Johnson & Johnson

Metallic taste, slight headache and elevated blood glucose numbers (normal 80-120, one hour post no food prior 243)

During the day that I was administered the vaccine I had pain in my arm (area in where I was vaccinated). The next day, I woke up with general pain in the body, pain in the arm where the vaccine was injected and it swelled up a little the skin under the eyes (hives). As the day goes by, the pain in the arm has diminished, as well as the hives in the eyes.

Time-line: - Started with achiness in both legs - Chills onset about 30 minutes after achiness - Chills briefly (1-2 minutes) were so severe I was shaking (convulsion like), only time this happened - Chills persisted for over 2 hours, covered up and took a nap - Upon waking, entire body had a hot/searing sensation (under skin), but no elevation in temperature - Eyes were extremely dry - Body aches continued into the next morning, hot/searing sensation had stopped - Was fairly fatigued the entire next day, dry eye issue persisted - After more rest than normal, I seem to be back to normal, no body aches, fatigue, or dry eye issues.

Day 1 ? 3:00pm vaccine Day 2 ? fatigue and slight chills, no fever Day 3 ? fatigue, fever of 100, headache Day 4 ? position and light sensitive headache, chills but no fever, fatigue At exactly 74 hours, it all disappeared.

The day I got it my mouth started having a metal taste. For the past weeks I?ve been lethargic, can?t sleep, body ache, soft palate is itchy as well as my throat. The metal taste is still there and gets more intense with exercise or stress.

Approximately seven minutes after the patient received the Janssen COVID vaccine, he had called out to his wife/pharmacy technician at the pharmacy stating he did not feel well. His head had fallen back and his eyes were starting to roll back into his head. Patient had saliva starting to foam at the corner of his mouth and it appeared to be the onset of a mild seizure (per wife, patient has had seizure once before after a head injury) and he was turning very pale. Patient seemed to be unresponsive at that time - not answering to questions. At this point, one of the pharmacists ran to the clinic to get help and the other pharmacist administered an Epi-pen to patient's thigh. Patient immediately came around after the injection, looked up and began talking. Staff called 911 and patient was monitored by pharmacy and clinic staff. When the paramedics arrived, the patient was doing better and was able to ride home with his wife.

Significant ringing is occurring in my ears. Never had any symptoms or ear problems in the past and it is now non stop.

I had the worst headache of my life on 3/22 but assumed it was a migraine and treated it as such. On 3/23 while playing hockey, nearly immediately after starting, the headache returned even stronger than on 3/22 and forced me to stop playing as I could not concentrate or focus. The headache lasted for several days. The following morning I went to my standard physician who immediately sent me to the ER because he was concerned about a potential aneurysm. No cause was ever determined as the tests were inconclusive but it was suspected to potentially be a pinched nerve. However, I never had any pain in my neck or elsewhere besides the headache.

I was working at and, around 5:30 am when I felt some strong pain both side of my chest. Sonner I felt a slight headache and from time to time it intensified to become unsupportable. At that time though about a lack of oxygenation, because I wore mask for the whole time I was working. About 9:am when I drove to home, I saw everything foggy in front of me. When I get home I took some paracetamol and another painkiller, because at that time my entire body was so warm, and the headache was very bad. I slept for 5 hours, when I woke up I went to the mechanic to fix my car. While I got back during the time I saw the same foggy vision.

Client returned to the clinic with c/o flushing and feeling very hot, numb, tingly lips, itching on the face. Benadryl 50 mg PO given. Patient added some of the previous c/o after the initial communication. Improvement after 15 minutes. Client remained with the Facility HCP.

Unusual exhaustion within an hour of the vaccine. Had to go to bed and slept into the evening developing a fever of 103, severe thirst and chills. The fever lasted until 10:00 a.m. the following day, but weakness, thirst, chills and body aches continued for 3 more days intermittently. I would feel like I could finally exercise and then be too weak and tired to go back to routine. My appetite declined for 4 to 5 days as food didn't taste appealing. On Thursday, April 8, I announced to my mom in the morning that I finally felt like I was back at almost 100% and later in the afternoon felt nauseous, incredible pain in my chest and had dry heaves. I finally vomited some and was once again overcome by a fever of 101 and all I could do was sleep from severe exhaustion. I am against medication, but finally agreed to taking ibuprofen and tums. After sleeping into the next day around noon, I finally was able to eat some breakfast but the pain in my chest continued and I could rid it for another day. I intermittently had to sleep and gave up my exercise routine until my body has had time to recuperate. I have not fully recovered, but my appetite is picking up. I still require more sleep than normal.

RINGING IN THE EAR; DIZZINESS; CONGESTION; This spontaneous report received from a patient concerned a 40 year old male. The patient's weight was 245 pounds, and height was 183 centimeters. The patient's concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient have no history of drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced ringing in the ear. On 07-APR-2021, the subject experienced dizziness. On 07-APR-2021, the subject experienced congestion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ringing in the ear, and dizziness, and the outcome of congestion was not reported. This report was non-serious.

Called Connections on 4/20/21. Pt c/o feeling swollen throat glands, hard to swallow, dry/sore throat, also random dizziness not constant, feeling body aches, tired, runny nose but pt denies sob, difficulty breathing, chest pain. Speech seems comfortable, AO X 3. Pt stated these sx started on 04/13/2021 after he got his Janssen(J&J) covid vaccine on 04/12/2021,he stated sx not getting better its getting more from then. This writer recommended pt to go to ED/call 911 for further evaluation and treatment. Pt took covid test yesterday awaiting for his result. Denies any past medical Hx

Patient reported acute onset of diffuse tingling sensation , light-headed, with cold sweats, blurred vision, and acute complaints of shortness of breath within 9 mins of injection. Shortness of breath was immediate after administration. VS at 11:30 AM T97.4, HR 60, RR 16 BP 88/58 O2 87- rechecked at 95--lungs CTAB Reports a controlled 1600 cal/day diet, OJ and gummy snack given. Patient encouraged to push PO fluids and focused respirations. O2 stabilized at 94-95% on RA VS rechecked at 12:15 PM 96.9 Tympanic, HR 58, RR 16 even and unlabored, BP 98/72 O2 97% Reported feeling better and with appetite, was able to walk around parking lot for several mins to make sure he felt ok to independently leave and opted to depart. A&O x 3. Insight and judgement intact.

Got injected, didn?t hurt much. Was told to wait 15 minutes in case of reaction. They walked away and left me sitting in a chair in a public space with everyone else who was waiting. I texted my wife to check in, when I started tearing up and crying for no real reason, then started feeling nauseous so I closed my eyes. Suddenly I felt like I had been given a shot of adrenaline out of nowhere so I?m just trying to figure out if it?s nerves or a physiological response to something. I?m trying to control my breathing but having a hard time breathing. Then the fever hit. The most intense flash of heat. I was hyperventilating. I couldn?t open my eyes or move or make a sound, I could just sit there struggling to breathe. My phone was in my hand and I couldn?t lift it. I just simply didn?t have the strength or energy to move. At some point I legit thought I was about to die. I managed to angle my wrist so I could check my heart rate with my watch. It was 47bpm. I was fading away but I made myself get control of my breathing and forced myself to take long deep slow breaths. It hurt, and I felt like passing out, but I kept doing it. Fever turned into chills and then I soaked through my jeans and T-shirt in under a minute. I was finally thinking clearly and breathing and getting oxygen. Everyone else near me was fine. Nobody checked on me the entire time including the 3 people who sat there and watched me suffer through this. I told the pharmacist about my reaction and asked if it was normal and didn?t receive any indication that I should be concerned, so I went home since I felt better. It wasn?t until my friend pointed out that this sounds like anaphylaxis that I thought I should report it. So here I am. Hopefully I?ll be okay.

A little after two weeks after vaccination I developed a extremely disgusting metallic taste in my mouth. I can no longer eat food without being disgusted and wanting to spit it out and it has not gone away

Patient within a few minutes indicated he felt dizzy and sweaty. I sat him down within minutes his eyes rolled back and he lost consciousness. He bagan to make gurgling noises as if trouble breathing. His color was grey and he was sweating profusely. 911 was called by a technician and I gave one dose of Epinephrine 0.3 mg into lateral right thigh at approx. 9:40 am. Within this period of time he began seizing. He regained consciousness prior to EMT's arriving and was brought to the hospital.

I experienced ringing in my left ear , non stop since the J&J vaccine about 5 minutes. I also have ringing in my right ear also have had a pressure headache since the moment of vaccine. I seen doctors, had ears cleaned, hearing tests, have seen an ENT specialist and also have had an MRI. MRI was to make sure there was no tumors in my ears, my results were negative. Lab work done for blood clots which were also negative. Today I still continue to experience these symptoms.

approx 10 minutes after injection, pressure in head and chest, sweating, blue lips, and white face, mostly lost vision for 10 minutes. recovered at 10 minutes then just exhausted. better next day except fatigue.

Pt received the Janssen covid vaccine. During the 15 minutes post-vaccination observation period, pt started not feeling well. He experienced dizziness, sweating, swelling of the lips and tongue, and shortness of breath. Pt was non-responsive. Rph administered an Epipen and staff called the ambulance. At this time, pt was becoming more responsive in response to the Epipen. EMS came and checked the pt's vitals. Vitals were within normal range. Pt was not sent to the hospital. EMS advised the family to monitor the pt and call EMS if symptoms worsen. Pt is doing okay.

While sitting five minutes after shot, pt turned white, eyes rolled back. Mother called for help. Reaction walking by an immediately laid pt on floor. Within approx. 10 seconds pt was awake, coherent, and speaking. Was mildly diaphoretic. Remained on floor for five min before sitting up. Still feeling fine up sitting up pt was AOx3. As precaution and at mother's urging pt was taking in wheelchair for brief observation and vitals check. 5:29 SEATED HR 77 RESP 12 BP 165/112 SPO2 99 5:30 LYING HR 69 RESP 12 BP 151/95 SPO2 98 5:35 LYING HR 70 RESP 12 BP 149/95 SPO2 98

DIFFICULTY/TROUBLE BREATHING; MIGRAINES; SINUS FLUID BUILDUP FEELING; TASTES SOME KIND OF WATER-LIKE LIQUID IN MOUTH; SNEEZING ON AND OFF; ITCHY NOSE ON AND OFF; STRONG HEADACHES; This spontaneous report received from a patient concerned a 42 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no history of allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAY-2021, the subject experienced difficulty/trouble breathing. On 23-MAY-2021, the subject experienced migraines. On 23-MAY-2021, the subject experienced sinus fluid buildup feeling. On 23-MAY-2021, the subject experienced tastes some kind of water-like liquid in mouth. On 23-MAY-2021, the subject experienced sneezing on and off. On 23-MAY-2021, the subject experienced itchy nose on and off. On 23-MAY-2021, the subject experienced strong headaches. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from strong headaches, migraines, sinus fluid buildup feeling, tastes some kind of water-like liquid in mouth, difficulty/trouble breathing, sneezing on and off, and itchy nose on and off. This report was non-serious.

After receiving the vaccine around in the afternoon, I developed extreme body aches, fatigue, night sweats, headache, dizziness, and chills around 10pm. Along with these side effects I also developed an extreme ringing in my ears. The ringing is so constant that it's difficult to sleep and even think. The ringing has shown no signs of improvement and can best be described as a high pitch sibilant sound.

Janssen COVID-19 Vaccine EUA. Approximately 15 hours after the vaccine the left eyelid began swelling. the swelling has lasted for 36 hours

Sever body aches, fever, chills, low energy and now 4 days later a right earache with slight throat discomfort on the same side and mild fever.

Headache lasting nearly 18 hours, cold sweat and flu-like symptoms overnight, visual light sensitivity from the morning to the mid-afternoon following the vaccination. All symptoms resolved within 24 hours.

Metallic taste in mouth - 5 min after injection Ringing ears - 45 min after injection Pain at injection site - immediate after injection

Getting blisters all over body including in mouth, very similar to , if not, chickenpox. A big bluster on the injection site. Taking Valacyclovir/Valtrex

Received vaccine at 2:15pm , waited 15 minutes as recommended left the facility driving home started receiving warm tingly feeling, lost consciousness, drifted off the road crashed my vehicle into a tree head on collision 2:45pm. Cannot hear out of my left ear.

The next day I noticed tinnitus (high pitch mild ringing in both ears) . Therefore it has been a total of 7 days with ringing in both ears and it has not gone away. It has been constant, no pulses, no frequency changes, etc. Just constant high pitch ringing in both ears. Sometimes by inner ear feels funny, slightly tingle feeling that is related to the tinnitus. The tinnitus is most noticeable in quiet settings, sleeping, reading, watching TV, I do not noticed it as much in office environments, listening to music, walking outside. I have experienced tinnitus in the past after loud music band or rock concert but do not attend live loud music often and try to avoid it because it hurts my ears. I do not have any known hearing problem, I try to protect my ears and use hearing protection often to avoid damage. When I cut my lawn I wear hearing protection, when I am working on shop floor I wear hearing protection. I am thinking the vaccine is related somehow. I never had COVID-19 in past. I use to be able to be in quiet settings and not have any tinnitus before vaccine.

12 hours after vaccine, woke to high fever and muscle cramps, violent shivering, splitting headache, spotty vision

I got the vaccine at about 12:55pm. About ten minutes after getting the vaccine, while sitting in a chair, I began to get tunnel vision and felt extremely tired. I broke out in a cold sweat all over my body. I began to lose my vision like I was fainting and I momentarily blacked out or dozed off, then came back awake. I started to get tunnel vision again for a minute, then it faded away. Then I continued sweating for a minute and then it faded away. After a couple minutes I felt fine again. I sat for another several minutes then left at 1:15 feeling ok with just a sore shoulder.

FEVER OF 102-107F; SHAKINESS; VOMITING; SENSATION OF COLD; CHILLS AND SHIVERING; HALLUCINATIONS; WEIRD TASTE IN MOUTH; This spontaneous report received from a patient concerned male. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, acid reflux, and heat burn. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 around 1-1:20 pm to the left arm for prophylactic vaccination. Concomitant medications include blood thinners, medication for heart burn and acid reflux. Patient did not take his medicines on the day of his vaccination and few days after the vaccination. On 01-APR-2021 23:00, the patient experienced chills and shivering, fever of 102-107F, sensation of cold, vomiting and shakiness. Patient had not contacted his MD and had not taken any medications to manage those symptoms. At the time of calling (on the day of reporting), patient was feeling better but was having weird taste in mouth. On the same night of the vaccination (01-APR-2021), patient started experiencing hallucinations. The person who took this report on call recommended patient seeing his doctor regarding hallucinations. There were no hallucinations at the time of reporting. Laboratory data included: Body temperature (NR: not provided) 102-107 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hallucinations, shakiness, sensation of cold, chills and shivering, and fever of 102-107f on APR-2021, had not recovered from weird taste in mouth, and the outcome of vomiting was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210406953-COVID-19 VACCINE AD26.COV2.S-hallucination. 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. 2021040695300-COVID-19 VACCINE AD26.COV2.S-fever. This event is labeled per RSI and is therefore considered potentially related.

About seven (7) days post vaccine injection I began to experience pain and numbness in both arms, numbness and swelling in my lips and face area and a feeling of indigestion/heartburn. I presented to urgent care and subsequently the emergency room on 03.27.2021 with those symptoms and was treated and released. The following day, the symptoms continued, specifically the pain and numbness in the bi-lateral arms and additionally began to experience pain in the chest area and increased resting heart rate (125+ bpm). Again presented to emergency room on 03.28.2021, treated and released.

Injection Friday. No issues Friday, Saturday, or Sunday other than slight pain at the injection site and slight body aches on Sunday. Monday morning at approximately 0230 i woke up to what i can only describe as lightning pains in my legs. It was a very intense pain shooting from my upper thighs to my knees and slightly bending around to the top of my calves on the outside of the leg. Monday all day i did not feel well. Had a dull pain in center of chest, and my left arm from the shoulder blade to the elbow had what i can only describe as a slight warm sensation. I was also very "foggy" and light headed. On Tuesday the pain in my chest worsened. My left arm kept going numb (and still does today 04.21.2021), my jaw hurt, i was light headed and again very foggy. On Wednesday it was the same thing and I called the VA and they told me to come to the ER for evaluation.

Bloody nose Left leg / foot pain Entire left side of body not correct Chest pain Shortness of breath Blurred vision Can't sleep

patient reported acute onset of left sided weakness with associated left visual field deficit with left sided lateral hemianopsia.

12 hours after injection, experienced normal side effects (e.g., muscle aches, chills, headache, fatigue) Within 1 week of receiving the vaccine, I began to experience blurriness in my left eye. After conferring with my primary care facility, it was recommended that I see an ophthalmologist. Confirmed that I had a Branch Retinal Vein Occlusion (BRVO) and recommended I meet with a retinal specialist. Dr. confirmed the BRVO was caused by a blood clot and commenced treatment via eye injection. I then met with my primary physician to discuss the situation. He recommend further tests to determine whether I had other clotting. In addition to blood work, he order MRIs of my brain, head and neck region and also recommended that I meet with a thrombosis specialist. I met with a Dr. who ordered additional blood work for additional testing. All tests performed to determine if I had additional clotting have come back negative.

Approximately 2 weeks after vaccination, patient diagnosed with UTI. Was prescribed a course of Cephalexin. Patient did not take full course but symptoms resolved one day after initiation. Approximately one week later, he began to experience a metallic taste for about 1.5 days, followed by right sided facial palsy. As of date of this report, facial palsy has not resolved.

Cant move a Lot of the left side of face, almost seems like bell palsy., left eye waters a bit as i cant independently blink my left eye, unless 8 close them both...cant move left cheek (can only smile on one side) difficulty drinking since i cant curve my lip on the left..talking challenges (lisp) since it seems im speaking out of one side of my mouth. When eating, a little hard to feel it on the left aide in jaw area.. I have zero pain, just unable to completely move all parts of the the left side of my face in general.. I had my shot on thursday, first felt this on saturday when i woke up.... hasnt gotten any worse, just the same (its 420pm on sunday now) - havent had any treatments, not usre if its temporary

COULDN'T TAKE A DEEP BREATH; FELT COLD; WHOLE BODY ACHY; DIZZINESS; WEAKNESS; CHILLS; EXTREMELY TIRED; NAUSEATED; EYES GOT HEAVY; This spontaneous report received from a patient concerned a 41 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included type2 diabetes. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. Concomitant medications included metformin for type2 diabetes. On 18-MAY-2021, the subject experienced whole body achy. On 18-MAY-2021, the subject experienced dizziness. On 18-MAY-2021, the subject experienced weakness. On 18-MAY-2021, the subject experienced chills. On 18-MAY-2021, the subject experienced extremely tired. On 18-MAY-2021, the subject experienced nauseated. On 18-MAY-2021, the subject experienced eyes got heavy. On 19-MAY-2021, the subject experienced couldn't take a deep breath. On 19-MAY-2021, the subject experienced felt cold. The action taken with covid-19 vaccine was not applicable. The patient recovered from nauseated on MAY-2021, was recovering from couldn't take a deep breath, had not recovered from extremely tired, whole body achy, weakness, and chills, and the outcome of dizziness, eyes got heavy and felt cold was not reported. This report was non-serious.

Tingling in hands/arms/legs and head. Also have headaches and pressure in head, mostly on left side. Elevated heart rate and fatigue. Dizziness and lack of focus. Overall feeling that something is wrong.

My arm started getting soar that nigh and persisted the next day followed by two days after that (headache, fatigue, fever). It gradually decreased in pain and on Wednesday it was gone (felt as though I had a rigorous workout). I slept all day Sunday after taking the shot on Saturday! The tele-doctor asked what were my symptoms (allergies and sinus trouble with a cough all the time). He had me to switch allergy medications and my eyes were no longer watering (switched from Zyrtec to Claritin. My eyes were watering so much until I could barely do anything.

5/21/21 10:00pm shortness breath, chest pain, shoulder pain, jaw pain, metallic taste, fatigue ?mini heart attack? symptoms 5/26-5/27 trouble breathing, fatigue, light headed 5/29 pain in left arm 5/30 night - second ?mini heart attack? symptoms General fatigue, hard to breath, overall feeling bad 6/2 - bruise on arm and lump Extreme headache, fatigue, chest pain, arm pain Emergency room visit = blood clots

Spot in slightly south of center of vision is grey. About size of thumbnail held out at arms length. Lights up when eyes closed. Suddenly appeared, hasn't gone away or changed since

Within minutes of receiving vaccination, pt stated he was hot and thirsty, became unrepsonsive to verbal stimuli. Pt proceeded to have tonic-clonic seizure lasting 25 seconds. Pt lowered to the ground by staff, monitored VS. No incontinence, no biting of tongue. pt regained consciousness, and oriented x3. VSS. pt reported he felt light-headed. When attempted to place in chair, symptoms returned, and pt was placed back in supine position. EMS arrived, and after VS established, EKG indicated sinus rhythm, placed in chair. Pt stated he did not feel good, and similar symptoms began with eyes rolling back and contractures. Pt taken to hospital.

When I got the vaccine I got an instant pain in my arm and into my neck, then an intense headache between my eyes above my nose, I was flush and sweaty, nauseous. Then had a bad headache on the top of my head, then soon I had left side facial numbness . Light sensitivity

Lip tingling, swelling and redness. No respiratory distress. No further signs of mucosal swelling. Benadryl 50 mg po given x1. Lips remained same to slightly improved. Normal vitals. No epinephrine given. Discharged after 50 minutes.

Drop in blood pressure on the day of vaccination, hives and swollen face/eyes several days after the vaccine, headache and weakness for several days after injection. Resolved after about a week.

NIGHT SWEATS; PAIN IN ARM; EYES PAIN; EYES SENSITIVE TO LIGHT; FELT LIKE FLU; FEELING BAD; This spontaneous report received from a patient concerned a 42 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 21-JUN-2021) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced eyes pain. On 06-APR-2021, the subject experienced eyes sensitive to light. On 06-APR-2021, the subject experienced felt like flu. On 06-APR-2021, the subject experienced feeling bad. On 06-APR-2021, the subject experienced pain in arm. Laboratory data included: Body temperature (NR: not provided) 100.1 F. On 07-APR-2021, the subject experienced night sweats. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from eyes pain, and eyes sensitive to light on 06-APR-2021, felt like flu, and feeling bad on APR-2021, and pain in arm on 07-APR-2021, and had not recovered from night sweats. This report was non-serious.; Sender's Comments: V1: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.

Per pt a few hours after vaccine noted that his entire tongue felt "like when you burn it on something hot." It has persisted since then, no worsening, no other symptoms. Just wanted to get it checked out and documented.

About 2-4 hours after shot husband had body aches and was sleepy. 12-14 hours post vaccination husbands vision would go blurry for about 10-20 seconds, happened about a dozen times over the course of the next 5-6 hours then stopped. At 30ish hours post vaccine woke up drenched in sweat, all bedding had to be washed, but said he felt better aside from mild Muscle pain/body aches that remained for about 48 hours from initial time of injection but was about return to work without issue on Wednesday. Still has mild soreness at injection site on Thursday 4/15.

As described by the patient: Patient (driver) was feeling anxious, received the shot and almost immediately started to see white spots and was dizzy. The patient asked to be directed out of the vaccine lane (prior to proceeding to the post administration area) to just get some air. The patient got out of the car, felt dizzy and fainted. Patient fell to the ground in a sitting position. Patient was assessed by BLS and refused transport. Patient switched positions and allowed his passenger to drive off scene.

EARS RINGING; VOMITING; TIREDNESS; FEVER; DIZZINESS; DISORIENTED; This spontaneous report received from a patient concerned a 42 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: 23/JUN/2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: Body temperature (NR: not provided) Over 100 (unit unspecified). On 10-APR-2021, the subject experienced dizziness. On 10-APR-2021, the subject experienced disoriented. On 10-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced tiredness. On 12-APR-2021, the subject experienced vomiting. On 14-APR-2021, the subject experienced ears ringing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting on 13-APR-2021, and had not recovered from dizziness, disoriented, tiredness, ears ringing, and fever. This report was non-serious.

EAR FEELS CLOGGED; RINGING IN EARS; This spontaneous report received from a consumer concerned a 42 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced ear feels clogged. On 12-APR-2021, the subject experienced ringing in ears. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ear feels clogged, and ringing in ears. This report was non-serious.

On 4/10 I started feeling tired with muscle aches. A few days later my skin started to hurt. Clothing was uncomfortable when it moved across my skin. Those symptoms lasted about a week. Then as they started to lessen I had some back pain (Sciatic) and a sore throat. Also the muscles behind my eyes were slightly painful and bright lights were uncomfortable. Then about 4/21 most of the symptoms reduced and I was feeling close to normal. Then on 4/22 I was brushing my teeth and noticed that I couldn?t spit water like normal. I called my GP doc and she recommended I head to the ER. After thinking about it I also remember on 4/21 while drinking something I had some water squirt out of my lips. At the time I thought I was just being clumsy but in hindsight the muscle weakness in my face started on 4/20. I checked into the ER on 4/22. When I checked into the hospital my facial weakness was very difficult to notice. By the evening of 4/22 it was noticeable if I tried to ?show my teeth? or make a big smile. By the morning of 4/23 it was very noticeable. The morning of 4/24 I couldn?t move my lips, nose or eyebrows. My tongue, jaw and throat were not impacted at all. I was started on plasmapheresis on 4/24. I had another treatment on 4/25. I noticed facial weakness was very slightly recovering the evening of 4/25. By 4/27 my facial weakness is still healing with noticeable improvement day to day.

started feeling dizzy and faint after about 5 minutes, became clammy and pale and started sweating, was hot and thirsty, I gave him cool wet papertowels, and ice pack a few sips of water and had him sit in imz booth while I talked to him and watched him. He felt better and had his ride pick him.

Patient is a 42 y/o male residing. At approximately 4: 40PM received a Johnson and Johnson Janssen vaccine in the left from . Client approached this nurse at 5:37PM complaining of pain in his left arm. Client described pain as ?pressure? in his left upper and lower arm and the pain radiated to the left side of his neck and left jaw. Client was alert and oriented; client was had no diaphoresis and client color was within normal limited; reparations deep even and unlabored; heart rate 70 bmp and pulse were strong and regular. Explained to client the need to call 911 and client refused.5:40PM Client remained alert and oriented without change in physical appearance; heart rate 80 bmp and pulse remained strong and regular. Resident denies any routine medications. Reports he had ibuprofen twice during the day from the staff. Client reports he had been clean from cocaine use for the last 6 weeks. 5:40PM Had Program Assistant/Counselor summoned to the room and explained to Patient client's refusal for 911 assistance. Patient was able to get client to agree to a 911 call. At 5:45PM 911 was called. 5:55PM Paramedics arrived and assessed client. According to paramedics? EKG and vital signs ?looked good?. Paramedics suggested client go to the emergency room for further evaluation; client declined. Paramedics explained to client the risk involved in refusing additional assessment by the emergency room. Client verbalized he understood the risks he was taking by refusing transportation to the emergency room. 5/21/2021 approximately 11AM Called to follow up with client; was not in but spoke with Manager. According to has no residual effects and was ?up and about? as usual.

Cold hands and feet, blood pooling in hands, blurred vision, loss of appetite, palpitations, excessive urination, and pain around left shoulder blade area of back.

This is to report my side effects since the vaccine shot, because I haven?t heard any of these regarding this vaccine. Lower leg below the knee on the left and right leg varicose veins have constantly burned and ached. Only my right leg had previous varicose veins that would burn ache in the evenings following a day of manual labor. From Friday morning to Monday late night my left temple would randomly throb. Same days either my lower left or right lung would ache or be sore. For about 2 hours everyday same days above I would have a metallic taste in my mouth no matter what I ate or drank. No pain ever severe enough for immediate medical attention

Current ongoing symptoms in order of severity include: lethargy/brain fog (daily since), thick mucus buildup (nose and back of throat throughout the day), regular headaches, depression, loose stool, eye redness, and tonsil stones (couched up daily). Events/symptoms after vaccine: tonic-clonic seizure (twice admitted to Hospital last event on 5/31/2021), petite-mal seizure (not admitted to hospital but noted by others in household), severe pounding headache (on and off in middle and back of cranium)

I did not have any adverse events initially, but on the evening of 7/4/2021 I had a fever and had trouble sleeping, I just chalked it up to a day in the sun. On Monday, 7/5/2021 I had a sore throat; Tuesday, 7/6/2021 small cough; Wednesday, 7/7/2021 it moved into my chest; Thursday, 7/8/2021 loss my sense of taste. Thursday night I purchased an over the counter Covid test and it came back positive. On Friday, 7/9/2021 I went to my doctor on Friday morning and on Monday 7/12/2021 I was informed from my doctor's office the test was positive. Today on 7/14/2021, I feel pretty good, I am not doing too bad, I have a cough every so often and my taste has returned.

Patient began to have metallic taste in mouth - felf like "he had braces on again." Also felt slight tightness in his cheeks. Dispensed 1 loratadine per patient request (his allergist told him to take one when he has signs of reaction), and shortly after administered 50mg benadryl liquid to the patient. Sat with patient for 45 minutes after administration, to which all symptoms resolved and patient stated they were ready to go, and they left.

AE: numbness of both arms, fingers, legs and toes Fatigue, dizziness, sweating, skin turned pale, difficulty breathing, numbness on tongue -- 1:20 pm about 5 mins after receiving vaccine Treatment: checked Blood pressure: 117/79 and HR 69. Gave 20ml children benadryl (50mg), water and chocolate bar. 1:30 pm Outcomes: pt stated symptoms gone away around 1:45. numbness on arms and legs gone, dizziness and sweating stopped. pt was able to stand up and walked around and went home

For 1 hour post injection, metallic taste in mouth. Beginning 6 hours later: myalgias, fatigue, fever -> resolved at 30 hours post vaccine.

On March 25, 2021 at 6:35pm I went into the urgent care center with the signs and symptoms of a sinus infection. The center issued me a rapid COVID test and I came back with a positive test result. By 9:00pm on March 25th, I lost my ability to taste and smell. I have a very bad chest cough and am having a stuffed up nose.

Patient felt dizzy after receiving vaccine. Pharmacist went over to assess patient and patient hands began shaking and eyes were moving erratically. Patient would not respond to verbal commands so called 911. The patient came responsive about 1 minute later and had no recollection of the event. Pharmacist checked bllod pressure and it was low (97/46 ) and upopn recheck in 3 minutes it was high (199/90). Paramedics arrived and patient said he felt fine at that point but he would still go to hospital to get checked out.

Metal taste in mouth with soda, water, coffee. 26 hours after vaccine and still have the metal taste. It started right away. I also had a sore shoulder that has turned into a sore arm.

on 4/9/2021 I felt very fatigue and had a headache all day long my eyes where burning of my headache. When I cough it hurts all the way down my right arm.

Had COVID on 2/7/21- Feverish feeling x 1 day, fine after. Tested negative 2/17/21. One half hour after receiving the vaccine, onset of hoarseness. Severe hoarseness persists until today. Eyelids pink, swollen slightly, persisted 2 weeks. Did not feel well. 4/15/21 -Hospital Emergency Room. Chest pain. Elevated blood pressure. COVID test positive. Disharged with azithromycin, zinc sulfate 220mg, ProAir. High blood pressure, new onset. On 4/6/21 BP 160/120 both arms. 4/7/21 Hospital ER. MRI, CT brain showed Dural Venous Thrombosis. To ICU for anti coagulation, until 4/14/21. MRV done. Now on floors, started coumadin. 9 days hospitalization so far. CT done again 4/15/

90% LOSS OF VISION IN ONE-EYE; BURNING EYE; FOGGY VISION; This spontaneous report received from a consumer (company representative) concerned a 43 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced 90% loss of vision in one-eye, burning eye, and foggy vision because of which patient visited his physician. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the burning eye, foggy vision and 90% loss of vision in one-eye was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210436318.; Sender's Comments: :20210436363-covid-19 vaccine ad26.cov2.s-90% loss of vision. 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).

EXTRA SALIVA PRODUCTION; LETHARGY; HOT AND COLD SWEATS; UPSET STOMACH; WASN'T FEELING HIS SELF; GAS PAIN; ARM PAIN AND TENDERNESS; NAUSEA; HEADACHE; FEELING VERY TIRED; This spontaneous report received from a patient concerned a 43 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included kidney stones. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced extra saliva production. On 08-APR-2021, the subject experienced lethargy. On 08-APR-2021, the subject experienced hot and cold sweats. On 08-APR-2021, the subject experienced upset stomach. On 08-APR-2021, the subject experienced wasn't feeling his self. On 08-APR-2021, the subject experienced gas pain. On 08-APR-2021, the subject experienced arm pain and tenderness. On 08-APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced feeling very tired. Treatment medications included: ibuprofen, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extra saliva production, hot and cold sweats, upset stomach, gas pain, nausea, and headache on APR-2021, lethargy on 10-APR-2021, and arm pain and tenderness on 11-APR-2021, and the outcome of feeling very tired and wasn't feeling his self was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.

Since getting the vaccine all I can smell is cigarette smoke and I am a non smoker and not around smokers? It has since given me headaches due to the smell.

Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Right upper eyelid bruise-Mild, Additional Details: patient came and said he woke up with right upper eyelid bruise and not hurting. I advised him to monitor and if getting worse , he need to go to emergency or urgent care

Johnson and Johnson vaccine. I have been experiencing ringing in the ears .. coming and going .. sometimes mild , sometimes more intense . I still have the ringing as of today , one week after . I am certain it is due to the vaccine as I have never experienced this before

ringing in ears, dizzy, scattered headaches, muscle cramps in arms. Classic flu like symptoms 24 hours after injection. 99.9 fever for 10 hours, headache, fatigue. They resolved 24 hours later.

patient reports pain and pressure in ears lasting about 4 weeks and currently resolved, and low pitch constant tinnitus that was severe and very distressing for the first week or so to the point that he considered harming himself. The tinnitus persists but is less distressing. He was treated at Urgent Care with a steroid dose pack, a course of prednisone 40 mg/day x 5 days, 10 days of augmentin 875 mg po bid and a week of cortisporin ear drops. None of the treatment helped the tinnitus. He refused an audiogram to evaluate the tinnitus and denies preexisting tinnitus.

Dizzy, full body sweat, temporary loss of hearing and sight. Symptoms came on 1 minute after injection and lasted for 20 minutes. Lingering ringing and dizziness 24 hours after.

Intense shoulder soreness that day. The next morning woke up with extreme muscle cramps all over my entire body. Developed sore throat later in the day. Symptoms worsened over the course of the week, sore throat, headache, malaise, extreme sinus congestion, coughing, sneezing, excess saliva production. It was as if I contracted a sever cold. Today is June 3'rd and it is the first day I am feeling close back to 100%. I should note that I have a strong immune system and have not been sick in years.

Experienced a severe, prolonged nosebleed on June 25. Blood was pouring from left nostril and mouth and took hours to begin to clot. Finally stopped in early afternoon on June 25. Started again in early morning of Sat. June 26. This was accompanied by intense pressure in forehead, behind nose and burning sensation in both eyes (visibly red). Gently blew nose as it was bleeding and passed a large clot the size of a quarter. From wife: We had to resort to using paper towels with sanitary napkins to try to soak the blood. Completely soaked 4 Always Infinity size 5 sanitary napkins in a matter of 10 minutes. Bleeding stopped around an hour later. Considering a minor medical visit due to reoccurrence, headache, eye burning and possible elevated blood pressure.

INTENSE PAIN; DIFFICULTY THINKING STRAIGHT; INTERMITTENT, INVOLUNTARY MOVEMENT OF LEFT FINGERS; SPELLS OF STUTTERING; SLURRED SPEECH 2-3 TIMES A DAY; DIFFICULTY SEEING; MIGRAINE "WORST PAIN IN LIFE"; RINGING IN EARS; NON-CONTAGIOUS MENINGITIS / BRAIN SWELLING / UNABLE TO MOVE NECK TO THE LEFT / STIFF NECK RADIATED TO SHOULDERS AND LEFT ARM AT INJECTION SITE / STIFF NECK TO THE LEFT SIDE; LIME DISEASE / CHILLS / MUSCLE ACHE / MILD FLU LIKE SYMPTOMS; HEADACHE; TIRED/ FATIGUE; COULD NOT SLEEP ALL NIGHT; KNEE SWELLED UP; LEFT KNEE PAIN; SPINAL CORD SHIFTING FROM BASE OF SKULL TO TAILBONE- POPPING AND CRACKING; This spontaneous report received from a patient concerned a 43 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure and penicillin allergy at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 and expiry: unknown) dose was not reported with frequency 1 total administered on 25-MAR-2021 at 16:00 to left arm for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the patient did not have any side effects initially and he was fine after vaccination and suddenly he felt tired an hour after arriving home, also could not be to sleep all night, mild flu-like symptoms including chills, muscle aches, fatigue and a headache. He took ibuprofen 200 mg via oral route (frequency unknown) for headache or pain. On 26-MAR-2021, the patient experienced headache again. On 02-APR-2021, the patient experienced headache which continued to get worse, brain swelling, non-contagious meningitis, lime disease (Lyme disease), migraine "worst pain in his life", difficulty seeing, ringing in ears. Then, he took more ibuprofen (frequency unknown) as the migraine was unbearable for him and had mild relief. The patient went to the hospital and was admitted on 02-APR-2021. At hospital he received morphine (indication unknown). On the same day, the laboratory testing or data of patient included CT scan reported as brain swelling reduced in size and spinal tap reported as unknown chemical found, positive for lime disease and meningitis. Laboratory testing revealed the meningitis of patient was non-contagious. The patient started on blood thinners and antibiotics (drugs name unknown). The patient got followed-up with (Centers for Disease Control and Prevention) CDC disease specialist who said that it could not be clearly revealed whether it was related to the vaccine or not. On 05-APR-2021, the patient experienced difficulty thinking straight, intermittent, involuntary movement of left fingers, spells of stuttering, slurred speech. The patient hospitalized for 4 days and got discharged from hospital on 05-APR-2021 at 20:00. On the night of 06-APR-2021, it was reported that in the middle of the night the patient woke-up at 01:00 as his spinal cord was shifting from base of skull to the tailbone, it was popping and cracking, no pain, just moving. It was gone when he work-up that morning. On 08-APR-2021 at morning, the patient experienced stiff neck to the left side / stiff neck radiated to shoulders and left arm at injection site as unable to move neck to the left side and the stiff neck got progressively worse each day and by 09-APR-2021, the stiff neck was more severe and radiated to the shoulders and to the left arm where he received his vaccine, not the right side, unable to move neck to the left side. However, this lasted until 13-APR-2021. On 26-MAY-2021, the patient woke up with pain and swelling in the left knee. On an unspecified date, the patient experienced intense pain. Treatment medications (dates unspecified) included: ibuprofen several times, morphine, antibiotics and blood thinners. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lime disease / chills / muscle ache / mild flu like symptoms, migraine "worst pain in life", difficulty seeing, and ringing in ears on 05-APR-2021, non-contagious meningitis / brain swelling / unable to move neck to the left / stiff neck radiated to shoulders and left arm at injection site / stiff neck to the left side, spinal cord shifting from base of skull to tailbone- popping and cracking on 07-APR-2021 and knee swelled up, and left knee pain on 30-JUN-2021, had not recovered from tired/ fatigue, headache, spells of stuttering, intermittent, involuntary movement of left fingers, difficulty thinking straight, and slurred speech 2-3 times a day, and the outcome of could not sleep all night and intense pain was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210718928-covid-19 vaccine ad26.cov2.s-spinal cord shifting from base of skull to tailbone- popping and cracking ; non-contagious meningitis / brain swelling / unable to move neck to the left / stiff neck radiated to shoulders and left arm at injection site / stiff neck to the left side; lime disease / chills / muscle ache / mild flu like symptoms; difficulty thinking straight; migraine "worst pain in life"; ringing in ears; intermittent, involuntary movement of left fingers; spells of stuttering; slurred speech 2-3 times a day; difficulty seeing; intense pain; could not sleep all night. 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). 20210718928-covid-19 vaccine ad26.cov2.s-headache; tired/ fatigue. This event(s) is labeled per RSI and is therefore considered potentially related.

patient received covid vaccine and went to sit out in waiting area. about 5 min later patients eyes rolled back, became unresponsive, was grunting, stiff muscles, and had uncontrolled urination. this continued for a few minutes. was able to get patient on the floor and in doing that he became responsive and alert. patient almost immediately felt fine. paramedics were called and they did check him out but he left without going to the hospital

Patient reported a "tingling sensation" to his face 10 minutes post vaccine. Swelling under eyes were also noted. At 1410 patient reported symptoms subsided. By 1440 patient requested that he leave and another individual to drive was confirmed. Importance of following with PCP was enforced.

Immediately tasted a metallic taste in my mouth. Within 12 hours experienced body pains (not aches...true pain) just like I had with Covid at Christmas. We are now almost a week later and the body pains have only gotten worse. Tylenol and Motrin have not helped. I don?t have a primary care doctor or insurance so I can?t follow up with a doctor, but I feel terrible.

Patient was given shot and asked to wait in pharmacy area at least 15 minutes. Within about 5-10 minutes his girlfriend comes to the pharmacy window and tells me he's feeling bad. By the time I get to his chair he is very lethargic and slumped over. I sit him up in the chair and his head rolls back and his eyes have rolled back in his head. I place him on the floor and instructed my staff to call 911. The patient presented with sweats and was unresponsive for about 10-20 seconds. When he came to he asked how he got on the floor. The patient never had any trouble breathing heart rate was steady the entire time. When EMS arrived they checked him out and was fine. He refused transport to the hospital. He walked out of the store after about 30 minutes from the point of his passing out.

PT ARRIVED VIA POV WITH WIFE DUE TO COMPLAINING OF HAVING JOHNSON AND JOHNSON VACCINE REACTION THAT HE RECEIVED YESTERDAY AT 1130 AM. PT VOICED HE WAS NOT ABLE TO SLEEP MUCH, HAD FEVER, CHILLS; WOKE UP WITH SWOLLEN UPPER LIP, RASH OVER HIS UPPER EXTREMITIES; RASH AND WHELPS SEEN TO HIS RIGHT RIB REGION-MODERATE AMOUNTS. PT ALSO VOICED, FEELING ITCHING ALL OVER HIS BODY. DENIED OTHER SYMPTOMS. PT IS STABLE. ER PROVIDER NOTIFIED. TX: FAMOTIDINE, BENADRYL, SOLU-MEDROL, DECADRON.

Five minutes after shot started losing consciousness, sweating, hot flashes, trouble breathing, numbness on tongue, seizure ( several minutes) came in and out of consciousness during it, eyes rolled back in head. Arms flailing.

- Arm Sore at injection site from 4-6-21 to 4-9-21 - Passed out at 1:00am 4-6-21, and fell to floor with disorientation. - Severe Chills, uncontrollable shaking of body/teeth, 4-6-21 to 4-7-21 - Feverish 04-6-21 to 4-8-21 - Heart Arrhythmia, causing abnormal breathing and inability to breath and sleep 04-6-21 to 4-7-21 - Dizziness 04-06-21 to 04-09-21 - Food/Water/mouth tastes of metal 04-7-21 to 4-8-21 - Loss of Appetite 04-06-21 to present - Bloating, feeling full when haven't eaten 04-06-21 to present - Brain fog, not able to concentrate - 04-06-21 to 04-09-21 - Excessive sweating 04-06 to 04-08-21 - Tired 04-06 to 4-10-21 - Irritability, 04-09-21 to 04-10-21 - Emotional, crying for no reason sporadically 04-06 to 04-9-21

-fever -body aches -head ache -abdominal pain -extreme dizziness/lightheadedness -dry cough -incresed tinnitus -nervous system disorientation -tiredness -weakness All lasting ~36+ hours.

Chest pains- 8 hours after administration for little less than 48 hours; in addition to migraines, extreme fatigue, shortness of breath and sensitive to light.

Day 1 after shot: body aches, headache, blurry vision. Day 2 and beyond: excruciating abdominal pains, no appetite, inability to have a bowel movement or even pass gas. Had I known this level of agony would happen, I would have refused the vaccine, and I will NOT take the J&J again.

12 hours after receiving injection, I began to feel aches and chills. Went to bed. After sleeping, woke up (about 24 hours after receiving the vaccine) feeling nausea and my head was aching. After several hours of feeling nausea, I began to vomit. I had only drank liquids since dinner the night before. Several days after the vaccine, I had a headache for 24 hours, with pain focused above my right eye.

Already had tinnitus, but now aggravated. Temporary lose hearing on one side, comes back in 30 seconds with loud tinnitus, which decreases over time.

Tinnitus with continued buzzing sound starting 2 days after the injection. This continues at all times and seems constant. Shoulder Pain - Beyond initial pain following injection, I have experienced arthritis like pain developing in my right shoulder joint.

Severe chill followed by low grade fever(98.2 F; normally I am about 97.5), mild headache that lasted about 12 hours, very dry mouth, and metallic taste in mouth. Accompanied by a feeling of mild intoxication / indifference / being unmotivated which lasted most of the next day. The lack of motivation with a slight tiredness seems to still be slightly present 11 days later.

Blurred vision, especially in right eye. Lasting for days. Dull steady headache. Terrible tinnitus in ears. Lethargic and tired for days

Starting 8 days after injection I will go into a brain fog for several hours mid morning. Difficulty concentrating and motor function seems mildly impaired. Visuon is slightly blurred. Also slight pressure across sinuses.

Allergic reaction, swollen lips, numb skin on face, itching all over body, scratching hives, blisters

Patient was starting to feel sweaty, light headed, and had ringing in his ears. Blood pressure was a little low. After giving him water and staying with him, symptoms dissipated and blood pressure returned to normal

At first on April 23rd, my tongue felt like it was burned and tingling. By 4/26 I woke up with right side of face dropping, swollen, and paralyzed. Went to the ER and was diagnosed with Bells Palsy. ER doctor also performed CT scan which was normal. Was given prednisone and valacyclovir, instructed to protect and dress my eye. The right side of my neck under my ear is very swollen and tender. I have pain in the back of my neck on the right side. I had a follow up with PCP 5/05/21. She told me to use an eye ointment. It has been two weeks and my face is still paralyzed. Some of the swelling has gone down in my check.

Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Within a few minutes, pt began to sweat/feel light headed/dizzy/ringing in the ears. Pt stated he felt like he was going to pass out. Pt reported no symptoms related to anaphylaxis. Pt did not lose consciousness and symptoms started improving within 10 minutes. Pt then noticed blurry vision which resolved. Pt's BP was checked: 120/90, pulse WNL. Pt. was feeling fine but per PCP guidance, went to ER for a follow up when I followed up via phone. Reported no further issues after leaving pharmacy

Patient approached pharmacy staff during 15 minute observation to report feeling of overheating and anxiousness. He was brought into the consultation room where blood pressure was taken which was normal. Patient was given water and a dose of Benadryl as well as provided direct cooling with table fan. He mentioned getting a taste in his mouth prior to the flushing and anxiety as well as blurred vision. He was observed for an additional 45 minutes with symptoms subsiding and was advised to seek medical attention if symptoms reappear as he refused any further medical intervention. Patient was called several hours after vaccine at home where he said he was feeling improvement but was resting.

METALLIC TASTE IN MOUTH; FACE WAS RED; FLUSHING ON FACE; RIGHT LEG PAIN DESCRIBED AS DULL ACHE; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included gout. The patient could not take statins because they cause muscle pain but not an allergic reaction. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 205A21A) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAY-2021, the subject experienced metallic taste in mouth. On 10-MAY-2021, the subject experienced face was red. On 10-MAY-2021, the subject experienced flushing on face. On 10-MAY-2021, the subject experienced right leg pain described as dull ache. The action taken with covid-19 vaccine was not applicable. The patient recovered from face was red, and flushing on face on 10-MAY-2021, and was recovering from metallic taste in mouth, and right leg pain described as dull ache. This report was non-serious.

1 hour after shot started sweating along with blurred vision and light sensitivity from outdoor to indoor. 4 hours after chills and mild to medium headache with fever 101.5 along with joint and muscle aches. Also my chest felt heavy with no breathing problem. Headache lasted for about 24 hours. Fever and chills lasted for about 60 hours after shot. Joint and Muscle pain lasted 72 hours. Blurred vision last about 18 hours with sensitivity to light. Took tylenol fever reduces to 99.7 - 100.4 After 72 hours body felt normal

Within a few minutes of receiving vaccine, patient got pale and was sweating. He was fading in and out of consciousness and closing his eyes. He also appeared as if he was going to vomit. I immediately called 911 and they were here within minutes, checked him out and he waited an additional 20-30 minutes before leaving.

BLURRY VISION; DIZZINESS; SEVERE HEADACHE; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and cigarette smoker, and other pre-existing medical conditions included the patient had no known allergies and no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAY-2021, the subject experienced dizziness. On 27-MAY-2021, the subject experienced severe headache. On 04-JUN-2021, the subject experienced blurry vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache, blurry vision, and dizziness. This report was non-serious.

At 12:30am 04/06/21, I was wakened to a nauseous feeling in my stomach, and on my way to the restroom I passed out. My head hit the floor and that is when I woke up and had Diarrhea. Went back to lay down, and I had trouble the rest of the night breathing with intense arythmic activity. It caused me to not be able to breath as my heart was skipping beats very aggressively. This lasted into the morning of 04/06/21, and did not cease until 7-8pm that evening. Symptoms lasted approx 5 days, and dropped off in severity. Other symptoms included the following the day of the 04/6 -4/10/21: - dizziness - metal taste in my mouth - nausea - mental confusion - fatigue - loss of appetite - severe shakes/chills/sweats

9:48am during his 15 minute wait time, reported having a tingling in tingling in his throat, feeling flushed, and light headed. Declined us calling 911. He reported that he has a lot of allergies to foods and has experienced this reaction after having exposures to poultry products. Patient was brought in the nurses office and vital signs checked and stable. Lung sounds clear on auscultation. Given benadryl 50mg and monitored in office. Once patient reported feeling back to normal he asked to leave and went home. We called patient to verify that he got home and continued to feel fine.

The day of the vaccine, I have the normal regular arm pain. The following day, I had minor body aches and a lot of joint pain in my knees and legs. Those symptoms lasted a few days and resolved. My doctor prescribed a new medication called Cymbalta for my depression on 5/3/2021. I took the medication and developed tinnitus on 5/8/2021 and thought the tinnitus from the medication and stopped the medication. I called my doctor who advised that Cymbalta does not cause that reaction. The tinnitus went away and I was not taking Cymbalta. Around mid June, I developed tinnitus again. I consulted my doctor and was prescribed Dramamine. I did not take the medication since the tinnitus have resolve. I had only those 2 episodes of tinnitus and haven't had any other episode. I am going to follow up with a specialist ENT doctor.

On 4/23/2021 patient began having pain in his lower legs and feet. The pain then moved up to his upper legs. Patient states " I felt like I had a really bad sun burn on my arms and chest". These symptoms lasted about one week. Patient states then his lower legs/feet and hands feel "numb and tingly with nerve like pain". He states the rest of his body has a numb like feeling. He says his tongue, lips, and back of his throat are really numb. He continues to have these symptoms. He says he has decreased taste and due to this has lost 28 pounds.

Really bad hurting in chest pain, swollen lips and a headache. Had to go to ER. Forgot to mention the vaccine shot. They finally decided it was an allergic reaction. Gave a steroid shot and Benadryl. Sent home on steroids for 5 days. The next day had rash and itching. The next day it was worse looked like lace pattern rash over most of his body and really bad itching. Like this through the 20th then he took Claritin and put on anti -itch cream. The next day the rash had mostly cleared but still a little itchy. Today the 22 I have had a really bad headache.

Around 09:00 pm I started to feel muscle pain, hot breath, hot ears, headache and a slight fever 99 ° F. Approximately at 10:30 p.m., the fever increased to 104 ° F, muscle pain intensified all over the body, my teeth hurt, headache and chills. I took one (1) tablet of ACETAMINOPHEN 650MG, I took a cold bath and I put an ice pack on my head to lower my fever. I kept monitoring the temperature that at some point reached 104.9 ° F. Around 1:30 am I began to see that the temperature started to go down little by little. Around 2:30 am my temperature returned to 98 ° F and I no longer felt chills, no hot breath, neither hot ears, nor muscle pain was mild, I felt tired, headache was minimal. My last temperature was 97.5 ° F at 3:00 am. I got up around 10:30 am and I just felt tired and mild muscle pain.

3/21 - Felt like a sinus infection/Ear infection. Swollen lymph nodes. No congestion. 3/27 - Went to urgent care. Was given antibiotic/steroid to combat sinus/ear infection type symptoms. Tested neg. for strep. 3/29 - Went to PCP for continues pain in head and starting to have pain in lower back and down both legs. Some pain in arms too. 3/31 - Went to PCP for increased pain, weakness and numbness in legs and arms. Took blood for tests. COvid test 4/3 - Went to ER with intense pain/numbness/weakness/ restlessness in legs and some in arms/hands. Head still hurts too. More blood work, given Hydrocodone/Ibuprofin to help manage pain. 4/5 - Returned to PCP. Was given Gabapentin to help with the pain. Was referred to neurologist. 4/8 - Initial exam at neurologist. Plan to complete MRI and Nerve Conduction studies. 4/9 - Had MRI completed of brain and upper spinal cord.

Approximately 15 minutes after receiving the vaccination, my throat became dry and my eyes began watering. It was hard to tell but my throat felt slightly swollen also. I drank some water and a few minutes later things seemed to clear up. Randomly throughout the afternoon I had similar dry/itchy/tingling in my throat but not as strong as the time right after the vaccination. I didn't suspect this was directly related to the virus since I have allergies to grasses, trees, pollen, etc. and take over the counter allergy medicine as needed. At 3:30am today (4/10/21) I woke up having to use the restroom and when standing up out of bed I was extremely dizzy. After laying down in bed the dizziness disappeared. When waking up later in the morning the dizziness/light headed feeling was still present when standing. I also have noticed random strange pinching pain in my legs that only last for 1-2 seconds and sends a quick short pain sensation throughout my body. I have no clue if any of this is related to the vaccination received, but after noticing news articles with issues in a few folks receiving the Janssen vaccine, I decided I would pass this info along just in case.

Took the vaccination on Sunday woke up Monday morning with flu like symptoms and a fever of 101, woke up today Tuesday feeling fine until this afternoon with a sudden severe migraine with both eyes going blurry and feeling really weak.

I started shivering uncontrollably in the evening. I could not warm up, and my body was shivering. I wasn't sure if I had a fever, but I did not feel well. My wife was trying to warm me up and she thought I was having a seizure because she had never felt someone shiver so violently. My eyes were watering abnormally as well. The shivering subsided after about 30 minutes. I was soar and weak over the couple of days, but I believe those are normal symptoms.

Woke up with eyes swollen almost shut, red rash all around eyes. Blurry vision, eyes feel like they are on fire. Skin on eye lids are peeling. Fever and chills

Severe headaches lasting a couple days at a time with a constant headache ever since the shot, severe ringing in the ears nonstop since the shot, severe fatigue since the shot

HYPOTHERMIA; LOSS OF TASTE; ARM WAS LIKE ROCK SOLID; RASH ON LEFT ARM AND WENT ALL OVER THE BODY; HURTING ARM; WEAKNESS; FEVER; FLUCTUATING BLOOD GLUCOSE LEVEL; LIGHT HEADED; DIARRHEA; This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. The patient's past medical history included sinus surgery, and spine surgery, and concurrent conditions included type 2 diabetes mellitus, allergy to pecan walnut, allergic to pollen, allergic to lobster/oyster, allergic to molds, allergic to dust, and allergic to cat hair. The patient experienced drug allergy when treated with doxycycline. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 05-APR-2021 16:00 to left arm for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, within 1-2 hours after getting vaccinated the patient experienced a rash on left arm where he got the vaccine and it went all over the body. On the same day, his temperature was 95.1 F On 05-APR-2021, he also experienced weakness that lasted for a week. His arm was hurting and was like rock solid for almost ten days. The patient was feeling light headed that started on the same day of vaccination and could be due to low glucose level. The patient had diarrhea that started the same day as vaccination and was still ongoing. The patient's blood glucose was going up and down since the vaccination. On 05-APR-2021 at 23:05, his blood glucose level was 249 mg/dl. On 05-APR-2021 around midnight the patient had a fever of 101.9F. The patient experienced fever for first three days after vaccination, for which he took Tylenol for three days as directed by his physician. The patient took Tylenol 500 mg for every four hours total he took 5 pills on day one. The next day he took 3 pills of Tylenol 500 mg. On 06-APR-2021 at 8:00, his blood glucose level was 349 mg/dl and then he took his medication and it went down to 169 mg/dl. The patient stated that since vaccination his blood glucose has been unstable and the blood glucose readings are between 47 to 389 mg/dl. On 06-APR-2021, his temperature reading was 94.3 F. The patient also experienced loss of taste on the day after vaccination which has resolved now. His taste came back about a week or 10 days. The patient was not sure if the loss of taste is due to his allergy or the vaccine. On 07-APR-2021, the patient's temperature was 99.7 F. On 07-APR-2021, he took 500 mg every 6 hours. The patient took Tylenol for only three days and fever stopped after three days. On 07-APR-2021 the patient experienced hypothermia of 94.3 F. On 18-APR-2021 at 6:30, his glucose level was 95 mg/dl. The patient said that he had such unstable blood glucose readings only when he had an infection going on. On Friday the patient was going to see his endocrinologist. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hypothermia, loss of taste, arm was like rock solid, hurting arm, and weakness on APR-2021, and fever on 07-APR-2021, had not recovered from diarrhea, and fluctuating blood glucose level, and the outcome of rash on left arm and went all over the body and light headed was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210438172- COVID-19 VACCINE AD26.COV2.S- Hypothermia, Fluctuating blood glucose level. 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.

Everything Tasted Or Smelled The Same and just now is things starting to taste or smell properly but only have a immediate Taste or Smell as it was when everything Tasted & Smelled the same

Tinnitus level 8/10. Bad swelling / inflammation. Brain fog. Diarrhea. Ear pain. Treated with large doses of Antronex with recommendation from Chiropractor. Antronex helped reduce swelling. Treated sinuses with Xlear nasal spray. Helped reduce swelling. Tinnitus still at level 4/10 after 9 days.

Developed and still have severe ringing in the ears or tinnitus several days after vaccine. I never had any symptoms of tinnitus before the vaccine. It is completely disrupting quality of life,

Patient felt warm and was sweating profusely later the evening on the day of vaccination. 1 week later patient started experiencing muscle spasm initially starting at the lower legs, progressively walking upwards to the upper thigh. And this time patient also developed a new left-sided facial droop, with facial muscle weakness. He was evaluated at the ED 2 weeks after his Covid vaccine. CT head, CT angio was unremarkable. However MRI showed some mild diffuse cerebral atrophy. On neuro exam There Is Mild Left-Sided Facial Droop, unable to raise left side eye, unable to puff out his cheeks. There is also stocking glove distribution of decreased sensitivity to vibration, temperature, light touch. At this time th

Shortness of breath, numb face , tingling arms and legs, tinnitus in both ears, heart palpitations, blurry vision. Still have tinnitus, hearing sensitivity, vison problems and chest pai.

slight fatigue anxiety slight but weird tingling lips (if it gets worse ill go to the urgent care but im not concerned at this time. its been tingling for about 12 hours now and i can feel the tingle going away slowly now. just teporting my findings.

Started off with extreme fatigue the morning after the vaccine, then throbbing intense migraine started around 11 am that lasted until the next morning after which a dull headache lasting till Friday, 102.3 fever, EXTREMELY painful body aches, metallic taste in mouth, thirst that could not be quenched, dizziness, blurred vision, confusing, nausea.

TEETH PAIN; JAW-LINE ON FIRE; RING-WORM LIKE RASH AROUND INJECTION SITE; FEVER; SEVERE HEADACHE; This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included familial mediterranean fever (genetic variant). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 23-JUN-2021) dose was not reported, administered on 06-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-JUN-2021, the subject experienced ring-worm like rash around injection site. On 06-JUN-2021, the subject experienced fever. On 06-JUN-2021, the subject experienced severe headache. On 07-JUN-2021, the subject experienced teeth pain. On 07-JUN-2021, the subject experienced jaw-line on fire. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, severe headache, ring-worm like rash around injection site, jaw-line on fire and teeth pain was not reported. This report was non-serious.

dry mouth , shiver and difficulty breathing and tightness in arms complained (05.10 pm)by patient within 15 minutes of administration( 450pm) . Patient was laid down on floor with raised legs and cold packs applied to face and hands. Bp monitored and benadryl given ( 5.15 pm) . patient was still breathing . BP was high. next 10 minutes patient was feeling better. was seated with elevated legs. Drank water and Ems was called . Bp was at 178/112 pulse 83 Per EMS possibly syncope or initial reaction to the shot.

About 3 minutes after vaccination while seating patient said that he fills that he is going to faint. 911 was called by the stuff. Second later his eyes rolled his and started shaking. In a few minutes he came back and said he fills better. EMS arrived checked his vitals. Hi seemed fine, refused to go to the hospital. Eventually he left after sitting for 30 more min saying he is fine.

I had cold-like symptoms - dry throat and cough, runny nose and a fever on the first day but it went away pretty quick. It has been two weeks now and I still have it. I do feel better than at first. OTC type stuff - Dayquil etc. I had to cancel doctor appt because they didn't want me to come in within two weeks of symptoms.

NUMB FACE INITIALLY, NUMBNESS DOWN BOTH LEGS. NO FEELING OF HOT OR COLD ON THIGHS, ARMS. LIPS CURRENTLY NUMB. ICY-HOT SENSATION WHEN WIND HITS BODY WHEN SWEATING. HANDS IN COLD WATER FEELS "ICE, ICE, ICE FREEZING COLD". HEAT FROM SUN IS SIGNIFICANTLY ENHANCED AS IF THE SKIN WERE BURNING

Almost 24 hours after receiving my shot on 7/20/2021 I felt extreme fatigue, malaise, moderate to severe headache and eye pain, chills all over body with sensitivity to skin all over body, diarrhea, loss of appetite, loss of smell. All of these symptoms have continued 48 hours later with no relief.

Redness around left eye developed into severe rash spread all over body. Intense itching and discomfort. All started to occur 3/16 and progressively got worse and continued to spread. 1st dx was shingles (2nd time having it?2018) treated with prednisone and then dx contact dermatitis steroid shot and antihistamines then diflucan and went to Derm gave another steroid shot and antibiotic?all since 3/16 still progressing

24 hours later had all the side effects and feels like my rectum is swollen, and ears are burning, belly is swollen, feels like I have the flu, I feel hot but don't have fever, and I started feeling better and it all came back at one week later, is this normal and will it pass. Lymph nodes hurt from back of head down shoulders, constipation, voice different, smells are different, taste is different, and skin feels half numb.

Pain at injection site, woke up next morning with double vision. With both eyes open, dizziness, loss of depth perception

Blurred vision, sore body, stiff neck and swollen glands, size of a lemon. Flu like systems but no fever.

Piercing sound in left ear began on March 28. Saw ENT on March 30; diagnosed with tinnitus. Follow-up visit with ENT scheduled for week of April 19. ENT indicated he may prescribe steroids if tinnitus has not resolved by then.

PATIENT REPORTED VISUAL DISTURBANCES (DARKENING OF VISUAL FIELD), SWEATING, AND WEAKNESS ABOUT 5 MINUTES AFTER VACCINE WAS GIVEN.

Red spot on my right eye. Eye doctor said "subconjuntival hemorrage". Very red on 1st day. Lessening on the second day (currently).

That evening , started getting feverish and had temperature fluctuations, night sweats, body was sore all over. Then the next day notied that my eyesite in my left eye seemed off- noted I had floaters and could not see as well as previously. I assume this is a flare up of Toxoplasmosis as the eye symptoms are the same.

Arm muscle pain, leg muscle pain, back pain, headaches, metallic taste in mouth : all lasting up to 2 weeks

BLISTERS ON RIGHT ARM BETWEEN ELBOW AND SHOULDER; SHORTNESS OF BREATH; BLURRED VISION; ITCHING ALL OVER ESPECIALLY IN RIGHT ARM; FEVER OF 101 F; TIREDNESS; SCAR ON ARM THAT WAS 4 INCHES LONG AND 2 INCHES WIDE; This spontaneous report received from a patient concerned a 46 year old male. The patient's weight was 225 pounds, and height was 66 inches. The patient's past medical history included umbilical hernia, and covid-19, and concurrent conditions included high cholesterol, non-smoker, and social alcohol drinker, and other pre-existing medical conditions included the patient had no known allergies. The patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. Concomitant medications included atorvastatin calcium for high cholesterol. On APR-2021, treatment medications included: diphenhydramine hydrochloride, oxygen, and paracetamol. Also given unspecified cream for right arm. He wanted help with the scar on arm that was 4 inches long and 2 inches wide. On 12-APR-2021, the patient experienced tiredness. On 13-APR-2021, the Patient experienced blisters on right arm between elbow and shoulder, shortness of breath, blurred vision an itching all over especially in right arm. On 13-APR-2021, the patient experienced fever of 101 F. Laboratory data included: Body temperature (NR: not provided) 101 F. On an unspecified date, the patient experienced scar on arm that was 4 inches long and 2 inches wide. The patient was hospitalized for 2 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blisters on right arm between elbow and shoulder, shortness of breath, blurred vision, itching all over especially in right arm, tiredness, and fever of 101 F on 14-APR-2021, and the outcome of scar on arm that was 4 inches long and 2 inches wide was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210435619-COVID-19 VACCINE AD26.COV2.S-blisters on right arm between elbow and shoulder, shortness of breath, blurred vision, itching all over especially in right arm. 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). 20210435619-COVID-19 VACCINE AD26.COV2.S-tiredness, fever of 101 F. This event(s) is labeled and is therefore considered potentially related.

Starting day of, fever of 102, lasting 2 days, despite taking Advil throughout. Chills, fatigue. The next day, started experiencing BPPV. This last 2 days. This was helped slightly by Hallpike maneuver. Sense of haziness, inability to concentrate/focus, irritable, difficulty sleeping, tired, which are all still here to the time of this reporting.

Immediately after getting the shot I broke out in cold sweats, body went limp, arms and hands were tingling very badly and I lost my hearing to fast ?whooshes? couldn?t really speak or move for at least 15-20 minutes. Then got up and couldn?t stand up felt almost drunk. I had another spell exactly the same about 4 hours later

I am experiencing slight ringing in what appears to be my right ear. I don't know if it is both ears. I have not seen my primary doctor yet. The feeling is similar to having head congestion or sinus pressure, I guess. It is not an emergency for me. I will be checking with my primary doctor soon. The only discomfort I have is when I try to fall asleep. I hear the slight ringing in my right ear. Still optimistic that it will go away on its own. I am tolerating it at the moment and can work throughout the day. But, sleeping appears to be the most interruptive. With that being said, I do end up falling asleep. I am pretty sure this is a vaccine reaction. I have not had any history of it before. As soon as I see my doctor, I will update the notes for more clarity on what these symptoms are. Thank you.

Experienced all covid symptoms including high fever. Last symptoms occurring now are congestion, fatigue and loss of taste and smell.

Within 2 minutes of receiving shot, overwhelming deadening of sound, blackness in eyes, full body sweats, full body discomfort, very close to fainting for first 6-8 minutes. As those symptoms started to diffuse severe muscle cramping started in opposite arm of shot, moved thru body. Within 15 minutes the only symptoms left were the muscle cramps. Those continued for several days. Still lingering today, a week later.

A few days after taking the shot, I had headaches, ear ringing, and heavy head pressure. The ear ringing has persisted and I am still dealing with it. The doctor advised me to take Mucinex. Then I visited a new PCP to take a CT scan.

Woke up with COVID-like symptoms similar to when I had contracted COVID 5 months earlier. Headache, mild loss of taste, body pains all over body, extreme back pains not typical of back problem, fatigue, nausea, vomiting

elevated heart rate (up to 135 while resting) beginning approximately 8-10 hours after receiving the shot. my heart also had strange, strong beats and did not feel right. I left the hospital before someone would read my EKG because it was crowded and I was worried about infection. The symptoms persisted for approximately 6 to 8 hours and mostly coincided with fever and chills. about a week or ten days later, I had another episode of strong heart beats lasting about 6 to 8 hours. I went to Hospital and was told I had premature atrial contractions. my other symptom has been louder tinnitus, which has not subsided since my shot.

within 12 hours of vaccine develop viral arthritis symptoms ( ankle, knee, hip and cervical spine pain) subsided after 24 hours but a concertation of pain develop orally- oral pain, feels like a tooth ache across all teeth, extreme sensitivity to temperature. over several days decreased to dull pain along the maxilla mostly on right side. Some days are better than others ie. just sensitive to cold (liquids and food) others days full pain along the upper and lower, primarily on right side but radiates to left side. on day 8 and 13 was having extreme break though pain, Alieve and Tylenol were not helping. on 13th day almost unbearable. Currenly on day 16th and still taking tylenol daily to help with discomfort.

End of May i had some vision issues seeing double but did not think much about it . Went to my PCP for annual physical exam where he did the bloodwork and everything came back normal except Cholesterol which was marginally higher. The issue was not causing much discomfort for me and it sort of went away the best i recall or dont recall. Around June 14th 2021 I started having trouble focusing with my eyes again. It was causing me more discomfort than before so i visited my PCP Dr June 15th. Dr mentioned there was slight difference in ear pressures and maybe it was that. Not totally satisfied with that i visited my Optometrist Dr the next day and he suspected 4th nerve Palsy and asked me to

Shingles in throat. Vertigo, dizziness, half of head numb. Disoriented, Throat and ear pain, eye pressure on face and in eye, tinnitus, tired. Most symptoms since April 12th. Took two doses of antiviral because I got sores in my throat twice three to four weeks apart. Vertigo, dizziness, disoriented persists.

Unexplainable dizziness, lightheadedness, body tingling, ringing in ears, fainting, rapid heart beat, unable to focus. All began a few weeks after shot and have not gone away.

POSSIBLE OCULAR MYASTHENIA GRAVIS; POSSIBLE FOURTH CRANIAL NERVE PALSY; SINUS INFECTION; ALLERGIC REACTION; SLIGHT DIFFERENCE IN EAR PRESSURES; This spontaneous report received from a patient concerned a 46 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included marginally high blood pressure, and the patient had no allergies to medications, food, or other products. The patient had no other illnesses at the time of vaccination and up to one month prior, and no prior medical history or neurological history in the family. The patient had no adverse event following any previous vaccine. 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 09-MAR-2021 at 11:00 to left arm for prophylactic vaccination. Concomitant medications included ascorbic acid (Vitamin C), Multivitamins, cod-liver oil, Vitamin D, and lisinopril. On an unspecified date in MAY-2021, the patient had some vision issues/seeing double, but did not think much about it . The patient went to his Primary Care Physician (PCP) for annual physical exam where bloodwork and everything was done and it came back normal except Cholesterol, which was marginally higher. The issue was not causing much discomfort for the patient, and it sort of went away, the best the patient could recall or couldn't recall. On 14-JUN-2021, the patient started having trouble focusing with his eyes again. It was causing him more discomfort than before so he visited his PCP, on 15-JUN-2021.doctor mentioned there was slight difference in ear pressures and maybe it was that. Not totally satisfied with that, the patient visited his Optometrist the next day and he suspected 4th nerve Palsy and asked the patient to make an appointment with the Eye Center with a specialist. The patient went and saw doctor at the eye Centre, On 17-JUN-2021 and he also suspected 4th nerve Palsy. Doctor ordered Magnetic Resonance Imaging (MRI) of the brain and Orbit which the patient completed on 22-JUN-2021 (later to come back normal). As the patient waited for the results that week, his condition was slightly deteriorating whereby he had to close his right eye to walk and go up and down the stairs. Just to rule out any Ear, Nose, And Throat (ENT) issues, the patient went and saw his ENT doctor on 21-JUN-2021. His hearing was normal and he conducted a Computed Tomography (CT) scan of the sinuses and he saw some infection but did not think it was in an area which would have caused any issues with the patient's right eye. The doctor, however, did prescribe antibiotics which the patient had started. The first dose and the patient started having an allergic reaction even though he had taken it before and not had any reaction (the patient had never had any reaction to any medication prior to that in his life). So the doctor changed the antibiotic and the patient started taking the other medication. On 27-JUN-2021, when the patient woke up, he noticed his right eye to be half closed, he thought maybe he had overworked his right eye and it might get better. However, on 28-JUN-2021, when the patient woke up, it had got worse. The patient decided to visit doctor that day itself at the Eye institute. Doctor, after his examination and consulting with another neurologist, said that he suspected Cranial nerve Palsy and possible Myasthenia Gravis. doctor suggested that if the patient wanted answers right away, then check into the Emergency Room (ER). The patient did check himself that same day and the neurologists and the ER doctors immediately admitted him to the hospital and conducted multiple tests. Laboratory data included: Antibody test (NR: not provided) Unknown, Carotid angiogram (Magnetic resonance angiography-MRA) (NR: not provided) Unknown, Chest X-ray (NR: not provided) Unknown, Electromyogram (NR: not provided) Unknown, and Lumbar puncture (NR: not provided) Unknown. The patient was at the hospital till 03-JUL-2021, and released with medications and possible diagnosis of cranial nerve palsy/Ocular Myasthenia Gravis. The patient was hospitalized for 6 days. The patient was waiting for a call back from the neurologists for a follow-up appointment and further treatment, if any. The patient's symptoms of droopy eyes persist on his right eye, and both his eyes cannot focus together. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected fourth cranial nerve palsy/right eye half closed/vision issues, seeing double/closes right eye to walk and go up and down the stairs, possible ocular myasthenia gravis, sinus infection, slight difference in ear pressures, and allergic reaction. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210731014-Covid-19 vaccine ad26.cov2.s -Possible ocular myasthenia gravis, IVth nerve paralysis. 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).

Doctor notes: Progress Notes, MD at 6/28/2021 3:30 PM Chief complaint: Neurologic problem.HPI:6/28/21Consult at request of Dr. 47 y/o man. JJ vaccine 4/6/21. Flew to Syracuse to get vaccine (friend is a pilot). Next AM had fever, flu-like symptoms which lasted 4.5 days. 1-2 days after vaccine developed vertigo. Vertigo occurred while lying down in bed and on getting up from bed. While walking lurched to either side. Couldn't stand on one foot. Turning over in bed with lifting head also caused it. Episodes subsided 1 min after stopped moving. Did not have vertigo while upright. Did not have double vision. No change in chronic tinnitus on L. No change in hearing. No change in speech, swallowing. No confusion. No facial numbness. No limb weakness or numbness. No new HA. Was taking Advil PM for fever, etc. Had covid test and Ab test a few weeks before vaccine. Vertigo lasted 4 - 5 days. On 4/18, after it ended, went on a date, had 2 drinks over course of 7 hours. 2 days later, on 4/20/21 again felt ill with temperature and vertigo, which persisted for another 5 days. Saw his acupuncturist Dr. and vertigo resolved after acupuncture treatment. Continued to have fatigue for several more weeks. Saw Dr. 5/13/21, dx BPPV. Sees functional medicine doctor. Lost 35 lb with diet. Started on B12 Data:3/12/21: covid ab neg5/13/21: covid ab neg PMH/PSH: Strabismus surgery 2002; psoriasis Social History: No substance abuse. Employment - business consultant; musicianFamily History: No neurologic illnessMedications: Vit d 500 daily; b12 1000 daily; topicals Allergies: Dust; shrimp; cocoa PE:General: NAD. MS: Oriented to person, place and time. Recent and remote memory intact. Attention and concentration normal. Normal fund of knowledge. Language - no evidence of aphasia or dysarthria. CN: VA grossly normal. VFF. PERRL. EOMI, no nystagmus. PP intact b/l V1-V3. Face symmetric. Hearing grossly intact. Palate elevates symmetrically. Shoulder shrug 5/5 b/l. Tongue midline.Motor: 5/5 x 4. Tone normal. No tremor or other abnormal movements. No drift. Sensory: PP intact x 4. Coord: FTN normal.DTR: Arms 1; KJs 1; AJs 2. Plantars: flexorGait: Narrow base. Normal heel, toe. Tandem slightly difficult. No Romberg. Impression:Positional vertigo and imbalance in setting of flu-like illness after Johnson and Johnson flu vaccine received 4/6/21. Symptoms currently resolved. MRI Brain/IAC and MRV head ordered to r/o CVA, venous sinus thrombosis. Covid PCR and Ab sent today. I will message with test results. FU PRN I personally spent a total of 60 minutes face-to-face and non-face-to-face time reviewing the patient's chart and documenting in the record. This total time was performed before, during, and after the visit on the same service date. 6/28/2021 3:30 PM1 sst tube, 1 viral swab sent to nyp lab

About 10 min after the vaccine was administered, the patient suddenly felt hot, dizzy, and his vision became blurred. Resolved after about 2 minutes after removing glasses and drinking water

Got vaccine at 12:30am, was home asleep by 2:30. Head was insanely stuffy when I woke up around 8:30, my ears hurt on the inside and I couldn?t hear well. My lungs felt kind of funny, as if I?d taken too much asthma medication. By noon my lungs were burning with every breath, my eyes were hot and weepy, the fever and muscle/joint aches had gotten really bad, and I had pain in my neck under my jaw between chin and ears.

Day 1: Saturday morning March 6 at 5:00am I was shaken out of my sleep with a nasty migraine, sour stomach, intense body aches, stuffy nose, fever (102f). Classic flu like symptoms. I was extremely sick all day Saturday (level of sick: 8/10). Day 2: Sunday morning March 7 I awoke again extremely sick, just as sick as Saturday. All same symptoms (level of sick: 7/10). Sunday night I was incredibly miserable, all flu symptoms, I did not sleep Sunday night, up all night and up all day the next day Monday. Day 3: Monday I continued to be sick, all same symptoms, all day long. This time the blood shot eyes & bloody nose came on, fever was steady at 101f (level of sick: 6/10). Day 4: Tuesday woke up still stick, same flu like symptoms. I feel the headache has gotten worse, in fact way worse. Fever steady at 101f all day. Overall I'm not as sick except the headache and fever (level of sick: 6/10). Day 5: Wednesday I was really hoping I'd make a full recovery but still still sick, fever dropped for a few hours then came back, fever peaks and bounces around at 101f. Headache is absolutely nasty, I feel intense pain in the back of my neck and head, hard to sleep or lay down. (level of sick: 5/10). Day 6: Thursday I feel like I'm just about kick this sickness, feeling way better. I dont have a fever today but I still have an incredibly nasty headache, really intense, my eyes hurt, back of my neck hurts. (level of sick: 3/10). Day 7: Friday, no flu symptoms, finally!! But the headache continues, really bad. It sort of disables my ability to function with the headache. Back of my neck and back of head hurts, inside my brain hurts. Ugh! Day 8: Saturday, no flu, no fever, although still bad headache. I've been taking Advil all week to help reduce the headache. It helps, but after about 6 hours later the headache returns. Late in the evening Saturday my head was pounding. Day 9: Sunday headache not that bad, mild headache lingered throughout the day, tolerable. Day 10: Monday no headache!! Today was the first full day of full happiness!! *NOTE*: In July 2020 I got COVID extremely bad, spent 4 days in the ICU, couldnt breathe!! I had a fever of 103 for 6 days straight before calling 911 to come and get me. I was in bad shape, lost 30 lbs, had respiratory breathing issue for about 2 months after hospital stay. Most sick I've ever been, total game changer, I will never be the same. To this day I feel my respiratory is at 90%, fatigue still comes around every so often. --- Thank you ---

Day 1: Saturday morning March 6 at 5:00am I was shaken out of my sleep with a nasty migraine, sour stomach, intense body aches, stuffy nose, fever (102f). Classic flu like symptoms. I was extremely sick all day Saturday (level of sick: 8/10). Day 2: Sunday morning March 7 I awoke again extremely sick, just as sick as Saturday. All same symptoms (level of sick: 7/10). Sunday night I was incredibly miserable, all flu symptoms, I did not sleep Sunday night, up all night and up all day the next day Monday. Day 3: Monday I continued to be sick, all same symptoms, all day long. This time the blood shot eyes & bloody nose came on, fever was steady at 101f (level of sick: 6/10). Day 4: Tuesday woke up still stick, same flu like symptoms. I feel the headache has gotten worse, in fact way worse. Fever steady at 101f all day. Overall I'm not as sick except the headache and fever (level of sick: 6/10). Day 5: Wednesday I was really hoping I'd make a full recovery but still still sick, fever dropped for a few hours then came back, fever peaks and bounces around at 101f. Headache is absolutely nasty, I feel intense pain in the back of my neck and head, hard to sleep or lay down. (level of sick: 5/10). Day 6: Thursday I feel like I'm just about kick this sickness, feeling way better. I dont have a fever today but I still have an incredibly nasty headache, really intense, my eyes hurt, back of my neck hurts. (level of sick: 3/10). Day 7: Friday, no flu symptoms, finally!! But the headache continues, really bad. It sort of disables my ability to function with the headache. Back of my neck and back of head hurts, inside my brain hurts. Ugh! Day 8: Saturday, no flu, no fever, although still bad headache. I've been taking Advil all week to help reduce the headache. It helps, but after about 6 hours later the headache returns. Late in the evening Saturday my head was pounding. Day 9: Sunday headache not that bad, mild headache lingered throughout the day, tolerable. Day 10: Monday no headache!! Today was the first full day of full happiness!! *NOTE*: In July 2020 I got COVID extremely bad, spent 4 days in the ICU, couldnt breathe!! I had a fever of 103 for 6 days straight before calling 911 to come and get me. I was in bad shape, lost 30 lbs, had respiratory breathing issue for about 2 months after hospital stay. Most sick I've ever been, total game changer, I will never be the same. To this day I feel my respiratory is at 90%, fatigue still comes around every so often.

Headache, Fever, Chills, Joint Pain, Kidney Region Soreness, Lethargy, Confusion and Difficulty in Expressing Thoughts Very similar to Malaria "type" symptoms without ringing in the ears. (Had malaria in 1997) Symptoms tempered by 40% day two.

After injection - experienced lightheadedness/dizziness/blurry vision. Patient was hypotensive -and once supine for a few minutes and his blood pressure returned to normal levels.

after 10 minutes after vaccination patient said he felt flushing in the forehead, dizzy, had a unsusual taste in mouth, tightness in throat. Patient was given 10 ml of beandryl oral liquid 12.5mg/5ml , monitored . After 5 minutes of oral benadryl administration patient said he was feeling better , his throat was getting better and dizziness was gone. patient was monitored was additional 30 minutes before he left.

PATIENT LOOKED AT WIFE AND SAID I DON'T FEEL RIGHT, AS I WAS CALLED BACK TO THE CAR HIS HEAD BEGAN TO ROLE FORWARDS, THEN IN A CIRCULAR MOTION. HIS EYES ROLLED BACK IN HIS HEAD AND HE MADE A GASP FOR BREATH THEN PASSED OUT. EPI PEN WAS IMMEDIATELY ADMINISTERED. PATIENT BECAME MORE RESPONSIVE, LAID SEAT BACK IN CAR. PATIENT SWEATING , COULD NOW SPEAK TO ME BUT STILL SOMEWHAT DISORIENTED. VERY FAINT PULSE. 911 WAS CALLED AND COOL WET PAPER TOWEL PLACED ON HIS NECK AND OBSERVED UNTIL 911 ARRIVED WITHIN 5-10 MINUTES. PATIENT TRANSPORTED TO ER DUE TO VERY LOW PULSE EVEN AFTER EPI ADMINISTRATION. PATIENT REMAINED AT ER UNTIL 1:30 PM FOR MONITORING. THEY TRULY FELT IS WAS A VASOVAGUL REACTION. PATIENT WAS OUTSIDE WORKING IN YARD AT 6:30PM WHEN I CALLED TO CHECK ON HIM, HAS NO RECOLLECTION OF RECEIVING SHOT OR EPI PEN, JUST SAID HE REMEMBERS MEDICINE FEELING "HOT" GOING DOWN HIS ARM.

SHORTNESS OF BREATH; FULL BODY ACHE; JOINTS HURT; SEVERE HEADACHE; NAUSEA; SENSITIVITY TO LIGHT; LETHARGIC; This spontaneous report received from a consumer concerned a 47 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 15:25 for prophylactic vaccination. Concomitant medications included benzylpenicillin for drug used for unknown indication. On APR-2021, the subject experienced lethargic. On 02-APR-2021, the subject experienced sensitivity to light. On 02-APR-2021, the subject experienced nausea. On 02-APR-2021 01:15, the subject experienced shortness of breath. On 02-APR-2021 01:15, the subject experienced full body ache. On 02-APR-2021 01:15, the subject experienced joints hurt. On 02-APR-2021 01:15, the subject experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, full body ache, and severe headache on 03-APR-2021 09:35, had not recovered from lethargic, and the outcome of joints hurt, nausea and sensitivity to light 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.

Shot at 1:50pm Saturday. Woke with headache at 2:45am Sunday. By 5:00am Sunday had bad stomach pain and fever of 100.9F. Headache varied, got worse, got better, got worse, etc. Bad stomach pain lasted straight through until about 1:00am Monday. It's now 8am Monday, a little bit of stomach pain but far less than what it was.

When injected after about 60 seconds semi severe achy-burning feeling in my arm that subsided in a few minutes. After 15 minutes slight tingling/numbness on the tip of my tongue and slight tingling in the upper lips of my mouth. I was not worried. I took 1 Benadryl and 2 Ibuprofen (400 ml) at that time for symptoms. I took additional 1 Benadryl and 4 Ibuprofen about 6 hours later as a precaution. Day 2 after about 36 hours I had slight soreness, and some sweating as I slept the 2nd night. Treated with 4 ibuprofen. Also I woke up with a feeling of uneasiness in the middle of the night on the 2nd night. Day three, just a general feeling of tiredness. Day 4 and 5 still slight ache in the injection sight if pressure is applied. Other than that I feel normal as of day 5.

EYES HURT; DIZZINESS; FATIGUE; HEADACHE; ARM SORENESS; SEVERE CHILLS; This spontaneous report received from a patient concerned a 47 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced arm soreness. On 07-APR-2021, the subject experienced severe chills. On 07-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced eyes hurt. On 08-APR-2021, the subject experienced dizziness. On 08-APR-2021, the subject experienced fatigue. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from arm soreness, and dizziness, and had not recovered from severe chills, headache, eyes hurt, and fatigue. This report was non-serious.

Near immediate metallic taste in my mouth. Resolved after 36 hours. Body aches developed within 8 hours. Resolved in 36 hours

47-year old male c/o frontal headache since Friday, 4/9/2021. Received his Johnson & Johnson vaccine on Thursday, 4/8/2021. Still having his headache now. 9/10 pressure-like on the frontal head - constant States, "I never had this kind of headache before". 6/10 burning epigastric pain. Also has bodyaches. Has mild dizziness. Denies any photosensitivity, fever, flu-like sx, nausea/vomiting, chest pain, dyspnea, numbness, tingly sensation, slurred speech, back pain, rectal bleeding.

Five minutes after injection I broke into extreme sweating, hot flash, nausea, fatigue and head ache. I was at work and requested to go home early. I fell asleep one hour into my arrival and slept for 17 hours. Up to and including today I am having headaches, pain in my legs on left side only, nausea, lack of sleep and a continued smell similar to dried blood after a injury. I have also have and continue to have shortness of breath and chest pains resulting in two panic attacks within the last three days. This has led me to report this and I have doctor visit scheduled for 4/22. I also reported today based on internet search of reactions.

Leg cramps pain especially at night. Worst with left leg. Headache and feeling heavy headedness. Lost of taste and small cramps on light side of tongue.

Went to the dentist on 4/17/21 for routine cleaning. My gums became sore the next day. Today is 4/21, 4 days later and my gums are still sore. Normal gum soreness for me after a cleaning goes away by the next day when I wake up. On Sunday 4/18, I was working on the car and bruised my arm/wrist in a couple of places. That evening the locations bruised up really good and was tender. Today the areas are still tender and have dark bruising patterns. I generally do not bruise like this, and frankly was surprised bruises even appeared. Yes, I did bang my arm on the car a couple of times, but no where hard enough to receive this kind of bruising. I do not think this is an issue for me -- more of "just dealing with the inconvenience," but am curious if this is some sort of side effect from the vaccine. I could not find any information online related to "easily bruises" at all.

The vaccination uncovered an ongoing, hitherto silent infection: after a few days, my teeth started hurting, with the pain intensity increasing over two days to the point where I had to see a dentist. It turned out I had a molar that was infected and needed a root canal. The immune response from the vaccine probably caused my body to react to the tooth infection as well. I normally wouldn't put the two things together, but I had a very similar reaction a few days after my flu vaccine back in October: sensitive teeth, wandering pain in different parts of my head, neck, and shoulder area. At that time, the dentist didn't find anything (although we now know it was probably the start of that same tooth becoming infected and dying), and antibiotics took care of it. The root canal specialist I saw, the dr, said she is seeing a number of similar cases in her patients, where vaccinations bring out undetected problems. I actually consider that a good thing - I wouldn't want to have a rotting tooth that goes unnoticed for a while.

TINNITUS; BRAIN FOG; PRESSURE BEHIND RIGHT EYE (WHERE HEADACHE PAIN WAS) ON AN OFF; ACHY BODY; INSOMNIA; HEADACHES; FEVER (LOW GRADE); LETHARGY; This spontaneous report received from a patient concerned a 47 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced lethargy. On 07-MAR-2021, the subject experienced achy body. On 07-MAR-2021, the subject experienced insomnia. On 07-MAR-2021, the subject experienced headaches. On 07-MAR-2021, the subject experienced fever (low grade). On 09-MAR-2021, the subject experienced pressure behind right eye (where headache pain was) on an off. On 10-MAR-2021, the subject experienced brain fog. On 07-APR-2021, the subject experienced tinnitus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lethargy, headaches, and fever (low grade) on 08-MAR-2021, achy body on 07-MAR-2021, and brain fog on 15-MAR-2021, was recovering from insomnia, and had not recovered from pressure behind right eye (where headache pain was) on an off, and tinnitus. This report was non-serious.

BLOOD SHOT EYES; BLOODY NOSE; DID NOT SLEEP DUE TO FLU SYMPTOMS; FEVER; NASTY MIGRAINE/ INTENSE PAIN IN THE BACK OF NECK AND HEAD, EYES HURT; SOUR STOMACH; INTENSE BODY ACHES; STUFFY NOSE; FLU LIKE SYMPTOMS; EXTREMELY SICK; This spontaneous report received from a patient via a company representative concerned a 47 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included heart coronary artery disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 05-MAR-2021 15:30 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included atorvastatin, hydrochlorothiazide, and losartan. On 06-MAR-2021, the subject experienced extremely sick. Laboratory data included: Body temperature (NR: not provided) 102 F. On 06-MAR-2021 05:00, the subject experienced nasty migraine/ intense pain in the back of neck and head, eyes hurt. On 06-MAR-2021 05:00, the subject experienced sour stomach. On 06-MAR-2021 05:00, the subject experienced intense body aches. On 06-MAR-2021 05:00, the subject experienced stuffy nose. On 06-MAR-2021 05:00, the subject experienced flu like symptoms. On 06-MAR-2021 05:00, the subject experienced fever. On 07-MAR-2021, the subject experienced did not sleep due to flu symptoms. On 08-MAR-2021, the subject experienced blood shot eyes. On 08-MAR-2021, the subject experienced bloody nose. Laboratory data included: Body temperature (NR: not provided) 101 F. On 09-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nasty migraine/ intense pain in the back of neck and head, eyes hurt on 15-MAR-2021, sour stomach, intense body aches, stuffy nose, extremely sick, did not sleep due to flu symptoms, blood shot eyes, and bloody nose, flu like symptoms on 12-MAR-2021, and fever on 11-MAR-2021. This report was non-serious.

Cold chills for three days post vaccination. Diarhea for 12 days post vaccination. Lump near ear NOT a gland from day 4 - 13 post vaccination. Numbness in top of left foot from day 4-13 post vaccination. Hazy thinking trouble concentrating from day 9-10 post vaccination. Altered "poop cycle" from day 2-13 post vaccination. Headaches, not migraine intense only 4-5 on a 1-10 scale from day 2-day 15 (currently still have them but only a 2 on a scale to 10).

Hospitalist Discharge Summary Admission date/time Apr 23, 2021 at 00:19 Discharge date: Apr 26, 2021 Hospital course 47M pmh DMII, HTN, HLD, L basal ganglia stroke, pw right-sided weakness, gait imbalance, double vision and slurred speech beginning at 2:00 p.m. 4/22. on admission, double vision resolved; slurred speech, headache and right-sided weakness imbalance gait remain. 4/23am pt developed L pupil dilation and lethargy, MRI brain demonstrating acute stroke, allow permissive htn treat for sbp>220mmhg or DBP >120mmhg, cont asa/statin; US carotid nonacute/benign; TTE pending; ST/PT/OT. Tele benign. 4/24 BPs remain elevated, allow permissive htn to standards <220/120; cont st/pt/ot, a little improved participation today po intake etc. 4/25 cont to improve slowly, will be good candidate. cont allow permissive htn, no events on tele, cont asa/statin for significant stroke, add plavix. 4/26 pt cont improve clinically, BP stabilizing still permissive htn, recommend start home BP meds within 2-3 days once out of acute phase, pt accepted today, TTE benign doppler benign, but doesn't seem like bubble study done, recommend repeat as outpatient to ensure no positive bubble defer to pt's pcp f/u. double vision persists, pt currently w eye patch relief, recommend outpatient ophtho follow up closely after or during time. cont asa/plavix/statin, then transition to asa/statin as rx per guidelines. no afib on tele, consider zio patch on d/c to ensure no afib in young patient w x2 stroke. recommend hypercoag workup outpatient. Acute stroke, L lacunar -asa/plavix/statin -permissive htn -tele -PT/OT/ST -TTE benign, nml ef, no bobble done? -repeat tte outpatient w bubble to ensure no R>L shunt -US carotid nonacute -MRI Brain 4/23 1. Focal patchy restricted diffusion and FLAIR signal hyperintensity in the left medial thalamus/rostral midbrain compatible with acute lacunar type ischemic infarct. 2. No significant intracranial mass effect, midline shift or extra-axial collection. 3. Chronic left basal ganglia infarct approximating the anterior limb of the left internal capsule involving the head of the left caudate nucleus.

90% LOSS OF VISION IN ONE EYE; BURNING EYE; FOGGY VISION; This spontaneous report received from a patient concerned a 47 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, frequency 1 total, start therapy date were not reported for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced 90% loss of vision in one eye, burning eye, and foggy vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the burning eye, foggy vision and 90% loss of vision in one eye was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to. Sender's Comments: V0.- Covid-19 vaccine ad26.cov2- 90% loss of vision in one eye. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

4.3.21: soreness throughout body, fever 4.4.21: fingers turned blue 4.5.21: tongue swelled and turned bright red fingers mottled for 5 days intense body aches for 6 days 4.26.21: antecubital fossa hot, swollen and red, significant pain 4.27.21: pain extends down into forearm and red and streaked 4.30.21: pain continues

03/10/2021 I started feeling fatigued, hard time breathing, got to point I checked my oxygen, almost felt like I had covid. o appetite. Next day It started with pain, body aches, severe, after pain, fever came 102.1, I was doing advil but fever would not break. It was really bad for the first 3 days. Got to point I had to go get covid test at PA in Wharton, had no test, no smell, lasted about a month. Visited Doctor first week in April because Doctor was out due to loss of kids in house fire so it took a while to get in. He had done some blood work earlier in March, my numbers were bad- WBC, and he put me on a antibiotic, Zpack, just in case I did have covid, but I didn't feel any of these symptoms until after I got J&J shot.

4/11 around 8am my nose just out of the blue started bleeding profusely. I tried about 40 minutes to stop it but wasnt successful so I was transported to hospital ER where they had to cauterize it just to get it to stop. I was advised I could not take anything but Tylenol to try to ensure the bleeding did not start again. It never really got any better and I began developing a weird head pain in my head, which caused severe headaches which the pain being felt in my face and behind my eye area. After the pain continued to get worse on 4/22 I had a virtual visit with Dr. who prescribed a steroid and antibiotic and advised I see an ENT. I havent had any more nose bleeds but I do still get intermitten headaches from time to time

Covid-19 Janssen vaccination administered on 5/24/2021 at approximately 1230. At approximately 1247 patient noted to have flat red rash to left side of neck moving towards chest and same rash on left antecubital space. Patient reported feeling hot. Diphenhydramine 50mg IM administered. Patient reported feeling short of breath, epi-pen 0.3mg IM administered. Respirations at 16 per minute, lungs clear to auscultation. Noted bilateral flat rash to underarms, improved with removing clothing from area. Patient symptoms improved. At approximately 1330 patient reported starting to feel short of breath. Patient self administered albuterol inhaler, two puffs. Lung sounds per auscultated expiratory wheezing bilateral upper posterior lobes and right middle lobe, no stridor. Post inhaler lung sounds very faint expiratory wheezing upper posterior lobe, right middle lobe cleared. At approximately 1400 noted rash to bilateral underarms started to return, rash to left side of neck started to raise, noted dermatography to bilateral sides. EMS activated. Perioral edema noted, patient reported starting to feel short of breath, epi-pen 0.3mg IM administered, oxygen at 2L per NC applied. Ambulance on prison grounds at approximately 1412, left grounds at approximately 1429 to Emergency Room for a higher level of care. Treatment at ER not available. Discharged from ER on same date at 2246. On 5/25/2021 at approximately 0215 patient reported pain in jaw, neck and chest. EKG obtained, normal EKG. Follow up scheduled with medical provider.

The morning of May 30th, experienced hives all over torso and legs, as well as swollen lips. As of this report (6/1/21), still dealing with bouts of on and off hives and alternating areas swelling in lips and eyes. Currently treating symptoms with Benadryl which is helping to moderate symptoms. However, symptoms are still present.

Blurry vision and pressure behind right eye. Seems to fluctuate in amount of blurriness. Pressure behind right eye has already been reported and started March 8 - 2 days after vaccination. Pressure was left after severe headache from vaccine resolved

This spontaneous report received from a patient concerned a 47 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and non-alcohol user, and other pre-existing medical conditions included the patient had no known allergies and no history of drug abuse or illicit drug use. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, expiry: UNKNOWN) dose was not reported, administered on 02-JUNE-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUNE-2021, the subject experienced pain in eyes. On 02-JUNE-2021, the subject experienced flu like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in eyes, and flu like symptoms. This report was non-serious.

On 5/31/21 I got a headache and noticed blurry vision. At approximately 11pm I noticed I was dribbling when I drank from a cup. At 2am on 6/1 I went to the Medical Office at my work and spoke to the Nurse. After seeing my face the Nurse determined I needed to go to the ER immediately. I went to the ER . After CT scan and physical test they determined I had Bell's Palsy.

Pulsatile tinnitus in right ear. This is a symptom I have never had in my life. It has persisted since onset.

Patient had a phobia of needle. He was calmed down and made to feel comfortable. Patient got his shot and was fine then after about 2 minutes he started saying " I am passing out" repeatedly then he started rolling his eyes. then he started sliding down the chair but he held his weight up thruoughout.. Pt was encouraged to breathe. 911 was called. After awhile, pt was asked if he wanted to lay on the flow and he said yes. He was carefully lowered to the flow and a pillwas used to support his head. after a few minutes, patient said he was ok howevr he was advised to wait till emergy services arrive. 911 arrived shortly after and took over. No drug were administered.

Back inflammation 04/12/2021- present , UTI 04/12/2021- 04/18/2021Bladder infection 04/12/2021-04/18/2021, blurred vision 04/12/2021- present.

The night of the vaccine I felt like I was coming down with a cold, had chills, felt cold and my body temperature was 100.4. A week later I still have adverse symptoms such as laryngitis, sore throat, runny nose, watery eyes and cough.

BODY ACHE/PAIN; ITCHY EYES; SKIN SENSITIVE TO TOUCH; FLU LIKE SYMPTOMS; CHILLS; GENERAL JOINT PAIN; MILD HEADACHE; FEELING TIRED; This spontaneous report received from a patient concerned a 48 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: 01808978, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 14:00 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced body ache/pain. On 03-APR-2021, the subject experienced itchy eyes. On 03-APR-2021, the subject experienced skin sensitive to touch. On 03-APR-2021, the subject experienced mild headache. On 03-APR-2021, the subject experienced chills. On 03-APR-2021, the subject experienced feeling tired. On 03-APR-2021, the subject experienced flu like symptoms. On 03-APR-2021, the subject experienced general joint pain. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache/pain, itchy eyes, skin sensitive to touch, mild headache, chills, flu like symptoms, and general joint pain, and was recovering from feeling tired. This report was non-serious.

Janssen COVID-19 Vaccine EUA Tinnitus in my left ear started about 4 hours after the shot. I have never had this condition before. Four days later and it?s still there. The ringing is constant and somewhat loud. I pray it goes away. Nothing but this shot could have caused this. I will go see a doctor if it persists.

I received the Jansen 1808978 vaccine on 03/25/2021 at pharmacy , on the following day 03/26/2021 at 8:30 pm I became disoriented / dizzy along with severe tinnitus and for the first 30 minutes I lost hearing in my right ear but it?s been over two weeks and the ringing is still going on .

PRESSURE BUILDING ON THE RIGHT SIDE OF THE HEAD (FELT LIKE SOMEONE TRIED TO STICK A REALLY HOT FINGER THROUGH THE EAR); NOSE BLEEDING WHEN BLOWING THE NOSE; RINGING IN BOTH EARS; Staphylococcal infection; This spontaneous report received from a parent concerned a 48 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and high cholesterol, and other pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 23-MAR-2021, the patient experienced staphylococcal infection. On an unspecified date, the patient experienced pressure building on the right side of the head (felt like someone tried to stick a really hot finger through the ear), nose bleeding when blowing the nose (dark colored blood), and ringing in both ears. Patient's mother was not sure when these symptoms started. All the symptoms have not been resolved. The mother was really concerned that the patient was not getting proper treatment and would like the company to ask for the medical facility to be provided. On MAR-2021, Laboratory data included:Staphylococcus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from staphylococcal infection, pressure building on the right side of the head (felt like someone tried to stick a really hot finger through the ear), nose bleeding when blowing the nose, and ringing in both ears. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210409259-Covid-19 vaccine ad26.cov2.s-Staphylococcal infection. 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).

on 4/9/21 around 8pm extreme cold chills , headache , body aches fever all night , flu like feeling for 3 days body ache and little sleep , consistent headaches . Had out patient knee surgery on 4/14 . Continues nasty headaches and body aches after . on saturday 4/17 bad headaches all night , bones in upperbody and skin hurt , from waist up felt like i had sunburn including on top of head , little sleep again . Went to Emergency room on 4/18 am . Tested for blood clot in leg and was negative , they gave me something for headaches and i was dehydrated , tongue was white and continues to wake up everyday white and feeling like dehydration , continues head aches from front to back with some continues neck pain in back . Havent slept more than 2 hours at a time . wake up with headache everyday and at night headaches are bad . i drink plenty of fluids all day , should not be feeling dehydrated . its now 15 days since vaccine and have no answers , i need to be able to sleep to do my job , vaccine was a mistake

BLURRY VISION; VOMITING; STOMACH UPSET; HEAD TO TOE SORENESS; WEAKNESS; FEVER; NAUSEA; HEADACHE AGGRAVATED; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. The patient's past medical history included previous neck injury, recent knee surgery, and shoulder injury, and concurrent conditions included penicillin allergy, use reading glasses, and headaches.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced blurry vision. On 13-MAR-2021, the subject experienced vomiting. On 13-MAR-2021, the subject experienced stomach upset. On 13-MAR-2021, the subject experienced head to toe soreness. On 13-MAR-2021, the subject experienced weakness. On 13-MAR-2021, the subject experienced fever. On 13-MAR-2021, the subject experienced nausea. On 13-MAR-2021, the subject experienced headache aggravated. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 15-MAR-2021, was recovering from weakness, nausea, blurry vision, headache aggravated, vomiting, and stomach upset, and had not recovered from head to toe soreness. This report was non-serious.

Facial muscle weakness, loss of taste, difficulties swallowing. Suspected vaccine induced multiple cranial neuropathy, most consistent with a Miller Fisher variant type of GBS. Received IVIG with improved symptoms.

Patient received vaccine at 1:23pm 4/30/21. He came back to the pharmacy at 4:45pm 4/30/21 reporting that his throat and tongue were burning, itchy, and felt swollen. He had excessive thirst and nausea. His symptoms were getting worse during the 10 minutes he were talking with him. The patient refused Benadryl and Epipen at the pharmacy as he wasn't sure he needed it. An ambulance was called and he was transported to the hospital.

Systemic: felt like was about to pass out or faint, but didn't, tunnel vision-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Severe, Systemic: Visual Changes/Disturbances-Medium, Additional Details: at12:12pm pt felt dizzy and faint and was sweating, bp1:12:22pm 117/38 pulse 79, bp2:12:30pm 97/53 pulse 51, bp3: 12:39pm 95/61, bp4: 106/69 pulse 49 at 12:46pm. pt left at 12:50pm advised not to drive had daughter driv ehim home

LEFT EYE WITH BLOOD SPOT IN THE EYEBALL; PAIN IN THE CENTRAL PART OF THE CHEST; DIFFICULTY BREATHING WHEN DOING ACTIVITIES; HEADACHE; LEFT ARM PAIN WHERE SHOT WAS ADMINISTERED; COULDNT SLEEP THE DAY OF THE VACCINE; BODY TREMBLING; This spontaneous report received from a 48-year-old, male patient The patient's weight was 184 pounds, and height was 74 inches. The patient's past medical history included gallbladder removal. The patient was non-smoker, social drinker (only in holidays mostly), and the patient had no known allergies. The patient did not have any drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 207A21A and expiry: 23-JUN-2021) dose was not reported, 1 total administered on 14-MAY-2021 around 13:15 to left arm for prophylactic vaccination. No concomitant medications were reported. On 14-MAY-2021, the patient experienced left arm pain where shot was administered, body trembling and couldn't sleep on the day of vaccine. On 17-MAY-2021, the patient experienced headache which had diminished, but suddenly they were like stabbing, left eye with blood spot in the eyeball and pain in the central part of the chest, which on occasions varies from right to left with breathing difficulty when doing activities. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body trembling, couldn't sleep, and left arm pain where shot was administered on 18-MAY-2021, was recovering from headache, and left eye with blood spot in the eyeball, and had not recovered from pain in the central part of the chest, and difficulty breathing when doing activities. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 : 20210555889-COVID-19 VACCINE AD26.COV2.S -Left eye with blood spot in the eye ball. 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.

I've never had problems with tinnitus in my life. The same night I got my shot, when I went to bed my ears were ringing and they haven't stopped since i got this shot.

14 days after the injection developed severe headache and fever. Went to ER. More symptoms developed: Severe Numbness from the waste down Severe pins and needles sensation from the waste down Severe Burning sensation from the waste down Severe coldness on feet that has moved up past ankles Unable to urinate Unable to have a bowel moment Blurry vision

JAW OPENING AND CLOSING VIOLENTLY ON IT OWN; STIFFNESS IN ANKLES; DIFFICULTY WALKING; LACK OF COORDINATION; EQUILIBRIUM AND BALANCE COMPROMISED; BAD DEXTERITY; ITCHING AROUND THE MOUTH; HANDS AND FEET CURLED DOWN; NUMBNESS (HANDS AND FEET); ELECTRICAL IMPULSES IN FACE AND SCALP AND ELECTRICAL IMPULSE AROUND MOUTH AND HAND; TINGLING AROUND THE MOUTH; PAIN IN ANKLES; TINGLING IN EXTREMITIES (HAND AND FEET); CONSTANT BRIGHT LIGHT FLASHING; LIP HANGING; UNCONTROLLABLE MOUTH MOVEMENT AND JERKING; MILD FLU LIKE SYMPTOMS; LACK OF APPETITE; TWITCHING ALL OVER; TREMORS; This spontaneous report received from a patient concerned a 48 year old male. The patient's weight was 182 pounds, and height was 68 inches. The patient's past medical history included extreme motor vehicle accident (other driver was drunk), and broken neck, and concurrent conditions included penicillin allergy. The patient was previously treated with methadone. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 2042T21H, and expiry: UNKNOWN) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. Concomitant medications included oxycodone. On MAY-2021, the subject experienced tremors. On MAY-2021, the subject experienced twitching all over. On 05-MAY-2021, the subject experienced mild flu like symptoms. On 05-MAY-2021, the subject experienced lack of appetite. On JUN-2021, the subject experienced uncontrollable mouth movement and jerking. On an unspecified date, the subject experienced numbness (hands and feet), electrical impulses in face and scalp and electrical impulse around mouth and hand, jaw opening and closing violently on it own, stiffness in ankles, difficulty walking, lack of coordination, equilibrium and balance compromised, bad dexterity, itching around the mouth, hands and feet curled down, tingling around the mouth, pain in ankles, tingling in extremities (hand and feet), constant bright light flashing, and lip hanging. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from mild flu like symptoms, and lack of appetite on 08-MAY-2021, was recovering from tremors, had not recovered from numbness (hands and feet), electrical impulses in face and scalp and electrical impulse around mouth and hand, uncontrollable mouth movement and jerking, jaw opening and closing violently on it own, stiffness in ankles, difficulty walking, lack of coordination, equilibrium and balance compromised, bad dexterity, itching around the mouth, hands and feet curled down, pain in ankles, tingling around the mouth, twitching all over, and tingling in extremities (hand and feet), and the outcome of constant bright light flashing and lip hanging was not reported. This report was non-serious.

Dizziness start on Sunday, 3/21/2021 and has been present every day since so far. This is abnormal for me. Prior to that, I have been having some problems breathing after getting the vaccine and have been using my Ventolin more often after the vaccine. Also noticed shortly after getting the vaccine, a feeling of liquid in my right ear. the liquid in the ear did go away a day before the dizziness started. Did not consider the ear or breathing issues as possible side effects as I do have asthma and figured the ear was congestion. Not sure if the dizziness and the feeling of liquid in my right ear are related and/or related to the vaccine.

Received COVID Vaccine on 03/14/2021. Pt had body aches and fatigue but on 03/17/2021 started with itching, pain on lips, forehead and waist line. Patient has lesions and significant pain consistent with shingles.

Pruritic rash on extremities began 3/11/21 and on 3/14/21 developed lip and facial swelling on right side of face requiring trip to emergency room at hospital

Extreme anxiety since day 3. Dry sinus since day 2. Inflamed sinus. Off and on rapid/hard heartbeat since injection. Insomnia. Rapid weight loss. Dry mouth. Loss of appetite. Ongoing chills (10 days after shot). Depression. Lack of energy.

Dry mouth, excessive thirst within the first hour post administration which persisted for about eight hours. About twelve hours post administration developed widespread, severe aches and a fever that persisted overnight into the following day. 36 hours post administration moderate aches and chills with no measurable fever.

Pain started in buttocks; then numbness in legs, then progressed up back to mid back pain, then to neck fullness and tightness, pain on both sides of neck, jaw and chin, feeling of something popping in neck and then Bell's Palsy of right side of face, difficulty speaking, eating, numbness of tongue; right eyelid unable to close, more pain on both sides of neck and back of head; cold and hot sensations on limbs today and no improvement of facial paralysis; hearing cricket noises in right ear at times, burning pain in patches of face.

Patient received vaccine and about 2-3 minutes after vaccination began sweating profusely. His wife was with him and alerted our staff that something was wrong. Our staff pharmacist, immediately attended to him and noticed that his tongue looked enlarged. He was not speaking for himself and was very disorientated. , RPh administered and Epi-Pen 0.3mg injection in the patient's thigh. The patient quickly stopped sweating, became more oriented and began talking. EMS was called and came to the pharmacy. EMS observed him for a short time then took him to the ERD

pt says he is not feeling well. He has become light headed, dizzy, and has severe stomach pain. He has developed some diarhea and has a sour taste in his stomach. He says when he stands up he feels like he may fall and he feels like he has a buzzing in head. He has back pain on this lower right side of his body. He has been taking anti-diarhea medicine medicine and Tylenol. He is not getting any better and will have to contact his PCP.

Immediately dizzy, nauseous and fatigue lasted 2 days. One week later (5/12) had severe allergic reaction including violent diarrhea with severe cramping and pain, and swollen lips, tongue, face, hands and feet. Acute swelling and diarrhea lasted 12 hours. Ongoing angioedema lasted 4 days and moved from mouth to face and hands and feet. No previous food allergies or allergic reactions.

Tinnitus and diminished hearing in the left ear only 5 minutes post injection. Pain at injection site lasting 1 week. Anxiety prior to receiving vaccine and post lasting 1 hour. Fatigue, body aches starting 5 hours post injection. Chills starting 12 hours post injection and lasting 2 hours. Headache lasting 24-36 hours. Elevated temp at 98.4, normally 97.4

Severe cold/flu symptoms beginning late evening of the shot date, lasting from 11:00PM until 7:00AM the following morning. Body shaking, extreme fatigue, feverish, significant aching in upper half of body including head. Tinnitus. After cold/flu symptoms subsided, heavy fatigue and some tinnitus persisted for 20 days. This was followed by approx. five days of tapering fatigue, after which approx 95% of symptoms had subsided. Unclear 5 weeks later if symptoms are 100% subsided, as diminished activity and exercise over three week period has left an unclear sense of physical norm (I suspect the symptoms are 100% subsided and my energy will return to normal with resumption of exercise habits).

While eating dinner, my lips and face around my mouth began to swell. They swelled to the point that it was very visible and became hard to enunciate due to the excessive swelling of the lips. The swelling lasted over 24 hours and did not respond to antihistamines.

He got the vaccine, He felt as if he was breathing shallow on the bus to get to work, within 15 minutes of the vaccine. He came home and collapsed due to the fatigue which is not normal for him. About 12 hours later his throat got scratchy, achy but doable. He went to work and had to leave early due to flu-like symptoms, felt feverish. Really bad aches now, and his breathing and heart rate are elevated right now. Achy-like headaches. He did take some Ibuprofen 800 mg and seems to be helping. He has had the typical soreness of getting the vaccine in the left shoulder, but otherwise ok. He also has a stuffy nose, scratchy throat and his eyes are a little red and glassy. He was directly exposed to somebody for 25 hours that was positive for COVID, but nobody else in the car got COVID in January.

Sore arm, extreme exhaustion, fever, body aches, racing heartbeat while resting, headaches out of the blue that's don't fade away, fluid in ears, soreness in left knee/inflamed hamstring, fever, sweaty, post nasal drip, minor cough, rattling noise in lung when breathing

BURNING ( AROUND EYEBALLS,NECK AND BODY); HOT FLASHES; SLEEPINESS; CHILLS; SUPER FATIGUE; HEADACHE; WEIRD TASTE IN MOUTH; This spontaneous report received from a patient concerned a 49 year old male. The patient's weight was 279 pounds, and height was 67 inches. The patient's past medical history included asthma younger, and concurrent conditions included non smoker. The patient experienced drug allergy when treated with methylprednisolone sodium succinate. 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: 23-JUN-2021) dose was not reported, administered on 24-MAY-2021 14:45 for prophylactic vaccination. No concomitant medications were reported. On 24-MAY-2021, the subject experienced weird taste in mouth. On 24-MAY-2021, the subject experienced headache. On 25-MAY-2021, the subject experienced sleepiness. On 25-MAY-2021, the subject experienced chills. On 25-MAY-2021, the subject experienced super fatigue. On 26-MAY-2021, the subject experienced hot flashes. On 26-MAY-2021, the subject experienced burning ( around eyeballs, neck and body). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, weird taste in mouth, super fatigue, hot flashes, chills, sleepiness, and burning ( around eyeballs,neck and body). This report was non-serious.

CONSTIPATION; PROBLEMS WITH BOWEL MOVEMENTS; DIARRHEA; PANIC ATTACK; HOT FLASHES; PAIN IN KNEES; PAIN IN CALVES,LEGS AND RIGHT ARM; COULDN'T SEE WELL; FELT CONFUSED; This spontaneous report received from a patient concerned a 49 year old male. The patient's height, and weight were not reported. The patient's past medical history included patient has taken tylenol.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 25-MAY-2021 for an unspecified indication. The batch number was not reported and has been requested Concomitant medications included paracetamol. On 25-MAY-2021, the subject experienced couldn't see well. On 25-MAY-2021, the subject experienced felt confused. On 25-MAY-2021, the subject experienced pain in calves, legs and right arm. On 26-MAY-2021, the subject experienced hot flashes. On 26-MAY-2021, the subject experienced pain in knees. On 01-JUN-2021, the subject experienced panic attack. On 02-JUN-2021, the subject experienced constipation. On 02-JUN-2021, the subject experienced problems with bowel movements. On 02-JUN-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from couldn't see well, and felt confused, had not recovered from pain in knees, hot flashes, problems with bowel movements, and pain in calves,legs and right arm, and the outcome of panic atack, diarrhea and constipation was not reported. This report was non-serious.

I've experienced 8 what appear to be seizures/body tremors since being vaccinated. The first beginning on the Saturday May 22, 2021 at around 1:00pm. That being the longest and most intense of the 8, which actually brought me to the ground. I generally have a few seconds to prepare as i can fill when they are about to come on. The most recent was on Sunday June 6, 2021 at 4:23am. It woke me up out of sleep and only lasted about 3 seconds, where as the first one i had lasted at least 15-20 seconds. The others in between have decreased in size and time since the one i experienced on Sunday morning. I've also experience cold spots or chills in strange areas, like behind forearms or one side of shoulder one day and the next side the other day. the top of my hands get the chills and there has been times that my waist and lower back will have it. I have experienced blurred vision occasionally but mostly it seems to be at night and seems to be not as bad like when it first started, which was Sunday May 23, 2021. I've experienced my teeth being very sensitive to hot and cold, and a tooth ache from time to time, and the most recent thing to experience has been an ear ache in my left ear, that started on the Monday June 7, 2021, that seem to happen when i first wake up in the morning and again when im about to go to sleep. They last for about 10 minutes and build up in intensity and then just stop. Those I've been have daily to this day or this morning i should say. Other then for the usual side effects of feeling fatigued and fever, those have went away, but other than for that... I guess i fill normal.

Patient states he can't control his mouth or his left eye, started yesterday morning and seems to be getting worse. He reports random tearing from the left eye. Also has left ear/jaw pain. Developed 4/29/2021. Dx with Bells Palsy.

Six weeks after the vaccine I started to get headaches. It is a dull headaches at the back of my head where my neck connect. I have not been able to find any medication that helps. I have the headache all day every day. Occasionally my eyes get blurry and I get some numbness and pins and needles on the right side of my face. I have been experiencing these headaches for ten weeks to date. I have seen a Neurologist and other specialists.

TONGUE TINGLING; FEVER; This spontaneous report received from a patient concerned a 49 year old male. The patient's height, and weight were not reported. The patient's past medical history included surgery. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 23-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 23-JUN-2021, the subject experienced tongue tingling. On 23-JUN-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and tongue tingling was not reported. This report was non-serious.

about a month after receiving the vaccine I started to notice ringing in my ears. It seems to be getting worse, not going away

Aching joints, upset stomach, sleepiness, slurred speech, drowsiness, blurred vision, weak muscles, lack of thirst and appetite, fever

EYESIGHT IS A LITTLE BLURRY; BLEEDING GUMS WHEN BRUSHING TEETH; LIKE A BLISTER; PAIN IN LEG; This spontaneous report received from a patient concerned a 49 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and other pre-existing medical conditions included the patient was healthy and fit. The patient experienced drug allergy when treated with codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prevention of covid-19 vaccine. No concomitant medications were reported. On APR-2021, the subject experienced like a blister. On APR-2021, the subject experienced pain in leg. On an unspecified date, the subject experienced eyesight is a little blurry, and bleeding gums when brushing teeth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in leg, eyesight is a little blurry, bleeding gums when brushing teeth, and like a blister. This report was non-serious.

- Severe fatigue, muscle cramps and weakness, dizzy, light headed, blurred vision - numbness and tingling in feet and hands, headaches, chest tightness, - prolonged severe daily headaches, blurred vision, high blood pressure

months later i started with a ear ache which spread 2 days later across my face. i go to hospital to be told i had bell pasy which i never had in my life. This reaction had to come from the shot.Never had anything else that would have caused this. Im going my doctor's office in a couple of days

Systemic: Allergic: Rash Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Body Aches Generalized-Mild, Additional Details: Patient experienced swelling of both hands, and a generalized blotch rash on arm, back, and ribs bilateraly

First, pain around the injection site; it appeared within a few hours after the injection, but it was bearable. Then, after about 23 hours after the injection, bad headache (especially around the eyes - which also caused light sensitivity) and general malaise. Shortly thereafter, low-grade fever (99.5 F) and significant muscle pain, all over the body. The most worrisome side effect was the last one, which appeared during the second night after the injection (about 32-33 hours after the injection): extremely fast heartbeat / racing heart. I did not use any treatments for these side effects.

Severe chills, aches, weakness, migraine, ear ringing. I was back to normal after 3 days, but after 11 days the ear ringing and headaches came back

Patient received first Johnson and Johnson, 2 minutes into a 30 min observation, patient began to have seizure like activity. Patient's eyes rolled back and he started to quickly shake for about 1 minute. Patient came to and was responsive. Provider arrived, vitals and physical exam were within normal limits. Patient was recommended to schedule an appointment with PCP and ask for a referral to Neurology, since patient had seizure like activity with a Tdap a few years ago.

Gave patient vaccination, patient rolled eyes back and then started having seizing activity. This happened at around 10:30 AM, held patient head to make sure he did not hit his head, patient was not responsive for about 1-2 minutes, 911 was called, EMT came.

5 days post vaccination I experienced sudden onset of generalized hives associated with itchiness. After use of benadryl the hives became more red, less raised, and resembled a confluent measles rash. From association with hives I experienced ear pruritus, sore throat, nausea. And fatigue. Hydrocortisone creme was used on the rash.

The patient came in for J&J vaccine. He said he had no history of severe allergic reaction to anything, including meds, food, vaccines or any injections. He said that he did not receive any other vaccine in the past 14 days. According to the patient, he did not have test positive for Covid or was in contact with anyone with Covid for the past 2 weeks. He appeared perfectly fine prior to receiving the vaccine. Once the vaccine was given, within about 5 seconds, he said that he was seeing spots, he closed his eyes and made sounds that were similar to snoring. His neck was completely down on his right side and he almost fell off his chair. I held him so he would not fall off the chair and called for help. A few of the co-workers came to hold him. He was non responsive and my co-workers helped to put his legs on the chair. At point, I gave him an epipen. Once the epipen was given, he opened his eyes in about few seconds and became responsive. The nurses came and took over at this point. I stayed with him and the nurses for a few minutes. The patient was fully responsive and talking by the time I left the nurses and the patient. 911 was activated after the first epipen was given. The patient was then evaluated by EMS and the onsite nurses. The patient was AOx4 with stable vital signs. The patient had orthostatic vital signs taken and were within normal limits. The patient demonstrated that he was able to ambulate with no assistance. The patient signed a refusal for transport to the hospital and was driven home by a colleague. The patient remains in care of that colleague for monitoring. The patient was instructed that if he were to begin feeling the previous symptoms that he is to activate 911 and be seen in a hospital. Patient understood the instructions and went back to his residence.

SWOLLEN EYES; RED EYES; RASH AROUND BOTH EYES; This spontaneous report received from a patient concerned a 50 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced swollen eyes. On APR-2021, the subject experienced red eyes. On APR-2021, the subject experienced rash around both eyes. Treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rash around both eyes, swollen eyes and red eyes was not reported. This report was non-serious.

Pain and swelling in my throat and severe tightness in my chest thirty minutes after the ijection. Severe ringing in my ears, could not sleep at night up to now. Went to ENT yesterday.

I received the J&J vaccine on 3/24, and by that evening I had a headache, and my tinnitus was louder than normal. I had mild barely perceptible tinnitus prior to the vaccine. I would normally never notice it during the day, but lying down and going to sleep in a quiet room I would hear it. Constant high pitch but not loud, in the background more. I always run a fan in my bedroom so that I have some white noise and don't hear it. I had the flu like headache from the vaccine for two days and then it slowly started to subside into the weekend. I was tired as well from the immune response. Five days out, I get out of the shower in the morning, and go to put underarm deodorant on, and notice my left armpit is all bright red. I check my right armpit, just as red.. Took photos of the red armpits and shared with some family and friends, as I read on the Internet that there were all kinds of crazy side effects that were possible. The red skin like rash is one of them, although my armpits never itched or burned. I could feel that they were warmer than normal, that was it. It was the 2nd day after my red armpits that my tinnitus ratcheted up to the current level that I am really unhappy with. The red armpits went away within 48 hours, never did anything about the redness, just didn't put underarm deodorant on until it passed. Sadly, the Tinnitus has remained and it is at a level that is distracting and persistent.

Systemic: Visual Changes/Disturbances-Severe, Additional Details: patients wife called to say that around 1 week after vaccine pt experienced vision issues. dr say he had a blood clot in eye which lead to partial blindess in one eye.

BLACKED OUT; RAPID/STRONG HEARTBEAT; TINGLING ARMS AND LEGS; COUGH; WHITE NOISE IN EARS; HEADACHE; This spontaneous report received from a patient concerned 50 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 administration not reported, batch number: 042A21A, and expiry: unknown) dose was not reported, administered on 06-APR-2021 at about 8:30 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, after about 5 minutes of vaccination, the patient experienced 'white noise' in ears, vision changes, had a visual aura (a pattern around side of vision and moved to front of vision) and blacked out only for few minutes. He blacked out in the pharmacy but was not sure for how long. On 06-APR-2021, the patient felt a little dizzy, experienced headache, and tingling in arms and legs (reported as ''arms and legs felt like they were gone''). On the same day, he also had a rapid/strong heartbeat for a while that made him cough and it went away after about 45 minutes. The strong heart beat had come and gone throughout the day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blacked out and cough, and the outcome of white noise in ears, tingling arms and legs, rapid/strong heartbeat, and headache was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210411724 - Covid-19 vaccine ad26.cov2.s- BLACKED OUT. 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.

Sudden onset Optic Neuritis, going blind. Extreme headache, Nausea. Loss of Color Vision. Gray Vision, Spots. Vision Loss. Extreme eye pain around eyes. continued extreme headache.

LEFT EYE DISCOMFORT; RED VEIN ON EYES; TIREDNESS; SENSE OF SMELL WENT AWAY; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's past medical history included cocaine use, marijuana use, abstains from alcohol, and smoker, and concurrent conditions included sleep disorder, high blood pressure, fast heartbeat, problem with urination, and allergy, and other pre-existing medical conditions included unspecified allergy medication a little white pill. 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 29-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced sense of smell went away. On 29-MAR-2021, the subject experienced tiredness. On 31-MAR-2021, the subject experienced left eye discomfort. On 31-MAR-2021, the subject experienced red vein on eyes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sense of smell went away, left eye discomfort, tiredness and red vein on eyes was not reported. This report was non-serious.

Patient was given Janssen vaccine on 05/11/21 at 3:02pm. Patient was asked to be seated for 30 minutes after receiving the vaccine, because he had food allergies. Immediately after administration, patient started complaining he felt dizzy. Pharmacist checked patient's vitals. Pulse was at 46. He was sweating profusely, drowsy, dizzy, not coherent, tingling in right hand, trouble seeing, blacking out. Paramedics were called to the scene by pharmacy technician. Upon arrival, they also checked his blood pressure, pulse, and blood glucose. Patient refused to go to hospital and signed a form provided by EMS. Before leaving, patient was alert and able to walk and carry a conversation on his own.

The Patient developed Optic Neuritis (headache, loss of vision and color vision in both eyes). He was ultimately diagnosed with Myelin Oligodendrocyte Glycoprotein Antibody Disease and will be treated either with IV IgG or Rituximab.

After receiving Janssen vaccine, I experienced feelings of fatigue, ringing in ears, blurry vision, migraine type headaches. I had not suffered from any of these symptoms prior to the vaccine. On 6/2/21, I was feeling similar symptoms, and particularly a severe headache and some fatigue. I was driving to the gym, to see if perhaps, doing a little walking or exercising may make me feel better, when I experienced a seizure while driving, lost control of vehicle and ended up, off the road and hit a tree, I do not remember anything from the crash. I awoke in an ambulance, and was taken by helicopter to Hospital. I received emergency care and was admitted to the hospital.

Event: (Symptoms) Eye swelling - Left eye, Discomfort in eye Treatment: Eye drops - Prednisolone Acetate SUS 1% Treatment Duration: 1 week

Male patient reported dryness in the lips, blurry vision, and hot flash in the neck. In that moment head of staff are notified and paramedic attended the situation. Vital was perform; HR 52, BP 100/60, SO2% 95. Patient was sweeting and was reclined in the floor we legs lifted. After works patient was observed by the paramedic and head nurse. Patient was alert, oriented and responding to questions. Final Vital sing; BP 120/70, SO2% 96, and was transfer to observation area with 30 minutes.

Within two weeks of vaccination: energy level down, muscle ache, diarrhea, congestion, extra gas (intestinal). Ongoing: extra gas (intestinal); cold flashes that course quickly through body; tingling in arms, hands (like a buzz or very fine pins and needles); irritability; itchiness (upper body, face and head); numbness on front of tongue; stiff finger joints; brain fog; quick onset of fatigue; sudden faint feeling; feeling of weakness in muscles; bruise on right upper arm which remained for a couple weeks; apparent reduced allergen/pollen resistance. Also, it seems I may now be having novel allergic reactions to peanuts. I had long consumed peanuts and peanut butter without incident before taking the vaccine.

Tinnitus. Started mid-day 8 days after shot. First right ear, then left ear as well. Still present four days later. Can not tell if it is getting better or worse but it is difficult for me to detect quiet sounds and I need to greatly increase the TV / Computer volume to be able to clearly understand speech.

migraines, vision issues within 12 hrs. On 4-29 I had a TIA (complete loss of right side and couldnt speak for 10 min). I went to hospital and had CT, ekg, blood work, all were ok. Cardiologist determined I did have a TIA and after an Echocardiogram discovered a Patent Ovale Foramen (hole in heart) and recommended immediate closure. Surgeon also said to get the procedure but as of now my insurance has not approved payment. I have been having numbness and pain in hands and feet (mostly left side) along with vision issues, dizzyness, problem finding words and concentration, fatigue. I went to Hospital again on 6-27 due to pain and numbness in left hand and foot and doctor said he could admit me but I did'nt stay. I have gone from a healthy person who is very active to someone who is always tired and is constantly worried about having another TIA.

Acute back pain leading to numbness in both legs causing paralysis in both legs, facial paralysis, blurred and double vision, trouble urinating and having bowel movements. Has been diagnosed with GBS/ Miller-fisher disease.

CELIAC DISEASE; COLD SWEATS; TROUBLE WALKING DOWN STEPS; TINGLING TIP OF LEFT HAND; HOT FLASHES; TIP OF TONGUE SWEAT; FEET SWEATING; SHIVERS; OVERALL BODY NOT FEELING WELL; SUDDEN HIGH BLOOD PRESSURE; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use (stopped drinking), and nonsmoker, and other pre-existing medical conditions included the patient had no known drug allergies and had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 21-JUN-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 17-JUL-2021, the patient experienced cold sweats, trouble walking down steps, tingling tip of left hand, hot flashes, tip of tongue sweat, feet sweating, shivers, overall body not feeling well and sudden high blood pressure. On 19-JUL-2021 the patient was concerned about sudden high blood pressure and was admitted to the emergency room, the patient undergone stress test and was given lorazepam and was diagnosed with celiac disease. The patient was hospitalized for 1 day and was discharged on 20-JUL-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cold sweats, shivers, trouble walking down steps, tingling tip of left hand, hot flashes, tip of tongue sweat, feet sweating, overall body not feeling well, and sudden high blood pressure, and the outcome of celiac disease was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210745177-COVID-19 VACCINE AD26.COV2.S-sudden high blood pressure, celiac disease, cold sweats, trouble walking down steps, tingling tip of left hand, hot flashes, tip of tongue sweat, feet sweating. 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). 20210745177-COVID-19 VACCINE AD26.COV2.S-shivers, overall body not feeling well. This event(s) is labeled per RSI and is therefore considered potentially related.

5/8/2021 buzz /dizzyness 2:30-7Pm. no fever,no aches. 5/21/2021 woke with body aches and slight fever 99. tylenol . 5/22/2021 slight fever 99 , no body aches . no tylenol 5/23/2021 fever 101, body aches . tylenol 2 tab every 6 hrs 5/24/2021 fever 102.5 no body aches tylenol 2 tab every 6hrs 5/24/2021 PCR test 5/25/2021 fever 101, no body aches , tyelnol 2 tab every 6hrs. started coughingduring day 5/25/2021 received results .negative pcr 5/26/2021 fever 102, coughing went to emergency dept

March 17 at 6pm - Experienced chills and fatigue. March 17, during the evening - experienced pain in left arm, right arm, nausea, chills, hot flashes, restless feeling, unable to get comfortable to get to sleep. Woke up several times during the night. Woke up, took up to 4 Tylenol, still could not sleep. March 18 - Woke up - Fatigued, dry mouth, and in a fog. All I wanted to do was sleep. This is what I ended up doing most of the day. By the end of the day, felt a little better. March 19th - Feeling a little better, but still weak, but still somewhat dizzy. March 20th - Same as the 19th. March 21st - Finally feel 80 - 100% better.

swolling on face. Mild Facial Swelling, decreased sensation and pressure behind eyes x 2 weeks. Pt states he received J&J vaccine on 10MAR21 and developed symptoms next day; swelling has since decreased but decreased sensation and pressure remains. Decreased sensation to bil cheeks; airway intact; Pupils PEERL Bil; NAD; steady and balanced gait.

I?m hearing a droning noise that isn?t there. It?s not a ringing or buzzing and definitely doesn?t seem to be coming from inside my head but it is. The noise is constant and most noticeable when I?m sitting or trying to sleep. Hoping it goes away but just thought I should report it

A few minutes after receiving the vaccine he felt like he was going to pass out. He became pale and diaphoretic, c/o having tunnel vision. He did not loose consciousness.

Experienced same typical symptoms such as fatigue and nausea for two days only after getting the vaccine. But also had an adverse reaction to my left eye for week where it became inflamed and very bloodshot red. Eye continued to swell and drain fluids and was extremely soar and painful with blurred vision. Made appointment at my family physicians office on 4/13/2021 where doctor subscribed drops to be administered 3X daily. This is where I am now.

Severe Nausea, burning eyes, dizziness, headache, body ache, diarrhea, fatigue. I took my husband to ER on day 5. He was given nausea meds, eye drops and anti- diarrhea meds. I also treated him with an Aleve/Tylenol regimen.

I started with rashes (red) on both ankles. then near arm pits. They I started with very itchy eyes which turned to Pink Eye. Addtionally I got very congested, trouble breathing, phelm production. Tired or fatigued. Got back enough and went to the doctor and receive a steroid shot, and eye drops. I am still have issues still.

NUMB CHEEK; WARM LEFT EAR; RED LEFT EAR; SENSATION OF TINGLE ON LEFT SIDE OF THE FACE; LEFT EAR SWOLLEN; FACIAL MUSCLE SWOLLEN; PAIN AT THE INJECTION SITE; This spontaneous report received from a patient concerned a 51 year old male. The patient's weight was 220 pounds, and height was 187.96 centimeters. The patient's concurrent conditions included penicillin allergy, allergic reaction to bee stings, insect bites allergy, alcoholic, and non-smoker, and other pre-existing medical conditions included none and did not had any drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: 25-MAY-2021) dose was not reported, administered on 06-MAR-2021 13:42 for prophylactic vaccination. Concomitant medications included esomeprazole magnesium for acid reflux. On 06-MAR-2021, the subject experienced numb cheek. On 06-MAR-2021, the subject experienced warm left ear. On 06-MAR-2021, the subject experienced red left ear. On 06-MAR-2021, the subject experienced sensation of tingle on left side of the face. On 06-MAR-2021, the subject experienced left ear swollen. On 06-MAR-2021, the subject experienced facial muscle swollen. On 06-MAR-2021, the subject experienced pain at the injection site. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from left ear swollen, and facial muscle swollen, and had not recovered from numb cheek, warm left ear, pain at the injection site, red left ear, and sensation of tingle on left side of the face. This report was non-serious.

dizzy,nausea. Pt received the J&J vaccine on Saturday. Pt had HA and body aches on Sunday. On Monday, pt has severe HA and ringing in his ears and has not gone away. 51 yo M w/ no known chronic medical conditions, J&J vaccine on Friday, presents w/ dizziness (room-spinning) that started this AM and has since resolved. Initially started when he sat up from bed after waking up; a/w moderate nausea (no vomiting). Pt went back to sleep, no sx when he woke up, but sx re-started when he stood up. Since then, dizziness has resolved. Pt has residual nausea, but currently no dizziness. He also reports constant ringing in his ears since this AM, w/ no associated muffled hearing, ear pain, ear discharge. Initially had fevers/

The day of the shot my lips and tongue were numb until the next morning. The next couple of weeks my tongue would go numb often. I was also feeling tired and unsteady. 12 days after the shot I became very sick for 10 days with severe diarrhea, no energy, stomach pains, weak, shaking, no more motivation. I saw a doctor and was given antibiotics to stop the diarrhea. Now 1 month after I have no diarrhea but still get nausea and shakes . I feel very anxious and will see a therapist and prescribe medication for my anxiety that I have due to the vaccine reaction. I took the vaccine so I can travel abroad much easier but now afraid to travel because of my symptoms. I will get blood tested tomorrow to see if all is ok. This vaccine is very dangerous as it has affected my DNA.

DIARRHEA; INJECTION SITE REACTION; EYE PAIN; TEETH PAIN; CHILLS; TIREDNESS; HEADACHE; GENERALISED ACHING; This spontaneous report received from a patient concerned a 51 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A and expiry: 23-JUN-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced generalised aching. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced tiredness. On 09-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced eye pain. On 10-APR-2021, the subject experienced teeth pain. On 14-APR-2021, the subject experienced injection site reaction. On 14-APR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from generalised aching, and chills on 11-APR-2021, was recovering from tiredness, had not recovered from headache, injection site reaction, eye pain, and teeth pain, and the outcome of diarrhea was not reported. This report was non-serious.

BOTH EYES HAVING PRESSURE-TYPE PAIN, NOW LOCALIZED TO LEFT EYE; HEADACHE; INJECTION SITE PAIN SPREAD IN LEFT ARM; BODY ACHES; CHILLS; This spontaneous report received from a consumer concerned a 51 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes ii, insomnia, neuropathy, tinnitus, vertigo, acne, chronic back pain (bulging discs), seasonal nut allergies, anxiety, smoker, non alcohol user, depression, hearing loss, and cholesterol.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 08-APR-2021 12:00 for prophylactic vaccination. Concomitant medications included atorvastatin for cholesterol, bupropion, lamotrigine, metformin hydrochloride, montelukast, and sertraline. On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced chills. On 08-APR-2021 12:00, the subject experienced injection site pain spread in left arm. On 08-APR-2021 15:00, the subject experienced headache. On 09-APR-2021, the subject experienced both eyes having pressure-type pain, now localized to left eye. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site pain spread in left arm, body aches, chills, headache, and both eyes having pressure-type pain, now localized to left eye. This report was non-serious.

Having lunch on 04/29/21, around 11:30 am. Talking with co-worker started noticing by vision went blurry. My hands & feet started tingling. I turned very pale in facial color. Had co worker call 911, paramedics to me to ER. All my vitals showed normal, ekg, blood work, platlet count all good !! Went home and over next few days felt a little off, made regular doctor appt. follow up. Doctor said all my vitals look normal. Not sure what the cause is, had a ultra sound done of my left leg pain also. Showed no blood clots. Waiting for a heart monitor appt. On 05/03/21 woke up at 3 am drenched in sweat. Still feel a little off, for no reason . At times I feel like I might pass out. Had epilepsy as a you child. But out grew with medications. No seizures in 40 years.

progressive skin tingling, back pain, neck pain First noted a problem 2- 2 ½ wks ago : tingling; touching cool surfaces would feel wet Mostly his legs at first: Tingling just in the spots where he would contact states he developed some back pain behind the lungs that he noted when he moved in a certain way would ? twisting side to side or standing up Couple days ago noted tingling was constant down the arms and legs and around the mouth: numbness around the lips like tingly cool sensation; as would feel with Novocaine Pain down the L side of his neck, mostly at night Now feels the pressure behind the muscles behind the lungs - feels it with deep breath or moving 5/22 a.m.when brushing his teeth, gargling couldn?t hold his lips together If tries to, only the R side puckers, weak on the L upper lip (in that area has less tingling) - denies any other weakness diffuse headache that he ranked as a 2 or 3

bottom lip and chin have gone numb on my left side(same side as the shot), like the effects of Novacaine. Started the day after vaccination and still numb 2 weeks later.

That evening after the injection I hot very sick...flu like symptoms w/ temperature of 102 - 104 degrees. Symptoms started to fade after a few days. About a day or two after the injection I experienced extreme fatigue, Severe Sinus infection along with Tinnitus. Worst I have ever experienced. I have been put on anibiotics starting the evening of 06/01/2021 and am scheduled to see an E.N.T. doctor at the end of June 2021.

No taste Muscle pains over the entire body Sore Throat Constant Cough Weak & Extremely Fatigued Nausea - throw up after eating Started within 7-8 hours of receiving the vaccine Took 2 Tylenol Felt better by the third day (Monday) - nausea has persisted and throat remains a bit sore and still cannot taste food

Tinnitus came on loud 30 days after shot. The tinnitus is bilateral non pulsation. No findings for the cause after several tests.

Light headedness, Muddy thinking Ringing ears Difficulty concentrating Sleep disruption Depression Irritability General feeling of being unwell

5min following administration of vaccine, pt c/o itching/tingling around mouth. Benadryl was administered. Pt remained onsite for additional 20min w/o complaints. next day phoned pt for f/u, pt states he remained w/o itching/tingling, however pt states he developed a temp of 101.9 this a.m. and has been managed with Tylenol.

Initial symptoms began with pain at the injection site and generalized fatigue. This developed into soft tissue pain in proximity of the large and small joints which could be elicited further on palpation. I had eye pain (left more severe than the right) which could be further elicited on palpation, headache, dizziness, chills, and an inability to feel warm. There was also significant skin sensitivity over the trunk, scalp, and upper extremities and more in the left arm than the right. The symptoms persisted over the second day albeit at less severity. Presently on the third day, I am experiencing continued eye pain, mainly in the left eye and mild dizziness.

Patient complaining of severe headache, chills, body aches, sore throat, running nose, cough, nausea and vomiting and watery, itchy, burning eyes

Patient began feeling arm tingling, throat tingling, and had redness to arm and chest. Patient denies shortness of breath but has a severe history of allergic reactions that he did not communicate to provider prior to vaccine administration.

This spontaneous report received from a patient concerned a 52 year old male. The patient's height, and weight were not reported. The patient's past medical history included marjuana, and concurrent conditions included allergy to skunks, non alcohol user, and non smoker.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: not reported) dose was not reported, administered on 02-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced flush. On 02-APR-2021, the subject experienced ringing in ears. On 02-APR-2021, the subject experienced sweating to feet. On 02-APR-2021, the subject experienced sore arm/aching to legs. On 02-APR-2021, the subject experienced headache. On 03-APR-2021, the subject experienced aching to back. On 03-APR-2021, the subject experienced morning wood. On 03-APR-2021, the subject experienced increased appetite. On 03-APR-2021, the subject experienced aching to neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flush, and headache on 02-APR-2021, ringing in ears, and aching to back, and sweating to feet on 04-APR-2021, was recovering from sore arm/aching to legs, had not recovered from increased appetite, and morning wood, and the outcome of aching to neck was not reported. This report was non-serious.

Very shortly after my injection on 3/7/21 (within 1-3 days after injection is when I first noticed) I have had a high pitch, steady (not pulsating) ringing in my head. It doesn't seem to favor either ear, just the sound is consistent in my head. It has not gone away, it is every day - all day.

BODY ACHES; SORE THROAT; RUNNING NOSE; COUGH; VOMITING; WATERY EYES; ITCHY EYES; BURNING EYES; CHILLS; NAUSEA; SEVERE HEADACHE; This spontaneous report received from a health care professional concerned a 52 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroidism, diabetes, hypertension, gastroesophageal reflux diseases, hyperlipidemia, seasonal allergies, and bph, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 06-APR-2021 08:15 to left arm for prophylactic vaccination. Concomitant medications included atorvastatin, carvedilol, fluticasone, levothyroxine, losartan, metformin, and omeprazole. On 06-APR-2021, the subject experienced body aches. On 06-APR-2021, the subject experienced sore throat. On 06-APR-2021, the subject experienced running nose. On 06-APR-2021, the subject experienced cough. On 06-APR-2021, the subject experienced vomiting. On 06-APR-2021, the subject experienced watery eyes. On 06-APR-2021, the subject experienced itchy eyes. On 06-APR-2021, the subject experienced burning eyes. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced nausea. On 06-APR-2021, the subject experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache, chills, body aches, sore throat, running nose, cough, nausea, vomiting, watery eyes, itchy eyes, and burning eyes. This report was non-serious.

I experienced two days later bad earaches for some hours. I also had SOB. Today, I am applying ear drops in my ear due to my ear aches.

Per pt report: Pt started having body aches within a couple hours of vaccine, developed severe 9/10 pain over the next several days. L shoulder pain radiating to ribs and neck w/ muscle spasms, causing HA, R hip and sacral pain, flank pain radiating down R leg. Pt reports that vision in L eye is blurry, R eye vision intact, numbness to L arm and hand, able to move. Pt reports 1in x 0.5 in blood clot when blowing nose Thursday morning, small clot subsequently about 1/2 the size, smaller clots later.

SWEATY; BODY ACHES; EXTREMELY THIRSTY; LEFT ARM PAIN/LEGS BURNING; LEFT ARM NUMBNESS; HEADACHE; FATIGUE; LUNG PAIN; LUNG WEIGHT/PINCH IN THE HEART/CHEST DISCOMFORT; This spontaneous report received from a patient concerned a 52 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced lung pain. On 24-MAR-2021, the subject experienced lung weight/pinch in the heart/chest discomfort. On 24-MAR-2021, the subject experienced body aches. On 24-MAR-2021, the subject experienced extremely thirsty. On 24-MAR-2021, the subject experienced left arm pain/legs burning. On 24-MAR-2021, the subject experienced left arm numbness. On 24-MAR-2021, the subject experienced headache. On 24-MAR-2021, the subject experienced fatigue. On 25-MAR-2021, the subject experienced sweaty. Treatment medications (dates unspecified) included: acetylsalicylic acid, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lung pain, lung weight/pinch in the heart/chest discomfort, headache, fatigue, sweaty, body aches, extremely thirsty, left arm pain/legs burning, and left arm numbness. This report was non-serious.

Client reported tingling of the tongue. Denies any other symptoms. HR 64, B/P 140/82, RR 12. Client waited for another 30 minutes with no new symptoms. Instructed him to call 911 or go to ER if new or worsening symptoms develop.

Metallic taste right after injection. Two days later I had joint pain, headache with congestion and more use of my asthma inhaler. These are still on-going as well as tightness through the chest and shoulders. Some coughing.

Three days after receiving the vaccine, he developed a headache which was intermittent with pain score of 5-8 out of 10. Headache became consistent around 4/11/21. Pain is in the occipital region and occasionally radiates behind the eyes. Also complains of dizziness, nausea, vomiting, and tingling in his hands bilaterally - worse in the mornings and goes away after waking up. He presented to Medical Center on 4/28/21 and transferred to Medical Center for treatment of vaccine induced thrombocytopenia and nonocclusive straight sinus thrombus. He was started on bivalirudin infusion 4/29 @ 0142 via continuous infusion. Still receiving treatment at the time of this report.

SEVERE BODY ACHES ON LEFT SIDE; MUSCLE SPASMS ON LEFT SIDE LEG EYE ARM AND CRAMPING ON RIGHT SIDE; PRESSURE BEHIND LEFT EYE; CRAMPING AND RIB PAIN ON RIGHT SIDE; This spontaneous report received from a patient via a company representative concerned a 52 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no underline health problems. The patient received covid-19 vaccine (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 2021, the subject experienced pressure behind left eye. On 2021, the subject experienced cramping and rib pain on right side. On 30-APR-2021, the subject experienced severe body aches on left side. On 30-APR-2021, the subject experienced muscle spasms on left side leg eye arm and cramping on right side. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from severe body aches on left side, muscle spasms on left side leg eye arm and cramping on right side, pressure behind left eye, and cramping and rib pain on right side. This report was non-serious.

Pt had "tingling" on his throat. Bilateral rash on arms. Elevated B/P 170's. Nausea and vomiting Pt was given 25mg Benadryl. Pts b/p lowered. Nausea and vomiting resolved.

Patient became dizzy after receiving vaccine and at the five minute mark, patient became unresponsive. His eyes rolled back in his head but stayed open. His jaw became very clinched. He was sweating profusely and not aware of anything goin g on around him. This lasted somewhere between 3-5 minutes.

1st day of vaccine; I felt very tired and fatigued and my joints started to hurt and I could not walk due to the pain in my joints. 3rd and 4th day of vaccine; I started to experience numbness sensation to my hands. I also had numbness sensation to my face, right side and lips and also to my head. I went to Urgent Care where lab work was performed as well as a CT scan of the head to check for blood clots and results came back normal. Also an U/S of the right leg to check for any blood clots was performed which came back normal. I then went to see my PCP who performed more tests and exams, again did lab work to check for blood coagulation and still continued with the numbness sensation to my hands and all to my body. After about 10 days of my vaccine, I noticed that my oxygen level was 87, 96, 86, 92 and where my oxygen level has always been around 98 or 99. I will be also having heart studies in a few weeks. I have not recovered from my symptoms and feel very fatigued and tired all the days.

Tinnitus in left ear started the Monday after the vaccination, I have also had what I can only describe as "fuzzy brain" indicated by a difficulty concentrating on complex projects. I have also been experience intermittent headaches and pressure in my head. My left eye started watering and feeling irritated.

Customer did not feel right within 7-10 mins after receving the Janssen vaccine. He complained of vision changes, "seeing dots". When he tried to walk, his legs buckled, but customer was slowly assisted to the floor. While on the floor, my technician heard grunting noises coming from him and his left arm was rigid and bent at the elbow. But within 5-10 seconds, he slowly sat up and said that he "doesn't remember being on the fall" and complained of being sweaty and "seeing dots". Paramedics were contacted and took him the hospital. Contacted the customer later in the evening and was informed that he was resting at home after spending half of the day in the hospital. He mentioned that the paramedics treated him with Epipen and bendadryl and then he felt better. He was treated "other things" but don't recall.

2 weeks from the day of the vaccination, 04/16/2021, I had heavy ringing in my ears, started feeling vertigo, nausea, dizziness and lightheadedness and just started persisting on ever since. At least 2 weeks after that, I was trying to wait it out, but it persisted on and I made a tele-doc appointment. The tele-doc prescribed me Prednisone. The tele-doc felt it might go away but set me up with an ENT. A week after that I saw the ENT. The ENT did a hearing test but didn't find anything. I am still having the Nausea and ear ringing, they are the 2 most persisting symptoms. I feel it's pretty detrimental to my quantity of life. I just try to keep going and tolerate the symptoms as much as possible.

Within 5 minutes of receiving vaccine, patient was seeing spots and passed out. 911 was called and patient was treated by EMTs. Epi-Pen and two shots of Benadryl were administered and patient was transported via EMTs to ER for further medical treatment and monitoring.

Within an hour to two after my vaccine I felt extremely exhausted. The next day (Thursday), I couldn't read anything. For the whole weekend I could not read anything. Not blurry vision, just could not read. Also on Thursday, I started to not be able to concentrate. To this day I still have trouble concentrating. I also experience dizziness after my vaccine. For the next two weeks I have had bad bout's of just feeling swimmy and weird. It has made me stay close to bed. I have been unable to do projects, I have had multiple migraines. For treatment, I have taken muscle relaxers and my migraine medicine as needed. I am going to see Dr. on 07/14/2021. I did see a doctor during a health fair on 07/09/2021 who recommended I see my doctor as soon as possible.

Started to notice facial droop left side of face about 2 weeks after receiving the Johnson & Johnson (Janssen) Covid 19 vaccine. Started behind the ear and worked to the front of his face. Included eye and nostril. Couldn't chew food on that side of mouth. It has been painful, but the pain and the drooping have gotten better. Did not seek out any medical treatment as he felt nothing could be done.

cough, malaise and fatigue. He states that he started to have symptoms about 3 days ago with chills, subjective fevers, cough, anosmia. He also had some chest pain that he states was left sided/substernal and felt like squeezing/heavy pain. It started yesterday morning and comes and goes. He has some SOB and he also has had a very poor oral intake.

4 pm severe headache (left temple until 10pm. At 10pm lost hearing in both ears for 15 minutes followed by 0-5% hearing with tinnitus for 24 hours. Fever starting at 9 am next day until 11pm that night.

5 minutes after injection developed metallic taste in mouth follwed by limited ability to taste starting to resolve 4/4/21.

Lightheaded about 5 minutes after injection. Medical team took HR and BP and was normal Took about 20 minutes and light headedness went away Later that night at around 12:30 am, felt very cold and shivering with severe headache Did not take temperature Had a hard time going back to sleep Got up around 1:00 am to take 800 mg of OTC Advil When walking back up stairs had severe muscle pain in arms and legs Was fine after that Seemed to get better by 2 am No issues next day About 7-10 days later developed severe frontal headaches/sinus pressure No other symptoms Used Neti Pot with saline solution and did nothing Took OTC allergy meds and Advil and did nothing Say my primary care Dr and he prescribed Flonase, Singular and Allegra + continue Neti Pot and Advil as needed Not much improvement on this regime after 3-5 days of use About a week later developed severe pain in bottom right jaw Took OTC Advil and again no improvement Went to Dentist and said not tooth related but probably TMJD Recommend dental appliance to help with grinding About a few days later after this jaw pain developed, developed sharp stabbing pain in bottom of left knee cap. No recollection of any insult that would cause this All three of these pain sites were perfectly fine prior to getting J&J vaccine. No history of pain or injury to these areas prior All of these incidents to me seem to be inflammatory/immune in nature and could be related to J&J vaccine based upon how I reacted to injection. Curious if others are seeing the same thing and if so what should be done or how long should this last?

Within 5 minutes of receiving vaccine, I developed a sharp chemical taste in my mouth. This lasted for 1 - 1.5 hours. Approx. 0300 on 19 Mar, I developed a 100f fever, with severe headache and chills. Fever and chills persisted until 20 Mar 2021 at approx 1530. Headache continued until 22 Mar 2021. It did diminish in severity after 20 Mar though, dropping from a 7 (on the 1-10 pain scale) to a 3.

Patient received vaccine approx 5-10 minutes patient fainted in his chair. A cardiac nurse was waiting to receive their vaccine and rushed over to help too. Patient began to convulse. We tried to get patient to respond approx 2 min later patient woke up and complained about being thirsty. We gave him Apple juice and placed a cold pack on his neck. Called 911, We took BP it was 77/49 pulse 45, we laid patient down and retook BP 123/73 Pulse 68. After 5 more min BP 135/85 pulse 72. EMS arrived and took patient away

Patient reported severe headache and eye ache on left side, normal blood pressure, left arm okay with no swelling

about 3 hours after injection i noticed i was flushed neck ears face, about 5 to 6 hours my ears started ringing, trouble sleeping legs pricing over night., 2 degrees elevated temperature from normal. this lasted for almost exactly 24 hours. my leg pain is in the same location as a severe blue of shingles i had two years ago. it is now 96 hours after injection and my legs are still tingling and occasionally feel prickly and painful. this is manifesting into right toes. there is an odd numbness to my right thigh. i was worried somehow i might have triggered another shingles type outbreak.

Patient was scheduled for an appointment for a Johnson &Johnson covid-19 vaccine through a drive thru Thursday April 8, 2021 @12:45pm. We arrived early and he received the vaccine at 12:15pm, waited 30 minutes for reaction and he was feeling fine. Later that same evening, the patient was driving to work on the freeway when he felt a dry throat so he coughed hard, at that cough he felt a massive pain in his head, like his "head was going to explode." He immediately had tunnel vision closing in on him, so he pulled over and later woke up in our parked car with flashing emergency lights on, parked on the shoulder of the freeway. Disoriented and confused why he was there, he looked at his watch and saw he lost 15 minutes when he had passed out. MY HUSBAND COULD HAVE BEEN SERIOUSLY INJURED OR KILLED IF HE HAD NOT PULLED HIMSELF OVER WHEN PASSING OUT. Today we reported this to our doctors office and to you!

Patient felt fine first week after vaccine. On the second week, developed itching to arms and legs. On the third week, developed swelling to upper and/or lower lips that happened off and on 4 times. Self treated with Benadryl. Patient thought might be related to vaccine.

Lost vision in left eye on Thursday evening (03/11/2021) around 7:00 pm. My condition was not improved when I awoke the next morning (03/12/2021).

Lost his vaccine card would not give him a new one. He got his vaccine, had burning sensation immediately after the needle was pulled out. About 5-10 minutes later he started sweating, and seemed to have calmed down and felt OK. He was observed for 30 minutes there and went for observation for another 30 minutes. He went to another doctors office and at about 15:00 started feeling light headed and weak. He drove back home, picked up some stuff at a grocery store, and outside the grocery store in 80 degree heat he felt the need to put on a jacket as he had the chills. he went home, went to bed feeling bad, his shoulder was still burning where he got hte vaccin.e He had a little bit of site pain, applied topical and the pain went away. He woke up the next morning feeling really bad, felt like a major flu, his head felt like it was going to explode, but no problem with sinuses, no cough, no sneezing. His eyes were watering from the pain, and chills on and off. He had to change his sheets a couple of times due to sweating. He then developed a fever of 99 degrees at about 18:00 that night, and about 19:00 he went to 102 when he checked it. After that it went to 103, and about 15 minutes after that it was 104, and then higher at 104.+. He took some vodka, honey and lemon juice and took an alcohol bath and the fever had not broken yet. He called the clinic and they told him to call 9-1- 1 and to go to the ER. He went to the ER at about 10:00, gave him fluids, did a chest x-ray and released him about midnight. He apparently disoriented and tried to walk off and didn't remember this. They took him back to the gate and called his son. He went home, took another bath and woke up in sweat and was in bed for the entire weekend. He got up Monday morning, 4/13/21 feeling a little bit better and went to see his doctor, who does not believe he was having any side effects and that the information that is being reported is true. He is still feeling a little weak and still fatigued and on bedrest. He was taking Advil besides his regular medicines every 6 hours with 500 mg of Tylenol for the intense pain as every joint in his body ached, and the worst headache he had ever had, as well as the high fevers. His fever subsided on Saturday morning, and still had some sweats following that. Did have hot/cold flashes on Saturday and Sunday. He was given a COVID test in the ER and he was negative, but did not give him any other information regarding his lab work.

Very bad headache that started on Monday night... progressed all day on Tuesday. I started feeling better when I woke up on Wednesday. The pain was in the left temple. It was also hurt to touch it. My face and teeth also felt some pain. On Wednesday morning, the headache started to go away but I could still feel it very slightly

Day 15 after covid vaccine I woke up at 12:30am with extreme vertigo and nausea. It woke me up with violent spinning. I could not focus my eyes at all. I felt very ill. I almost threw up multiple times during the day and could not move my head up or down and to the left without spinning out of control. I saw the ENT later that day and he performed the Epley Maneuver on me. I followed his directions for home care but am currently still experiencing vertigo. The doctor told me it should dissipate within one week. It has not. I have never had vertigo in the past.

PRESSURE IN THE HEAD; SORENESS ALL OVER/PAIN; NO TASTE; NO APPETITE; FEVER; BAD HEADACHE; This spontaneous report received from a patient concerned a 53 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced bad headache. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced pressure in the head. On 10-APR-2021, the subject experienced soreness all over/pain. On 10-APR-2021, the subject experienced no taste. On 10-APR-2021, the subject experienced no appetite. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bad headache, fever, pressure in the head, soreness all over/pain, no taste, and no appetite. This report was non-serious.

starting 4/8/21 headage, feeling slighly ill starting 4/9/21 pain in right ear tragus during whole day on 4/10/21 in the afternoon: strong vertigo lasting about one minute, no longer pain in ear that day

SORE THROAT; SORE ENTIRE UPPER BACK; RIGHT SHOULDER SORE; HEADACHE; SORE NECK; LEFT SHOULDER INJECTION SITE PAIN; ROOF OF MOUTH TENDER; EAR ACHE; RIGHT KNEE AND SHIN BONE PAIN; SORENESS FROM LEFT SIDE TO LEFT WRIST; FLUSHED; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included severe allergies to grass, severe allergies to cat, and severe allergies to bees. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 08:50 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, the subject experienced sore neck. On 08-APR-2021, the subject experienced roof of mouth tender. On 08-APR-2021, the subject experienced ear ache. On 08-APR-2021, the subject experienced right knee and shin bone pain. On 08-APR-2021, the subject experienced soreness from left side to left wrist. On 08-APR-2021, the subject experienced flushed. On 08-APR-2021, the subject experienced left shoulder injection site pain. On 10-APR-2021, the subject experienced sore entire upper back. On 10-APR-2021, the subject experienced sore throat. On 10-APR-2021, the subject experienced right shoulder sore. On 10-APR-2021, the subject experienced headache. Laboratory data on 08-Apr-2021 included: Body temperature (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore neck, sore entire upper back, roof of mouth tender, ear ache, sore throat, and headache on 12-APR-2021, and flushed on 08-APR-2021, and had not recovered from right knee and shin bone pain, left shoulder injection site pain, right shoulder sore, and soreness from left side to left wrist. This report was non-serious.

Patient describes right side of face became red/purplish and swollen roughly 3 days after vaccine. Symptoms were accompanied by sinus pressure on right side of face. Eye was also red and mildly itchy. Facial symptoms were accompanied by arm pain and tenderness. Symptoms resolved after roughly 3 days

about 8 am the day after shot, left eye had blurry periphery vision for about 15 minutes, slight headache in right hemisphere for about 15 minutes afterwards. blood pressure during this time was about 160/90 taken by nurse at work. Symptoms went away about 8:30 am

facial swelling, facial drooping, complaints of left ear pain Emergency department visit diagnosed with Bell's palsy treated with valtrex prednisone

Massive ringing and tinnitus in both ears within 8 hours of receiving the vaccine. Constant loud ringing in ears is ongoing, it has not gotten any better since the shot. Initially got fever (100.5) and chills and muscle aches and ringing in ears, the fever/chills/aches have resolved after 3 days, but the ringing in both ears is still present and loud.

That evening - 04:30 pm, I started feeling body aches and pains and fatigue. The aches getting worse in the night. Felt feverish but didn't have a fever overnight. The next day the same - general aches and pains and fatigue. Early afternoon, I took Tylenol and at night time I had headache and I took Tylenol again that evening (about 11:00P). Next morning, just fatigue - no more aches. Site of vaccination was more sore than initially. I had a sort of sinus headache - left side of face and head. My wife noticed I had bags under my eyes - very odd bags under eyes. I took Sudafed. Inside of my left nostril was aching. Tuesday morning, the bags weren't there but I got bad acne on the same nostril - my left nostril. It was like - I was worried that the acne was cystic (very deep - through the nose). I haven't gotten acne in a long time. I had the sinus headache and acne which lasted two to three days. I tried nasal saline - on that Wednesday and Thursday. The acne lasted into the next week - subsided beginning on the 12th or 13th. The bagginess in eyes had been gone by end of the 5th. Headaches didn't persist after the 7th or 8th or so. Had trouble getting a doctor appt because they didn't know what doctor to send me to.

BLURRED VISION TO RIGHT EYE; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and cigarette smoker, and other pre-existing medical conditions included patient had no known drug allergies and patient did not have 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: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 29-APR-2021 16:00 for prophylactic vaccination. No concomitant medications were reported. On 01-MAY-2021, the subject experienced blurred vision to right eye. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blurred vision to right eye. This report was non-serious.

BLURRED VISION; This spontaneous report received from a physician concerned a 53 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 05-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-MAY-2021, the subject experienced blurred vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blurred vision was not reported. This report was non-serious.; Sender's Comments: Medical assessment comment is not needed as per standard procedure since case is assessed as non-serious.

TINGLING IN LIPS; LIPS GOT WARM; UNEXPECTED THERAPEUTIC BENEFIT; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's past medical history included cold sores. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced unexpected therapeutic benefit. On 08-APR-2021, the subject experienced tingling in lips. On 08-APR-2021, the subject experienced lips got warm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling in lips, and the outcome of lips got warm and unexpected therapeutic benefit was not reported. This report was non-serious.

Posterior vitreous detachment in the left eye resulting in a vitreous hemorrhage. Examination showed bleeding near the optic nerve with no retina damage. Treatment is a follow-up in 3 weeks to monitor the retina and no heavy lifting or gym for 2 weeks. There is a large blood swirl/floater in the left eye.

Left side stroke;severe headache;blindness;treatment was TPA;no significant finds in any test;currently being treated as a cardiac patient

Patient complained of exhaustion and malaise within 24 hours of receiving the dose. This never resolved. Three weeks later he complained of the same exhaustion and malaise. Jaw pain was reported on 5/23/2021. Patient found deceased 5/24/2021 at age of 53.

2 days after applying the vaccine I felt body pain, then a week later I began to have pressure in my chest that reached my throat so I was for a full week the third week I decided to go to the hospital and they discovered that I had blood clots in an artery in my heart. Then they installed 2 stents in my heart 2 days later they sent me home and 1 week later I had to return to the hospital after the studies they detected that I had blood clots in both legs, I had no problem before the vaccine and I'm almost 100 percent sure this is what caused these problems.

Adverse Events: Tinnitus, Veritgo, Nausea 36 hours post injection there was a significant increase in volume of bilateral tinnitus which has been constant for 40 years with left side being louder and right side occasionally pulsating. Vertigo and nausea also set in 24x7 for the first week before reducing somewhat. Now 3 weeks post injection my tinnitus has increased from what was a volume of 4 out of 10 for 40 years to a solid 7/10. The vertigo is present although not triggering nausea until I am lying on my back looking up in activities such as lying back to read a book, work under a car, read a phone/Kindle device. The increased tinnitus volume has made falling asleep in a quiet room or focusing on my work where I wear a headset for virtual meetings extremely difficult at times.

I took aspirin, tylenol and I ate soup, took 2 days off from work to rest. Vision got blurry Upset stomach Left arm in pain Ever since I took the shot I've been tired.

I experienced diarrhea and headaches on the third day. I also experienced cold sweats and I also had a bad taste in my mouth approximately 3 days.

Inflammatory storm, crested at 7 weeks post; affected all joints, incl healthy ones. Daily fever by at least afternoon for 7 weeks. New demyelination w inflammation, new vision problems, dysphagia (permanent). Six days post shot, chest pain started, same as post-virally spring 2020. Chest pain, burning sensation ongoing, presumed carditis. Cardiorespiratory performance beginning to lessen further, beyond last year's damage. Day of vaccination, about 1-2 min post injection, strong dizziness, balance problems, identical to past allergic reactions to other injectables, but time limited, only an apparent blood pressure problem - passes in its own, heavy caffeination helps reduce the problem, temporary nuisance only & apparently affected a fair number of folks at the site. Chose not to report that issue at the time, since familiar and not serious, only unpleasant.

Within 5 minutes of receiving vaccine I started to get a metallic taste in my mouth that has persisted for over 24 hours

Had sudden ?eye? stroke. Neurologist at hospital could not rule out this being an adverse affect from vaccine since there were no underlying health issues or past history of any health issues. Lost 25% vision in right eye due to sudden stroke.

At first warm flu like feeling followed by severe flu like feeling without fever. Ear pressure pain and severe ringing in head. Increase in severe muscle weakness in arms and legs for 3 months plus high blood pressure weakness

Sudden onset of tinnitus 4 weeks after receiving vaccine. This was not a gradual progression. Level of tinnitus is not debilitating but is significant.

Vaccinated at approx 1300 hrs. I began feeling chilled 6 hours later. Chills continued for hours. I developed a significant headache. Also experienced some body aches. Took my temperature via oral thermometer at 10:00 PM and it was 101.5. Went to bed at approx 11:00 PM wearing all my clothes and under a quilt and two wool blankets. Chills continued, but then I also began sweating profusely. I did not rest well and was up approx every hour drinking water and urinating. I noticed an elevated heart rate for several hours through the night. cont'd below

10am vaccine given. No side effects noticed. 630pm developed chills, headaches, ringing in ears, dizzy, eyes fluttering and 102.0 fever. 645pm - Took 3 Tylenol and BP 144/85 HR 83. Bed rest with Gatorade and water. 1100pm - Took 2 Tylenol. Fever reduced to 99.8. Headache and extremely tired. No energy. Bed rest with fluids. 24 hours after vaccination : Fever almost gone, 11am 2 more Tylenol, extremely tired and weak. Low energy. Ringing in ears. Minor headaches. 48 hours after vaccination; No fever, extremely tired and weak. Low energy. Ringing in ears.

Left-sided Bell's Palsy, facial droop, headache syndrome, neck and jaw pain, facial paralysis and numbness, left eye dryness (does not close) Treatment: ketorolac (TORADOL), followed by 10 days predniSONE 20 mg and 5 days valACYclovir 1gram 2 weeks later, still have all symptoms... some improvement with facial droop. Numbness remains, headache neck and jaw pain remain fairly constant... Ibuprofen and Naproxen used for treatment.

Placed follow up call to patient relative on 4/5/2021 at 1:04pm: reported that the patient is feeling much better today. All his ADE has subsided. Patient rcvd Janssen vaccine on 4/3/2021 at 11:15am in Right IM Deltoid, and at approx. at 7pm that same night patient experienced lightheadedness. The next day on 4/4/2021 patient had a fever, chills, rash on back and swelling on the face and lips. Patient relative reported that she gave the patient Mortin last night (4/4/2021) for his fever as recommended and his fever broke this morning. She also reported that she gave the patient Benadryl as recommended, and this helped cleared up the rash last night (4/4/2021). She reported no contact was made to patient's PCP regarding ADE experienced. Advised if she or the patient have additional information to contact the COVID-19 Information Line back.

FELT WORSE WITH BLOCKING OF BOTH EARS AND SOME PRESSURE IN BOTH EARS; FELT WORSE WITH RINGING IN BOTH EARS; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and nonsmoker, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 at around 11:00 on right arm for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced felt worse with blocking of both ears and some pressure in both ears. On 02-APR-2021, the subject experienced felt worse with ringing in both ears. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt worse with blocking of both ears and some pressure in both ears, and felt worse with ringing in both ears. This report was non-serious.

Severe Tinnitus flare up and dizziness started approximately 12 hours after vaccine administered. No tinnitus or dizziness in prior two weeks before receipt of the vaccine on April 8th at 2:00 pm. Dizziness resolved after about 72 hours. Tinnitus still present 24 hours a day, every day. Moderately disruptive to sleep and ability to function.

I really dont know if its connected or not but for the sake of science, Im reporting whats Im experiencing right now. Who knows, this will be useful someday if it will taken in consonant with other experiences. Im experiencing a slight pain in my inner ears and Tinnitus.

I had previously had COVID during the first week of January 2021 and recovered. During that time, I had lost about 80% of my sense of smell which I still have not regained. But at time, I never has any loss of taste. However, immediately after receiving the vaccination I noticed an altered sense of taste. I would describe it as almost all of my sense of taste is gone but actually everything I eat has a rancid taste. Some foods cause the bad taste more than others. Some foods I used to love now bring out the worst after taste such as peanut butter. The more bland the food usually results in less "bad" taste. But overall I can't really taste the actual taste of any food. And to make it worse, before when I couldn?t smell, it was bearable, but now most of the same foods that taste bad also have the same rancid odor I smell also. So to summarize, I now can?t really taste or smell anything except for the rancid taste and odor the food has. It is amazingly challenging as people don?t understand when I describe it to them that almost all food smells and tastes bad since that isn?t just loss of taste. As of today, it has now been over 3 weeks since my vaccination and I don't see any improvement yet. I did recently (about 2 week ago) have full lab work done as part of an annual checkup and all results came back normal. So now I have reduced smell from COVID and loss of taste from the vaccine. I don?t see any other explanation than that the vaccine caused this new phenomenon. It could has something to do with the fact that I previously had COVID. I am hesitant to even go to the doctor since I am certain they will have no idea what to do.

Acute severe headaches and blurred vision after vaccine and acute ischemic stroke with resulting right hemianopsia

Evening after getting vaccination I developed fairly loud tinnitus in both ears. The ringing was loud enough to keep me awake, even though I felt pretty weak and achy from the vaccine. It subsided after about a week but is still present to some extent. I've noticed it off and on before the vaccination, but never so steady or strong. About one month after the vaccine I'd say it's a little worse than before, but not terrible.

4 hours after injection - started experiencing pervasive Tinnitus (ringing in the ears). It has not stopped since that time. I have seen my family doctor - and also had an initial visit with an ENT specialist. Current advice is to limit caffeine - and wait and see if it subsides.

I felt fine immediately after the shot and had no physical pain or discomfort other than mild soreness at the injection site. The next morning I woke up and noticed a loud ringing in both ears. That ringing has not diminished or gone away since then. When surrounded by loud ambient noise I don't notice it unless I concentrate on doing so. Otherwise, it is quite loud and constant.

Severe head ache30+ hrs started 5hrs after injection . abdominal cramping and musscel pain in leg and butt area.sever joint pain in lower back and hips and knees hands and feet.at 5 hrs of injection. Sore throat and inside if ckeeks and swellind of lower lip1 sat after injection. Joint pain in knees and lower back pain was severe and lasted 3 days. Numbness in fingers at 1 day - oresen confysen in thinkinj

At 12-00pm the pharmacist gave patient a J & J Covid Vaccine. He asked him to sit down for 15 minutes. At approximately 12-10PM Patient yelled for assistance. At the time the pharmacist ran over to the chair. Patient siaf that he was going to pass out. His eyes rolled back and it seemed like a seizure, at that point he began to pass out. The pharmacist assisted him to the floor. He was unresponsive on the floor for 10 seconds. After 10 seconds he regained consiouness. He said he felt fine. We called the ambulance. They came 15 minutes later. The pharmacist did his vitals pulse: 60 respirations:16 blood pressure 115/70. At that time the ambulance came and assisted him to the hospital.

Constant bilateral tinnitus of varying degrees of severity from strong to debilitating, with episodes of deafening/muffled, pressure-like sensation in the left ear. During these events of functional loss of hearing in the left ear, the tinnitus is often debilitating, affecting my ability to participate in a conversation, concentrate or even perform common tasks. These episodes last from hours to days. Tylenol 1000mg PO has not remedied the symptoms

Patient has staring to develop a twitching in the left eye followed by pressure and a gritty feeling with redness.

The patient's wife called the pharmacy July 19,2021 to inform of the problem. She reported that her husband was feeling excrutiating generalized pain,weakness,numbness and tingling of arms and legs,speech slurring,weakness of left side of the face causing his left eye to remain opened. She reported that they visited the emergency room and his doctor's office several times but was discharged with no diagnosis.

About 9:00 PM got chills. Finally broke around midnight and after that was hot and achy. Today body aches, head ache, and eyes hurt. This is a similar reaction to what I have with the flu vaccine. I no longer get the flu vaccine because of this.

Around 7:00 P.M. on March 12, 2021 approximately 9 hours after receiving the Jansen COVD-19 vaccine in my left arm. I developed extreme fatigue, muscle aches, skin hurt to the touch of anything including clothing, headache, and fever 101.5. I had to go to bed and was very weak. I took ibuprofen and Tylenol for the discomfort. I slept 14 hours and was able to get up at 11:00 A.M. on March 13, 2021. The soreness at the site of the injection is not problematic. There were other odd symptoms overnight I would awake with strange nerve like sensations tingling and itching that occurred on the bottom of the left foot, upper lip, and neck. I also had several episodes of restlessness that was so bad that I had to stand for a few minutes before being able to lay down again. The worst is the skin hurting and headache. I have also had a few dizzy episodes since getting out of bed this morning. It passes if I sit down or hold onto something. None of these symptoms are normal for me and I cannot remember having a reaction to any vaccinations that I have received in the past. I hope this helps with your study.

Janssen COVID-19 Vaccine EUA Fever of 101.3 for over 24 hrs. Only could control with Tylenol. Once I stopped, fever would spike up. Severe joint pain Headache Severe pain at injection site for 48 hours Burning eyes Uncomfortable urination

Arm is still sore two weeks after shot. I had all the signs of Covid a week after the shot. Taste is still off.

Several hours after injection, the patient began shaking with chills, burning eyes and a fever of 101. This continued most of the night and subsided by 9 AM on 4.1.21. Since then he has continued with regular activities with minor discomfort.

4 days after vaccination, suffered diplopia that resolved, recurred again 7 days after vaccination, lasted 20 minutes and then recurred 8 days after vaccination with associated headache. Patient to emergency department and noted to have orbitopathy with asymmetric swelling of rectus muscles of left eye.

SMELL OF COVID; TASTE WEIRD; HIP PAIN; MUSCLE ACHES; CHILLS; FEVER; BLOOD IN URINE; This spontaneous report received from a patient concerned a 55 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, and hyperlipidemia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 22-MAR-2021 for prophylactic vaccination in right arm. The batch number was not reported and has been requested. No concomitant medications were reported. On JUL-2020, Laboratory data included: COVID-19 antigen test (NR: not provided) POSITIVE. On NOV-2020, Laboratory data included: COVID-19 PCR test (NR: not provided) NEGATIVE. On MAR-2021, the subject experienced blood in urine. On 22-MAR-2021, the subject experienced smell of covid. On 22-MAR-2021, the subject experienced taste weird. On 22-MAR-2021, the subject experienced hip pain. On 22-MAR-2021, the subject experienced muscle aches. On 22-MAR-2021, the subject experienced chills. On 22-MAR-2021, the subject experienced fever. The patient was recovering from fever, muscle aches, smell of covid, taste weird, and hip pain, had not recovered from blood in urine, and the outcome of chills 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.

RINGING ON THE LEFT EAR; This spontaneous report received from a patient concerned a 55 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: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced ringing on the left ear. The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The patient was recovering from ringing on the left ear. This report was non-serious.

After vaccination patient ambulated with steady gait to waiting area to sit recommended 15 min, after sitting in chair in waiting area (1310) reports feeling "hot & dizzy", skin became pale and diaphoretic, eyes rolled back and didn't respond for a few seconds then was able to answer questions, kept complaining of feeling hot & dizzy, and yawning. EMS was called at 1:12 pm and arrived on scene at 1:18 pm. Patient was responsive, sitting BP 58/22, SaO2 96% on room air. Denies shortness of breath or chest pain/discomfort. 1:23 pm BP 98/60, 1:30 pm BP 108/75, 1:26 pm BP= 116/74; alert and oriented x3, speech clear and appropriate, ambulates 50 feet with steady gait/balance. Refused medical care and treatment. Signed refusal form for EMS. Patient's wife, son and parents present with him. Wife reports that he gets worked up about needles especially with blood draws. Patient leaves ambulatory with steady gait in stable condition accompanied by his wife, son and parents. Followed up via phone on 4/8/21 at 12:30 pm, patient reported he is feeling fine with no problems at present time. Reported that approximately 10 min after leaving he had another feeling of being hot for a few seconds then went away after drinking some water then had no other episodes.

Extreme left arm and shoulder neck pain and tightness within a week of shot and has persisted for over a month. Treated with Methocarbamol and Diclofenac Sodium. Within two and a half weeks of the shot, on March 23rd, sudden loss of peripheral vision in right eye. Doctor diagnosed as NAION, non-arthritic anterior ischemic optic neuropathy. Vision loss in one eye is blurred from varying angles and grayed out and is considered permanent. Eye problem caused pain down neck and jaw. Also, a rash developed over chest with symptoms similar to shingles.

within 24 hours of vaccine, minor swelling of left upper eyelid and upper lip, lasting around 12 hours. Two weeks after vaccine, minor swelling of lower lip, lasting around 12 hours. Just under 4 weeks after vaccine, minor swelling of lower lip, lasting around 12 hours.

The next day woke with worse headache of my life , nausea, pain behind my eyes,confusion, throwing up brown liquid, left work early came home , went to bed , next day still really sick , so missed work again , 3 days total missed , thought it should be know men are having bad reactions too

Full body hives started roughly about 20-22 hours after injection. Ended up covering body within the coming days. Saw doctor virtually and prescribed prednisone and two trips into the emergency room. ER administered epinephrine shot along with Benadryl, famotidine, and Ativan as the hives become in mouth and lips and swelling was occurring.

SWOLLEN UPPER LIP; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 55 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: 201A21A, and batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 09:40 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced injection site pain. On 14-APR-2021, the subject experienced swollen upper lip. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swollen upper lip, and had not recovered from injection site pain. This report was non-serious..

Patient awoke on the morning of 4/14/21 and noted swelling of the lip/left facial region; swelling got worse throughout the day. Patient received epinephrine inhalation, famotidine IV, methylprednisolone IV, and diphenhydramine IV. Discharged 4/14/21.

I had tinnitus before but now it is louder. Gingko Biloboa was helping to keep it manageable but that doesnt seem to have any effect now.

Day of injection:fever over 100, body aches, fatigue Day 2-same as day 1 plus dizziness, extreme high blood pressure and a seizure Day 3&4-all symptoms continue except the seizure Day 5&6-fever broke, now just dizzy and blood pressure spikes Day 7-most symptoms subsided, but blood pressure still spikes slightly and tinnitus began and continues

Numbness in nose and upper lip shortly after receiving shot. Both arms pain and numbness and tingling. Back and neck pain. Arm swelling.

Worst pain ever right side of my face, starting from my right Jaw, coming up all the way to my front head with a duration of almost 2 hours (04/10/2021, about 11:00 pm until 1:00 am), fever every night with night sweats since 04/09/2021, followed by body chills, sharp headache similar to first episode of 04/10/2021, light headed, dizziness since vaccine was taken, always very tired, no energy at all, since vaccine was taken, I lost all my energy, my body is always on fire inside, my life is not going to be the same after I took this Covid 19 vaccine on 04/09/2021

Very strong headaches and high blood pressure for two weeks. Went to the hospital twice in that span of time. Monday May 10, he couldn?t see through his right eyes. He went to the ER and they found a blood clot in his artery(thrombosis) and that night had a stroke in the brain. Still at hospital.

Starting approximately one week after vaccination I started to experience onset of loud tinnitus primarily in my left ear. I have experienced mild tinnitus for 8 years but this was much more severe. The night of 04/19/2021 I noticed the onset of dizziness which progressed to strong vertigo the morning of the 20th. It was so severe I was unable to work and stayed in bed for the better part of two days. It was accompanied by the increased tinnitus. I scheduled an appt with my primary care physician for 04/23 and by Thursday 04/22 the vertigo had decreased to a general dizziness with tinnitus in my left ear. Dr prescribed Meclizine 25mg to me which has not appreciably addressed the symptom which as of 05/21 continues to be a constant mild dizziness with pronounced tinnitus in my left ear. I am planning to see an ENT that specializes in AIED (auto immune inner ear disorder) which I suspect was triggered my my immune system response to the vaccine. I should note that 8 years earlier I had a milder but similar case of vertigo w tinnitus which was never diagnosed despite extensive testing (vestibular migraine as a diagnosis by exclusion). It gradually subsided over 2 years with only mild tinnitus remaining as a symptom.

The participant woke up with a severe migraine headache. He couldn't focus on anything everything looked blurry, He went to work and couldn't focus on numbers, every time he tried to read everything was blurred, He had a constant headache for 2weeks and his eyes are still experiencing blurred vision. He heard that several others also experienced reactions who were vaccinated at his job. He missed 2 days of work and went to urgent care, where he was advised to go to the ER immediately. He had someone take him to ER because he was advised not to drive. To this day he still has a hard time focusing on numbers, When reading the shelf tags at his job everything needs a lot more focus to help with blurriness.

This spontaneous report received from a patient concerned a 55 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included psoriatic arthritis. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) dose was not reported at 1 total frequency, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number: 1133817 expiry: UNKNOWN) dose was not reported, 1 time every 1 total, therapy dates were not reported for psoriatic arthritis. No concomitant medications were reported. On an unspecified date in 2021, the patient experienced bloody stool and diarrhea. On an unspecified date, the subject experienced sore mouth, and sore gums. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable and for adalimumab was not reported. The outcome of the bloody stool, diarrhea, sore mouth and sore gums was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210601168-COVID-19 VACCINE AD26.COV2.S- Bloody Stool. 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).

Day one was headache as expected and right arm pain. Day two I had bad headache (9) joint pain in my shoulder and hips, loud ringing ears. shortness of breathe, left lung pain. This repeated for three days so I tested by BP and found it to be 160/130. Past day 3 I started with adrenaline spikes where heart would race up and I felt like hulk and blood pressure spikes out of the random. 5/24/21, I saw my family doctor and since my BP was so random high and then low she did not want to give me meds since it could drops too low at time. For my difficulty breathing and lung pain she gave me an prescription inhaler. As of today I still have the ringing left ear, shoulder joint pain like a pin stuck in it and unable to raise over my head without using my left arm to support, high BP on average 140/132. 167/151, 126/89, 122/91,110/87, 126/84 are some examples. These at the lowest is 10+ point higher than my normal range of 120s over 70s. Headache continues but may be due to the higher than normal BP.

JAW PAIN; This spontaneous report received from a patient concerned a 55 year old male. The patient's weight was 201 pounds, and height was 194 centimeters. The patient's concurrent conditions included alcoholic, and non smoker, and other pre-existing medical conditions included patient had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 05-AUG-2021) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced jaw pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from jaw pain. This report was non-serious. This case, from the same reporter is linked to 20210626627.

trout closing , chills , high fever, bells palsy , ringinging in right ear , very sensitive to noise, smell and taste off, dizziness, nauseousness

So roughly a week after my vaccine, I started having acid reflux and wheezing and a ringing in my left ear as well. I went to see an ENT and he prescribed a medication which was to help reduce swelling in my esophagus, I do not remember the dates or the medication name I am sorry, I am in the field right now not home. He also told me to refrain from chocolate, caffeine, carbonated drinks and those things. Doing that has helped with those. The ringing in my ear he addressed as well and I went to an audiologist and they told me I had Tinnitus. Since then I have been fitted for hearing aids and that has helped the Tinnitus a little bit.

RINGING IN THE LEFT EAR; This spontaneous report received from a patient concerned a 55 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included patient did not took any medications, 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: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUL-2021, the subject experienced ringing in the left ear. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ringing in the left ear on 09-JUL-2021. This report was non-serious.

No effect for approx. 6-weeks; then, headache, complete body fatigue and muscle weakness developed overnight. A "charged-nerve"/anxious-energy feeling developed throughout body. Then- over the next couple-weeks- numbness in hands/fingers, feet/toes, tremors in head, neck, face hands and fingers and shakiness in arms and legs, developed and continue until today. The headache and charged-nerve feeling has continued, and pain in neck and mid/lower-spine has developed. Muscles in legs especially continue to be weak and some pain has developed in thighs. A ringing in ears is continuous and fasciculations have developed throughout entire body.

Felt rush towards his nose and mouth right after he had the injection Then developed metallic taste in his mouth and altered sense of smell since then

worsening/amplification of tinnitus symptoms. I have had steady symptoms for approx 5 years. These symptoms are double what they were previously.

chills Narrative: Patient is a 56-year-old male with history of paranoid schizophrenia, COPD/ emphysema, alcoholic hepatitis and alcohol use remission who presents for ED evaluation of 1 day of pressure-like frontal headache with light sensitivity, myalgias, chills and fatigue, the symptoms are following the first Covid vaccine yesterday. Patient has not tried anything for the headache at this time, describes that is not different from his previous headaches. Does report some nausea without vomiting.

My decades-long MILD tinnitus has become EXTREME. It started a few hours after vaccination, and has not stopped since (14 days).

Headaches, migraines, and tired after vaccine for 2 weeks. 14th day after vaccine noticed some red spots on leg that looked similar to a heat rash and over the next 24 hours entire legs were covered in red dots and feet were almost solid purple. On the morning of 16th day constant nose bleed and multiple blood blisters in mouth inside cheeks and all over tongue. Blood was coming from mouth. At that point legs were covered in dark red almost purple and spreading to chest, back, and arms.

1503pm Pt states that he feels that his tongue is swelling. denes sob/difficulty breathing, itchiness or rash. RN and another RN with pt. reviewed pts allergies with pt as he circled NO allergies on his consent form. pt states that he has multiple allergies to meds and has had tongue swelling to antibiotics in the past which he did not disclose on his consent. BP- 142/82 P-62 SAO2- 96% called for Dr to assess pt. 1513pm Dr came to assess pt. lungs are clear bilat with good air exchange. tongue with some mild swelling per pt. no throat swelling. pt denies sob or difficulty breathing, itchiness or rash. V.O. Dr Benadryl 25 mg IM now and observe pt for another 15 mins 1514pm administer Benadryl 25 mg IM R del RN 1530pm BP- 126/74 P-60 SaO2- 96% Pt states that he still has some tongue swelling however he thinks it is getting better. denies throat swelling. pt denies sob or difficulty breathing, itchiness or rash. 1545pm BP- 126/78 P-60 Sa)2- 97% Pt reports decrease in tongue swelling, almost gone. still no throat swelling. pt denies sob or difficulty breathing, itchiness or rash. Dr came back to assess pt. pt is okay to go home. advised to take his evening dose of hydroxyzine tonight. pt given ER precaution for serious side effects and precautions for Benadryl. pt states he is familiar with Benadryl usage as he uses Benadryl and hydroxyzine. cautioned pt to always inform healthcare personnel of all allergies any time he is receiving any meds, vaccines, procedures or testing just to be on the safe side given his allergies and history of allergic reactions. pt verbalized understanding ..... RN April 8, 2021.

Patient stated feeling dizzy, diaphoretic, blurry vision Patient vomited and had syncopal episode EMS called and evaluated patient Patient refused medical transport and signed AMA form Patient stated symptoms resolved and will be going home with son

Pt became dizzy and called for help. Upon arrival ambulance was called and pt was ALOC w/bilateral weakness slowly progressing and sweating profusely. Pt was A&O x 3 to self and location. Then patient seemed to have lost consciousness completely for about a minute. Pt was still breathing normally, and was tachycardic. Left sided drooling was present. By the time the ambulance arrived patient regained consciousness and strength. Pt stated this happened before when he had a root canal fixed. Stated he seems to have anxiety induced seizures. Pt VS were taken by EMTs and where stable, Pt refused to go to the hospital. He called his wife to pick him up and pt was monitored until she arrived.

First adverse event was a severe headache. About 12 hours later, experienced chills and muscle aches. 24 hours later , experienced severe pain in both sides of jaw and ears, along with hip pain.

Vision blurriness and shimmering. Usually a precursor to migraine headaches. Issue is not constant, it comes in waves. Sometimes triggered by bright flashes of light. These symptoms have not occurred before the vaccine.

I developed a high pitch ringing in the ears the morning after the vaccine. It was noticed when I woke up. I did have a low fever, high chills, and significant neck muscle "cramping" during the night when this reaction developed. The ringing (Tinnitus) is pretty loud and bothersome. The volume has not changed since the day after my vaccine shot (two weeks now).

At work while sitting at my desk I became dizzy, broke out in sweat, disoriented, blurred vision, slurred speech. Called plant nurse. She said my face was drooping, I couldn't smile or stand. She called Ambulance. Ambulance arrived and decided symptoms of stroke and called for helicopter to take me to medical center. When I arrived they did CT and I was later told it showed possible areas of no oxygen to brain. They gave me TPA drug and almost immediately I could see improvement - my headache cleared. Throughout the next couple hours I regained movement on right side and all functionality returned except weakness in right arm. I stayed in ICU for 24 hours as required after receiving TPA and while additional tests were ran then was discharged on Friday, April 16, 2021

The morning following vaccination, I noticed intense ringing in the ears. Since then, the ringing has been persistent and constant. The sound changes from that of secadas to a high-pitched ringing

Patient received Jassen vaccine 4/10/21. 4/11/21 began with symptoms of fever, headache, chills, nausea, vomiting, and diarrhea, loss of taste and smell. 4/15/21 he presented to ED with symptoms of fever, chest pain and pressure, shortness o breath, myalgias, headache, tachypnea, tachycardia, hypoxia. Was given IV Decadron, DuoNeb and albuerol in ED. Inprovment seen, but patient continued with tachypnea and difficulty breathing. He was admitted to ED with a diagnosis of COVID 19 , asthma exacerbation and elevated Troponin at 31.52 (Ref Range 19) . During admission, glucose levels were labile, requiring adjustment to routine insulin regimen and Glucovance for hypoglycemia. An Echocardiogram was ordered due to elevated Troponin levels on admission. Echocardiogram 4/19/21 showed a density in the right atrium. Cardiology recommended a cardiac MRI. Patient was transfered to Hospital 4/19/21 for elevated care and evaluation, with diagnosis of

SORE THROAT; MIGRAINE; DRY MOUTH; This spontaneous report received from a patient concerned a 56 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced dry mouth. On 09-APR-2021, the subject experienced sore throat. On 09-APR-2021, the subject experienced migraine. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore throat on 12-APR-2021, and had not recovered from dry mouth, and migraine. This report was non-serious.

SWEATY; SWOLLEN LIP; CHILLS; TIRED; FEVERISH; ITCHY FOREARMS; FLU-LIKE SYMPTOMS; ACHEY; This spontaneous report received from a patient concerned a 56 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced itchy forearms. On APR-2021, the subject experienced flu-like symptoms. On APR-2021, the subject experienced achey. On APR-2021, the subject experienced tired. On APR-2021, the subject experienced feverish. On an unspecified date, the subject experienced sweaty, swollen lip, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu-like symptoms, tired, achey, feverish, sweaty, chills, swollen lip and itchy forearms was not reported. This report was non-serious.

1. The left eye was red for a couple of days. 2. Many red spots on the body like rashes. Still going on.

ITCHY EYES; EYE SWELLING; This spontaneous report received from a health care professional concerned a 56 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: unknown) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-APR-2021, the subject experienced eye swelling. On 29-APR-2021, the subject experienced itchy eyes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from eye swelling, and itchy eyes. This report was non-serious.

Immediately after vaccines had headache and soreness of the arm. on 5/6 numbness of the arm and loss of strength, dry mouth.

Janssen COVID-19 Vaccine EUA. Fatigue, hypersomnia, painful white blisters on tongue and in throat, laryngitis, headache, difficulty breathing (more severe than pre-vaccine) Started 5 days after vaccination. Symptoms have not subsided 17 days after vaccination.

4/13 awoken at 6am with a sharp severe headache on the right side of the head. I had blurry vision the entire day and a little the next day. Since 4/13 I have had almost daily light headaches and light to moderate nausea. I had several doctors appointments after that who treated me for migraine. Since the symptoms persisted into June I was sent for an MRI on 6/1. I received a call on 6/2 stating that I had suffered a stroke. I followed up with an MRA on 6/9. I met physician on 6/10 and stated that there were no issues reported in the MRA, however they confirmed that I had suffered a stroke. I After presenting the physician information that the symptoms described in Jansen vaccine were similar to mine they ordered an MRA scheduled for today and blood tests also today.

210/112 blood pressure. Went to ER. MRI and CT scans showed no reason. Pressure came down after several hours to 160/90 range. Ringing in ears. Subsided somewhat.

JAW PAIN; This spontaneous report received from concerned a 56 year old male. The patient's concurrent conditions included alcohol user, and smoker, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. the patient had no known allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAY-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 jaw pain. The action taken with covid-19 vaccine was not applicable. The patient recovered from jaw pain. This report was non-serious. This case, from the same reporter is linked to 20210627868.

Sudden onset hearing loss, left ear 2 days after receiving vaccination. Gradual recovery over 30 days to approximately 10% permanent hearing loss.

Pt received JJ vaccination, sat in the observation area for 15 minutes, when his 15 minute observation time lapsed the patient got up to leave and I noted pt walking towards the exit with a staggered gait. I immediately asked the patient if he was ok and got him seated. Pt noted to be diaphoretic with no signs of distress. Pt was breathing and speaking in clear complete sentences and denied chest pain, shortness of breath and swelling to the mouth/ throat. Pt stated he started to experience tunnel vision when he got up and felt dizzy. Its vitals were taken and noted to be stable. I offered to call EMS which patient declined. Pt drank water and ate chips while being observed and vitals were repeated approximately 10 mins later at which time patients vitals were stable and diaphoresis resolved. While patient was being monitored I noted he seemed to be experiencing nasal congestion and left eye watering. Pts lungs remained clear to auscultation bilaterally. I offered to call EMS again and pt agreed. I called EMS who arrived approximately 4 mins later. Pt was evaluated by EMS and taken to local hospital with a stable disposition.

Have developed constant plugged up ears, with non stop tinnitis and vertigo episodes since 6/7/2021 and symptoms are constant and ongoing

SWELLING OF TOUNGE, HIGH HEART RATE, BLURRED VISION, RINGING IN EARS, METAL TAISTE IN MOUTH, RED RASH ON HEAD AND CHEST. WAS TREATED AT THE EMERGENCY ROOM AND RELEASED.

Stroke. Treated with the prescribed dosage of TPA. Hospitalization of24 hrs. Loss of right-side vision in both eyes at the onset. Resolved to a partial loss of right-side vision in the right eye.

Diarrhea and soft/loose stools EVERY DAY since to this day! Leg swelling...mostly in right leg & foot. Trouble walking. Some unusual & day long blurred vision.

Began having trouble swallowing about a month later until present. Also had pain behind the right eye and blurring vision. The pain has subsided but the blurry vision persists.

On 6/24/2021 I woke up with gastral issues, which subsided late in the evening of 6/25/2021. On 6/26 went back to my normal routine and worked out in the gym and 6/27 played basketball for 2 plus hours. I was fatigued on 6/28 and 6/29. On 6/30 still fatigued went to the gym and did a light cardio workout and developed a heat rash on buttock and upper thighs. I took a Benadryl which cured the heat rash. on 7/1 in the evening I developed a dry cough that was pretty intense. At this time I noticed my eye sight was blurry at a distance. 7/2 the cough went away, Looking back I now notice I had balance issues on 7/2. On 7/3 eyesight was worse and I was seeing double. I went and had an eye exam and the Dr. thought I may have a retinal issue in my left eye and suggested I go to the hospital which I did.

After the injection on Friday 03/12 at 1:50 PM at facility, I started to get a slight temperature, Along with chills as well. This continue throughout the weekend. I remained at home and did not have any energy to go out and be around people. The next day, I also got diarrhea and was very dehydrated. Immediately, after I left the vaccine shot location, like within 5 minutes, I started to smell fish and my mouth tasted like salt for three days. I also had excruciating headaches that did not go away with advil. So I rested a lot and had no real big appetite what so ever!. Today, I am concerned that on my left side below my left clavicle, I feel a big bump what appears to be possibly a lymphatic swelling of node? I am concerned because I did not have this swelling before and do not know if it's a reaction to the vaccine. Pls contact me via phone, this is urgent. Thanks

He got his vaccine, had no issues immediately. He went to bed and woke up with headache, aching muscles, dry mouth, sore throat, and now has fever of 100.8. He took 2 baths to soak to get relief.

LOW GRADE FEVER; MINOR OR BRIEF HEADACHES; FATIGUED; FLUSHED; HOT FLASHES; PAIN BEHIND HIS EYES; This spontaneous report received from a patient concerned a 57 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, non smoker, and non alcholic, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 28-MAR-2021 14:00 for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 2021, the subject experienced pain behind his eyes. On MAR-2021, the subject experienced flushed. On MAR-2021, the subject experienced hot flashes. On MAR-2021, the subject experienced fatigued. On 29-MAR-2021, the subject experienced low grade fever. On 29-MAR-2021, the subject experienced minor or brief headaches. On 31-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99.3 F. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 97.5 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from low grade fever, flushed, hot flashes, fatigued, and minor or brief headaches, and the outcome of pain behind his eyes was not reported. This report was non-serious.

Patient reports: 3/20/21 began experiencing tingling feeling in all four limbs at different times 3/28/21 experienced slurred speech 3/30 experienced what he describes as near blindness-was driving down road and all of a sudden most of visual field went black and could only see the white line of the road. Was close to hospital and was able to see enough to get himself to the hospital. Patient reports he was hospitalized at Hospital from 3/30/21-4/1/21 and was diagnosed as having a stoke

Headache, chills, muscle aches, dehydration, loss of appetite, blurred vision, loss of taste, and loss of smell.

After 4th day of receiving J&J Covid Vaccine to present, I have dull headache, fogged brain, equilibrium seems off, slight loss of balance, increased heart rate of 170-190 BMP, my normal rate is 70 BPM, I took 25Mg of Metoprolol which brought my rate down to 70 BPM. I have increased wheezing and feeling shortness of breath, whereby having to using my albuterol inhaler quite often and I also took 20MG of Prednisone after which my breathing has improved.

Severe throbbing pain in center of chest, jaw pain and severe pain on right side of neck through the night starting about 12 hours after the injection.

Janssen Lot # 1850022. On the evening of receiving the SARS coV2 vaccine, was awoken from sleep with a severe headache (complete with visual blurryness and fortification patterns. The headache was non-responsive to caffeine and Tylenol. After several really uncomfortable hours, pt took OTC Naprosen Sodium and the HA abated. No other signs or symptoms

SMOOTHER AND CLEARER SKIN; INCREASED SENSITIVITY IN FINGERS AND TOES; HEARING INCREASED; INCREASED COORDINATION IN HANDS, FINGERS, ARMS; This spontaneous report received from a patient concerned a 57 year old male. The patient's height, and weight were not reported. The patient's past medical history included completely Paralysed, and concurrent conditions included Guillain-barre syndrome. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-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 smoother and clearer skin, increased sensitivity in fingers and toes, hearing increased, and increased coordination in hands, fingers, arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the smoother and clearer skin, increased sensitivity in fingers and toes, hearing increased and increased coordination in hands, fingers, arms was not reported. This report was non-serious.

My dad has been experiencing what seem to be definite blood clot symptoms since the vaccine but he refuses to go to the dr. Shortly after the vaccine he experiencing stabbing headaches that came on quickly and went away in an instant. I thought they were gone after that but he later told me the stabbing headaches continue, along with horrible pain in his legs, and ringing in his ears. He told me recently that the symptoms stopped exactly two weeks later but his legs are hurting again.

The night after the COVID vaccine had fever 101.4, feeling cold, until the follow day. Went to the Emergency Department the following night because I noticed that I was drooling, feeling very dizzy and weak.

SLURRED SPEECH; TINGLING FEELING IN ALL FOUR LIMBS; STROKE; VISION DECREASED; This spontaneous report received from a patient via the VAERS (Vaccine Adverse Event Reporting System;) a 57 year old male. The patient's height, and weight were not reported. The patient's past medical history included history of CABG (Coronary artery bypass grafting), and concurrent conditions included diabetes mellitus, congestive heart failure, and diabetic retinopathy, and other pre-existing medical conditions included the patient had no known allergies to medications, food, or other products and did not had other illnesses at the time of vaccination and up to one month prior. The patient did not have an adverse event following any previous vaccination. The patient, at age of 57 years, received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 to left arm for prophylactic vaccination. Concomitant medications included insulin and insulin lispro for drug used for unknown indication. On 20-APR-2021, the patient began experiencing tingling feeling in all four limbs at different times. On 28-MAR-2021, patient experienced slurred speech. The patient experienced what he described as near blindness. The patient was driving down road and all of the sudden most of visual field went black and could only see the white lines of the road. The patient was close to hospital and was able to see enough to get himself to the hospital and was diagnosed as having a stroke. The patient had CT, MRI, and ultrasound of heart (results unspecified). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tingling feeling in all four limbs, slurred speech, vision decreased and stroke was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: 20210440193-covid-19 vaccine ad26.cov2.s-Stroke, Vision decreased, Tingling sensation in all four limbs, Slurred speech. 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: history of CABG, UNDERLYING DISEASE: congestive heart failure, and diabetic retinopathy

Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: 3 minutes post vaccination patient was pale, experiencing diaphoresis, felt funny. Immediately he drank apple juice and right after still felt like he was going to faint. As he was sitting upright in chair talking his eyes rolled back in his head and he became unresponsive. I had him lie down and propped up his feet. Called 911 and took his blood pressure. He regained consciousness but was still not coherent. He attempted to sit in chair again and immediately felt like he was going to pass out

The day of the injection there was no reaction. Three days later I started getting a headache that would?ve been April 11 or 12th 2021. I do not usually get headaches I?ve had this headache since then it never goes away I?ve also experienced ear ringing , jaw joint pain In what feels like inflammation I?ve been to my ear canals. No present sinus infection or allergy type symptoms related to sinus pressure and pain.. Almost constantly. Over the course of week two and week three had extreme fatigue , tiredness, insomnia, And also very narrowly localized pain?s of which I?ve never had before. The fatigue tiredness insomnia and pains seem to be Diminishing but the headache and ear ringing now goes away. Headache has increased and then decreased but it?s always present. Ear ringing Constantly. Jaw joint pain Changes between mild to moderate.

History of Present Illness: Patient has a history of sinus problems. He was schedule for sinuplasty and had preoperative evaluation on 04/21/2021 with WBC 5.8, Hb 15.5, PLT 193,000. He had J&J covid vaccination on 04/27/2021. He underwent sinuplasty on 05/05/2021. Subsequent to his surgery he was having headache. He had some nasal discharge with blood. He took tramadol but had persistent pain. His symptoms were worsening up with some weakness of his right upper extremity. Was having generalized fatigue and weakness. He states he was getting short of breath with a flight of stairs. He had decreased appetite. He was given Vicodin for his headache with some improvement. He noted discoloration and bruising with pain pain in his left internal thigh area. Was noticing some changes in his vision but no loss of vision. He presented to the ED on 05/11/2021 and laboratory showed WBC 8.7 Hb15.2, PLT 6,000, segs 77%, lymphs 9%. He had no dark colored urine. INR 1.4 PTT 33, immature platelets 30.2. His bili was 2.1. He was treated with dexamethasone 40 mg. There is tiny focus of restricted diffusion in the both cerebellar hemispheres measuring up to 0.4 cm white matter left cerebellar hemisphere of left parietal junction measuring 0.5 cm compatible small lacunar infarcts. Chronic paranasal sinusitis. Patient described minimal blood with flushing his sinuses. Patient was ultimately transferred to Hospital after 3 days (on 5/11) for further acute care management given the multiple clots and bleeds associated with severe thrombocytopenia.

Top teeth on roof of mouth feel numb" like when you get novacaine at dentist" also salivating . Starting 20 minutes after getting shot. These symptoms still exit

ELEVATED HEART RATE; DISCOMFORT SLEEPING ON THE LEFT SIDE; 4 EPISODES OF CAPILLARY BURSTING, 2 IN EACH EYE; CHRONIC DIARRHEA 2-3 TIMES DAY; RIGHT HAND/FINGERS JOINTS ACHY; SEVERE HEADACHE; INJECTION SITE SWELLING; This spontaneous report received from a patient concerned a 57 year old male. The patient's weight was 172 pounds, and height was 71 inches. The patient's past medical history included covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On OCT-2020, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On 12-MAY-2021, the subject experienced right hand/fingers joints achy. On 12-MAY-2021, the subject experienced severe headache. On 12-MAY-2021, the subject experienced injection site swelling. On 15-MAY-2021, the subject experienced chronic diarrhea 2-3 times day. On 19-MAY-2021, the subject experienced 4 episodes of capillary bursting, 2 in each eye. On an unspecified date, the subject experienced elevated heart rate, and discomfort sleeping on the left side. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from right hand/fingers joints achy, and injection site swelling on 15-MAY-2021, 4 episodes of capillary bursting, 2 in each eye on 29-MAY-2021, and severe headache on 12-JUN-2021, had not recovered from chronic diarrhea 2-3 times day, and the outcome of elevated heart rate and discomfort sleeping on the left side was not reported. This report was non-serious.

RINGING IN BOTH EARS; NUMBNESS UPPER GUMS/TEETH; INCREASED SALIVATION; This spontaneous report received from a patient concerned a 57 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and alcoholic, and other pre-existing medical conditions included patient had no known allergies and drug abuse or illicit drug use, no significant medical history, no prescription medications, no caffeine use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 205A21A) dose was not reported, administered on 22-JUN-2021 10:13 for prophylactic vaccination. No concomitant medications were reported. On 22-JUN-2021, the subject experienced ringing in both ears. On 22-JUN-2021, the subject experienced numbness upper gums/teeth. On 22-JUN-2021, the subject experienced increased salivation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from ringing in both ears, numbness upper gums/teeth, and increased salivation. This report was non-serious.

blurred vision, paralysis all over body. Time of occurrence was about 12:30 am 7/13/21. No treatment has been given since vaccine. Has had cuts in ligament on ankle (work related injury) the day before covid shot.

Patient admitted with worsening numbness and weakness 2 weeks after vaccination; Neurology consulted and patient diagnosed with acute inflammatory demyelinating polyradiculoneuropathic form of Guillain-Barré syndrome and underwent plasmapharesis. Patient continued with progressive weakness difficulty with swallowing and choking on food as well as progressive loss of voice. Patient subsequently developed acute respiratory failure, transferred to critical care and was intubated.

5 days after taking the injection I experienced ringing in both of my ears (tinnitus) along with fullness. The doctor removed ear wax from my ear but it did not alleviate the problem.

Approximately 2 months after the vaccine the patient began to have pain in his right calf. No treatment at that time. About 2 weeks later the pain came back, an ultrasound was done and blood clots were seen. Zorelto was started however patient had a reaction to that of( lips swelling and nausea). At that time Eliquis was started at 5mg BID until current.

Tested positive for COVID on 07/29/2021 has had moderate symptoms, headache, muscle aches, cough, change in taste and smell, fatigue.

Started with a fever - that began about 6 hrs after the injection. That lasted a little more than 24 hours, then went away. Last night - about 55 hrs after that vaccine, I have developed an itching rash over most of my body - I still have it as of this morning. Also, slight swelling of my lips

felt like his eyes were burning from the inside out and lasted 3 days. Patient did not seek treatment

ABOUT 4 HRS AFTER SHOT(THAT FRI. NIGHT), LIGHTLY FEELING WEAK, GRADUALLY OVER THE NEXT 6 HRS WEAKNESS STRONGER 3 FULL DAYS. MONDAY MORNING WEAKNESS EVENED OFF. TUESDAY MORNING FEELING SICK,WEAK, NAUSEA, SHAKY, HARDER BREATHING, COUGHING, WIERD TASTE IN MOUTH, DRY MOUTH, LIGHT HEADACHE, SLEPT VERY HEAVY, SWEATY

Headache started 4:30 pm 4/8/21 - 6:00am4/10/21, body ache 3:30am 4/9/21 -10:00pm 4/9/21, very tired 3:30am 4/9/21 - 6:00am 4/10/21, slight pain swelling under both side of jaw and left armpit 3:30am 4/9/21 - 6:00am 4/10/21.

Patient woke up on 4/3/2021 at 7:30am with the symptoms of Light Headedness, Dizziness, and not feeling like himself. He got up and continued with his normal daily routine until around 10:30 when his vision started to double and he was off balance on his feet. He was taken by ambulance to a Hospital at 11:15am upon arrival his vision trippled and his eye right started to veer outward. He was taken in for a CT scan immidiatly and then was transfered to another campus to have a MRI scan done. He was then admited to the hospital for evaluation where he stayed overnight and was released the next afternoon (4/4/21)

Approximately a week after vaccine administration a rash developed on torso. Then on April 12, 2021 after working throughout the morning sitting in front of my computer, I took a lunch break. While preparing a meal, I felt discomfort in the left eye and it became very uncomfortable. When I checked in the mirror, I discovered my left eye was filling with blood. Upon seeing an eye doctor that same afternoon, the doctor explained that my left eye had ruptrued a large vessel and hemmoraged. However, the reason for the hemmorage could not determined because I was not under stress, had not lifted anything heavy, was not on blood thinner medication, was not constipated and have no underlying health condition.

I received my J&J vaccine on 04-05-2021 at 11am and on 04-6-2021 around 6pm I experienced a plugged white ear. The sound in my right ear was completely deformed, I had muffled hearing. I saw an ENT doctor, on 04-07-2021 at 4pm and he performed an audiology test but by that time my hearing had degraded. I have cohesive hearing loss, age related and my hearing has worsened since last appointment. My symptoms lasted less than 24 hours and I did not receive medicine treatment. On the other hand, I also had secondary symptoms to my left ear, similar to what I experienced in my right ear. I experienced a pulsating drum beat hearing to my left ear and I also did not receive care or treatment. These symptoms lasted temporarily and again I did not receive any medicine for my right and left ear.

9 days after receiving vaccine started experiencing sore throat, swollen / infected eyes, bronchial irritation that progressively worsened. Went to dr after 5 days and tested for COVID which was negative. Symptoms continue to worsen. I have not been sick in over 5 years.

After my J&J vaccine, about 2-3 days after I developed flu like symptoms, chills and headaches. On the 6th day after my vaccine, I developed a lump on the right side of my throat which progressively got worse. I also experienced diarrhea which lasted three days. I went to see my PCP, Dr. who ordered a CT scan of my neck. The CT scan demonstrated I had an ulcer in my throat located in my larynx box. MY PCP doctor then referred me to an ENT doctor, Dr. The ENT doctor gave me antibiotics and a shot in my arm. My throat kept getting worse and the ENT doctor have me reflux medicine and Prednisone and Bactrum medication. Today I woke up feeling much better although the pain and swelling to my left side of my throat and ear has gone down but I still have a sore throat and ulcer and is being treated with medicine.

BLOOD CLOT IN UPPER THIGH; NO PULSE FROM KNEE DOWN ON RIGHT LEG; RINGING AND BUZZING IN EARS; PURPLE TOE; COULD NOT MOVE; FEELING CRAPPY; TIRED; NAUSEOUS; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included Barrett's esophagus, and controlled high blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular batch number: 1805031, and expiry: unknown) dose was not reported, 1 total administered in left arm on 24-MAR-2021 for prophylactic vaccination. Concomitant medications included Nexium (esomeprazole sodium) for Barrett's esophagus, and lisinopril for high blood pressure. On 25-MAR-2021, the day after the vaccination, patient felt crappy and could not move, had tiredness and nauseous. After 10 to 12 days of vaccination on an unspecified date in APR-2021, the patient had ringing and buzzing in ears, pain in the bottom of feet on walking, and purple discoloration to front of the right toe. The patient had visited health care professional (HCP). The patient had undergone some tests and HCP identified no pulse from the knee down on his right leg and a blood clot in upper thigh. The patient had experienced pins and needles and buzzing on his leg. He has also has a ringing and a buzzing in his ears and the bottom of his feet hurt when he walked on them. The patient was scheduled for an appointment with cardiovascular surgeon on 28-APR-2021, prior to the visit the patient has to tested negative for COVID. The patient went to take test on 23-APR-2021 and results not yet received. Laboratory data included: Peripheral pulse absent (NR: not provided) no pulse from the knee down on right leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling crappy, tired, nauseous, no pulse from knee down on right leg, blood clot in upper thigh, ringing and buzzing in ears and could not move was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to.This spontaneous report received from a patient concerned a 58 year old male.; Sender's Comments: V0: This 58-year-old male patient was found to have blood clot in upper thigh with no pulse from the knee down 10 to 12 days after receiving COVID-19 VACCINE AD26.COV2.S for the prevention of symptomatic SARS-CoV-2 virus infection. Concurrent conditions include Barret's esophagus and "controlled" high blood pressure; concomitant medications includes Nexium and lisinopril. The symptoms reported were ringing and buzzing in ears, pain in the bottom of feet on walking, pins and needles and buzzing on his leg, and purple discoloration to front of the right toe that prompted consult with HCP, who advised the patient that there was no pulse from the knee down on his right leg and a blood clot in upper thigh. Prior COVID test was negative. No other details reported. 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.

HEADACHE; SOMETIMES LOOSE MEMORY; HIGH BLOOD PRESSURE AFTER VACCINE; DIFFICULTY BREATHING; FEELING ABNORMAL; LOOSING WEIGHT; VOMITING; MY TONGUE WAS SWOLLEN; POOR APPETITE; NAUSEA; FATIGUE; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's past medical history included blood pressure abnormal, and concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included no known allergies or 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: 1200287383 expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced sometimes loose memory. On APR-2021, the subject experienced high blood pressure after vaccine. On APR-2021, the subject experienced difficulty breathing. On APR-2021, the subject experienced feeling abnormal. On APR-2021, the subject experienced loosing weight. On APR-2021, the subject experienced vomiting. On APR-2021, the subject experienced my tongue was swollen. On APR-2021, the subject experienced poor appetite. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced fatigue. On 09-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, fatigue, sometimes loose memory, high blood pressure after vaccine, poor appetite, nausea, vomiting, loosing weight, and feeling abnormal, and the outcome of my tongue was swollen and difficulty breathing was not reported. This report was non-serious.

Developed constant ringing in ears (Tinnitus) within an hour of vaccination, it has not subsided since...

03/23 Sore arm after shot for three days and general soreness in left shoulder. No other side effects, Soreness fade within a weeks 05/10 /2021: Woke up with what was felt like a closed eustachian tube (right side). Teble, high end hearing muted all day. Minor post nasal drip. 05/11/2021 No nasal drip, sounded better in the morning. By 12pm, hearing in my right ear is completely gone. 05/12/2021 Visit to GP : clean out ear with not relief. Simple Test confirms hearing loss is not viral but sensorinrual loss.

Immediately after injection significant arm pain that resolved quickly. Approximately 36 hours after injection dizziness. 48 hours after injection neck and head pain on left side, arm soreness, and swollen lymph node on left side of throat. Minor pain in mouth and throat with fatigue and dizziness. Neck and head pain decreasing on day 3 with all other effects resolving but injection site is still fairly sore. Overall, I would say this was probably a normal response associated with my immune system reacting to the injection. I had the virus the first week of December 2020. I would classify my infection as moderate. I was sick with fever, chills and severe body aches and it lasted for 10-14 days.

SORE THROAT; PINK EYE; HEADACHE; RIGHT EYE PAIN; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included smoker, and non alcohol consumer, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 08-MAY-2021 for prophylactic vaccination. The Batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAY-2021, the subject experienced right eye pain. On 14-MAY-2021, the subject experienced sore throat. On 14-MAY-2021, the subject experienced pink eye. On 14-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right eye pain, sore throat, and headache, and the outcome of pink eye was not reported. This report was non-serious.

DIARRHEA; THROWING UP; MOUTH FEELS LIKE GARBAGE; NOT EATING; HEADACHE; WEAKNESS; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, and other pre-existing medical conditions included the patient did not have any known drug allergy. He had not taken any over-the-counter medications. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 15-MAY-2021, the patient experienced diarrhea. On 15-MAY-2021, the patient experienced throwing up. On 15-MAY-2021, the patient experienced mouth feels like garbage. On 15-MAY-2021, the patient experienced not eating. On 15-MAY-2021, the patient experienced headache. On 15-MAY-2021, the patient experienced weakness. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from diarrhea, throwing up, mouth feels like garbage, headache, weakness, and not eating. This report was non-serious.

I went to the vaccine shot and we were crammed in there. I got the shot and I went home and I felt fine and then 11 that night I started to get a fever and chills and I started ranting, yelling couldn?t get to sleep the next day everything was gone. I started to have a small cough on Sunday morning. On the Monday I went to a college visit when my daughter to and I didn?t feel bad at this time I was masked for most of the time. And Tuesday morning I woke up and had a sore throat and a cough that grew in to some body aches and I contacted the doc I lost my sense of taste and smell I contacted a doctor telehealth who set up and a covid test (positive) . From the time that I was not feeling well I did separate my self from everyone. The aches lasted for about 5/6 days and the body aches I did have a lingering cough. My instructions were to stay out 10 days starting 04/02 and I could go back to work on 04/12 if I was fever free and the other symptoms were improving

Very loud and debilitating ringing in my ears. I?ve always had ringing in my ears for the last 36 years from my time spent board the flight deck of an aircraft carrier, however, shortly after receiving the vaccine the sound is very very loud and debilitating

Patient felt fine during observation period after receiving Janssen. On his drive home he experienced blurred vision in his right eye that lasted for about 3 minutes. He returned to vaccine site. Doctor on site was called and patient was transferred to the doctor's office for further evaluation. No symptoms of anaphylaxis. Neurological exam normal. No other symptoms of stroke. Vital signs stable. Patient feels fine. Due to patient's cardiac history, doctor was concerned about a possible transient ischemic attack. Therefore, he was transferred to the emergency department for further evaluation. Patient declined additional tests in the ED. Patient admitted to the ED, pt with normal exam. Sx only lasted 2-3 minutes. Consulted with neurologist. Does not sound like stroke. Also not suggestive of known J & J vaccine reaction. Suggest ophth eval.

Approximately 2 weeks after the Codid vaccination I experienced frequent tinnitus in both ears. The frequency is now CONSTANT and the intensity is causing sleep and ability to concentrate issues

swelling of extremities, legs and feet and toes were swollen badly . eyes were blurry and constantly watering. hbp

Sudden sensorineural hearing loss on the LEFT. 2 weeks after vaccine. No other etiology identified. No trauma or illness.

About 5 hours after I received my shot, I noticed a strange taste in my mouth...The next morning even after eating breakfast, brushing my teeth, within a few hours the taste returned...

I had the vaccine on my left arm. I was advise of being thirsty symptom the next day as a side effect. I got up as usual. I did my daily physical exercise routine as usual ( lift weight 80 lbs), Went to clean my face and look the mirror, and I notice I have my LEFT EYE bloody AND RED. Second day is more. I am using eye drops to remove this problem. Never had this situation happened before and I have never had any shot for 55 years.

Chills, Aches, Fever, light headed, headaches, Eyes being very tired and sore ( I could feel this behind my eyes in the sockets).

Slight swelling right eye (left corner) small mole - swelled up no other affects surfaced about 1 hr after vaccine.

Received Johnson & Johnson vaccine at pharmacy on Friday April 9, at 8 am. Injection in left arm. Mild flu like symptoms Friday night and most of day Saturday. Symptoms dissipated over the day Sunday. Monday received my weekly allergy shot and exercised for first time. Headache returned Monday evening. Took some Tylenol. Awoke at 2 am with tinnitus in both ears. Mostly in left. Never experienced before. Scheduling appointment with ENT. Very concerned.

I received the dose on March 12. On March 16 I got sick, throwing up and head ache. Since then I have had no energy with a slight head ache. My right knee has arthritis and I get cortisone shots. However that knee started really hurting after the vaccination.

SWOLLEN LIPS; SWOLLEN THROAT; DIZZINESS; FLUSHED FACE; FLU-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 59 year old male. The patient's weight was 194 (unit unspecified), and height was 71 inches. The patient's concurrent conditions included gout, alcohol use, non-smoker, cipro allergy, high cholesterol, and high blood pressure, and other pre-existing medical conditions included the patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 08:00 in left arm for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for drug used for unknown indication, febuxostat for drug used for unknown indication, losartan for drug used for unknown indication, pravastatin for drug used for unknown indication, probiotics nos for drug used for unknown indication, selenium for drug used for unknown indication, vitamin d nos for drug used for unknown indication, and calcium. On 08-MAR-2021, the subject experienced swollen lips. On 08-MAR-2021, the subject experienced swollen throat. On 08-MAR-2021, the subject experienced dizziness. On 08-MAR-2021, the subject experienced flushed face. On 08-MAR-2021, the subject experienced flu-like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen lips, swollen throat, dizziness, and flushed face on 08-MAR-2021, and flu-like symptoms on 10-MAR-2021. This report was non-serious.

Week after vaccination very bad headaches and ringing in ears Now is fifty days after vaccination still have headaches every day and buzzing and ringing in ears

From Physician H&P: Patient is a 59-year-old man multiple medical chronic conditions, including known protein S deficiency not on anticoagulation, sinus bradycardia, hypercholesterolemia, chronic neuropathy of the lower extremities, who presented to the emergency room at the recommendation of his primary care office for possible stroke and persistent headache. He reports that his history of present illness begins on 4/7/2021, for which after he had received the COVID-19 Johnson & Johnson vaccine he started to have throbbing headache. He stated that it was diffuse and pounding in quality, up to 10 out of 10 pain. However this resolved on its own, and since then and has been intermittent with this type of headache. He did report 2 weeks ago, that he had a brief episode of tunnel vision as he describes it, where his vision seemed to narrow while he was looking at his phone. This only lasted no more than 10-30 minutes, and this resolved on its own as well. He continues to have intermittent headaches, again otherwise nonspecific with pounding quality however the intensity is improved. Humidifier regarding the Johnson & Johnson vaccine to report any side effects, for which she had notified his primary care doctor who then decided to proceed with MRI of the brain to evaluate for possible etiology. The MRI was done with and without contrast at facility on 5/4/2021, for which there was concern for possible left temporal posterior stroke, and if there was any concern for venous thrombosis, further imaging was necessary. He was then recommended to go to the emergency room for evaluation. He otherwise is in his regular state of health. He denies any recent fever or chills or cough, no chest pain or shortness of breath, nausea, vomiting, abdominal pain. No changes in bowel or bladder habits.

CONSTIPATION; LETHARGY; COLD; SWEATING; MUSCLE WEAKNESS; CHILLS; MUSCLE ACHES/MYALGIA; FEVER; DARKLY COLOURED URINE; TREMOR; TINNITUS; LOSS OF APPETITE; STUFFINESS; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included knee pain, alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies and he consumed alcohol no more than 2-3 drinks at any one time. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A expiry: 23-JUN-2021) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. Concomitant medications included celecoxib for knee pain, and minerals nos/vitamins nos. On 19-APR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) negative. On 24-APR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) NEGATIVE. On 30-APR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) Negative. On MAY-2021, the subject experienced stuffiness. Laboratory data included: Body temperature (NR: not provided) 99.6-99.8 F. Treatment medications included: paracetamol. On 06-MAY-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) negative. On 09-MAY-2021, the subject experienced darkly coloured urine. On 09-MAY-2021, the subject experienced tremor. On 09-MAY-2021, the subject experienced tinnitus. On 09-MAY-2021, the subject experienced loss of appetite. On 09-MAY-2021, the subject experienced constipation. On 09-MAY-2021, the subject experienced lethargy. On 09-MAY-2021, the subject experienced cold. On 09-MAY-2021, the subject experienced sweating. On 09-MAY-2021, the subject experienced muscle weakness. On 09-MAY-2021, the subject experienced chills. On 09-MAY-2021, the subject experienced muscle aches/myalgia. On 09-MAY-2021, the subject experienced fever. On 12-MAY-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) Negative. On 13-MAY-2021, treatment medications included: guaifenesin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from darkly coloured urine on 15-MAY-2021, tremor, tinnitus, loss of appetite, constipation, lethargy, cold, sweating, muscle weakness, chills, muscle aches/myalgia, and fever on 17-MAY-2021, and stuffiness on MAY-2021. This report was non-serious.

103.7 Fahrenheit fever next day, chills, waking up in cold sweats, severe headache, was regaining taste and smell from Covid-19, then the taste and smell went away again, metal taste. About 3 days long. Took tylenol, which helped with fever. Metal taste has not gone away. Needed to increase his intake on oxygen tank.

Sense of taste is severely affected. I can smell, but foods either have little to no flavor or they seem to be spoiled. i can taste certain things, but the flavor is off.

Developed dizziness , light sensitivity the next day last about 2 weeks. Soon after that I noticed a ringing in my ears that won?t go away.

NECK PAIN; UNDER ARM PAIN; PAIN IN THE ARMS RADIATES FROM ONE ARM TO THE OTHER (BOTH ARMS); CHEST PAIN; BURNING SMELL; STOMACH PAIN; DRY EYE; RED EYE; HEADACHE; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, non smoker, vitamin b12 allergy, and fish product allergy, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced dry eye. On 10-APR-2021, the subject experienced red eye. On 10-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced stomach pain. On 12-APR-2021, the subject experienced burning smell. Laboratory data included: CT scan (NR: not provided) Normal. On 19-APR-2021, the subject experienced chest pain. On 19-APR-2021, the subject experienced pain in the arms radiates from one arm to the other (both arms). On 22-APR-2021, the subject experienced under arm pain. On 27-APR-2021, the subject experienced neck pain. Laboratory data (dates unspecified) included: Diagnostic ultrasound (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dry eye, and red eye, was recovering from stomach pain, and had not recovered from chest pain, pain in the arms radiates from one arm to the other (both arms), headache, neck pain, burning smell, and under arm pain. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case was assessed as non-serious.

TASTE OF MEDICINE AT THE BACK OF THROAT; BURNING SENSATION BACK OF THROAT; FEELING VERY FATIGUE; This spontaneous report received from a patient concerned a 59 year old male. The patient's weight was pounds, and height was inches. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 27-JUN-2021 09:30:00 for prophylactic vaccination. No concomitant medications were reported. On 27-JUN-2021, the subject experienced taste of medicine at the back of throat. On 27-JUN-2021, the subject experienced burning sensation back of throat. On 27-JUN-2021, the subject experienced feeling very fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling very fatigue, and taste of medicine at the back of throat, and the outcome of burning sensation back of throat was not reported. This report was non-serious.

approximately 12 hours after receiving the vaccine, patient awoke with angioedema with tongue swelling, but no airway compromise. He was given Benadryl, famotidine, and 100mg steroids.

HYPERSENSITIVITY TO THE SUN; LIGHT RASHES ON ARM BILATERALLY; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and alcohol user, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. the patient did not have pertinent medical history. The patient experienced hypersensitivity when treated with erythromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced hypersensitivity to the sun. On JUN-2021, the subject experienced light rashes on arm bilaterally. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from light rashes on arm bilaterally, and hypersensitivity to the sun. This report was non-serious.