or roughly 24 hours after the shot. Intermittent doses of Tylenol helped with symptoms to allow sleep. After that 24 hours I felt substantially improved.

the evening after the vaccination felt generally poorly, then developed fever allegedly up to 104.0 associated with mental status change; felt better in AM, afebrile, and back to baseline state

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

SKIN PEELING BETWEEN INSIDES OF FINGERS OF RIGHT HAND; HEADACHES; NAUSEA; BLURRY VISION; SORENESS OF KIDNEY/LOWER BACK AREA; MASSIVE BODY ACHES; DIZZINESS UPON STANDING (HYPOTENSION); CHEST TIGHTNESS; FOGGINESS; FATIGUE; This spontaneous report received from a patient concerned a 35 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included no known drug allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: Pain scale (NR: not provided) 5-6 out of 10. On 09-APR-2021, the subject experienced fogginess. On 09-APR-2021, the subject experienced fatigue. On 10-APR-2021, the subject experienced blurry vision. On 10-APR-2021, the subject experienced soreness of kidney/lower back area. On 10-APR-2021, the subject experienced massive body aches. On 10-APR-2021, the subject experienced dizziness upon standing (hypotension). On 10-APR-2021, the subject experienced chest tightness. On 10-APR-2021, the subject experienced headaches. On 10-APR-2021, the subject experienced nausea. On 13-APR-2021, the subject experienced skin peeling between insides of fingers of right hand. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fogginess, blurry vision, fatigue, massive body aches, dizziness upon standing (hypotension), headaches, nausea, chest tightness, skin peeling between insides of fingers of right hand, and soreness of kidney/lower back area. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.

35 y.o. male who received the Janssen Covid-19 Vaccine, Ad26.COV2.S (PF) 0.5 mL IM Susp, Lot 042A21A on 4/30/2021. 4:00-The patient experienced the following reaction(s) during the immediate of observation: After receiving vaccine pt experienced anxiety attack, and was cyanotic in appearance as well as visibly perspiring. Pt c/o feeling hot. 4:05-Patient was treated/managed as follows: Pt brought to treatment area and given water and ice packs. Vs performed: BP-142/70, HR-84, R-17, 02-94-96%. Pt reports feeling better at this time. Pt difficulty swallowing, in no distress. Paramedics arrive on the scene and take second set of VS, transfer of care. Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance.

PATIENT RECEIVED DOSE IN ARM AND QUICKLY BECAME LIGHTHEADED, ASKED FOR WATER, THEN PASSED OUT. PATIENT FELL ONTO FLOOR, AT WHICH POINT TECHNICIAN ADMINISTERING THE VACCINE CHECKED PATIENT FOR PULSE/BREATHING - NOTED PT WAS OK, AND CALLED FOR PHARMACIST FOR HELP. PT AWAKE BUT CONFUSED ON FLOOR WHEN PHARMACIST ARRIVED, SLOWLY REGAINED AWARENESS AFTER LEGS PROPPED UP. HE DECIDED TO GET UP ONTO A CHAIR AND DRINK SOME WATER, PHARMACIST SAT WITH PATIENT UNTIL HE WAS FINE TO WALK TO WAITING AREA OUTSIDE OF PHARMACY. HE WAS OBSERVED FOR 25 MORE MINUTES (TOTAL 30) AND FELT FINE TO LEAVE ON HIS OWN ACCORD

Patient passed out after receiving vaccine while waiting afterwards. He woke up disoriented, sweating. He said he had passed out previously and it felt the same. EMS checked him out and he left on his own.

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

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

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

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

lightheadedness, fatigue, headaches, mood changes, shortness of breath, nausea, concentration issues, forgetfulness

ANOREXIA; GENERALIZED PAIN; FOGGY FEELING; FEVER; FATIGUE; This spontaneous report received from a health care professional concerned a 35 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included attention-deficit/hyperactivity disorder, and other pre-existing medical conditions included the patient does not have any allergies to medication, food, or other products, no other illnesses at the time of vaccination and up to one month prior, and no adverse event following any previous vaccine. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 08-MAY-2021 16:45:00 for prophylactic vaccination. Concomitant medications included amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate, ergocalciferol, magnesium, and rhodiola rosea. On MAY-2021, treatment medications included: paracetamol. On 09-MAY-2021 06:00:00, the subject experienced anorexia. On 09-MAY-2021 06:00:00, the subject experienced generalized pain. On 09-MAY-2021 06:00:00, the subject experienced foggy feeling. On 09-MAY-2021 06:00:00, the subject experienced fever. On 09-MAY-2021 06:00:00, the subject experienced fatigue. The action taken with covid-19 vaccine was not applicable. The patient was recovering from fatigue, fever, foggy feeling, generalized pain, and anorexia. This report was non-serious.

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

Systemic: anxiety, nervousness, shortness of breath-Severe, Additional Details: patient presented to pharmacy next day following janssen covid vaccine. presented with shortness of breath, anxiety, nervousness, cough. patient states symptoms started around 2AM. Ambulance was called. EMT took patient to hospital

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

The night after receiving the vaccine I started to develop a fever and headache. It lasted 3 days for the fever. On Tuesday I felt something different in my body. On Thursday I went to see an Optometrist. While there he found that there was something going on in my eyes. He noticed there was blood clot in the back of my right eye. I did go to the ER because of the blood clot. At the ER I had a CT scan and bloodwork completed. I was told that everything looked normal and I was told to go to a different hospital. I was transferred to Medical Center. While I was there they performed an MRI, CAT scan and Lumbar function test. I was told that everything looked fine from the neurology point of view. I need to follow up with an Ophthalmologist. I have gone completely blind in my right eye and my left eye is not clear anymore. On 05/20 I had an appointment with the ophthalmologist. There was something wrong with my optic nerve as well. There was a test performed 05/21. I went back to the doctor on 05/26 he said that the reports he received are not making sense to him. My next f/u appointment with Dr. is 06/09 because the doctor asked to have2 weeks to read through my hospital reports. I saw a different doctor instead on 05/27, Dr. , and he said that this can happen from the vaccine. He said that there is a swelling and I need to see a different doctor about my retina. I was told that I need to see another physician. I saw Dr. . on 05/27 and he said that there are fluids there, but no one can confirm that this is because of the vaccine. He gave me the option to take prednisone 10mg and I feel that it is working, but it is very slow. It was moved to 3x per day. I can see objects now even though it's still not clear. I have a f/u with Dr. 06/03.

After giving vaccine, patient was in observation area and stated he felt light headed. He was nervous about the vaccine and feeling anxious. After speaking with him, he calmed down and stated he normally gets anxious regarding immunizations. He sat for 20 minutes and felt fine enough to go home.

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

Side effects began few hours after receiving the Covid-19 Janssen vaccine. Side effects included suddenly freezing followed by full body shivers, hallucinations, extreme thirst, woke up feeling extremely hot as if overheating but no sweating, confusion, headaches/migraines, nausea, and muscle tightness.

Once vaccine was administered patient was still seated in vaccine room and we were reviewing the vaccine card, he reported that he was 'not feeling well'. He then had stated he was feeling dizzy and had an episode of syncope. He remained in the chair but was not able to respond to me. His mother was present and I called for assistance and she came into the room at which point the patient was able to respond to me verbally but he reported being confused, feeling nausea and fatigued. He was visibly sweating. His mother reported that he had previous episodes of syncope when having blood draws or other injections. He remained seated and I offered multiple times to contact emergency medically services but he and his mother wanted to just wait as he usually feels better after a short time. We did give him cold water bottles which his mother used at the nape of his neck. We also provided him with wet paper towels.

I have pain internally at the injection site that isn't subsiding and it has been over two months. The pain affects my range of motion and ability to perform tasks as simple as reaching for my seatbelt, washing my body, and doing a push-up.

Low grade fever from 99.1-100.3 every day since getting the shot. Pre-shot daily average temp was 97.9. Fever affects daily life and work. Brain fog affects daily life and work. Restless legs. Difficulty sleeping. Tingling in legs and feet. Anxiety. Onset occurred the day after vaccine was administered and there has been no abatement of symptoms since onset. My doctor did extensive blood work as well as antibody testing. Antibodies were negative as of 7/20/2021. All other tests were within range/negative, except for elevated immature granulocytes. Ability to carry on daily life and work is greatly impaired by these symptoms, especially the relentless fever and inability to sleep. Health care professionals are unable to give me any time frame within which I can expect symptoms to stop.

High fever (99-103F) for about 12 -16 hrs, numbness in arm for 1.5 days, injection site soreness lasting 4-5 days Rested and hydrated for 2 days Returned to work after 2 days

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

2021-03-20 07:30 PM - chills, 11:00 PM - vomited, 11:30 PM- seen in the Emergency Department 2021-03-21 11:30 AM - fatigue, somnolescence, nausea 2021-03-22 08:00 AM - nausea, 11:30 AM - altered mental status, vision loss, headache, balance problems, numb left arm and hand, hypoxia (SpO2 < 50%), 01:00 PM - seen in the Emergency Department, 03:00 PM Creatinine > 6.8, eGFR < 10

Patient reported feeling anxious before vaccination Patient reported after of dizziness, lightheaded ness, anxious and appeared pale Patient provided with water and car AC turned on, patient seen by medical team, refused medical transport and signed AMA form Patient stated feelings have resolved

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

Extreme headache and high fever, numbness in face, tingling fingers, impaired vision and loss of balance, very confused. Fever and worst of symptoms lasted approximately 6 hours. After major symptoms subsided, nausea, confusion , and generally sick feeling lasted 24 hours additional.

I had the shot on Sunday. After the shot, I feel dizzy and felt asleep. On the same Sunday night around 12 a.m. , my body is so chill and I kept on sweating. It has been for three days till Wednesday, my body is so warm, sweating, tired,hand palm and feet is so cold everyday, low energy, cannot focus on work.

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

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

A healthcare worker was setting up and approached me and asked if I wanted a free J&J vaccine. I was very hesitant . I told him that I had a flight later that night and didn?t want to have any side effects on the plane. He assured me hardly anyone ever has bad reactions to it and was very salesy, not seeming concerned much for my health or my questions, more like he needed to meet a quota. Against my better judgment, I got the shot and was absolutely miserable on the flight and that whole night. I developed a fever, body aches, headache, chills, and fatigue around 8 hrs after receiving my shot. It was one of the worst nights of my life with a fever reaching 103.5, and that was with Tylenol in my system to try to keep the fever down. I didn?t feel normal for 3 days.

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

Started with headache on 3/20 3/21 am - flu like sx 11:00 became unresponsive, disoriented, started having hearing & vision problems, left hand wasn't working. Problems worse upon standing, dx w/ hypovolemic shock

light headed, dizziness, sweating, anxious, vision blur saw yellow, had him sit extra 15 minutes until felt better took temperature - low registered 95, drank juice had a granola bar , stayed seated until felt better was with friend who was able to help when left temperature was at 96

Patient became diaphoretic and light headed 6 minutes after being injected. Patient was 'dazed'. States that he has done this before with normal venipunctures.

Pt. requested and received the J&J / Jansen COVID 19 vaccination yesterday at 1317. While he was being monitored for any adverse reactions, Pt. asked if lightheadedness was a side effect of the shot. Writer advised that it could be and that everyone is different. Writer asked if he would like some water, and he declined. Pt. was advised to remove his mask so he could breathe better. Writer took his pulse while I gathered information. It was 96. Pt. reported that he did eat lunch, is drinking plenty of water and fluids. He relayed he is keeping food down and not having any other issues. Pt. is currently on opiate withdrawal protocol. Writer asked about his breathing and his chest. Pt. relayed he was not having difficulty breathing and denied any chest pain at all. Writer spoke with the Deputy to be sure that we kept an eye on him for a bit longer after his 15 minutes while he was in his cell, due to his lightheadedness. Pt. was talking with writer, answering questions with ease. Pt. was not diaphoretic and did have good color. His pulse was checked again, and it was 84. At 1333, when his 15-minute observation was done, writer went to assist pt. to his feet and informed him that I would escort him back to his cell because he was still feeling a bit uneasy. When he stood, pt.'s knees buckled, and he knelt to the ground. Writer helped pt. to lay down. It was a smooth transition, and he had no injuries to his head or body. Pt. had what appeared to be a short spell where his body completely tensed for a few seconds, then he relaxed. He was having a hard time keeping his eyes open, but when prompted, was able to open his eyes. The Deputy standing by was asked to call for the Public Health Nurses, who had moved on to the next POD to continue vaccinating. Once on the scene, pt.'s blood pressure was obtained. 142/80. His pulse was 82. During this time, it appeared that the tensing episodes became more frequent and a bit more severe. They were happening approximately every 30 seconds, and lasting between 5 and 10 seconds. EMS was activated at approximately 1340. Pt. was awake during these episodes, and communicated with the nurses attending to him. While attending to pt. and waiting for EMS, it was at that time that pt. admitted that this was not the first time this had happened. He admitted that about a week ago, the same thing happened. When that new information was explored, pt. reported that his wife thought he had "Serotonin Syndrome". Writer asked what meds he was taking on the outside and he reported that he only takes methadone form the clinic. He denied any other medications or street drug usage. He does not take any mental health medications at our facility. Collectively, the nurses that attended to him after this episode agreed that this is an isolated incident and not related to receiving the COVID vaccine. EMS arrived at approximately 1347, and report was given. He was transported to the hospital for evaluation. Pt. was returned from the hospital at approximately 1600. The Officer that accompanied him reported to facility that the hospital also believed this was an isolated incident, most likely related to withdrawals. They did not believe that receiving the vaccine was a factor in today's events. Labs were drawn at the hospital, and were all WNL. Once back in custody, writer spoke briefly with pt.. He was feeling much better, and was sent back to his cell without further incident.

Patient anxious complained of arm pain with injection and approximately 3 minutes later patient had loss of consciousness for approximately 2 minutes. BP low normal 108/60. Patient pale, diaphoretic and cool to touch, Patient assisted to stretcher and on monitor and found to be bradycardic HR as low as 38 . CODE team arrived and within 5 minutes patient back to baseline

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

SHARP HOT PAIN THROUGHOUT BODY; DIFFICULTY CONCENTRATING; INJECTION SITE PAIN/BURNING; FATIGUE; SHARP PAIN IN FOREHEAD; This spontaneous report received from a patient concerned a 36 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAY-2021, the subject experienced sharp hot pain throughout body. On 26-MAY-2021, the subject experienced difficulty concentrating. On 26-MAY-2021, the subject experienced injection site pain/burning. On 26-MAY-2021, the subject experienced fatigue. On 26-MAY-2021, the subject experienced sharp pain in forehead. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain/burning on 26-MAY-2021, and had not recovered from sharp hot pain throughout body, difficulty concentrating, fatigue, and sharp pain in forehead. This report was non-serious.

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

Attendee received Johnson & Johnson vaccine at 14:20 in the left arm. Lot# 205A21A. Attendee was directed to observation area. At 14:35 voiced complaints chest tightness and anxiety. Attendee's skin was warm and dry. Attendee's respirations were not tachypneic or dyspneic. Attendee refuse to go to the cot. 14:47 – Reported being anxious and that he is going on a flight out of the country later today. Did not want 911 to be called. HR: 77 BP: 125/70 RR: 19 O2Sat%: 99 14:55 - Attendee decided that he was leaving. He did let them get another set of vital signs, before he left.

Chief Complaint Patient presents with o Shortness of Breath Chest Pain 36-year-old male without significant past medical history presents with concerns for vaccine reaction. The patient reports that he got the J&J vaccine yesterday, while at work today he developed some dizziness. He went home, while resting at home he developed some chest pressure, shortness of breath. He reports the symptoms have largely resolved at this time, he just feels mildly dyspneic at this time. No known fevers. No recent illness. Patient does report some anxiety related to the vaccine. Well-appearing 36-year-old male presents 1 day after J & J Covid vaccine. While he did experience some dizziness, dyspnea and chest pressures earlier, at this time the symptoms have resolved. He appears well, is breathing comfortably, stable vitals. Patient is PERC negative. Will check an EKG, but otherwise recommend symptomatic management at home. Differential diagnosis: Vaccine reaction, viral illness, arrhythmia Low concern for PE given that the patient is PERC negative EKG Interpretation: normal sinus rhythm, no ischemic changes ED Course and Disposition: Patient reassured and discharged home.

Initial symptoms were as expected and quite intense - strong fever, chills, headache, and nausea starting 6 hours after injection and lasting for 24-48 hours. Lingering side-effect has been headaches. Dull general headaches at least 4 days a week that last much of the day and are cause to disengage from normal activity. I HAVE NEVER HAD REGULAR HEADACHES IN MY LIFE AND HAVE NEVER HAD A MIGRAINE. This is ONGOING TODAY (July 12).

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

short-term memory problems , dizziness , slurred speech for 3 months He has short-term memory problems before that and per patient he took an 8-hour test and his score was similar to 6 grade level. Short-term memory problems are forgetting peoples names but not so much faces and some language problems and walking into the room and not remembering why he went there, the latter symptom is particular new and not old. About once a week he has lightheadedness where he could be sometimes walking or sometimes in the shower and like he is going to pass out but does not and it is very transient quickly. Pt is well-hydrated. Rare alcohol no illicits no tobacco. Slurred speech happens about once a day for 10 to 20 seconds per patient and is brand-new over the last 3 months. Denies facial droop or weakness.

Moderate pain at injection site beginning +6 hours from vaccine. Moderate swelling at injection site for 48 hours from vaccine. Fatigue beginning at +6 hours from vaccine requiring additional sleep and continuing for at least 72 hours. Fatigue results in some periods of moderate weakness and general malaise requiring lying down. Stomach cramps and discomfort.

Patient came in for Janssen COVID vaccine that was scheduled electronically online. All appropriate prescreening was done and patient had no previous allergies or issues. Patient was instructed to sit in one of the chairs designated for post vaccine observation. Within minutes (less than 3), patient was very dizzy, clammy (cold sweats), pale and said he did not feel right. I assisted him to a sitting position on the floor from his chair and we were able to ease him back to a lying down position from there with his head on the floor and feet elevated above heart on a chair. Patient said that the cold floor actually made him feel better instantly. At 4:18pm after lying down for about 3 minutes we checked his blood pressure with him still lying down. It was 110/88 and pulse of 104 (so slightly elevated pulse). He said he was feeling better and we kept him lying down. Patient's wife was also there so she was able to provide information in addition to him doing it also. She did state that he occasionally had panic attacks and she thought this might be one, the patient was adamant that it was not. At 4:24 pm we checked his blood pressure again and it was 100/90 and Pulse of 104. He was feeling quite a bit better so we had him come to a sitting position on the floor and he had not eaten in a while so we got him a granola bar and water. Pt slowly ate these and begin to feel clammy and sweaty again within 3-4 minutes. We checked his blood pressure again and it was 104/90 and pulse of 100. He wanted to stay sitting to see if it would pass. We did continuously observe injection site and screen for any other symptoms of an allergic reaction (nausea, cramping, swelling, and none of these were occurring). Since he was still not feeling well we gave the patient 50mg of benadryl (20 mls of 12.5mg/5ml liquid benadryl) with his approval. After about 10 minutes of sitting total he was still having cold sweats and feeling dizzy so we had him lie back on his back with his feet elevated while the benadryl kicked in. By 4:50pm he was feeling well enough to sit back up and we got him some wraps and a coke from the cafe to eat. Pt continued to consistently improve and was ready to leave about 5:20pm. We advised him and his wife of signs and symptoms of allergic reaction and to have those treated to immediately at urgent care or and ER. We also told him to follow-up with his PCP. I had a manager help walk them to their car. They were very kind and grateful. I will follow-up with a call tomorrow and again on Friday to make sure he continues to do well.

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

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

Patient felt like he was going to "go down", he has a history of vasovagal response. Patient has a second vasovagal and EMS was contacted. Patient then stated he had been standing for the last 5 hours during a swim meet and did not take his Norvasc that was to be taken daily.

Started feeling tired and drained around 10pm the same day of receiving the vaccine and then after going to bed around 11pm I felt body aches, chills, and I assume I had a fever. I could simply not get warm or comfortable and tossed and turned for hours. Felt like I had the flu. Finally fell asleep around 2am. Woke up the next morning around 6:30am and took Tylenol but no longer had a fever or chills. I felt drained and tired throughout the whole next day but unsure if that was vaccine related or simply due to lack of sleep. Slept fine that evening and had no other effects.

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

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

Vaccine was administered at 10:25am. Patient walked over to the waiting area and as he was walking he passed out and fell to the ground. Vitals were taken at about 10:28am: B/P 132/74 HR 70 RR 18, glucose 120. Patient was able to state his name and where he was located, but kept his eyes closed and kept stated he felt "confused and dizzy" and was apologetic. EMS was called at 10:30AM and when EMS was here pt was noted to have another syncopal episode. Patient was transported to Hospital via ambulance.

Cannot stay asleep. Waking up every 2 hours with vivid nightmares for 5 straight days and counting. Feeling terrible every 2 hours I wake up like an alarm bell during middle of REM sleep or taking a 2 hour nap in the afternoon.

Starting at 11 PM (roughly 7 hours after injection), I developed severe flu-like symptoms. Fever, nausea, chills, and headache. I was unable to sleep for most of the night. I had a fever of over 100 degrees. The symptoms were the worst from 11 PM - 4 AM. They persisted throughout the next day (thus far), but have lessened in severity. They are still present, however, 28 hours after initial injection - although roughly 50% less severe. Acetaminophen seems to help.

PATIENT WAS SITTING IN A CHAIR, HEAD BENT FORWARD, AND HE WAS PALE, WITH A 50 PULSE AS READ FROM HIS PHONE THEN WENT BACK UP TO 80 . (PATIENT REPORTS HE FELT A 'RUSH" AFTER THE SHOT, THE LAST THING HE REMEMBERED WAS SEEING HIS HR SHOOT UP TO 100 . HIS BLOOD PRESSURE WAS 97/70

Patient was waiting in designated waiting are following vaccine administration. About 5 minutes after vaccine I heard wife calling for help. When I went out to assess patient I found him laying back in chair with his head back, shaking, eyes open, and making fists with his hands. I asked him if he wanted me to call 911. He was able to respnd through clenched teeth that he felt very strange and to call 911. He remained conscious and knew his name. We contacted 911 and I supported pt from opposite side of wife. After a few minutes he calmed down and asked for water, he appeared to be sweating around head area. He took a few sips of water until operator on phone asked us to withhold further liquid until EMTS arrived. He was completely back to normal status within 5 minutes, EMTS came and assessed pt and allowed him to leave of his own accord. After the incident her relayed that similar reactions including full fainting spells have occurred to him in the past when receiving vaccines. this was not indicated on his intake form

Have severe body aches, fever, fatigue, no energy. About 17 hours till I was able to get out of bed. I had COVID 19 in December and had identical symptoms.

QUIETER THAN NORMAL; FEVER; This spontaneous report received from a consumer via a company representative concerned a 37 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included Crohn's disease, and cerebral palsy, non-verbal. 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 22-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included ustekinumab for Crohn's disease. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced quieter than normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and quieter than normal was not reported. This report was non-serious.

Patient was administered the COVID vaccine and felt fine. He relocated to our pharmacy waiting area for observation. Once there he started to read the provided material (EUA, V-Safe) and started to feel anxious. He said the next thing he knew he was sweating and had tunnel vision. He wasn't 100% sure he passed out. A fellow associate helped him to the ground and elevated his feet. We got ice for behind his neck, and a cold cloth for his forehead. We took his blood pressure and it started to come back up. He waited for about 30 minutes before leaving. His color had returned and he stated he felt fine.

High fever 103.4 chills body aches lightheaded dizzy fast heart rate no sleep it all came about around 11:30 pm on the 04/10/2021

loss of consciences after injection was given, seizure, vomiting and confusion, monitoring in EMS and transferred to higher level of care via EMS services

Day of shot - extreme nausea. First night - no sleep due to waves of shivers/chills and then fever and overheating. Shortness of breathe Day after shot - fatigue; some flu-like symptoms Day 2 after shot - fatigue and shortness of breathe

GENERAL RESTLESSNESS; HEART PALPITATIONS; SEVERE CHILLS AFTER 7 HOURS OF VACCINE; POUNDING HEAD/HEADACHE; GENERAL FATIGUE; This spontaneous report received from a patient concerned a 37 year old male. The patient's weight was 195 pounds, and height was 76 inches. The patient's concurrent conditions included seasonal allergies, non-smoker, and alcohol use, and other pre-existing medical conditions included patient did not have any drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced general restlessness. On 07-APR-2021, the subject experienced heart palpitations. On 07-APR-2021, the subject experienced severe chills after 7 hours of vaccine. On 07-APR-2021, the subject experienced pounding head/headache. On 07-APR-2021, the subject experienced general fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart palpitations, and severe chills after 7 hours of vaccine on 08-APR-2021, and had not recovered from pounding head/headache, general restlessness, and general fatigue. This report was non-serious.

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

DIFFICULTY BREATHING; MENTAL CHANGES; RAPID HEART BEAT; FULL BODY PAIN; FEELING OF LEAD IN VEINS TOE NAILS TO HEAD; ANXIETY; BRAIN ZAPS; FEELING OF HEAT IN BRAIN; SEVERE PAIN; LEG PAIN; LEG FALLING ASLEEP; FEELING OF CHANGES IN NERVOUS SYSTEM; FEELING SPACEY; PALPITATIONS; DIFFICULTY SLEEPING; BURNING IN CHEST; LIGHTHEADED; FEELING LIKE GOING TO PASS OUT; PANIC ATTACK; EXTREME BONE PAIN; SUFFOCATING; SUFFERING AND TORTURE; FOOT FALLING ASLEEP; POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME; This spontaneous report received from a patient concerned a 37 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, non alcoholic user, and postural orthostatic tachycardia syndrome, and other pre-existing medical conditions included the patient had illicit drug use as a teenage. the patient was homeless from age of 14 to 22. the patient was sober as of 26-mar-2006, past 15 years was sober. The patient experienced drug allergy when treated with ciprofloxacin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and batch number: 1805029 expiry: 25-MAY-2021) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: CT scan (NR: not provided) not reported, Contrast media reaction (NR: not provided) not reported, Diagnostic ultrasound (NR: not provided) not reported, Echocardiogram (NR: not provided) not reported, Fibrin D dimer abnormal (NR: not provided) not reported, and Heart rate (NR: not provided) Increased. On MAR-2021, the subject experienced difficulty breathing. On MAR-2021, the subject experienced mental changes. On MAR-2021, the subject experienced rapid heart beat. On MAR-2021, the subject experienced full body pain. On MAR-2021, the subject experienced feeling of lead in veins toe nails to head. On MAR-2021, the subject experienced anxiety. On MAR-2021, the subject experienced brain zaps. On MAR-2021, the subject experienced feeling of heat in brain. On MAR-2021, the subject experienced severe pain. On MAR-2021, the subject experienced leg pain. On MAR-2021, the subject experienced leg falling asleep. On MAR-2021, the subject experienced feeling of changes in nervous system. On MAR-2021, the subject experienced feeling spacey. On MAR-2021, the subject experienced palpitations. On MAR-2021, the subject experienced difficulty sleeping. On MAR-2021, the subject experienced burning in chest. On MAR-2021, the subject experienced lightheaded. On MAR-2021, the subject experienced feeling like going to pass out. On MAR-2021, the subject experienced panic attack. On MAR-2021, the subject experienced extreme bone pain. On MAR-2021, the subject experienced suffocating. On MAR-2021, the subject experienced suffering and torture. On MAR-2021, the subject experienced foot falling asleep. On MAR-2021, the subject experienced postural orthostatic tachycardia syndrome. On APR-2021, Laboratory data included: Stress test (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rapid heart beat, difficulty breathing, full body pain, feeling of lead in veins toe nails to head, anxiety, brain zaps, feeling of heat in brain, severe pain, leg pain, leg falling asleep, feeling of changes in nervous system, feeling spacey, palpitations, difficulty sleeping, burning in chest, mental changes, extreme bone pain, suffocating, and suffering and torture, and the outcome of lightheaded, feeling like going to pass out, panic attack, foot falling asleep and postural orthostatic tachycardia syndrome was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.

Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Severe, Additional Details: Pt experienced syncope and had a blood pressure reading of 70/40 and a pulse of 44. EMT was called and pt resolved to blood pressure of 105/65 and a pulse of 55. Pt was chose not to go to hospital after filing consent with EMT, he was then pickd up by a coworker and will return for his car later. Pt noted to have a history of low BP in the past but has not see a MD recently and was advised to follow up with new pcp.

Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Medium, Additional Details: About 5 minutes after the shot, the patient lost conciousness, fell face forward on the ground. Face appeared grey, was unresponsive, but was making grunting sounds. His body appeared to be shaking lightly, possible seizure, was not responsive. Oral benadryl was not possible at this point. Turned patient on back/side in order to adminster the epipen. Patient quickly became alert and responded. No injection site reaction. Paramedics arrived shortly to check vitals and transfer him

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

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

Pharmacist gave a Johnson + Johnson shot to the patient. After the shot the patient got up and sat down in a "Post-Vaccination waiting area" chair. A few minute later the patient got up and walked towards the pharmacy asking for water, as he was walking to the pharmacist the patient fainted, fell to the ground and bumped his head on the counter. Patient woke up a several second later confused and laid on the floor. Code white and 911 was called. Another pharmacist grabbed an ice pack and a bottle of water for the patient. Patient said he went to the dentist office recently and received a shot in the mouth and something similar happened as well. The patient did not disclose this information to the immunizing pharmacist. Patient told us to cancel the 911 call and asked to leave, the pharmacist recommended he stay a while longer so we can monitor him. Patient said he had no history of diabetes or seizures. Patient forehead was slightly red.

Systemic: Nausea-Medium, Additional Details: Possible Vasovagal reaction, out for a very short time, then had nausea, a bit confused, shakiness, headache

37-year-old foreign-speaking patient walked into the vaccination site accompanied by wife at about 11:45am. They requested the Janssen Covid-19 vaccines for the both of them. Patient signed all necessary consent forms and pre-vaccination checklist requirements, and entered the vaccination section at around 11:50am. The Janssen vaccine was administered at 11:57am. At 12pm patient started to experience light-headedness, dizziness, and change of LOC. At 12:01pm charge nurse called 911. Patient?s wife and observation nurse asked patient how he was feeling but patient was unresponsive and disoriented for about 30-60 seconds. Soon after patient was able to speak and started complaining of being nauseous and observation nurse handed patient a garbage bag to throw up. Charge nurse hooked up patient with pulse oximetry at 12:02pm with a reading of 98. Nurse assessed if patient is experiencing any symptoms of hives or redness, shortness of breath or any difficulty breathing or swallowing, and patient denied any symptoms. Administering RN hooked up patient with the blood pressure machine and BP reading was 167/156 with a pulse of 56. At 12:03pm BP reading was 139/75 with a pulse of 62 and pulse ox reading of 95. At 12:06pm BP reading was 153/115 with a pulse of 67 and pulse ox of 95. Patient also stated that his left arm started to get numb and tingly feeling. At 12:07pm first responder 911 came and took over. Patient was hooked up to EKG and found some arrhythmia and was advised to go to the hospital to further evaluate. Patient agreed and was taken to the nearest hospital at about 12:20pm. Action taken: Charge nurse called 911 for help and hooked up patient with pulse oximetry and assessed patient for any sign and symptoms of any allergic reactions to Janssen Covid-19 vaccine. Administering RN and observation nurse continuously monitored patient?s B/P, Pulse, Pulse oximetry, and LOC until first responder paramedics came.

Severe tinnitus, variable throughout the night, louder than the train horn 4 blocks away. Severity slowly lessened the next day, by evening June 2 it was at the steady state level it is still at now, 2 weeks later. It's extremely distracting and reduces my ability to focus or think clearly. I have a purely thinking job and this is an extremely disruptive and productivity reducing level of sound. Related but not what is being reported: Fever of 103F from about 7pm (6 hours after injection) to early morning. Down to 101F by 8am. 400mg ibuprofen taken at 9pm. I've never had any negative reaction to any other vaccine before.

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

Intractable Nausea/Vomiting, Slurred Speech, Loss of Balance, Difficulty Walking, need increase assistance with all Activities of Daily Living

After about 3 days of flu like symptoms the flue like symptoms began to decline however late in the night, roughly 2am wednesday night/thursday morning, I woke up with a high pitched squealing in my left ear. The pitch started at 9,000Hz. After about 2 weeks I saw my family physician where I was prescribed corticosteroids orally. That slightly diminished the high pitch and changed it to more of a oscillating frequency however once one the steroids were complete the pitch continued to get worse and back to original levels. I went back again about 4 weeks later and was prescribed a second dose. Same outcome occurred. I then went to a ENT and was prescribed a different corticosteroid and again same outcome occurred. The frequency is so bad I can't sleep, read, and can barely do my job. Besides the tinnitus their is consistent pressure on my left ear and ear popping every time I swallow. I have taken Zyrtec-D however this only mildly works for the pressure. Although the pressure is consistently there it varies in intensity. This has been one of the worse experiences of my life and I hope the matter is taken seriously as both physicians correlate the occurrence with the vaccine but are unsure why it's happening.

Received vaccine on 6/5/21, next morning at 7:00 am mother heard a loud noise and found PT face down lying half way in bathtub unresponsive, attempted to lift him observing his eyes were rolled back in head, was unconscious for approximately 1 min trying to lift him out, then he blacked out a second time hitting bathtub a second time. Lifted him out and placed on floor, he was unresponsive - called 911, he came to slightly after 3 minutes. Ambulance took him to ER and we stayed all day receiving fluids and chest XR (clear). We were discharged in the afternoon with the doctor saying he has a syncopy episode. At 4:00 PM PT was going to the bathroom and he stated he didn't feel good. I stood in front of him because he turned white and eye rolled up into his head and he blacked out and stopped breathing for approximately 2 minutes while I got him on floor and gave CPR. Called 911 and he began breathing again . Back in ambulance to hospital and we stayed in hospital for 2 days.

About 2 weeks after I received my shot I became almost lifeless ,my wife had to do every thing for me my body shut down never see or had anything like this before,I had extreme temporarily poleralisysis

Patient fainted momentarily and fell to the floor from seat. Patient was breathing and groaning before being flipped face-up. Patient was sat upright on the floor and was alert and awake within one minute. Mild impact to right forehead on fall with slight bruising. Suspected vasovagal syncope. ED called, but patient declined ambulance transport to hospital for further help/examination/treatment. Patient stayed at pharmacy for extended amount of time for observation and in order to calm nerves. Patient called friend/family for transport from pharmacy.

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

On Saturday 3/20 I experienced the usual symptoms that were noted. On Monday 3/22 I began to get very dizzy with a heart rate of 150bpm. My blood pressure went up to 210/138 which is extremely abnormal for me. I began to tremor uncontrollably. I thought it was an anxiety attack so I took my Xanax. .50mg. That did not work at all. I experienced nausea and stomach pain. I called 911 and was taken to the hospital where after 4 hours I started feeling better. Tuesday I continued to have tremors. Wednesday the rapid heart rate, stomach pain, and nausea returned. The rest of the week did not get any better. On Saturday 3/27 I slept all day long which again is not normal for me at all. At this point we are 1 full week into the vaccine administration. On Sunday 3/28 I bagan to have the same feeling as the prior Tuesday. Sweating, couldn't breath, heart rate hit 170 this time. BP was the same, tremors, stomach pain, nausea, dizzyness, and this time my Carbon Dioxide level dropped to 24. This morning 3/29 I woke up with extreme tremors. No dizzyness.

Patient felt "funny" a few minutes post vaccine but couldn't describe what that meant. Vital signs were stable and patient was observed for 55 minutes. 128/64, pulse 84 resp 24. Vaccine was given at 11:50, vitals at 12:20, left clinic at 12:45. At 5pm patient began wheezing and feeling short of breath. PCP ordered prednisone, Benadryl and Pepcid. Wheezing has improved some today. Today patient has fatigue, body aches and fever.

I began having cold chills in the evening about 6-7 hours after I got my vaccine shot. Got a headache soon after. Woke up the next day with a migraine headache, feeling very woozy and running a fever. Had to call off work to recover from flu-like symptoms.

Fever, chills, nausea, and fatigue. Kept waking up during the night being hot or cold. The next day mild fever and chills, but still feeling fatigued.

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

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

Patient received vaccine through drive through clinic. Patient was driving his truck and seemed to veer off, a vaccinator noticed and ran to truck, writer then followed. Initial person told patient to park the truck. Patient appeared to be snoring and un responsive but did put truck in park. Sternal rub was preformed and patient began to come to, seemingly disoriented. Patient was evaluated by EMS in ambulance but no transfer happened. Patient was incontinent as well. Patient states this happens after he gets injections or lab work done but did not disclose this to the vaccinators at time of vaccine administration.

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

I have woken up in the middle of the night three times with a terrible headache. I attributed it to possible dehydration even though I was hydrated. The issue occurred sporadically over three weeks after the vaccine.

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

About 7 hours after the injection I woke up with intense chills. I was awake for 6 hours in the night with intense chills, sweating, and a temperature of at least 102. I was unable to take Tylenol until having the chills for 9 hours. Tylenol helped. I slept about 20 hours the first day with a fever all day. I had a fever for about 24 hours. The following week I was completely exhausted and slept about 12 hours a day. I am 38 years old and this was the sickest I have been in probably 20 years. It was bad and that's why I am reporting it. I am very thankful to have had the vaccine though. Thank you all for what you do!

pt developed a severe migraines and is still having them. He vomits every time he eats. He developed a rash on his chest, has shortness of breath, runny nose. Some confusion and brain fog. He went to ER in on 4/16/2021 for migraine headache and other symptoms. He was given a CT and a shot of Demerol and sent home to FU w/ neurologist. He continued having migraines so went back to ER on 4/18/2021. He had an EEG, ECG, and abnormal lab work. He was given another shot of Demerol, Phenergan and IV fluids. He was monitored for a few hours and released to FU w/ Neurologist.

BODY PAINS; SNEEZING; RUNNY NOSE; FEELING OUT; SORE ARM; EXTREME TIREDNESS; MILD NAUSEA; MILD FEVER; HEADACHE; This spontaneous report received from a patient concerned a 38 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, treatment medications included: diphenhydramine hydrochloride, and pseudoephedrine hydrochloride. On 09-APR-2021, the subject experienced body pains. On 09-APR-2021, the subject experienced sneezing. On 09-APR-2021, the subject experienced runny nose. On 09-APR-2021, the subject experienced feeling out. On 09-APR-2021, the subject experienced sore arm. On 09-APR-2021, the subject experienced extreme tiredness. On 09-APR-2021, the subject experienced mild nausea. On 09-APR-2021, the subject experienced mild fever. On 09-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from extreme tiredness, and feeling out, and had not recovered from headache, body pains, mild fever, mild nausea, sneezing, runny nose, and sore arm. This report was non-serious.

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

Beginning the night after receiving the vaccine, I have had noticeable difficulty falling and staying asleep through the night. I retire around 12-1 a.m. and consistently awake between 4 and 6 a.m., unable to fall back asleep. This has led to serious drowsiness during the day. Prior to the vaccine, I would regularly sleep until 8 or 9 a.m. uninterrupted.

I had a severe headache starting in the evening. The pain was constant, dull, and felt like it was coming from the center of the head. I don't have a history of headaches, so this was unusual. After going to bed at 11PM, I woke up around 2AM from the intense pain. I could not sleep for a couple of hours in the night and I took Nyquil, which helped a little bit. I considered going to the emergency room, but decided to wait until morning to make the decision. I was able to go back to sleep and then slept until 11AM. I woke up feeling weak and groggy, although it may have been due to the Nyquil. The headache was improved and gradually diminished throughout the day. The next morning, it was completely gone and I felt back to normal.

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

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

I went to bed around 10:30 and felt completely normal. Around 1AM I woke up with the chills that lasted for about an hour or so. I could not get warm. My body would go from hot to cold and shiver/spasm in a pattern that lasted about a minute or so. this pattern of hot cold and shiver/spasm lasted approximately an hour. when that subsided I started to experience relatively extreme fever and flu symptoms. I completely sweat through my pajamas. My entire body ached and hurt like a normal fever flu but more extreme. Around 2:30AM I took three 500mg acetaminophen, 2 mg Xanax and a 10 mg Valium. I fell back asleep some time between 3:30 and 4:00AM. I woke up at 8:30 with most of the symptoms having dissipated. It's now 10AM. I still feel groggy and a little achy in my body, but the fever seems to have subsided. For now that is about it

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

Site: Pain at Injection Site-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: close to fainting several times-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Mild, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Medium, Additional Details: Specifically tingling in Hands. Patient was very disoriented and appeared close to fainting a couple of times post vaccination. Was closely monitored for 30 minutes. He did not think it was due to being nervous, he was slightly nervous before the vaccine, but nothing of concern.

Patient received vaccine and immediately felt light-headed and faint. He turned white upon standing and sat back down. He continued to have labored breathing and starting sweating. We were monitoring him and he informed us that it was anxiety related. He couldn't move his hands and started blacking out. When EMT arrived he started to feel better. They were able to rule out an allergic reaction and it was most likely anxiety related. Patient refused to go to the hospital and was walked out by EMT to make sure he could drive home.

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

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

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

More than 30 days after receiving the Janssen vaccine, I tested positive for COVID-19. Symptoms began as runny nose, sneezing, and sinus pressure/burning on April 6, 2021. Tested for COVID-19 on April 11, 2021 (nasal swab, PCR test) after a family member tested positive. Symptoms worsened on April 12, 2021, including shortness of breath, chest pain, complete loss of taste and smell. Sought treatment for breathing difficulty at ER on April 13, 2021 (Vidant Medical Center and was instructed to rest at home. Sought treatment for breathing difficulty at PCP on April 14, 2021 ( Medical Center) and prescribed Prednisone. Symptoms worsened on April 15, 2021, including shortness of breath, chest pain, numbness in face/arms/legs, dizziness, loss of balance, memory and speaking difficulty, near fainting. Sought treatment at ER on April 15, 2021 (Vidant Medical Center, Greenville, NC). Held for three days, treated with Remdesivir (3 doses) and supplemental oxygen. Discharged from hospital on April 18, 2021. Symptoms did not improve following discharge. Sought treatment for ongoing symptoms at ER on April 21, 2021, instructed to rest at home. Symptoms continued to worsen on April 24, 2021, including shortness of breath, chest pain, numbness in face/arms/legs, dizziness, loss of balance, memory and speaking difficulty, near fainting, and slurred/incoherent speech. Sought treatment at ER on April 15, 2021, admitted to hospital on April 25, 2021 diagnosed with probable TIA. Treated with Optiflow high-flow oxygen therapy, nebulizer, and steroids. Received a variety of tests and scans of head, neck, spine, chest, heart; none showed signs of any serious cardiac, vascular, or neurological problems. Transferred to in-patient rehabilitation on May 1, 2021 for physical and occupational therapy. Discharged from in-patient rehabilitation on May 6, 2021. Prescribed out-patient physical and occupational therapy to resolve remaining dizziness, balance, and endurance deficits.

Patient suffered a hemorrhagic stroke (brain bleed) in the right deep brain structures with significant brain swelling and build up of cerebral spinal fluid requiring drainage. Patient's confusion and motor function have been improving and the bleeding has not worsened.

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

Patient started feeling light headed and shaky/anxious about 10 minutes after vaccine administration. Patient sat in immunization booth for a total of 35 minutes and was given something to eat and drink, as he had nothing to eat yet for the day and only had caffeine and nicotine in his system. Patient started to feel less shaky but was still light headed. It was suggested we call the paramedics for evaluation and he refused, and then left the pharmacy 35 minutes after vaccine (against pharmacist advise). The patient called approximately 2 hours later and said he was feeling better, no longer shaky or light headed and had a headache as the only symptom at the time.

5 minutes after receiving the J&J vaccine, I went lights out. As I was sitting in the monitoring area, I was completely fine and then a wave came crushing down on me and I was out for about 5 minutes. The nurses said it looked like I was having a seizure. The EMTs called it a syncope event. I am a member of the military and and have been pumped full of vaccines. I get my annual flu shot every year. I have survived 6 rounds of Anthrax vaccines and every other vaccine the military has pumped into me. This is the First Time I have ever REACTED this way. It was CRAZY!

I administered a Janssen covid imz to patient at 1:07pm. Immediately following the patient proceeded to faint, his head fell back and limps went limp. I called for pharmacist to come into the immunization room for assistance and bring an ice pack. She ran into the room to help. At this time 1:08pm the patient began to shake and had what appeared to be a seizure. I dialed 911 and pharmacist was helping patient and protected his head. After shaking for about 10 seconds, the patient stopped. He then awoke, jumped awake confused and scared. We sat patient down and monitored him. At this time the pharmacy tech called management. After patient was calm and sitting, we called his wife into the room. Management arrived in pharmacy. At 1:12pm patient felt cold and clammy. He said he very much had to use the restroom. With assistance, he used the pharmacy bathroom. EMT arrived at 1:16pm. EMT determined low blood pressure. Patient had worked outside all morning in heat and was likely under hydrated. Over the next few minutes, EMT determined the patient's blood pressure was increasing. At 1:22pm, patient declined to go to the hospital. EMT signed off and left. Patient remained in room until about 1:40 with his wife to rest. Management got him candy and a fan to help. His wife and management then took him to their car.

TIRED; BRAIN FOG; ACHES; CHILLS; This spontaneous report received from a pharmacist concerned a 38 year old male. The patient's weight was 130 pounds, and height was 62 inches. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. the patient had no premedical history. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-JUN-2021, the subject experienced brain fog. On 02-JUN-2021, the subject experienced aches. On 02-JUN-2021, the subject experienced chills. On 03-JUN-2021, the subject experienced tired. The action taken with covid-19 vaccine was not applicable. The patient was recovering from brain fog, chills, aches, and tired. This report was non-serious. This case, from the same reporter is linked to 20210456372.

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

ANGIOGRAM PULMONARY ABNORMAL; SCAN WITH CONTRAST ABNORMAL; SARS-COV-2 TEST POSITIVE; FULL BLOOD COUNT NORMAL; SARS-COV-2 ANTIBODY TEST NEGATIVE; ANGIOGRAM; ANGIOGRAM PULMONARY; BLOOD GASES; BLOOD MAGNESIUM; BLOOD PHOSPHORUS; BLOOD THYROID STIMULATING HORMONE; CHEST X-RAY; COMPUTERISED TOMOGRAM; COMPUTERISED TOMOGRAM HEAD; COMPUTERISED TOMOGRAM THORAX; ECHOCARDIOGRAM; ELECTROCARDIOGRAM; ELECTROENCEPHALOGRAM; FIBRIN D DIMER; GLOMERULAR FILTRATION RATE; GLYCOSYLATED HAEMOGLOBIN; MAGNETIC RESONANCE IMAGING HEAD; MAGNETIC RESONANCE IMAGING SPINAL; METABOLIC FUNCTION TEST; SCAN WITH CONTRAST; TROPONIN; LIPIDS; PULMONARY EMBOLISM; TRANSIENT ISCHAEMIC ATTACK; AGEUSIA; AMNESIA; ANOSMIA; BALANCE DISORDER; CHEST PAIN; COVID-19; DIZZINESS; DYSARTHRIA; DYSPNOEA; EXPOSURE TO SARS-COV-2; PRESYNCOPE; RHINORRHOEA; SNEEZING; PARANASAL SINUS DISCOMFORT; HYPOAESTHESIA; SPEECH DISORDER; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient via a Regulatory Authority, VAERS (Vaccine Adverse Event Reporting System) (VAERS ID 1347147), concerned a 38 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high cholesterol. The patient had no known allergies. The patient had no current illness at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070 expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 03-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the patient experienced pulmonary embolism, ageusia, amnesia, anosmia, balance disorder, chest pain, dysarthria, dyspnoea, paranasal sinus discomfort, presyncope, rhinorrhoea, scan with contrast abnormal, sneezing, speech disorder, dizziness, hypoaesthesia, angiogram, angiogram pulmonary, angiogram pulmonary abnormal, blood gases, blood magnesium, blood phosphorus, blood thyroid stimulating hormone, chest x-ray, computerised tomogram, computerised tomogram head, computerised tomogram thorax, echocardiogram, electrocardiogram, electroencephalogram, exposure to sars-cov-2, fibrin D dimer, full blood count normal, glomerular filtration rate, glycosylated haemoglobin, lipids, magnetic resonance imaging head, magnetic resonance imaging spinal, metabolic function test, sars-cov-2 antibody test negative, sars-cov-2 test positive and troponin. More than 30 days after receiving the Janssen vaccine (on 06-APR-2021) the patient tested positive for COVID-19 (Confirmed COVID-19 Infection) and was confirmed Clinical Vaccination Failure, the patient experienced symptoms runny nose, sneezing, and sinus pressure/burning. Laboratory data included: Angiogram (NR: not provided) Not reported, Angiogram pulmonary (NR: not provided) Not reported, Angiogram pulmonary (NR: not provided) Abnormal, Blood gases (NR: not provided) Not reported, Blood magnesium (NR: not provided) Not reported, Blood phosphorus (NR: not provided) Not reported, Blood thyroid stimulating hormone (NR: not provided) Not reported, Chest X-ray (NR: not provided) Not reported, Computerised tomogram (NR: not provided) Not reported, Computerised tomogram head (NR: not provided) Not reported, Computerised tomogram thorax (NR: not provided) Not reported, Echocardiogram (NR: not provided) Not reported, Electrocardiogram (NR: not provided) Not reported, Electroencephalogram (NR: not provided) Not reported, Fibrin D dimer (NR: not provided) Not reported, Full blood count (NR: not provided) Normal, Glomerular filtration rate (NR: not provided) Not reported, Glycosylated haemoglobin (NR: not provided) Not reported, Lipids (NR: not provided) Not reported, Magnetic resonance imaging head (NR: not provided) Not reported, Magnetic resonance imaging spinal (NR: not provided) Not reported, Metabolic function test (NR: not provided) Not reported, SARS-CoV-2 antibody test (NR: not provided) Negative, SARS-CoV-2 test (NR: not provided) Positive, Scan with contrast (NR: not provided) Abnormal, Covid-19 virus test (NR: not provided) Positive and Troponin (NR: not provided) Not reported. On 11-APR-2021 tested for COVID-19 (nasal swab, PCR test) after a family member tested positive (confirmed covid-19 infection). Laboratory data included: SARS-CoV-2 PCR test (NR: not provided) Positive. On 13-APR-2021, Laboratory data included: Basic metabolic panel (NR: not provided) Not reported, CBC (NR: not provided) Not reported, and EKG (electrocardiogram) was normal. On 12-APR-2021 symptoms worsened including shortness of breath, chest pain, complete loss of taste and smell. On 13-APR-2021 the patient received sought treatment for breathing difficulty at ER (emergency room) and was instructed to rest at home. On 14-APR-2021 the patient received sought treatment for breathing difficulty at PCP (primary care physician) medical center and was prescribed prednisone. On 15-APR-2021 symptoms worsened including shortness of breath, chest pain, numbness in face/arms/legs, dizziness, loss of balance, memory and speaking difficulty, near fainting and patient received sought treatment at emergency room. The patient was held in hospital for three days and was treated with remdesivir (3 doses) and supplemental oxygen. Laboratory data included: CBC (complete blood count) Not reported, Chest X-ray (NR: not provided) Not reported, Comprehensive metabolic panel (NR: not provided) Not reported, EKG (electrocardiogram) Normal, Magnesium (NR: not provided) Not reported, Phosphorus (NR: not provided) Not reported, SARS-CoV-2 IgG antibody test (NR: not provided) Negative, TSH (thyroid stimulating hormone) Not reported, Troponin I (NR: not provided) Not reported, and Urine analysis (NR: not provided) Not reported. On 16-APR-2021, Laboratory data included: Basic metabolic panel (NR: not provided) Not reported, CBC (complete blood count) Not reported, Computerised tomogram scan (NR: not provided) Not reported, Computerised tomogram thorax (NR: not provided) Not reported, Echocardiogram (NR: not provided) Not reported, HbA1C (Glycated hemoglobin) Not reported, Lipids (NR: not provided) Not reported, Magnesium (NR: not provided) Not reported, Phosphorus (NR: not provided) Not reported, Troponin I (NR: not provided) Not reported, and Vitamin D (NR: not provided) Not reported. On 17-APR-2021, Laboratory data included: Comprehensive metabolic panel (NR: not provided) Not reported, and Fibrin D dimer (NR: not provided) Not reported. On 18-APR-2021 the patient was discharged from hospital. The patient reports that the symptoms did not improve following discharge. On 18-APR-2021, Laboratory data included: Comprehensive metabolic panel (NR: not provided) Not reported. On 21-APR-2021, the patient undergone sought treatment for ongoing symptoms and was instructed to rest at home. Laboratory data included: Basic metabolic panel (NR: not provided) Not reported, CBC (complete blood count) Not reported, Chest X-ray (NR: not provided) Not reported, Computerised tomogram thorax was found to be pulmonary embolism with contrast, EKG (electrocardiogram) Not reported, Estimated glomerular filtration rate (NR: not provided) Not reported, and Troponin I (NR: not provided) Not reported. On 24-APR-2021 the patient reports that the symptoms were continued to worsen including shortness of breath, chest pain, numbness in face/arms/legs, dizziness, loss of balance, memory and speaking difficulty, near fainting, and slurred/incoherent speech. Laboratory data included: Arterial blood gases (NR: not provided) Not reported, Chest X-ray (NR: not provided) Not reported, Comprehensive metabolic panel (NR: not provided) Not reported, Computerised tomogram head (NR: not provided) Not reported, EKG (electrocardiogram) Not reported, SARS-CoV-2 IgG antibody test (NR: not provided) Positive, and Troponin I (NR: not provided) Not reported. On 25-APR-2021 the patient received sought treatment at emergency room and admitted to hospital on the same day again, patient was diagnosed with probable TIA (transient ischaemic attack) and was treated with Optiflow high-flow oxygen therapy, nebulizer, and steroids. Laboratory data included: CBC (complete blood count) Not reported, Comprehensive metabolic panel (NR: not provided) Not reported, Computerised tomogram head (NR: not provided) Not reported, Computerised tomogram neck (NR: not provided) Not reported, Computerised tomogram thorax (NR: not provided) Not reported, Echocardiogram (NR: not provided) Not reported, HbA1C (Glycated hemoglobin) Not reported, Magnetic resonance imaging brain (NR: not provided) Not reported, Magnesium (NR: not provided) Not reported, and Phosphorus (NR: not provided) Not reported. On 26-APR-2021, Laboratory data included: CBC (complete blood count) Not reported, and Lipids (NR: not provided) Not reported. On 27-APR-2021, Laboratory data included: CBC (NR: not provided) Not reported, and electroencephalogram (EEG) (NR: not provided) Not reported. On 28-APR-2021, Laboratory data included: Basic metabolic panel (NR: not provided) Not reported, CBC (complete blood count) Not reported, Fibrin D dimer (NR: not provided) Not reported, Magnesium (NR: not provided) Not reported, Magnetic resonance imaging spinal (NR: not provided) Not reported, Magnetic resonance imaging thoracic (NR: not provided) Not reported, Phosphorus (NR: not provided) Not reported, and SARS-CoV-2 IgG antibody test (NR: not provided) Positive. On 30-APR-2021, Laboratory data included: CBC (NR: not provided) Not reported, and SARS-CoV-2 PCR test (NR: not provided) Positive. On 01-MAY-2021 The patient was transferred to in-patient rehabilitation for physical and occupational therapy, Laboratory data included: CBC (complete blood count) Not reported, Magnesium (NR: not provided) Not reported, and Phosphorus (NR: not provided) Not reported. On 03-MAY-2021, Laboratory data included: CBC (complete blood count) Not reported, Magnesium (NR: not provided) Not reported, and Phosphorus (NR: not provided) Not reported. On 06-MAY-2021 patient was discharged from in-patient rehabilitation and was prescribed with out-patient physical and occupational therapy to resolve remaining dizziness, balance, and endurance deficits. The patient was hospitalized for 16 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ageusia, amnesia, angiogram pulmonary abnormal, anosmia, balance disorder, blood gases, chest pain, dysarthria, dyspnoea, paranasal sinus discomfort, presyncope, pulmonary embolism, rhinorrhoea, scan with contrast abnormal, sneezing, speech disorder, transient ischaemic attack, blood magnesium, blood phosphorus, blood thyroid stimulating hormone, chest x-ray, computerised tomogram, computerised tomogram head, computerised tomogram thorax, covid-19, dizziness, echocardiogram, electrocardiogram, electroencephalogram, exposure to sars-cov-2, fibrin d dimer, full blood count normal, glomerular filtration rate, glycosylated haemoglobin, hypoaesthesia, lipids, magnetic resonance imaging head, magnetic resonance imaging spinal, metabolic function test, sars-cov-2 antibody test negative, sars-cov-2 test positive, troponin, angiogram, angiogram pulmonary, and scan with contrast, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). The case is associated with Product Quality Complaint number: 90000181966. The suspected product quality complaint has been confirmed to be not confirmed. The reported allegation was not confirmed and the root cause was determined to be not manufacturing related, based on the PQC evaluation/investigation performed. Additional information was received from Central Complaint Vigilance on 21-JUN-2021. The following information was updated and incorporated into the case narrative: Product complaint investigation result was added.; Sender's Comments: V1. The follow-up information in this version updates Product complaint investigation result. This updated information does not alter causality of previously reported events. 20210609990 -covid-19 vaccine ad26.cov2.s - Pulmonary embolism , transient ischaemic attack, Ageusia, amnesia, angiogram pulmonary abnormal, angiogram pulmonary , anosmia, balance disorder, blood gases, chest pain,dysarthria, dyspnoea, paranasal sinus discomfort, presyncope, rhinorrhoea, scan with contrast abnormal, sneezing, speech disorder, blood magnesium, blood phosphorus, blood thyroid stimulating hormone, chest x-ray, computerised tomogram, computerised tomogram head, computerised tomogram thorax, covid-19, dizziness, echocardiogram, electrocardiogram, electroencephalogram, exposure to sars-cov-2, fibrin d dimer, full blood count normal, glomerular filtration rate, glycosylated haemoglobin, hypoaesthesia, lipids, magnetic resonance imaging head, magnetic resonance imaging spinal, metabolic function test, sars-cov-2 antibody test negative, sars-cov-2 test positive, troponin, and angiogram. 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). 20210609990-covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS

High blood pressure I work out often and always watched diet. I have been having constant migraine headaches, also my nerves seem to be heightened

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

Soreness at injection site immediately and lasting afterwards at least 24h. About 6 hours after vaccination, general aches, headache, fever (~101 oral reading while taking ibuprofen), chills, insomnia; all of these symptoms lasting (so far) about 16 hours and continuing.

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

I had painful gas pain in my chest. Lasted most of the night and I couldn't sleep. Went into the Pagosa Medical Group Urgent Care the next day to get checked out. EKG came back normal. Doc and I both thought it was gas, but we wanted to be sure it wasn't heart related.

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

PATIENT WAS FEELING FINE AFTER THE VACCINE WAS ADMINISTERED. AFTER 5 MINUTES THE PATIENT LAYED ON THE FLOOR DUE TO SOME DIZZINESS. PATIENT LET US KNOW HE WAS UNWELL AND PROCEEDED TO FAINT WHILE I STOOD NEXT TO HIM. HE WAS VERY SWEATY AND LOOKED LIKE HE WAS HAVING A PANIC ATTACK. HE WAS TOLD TO LAY DOWN AND DRINK SOME WATER ONCE HE REGAINED CONCIOUSNESS. AFTER 45 MINUTES THE PATIENT WAS ABLE TO WALK FINE AND ABLE TO DRIVE HOME.

INAPPROPRIATE ROUTE OF DRUG ADMINISTRATION; FEELS BEAT; SEVER HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 39 year old male. The patient's weight was 70 kilograms, and height was 177.8 centimeters. The patient's past medical history included non smoker, and concurrent conditions included 4 drinks per week. The patient had no known drug or non-drug allergy. The patient had no history of drug abuse or illicit drug use. The patient was non-smoker. The patient had no pre-existing acute illness or illness at the time of vaccination or 30 days prior to vaccination. The patient did not have significant past history of similar events and not had any adverse events after any previous vaccinations. The patient did not have significant history of hospitalizations. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intravenous, batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 15:00 to left arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced feels beat. On MAR-2021, the subject experienced sever headache. On MAR-2021, the subject experienced fatigue. On 13-MAR-2021, the subject experienced inappropriate route of drug administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from inappropriate route of drug administration on 13-MAR-2021, and the outcome of sever headache, feels beat and fatigue was not reported. This report was non-serious.

The day of my shot, I fell asleep on my couch around 10p and woke up at 2:30 am shaking uncontrollably. I didn?t have goosebumps, but felt cold from the inside, if that makes sense. The only way I could get comfortable was to sleep in a bathtub in hot water for 4-5 hours. I then went to my bed and slept for another 5 hours. I called out of work Friday.

At 1500 started having chills, running a fever and was very shaky. Took Tylenol and rested. Around 2100 woke up feeling even worse and felt like heart was racing with frequent pauses (3-5 PVC's/minute). Following ER visit continued to feel tired, achy, and occasional SOB.

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

After i gave covid-19 Janssen shot to patient, he passed out (Syncope), out of anxiety and nervousness from the shot per patient and his wife. Incident happened around 3:40 pm. His senses soon come back. We called emergency (911) and they ran some test and took the patient to the emergency. Patient was in senses, responding and alive when he left .

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

Later on that evening around 10:30pm I started having chills. Around 1am I woke up with high fever of 103 my body was very hot. By 5am the fever broke I was at normal temperature I felt better and was able to sleep. On 04/8/2021 around 6pm I went to reach out for something & I couldn't feel my arm my legs then I felt that my face was numb as well It was only left side. I felt tingling . It lasted for like 4 or 5 seconds. I went to the ER they did some lab work & a CT scan and everything came back normal. I will be scheduling an MRI as well.

This was one of the worst headaches I've ever had in my life. Migraine headaches run in my family so I'm no stranger to them, which is why it is particularly surprising. Along with the headache I had severe flu symptoms - body ache from head to toe, legs toward the end. Abdominal pain toward end. I was breathing heavily throughout, except for an hour or two of bad sleep. It was almost certainly a high fever, but I didn't measure. Chills, sweating. Complete misery. The extremely painful cycle lasted about 10 hours before it started to recede. I felt better close to 100% within 48 hours. I'm reporting this because I've realized that most people have "mild flu like symptoms" while my symptoms were extreme. If I had any other health issues (I don't) it seems obvious that it could have created a bigger problem. I didn't go to a hospital, but I should have, in hindsight.

is a 39 yo M with no significant PMH. He presents for symptoms following Johnson and Johnson vaccine. PMH: none PSH: Right knee surgery, Lasik Family Hx: Denies any family history of HTN, clots, heart disease Patient received the Johnson and Johnson COVID-19 vaccine on 4/11/21, he began feeling tiered, headache and bilateral leg pain on 4/12/21. He had one dose of Tylenol 4/12/21. At around 4pm on 4/14/21 he reports that he had SOB, more bilateral leg pain, and dizziness. He states he went home and slept. Woke up Thursday and all his symptoms had resolved. Denies chest pain, numbness, tingling, swelling in his legs. Patient does endorse that he does have a stressful job working for airport and he had 3-4 cups of coffee daily. He also endorses that after the new of the side effects of the Johnson and Johnson vaccine appeared, he did notice he had more anxiety. Occupation: Works at airport, 12 hours shifts, on-call Social: no drinking, no drugs, smokes 1 cigarette per day for past 8 years

Was at the grocery store and was having a hard time focusing. All of the colors were running together. I then fell backwards, and began having a seizure. Bystander said my eyes got huge and mouth and tongue turned blue as I couldn?t breathe. I had a seizure for about 5-8 minutes and was totally blacked out. During the seizure I lost control of my bladder and dislocated my jaw.

Monday, April 12th, around 2pm I started to develop extreme stomach pain, as well as noticed some shortness of breath or elevated heart rate. The stomach pain worsened after dinner. I assumed it was something I ate, which was the same thing I eat every day, and expected it was some type of gas that would resolve itself naturally. I went to bed in lots of pain. I didn't sleep well due to the issues and woke up still in pain in my mid stomach, mostly on the left side. I called the nurse who did an intake and advised that I go to the ER (Tuesday, April 13th)

I got the vaccine and chills, fever, nausea, diarrhea and dizziness. I was kind of our of breath and fatigue, I wasn't able to life anything and constantly out of breathe. It was hard for me to do anything, I had to rest all the time and take off of work. I was driving to work and had to keep pulling over because I felt dizzy. I ended up going to the Dr. and had test ran and they said I was extremely dehydrated and I didn't understand because I drink a lot of water. they hooked me up an IV and gave me fluids. They said I was Healthy just extremely dehydrated it. My injection site was kind of tender but nothing more. I'm still having issues. I'm just always thirsty no matter how much water I drink.

I developed a very itchy rash on my back, hands, feet, arms and what felt like everywhere. The just today stopped. The rash lasted about 8-10 days I would say. It got worse over the course of a week and then started getting better. Someone suggested I take an anti-inflammatory, because my hands were swelling and it was difficult to work at the computer. That seemed to help immediately or it could've just started to go away on its own. Regardless, I've kept the twice daily naproxen for the past 4 days and things seem to be all better now. My wife suggested I report my reaction. The small red bumps were scattered mostly on my back, feet and hands. They looked very similar to shingles but without the big red splotches only the small red bumps. As they were forming they appeared to be sun blisters and then turned bright red. Extremely itchy and kept me up scratching at night and scratching all day.

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

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

SWEATING; LIPS TURNED INTO PALE; VISION BLURRED; NO ENERGY; STRESSFUL HEADACHE; NUMBNESS IN THE GROIN AREA AND LEFT TESTICLES; SWOLLEN LEFT TESTICLE; FEEL EXTREME PAIN; FEELING SENSATION IN DEEP INSIDE BODY AND WAS NOT SUPERFICIAL/FEELING WAS GOING TOWARD LEFT SIDE OF PELVIS/FEELING BLOOD BEATS IN LOWER PART AREA; LEFT SIDE OF LOWER ABDOMEN AROUND THE WAISTLINE SWOLLEN; This spontaneous report received from a patient concerned a 39 year old male. The patient's height, and weight were not reported. The patient's past medical history included surgery, and concurrent conditions included non alcohol user, and smoker, and other pre-existing medical conditions included the patient had no known drug allergies. the patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced numbness in the groin area and left testicles. On APR-2021, the subject experienced swollen left testicle. On APR-2021, the subject experienced feel extreme pain. On APR-2021, the subject experienced feeling sensation in deep inside body and was not superficial/feeling was going toward left side of pelvis/feeling blood beats in lower part area. On APR-2021, the subject experienced left side of lower abdomen around the waistline swollen. On APR-2021, the subject experienced stressful headache. Treatment medications included: morphine, and oxycodone hydrochloride. On 03-APR-2021, the subject experienced sweating. On 03-APR-2021, the subject experienced lips turned into pale. On 03-APR-2021, the subject experienced vision blurred. On 03-APR-2021, the subject experienced no energy. On 30-APR-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) no sign of infection, Physical examination (NR: not provided) no sign of infection, and Urine analysis (NR: not provided) no sign of infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vision blurred, and the outcome of numbness in the groin area and left testicles, sweating, swollen left testicle, lips turned into pale, no energy, feel extreme pain, feeling sensation in deep inside body and was not superficial/feeling was going toward left side of pelvis/feeling blood beats in lower part area, stressful headache and left side of lower abdomen around the waistline swollen was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.

I have had headaches every day since I received the vaccination that last most of the day. There is a constant pressure in my head that moves around all areas, from the back base of the head, to the sides, temples, forehead/sinus regions. It is from waking until sleeping. Not incredibly intense, but constant. I have difficulty sleeping through the night and have not slept well since, either. I have also experience blurred vision. I have also experience bruising on various parts of my body including my arm, abdomen, and toe nails. My quality of life has suffered tremendously and I wish I hadn't gotten the vaccine.

After administering IMZ, patient leaned over and fell to the ground while on his way to post IMZ waiting area chair. He fell and was unaware of what had happened. 911 was called and RPh followed instructions. Patient was speaking to me, but was unaware that he just received IMZ. After 911 came, patient declined further assistance and was advised by EMS to drink water and sit.

Slight ache where vaccine was. I woke up the next morning and it felt like I couldn't sleep. I worked that day but had extreme fatigue. Couldn't get up for work the next two days - extreme fatigue. It was a little better on Saturday and by Sunday it felt like I was getting my energy back. IF I hadn't been working at home, I probably would have missed my Wednesday work day that first day. I had at Hospital Hemorrhoid Surgery (outpatient surgery) on the 22nd of April. My recovery had been going well for the first week or so but now I am having an issue with hard stools. I am taking liquids every and I am having a bowel movement every day and I can't get them soft - they are all hard. I am taking two stool softeners a day. and I'm taking fiber. I am being impeded my recovery of my surgery - I'm a week or two behind in recovery because of this.

Patient was accidently administered 3ml of vaccine; patient did not report any adverse signs or symptoms during the observation period of 60 minutes; patient was sent for evaluation to Hospital, and returned to work the same day where he worked the remainder of his shift without complaint of symptoms and no adverse signs were observed. At some point a few days later patient c/o chest discomfort and sought medical attention; currently patient is off work

Was fine at the time and shortly after the injection. Woke up the next morning to a 103 degree fever, chills, sweating, disorientation, headache, vertigo. several days later developed a "shingles-like" rash around the injection site which is now radiating down the arm and back of shoulder. Rash is only in that area and no where else on the body. no previous history with vertigo or shingles rashes

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

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