Johnson & Johnson

Sore left arm, tight neck left side of injection, slight headache. Eyes slightly achey. Slightly tired.

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.

abdominal aches and cramps gradually increasing in severity; walking and other core body movement provided temporary cessation of increasing severe pain; the peak of severe pain was accompanied by a bowel movement, followed within about 5 minutes by body temperature increase, sweating, and profuse salivation such that saliva was swallowed every 2-3 seconds for a few minutes. Treatment was a focus on breathing while practicing the turtle yoga position (forehead on floor with knees folded under abdomen) and then laying flat on back with one or both knees bent. After 10-15 minutes of this treatment the symptoms (abdominal pain, high temp, profuse salivation) subsided.

Patient is a 60 year old male who has completed a 45-minute observation period with the following signs and symptoms of an adverse reaction: tingling and numbness around lips area, left arm and bilateral lower extremities 30 minutes after Janssen/J&J COVID-19 vaccine# 1 in series administered. Action(s) taken: Vital sign at 1626 blood pressure ; 153/95, heart rate: 70, respiration ; 16, Spo2: 98 % Repeat Vital sign at 1635: blood pressure ;148/101, heart rate:69, respiration ; 16, Spo2: 98 % - Patient denies chest pain ,shortness of breath, nausea vomiting, diarrhea, abdominal pain, difficulty swallow, headache, dizziness, or vision changes. Action(s) taken: Transferred to higher level of care/urgent care, report given to doctor. Doctor states that he is going to prescribed benadryl and will observed for 30 minutes. Patient advised to follow up with Primary Care Physician

Received shot at 11am. Around 9:30pm that evening started having the chills and a slight headache. Around 1:30am woke up with severe chills and a very bad headache where even my eyes were hurting. Also my arm was hurting from my upper shoulder down to my elbow and was warm. Around 2:00 am I started to throw up and had dry heaves for about 30 minutes. Once that stopped I took 2 Tylenol and fell back to sleep about an hour later. Woke up around 6am with a slight headache, took 2 more Tylenol and by noon time I felt completely fine and not even tired

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.

Patient received Janssen COVID vaccine 4/9/21 around 9 am. Patient reported to emergency department around 10 pm that day (4/9)- says tongue began swelling since 7pm, he took a benadryl at 8pm with no improvement. Per ED physician, patient had "tremendous amount of tongue swelling, I am not even able to visualize the palate he has fullness to his left neck as well". Patient intubated in emergency room to protect airway. Patient admitted to ICU where he is still today (4/13). Per chart, the edema subsided on 4/12 and patient was extubated today (4/13). Patient received IV steroids from 4/9- 4/13 (discontinued this morning). Of note: patient does take lisinopril 20mg daily (start date July 2020). There is concern the angioedema was caused by this medication. Patient received tranexamic acid and Berinert in the emergency department to assist in treating this potential etiology.

In order experienced: 1) muffling effects in ears 2) head ace 3) rash and ich on ears (both, worse on right) 4) sore spot across forehead, center/right 5) rash and ich on throat and neck (right side)

As I am driving home from the vaccine, I got the shot on my left arm so numbness there seemed normal. I also got numbness in my left jaw and left thigh which seemed strange. I thought later maybe this was a mini stroke. It went on for at least 30 minutes.

Patient phoned and reported continued headache since vaccination, SOB, and continuous watering of unilateral eye.

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.

Patient has had severe headache since vaccine - starting day after - "worst headache of his life". Now has loss of smell, shortness of breath and nasal drainage

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.

LOSS OF VOICE; CHEST TIGHTNESS; CRAMPS IN THE STOMACH; SORE THROAT; BAD HEADACHE IN THE BACK OF THE NECK; NAUSEA; 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: 1805020 expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced loss of voice. On 12-APR-2021, the subject experienced chest tightness. On 12-APR-2021, the subject experienced cramps in the stomach. On 12-APR-2021, the subject experienced sore throat. On 12-APR-2021, the subject experienced bad headache in the back of the neck. On 12-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bad headache in the back of the neck, sore throat, nausea, loss of voice, cramps in the stomach, and chest tightness. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.

on April 2nd patient woke up at around 4:30 am and complained of pain in his back. I rubbed his back and he wondered if it was just something he ate. He then tried to calm down and got back into bed . He was holding my hand when suddenly his hand felt cold. I turned on the light to find his eyes rolled back and he was gasping his last breath . This was about 5:20 AM . Patient was a healthy active man.

Day 2 following the vaccine, patient began to experience flu-like symptoms (fatigue, head ache, body ache). Followed by a syncope episode, did not follow up with any emergency care. Did not contact primary care or go to the hospital, or take any medication to treat symptoms. Mentioned having eye soreness, eyes feeling fatigued which is not usual for the patient and coincide with timing of adverse effects.

As per patient 2 days post vaccination he develop blurry vision in his left eye, he went to local ER but they said they could not find anything wrong so they refer him to clinic for further evaluation. Their Doctor diagnose him with Retinal Detachment, left eye (Dx: H33.022). on 04/29/2021 pt had Pars plana vitrectomy, air-fluid exchange with internal drainage retinotomy.

In the beginning a very strong pain arms whole body after the stomach started the back and everything got worse for 4 days going to and from the emergency room and then still hospitalized all due to problems after the vaccine in the last exam the variant was positive for guillen barrer before discovering this he lost his sight for two hours he cannot walk he lost the strength of his limbs and his pressure shot up he has dysphacia and is still hospitalized with physical therapy

SUSPECTED CLINICAL VACCINATION FAILURE; METALLIC TASTE; SUSPECTED COVID-19 INFECTION; 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 concurrent conditions included seasonal allergies, and the patient have no other health history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, Frequency: 1 total, batch number: 1808978 expiry: Unknown) dose was not reported, administered at left arm on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-APR-2021, the patient experienced suspected covid-19. On 01-MAY-2021, On the same day the patient underwent rapid swab test and tested positive for COVID-19 (suspected clinical vaccination failure, Stuffiness, Runny nose, Drainage, Congestion, Anosmia, Ageusia). It was reported that, the symptoms started about 4 days prior, but it was hard to discern due to allergies. On the same day, the patient went to gym for about 45 minutes and felt okay except for slight metallic taste in mouth. Later, he went home and tried smelling whiskey and realized he had lost his sense of smell and experienced loss of taste. The patient did not present with typical symptoms and had felt okay because he had been working out prior. It was reported that, the patient could smell firewood burning but nothing else. Later, all vitals checked at urgent care and all was normal. The patient's laboratory data revealed blood pressure was normal, Oxygen level on Oximeter 99%, Smell and Taste was 90-95% gone. At the time of this report, the patient had a tiny amount of fatigue and was in quarantine for the next ten days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from metallic taste, had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210504165-covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

pt woke up with an extreme severe headache and nausea. Vision was blurred, he had joint point, body aches and pains. He used ice pack for headache. These symptoms lasted about 24 hours. On 5/13/21 Pt still has blurry vision but other symptoms have subsided.

Dryness in mouth when eating anything would cause an abrasion, was rough and sensitive. When opening mouth all the way feels as though rubber bands holding him back. Thought it was something that would go away, but continues to feel the same way. Attributed it to mouth disease, physician says it is not a mouth disease, he should get a biopsy.

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.

Client received the Janssen COVID vaccine lot #205A21A and expiration date 6/23/21 at approximately 3:01PM. Client arrives to the vaccine observation room and within 10 minutes reports feeling lightheaded and having tunnel vision to EMTs. EMT takes vitals: blood pressure 170/92, heart rate 80 and oxygen sat: 94%. PHNs arrive to assess client. Client is upright in chair alert and oriented x 4. Client denies any shortness of breath. PHNs observe sweating and rashes on left and right arms. Client reports his oxygen is normal for him since he has COPD. Client reports having a history of severe anaphylaxis allergy to penicillin, client reports taking morphine, lexapro, tizanidine, lyrica, and remeron. At 1:15pm client reports feeling "clammy and cold". Clients face is flushed and rash is spreading to neck, upper chest, lower left leg. PHN offers client Benadryl and he accepts. PHN starts calling 911 at 1315. PHN administered 50 mg of IM Benadryl at 1:17pm. At 1:17pm, vitals by EMT: heart rate:88 and oxygen: 94%. Client reports he "feels something in his throat" at 1:18PM. At 1:20pm client reports feeling in his throat is improving. At 1:20pm paramedics arrive and assume care. Client left facility wheeled out on a gurney at 1:27pm. Client will get transported to hospital. PHN alert security that a car left here overnight might belong to client being transported.

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.

BODY ACHES; CHILLS; FEVER/TEMPERATURE DECREASED FROM 102.8 TO 101.5; EYES HURTING; 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: 201A24A, expiry: UNKNOWN) dose was not reported, administered on 24-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-JUN-2021, the subject experienced eyes hurting. Laboratory data included: Biopsy prostate (NR: not provided) Not reported. On 25-JUN-2021, the subject experienced body aches. On 25-JUN-2021, the subject experienced chills. On 25-JUN-2021, the subject experienced fever/temperature decreased from 102.8 to 101.5. On 27-JUN-2021, Laboratory data included: Body temperature (NR: not provided) Decreased from 102.8 to 101.5. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever/temperature decreased from 102.8 to 101.5, and had not recovered from eyes hurting, chills, and body aches. This report was non-serious. This case, from the same reporter is linked to 20210661848.

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.

DIARRHEA; SICK; FEVER; COULD NOT BREATH DEEPLY; LOSS OF TASTE; LOSS OF SMELL; SALIVA LIKE FOAM; DRY COUGH WITH NO SECRETIONS; LOSS OF APPETITE; 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: 1808978 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced loss of appetite. On 27-JUN-2021, the subject experienced loss of taste. On 27-JUN-2021, the subject experienced loss of smell. On 27-JUN-2021, the subject experienced saliva like foam. On 27-JUN-2021, the subject experienced dry cough with no secretions. On 27-JUN-2021, the subject experienced could not breath deeply. On 28-JUN-2021, the subject experienced sick. On 28-JUN-2021, the subject experienced fever. On 29-JUN-2021, the subject experienced diarrhea. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Twice Negative. Treatment medications (dates unspecified) included: dextromethorphan hydrobromide/guaifenesin/paracetamol/pseudoephedrine hydrochloride, and guaifenesin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of taste, loss of smell, saliva like foam, dry cough with no secretions, and fever, and the outcome of sick, could not breath deeply, loss of appetite and diarrhea was not reported. This report was non-serious.

first night high fever 103, bad chills, muscle pain. Next night tinnitus. I have existing tinnitus that is not that noticable. This increased the volume 3 times. lost weight, 3 pounds not since injection. stomach pain 3rd night.

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.

On day 4 after the Vaccine was administered, I felt a burning in my throat about the size of a dime. On day 5 the burning feeling was in my entire throat. I was treating this like a Acid Reflux problem. On day 6 the burning was there and I was also having an issue with my sinus. There was blockage at times and other times a lot of mucus was coming out of my nose. I also developed a cough. I now started treating it like a head cold. I took day and night cold remedies. This continued for 8 more days without relief. On day 9 I did have a 100.5 fever that went away while I slept throw the night. I contacted my doctor and was able to see his PA. I was tested for COVID19 and given a prescription for Doxycycline Hyc 100mg. My COVID19 results were "None Detected". I've taken 4 of my prescription pills and haven't noticed a change. I still have an Earache, sensitive left cheek bone, mucus coming from my nose and coughing. The amount of coughing and mucus has lessened but the earache pain has not diminished. I also have a bad headache this morning, 16 days after my vaccine was administered.

started getting numbness in hands-fingers and lips and then numbness to feet and fell to ground with inability to walk - no strength in legs knees or arms. left facial drooping and slurring of speech and severe weakness -paralyzed

For the first time ever, I had what I determined (based on internet searching) to be an ocular migraine. My vision was distorted in both eyes, although the distortion was stronger when looking to the left. There was a circular area that was fuzzy and a bit wavy like looking through water. The circular distortion area seemed to be outlined by a ring of brighter light. No flashes or floaters. I did not have a migraine headache then or afterwards; I've never had a migraine headache. I followed the on-line advise and laid down and did try to use my eyes for about an hours. The distortion faded within an hour or two; it has not recurred. I did not connect it to the vaccine as a potential source at that time.

The Jansen vaccine was given on 3/18/21. Patient began to experience symptoms of bells palsy on 4/6/21. Patient noted R hemibody numbness, which began with right-sided facial numbness when brushing teeth. He was evaluated by his PCP (no exam noted) and initiated on Bells Palsy regimen of doxycycline 100mg BID, acyclovir 800mg TID, and prednisone 40mg. On 4/9, a referral to neurology was made after pt returned to clinic w/ burning deep low back pain that radiates up to his shoulder, and his b/l temples. Pt again re-presented to urgent care on 4/12 due to severe burning back pain that resolved w/ activity. At this time again only L sided facial weakness noted (documented as reduced ability to close eyelid, raise eyebrow, weakness puffing out check, and reduced smile on L), no other weakness, drift, or sensory findings. Pt was instructed to continue doxycylilne 100mg BID 10d course (4/6- 4/15), prednisone 40mg 7d course (4/6- 4/12), acyclovir 800mg TID 7d course(4/6-4/12).

shortness of breath, foot swelling, chills, body aches, dry mouth, fatigue, wheezing, eye burning sensation, joint pain, Blood clots in lungs, prescribed Xarelto

BUZZING IN HIS EARS; RINGING IN HIS EARS; BAD RASH ALL OVER HIS BODY; BOTTOM OF HIS FEET HURT TO WALK ON; This spontaneous report received from a consumer concerned a 61 year old male. The patient's height, and weight were not reported. The patient's past medical history included stomach disorder. The patient was previously treated with esomeprazole magnesium for stomach disorder. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, 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 buzzing in his ears, ringing in his ears, bad rash all over his body, and bottom of his feet hurt to walk on. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the buzzing in his ears, ringing in his ears, bad rash all over his body and bottom of his feet hurt to walk on was not reported. This report was non-serious. This case, from the same reporter is linked to.

DIFFERNCE OF LOT # TO MANUFACTURER: Told got Janssen but lot # is Moderna. He got his vaccine, had no reaction other than his arm hurting. Then on 4/10/21 in the afternoon he started having ringing in the ears. He said that it is pretty bad, and is on and off and bad when it occurs. He has it more days than not and has never had this condition before. He did a telephone APT and informed him of his issue and is aware. He told him to wait and see if it goes away.

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.

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.

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.

Patient denied history of fainting. Patient received Janssen vaccine at 11:49. Immediately after receiving vaccination patient was complaining of arm pain. Patient was asked by charge RN to stay seated at table instead of moving to observation area. Patient started complaining of feeling dizzy at 11:53 am. RN asked patient to lie down. Patient wanted to remain seated. Patient asked if he was diabetic. Patient confirmed he had type 2 diabetes and was unsure of last time he ate and blood sugar. Snack and cold water was obtained for patient. Patient became diaphoretic and was breathing fast. Blood presssure obtained and read 195/177. Blood glucose was obtained and read 132. RN asked for assistance lowering patient to ground. Patient's eyes rolled back while lowering patient. Patient was unconscious for approximately 60 seconds. EMS was called by bystander. Patient came back to consciousness and was alert and oriented. Patient's Blood pressure was obtained adnd read 156/80. HR was 58. EMS arrived and obtained vitals. Patient refused further treatment by EMS. Patient had ride pick him up at 12: 40. Patient was alert and oriented and no other symptoms upon leaving vaccination site.

The patient first exhibited diaphoresis, then was thirsty. He was then unresponsive and started seizing, and lost control of his bladder. The seizure lasted approximately 1 minute. Emergency services were contacted, and they assessed the patient after the event. He was released from their care back into the community.

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

Double vision. I also read about Guilluan Barre and respiratory and sinus infection of which I was just diagnosed w sinusitis and bronchitis, of which I've never had in my life.

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).

Double vision about 25 minutes after treatment. Driving home and had to pull off side if road. Lasted 2 to 3 minutes. Continued then on to home.

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).

About 4 hours after the administration of the vaccine suddenly I began seeing bands of "floaters" on my left eye. Is still going on.

After my vaccine, on 03-10-2021 at 1:00am, I experienced intense headaches and muscle body aches. I called my PCP due to my symptoms and loss of taste and smell. As of today, I am concerned since I have not regained my loss of taste and smell.

Male patient received vaccine in the morning, then around lunch time started feeling symptoms of headache, runny nose and ringing in ears. He then got shortness of breath, which got exacerbated so Pharmacy called ambulance and because patient became hypertensive , it was recommended he go to the E.R. Patient is currently at the E.R. at time of this report

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.

1st day, and 2nd day, slight hearing loss particularly to mens speaking voice on TV. Now gone. 1st night frquent night time urination, now gone.

I had a sudden hearing loss in my right ear still present as of 4/12. I went to the ENT had hearing test which showed 90% loss, MRI(no tumors) and prescribed Prednisone.

0835 Injection, 0930 Blurry Vision driving home / 150-200 feet before I could read road signs. 1000 hours chicken noodle vegetable soup. Lie down / chills them "hot" off and on PM / rest of the day / no discernible fever by forehead touch / mild headache. 0700 4-11-2021 no headache, but brain "felt sore"; best I can describe it. 1030 hours 1000mg Tylenol, repeat at 1900 hours / repeat at 0400 hours 4-12-2021. 0800 hours 4-12-2021 "brain soreness" mostly gone. Many bowls of chicken noodle vegetable soup 4-10 / 11- 2021. Muscle / joint pain 4-10 / 11 / 2021 but I expected that. Some joints surprised me. Blurry Vision / brain soreness was a total surprise.

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.

Pt here for in office visit converted from virtual. He developed painful rash on Friday late morning 4/9. Bumps on his right side of forehead and pain traveling down front of his right ear and into lower part of his jaw. No tinnitus, hearing issues, pain inside ear. No eye issues such as eye pain, vision issues or blurriness, tingling. He had an eye exam 2 weeks ago. No facial paralysis, tingling or numbness. He has been taking tylenol. No hx of shingles. No hx of vaccine for shingles. Chicken pox as a child. He sees GI for UC. On medication last few years. He last saw his GI last year and is overdue to see him this year. He did get his janssen vaccine 2 weeks ago 3/17.

BAD TASTE IN MOUTH AND THROAT; STOMACH PAIN; BODY ACHE; FEVER; FATIGUE; HEADACHE; FEELS LIKE KNOT RIGHT BELOW HEART; 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 infection, and concurrent conditions included high blood pressure, and hypothyroidism. The patient experienced drug allergy when treated with morphine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced feels like knot right below heart. Laboratory data included: Body temperature (NR: not provided) 99.9. On 08-APR-2021, the subject experienced body ache. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced fatigue. On 08-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced stomach pain. On 10-APR-2021, the subject experienced bad taste in mouth and throat. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, fever, and fatigue on 09-APR-2021, had not recovered from stomach pain, and bad taste in mouth and throat, and the outcome of headache and feels like knot right below heart was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.

Pt. 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'!

FROM THE AFTERNOON OF THE INJECTION I NOTICED A DEFINITE INCREASE OF TINNITUS FOR 13 DAYS. 14TH DAY TO CURRENT AN EVEN MORE PRONOUNCED RINGING IN BOTH EARS ALMOST UNBEARABLE AT TIMES.

Patient states he received J&J vaccine on 4/1; on 4/10 he had nonradiating persistent low back pain. A few days after that (on 4/13) he felt numbness and pain in his legs, in addition to ?decreased sensation in his inner thighs. These sensations were migratory and intermittent. Also noted in his upper extremities as well. He also had issues with temperature sensation in his lower extremities. On 4/14 he had slight haziness in vision while driving which resolved after 30-60min and has not recurred. He also had slight difficulty walking. On 4/15 he had an appointment with his PMD; had L-spine XR which revealed moderate lower lumbar facet arthritis, and was thought that change in sensation was likely d/t radiculopathy - was prescribed ibuprofen, muscle relaxant, oxycodone (took oxy x1, ibuprofen for a few days). Since then he has also had intermittent stabbing pains in various parts of his body which resolved spontaneously. On 4/17-4/18 his back pain resolved. On 4/18 at 4:30am he woke up with R-sided facial weakness. He has not had focal weakness aside from the face. Was seen in ED that morning for this R-sided facial droop involving the forehead, diagnosed with Bell's palsy and given prednisone/valacyclovir. Yesterday 4/19 around mid-day he started having L-sided facial weakness and slurred speech. This has progressed since yesterday. Reports ability to swallow, though a little difficult d/t cheek weakness. Low back pain has returned as well. Does report constipation and possible poor bladder emptying for the last few days. He was seen by a Doctor and referred to ED to rule out AIDP and other diseases after J&J vaccine.

Besides the aches, pains and fatigue I also had a sore throat & ear ache (right side only). This is probably something underlying that my immune system was suppressing and became apparent after the vaccine, Seems to be clearing up now?

VACCINE TEMPORARILY WEAKENED IMMUNE SYSTEM; SORENESS IN THROAT; EAR PAIN; HEADACHE, ACHES, FATIGUE; .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 arthritis, bursitis, kidney issues, hernia, angioplasty, and dental implant, and concurrent conditions included microbial or viral present in jaw, and other pre-existing medical conditions included the patient was non alcoholic, non smoker and had no known drug allergies. The patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (form of admin, route of admin were not reported) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced vaccine temporarily weakened immune system, soreness in throat, ear pain, and headache, aches, fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the soreness in throat, vaccine temporarily weakened immune system, ear pain and headache, aches, fatigue was not reported. This report was non-serious.

Started at 430 am on the 13th of April, my stomach started hurting. It does not matter if or what I eat, it still hurts. I got headaches, those have also continued since the 13th. The following week my mouth began to hurt, I started coughing more than normal. First a dry cough, now I'm coughing up phlegm with specks of blood. And I can not stop itching, and I'm getting tired of taking benadryl for it. I contacted my doctor, all I got was these are normal reactions to the vaccine. They last 2 to 4 weeks. I already get migraines, my gut is picky since that shot. I used to eat hot peppers, now if I use pepper on my dinner my stomach is in pain. These side effects should be gone by now. I am one pissed off person.

Temporary partial blindness in the left eye. Event lasted 1 minute. One quarter of the top portion of sight in my left eye was blocked by what appeared to be a dark curtain, this went away after 1 minute. Had an exam by eye doctor the same day , no eye problems were found. Had an exam by cardiologist the following day. He prescribed a imaging order for a head scan and prescribed Clopidogrel 75 mg and to monitor a fib for 30n days with Apple Watch.

SEIZURES; PAIN IN JOINTS; VISION BLURRY; 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 he had been healthy individual all his life. The patient's concurrent conditions included patient was non-alcohol user, and non-smoker. The patient had no history of comorbidities. The patient had no known allergies and drug abuse or illicit drug usage. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: 11-MAY-2021) 1 total dose was administered at left arm on 10-MAY-2021 (reported as Monday) for prophylactic vaccination. No concomitant medications were reported. On 10-MAY-2021, the patient experienced blurry vision (vision blurry) which had happen all of sudden. On 12-MAY-2021, (reported as Wednesday) after taking JNJ vaccine he was taken to the emergency room because he had developed seizures (seizure), the patient experienced pain in joints (pain in the joints) which had happen all of sudden and was hospitalized. The patient was treated with Levetiracetam 500 mg for seizure. He was hospitalized for a day. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from seizures, and had not recovered from pain in joints, and vision blurry. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210529765-COVID-19 VACCINE AD26.COV2.S-Seizures. 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: 20210529765-COVID-19 VACCINE AD26.COV2.S-Pain in joints. This event(s) is labeled per RSI and is therefore considered potentially related.

Injection site swelling and moderate pain within 20 minutes of injection; within 30 minutes the left forearm, left metacarpal region (in particular, tissue surrounding base of left pinky finger) experienced swelling. Left calf (gastrocneuius) experienced mild, yet noticeable, swelling which diminished and was gone within 8 hours. Pronounced fatigue set in within 3 hours after injection and I was in bed the following 2 days. Mild, continuous ringing in the ears began on day 2. By day 4 was back 100% to a normal routine. The only remaining symptoms as of the date of this report are the mild, continuous ringing in the ears and the small, yet noticeable swelling of tissue around the base of the left pinky finger.

BLURRED VISION; NECK PAIN; JAW PAIN; NERVE PAIN; ARM PAIN; SHOULDER PAIN; HEADACHES; This spontaneous report received from a consumer 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 30-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 30-APR-2021, the subject experienced blurred vision. On 30-APR-2021, the subject experienced neck pain. On 30-APR-2021, the subject experienced jaw pain. On 30-APR-2021, the subject experienced nerve pain. On 30-APR-2021, the subject experienced arm pain. On 30-APR-2021, the subject experienced shoulder pain. On 30-APR-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm pain, headaches, nerve pain, neck pain, shoulder pain, jaw pain, and blurred vision. This report was non-serious.

On March 24 I began experiencing severe pain in my right arm. The er thought it might have been a pinched nerve or something along those line. March 28, noticed a lack of muscle control on the right side of my lips while drinking from a straw. This time I was admitted as a possible stroke. Two different MRI sessions revealed no stroke. They performed a lumbar puncture and discovered that I had extremely high protein levels. After having been admitted, for the next couple of days my face slowly lost the ability to close my eyes fully and a complete lack of control of my lips (total paralysis on my face). I also began to experience bouts of stabbing pain throughout my body and weakness in my limbs. After the after th

SUDDEN SENSORY NEURAL HEARING LOSS LEFT EAR; 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 concurrent conditions included non-alcohol user, and non smoker, and he had no known allergies and he was not a drug abuse or illicit drug user. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on 18-MAR-2021 to right deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-JUL-2021, the patient experienced sudden sensory neural hearing loss left ear (ringing in left ear) and which was still ongoing and she visited physician's office. On an unspecified date, the patient experienced ringing in left ear. The patient was treated with prednisone 50 mg first 2 days and taper over 10 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sudden sensory neural hearing loss left ear. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210738424 - Covid-19 vaccine ad26.cov2.s-sudden sensory neural hearing loss left ear. 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.

Patient passed out after receiving janssen covid-19 vaccine. There was no injection site reaction, no wheezing, or rash/hives. Patient had vision loss, dilated pupils, sweaty, unable focus or respond to use questions being asked, and was having trouble hearing-said he had ringing in his ears. We were able to lay him on the floor without injuries-he did not fall. I was fanning him and we were talking to him. He got a little worse but then got better. When he was better, he said that he had passed out before when having blood taken. He did not mention this to me before the vaccine was administered. I do not feel that the Janssen COVID shot was the cause, I think he just passes out from injections or needles. We did call 911 when he was getting worse. By the time they got here, he was better but they did check him.

3/9 patient began with rash to left side of face, sore throat, left ear pain and productive cough. Was evaluated @ the facility on 3/10 where the vaccine was administered- Johnson and Johnson. Evaluated @ facility on 3/12/21. Herpes Zoster affecting left side of scalp and face extending to eyelid. Referred to Ophthalmology for evaluation. Zpak discontinued and changed to Amoxil.

Injection site soreness for 6 days. Mental and physical lethargy for 7 days with a mild headache and odd taste in throat for the first couple. Workout reduction of capability of 20% slowly edging back up to 95% on day 6.

The patient presented to the ER after having the vaccine several hours earlier in the day complaining of chills, shortness of breath, chest tightness, abnormal jaw movements and twitching of his eyelids with uncontrollable movements of his eyes as well.

COVID LIKE SYMPTOMS, RUNNY NOSE, LOSS OF TASE AND SMELL, SHORTNESS OF BREATH, NAUSEA/VOMITING, STOMACH HURTS

I experienced ringing sensation to my ears, tinnitus. I have referral to see ENT in beginning of May 2020.

I experienced after my J&J vaccine, tinnitus worse, R>L. I got skin rashes, eczema on my face and scalp and nose bleeds. I also experienced chills,, fatigue for the first two days. I still continue with skin rashes, eczema on my face and scalp and nose bleeds. I have been seeing my ENT and PCP at this point since I still continue with symptoms.

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:

Janssen shot on Mar 12, 2021. On Mar 25,2021 at 10 AM, I woke up with a headache, sore joints, nausea. Also blurry vision and inability to read words on a page. Sensing something wrong, my sister drove me to emergency room at Hospital where I was admitted. I was later told I suffered a stroke. I was in the hospital for 5 days, receiving various tests. (Hospital has all info on record). I am awaiting surgery to remove blockage from carotid artery. Doctor has all my information and should be reporting the event also to VAERS.

3/17 Vaccination By 6PM, stiff shoulder, stiff neck. Got progressively worse thru night. The diarrhea went away within 24 hours. The floaters in L eye appeared that first night. It started to increase, swatting at 'flies'. 3/18 It got worse; floaters. I made appt with eye doctor. 3/30 Saw Dr. She stated was a lot of floaters in L eye. It is still a few every couple of minutes. Has improved but still ongoing.

5 hours after had mild stroke like effects to include blurred vision followed by headache. 5 days after had muscle and joint aches in the night which are continuing.

PATIENT DEVELOPED BLOOD CLOT IN EYE. WENT TO RETINA SPECIALIST. WENT TO ER. COROTID ARTERY HAS 80% BLOCKAGE

Client left message on immunization nurses line 04/13/2021 stating he received J&J vaccine on Friday, and is having a severe reaction, can't eat, drink, breathing problems, hasn't been able to pee for 4-5 days, throwing up and severe diarrhea, and he can't stand. I returned his call and he verbalized all issues above and also said his legs, arms and hands were cramping up and having ringing in the ears. I recommended him to go to the ER now, he said he had called his PCP and was told the same thing. He stated he is single and lives alone and does not drive. I told him to call 911 and he verbalized he is too embarrassed to do that and states he will wait for his daughter to call him. I offered to call his daughter for him and he declined. Addendum: Created by RN. 04/16/2021 02:01 PM 04/16/2021 Client called reporting the same symptoms as in 4/13 message -- I told him to go to the ER immediately. He stated he could not drive due to muscle spasms and feet and leg pain. Asked if he would please call 911 and stated that was not necessary. He verbalized he understood my directions and stated he would go to urgent Care. Called Sheriff office to make a well person check.

Woke up the following morning (1 AM) with fever, chills, and considerable discomfort. This subsided by morning. The following day I began seeing swelling, redness, itching and burning of extremities (mainly the hands, but also feet, ears, face). These symptoms seem to be triggered by the slightest exertions, but have also exhibited without physical activity. These appear to be getting more prevalent each day.

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.

I experienced extreme vertigo on the in the middle of the first night after the shot. When rolling over in bed from flat on my back to my left side my body felt like it kept moving when I had in fact stopped. It feels like I am rolling out of a hammock. Right side has the same sensation. Also happens if I bend over when standing. It is not always accompanied with dizziness. Severity increased over a few days, then gradually decreased over the next 5 days or so and is now increasing again. I HAVE NEVER HAD THESE SYMPTOMS IN MY ENTIRE LIFE. My pre existing tinnitus has grown very much louder. I have had occasional low pain / pressure deep in my sinuses.

My symptoms are getting worse, my left ear has gotten worse and I difficulty concentrating. I was checked by an ENT doctor, had a hearing test, they did not found anything wrong and all my tubes were clear and all points out that it is related to the J&J vaccine. My hearing varies from day to day, other times of the day it gets louder. On Thursday 04-29-2021, it will be 6 weeks since I last got vaccinated.

Sudden deafness in right ear with constant ringing. Tinnitus symptoms. Completed a hearing test today, April 29, 2021 and results show loss of hearing in right ear.

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.

I started feeling kind of puny and sat down for supper - no taste or smell. After that I felt cold symptoms - and I had no energy whatsoever. I talked to the Dr online and he told me take Zinc Sulfate and Hydroxychloroquine; nebulized a medication but I can't remember what it was. I got pretty sick for about three days. I got to the point that I was so weak I could hardly move. I went to ER and was there for 1/2 day. They gave me IV fluids. They said that my lungs still sounded good The illness ran it's course of about 10 days. I still feel winded two months later. I have a little nagging cough yet. I can still go to work though.

Patient has been diagnosed with Retinal Vein Occlusion in left eye. No treatment has been obtained yet. Symptoms are burning pain and blurred vision . Went to regular eye doctor on 5/172021, and was scheduled appointment that same day with specialist. Has a follow up appointment on 6/25/20211.

My tinnitus is worse on right ear, gotten worse than on my last visit. My tinnitus had not gone away. I I went to see my doctor who ordered MRI of the brain and ears with and without contrast. My MRI was negative, nothing abnormal. Also did a full hearing test, other than normal range of hearing loss. The tinnitus is more variable, louder than it was, get periods of quietness. I have noticed that my tinnitus gets louder during exercise. I can not find rhyme or reason that my tinnitus gets quieter and louder. I have no problem for the CDC to contact my PCP to help with my diagnosis. I also had severe nose bleeds, which have subsided now. My skin rashes are also gone and get treated with topical creams. Before my vaccine, I had oily skin and now I noticed my skin started to get dry, along with tinnitus, and also dry skin on my scalp. When I get dry skin I apply topical lotion.

At approximately noon on May 9, 2021, I observed that I was having some difficulty with hearing in my right ear consisting of a "blocked" feeling with some distortion – I have had occasional issues of this nature previously which have normally been rectified by "over the counter" products.On the afternoon of May 12, 2021, there had been no improvement, so I sought assistance at the facility located in town. Personnel there initially attempted to "flush" my ear without any improvement. I was then seen by a Dr. who was on duty at the facility – Dr. indicated that there appeared to be some sort of plastic "tube" in my ear. Dr. indicated that this was best handled by a specialist in the field, and provided me with the information on a local practice. I was seen on May 18, 2021 at the offices of facility located near a Dr. I explained to Dr. what Dr. had seen – he located the item and removed it from my ear. This item has not, as yet, been identified – Dr. initially speculated that it may be part of a hearing aid, which I have NEVER had. I subsequently saw Dr. again on June 1, 2021, as the issues were persisting. At that time, a "Hearing test" was administered by a ophthalmologist. Dr. prescribed a course of 50 Prednisone (10 MG tablets) to be taken as follows at breakfast time: Six tablets for the first six days Four tablets for the next two days Two tablets for the next two days One tablet for the next two days Dr. reasoning at that time was that he believed that the vaccine may have provoked some sort of "immune deficiency". He advised that I should see him again in two weeks for a further hearing test/consultation. I completed the course of Prednisone on June 13, 2021. I underwent a further hearing test with ophthalmologist on the morning of June 15, 2021 as agreed – prior to the test, I indicated to ophthalmologist that I expected the results to be, to all intents and purposes, identical to the previous one: this proved to be the case. I subsequently indicated to Dr. that the Prednisone had been, from my perspective, totally ineffective. He is, at the time of writing, unable to offer any explanation for the issue or "path forward" from it: I am presently seeking a second opinion.

Bells palsy is what I got two weeks later - on the left side of the face. All way from forehead to chin. Including the ear which is actually the worst part. It hurts. I went to the doctor on 6/11/2021 and was given steroids for a week. It helped with the ache in my neck and ear but once I was off the steroids all that came back. They didn't help with my face. Bells Palsy takes months to heal - so I didn't notice any healing on face. Ibuprofen and Tylenol OTC for pain is what I'm currently taking.

HEADACHES, SOMETIMES BLURRED VISION, AND SLITHG PAIN IN THE STOMACH, ALONG WITH SOMETIMES LIGHTHEADED (DIZZINESS) C.HEST PAINS

Light sensitivity, similar to having your eyes dilated at the eye doctors office. Started 2 hours after injection and continues on.

I woke that Friday and the bottom half of my right eye was full of netting, within a week entire eye was like that, so about 50% of those optical nerves are permanently dead. Saw Dr. on 05/26/2021. Doctor said My blood supply to eye was restricted, right eye, to the point most of my optical nerves died. I also feel pressure in my head behind my eye. Turns out I also developed a sty. This head pressure on right side of head is killing me. My back and neck are also very sore.

Patient had autoimmune appearing reaction with rash, iridocyclitis, DVT right femoral vein, thrombocytopenia, lymphadenopathy, aphthous ulcers, pharynigitis rheaumatology consultation, anticoagulation, ophthalmology care, hematology consultation, ENT consultation

After receiving the vaccine with in minutes the patients left arm began to swell and bruise. He began to become pale and his eyes rolled back into his head and passed out. He woke up a min later and had SOB. Very pale and almost threw up. Paramedics and Firefighters were called. The eveulated the patients and gave him a liter of sodium choride. His Heart Rate was in the 30's. After several min and a liter of fluid, patient was alert. Once stable he was transported to Hospital.

Woke up in the early morning and was real dizzy, a little later in the morning in went away. Itchy around the eyes for a day and a half. Seems to of gone away this morning.

Woke with bilateral conjunctivitis and scleral erythema. Burning of both eyes. No vision impairment but a lot of tearing. No treatment needed and resolved in 48 hrs.

Could taste vaccine immediately. Mouth and throat are raw and sore. Bottom lip is very red and swollen. Difficulty swallowing and have no taste buds. Arm is sore but minor issue compared to mouth and throat

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.

I experienced after my vaccine, after a few days I had a runny nose, head cold and I thought it as hay fever. At the end of my day it would clear up, my runny nose was back again. On the next morning I also experienced sore throat and a runny nose. This lasted about one week. I went to my PCP, and they did a COVID test and I tested positive. I can not taste anything, my nose is not runny and I have to blow up a few times a day. I have no fever 96.7F. I also get a minor phlegm when coughing. At this time I can say my symptoms are a bit better when taking OTC Tylenol medication though I still can not taste anything. I am taking fluids and taking Tylenol for my Covid symptoms.

6 hour after shot; Bloating, burping with foul taste, diarrhea, nausea 8 hours after shot; Vomiting, diarrhea, nausea, weakness 8-30 hours; Discomfort, nausea, weakness 36 hour; Feeling fine again. Fyi,

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

Patient vaccinated on 3/7/21, on 4/2 presented pain in left leg and some redness, on 4/3 some dizziness, lightheadedness, difficulty with vision in right eye, some slurred speech; on 4/5 his health agravated and EMS was called and taken to hospital; spouse informed that patient had a blood clot in stem of brain; on 4/6 patient died. No autopsy performed

Patient awoke 04/09/2021 with visual disturbance and limited field of vision. Went to eye center and was evaluated. MD at eye center sent him to ER and told patient that it appeared he was having a stroke. Admitted to medical center 04/09/2021. Patient reports he was diagnosed with a stroke affecting the occipital region that affects his vision. Patient was discharged from the hospital 04/11/2021.

1. metallic taste in mouth lasting about one day on day of injection march 25 2. body aches and pains, severe headache, fatigue, stomach distress nausea March 26-28 3. April 5-7 another incidence of fatigue including fever and shaking 4. April 9 a mini-flu type illness including vomiting and shaking/constipation/diarrhea 5. today April 25, metallic taste in mouth again

BLOODSHOT IN EYE/EYES WERE RED; KNOT IN CENTER OF RIGHT ARCH OF FOOT; NECK HURTS/COULD NOT MOVE NECK; HEAD SWELLING AND TENDER; SLEEPY; HEADACHE; CHILLS; HEART ACHE; This spontaneous report received from a patient concerned a 64 year old African American, not Hispanic or Latino male. The patient's height, and weight were not reported. The patient's concurrent conditions included blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: unknown) dose was not reported, 1 total administered on 08-APR-2021 between 09.30 and 09.40 to left arm for prophylactic vaccination. Concomitant medications included acetylsalicylic acid (Aspirin) for blood pressure. On 08-APR-2021, 20 minutes after vaccination, the patient started having symptoms. The patient's heart started aching and that lasted for 15-20 minutes and then went away. On 09-APR-2021, the patient had chills that had lasted for four hours. On 10-APR-2021, the patient could not move his neck left or right and back of his head felt like it was swelling and tender; he also had a headache, and he was extremely sleepy. The patient's neck and head tenderness lasted three to four days. On 11-APR-2021, the patient eyes had blood shot and were red and reported that he might had a stroke or blood clot. On 17-APR-2021, he had a knot came up in the center of right arch on foot. On 19-APR-2021, at the time of this report, the patient's eyes were still red and had a slight headache; the patient's neck still hurts, he was sleepy, and the knot was still there on his right arch of his foot. The patient took acetylsalicylic acid (Aspirin) but he was already taking that for his blood pressure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart ache on 08-APR-2021, head swelling and tender on 14-APR-2021, and chills on 09-APR-2021, and had not recovered from neck hurts/could not move neck, bloodshot in eye/eyes were red, headache, sleepy, and knot in center of right arch of foot. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This 64-year-old African American (non-Hispanic/Latino) hypertensive male patient reported "heart aching" 20 minutes after receiving COVID-19 VACCINE AD26.COV2.S for the prevention of symptomatic SARS-CoV-2 virus infection. The event lasted for 15-20 minutes. Other associated symptoms developed in the succeeding 3 days: chills that lasted for hours, could not move his neck and felt it was swelling and tender, headache, sleepiness, blood shot eyes. Nine days after vaccination, the patient reported he had a knot in the center of arch right foot. The patient took Aspirin. No other details was reported. The event is confounded by the underlying hypertension. The information available precludes a complete and meaningful assessment. However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded. Additional information was requested.

Blurred vision began one week after vaccination. Pt reports it has gotten better, but is still intermittent. Pt reported having had cataract surgery the previous year (March 2020) so recommended to discuss with opthamologist

Ear canals felt plugged suddenly and hearing was diminished. Several days later tinnitus (ringing in ear) started. I have not be treated.

CEREBRAL VENOUS THROMBOSIS; VISUAL IMPAIRMENT; HYPOAESTHESIA/ NUMBNESS IN ARM; This spontaneous report was received from a health care professional via a Regulatory Authority Vaccine Adverse event Reporting system (VAERS) (VAER reference number 1207958) and concerned a 64 year old male of unspecified race and ethnicity. The patient's height and weight were not reported. The patient's concurrent conditions included pollen allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029 expiry: UNKNOWN) dose was not reported. 1 total, administered on 16-MAR-2021 for prophylactic vaccination on left arm. Concomitant medications included atorvastatin and lisinopril; both for unknown indication. On 07-APR-2021, the patient experienced cerebral venous thrombosis, hypoaesthesia, and visual impairment. The patient had cerebrovascular thrombus with partial loss of sight and numbness of his left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cerebral venous thrombosis, hypoaesthesia, visual impairment. This report was serious (Disability Or Permanent Damage). This case version (1) was created on 30-APR-2021 for the purpose of quality improvement the following corrections were made. The MAC was added for the pharmacovigilance narrative.; Sender's Comments: V1: This spontaneous report was received from a health care professional via VAERS (ID: 1207958) and concerned a 64-year-old male of unspecified race and ethnicity who experienced cerebral venous sinus thrombosis (CVST) 22 days after vaccine. Concurrent conditions included pollen allergy and concomitant medications included atorvastatin and lisinopril. Twenty-two days after vaccine, the patient experienced CVST, hypoaesthesia, and visual impairment. The patient had cerebrovascular thrombus with partial loss of sight and numbness of his left arm. Specific imaging and laboratory results, including platelet count, were not reported. Information is limited in this case, and the occurrence of CVST could represent background incidence of such events in the general population. The platelet count is not reported and thus this case does not meet the Brighton Collaboration (BC) definition for Thrombocytopenia Thrombosis Syndrome (TTS) with BC Level 5 (not a case of TTS.)

Initially I experienced nerve pains across my body, including under both of my armpits, in my groin area, in my arms including my triceps, forearms and they were very sharp pains. Then I started to get a severe headache that was pretty constant. After multiple days, my face became paralyzed. I also experienced severe fatigue. This was over 10 days. Once paralysis happened we went to the Medical Center. I was treated with IVIG for many days and oral steroids. I was in the hospital for 6 days. I also experienced my BP spiking. I had an abnormal EKG. I'm still unable to chew properly. I was told that now I have Encephalitis and GBS (Gillian Barres syndrome).

COUGH; SLIGHT ARM SORENESS; WEAKNESS/REALLY WEAK; HEADACHES EXCRUCIATING AFTER THE VACCINE; FEVER; SORE THROAT; COVID EYES; POST NASAL DRIP; This spontaneous report received from a consumer concerned a 64 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced post nasal drip. On 02-APR-2021, the subject experienced sore throat. On 02-APR-2021, the subject experienced covid eyes. On 02-APR-2021, the subject experienced cough. On 02-APR-2021, the subject experienced slight arm soreness. On 02-APR-2021, the subject experienced weakness/really weak. On 02-APR-2021, the subject experienced headaches excruciating after the vaccine. On 02-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine was not applicable. The patient recovered from sore throat, covid eyes, cough, and fever on 06-APR-2021, and slight arm soreness on 04-APR-2021, was recovering from weakness/really weak, and headaches excruciating after the vaccine, and the outcome of post nasal drip was not reported. This report was non-serious. This case, from the same reporter is linked to 20210545446.

April 20, 2021. PT needed to use the restroom. We stopped, he walked to the restroom, I went to the gift shop. Upon returning, I saw PT sitting on a bench. He was leaning to his left, could not see out of his left eye, very unstable when sitting. We missed lunch, so we thought it was his sugar dropping. I started to feed him jam and a chocolate bar. After 2 hours, his vision returned & he seemed better. He drove us back to the rental cabin. He rested the next 2 days. Then on Friday, we packed up our vehicle and Pt drove us back home. After arriving home, Pt's condition got worse. We went to the Dr, explained the events of the previous week & she came to the same conclusion, Diabetes spell. His condition continued to worsen, we went back to Dr several times, the ER 2 times and finally we got into see a Neurologist. That appointment, the doctor said he thought stroke. Dr scheduled a MRI for June 1, 2021. Results of that MRI was a definite stroke. Now he has started outpatient rehab with no promise he will ever regain full mobility. He can no longer drive, mow grass, walk without a cane and help, etc. Life has changed dramatically for both of us.

BODY ACHES; CHILLS; FEVER; HEADACHE; FATIGUE; SORENESS AT INJECTION SITE; NO SENSE OF SMELL; This spontaneous report received from a patient concerned a male. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included osteoarthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced no sense of smell. On 02-JUN-2021, the subject experienced body aches. On 02-JUN-2021, the subject experienced chills. On 02-JUN-2021, the subject experienced fever. On 02-JUN-2021, the subject experienced headache. On 02-JUN-2021, the subject experienced fatigue. On 02-JUN-2021, the subject experienced soreness at injection site. Laboratory data included: Body temperature (NR: not provided) 99, 100.9. Treatment medications included: naproxen sodium. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness at injection site, fever, body aches, headache, and chills, and the outcome of fatigue and no sense of smell was not reported. This report was non-serious. This case, from the same reporter is linked to 20210604773.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case is assessed as non serious.

About a half hour after I had received the J&J vaccination which was after I had left the vaccination site and was headed home I noticed that my right eye was impacted by some kind of outline that looked like a spider or cockroach in black lines. The position shifted in light and based on where my eye was pointing. So it could be at the top or side of my view. This ghost image has been there ever since the vaccination. I notice it every day. My primary care doctor left his position and I haven't got a new one. My wife spoke with her eye doctor who did not see my eye. The doctor said that it was most likely caused by a bubble. I have been able to deal with this distraction even though it has remained the same since it appeared. I became more concerned that a booster shot for the J&J might make my situation worse. I also wasn't sure if I would have to have the J&J injected for the booster or could have a separate booster shot.

I woke up with severe face swelling it continued to my lips and then my tongue . I went to hopital . I was there for around 14 hours until they could monitor swelling and ensure my throat was. not obstructed . I was referred to an allergist that did blood tests and determined i have no allergies. He prescibed an EPI PEN and steroid to use if it occurred again . Symptoms did not go away for about 5 days . Since then I have had 8-10 episodes of severe swelling and welts all over my body.TodayI woke with the left side of my face very swollen and welts on my thigh. I am taking the benadryl and steroid he prescribed. The

Pt experienced worsening of tinnitus after vaccination. Slowly improving now. Also experienced headaches after vaccination, also improving now.

Four days after my vaccine, my eyes were very water with a clear, thick discharge. They were itchy as well. I went to see my optometrist who told me I had some sort of allergic reaction. I do not know if the vaccine caused my allergic reaction. My optometrist prescribed eye drops. I had no soreness or pain to my left arm after myvaccine. Today I still have some clear, thick discharge that is present.

Pt received Janssen vaccine, pt waited 30 minutes post vaccine administration due to his allergies. Pt reported throat pressure and difficulty swallowing approx 30 minutes post vaccine. Pt alert and no difficulty with speaking. EMS activated and patient transported to ER for evaluation

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.

Experienced headache, earache, chills, tongue felt swollen, fatigue, joint pain for 2 days after vaccine. It felt like I had Covid again

BURNING CHEST; FEVER; DIFFICULTY BREATHING; COUGHING; WHEEZING; FEELS LIKE SOMETHING IN THE BACK THROAT; TOTAL BODY ACHES; This spontaneous report received from a consumer concerned a 65 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had unknown allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 14:15 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced difficulty breathing. On 06-APR-2021, the subject experienced coughing. On 06-APR-2021, the subject experienced wheezing. On 06-APR-2021, the subject experienced feels like something in the back throat. On 06-APR-2021, the subject experienced total body aches. On 06-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced burning chest. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning chest on 09-APR-2021, and had not recovered from difficulty breathing, coughing, wheezing, feels like something in the back throat, total body aches, and fever. This report was non-serious.

1.stiffness in joints, 2. achy 3. coughing 4.runny nose 5. feeling tired 6. nauseous 7. blurred vision

On Saturday April 24, 2021, I began experiencing severe headaches, eyeball pain, light-headiness, weakness and lack of energy, pain at the injection site and flu like symptoms.

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.

2 weeks ago on April 17th, I woke up feeling very dizzy and nauseous. The room was spinning. My left ear was ringing, My balance was off. Every time I bent over it was worse. I vomited after I ate. Spent the day and the next day in bed. On Monday I called my doctors office and explained how I was feeling and a tele visit was scheduled later in the day. During the tele visit, the doctor diagnosed my symptoms as vertigo. I never had vertigo in the past. She couldn't tell me if it was from the vaccine or not. She did mention she had patients complaining of vertigo after getting the covid vaccine. Medication and exercises were given to me. A few days later, my big toe on my right foot was aching terribly. Each day it seems to be worse and I am at the point where I can barely walk. Today I did some research online and saw that it could be gout. I never had gout n the past. I read vaccines can cause gout. So here I am 2 weeks since my symptoms began and I am still dizzy and have the toe pain. Exercises and medication is not helping.

Lightheaded, extreme fatique, red dots on skin and in mouth, bruising, low blood platelets, low hemoglobin

BLEEDING IN EYES; RETINAL TEAR OR DETACHED RETINA; RETINAL TEAR OR DETACHED RETINA; INCREDIBLY PAINFUL INJECTION; REALLY TIRED; This spontaneous report received from a patient concerned a 65 year old white not Hispanic or Latino male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no eye problem in the past. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 042A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 05-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the patient experienced incredibly painful shot upon administration, immediately the patient was really tired. Three hours after the vaccination, his vision became cloudy and blurry. He then fell asleep. On 05-APR-2021, the patient experienced no peripheral vision. On 06-APR-2021, the patient woke up and had a little improvement in cloudiness but the patient stated that about 20 percent of his vision was still cloudy/blurry. The patient experienced pressure behind eyes, right eye distortion. The patient began to see bright flashes and round floaters. On 06-APR-2021, the patient experienced bleeding in eyes, retinal tear and detached retina that affected the patient's ability to work. On 07-APR-2021, morning, he was then referred to an eye specialist for ongoing eye issues. He went to see physician. He had been back to the eye specialist 2 additional times since then with ongoing eye issues. He had been told he has bleeding in his eyes, a retina tear or detached retina and still no peripheral vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from incredibly painful injection on 05-APR-2021, had not recovered from retinal tear or detached retina and bleeding in eyes and the outcome of really tired was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210509138-Covid-19 vaccine ad26.cov2.s-Eye heamorrhage, Retinal tear ,Retinal detachment. These events are considered unassessable. The events has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events

About a week after the injection my right eye started getting cloudy. I went to the eye doctor and he said I had lost some peripheral vision in that eye.

Dont know if related or not-- around vaccine date noticed I was "dribbling" when drinking out of water bottle about 4-20-21-, mentioned to Doctor have been dribbling last week or 2 - look at me- told me right side of mouth not moving- thought I had stroke and told to go to e.r where they confirmed there was a stroke and I also had 30 % blockage in right carotid artery. Could also be related to ADD med( Vyvanse have been taking for last 10 years)- as med causes spike- high blood pressure.

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.

HEADACHE; COULD NOT SEE CLEARLY; FELT THERE WAS SOMETHING IN HIS EYE; This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, non-smoker, and wears readers. The patient experienced drug allergy when treated with methotrexate. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A and expiry: UNKNOWN) dose was not reported, administered on 20-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-JUL-2021, the subject experienced could not see clearly. On 20-JUL-2021, the subject experienced felt there was something in his eye. On 21-JUL-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 21-JUL-2021, and had not recovered from could not see clearly, and felt there was something in his eye. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.

Approximately 4-5 days after vaccination, the skin of my face, scalf and around my eyes became itchy. I think there's very minor puffiness of my upper cheeks at either side of my nose. Now, ten days later, the itching persists.

Left side of upper lip started swelling the next morning after the shot. Tingling and numbness around the mouth area. Pimple like blister formed on the inside of lip.

DIZZY; NAUSEA; HEADACHE; FEELING HOT; COLD FINGERS; DRY LIPS; This spontaneous report received from a patient concerned a 66 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: 043a21a, expiry: not reported) dose was not reported, administered on 04-APR-2021 16:30 to left arm for prophylactic vaccination. No concomitant medications were reported. On 04-APR-2021, the subject experienced feeling hot. On 04-APR-2021, the subject experienced cold fingers. On 04-APR-2021, the subject experienced dry lips. On 04-APR-2021 23:00, the subject experienced dizzy. On 04-APR-2021 23:00, the subject experienced nausea. On 04-APR-2021 23:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, nausea, feeling hot, cold fingers, and dizzy, and the outcome of dry lips was not reported. This report was non-serious.

7 days after receiving J&J COVID19 vaccine, patient developed left ear pain, left sided facial numbness/droop, vertigo. Pt was seen in clinic and physician diagnosed pt with Left Bells Palsy. Prescribed 12 day prednisone course. Pt on Day 3 of steroid course today and slowly feeling better.

Brief episode of vision corruption.. perceived colors changed. White toilet bowl appeared pale blue. Preceded by strong headache behind eyes.

Warm flush in neck and head a few minutes after injection. Six hours after injection, headache with mild fever, chills and join aches. Nine days after start of symptoms, severe headache with neck pain. Was prescribed antibiotics for sinus infection symptoms and given a chest X-ray. On March 26th was instructed to go to ER by primary but I refused at the time. On 12th day after vaccination vision in left eye became blurry with swelling. Also had numbness in lower back radiating to the front. On 16th day, 03/29/2021, primary care physician again instructed me to go to ER. I was admitted to the hospital. Released 03/31/2021. Was treated for head and neck pain and given several tests.

2 days after shot, fatigued, minor muscle ache, dizziness, blurry weak vision. Some nausea in a.m., then today, 7 a.m. nausea and weakness, chilly and extreme fatigue, in bed all day so far. Feeling like not enough air all week since shot.

Numbness on right side of face , numb tongue, water build up in ears, right nostril closed up right side of face sags and eye will not close can?t blink. Diagnosis Bell?s palsy nad viral infection

3 days after receiving injection i lost my sense of smell and taste. no fever or chest congestion. taste and smell returned i 5 days 03/19/2021 woke up with vision loss i left eye. eye care assoc. diagnosis is NAION, optic neuropothy due to lack of blood flow to optic nerve damaged.

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.

March 25 - loss of taste - March 30 - shortness of breath - resp failure - March 31 - transferred to ER - intubated for three days. Transferred to hospital - March 5 - transferred to Rehab - 4/15; released to home 4/24.

Patient was administered the Johnson and Johnson Janssen COVID-19 vaccine. Shortly after, a few seconds, the patient stated he felt flushed and head started to fall back. Staff member cradled his head and called another staff member over. Staff member called 9-1-1. Patient went unconscious and his eyes rolled back for approximately 30 seconds. When aware, we (staff members) transferred patient from the chair to the floor where staff member supported his back and fanned him due to his profuse sweating. Staff member continued talking to him when he became unconscious again, this time gasping for air and turning pale. We kept saying his name until he came to again and was somewhat aware of his surroundings. He fainted one last time. After this time, he sat up on his own and seemed to be very coherent. The EMS arrived shortly after and took over. They said they would take him out to check him out but he seemed to be doing better. An EMS personnel let us know the patient did tell him that he has fainted from vaccines before. However, he did not disclose this to us on the PQCF form or when asked verbally.

Horrible tinnitus....non stop... there is no treatment...If I had know about this I would have skipped the shot. This is NOT acceptable.

SKIN PEELING/SKIN FLUFFING; SEVERE RED RAISED LARGE PAPULAR RASH ON UPPER TORSO AND UPPER ARM; RASH ON BILATERAL INNER THIGHS; EAR LOBES SWELLED UP; UPPER NECK SWELLED UP; NECK DOWN RED; ITCHY SKIN; This spontaneous report received from a consumer concerned a 66 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: 20A21A expiry: UNKNOWN) dose was not reported, administered on 05-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced ear lobes swelled up. On MAY-2021, the subject experienced upper neck swelled up. On MAY-2021, the subject experienced neck down red. On MAY-2021, the subject experienced itchy skin. On 08-MAY-2021, the subject experienced severe red raised large papular rash on upper torso and upper arm. On 08-MAY-2021, the subject experienced rash on bilateral inner thighs. On 09-MAY-2021, treatment medications included: diphenhydramine hydrochloride. On 10-MAY-2021, the subject experienced skin peeling/skin fluffing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe red raised large papular rash on upper torso and upper arm, upper neck swelled up, itchy skin, and rash on bilateral inner thighs on MAY-2021, and skin peeling/skin fluffing on 12-MAY-2021, and was recovering from ear lobes swelled up, and neck down red. This report was non-serious.

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

PAROXYSMAL ATRIAL FIBRILLATION; FEELING OR SENSATION OF DRAINAGE IN LEFT NOSTRIL; OCCASIONAL PRESSURE IN BOTH EARS; SLIGHT BURNING SENSATION IN JUST LOWER LIP WITH SMALL, TINY PROTRUSIONS; LOCALIZED BACK PAIN BILATERALLY INFERIOR TO THE POSTERIOR RIB CAGE BUT MOSTLY ON LEFT SIDE; SLIGHTLY HIGH PITCH SOUND IN LEFT EAR; HEADACHE; FATIGUE; SMALL AMOUNT BLOOD IN STOOL; NODULE IN CUBITAL FOSSA AREA ON MEDIAL SIDE OF ARM; SMALL AMOUNTS OF BLOOD IN PHLEGM; IRREGULAR, LESS FREQUENT AND MORE SOLID BOWEL MOVEMENTS; INCREASED URINATION LASTED 2-3 WEEKS; OCCASIONAL LOCALIZED PRESSURE AND HEADACHES IN OCCIPITAL, FRONTAL, AND TEMPORAL AREAS; 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 past medical history included covid-19 (experienced all the typical symptoms, but waited 13 days to get tested) and concurrent conditions included paroxysmal atrial fibrillation (last time he had an episode until after he received the vaccine). He did not have any recent episodes of atrial fibrillation The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 29-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 29-MAR-2021, the patient experienced occasional localized pressure and headaches in occipital, frontal, and temporal areas which were intermittent and pulsating in nature. On APR-2021, the patient experienced small amount of blood in stool and had irregular, less frequent and more solid bowel movements about 2-3 weeks post vaccination. He mentioned around the same time he was urinating more (increased urination lasted 2-3 weeks), and then his bowel movements and urinations became regular again. He also experienced a nodule that appeared in the cubital fossa area on medial side of his arm two weeks after the vaccination and then gradually resolved over 2.5 weeks after it appeared and small amounts of blood in his phlegm which appeared 1.5 weeks post vaccination and he continued to experience this on week 2, week5 post-vaccination and then resolved. On 14-APR-2021, Laboratory data included: Antibody test (NR: not provided) Negative, Complete blood count (NR: not provided) unknown, and Platelet count (NR: not provided) Normal. He reported experiencing 5 episodes of atrial fibrillation within the 7 weeks after vaccination, a diagnosis of paroxysmal atrial fibrillation was confirmed by his cardiologist. He also experienced fatigue about 5-6 weeks after vaccination. He had intermittent waves had fatigue throughout the day which lasts for an hour and then came back later in the day, with no consistency and stated this was still unresolved. (Later on he stated he had no fatigue spells lately and considered this resolved). On an unspecified date, he experienced feeling or sensation of drainage in left nostril, (even though had no excess blood or fluid) which started a few weeks after received the vaccine and then lasted for several months but now resolved and occasional pressure in both ears (opening and closing his mouth did not relieve the pressure) and slight high pitched sound in the his left ear. His ear side effects came and gone and considered them to be resolving but not fully resolved. He noticed a few weeks after vaccination he had slight burning sensation in just his lower lip with small, tiny protrusions (He initially said this was unresolved, but then later said this was resolved). He also experienced localized back pain bilaterally inferior to the posterior rib cage but mostly on the left side. He mentioned he have a checkup next week and will discuss his concerns since this side effect was still unresolved and headache. The patient stated he did not experience any of these side effects before receiving the vaccine. He was generally healthy and tried not to take medication if possible. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from paroxysmal atrial fibrillation, nodule in cubital fossa area on medial side of arm, feeling or sensation of drainage in left nostril, slight burning sensation in just lower lip with small, tiny protrusions, and fatigue, and small amount blood in stool, small amounts of blood in phlegm, irregular, less frequent and more solid bowel movements, and increased urination lasted 2-3 weeks on APR-2021, was recovering from occasional pressure in both ears, and slightly high pitch sound in left ear, and had not recovered from headache, localized back pain bilaterally inferior to the posterior rib cage but mostly on left side, and occasional localized pressure and headaches in occipital, frontal, and temporal areas. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210667239-COVID-19 VACCINE AD26.COV2.S. Paroxysmal atrial fibrillation. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: UNDERLYING DISEASE 20210667239-COVID-19 VACCINE AD26.COV2.S. Small amount blood in stool. 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.

ANGIOEDEMA AND ANAPHYLAXIS. 4/6/202021- SWELLING OF LEFT EYE- WENT AWAY IN 2 DAYS. 4-9-21 SWELLING OF ENTIRE FACE TOOK TO URGENT CARE AND GIVEN SHOT OF SOLUMEDROL AND A PREDNISONE PACK. 4-16-21 SWEELING OF EYES AND FOREHEAD GIVEN PREDNISONE PACK. 4-23-21 ANAPHYLAXIS ON A VENTILATOR FOR 43 HOURS AND ICU

Patient complaining of shooting , neuropathic type pain from top of head radiating down. Patient complaining of increased saliva production, difficulty swallowing.

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!

Narrative: Patient presented to ED triage 12 days after receipt of vaccine. States he was having severe headache and double vision. CT head demonstrated supraseller mass possible bleed. MRI demonstrates large enhancing sellar and supraseller mass extending into the left sphenoid sinus and causing mass effect on the optic chiasm and inferior left hypothalamus likely representing a microadenoma, no hemorrhage. Patient was transferred to a facility with neurosurgical expertise. Platelets are normal, PT/INR are normal.

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).

Tinnitus continuous high frequency ringing in both ears... No treatment.... No cessation since inception

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.....

Patient and wife stated that he has had many vasovagal syncope events when he has had vaccines administered, both more recently, and in the past. The patient was seated in a chair with arms. Within a couple of minutes of administering the vaccine, his eyes rolled back in his head, he broke out in a cold sweat, BP was 75/55, pulse 55. He never stopped breathing (was snoring); epinephrine for an anaphylactic reaction was not indicated. I offered to call 911 multiple times but his wife said this was the normal course of his reaction and held an icepack on his neck for the duration. After 5-10 minutes the patient was once again responsive. He sat for an additional 10 minutes and then said he was ready to leave. His wife walked him out of the store.

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

Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Medium, Systemic: Nausea-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Severe

METALLIC TASTE; This spontaneous report received from a consumer concerned a 67 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, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAY-2021, the subject experienced metallic taste. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from metallic taste. This report was non-serious.

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

BLEEDING IN BRAIN; COULD NOT SEE WITH HIS EYES; COULD NOT WALK; PAIN IN LEGS; SHARP PAINS THROUGH HEAD; BLEEDING FROM HIS EYES; BLEEDING FROM HIS EARS; SICK; This spontaneous report received from a consumer (patient's sister) concerned a 67-year-old, White, not Hispanic or Latino male patient. The patient's height, and weight were not reported. The patient's past medical history included covid-19. His concurrent conditions included inability to see after he got something sprayed into one of his eyes in jail and wheelchair user. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on 31-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. Since the day of the shot, the patient had been sick. On 02-JUN-2021 (about 2-3 days after the vaccination), the patient experienced side effects. He had bleeding in his brain due to which he could see with his eye, could not walk, had so much pain in legs, and sharp pains through his head. The patient was getting worse. On an unspecified date in JUN-2021, the patient had bleeding from his eyes and ears. The patient could not walk at the time of reporting. He had one good eye (not the eye with which he could not see due to bleeding in brain) but could not see from it too as he got something sprayed into it previously. Hence, he lost both eyes and could not see at all at the time of report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bleeding in brain, could not walk, could not see with his eyes, pain in legs, and sharp pains through head, and the outcome of bleeding from his ears, bleeding from his eyes and sick was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 - 20210632304 - Covid-19 vaccine ad26.cov2.s - BLEEDING IN BRAIN , COULD NOT SEE WITH HIS EYES , BLEEDING FROM HIS EYES . 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).

After 4 days Tinnitus started. After 14 days this became rather severe. Now at 16 days this is constant and has not gotten worse, but still is rather severe.

Started quite Loud Tinnitus of motor running noise after COVID-19 vaccine dated 3/13/2021, and still same as of today 3/23/2021. Suspect the virus carrying the vaccine is causing the tinnitus in the ears.

Have been feeling pressure in head entire time, discomfort but short of pain. I have had a ringing or buss in my head from approximately day 3 that still persists and is still the same today.

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

Tinnitus much increased loudness both ears, but additionally high pitched clicking sound physic intermittently, frequently throughout day and night, not improving

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.

BLOOD IN THE URINE; SHINGLES; RASH LOOKING LIKE SHINGLES; FATIGUE/FEELING TIRED; BAD HEADACHE; LOSS OF APPETITE; FOOD DOES NOT TASTE QUITE WELL; NUMB AREA; ITCHING; FELT LIKE ELECTRIC CURRENT GOING THROUGH; PAIN 24/7; BUMP AND IT SPREAD TO SHOULDER AND IT SEEMED TO AFFECT THE NERVE; DISCHARGE FROM RASH; This spontaneous report received from a patient concerned a 68 year old white, not Hispanic or Latino male. Initial information was processed along with the additional information received on 10-MAY-2021. The patient's height, and weight were not reported. The patient's past medical history included ruptured pancreas for which he had a major surgery, eczema, femoral by pass of the right leg to increase blood flow, and blood in urine (which had occurred due to unspecified medical conditions and was cured), and concurrent conditions included prostate cancer, home bound (got vaccinated at home), and the patient was on foley catheter. The other pre-existing medical conditions included the patient had no known allergies, no history of mumps or chickenpox when he was a child and had not been in contact with anyone having chickenpox. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 06-APR-2021 for prophylactic vaccination. Concomitant medications included triamcinolone for eczema. On an unspecified date in 2020, 6 months ago at the time of reporting, laboratory data included: Blood cholesterol (NR: not provided) unknown, and Lipids (NR: not provided) unknown. On 06-APR-2021, after vaccination the patient experienced bad headache for a couple of days, fatigue/feeling tired, loss of appetite that was still lingering. Per patient the food wasn't tasting quite well. on an unspecified date the patient experienced rash like shingles. On 27-APR-2021, the nurse said that the patient experienced a kind of rash that looked like shingles on left shoulder and left neck and had dark colored urine which indicated blood in urine (patient was on foley catheter). On an unspecified date in 2021, the patient experienced a small bump ( injection site lump) at the site of shot on the left arm which spread to the shoulder and it seemed to affect the nerve, the area was generally numb, itching and electric current going through (electric shock sensation), the pain was 24/7 and discharge from rash. The bumps ruptured easily and the patient was advised not to spread the discharge from rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bad headache on 08-APR-2021, was recovering from fatigue/feeling tired, had not recovered from rash looking like shingles on left shoulder and left neck, loss of appetite, blood in the urine, and pain 24/7, and the outcome of numb area, food does not taste quite well, injection site bump spreading to shoulder and affecting the nerve, itching, discharge from rash and felt like electric current going through was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210516869-COVID-19 VACCINE AD26.COV2.S-Blood in the urine . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY

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.

Swelling in the eye on the bottom, and a little on the face, itchy, red, and is claiming to have tachycardia These symptoms are likely not due to COVID vaccine. Check with cardiologist for tachycardia and make sure eye drops have not expired or have not been contaminated. If symptoms worsen seek medical help.

Pt has had tinnitus for decades, he's used to it. Directly after shot, it became approx 4 times louder - noticeably much louder. This was reported on V-Safe, but V-Safe has d/c requesting reports after day 8. Tinnitus continues about 2x louder now 9 days later, and has been that loud since subsiding from 4x over the initial few days.

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.

PATIENT SUFFERED AN ISCHEMIC OCCIPITAL LOBE STROKE, CONFIRMED BY CT SCAN, ON 4/2/2021. PATIENT WAS TRANSFERRED TO AND ADDMITTED TO HOSPITAL. PATIENT WAS NOT ADMITTED TO THE ICU PER HIS WIFE. PATIENT WAS RECENTLY TRANSFERED TO REHAB WHERE IS HE IS CURRENTLY AS OF 4/13/2021. PATIENT LOST VISION IN LEFT EYE AS WELL AS FUNCTION IN HIS LEFT ARM PER THE PATIENTS WIFE. PATIENT IS REGAINING SIGHT AND STRENGTH IN BOTH HIS LEFT EYE AND ARM BUT PROGRESS IS SLOW, PER HIS WIFE.

on March 18, 2021 ( the day following my J&J vaccination ), While on my way back from a 2 mile run , I experienced left-sided listing and lack of control of my left leg and arm. I was dizzy and saw black spots. My wife and son took me to emergency room. My symptoms abated while at the hospital. Hospital staff conducted many tests and I was kept overnight and discharged the next day around 5:00 p.m. with possible TIA as diagnosis.

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

Started 1 week after injection. Swelling in lower legs, felt like balloons. Feeling of swelling in lips. Headache started in left temple area of head; after a couple of days went across forehead and on back of head with intensity increasing but not extreme pain. Slight nausea; no vomiting. Some abdominal pain that would come and go. Periods of shortness of breath; tightness feeling in upper chest. Loss of energy and some light headed feeling.

After my J&J vaccine I has soreness to my right arm at the injection site. On 04-08-2021 woke up with a head cold, loss of sense of smell. I On 04-09-2021, I went to clinic where I got tested for Covid-19 and my results were positive at 11:20pm.

SUDDEN ELEVATION OF TEMPERATURE= 102, NAUSEA, BLOOD SHOT EYES, GENERALIZED JOINT PAIN. TOOK TYLENOL/ASPIRIN. LESSENED THE EFFECTS.

Blindness in left eye, blood clot in left eye- no treatment available. Permanently blind in left eye now.

DIZZINESS; MUSCLE ACHES; SWELLING IN THE NECK AND SHOULDER AREA; UNUSUAL TASTE IN THE MOUTH; UPSET STOMACH; This spontaneous report received from a patient concerned a 69 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: 1805029, expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the subject experienced swelling in the neck and shoulder area. On 22-MAR-2021, the subject experienced unusual taste in the mouth. On 22-MAR-2021, the subject experienced upset stomach. On 22-MAR-2021, the subject experienced muscle aches. On 24-MAR-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling in the neck and shoulder area, muscle aches, unusual taste in the mouth, upset stomach, and dizziness. 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.

Left side of face would go numb from top of head to chin. Left side of face drooping Left eye swollen, watery, blurry Left eye ball quivers when having an attack of the above

Migraine Auras (lightning bolt). Although I would get 1 or 2 a year, since the vaccine I have had at least 1 every 2 weeks.

SHORT LASTING PAIN IN RIGHT EYE; SHARP SHORT LASTING PAIN IN LEFT EAR; 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: 1808609, expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 on left deltoid for prophylactic vaccination. Concomitant medications included aflibercept. On 20-MAR-2021, the subject experienced sharp short lasting pain in left ear. On 23-MAR-2021, the subject experienced short lasting pain in right eye. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from short lasting pain in right eye, and sharp short lasting pain in left ear. This report was non-serious. This report was associated with a product quality complaint: 90000174005. The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria) based on the PQC evaluation/investigation performed.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.

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

Per my aunt (uncle's wife), my uncle complained of severe headache especially on the right temple area, nausea, and dizziness at around 6am on 4/11/2021. Soon afterward, she noted my uncle has left side weakness and drooling when drinking.

EXCESSIVE DROOLING/SLOBBERING; 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 diabetes, and high blood pressure, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 205A21A expiry: 07-AUG-2021) dose was not reported, administered on 05-JUN-2021 for prophylactic vaccination. Concomitant medications included metformin for diabetes, lisinopril for high blood pressure, and tamsulosin. On JUN-2021, the subject experienced excessive drooling/slobbering. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from excessive drooling/slobbering. This report was non-serious.

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

Everything is salty, all the food I eat even the water I drink. Salty after taste. All the time even now.

Pt received vaccination around 9am on 3/18. Started having lip swelling next day and presented back to the pharmacy on 3/19 around 1:15pm. Pt states he was having no tongue swelling or any other symptoms, just swelling of the lower lip. We administered 25mg of benadryl and kept an eye on him in pharmacy for 15 minutes and he said he was feeling fine and would check back with us. Pt is an associate so pharmacy is keeping an eye on him.

About 4 days after receiving his vaccine he began to have difficulty with chewing, swallowing and speaking. He describes waking up in the morning with paresthesias of numbness from the nose down to his jaw. He is scared to eat due to fear of choking. He notes as he continues to chew or speak he gets fatigued. He denies any difficulty with breathing or generalized weakness. He does report coughing with secretions. He reports his symptoms have been ongoing for 2 weeks with no improvement. Patient ended up getting admitted to the hospital for IVIG treatment for the myasthenia gravis flare.

Approximately 27 hours after receiving the injection I had approximately 15 minutes of uncontrollable shaking. I stopped when I got into a hot shower. I also had a headache and muscle aches and pains the day after the injection. Approximately 72 hours after the injection I developed ringing in my ears and it is continuing now.

Bells palsy happening on left side of his face, everything is paralyzed, small pain behind left ear, left eye will not close(drys out), and is still going on with no improvement Went to ER because they thought it was a stroke .

BACTERIAL INFECTION; DIFFICULTY SWALLOWING; DIFFICULTY CHEWING; This spontaneous report received from a patient concerned a 72 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included myasthenia gravis, and other pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-MAR-2021 at Left Arm as prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the patient experienced difficulty in swallowing and chewing . He was diagnosed also with a bacterial infection of unknown origin. On 23-MAR-2021, the patient was hospitalized for 11 days in the ICU. The patient was recovered from the infection but continues to experience symptoms of myasthenia gravis. The patient was discharged from the hospital on 02-Apr-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bacterial infection on 02-APR-2021, and had not recovered from difficulty swallowing, and difficulty chewing. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210422146-covid-19 vaccine ad26.cov2.s-bacterial infection. 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. 20210422146-covid-19 vaccine ad26.cov2.s-difficulty swallowing and difficulty chewing. These events are considered not related. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There are other factors more likely to be associated with the events than the drug. Specifically: UNDERLYING DISEASE

TONGUE HURTS TO CHEW AND EAT; This spontaneous report received from a patient concerned a 72 year old male. The patient's height, and weight were not reported. The patient's past medical history included hip replacement surgery on right side, and concurrent conditions included smoker, and non alcoholic, and other pre-existing medical conditions included the patient had no known allergies, and drug abuse or illicit use. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. Concomitant medications included gabapentin for post hip replacement pain, and methadone for post hip replacement pain. On 16-MAY-2021, the subject experienced tongue hurts to chew and eat. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from tongue hurts to chew and eat. This report was non-serious.

Thursday, March 11, 2021 (approximately 8:30 am) Patient experienced blurred vision, unbalance, and slurred speech and had an irregular heartbeat. March 11, 2021 (approximately 11:30 am) Patient was admitted to Hospital administered CT scan, MRI and multiple blood tests. Diagnosis - Ischemic Stroke

Headache and pain behind Rt. eye, developing into a low grade reaver and vomiting. By Tuesday the 11 I developed a rash on my face with pain shooting behind my eye to the back of the head. Tuesday at Emergency room eye was swollen closed, rt. side of face was broke out in scabs and sharp pains through the eye and scalp.

VACCINE TASTE (STRONG BITTER ODOR); INJECTION SITE REACTION; 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 pre-existing medical conditions included no past medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 08-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAY-2021, the subject experienced vaccine taste (strong bitter odor). On 08-MAY-2021, the subject experienced injection site reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vaccine taste (strong bitter odor) on 12-MAY-2021, and injection site reaction. This report was non-serious.

PATIENT HAS HAD LOSS OF TASTE STARTING 7-10 DAYS AFTER VACCINATION AND IS STILL EXPERIENCING LOSS OF TASTE AS OF 6/7/21

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).

Had mild symptoms of headache, fatigue, nausea, light headedness for starting about 3 hrs. after shot given and lasting into evening of next nigh; No fever or shortness of breath experienced. Except for fatigue was generally OK for next 6 days. Then eyes started blurring down my vision, and started seeing double/triple vision... symptoms are intermittent; worse in evening when eyes are fatigued. Called medical center for info and course of action and was advised to report to medical center emergency Room. Will see what eyes are like in morning

Patient called in and stated that approximately two hours after his vaccination he had "blood clots" in his mouth. Patient didn't know what other words to use to describe it. He said he was not coughing it up, but didn't know where it was coming from. I asked if it could possibly be from his gums and he said yes. It was coming from the upper part of his mouth and it was a thick, dark red blood. It was not bright red. He stated that it would congeal together and then become big enough that he would want to spit it out and this had been occuring throughout the day yesterday and into today. He reports no other loss of blood, dizziness or other symptoms. I requested patient reach out to his physician to discuss this matter.

Extreme vertigo, weakness, unable to walk, extremely unbalanced when attempting to stand up, severe Headaches, blurred vision.. Also with sinus type drainage. Extreme nausea and fatigue. Literally couldnt even hold his head up. All sypmtoms started within 48 hours of injection and came on with a vengance. He was so unsteady and unstable he fell with attempts to get up. Prior to the vaccine he was great! Strong and healthy for all of his underlying medical condtions. Completely Independant, driving , working around the house ect. Unfortunaley this is still going on. He is very weak, and still unsteady when he is up. Nausea continues. He is doing Vestibular therapy for the balance issues. Took a round of seroids.