Johnson & Johnson

Fever,headache,cold/hot sweats,bad muscle aches,no appetite,dizzy ,stiff neck ,stinky major sweat , uncomfortable no sleep felt like i had the Corona virus...

I had some fatigue the first couple of days but nothing that kept me from going to work - just took it slower and easier those days. The tinnitus started on 19th - ear pain on the right ear. I woke up that morning, I had pain. When I touched it I had pain on the front of my right ear. ( It appears to be coming from my right ear.) I took some Zyrtec D to see if that would help me and I took that for two days and that seemed to help but then the ringing started. I notice it more at night when it's quiet or when I'm working myself doing my maintenance work at rental units. I thought it was clogging of ear and so I was going to go to the doctor but I did ear drops and flushed for two days. It didn't subside anything with the ringing - I might be able to hear a little better. I don't have pain anymore as to the touch but I still have the tinnitus - the ringing in the ear - that constant sound. It has been continuing it seems to not be as bad but others it is. When I go to bed or when I wake up at night the ringing there it's hard to go back to sleep. I have an appt with the Ears, nose and throat doctor. My hearing doesn't seem to be affected, but I can't say for sure if it's any different - I'm left handed so I use my left ear in the phone.

Immediately following the injection, felt "spacey." He went home to rest and developed a headache. Symptoms seemed to subside until the evening of April 1. He woke up from a nap with chills and had a 100.9 fever. The fever has subsided but for 6 days he has had a headache, body aches, fatigue and nausea. The morning of April 8, he has vomited.

Too weak to lift himself out of bed into the wheelchair or from wheelchair onto toilet. Fell twice on two consecutive days when trying to get from the bed into his wheelchair. 911 was called each time to help him get off the floor and into his chair.

9/10 MAR: Fatigue, chills. 11 MAR: Diadiarrhea. 20/21 MAR: sharp pain between shoulder blades, pain in back of upper arms, back of thighs and legs. 22-Present Mar: Numbness in face, toungue, nose, &Total Pelvis area waist down to upper thigh. 24 - present MAR: Lower back pain. Unable to sleep well due to pain. 26-Present MAR: Severe numbness in fingers, toes & Feet. 3 Days in Hospital: 20-22 MAR. hospital CSF cell count was normal. Protein 60 glucose 105. CSF culture normal. CSF VDRL negative. Serum ACE HIV Sjogren's antibodies and Lyme antibodies were negative.

Severe headache and high fever; the headache persisted until around 12 Noon on 4/11. Just lost a nights sleep. Feeling well as of 4/12.

8 hours post-vaccine, experienced rather severe chills and fever spiking around 101.5, restless sleep, aches, pains, slight headaches all lasting around 24 hours.

6 hrs after neck stiffness, Throat swell a little (like trying to get a cold, slight headache, 8 hrs headache worse took tylenol, 10 Hrs after felt like a migrane , felt blood pressure elevated & took Ibuprofuen 800 mg, that calmed my haeadache down , went to bed woke up in a sweat/ slight headache, after eating took another Ibruprofuen 800mg & by 4pm headache was minimal, took tylenol after that no more headache after 9 pm, More tylenol before I went to bed , woke up fine really tired did not go to work on monday, tuesday went to work still tired , wednesday woke up no problems felt refreshed.

Initial sore and very tired 03/31 then April 3 developed fever body ache Covid like symptoms fatigue body ache fever headache slight cough flu like symptoms extremely tired requiring sleep. Unable to go to work. Bed rest. April 5 went to urgent care for Covid test- negative chest xray referred to hospital for CT confirmed pneumonia My treatment is two different types of antibiotics. 1. Azithromycin for 5 day and Amoxicillin 3000mg per day for 10 days

SWEATING REALLY BAD; WHOLE BODY HURTS; LIGHT HURTING EYES; HIGH ANXIETY; HEART RACING; FEELS LIKE SHIT; PAIN AT THE INJECTION SITE; HEAD WAS HURTING REALLY BAD; This spontaneous report received from a patient concerned a 60 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: 205A21A, expiry: 23/JUN/2021) dose was not reported, administered on 08-APR-2021 14:50 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced head was hurting really bad. Treatment medications included: ibuprofen. On 09-APR-2021, the subject experienced sweating really bad. On 09-APR-2021, the subject experienced whole body hurts. On 09-APR-2021, the subject experienced light hurting eyes. On 09-APR-2021, the subject experienced high anxiety. On 09-APR-2021, the subject experienced heart racing. On 09-APR-2021, the subject experienced feels like crap. On 09-APR-2021, the subject experienced pain at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from high anxiety, and heart racing, had not recovered from sweating really bad, whole body hurts, light hurting eyes, feels like crap, and pain at the injection site, and the outcome of head was hurting really bad was not reported. This report was non-serious.

muscle tightness, Onset: 3 weeks ago. The problem has worsened. The frequency of pain is constant. Location of pain is bilateral anterior neck, bilateral lateral neck and right shoulder. Associated symptoms include difficulty sleeping and muscle spasm. Pertinent negatives include numbness. Additional information: Pt here alone. Pt reports that 3-4 weeks ago he awoke with neck, right shoulder and arm pain. States he can't turn his head, raise his right arm due to pain. Taking 800mg of ibuprofen and it is not helping. States "it just dawned on me, I had the J/J vaccine 3days prior" Per pt and it was given in. right arm. Not sleeping well. Feels it is triggering his reflex sympathetic dystrophy.

Tues 4/13/21- Headache and dizziness started about 4p. Wed 4/14/21- Could not go to work because of headache and dizziness. Made appt for 4/15 at 6:45a with Dr Thur 4.15/21- Awoke with intense headache and dizziness. Ready to go to appt but emergency room called at 6:37 to switch to a Virtual appt. I never received a call so I walked to the office. They told me they would not see me as I had Covid 19 symptoms. Went to airport and received a Negative Covid test. Went o Clinic and was diagnosed with fluid in the ears and a sinus infection. Went to work and only stayed 2 hours. Drove myself to the emergency room with weakness, shortness of breath and intense pain under the sternum. Diagnosed with a blood clot in the right ventricle. The cardiac cath lab removed it. Was in intensive care Thur-Sat.

THE PATIENT BECAME SEVERLY HOARSEAND HIS VOICE WAS VERY UNCLEAR. HE ALSO WAS UNABLE TO SLEEP SINCE HE WAS VACCINATED. HE WAS NOT MANIC OR AGITATED. HE HAD NO PANIC ATTACKS AND HE HAD NO ANXIETY..

FEELING FOGGY; NERVE PAIN; JOINT PAIN IN FEET, CHEEK, TOP OF HEAD, TIP OF TONGUE; FATIGUE; HEADACHE; MUSCLE PAIN IN FEET, CHEEK, TOP OF HEAD, TIP OF TONGUE; This spontaneous report received from a patient concerned a 60 year old male. The patient's weight was 200 pounds, and height was 72 inches. The patient's past medical history included autoimmune disorder, and concurrent conditions included sleep apnea, auto-immune disorder with nerve pain flare-ups, chronic nerve pain, seasonal allergy, alcohol user, non smoker, asthma, blood pressure, acid reflux, and gout control, and other pre-existing medical conditions included patient event occur at locations feet, cheek, top of head, tip of tongue the patient have no history of drug abuse or illicit usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070) dose was not reported, administered on 10-MAR-2021 09:00 for prophylactic vaccination. Concomitant medications included pantoprazole for acid reflux, formoterol fumarate/mometasone furoate for asthma, losartan for blood pressure, allopurinol for gout control, and oxycodone hydrochloride for nerve pain. On 10-MAR-2021, the subject experienced feeling foggy. On 10-MAR-2021, the subject experienced nerve pain. On 10-MAR-2021, the subject experienced joint pain in feet, cheek, top of head, tip of tongue. On 10-MAR-2021, the subject experienced fatigue. On 10-MAR-2021, the subject experienced headache. On 10-MAR-2021, the subject experienced muscle pain in feet, cheek, top of head, tip of tongue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from joint pain in feet, cheek, top of head, tip of tongue, and muscle pain in feet, cheek, top of head, tip of tongue on 14-MAR-2021, and headache on 11-MAR-2021, was recovering from nerve pain, and had not recovered from fatigue, and feeling foggy. This report was non-serious.

LETHARGIC; FLUSHED; FEELS WORSE EVERY DAY; WOOZY AND UNSTEADY; A BIT TIGHT IN THE BOTTOM OF HIS CHEST; NO ENERGY; PAIN IN ALL MAJOR MUSCLES, HURTS EVERYWHERE; NAUSEA; LOW GRADE FEVER UNDER 99F; SPLITTING HEADACHE; TIRED; RESTLESS SLEEP; This spontaneous report received from a patient concerned a 60 year old male. The patient's weight was 350 pounds, and height was 75 inches. The patient's concurrent conditions included high blood pressure, chronic lyme disease, seasonal allergies, arthritis, hives allergy, non smoker, and alcohol user. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Concomitant medications included ibuprofen for arthritis, naproxen sodium for arthritis pain, lisinopril for high blood pressure, and fexofenadine hydrochloride for seasonal allergies. On 11-APR-2021, the subject experienced flushed. On 11-APR-2021, the subject experienced feels worse every day. On 11-APR-2021, the subject experienced woozy and unsteady. On 11-APR-2021, the subject experienced a bit tight in the bottom of his chest. On 11-APR-2021, the subject experienced no energy. On 11-APR-2021, the subject experienced pain in all major muscles, hurts everywhere. On 11-APR-2021, the subject experienced nausea. On 11-APR-2021, the subject experienced low grade fever under 99 F. On 11-APR-2021, the subject experienced splitting headache. Treatment medications included: paracetamol. On 12-APR-2021, treatment medications included: acetylsalicylic acid/caffeine/paracetamol/salicylamide. On 13-APR-2021, Laboratory data included: Blood test (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tired, restless sleep, splitting headache, pain in all major muscles, hurts everywhere, no energy, lethargic, nausea, low grade fever under 99 F, flushed, feels worse every day, woozy and unsteady, and a bit tight in the bottom of his chest. 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

Approximately 1 week after receiving the Janssen vaccine, pt developed fever, headache, lethargy, and confusion. He was admitted to hospital from April 1-5 with initial concern for bacterial meningitis however his workup was negative.

Got up on Friday morning and almost fell over and had to be careful not to fall while walking to bathroom to get a shower. That night I was dizzy and could not lay down and especially could not lay on side so I propped up pillows and slept upright. Same thing Saturday night but less. Some thing on Sunday night but much less. Just a little spaced out on Monday and slight headache. CAlled doctor, no call back yet but I did not want to go to ER. So far it is going in the right direction. Had minor headache initially, night 2, but tylenol worked to relieve.

Went in to BiPolar Mania and Rage. One of the worst events I have had. I take my meds, and have not had a Mania event since 2014. There were no triggers for this event. I have had Rage events more recently, last one 11 months ago. But never both of these together.

Saturday shot, on Tuesday my ears started feeling clogged, by late Tuesday they were clogged enough that I felt I had about a 50% loss of hearing and loud ringing in my ears. kept me up late Tuesday, by wednesday morning I my hearing was slowly getting better. by midmorning it was feeling getting better as far as hearing. Ringing in ears is still very intense in both ears as of time of this report.

weeping rash in the butt crease. Just reporting it now, but it started in May, I would wake up in the middle of the night with a terrible wet itching sensation in my buttocks. Treated it with athlete's foot Tinactin, other medications. Silver paste. Nothing stops it. Burning sensation when using Tinactin and then would apply other stuff, twice a day after washing area with soap. Nothing changes. Rash on the skin, scaly.

BAD REACTION; ALLERGIC GROWTH UNDER SKIN, ON HEAD AND FACE, AND IT IS NOW GOING DOWN TORSO; COLD SWEATS; RESPIRATORY ISSUES; LOSS OF TASTE; LOSS OF SMELL; SLEEPING 20 HOURS PER DAY; RED AND ITCHY GROWTH; NO ENERGY; This spontaneous report received from a patient concerned a 60 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: 043A21A, expiry: 21-JUN-2021) dose was not reported, administered on 27-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-APR-2021, the subject experienced bad reaction. On 29-APR-2021, the subject experienced allergic growth under skin, on head and face, and it is now going down torso. On 29-APR-2021, the subject experienced cold sweats. On 29-APR-2021, the subject experienced respiratory issues. On 29-APR-2021, the subject experienced loss of taste. On 29-APR-2021, the subject experienced loss of smell. On 29-APR-2021, the subject experienced sleeping 20 hours per day. On 29-APR-2021, the subject experienced no energy. On 29-APR-2021, the subject experienced red and itchy growth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bad reaction on MAY-2021, and cold sweats, respiratory issues, loss of taste, loss of smell, sleeping 20 hours per day, and no energy on 06-MAY-2021, and had not recovered from allergic growth under skin, on head and face, and it is now going down torso, and red and itchy growth. This report was non-serious.

IRRITABLE BOWEL SYNDROME; DIFFICULTY SLEEPING; HEADACHES; This spontaneous report received from a patient concerned a 60-year-old white and not Hispanic or Latino male. The patient's weight was 280 pounds, and height was 71 inches. The patient's past medical history included upper/lower GI (gastrointestinal) done take some bowels removed, and concurrent conditions included lactose intolerance, alcohol user (2 Drinks per week), and smoker (1 pack per 2 week). Patient had no known allergies. He had no any drug abuse or illicit drug usage. On an unspecified date colonoscopy was done and result was unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072 and expiry: UNKNOWN) dose was not reported,1 total administered on 17-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the patient experienced IBS (irritable bowel syndrome)/stomach pain/constipation/nausea. On same day patient experienced difficulty sleeping and headaches. On an unspecified date, he was admitted to hospital emergency room for several days. His physician was aware of his situation and patient was advised to take Miralax and fiber and was also prescribed morphine during hospital visit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from difficulty sleeping, IBS (irritable bowel syndrome), headaches. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210629530.; Sender's Comments: V0: 20210629309-covid-19 vaccine ad26.cov2.s-irritable bowel syndrome. 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).

Numbness in my hands and peripheral neuropathy -- extreme sensitivity to clothing and fabrics, particularly cotton ones. Also: mind fog, but that lasted about three days whereas this lasted two weeks.

One day post vaccination, the patient reported "massive headache" x 1 week, and continuous burning in the eyes and "mental fog". He doesn't feel like being social.

Patient was taken to the ER by his wife, on 4/12/21 with shortness of breath. He was sent home on continuous O2, which was never needed prior to his vaccination. Wife denies any chronic health conditions and reports that pt has been to more that one specialist because of his continued need to be on O2. She reports his saturation drops with minimal exertion and that the client has not even been able to return to work. When asked what the doctors had said, she reported that they blamed it on his weight. She reports that his weight has been the same since well before the vaccination.

Felt bad the day after but everyone complained of that, but two days after, sufferered from "pressure" in my head and headaches, some days light, some days bad. This has continued every day since 11 Mar. I take Motrin and/or Tylenol almost every day .

RESLTESSNESS IN ALL OVER BODY; TREMORS ALL OVER THE BODY; SHOOTING PAIN IN LEGS; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's past medical history included car accident, surgery for disk infusion c 4 5 6 7, left foot surgery for neurological issue, and right foot surgery for neurological issue, and other pre-existing medical conditions included on an unknown date in feb-2021, after surgery, left arm started to lose muscle tone, muscles started to get smaller and weaker and on left hand he felt tremors and weakness.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816027 expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUN-2021, the subject experienced resltessness in all over body. On 09-JUN-2021, the subject experienced tremors all over the body. On 09-JUN-2021, the subject experienced shooting pain in legs. Laboratory data (dates unspecified) included: Blood test (NR: not provided) No Parkinson, no other disease, and EEG (NR: not provided) No Parkinson, no other disease. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the resltessness in all over body, tremors all over the body and shooting pain in legs was not reported. This report was non-serious.

Muscle pain in left arm from shoulder to wrist, mostly in tendons or ligaments. Muscle pain went away to be replaced by constant tingling in left arm (like hitting your funny bone, a constant fiery tingle). Constant tingling is now intermittent flair-ups, sometimes so intense that it interrupts my work and causes a safety issue. Injection site still sore to the touch ( a hard touch or press at injection site). Issue still ongoing 12 weeks after vaccination.

61 y.o. right handed male who the Program is consulted for possible stroke. Patient reports that he got his COVID vaccination (Johnson & Johnson) today (3/11/2021) at about 10:30 AM. While waiting after the vaccination, at about 11 AM he became dizzy and felt like he was "loaded" ("stoned from smoking weed") and the started shaking "as though he has a fever but without a fever." and left side sensory loss which is non-disabling. He was taking to a CT scan which was negative for stroke and was discharged home.

Onset of a feeling like I was drunk the afternoon of the vaccine. The evening on 3/9 sleeping was difficult and I was very restless. When I awoke the next day (3/10) the only symptom was pain at the injection site. The afternoon of the 10th I began to experience flu like symptoms and was lethargic. No fever but did have chills. Slight headache. Awake the morning of 3/11 and symptoms had subsided.

Had suddenly didn?t feel good. Passed out was out for five minutes, Had a strange reaction when he came to, His vision was blurred, he has vomited 6-7 themes. I contacted the pharmacy where the sot was given and the clinic. He refused to go to E R The have taken notes to this. He sat in his recliner and took a nap. Took temp he does not have a fever. If his symptoms get worse I will call for ambulance.

Approximately 4:30 pm I started feeling leg/calf pain. I was driving at the time. Got home about 6:30pm, got out of the car and felt immediately sore all over. I took our trash can to the street and started feeling very cold and intense body cramps and shaking, also feverish, hot flash. It felt difficult to walk. I went immediately to lay down. Now I felt very cold. I slept on/off until 10pm. Woke a few times with intense leg/hip pain, Woke up around 10pm, vitals 115/77 107 temp 101.5 Took a long hot shower, feel better, but still feel some hip and leg pain, slight fever. I took one Acetaminophen 325mg.

After receiving vaccination, patient proceeded to observation area. He passed out briefly, then regained consciousness, but was sweaty, disoriented, dizzy and drowsy. EMS was called, he asked to lie down and was helped to ground into a recovery position. EMS arrived and took him for further evaluation.

Event free for 1 week then last night (1/23/21) experienced painful full body ache (no position could relieve discomfort so could not sleep) Felt queasy but not to point of throwing up Felt some acid reflux

After patient received the covid -19 vaccine, he reported: anxious, and does not feel good. We observed him for 15mins, after 15mins, patient reported he wants to pass out, developed cough and then he developed wheezing, his breathing is heavily, I gave him a dose of Epipen and called 911.

Dizziness and light headedness beginning approximately four (4) hours after injection. Currently (04/10/2021) experiencing mild light headedness and impaired ability to mentally concentrate and focus. Mild pain with palpation at injection site.

The patient called today to inform us he has adverse events on Saturday evening, 40 minutes after getting the Covid Vaccine, he had a sensation of floating, and 4 hours later sharp chest pain which occurred every 3 minutes , lasting 10-15 seconds for a duration of 3 hours, he could not move. then at 2am Sunday morning, he woke up gasping for air, he drank some water and tried drinking coffee which he spilled and blacked out, by Sunday afternoon he felt better, and today he is feeling a lot better

Chills started 7 hours after the vaccine. Chills, shivers & shakes went on for almost 8 hours that evening. I Could not eat dinner. I was weak and didn't feel good the next couple of days. Saturday 4/1012021 my left knee started hurting & still is bothering me.

J&J vaccine today, given at 10:30 am. Patient has allergy to bees, carries an Epi Pen. He was waiting for about 30 minutes after the vaccination when he started to complain of "feeling weird" to an RN whom performed his vaccination. Patient had confusion, slurred speech, left sided arm and leg weakness, altered mental status and severe shaking chills.

Janssen COVID-19 Vaccine EUA Days 1 & 2: extreme muscle fatigue and 100% bed rest. Days 3 & 4; fatigue and 100% bed rest. Days; 5 through 8; limited morning activity, 1/2 day bed rest. Days 9-10; very limited activity without exhaustion. Days 11-15; moderate activity with exhaustion

MELT DOWN; SHIRT WRINGING WET; ALLERGIC REACTION; BODY CHILLS ON/OFF; BURNING/CHERRY RED LEGS AND WHOLE BODY BURNING; ABDOMINAL PAIN; This spontaneous report received from a patient concerned a 61 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 batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced burning/cherry red legs and whole body burning. On APR-2021, the subject experienced abdominal pain. On APR-2021, the subject experienced body chills on/off. Laboratory data included: Audiogram (NR: not provided) Negative, and Blood test (NR: not provided) Everything came back negative. On 09-APR-2021 17:00, the subject experienced allergic reaction. On 15-APR-2021, the subject experienced melt down. On 15-APR-2021, the subject experienced shirt wringing wet. On 17-APR-2021, treatment medications included: pregabalin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from allergic reaction, burning/cherry red legs and whole body burning, body chills on/off, abdominal pain, melt down, and shirt wringing wet. This report was non-serious.

Fever, chills, generalized weakness after vaccine 4/27 4/28 altered mental status, hypotensive, tachycardic and admitted to the hospital

Sore arm - five or ten minutes after the shot - hurt right after but then it kind of subsided. It took a full month for the pain to stop - especially if pressed on. After two weeks, the pain in the arm migrated to the central right back. I could sleep on my right side only. Lasted about two days and then subsided. About a week or so after that, I was getting a throbbing pain on my left calf. That lasted a couple of days where it would intermittently start throbbing. I called the doctor. When I went in the symptoms has subsided but the doctor (on April 13) said to do an ultrasound if it returns. It didn't return so I have not had an ultrasound.

Foggy mentally. Slowed thought process. Dull headache. Back of head lower. Sides of head above ears. Seemed harder to focus mentally and visually. Aspirin works but symptoms still coming back after 4-6 hours when aspirin wears off.

VERY SLEEPY; FEELING IRRITABLE; SOAR ARM; FEELING TIRED AND FATIGUE; This spontaneous report received from a patient concerned a 61 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced very sleepy, feeling irritable, soar arm, and feeling tired and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soar arm on 03-MAY-2021, and had not recovered from feeling irritable, feeling tired and fatigue, and very sleepy. This report was non-serious.

For the first two weeks, there was only mild headache and fatigue. But on day 12 (or 13) following the shot, my husband had severe abdominal pain and black, tarry poop. He passed out on the toilet in the middle of the night and hit his head, woke up in a puddle of blood (from hitting his head) . He was severely lightheaded, short of breath, could not walk. He had to crawl back to bed. He continued to have severe lightheadedness, shortness of breath, muscle aches, abdominal pain, and also ringing in his ears. He called me early Saturday morning and told me what happened and that he called out from work. (We do not live together. He is 280 miles away because of his job.) That man has called out sick only one time since I've met him in 1998; so when he told me he did not go to work, I knew it had to be really bad. I drove up there ASAP the same day, and I took the pulse oximeter with me. His oxygen levels were all over the place. They were usually better (like high 70s to low 80s) while he was lying down. When he would sit up or stand up, the number would plummet, reading so low I thought he was going to die. One time his finger was so cold that it took me 4 tries to get a reading. It read at 55, but I realize that might be because his finger was too cold.

The day after the vaccine I was working and later in the day I started to feel dizzy. Within an hour and a half I could not stand up and I was very dizzy. My coworkers said my eyes rolled back in my head. The ambulance transported me to the ER and my Blood Pressure was at 80 Systolic. I was given fluids and I was discharged after five hours. I still couldn't work the next day and I was still really tired for the rest of the week. It seemed to take a couple of weeks to feel normal but the fatigue was extreme for the first week after the episode of dizziness. I have two autoimmune diseases and a history of blood clots so I might not have gotten the Janssen vaccine if the risk was known. The blood thinner I was taking at the time might have helped but my blood pressure on discharge was still only 110/60.

Almost immediately after patient sat down in observation chair after vaccine administration, he stated he was feeling extremely dizzy and light-headed. He also became extremely sweaty and cold/clammy to the touch. Took his blood pressure and it was 80/56 mmHg. HR was 49 bpm. Grabbed him some cool cloths to apply to his face/head/neck. He stated he was extremely anxious about the vaccine as he has an extremely phobia of needles & thought this may have contributed to the event, but was not sure. After a few minutes, he began to feel better. He stopped sweating, skin warmed up and he was no longer dizzy or light headed. By the time his 15 minutes were up, he was back to normal again.

The afternoon after receiving the vaccine I had a job interview at 1:00PM EST and I wasn't certain I could make it because I felt a little off. I drank a bottle of water that was offered and I started feeling lightheaded and worse. As soon as I stood up, I thought I was going to fall so I sat back down. I waited around for about an hour before leaving. I stood up and felt a little better, but still a little off. I felt okay enough to drive and went to my interview. Once I got to the building, I had no clue how I got there. I completed my interview and remember leaving the building and sat in my car for a long time. I don't remember how I got home. I walked into my apartment and I lay on my bed and didn't wake up until the next morning. In the morning I went to my kitchen and grabbed more water. My ears started hurting, my head starting hurting and I felt off. I called and made an appointment with Dr. and informed her that I did not feel right. She wasn't sure if my feeling was from the vaccine or if it was a sinus infection. She gave me vancomycin 160mg capsule and tobramycin 20mg capsule. I feel that the shot is what messed me up. I felt like someone stuck a pencil in my ears. I felt like I wanted to sleep all the time. I also had chills in 65 degree weather. I had to have the heat on in my house. I'm still feeling a bit of pain around the injection site.

dementia like feeling occurred after 2 days , worse after 4 and still has slightly , joint and muscle pain. pt very concerned about this

After a week from shot, developed itchy rash and red pimples on legs. Spread to torso, shoulders and back. Unable to sleep at night. Lasted for over 2 weeks; thank God is finally subsiding. Not a happy person!

Fatique, joint pain, tunnel vision, memory fog. Bad tunnel vision (4 by 4 range) Severe memory fog (called doctor) Bad word recall, poor eye hand cordnation, poor cordnation, balance. 6/23/2021 went back to work, had trouble walk and stacking crates. Very tired, severe joint point. Had to leave work. Felt disoriented

sat-ok, sun sore arm weak sleep all day,mon tired weak left arm restricted tues tired left arm weak bad headace wed seem better left arm weak, sharp pain in center chest slightly labored breating, thur severe pain still in center chest like something is stuck. the pain subsided , fri sore area center chest , tired. seem better sat tired weak. have been slow and weak since. through july . otherwise ok but tired and sleeping alot.

Pt claims to have lockjaw and has visible edema. Claims this has been going on for three weeks. He also claimed he had serious fatigue and fell asleep doing daily tasks. He states this is interfering with his ability to work as he is "always in a daze." Patient also has had trouble speaking and had visible facial paralysis (but not bilateral facial paralysis).

5/23 chills,headache, sore throat, diarheah, vomiting, cough, low energy 5/24 Seen doctor given steriod and antibiotic injections, prescribed prednisone and antibiotics. Condition improved for a few days but never went away. Then condition started to worsen as energy and breathining became worse. condition continued to decline as breathing becomes more labored and energy level dropped more. had to stop working as condition worsend. couldnt walk 20 feet without having to stop and rest. i was out of breath and struggling. decided to see doctor again. 6/17 seen doctor and given steriod and antibiotic injections again. given new scripts for prednisone and antibiootics. condition did not improve. more to add

Chest pain, loss of energy, no sleep, loss of consciousness while walking, coughing, change in bowel movements, weight loss.

went to bed, got chills for half the night then got hot and was uncomfortable most of the night with stomach ache and little or no sleep

Day 1: 11 hours after injection - severe fatigue, dizziness, diminished ability to mentally focus, severe weakness in legs and diminished ability to control legs. Legs intermittently felt numb and at time with "pins and needles" tingling. Knee joints felt as if in danger of flexing backwards. Arms were similarly affected but not as drastically as legs. Arms had better function and control than legs but with marked weakness. Day 2: Some improvement. Able to go to work but still have fatigue and leg weakness persist. It takes additional mental and physical effort to walk. Walking does not feel automatic or safe like it was before. Still have high level of fatigue. Symptoms improve some later in the afternoon. Days 3

Janssen COVID-19 Vaccine EUA 2 1/2 days of severe flu symptoms. Nausea, Fever, Chills, weakness,no sleep. The next days nausea and light headedness Day 7 (today 3/20/2021) nausea, weakness, and fainting spells. Fainting spells include vision impairment (everything looks fuzzy like a bad tv reception).

patient was given covid vaccine. he stated that he had needle phobia. the vaccine was given without issue. he proceeded to the waiting room to be observed for 15 minutes. customer in line and technician at registered saw patient lost contentiousness briefly but quickly came back. pharmacist came immediately out to patient. he was confused and disoriented but responding appropriately to questions. 911 was called. pharmacist on duty stayed with and observed patient until paramedics arrived.

I have been experiencing severe pain in my joints, my shoulders and lower back are the worse. It's bad enough I can't sleep very well or even walk right.

Rapid Heart Beat above 90 bpm began 11 hours after covid-19 vaccine. Rapid heart beat was constant for just over eight hours. Could not sleep that night because of this. Fever was 101° stuffed up nose, swollen tonsils and extream body aches with joint pain lasted 24 hours.

WARMTH; BODY ACHES; CHILLS FOR 2 HOURS; FEELING TIRED; ANXIETY; This spontaneous report received from a patient concerned a 62 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced anxiety. On APR-2021, the subject experienced feeling tired. On 06-APR-2021, the subject experienced warmth. On 06-APR-2021, the subject experienced body aches. On 06-APR-2021, the subject experienced chills for 2 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from warmth, body aches, and chills for 2 hours on 07-APR-2021, and the outcome of anxiety and feeling tired was not reported. This report was non-serious. This case, from the same reporter is linked to 20210413340.

On 04/12/21 I had just eaten and sat down at the computer. I started feeling disoriented, light headed and my vision started to become affected. I could not focus my vision and tried to vomit also also but immediately went to bed. Throughout the day/night when i got up I was unable to walk/see as normal and required my hand on the wall for balance. I also felt nauseated and could not eat anything during this time. I was able to sleep mostly and as of this submittal(04/13/21 7:51 pm CT) i have been symptom free for several hours. No medical treatment was sought due to no health insurance. All symptoms indicate stroke .

First 72 hrs....Extreme joint stiffness, cramping, lower extremities ( both legs to feet) felt extremely hot, chills, , disoriented, weakness in legs while standing, and extreme fatigue. The fatigue and weakness has continued and now experiencing headaches and blurred vision with brain fog since the vaccine.

Very tired about an hour after the shot, Migraine woke me up a little after midnight, and then had a fever up to 102 and chills the rest of the 9th. I just rested on the 9th and by the 10th I was feeling better.

Patient received the Janssen vaccine on 3/17/21 at 4:42 pm. Beginning at 2:30 am on 3/18/21 the patient began to experience dizziness, vertigo, shaking, tremors, nausea, and vomiting. The shaking and tremors occurs all over but is most significant in the hands and arms leaving the patient unable to do simple daily tasks or return to work. These symptoms began 3/17 and have persisted every day since in varying severity. Sometimes the tremors last for more than 20 minutes straight. The patient was seen in the emergency department on 3/26/21 but the hospital notes are unavailable to the pharmacy at this time. Per patient, he had an MRI and no other tests and was given a prescription for ondansetron for nausea and discharged. The patient believes he was not adequately assessed and is still suffering from symptoms. He has a follow up with a primary physician 5/28/21 which is the soonest he was able to be referred.

-Nausea, Vomiting, Memory loss, headache, seizure - 4/12/2021 at 4 am -Seen in ED on 4/12/2021 and had a negative non-contrast brain CT -MRI 4/15/2021 showed a Nonpygenic thrombosis of intracranial venous system

Pt. Vaccination was March 5,2021, became immediately dizzy and light headed onsite paramedic walked with him around the site for observation and evaluation. Allowed to leave was fatigue and nap and when he awoke had the within 24 hrs . Tenetus increase dramatically in high pitch and intensity that was constant. Had disruptive sleep since the vaccine because of the ringing in ear. Average 4.5 and 5. Never straight sleep it is disruptive sleep. Three telehealth appt. March 26, 2021 because of anxiety because of the ringing.

My head felt like it was weightless! It felt two feet above my shoulders! No dizziness but a vacantness feeling. No confusion and no forgetfulness, just a weightless head. Also, beginning the 4th day, my upper teeth feel as though they were heavily flossed the night before...like swollen gums, but tight...in the Maxilla! They don't ache, they feel 'tight'!

4/9 thru 4/12, body aches, chills. 4/12 0400 throwing up stomach pain from dry heaving throughout the day, confusion starting at 6pm on 4/12. Seizure on 4/12 at 8 pm. 911, ambulance. to Hospital Seizure so severe caused a Fracture in the Right Scapula. MRI on 4/15 showed a venous thrombosis partial occlusion in the brain.

FELT OFF; FEVER; This spontaneous report received from a consumer concerned a 62 year old male. The patient's height, and weight were not reported. The patient's past medical history included sulfa allergy, and concurrent conditions included nonsmoker. 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 13-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included levothyroxine sodium for drug use for unknown indication, linaclotide, melatonin, and zolpidem tartrate. On 14-MAR-2021, the subject experienced felt off. On 14-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt off, and fever on 14-MAR-2021. This report was non-serious.

Flu-like symptoms chills fever up and down shortness of breath itchy skin dry cough shaky hands restless urinating frequently urination blood clotting in calves

His brother reporting that he got the vaccine, the following day he was coughing. The coughing caused him not to be able to sleep and was weak due to that. He could feel his throat closing and he was having a hard time breathing and he called his brother who told him to call 9-1-1. He was taken to Medical Center 4/17/2021, diagnosed with possibly COVID. He was admitted to the COVID ward and he died on 4/26/2021. The doctor that pronounced him was . Cause of death diagnosis. Hypoxic respiratory arrest, COVID 19

Feels bad; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included rectal surgery. The patient received covid-19 vaccine (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. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced feels bad. The action taken with covid-19 vaccine was not applicable. The patient recovered from feels bad. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case assessed as non serious.

Site: Pain at Injection Site-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Tingling was only located in fingers and hands. Patients Blood Pressure after event was recorded at 106/58. Patient states he naturally runs lower blood pressure and heart rate. Also mentioned that he has a fear of needles.. Patient is now responsive and feeling better.

Janssen COVID-19 Vaccine EUA. Severe headache in the night of Vaccine followed by vomiting. Sleepiness and disorientation the next two days. Hospital ER and discovery of bleeding in the brain and admission to the NICU

Patient received a J&J COVID-19 vaccination. 3 hours post immunization patient began to have cramps/hot feet. 3 days later he took some APAP because he wasn't getting better. 1 week later he began to experience congestion (pt suspected pneumonia). 1 week later- hurt all over and couldn't sit or lay down. Proceeded to go to ER. The ER admitted the patient for observation. He states they performed 4 X-rays & 2 lumbar punctures. States he had protein in his lumbar. Patient states his nerves are burnt in his legs. Doctor told him he would be in a wheelchair. States Sept. 1 st he will lose insurance because he is unable to work and needs disability.

Approximately two weeks (05/12/2021) after receiving the vaccine, I started to experience tightening in my legs all around. It felt like every time I would massage the cramps out of my legs, an hour later the muscle tightness/pain would come back. It was interrupting my sleep. I also experienced knee and hip pain along with the tightness in my legs. I also experienced some brain fog on and off for about 3 weeks. I visited my PCP on 05/19, but by 05/17 my symptoms had improved. On 05/18 my pain/tightness had gone away completely. I had to do vigorous stretches and I took 4 tablets of 200mg per day for a couple days.

Slept badly 9-Jul-2021. Woke up with strong flu-like symptoms - fuzzy headed, ears hot (probably fever, but thermometer broken), total lack of energy. Did not make it out of bed beyond bathroom visits and light snacks 9-Jul-2021 or 10-Jul-2021. More energy Monday 11-Jul-2021 and was able to work a few hours. I then noticed a lump on lower left neck jaw that looks like mumps, which I had as a child, and pox all over my body that look like chicken pox, which I also had as a child. I believe mumps/chicken pox symptoms began earlier, probably before the flu-like symptoms, but they were not yet severe and I did not carefully note them. Chicken pox has gotten worse through 11-12-Jul-2021 with over 100 pox, particularly bad on knees and elbows with about 70 in those areas alone. Prior to vaccination, I had taken only 1 sick day in over 20 years. I just don't get sick beyond minor cold-like symptoms.

ANXIETY/SLEEP ISSUES; This spontaneous report received from a patient concerned a 62 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: unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On MAY-2021, the subject experienced anxiety/sleep issues. Treatment medications (dates unspecified) included: melatonin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from anxiety/sleep issues. This report was non-serious.

PATIENT FELT TO KILL HIMSELF; RETINAL DETACHMENT, LOOSING VISION, BLINDNESS OF LEFT EYE; SORENESS/PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's past medical history included bilateral cataract surgery a few years ago, and concurrent conditions included glaucoma, COPD (Chronic obstructive pulmonary disease), smoker (a little less than a pack a day), and alcohol user (about 1 drink a day). The patient had allergies to some of previous COPD medications (but the patient could not recall which). The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A31A, expiry: unknown) dose was not reported, 1 total, administered on left arm on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the patient experienced soreness, pain at injection site after vaccination. On 13-APR-2021, 3-4 days after vaccination the patient started losing vision in his left eye. He visited his physician's office- primary care provider (PCP). He was referred to a specialist and was diagnosed with retinal detachment. It was reported that there was a slight vision improvement in his left eye since symptoms started. It was also reported that the patient was going blind from retinal detachment. The patient felt to kill himself (captured as suicidal thoughts), if he did not receive help for his condition. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from retinal detachment, loosing vision, blindness of left eye, and soreness/pain at injection site, and the outcome of patient felt to kill himself was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210738594-Covid-19 vaccine ad26.cov2.s- Retinal detachment, Patient felt to kill himself. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Pt was held for 15 minutes. Past 15 minutes, patient was ready to leave but complained of nausea. Asked pt to stick around. Took blood pressure. It was low ~90/55. Asked again how he was doing, stated okay but feeling chills/cold. Started to shake uncontrollably. Ask pt if he thought a hospital visit was necessary; he stated no at that time. Decision was made to call squad; BP was elevated now and still shaking. Transported at that time.

Four hour after injection I started to shiver almost uncontrollably. My temperature around midnight spiked to 103 and my heart rate was constant at 150. I was dizzy. Very little sleep. Temperature broke at 4:00AM

Dull lingering headache lasted approximately 30 hours. fatigue; slept for over 12 hours. Severe body / joint pain that started in mid back and spread to rest of body. Worst pain was focused in lower back, hips, knees and ankles. Climbing stairs was difficult. Facility nurse said my face was flushed but I had no fever. Symptoms were 90% gone shortly after headache subsided. I did need to call off of work on 03/07/2021.

3/16/2021 1330 Injection. No immediate adverse reaction. 1350 Discharged. 2100 Chills begin. 2200 Very mild nausea. 2230 Fever 98.9. (I usually run between 97.8 and 98.3). Also, mild joint and muscle aches (knees and shoulders). 3/17/2021 0100 - 0300 Nausea, retching, dry heaves, chills, sweats. Fever 99.7. 0300 - 0400 Unable to sleep. Would awaken with spasm of nausea upon nodding off. 0400 - 0430 Got to sleep, but woke with muscle cramps in both ankles. 0500 - 1000 Fitful sleep. 1000 - 2400 General muscle aches and low grade headache all day. 3/18/2021 0000 - 0500 Fitful sleep. 0500 - 0900 Restful sleep. 0900 Woke with just mild muscle aches. 1600 Side effects gone. No medical treatment sought. One night of discomfort worth it for protection against COVID.

After a few hours starting feeling like I had the flu. Fever continued to rise and topped out at 100.7 around 9 pm. Had severe chills where I was visibly shaking. Fever broke around 2 am and was severely sweating. Chills had mostly stopped by this time. Still continued with a slight fever until it once again broke around 10:30 am. Continued to get better throughout the rest of the day and finally returned to work on Thursday morning.

Within about 30 mins of getting the vaccine I felt a little dizzy/disoriented. This feeling passed within an hour. That night, 3/27 around 9 PM I began to feel cold as if I was running a fever and started having body aches. I did not take my temperature to see if I actually did have a fever. The symptoms lasted most of the night. The next day, 3/28 I had the flu-like symptoms again at night.

Started feeling ill a few hours after vaccination. Became increasingly ill over the next few days with nausea and vomiting, severe diarrhea, leg cramps that progressed to where he was not able to ambulate, flushed, confused.

Sx: Perfuse sweating, loss of consciousness, vomiting, inability to answer questions, decrease in HR, loss of color to face. Txt: HR, observation, patient remained seated as they were seated when they lost consciousness and were vomiting concurrently, 911 called, BP, HR taken Outcome: Post emesis patient regained consciousness within 2 minutes regained normal color and was alert and oriented

around 3 AM patient got dizzy and passed out. When I talked to patient at 6:30 AM, he stated to me that he was dizzy and fell during the night, his voice was very slurred and I could hardly understand him, he was also very disoriented. Took him to hospital ER around 7 AM

63 year old male with progressive weakness at bilateral faces and extremities, LEs > UEs, absent DTRs throughout x 2 weeks. Received J&J vaccine at 3 weeks ago. His current neurological examination and clinical history is suggestive of GBS NEUROLOGICAL EXAM: MSE: A+Ox 3 Language: no aphasia CRANIAL NERVES: 2nd CN: bilateral pupils are equal round and reaction to light, visual field-full 3rd,4th and 6th CN: EOM-I 5th CN: no sensory deficite 7th CN: face: symmetric, not able to smile or blowing air or holding water 8th CN: hearing loss: no 9, 10th CN: no dysarthria, palate movement:normal 11th CN: no neck weakness 12th CN: tongue: middle, no atrophy MOTOR EXAM: Tone: normal Strength: 4+/5 at bilateral UEs, 4 Pt symptoms started very early. Narrative from family below: "Day 1 (The day he took the vaccine): My father was complaining of very heavy chest pressure (said he felt like his chest was being pushed down with force.) He felt really tired and had a nasty headache. Day 2 He began to feel tingles in his legs and arms. Said he felt sore and had mild pain around his back, feet, legs, hands, and arms. The headache came in and out. Day 3 He began feeling more severe pains in both legs + headache. More tingling around his face, lips, and jaw. Day 4 Severe pain continued around his entire body. Had an episode where he lost vision from 1 eye (he described it as blurry vision) felt like he was going blind from one eye. Day 5 Could barely stand on his two feet and could no longer go to work. He stayed in bed and then hospital visits began. My mom took him to emergency for the first time. I was able to get details of the location where he was vaccinated and onsite contact information. The info is below:

3/16 - 3/23 : fewer ( 100 -101 F), headache. used Tylenol 3/24 : fewer, headache, nausea, vomiting. used Tylenol 3/25 : fewer, headache, watery eye. stayed in ER. diagnosed sinus infection. treated with Amox/clav 875mg-125mg; claritin; Tylenol 3/26 - 3/28: fewer, serious headache, double vision. continue used butal/apap/caf 50-325-40; Amox/clav 875mg-125mg; waiting for schedule MRI. 3/29 - 3/31: fewer, serious headache, double vision. stayed in hospital. continue used butal/apap/caf 50-325-40; Amox/clav 875mg-125mg.

SHAKES; COULD NOT SLEEP; HOT AND COLD CHILLS; COUGHING WAS DRY TODAY BUT PRODUCTIVE YESTERDAY (STUFF WAS COMING OUT); LUNGS WITH BURNING SENSATION LIKE BRONCHITIS; SORE LUNGS; COULD NOT STAND UP; STOMACH ACHE; BURNING ARM FROM SHOT; PAINFUL /SORE ARM; NAUSEA; FEVER; This spontaneous report received from a patient concerned a 63 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 expiry: 23/JUN/2021) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced shakes. On 06-APR-2021, the subject experienced could not sleep. On 06-APR-2021, the subject experienced hot and cold chills. On 06-APR-2021, the subject experienced coughing was dry today but productive yesterday (stuff was coming out). On 06-APR-2021, the subject experienced lungs with burning sensation like bronchitis. On 06-APR-2021, the subject experienced sore lungs. On 06-APR-2021, the subject experienced could not stand up. On 06-APR-2021, the subject experienced stomach ache. On 06-APR-2021, the subject experienced burning arm from shot. On 06-APR-2021, the subject experienced painful /sore arm. On 06-APR-2021, the subject experienced nausea. On 06-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not sleep on 07-APR-2021, and lungs with burning sensation like bronchitis, stomach ache, and burning arm from shot on 11-APR-2021, was recovering from painful /sore arm, had not recovered from hot and cold chills, shakes, nausea, fever, and coughing was dry today but productive yesterday (stuff was coming out), and the outcome of sore lungs and could not stand up 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.

Exactly two weeks after my one and only J&J vaccination shot my "shot arm" developed deep, dull, and persistent aching lasting for about two weeks. Sometimes I was unable to sleep and over the two weeks took 2 or 3 Advil per night to get to sleep. After about two weeks the pain receded and has gone and stayed away. But no surface indications on skin, no restrictions in range of motion...just persistent, deep, ache. I have subsequently spoken with a friend who also took the J&J shot and reports the SAME symptoms.

UNKNOWN CAUSE OF DEATH; ELEVATED HEART RATE; HYPER RESPIRATIONS; FLU LIKE SYMPTOMS; MENTAL CONFUSION; WEAKNESS WORSENED; This spontaneous report received from a consumer concerned a 63 year old male. The patient's height and weight were not reported. The patient's pre-existing medical conditions included the patient did not had medical and underlying condition and was healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 041A21A, expiry: Unknown) frequency one total, dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The patient was not taking any concomitant medications. On 03-APR-2021, the patient experienced elevated heart rate, hyper respiration, flu like symptoms including chills, weakness, fatigue, cough; the patient also had mental confusion and nausea. He was called in urgent care centre and they treated him with over the counter medications, Tylenol (paracetamol). On 16-APR-2021, the patient died due unknown cause. The daughter stated that she was taking him to emergency room the day he passed away. It was unknown if the autopsy was performed. The cause of death was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of unknown cause on 16-APR-2021, had not recovered from mental confusion, and the outcome of weakness worsened, elevated heart rate, hyper respirations and flu like symptoms was not reported. This report was serious (Death).; Sender's Comments: 20210439259-COVID-19 VACCINE AD26.COV2.S -Unknown Cause Of Death. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH

One week after vaccination, I had to all 911 and was put in the hospital, I had a stroke, I had a blood clot in my brain, and severe abdominal pain, and terrible headache where the clot was, I couldn't see, my legs weren't working right. My head was sensitive on the right side, like a tingling and sore to touch, then the headache started in the center of my head. I stayed in the hospital for 3 weeks. I'm home but have slurred speech and I use a walker now.

Swollen knot on left arm, Pain that travels from my left arm across my shouders into my neck, stiff neck, Left hand and finger numbness, Confusion, Painful joints, Pain in previous broken bone sites. Fatigue. Sleeplessness.

Combine a status asthmatic event lasting with a serious sinus and chest cold as well as occasional racing heart. That is how I felt. It felt like sudden pneumonia and chronic bronchitis onset. The second day was very serious in the third day and the fourth day I started to regain strength. I received an antibiotic on day 2 after my vaccine. I went from my normal daily activities to bedrest for 3 1/2 days straight. I called out sick from work because of it. I'm glad I was well versed with my chronic illnesses because it helped me handle the adverse event that started after receiving my vaccine. I feel that if I was a normal person I would have gone to the hospital.

DIFFICULTY BREATHING; LOSS OF APPETITE; DIFFICULTY SLEEPING; UNABLE TO TAKE KIDNEY MEDICATIONS; This spontaneous report received from a patient concerned a 63 year old male. The patient's weight was 180 pounds, and height was 75 inches. The patient's concurrent conditions included kidney failure, dialysis, non smoker, and marijuana drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 882A286 expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced difficulty breathing. On MAY-2021, the subject experienced loss of appetite. On MAY-2021, the subject experienced difficulty sleeping. On MAY-2021, the subject experienced unable to take kidney medications. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the loss of appetite, difficulty breathing, difficulty sleeping and unable to take kidney medications was not reported. This report was non-serious.

SLEPT ALOT; NOT FEELING WELL; FATIGUE; BODY TEMPERATURE OF 99.3 DEGREES FAHRENHEIT; LUNGS FELT HARD TO BREATHE; DIARRHEA; BAD BODY ACHES FROM HEAD TO TOE; VOMITING; HEADACHE; NAUSEATED; This spontaneous report received from a health care professional concerned a 63 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included cancer diagnosis: cutaneous lymphoma, and other pre-existing medical conditions included the patient had no respiratory issues, still maintained 92 oxygen saturation, but could not take care of himself and went out of it in 2 weeks. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 203A21A, expiry: 23-JUN-2021) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On DEC-2020, Laboratory data included: Body temperature (NR: not provided) 102 F. On 2021, Laboratory data included: Oxygen saturation (NR: not provided) 92 %. On MAY-2021, the subject experienced vomiting. On MAY-2021, the subject experienced headache. On MAY-2021, the subject experienced nauseated. Laboratory data included: Oxygen saturation (NR: not provided) 93-98 %. On 28-MAY-2021, the subject experienced lungs felt hard to breathe. On 28-MAY-2021, the subject experienced diarrhea. On 28-MAY-2021, the subject experienced bad body aches from head to toe. On 28-MAY-2021, the subject experienced not feeling well. On 28-MAY-2021, the subject experienced fatigue. On 28-MAY-2021, the subject experienced body temperature of 99.3 degrees fahrenheit. Laboratory data included: Body temperature (NR: not provided) 99.3 F. On 29-MAY-2021, the subject experienced slept alot. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient recovered from lungs felt hard to breathe, and diarrhea on 28-MAY-2021, had not recovered from bad body aches from head to toe, fatigue, and body temperature of 99.3 degrees fahrenheit, and the outcome of not feeling well, slept alot, headache, vomiting and nauseated 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 was assessed as non-serious.

Desorientation while working at design work in computer Sudden weight loss -muscle mass Tiredness Extremely often urination Demotivation

FEELS LIKE SOMEONE PUNCHED IN THE ARM AND IT THROBS AT NIGHT; ARM FEEL WEAK AND LIMITS WHAT CAN DO; ARM HURTS ALMOST CONSTANTLY; PAINFUL SHOT/ARM REALLY HURTS IN THE INJECTION SITE AREA/THE SEVERITY OF THE PAIN FLUCTUATES; This spontaneous report received from a patient concerned a 63 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: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced painful shot/arm really hurts in the injection site area/the severity of the pain fluctuates. On an unspecified date, the subject experienced feels like someone punched in the arm and it throbs at night, arm feel weak and limits what can do, and arm hurts almost constantly. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from painful shot/arm really hurts in the injection site area/the severity of the pain fluctuates, arm feel weak and limits what can do, arm hurts almost constantly, and feels like someone punched in the arm and it throbs at night. This report was non-serious.

Patient received Janssen vaccination on his right deltoid via intramuscular injection at 16:40. At 16:41 while sitting outside under shade, patient experienced an episode of delayed awareness that lasted about 5 seconds. Patients vital signs were monitored and patient mental status was accessed. Patient regained awareness of person, tome, place, and event however stated that he often had syncope episodes after stressful experiences. Patient denied ambulance services called in his behalf and family members proceeded to take patient home under watch for any continued or worsening conditions. Patient and family were educated to contact emergency services if condition did not improve.

Site: Bruising at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Mild, Additional Details: Paramedics and Firefighters came out. Gave him 1 liter of normal saline. His heart rate was in the 30's. They stablizied the patient and took him to hospital.

Exhausted, no energy, no motivation, not wanting to get out of bed or go to work. Maybe depression from shot

I was up all night with chills, fever (101+) and severe headache. The headache is what kept me from being able to sleep. I wasn't sure if it was ok to take otc pain meds so I waited until morning (9:30 am) to call my doc. Fever had subsided, but still had intense headache. Doc told me to take 2 extra strength Tylenol which I did. Headache was relieved within 45 minutes. I was able to sleep. Felt much better afterwards although still struggled with fatigue and mild headache for approx 80 hours following vaccine.

Chills, fever 100.1 deg F, headache, stiff neck, loss of appetite, joint and bone pain, sciatica, throbbing kidneys, unable to sleep

I was driving a car and suddenly I experienced extreme blurred vision and disorientation. the event lasted for about 2 minutes. It then cleared up with no lingering ill effects.

Felt like I had a bad flu. 12 hours after injection. woke at 12:30 AM with Bad headache, chills, had low grade fever. no energy. slept on and off from 12:30 AM to 4:00 PM on Friday. Had to miss work on Friday, and I never call in sick, it was bad. Felt a bit better the next morning, 4-10-21. went to work, still not right but better

Symptoms: numbness/tingling and cold skin all over body (both sides of body), headache, facial droop, blurry vision. Stoke, CVA.

I received the shot and waited there about 15-20 minutes after before returning home. No issues at that time. About an hour after the vaccination, I began to lose my mental function. My brain/mind were not functioning properly - to the point that I could hardly remember my name, let alone do anything on the computer that I was attempting to do. At about that same time, I had a feeling of near complete exhaustion come over me, to the point of thinking I might faint at any moment. I went to my bedroom and laid down. I fell asleep shortly there after and woke up approx 2.5 hours later. After waking, I felt normal again. I was able to process my thoughts and did not feel faint or exhausted any more. It has been 1 month today since having the shot. I have not felt any additional adverse affects to this point, other than the several hours after the shot. On a side note, I had not been sick prior to the shot or in the several months leading up to the shot. I have also not been sick since the shot. It was only the several hours on the day of the shot.

TINGLING HAND; SHAKING INSIDE; NO ENERGY; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 64 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 tingling hand. On 08-APR-2021, the subject experienced shaking inside. On 08-APR-2021, the subject experienced no energy. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, tingling hand, fatigue, and no energy, and the outcome of shaking inside was not reported. This report was non-serious.

INSOMNIA; INJECTION SITE REDNESS; FATIGUE; MYALGIA, MUSCLE PAIN; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 64 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 expiry: UNKNOWN) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced injection site pain. On 29-MAR-2021, the subject experienced fatigue. On 29-MAR-2021, the subject experienced myalgia, muscle pain. On 07-APR-2021, the subject experienced insomnia. On 07-APR-2021, the subject experienced injection site redness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site pain, fatigue, myalgia, muscle pain, insomnia, and injection site redness. This report was non-serious.

DIZZINESS; VERTIGO; SPINNING AND FALLING SENSATION; FELT OFF; This spontaneous report received from a patient concerned a 64 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had not known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced dizziness. On 19-MAR-2021, the subject experienced vertigo. On 19-MAR-2021, the subject experienced spinning and falling sensation. On 19-MAR-2021, the subject experienced felt off. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from dizziness, vertigo, spinning and falling sensation, and felt off. This report was non-serious.

4/8/21 pt had brain fog like he was in a haze and felt strange being very relaxed like he had taken a tranquillizer he felt better next day. pt seemed to be fine at this point. 4/22/21 pt seemed to be fine and went to the store where he went shopping. He put shopping bags in car. He was found in his car after and hour and 20 minutes by a couple of bystanders unresponsive. 911 was called and he transported to ER. He was intubated but patient died. Unknown is any test were performed.

Guillain-Barre Syndrome - mild case. Tingling, numbness up entire legs more prominent in feet. Mild back pain. No weakness. Some numbness and paresthesias hands. Restlessness.

64 yo M with PMHx HTN, HLD, Diverticulitis s/p sigmoid colectomy 6/2020, and Hep C who presented as a transfer from hospital due to acute onset R sided weakness with ICH found on CT scan. History taken from patient bedside. Around 8pm last night 4/27, patient felt acute onset of numbness and weakness to his right lower extremity as he was coming out of the shower. He then tried to sleep and had a restless night. He noticed ataxia with his right leg as he tried to walk around. In the morning, his right upper extremity became numb and weak as well and he decided to go to the ED. Upon arrival, CT Head showed "Acute hematoma of L Lateral thalamus 2 x 2.6cm with surrounding edema and mass effect".

Within 48 hours began to ache at major joints, experience lethargy. Following weeks joint pain ebbs and flows but remains constantly higher than before the vaccine. It isn't debilitating, but it does interfere with the quality of life and activity. I reported the issue to my pain management provider, and we are monitoring it at this time to see if it will subside.

FALLEN SEVERAL TIMES; BARELY MOBILE; DIFFICULTY SPEAKING; SHORTNESS OF BREATH; BARELY ABLE TO SLEEP; HEADACHES; FEVER; This spontaneous report received from a patient concerned a 64 year old male other race and unspecified ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 in total administered to right deltoid on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced fever, headaches and shortness of breath. He stated that he was barely mobile (severe discomfort, feels like a handicapped, needs assistance to do anything) after receiving vaccination about 2 months ago. He felt like a handicapped person who needs assistance to do anything. He was barely able to sleep and found it difficult to speak. He stated he had fallen several times after receiving the vaccine. On an unspecified date, he had been hospitalized at 2 different hospitals and both instances did not help with his symptoms. He stated his HCP was aware and he could not help. He sounded to be in severe discomfort and as stated several times to fix it. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from barely mobile, fever, difficulty speaking, shortness of breath, headaches, fallen several times, and barely able to sleep. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: - fallen several times, barely mobile, difficulty speaking, shortness of breath, barely able to sleep. 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). - headaches, fever. This event(s) is labeled per RSI and is therefore considered potentially related.

07/08/21 I woke up with a really bad headache. I have never had a headache like it. Lasted 3 daysSo far. Today being the 3rd. Cold chills, congestion and really tired. Got the shot on the 7th, started feeling miserable on the 8th. Actually left my keys walked away from my job. That night I was up and down just wanting some relief. It could have felt worse for me because I don?t normally experience headaches. Feel some what more comfortable today.

On Friday, March 12, 2021, at the pharmacy I had an 8:00 am appointment to receive the Johnson & Johnson?s Janssen COVID-19 Vaccine. I received my vaccine in the left arm but the injection seemed to me (and my wife) to be in an odd location, which was very high up on the shoulder near the shoulder joint. Things seemed fine until Saturday evening when I started to feel some tightness in my left trapezius between my scapula and my occipital bone. By Sunday morning that same area was very tight and painful; what we used call a ?crick.? Sunday afternoon I began to feel some sharp pain in my left shoulder joint. I had very little sleep on Sunday night and by Monday morning I had significant pain in what felt like my humerus. I made an appointment with a chiropractor for Monday afternoon and he suggested the vaccine shot might have started an inflammation that led to the tight trapezius, which in turn was causing the cervical spinal nerves to react, thus causing the pain in my arm. At this point I was in a lot of pain and the pain was moving further down toward my elbow. The chiropractor did his usual things and told me to put ice on it and take OCT Ibuprofen and or Naproxen. I was a bit better on Tuesday and decided to attend a three-day pastors? retreat. By Tuesday afternoon the pain had expanded to just below my elbow. I consulted with a doctor friend and he thought it was likely that I was having a reaction to the vaccine and that it would pass. He as concerned to hear of the odd location of my injection. I had another sleepless night and on Wednesday I noticed that the ends of my left thumb and index finder were numb and by that night the numbness had expanded to include most of my index finder. The other arm and shoulder pain continued but varied in intensity. On Wednesday morning I called my wife and asked her to come get me at the retreat and that afternoon I called my doctor's office office and made an appointment for Thursday morning (3-18-21). I'm feeling the cumulative effects of the pain and fatigue. My overall pain level is a little less but still present, as is the numbness in my index finger and thumb. My doctor suggested the nerve inflammation was a reaction tot he vaccine.

Serious increase in tinnitus since vaccination. Can?t sleep. Tinnitus started when contracting COVID in December. Had that with vertigo. Vertigo has passed. Tinnitus is a 4out of 5 and is debilitating.

The day after the shot, I felt real tired for at least a half day. My hands tingled on and off, which felt strange and kind of went up my arms slightly. I also felt slightly nausea on and off through the day. I had a slight headache most of the day, which seemed to make my head feel a little warm. About 22 hours after the shot, I felt norm

memory loss of all events that happened that day. For a 3 hour period patient could not remember what had happened that day at work, his appointments after work, that he had gotten hearing aids 2 weeks prior and that he had ever seen or worn hearing aids. He was very confused for about 3 hours. I called our doctor and he advised me to take him to the ER, it took me 45 minutes to get him there and by that time his memory was back. He has never had a problem like this before and I thought he might be having a stroke or something. there was definitely something severely wrong.

Extreme dizziness to the point of falling down even when attempted to just sit up, lasting around18 hours. Extreme headache with mild fever and other flu like symptoms. The reason why I am reporting this is that in my entire live I have have been so dizzy and unbalanced. I literally could not even sit up, I was super foggy and achey. By 3 days all the symptoms cleared.

I spoke to patient by phone on Saturday morning around 9:20am. He was concerned about the fatigue, nausea, headache, chills, and muscle aches he had the night before. He felt better when I spoke to him. He wanted to know when those side effects would go away finally. Since I had the Moderna vaccine I said 24 to 36 hours. But I didn't know about the J&J vaccine. We disconnect the call at 9:40am Saturday morning. After the call at some point he fixed lunch or dinner and stopped eating before finishing his meal. He had left the food on the table and in the pans he fixed it in. Very unusual for him. The patient then went to his room where is was found Monday 3/22/21 around noon in his bed laying on his chest (he hated to lie on his chest) by the police and the HR officer from his work. The HR officer had called my other brother around 11:15am on 3/22 /21 to ask if we had heard from the patient because he had not reported to work or phoned in. He has passed sometime between noon on Saturday till Sunday evening alone at his residence. He had towels and a trash can beside his bed when he was found. The coroner call it death by natural causes and would not do an autopsy when even asked by his PCP.

Friday, approximately 5:00 pm, my wife and I were leaving home to drive to grandson's baseball game. Out of the house and on the driveway I became confused, couldn't speak, felt "clammy" and began to perspire, and couldn't drive. My wife was asking me questions and I couldn't answer wedding date, her DOB, etc. The symptoms disappeared after 10-15 minutes but I felt almost the same as the minimal symptoms I had with my Covid positive, January 14. (My Covid experience resembled having a Cold).

Patient presented to clinic 9 days after vaccination in acute distress, shivering, tachypneic and having difficulty with speech. Heart rate at 130 beats per minute, Spo2 91% on room air, temp 99.9f oral. Initial difficulty obtaining blood pressure due to shaking. Patient was treated with 500mL NS and 2L O2 via nasal cannula, which immediately improved symptoms. Due to elevated glucose and minimal austere conditions, patient was evacuated from camp to hospital. There, patient diagnosed with COVID-19 infection, bilateral basilar and right apical pneumonia, diabetes and sepsis.

Muscle in shoulder is still very painful. Hard to lift arm over my head. Hard to take off a shirt and make certain motions.

I'm dizzy a lot. It comes and goes through out the day. Sometimes I'm dizzy all day long. Sometimes I'm not dizzy at all. But it's more often than not. This started a few days after the vaccine and I'm still experiencing it. It's kind of a floaty, unstable feeling. I didn't put two and two together at first. I've been to my doctor two times.

On April 16 patient came home fatigue, pale and legs hurting. The next day complained of right knee pain, Fatigue and looked pale. He woke up in the middle of the night complaining of right calf tightness and pain. On Sunday 18th he started to limp and when we looked at his calf it was double in size, warm to touch, and redness. We then went to the ER and had an ultrasound and CT scan . We were told he has multiple blood clots in the right leg and clots in both lungs. He was then transported to a hospital and given blood thinner shots in stomach. He was released from the hospital 4/20 and given blood thinners and assigned a hematologist. He?ll be on blood thinners 6-12 months, out of work a month and tested regularly to check platelets.

Horrible instant pain when give. Started to feel suck in two hrs . Still very sick, very weak and cant do anything . Get winded .

Patient received the Johnson & Johnson COVID vaccine on 4/11/21 and developed dyspnea, fevers, and nonproductive cough about 2 days later. He continued to feel worse over time and presented to urgent care on 4/22/21. He had a chest X-ray done which showed bilateral infiltrates and he was found to be hypoxic, so he was sent to the ED. Patient was then admitted to the hospital for COVID treatment since he required 4 L O2 in the ED.

pt had severe vomiting with red color and an order it. He had massive pain in his leg. Patient had loss of appetite, nausea, and headaches. His eyes were rolling in the back of his head, which this symptom would come and go. He would have hallucinations. On unspecified date Pt woke up screaming the house was on fire and there was a dog by the bed and a person in the closet, talking out of his head. An ambulance came and brought him to ER. Pt coded in the ambulance and brought back. Pt was coherent upon arriving to the ER. He had to be intubated and bagged and died about 15 minutes later. Pt had blood work which was totally out of whack. Family was told they did not understand what had happened to him. The only thing the family could think of that was different was he had recently been vaccinated.

About three weeks after the vaccine, I started to experience an inability to concentrate. I had Diarrhea and a low grade fever for one day and I couldn't concentrate. I started to have symptoms of depression that I do not normally have. I felt restless and I had trouble sleeping. I was very aggravated, and I was having repetitive thoughts. I had trouble working and my brain was a little. It went on for two weeks. I have had a few more episodes since then but it is much better.

PATEINT RECEIVED THE VACCINATION ON 5/21/2021 AT 1330 HOURS. BY 5/22/2021 HE HAS REPORTED THAT HE HAS DEVELOPED PERIPHERAL NEUROPATHY IN BOTH OF HIS HANDS THAT HAS PROGRESSIVELY GOTTEN WORSE OVER THE LAST 6 DAYS. TODAY HIS HANDS HURT SO BAD THAT HE CAN HARDLE ZIP UP HIS PANTS AND CANNOT LIFT MOST OPTIONS. ANYTHING THAT PUTS ANY PRESSURE ON HIS FINGERS OR HANDS CAUSES PAIN. AT THIS TIME, I AM GOING TO CONTACT HIS PHYSICIAN TO SEE IF INCREASING HIS GABAPENTIN WILL BE OF ANY BENEFIT AND IN THE MEANTIME WE ARE STARTING SCHEDULED APAP 1000 MG QID AND NAPROXEN 440 PO BID-TID UNTIL A PHYSICIAN CONSULT CAN BE MADE. CONDITION DOES NOT APPEAR TO BE LIFE THREATENING AT THIS TIME, HOWEVER THE PATIENT IS EXTREMELY DISABLED AT THIS POIN AS USE OF EITHER HAND FOR COMPLETION OF DAILY ACTIVITES IS EXTEREMLY LIMITED.

It's difficult to say when I first started with this adverse reaction but it was at least 3 months ago. I have experienced uncontrollable itching since then. I have also lost my taste/smell for many foods such as coffee, hamburgers, hot dogs, snacking chips/dip, and normal smell of meat cooking. I experienced a low grade fever (100.6) and chills on the night of March 19 (date I received the vaccine shot) and March 20, 2021. I don't like to go to the Doctors' but I see that I have been seeing the doctors over 11 times since I received the J&J vaccine shot. I am miserable with the itching and it seems that I am very anxious now. The itching occurs mainly at night all over my body--and lately, it has begun to itch on my forehead and face. It is all over my body. I thought I should get this information to you in case someone else is experiencing it. I began my quest to stop this itchy feeling with my primary doctor. She prescribed hydroxyzine 50 mg. I take 1 pill every 6 hours as needed for anxiety. She also ordered buspirone 10 mg 1 pill 2xday but it makes no difference so I will not refill it. I told my doctor that I would go to a dermatologist next for relief. That's how I began going dermatologist. So it has been since around March 30, 2021 that I have been trying to stop the uncontrollable itch. Just not sure if the vaccine caused this problem but I highly suspect that it did.

cold, shivering as if with a fever yet no fever present along with sore leg muscles, a long hot shower relieved the symptoms temporarily but they lasted till approx. 3AM. Then waves of oversensitivity with knee and foot joints hurting as if arthritis, and this lasted most of the night. I also experienced strange hallucinations in the night as if I had a high fever but I don't believe I had a fever, and I also had a migraine and neck pain. The arm where the vaccine was applied is fine and not sore at all. I also have a slight soreness in my stomach as if I had been coughing for a while, which was not the case. It is now 11:34 AM the following day and I believe I'm getting back to my normal self but it sure was a rough night and I though you should be aware.

Body chills. In going to bed I had heavy clothing, bathrobe and multiple blankets to offset the chills. During the night I woke up overheated and bathed in sweat. Got up to go to the bathroom for BM but was nauseous, feeling need to vomit at the same time. After BM I stood and still felt need to do one or the other or both when I passed out. Wife came upstairs and found me sitting up against the corner wall. She was able to shake me awake while calling 911. I was groggy but aware I was still nauseous and stayed down next to toilet until stomach settled. I came downstairs and EMTs arrived. Took blood pressure. Result was it was low. Took EKG and that was normal. Second blood pressure test showed that I rebounded. When offered I felt it unnecessary to go to hospital.

Started feeling bad two=three days after shot, became fatigued, lost 15 pounds and could not go to work. On morning of 4/21 was found unresponsive and rushed to hospital where he died 2 hours later

pt says on 4/8/21 he got chills and dry cough. On 4/9/21 day he got body aches and pain w/chills. He had loss of appetite and had no taste. On 4/10 he developed night sweats. By 4/11/21 he was not able to control his bladder. On 4/12/21 he had diarhea. He went to Urgent Care. They did Covid Test, blood work and X-ray w/ negative. He was given a shot of penicillin. He was prescribed Cefuroxime Axetil 200mg. He feels like he is getting better but still has no taste. Pt says he has never felt like this bad in his life.

By 10:00 pm that evening I got Chills, fever, muscle aches, headache, nausea and low back pain. Stayed home from work for 1 or 2 days. Felt better in all ways except my low back got very, very painful. I asked my wife to buy me a walker to take to work because I had difficulty walking the distance from the parking lot to inside my office. Also used the walker at work. My boss said to go home, it looks like you're in pain. Saw Dr. on Monday March 15 because the low back was getting worse. He prescribed muscle relaxors and anti-inflammatory medicine. Called the next day asked for something stronger for pain because worse. Nurse responded to continue on existing meds. Went to Chiropractor on both March 16 and 18 without back pain relief. On March 19 went to urgent care, got X-ray and pain meds. MRI done 2 days later on March 21st which revealed a spinal abcess. Admitted to Hospital, surgery done to remove spinal abcess on March 22. Bacteremia, laminectomies in L3,4,5 S1 to relive spinal cord pressure. Puss had the filled spinal epidural cavity, cultured out as Strep bacteria. Remained hospitalized until April 2nd. Sent home for 1 night then returned to hospital via ambulence the next day April 3rd with 103 degree fever. Discharged April 8th. Readmitted to hospital for 3rd time on April 17 where I remain today with Kidney and liver function problems likely reactions to meds. Continue to have excruciating low back back which is why continues to be hospitalized at the time of this report.

has the following symptoms: mild dyspnea;myalgia;headache;anosmia/dysgeusia Date of symptom onset: 05/08/21

DECREASE MOBILITY IN SHOULDER; UNABLE TO WORK; DEPRESSED; SEVERE SHOULDER PAIN; This spontaneous report received from a consumer concerned a 66 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient was in good health. patient had undergo physical therapy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown expiry: UNKNOWN) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced decrease mobility in shoulder. On 2021, the subject experienced unable to work. On 2021, the subject experienced depressed. On 2021, the subject experienced severe shoulder pain. Treatment medications (dates unspecified) included: ibuprofen, paracetamol, cortisone, prednisone, and hydrocodone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe shoulder pain, decrease mobility in shoulder, unable to work and depressed was not reported. This report was non-serious.

Per patient via phone call on 6/1/21: Woke on Sunday, 5/23/21 with high fever, sweats and swollen veins on hands. Went to ED on 5/25/21. At that time, he thought he had an infection "eating him away from the inside". Now he believes, after thinking about it, that it must be a reaction to the COVID vaccine he received on 5/21/21. He stated that he still has weak, cramping hands and swollen veins in his hands.

PAIN IN LEFT SHOULDER RADIATING ALL THE WAY DOWN FOREARM INTO DIGITS AND EXTENDS INTO THE SHOULDER; SUSPECTED INAPPROPRIATE ROUTE OF VACCINATION; DIZZY; SWELLING AT INJECTION SITE; INTENSE PAIN AT THE INJECTION SITE THAT SEEMS TO HAVE GOTTEN WORSE; UNABLE TO SLEEP AT NIGHT DUE TO PAIN; LARGE HEMATOMA AT INJECTION SITE; UNUSUAL AMOUNT OF BLOOD IN ARM AFTER INJECTION; This spontaneous report received from a patient concerned a 66 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug usage. The patient was treated with covid-19 vaccine (intramuscular, and 205AZ1A, serial number, model number, UDI number, and expiration were not reported) therapy dates not reported for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the patient experienced large hematoma at injection site, unusual amount of blood in arm after injection, unable to sleep at night due to pain, swelling at injection site, and intense pain at the injection site that seems to have gotten worse. Laboratory data included: Pain scale (NR: not provided) 7/10. On 08-MAY-2021, the patient experienced pain in left shoulder radiating all the way down forearm into digits and extends into the shoulder, suspected inappropriate route of vaccination, and dizzy. Treatment medications (dates unspecified) included: hydrocodone, and ibuprofen. The action taken with covid-19 vaccine was not applicable. The patient recovered from pain in left shoulder radiating all the way down forearm into digits and extends into the shoulder on MAY-2021, and dizzy on 08-MAY-2021, had not recovered from intense pain at the injection site that seems to have gotten worse, large hematoma at injection site, and swelling at injection site, and the outcome of unusual amount of blood in arm after injection, unable to sleep at night due to pain and suspected inappropriate route of vaccination was not reported. This report was non-serious. This case is a duplicate of 20210544916.; Sender's Comments: V0-Medical assessment comment is not required as per standard procedures, as the case was assessed as non-serious.

Fever, delirium, unable to control body temperature, searing headache, pervasive, unrelenting nausea,

Two weeks after receiving vaccination, severe dull ache began in right shoulder. Pain is sometimes in shoulder blade, shoulder (deltoid), right upper arm (bicep area). Pain is worse at night, enough to cause sleeplessness and inability to lie on right side. Pain somewhat eased by Tylenol or Tylenol/ Advil. Pain has not subsided or lessened since it began three weeks ago. I am an active healthy male in excellent health otherwise. I exercise regularly, maintain a healthy weight and have no chronic conditions.

Fever, chills, sore achy joints, night sweats, excessive urination, insomnia. Got some temporary relief with Acetaminophen. Symptoms lasted about 14 hours.

About 7pm I started feeling terrible chills and headache. by 10pm I had extreme body aches, bones , muscles, etc. Headache was very intense,eyeballs ached ,face etc. I was dizzy, jaw was stiff but mostly terrible pain. had some wheezing by it went away when I coughed up mucus. Had a 101.5 degree temperature all night which went down to 100 in the morning and back up to 101.2 later on the 14th. I had nausea and extreme pain all over my body and restlessness. it got a little better the next day but still feels like I have the flu. I had covid back in march of 2020 and was tested for the antibodies at the end of August. There is a horrific dearth of research on people who have had covid and whether they should get the vaccines. It is disgraceful, and the next time I will listen to my gut which told me NOT to get vaccinated!

Started that day with sore right arm, felt weird, following day it got worse, extremely tired no energy, slept all day, later in day had fever of 100, fever only lasted a couple hours, next day still felt tired but improving

One day after the vaccine I had extreme muscle and join pain all over body, general malaise, fever. This lasted for about 3 days. About 10 days post vaccine, the symptoms returned with a ferocious energy. The pain in my muscles and joints is so severe that I can't roll over in bed, have difficulty walking, and getting on and off the toilet. It interrupts my sleep so that I play musical bed-chair-couch throughout the night. Needless to say, it exacerbates the level of pain and fatigue I'm already experiencing. It is life debilitating as I cannot participate in my usual daily activities of walking, hiking, gardening, biking, etc. As a result of joint and muscle stiffness, I am also now experiencing headaches. These extreme conditions have persisted from March 23- April 9...and I don't see relief in the future.

LIGHTHEADED; FELT STRANGE; BRAIN FOG; SORE ARM/ARM FEELS PUNCHED; FELT UNWELL; TIREDNESS; LOCAL REACTION / REDNESS; This spontaneous report received from a patient concerned a 67 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid19 infection, and concurrent conditions included high blood pressure, and white coat syndrome. 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 10-APR-2021 for prophylactic vaccination. The batch number was not reported the company is unable to perform follow up to request batch/lot number. No concomitant medications were reported. On NOV-2020, Laboratory data included: SARS-CoV-2 test (NR: not provided) Positive. On APR-2021, Laboratory data included: Blood pressure (NR: not provided) Elevated. On 10-APR-2021, the subject experienced lightheaded. On 10-APR-2021, the subject felt strange. On 10-APR-2021, the subject experienced brain fog. On 10-APR-2021, the subject experienced sore arm/arm feels punched. On 10-APR-2021, the subject felt unwell. On 10-APR-2021, the subject experienced tiredness. On 10-APR-2021, the subject experienced local reaction / redness. Laboratory data included: Blood pressure (NR: not provided) Low grade 100. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lightheaded, felt strange, brain fog, and felt unwell on 10-APR-2021, and was recovering from tiredness, sore arm/arm feels punched, and local reaction / redness. This report was non-serious.

Mild fever, chills, fatigue and brain fogginess I first 36 hours. At 48 hours developed temporary hives, swelling, ichiness in right abdominal area and genitals. This took two additional days to resolve with no subsequent recurrence.

DIZZINESS; FEELING HIGH; WEAKNESS; This spontaneous report received from a patient concerned a 67 year old male. The patient's weight was 167 pounds, and height was not reported. The patient's past medical history included blood clots, and concurrent conditions included flu shot and weed smoker. 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 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced dizziness. On 09-APR-2021, the subject experienced feeling high. On 09-APR-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, and weakness, and the outcome of feeling high was not reported. This report was non-serious.

DOUBLE VISION; SHORT TERM MEMORY LOSS; LACK OF ATTENTION; COGNITIVE DEFICIENCIES; HEADACHE; POSSIBLE INFARCTION DUE TO RECENT EVENT; This spontaneous report received from a health care professional concerned a 67 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) dose was not reported, 1 total, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-MAR-2021, the patient experienced headache and dizziness. On 15-MAR-2021, patient had experienced double vision, trouble reading, lack of attention, short term memory loss and cognitive deficiency. One or two days later, (possibly on 16-MAR-2021), the patient visited emergency room and his computerized axial tomography (CAT) scan was normal. In MAR-2021 (a week after), the patient's symptoms got worsened and he consulted primary care physician. The patient underwent magnetic resonance imaging (MRI) scan which showed possible infarction due to recent event. It was reported that, the patient was yet to visit cardiologist and neurologist for follow up on the MRI scan. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 18-MAR-2021, had not recovered from double vision, short term memory loss, lack of attention, and cognitive deficiencies, and the outcome of possible infarction due to recent event was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210427306-covid-19 vaccine ad26.cov2.s-possible infarction due to recent event. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

The Headache/Pressure is there in the morning, and I feel fatigued, like I really didn't get any rest in the night., And the headache/pressure stays with me all day., But I don't believe it wakes me in the night, I did developed blurry vision, but only in one eye (right)., I went to Eye doctor, and they said it appeared a cataract had developed since the last visit. but the blurry vision has somewhat improved with reduction of the blood pressure., as far a dizziness., I would not feel comfortable going out and flying a plane since the covid vaccine shot, so I'd say I am a little unstable on my feet right now.....

Nauseous, vomiting, headache, light headed, disorientation, vision changes, jaw pain, lymph node inflammation, lethargy, mental confusion, sense of hopelessness, 15 days taper Prednisone, ibuprofen, acetaminophen, still currently experiencing symptoms today

extreme fatigue, shortness of breath with exertion, weakness in arms and legs with tremors. occasional word finding problems , and cognitive fog. Startle reflex.

To ED via ambulance for chest pain and shortness of breath. Decompensated during transport, hypoxic, cyanotic, hypotensive. Intubated in ED. CTA of chest positive for saddle embolism. 1/2 TPA/heparin given. Admitted to ICU. Change in mental status, CT of head showed intracranial hemorrhage. Patient had reportedly been sick about a week or 2 earlier, covid positive PCR on admission to hospital.

Pain in top of head, blurred vision, weak, tired, diarrhea, confused; lasted about 10 days; symptoms came on about 45 minutes after injection.

Approx. 1 week after vaccine administration, developed severe pain in my right shoulder area. The right arm received the vaccine. No pain prior. All felt well. Went to see primary care doctor who said I have sub-deltoid bursitis possibly from vaccine shot. Gave me an injection of Triamcinolone (steroid) in my right shoulder. This was done on 6/8/21. Today is 6/15/21 and still have pain but not as severe as initially. Still hurts when moving my shoulder or right arm. I can hear snapping noises in shoulder area when I move my arm around. Difficult to sleep due to the pain. Have been doing range of motion exercises. I Notified public health about bad rxn. but no one has yet returned my call

DId not know body site of injection Worsening confusion, exposed at a birthday party daughter wanted patient to come in / patient was very cofused per daughter patient is poor historian dry cough at exam considelation on right lower love on chest x-ray patient did an infusion on 7/12 casirivimab-imdevimab patient was admited on 7/18/2021 to hospital.

april 20th his foot started to hurt, April 21st his legs felt slightly weak, April23 & 24th felt sick had a hard time getting out of bed and dressing. April25th felt numb mid body and legs really weak had a hard time standing took him to the ER had a MRI on Back and Bloodwork done. April 26th saw his doctor ordered another MRI for head and neck. April 27th had MRI for head and neck. April 28th rushed to hospital symptoms got worse and was admitted also had a CAT scan and an MRI again. April 29th another MRI was diagnosed with GILLIAN-BARRE syndrome. Had six doses of IGG transfusions May 6th moved to rehab. was in Therapy till June 10th and Back to the hospital for 5 more treatments because his legs quit working again. WAs in the hospital for a week and then insurance denied therapy so had to find skilled nursing, found one moved him . He was at his new place maybe 8 hours then rushed back to the Hospital because a fever and may had an infection had medician to help get rid of that lost his facility he came from and then took a week to find another place he was there 3 weeks and had a EMG and the nerves in is legs are Damaged in and out so he will take a long time to heal and walk again and he is also very depressed because the whole situation.

3/16: Tired late evening, poor sleep overnite. 3/17: Upper body aches and very tired, sleeping a lot during day. Body aches and low fever (99) in evening. Sleeplessness, body aches, mild chills overnight. 3/18: Body aches and tired daytime. Aches and low fever (99-100) in evening. Poor sleep, aches, chills, sweated out (fever?) overnight. 3/19: Felling better daytime. Still some tiredness. Mild body aches. No fever. Better sleep overnight. 3/20-23: General feeling of tiredness but getting better. Have noted some difficulty keeping good train-of-thought (also noted by spouse). I do have a lot to keep up with. 3/24: Still have a feeling of delayed recovery in general, but improving.

Initial complaints were of a headache and dizziness, follow by unsteady gait, confusion and eventually was unresponsive.

This was the Johnson&Johnson vaccine. I had covid in January, and this was similar to having it all over again. Awoke night of vaccination at 0130 with bad case of chills and shakes. Awoke again at 0330 with same. Took an ibuprofen at that time, which ameliorated problem. Had a headache for 36 hours. Awoke in the morning exhausted with headache. Next evening, awoke in the middle of the night with soaking wet PJs. Still lethargic and not feeling normal 48 hours later.

I developed pressure in my head in about an hour after receiving the vaccine, and this continued for approximately 8 days. I also had violent shivering, chills, fatigue, and insomnia. Now, I still have a little fatigue and insomnia still a problem.

SEVERE INSOMNIA; ELEVATED HEART RATE; CHEST PAIN; STOMACH ACHE; WEAKNESS; WHOLE BODY SHAKING; SWEATING; SEVERE PSYCHIATRIC REACTION; SUICIDAL IDEATION; HEAD TURNED INTO A CLOUD; EXCRUCIATING PAIN IN THE PALM PART OF LEFT HAND NEAR THUMB; FRONTAL LOBE HEADACHE, TO THE LEFT AND RIGHT OF FRONT LOBE; This spontaneous report received from a patient concerned a 68 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and nonsmoker. The patient had no known allergies or drug abuse. The patient's genetic test showed he came from all around the world. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, 1 total dose administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, 1.5 hours later, the patient experienced "severe brain symptoms". He has developed several incidences of severe insomnia (no sleeping pills have help), for which has been awake for 24 hours at a time. He experienced head turned into a cloud, frontal lobe headache, excruciating pain in the palm part of his left hand near his thumb in which he had previously injured. On 20-MAR-2021, he developed severe psychiatric reaction to brain, he could not have control over his body, and he was afraid of the Psychological Evaluation Team. His health care professional (HCP) deployed a team to arrest his for-psych evaluation. On Mar-2021; event head turned into a cloud was resolved. On 09-APR-2021, he developed most severe symptoms of entire body shaking, nervous feeling of shaking, weakness, sweating profusely, unsure if he has a fever or not. On an unspecified date, he also developed stomach aches, elevated heart rate, chest pain and weakness. There were days where his heart rate was high around 160 bpm for 3-4 days in a row (normal 80-100 bpm). His chest pain was still ongoing. Laboratory data (dates unspecified) included: Heart rate increased (NR: 80 - 100) 160 BPM. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from head turned into a cloud, had not recovered from frontal lobe headache, to the left and right of front lobe, excruciating pain in the palm part of left hand near thumb, suicidal ideation, severe psychiatric reaction, severe insomnia, whole body shaking, weakness, sweating, and chest pain, and the outcome of elevated heart rate and stomachache was not reported. This report was serious (Other Medically Important Condition, and Life Threatening).; Sender's Comments: V0: 20210420137 - COVID-19 VACCINE AD26.COV2.S - SUICIDAL IDEATION. This event is considered Unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

Facial pain or headache becomes more severe, drowsiness or confusion , swelling of the forehead or eyelids, vision problems including blurred and double vision, seizure, dry mounth nausea tiredness constipation, double vision Diplopia, one aye is affected, vertigo, speech or walking

LOWER INTESTINAL DISCOMFORT; FOGGY THINKING; FORGETTING THINGS; DIARRHEA; HOT EAR; COULD NOT SLEEP; NAUSEA; HEADACHES; INJECTION SITE PAIN; INCORRECT PRODUCT ADMINISTERED; ARM PAIN; FELT LIKE POSTICTAL PHASE OF EPILEPSY; DISORIENTATION; DAZE/FEELING WONKY; ITCHING; OVER-SENSITIVE SKIN; FACE FEELING "SUNBURNED"; This spontaneous report received from a patient concerned a 68 year old male. The patient's height, and weight were not reported. The patient's past medical history included polycythemia year diagnosed, and concurrent conditions included frontal lob partial focal epilepsy, recovering alcoholic, nicotine free, vegetarian, anaphylactic shock to contrast dye, no alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no any drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Concomitant medications included oxcarbazepine for frontal lob partial focal epilepsy. On 06-APR-2021, the subject experienced felt like postictal phase of epilepsy. On 06-APR-2021, the subject experienced disorientation. On 06-APR-2021, the subject experienced daze/feeling wonky. On 06-APR-2021, the subject experienced itching. On 06-APR-2021, the subject experienced over-sensitive skin. On 06-APR-2021, the subject experienced face feeling "sunburned". On 06-APR-2021, the subject experienced incorrect product administered. On 06-APR-2021, the subject experienced arm pain. On 06-APR-2021, the subject experienced headaches. On 06-APR-2021, the subject experienced injection site pain. On 07-APR-2021, the subject experienced nausea. On 13-APR-2021, the subject experienced hot ear. On 13-APR-2021, the subject experienced could not sleep. On 16-APR-2021, the subject experienced diarrhea. On 18-APR-2021, the subject experienced foggy thinking. On 18-APR-2021, the subject experienced forgetting things. On 19-APR-2021, Laboratory data included: Blood pressure (NR: not provided) 111/70 mmHg, and Body temperature (NR: not provided) 96.7 F. On 20-APR-2021, the subject experienced lower intestinal discomfort. Treatment medications (dates unspecified) included: ibuprofen, cortisone, hydrocortisone, and hydroxyzine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from itching on 19-APR-2021, arm pain on 06-APR-2021, and headaches on APR-2021, was recovering from face feeling sunburned", had not recovered from nausea, and the outcome of injection site pain, disorientation, daze/feeling wonky, felt like postictal phase of epilepsy, over-sensitive skin, diarrhea, foggy thinking, forgetting things, hot ear, lower intestinal discomfort, could not sleep and incorrect product administered was not reported. This report was non-serious.; Sender's Comments: MAC comment: V0; Medical Assessment comment not required per standard procedure as the case is assessed as non-serious.

day after vaccination had violent headache. chills, extreme muscular, joint pain, nausea., eyes glossed over, disorientation, dizziness . had weakness in left arm [site of vaccination and left leg .didn't take anything. only ate 2 dry english muffins. day 2. same with marginal relief. day 3 woke up at 4 am with sweats. clothes soaked with sweat. violent diarrhea . at 9 am. still have some disorientation, glossy eyes. afraid to eat because of diarrhea. had 2 , 2 liters of room temperature coke for previous 2 days. now 6 hours later somewhat better feeling.

Patient's body was found on May 1st. Since the shot , he was complaining of tinnitus, sore legs, dizziness (passed our several times), loss of bowel control, and unable to maintain a stream of thought, which are stroke symptoms. He has had surgery for blood clots in the past. He seemed to get worse in the weeks following the Jansen shot.

4/15/2021: Severe headache, hip/joint pains, Nausea & vomiting. Mobility & balance issues, unable to walk or stand, tinnitus & extreme fatigue, change is mental status. *tinnitus, fatigue, nauseous feeling and balance problem & sudden depressed feeling continuous for weeks. 5/20/2021: severe neck pain and neck stiffness. Fatigue, nausea, tinnitus, confusion & mood changes

FUZZY FEELING IN HEAD; WEAKNESS IN LEGS; NUMBNESS BEGAN TO TRAVEL AROUND THE REST OF THE BODY/ NUMBNESS SPREAD TO TOES/ NUMBNESS IN RIGHT LEG; SCREECHING IN EARS; SHARP PAIN ON TIP OF LEFT TOE; TIGHT BAND AROUND HIS LEFT CALF; LUMP IN LEFT CALF; MILD BURNING SENSATION; LOT OF PRESSURE IN HEAD; FELT VERY TIRED/ EXTREME TIREDNESS; This spontaneous report received from a patient concerned a 68 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcoholic, and non-smoker, and other pre-existing medical conditions included the patient was not on any medication or diagnosis before taking the vaccine, no known 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, batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced mild burning sensation. On 12-APR-2021, the subject experienced lot of pressure in head. On 12-APR-2021, the subject experienced felt very tired/ extreme tiredness. On 13-APR-2021, the subject experienced tight band around his left calf. On 13-APR-2021, the subject experienced lump in left calf. On 13-APR-2021, the subject experienced screeching in ears. On 13-APR-2021, the subject experienced sharp pain on tip of left toe. On 30-APR-2021, the subject experienced numbness began to travel around the rest of the body/ numbness spread to toes/ numbness in right leg. On 19-MAY-2021, the subject experienced fuzzy feeling in head. On 19-MAY-2021, the subject experienced weakness in legs. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild burning sensation on 12-APR-2021, lump in left calf on APR-2021, and screeching in ears on 13-APR-2021, had not recovered from felt very tired/ extreme tiredness, lot of pressure in head, tight band around his left calf, sharp pain on tip of left toe, and numbness began to travel around the rest of the body/ numbness spread to toes/ numbness in right leg, and the outcome of weakness in legs and fuzzy feeling in head was not reported. This report was non-serious.

FLU LIKE SYMPTOMS; EPISODES OF DIARRHEA EVERY 1 WEEK; WEAKNESS WITH UNCERTAIN CAUSE; ABDOMINAL PAIN; ABDOMINAL BLOATING; ANXIETY REACTION; DEPRESSION; FEELS LIKE DYING/FEELS LIKE SHIT INSIDE; POSSIBLE DEHYDRATION; VERY FRUSTRATED; This spontaneous report received from a patient concerned a 68 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, thyroid disease, all grass allergy, trees allergy, non alcohol user, and non smoker. The patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination into left arm. The batch number was not reported and has been requested. The patient was under 6 to 7 other medications which are not related to these symptoms. On 07-APR-2021, the patient had begun experiencing diarrhea which lasted approximately a couple of days and then it went away, and the patient had begun feeling fatigued, weakness with uncertain cause, nausea. Every once a week the patient had claimed having a diarrhea episode. In Apr-2021. the patient had abdominal pain, abdominal bloating and it has been consistent. The patient rates abdominal pain a 9/10 on a scale of 1-10, 10 being the worst. The patient felt like these are flu like symptoms. The patient had about 7-8 emergency room (ER) visits because of these symptoms. The patient does not remember the exact dates. In 2021, the patient stated he felt like shit inside, developed depression, possible dehydration, felt like dying, anxiety reaction and very frustrated. On an unspecified date, the patient was hospitalized for diarrhea, abdominal pain, abdominal bloating, weakness for uncertain cause, fatigue and nausea. The patient narrated he has hospital records. The patient was prescribed with an unspecified anti-emetic medication and it has not been effective. The patient had a planned follow up with his primary health care professional (HCP) on 06-JUN-2021. The patient was even looking into palliative hospice care might be into a mental health ward. The patient was very concerned that his symptoms have now lasted approximately two months. The patient stated they took his vitals, electrocardiogram (EKG), computerized tomogram (CT) scan and did testing on him and they could not find nothing wrong with him and they cleared him. The patient had stated that a rehab nurse would be coming out to his house to do some blood work, a physical on him. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from abdominal pain, abdominal bloating, weakness with uncertain cause, flu like symptoms, episodes of diarrhea every 1 week, depression, anxiety reaction, feels like dying/feels like shit inside, possible dehydration, and very frustrated. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210604777-covid-19 vaccine ad26.cov2.s-abdominal pain, abdominal bloating, flu like symptoms, episodes of diarrhea every 1 week. 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). V0: 20210604777-covid-19 vaccine ad26.cov2.s-weakness with uncertain cause. This event(s) is labeled per and is therefore considered potentially related.

ACHY; MIGRAINE HEADACHE; COULD NOT DO ANYTHING; STARTED FEELING TIGHT IN ARMS; MUSCLE ACHES; FATIGUE; This spontaneous report received from a patient concerned a 68 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: 1808609, and expiry: 09-JUN-2021) dose was not reported, administered on 01-APR-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced achy. On 02-APR-2021, the subject experienced migraine headache. On 02-APR-2021, the subject experienced could not do anything. On 02-APR-2021, the subject experienced started feeling tight in arms. On 02-APR-2021, the subject experienced muscle aches. On 02-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achy, migraine headache, could not do anything, started feeling tight in arms, muscle aches, and fatigue on 03-APR-2021. This report was non-serious.

BODY ACHES; BODY TEMPERATURE 95.5 F; LETHARGY; NOT FEELING LIKE HIMSELF; CHILLS; HEADACHE; FEELING WORSE; This spontaneous report received from a patient concerned a male of unspecified age. 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: 1821286, expiry: 23-JUL-2021) dose was not reported, administered on 14-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced feeling worse. On 15-JUN-2021, the subject experienced body aches. On 15-JUN-2021, the subject experienced body temperature 95.5 f. On 15-JUN-2021, the subject experienced lethargy. On 15-JUN-2021, the subject experienced not feeling like himself. On 15-JUN-2021, the subject experienced chills. On 15-JUN-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 95.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body temperature 95.5 f on 17-JUN-2021, and had not recovered from headache, body aches, chills, lethargy, not feeling like himself, and feeling worse. This report was non-serious. This case, from the same reporter is linked to 20210651363.

After five days, I experienced a lot of pain and was hospitalized. The pain returned and I was recently hospitalized as well. I feel heart pains and don't feel the same, fatigue and extreme nervous.

Pt felt like he was going to pass out - seemed to go in and out of consciousness for a few minutes but then was fine

3/17 vaccination Later that evening, I got little sleep, tossing and turning. The next day I was achy, arm hurt. That night I noticed loud ringing R ear; screeching noise. As the days went on, it calmed down but there 24 hours a day. I waiting 4-5 days and then saw PCM. No infection, no blockage. Referred to ENT; hearing test. Hearing test came was fine, ears look good. No cure for Tinnitus. I did go buy a white noise machine to help sleeping at night. It is there 24 hours a day.

BODY ACHE; DID NOT SLEEP WELL; CHILLS; FATIGUE; This spontaneous report received from a patient concerned a 69 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 //2021 for prophylactic vaccination. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On //2021, the subject experienced body ache. On //2021, the subject experienced did not sleep well. On //2021, the subject experienced chills. On //2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, did not sleep well, chills, and fatigue on //2021. This report was non-serious.

symptoms began the next day (April 3) and continue to the present... exhaustion, difficulty staying awake / falling asleep during the daytime, confusion, disorientation, severe headaches, sensitive to sound and light

WEAKNESS, ALLERGIES, SICK, COULD NOT SLEEP FOR DAYS, BODY PAIN, THEN I HAVE TO GO TO THE HOSPITAL WITH AN INFECTION. VISITED THE ER.

On April 6th at 8:30am, wife noticed her husband had facial drooping and slurring of speech, and left hand weakness. He was taken to Good Hospital.. Upon arrival a CT was performed, in which it was confirmed a right middle cerebral infarction. He was then transfered priority to a Trama Hospital for a thrombectomy by Dr. This was successful in removing the clot. He spent 3 days in ICU and then moved to progressive care. Pt is on his 13 day in the hospital where he is no longer able to care for himself. He now has behavioral disturbances, aggitation, confusion, delium, halluciantions. He is under Psychiatric care, physical, occupational, and speech therapy.

RLE swelling starting ankle then progressed to knee. Associated with pain in the Achilles tendon with ambulation. Severe enough to prevent sleep. Went to the ER and was evaluated. Given dose of lovenox and had formal doppler on 4/19/21 which showed no DVT. The pain and edema have improved but not resolved yet. There were no injuries around this time to explain the edema or pain.

INSOMNIA; FEVER; MUSCLES SORENESS ON THE BACK; FATIGUE; LIGHT HEADACHE; This spontaneous report received from a patient concerned a 69 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported. On 06-APR-2021, the subject experienced insomnia. On 06-APR-2021, the subject experienced fever. On 06-APR-2021, the subject experienced muscles soreness on the back. On 06-APR-2021, the subject experienced fatigue. On 06-APR-2021, the subject experienced light headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from insomnia, fever, and light headache on 06-APR-2021, and had not recovered from fatigue, and muscles soreness on the back. This report was non-serious.

Hives 3/15/21: patient reported rash to arms day after injection; seen by APRN-CNP for rash to lower extremities with open areas and oozing. Referral to Dermatology. 3/18/2021: Seen by ( Dermatology) for 4 large spots on legs. Rash was present for approximately a month but became bigger since J&J shot with addition of hives; rash present on arms 4/1/2021: punch biopsy of hives' instructed to use Sarna lotion for itching, start; Diprolene twice daily for 2 weeks on, 2 weeks off, and 2 weeks on.; rash now present on arms and new sores forming on lower legs. Report showed hypersensitivity reaction. 4/9/21: patient hives worsening. Provider contacted patient PCP,. . Kenalog-40 injection given. Hydroxyzine HCl also prescribed to be taken TID as needed for itching. 5/10/21: PC with provider . Hives had returned. Still using Zyrtec, ointments and Sarna cream; recommended increase of Zyrtec to BID; Referral to allergist pending

PAIN ALL OVER BODY, FROM ANKLES UP TO HEAD (WORST BACK, CHEST NOT GOOD); SLEEPLESSNESS; FEELING LIKE DYING, NOT MAKING IT; SHORTNESS OF BREATH; NOT EATEN ANYTHING IN DAYS; This spontaneous report received from a patient concerned a 69 year old male. The patient's height, and weight were not reported. The patient's past medical history included horrible accident, right femur replaced, both ankles replaced, both knees replaced, and fuse lower back, and concurrent conditions included artificial hip, blurry vision, ptds (post traumatic demoralization syndrome), and panic attacks. 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 10-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced pain all over body, from ankles up to head (worst back, chest not good). On MAY-2021, the subject experienced sleeplessness. On MAY-2021, the subject experienced feeling like dying, not making it. On MAY-2021, the subject experienced shortness of breath. On MAY-2021, the subject experienced not eaten anything in days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain all over body, from ankles up to head (worst back, chest not good), and the outcome of sleeplessness, feeling like dying, not making it, shortness of breath and not eaten anything in days was not reported. This report was non-serious.

I experienced 3 strokes consecutively. First one came when I was sitting in the couch and they took me to the hospital. They took me in and we stayed there for about 2-3 days (Can't focus) and then they dispatched me. I was pretty messed up. Then I spent like the next 2 weeks with micro strokes. I didn't know what was going on and went back to the hospital only for them to send me back home. Shortly after that, I saw Dr. and told him that I wasn't feeling well and went home. At about 4 o'clock I took a shower and didn't feel well. My wife drove me to the hospital and when I went I couldn't do anything. I got shots for strokes and took me to a bed. That is where I stayed and saw Dr. who told me that I got a stroke. I stayed there for 3 days and they sent me home. By now, I have lost my eyes, speech and it is really hard to focus or remember everything. I was going to a speech therapist and walk funny. I was stumbling at home.

PASSED OUT ABOUT 15 MINUTES; DOES NOT REMEMBER ANY OF IT; RASH ALL OVER HIS BODY; This spontaneous report received from a patient concerned a 70 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, once in total administered on 18-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. In MAR-2021, the patient broke out in a rash all over his body and passed out and was out for about 15 minutes or more. The patient's neighbor helped to get into bed. The patient does not remember any of it and don't know if it was vaccine or whatever was wrong with him. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rash all over his body, does not remember any of it and passed out about 15 minutes was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210347765 and 20210347766. Version created to amend previously reported information on 21-MAR-2021. Upon review, following information was amended: The case upgraded to serious and new event passed out about 15 minutes added in case.; Sender's Comments: V1: Version created to upgrade case to serious with event (passed out about 15 minutes added). 20210342307-Covid-19 vaccine ad26.cov2.s-passed out for about 15 minutes or more. 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).

UPPER RESPIRATORY ISSUE; INSOMNIA; FATIGUE; INTERMITTENT HEADACHE; This spontaneous report received from a patient concerned a 70 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included morphine allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: 25/MAY/2021) dose was not reported, administered on 12-MAR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced insomnia. On 13-MAR-2021, the subject experienced fatigue. On 13-MAR-2021, the subject experienced intermittent headache. On 28-MAR-2021, the subject experienced upper respiratory problem. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, upper respiratory problem, insomnia, and intermittent headache. This report was non-serious.

Muscle pain at site of injection making it difficult to sleep. No known injury to the affected area and has been ongoing for about 3 weeks.

I had the shot on Tuesday and had a headache early friday morning, when I woke up my wife noticed that my left side of my face looked like it was sagging. By saturday i was unable to close my eye and my speech began to slur.I began to have a headache and my condition remanined the same through Sunday. I went to urgent care on Monday 9/15/2021. I was diagnosed with Bells Palsy and perscribed Predinson and Valacyclovir Iwnet to my primary Doctor o 9/16/21.When the medication ran out I contined to have headaches and it was difficult to sleep at night do to the pain. On 9/31/21 got a refill fo the predinson (7 tablet). The headaches continued. I saw my doctor again ON 4/06/21. Perscriptions (x2) refill

Arm pain and continued muscle and nerve pain. Waking up at night / taking ibuprofen to get back to sleep. Still persisting a month later

The patient received the Janssen vaccine lot # 1808980 in his left deltoid muscle at 1250pm on the side of the road from our mobile foot team. He was seated on the sidewalk during vaccination and remained seated for his observation period. At 1301 the patient said he felt "fuzzy," and "light headed" but said "I do not feel like I'm going to pass out." The patient refused to lay down. He was offered a mat or the back of the car to lie down on. He was also given water by RNs and a snack by the police. He drank a few sips of water and refused the snack. His BP was 150/100, HR 76 and regular per palpation, RR 16 and unlabored. No signs of respiratory distress. The patients skin was dry and color was appropriate for ethnicity. At 1306 the patient said " I feel the same, a little light headed." RNs and asked him to describe what he meant by light headed as he still denied feeling like he was going to pass out. He said "I feel dizzy." RNs asked patient if he felt like he was spinning but he said no. BP 158/90, RR 18 and unlabored, HR 74 and regular per palpation. Pt still declined to lay down. At 1311 the patient still felt the same. RNs asked the patient to lie down again. The patient agreed to lay down in the back of the car. The patient stood up and said he felt short of breath upon standing. He has a Hx of COPD and said that he often feels SOB when he first stands. He took his own Ventolin Inhaler before laying down in the back of the car with the air conditioning on. It was 1316 when he laid down and vitals were taken again. BP 130/90, HR 70 and regular per palpation, RR 18 and unlabored. At 1321 the patient said "I feel a little better but still light headed and my head is throbbing but I get headaches every day." Vitals: 138/90, HR 70, Spo298%. At 1326 the patient tried to sit up but became flushed and said he felt "weird." Vitals were 144/90, HR 75, RR 18, Spo2 97%. RNs assisted the patient to lay back down. At 1328 RN asked the police to call 911 while RN placed a call to our lead RN. Vitals were taken again at 1331 BP 150/90, RR 18 and unlabored, HR 81, Spo2 98%. At 1337 the paramedics arrived with the ambulance and resumed care. The patient was transported to Hospital.

Patient experienced severe diarrhea, sore arm, achey joints, fatigue, depression, chest and lung pressure, injection site pain, leg pain. 2 to 3 weeks after the vaccine, patient experienced tinnitus and head pressure Patient noticed a blood pressure increase

On Thursday, March 18, I had some slight dizziness during the day. After going to bed that night I woke up and the night light in the smoke alarm on the ceiling appeared to be spinning. I sat, then stood, grabbling walls for support and attempted to reach my recliner. At that point I was severely dizzy, completely lost any sense of balance and collapsed into the chair. I could not stand or walk. After 20 minutes, I asked my wife to call an ambulance. I did not think she would be able to get me into our car. The paramedics ran an EKG and tested me for a stroke. Both were normal. I was transported to the ER. The doctor gave me Meclizine. Had a CT scan of my brain, and blood work. All results normal. Dizziness resolved. They tested my balance and then released me at 3:30 a.m. on March 19. I was tired that day, but did not need further medication. During that night, as I turned over in bed, the vertigo returned. I took a Meclizine and went to the recliner for the remainder of the night. I am feeling somewhat fuzzy today, March 20. Not sure how long this will continue, or if it is related to my Covid vaccination. However, I am reporting it in the event that others may be experiencing this problem as well.

FELT A LITTLE WEIRD; LITTLE TROUBLE FALLING ASLEEP; FELT SLIGHT WEAK; SORE AT THE SIGHT OF THE NEEDLE STICK; This spontaneous report received from a patient concerned a 71 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: 1805018, and batch number: 1805018 expiry: 25-MAY-2021) dose was not reported, administered on 15-MAR-2021 14:00 to right arm for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced felt a little weird. On 15-MAR-2021, the subject experienced little trouble falling asleep. On 15-MAR-2021, the subject experienced felt slight weak. On 15-MAR-2021, the subject experienced sore at the sight of the needle stick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt a little weird, little trouble falling asleep, felt slight weak, and sore at the sight of the needle stick on 16-MAR-2021. This report was non-serious.

Patient brought in by EMS due to 2 episodes of emesis, not eating for past week with on and off vomiting episodes, and altered mental status. Possible urinary tract infection, treated with antibiotics

Patient developed cough, poor appetite, decreased po intake, altered mental status, failure to thrive, increased work of breathing, approximately three weeks after vaccine administration. He presented to the hospital where he was found to be covid-19 positive on admission. Patient is currently hospitalized (hospital day 1)

Patient's wife states that he was not the same the evening after receiving the vaccine. She stated that he was unable to hold objects and his eyes were bulging from his head. He was going to a nursing facility after vaccination and later died on 7/4/21.

Chief Complaint Patient presents with ? BLOOD PRESSURE coming from facility round 10am, staff went to check on him and he was only responding to painful stimuli, baseline A&O3. Found to be hypotensive by EMS 50s/30s ? Altered Mental Status Patient presents via EMS from his nursing facility for altered mental status. He was last seen as normal at 10 AM. Patient had an appointment with his doctor but when they went in to check on him he was minimally responsive. He is normally a and O ×3. He was found to be hypotensive by EMS. No fever. No known trauma or injury. Upon arrival his blood pressure improved. No other acute issues, symptoms, complaints. Patient is unable to provide a history. 5/5/2021 admitted to the hospital tested + for Covid 19

About 2 weeks after receiving the J&J Covid-19 vaccination, I became ill with confusion, lethargy, and disorientation. Taken to hospital in town to rule out possible CVA. MRI, CT, Carotid sonograms, were all negative. While waiting on lab, the preliminary DX was metabolic Stroke. After all lab returned, the diagnosis was Hemolytic Uremic Syndrome (HUS). Transferred to ICU in different town for dialysis and plasmapheresis. Hospital in another town had closed their department for holiday. I spent about 2 weeks at hospital. My Hgb on admission was 7.0 and kidney function was 20% . the platelets were being destroyed in the glomeruli. Blood transfusion and platelets were contraindicated.

SEVERE DIARRHEA (8-10 EPISODES PER DAY); FATIGUE (MEDIUM TO HIGH SEVERITY); LOW GRADE FEVER; DISORIENTED (MEDIUM TO HIGH SEVERITY); SHUFFLING FEET AND UNSTEADY (NEEDED TO HOLD ON TO STUFF TO PREVENT FALLING); This spontaneous report received from a consumer concerned a 72 year old male. The patient's weight was 180 pounds, and height was 72 inches. The patient's concurrent conditions included alcohol use, non smoker, and penicillin allergy, and other pre-existing medical conditions included no drug abuse or illicit drug usage. the patient was healthy as a horse. patient did not had diagnostic data available'. The patient experienced reaction to a flu vaccine when treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2008, the subject experienced reaction to a flu vaccine. On MAY-2021, Laboratory data included: Body temperature (NR: not provided) 101 F. On 01-MAY-2021, the subject experienced disoriented (medium to high severity). On 01-MAY-2021, the subject experienced shuffling feet and unsteady (needed to hold on to stuff to prevent falling). On 01-MAY-2021, the subject experienced low grade fever. On 02-MAY-2021, the subject experienced severe diarrhea (8-10 episodes per day). On 02-MAY-2021, the subject experienced fatigue (medium to high severity). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe diarrhea (8-10 episodes per day) on 10-MAY-2021, disoriented (medium to high severity), and shuffling feet and unsteady (needed to hold on to stuff to prevent falling) on 03-MAY-2021, fatigue (medium to high severity) on 15-MAY-2021, and low grade fever on 08-MAY-2021. This report was non-serious.

I ;began having numbness in my legs, thighs, and everything below my waist. It felt like something had hold of my bones in these areas, and began twisting them. As the pain worsened, it was if someone had taken all the nerves in the lower part of my body and folded them over, in half, and then began twisting them ever so tight

Started shaking inside my body 8 hours after the shot plus a fever of 100. Shaking then turned violent on outside of my body. Took 2 Motrin (225) each. Shaking stopped after 30 minutes, fever disappeared overnight.

My husband is still in hospital trying to recover. He had bad headaches that then led to seizures and confusion ,blood clots, and has been hospitalized since. He's literally fighting for his life and tomorrow Wednesday April 14 th he will be transferred to a rehabilitation center.

6 days after injection woke with soreness in all joints, stiffness, fatigue. Now on day 10, the S/S are getting worst. Fingers are swollen,. I can't grasp or pinch things. I must use both hands to hold a glass or cup. Very weak, sleeping 16-18 hours a day. At times I get very chilled and start to shiver. Never have had a fever, loss of taste, or smell. I tested NEG for the virus on day 3 (10 days after receiving the vaccine). Soreness is turned into pain. Feels like full-blown RA and if I was black I would be thinking sickle-cell because of the general pain.

LOST LITTLE BIT WEIGHT; NIGHT SWEATS REALLY BAD; DID NOT HAVE SAME ENERGY (LOW ENERGY EACH DAY); CHILLS; TEMPERATURE WENT UP EVERY NIGHT CLOSE TO 100F (FEVER); FELT LIKE HAD FLU WITHOUT VOMITING; HARD TIME SLEEPING; This spontaneous report received from a patient concerned a 73 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included copd (chronic obstructive pulmonary disease), hypertension, diabetes (undiagnosed), skin issues, and allergic to pneumonia vaccine (bad reaction from second dose).The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 2038218, and 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 felt like had flu without vomiting. On 26-MAY-2021, the subject experienced hard time sleeping. On 26-MAY-2021, the subject experienced night sweats really bad. On 26-MAY-2021, the subject experienced did not have same energy (low energy each day). On 26-MAY-2021, the subject experienced chills. On 26-MAY-2021, the subject experienced temperature went up every night close to 100f (fever). Laboratory data included: Body temperature (NR: not provided) 100 F. On 02-JUN-2021, Laboratory data included: Body temperature (NR: not provided) 97.4 F. On an unspecified date, the subject experienced lost little bit weight. The action taken with covid-19 vaccine was not applicable. The patient was recovering from felt like had flu without vomiting, night sweats really bad, hard time sleeping, did not have same energy (low energy each day), lost little bit weight, temperature went up every night close to 100f (fever), and chills. This report was non-serious.

Coughing started about May 5, 2021, confusion started on about May 8, 2021, put on oxygen in Emergency room on May 9, 2021. Admitted to hospital where he stayed until his death on June 18, 2021.

Two weeks to the day, high fever up to 103.5 for a week; tired slept for about a week, shaky, no appetite. Could barely function.

blurred vision, hallucinations, rash around his eyes, HA, running nose, off balance patient refused going to emergency room, is waiting to consult with provider

Severe diarrhea, blurry vision, inability to focus, inability to "have a normal conversation" (all started today, per patient report).

No pain at injection site nor abnormal symptoms that day (Friday) Next day (Saturday) had general body aches and light chills but no fever and slept all day on the couch On the second day (Sunday) felt ok again except did not sleep well the night before Monday felt agitated and could not sit still: I had to be "doing something" to feel like I wasn't going crazy, slept very poorly that night or the prior night Symptoms described above worsened each day and night up until today. I have slept very little each night and because I have to be "doing something" I am worn out by late in the day. Yesterday (Tuesday 4/20/2021) I felt a little better and slept reasonably well last night. Today I am feeling restless and agitated again but not as severe as it was earlier....

PAIN IN LOWER RIB CAGE; BODY ACHE; LOSS OF APPETITE; SLEEP WAS LIMITED; CHILLS; LACK OF ENERGY; HIP MUSCLE PAIN; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 74 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included above average health and no daily medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: Unknown) 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 an unspecified date, the subject experienced pain in lower rib cage, body ache, loss of appetite, sleep was limited, chills, lack of energy, hip muscle pain, headache, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99 and plus. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in lower rib cage, chills, hip muscle pain, and fever, and was recovering from body ache, headache, loss of appetite, lack of energy, and sleep was limited. This report was non-serious.

13th of April. I had a blood clot in my hand. My index finger on my left hand was numb and black and blue all around the knuckle area and into my hand area. I went to my primary care - I went to the acute center there. She said the hand was cold and could see the black and blue. They put me on Plavix for 30 days and I haven't had any reoccurrence of that. I think it was the 21st, I couldn't sleep all night, I had a kidney stone - the pain was so bad I got nauseous - around my back and side and in my front. I didn't have a fever. I went to the doctor office and they checked urine - and said there was blood in the urine. I was prescribed - Tamsulosin HCL. They thought I had passed most of it by the time I got there.

Pt reports intermittent brain fogginess since having the vaccine. It has not resolved in the 3 months since administration. He also reports increase nausea since the dose.

Initial Complaint of Constipation, admitted for altered mental status, respiratory failure, HTN, hypothyroidism. Information pulled from Report

STAY ASLEEP / REST LONGER; INJECTION SITE ARM PAIN; FEELING TIRED; LOSS OF ENERGY; This spontaneous report received from a patient concerned a 74 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and other pre-existing medical conditions included patient had no known drug allergies. patient was taking multivitamins and multivitamins for the eye. The patient was previously treated with lisinopril for high blood pressure, and amlodipine for high blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 180978 expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-JUL-2021, the subject experienced stay asleep / rest longer. On 15-JUL-2021, the subject experienced injection site arm pain. On 15-JUL-2021, the subject experienced feeling tired. On 15-JUL-2021, the subject experienced loss of energy. Treatment medications (dates unspecified) included: menthol/methyl salicylate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site arm pain on 16-JUL-2021, and the outcome of feeling tired, loss of energy and stay asleep / rest longer was not reported. This report was non-serious.

the ability to take and sustain a deep enough breath to sustain oxygen level ONLY when reclining for sleep. During the day, while ambulatory, vertical or sitting, my breathing is normal. As soon as, immediately, when I get into bed for sleep, my breathing is immediately restricted so I cannot maintain lying down. I have to sit up. I can't sleep. I get exhausted by 3-4-5 a.m. and finally am so distressed I sleep in a sitting up position or catch a snippet of sleep up to an hour or so. Often wake up with panic attack of suffocating, sit up, jump out of bed, get vertical.

pt says a couple of days after taking the vax he woke up feeling woozy. He says his head hurt and he couldn't think straight. He felt like he was coming unglued. He had some confusion and trouble with his memory. He had burning in his stomach. On 3/12/21 he contacted his PCP for a tele-visit. He couldn't remember what the doctor told him after speaking with him because of his confusion. He was prescribed Raglan. He said the food going in his stomach does not come out. He saw his gastro Dr. regarding his stomach pain. He had a scope procedure and had bile pumped out of his stomach. He was prescribed famotidine, tenatoprazole, Amitiza, and Sucralfate. He is not taking the Amitiza or Sucralfate. It is 2 months later and he still has these symptoms and still doesn?t feel normal.