Johnson & Johnson

Patient passed out about 5 minutes after vaccine, did not respond to stimulus, 911 called, pt woke up after about 10 seconds, blood pressure 110/58. Pt was awake for about 5 minutes then pass out again, this time was longer with no response to stimulus, patient was moved to the floor from a chair where he woke back up. EMS arrived and monitored patient.

Post-injection patient reported feeling hot, sweaty, dizzy, and flushed. Blood pressure was low. Patient began vomiting. Patient was transferred to a nearby doctor's office for further observation. Patient's symptoms resolved.

On March 11th at around 10pm I experienced severe shaking, fever, headache and delirium. The next day I improved but had a fever on and off of 99.1. I felt like I was stable, but felt dizziness increasing, and was lethargic through the weekend. Then on Monday the 15th, I had a noticeable cramp in my right abdomen. At around 8pm CST I began feeling like I needed to burp and that I had GI problems. The problems increased that night at around 10pm I had pain where the cramp started. Two hours later I started throwing up because of the pain and feeling of too much air inside of me. I could not stop vomiting after 2 hours so went to the Hospital ED at around 2:30 AM Tuesday the 16th. I was admitted after a CT scan showed and white cell counts confirmed and infection and drastically enlarged appendix. I was diagnosed with an appendicitis and they immediately scheduled me for surgery.

3 minutes after vaccination, I started to feel warm, sweaty, and tingling sensation. On-site nurses noticed I started to look pale and clammy and took me into evaluation room and checked my vitals. My vitals came back with low blood pressure and low oxygen levels. After resting and a cup of water, my vitals became all normal.

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.

Tingling sensation in left hand and on left side of head. Sore neck muscles and very sore joints all within 2 hours of the shot. Late that night (day of shot) I had a low grade fever. The first day after the shot I felt very sick and had very sore joints and stiff/painful muscles. By the second day I felt better but again had sickness and soreness in the evening.

Approximately 9 hours after injection, and in mid sleep, intense body heat and severe chills woke up me up every hour for 5 hours(midnight to 5am). My body felt incredibly hot but I did sweat at all. If I would move the bed covers and any part of my skin below my neck felt the air I would get chills the would shake my entire body for a few seconds. Later that morning; body aches all over, a fever reaching 101.3, fatigue. Over the counter medicines, napping, and a shower helped reduce symptoms. All was gone by the next morning.

Patient reported at 1210 with hx of allergy to PCN (reaction hives), cephalosporins. Patient reported flushed, L side of face warm, 0 dizziness, 0 lightheadedness, 0 CP, 0 SOB, PMH-0. Hx of feeling warm with injections. Water was provided to patient, snack was as well but declined. VS initially were 173/104, 102, 98% Sp02, R 16 unlabored. Repeated after water and assessment at 135/90. Patient left at 1226.

I started to feel really tired around 7:30pm and got a head ache so I went to bed early. I couldn't sleep well because I got the chills and a fever. I went to use the bathroom around 3am. All of a sudden I got really nauseous, the room spun, everything went black and I fainted in the middle of my bathroom. My wife woke up and helped me back to bed. The next day I was very weak and tired. The chills and fever faded the next afternoon.

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.

Patient came in to the clinic to receive his dose of the Janssen COVID vaccine. Within the 15 minute post-vaccine period, the patient reported feeling warm, sweaty, having clammy hands, and the feeling of almost "passing out". Patient was taken to a patient room to rest, vitals were taken at 13:16 PM with readings of BP: 91/57, HR 72, SpO2 98%, temp 98.5. Patient denies any past medical history, reports he only takes vitamin supplements, and denies any past history of anxiety. He denied any chest pain or SOB. Patient was provided water and was told to rest for a few minutes. Vitals at 1:42 PM were noted to be: BP 108/71, HR 72, SpO2 99%, and temp of 98.1. He says he feels much better and denies any symptoms at this time. ER precautions were given to the patient Called patient again 4/2/21 at 09:59 AM - pt denies any ER visits, hospitalizations, or any visit to any other healthcare provider since his vaccine. The day after his vaccine, he says he developed a headache with left arm soreness (injection site was left upper arm) which was all improved by Monday, 3/22/2020. He says he took Advil, drank plenty of fluids, and rested for his symptoms of headache and arm soreness. He denies any other symptoms of near syncope after his near syncopal episode at the clinic. He denies any symptoms of fevers, CP, SOB, swelling, drainage, or pain at injection site, abdominal pain, dizziness, lightheadedness, or any other side effects/averse effects of the vaccine. He says he is doing well overall

dizziness and weakness 10 minutes post vaccination. observed patient for 20 more minutes while seated. called 911 for patient but patient refused service. patient was alert the entire time and able to converse coherently. Patient felt fine afterwards to drive home. Followed up with patient on 4/5/21. Patient stated that he's perfectly fine after reaching home with just a slight arm soreness which was resolved the next day.

Fever (100 F at 11 pm, 4/3/21, 7 hours after vaccine; 101.9 F, at 11 am, 4/4/21, 19 hours after vaccine: fever fell to normal 98.6 F by 7:30 am 4/5/21. Severe chills, uncontrollable shivering for about 10 minutes at about 11 pm 4/3/21; chills and hot flashes, sweating, on and off all day 4/4/21. Moderate body aches 4/3/21 and 4/4/2 Slight nausea 4/3/21

Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: PT HAS HISTORY OF FAINTING WHEN GETTING ANY INJECTIONS-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: THE PATIENT SAID HE HAS A HISTORY OF FAINTING WHEN GETTING ANY INJECTIONS (BLOOD DRAWS, IMMUNIZATIONS, OR ANY INVOLVING NEEDLES). THIS WAS NOT AN ACTUAL REACTION TO THE VACCINE.

CHILLS; FEVER; BURNING SKIN; HOT FLASHES/FEELING HOT; FATIGUE; This spontaneous report received from a patient concerned a 40 year old male. The patient's weight was 77.1 kilograms, and height was 175.26 centimeters. The patient's concurrent conditions included seasonal allergy, alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. The patient was previously treated with diphtheria vaccine toxoid/pertussis vaccine acellular/ toxoid for prophylactic vaccination; and experienced reactions to vaccines when treated with diphtheria vaccine toxoid/pertussis vaccine acellular/tetanus vaccine toxoid, and tetanus vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808609 expiry: 09-JUN-2021) dose was not reported, administered on 19-MAR-2021 14:00 in the right arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced hot flashes/feeling hot. On MAR-2021, the subject experienced fatigue. On 19-MAR-2021, the subject experienced burning skin. On 19-MAR-2021 22:00, the subject experienced chills. On 19-MAR-2021 22:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning skin, hot flashes/feeling hot, chills, fever, and fatigue on 20-MAR-2021. This report was non-serious. Additional information was received from the patient on 30-MAR-2021. Following information was updated into the case: other identification numbers added, patient's contact details added (address, city, zip code, email address and phone number), patient demographics added (age ,age group, gender, height, and weight), concurrent condition added ( seasonal allergy, non-smoker, alcoholic), event added (fatigue and hot flashes/feeling hot), past reaction added( reactions to vaccines), suspect drug route of administration added ((intramuscular), vaccination time added, past drug added (Tetanus and TDAP) and due diligence updated.

Site: Bruising at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Severe, Additional Details: vasovagel reaction pt layed down on floor with legs elevated for 30 min felt better and coloring came back to skin and he was released, tried to call at 5 pm after clinic to follow up to see how feeling no answer on above phone number

Patient reported burning sensation shortly, ~10 minutes, after receiving vaccine that carried across back of shoulder. Patient reported feeling "loopy/drunk". Patient refused all treatment and EMS. Around 40 minutes or so, patient vomited. Patient left with friends an hour after vaccine given.

States he started feeling hot lowered to ground. Did hit his head. States this has happened in the past with draws. Has allergies to PCN as hives Awake, alert and oriented x 3 99% O2 Sat, RR 18, BP 156/86, HR 88 Feels better while sitting in observation Only medical history of hypertension, is not taking meds

States he started feeling hot, lowered to the ground. Did hit his head. states this has happened in the past with blood draws. Has allergies to PCN= Hives. Awake and alert x 3 99% O2, RR 18, BP 156/84, HR 88 Feels better while sitting in observation Only medical history hypertension and patient doesn't take any meds

Body aches, headache, weakness in the receiving arm and hand, feels like the injection site is on fire (very painful 7 on the pain scale), my phantom pain is going nuts in my missing left forearm and hand (very painful too 7 on the pain scale)

ACHING BODY (INCLUDING THE CHEST AND AROUND THE AREA OF THE VACCINATION); NUMBNESS IN LEFT FINGER; CHILLS; HEADACHES; NAUSEA; This spontaneous report received from a patient concerned a 40 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: 042A2A and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021; 13:16 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the patient experienced aching body (including the chest and around the area of the vaccination). On 06-APR-2021, the patient experienced numbness in left finger. On 06-APR-2021, the patient experienced chills. On 06-APR-2021, the patient experienced headache. On 06-APR-2021, the patient experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from nausea, chills, and aching body (including the chest and around the area of the vaccination), and had not recovered from headache, and numbness in left finger. This report was non-serious.

Patient received Janssen vaccine around 10:30. He left the observation room feeling fine. once he got at his car and started to drive, he felt shortness of breath and some weakness. Then, he came back to the SR Vaccine site to get help around 10:50. We met him in front of the parking lot, he was having some trouble of breath and weakness. We put him in a wheelchair, brought him back to the Observation area. I asked him to lay down with elevated legs on a chair. He instantly felt better, no more shortness of breath. He did not need to use any Oxygen supply. Also, he drank some water, sit back in the chair and felt better ready to leave with his brother who came to help him just in case. At 11:10 he left the building with orientations about worsening of symptoms and when to call EMS.

Heart racing the next day after vaccination. I went for a walk in the park and i noticed my hear rate jumped up to 165bpm on my fitbit for a period of time even though i just began walking. I wasnt running or anything. I was foggy and very jittery. I also experienced the same symptoms today, 4.12.21 while also heading for a short walk. Im an athlete and in great shape and ive never had my heart jump to 165bpm just walking. That would happen normally after a sprint or long run, but not just walking.

Ten minutes after the vaccination, pt passed out and came right back. He said he was fine except his hands were tingling. We called 911 and they took him for the vital.

SEVERE MUSCLE CRAMPING AND PAIN THROUGHOUT BODY. PROLONGED FEVER OF 102.9 DEGREES. SEVERE CHILLS AND BODY SHIVERS. EXTREME HEADACHE. ENLARGED AND PAINFUL LYMPH NODE ABOVE LEFT COLLARBONE

I waited the advised 15min to assess any allergic reaction. I felt fine aside from a sore arm. I called my wife and drove home. Once on the freeway I felt dizzy. This came on me very fast. I thought I better get off at the next exit.. but instantly blacked out. While unconscious I struck another vehicle going approximatley 65mph, rolled my vehicle on its side, skidded, then rolled back upright. I awoke to my car spun sideways on the freeway, paramedics, and fire dept working the wreck from my window, and no recollection of what happend. It felt instantaneous to me. I ate a breakfast of granola, yoguirt. I hydrated before the shot. I even took extra Vitamin C.

Woke up in middle of night extremely dizzy, lightheaded, weak, and shaking. Went to ER. They gave me an aspirin, drew multiple blood samples, performed two EKGs, and a chest x-ray. They could find nothing wrong with me. After about an hour at the hospital the symptoms begin getting better, and I was discharged approximately four hours later.

First evening of the J&J vaccine (4/1/2021) I had a fever, chills, headache, and was lethargic. This lasted for 2 nights. These symptoms I anticipated. What I didn?t anticipate was my abdominal pain. I still feel as of today (4/14), pain in my abdomen. The areas of the discomfort are all over my mid-section. I was so worried that I went to ?Urgency Care? doctor on 4/5/2021 and the nurse had me go for a ?CT Scan?. I also went to my Primary care physician on 4/13/2021 and described my concern and abdominal pain but didn?t get a diagnosis.

Developed a fever 6 hours after vaccine administered, had chills, muscle aches, and severe headache, around 10 hours after vaccine, fever peaked at 101.4 then subsided, about 12 hours after shot woke up in night with cramping in my feet, severe headache continued 18 hrs after vaccine and took two Tylenol, headache subsided and went away, fever was reduced to below 99 degrees about 16 hrs after vaccine. After 24hrs from vaccine all symptoms were gone and has not return to date.

Significant leg pain in the thighs of both legs. Including stiffness and hard to move them. This lasted for 2 days at the same pain level. On the third day the stiffness, pain, hard to move went down to about 5% of what it was.

Dizzy; HOT FLUSHES FACIAL; ELEVATED BLOOD PRESSURE; This spontaneous report received from a pharmacist concerned a 40 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known medication and food allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 14:03 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021 14:15, the subject experienced dizzy. On 10-APR-2021 14:15, the subject experienced hot flushes facial. On 10-APR-2021 14:15, the subject experienced elevated blood pressure. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) elevated, and Oxygen saturation (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure, had not recovered from dizzy, and the outcome of hot flushes facial was not reported. This report was non-serious.

Injection administered on a Wednesday, by Saturday severe pain and inflammation on forearm below injection location. Not at injection- but on same arm. Forearm stayed swollen and stay in severe pain with no ability to grip. Feels like internal grinding at joints, muscle and wrist. Resting has minimized pain, but has not improved much since Saturday.

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.

Starting from 04/07/21, Sudden waist and back pain, cannot straighten up the body. When straighten up the body feels breathing difficulties . After 3-4 days there?s a continuous pain in both thigh and the calf, and red marks are spawning on the legs.

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.

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.

Bell's Palsy diagnosis. Paralysis on left side of face. Severe headache behind left ear. Numbness in feet/toes.

LOSS OF APPETITE; FEELING WARMER THAN USUAL; FEELING ACHY; FEELING SICK; WEAKNESS; CHILLS; HEADACHE; WOOZY/DIZZINESS; This spontaneous report received from a patient concerned a 40 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 and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced woozy/dizziness. On 13-APR-2021, the subject experienced loss of appetite. On 13-APR-2021, the subject experienced feeling warmer than usual. On 13-APR-2021, the subject experienced feeling achy. On 13-APR-2021, the subject experienced feeling sick. On 13-APR-2021, the subject experienced weakness. On 13-APR-2021, the subject experienced chills. On 13-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from feeling sick, headache, chills, loss of appetite, weakness, woozy/dizziness, feeling achy, and feeling warmer than usual. This report was non-serious.

Pain developed early on and persisted till ~ 3 weeks remains persistent. Went to internist following tests Positive ANA, Elevated RO-SSA >200, Elevated sed rate, Elevated crp, change in hgb from 14.9 to 12.7, low iron, muscle pain, bilateral leg swelling, joint pain, tightness, rash on both legs, ankle up to knee over 3-4 days, at four weeks out continued pain, weakness, and swelling. Persistent soaking night sweats and low grade fever in the evenings. Purple rash on arms and legs with nodules. Referral made to rheumatologist for further work up.

The evening of the vaccination I began experiencing tingling at the site of the shot, then this extended through the night to chest pains and tightness in the chest. That continued through the night and into the following day. The following day and lasting until present (4/27/2021) I have continued to experience tingling at night, extending to my arm and fingers, random very sharp pains in my chest, and some feeling of strong heart throbbing. This subsides during the day-time (when I'm upright versus lying down) but all of these symptoms return during the evening. These are all things I never experienced prior to the vaccine. Also, I have tested regularly for COVID-19 since my companyconducts covid-19 testing and I have not been infected with COVID-19 at any point during the past year. The continuation of these symptoms is concerning. There have been at least two instances where the sharp pains in my chest were much more intense than the other chest pains I have felt since the vaccine.

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.

My face went numb for several hours a day and a half after injection. I also had extreme fatigue, headaches, and pain and swelling at the injection site for 7+ days.

Arm soreness, fever, chills, body aches, and headache. All occurred throughout the night and improved by the following morning.

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

Mild aches and joint pain all day. Didn't think anything of it. Then at 830 pm I very suddenly got the chills. Chills turned into shakes. My temp read 99.1. Normal is 97.4-97.7. Took Tylenol and went to bed. Woke up a few hours later sweating profusely. Took temp again, was 101.6. Was very unpleasant. Fever broke a few hours later, though it went up and down throughout the next day, but not nearly as high. This was easily the sickest I've been in 10-15 years.

patient became diaphoretic and dizzy, mild nausea hands went tingling and numb. pt was moved to well ventilated area and recovered quickly. regained color and dizziness diminished.

Left sided numbness/paresthesia with difficulty with dexerity on the left side. Severe pain on entire left side. Fatigue.

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.

Patient looked normal and relaxed before and during vaccination. About 5-10 minutes after vaccination, patient passed out (fainted) while sitting down in a chair. Moved patient on to floor lying down flat and observed him for a few seconds. Patient was un responsive and appeared to struggle to breath. Asked my staff to call 911 for emergency services, and to bring an Epipen just in case, and started to perform CPR on the patient. The patient gained consciousness in about 15 chest compassions and became responsive. He answered the questions like his name, where he lives etc. As the patient became conscious, responsive and appeared to breath normally, I did NOT administer Epipen. Kept patient in observation and kept him engaged in talking until EMS personnel have arrived. They checked his vitals and blood glucose. In the conversation with EMS personnel, they said he is hypertensive and hyperglycemic. Ems took him to the ambulance by walking him (stretcher wasn't necessary)

STOMACH HURT; VOMITING /THREW UP BROWN LIQUID; CAN'T EAT OR DRINK ANYTHING; FEELING COLD; BODY CHILLS; WEAKNESS; LEFT ARM PAIN; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 40 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, non smoker, and non alcoholic. The patient experienced drug allergy when treated with amoxicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 21-MAY-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 21-MAY-2021, the subject experienced stomach hurt. On 21-MAY-2021, the subject experienced vomiting /threw up brown liquid. On 21-MAY-2021, the subject experienced can't eat or drink anything. On 21-MAY-2021, the subject experienced feeling cold. On 21-MAY-2021, the subject experienced body chills. On 21-MAY-2021, the subject experienced weakness. On 21-MAY-2021, the subject experienced left arm pain. On 21-MAY-2021, the subject experienced headache. On 21-MAY-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting /threw up brown liquid, left arm pain, and nausea on 21-MAY-2021, had not recovered from headache, body chills, stomach hurt, weakness, and feeling cold, and the outcome of can't eat or drink anything was not reported. This report was non-serious.

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.

Headache, fatigue, muscle ache (mainly in back), joint ache (legs), soreness at injection site. All of these started within 6 hours of having been vaccinated. Alternating ibuprofen and acetaminophen provided good relief for muscle/joint ache. This also reduced the severity of the headache, but did not relieve it. Headache, muscle ache, and joint ache resolved by 40 hours post-vaccination. Mild fatigue/tiring more easily gradually improved over the next 48 hours. I took one day of sick leave from my job to rest.

Complained of Right lower leg pain, sent to radiology at local hospital for Ultrasound. Ultraspund was positive for DVT. Went from Radiology to Emergency room. Started on blood thinner medication and returned

Patient received his Janssen Covid-19 immunization. The patient arrived at 11:00am on 6/1/21 and completed his pre-screening questions and temperature check. The patient then completed his "Patient Questionnaire and Consent Form." The patient was administered his Janssen Covid-19 vaccine around 11:05am. About 2 minutes after administration, the patient appeared pale and sliding out of his chair. The pharmacy technician responded and held the patient under his arms. The patient convulsed and then became unconscious. We called 911, checked the patient for breathing and responsiveness. The patient didn't stop breathing and became conscious about 1 minute after losing consciousness. We placed the patient on the floor and placed cold compresses under his neck and on his wrists. EMTs arrived and evaluated the patient and made sure the patient was stable. EMTs offered to take the patient to the hospital but the patient declined.

Shortly after receiving the Janssen vaccine, he saw his wife also receive the vaccine after which he felt extremely nauseous and looked very pale. His blood pressure was checked and measured 120/66, he said he was starting to feel warm but did not have any chest tightness, difficulty breathing, or swelling. After about 2 more minutes he said he was starting to feel better and then after 5 more minutes his blood pressure was 120/81, and he was starting to show more color to his face. He said he felt fine to leave. In hind-sight he stated that he has fainted in the past after seeing his wife receive a previous immunization as well.

Patient received COVID-19 vaccine. After approximately ten minutes of sitting in the waiting area, patient began feeling ill. As he was walking up to the drop-off window to tell staff how he was feeling, he fainted and hit the back of his head on the ground. Patient was unresponsive so 911 was called. Patient was extremely pale, hot, and clammy, but slowly started to regain responsiveness. Patient reported blacking out. While waiting for paramedics, two cold ice packs were applied to the patient's head and neck. Paramedics arrived and assessed the patient. They released him from their care as free to go. Patient sat down outside the pharmacy for approximately ten more minutes. Once he decided he was feeling better, he walked around outside the pharmacy until he felt okay to leave. Prior to leaving, patient reported he was feeling better and appeared to be in good spirits. He also reported having fasting labs drawn 45 minutes prior to receiving the vaccine, as well as low blood pressure at his doctor's office. He confirmed ability to drive. Patient left the pharmacy approximately 45 minutes after receiving the vaccine.

Pt. was in his dorm, stood up and stated he could breathe, then went unresponsive. A medical response was called and staff arrived to the dorm within 2 minutes. Pt. took a couple of agonal breaths and stopped breathing, no pulse was found and CPR was initiated. Staff and EMTs administered 45 minutes of CPR, narcan and cardiac medications. He was pronounced dead by EMT at 10:45 am.

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.

06/10/2021 Pt, per EMS report pt had his second covid vaccine shot, started having bad reaction, ems on scene, pt GCS 10, spo2 92% RA, hypotensive. at home pt having bad reaction, vomiting, defecated. Pt on gurney moaning, shaking answering questioning. Per MD, CT results show multiple Pulmonary emboli

Main lingering adverse event is loss of sensation in the median nerve in both hands. Waited over two months hoping it would go away but hasn?t. Brought it up at annual check up with doctor who ran labs and has recommended EMG.

The following day I was shaking uncontrollable head to toe. I could feel nothing but pain. If 10 was the standard before, this was 20-25. a month later a storm came and I had the exact same pain issues and the same pain levels. I went to see my rheumatologist and told him my issues. He sent me to a neurologist and scheduled an appointment with a pain clinic. The rheumatologist gave me a prescription for gabapentin after than, 300 mg two times a day, and it has seemed to help, but my pain problems are getting worse. It is now 3 months later and I am quickly loosing the ability to hand the pain. I have been in none stop pain for the last 18 hours. I am taking a 7.5mg/325 mg pill of Tylenol three that I got from the pain clinic, but it is barely holding the pain back. I have never felt pain like this in all my days.

I have had severe pain in my right leg, it feels like nerve pain. Its very uncomfortable to sit and drive. I saw my PCP ( Kip ) who ordered two rounds of oral steroids. I was then referred to an Ortho who ordered PT, I completed 4 weeks with little to no improvement. I had an X-Ray and MRI of lower back and just received an cortisone injection last Friday.

Neck/muscle pain. From back, bottom, right base of neck, up the neck, to the hairline of head. Barely able to turn my neck to the right. A lot of pain and discomfort. Limited mobility of neck.

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.

Since 7/3/21 patient complains of fever 104.5F, malaise, weakness, rigors, also developed cough and shortness of breath on 7/6/21

SWELLING IN SPINE; INCREASED HEART RATE WHICH GOT WORSE WITH PHYSICAL ACTIVITY; PAIN IN LOWER PART OF BOTH LEGS; TINGLING IN LOWER PART OF LEGS/TINGLING IN TOES; HEADACHE; This spontaneous report received from a patient concerned a 40 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included no known allergies, 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 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced headache. On 23-APR-2021, the subject experienced tingling in lower part of legs/tingling in toes. On 23-APR-2021, the subject experienced increased heart rate which got worse with physical activity. On 23-APR-2021, the subject experienced pain in lower part of both legs. On MAY-2021, Laboratory data included: Blood test (NR: not provided) Unspecified, MRI brain (NR: not provided) Unspecified, and Magnetic resonance imaging spinal (NR: not provided) Unspecified. On 03-MAY-2021, the subject experienced swelling in spine. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from increased heart rate which got worse with physical activity on 28-MAY-2021, and headache on 23-APR-2021, was recovering from pain in lower part of both legs, and tingling in lower part of legs/tingling in toes, and had not recovered from swelling in spine. This report was non-serious.

Woke up around 5:30AM having to go to the bathroom. Went to Flush the toilet and passed out on the floor. My wife found me unresponsive but breathing on the floor. My wife called 911 and was at the hospital around 6:15AM.

Upon wakening this morning pt reports L arm numbness, tingling and flaccidity. pt walked to kitchen and he began feeling sweaty and hot, the next thing he awoke laying in the floor after passing out . Pt was incontinent of urine during event. He now reports some mild shortness of breath but no acute distress or known injuries from syncope episode. pt advised to go to the ER. Pt's states his wife is on her way home and will drive him to the ER.

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.

Patient reports that as soon as he received he experienced tingling through out the his body - to the tip of his toes; experienced light headedness and slight nausea. Shortly after experienced tightness of throat, though denies having difficulty breathing. Patient described as, "having a knot in my throat." Denies experiencing hives, nor itching, no nasal drainage, no cough. States he waited 50 minutes post receipt of vaccine to ensure he could drive. Reports on 03/17/2021 he again experienced tightness of throat; denies difficulty breathing; states it felt like, "my throat was swollen." Again patient denies having difficulty breathing, no hives, itching, no cough. Advised should he experience difficulty breathing to please call 911 since that could be a life threatening emergency; or nearest ER. Denies tightness of throat today, no shortness of breath, nor difficulty breathing.

pt stated after getting the vax he woke about 1 AM feverish, sweating, severe headache, his body was shaking and his teeth chattering. He put a blanket over him to break fever. His teeth were chattering. He took Tylenol and his temp it was 100.4. These symptoms latest a couple of days.

Pt passed put after vaccination with the Janssen COVID-19 vaccine. Roughly 5 minutes after administration of the vaccine, the lady who accompanied the patient got the attention of the pharmacist. Pharmacist ran out to assess patient and saw that he seemed unresponsive. Pharmacist then called for an EPIPEN, but pt woke up before the EPIPEN was ready. No EPIPEN was given. We then monitored the patient's BP every 10 minutes or so. Pt stablized after roughly 45 minutes to an hour and then left the store.

Felt tired at 2:15pm, stayed awake a bit longer than napped for a couple hours. At about 10:30pm I started feeling sick, fever of 99.6, muscle and joint pain, chills, dizziness, weakness. Left arm where I got injected also felt like it was falling asleep at some point when it shouldn't have been based on how I was positioned. I finally took an ibuprofen so I could sleep around 2:30am, and felt better a couple hours later or so. Today so far I feel fine but my resting heart rate is about 30 beats higher than normal so I'm still responding to vaccine. I think overall my symptoms aren't out of the ordinary, just way stronger than I was expecting. I felt miserable.

The effects started off as a general weakness, then progressed into nausea and, by the end of the day, chills. I did not have a fever. I took my temperature and it was normal at 98.1. I describe it as having a cold without the congestion and runny nose. I was fine by the next morning.

Vasovagal event with syncope and seizure activity fir 15 to 20 seconds Client stated he always responds this way to shots. Hx of TBI at age 4 years. Blood pressure 106/68 pulse 84 and 02 saturation 100%. EMS and Dr on site and client released when symptoms resolved. Advised to seek medical attention later if needed. Client verbalized understanding.

Severe chills, shaking Fever of 101F Knee partially paralyzed for 3 days in a row (difficulty walking) Severe headache

Neck pain, back pain, fatigue, weakness, muscle soreness in back, injection shot pain, headache, out of sorts - all lasted from 3-4 hours after shot for approximately 48-72 hours

Severe Axillary Lymphadenapathy shown in left side, with pain radiating into back and chest. Slight Axillary Lymphadenapathy shown in right side, tender to touch. Moderate headache treated with ibuprofen.

At 12:05 am client came to the staff office treatment facility stating he feels sick and has been throwing up. He stated he had the Johnson & Johnson vaccine Tuesday 4/6/21 in the morning and around 6 pm on Tuesday he started to feel sick. The staff took his temperature and it was 100.9 degrees. The client was dry heaving and red in the face and having cold sweats. Staff monitored him while 911 was called and paramedics showed up within 10 minutes. The Program Manager was notified and the client was given instructions for when going to the hospital.

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

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.

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.

Fever as high as 103.7, normal fever in 100-101.5 range, hot and cold flashes, sore arm and swelling in left hand, diarrhea, head aches

Hives start forming 12 hours after receiving vaccine. When I woke up in the morning my body was covered in hives. I went to e.r. in the night as advised by my doctor. They gave me a oral steroid, a pepcid and some benadryl, also gave me prescriptions. When I woke up the next morning hives had mostly gone away, but returned later that evening due to not picking up prescription from pharmacy. I have it now and am taking them. I still get itchy and have some burning but it's very minor and a little more tolerable with the medications.

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.

Patient stated he felt a tingling sensation and really hot about 5 minutes after receiving the vaccine. Patient received Benadryl Liquid at 10mL (25mg) about 2 minutes later (4:07). At that time he stated that the tingling had stopped but he still felt hot. 5 minutes later (4:12) patient stated that he no longer felt hot and thought that it may have just been nerves about the vaccine. Patient left the pharmacy at 4:25 with no symptoms.

About 10 minutes after shot I asked patient how he was feeling, he said he was hot. I walked out to talk to him and he said he felt dizzy. He turned pale and fell sideways off chair onto floor lowering himself with his knee. He did not bump his head, he was sweating profusely, but did not lose consciousness. I yelled to the tech to call 911. Patient was sitting on floor. He said he did not eat much all day. He was alert and talking. He said he fainted when his wife had their baby. We gave his some orange juice. The paramedics arrived 8 minutes later and checked his vitals. In the meantime we called his wife. Paramedics checked his BP, glucose and questioned patient. Patient refuse to go with paramedics. Wife came and paramedics released him to her.

Shot on Friday at 7pm, Immediate arm soreness (fairly severe), then I woke up at 4am sweating and shaking and vomiting. I threw Up 8 times between 4am and 3pm the following day (Saturday), and it is now Sunday morning at 9:30 and the sweating and shaking seems to be subsiding. I would Describe Saturday as ?violently ill?. These were not minor side effects.

Patient was feeling warm and light-headed at 15 minute mark, so we kept for further observation and gave water to hydrate. At about the 17 minute mark patiently suddenly fainted in his chair for 15-30 seconds. He then began to vomit and woke up in the process. Once he fully came back to, he said he felt remarkedly better and no longer felt light-headed or clammy. Following this episode he reported feeling back to normal and that he had just ate a large breakfast before coming in for the shot, but did not feel bad in any way anymore. We observed for another 30 minutes and patient showed no further sign of issues. He was released with his wife.

Severe Chills, Temp of 102, muscle spasms in back, and minor headache Lasted for several hours in the evening following vaccination. Needed to sleep in a heated blanket for a few hours. Took NyQuil for symptoms relief and sleep aid. The headache persisted for additional 24 hours (36 hours from vaccination)

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.

Chills and shivering before bed, (could not get warm). Lasted until morning 10APR. Headache in the AM 10APR. Lasted a few hours. Achy feeling all over. Very tired. Lasted until morning 11APR.

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.

I had chills the first night after the vaccine. In addition to that I have continuous pain in the legs, feeling of dizziness and fatigue even after sound sleep in the night. I am having feeling of nausea and vomiting on a continuous basis which have not gone away even after four days have been complete since vaccination.

Awoke with right lower leg paresthesias. Intermittent, anterior aspect of leg, no other explanation for symptoms. Normal exam, no swelling, normal neuro exam.

Seizure and lost of consciousness 3 minutes after vaccine was administered. No treatment was given at pharmacy, but patient was taken by paramedics.

never ending headache on the right side of my head, temple to jaw, ear, since about four days after receiving the vaccine on 3/27/21. The first three days were weakness and flu like symptoms

11 days after vaccination patient had the onset of generalized myalgias, headaches. This was followed by the onset of unilateral facial weakness 17 days after vaccination. On examination, he had ataxia and facial weakness. He had MRI's, LP and EMG/NCS which confirmed demyelinating polyradiculoneuropathy, presumably Miller Fisher variant of Guillain Barre Syndrome.

I woke up Monday morning after receiving vaccine on Sunday with a severe headache and cold sweats. The cold sweats have subsided however I am still having a headache. Its not as severe as it was on Monday but i have kept a headache since Monday even taking Tylenol and ibuprofen doesn't make it completely go away.

Night of vaccination approx. 10pm, very painful body aches with fever and chills; especially in lower legs, felt like a deep muscular ache that could not be stretched out; I would relate this feeling to "growing pains" experienced as an adolescent. Fatigue lasted for 3 days after this event

Patient had initial onset of headache which worsened to left facial droop and left sided weakness prompting his presentation and subsequent admission to the hospital. The patient's left sided weakness has resolved, however, his left sided facial droop persists. It includes significant left obicularis muscle weakness and tearing suggestive of LMN etiology (Bell's)

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.

Patient became pale, diaphoretic, and experienced a syncopal episode, laid flat and then had simple partial seizure lasting 10 seconds, became incontinent, IV started, A and O x4 , transported to hospital via ambulance

pins & needles sensation and "twitching" in muscles of bilateral lower extremeties, chest discomfort, abdominal pain, headache

CRAMPING SENSATION; BAD LEFT LEG PAIN; HEADACHE DAILY; LEFT LEG MUSCLE PULLED; This spontaneous report received from a patient concerned an adult male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no known drug allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced left leg muscle pulled. On 10-APR-2021, the subject experienced headache daily. On 21-APR-2021, the subject experienced cramping sensation. On 21-APR-2021, the subject experienced bad left leg pain. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bad left leg pain, headache daily, and cramping sensation, and the outcome of left leg muscle pulled was not reported. This report was non-serious.

TINGLING AND NUMBNESS ON LEFT SIDE OF FACE; CHILLS; FEVER; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 41 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, the subject experienced tingling and numbness on left side of face. On 21-MAR-2021, the subject experienced chills. On 21-MAR-2021, the subject experienced fever. On 21-MAR-2021, the subject experienced headache. On 21-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fever, and headache on MAR-2021, and had not recovered from tingling and numbness on left side of face, and fatigue. This report was non-serious.

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.

Day 1-3-headache, body pain, cold sweat, so took tylenol. Day 4-6- hard to walk and leg pain, take tylenol. Day 7-13- can walk but my leg and hand pains and shaking and headache feel like electric thru my head, take tylenol. Day 13-present- still have leg pain and headache like electric thru my head and my b ody shake itself when i move or stand little while

continuous muscle pain on the left shoulder/neck area. identical feeling to having a crick in the neck

INTERNAL ITCHINESS; MILD CHILLS; FATIGUE; This spontaneous report received from a consumer concerned a 41 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced fatigue. On 23-APR-2021, the subject experienced internal itchiness. On 23-APR-2021, the subject experienced mild chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue on 11-APR-2021, and was recovering from internal itchiness, and mild chills. This report was non-serious.

5/5/21: "Good morning sorry to bother you had a question about this shot (Janssen Covid19 vaccine). I have been checking in with that website (V-safe App) you gave me no one has contacted me. Monday (5/3/21) I missed work due to me not feeling good and still today (5/5/21) I'm at work but feel like I could fall asleep, no energy, nausea still, and like I haven't slept in weeks even though I get good sleep. My breathing has gotten to the point that it hurts to take a deep breath. I believe this is all due to the shot but didn't know what you thought."

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.

Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: 15 minutes post administration patient reported numbness /tingling @ left wrist and left hand (outside edge of hand along little pinky finger side).

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

Systemic: Fainting / Unresponsive-Mild, Additional Details: Fainted. Responded after about 10 seconds. Has history of fainting / abscent seizures. Pulse and blood pressure normal immediately after incident occured.

April 30th began to notice dull ache in calf. At first assumed it was a muscle cramp. The pain began to increase through the weekend and into the following week. I went to urgent care on May 6th. They sent me to the ER to get an ultra sound as their preliminary evaluation was that it could be a blood clot. The ER ultrasound confirmed the presence of a superficial thrombosis in my left calf. No blood work was performed. I was told to take ibuprofen and use a heated compress and to wear compression stockings. If the pain grew worse, I was to return to the ER. I scheduled a follow-up with my Primary the next day. Blood tests show all values to be in normal range. I have no history of blood clots and perform cardiovascular exercise on a daily basis.

Patient is 41 year old who presented with right sided upper and lower extremities weakness with facial drip , call as code stroke level 1 -CTbrain, CTA showed right basilar ganglia hemorrhage with small volume subarachnoid hemorrhage, left middle cerebral artery thrombosis with left basilar ganglia infarct and right basilar ganglia infarcts. TEE was negative for LV thrombus /vegetation .

Patient claims 3 minutes after vaccination, his body felt like "it was on fire", he started sweating and he felt like passing out. He also claims he could not move or speak for 30 minutes. The patient then claims he was completely fine after 1 hour and has no reaction today.

Tingling in arms/hands/legs/feet. Headaches and dizziness and brain fuzziness. Can?t focus and head hurts constantly. Tingling still comes and goes. It?s been 5 weeks after vaccination.

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.

Felt severe burning/stinging pain in injection site upon injection. Left pinky and ring finger were pretty numb shortly thereafter for about a day or two. Numbness still comes and goes, but not as bad as after the initial injection. After about day 2 started to have severe pain in joint of left shoulder along with impingement, popping. Uncomfortable to sleep on left shoulder as it starts to hurt and "feels" as if it will pop out. Range of motion seems pretty normal, but still getting some pain, popping, and impingement with certain movements/actions throughout the day. I believe it to be SIRVA.

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.

Patient presented 6/3/2021 with thrombus in the top of the basilar artery. Received IV alteplase. Went for mechanical thrombectomy, but catheter angiogram showed resolution of basilar thrombus. He is improving neurologically, currently has some L visuospatial neglect, left lower motor neuron facial weakness and mild dysarthria. He remains hospitalized. This week he will have MRI of brain, cardiac MRI and transesophageal echocardiogram performed. He may have right heart catheterization and closure of the patent foramen ovale.

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

Background:41-year-old male reported that he awakened with right lower leg pain intermittently since approx. May 10 2021. Woke on June 10 with increased pain and swelling to RLE. He tried to "run it out" but the pain worsened. In the ER he was noted to have elevated D-Dimer- 1980, ESR of 27, labs otherwise normal. Ultrasound showed DVT. He was started on hydrocodone-APAP and Xarelto. Returned on 11 June with SOB. PE was confirmed. Admitted to ICU Note today states continued swelling and pain to RLE. Considering transfer to hospital for vascular consultation and further management.

FEELING FAINT, PALE, SKIN COLD AND CLAMMY, ICE PACK APPLIED TO FOREHEAD STATES FEELING FINE WENT HOME WITH FATHER

fainting multiple times, significant drop in blood pressure, sent in ambulance to ER, returned home that evening but remained very physically weak and had spurts of fever for several days following

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.

Pain started at elbow and shot down to the wrist and hand. Worsened with time. Could not lift anything, had to wear a sling to avoid movement and pain has not fully gone away until now. It's lessened, but I have to avoid doing many things with my left arm now. Diagnosed with Compression of right radial nerve, left lateral epicondylitis, left ulnar nerve irritation on Friday April 23, 2021.

Woke up on morning after shot with uncontrollable shaking. I ended up needing to lay under several blankets in order to feel warm and stop shaking. My temperature was normal and shaking was not due to a fever. The shaking stopped about 15 hours after I received the shot but then I continued to have a headache and extreme fatigue. The following day (about 48 hours after injection) I had an extremely high pulse. I took both my blood pressure and was able to take an EKG using a EKG recorder. Both devices came back that I was having an irregular heartbeat. I repeated both tests about a half dozen times and they kept coming up the same indicating an irregular heartbeat. I have never had an irregular heartbeat before in the past. Finally after a couple of hours my heart rate slowed and the irregular heartbeat went away. As of right now (6 days post injection) it has not come back.

NUMB IN HANDS; SHOCKING PAIN/EXTREME PAIN; NEUROPATHY PAIN; CRAMP IN HANDS AT NIGHT; This spontaneous report received from a patient concerned a 41 year old male. The patient's weight was 240 pounds, and height was 76 inches. The patient's concurrent conditions included diabetes, high dose penicillin allergy, adhesive tape allergy, non-smoker, and non alcohol user, and other pre-existing medical conditions included the patient had otc drug allergy. the patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with morphine, and pseudoephedrine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. Concomitant medications included insulin for diabetes. On 21-MAR-2021, the subject experienced shocking pain/extreme pain. On 21-MAR-2021, the subject experienced neuropathy pain. On 21-MAR-2021, the subject experienced cramp in hands at night. On 02-JUL-2021, the subject experienced numb in hands. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from neuropathy pain, shocking pain/extreme pain, cramp in hands at night, and numb in hands. This report was non-serious.

SHAKY HANDS AND LEGS; CANNOT WORK; CANNOT EXERCISE; MUSCLE PAIN ON FEET AND LEGS; MUSCLE WEAKNESS/WEAKNESS ON FEET AND LEGS; NUMBNESS ON NECK, CHEST, ARMS, FEET AND LEGS; STOMACH PAIN/BURNING SENSATION; COLD SENSATION COMING FROM INSIDE OF BODY LEADING TO HEART; PAIN AROUND HEART, SHOWING UP INTERMITTENTLY; DIZZINESS; HOT SENSATION OVER FEET AND BODY; BACK PAIN ON KIDNEY AND LUNGS AREA; PAIN ON FEET AND HANDS/ PAINS WORSEN AT NIGHT ON FEET, HANDS, LOWER PAIN, AND UNDER ARMPITS; BURNING SENSATION ON FEET AND HANDS; MUSCLES SPASMS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 41 year old male. The patient's weight was 134 pounds, and height was 155 centimeters. The patient's past medical history included covid-19, and covid-19 like symptoms, and concurrent conditions included tomato allergy, alcohol use, non smoker, and gum infection, and other pre-existing medical conditions included the patient has no history of drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced muscles spasms. On 17-APR-2021, the subject experienced pain on feet and hands/ pains worsen at night on feet, hands, lower pain, and under armpits. On 17-APR-2021, the subject experienced burning sensation on feet and hands. On 18-APR-2021, the subject experienced stomach pain/burning sensation. On 18-APR-2021, the subject experienced pain around heart, showing up intermittently. On 18-APR-2021, the subject experienced dizziness. On 18-APR-2021, the subject experienced hot sensation over feet and body. On 18-APR-2021, the subject experienced back pain on kidney and lungs area. On 18-APR-2021, the subject experienced cold sensation coming from inside of body leading to heart. On JUL-2021, the subject experienced numbness on neck, chest, arms, feet and legs. On 01-JUL-2021, the subject experienced muscle weakness/weakness on feet and legs. On an unspecified date, the subject experienced shaky hands and legs, cannot work, cannot exercise, and muscle pain on feet and legs. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Unknown, Stool culture (NR: not provided) Unknown, Tuberculosis test (NR: not provided) False-positive, and Urine culture (NR: not provided) Unknown. Treatment medications (dates unspecified) included: omeprazole, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numbness on neck, chest, arms, feet and legs on JUL-2021, dizziness on 19-APR-2021, headache on 13-APR-2021, and fever on APR-2021, had not recovered from stomach pain/burning sensation, pain on feet and hands/ pains worsen at night on feet, hands, lower pain, and under armpits, muscle weakness/weakness on feet and legs, pain around heart, showing up intermittently, muscles spasms, hot sensation over feet and body, back pain on kidney and lungs area, shaky hands and legs, burning sensation on feet and hands, and muscle pain on feet and legs, and the outcome of cannot work, cold sensation coming from inside of body leading to heart and cannot exercise was not reported. This report was non-serious.

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

have been extremely fatigued, headaches, muscle aches, swelling in my fingers (joints), weak, dizzy, weird feeling in my chest

About 8 hours after the injection I felt chills, night sweats, headache, lethargy, dizziness, muscle aches, pain in my entire right arm and loss of appetite. Lasted about 36 hours.

20 minutes after receiving vaccine patient reports paresthesia in bilateral feet traveling up legs to bilateral arms and hands. Patient reports fatigue and headache. Patient able to hydrate with water. After 1 hour of observation, patient reports symptoms improved significantly. Patient informed to take Acetaminophen/Ibuprofen, to consume food/fluids and rest. Advised to follow up with primary care physician. Advised to call 911 if symptoms persist or respiratory distress. Patient declined transportation to hospital for evaluation. Patient reports able to drive home safely which is about 10 minutes away. Patient was ambulatory upon discharge. BP 118/80. HR 82.

I had the vaccine at 4:00 PM. I woke up at 12:05 AM with severe chills that turned into uncontrollable shaking for the next hour and twenty minutes. The shaking stopped at that time and my temperature went from 101.1 to 102.5. My skin was warm and I began to be very clammy. Around 3:45 AM, the fever broke and I was down to 99.5. I?ve subsequently had muscle aches and the feeling of being fatigued.

Around 8pm I became very cold and tired. I took a bath, which is out of character, and tried to sleep. By 9 pm I was alternating between hot and cold sweats. By 10 pm I was vomiting and defeating uncontrollably while still alternating between hot and cold sweats. I dry heaved until around 3 am and then finally passed out. My fever never exceeded right about 100 degrees. For the next 2 days I was incredibly exhausted with muscle aches and a minor headache. I didn?t return to baseline for approximately 6 days after the shot.

Severe Headache, Extreme inflammation in already injured neck and upper body bringing current pain level to 10. Fever, chills, naseau, dizziness, tiredness.

Muscles started to shake mildly, 8-10 hrs later. Next day Severe HEADACHE. Not pounding, but stiff pressure on both sides of temples. Treatment was 2 IB motrin, Slept for an hour and felt GREAT afterward. By 3 pm I was in great shape, no other issues to report even after 10 hours have past.

After the initial 12 hour period, I experienced night-time chills followed then by being too warm and night sweats. This happened both the first and second night. During the day I was taking Tylenol every 6 hours for aches and pain. Mainly my neck and back have been what hurts, although my knees, elbows, hips, etc. also were achy. The third and fourth days I still continued to have chills, no fever throughout as far as I am aware (took my temp 2-3 times). The fourth day I was very faint and somewhat unbalanced, felt shaky and light headed and I ended up having an anxiety attack. I mention the last symptom as I have never had an episode like this previously in my life. Today is day 5, still feel tired, slightly nauseous, neck and back pain, headache, difficulty focusing.

KNOT ON LEFT ARM; OFF LABEL USE; INAPPROPRIATE ROUTE OF VACCINATION; INCREASED BP; INCREASED HEART RATE; DIZZINESS SUNDAY AND MONDAY; PAIN IN ARM; DONT FEEL WELL; SOME NAUSEA; TINGLING OF HAND; This spontaneous report received from a patient concerned a 42 year old male. The patient's weight was 239 (unit unspecified), and height was 5 (unit unspecified). The patient's concurrent conditions included allergy, thyroid, sinus infection, elevated growth hormone, non-alcoholic, and non-smoker, 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, intravenous, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on left deltoid on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced tingling of hand. On 27-MAR-2021, the subject experienced off label use. On 27-MAR-2021, the subject experienced inappropriate route of vaccination. On 27-MAR-2021, the subject experienced increased blood pressure. On 27-MAR-2021, the subject experienced increased heart rate. On 27-MAR-2021, the subject experienced dizziness Sunday and Monday. On 27-MAR-2021, the subject experienced pain in arm. On 27-MAR-2021, the subject experienced don't feel well. On 27-MAR-2021, the subject experienced some nausea. On 28-MAR-2021, the subject experienced knot on left arm. Laboratory data (dates unspecified) included: EKG (NR: not provided) clear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness Sunday and Monday, and had not recovered from knot on left arm, tingling of hand, pain in arm, some nausea, increased blood pressure, increased heart rate, don't feel well, inappropriate route of vaccination, and off label use. This report was non-serious.; Sender's Comments: V1: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.

Patient received covid vaccine at 12:56pm on March 31, 2021. At 1:00pm he sat down on the floor. He remained conscious but complained of feeling dizzy. HR was 40. Staff was able to assist pt into a wheelchair and escort him into a private side room. Pt was assisted onto a cot and his legs were elevated. At 1:05 his BP was 130/75 and HR 60's. Patient's skin at 1:06pm appeared pink and WNL. 1:13pm = BP 115/75 and HR 67. 1:23pm = 130/75 HR 68. Patient denied shortness of breath/chest pain throughout the entire episode and did not lose consciousness. At 1:23 patient stated he no longer feels faint, just a bit weak. At 1:24pm patient dangled on cot. 1:27pm = 130/80, HR 70. 1:33pm = left facility in the care of his mother who is driving. He stated he feels a little weak, but not faint or dizzy. He left ambulatory. He refused transport or the need for additional medical care. Follow up call was placed to pt on Friday, 4/2/21. Pt denied any residual effects and stated he is at baseline.

Patient received Janssen lot#1805020 with expiration of 05/25/2021 at 1420 sitting in upright chair. Vaccinator was notified that he has a history of vasovagal response with needles. This response presents itself as sweating (and possible fainting) and is alleviated by lying down. Client mentioned that previous nurse advised him to smell an alcohol pad to distract and prevent a vasovagal response, as this had worked previously on a glucose check. No medications were disclosed or history of anaphylaxis reported. With this background information, RN offered to have vaccine administered in reclined position, however client refused. RN conferred with co-lead about administration recommendations. Vaccinator then checked in with patient at 1423 to see if patient was okay and patient did not answer the question. RN then felt the client's hand and noticed hand was clammy. At 1425 the reclining chair was brought to the station and patient was transferred into chair, appearing diaphoretic. RN palpated pulse and noted patient was not tachycardia, but RN did note tachypnea and uneasiness. RN then provided distraction and promoted relaxation. Then at 1426 patient reported feeling okay and RN noted patient no longer felt clammy. At 1440 patient was asked if he would prefer if EMS should be called, patient declined and stated that he was able to drive home. Then at 1447 patient left the site appearing well, alert and oriented x3 leaving by self in private car.

3/13/2021 began having right forearm wrist was sensitive to touch and skin clammy. 3/14/2021 still clammy in both hands. 3/15/2021 whole body clammy and sticky. Both shins and ankles had burning sensation. 3/17/2021 both ankles painful mostly at night. 3/18/2021 both ankles, shins and legs painful all day. Unable to sleep at night. 3/19/2021 left work early due to nauseated, headache and pain and burning both legs. Blood pressure elevated. 3/20/2021 head pounding and elevated rate and nauseated. Went to ER for continued leg/shins burning and pain. ABI was normal. Diagnosed with neuropathy. 3/23/2021 blood pressure elevated due to pain 3/24/2021 pain to legs and shins continue below know. pain scale 5. 3/26/2021 pain to legs and shins pain scale 7 3/27/2021 pain to legs and shins pain scale 3 3/29/2021 burning and sensitive legs. Sensitivity now present in both arms. 3/30/2021 burning to forearms and legs 4/1/2021 pain scale 3 burning pain to forearms and legs. 4/4/2021 improved pain 4/5/2021 tingling resumed to legs and calves. Pain scale 4. 4/6/2021 sensitive/burning bilateral forearm and wrist and bilateral legs. 4/7/2021 left leg burning more and feels warm. Back ache began 4/8/2021 both legs still burning and tingling. Heart rate elevated. Back pain continues.

DID NOT SLEEP; FEELING HOT; This spontaneous report received from a vaccine facility concerned a 42 year old male. The patient's height and weight were not reported. The patient's pre-existing medical conditions included unspecified medical history from military service. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On 31-MAR-2021, the subject experienced did not sleep. On 31-MAR-2021, the subject experienced feeling hot. The action taken with covid-19 vaccine was not applicable. The patient recovered from did not sleep on 01-APR-2021 and the outcome of feeling hot was not reported. This report was non-serious.

He got cold and clamy and passed out in the chair with head slumped. His wife rubbed his chest and spoke to him and I, waved ammonia inhalants under his nose. He immediately came to. We got him a bottle of water and a snack (he had not eaten yet today). I also checked his blood pressure and it was normal. We had him sit a little longer until he felt better. We initially called an ambulance, but called it off at his request.

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.

Started with a mild rash on my neck, shoulders, head and inner thighs. After about 30 minutes of noticing that I started getting tremors for about 30-45 minutes in my legs. All symptoms started at 7:15pm cst amd lasted until 9pm cst. No symptoms after that.

Vasovagal / syncope episode with subsequent fall to the ground, striking head; taken to the Emergency Department, stated prior to syncopal episode felt lightheaded, sweaty, clammy. Patient discharged to home within 3 hours of ED admission.

Vasovagal / syncope with subsequent fall to the ground, striking head; transferred to Emergency Department - stated lightheaded, dizziness, clammy prior to syncope and fall. Patient discharged to home in stable condition from facility within 3 hours.

My initial symptoms were light swelling a region around the shoulder of my injection arm and excessive sweating in the armpit on my injection arm side. Following this, symptoms similar to being on a hallucinogenic gradually manifested over the next several hours, including euphoria, a persistent urge to grind teeth, and some mild-to-moderate visual and physical effects. Following the date of the injection, the primary symptom has been a bruise/cramp hybrid pain in the upper arm of the injection site that is gradually receding (but still ongoing), along with random light bouts of nausea and headaches, random light pains throughout my injection arm, and occurrences of coldness in my injection arm (lasts about an hour)

Started feeling dizzy and started to respond slowly to things and felt weak around 8pm. Shortly after these symptoms I begin to have uncontrollable chills followed by a fever and Nausea. The whole time starting around 8pm I had pretty bad muscle aches as well. I took a warm shower and bundled up the whole night because I had a fever, aches, chills, and nausea. It was impossible to sleep because of this and sometimes my heart was beating fast as well. The next morning I had a headache that would not go away until I took Tylenol. The whole next day I felt exhausted as well and very weak. I began to feel better on day 3 but still feel somewhat foggy from the shot. I would not recommend this vaccine to anyone and would never get it again and hopefully the foggy sensation goes away.

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.

Severe leg pain first, then trouble breather. Shortness of breath and tightness in chest. Thought it was severe congestion... delayed going to the ER. Finally went in due to vomiting trying to get breath. Had LAD 90% blocked and blockage in the right leg still in hospital receiving treatment. Will Catheter scope the right leg to very clots and severity.

About 45 minutes after, my left arm started to feel like there was pins and needles all the way down to my finger tips, and I started to feel very lethargic on and off for 2 days and I also had a few rounds of tachycardia. As of Monday I have developed severe lower back pain

At the day of vaccine the only side effect was arm sore and tingling on the face. On 04/14/2021 I was at the doctors clinic for an appointment and suddenly felt tingling on the left side, temporal area, after some minutes start having rapid heart rate and blood pressure was high, felt lightheaded, weak. The symptoms last for few minutes.

Received vaccine 3.24.21. Had been incarcerated / in prison system until 4.7.21. Complex past medical history. 4.10.21: Went to ED on 4.10.21 - for hematuria. CHIEF COMPLAINT: BLOOD IN URINE (patient reports hematuria an hour prior to arrival along with spitting up a large clot (hemoptysis). denies rectal bleeding at this time. denies being on a blood thinner. c/o back pain starting a few hours ago. HX aortic aneurysm and scheduled to get surgery in a few weeks. )Urinalysis returned showing moderate amount of blood was 73 RBCs. Patient did not have frank hematuria on specimen. Patient's laboratory work otherwise remains unremarkable. Electrolytes within normal limits. Patient has a stable hemoglobin of 13.8. CT scan showed evidence of acute aortic dissection. There were scattered faint ground-glass opacities along the right upper lobe as well as left upper lobe. COVID-19 testing was added on after results. At this time I do not have a great explanation for the patient's hematuria. I did instructed to follow up with Urology for further evaluation of this. He is hemodynamically stable I do not believe further testing is warranted at this time. Return precautions were discussed including urinary retention, large volume bleeding or any other concerning symptoms. He voiced understanding of this and was discharged stable condition. He was provided a work note as he is on probation and it is for her of his hospitalization at this time. 4.13.21: Went to ED on 4.13.21: CHIEF COMPLAINT: LEG PAIN (pt c.o. right leg swelling/pain that started 3 days ago; had johnson&johnson vaccine on 3/24 and is concerned for blood clots; supposed to have surgery at the end of the month; recently seen for blood in urine; c.o. generalized body aches)42-year-old male presents with right calf pain and reported swelling. On presentation patient is well-appearing and nontoxic, afebrile, hypertensive 134/113 with otherwise normal vital signs. On exam, the patient has no swelling in the bilateral lower extremities, he does have very mild tenderness to palpation in the right posterior proximal calf just below the knee. Remainder of physical examination is otherwise unremarkable. Given history of blood clot and reported right calf pain, right lower extremity duplex venous ultrasound ordered to evaluate for DVT. EKG was obtained on arrival, and showed normal sinus rhythm with no evidence of ST segment elevated for depression, no dysrhythmia, no comparison when compared with prior EKG from July 2019. Right lower extremity ultrasound showed no evidence of DVT. I shared results of the workup with the patient and told him that there is no indication for further workup or treatment at this time. I recommended Tylenol or Motrin as needed for right leg pain. I recommended compression stockings as needed for right leg swelling. I encouraged him to follow up with all specialists physicians as previously scheduled and with his primary care physician as needed. Office visit 4.14.21: Subjective: a 42 yr.. male evaluated with a video visit on 4/14/2021 Currently he complains of headache, hot/cold flashes (no fever), nasal congestion, and Bilat ear pain. R leg is swollen. The symptoms have been present for 2 day(s). Was incarcerated - has been out for about week. He denies a history of chills and fevers He has tried acetaminophen, Flonase for his symptoms. Sick Contacts: none known History is provided by patient There is history of asthma or recurrent respiratory infections. Went to the ER yesterday and 4/10 Had his J&J vaccine: 3/24 COVID19: negative 4/10

SORE ARM; CHILLS; FATIGUE; NAUSEA; FEVER; TOTAL BODY MUSCLE ACHES; 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: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: Body temperature (NR: not provided) UNKNOWN. On 08-APR-2021, the subject experienced sore arm. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced fatigue. On 08-APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced total body muscle aches. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, nausea, fever, and total body muscle aches on 10-APR-2021, and had not recovered from fatigue, and sore arm. This report was non-serious.

Arm pain, excessive fatigue, nausea, confusion, dizziness, sweats, cold, pain in joints. started Monday and continues today, 5 days later

1st Adverse Event 4/13/2021, Left posterior lower leg(calve) pain, lasted 2 days, no treatment 2nd Adverse Event 4/16/2021 Left posterior knee pain, pain is still present but pain level has decreased, no treatment 3rd Adverse Event 4/16/2021 Left supraclavicular tender and enlarged lymph node for 2 days, no longer tender but lymph node is currently slightly enlarged, no treatment.

HEART PALPITATIONS; FAST HEART RATE; SHORTNESS OF BREATH; SHAKINESS; WEAK FEET; 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: 1808980,expiry: 20/JUN/2021) dose was not reported, administered on 07-APR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced heart palpitations. On 07-APR-2021, the subject experienced fast heart rate. On 07-APR-2021, the subject experienced shortness of breath. On 07-APR-2021, the subject experienced shakiness. On 07-APR-2021, the subject experienced weak feet. Treatment medications included: paracetamol. On 08-APR-2021, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heart palpitations, shakiness, shortness of breath, and fast heart rate, and the outcome of weak feet was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.

First 2 days after vaccine I had the expected slight sore arm, some minor headache, some muscle aches. Nothing major that kept me from working or sleeping. Some time after, maybe 3rd or 4th day, I noticed a shortness of breath. This I did not expect since it's not a listed side effect for the vaccine but it is one for Covid. I notice it everyday while sitting/working. It does not keep me from being active (running/yard work) but I notice I'm not 100% healthy feeling. It feels like the shortness of breath is closer to the top of the chest/throat area if that makes any sense. If I breathe deeply it feels like I may want to cough although I don't usually cough from doing so. It's mostly just a constant feeling of a very slight shortness of breath.

Leg pain, Back pain , Developed shingles 5-6 days after the leg and back pain started. (April 11-12th.)

PASSING OUT/FAINTING; LOW HEART RATE (30 BEATS PER MINUTE); DECREASED BLOOD PRESSURE (60/50); SHAKING; This spontaneous report received from a patient concerned a 42 year old white, not Hispanic or Latino male. The patient's height and weight were not reported. The patient's concurrent conditions included seasonal allergy, non alcoholic and non smoker. The patient did not had drug abuse or illicit drug use. The patient did not had reactions before with any other vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) frequency one total, dose was not reported, administered on 12-APR-2021 at left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021 after vaccination, the patient immediately experienced low heart rate (30 beats per minute), decreased blood pressure (60/50), profuse sweating and shaking and as the result he passed out immediately. The patient reported that he was under care of the medical staff at the facility and both his heart rate and blood pressure were reassessed multiple times within the hour of observation. The patient reported that vaccination provider advised him that his reaction was not related to the Janssen Covid-19 vaccine and that he fainted only because he was afraid of the needle but the patient denied and stated that he was not afraid of the needle. Laboratory data included: Blood pressure (NR: not provided) 60/50 mmHg and heart rate (NR: not provided) 30 beats per minute. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passing out/fainting on 12-APR-2021, and low heart rate (30 beats per minute), decreased blood pressure (60/50) and shaking on unspecified date APR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210428755 -JANSSEN COVID-19 VACCINE Ad26.COV2.S- Passing out/fainted, low heart rate, Decreased blood pressure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

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.

NECK LOCKED UP; ARM DEAD; PAIN ABOVE ELBOW; HIGH FEVER; SHEETS COMPLETELY SOAKED; This spontaneous report received from a consumer concerned a 42 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no 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: Unknown) dose was not reported, administered on 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 sheets completely soaked. On APR-2021, the subject experienced high fever. Treatment medications included: diazepam, and lidocaine. On 15-APR-2021, the subject experienced neck locked up. On 15-APR-2021, the subject experienced arm dead. On 15-APR-2021, the subject experienced pain above elbow. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from high fever on APR-2021, was recovering from neck locked up, had not recovered from arm dead, and pain above elbow, and the outcome of sheets completely soaked was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.

Right side tingling past 10 days. Reports tingling to right face and right arm feels like intermittent pins and needles. Received Janssen COVID vaccine on 4/12/21 at an outside facility. Diagnostic workup revealed Cerebral Vascular Accident (CVA).

Patient vaccinated with J&J vaccine 3 weeks ago with 4.5 weakness and decreased mobility in the arm that he received vaccine in- cannot lift arm above shoulder . No inflammation noted

fever of 102, body aches, muscle twitching and shaking, extreme sweating, started approx. 10pm, fever broke approx 7am, still having muscle twitching and body aches

Patient started filling dizzy about 10 minutes after vaccine. He felt weak and tired and also started sweating profusely. Skin was cold and clammy to the touch. I checked his BP and it was 89/53. I called 911 as precautionary and ems arrived within 5 minutes. Patient had stopped sweating by then and was able to stand and walk with EMS to another area of the store to be evaluated further and monitored.

Complain of headache to right back side of head and reports its moving to front of head. Reports its started on Monday. Was using ice packs and heating pads. Reports 10/10 on pain scale. Reports his head is tender to touch in the back. Denies any head injuries recently.

Hours later I experience a crushing migraine, chills, fever, body aches, and soreness through the night for the next 14+ hours

Fever spiked at 101.9 14 hours after the shot but has was completely gone 28 hours after the shot. Mild headache the day following the shot. Arm is mildly sore two days after the shot.

Systemic: Confusion-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Additional Details: patient was given jassen vaccine. during 15 minutes observation. patients appeared to black out for 3 seconds. patient can breath ok. no epipen injection was given. after 30 min. patient is coherent. BP 117/75. normal sinus rythm. 911 was called. Patient stated that he doesnt want to go to the hospital and doing fine. Patient had pee himself.

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.

Right toe began hurting on May 8. 3 out of 10 pain. No redness or warmth. Fever (103 F), body aches, and fatigue on May 8. Took Tylenol 500 mg TID that day. No fever, body aches on May 9 but fatigue remained. Fatigue remains mild to moderate. Right toe continues with discomfort.

I experienced three days later bilateral leg pain, left greater than right., I also had headaches that were constant. I went to urgent care where they did exams. I can say that to this day I still have leg pain, L>R and some headaches that come and go.

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.

I, am reporting this VAER on behalf of my brother who is currently incarcerated in a state correctional facility in PA. During a phone call a few days following his vaccine, he told me that his continues to experience shoulder pain and issues with range of motion following administration of the J&J COVID vaccine. When he first informed me, I asked him if the discomfort he was feeling was expected pain and discomfort at the injection site, to which he responded no. He reports that a couple days following administration upon stretching when waking he experienced shooting left upper arm/shoulder pain and reduced ROM the arm in which he received the vaccine. I am reporting this adverse event as he is still having this issue.

Could not get air into lungs, made sugar get out of control, had a seizure and turned purple, passing out , ambulance had to come get me from vehicle and take me to emergency room in the hospital, kept me there for about 6 hours then released me to go home, went to my Doctor next day and he immediately sent me to hospital. I was checked for Blood Cloth due to the signs being there along with other tests I am home however I still do not feel well.

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

I had general soreness and stiffness. I took a bath before I went to bed because I noticed a fever. I had a fever of 103 F. I also realized I lost my motor skills. I was not able to do normal functions. Around 3:00am I experienced shakiness, and I experienced the worst headache in my life. I also have bumps that have appeared on my face. My right arm where I did not receive the shot I saw bruises down my arm. April 25,2021 is when I was in the hospital my blood pressure dropped and my pulse because very low. My blood pressure has been very high since I have gotten the vaccine.

Soreness in feet, ankles and calves starting on March 24th, then soreness started progressing up the body with numbness and tingling within my trunk, skull, arms, hands, legs and feet. Lightning Strikes throughout my whole body

11 days following the single shot I developed severe pain in my right calf muscle that felt like a charlie horse and on my leg from knee to my ankle felt a squeezing sensation like I was wearing a very tight sock that I couldn't take off. After a few days the pain subsided and the similar pain began in my left leg however not as severe. The pain would seemingly move around and come and go. Some days it was so bad I couldn't walk or balance. I believed I had a muscular issue. I then began having swelling on the top of my left foot and around the ankle of my left foot. After about a week, my right leg began to swell from the knee to ankle fairly significantly. New veins appeared on the front of my right leg and other veins on the back of my right leg began to bulge. Pain on both legs started to subside on the evening of 5/23, however swelling continued. On the evening of 5/25 I was experiencing severe squeezing sensation and bulging veins in my right leg.

Reported he walked to health department from home. After administration of vaccine, complained of tingling in right hand and wrist at 1544. Drank some bottled water. Complained of feeling sleepy and a headache. Began nodding off and then became unresponsive. BP at 1600: 98/78. Pulse: 80. BP at 1607: 100/70. Pulse: 72. Was beginning to rouse around this time but drowsy. Respirations 16. BP at 1615: 86/60. 911 called. Taken to hospital via ambulance at 1628.

HYPOAESTHESIA; NEURALGIA; HEADACHE; This spontaneous report received from a health care professional via a Regulatory Authority [VAERS FDA Inbound Unit] 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 known allergies and illness at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 265AZ1A expiry: UNKNOWN) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-APR-2021, the subject experienced hypoaesthesia. On 30-APR-2021, the subject experienced neuralgia. On 30-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, hypoaesthesia, and neuralgia. This report was non-serious.

PATIENT FELT DIZZY, LIGHTHEADED, GOT VERY COLD AND CLAMMY, WAS "OUT OF IT" FOR A FEW MINUTES. TREATED BY LAYING PATIENT DOWN, GIVING COLD WATER, AND MAKING SURE SAFE AND NO AMBULANCE NEEDED. RECOVERED SOON AFTER.

Pt with no PMH. Was administered IM vaccine at approximately 08:45. Within 5 minutes endorsed feeling dizzy, appeared pale and slightly diaphoretic. Pt had witnessed syncopal episode at approximately 08:50. Pt seated with nurse and site employees at side to assist in ensuring safety. No injury occurred. Syncopal episode duration approximately 30 seconds. Pt became unresponsive, bradycardic and slightly hypotensive. Vitals: 110/55, 50, 13, 98%. EMS activated, PD called, and Capt called to be made aware of situation. Pt given Gatorade 150 ml and endorsed prior syncopal episodes with vaccines and blood draws. 8:53- Pt able to sit upright independently, drink fluids w/ no complication, AAO x4. Pt vital signs stabilized within 5 minutes with no other interventions other than PO fluids. PD arrived onsite 8:56, asked pt if he required medical assistance, pt declined. PD officer given report by lead RN. RA 51 arrived 8:58, report given by lead RN, pt evaluated, performed EKG finding NSR, and fingerstick glucose result of 163. 09:00- pt reports dizziness resolved, and declined transport to hospital by PD and signed AMA. 09:45 pt remained continuously monitored by site RNs, along with PD assessment. Pt exited site ambulatory with no further incidents accompanied by wife.

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)

Symptoms of extreme skin pain on extremities (Hands, Feet, Knees, Face) upon being exposed to cooler temperatures. Symptoms of extreme pain upon being brushed against or scratched causing feelings of being cut on skin. Symptoms started approximately 2 weeks after receiving COVID19 Vaccination- Johnson and Johnson.

I have been getting migraines since the vaccine. I get 3-5 every week and I NEVER had them before. They especially occur when pushing like going to the bathroom.

BEGINNING ABOUT 1 WEEK AFTER VACCINATION PATIENT BEGAN EXPERIENCING MUSCLE WEAKNESS AND TINGLING IN THE LEFT ARM, HAS PROGRESSIVELY GOTTEN WORSE AND HAS IMPACTED DAY TO DAY ACTIVITY

In the beginning, my feet and hands had poor circulation and became discolored, cold, and painful (like Reynaud's syndrome). I was able to get the circulation going by exercising. This lasted for a couple of weeks. I had cold sweats and chest discomfort, which I thought were symptoms of WPW. I went to the cardiologist. An EKG was done and I was put on a 2-week halter monitor. Everything checked out as not being a heart issue. Blood tests were done, and the results were normal. After the cold hands symptom, I developed palmar erythema. I also developed a lot of abdominal pain. I became really gassy, and my bowel movements became a light yellow. I had frequent urination. My weight dropped from 191 to 180, and I lost my appetite completely; the appetite loss happened for a week and a half. I had to force myself to eat. My hunger is now back, and I currently weigh 187. The gassiness, yellow stools, abdominal pains, and the frequent have all largely subsided. The stools are now a normal color. The palmar erythema is still present, though.

The first day after the vax was fine, but towards the end of the day I felt strange. Half way through the second day, my pancreatitis came back with a vengeance for about a month, along with whole body inflammation for about a week, resufacing of neuralgias and other pain also. The first week was the worst. The whole body inflammation went away after a week. But the pancreatitis flare up was worse than experienced before, and the amount of pain increased since the injection of the pancreas has increased by about 10 to 15 %, and has not returned to pre-vaccination levels. I am taking more tramadol than ever now. I WILL NEVER GET A COVID VACCINE AGAIN.

April 24 rush to ER because of urine retention then april 28 he started with facial paralisis wich the doctor said it was bellpalsy but 1 week after all that he lost all the strenght on his legs he was using Foley cateter sin april 24 thrue may 21 and now he could barely move he has limited balance i have to take him out of bed hold him he could not be seat because he feel sever pain on his legs an feets and sever cramps and tingling

5/17/21 - general body soreness, didn't leave bed 5/18/21 - Extreme abdominal pain, couldn't eat, didn't leave bed 6/9/21 - Severe side pains and bloating below rib cage 6/16/21 - Woke up to 10/10 pain in my abdominal region, felt like knives were being stuck directly under my rib cage, around this same time, I noticed that both of my inner legs, from roughly my ankles up was going numb to the touch, severe stomach bloating as well 7/6/21 - Everything described for 6/16/21 progressively getting worse to the point where my legs were so sore that I can barely climb up stairs, can't eat much so went to the ER. During the visit they didn't address my leg issues, released me with diuretics to deal with bloating (which have not helped). My stomach is generally bloated anywhere from 50-75% and I have pain in my stomach , legs, and shoulders and seem to be losing muscle and a rapid rate. I'm a healthy eater so all of this is very unusual and extremely concerning. I cannot work as well.

Patient reports feeling hot and warm all over body. Reported itching on palms of hands, nurse noticed sizable welts. Patient contacted his PCP and PCP recommended giving patient 2 doses of Benadryl. Patient was given 2 doses of Benadryl per PCP request and reported feeling better.

Janssen COVID-19 Vaccine EUA - Tingling started on left side of face, left arm and left leg. Paresthesia worsened to both sides of my face and has not gone away; have experienced this for 10 weeks now. Also experiencing sporadic parethesia in right forearm down to fingers, and right calf down to toes. I have also experienced intermittent bouts of muscle fatigue/weakness in arms and legs, as well as lightheadedness.

Developed muscle pain in left leg. No swelling, tenderness, or visible signs of issue. Other symptoms from vaccine have resolved, but this area is still sore. States it feels like a pulled muscle. Patient was advised to seek medical care if symptoms have not resolved soon.

Began as headaches (4/4/21), progressed to strange skin sensations painful and hot to touch (4/6/21). This then progressed to numbness in lower body (4/12/21), the numbness then became weakness and inability to walk (4/26/21). I was then hospitalized 5/5/21 and had many, many tests. Ultimately I have been diagnosed with neurosarcoidosis and am currently undergoing treatment.

Patient has history of MS well controlled with Cosentix injections. Patient reports approximately one week after taking vaccine he began experiencing pain in his feet and ankles. Reports the pain has ascended to lower back and reports he can no longer lift heavy objects and cannot perform required duties for his occupation. Denies numbness, tingling, burning. Difficulty with walking, especially distances or stairs. Reports pervasive fatigue and sleeping until late in the day but waking up exhausted.

MUSCLE LOSS TO THE ARMS AND SHOULDERS; BITES MARKS TO THE INSIDE OF THE THIGHS; NUMBING SENSATION TO BOTH LEGS FROM TOP OF CALF TO BOTTOM OF QUADS AND PAIN WORSEN AND SPREAD EVERY DAY; DIFFICULTY EATING DUE TO ABDOMINAL DISTENTION; SEVERE PAIN TO BOTH SIDES OF THE ABDOMEN AND IT IS PAINFUL TO TOUCH; DISTENDED ABDOMEN; NUMBNESS AND TINGLING TO UPPER BODY, UP TO NECK AND DOWN TO THE ANKLES.; FELT LIKE "PINS AND NEEDLES IN ALL ORGANS"; CURLED UP IN THE BED; GENERAL BODY ACHES; 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 known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A and expiry: UNKNOWN) dose was not reported, administered on 16-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAY-2021, the subject experienced general body aches. On 18-MAY-2021, the subject experienced felt like pins and needles in all organs. On 18-MAY-2021, the subject experienced curled up in the bed. On 08-JUN-2021, the subject experienced severe pain to both sides of the abdomen and it is painful to touch. On 08-JUN-2021, the subject experienced distended abdomen. On 08-JUN-2021, the subject experienced numbness and tingling to upper body, up to neck and down to the ankles. On 08-JUN-2021, the subject experienced numbing sensation to both legs from top of calf to bottom of quads and pain worsen and spread every day. On 08-JUN-2021, the subject experienced difficulty eating due to abdominal distention. On 03-JUL-2021, the subject experienced bites marks to the inside of the thighs. On 06-JUL-2021, Laboratory data included: Laboratory test abnormal (NR: not provided) Elevated liver enzymes, diagnosed with ascites, and Sonogram (NR: not provided) Free fluid in the abdomen. On 09-JUL-2021, the subject experienced muscle loss to the arms and shoulders. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from curled up in the bed on 19-MAY-2021, and bites marks to the inside of the thighs on 09-JUL-2021, recovered with sequelae from felt like pins and needles in all organs on 19-MAY-2021, and had not recovered from general body aches, severe pain to both sides of the abdomen and it is painful to touch, distended abdomen, numbness and tingling to upper body, up to neck and down to the ankles., muscle loss to the arms and shoulders, numbing sensation to both legs from top of calf to bottom of quads and pain worsen and spread every day, and difficulty eating due to abdominal distention. This report was non-serious.

Fever of 104, heart rate in 160's, rigor, severe back pain. 911 called and ambulance brought to Hospital at 1am. Took 3 bags of fluids, Ativan, Tylenol and Toradol to get the heart to the 110's over the 3 hours there. It is now 12:30 on the following day (3/7) and the fever, shakes, and elevated heart is starting up again but not to the extreme of last night

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

About 12hours after dose fever chills and joint pain with side of headache lasting untill Saturday Mar 13th.

Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient did experience fainting with Janssen, though important to note that patient said he has fainted before in past with vaccinations. He said he is fearful of them and it is more \"mental\" and does not attribute it to the vaccine itself.

Fever, chills, significant aches in lower back and lower body, weakness, and worst of all, intense headache that dulled after about 24 hours, but has persisted for 4 + days at this point. It is now day 5, and I still feel quite weak and my headache, though getting better, persists. I experienced dizziness on days 1 and 2 that has also dulled, but has not quite fully resolved. Frequent urination on days 1, 2, and 3.

103 degree fever, uncontrollable chills/shaking, headache, nausea, body aches, dizziness, weakness. Fever lasted 36 hours, aches and headache lasted 48. Felt like the worst flu of my life. Sickest I've felt in 10+ years.

Strong heart palpitations for 2-3 hours starting about 8 hours after injection. As soon as the palpitations passed I got an onslaught of symptoms including fever, chills, sore muscles, weakness, headache, and light headed.

While waiting 15 minutes after receiving the shot patient suffered a seizure roughly 5 minutes after receiving the vaccine. Seizure lasted approximately 10 seconds. Paramedic was on site and assisted in monitoring the patient until ambulance arrived. While waiting patient was sweating, nauseas and 'didn't feel well'. Patient suffered a second smaller seizure before the ambulance arrived. Patient was monitored and taken to ER.

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.

Fever (101.5), Chills, Aches, Headache, Racing heartbeat for about 4 hours and then started to get a bit better. Took Tylenol and slept. Next morning felt weak and achey, but better. Was find within 24 hours

Body temperature increase to 102.5 degrees Fahrenheit. Shaking, fever, and severe fatigue and sweat all over body.

Customer had dizziness, hot, sweaty, nervous, pass out, call 911 EMT took him to the hospital all his vital signs are fine, he called to let us know that he is at home and is feeling well.

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.

I have a strange pin prick feeling in the top of my head that only exhibits pain when my facial expressions or other movements cause my scalp to be moved or stretched. When I try to feel for something poking the top of my head, there is nothing there and touching the area does not cause pain. But then I may look to the right and frown, and suddenly there is a sharp needle feeling in the top of my head.

Patient is a 43-year-old, male with a history of fear of needles. At 2:39 pm, the patient received a dose of the Janssen vaccine, (lot number 1808980, expires on 06/20/2021) on right deltoid, given by RN. Immediately following the vaccination at 2:40 pm, Patient reportedly slumped his head forward in his seat and was caught by RN, sustaining zero physical bodily injuries. The patient was unconscious for approximately 2 seconds. EMT'S responded immediately at 2:40 pm and took the patient's vitals. At 2:40 pm, the patients vitals were: 117 systolic BP and HR 89 (EMT unable to hear the diastolic BP due to environmental noise). The patient appeared diaphoretic, pale, with warm, clammy hands and a weak radial pulse. The patient was given a water and tolerated intake of water. The patient was assisted by EMT to a anti-gravity chair at 2:43pm. The patient was observed to have a steady gait and reporting no dizziness. At 2:44 pm, the patient's vitals were: HR 54 and 110 systolic BP (EMT unable to hear the diastolic BP due to environmental noise). At 2:50, the patient had a strong, bounding radial pulse with a HR of 70 BPM and 115 systolic BP (EMT unable to hear the diastolic BP due to environmental noise). At 2:55 pm, the patient's vitals were: HR 75 BPM and 115 systolic BP (EMT unable to hear the diastolic BP due to environmental noise). At this time the patient reports feeling "better". At 3:00 pm the patient's vitals were: HR 81 BPM and 118 systolic BP (EMT unable to hear the diastolic BP due to environmental noise). At 3:05 pm the patient's vitals were: HR 77 BPM and 120 systolic BP (EMT unable to hear the diastolic BP due to environmental noise). At 3:10 pm the patient's vitals were: HR 74 BPM and 118 systolic BP (EMT unable to hear the diastolic BP due to environmental noise). At 3:15 pm, the patient was assisted up from anti-gravity chair. The patient had a steady and balanced gait. The patient denied any additional dizziness, lightheadedness, or nausea. EMT provided patient with education related to when to call his HCP (i.e. dizziness, itching of throat). The patient reported he was "ok to drive home" and left to the parking lot at 3:15 pm.

PATIENT RECEIVED VACCINE ON 4/4/21. ON 4/7/21, WAS AWAKENED DURING SLEEP WITH SHARP, STABBING PAIN IN LEFT LEG CALF MUSCLE. PAIN LASTED FOR 30-40 SECONDS. FOR THE NEXT 2 DAYS, PAIN IN THIS AREA REMAINED SORE, IRRITATED, AND TENDER. RATED PAIN 1-2/10 IF NOT TOUCHING THE AREA, BUT UP TO A 3/10 WITH TOUCHING THE AREA. IN ADDITION, FELT BREATHING HAS BEEN HEAVIER AND LITTLE WORSE THAN HIS NORMAL BASELINE (BASELINE DUE TO HISTORY OF ANEMIA/LOW IRON), AS WELL AS FEELING BRAIN FOGGY SINCE RECEIVING THE SHOT.

Approximately five minutes after the shot, I experienced vasovagal syncope. I was, reportedly, non-responsive for about three minutes. When aroused, my heart was reportedly beating about 40 beats per minute, my blood pressure was low, and it took me quite a while to regain my senses.

Headache will not go away , shortness of and trouble with breathing , weak after a short time of physical anything , chest pains , veins in legs are showing. These all came on a few days ago and the headache last night was almost unbrarible and i never have headaches

Numbness and weird feeling in left arm (injected in left arm) started like 8pm got worse. Also still felt awful comes and goes cold and feverish again. Felt good a day and a half. Then bad again but was at work. Woke up 2am with pain in chest and arm felt numbness and very strange and pain in chest - which did subside but almost called 911. Will go to urgent cate today to get checked out. Took BP at home and it was normal/ took an aspirin at 2am as well/

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.

COULDN'T SLEEP LAST NIGHT; TINY HEADACHE; LEFT ARM HURTING; LEFT SHOULDER HURTING; This spontaneous report received from a patient 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, and batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 at 14.30 to left deltoid at 14:30 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the patient experienced couldn't sleep last night. On 07-APR-2021, the patient experienced tiny headache. On 07-APR-2021, the patient experienced left arm hurting. On 07-APR-2021, the patient experienced left shoulder hurting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tiny headache, left arm hurting, and left shoulder hurting, and the outcome of couldn't sleep last night was not reported. This report was non-serious.

sharp pain in arm starting approximately 5 minutes after injection, lasting about 5 minutes. dull ache in arm at injection site for four days after injection. flu-like symptoms including body ache, tiredness, weakness, fatigue, loss of appetite & general malaise starting approximately 24 hours after injection, lasting about 12 hours.

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/

SHAKING; STIFF BODY; SHIVERING; 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 chronic breathing problems .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 10:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced shaking. On 09-APR-2021, the subject experienced stiff body. On 09-APR-2021, the subject experienced shivering. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the shaking, shivering and stiff body was not reported. This report was non-serious.

SHAKING; CHILLS; HEADACHE; FEVER; LOWER BACK HURT; NOT FEELING WELL; This spontaneous report received from a patient concerned a 43 year old male. The patient's weight was 183 pounds, and height was 69 inches. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included patient had no known allergies. patient had no history of 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: Unknown) dose was not reported, administered on 08-APR-2021 13:30 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced not feeling well. On 09-APR-2021, the subject experienced lower back hurt. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) Low grade fever 100. On 09-APR-2021 02:00, the subject experienced shaking. On 09-APR-2021 02:00, the subject experienced chills. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking, and not feeling well, and chills on 09-APR-2021, and was recovering from fever, lower back hurt, and headache. This report was non-serious.

By midnight after my vaccine: Shortness of breath. Three days later around 6:25 am on April 15, 2020: I got out of bed, next moment I recall is of me on the floor. No memory of falling. I was shaking uncontrollably as if my body was getting many commands at the same time but I had no control over it. I could not call out for help. At one point I was biting my right hand but could not make myself stop until my shaking stopped. Bite did not penetrate skin but I had visible bite mark on my hand. I regained control suddenly and just got up slowly and shaken by the experience. Wife then drove me to the ER. Been feeling pressure on my head.

Patient presented to ED with right sided numbness including arm, leg and body. Face not involved. Over 14 days since J&J COVID vaccine. Patient admitted with left thalamic stroke, neurologist involved, not believed to be related to vaccine. Started on aspirin 325 mg daily and Plavix. Still hospitalized.

The day of the vaccination 5 hours after receiving the vaccine I started to get bruises the size of my hand on my left leg then I kept getting more on the upper part in the leg and in the buttock I take photos to have the record then I started to feel dizzy that I couldn't walk and I was going to faint, I had to call the rescue to come to my house because I felt very bad I could not move then I went to the emergency room to the hospital with the same symptoms I couldn't move it seemed that if I get up I was going to faint, I was under observation the bruises did not continue to appear, but I have been left with nervous tic symptoms in the left eye and in the left arm I have involuntary reflexes in the muscles of the left arm

I received the shot on 4/10. First 24 hours I had a slight fever and headache. Treated with Acetaninophhen. Since that time, I had relatively mild symptoms 4/11 - 4/13. Mostly fatigue. On 4/14, I had a sudden increase in heart rate, dizziness, tingling sensation in all arms and legs and weakness in my limbs/grip. This prompted me to visit the ER. They ran numerous blood tests amd scans on me but found no abnormalities. Various unusual symptoms have continued to persist since 4/14. For brief moments I feel fine. At other times I have experience fatigue, diziness/vertigo, rapid heart rate, pins and needles feeling in my left hand and left leg. Left leg numbness/tightness and heaviness. The fingers on my left hand sometimes move involuntarily. And my anxiety has also gone up during this time. Tonight it has migratee to my left foot, where I have numbness in several of my toes. I'm looking for advice. Should I be concerned? Should these symptoms still be occurring 11 days after receiving my shot? It has been very distressing and there seem to be very few people who have knowledge on this subject. My care providers keep saying to self monitor and contact them if symptoms worsen. The problem is symptoms don't necessarily worsen, they just migrate from one area of my body to another. The numbness comes and goes in maybe 1-2 hour intervals.

INCREASED SEIZURES; THREW UP; INCREASED PHLEGM / INCREASED COUGHING; This spontaneous report received from a parent concerned a 43 years old white Hispanic or Latino male. The patient's height, and weight were not reported. The patient's past medical history included cerebral palsy, mental retardation, and epilepsy, and concurrent conditions included seizures, cough, and phlegm. Patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 06-APR-2021 on right deltoid for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the patient experienced increased phlegm / increased coughing. On 07-APR-2021, the patient experienced increased seizures. On the same day, he experienced threw up. The patient usually had a cough and phlegm. On the following day of vaccination, the patient's amount of phlegm and cough was increased and he throw-up and had 2 seizures. On 08-Apr-2021, the patient had 10 seizures. The patient regularly had seizures but the number per day increased after vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from increased seizures on 09-APR-2021, and threw up on 07-APR-2021, and had not recovered from increased phlegm / increased coughing. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210428761-covid-19 vaccine ad26.cov2.s-increased seizures. 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

COUGH; DIFFICULTY SLEEPING/STRUGGLING TO SLEEP; LOSS OF ENERGY/ESPECIALLY NO ENERGY; SHIVERING; FATIGUE/FEELS VERY TIRED; COLD SYMPTOMS; HEART RATE INCREASED/FAST HEART BEAT; VERTIGO; BRAIN FOG; CHEST PAIN; 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 past medical history included pneumonia, and concurrent conditions included covid-19, 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: 1805029, expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 (vaccinated at left deltoid) for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced cold symptoms. On 19-MAR-2021, the subject experienced heart rate increased/fast heart beat. On 19-MAR-2021, the subject experienced vertigo. On 19-MAR-2021, the subject experienced brain fog. On 19-MAR-2021, the subject experienced chest pain. On 19-MAR-2021, the subject experienced difficulty sleeping/struggling to sleep. On 19-MAR-2021, the subject experienced loss of energy/especially no energy. On 19-MAR-2021, the subject experienced shivering. On 19-MAR-2021, the subject experienced fatigue/feels very tired. On 20-MAR-2021, the subject experienced cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold symptoms, and shivering on 20-MAR-2021, and was recovering from heart rate increased/fast heart beat, fatigue/feels very tired, vertigo, brain fog, chest pain, loss of energy/especially no energy, cough, and difficulty sleeping/struggling to sleep. This report was non-serious.

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.

Experienced severe leg pain for several days. Ultrasound in ER revealed right calf DVT. Prescribed 21 day regimen of Xarelto starting yesterday.

Systemic: Flushed / Sweating-Mild, Additional Details: Pt experienced a brief episode of sweating, after drinking water and eating something he felt fine.

I thought I was going to get the first shot of the Moderna vaccine, it wasn't until the needle was in my arm that I was told I had received the Janssen vaccine. At approximately 4:46pm I developed a strong pain at the injection site. At approximately 8pm I began to run a fever and feel extremely fatigued. My back and all my joints started to ache, I was sweating but also freezing cold. I had a dull, throbbing pain in my testes. I had pain in my scalp, my eyebrows, my ear lobes, my fingernails, my toes and toenails, the soles of my feet hurt. Least of all I also had a headache. I took 500mg Ibuprofen for the pain. Now, almost 48 hours later I still have a low grade fever, still have considerable pain at the injection site, still have a headache. The remaining symptoms dissipated on 5/2/21 at about 12pm. Took another 500mg Ibuprofen for breakfast, but otherwise have had no appetite since receiving the vaccine.

Severe pain in bones and joints for 3 days extruciating pain the worse pain imaginable unable to even get up from bed. Extreme fatigue and weakess

I received the vaccine on April 12. I was to have my next period on April 19. Instead it came early on April 13. I had a lot of cramping and breast pain the first 48 hours after the vaccine injection which is not normal for me. My period also lasted 15 days. It normally lasts 2 - 3 days.

on 4/10/21 headache, feet felt numb, continued to get worse until almost total paralysis of body. He is still currently in hospital getting treatments. ,

PT COMPLAINED OF INTENSE PAIN IMMEDIATELY AFTER INJECTING, THEN NAUSOUSNESS, THEN WANTED TO STAND, AS I WAS PREVENTING HIM FROM STANDING HE BEGAN TO SHAKE AND THEN WENT LIMP, I USED SMELLING SALTS AND HE CAME TO, HE WAITED IN PHARMACY HIS BP WAS LOW, WE GAVE WATER AND AFTER ABOUT AN HOUR HE WAS ABLE TO WALK OUT ON HIS OWN

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.

Initial extreme fatigue 1 day following the vaccine, which resolved after overnight rest Five (5) days after vaccine, extreme fatigue and chills, and several hours later a temperature of 103.5, as well as some muscle soreness Night sweats first night; next morning temperature returned to normal. Fatigue continued with some daytime sweating for 2-3 days. Saw primary care doctor 5 days after symptom onset; mostly cleared up, normal temperature Patient suspected a flare-up of mononucleosis / Epstein Barr as cause.

Painful Arm, 4 days Fever 2 days Swollen lymph nodes in groin with tenderness, from day 7, currently ongoing.

Blood clot in superficial vein behind right knee as well as vertigo and nausea. Currently on 30mg/day of XARELTO blood thinner (I've been taking since diagnosis on 5/5/21). Will continue to take 20mg/day for the next 30 days. Background: I started to notice my right calf get tight and sore approximately ~3 weeks following my vaccination. I had been doing a lot of running and hill training so I assumed it was a muscle strain/aggravation. After approximately 1-2 weeks I noticed the tightness worsen and also noticed significant swelling around my lower calf/ankle. I went to the doctor on 5/4/21 and was given a D Dimer blood test which came back 1.27 mcg/mL FEU (over the recommended 0.5 mcg/mL). The next day I had an ultrasound of my right leg where they discovered the SVT clot behind my right knee in a superficial vein (but near a major/deep vein intersection). I was immediately prescribed XARELTO blood thinner - to be taken for ~51 days. ~21 days of 30mg/day (15mg twice/day) followed by ~30 days of 20mg/day 1x per day. The morning of 5/20/21 around 6:30am I started to feel nausea and vertigo after returning home from walking my dog. I finished a low-intensity exercise routine at my home and around ~7:15am my symptoms worsened. I went upstairs to my bedroom to lay down on my bed and the room started spinning. I then went to the bathroom and vomited clear fluid. I started feeling a little better after vomiting but was still slightly dizzy and light-headed. I made an appointment and went to the doctor around 10:30am. The doctor suggested doing further bloodwork and a CT scan of my head. Both tests came back normal. The doctor suggested the vertigo and nausea were inner ear related and that I should continue taking XARELTO and to also start wearing a compression sock (especially during exercise/activity).

PAIN IN STOMACH; SWEATS; REDNESS ON BODY LOOKS LIKE SKIN IS DISCOLORED; CHILLS; FEVER; NAUSEA; BODY PAIN; MIGRAINE; EVERY BEAT OF HEART HURTS; HYPERVENTILATION; COULD NOT GET A FULL BREATH; PASSED OUT'; FINGERS WENT NUMB; GOT A CHARLIE HORSE ON LEG; EVERY SINGLE JOINT AND ANKLES HURTS FOR NO REASON; This spontaneous report received from a patient concerned a 43 year old male. The patient's weight was 135 pounds, and height was 66 inches. No past medical history or concurrent conditions were reported. The patient's concurrent conditions included migraine The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered, 1 total to right deltoid on 19-MAY-2021 around 10 am for prophylactic vaccination. No concomitant medications were reported. On 19-MAY-2021, around 7 pm patient started experiencing side effects. After 1 hour of shot patient had his heart hurt at every beats, hyperventilation. It lasted for 1 -2 hours. The patient also had fever, chills, nausea, sweats and had not taken any medication, as he was afraid of another side effects, had redness on his body which looked like skin was discolored and was like hives. The patient also had body pain appeared suddenly. The patient also had pain in stomach which felt like nastiest gas cramp patient had ever and it was continuous like a rock blocking in stomach, he did not know if it is pain or gas but was hurting. Patient had migraine which lasted long time and was continuous than he ever had. The patient was fine as he was speaking at the time of reporting. On MAY-2021 (dates unspecified) the patient experienced Charlie on his leg (muscle spasm) for which he stood up and didn't do anything on leg, he was passed out and fingers went numb, felt every single joint and ankle hurt with sharp pain like a stuffed knife (intermittent pain for 3-5 minutes).He could not get a full breath of air, and was breathing really fast. Then patient tried to slow down breathing as he didn't want to be hyperventilated but it happened. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body pain, hyperventilation, migraine, pain in stomach, chills, fever, nausea, and sweats, and the outcome of passed out, could not get a full breath, redness on body looks like skin is discolored, got a charlie horse on leg, every single joint and ankles hurts for no reason, fingers went numb and every beat of heart hurts was not reported. This report was serious (Other Medically Important Condition); Sender's Comments: V0: 20210540430-COVID-19 VACCINE AD26.COV2.S --Every beat of heart hurts, Passed out. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Extraordinary chills and body shakes, painful joints, burning sensation of skin all over, fever of 103.6, slight nausea - all lasting 12 hours and then subsiding.

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.

Patient was administered 0.5 ml Jannsen COVID-19 vaccine into the left deltoid with no complaints. After completion of vaccine patient continue to sit in waiting area, while sitting in waiting area patient described feeling extremely dizzy and hot. Patient was given water/Benadryl and was able to alleviate issue without any further action necessary.

Patient stated that starting 3 days after vaccine he started with pain in his left arm and chest, pain in his joints to his bones. He says he has trouble sleeping. He did go to the Emergency Room and was evaluated. He says he still currently has the pain.

High fever, muscle aches, shaking, nausea, shortness of breath. All of these lasted for 18 full hours, and slightly shortened breath is still present 5 days later.

Received vaccine, sat down as advised, 3-mins later felt nauseous (about to vomit), got up and walked away from people around me. Fortunately my wife was there, I called out to her because I was getting dizzy, she came over as I was passing out, I grabbed onto her and we both fell to the floor (I used her to cushion my fall). I passed out on her as she screamed for help. Two male customers assisted me into a chair as I was disoriented, my wife asked me what her name was and I didn't her name as I was pale, trembling, and sweating. The pharmacy tech thought I was going into convulsions and called 911. The paramedics arrived and fortunately I was breathing and slowly coming back. Paramedics remained there and took all my vital signs and stayed with me. Since my vitals were okay and my color came back, I felt much better and was coherent again. This event was at least 30-minutes or more. I declined going to the hospital with ambulance and the paramedics told me to call 911 if it happens again.

patient was asked to stay in the waiting are for 15 minutes.he went and sat down then he got up to talk to his wife at that time he felt sick and passed out. his breathing was shallow and he was unresponsive for 2 minutes. he was pale. paramedics were called and they came right away and assessed him. he did not need any medical help. he felt fine. they did not take him to hospital.

after the vaccine I had a fever and was able to treat with Tylenol, and within two days my legs and knees were in pain and I had a cough. The pain is behind my knee on both legs and does up to my thigh and down to my ankle. When i sit it hurts realy bad behind the knee, especially when sitting on the toilet.

COLD; COUGH; FEVERISH; FEELING LIKE KNEES BENDING WHEN STANDS UP; CAN NOT SIT TOO LONG IN TOILET AND CHAIR; SEVERE PAIN IN LEGS BEHIND THE KNEES; This spontaneous report received from a patient concerned a 43 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 16-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced feeling like knees bending when stands up. On JUN-2021, the subject experienced can not sit too long in toilet and chair. On JUN-2021, the subject experienced severe pain in legs behind the knees. Treatment medications included: paracetamol. On 16-JUN-2021, the subject experienced feverish. On 17-JUN-2021, the subject experienced cough. On 18-JUN-2021, the subject experienced cold. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold, and feverish on JUN-2021, had not recovered from cough, feeling like knees bending when stands up, and severe pain in legs behind the knees, and the outcome of can not sit too long in toilet and chair was not reported. This report was non-serious.

ive never been sicker throwing up,diarehaa,cold/hot flashes,super tired,and basically havent felt all trhe way well since taking shot i totally regret getting shot

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.

"Janssen COVID-19 Vaccine EUA" Seven minutes after recieving the vaccination I started to feel light headed so I sat on the floor and notified medical personnel. I then passed out for an unknown amount of time but long enough to urinate on myself. Medical staff put me on a bed and started taking vitals. My Blood pressure was low but had a high heart rate. Medical Personnel called the ER to see if I needed to be transfered but it was reccommended to continue observation. After an hour or two I was released to go home. I felt weak for over a week after the vaccination.

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

Fever, chills, shakes approximately 13 hours after shot. Lasted for an hour until asleep. No issues in the morning.

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.

pt has h/o htn and take 4 different meds. he has taken all of his meds today . pt received his covid vaccine on 03/13/2021 in the left shoulder and he woke up this morning with pain in the left shoulder radiating down his arm and it originates at the site of the vaccine. pt denies substernal chest pain , dyspnea , doe. he has h/o elevated blood pressures at the level seen today (180/100) when he has poor sleep and he had poor sleep last night due to pain at injection site. no CAD hx. pain is not changed with walking but will be worsened by moving his left arm. PE: a+ox3, in moderate pain left arm: injection site clean and intact. left arm is neurovascularly intact. no bony deformity of the shoulder lung: normal respiratory status, cv rrr no mgr Signed on 3/14/2021 at 11:54am

3/12 4:30 pm started with frequent liquid diarrhea for the next 3 days but on 3/13 at about 9pm broke out in full body hives, very red and became flushed and hot

At 15:00 Patient received Janssen vaccines, Lot 1805018 Exp 05/25/2021 At 5:15 Patient started experiencing tingling around the nose. VS: 74 HR , BP 137/101, O2 97 % Room air. Observed patient an additional 15 minutes. Offered patient a bottle of water. 15:35 VS: 62 HR, BP 135/93 Left arm. 98 O2, sat room air. Patient states he feels better and the tingling is gone.

03/08/2021 11:31 am Patient C/O feeling light headed and dizzy. Patient also noted pale and clammy and laid himself on the floor. Patient stated that he ate a granola and coffee for breakfast. V/S 97.4 temp. BP 101/60, R 18, Pulse 48. Snacks and water offered, water taken only. Patient then stated that he feels sick and cannot sit up on his own, close monitory in progress. 11:34 am Wife called and notified. 911 rescue called. 11:50 am Rescue arrived and assessed patient declined going to the hospital. 12:00 pm. Patient VS 97.7 temp, BP 110/64, Pulse 56, R 16.. Patient left facility with wife.

Cold hands/feet, shivering, chills, fever, massive sinus-like headache, nausea and felt like vomiting.

Three hours after the vaccine I had nausea and tiredness, slept for five hours. After waking up, I've had muscle ache, high fatigue and weakness, soreness all over the body, headache, head pressure, and pain in my muscles when an area of my body is pressed or grasped. Yesterday at 4pm, had chills and temperature for a total of 4 to five hours.

Felt a little warm for first 30 minutes after receiving the shot at 1015am but then felt fine until about 6pm that same day. At that point, started getting chills, which progressed into mix of chills and hot spells, fever, headache, and frequent urination throughout the night (though was also hydrating a lot). Had fever the next morning still and Diarrhea. Still feel modest headache and chills the next evening (before bed where I had felt the worst overnight the first night of the vaccine) but feeling better than the first night. Per the form I received, I was told to include Janssen COVID-19 Vaccine EUA in this section of the form. I am reporting this on the day after the vaccination, so don't yet know final outcome, but again, improving and don't feel like I need medical attention.

TENSION; SHIVERS; HEADACHE; VOMITING; LETHARGIC; SORE ARM; MYALGIA; 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 high blood pressure. The patient experienced drug allergy when treated with ibuprofen. 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 27-MAR-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-MAR-2021, the subject experienced lethargic. On 27-MAR-2021, the subject experienced sore arm. On 27-MAR-2021, the subject experienced myalgia. On 30-MAR-2021, the subject experienced vomiting. On 31-MAR-2021, the subject experienced tension. On 31-MAR-2021, the subject experienced shivers. On 31-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lethargic, vomiting, myalgia, sore arm, shivers, headache, and tension. This report was non-serious.

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.

I felt fine all day and went to bed at 9:30pm. I woke up to my body shaking uncontrollably and I was freezing at 10:30pm. My wife felt my skin and she said I was burning up. Unfortunately our thermometer wasn't working so I don't know my temperature, but I have never in my life shaken so badly with a fever. I couldn't control myself and I was shaking so hard that my muscles were sore from it, but I still couldn't stop. I then began vomiting every 45 minutes or so. This happened for nearly 4 hours until 2:18am. Then very suddenly everything just stopped. No more feeling cold (actually I then felt very warm and couldn't cool off. I was sweating quite a bit). No more shaking. No more vomiting. I did get a wicked headache, but I figured it was due to dehydration and took two Advil. The Advil didn't do anything and I was awake until 5:59am because my head hurt too badly to sleep. Finally I slept for about 4.5 hours. Then I just felt worn out for most of the day on the 10th, and couldn't shake the headache. Then on the evening if the 10th, I started getting a sore throat and a slightly runny nose. I went to bed that way. When I woke up on the 11th (today) I still had the sore throat and slight runny nose. The headache was gone, but I felt tightness in my chest. As I went throughout the day, I've noticed that I'm short of breath with doing most things. I have two young children, so even taking care of them I feel like at times I'm struggling for breath. I'm not in bad shape and am a runner, so my cardio isn't bad. So I was surprised by this.

Neck numbness - 90 minutes after shot, lasted 30 minutes Dizziness - 120 minutes after shot, lasted 40 minutes Chills - 120 minutes after shot, lasted 10 minutes Body aches - 4 hours after shot, lasted 16 hours Fever - 12 hours after shot, lasted 1 hour Headache - 19 ours after shot, lasted 20 minutes Stuffy head - 20 hours after shot, lasted 1 hour

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.

Left arm felt thick and stiff; fingers on same side began to tingle; became dizzy; sweaty; got up to ask for help as instructed, fainted and hit the top on my head on the counter, I believe; came to; threw up; laid on the floor for a while; moved to a chair; wife came to pick me up; slept for 2 1/2 hours after that; felt better in the evening; typical sore arm

Had normal pain, fatigue and low grade fever after vaccination. About 3 weeks later I experienced onset of Bell?s Palsey defined as mild to moderate by the ER doctor.

Symptoms: Extreme cold and shaking from cold. No fever. Was taken by ambulance to ER. They used heated blankets to warm me up and gave me a shot of Motrin. Symptoms began approximately 11 hours after shot was given. After returning home and sleeping, currently have a headache and muscle aches.

Felt tightening of chest cavity along with warm ?flush? feeling. After a few minutes left side felt less pressure but pressure persisted in right chest area with pain radiating from right arm to back (behind shoulder blade). The right back pain persisted for multiple days. Sought Urgent Care help after a few days. Was prescribed muscle relaxant and pain relief gel, and advised to continue using inhalers.

Got the J&J on March 9th. Had severe cramp/knot in my left leg starting the 19th. Lasted through the 29th and right leg got it the 24th through 30th. I attributed it to pushing too hard at the gym. When they didn't go away after heat/cold/rolling/hot tub I did worry about clots, but not due to vaccine. Was going to call Dr but they went away.

In sleep, on the night of vaccination, i thought I twisted my left leg ankle. It was not hurting if not moving but hurt when walking on uneven surface or when tried to move the ankle. I used bandage few days. its not completely gone, but much better and hurts when try to push the foot/toe downwards.

Patient developed mild case of Guillain Barre Syndrome 34 hours after injection of the Johnson and Johnson vaccine. Patient has severe extremity pains. The patient has a personal history of being diagnosed with Guillain-Barre after a yellow fever vaccination.

Blood Clot and bruising on lower backside of leg, I noticed leg Pain (just uncomfortable) in the right leg at the location of clot. A time frame in relationship to the time of shot is unkown. Estimated within 24 hours. Bruising appeared morning of 04/14/21, PCP recommended in person visit. I went to urgent care, they had me drive to emergency Room at local hospital. Evaluation, blood testing and imaging concluded a blood clot in the lower right leg. Blod thinners was prescribed Eliquia 5 mg, discharged same day. It may be possible the hospital had submitted this form on my behalf.

Got COVID (Janssen) vaccine shot on April 6th at noon. Felt fine Tuesday and went to bed as normal. Woke up April 7th at 7AM with sharp pains in my left shoulder (same side as shot) and slight shortness of breath, and slight chest pain in the left quadrant of my torso (same side as shot). Proceeded to take Advil and seemed to help a bit. Minor aches/pains and shortness of breath throughout the day until about 8PM. At this time shoulder chest pain became more severe, and breathing became very strained, short, and painful. Pain and breathing kept getting worse and at midnight on Wednesday night thought I was having a heart attack due to extreme chest pain, couldn't breath, lightheaded, dizzy, tingly extremities. My wife drove me to ER at 12:30 AM Thursday.

pt called vaccine hotline saying since last week patient has had migraines every evening after work , lasting 2-3 hrs. Pt does not have a family hx or personal hx of migraines. He is not taking medications and is drinking a lot of water. Pt is currently working in a remote area. Pt was concerned re ER costs and was reluctant to go but did say he would try. He was advised to go to the nearest ER. He then had to get off phone

At injection muscle spasmed, nurse stated never seen that before. Within 1-2 hours had runny nose and felt stuffed up, thought it could be allergies or something and didn?t really attribute to vaccine. 4-5 hours after injection felt something across the top of my brain ... felt as though something had been stuck in a blood vessel and became unstuck allowing blood to shoot through. Was certainly freaked out by this, but was at an event and head of the ER department of the local hospital was also attending - so figured I had quicker access to medical care there if needed, than at home. 30-60 minutes later congestion completely cleared up. 9-12 hours after vaccination had extreme chills. Day after vaccination had pain below the injection site... injection was 2? above pain. Also neck pain. Day 2-8 since vaccination, on/off muscle pain or injection site pain. Today, day 9, have muscle pain in wrist of injection arm.

6/11-6/14 : Extreme migraine, fever, extreme chills, fever, extreme body aches, extreme fatigue, diarrhea 6/14-present: moderate migraines, moderate fatigue, moderate body aches, moderate fatigue, diarrhea

LOSS OF CONSCIOUSNESS(PATIENT WAS COMING IN AND OUT OF CONSCIOUSNESS); BRADYCARDIA; SEIZURE (EYES ROLLED BACK, HEAD WENT BACK); ARM WEAKNESS; PROFUSELY SWEATING; This spontaneous report received from a consumer concerned a 44-year-old male. The patient's height and weight were not reported. The patient's pre-existing medical conditions included patient did not have any known allergies. The patient did not have any reaction to vaccine before. 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, 1 total administered on 09-APR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, five minutes after vaccination, patient started profusely sweating and he had a seizure (eyes rolled back, head went back) and lost consciousness. Paramedics were on site came and they did a Electrocardiogram. He had bradycardia (heartrate was very low : 30 bpm). During all this time, he kept on coming in and out of consciousness. Patient also had arm weakness. Paramedics took him by ambulance to the emergency room; they administered some kind of medication because of his heart rate. Reporter thought it was atropine and took him to the hospital. In emergency room, they did a chest x-ray, Computerised tomogram scan and blood work, they did not see anything abnormal that would have caused the seizure. Emergency room Doctor determined that, it was the vaccine or a component of the vaccine that caused the reaction. Laboratory data included Blood test (NR: not provided) Normal, Computerised tomogram scan (NR: not provided) Normal, Chest X-ray (NR: not provided) Normal, and EKG (NR: not provided) 30 bpm. Treatment medications included atropine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from seizure (eyes rolled back, head went back) on 09-APR-2021, and bradycardia on 10-APR-2021, and the outcome of arm weakness, loss of consciousness (patient was coming in and out of consciousness) and profusely sweating was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210422272- covid-19 vaccine ad26.cov2.s-loss of consciousness (patient was coming in and out of consciousness), bradycardia, seizure (eyes rolled back, head went back) . 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).

5 MINUTES AFTER INJECTION WHILE IN THE CAR, I FELT HOT, NAUSEUS THEN FOLLOWED A STRONG SURGE OF DIZZINESS. IT HAPPENED TWICE WITHIN 15 MINUTES. 12 HOURS LATER, I WOKE UP WITH HEAVY LEGS AND SLIGHTLY FEVERISH. MILD FATIGUE PERSISTED THROUGHOUT THE DAY EVENTUALLY GOING AWAY AFTER A DAY OF REST.

Bell's Palsy on right side of face developed 4/22/21. Pt thought he was having a stroke and went to the ER. Doctor gave him B12 to inject 2 doses. Worsening 4/24/21 and having a lot of trouble speaking and eating/drinking.

Patient reports seizures on 4/25/2021 requiring 911 call, ambulance, and hospitalization stay. Patient mental status changed to violent and resulted in a dislocated shoulder when hospitalized. Patient has no history of seizures or violent behavior.

CHEST PAIN (WHOLE CHEST HAD LOT OF PAIN)/THOUGHT THAT HE HAD HEART ATTACK; SHORTNESS OF BREATH/COULD NOT BREATH; SEVERE CRAMPING IN LEFT SHOULDER AND UPPER BODY; DIFFICULTY IN STANDING; SINUS; THOUGHT THAT HE WAS ABOUT TO PASS OUT; BUNCH OF CLOTS IN THE BOTTOM SIDES OF BOTH LUNGS AND ON THE TOP OF ONE OF THE SIDES; BEGINNING STAGES OF PNEUMONIA ON BOTH LOBES OF THE LUNGS (COLLAPSED); CRAMPING IN CHEST; This spontaneous report received from a patient concerned a 44 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) frequency 1 total, dose was not reported, administered to left arm on 06-APR-2021 at 12 noon for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 6-APR-2021 at 12 noon, patient got vaccinated and was fine that day . Next morning on 07-APR-2021, patient woke up with sever cramping in same shoulder which he got the shot in, most pain was in the upper left quarter of his torso to down half way to chest up to the shoulder till the neck . By the end of the day it spread to his whole chest and upper body. Also he had shortness of breath ,could not breath .The cramping and shortness of breath came at same time. He took Advil and went along with his day . He took 3 tablet of Advil 200mg every 4-5 hours all day ( total of 3 dose that day) . By night time the case was progressively worse as the whole chest had a lot of pain . He thought that he had heart attack . He thought that he was about to pass out . He could not stand on his own . So his wife took him to emergency room at mid night at 12:30 am on 08-APR-2021. He stayed there for 5 hours and they did bunch of tests , EKG which rolled out the heart attack .They did Chest X-ray which found things then did D-dimer which its level was very high . They found bunch of clots in the bottom sides of both lungs and on the top of one of the sides. They did ultra sound on the legs which had no evidence of blood clots . They discharged him from the emergency room as they felt that he was ok to be out . After couple of hours after discharge , patient's health care professional wrote for him Eliquis, antibiotic and pain reliver. He was given antibiotic because he had beginning stages of pneumonia on both lobes of the lungs (collapsed) . It was found air sacs in lung with signs of pneumonia in both lobes . He came home and started to monitor his blood oxygen . He stayed in the same position till recovery . He was better each day since last week but still had sinus and cramping in the chest ( very minor but was still there). The lung capacity was very limited to take some steps. Patient stated that he needed a specialist to understand his condition. He had no medical history before that incidence . He was wondering regarding which type of blood thinner was good for this type of blood clots because he read that the regular blood thinners are not good for that type of blood clot which his HCP gave (regular blood thinner). Laboratory data included: Total lung capacity decreased (NR: not provided) lung capacity is very limited. On 08-APR-2021, Laboratory data included: Chest X-ray (NR: not provided) found things, EKG (NR: not provided) rolled out heart attack, Fibrin D dimer (NR: not provided) level was very high, and Ultrasound scan (NR: not provided) no evidence of blood clots. Treatment medications (dates unspecified) included: apixaban, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe cramping in left shoulder and upper body, chest pain (whole chest had lot of pain)/thought that he had heart attack, shortness of breath/could not breath, thought that he was about to pass out, difficulty in standing, bunch of clots in the bottom sides of both lungs and on the top of one of the sides, beginning stages of pneumonia on both lobes of the lungs (collapsed), cramping in chest and sinus was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: This 44-year-old male patient reported blood clots of both lungs 2 days after receiving COVID-19 VACCINE AD26.COV2.S for the prevention of symptomatic SARS-CoV-2 virus infection. The patient denies any medical history/condition prior to vaccination. The symptoms reported were severe cramping of arm that spread to his whole chest and upper body and shortness of breath; the patient thought he had a heart attack, about to pass out and could not stand because of the progression of pain. EKG done at the emergency room ruled out heat attack, D-Dimer was reported to be very high, clots were found in the bottom sides of both lungs and on the top of one of the sides, x-ray showed beginning stages of pneumonia on both lobes of the lungs (collapsed). The patient was prescribed with Eliquis, an unspecified antibiotic and pain reliever. Outcome of the events were not reported. Based on the information that is available, the event is assessed as plausible with the causal association to immunization, per WHO causality classification of adverse events following immunization based on a lack of a definitive plausible biological mechanism. 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.

1 day after the vaccine (4/28) - low energy level, achy, tired, shortness of breath 2 days after vaccine (4/29) - shortness of breath after physical activity, irregular pulse 3 days after vaccine (4/30) - back to normal - no symptoms

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

SHORTNESS OF BREATH; ASTHMA ATTACK; DIZZINESS; EXPERIENCING HOT FLASHES; SORE ARM; SWEATING; PASSING OUT RIGHT AFTER VACCINATION; SLEEPY; LOW ENERGY; WEAKNESS; TIRED; 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 codeine allergy, penicillin allergy, anxiety, smoker, and alcohol user. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 on right arm for prophylactic vaccination. Concomitant medications included clonazepam for anxiety, and ibuprofen for pain/ and inflammation. On 12-APR-2021, after 5 minutes, the patient started feeling dizzy and passed out. He woke up as nurse pulling his chest hair and nurse was about to give him adrenaline shot. The patient was for his vitals until restabilized and was asked to walk around for sometime. The patient had sore arm. The patient was at facility for 2 hours. On 12-APR-2021, at night, he woke up sweating and experiencing hot flashes as if med going through his body. On 16-APR-2021, the patient was not breathing well at night and woke up with an asthma attack which lasted for about 3 hours and the whole next day. He visited clinic for asthma attack and was prescribed with medicines. He had a week and half of low energy. On 27-APR-2021, the patient stated that he was still feeling sleepy, dizzy and tired sometimes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passing out right after vaccination on 12-APR-2021, experiencing hot flashes, shortness of breath, asthma attack, and sweating, and sore arm on 19-APR-2021, and had not recovered from dizziness, weakness, sleepy, tired, and half of low energy. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210453787-COVID vaccine-loss of consciousness. 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

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

RED SPOT UNDER SKIN; BODY ACHES; HEADACHE; PAIN IN ARM; 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 past medical history included hematomas, and concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included patient had no known allergies and drug abuse and drug illicit use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 205A21A expiry: 23-JUN-2021) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) Negative. On 30-APR-2021, the subject experienced pain in arm. On 01-MAY-2021, the subject experienced body aches. On 01-MAY-2021, the subject experienced headache. On 02-MAY-2021, the subject experienced red spot under skin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and headache on 02-MAY-2021, and pain in arm on 01-MAY-2021, and was recovering from red spot under skin. This report was non-serious.

Pt had progressive shortness of breath/weakness and fatigue. CT scan did not show PE. CK level was 17000, inflammatory labs were mixed. Rheumatology consult concluded it was myositis related to COVID vaccine. admitted to hospital 4/27-4/30.

Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient fainted after receiving covid vaccine (Janssen). He was sitting for the required 15 mintute interval and collapsed from his seat after about 5 to 7 mintutes. I quickly help position pt. against the wall. He was disoriented and slighlty confused. He was conscious and alert but dazed. I immediately had by technician call 911 and the paramdeics attended to pt. After doing thorough evaluation of symtoms, pt. declined further treatment. His friend picked him up

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.

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.

12 hrs after shot felt exhaustion, mental brain fog, mild nausea and migraines. In the weeks following vaccine, exhaustion and migraines have persisted at an interval of several times a week. This is abnormal for me - i do not have headaches regularly or migraines. It has almost been 2 months and I am still having exhaustion and migraines.

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

The patient woke up at around 0230 on 5/11/21 with aphasia, right sided weakness and facial droop. He was immediately brought to the ER and after CT was given tenecteplase.

For about 4 days after the vaccine I had chills, vertigo, fatigue, loss of appetite, hot flashes, and general malaise. Then, after the first week of having the vaccine, I began to have these symptoms about once a week. Last week, it was on 5/6 when I gradually become colder regardless of layers and my stomach was repelling the idea of food (no vomiting or actual nausea). I went to bed and I was better by morning. Yesterday (5/12), I had the same thing. Chills and the inability to stay warm, loss of appetite, and a sort of sleepy vertigo.

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.

COLD SWEATS; COUGHING; DIARRHEA; TIRED AND SLEEP; NAUSEA; This spontaneous report received from a consumer concerned a 44 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808982, expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAY-2021, the subject experienced cold sweats. On 14-MAY-2021, the subject experienced coughing. On 14-MAY-2021, the subject experienced diarrhea. On 14-MAY-2021, the subject experienced tired and sleep. On 14-MAY-2021, the subject experienced nausea. The action taken with covid-19 vaccine was not applicable. The outcome of the cold sweats, tired and sleep, diarrhea, coughing and nausea was not reported. This report was non-serious.

MIGRAINE HEADACHE; PRONOUNCED FATIGUE; NAUSEA (NO VOMIT); This spontaneous report received from a patient concerned a 44 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. No concomitant medications were reported. On MAR-2021, the subject experienced migraine headache. On MAR-2021, the subject experienced pronounced fatigue. On MAR-2021, the subject experienced nausea (no vomit). Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine was not applicable. The outcome of the pronounced fatigue, nausea (no vomit) and migraine headache was not reported. This report was non-serious.

Dull head pain located at the front of the head to the temples, almost like when you have a fever but without a temperature. Severe night sweats, and have had hot flashes around the ears a few times. This has been going on since the evening of my vaccine. The head pain is constant and the night sweats have occurred almost every night. On night one the head pain was moderate.

102 temperature. Strong involuntary shaking. Chills. Back pain. Elevated pulse. Muscle Weakness. Fever broke around 0600. Adverse reaction appeared to be resolved by 36 hours from time of administering vaccine.

Still having aches, chills, and sweating at night over a week later. I had the same shot the day before and my issues were gone 48 hours later.

HEAD PRESSURE; ABDOMINAL PAIN; STUCK THROAT; DIZZINESS FOR APPROXIMATE HALF A DAY BUT GONE ON THE NEXT DAY; NAUSEA; MILD HEADACHE; HALF OF MY HEAD TO THE NECK IS SO STIFF AND GIVING HEADACHES AND DIZZINESS; CHEST FELT LIKE A TIGHT SQUEEZE; HEAD FELT LIKE A TIGHT SQUEEZE, COMPRESSION AND GIVING ME HEADACHES; 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 pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced half of my head to the neck is so stiff and giving headaches and dizziness. On APR-2021, the subject experienced chest felt like a tight squeeze. On APR-2021, the subject experienced head felt like a tight squeeze, compression and giving me headaches. On 06-APR-2021, the subject experienced head pressure. On 06-APR-2021, the subject experienced abdominal pain. On 06-APR-2021, the subject experienced stuck throat. On 06-APR-2021, the subject experienced dizziness for approximate half a day but gone on the next day. On 06-APR-2021, the subject experienced nausea. On 06-APR-2021, the subject experienced mild headache. On 03-MAY-2021, Laboratory data included: Blood test (NR: not provided) Not provided., Chest X-ray (NR: not provided) Not provided, EKG (NR: not provided) Not provided, and MRI (NR: not provided) Not provided. Treatment medications included: acetylsalicylic acid. The action taken with covid-19 vaccine was not applicable. The patient recovered from dizziness for approximate half a day but gone on the next day on 07-APR-2021, had not recovered from head pressure, abdominal pain, stuck throat, nausea, head felt like a tight squeeze, compression and giving me headaches, and half of my head to the neck is so stiff and giving headaches and dizziness, and the outcome of mild headache and chest felt like a tight squeeze was not reported. This report was non-serious.

It started with a pain around my spine and it proceeded through my hand. I thought it was a muscle strain. I had blotches in the crevice area of my arm.

FEELING NUMB ON RIGHT SIDE INCLUDING ARM AND LEG; WEAKNESS ON RIGHT SIDE INCLUDING ARM AND LEG; NAUSEA; COLD SWEATS; FEVER; CHILLS; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUN-2021, the subject experienced cold sweats. On 02-JUN-2021, the subject experienced chills. On 02-JUN-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 103 F. On 03-JUN-2021, the subject experienced nausea. On 04-JUN-2021, the subject experienced feeling numb on right side including arm and leg. On 04-JUN-2021, the subject experienced weakness on right side including arm and leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold sweats, chills, and fever on 04-JUN-2021, had not recovered from nausea, and weakness on right side including arm and leg, and the outcome of feeling numb on right side including arm and leg was not reported. 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.

Cold chills, cough, muscle aches, swelling at injection site, dizziness, body aches, headache, fatigue

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.

Flu like symptoms. Stuffy nose, cough, shortness of breath, muscle aches, chills. Numbness in the whole right arm from shoulder to fingertips.

Pins & needles in fingers and toes. Started in the days following my Covid Shot (J&J) and has lasted about 4 months, although it seems like it's been going away gradually. I can barely feel it anymore, but still a bit. It was at its worst about a month after the vaccine shot. My left fingers were the worst. I went to Urgent Care and saw my doctor, but they couldn't explain it. In the news this morning I read about Guillain-Barré syndrome from the J&J vaccine, so thought I should write in case it's of any help.

After getting vaccinated I was fine for almost a month, then I started getting tingling in toes and feet, I went to the ER and was x-rayed and CT, I had lose of feeling in left cheek. I saw a Neurologist that referred me to a nerve spesi9list that said I am having aggressive neuropathy in my feet, and now the tingling has traveled to my left hand also. I went to the ER 3 times.

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.

About 6 to 8 weeks after my vaccine shot, i started to experience numbness in my last 3 fingers on my left arm. The fingers tingle / numb through out the day and is most noticeable when i shower or when i sleep in a certain way and my fingers really tingle. It has been about 6 weeks now and it hasn't gotten worse nor really better. I feel like I got a mild case of guillain-barre.

Sharp stabbing pains weakness in my right hip, and tingling sensation in my right upper leg. Lower back tightness and pain. Recently my leg pain has turned to burning, ripping pain.

Fatigue, Muscle weakness, and soreness primarily in arms. Constant Numbness in arms, numbness in rest of body, washing feeling of numbness (Ice cold) sensation through body, when getting up from a resting state.

5 mins post administration of J and J vaccine, patient complained of flushing nausea and light headedness. Vital signs obtained 98% room air, post rate of 72, blood pressure 138/72 temp 97.1. Patient provided water and 1 cooling pack and observed for 10 mins. 2nd vital signs were obtained which was 98% room air 72 heart rate 130/70 and 98.1. Patient was observed until symptoms resolved. final vital signs showed 98 room air, 74 heart rate 126/78 BP 98.1 temp. Patient was safely discharge without further incident.

Nine hours after receiving vaccine I started "trembling, shaking." Not convulsing, more like really cold. My temperature read 97.2 degrees. My normal temperature is 98.6 degrees. Shaking stopped around 11:30 p.m. I woke up at 3:15 a.m. very hot with my heartbeat racing. I did not measure heartbeat rate. I woke up this morning at 5:30 a.m. with no side effects.

Mild fever (99.5), slight chills, flush face. Still ongoing after 2 hours with 1000 mg Tylenol taken promptly after symptoms started.

Extreme chills starting at 11:30pm. Needed to wear layers of clothing and turn up heat to get warm. Wife was hot while I was freezing and shivering uncontrollably, so I know something was wrong with me. The shivering and chills lasted for a couple of hours until about 2:30-3:00am. Then I got really hot. Took my temperature, was at 99.1 degrees. But room was really warm so I turned down the temperature and took off my layers of clothing. Woke up this morning, around 7am, to a headache and aching legs. I took 2 Excederin, but the headache is still there. Legs are feeling better after a couple of hours.

About five hours after I received the vaccine I began to run a fever that averaged 102 degrees fahrenheit. At that time I also developed chills and extreme fatigue. These symptoms persisted until I fell asleep at 10:00 PM 3/13/21. I was awakened at 1:00 AM with severe muscle spasms in my left bicep and a fever of 102.5 I started taking tylenol to begin reducing the fever. I also lost my appetite around that time. Things were pretty much the same all day 3/14/21. I went to sleep at 10:00 PM I got up every four hours to take tylenol. I woke up at 7:00 AM 3/15/21 to prepare for work my bed sheets and shirt were soaked with sweat but my fever was gone. I ate breakfast and drank a cup of coffee. When I got to work I begin having stomach problems. When I started working I noticed that I was having a lot of trouble concentrating. I decided to leave early to go home and rest. Things have improved since then but I do have a headache that won't go away.

Lightheaded, shaky; B/P-135/78, P- 78, pulse ox- 95%; cleared by onsite nursing supervisor Client reports past history of fainting with blood draws

After the shot, I was feeling fine for 12 hours, I worked out at the gym, helped my roommate carry a desk up a flight of stairs. Then 12 hours into the shot I started getting chilly and immediately statrted shaking for 20 minutes, no warning, head to toe, more than just the average chills. So I took two tylenol and hoped in bed with a few blankets. The next day I felt like crap, but ok

Mach 24 1700-1730 feeling odd with some joint pain in knees. Injection shot pain normal as most injuections. 1900 achy 2000 chills started 2100 fever of 99.8 March 25 0015 sweaty and hot fever of 102.5 entire body aches, joint pains knees and arms. Musclar aches all over felt slight nausea 0700 aches continued fever down 100.2, fatigued slept most of the day. Injection site tender. Drank water ate toast. 1300 fever subsided 98.6 (my normal is 98.2) Took motrin for aches. Rest of day and night slightly achy stiff joints fatigued. March 26 Still achy and stiff. No fever. Took Motrin. By midday had more energy and able to get around and walk. Noticed taking deep breaths was hard to do with out slight pain. Was gone by the 28th.

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.

Patient began having a seizure approximately 5-10 minutes after receiving the vaccination. Patient came to before epipen was given. EMS were called to the scene and continued care for patient.

Pt experienced dizziness, feeling light-headed, and numbness, and tingling in L arm, face, and BIL LE within 15 minutes of vaccine administration. Pt BP and HR were elevated for approximately 30 minutes after administration as well.

At 5:45 I suddenly felt weak all over and had to lay down. Within 15 minutes I started shaking uncontrollably from body chills. Within a half an hour I had a 102.5 fever. After 2 hours the chills had dissipated but my fever was at 103.5. I took acetaminophen and slept fitfully all night. The next morning at 6:00 my fever was still 102 and I felt weak. By mid morning the fever was finally gone and I was exhausted and mildly nauseous for the rest of the day.

Pt reports body feeling "tingly and off" By received water and stated "the tingly was less" at 1210. Pt stayed for 30 minutes

Patient post Johnson and Johnson vaccination and in observation period when EMS and Nursing staff noticed patient to be unresponsive with 10-20 seconds of mild jerking movements. Patient able to regain consciousness and state that he has a history of seizures Blood pressure124/80, blood glucose 63. Patient transported by EMS to hospital.

Complaints of diarrhea, sweating, weakness suffered sudden cardiac arrest. CPR, AED, Lucas device applied ACLS protocol initiated by EMS. Efforts terminated. Patient pronounced deceased at 1003am.

At 0932, RRT was initiated for a 45 y/o M with c/o feeling dizzy, nauseous, and clammy. He also vomited about 50 cc of yellowish emesis. Vaccinated on the L arm at 0923. Vitals: BP - 128/58, HR ? 62, RR ? 18. Head-to-toe assessment completed. After vomiting, client states he felt so much better. He stated, ?I probably did not eat enough.? He has no PMH, NKA, and did not take any medications today. He has not experienced a reaction with any other vaccine, medication, or food product. Throughout monitoring period, client?s condition improved. By the end of monitoring period, client was in stable condition and did not experience dizziness or nauseousness anymore. He was no longer clammy. Client left vaccination clinic at 0948, accompanied by his family, ambulatory, in stable condition.

my husband has asthma and this shot made him very sick. today is day 4 and he still has fever, chills, is perspiring profusely. an hour after his shot was administered, he started to feel cold, shortly after, he was having chest pains, not long after his fever spiked to 104. his side effects were, fever, chills, vomiting, chest pains, perspiring, asthma attaches, sever body aches, head aches.

nausea, faint, migraine, chills, fever, muscle pain, shortness of breath, joint pain, weakness, fatigue, dizziness, heart acceleration, lots of sleep, anxiety, drowsy.

EMS dispatched to the Vaccine Clinic for the syncopal. Found male supine in vehicle ico event paramedic. Stated male received a Johnson and Johnson vaccine. Stated he drove his car to the medical monitoring location. Stated he had a syncopal episode with muscle rigidity. IV established. Fluids administered. Vitals noted to be hypotensive. Patient-stretcher-ambulance. Patient stated he felt dizzy. Muscle rigidity present. Patient stated he feels his whole body cramping. Stated he remember events that occurred. Denies chest pain. Denies SOB. Denies ABD pain. Denies N/V. Stated he felt healthy prior to the vaccine. No incident during transport. Muscle rigidity resolved PTA at the ER. Patient received 900cc NS. Transfer of care to ER nurse w/ report.

Sudden fever of 101.7 with severe headache, severe chills, and shaking. Some nausea. Arm only slightly sore from injection. Took 2 Advil which did not seem to help much. Could not sleep all night and held cold pack on head to try to help headache. At 4:00 am was due to take 2 more Advil, and that finally seemed to help so he finally stopped having chills and could sleep. Woke up in the morning tired, but feeling better, symptoms pretty much gone.

Pt. received the vaccine at approximately 2:44pm. Before I could hand him his card, his hands began trembling and he looked pale. I asked how he was feeling. He reported feeling shaky, dizzy, and very hot. I asked him if he was having any difficulty breathing, had tightness in his throat/airways, or even felt a tingle. He said no. Noting the time, I asked if he had eaten lunch. I asked if he has ever felt this way before. He said he had when he gets a "hypoglycemic attack." While not diabetic nor on any medications, he said he will occasionally get very low blood sugar. He said he had not eaten since early that morning. Another employee brought some juice I requested. I again asked him about symptoms related to anaphylaxis, to which was not an indication of an anaphylactic reaction. I gave him the juice to sip. I asked him again about symptoms. Because he was still dizzy, I took his blood pressure/heart rate. His BP was 160/119 and heart rate 96bpm. His color became more gray over the next several minutes. He was still too dizzy to stand, felt hot, shaky, and now nauseous. He handed over the juice and was given a receptacle if he vomited. We suspected a vasovagal response, but was still symptomatic after 10 minutes. Meanwhile, the other pharmacist tried to call his doctor's office. We learned his doctor had moved away and he had not yet come in nor selected a new provider. We asked him if he felt he needed to be seen by a doctor. He said he did and agreed to us calling an ambulance. The ambulance arrived around 3:10. The EMTs took his BP. It had come down, but he could not stand up without his knees buckling. The EMTs got him on the stretcher and took him to the hospital.

Spent 2.5 days off work feeling like a moderate severity stomach flu. Lower GI cramping, which moved higher on day 2, hot and cold flashes, sweating, extreme fatigue, upper back muscle aches (severe). Diarrhea, total loss of appetite.

Immediate intense internal heat with excessive sweating; nausea; light headed; faintish; severe dizziness. After 40 minutes, the lightheadedness, faintish and dizziness subsided. However, the intense heat, sweating and nausea continued. By the evening an intense migraine started and by 4/10/21 my sister vomited and started running a fever 100.5. Complete muscle aches, overall feeling extremely ill, totally bed ridden and a migraine that cannot be controlled at all.

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.

Approximately 2.5 minutes post vaccination- patient became diaphoretic, pale, and exhibited a flat affect. Upon opening his car door to further assess, client began to jerk and froth at the mouth. Event lasted <30 seconds. Epi pen administered at 5:20 pm and ambulance called. B/P 88/42, P-120, R-20, SaO2- 96%. Patient evaluated by ambulance personnel, but refused transfer. His girlfriend stated that she would take him via private car to hospital. Patient strongly encouraged to go via ambulance- repeatedly refused.

Became light headed, Fainted, Turned Pale, Sweated. EMTs were called who took BP, Blood Sugar, and ran EKG (I think). and was told all were normal.

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.

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

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.

Had leg pain in the form of a knot in my left calf muscle. The muscle would tighten and feel like a Charlie horse. The issue lasted for about 3 weeks. I tried cooling and then warming it since it felt like a pulled muscle at first. Then as the days went on there was more of a knot in the muscle and then tried warming, stretching, compression sleeve, hot tub, and then tried a massage gun. The issue finally went away but not sure if it was rest or a combination of the treatments.

Beginning two days after getting the vaccine, I completely lost my appetite and developed severe abdominal pain, my blood pressure and heart rate were elevated and my stomach continued to hurt. I also had chest and back pain, muscle aches, insomnia and cramping. Finally went to the Emergency Room on the third night.

Left lower thigh muscle/gout-like pain/can?t add weight without buckling/Started 11 April, gradually got worse until receiving care from the hospital.

Constant headache, and I never get headaches. Flu-like symptoms, general weakness, fatigue and feeling sleepy all day.

SHARP HAND PAIN; SWOLLEN INJECTION SITE; FATIGUE; INJECTION SITE PAIN; BODY ACHES; 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 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: 206a21a, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced swollen injection site. On 08-APR-2021, the subject experienced fatigue. On 08-APR-2021, the subject experienced injection site pain. On 10-APR-2021, the subject experienced sharp hand pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen injection site on APR-2021, and injection site pain on 08-APR-2021, was recovering from body aches, had not recovered from fatigue, and the outcome of sharp hand pain was not reported. This report was non-serious.

Typical arm soreness right after the shot. The next morning however, a severe headache that lasted most of the day and the soreness was more pronounced - treated with Advil II.

after receiving vaccine, about 12 hours later i had the standard side effect of moderate fever (approx 102), chills, and was very fatigued. The fever was gone the next day, but i took the next day off and stayed in bed. The concerning problem was i developed tingling and numbness throughout most of my body, especially on the side where i had the shot, in my arm, neck mouth and tongue. After about 36 hours after the shot i started to feel about 80% better, but the tingling/numbness continued and i continued to have major fatigue. From day 3-5, i was having some trouble moving around - almost like my legs weren't wanting to respond to my brain. Since these symptoms lasted until about day 5, i got concerned and called the doctor. However, right before talking with the doctor in day 5 i was able to do some yoga and was feeling much better, and it all seemed to resolve. I feel better now.

I had mild pain radiating in my arm within 2 minutes of the vaccine. 1-2 hours later I developed unusual and intermittent pain on the volar surface of my wrist. 8 hours after the vaccine I developed chills, severe fatigue, myalgias, loss of appetite, and a fever up to 101. I was bedridden for 36 hours and then the symptoms gradually subsided by day 3. I then developed a sense of chest tightness intermittently for the next 4 days usually at night. I did not have chest pain, but had tachypnea at times with a respiratory rate up to 22/min. At day 7 this resolved.

FINGER TIPS GETTING HOT; FINGER TIPS GETTING NUMB; INSIDE OF LEFT ARM EXCRUCIATING PAIN; COULDN'T WALK DUE TO SWOLLEN ANKLES; COULDN'T WALK DUE TO SWOLLEN ANKLES; SHORTNESS OF BREATHE; HOT AND SWEATY; PAIN ALL OVER BODY; EXTREME CHILLS; REALLY COLD; 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 headaches. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 12:30 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced shortness of breathe. On 11-APR-2021, the subject experienced hot and sweaty. On 11-APR-2021, the subject experienced pain all over body. On 11-APR-2021, the subject experienced couldn't walk due to swollen ankles. On 11-APR-2021, the subject experienced extreme chills. On 11-APR-2021, the subject experienced really cold. On 11-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced couldn't walk due to swollen ankles. On 16-APR-2021, the subject experienced finger tips getting hot. On 16-APR-2021, the subject experienced finger tips getting numb. On 16-APR-2021, the subject experienced inside of left arm excruciating pain. Treatment medications (dates unspecified) included: tramadol, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breathe on 11-APR-2021, and hot and sweaty, couldn't walk due to swollen ankles, couldn't walk due to swollen ankles, extreme chills, really cold, and headache on 12-APR-2021, was recovering from pain all over body, and had not recovered from inside of left arm excruciating pain, finger tips getting hot, and finger tips getting numb. This report was non-serious.

NUMBNESS IN LEG; PAIN IN HIS RIGHT LEG BELOW THE CALF AND PAIN MOVE UP AND INCREASING IN SEVERITY; BODY PAIN; DIZZINESS WHEN HE STOOD UP; CHILLS; FEVER; This spontaneous report received from a patient concerned a 45 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 expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021 02:00, the subject experienced chills. On 11-APR-2021 02:00, the subject experienced fever. On 11-APR-2021 06:00, Laboratory data included: Body temperature (NR: not provided) 100.7 (unit not reported). On 12-APR-2021 06:00, the subject experienced body pain. On 12-APR-2021 06:00, the subject experienced dizziness when he stood up. On 13-APR-2021, the subject experienced numbness in leg. On 13-APR-2021, the subject experienced pain in his right leg below the calf and pain move up and increasing in severity. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in his right leg below the calf and pain move up and increasing in severity, and numbness in leg, and the outcome of fever, chills, body pain and dizziness when he stood up was not reported. This report was non-serious.

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 acid reflux, and eye twitches. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 09:00 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced eye twitching. On 13-APR-2021, the subject experienced slight pressure on side of head. On 13-APR-2021, the subject experienced burning sensation in chest. On 13-APR-2021, the subject experienced shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from eye twitching, slight pressure on side of head, burning sensation in chest, and shortness of breath. This report was non-serious.

Patient does not remember most of the adverse event. Patient's partner reports that patient started feeling a tingling sensation on his left arm about 10 minutes after vaccination. Partner also reports that patient was hallucinating and sending her confusing text messages during his 15 minute observation period. The patient did not report feeling any adverse symptoms at the checkout station after his 15 minute observation period and before leaving the vaccination clinic. After patient returned home, his partner reports considerable swelling on his left arm, continued hallucinations and trying to dismiss her concerns. Subsequently, that same day, partner reports the patient had a severe migrane and began to lose feeling on his left arm and leg, at which point the patient also lost consciousness. Also at this point, the partner calls 911. After arrival of emergency personnel, the patient regains consciousness, but does not remember name and complains of continued pain on his arm. He is transported to hospital where he spends 3 nights and receives treatment and care for stroke symptoms. Patient reports that he does not remember much of anything 1.5 days after vaccination. After returning home from hospital, patient complains of memory lapses and begins seeing neurologist for minor seizures during his sleep. Wife reports that patient now lashes out and easily loses temper due to the fact that his memory is foggy.

CHEST PAIN; CHEST PAIN RADIATING TO STOMACH ON AND OFF; PAIN LIKE SENSITIVE TO TOUCH ON LOWER BACK OF LEGS BELOW KNEE (RIGHT LEG IS MORE SENSITIVE TO THE TOUCH THAN LEFT); 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 non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient did not 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: UNKNOWN) dose was not reported, administered on 13-APR-2021 for prophylactic vaccination. The batch number was not reported, per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 17-APR-2021, the subject experienced pain like sensitive to touch on lower back of legs below knee (right leg is more sensitive to the touch than left). On 20-APR-2021, the subject experienced chest pain. On 20-APR-2021, the subject experienced chest pain radiating to stomach on and off. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain like sensitive to touch on lower back of legs below knee (right leg is more sensitive to the touch than left), and chest pain, and the outcome of chest pain radiating to stomach on and off was not reported. This report was non-serious.

5 minutes post vaccination, client left an "adrenalin rush" and "tightness on his chest and tingling and tense all over his body." Client felt very anxious today and he reports having history of anxiety. His BP is 155/97 p 101, after 5 minutes manual BP is 142/90 p 110. 911 was called and medics performed an EKG on site. Client indicates that his symptoms are improving and was not transported to the hospital.

SHAKING; BODY ACHE; CHILLS; FEVER; HEADACHE; This spontaneous report received from a consumer concerned a 45 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included aspergers. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 12:30 for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021 17:00, the subject experienced shaking. On 25-MAR-2021 17:00, the subject experienced body ache. On 25-MAR-2021 17:00, the subject experienced chills. On 25-MAR-2021 17:00, the subject experienced fever. On 25-MAR-2021 17:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking, body ache, chills, fever, and headache on 27-MAR-2021. This report was non-serious.

Bell Palsy, left side of face severe paralysis. Treatment Prednisone 20MG Tablets (7 days) / follow up with primary care doctor.

Patient started to have left leg pain. Presented to facility on 4/26/21. Ultrasound examination showed DVT

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.

Guillain Barre syndrome- symptoms of BLE numbness with ascending bulbar weakness developed 4/18 and diagnosed on 4/27

VIRAL PERICARDITIS; LEFT ARM PAIN; SEVERE HEADACHE; ABDOMINAL PAIN; This spontaneous report received from a patient via a company representative concerned a 45-year-old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and social alcohol drinker, and other pre-existing medical conditions included no known allergies and no history of drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: 09-JUN-2021) dose was not reported, 01 total, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the patient experienced abdominal pain. and severe headache. On 03-APR-2021, the patient experienced severe chest pain and left arm pain. On 04-APR-2021, the patient was admitted to the hospital and diagnosed with viral pericarditis and was discharged on 06-Apr-2021. Laboratory data included: On 04-APR-2021, Angiogram (NR: not provided) Not reported, CT (computed tomography) scan (NR: not provided) Not reported, EKG (electrocardiogram) (NR: not provided) Not reported, Echocardiogram (NR: not provided) Not reported, Troponin increased (NR: not provided) Troponin levels increased, and X-ray (NR: not provided) Not reported. On 05-APR-2021, Laboratory data included: Angiogram (NR: not provided) No blockages. On 06-APR-2021, Laboratory data included: Echocardiogram (NR: not provided) No blockages. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from abdominal pain, and left arm pain on APR-2021, and had not recovered from severe headache, and the outcome of viral pericarditis was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: 20210436265-covid-19 vaccine ad26.cov2.s-Viral pericarditis, Abdominal pain. 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). 20210436265-covid-19 vaccine ad26.cov2.s-severe headache, Left arm pain. This event(s) is labeled per Agency and is therefore considered potentially related.

Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Medium, Additional Details: Patient Refused epi-pen. Most likely anxiety-related event per patient and wife/observation. EMS showed up to store within 20 minutes; patient was discharged to home and did not follow up with ER. Spoke with wife at 5PM --patient has been fine all afternoon and went shopping after AE.

Patient felt unwell after administration. He complained of headache and muscle soreness in both arms

Started with nausea, then it followed. Migrane, unable to talk, unable been awake ,I even fainted I don't know for how long but when I woke up was on the floor and sweating, chills, fever, shortness of breath, tireness, muscle pain and cough. Did not go to the doctor or hospital, I have no insurance. Even until today I still have a light cough and shortness of breath. All this stopped me from going to work for 2 weeks, and unenployment did not pay.

Patient was waiting/ being observed after receiving the Janssen Covid vaccine. Approximately 10 minutes after the vaccine, he reported feeling very faint and was about to pass out. He wasn't feeling well so 911 was called. He also reported feeling hot and was visibly sweating. He drank some water and sat in front of a small fan until medics arrived. They assessed him and he walked out with them for further evaluation. I called patient at 7:30 to see how he was feeling. There was no answer and his voicemail didn't allow me to leave a message.

Before receiving the vaccination the patient mentioned he had a fear of needles. Patient was asked if he ever fainted after getting a vaccination or injection and patient reported no. The vaccine was administered to the patient and patient appeared to be fine for the next few minutes after getting vaccinated. Patient was told he could take a seat in the waiting area and wait until his 15-minutes were up and he could go. Patient was seated in the waiting area for about a minute but then got up to walk down one of the isles. When walking down the isle patient fainted and collapsed. This occurred approximately 10 minutes or so after he received the vaccine. Patient was helped to a chair and once seated appeared to shake/convulse (almost like a seizure) for approximately 5-10 seconds before snapping out of it and regaining consciousness. Afterwards he was alert and talking but didn't remember fainting. 911 was called and he was checked out by paramedics. After observing him for 15 minutes or so and determining his heartrate and blood pressure were normal and he appeared to be ok, the paramedics told him they can take him to the hospital to be evaluated further, or he was free to leave on his own without going to the hospital. The patient said he felt fine and declined being taken to the hospital. After another 10-15 minutes the patient left under his own power. Patient mentioned he would possibly be calling his physician and alerting them to the episode.

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

On 5/13/2021 patient developed a cough in the evening. Patient woke up not feeling well on 5/14/2021, and also had nausea and vomiting. Patient was driving a vehicle when he had a seizure. No prior history of seizures. Drifted off the road, no significant damage to vehicle. Patient post-ictal following seizure, seizure activity was witnessed by bystanders. CT brain showed small subdural hematoma. A CTA chest performed due to hypoxemia and tachycardia at Hospital showed Multifocal groundglass type nodular infiltrates throughout the right lung involving the upper lobe, middle lobe, and lower lobe, minimal left lower lobe patchy infiltrate, as well as patient's known thymoma. These multifocal groundglass infiltrates were not previously mentioned on a CT chest performed on 4/10/2021. Patient was transferred to this facility for evaluation by neurosurgery. Patient was mildly tachycardic, hypoxemic to 88% on room air, and tachypneic. Patient reported decreased sense of taste & smell for 1 month, which he attributed to his losartan use. A covid/flu/rsv PCR on 4/10/2021 was negative, and a viral respiratory pathogen panel with covid PCR was negative on 5/14/2021, as was an antigen & NAAT for COVID on 5/14/2021. Patient was treated with antibiotics and admitted for further management.

Bilateral facial paralysis - symptoms started on the right on April 21, 2021. Patient was seen by PCP on April 22, 2021 and started on Valtrex and steroids for the treatment of Bell's Palsy. On April 24, 2021 the left side developed paralysis as well. Patient was seen in the ED. Labs, MRI and CT of the head were performed. Lumbar puncture was attempted but unsuccessful. Patient was discharged home and had lumbar puncture as outpatient on April 29, 2021 as well as additional blood work. Tests showed no malignancy or infectious etiology. He was started on another round of steroids on May 7, 2021. Started physical therapy the following week. Still has minimal facial mobility at the time of this submission.

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.

MOTHER REPORTED HE HAD ADDITIONAL SEIZURES, VOMITING, EXTREME FATIGUE,STIFF ARM, SLURRED SPEECH, COULDN'T WALK WELL. MOSTLY AFFECTED RIGHT SIDE.

Complained of right lower leg pain and swelling, shortness of breath, sent to hospital for Ultrasound of right lower leg, Ultra sound was positive for a DVT. Was then sent to the Emergency room for evaluation and treat for DVT. Complained of Shortness of breath. CT Scan Angiogram completed and found to have bilateral Pulmonary Embolism

FATIGUE; HEADACHE; CHEST PAIN; TACHYCARDIA; CRAMPS ON HANDS, ARMS AND RIGHT LEG; PAIN ON LEFT ARM; This spontaneous report received from a patient concerned a 45 year old white and Hispanic or Latino male. The patient's height, and weight were not reported. The patient's past medical history included gastritis, and concurrent conditions included glaucoma, avocado allergy(it causes nausea). Patient had Reglan allergy which causes nervousness. Patient was alcohol user (one time a month socially) and non-smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: unknown) dose was not reported, administered on 28-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in APR-2021, the patient experienced chest pain, tachycardia, cramps on hands, arms and right leg and pain on left arm. On an unspecified date in MAY-2021, the patient had fatigue, headache. On 01-MAY-2021, patient underwent PCR Covid-19 test which was negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest pain, headache, cramps on hands, arms and right leg, fatigue, pain on left arm, and tachycardia. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210604719-COVID-19 VACCINE AD26.COV2.S-Chest Pain, Tachycardia. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Patient came to the pharmacy for the Janssen COVID vaccine. He was feeling fine, and was injected with vaccine in the left deltoid at 1:05pm. He remained alert throughout the time information and instructions were provided. Later, he mentioned fear of needles and looked pale. I gave him a Gatorade drink and glucose tablets. At about 1:10pm he fainted while seated in our pharmacy waiting area. He was accompanied by his significant other. He had mild convulsions that lasted less than 5 seconds. Our request to call 911 was denied. Store management responded to our call immediately. Observation and care was provided. Moist cloths were given to patient. He recovered in about 15-20 minutes. He walked out with his significant other. He was very thankful and said he felt normal.

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.

pt received Janssen vaccine around 10:28a. Patient was sitting in the post vaccination area. Around 3-5mins, he fainted, hit the floor. I ran out once this was brought to my attention. I found him on floor, blood on the floor and he was shaking and then stop. I don't know how long he was shaking but it stop. I checked the pt and he regained conciousness. I asked if he is ok. He ask what happened because he does not remember. He speaks another language and an associate was there to translate. We asked if he wants us to call 911, he refused. The firefighter/paramedics suggested they will come over anyway to make sure he is ok, he does not have to go with them to go to the hospital. Pt did not want to go to hospital because he does not have insurance. He was checked by a medic who also speaks his language. He checked pt's vital signs, asked questions like allergies, medical conditions, asked what day is today and what is his name (which were the same questions I asked before medic arrived). Medic informed patient the importance of seeing to a dr, the sooner the better. Pt still does not want to be taken to the hospital. Patient signed a refusal form. Nephew picked up the pt

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.

Superficial thrombophlebitis in left medial lower calf, along with edema in foot and ankle on same leg and pain in calf, foot, and ankle. No explicit treatment prescribed. Symptoms are ongoing as of 6/25/2021, but have reduced in intensity. The was the first blood clot I've ever experienced.

On vacation in, just got to hotel and fell asleep. Wife said I lifted my head with a strange look on my face, laid back down. Then one minute later had a grand mal seizure. Called 911 and was sent to ER via Ambulance. ER conducted EKG, CAT Scan and other tests to determine the root cause. Found, no tumors or other explanations for the seizure. No prior history of neurological problems. Interestingly both of my parents are also now suffering neurolgical side effects after taking the Pfizer Covid vaccine.

CHEST PAIN; NUMBNESS IN FINGERS ON LEFT HAND AND LEFT ARM; FELT WEIRD; PAIN; PAIN IN NECK; PAIN IN ARM; PAIN IN HEAD ON LEFT SIDE; LACK OF ENERGY WHEN WALKING OR WORKING; This spontaneous report received from a patient concerned a 45 year old male. The patient's weight was 175 pounds, and height was not reported. The patient's concurrent conditions included glaucoma. The patient experienced does not feel good when treated with metoclopramide. 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 for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported. On 18-APR-2021, the subject experienced chest pain. On 18-APR-2021, the subject experienced numbness in fingers on left hand and left arm. On 18-APR-2021, the subject experienced felt weird. On 18-APR-2021, the subject experienced pain. On 18-APR-2021, the subject experienced pain in neck. On 18-APR-2021, the subject experienced pain in arm. On 18-APR-2021, the subject experienced pain in head on left side. On 18-APR-2021, the subject experienced lack of energy when walking or working. Laboratory data (dates unspecified) included: CAT scan (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest pain, numbness in fingers on left hand and left arm, lack of energy when walking or working, and pain in head on left side, and the outcome of felt weird, pain, pain in arm and pain in neck was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.

Attendee with history of fainting with needles. was given his single shot while sitting. Had declined offer to go to cot, Staff observed Attendee's color changed after Initially attempted to stand up, observed and told to remain sitting. Given ICEPacks, Monitored, reports tingly cold hands Transitioned to lying down. declines EMS and medications, Symptoms resolve after WIfe arrives, transitioned to standing, D/c to wife /daughter/ car to home.

On 7/6/2021 while on vacation, I started developing sharp tingling feeling in my left leg. I then nearly had a syncopal episode, had trouble speaking and was leaning to the right. My wife had to hold me up. My brother in law had to carry me to the car as my left leg was not working at all. I was taken by ambulance to the nearest hospital and was worked up for possible CVA (which was ruled out). I was also checked for DVT of lower extremities which was negative. I am still having residual numbness and tingling to my left leg. I am still having symptomatic bradycardia with near syncope.

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

After receiving the vaccination I experienced headaches, face drooping on the left side possible Bells Palsy. I also experienced panic attack symptoms as well.

Systemic: Dizziness / Lightheadness-Mild, Systemic: loss consciousness for 10 seconds-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Pt HR at 49-55, loss consciousness for less than 10 seconds, became diaphoretic. BP at 96/62. Pt felt better after 5 minutes.

Within about 5 hours of the vaccine, started to feel skin sensitivity all over my body. It felt like every pore on my body was open and hyper sensitive to touch. My scalp was very sensitive to touch and there was a strange sensation when my clothes touched my body- I've never been hyper sensitive like this before. Within about 12 hours, developed a fever, chills and inability to get warm. Symptoms persisted for about 36 hours.

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.

Tingling in hands and feet, started estimated 2-3 weeks after receiving the vaccine. Still there, as of today 7/22. But has not gotten worse nor have I experience muscle weakness or other symptoms.

MEMORY LOSS (SOMETIMES CAN'T REMEMBER THINGS); SORENESS THROUGHOUT THE BODY; INSOMNIA/CAN'T SLEEP; PAIN IN RIGHT ELBOW IS GETTING WORSE; CHILLS AFTER WIPING AWAY SWEAT AT NIGHT; HEAVY SWEATING AT NIGHT (DESCRIBING IT AS LITERALLY SWEATING BUCKETS, HAVE TO SLEEP ON TOWELS AND CAN'T SLEEP); 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 non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no medical history, no known drug allergies and no drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 24-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-JUN-2021, the subject experienced heavy sweating at night (describing it as literally sweating buckets, have to sleep on towels and can't sleep). On 27-JUN-2021, the subject experienced soreness throughout the body. On 27-JUN-2021, the subject experienced insomnia/can't sleep. On 27-JUN-2021, the subject experienced pain in right elbow is getting worse. On 27-JUN-2021, the subject experienced chills after wiping away sweat at night. On 13-JUL-2021, the subject experienced memory loss (sometimes can't remember things). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heavy sweating at night (describing it as literally sweating buckets, have to sleep on towels and can't sleep), memory loss (sometimes can't remember things), soreness throughout the body, insomnia/can't sleep, chills after wiping away sweat at night, and pain in right elbow is getting worse. This report was non-serious.

Received vaccine at 9:00am, 9:15am light headache 10:30am felt light headed when walking. 12:00pm headache slightly stronger and discomfort in knees. 4:00pm joint aches specially in the knees, ankles and finger joints. 6:00pm tingling sensation on cheeks and headache persist. Walking uncomfortably because of joint aches.

The 46yo patient came in to get his covid vaccine. His parents reported he has a medical condition/disability that requires him to receive services in their home. After receiving the vaccine the patient reported feeling lightheaded, dizzy, hot, and that his blood pressure felt abnormal. He requested an ambulance and some water. I called 911 and provided him water, but did not administer any epinephrine or any other medications. The paramedics arrived and talked to him for about 15 minutes. He then left on his own accord with his parents and declined further medical attention.

Body shaking and aches 5 hours after vaccine, fever started 6 hours after vaccine, along with headache and inability to sleep, fever lasted for almost 36 hours, nausea which led to vomiting 16-17 hours after vaccine, vomiting off and on for the next 8 hours, 3 days later and still have headache and some dizziness and brain fog and some moments of nausea, day 2 had some itching on legs, day 3 and still don?t feel back to normal

Violent uncontrollable shaking (convulsions) for about 30 minutes in the middle of the night. Started around 2 am I believe. My wife had the same vaccine the day prior and a similar experience. Can't overemphasize how serious the shaking was and it was scary.

Within two minutes of receiving the shot, began to feel very nauseous. Inside of ears then felt very hot and body below neck felt very chilled. After five minutes these symptoms intensified, feeling hot flushed in face and vision darkened, feeling like a black out may occur. Pharmacist provided water. Symptoms began dissipating after 20 minutes after injection. After 30 minutes, symptoms ended.

Symptoms began immediately. I felt an aching pain in my left arm immediately after the vaccination. It then moved to my scapula. It persisted the rest of the day and all day Tuesday. I also felt soreness of limbs (both arms and legs) intermittently for the 48 hours. I had shortness of breath for the next day. I felt extreme fatigue for the next 48 hours. I felt my heart racing off and on for 24 hours, I felt a loss of strength in both arms and legs for the next 48 hours. Monday Night I woke up sweating as I had a fever. The fever persisted off and on for about 24 hours. I was irritable (probably due to not feeling well) for about 48 hours. My wife had to drive me home.

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.

immediately felt tingling in left arm (like ben gay), then after about 10 min felt go into neck and and cheek. A little light headed. At 15 minutes asked nurse if normal. Then started sweating. left hand turned purple. Dont really remember anything else. Went unconscious. Remember them yelling Code something and Cardiac arrest. Taken to ER. Think they may have said anaphalatic shock. I think they gave me epinepherine. Had paralysis in left hand when i woke up for a few minutes. Blood work and EKG were normal. Went home within a couple of hours. Light-headed two days later still. Saw doctor two days after. Blood pressure is high. Little bit of fatigue and brain fog.

I received the J&J shot after work on Friday around 5:30 p.m.. Around 3 a.m. Saturday morning, I woke up with a fever and chills. My head was hot. My body was cold. I had a pretty severe headache as well. My body ached all over. Muscle and joint pain. I took Tylenol, but it didn't seem to do much. I spent all day Saturday in bed or on the couch. I ran a fever of 100.9 to 101.6 all day Saturday. My body ached making it hard to go up or down stairs. I was weak feeling and I was exhausted just going to refrigerator to get juice or water. Not much of an appetite all day. Also, arm was sore and bruised at the shot location. That was the least of my issues. Today is Sunday and I am feeling better now. I feel like the worst is absolutely behind me, but I felt so terrible yesterday, I thought I should report my issues.

At 1412, RRT was activated for a 46 y/o M with c/o feeling warm. 5 minutes after this complaint, he threw up about 100 cc of yellowish emesis. Client stated he felt better after vomiting. Vaccinated at 1350 on the L arm. Vitals: BP ? 118/72, 0/0 pain. Head-to-toe assessment completed. No PMH, NKA, and did not take any medications today. During monitoring period, client?s condition improved. At the end of observation period, client was in stable condition and did not feel warm anymore. Client left vaccination clinic at 1432 ambulatory, in stable condition, accompanied by his family (Wife and daughter).

day after, was severe nausea, body aches, low grade fever. headache. 2nd day I was fine, about a week later I had a relapse without the nausea. I have felt off ever since, low grade fever comes and goes 99-100 degrees. My skin feels constantly hot and has become extremely sensitive, scratching my head is painful. I am more shakey in my hands than normal, my head is foggy and cant concentrate at times, insomnia. Which is essential for my work. My heartbeat is rapid at times but my blood pressure isn't up. All of my bloodwork looked fine except for weak anemia which is new for me. the last thing is a rash appeared on my feet and legs but doesn't itch and I started getting shooting pains in my legs, this is new, started about a week ago.

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

Seizure-like episode. Patient was seated when his body went rigid and he lost postural control and started to slide sideways. His body was shaking slightly and his eyes were open but there was no cognitive awareness. This lasted no more than 90 seconds and then patient came to abruptly and reoriented himself on the chair before I had the opportunity to get him to the floor. Patient then stated that he was lightheaded, warm and sweaty. EMT had been called and upon assessment of the patient transported him to the ER.

Headache, chills, fever, vomiting, diarrhea, weakness. From just after midnight day of injection for around 12 hours following on and off.

DIZZINESS; FEELING UNWELL; FATIGUE; WEAKNESS; This spontaneous report received from a consumer concerned a 46 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no history of medical conditions and no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number not reported) dose was not reported, administered on 06-APR-2021 14:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, the subject experienced dizziness. On 06-APR-2021, the subject experienced feeling unwell. On 06-APR-2021, the subject experienced fatigue. On 06-APR-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, dizziness, weakness, and feeling unwell. This report was non-serious.

Fever, sever chills for 2 hours, sustained heart rate around 90~100 for more than 4 hours, intermittent headaches 24 hours, mild confusion for 4 hours, loss of appetite for 48 hours

Felt numbness on bottom of left foot primarily at back of heel to fourth and fifth toes. Slight numbness/tingling just above and below left elbow. Symptoms lasted for approximately 2 days from onset.

EMS, who was working in the clinic, stated that the patient had a partial seizure and directed the Clinic Lead Nurse to call EMS. Patient became pale, 5 second seizure, dizziness and vomiting. EMS was called and vital signs were taken but patient declined to go to the hospital. Patient recovered and drank some water and ate some crackers. Patient waited another 30 minutes and stated he felt much better. Clinic Lead Nurse called the patient, on April 13, 2012, who stated that he went home, ate some food and relax the rest of the day. He stated he felt better and had no more problems. He did not seek additional medical care.

Burning Arm initially, later that day, high fever, chills, vomiting, body aches, and overall clamminess that lasted for 2 days.

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.

After receiving the J&J vaccine on Sunday afternoon, when my husband got up on Monday morning he passed out in the bathroom and was unresponsive. The EMTs arrived and were able to revive him in the ambulance. When they reached the hospital he was put on life support. After he coded again in the Emergency room they told me he was without oxygen for too long and was taken off the respirator. He passed away at 4:10 PM.

Pain all over the body! Swelling in both feet ankles, fever, stomach pain, fatigue, chest pain and phlegm! Extreme tiredness, pain and swelling in the vaccinated arm, swollen of the shoulder of the vaccinated arm, severe headache

FOOT NUMBNESS; HEADACHE; FEVER; SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a 46 year old male. The patient's weight was 165 pounds, and height was 69 inches. The patient's concurrent conditions included penicillin allergy, smoking, and abstain from alcohol, and other pre-existing medical conditions included no illicit drug usage. 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 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced fever. On 01-APR-2021, the subject experienced shortness of breath. On 04-APR-2021, the subject experienced headache. On 15-APR-2021, the subject experienced foot numbness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, was recovering from headache, and had not recovered from foot numbness, and shortness of breath. This report was non-serious.

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

At 10PM day of vaccination, started feeling weakness. Weakness became fever and mild headache around 11PM. Low grade fever and weakness and intense fatigue persisted into the next day, April 30th. Low grade fever still ongoing at time of this writing. Headache has mostly resolved, along with regaining some strength.

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.

HIGH BLOOD PRESSURE; BRAIN FOG; FATIGUE; ANAPHYLACTIC SHOCK; PARALYSIS IN LEFT HAND; LIGHTHEADED; 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 pre-diabetic, and other pre-existing medical conditions included the patient had no known drug or non-drug allergies. The patient had no illness 30 days prior to vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) 1 total dose was administered at left arm on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021 at 14:35, the patient immediately felt tingling in left arm (like ben gay) after vaccination, 10 minutes later he felt tingling in neck and cheek. His left hand turned purple. He became unconscious (he did not remember anything). He had cardiac arrest (patient remembers yelling code). He was taken to emergency room. He thought people in emergency room said anaphylactic shock and gave him epinephrine (patient was not sure). He had paralysis in left hand when he woke up for a few minutes. His blood test and Electrocardiogram were normal. He went home in couple of hours (on 31-MAR-2021). On 02-APR-2021 (two days later) he was light-headed, he went to his doctor. His blood pressure was high, he felt little bit of fatigue and brain fog. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lightheaded, anaphylactic shock, paralysis in left hand, high Blood pressure, fatigue, and brain fog. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210443005-covid-19 vaccine ad26.cov2.s- anaphylactic shock, paralysis in left hand. 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).

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.

For about 36 hours after vaccine - I started getting headaches and I never get them. I had backaches and my legs were hurting too. My blood pressure was elevated as well. And that was not going away either. I went to doctor. My headaches have decreased. But for the last two to three days I have been getting chest pains. I have called the doctor this morning and I'm waiting to call me back. It's not ongoing pain - just every now and then - I'm not sure what it is.

pt was hot and lightheaded while sitting then fainted in his chair pt reawoke after maybe 2 minutes and then was helped to floor 911 was called and ambulance crew checked pt over he refused to go to hospital after they checked him out and said that he looked fine he sat for maybe 5 more minutes then walked out of pharmacy

Systemic: Hypertension-Medium, Systemic: Seizure-Medium, Additional Details: Pt had seizure like activity / HTN crisis 3 min after injection. Hx of heart problems and phobia of needles. Pt lost airway and then consiousness, Pt was assisted to floor. EMS was called. After airway postioning and sternal simulation pt regained consiousness. Pt was handed off to NP care and then later to EMS after being evaluated. Wife stated they did not go to hospital and later went to dinner, when she picked up vaccine cards.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Additional Details: Patient fainted after receiving vaccine, he tipped forward in his chair and hit his head on counter in front of him. 2 minor laceration on forehead and cut upper lip. Pt unconscious for less than 1 minute. Blood pressure taken about 5 minutes later and was 65/40. 911 was called and paramedics arrive on scene. Care was transferred to them

Site: Pain at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: patient was unresponsive for few seconds less than a min and came back 911 paramedics evaluated him and took to emergency for further evaluation

Patient got faint, cold and clammy about five minutes after his vaccination and was visibly pale. When we went to assist him he asked to lay on the floor, before we could help him to this position he fainted, we got him on the floor and on his side, within about twenty seconds he woke up and was very aware of his situation. We applied ice packs under his neck and on his forehead. After about twenty minutes he sat up and started to gain his color back. At this point he told us he had fainted before after a flu shot and and donating blood. Several minutes later he was able to stand up and sit in a chair. Cold packs were continued and he drank a bottle of orange juice. Twenty minutes later he said he was back to normal just felt weak like after a work out. He wanted to use the restroom and was escorted, showed no additional signs or symptoms at this point, and wanted to go home.

3 minutes after injection patient started to stand up to get pharmacist's attention and pharmacist looked over at patient and noticed patient was clammy and looking like he was going to fall over. Pharmacist told patient to sit back down and immediately grabbed e-kit and headed to patient's side. Patient was clammy (like just got out of shower). At 3:45 PM BP was 128/63 and PR was 44. At 3:50 PM BP was 92/56 and PR 51, at this point RPh decided it was more than a vaso-vagal reaction and administered the epinephrine injection at 3:51 PM - EMS was called. At 3:52 PM BP was 130/76 and PR 59, 3:55 PM 134/86 PR 66, 3:58 PM BP was 148/83 and PR 68 at 3:59 PM EMS arrived and patient declined them taking him to hospital via ambulance due to no insurance. He had pharmacist escort him to his car so he could get his cell phone and back to pharmacy so he could call his son to pick him up and take him to the hospital. Unknown if patient ended up going to hospital.

Freezing (no chills) literally woke up freezing and shaking bad trying to get warm, fever, bad muscle and joint pain and bad fatigue

Vaccine administered at 12:30 pm. By 6:30 pm, a fever and chills started. I woke up at 11:00 pm and had a 104.7 fever with vomiting, nausea, join pains, weakness, fatigue, and headache, along sinus tachycardia. Went to the ER to be evaluated, it was determined that this was an adverse reaction. I was released from care around 2:30 am.

Since I got the vaccine I felt cold and I had flu till now and my buddy so tired but the main problem is MY BLOOD PRESSURE IS TOO HIGH SINCE I TOOK IT UNTIL NOW it's over one month. My blood pressure never get down 160.

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.

Patient became non responsive within 2 min of receiving shot. Was lowered to the floor, diaphoretic and pale, revived within 1 min, confused. States he has had this effect during previous shots/ blood draws/ being around ?sick people?. Patient given water and crackers (has only some green beans at noon today). Feels fine 10 min later.

I experienced a bit of soreness to my left arm, my arm felt a little bit warm to touch. I also felt tired and some fever on the second day. The pain went away in 3-4 days.

Patient was known to have fainting spells due to vaccinations in the past. Shortly after immunization took place he became hot and fainted while sitting in his chair. After a few moments he came to and we provided him a cooling pack for the back of his neck. He confirmed he was able to leave after another 15 minutes of monitoring.

24 hour after vaccination patient experienced hot flashes and dizziness that lasted on and off for three consecutive days. On the third day patient experience bilateral lower leg cramps and muscle tightness in both calves, patient also experience the same cramps and muscles tightness lower left abdomen. Symptoms resolved after three day with slight residual tight experienced in lower left calf muscle

All my Lyme Disease symptoms returned after 19 months of absence. Tingling sensation in my left hand. Dropping and coordination issues has become a constant occurrence.

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.

random body rashes from my feet to my neck for 15 days now. None on the genitals. Itchy and skin welts without even touching it. I've changed my diet, changed detergents, stopped taking all vitamins, nothing helps. they come and go all day and night. On 7/13/21 between 3pm-10pm my whole head went tingly, itchy, and semi-numb, including when I flossed my teeth.

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.

Patient was a healthy 46 y/o male with no significant medical history. He was taking no medications. He received the J&J vaccine on 04/06/2021. On 04/28/2021 he had a fall from probable syncope. He sustained a laceration to his forehead. He was sent to Hospital for evaluation. He had CTs of head and neck, which were unremarkable. A drug screen was negative. Both before and after his return he was having issues with his speech. He seemed to understand words but when he tried to respond, his speech was garbled . He was observed in the infirmary. There was slight improvement in speech. He returned to his block. Because of persistent issues with speech he had an MRI of his brain on 06/03/2021. This showed a left middle cerebral infarct which appeared as a late subacute/early chronic infarct. While an outpatient workup was being scheduled, he had another episode of witnessed syncope. This was on 06/14/2021. An MRI at hospital showed a larger infarct than seen on 06/03/2021. He was hospitalized for 3 days. No cause for the CVA was found during this hospitalization. He has continued with speech symptoms and is starting speech therapy in the near future. In summary, this I/M was in a normal state of health with no risk factors for vascular disease. Two weeks after receiving the J&J vaccine, he had a CVA which may have extended on 06/14/2021. After multiple tests, no reason was found for the CVA to occur. It is certainly possible that the CVA was related to his COVID-19 J&J vaccine.

The vaccine gave me quite severe side effects (COVID symptoms). I think this is because I had COVID twice previously (last time in Dec 2020). About 8 hours after injection, I had sudden onset of high fever, chills, aches, headache - the symptoms were worse than full blown COVID itself (without the breathing problems) and lasted about 4 full days. I was so sick I took 2 days off work, which is very uncommon for me. My arm was quite sore for about 5 days. I've never had any reaction to a vaccine before and thought I should mention this. I didn't have any anaphylaxis or allergic reaction that I know of, just very, very severe COVID symptoms.

Client received the J& J Covid vaccine injection at the Health clinic and within 40-60 seconds had c/o "feeling funny" and felt like he was going to pass out. Client started to have a seizure-like activity, and loss consciousness two times. Ice packs and cooling clothes were applied to clients forehead and neck after client seizure-like activity stopped, feet elevated. Client was diaphoretic, gray, started twitching (which he said is normal when he gets nervous.) BP was low at 86/64. EMT called and client evaluated. Client refused transport to hospital. Client recovered from episode after an hour and left with his wife from the health department able to walk and communicate on his own.

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.

Shingles on left side of face. It's a mild case, but pain and extreme sensitivity to touch, numbness in some areas, fluid-filled blisters that break open and crust over, itching.

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 ---

Within 2 hours of receiving vaccination I had a very mild bout of diarrhea that lasted around 20 minutes, had to go to the restroom twice. The next morning at 4:45 am I woke with chills and moderate muscle , joint aches and random sharp muscle pains all over my hips, arms, and legs. Chills, aches, and fever continued until 8:30pm the same night. My fever would go to 102.8 as a high to 100.2 depending on how close I was to my next timeframe to take Tylenol. I took 4 extra strength Tylenol (2000 mg) every 4 hours, give or take 30 minutes. Around 8:30 pm my fever broke and I sweated mildly Until around 10:30pm

After 2 minutes felt wave of flush, heart rate accelerated from 55 to 90, blood pressure rose to 150/100. Experienced light headedness. BP and HR returned to normal after 30 minutes. Light headedness remained for 2 hours. After 20 minutes heart started squeezing feeling and remained for two days. After 2 hours, began feeling sharp pains in heart and palpitations, continued for 5 days. After 12 hours began feeling mild aches and chills and fatigue. Continued for 3 days.

Woke up with intense arm pain at injection site on 15th day after vaccine. Radiated down arm , subsided after approximately 30 minutes. Deep tissue, burning pain. Remained only slightly sore remainder of day. Had not experienced arm pain at injection site since day 3 previously.

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.

I am filling this this out to report similar symptoms and reactions for three of us in the same household (ages 47, 45, and 18). Flu-like symptoms: fever reaching as high as 101.2, night sweats, joint pain, chills, unable to get warm, exceedingly tired, loss of appetite, upset stomach. Missed work (two of us) and school (one of us) within a couple days of the shot.

pt states he started feeling nauseas, developed a headache, and had diarrhea. The next day he had fever, chills, body aches, he was shaking. His headache was getting worse. All symptoms were getting better except the headache. He thought he was feeling better but when he woke up today 4/6/2021 he was SOB and diarrhea was back. Pt has taken Pepto Bismol for his symptoms and will probably need to go to the ER since he is having trouble breathing. He feels like he has had such a bad reaction to this since he possibly has had the covid vax in the past 90 days.

Patient received the vaccine. Immunizing tech stated: the patient seemed fine at the time of the shot. After administration of the shot the patient began to bleed out of injection site (like normal). The immunizing tech swabbed the area with cotton and placed a Band-Aid on the patient then stepped back into the pharmacy to grab another band aid while the patient remained at the immunization chair. The tech applied another band aid and told the patient to wait 15 minutes after the immunization and directed him to a waiting chair. The tech came back into the pharmacy and was cleaning the immunization basket when the patient's wife yelled for help. At this point I went out to the patient. Another tech called 911, another grabbed a nearby EpiPen. The immunizing tech grabbed the e-kit while I was out with the patient while he was unresponsive. Patient was unresponsive and slouched in chair. His wife and I supported the neck of the patient and laid him on the floor. I checked pulse and breathing to which both were present. Patient was still unresponsive and making strange movements. Pulse and breathing remained present and then the patient became responsive relatively quickly. At this point patient responsive and answering questions and moving fine. He asked if he had passed out then stated, he had a phobia of needles and said he felt nauseated. (wife previously stated he had a fear of injections). Soon after the ambulance showed up and I told the paramedics the above story. After a few more minutes I checked in with the paramedics and they said the patient was doing fine. Lastly, he was taken out of store with paramedics.

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.

Extreme chills causing full body shaking Extreme fatigue to the point that holding head up and staying conscious was difficult Mild Fever All started about 12hrs after the vaccine and lasted about 32hrs

1 hr after shot (tuesday 0831 hrs), right bicep was twitching. Next morning (wedenesday 0700 hrs) pain an redness in Right shoulder. Most importantly pain in the spine from middle to lower back.. (Thursday 0510 hrs) while brushing teeth, a sharp pain put me to my knees.. 1200 hrs pain was still there... Went to urgent care.. Doctor said it was back spasms.. Said he didn't know if it was related to the vaccine. Then also said nobody knows. I have not worked out nor have I lifted anything heavy in 2 weeks prior to receiving the covid vaccine.

about 3 hours post shot, mild headache,. about 7 hours after severe chills, lasted 4 hours, switched to overheated, low grade fever 101. resolved with acetametaphine. All symptoms resolved with 24 hours.

Symptoms started around 4pm with muscle ache all over and the body chills. Severe muscle spasms followed in back and chest area, hard to relax. By 6pm, very high fevers - T-105.5, 105.6. interventions didn't drop temp unless stripped completely naked and temp would drop to 103.3 at lowest, Tylenol administered and temp and no clothes - just a sheet on temp is 101.9. and bad body aches currently.

Systemic: Confusion-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hyperventilation-Medium, Systemic: Seizure-Severe

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.

Did the adverse event start after the first or second vaccination? only one dose (after the shot 5min after his arm completely went numb) when waiting at the site for 15min he experienced nausea and dizziness Recommendation: Please make sure he drinks lots of fluids he could take Pedialyte and if symptoms worsen please contact doctor and go the nearest ER. Mother would like a follow up call tomorrow at 10:00am I told her we would try to call her back at that time if its not busy, if not expect a call later in the afternoon.

Thursday April 8th 1:00PM Shot was injected into my left arm 1:15PM left hand was numb and tingling 2:00 PM left side of my face went numb and tingled. cheek, ear, neck and into my hair line Friday (4/19) midnight my heart was racing for about 2 hours. It was like I drank WAY too much caffeine Sunday (4/11) my hand was back to "normal" Tuesday (4/13) my left side of my face is getting much better, but it still feels a little different

04/09, ~11:15 a.m.: Received injection in left arm, released at 11:30 a.m. 04/09, ~1:00 p.m.: Mild headache, dizziness and fatigue, mild pain in left arm 04/09, ~7 p.m.: Moderate headache, dizziness and fatigue, mild nausea, spasms in muscle around injection site/itching/redness 04/09, ~8 p.m.: Went to bed and slept 04/10, ~2 a.m.: Awoke with severe headache, fatigue and dizziness, chills/fever, moderate nausea, sleeplessness, moderate pain in arm, moderate joint and muscle pain all over body 04/10, ~3 a.m.: Symptoms progressed to include delirium and hallucinations, rapid heart rate, itching in extremities, neuropathy and hyperesthesia 04/10, ~8 a.m.: Symptoms began reversing in order of occurrence over next 36 hours, starting with delirium and hallucinations; unable to concentrate or function properly 04/12: Lingering mild dizziness and headache, fatigue

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.

I hurt for three days,headache, body hurt, tired, sick to my stomach, sore arm, tired and felt like I had the flu. I then got better. About a week later, I started coughing a lot. My head hurt,but i didn't run any fever. I thought I was having bad allergies from changing weather, but it lasted longer than usual, over a week. I was sore, tired, not really hungry. I feel better now, but I still have this lingering dry cough and it won't completely go away. I still feel sore and very tired. I get a headache every now and then. I thought it was allergies, but it falls into the time period that people are having reactions to this JJ Janssen shot. The cough is annoying. I get short breathed and winded rather easily or more easily now. I thought I'd at least report it.

Hives itching burning and with intermittent pain extremely painful like large needles stabbing. Right Chest and right back close to injection site. About 10-15 hives

About 10 hours after shot I had uncontrollable shakes, restlessness, and insomnia. Fever between 101-102 all the following day. Fever between 100-101 all the day after that. Along with the fever I had body and head aches.

Longer-term headaches, tired feelings, abdominal cramping in the mornings, tiring pain in legs. Specially left leg feeling Sharp shooting pains.

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.

The day after injection: severe flu-like symptoms (high fever, body aches all over (former injury sites), headache. Symptoms subsided after 24 hrs. The following days featured muscle cramps all over my body, brought on by exercise. Calves cramped the most with the left calf being injured from cramps. Upper shoulders and neck muscles seized. 'Hot spots' on my torso. Skin very sensitive to touch on side and back. Sleeping a lot more than usual. Fatigue has lasted a week. A week later and muscles are feeling somewhat better. Skin still very sensitive. Still more tired than usual. Still avoiding exercise until muscles feel 100%.

about 1 hour after injection got a nose bleed, then started experiencing on 2nd week after shot started feeling nauseous and fatigue, 3 rd and 4th week started feeling extreme fatigue, gut issues, no appetite, chills ,sweating profusely, muscle cramping all over body. Went to my Dr. April 6 & 13, all vitals good, had flu and Covid test both negative, Had labs drawn both times, liver enzymes was high with both results. Still currently having all symptoms

1st day: 2hours after the shot, felt dizzy for rest of the day, low grade fever. 2nd day: low grade fever, body aches, muscle weakness 3rd day : low grade fever, body aches, muscle weakness, right fore arm and lower right leg bottom half felt little stiff, moved leg around to avoid getting stiff. 4thday : general weakness , Headache started in the night. 5th day: Nausea, dizziness , head ache 6th day, head ache, dizziness, little stiff right leg bottom half ( as if muscle is become stiff ) 7th day: dizziness , as if I move head one side whole body moves that side ( dizziness still there as of this reporting day)

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.

Severe neck and arm pain started about 30 minutes after vaccination was given. Often times it is a tingle from the neck to my elbow and the pain lasts 24 hours a day.

On 4/14/2021, right elbow started to hurt. This was a site of a removed gout-caused mass over a year ago. That subsided within a day. On 4/15/2021, left foot started to hurt. By 4/17/2021, the next to smallest toe and the large toe was swollen and very tender to any sort of touch. It was not warm. The pain was almost unbearable on 4/18/2021 and the suspicion that it might be gout was considered. On 4/19/2021, after a visit with his doctor, gout was confirmed as the likely cause of the pain/swelling. However, no blood tests were run to confirm. Treatment for gout was initiated.

Pt. had (what we think) a small seizure on Thursday, March 18th and then again on Saturday, March 20th. On Sunday, March 21st, 911 had to be called as his seizure did not end. He had a grand male. He was seizing for several hours. At the time this was all occurring he has been on anti seizure meds for a few years Divalproex 1000 mg am and 1000 mgs pm daily). He passed 1 week later, March 28 at approx 6:45pm at the Clinic. I am unable to get any information on his medical report for that week. Statement from his Nurologists is on second page. Additional information for Item 18: Statement: 47 year old gentleman who passed away on March 28 from aspiration pneumonia secondary to status epilepticus and on a history of multiple sclerosis / additional leukoencephalopathy of unknown etiology (both treated with rituximab), prior seizures (on valproic acid) and pulmonary embolism (on apixaban). The key reason for reaching out is in light of the announcement about the side effects of the Johnson & Johnson vaccine specifically cerebral venous sinus thrombosis. While he had a known history of seizures, he had no clear trigger for these seizures; including that his valproic acid level was therapeutic (83.0 mcg/mL) at time of presentation. He had, however, received the Johnson & Johnson vaccine on March 12 before having what in hindsight appeared to be repeated seizures between March 18-21; he had a more significant one on March 21 that hospitalized him. This time frame appears consistent with the reported cases of central venous sinus thrombosis associated with the Johnson & Johnson vaccine. Equally, he was taking apixaban at that point in time and his PLT (173) / INR (1.1) / PTT (36.6) at time of presentation were all normal and stable. He did have an elevated ProBNP (552.0) at presentation; nasopharyngeal swab was negative for COVID / Influenza A/B / RSV and non-contrast head CT did not show any clear new abnormalities. His only D-dimer was obtained on March 23 and was 226. He did not have a CT angiogram or venogram. Overall the link between the vaccine and pt. seizures is not definite. At the same time, the similarity with the reported cases has led to me wanting to report it in case of the possible link. If you require further information then please don't hesitate to email me Pt. med list at the time of this incident Modifinil - 100 mg/1per day/AM Sertraline - 100 mg/1per day/AM Vitamin D3 - 50 mg/1per day/AM Divalproex - 500 mg/2per day/AM Eliquis - 5 mg/1per day/AM Furoseminde - 20 mg/1per day/AM Metroprolol - 100 mg/1per day/AM Lisinopril - 10 mg/1per day/AM Divalproex - 500 mg/2per day/PM Eliquis - 5 mg/1per day/PM Metroprolol - 100 mg/1per day/PM Melatonin - 5 mg/1per day/PM Quetiapine - 50 mg/3per day/PM

Two days after receiving vaccine, patient developed acute swelling and tenderness in right lower extremity and diffuse whole body urticaria.

7 DAYS AFTER THE SHOT (APRIL 12TH 2021, THERE ARE HOT TINGLY AND PRICKLY SENSATION ALL OVER (AND STILL HAS THIS SIDE EFFECT ON APRIL 21ST 2021) 2ND AND 3RD DAY, HAD FEVER AND FATIGUE BUT WENT AWAY ON THE 4TH DAY

Pt experienced pain/cramping in his right leg on or about 4-15-21. Thought this was due to new work shoes. Pain continued through the weekend and on Monday 19th visited his PCP where a scan was preformed confirming a clot in his right leg between his thigh and ankle. Pt started on therapy and has a follow up with his physician on Friday 23rd. Pt doing well and in good spirits.

Chief complaint of worsening lower leg pain. Initially the patient though that he had pulled a muscle however he had complaints of claudication upon ambulation. Patient reports having J&J COVID vaccination approx 2.5 weeks prior. Patient reported his friend informed him that he might potentially have a blood clot and that he should come to the emergency department. Imaging consistent with acute DVT and patient taken to IR for tPA direct catheter infusion.

RIGHT SHIN PAIN; ANXIETY; DIFFICULTY CONCENTRATING; HEAD FELLS FUZZY; POTENTIAL SHINGLES; SEVERE LEG PAIN IN RIGHT LEG/RIGHT THIGH PAIN; RIGHT HIP PAIN/RIGHT ANKLE PAIN; LOWER AND MID BACK PAIN; SENSATION IN HEAD AND NECK; 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 inflammation, blood pressure, abstains from alcohol, and smoker (1 pack/day or a little less), and other pre-existing medical conditions included the patient had no known allergies and there was 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: 1808978, and expiry: 13/JUN/2021) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. Concomitant medications included chlortalidone for blood pressure high, and ibuprofen for inflammation. On 26-MAR-2021, the subject experienced sensation in head and neck. On 27-MAR-2021, the subject experienced right hip pain/right ankle pain. On 27-MAR-2021, the subject experienced lower and mid back pain. On an unspecified date, the subject experienced right shin pain, anxiety, difficulty concentrating, head fells fuzzy, potential shingles, and severe leg pain in right leg/right thigh pain. Laboratory data (dates unspecified) included: Platelet count (NR: not provided) 271 (units unspecified). Treatment medications (dates unspecified) included: cefalexin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe leg pain in right leg/right thigh pain, right shin pain, difficulty concentrating, head fells fuzzy, and lower and mid back pain, and the outcome of sensation in head and neck, right hip pain/right ankle pain, anxiety and potential shingles was not reported. This report was non-serious.; Sender's Comments: V0- Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.

SEVERE PAIN IN ARM; This spontaneous report received from a patient concerned a 47 year old male. The patient's weight was 205 pounds, and height was not reported. The patient's concurrent conditions included pencilin allergy, non smoker, and alcohol user, and other pre-existing medical conditions included patient had no drug abuse or drug illicit usage patient had no available diagnostic lab data. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042192119 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 severe pain in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe pain in arm. This report was non-serious.

My full list of symptoms were: Pins and needle feeling as well as hypersensitivity all over my skin that originated in my lower legs but traveled up my body to include my entire legs, hips, and arms. It was more severe on the left side of my body which is the side I received the vaccine. I did not notice it on my head, face, and upper torso. I had full muscle control but I did have problems with my bladder and bowels. I'm not sure if I could not control them or did not feel them because the sensitivity was high in my hip area but I could not control them fully. No treatment was administered except to wait and see. Three days later and I am improving but not fully recovered yet.

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.

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.

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).

on the evening of the vaccination , had the expected effects, such as fever, muscle pains, stomach ache, nausea, headache, ..the nest day, my legs were so sore that I could barely stand & I had to wait for. while until I could walk. the headache lasted for a few days, the muscle pain is lessening but not gone until today, it makes my legs & feet grow sore & tired very quickly. last Sunday, April 18 2021, started around 5 pm, I started having nausea , then stomach pain so bad & vomitted many times until I was admitted to ER around midnight . the med staff at the ER did X-ray & citi scan, told me there was some bowel obstruction , gave me ivy, painkiller injection & some others then I was transferred to a medical center. they did another citi scan & found everything was ok, I asked what may cause it, they didn't really know beside probably not enough water etc .

NUMBNESS IN LEFT ARM FROM SHOULDER DOWN TO FINDERS AND IN BOTH LEGS; SWOLLEN RIGHT FOOT 2X BIGGER; LOSS OF COORDINATION; HARD TO WALK; LITTLE FEVER; 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 pre-existing medical conditions included the patient had no history of diabetes except family history.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced little fever. On 15-APR-2021, the subject experienced numbness in left arm from shoulder down to finders and in both legs. On 15-APR-2021, the subject experienced swollen right foot 2x bigger. On 15-APR-2021, the subject experienced loss of coordination. On 15-APR-2021, the subject experienced hard to walk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little fever on 03-APR-2021, and had not recovered from numbness in left arm from shoulder down to finders and in both legs, swollen right foot 2x bigger, loss of coordination, and hard to walk. This report was non-serious.

Within 5 minutes, patient was sweating, flushed, and stated that he was about to faint. Patient fainted and was unable to respond to verbal or motor commands. Patient had rapid, shallow breathing. Patient's hands/arms were twitching very slightly. Patient was moved onto the floor and rolled onto his side after he started to gag like he would vomit. Once on the floor, patient regained consciousness within 1-2 minutes and was able to sit up after another 5 minutes. Paramedics arrived and examined him. He left under his own power.

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

Patient experienced a seizure episode immediately after I administered his COVID-19 vaccine. I administered the vaccine at 10:22 AM and a few seconds later Patient started to shake and toss his head back. I immediately called 911/paramedics after his wife and I helped him to lay to his side. His seizure episode lasted about 2 or 3 minutes. He quickly regained consciousness and became fully responsive before the paramedics arrived.

Intense uncontrollable shaking, uncontrollable contraction of all muscles, inability to control breathing, intense very shallow hyperventilation, Inability to speak or answer questions, severe muscle aches, soreness.

FLUSHED; MINOR GOUT SWELLS; SORE ARM/THROBBING ARM; TIRED; SHORTNESS OF BREATH; ANXIETY; DIARRHEA WITH BLOOD; This spontaneous report received from a consumer concerned a 47 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic gout. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205ANA, expiry: UNKNOWN) dose was not reported, 1 total administered on 08-MAY-2021 vaccination at left arm 16:30 for prophylactic vaccination. Concomitant medications included allopurinol for gout. On 08-May-2021, The patient experienced Shortness of breath shortly after vaccination, but this resolved in 15 minutes. He waited for 20 minutes after getting the vaccine. Patient noted that it could have been anxiety driven. On 08-May-2021 night (10 hours after), patient experienced diarrhea in the middle of the night and progressed to blood in the stool. The patient also very tired. Patient slept for almost 24 hours from Saturday to Sunday night, but now feels better. Patient felt very flushed, also experienced arm super sore for 1 day after vaccination, and throbbing for about an hour. The patient suffers from chronic gout and experienced minor gout swells (unsure if it is related to the vaccine or not) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, and anxiety on 08-MAY-2021, and sore arm/throbbing arm, and tired on 09-MAY-2021, was recovering from diarrhea with blood, had not recovered from minor gout swells, and the outcome of flushed was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210522256-COVID-19 VACCINE AD26.COV2.S-diarrhea with blood. 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).

Increased pain and swelling in left arm - started within 12 hours and continued for 2 weeks Fever over 100 - started within 12 hours and continued for 1 month (fever between 100 and 102) Nausea - within 12 hours (continued for 1 month) Vomiting - within 24 hours (continued for 3 days) / then again 2 weeks out for 3 days) Migraine Headache - started within 12 hours and continued for 6 weeks (and on-going) Labored breathing - started within 12 hours and continued for 5 weeks (and on-going) Low oxygen - started within 36 hours and continued for 1 month) General muscle and body aches and pains (started within 24 hours and continued for 6 weeks (and on-going) Extreme exhaustion and lethargy (started within 6 hours and continued for 6 weeks (and on-going)

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

RESTLESS SLEEP; FELT COLD; INJECTION SITE SORENESS; TIRED; LOW GRADE FEVER; 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 (suspension for injection, route of admin not reported, batch number: 203A21A, and batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2021, the subject experienced restless sleep. On 15-MAY-2021, the subject experienced felt cold. On 15-MAY-2021, the subject experienced injection site soreness. On 15-MAY-2021, the subject experienced tired. On 15-MAY-2021, the subject experienced low grade fever. Laboratory data included: Body temperature (NR: not provided) 99.4 (unit unspecified). On 16-MAY-2021, Laboratory data included: Body temperature (NR: not provided) normal. The action taken with covid-19 vaccine was not applicable. The patient recovered from restless sleep, felt cold, and low grade fever on 16-MAY-2021, injection site soreness on 19-MAY-2021, and tired on 17-MAY-2021. This report was non-serious.

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 first day I noticed a burning rash on the back of my leg, that lasted for about a few days until the pain was unbearable. Blisters started to appear and spreading. Nerve pains started to occur throughout the body that resulted into going to the clinic and was diagnosed with Shingles. The doctor prescribed a 7 day anti-viral prescription that helped with the pain, after taking it the pain went away a few days later. After taking the medication as prescribed I did recover from my symptoms.

Flu symptoms immediately. 1 week +1 day post injection, severe body aches, fever, 1 week + 2 days seizure requiring hospitalization, ICU and vent for 4 days.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Medium, Systemic: Shakiness-Medium, Additional Details: Patient fainted 1 min after receiving vaccine, then started seizing in chair was moved to ground with legs up. Was checked to make sure breathing was occuring, after 3 min patient was back to normal. when woke up felt dizzy asked what year and where they were and answered correctly. Ambulancewas called pt denied being taken to hospital. bp low

Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Additional Details: Pt had syncopal episode but recovered quickly

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.

Patient fainted 10 minutes after getting the vaccine, he felt light headed and had seizure like symptoms, and his body was rigid and shaking . He wasn't able to breathe, patient was put on his back and CPR was performed for 20 seconds, and 911 was called. Patient was able to breathe again and felt okay. Patient stated that he didn't eat or drink anything prior, he was given a sports drink and sat back in a chair for 20 minutes after. EMTs showed up and took his vital signs, patient refused to go to the hospital.

Had a raspy throat and nasal itch almost like allergies but more. 2nd day it increased its severity. The third day I was really congested. I felt like my lungs were only filling up half way; I was a little shortness of breath. Mucous buildup and had to cough to clear my throat to breathe. I felt like there was swelling in my throat. By Thursday, I went to get seen by doctor. Dr. noticed little pustules on my lymph nodes and she tested me for strep, negative. QR, inhaler steroid, prednisone for 5 days. Nasal spray to clear the nasal passages, Flonase. I have taken albuterol when needed to help clear up my breathing. I'm still feeling a little congested with sinus drainage, voice a little horse. Note: I did have a Tetanus shot about a month or a little bit more than a month before this vaccine.

~01:15PM PATIENT RECEIVED IM VACCINE IN LEFT DELTOID WHILE SEATED. ADMINISTERED BY PHARMACY INTERN, PATIENT REPORTED NO ISSUES. "FEELING FINE, I'M OK" ~01:17PM AFTER RECEIVING VACCINE CARD AND BEING REQUESTED TO WAIT THE 15 MINUTES FOR OBSERVATION, PATIENT STATED THAT HE HAD NEVER FAINTED AFTER A SHOT, ONLY AFTER BLOODRAWS, BUT WAS ADVISED TO REMAIN SEATED JUST IN CASE. IMMEDIATELY AFTER HE STATED HE FELT LIGHT HEADED AND THEN PROCEEDED TO SLUMP IN AN ADJACENT CHAIR. PATIENT WAS UNRESPONSIVE TO INQUIRIES, BUT SNORING WAS AUDIBLE. ~01:17PM PATIENT WAS LOWERED TO THE FLOOR INTO A SUPINE POSITION WHILE NECK WAS SUPPORTED DURING THE MOVEMENT PROCESS, AND EMTS WERE NOTIFIED BY PHARMACY STAFF VIA 911. ~01:18PM PATIENT REGAINED CONSCIOUSNESS AFTER ABOUT ~10-20 SECONDS TOTAL, OPENED HIS EYES, AND WAS SPEAKING TO HIS WIFE AND STAFF. PATIENT WAS ADVISED TO REMAIN IN POSITION UNTIL EMTS ARRIVED TO ASSESS THE PATIENT ~01:21PM EMTS ARRIVED ON SITE TO ASSESS SITUATION, VITALS WERE CONSIDERED NORMAL AND PATIENT REFUSED AMBULANCE TO HOSPITAL. ~01:30 EMTS LEFT SCENE, PATIENT REPORTED FEELING NORMAL AND WOULD BE ASSISTED BY WIFE, LEFT THE SCENE WALKING NORMALLY BELIEVED TO BE A VAGAL RESPONSE FOLLOWING THE IMMUNIZATION

Several weeks after vaccination, had mild cough, fatigue, and fever whenever tired, usually at night. Cough and night sweats still recurring when fatigued 5 weeks after vaccination.

Monday, March 29 I was warming up for a chest workout - bench press with 135# (2- 45# plates) on the bar. On my first rep I noticed the muscles in my right arm were not firing properly and I pressed the wt up very unevenly - I repeated two more reps (total of 3) and repacked the bar. I then proceeded to attempt push ups- on my first rep my wt shift over my left arm and my right arm only served to balance me- again no pushing strength. I then proceeded to do a pull up- as I attempted my first pull-up my weight again shift to my left side- no pulling strength in right arm. The week prior I was showing signs of tennis elbow in my right arm. The week of March 29, the intensity of discomfort was high as I experienced muscle spasms alternating between my right tricep, right lateral muscle and my right pectoral muscle- my tennis elbow pain was intense and I experienced tingling in my right ring finger and pinky. On April 9 I went to family Dr they gave me a muscle relaxer and pain pills and scheduled an x-ray of right elbow and shoulder. April 16 the pain continued and I went back into the doctor and had an MRI scheduled for Sunday May 2 along with a referral to an ortho doctor. May 17 I went to the ortho doctor who did another X-ray. The ortho doctor first Mentioned that this could be GBS. I started Physical therapy on June 21.

About a month after receiving the vaccine I began getting migraine headaches during sex, specifically at the time of ejaculation.

I went home got something to eat felt dizzy and nausea. I went to sleep woke up clammy and sweating. I slept 13 hours and woke up with a fever . I took IB-profrin and the fever continued for about 3 days. I still have chest pains

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.

severe lower back pain, radiating down left leg; legs became wobbly; lost balance; fell several times enroute to ER. Admitted to hospital. MRI x3. Diagnosis Guillain Barre syndrome; treated with IVIG & steroids x 1 week Transferred to Rehabilitation Institute. Dr. primary rehab doctor. Neurologists consultants.

Approximately 12 hours after getting the vaccine, I began shivering uncontrollably for about an hour and felt hot (like a fever) at the same time. I also ached all over. I took 2 Tylenol and was able to fall back asleep. I woke up sweaty, but the chills and fever were gone. I?m now just stiff, with some mild pain at the injection site.

Jansen COVID-19 Vaccine EUA I got strange sensations in the back of my neck, then later on in the day I have numbness in the back of my neck and some fin the upper back and shoulders. Don't know how much more will go numb and how bad it will get. But I can feel the back of my neck and shoulders and upper back, but it is like there is a layer in between that is numb.

Fever 101, severe aches, swelling of face, fast heartbeat, bad rash all over body, dizziness and weakness, headache

Within 30 minutes post vaccine administration, patient started having seizure like symptoms (Altered mental status, clenched jaw, non-verbal, right sided headache) - V/S WNL, Ambulance called and patient was taken to ED for evaluation. Responsive during transport to ED. Patient reported back to baseline after 1.5 hours.

7hrs post- Fever, 100 & chills begin 9hrs post- Fever, 100 11hrs post- Fever 101 13hrs post- Fever 103, mild sore throat 15hrs post- Fever 103-104 16hrs post- Fever 102, headache begins (Ibuprofin Taken) 22hrs post- Fever 100, (Ibuprofin Taken) 28hrs post- Fever 100, (Acetometaphin Taken) 30hrs post- Fever 102, severe convulsing 36hrs post- Fever 100, headache 42hrs post- Fever normal, headache ends (Acetometaphin taken)

I started having the next day after vaccine a fever and a severe muscle and body aches, headache , then a day later I had severe knee and foot pain that is continuing to this day it?s unbearable.

Fever started approximately 6 hours after injection. Symptoms included high fever, sweating, chills, shaking, entire body aches and pains, headache and disorientation. Fever peaked about 11pm and began for the most part subsided by morning with a persistent headache.

AT ABOUT 1PM, PATIENT BECAME APPEARED TO BE HAVING A SEIZURE WITH HEAD BACK SITTING IN A CHAIR, WAS TONIC, CLONIC AND STIFFENED WITH A SHORT LOSS OF CONCIOUSNESS. CALLED 911 AND ADMINISTERED EPI-PEN X 1 DOSE AT 1:03PM PATIENT WAS ALREADY CONSCIOUS AND TALKING. FELT CLAMMY TO TOUCH AND WAS PALE. BP 144/82 PULSE 97, O2 SAT 98. MOVED PATIENT TO BENCH IN SHADE WHILE WAITING FOR EMS. BP 140/95 PULSE 88 WHEN EMS ARRIVED AROUND 1:20, PATIENT DID NOT WISH TO BE TRANSPORTED TO THE HOSPITAL AS HE WAS FEELING BETTER AND EVERYTHING SEEMED OK. HE REMAINED WITH US AND HAD A CLIFF BAR, COKE AND WATER UNTIL 2:20PM AT WHICH TIME HE LEFT. I FOLLOWED UP WITH HIM AT ABOUT 3PM AND HE WAS STILL DOING WELL. HE WAS ADVISED TO FOLLOW UP WITH PRIMARY CARE PHYSICIAN AND IF HE HAD ANY OTHER SYMPTOMS TO GO TO THE ER/CALL 911.

Patient received the J&J vaccine on 3/10. On 3/13 he developed slurred speech, unilateral lower facial droop, weakness of extremities, generalized fatigue. On 3/15 he sought medical attention and was sent to ER -- > diagnosed w/ TIA. Pt sent back to jail where simvastatin -- > atorvastatin, pt started lisinopril, ASA. Pt denies deficits today

rapid heart rate, excessive sweating, chills, muscle aches, pain all over body, chest pain. Weakness, brain fog, out of sorts, flu like symptoms, break outs on face, trouble breathing. These conditions have lasted over 5 days so far.

Full body sweats, migraine for 2 days, threw up 4 times, shakes, pain at injection site/shoulder/chest, extreme fatigue, body aches

Just before going to bed I started feeling very cold, shivering, I had similar sensation in the past when fever went up extremely quick. I did not measure my body temperature because I immediately ran under the blanket. Icy-cold hands and feet, even after my body temperature seemed to stabilize. I fell asleep but not a restful sleep. I woke up after 2.5 to 3 hours with the feeling that it was morning, but in fact it was between 2am and 3 am. At that point I felt the worst part had gone, I felt weak and with muscle aches but I could drink water and go back to bed. I did not have a restful sleep all night and I woke up may times. By the morning I was tired but no fever.

pt says he developed a fever, was shaking with chills, and he had trouble sleeping. He still has fatigue and headache but is feeling about 70% better today 4/8/2021.

Full body aches, fatigue, mild euphoria/delerium. Periods of chills and hot feeling though no fever. Symptoms started 24 hours after injection, 90% resolved at 42 hours post. Took low dose of Ibuprofen and drank liquids.

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.

Pt stated he was nervous about drs office/vaccines. Shortly after (1 or 2 mins) patient got shot he got warm around the face and said he felt slightly dizzy. So we laid him on his back and elevated his feet. We put cold compress around his neck. This only lasted about 5-10 mins. Called pt couple hours later with no concerns.

At night time, felt my face getting hot and felt as if I had a fever. 4 days later, developed itchy rash under the armpits, and sides, lower stomach inner thigh near groin.

Severe achiness, leading to spasms in legs and particularly in chest wall muscles, causing difficulty breathing. Nausea, vomiting. Headache.

Extremely bad headache, shortness of breath, dizziness lump in throat, chills followed by getting hot flashes and very lethargic and fatigued. Shot was administered at 11:45am on the 9th and by 03:00am on the 10th felt the above symptoms. Today date I am feeling better with minor unsteadiness here and there and a slight pain deep inside the middle of head almost like a headache for a few seconds then goes away, So far so good I think. I did call doctor to note on chart. Thank you!

Ongoing, beginning two days after injection. In addition to injection site/arm soreness, began to experience a constant tightness (cramp-like) within the left side of torso, like the muscles around heart or lung is cramping. Unable to take a full inhale of breath without discomfort/pain.

Started with chills and fever, progressed into body aches and joint pain in knees and ankles, continued with 102.5 degree fever and exhaustion over the course of 2 days. Third day was severe dehydration and exhuastion. Pain continues in legs, knees, hips, feet and ankles.

Began with headache. Turned to nausea roughly 8 hours after shot. Nausea turned to sever vomiting and for several hours. Tremors. Sweating. Fatigue. More headache. Loss of appetite. Joint and muscle aches. Continued joint pain, appetite loss and fatigue.

I had received the vaccine on April 12, 2021 at 11:30am. I felt a warm sensation go down my arm when I received the vaccine. No ill effects however. Around 2:30am the following morning (April 13, 2021) I started feeling ill. I had flu-like symptoms including: body aches, chills, fatigue, etc. I did not take my temperature, however, I believe I was feverish. I took 400mg of Ibuprofen around 11:30am (24 hours after receiving the vaccine). After sleeping for 2 hours, I began feeling better.

Fever, chills ,muscle cramps, headache approx 14 hours - all symptoms subsided approx 48 hours from time of vaccination

The following morning I felt mild flu like symptoms and very low energy. While at working my right upper ankle/ lower knee became extremely sore for no reason. A mild headache and upper respiratory irritation also occurred. My right arm at injection point was extremely sore. I figured it was a immune response and didn?t get too worried. These symptoms have persisted. Hopefully will subside soon

On April 7th in the morning, I woke with sharp pain in right calf. It was not swollen, discolored, or hot. I had not participated in any activity recently that I felt caused an injury. I took Advil and Tylenol and rested for a few days, but the pain got worse. On April 14th, after reading reports on some adverse affects from the J&J vaccine, I made an appointment to see my primary physician. After blood work and an ultrasound, I was diagnosed with a DVT in my right calf. I have a started a 90-day cycle of Xarelto to treatment the DVT.

Flu-like symptoms which patient expected but also severe leg pain and loss of appetite. Pt was advised to consult with physician who advised patient seek emergency help if issue persisted which it did not. Patient's spouse reported symptom onset the morning after the vaccination

SWOLLEN ARMPIT; SORE ARM; 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 pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced sore arm. On 07-APR-2021, the subject experienced swollen armpit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen armpit, and sore arm. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.

STRONG HEADACHE; CRAMPS IN HAND; ARM PAIN; This spontaneous report received from a patient via a company representative concerned a 48 year old male. The patient's height, and weight were not reported. The patient's past medical history included thyroid removed.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 07-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included levothyroxine sodium. On APR-2021, the subject experienced cramps in hand. On APR-2021, the subject experienced arm pain. On 12-APR-2021, the subject experienced strong headache. Treatment medications included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cramps in hand, and arm pain on APR-2021, and was recovering from strong headache. This report was non-serious.

Developed symptoms of pain, redness, swelling to left anterior shin on 4/13, symptoms worsening so presented to clinic for evaluation. Has multiple varicose veins in this area.

L leg pain starting 4/15/2021, symptoms similar to superficial thrombus he has in the same leg in 2017 . No recent injury. J and J COVID 19 vaccine on 4/6/2021. Started on Eliquis on 4/16/2021. Improved but still having significant L medial thigh pain during follow up appt on 4/20/2021. Scheduled to be seen by PCP next on 5/10/2021.

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.

TIGHT BURNING FEELING IN UPPER RIGHT BACK AND RIGHT ELBOW; CRIPPLING CONSTANT PAIN; MUSCLE WEAKNESS TO THE RIGHT ARM; TIGHTNESS ON UPPER RIGHT SIDE ON BACK NEAR RIGHT SHOULDER; INJECTION SITE PAIN; INITIAL BURN WHEN VACCINATED; DISCOMFORT; DID NOT SLEEP WELL AT NIGHT; 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 concurrent conditions included shellfish allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 12:30 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced discomfort. On MAR-2021, the subject experienced did not sleep well at night. On 11-MAR-2021, the subject experienced muscle weakness to the right arm. On 11-MAR-2021, the subject experienced injection site pain. On 11-MAR-2021, the subject experienced tight burning feeling in upper right back and right elbow. On 11-MAR-2021, the subject experienced crippling constant pain. On 11-MAR-2021, the subject experienced tightness on upper right side on back near right shoulder. On 11-MAR-2021, the subject experienced initial burn when vaccinated. Treatment medications (dates unspecified) included: ibuprofen, naproxen, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on 12-MAR-2021, was recovering from tight burning feeling in upper right back and right elbow, crippling constant pain, did not sleep well at night, discomfort, initial burn when vaccinated, and tightness on upper right side on back near right shoulder, and had not recovered from muscle weakness to the right arm. This report was non-serious. Additional information was received on 19/Mar/2021. The following information was updated and incorporated into the case narrative. Reporter details added, patient information (date of birth, sex, ethnic origin, race) added. patient allergy details, batch number of suspect, site of administration, Vaccine facility details, events: injection site pain and muscle weakness to the right arm were added.; Sender's Comments: V1:Medical assessment comments not required as per the standard procedure as the case is considered non serious.

Headaches? nothing helps Fatigue Right side body pain?especially joints, wrist shoulder and hip and knee Two bumps on right side chest Loose stool General achiness No energy Bad sleep Intermittent nausea Higher bp

Patient evaluated in ED 04/26 for bilateral leg cramping, swelling that started just over a week prior. Reviewed records from that visit. Work up was significant for bilateral lower extremity DVTs and thrombocytopenia. Patient was started on Xarelto at that time. Patient does not have any significant risk factors for blood clots. He is not obese, denies tobacco use, recent procedures, recent travel, prolonged immobility, family history of bleeding or clotting disease, etc. He is up to date on cancer screenings based on age/family hx. He did receive the Johnson and Johnson vaccine on 04/07.

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.

LEFT CALF TO ACHILLES SORENESS; FLU SYMPTOMS/ BODY ACHES/ LETHARGY/ DECREASE APPETITE/ CHILLS/ FEVER; LEFT CALF TO ACHILLES SORENESS; 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 difficult breathing, and concurrent conditions included asthma, non-smoker, non-alcohol use, and penicillin allergy, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug usage. The patient experienced drug allergy when treated with acetylsalicylic acid. 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 11:00 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced left calf to achilles soreness. On 12-APR-2021, the subject experienced flu symptoms/ body aches/ lethargy/ decrease appetite/ chills/ fever. On 12-APR-2021, the subject experienced left calf to achilles soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu symptoms/ body aches/ lethargy/ decrease appetite/ chills/ fever on 14-APR-2021, and had not recovered from left calf to achilles soreness, and left calf to achilles soreness. This report was non-serious.

Right sided facial paralysis, diagnosed as bells palsy, also right facial pain later diagnosed as trigeminal neuralgia, patient was seen in hospital for symptoms

I had some head pressure - dull headache each day for a couple of weeks starting about five days after vaccine; I didn't notice until the evenings when I was relaxing. From day 5 or so - for about two weeks I noticed this head pressure. My blood pressure did rise at that time-it was elevated - within about two weeks after the shot, I couldn't control my blood pressure. I went to the doctor - they had to raise my blood pressure medication to the max because I couldn't get my blood pressure down and I even donated blood. Today I am at 135 over 90 which is good for me but at that time when I noticed the rise after the vaccine - I was running 165 over 115 . I'm still taking the maximum blood pressure medication that I can take currently but it is at a good level currently. I was taking 20 mg pills and after the vaccine we tried to raise it to 25 mg and then raised it up to 30 mg and then they finally said up to 40 mg a day. It's the most I can take. I have chest pains on the right side of my chest -it will start (on a scale from 1 to 10 - it's about a four) - it's shooting pain - in my chest for about 10 minutes and then it will move to my left side - not my pecs - it feels like it's my heart. It's not enough that I feel like I'm having a heart attack - it happens about four days a week. It doesn't last real long - but it's intense. A "4" pain for me is intense. It goes on for about 5 minutes - switch sides and then another five minutes - I try to relax/watch tv during that. I did have leg pains in the middle of all of this time - hand, inner thigh, then on my right leg - single spots of pain that moved - like ant bites - that happened in the beginning - at day five and after - the same time I was getting the head pressure. I would rub over the spot with my hands and then it would go away and go to a different spot.

CHEST PAIN; RIGHT HAND/WRIST WEAKNESS; REDUCED HAND/GRIP STRENGTH; PLEURISY; 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 concurrent conditions included seasonal allergies, 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: 203A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced pleurisy. Laboratory data included: Computerised tomogram (NR: not provided) It was clear, and Fibrin D dimer (NR: not provided) Elevated. On APR-2021, the subject experienced reduced hand/grip strength. On 20-APR-2021, the subject experienced chest pain. On 20-APR-2021, the subject experienced right hand/wrist weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain on 30-APR-2021, had not recovered from right hand/wrist weakness, and the outcome of reduced hand/grip strength and pleurisy was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.

Systemic: 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

Patient said he had a seizure at home in his sleep. He said he wetted his pants and his wife told him he had a seizure. He sought medical attention after and his doctor changed his seizure medications. He is now asked by his doctor not to drive for 2 months

Approximately 8 hours after vaccine, high fever ranging 102-103 degrees began. Severe chills set in. Shaking and teeth chattering to the point one tooth was chipped (small) Fever and chill continue through the rest of the day. Down to 100 by 5pm on 5-20-21. Also extreme fatigue, joint and muscle aches, as common with the flu.

About three weeks ago began to experience swelling in lower right arm, above wrist (he had vaccine in left arm), fever, cough at nighttime and tingling to point of pain from right shoulder to elbow, and left little finger numb

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.

Within 72 hours of receiving the vaccine, I began experiencing itchiness in random locations on my body. However, it was intermittent and not too severe - initially. The itchy rash would pop up and subside, until Weds May 26th. In the middle of that night (5/26) I awoke with the most severe itching and discomfort that I've ever experienced, and it was in spots across my arms, legs, abdomen, inner thighs, underarms, soles of feet, wrists, and elsewhere. The next morning (Thursday 5/27) I began calling dermatology offices and clinics hoping to secure a Doctor's appointment ASAP to get a diagnosis and hopefully some relief. I was able to secure an appointment at Immediate Care for later that morning. At that time I received a steroid shot in my arm, and began a cycle of Prednisone to address the rash. It persisted and was very uncomfortable for the following three days, but thankfully began to subside due to the steroids by Monday 5/31. I would like to stress that I've had no known allergies in my life, and that this was the most extreme rash and itching I've ever experienced. If I had it to do over again, I would not get the vaccine.

PATIENT CALLED JUNE 10TH OF 2021 AND REPORTED HE HAD A SORENESS IN THE MIDDLE OF HIS BACK STARTING THE DAY AFTER THE COVID-19 JANSSEN VACCINATION. PATIENT REPORTED THE SORENESS IN HIS ARM WENT AWAY AFTER THE THIRD DAY FROM RECEIVING VACCINE. PATIENT REPORTED THE SORENESS IN THE MIDDLE OF HIS BACK CONTINUED TO BE SORE TO PAINFUL. PHARMACY HAS THE PATIENT RECEIVING VACCINE IN THE LEFT ARM. PATIENT REPORTED ABOUT A WEEK PRIOR TO HIM CALLING THE PHARMACY HIS LEFT ARM HAVING NUMBNESS AND NOW HIS HAND IS GOING NUMB. PHARMACY TOLD HIM TO CONTACT HIS DOCTOR. PHARMACY CHECK WITH PATIENT ON JUNE THE 11TH OF 2021 AND PATIENT STATED HE HAD MADE AN APPOINTMENT WITH HIS DOCTOR'S CLINIC.

My left are never stopped hurting and it has progressively gotten worse I can barely lift my arm up and I?m in constant pain.

BODY ACHE; NOT EATEN ANYTHING OR DRINK ANYTHING; CHILLS; FEELING VERY WEAK; FEVER; This spontaneous report received from a pharmacist concerned a 48 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 13-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-JUN-2021, the subject experienced body ache. On 13-JUN-2021, the subject experienced not eaten anything or drink anything. On 13-JUN-2021, the subject experienced chills. On 13-JUN-2021, the subject experienced feeling very weak. On 13-JUN-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, body ache, feeling very weak and not eaten anything or drink anything was not reported. This report was non-serious.

RIGHT ARM PAIN; 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 concurrent conditions included non-smoker, and non alcohol use, 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: 201ALIA expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced right arm pain. On 21-JUN-2021, Laboratory data included: Pain scale (NR: not provided) 8/10. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right arm pain. This report was non-serious.

BILATERAL LOWER EXTREMITY PAIN; MULTIPLE ACUTE BILATERAL PULMONARY EMBOLI; PLATELET COUNT DECREASED; DEEP VEIN THROMBOSIS; VACCINE INDUCED THROMBOTIC THROMBOCYTOPENIA; ULTRASOUND DOPPLER ABNORMAL; FULL BLOOD COUNT; METABOLIC FUNCTION TESTS; MUSCLE SPAMS; SWELLING; MILD HEADACHE; This spontaneous report was received from a health care professional via a Regulatory Authority and from literature: Vaccine-induced thrombotic thrombocytopenia following Ad26.COV2.S vaccine in a man presenting as acute venous thromboembolism. 2021 Jun 03;1-4., and concerned a 48 year old white male (not Hispanic or Latino). The patient's height, and weight were not reported. The patient's concurrent conditions included exercise induced asthma, and no tobacco use (both current and historically), and other pre-existing medical conditions included the patient had no known allergies. The patient was not obese, denied recent procedures, prolonged immobility, family history of bleeding or clotting disease, etc. The patient was up to date on cancer screenings based on age/family history. He was reported as being an unusually physically active and fit 48 year-old male who has enjoyed good health and exercised regularly. In 2019, his platelet count was 177 10*9/L. The patient reported flying out of town and back on 30-MAR-2021 and 04-APR-2021 respectively with the longest continuous flight lasting around 4 hours. The patient at age 48, received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 07-APR-2021 for prophylactic vaccination. Concomitant medications included finasteride, and salbutamol. On an unspecified date in APR-2021, the patient experienced mild headache. On 18-APR-2021, 11 days after receiving the vaccine, the patient experienced deep vein thrombosis, vaccine induced thrombotic thrombocytopenia; new pain in his big toe, bilateral leg cramping (muscle spasm), bilateral lower extremity pain, and swelling. The patient attributed soreness in the large muscle groups of his thighs to Peloton riding and exercise. The patient travelled again via airplane to an unspecified location 22-APR-2021 and 25-APR-2021 (both1 hr long flights). The patient administered Advil for the leg pain when he returned on an unspecified date. On an unspecified date he felt a leg vessel that "didn't seem right." On 26-APR-2021 the patient went to emergency department for evaluation presenting with leg pain and chest discomfort. He had normal vital signs and oxygen saturation. Additional laboratory results: Platelet count (NR 140-440 K/uL) 74; fibrinogen (NR 150-430 mg/dL) of 254; D-dimer (NR 0-499 ng/mL FEU) 15,109 ng/mL FEU; activated partial thromboplastin time (aPTT) (NR 25.1-36.5 s) 31.8. Venous duplex ultrasound of the lower extremities revealed non-occlusive DVT in the bilateral popliteal veins extending to the gastrocnemius veins, an occlusive DVT of the left posterior tibial vein, as well as occlusive superficial venous thrombosis in the bilateral saphenous veins. The patient was discharged from the emergency room on rivaroxaban 15 mg twice daily with two-day follow-up with his primary care physician. He had no known exposure to heparin before the onset of symptoms and no exposure during his emergency room visit. On 28-APR-2021 (also reported as the next day), the patient complained of a new onset of chest pain (pleuritic) and presented again to the emergency room. Chest CT showed presence of acute pulmonary embolism, with emboli present in segmental and more proximal arteries. He had already taken his rivaroxaban for the night (1800). The patient was hospitalized for further evaluation and work up. A peripheral smear showed thrombocytopenia without schistocytes. The hematology service was consulted, and a presumptive diagnosis of VITT (vaccine induced thrombotic thrombocytopenia) was made. His anti-PF4 enzyme-linked immunosorbent assay (ELISA) (LIFECODES PF4 IgG), performed on a sample collected prior to initiating IVIG therapy, demonstrated a strongly positive result of 3.323 optical density (OD) units (reference interval < 0.399), consistent with a diagnosis of VITT. The patient was immediately treated with 1 g/kg of intravenous immunoglobulins (IVIG) for 2 days, 1 mg/kg of prednisone, and switched from rivaroxaban to an intravenous argatroban infusion drip, during which he achieved therapeutic aPTT levels between 44 - 50 sec. The patient was also treated with apixaban. Other studies included: Magnetic resonance venography (MRV) and angiography (MRA) of the brain, performed due to symptoms of mild headaches, were unremarkable. Platelet factor 4 (NR: not provided) strong positive at 2.9 OD; Prothrombin mutation G20210A not detected, Red blood cell count (NR: 3.98 - 5.98) 5.07 M/ microliter, Red blood cell sedimentation rate (NR: not provided) Normal, SARS-CoV-2 test was negative, Serotonin release assay was positive, and WBC (NR: 3.2 - 10.6) 5.8 K/microliter. Anticardiolipin antibodies (NR: not provided) 5 GPL, Beta-2 glycoprotein 1 antibodies (NR: 0 - 20) 0 SGU, 5 SMU, Blood homocysteine (NR: not provided) 13.4 nml (normal), C-reactive protein (NR: not provided) 2.6, Cardiolipin immunoglobulin G (NR: 0 - 12) 6 MPL, Cell marker increased was positive, EKG (NR: not provided) Normal, Hematocrit (NR: 36.9 - 52.1) 42.2 %, Hemoglobin (NR: 2.5 - 18.0) 15.0 g/dL, Lupus anticoagulant (NR: not provided) not detected, MCHC (NR: 33.4 - 35.3) 35.5 g/dL, MCV (NR: 80.6 - 97.6) 83.2 fL. On an unspecified date the serotonin release assay was no longer positive. Within a week post-discharge, the patient developed recurrent thrombocytopenia, with a platelet count that down trended to 107 10*9/L His thrombocytopenia appeared to somewhat correlate with prednisone dose adjustments, suggesting an autoimmune-driven process, although it did not respond to repeat IVIG administration. Due to the normalized D-Dimer levels and negative SRA, it was assumed that there was no further ongoing platelet activation. The authors stated the patient had no prior risk factors for thrombosis other than the 2 recent 4-hour flights. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bilateral lower extremity pain, was recovering from deep vein thrombosis, vaccine induced thrombotic thrombocytopenia, platelet count decreased, swelling, full blood count, metabolic function tests, muscle spasms, ultrasound doppler abnormal, and multiple acute bilateral pulmonary emboli, and the outcome of mild headache was not reported. This report was serious (Hospitalization Caused / Prolonged). This case is a duplicate of 20210642952. Additional information was received from literature article on 19-JUN-2021. The following information was updated and incorporated into the case narrative: literature reference information, additional reporters, laboratory data, updated events. It has been determined that Manufacture Report Number 20210514958 is a duplicate of deleted case 20210642952. All relevant information from Manufacture Report Number 20210642952 will be reported in this case 20210514958.; Sender's Comments: V2: Follow up consisted of a literature citation, presenting this case as a case report. This does not change the previous assessment. This case obtained via VAERS (ID 1264060) concerns a 48-year-old White male who developed symptoms of bilateral lower extremity deep vein thromboses (DVT) and thrombocytopenia 11 days after receiving Janssen Covid-19 vaccine. Concurrent conditions included exercise induced asthma. Patient was not obese, did not smoke, denied recent procedures, family history of bleeding/clotting disease & was physically active. He was up to date on cancer screenings based on age/family history. He had taken two 1-hour long flights 15 days and 18 days post-vaccination. Concomitant medications included finasteride & salbutamol. After 1 week of bilateral leg cramping & swelling which began 11 days post-vaccination, he presented to emergency department (ED) where complete blood count showed platelets 74 k/uL, peripheral smear with giant platelets, and d-Dimer 15K. Venous duplex ultrasound showed nonocclusive DVT in the bilateral popliteal veins extending to the gastrocnemius veins, occlusive superficial vein thrombosis in the bilateral saphenous veins, and occlusive DVT of the left posterior tibial vein. He was started on rivaroxaban & was not hospitalized. Two days later, he developed new chest pain & returned to ED, where CT chest showed numerous bilateral pulmonary emboli. He was hospitalized; empiric treatment for vaccine-induced immune thrombotic thrombocytopenia was started: IVIG, steroids, & argatroban. Anti-PF4 resulted as OD=2.9 and 3.323 (strong positive), confirming diagnosis. The patient was recovering from the events. Based on evolving knowledge of Thrombosis with Thrombocytopenia Syndrome (TTS, per definition from Brighton Collaboration), low platelet count & temporal relationship to vaccination, the events are assessed to have a plausible relationship with vaccination.

WAS FINE AFTER SHOT, SOAR ARM AND TIRED. IN EARLY MAY NOTICED MY LEFT SIDE OF FACE WAS NOT ABLE TO MOVE, SEEMED DROOPY. I WAITED TO SEE IF THE SYMPTOMS WOULD GO AWAY. ON MAY 28, WENT TO ER. MY BLOOD PRESSURE WAS HIGH AND ALSO MY SUGAR WAS ALSO HIGH. THEY BELIVED I HAD BELLS PALSY.

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

About a month after receiving the J&J vaccine, I noticed a bump in the top of my left calf, which caused some discomfort and also noticed slight numbness in left foot / toes. Primary, Dr., sent me for ultrasound, which showed I had several blood clots in my leg. I have never had any blood clots before. Dr. referred me to Hematologist, Dr. She ran extensive blood tests and found no genetic predisposition for clots. She stated it was likely the vaccine that caused me to develop blood clots. I am now on blood thinners to try to dissolve them and may have to take them for life if the clots don't go away in the new few months. Follow up ultrasound scheduled 9/7/21.

Night sweats and overall feeling tired. Hot flashes. Low grade fever. Missed 60 hours of work in the 2 weeks following the vaccine due to not feeling right

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.

SHORTNESS OF BREATH; UNABLE TO WALK; BRUISE IN THE STOMACH; HEADACHE; ARM PAIN; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 09041738 expiry: UNKNOWN) dose was not reported, administered on 16-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-JUN-2021, the subject experienced arm pain. On 19-JUN-2021, the subject experienced headache. On JUL-2021, the subject experienced bruise in the stomach. On an unspecified date, the subject experienced shortness of breath, and unable to walk. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, had not recovered from arm pain, bruise in the stomach, and shortness of breath, and the outcome of unable to walk was not reported. This report was non-serious.

Torso: Pain/Discomfort across front of chest (about 2 inches above nipple) ? started on left side but also presented on the right too. Pain/Discomfort in back on both sides. Sometimes upper back, sometimes lower. Pain/Discomfort and sometimes a burning sensation in ribs. Many times this presented itself at the lower tips of the ribs. Arms: Pain/Discomfort under armpits. Tingling in arms. There was a point where my arms would fall asleep when I was laying down at night. General weakness/fatigue in the arm. Sometimes arms (particularly the forearms) feel tight Leg Pain/Discomfort in calves. Many times, the pain would be a sharp, pointed sensation in both calves. This discomfort always presents itself in the back of my calves. *Weakness/Fatigue in thighs. Many times my thighs will feel weak/fatigued. Neck: Pain/Discomfort in my neck. Primarily this occurs on the sides of my neck. There is also a tightness that occurs on the sides of my neck too. At times, the back of my neck is also tight and uncomfortable. Spine: General tightness and discomfort running down the middle of my back. This occurs primarily in the upper to middle part of my back. Overall: Along with the different sensations listed, I have battled constant fatigue and a feeling of weakness. This weakness could be overall throughout the body or sometimes just in certain regions in my body. For example, some days I might feel like my arms are weak/fatigued, other days it might be my legs, and then sometimes throughout my body. I have also been dealing with persistent headaches from time to time.

OCCASIONAL CRAMPING SPECIFICALLY IN THE CALF MUSCLES/ LEGS - SYMPTOMS OF CRAMPING; LEGS-NUMBNESS; FEELING OF LEGS TIREDNESS; LEGS-WEAKNESS; WARM FEELING BUT NO FEVER - TEMP 99.0F; GENERALIZED BODY ACHES (NO SPECIFIC LOCATION OF PAIN); INJECTION SITE MINOR PAIN/ NO RASH OR MUSCLE PAIN; 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 concurrent conditions included alcohol use, seasonal allergies, and non smoker, and other pre-existing medical conditions included patient does not have medical history and not taking prescribed medications .the patient does not have history of illicit drug abuse. patient does not experienced headache, fever, nausea. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 10-JUL-2021 for prophylactic vaccination. Concomitant medications included ibuprofen for drug used for unknown indication. On 10-JUL-2021, the subject experienced warm feeling but no fever - temp 99.0f. On 10-JUL-2021, the subject experienced generalized body aches (no specific location of pain). On 10-JUL-2021, the subject experienced injection site minor pain/ no rash or muscle pain. Laboratory data included: Body temperature (NR: not provided) 99.0 F. On 15-JUL-2021, the subject experienced occasional cramping specifically in the calf muscles/ legs - symptoms of cramping. On 15-JUL-2021, the subject experienced legs-numbness. On 15-JUL-2021, the subject experienced feeling of legs tiredness. On 15-JUL-2021, the subject experienced legs-weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from warm feeling but no fever - temp 99.0f, generalized body aches (no specific location of pain), and injection site minor pain/ no rash or muscle pain on 11-JUL-2021, and had not recovered from occasional cramping specifically in the calf muscles/ legs - symptoms of cramping, legs-numbness, feeling of legs tiredness, and legs-weakness. This report was non-serious.

Patient experienced hives on face/neck after first Moderna dose in Feb, treated w/ benadryl at that time, lasted several hours, no mouth/throat swelling. Patient was scheduled for his 2nd Moderna dose at clinic. Given his reaction to moderna previously he was sent to outpatient pharmacy to get Janssen (J&J) vaccine. After the Janssen Covid vaccine was administered patient immediately began feeling red, hot, and itchy. Was given benadryl 25mg/5ml oral dose x2 after being monitored for 30 min. Told patient if symptoms got worse or persisted to come back to hospital. After monitoring patient he felt safe to go home and had no visible signs of reaction after 30 min. Called patient to follow up 24 hours later and he stated he felt a "little itchy" that evening and had flu like symptoms when he woke up in the morning (achy, chills) but the itching went away last night.

Pain in left arm, left shoulder and left shoulder blade. The pain comes and goes, but has not waned since getting the vaccine shot in April.

FEELING TIRED; LOW ENERGY; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820096, expiry: UNKNOWN) dose was not reported, administered on 23-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-JUL-2021, treatment medications included: paracetamol. On 24-JUL-2021, the subject experienced feeling tired. On 24-JUL-2021, the subject experienced low energy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling tired, and low energy. This report was non-serious.

"Janssen COVID-19 Vaccine EUA" Joint pain, including shoulders, hips knees and ankles. Chills. Sweating during sleep. Low grade fever. General body aches. Symptoms began approx 12 hours after dose was given and still persist approx 36 hours later. No doctor or hospital visit is required at this time.

Was in his USOH until this morning whilst he was at work. He noticed that he was having difficulty finding his words and that he felt spaced out. Decided to schedule appointment see his PCP early afternoon. He was brought to the emergency room for further evaluation due to concern of an underlying stroke. On further questioning, he has a history of atrial fibrillation for which he has been on Cardizem. Not placed on any anti-platelet or anticoagulants. Does mention that he has a family history of this. Recently had the COVID-19 vaccine. Notes that he did have some body aches and fatigue. The symptoms cleared up by yesterday was went to work. He was feeling normal today until he began to develop the above symptoms. He denies any weakness today however he does recollect that last week, as he was walking the dog, he fell. He was able to get up unassisted. About a year ago in August, he had a similar episode of falling, came to the emergency room the following day and was found to be in atrial fibrillation with a rapid ventricular rate. States he has been diagnosed with atrial fibrillation since his early 20s. He is unaware of any history of hypertension. He states that he is on Cardizem for treatment of atrial fibrillation

Debilitating headache from 1030pm on night of vaccination til about 48 hours later. Lower right back of head. Random muscle aches overnight. Night sweats on 2nd night. Weak and tired 2nd day.

3/15 13:30 Tightness in right shoulder about 30 minutes after application. 21:00 Burning in lower back and hips. 23:00 Burning extending down the legs and further around the core. No swelling, but almost as though nerves are being stimulated. Chills. Pain at a 6. 3/16 Same burning in joints down legs, pain still at 6. Persistent with low dosage of Tramadol. 3/17 02:00 still burning, with pain generalized in the hips, back and legs. Still at a pain level of 6

Vasovagal event without syncope post vaccine. Clammy and nauseous with tingling to hands. EMS and Dr on site. Blood pressure 90/49 at 18.10. at 18.15 blood pressure was 114/81. Released home and advised to seek medical attention later if needed, client verbalized understanding.

hard chills, cold hands, fever of 101.4 Fahrenheit, muscle aches, joint pain began approximately 10 hours after receiving vaccination. Acetaminophen was taken every 4 hours to reduce fever.......by 2a.m. the fever broke and fatigue sat in.......by the next morning around 10:30am, subject had normal temperature and returned to regular activity. The side effects of the vaccination lasted only about 14 hours total but were severe.

9 hours after shoot woke up feeling very poorly and feverish. Went to take Tylenol and passed out. Came to with wife shaking my arm. Suffered trauma to noise and back during fall as a result of passing out including laceration from hitting face on counter. After coming to sever body shakes. Temperature was taken twice and recorded 92.5 and 93.0. Blood pressure and pulse after moving to couch to lie sit down was normal. Next day couldn't do much and was very tired. By second day I was recovered but sealing with injuries from the fall.

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.

headache on day 2 with low energy and felt lethargic Also felt hot all night like I couldn?t cool off. Woke up with rash all over body. Mostly around neck and right chest/armpit area. Also speed to arms and legs but to a lesser degree.

Patient received Johnson&Johnson COVID vaccine in the afternoon on 3/31/21. Patient reported having right arm pain, diaphoresis, chills, nausea, and muscle aches/pain in upper leg/lower back at 5:30am the following morning. Patient took 2 tablets of 500mg naproxen in the morning and in the afternoon. Symptoms did not resolve and patient had to leave work early. Upon getting home patient took 2 tablets of 650mg tylenol and symptoms resolved within 48 hours. On 4/3/21 patient reported mild to severe pain in heel of left foot. The following day the patient went to WellNow urgent care to get his heel examined. During examination provider noticed patient's lesions and patient stated more lesions have appeared since getting the vaccine. 1 on his stomach, 1 on the dorsum of his left foot, 1 on his back, 1 on his left elbow, in between his toes of his left foot, and in between the fingers of his right hand. Patient stated that these lesions cause a burning sensation and can become itchy. Patient was sent to Hopsital ED as provider at urgent care was concerned patient may have purpura. Patient was seen and discharged on 4/4/21 from the ED. The heel pain was determined to be plantar fascitis which was treated with at home exercises with a heel cup. The patient was given clotrimazole for his lesions. The patient had a follow-up visit with his primary care provider at hospital on 4/6/21 in which he explained the clotrimazole only made his lesions worse. Patient was referred to follow up with dermatology on 4/8/21. Primary care provider believes progression of the lesions since getting the vaccine leads to concern of an underlying autoimmune exacerbated by vaccine.

After receiving the vaccine, I sat down to rest and gave me tachycardia with difficulty breathing, my feet were weak with tiredness and cold. Then I drank water and fluids and my heart rate stabilized. Then within 2 hours I had 4 tachycardia events but milder and then normalized.

Patient passed out fell to ground and started with jerking motions. Pateinet was taking by ambulance to the emergency room. Pateints blood pressure and pulse where low when checked by paramedics.

Flushed at first. Extreme fatigue for two days. Rash on chest which is most visible after showering. Rash seems to be lessening with each passing day.

One minute after he got the shot, he did not feel ok, he was shaking, sweating and dropped his phone. The pharmacist was next to him, we called 911 immediately. They came like 10 minutes after, but by this time, he was ok, they checked his blood pressure , it was 115/75. He was completely alert, and did not want to go with them. we asked him to stay at the pharmacy till he feels completely fine. we called him at 7 pm to follow up, he said he is ok.

6 hours after shot, body started shaking involuntarily for 3 hours. I was extremely cold, 3 layers of clothes and 3 layers of blankets. Unable to sleep all night. Got up 6 am, had major headache, swollen nodes in neck, all over body aches and still had chills. After 24 hours I may have been 50% to normal, after 48 hours approx 75%, 72 hours about 85%. Headache was gone unless cough or sneeze. On third day. I did not take any over the counter Medicine after the shot at all in fear of affecting the vaccine.

chills; started night of started 09Apr2021 fatigue started 09Apr2021 muscle aches started 09Apr2021 anal bleeding when going to restroom - quite a lot and did not stop right away - started 11Apr2021 migraine starting 09Apr2021

Pt was in the waiting room in his motorized wheelchair when he complained that he feels like he's going to pass out. He also c/o being dizzy. His skin was cold and clammy. This happened about 5 minutes after the vaccine. We assisted him to a room where he laid down flat and I applied ice pack to his head and chest. Pt felt better after about 30 minutes. Pt stated he had never had this reaction before. Pt was discharged from the clinic with his father, in stable condition.

5 minutes after vaccine received, patient reports feeling dizzy and lightheaded. Patient diaphoretic, skin cool and clammy to touch. Patient instructed to drink orange juice. No respiratory issues noted. Patient reports not eating anything today and he woke up at 9 am. Patient reports feeling nervous about vaccination before appointment. Patient observed for 30 minutes. Patient able to answer questions and follow commands appropriately. Patient advised to follow up with primary care provider and to call 911 if symptoms persist or experience respiratory distress. Patient instructed to have food/fluid and rest. Patient ambulatory and reports symptoms resolved about 10 minutes after drinking juice. Patient returning to work; manager and supervisor aware of patient's condition and notified to allow patient food/drink/rest as needed. Patient declined transportation to hospital. BP 110/70. HR 74.

Injection at 9:30 am on 4/8. Dizziness and euphoria beginning at 1:30 pm, 4 hours post-injection. Dizziness became severe at 5:30 pm, 8 hours post-injection with fever, chills, and nausea. Severe headache beginning at 7:30 pm, 10 hours post-injection, becoming severe migraine headache lasting for 24 hrs until ~7:30 pm on 4/9, 34 hours post-injection. Mild headache persisted until 2:00 am on 4/10, 40.5 hours post-injection.

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.

8:00 PM- felt tired, achy, headache, cough, nausea, tenderness left axilla. Resolved today. On April 4th, felt like he had shingles rash starting, (client has history of shingles) but no rash erupted. Skin affected across chest across the nipple line, and back.

Patient began having back pain on Friday but by Saturday was having a hard time walking. Having pain at the left elbow, both shoulders, left knee and left foot. Dr. came in to examine patient as well. Think he is having tendinopathy as pain was not in the joint itself. Patient having pin point tenderness. Denies fever.

1 week post vaccination - patient, not responding to albuterol HFA, called 911, he passed out, was unresponsive, pronounced dead.

Swollen lymph nodes and abdominal pain from right him bone down to scrotum. Pain on 4/7 was such that i though i was suffering a hernia. Couldn't get out of car or move my right leg across my body. Could put right leg into pants leg. Hurt to bend over and do much of anything on 4/7. Initially thought pain was in testicle but doesn't hurt at all to the touch. Realized it more a swollen area in the groin between hip bone and scrotum. Nothing hurts to the touch at all in that area either which lead my to believe it was swollen lymph nodes. The Feeling is as if i got hit in the right groin and my testicle has been hit and discomfort is 8 inches above right testicle in my groin area. It has been improving every day since then, the more i walk the better it is. It only hurts when i sit now and it seems to aggravate it pretty well but once i start moving the pain goes away. It has been 9 days now and the i don't notice it all day until i come back to the office and sit at my desk and again it gets aggravated and the discomfort feels like my right testicle is near my appendix Since this all started my legs feel heavier in the calf and have little nerve sensations when i sit too, which concerns me about the blood clot possibility and so i have been emailing with my doctor. I am going to make appt for Monday 4/19

received Janssen J &J shot 9:15 am on April 7th approx, 24 hours later had to leave work for home because I became incredibly weak, tired and without energy. struggled at driving home had to repeatedly slap my face to stay awake. checked my temp. when arrived home, had a low fever (100.1) went to bed slept for 4 hours, checked temp (100.1) went back to sleep. woke 9 am on 4/9/2021 checked temp. (normal) fever broke on 4/9/2021 used restroom at 11:01 am 4/9/2021 large amount of bleeding from rectum LARGE AMOUNTS of blood clots in stool (shaped like Candy) Contacted medical provider. Spoke to a triage nurse, explained my concerns about bleeding from rectum and blood clots in stool... she dismissed that my restroom issues were related to the vaccine,

Headache, chills, fever, body headache, rigors, fatigue, malaise, through the vaccination night. Since vacation has continuous fatigue and headache. 4/12/21 right side neck/face pain and headache on right side.-worsening 4/16/21-went to walk in clinic. 4/17/21 headache/neck pain extreme went to ED. Continues to have neck/face and headache.

INJECTION SITE PAIN; HEADACHE; TIREDNESS; SORE TO TOUCH; This spontaneous report received from a consumer concerned a 49 year old male. The patient's height, and weight were not reported. The patient's past medical history included stroke, and concurrent conditions included high blood pressure, and other pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022) .5 ml, administered on 05-MAR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced injection site pain. On 06-MAR-2021, the subject experienced headache. On 06-MAR-2021, the subject experienced tiredness. On 06-MAR-2021, the subject experienced sore to touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain, headache, tiredness, and sore to touch. This report was non-serious.

Patient seen at medical facility 4/6/2021 with headache, fatigue, lower extremity petechial rash, unexplained bruising, small amount of blood in stool. CBC ordered 4/6/2021 and obtained on 4/8/2021. Platelet count was 4 x 10^9/L. Patient admitted to hospital. Hematology/Oncology consult obtained. Patient diagnosed with Immune Thrombocytopenia Purpura (ITP). 4/9/2021 Given 1g/kg IVIG and 125mg IV methylprednisolone. Platelets increased to 15 x 10^9/L. 4/10/2021 Given 1g/kg IVIG and 125mg IV methylprednisolone, platelets increased to 81 x 10^9/L. Patient discharged on oral prednisone with Hematology/Oncology outpatient follow-up. Patient advised to stop Goodies Powder for Headache. 4/13/2021 patient returned to hospital emergency department with generalized weakness. His platelets were rechecked and were 277 x 10^9/L. D-Dimer was undetectable at <0.27. Patient was discharged home from the emergency department.

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.

about 8 days after receiving my shot, i noticed muscle cramping in my hands, legs and feet. As of today, I still have some cramping but not as bad.

The patient is a 49 year old male who has a past medical history significant for bipolar disorder with manic episodes, OSA on CPAP, morbid obesity, HLD, and relapsing remitting MS. Per chart review, patient's MS was initially diagnosed in 2012 on MRI and LP and was on Copaxone for several years but stopped taking in 2017. Symptoms and imaging remained stable through 2019 then patient was lost to follow up until he was seen by Dr. on 4/12/21 who ordered an outpt MRI. Patient had COVID vaccine with Jansen vaccine on 4/10/21. He developed bilateral upper and lower exremity weakness and urinary retention on 4/21/21 which prompted presentation. He came into ED 4/21/21 and had foley placed but removed foley and decided to leave AMA. Returned on 4/22/21 with worsening symptoms and was subsequently admitted. Patient was seen by neurology and started on high dose steroid x5d for MS exacerbation. Initial MRI of the brain obtained on 4/22/21 was notably stable without change in previously described white matter disease. No new lesions to suggest active demyelination. New plaques were noted on MRI C and T spine (4/22/21). It is noted that patient received COVID19 vaccination with J&J vaccine on 4/10/21 and temporal relationship between his acute presentation and recent vaccination was questioned. On 4/30/21, patient developed severe bilateral facial weakness and he additionally was reported to have had an episode of aspiration. Repeat MRI brain on 4/30/21 showed new bilateral facial nerve enhancement. Etiologies could include: GBS, Lyme disease, botulism, neurosarcoidosis, less likely myasthenia gravis. LP was pursued on 5/1/21 which was significant for tube 4 with 136 WBC, 88% lymphocytes, glucose 89, protein 632. Meningitis/encephalitis panel was negative. Lyme CSF was negative, Lyme antibody panel was positive. MuSK antibody negative. ACE blood level normal. Ganglioside antibody panel and myasthenia graivs adult panel pending. He is being treated for Lyme disease with Ceftriaxone 2g IV daily since 5/1/21 with plan for 2-4 week course to cover for Lyme disease. He is still admitted and is still having symptoms of facial palsy as of today (5/4/21)

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.

Pt. stated, "I have a history of passing out after shots or blood draws". After receiving the injection, he was asked to remain seated for a few minutes. After 2 minutes he stated that he felt dizzy and warm. He put his head down on the table and continued to feel hot and sweaty. He was given water and the EMS team came in to evaluate him.

The big toe on my left foot started to hurt. It lasted a few days and then went numb on the bottom and tip and has stayed numb. Feeling does return on occasion but infrequently and not noticeable usually.

I started having a lot of pain in my right leg. I could actually feel and see that my veins were swollen. It progressed and started moving around. I started having chest pain and headaches. I ended up at ER. They gave me pain meds and did a CT Scan and ultrasound, which were both clear. The next day, I was walking around and my hand and arm started hurting and then went numb. My right wrist was swollen to twice its size. I went to care and they told me to go back to the ER. They eventually did another ultrasound, but the swelling had gone down by then. A few hours later, my left arm started to swell and lasted for about 4 hours. From there, I had pain in my arms and legs for a few days after that, but then I was fine.

about 10 at night I started feeling cold, followed by chills that were uncontrollable for like four hours, body aches, sweating cold sweat all through the night. about 6 weeks later started having symptoms like a sinus infection went to an Urgent care, they did a covid test it was positive.

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.

initially no symptoms until on day 8 after vaccine (1 Jun 2021), rapid onset progressive severe muscular pains in calves, thighs, buttocks and then upper arms. Within 24 hours unable to walk easily. No other symptoms and no physical signs of infection. Urine became dark brown at 24 hours and clinically has myositis with suspected rhabdomyolysis - was admitted for iv fluids and analgesia and is improving clinically but gait still disturbed. No demonstrable weakness and no neuro deficit or symptoms. no other obvious cause for acute myositis so consider ?vaccine related.

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.

SEIZURE LIKE ACTIVITY; BP 87/64; DIAPHORETIC; PULSE RATE 50; NOT FEELING WELL; This spontaneous report received from a health care professional concerned a 49 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. 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, 1 total, administered on 12-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-JUN-2021, health care professional (HCP) reported that patient received Janssen Covid-19 vaccine. About 2.5-3 minutes after receiving the injection, the patient began having seizure like activity. HCP described that as full postured seizure like in the upper extremities and chest, and the eyes had been nystagmus. This activity lasted approximately 45 seconds. Emergency medical services (EMS) staff was on the scene and when they came to, the patient self-reported that he was not feeling well and the HCP described him as diaphoretic and was appearing shaky. EMS took his vitals initially (Blood Pressure, BP 87/64 mmHg, Pulse rate 50 unit unspecified and oxygen saturation 100 percentage). Vitals at 5 Min (Blood Pressure, BP 124/80 mmHg, Pulse rate 76 unit unspecified, oxygen saturation 100 percentage and blood glucose level 125 unit unspecified). An ambulance was called to transport the patient to the ER, and upon arrival vitals were taken again at about 10 Min. Post-ictal (Blood Pressure, BP 115/76 mmHg and pulse rate 76 unit unspecified). Patient was taken to the ER for further evaluation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the seizure like activity, not feeling well, BP 87/64, pulse rate 50 and diaphoretic was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210627629-covid-19 vaccine ad26.cov2.s-seizure like activity, BP 87/64 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).

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.

arm soreness from vaccine - Vaccine was placed in freezer upon receipt from manufacturer, then thawed prior to administration

Tired and sleepy - for the next couple of days right after the vaccine. June 14, I started getting on my right side - from cheek to toes - and my whole leg and is still in pain today. For the last three weeks - the pain level was from 9 or 10 out of 10. I missed work for three weeks. I can barely sleep at night - maybe for three to four hours because the pain would wake me up. Today was my first day after three weeks that I was able to go to work. Today the pain is 5 out of 10. No treatment at the hospital. They prescribed me with 800 mg of Ibuprofen - two pills at night. The medicine was not strong enough. The prescribed me cream on my neck. The day I went to pick up my prescription to the pharmacist advised me to take another brand - so found a generic brand for $25 instead of $525. The cream doesn't numb my leg or make me fill better. I was applying hot water in the shower on my neck and that helped a bit. Told me to watch videos to stretch and exercise my neck every day.

Patient started experiencing periods of sweating and cold/hot sweats with visible beads of sweat on his face.

He reports right after getting the vaccine he got a golf ball sized lump on his arm. His left arm is now numb and it is radiating more "out". Denies any shortness of breath, headaches, or chest pain.

Started having nerve issues which I thought needed chiropractor care. Several adjustments over the last couple months with no relief. Symptoms are tingling left arm and left leg to fingers and toes. Muscle spasms and twitches and cramps in the forearm, wrist, and foot that cause my fingers and toes to pull in

Strong pain in the hips. Difficulty to walk.Numbness in the legs. Tingling in the legs. Numbness in my fingers. Pressure on the chest. High blood pressure.

Strong pain in the hips. Numbness in the legs. Tingling in the legs.Difficulty to walk. Trouble breathing. Numbness in my left fingers. Pressure on the chest.High blood pressure.

- 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

arm numbness or tingling, similar to what was reported for Guillain-Barré syndrome. Always since vaccination

49M with PMH significant for anxiety and depression; unmedicated due to lack of health insurance presenting with vasovagal syncope 15 minutes after Janssen vaccine administration in left arm. Pt reported feeling nervous prior to vaccine administration with remote history of fainting one time due to needle phobia, pt was offered to prophylactically lie down in a cot to receive the vaccine, he refused. Pt stated that he began feeling flushed and sweaty when he lost consciousness falling from a seated position, hitting his face and head. Pt was lying in prone position unconscious for 10-15 seconds, EMS was notified and pt was turned using C-spine precautions and transferred to stretcher. Pt was placed in trendelenberg,

PLATELET COUNT WENT DOWN TO 96; NEUROLOGICAL SYMPTOMS; ANXIETY; DIMINISHED QUALITY OF LIFE; LOSING INTEREST IN LIFE; DIFFICULTY IN WALKING/ DIFFICULTY GETTING OUT OF THE CAR; GENERALIZED HEAVY MUSCLE PAIN ALL OVER THE BODY ESPECIALLY ON ARMS AND HANDS; FEELING OF ELECTRIC SHOCK ON LEFT SIDE OF BODY ESPECIALLY UNDERNEATH THE LEFT FEET AND LEFT INDEX FINGER; SEVERE HEADACHE MOSTLY ON LEFT SIDE AND TOP PART OF HEAD; 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, pre-diabetes which the patient controls with exercise and diet and no medications, alcohol user (had been drinking vodka for the past few weeks), and non-smoker. 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, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 27-MAR-2021 for prophylactic vaccination. Concomitant medications included olmesartan for blood pressure. On an unspecified date before vaccination the laboratory data (dates unspecified) included: Platelet count (NR: not provided) 160. On 18-APR-2021 (3 weeks after vaccination), the patient experienced severe headache mostly on left side and top part of head and ended up in the emergency room at 01:00 AM in the morning. In the emergency room, the patient had a brain scan and he was told that the brain scan showed no blood clot and that his platelet counts were good. After these tests the patient was sent back home. On 27-JUN-2021 (for the past 2 weeks prior to this report), the patient experienced generalized heavy muscle pain all over the body especially on arms and hands and difficulty in walking and getting out of the car. On an unspecified date in JUN-2021, the patient experienced feeling of electric shock on left side of body especially underneath the left feet and left index finger. On an unspecified date, patient reported that his platelet count went down to 96 after the vaccination, had anxiety and had been drinking vodka every night because his quality of life was diminished and he refused to go back to the emergency room. The patient was irritated and he was losing interest in life. The patient had not experienced any fever or nausea. The patient had scheduled an appointment with the physician on 26-JUL-2021 due to his concern about the neurological symptoms. It was reported that, the emergency services were called and informed about the patient. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache mostly on left side and top part of head, platelet count went down to 96, generalized heavy muscle pain all over the body especially on arms and hands, difficulty in walking/ difficulty getting out of the car, anxiety, losing interest in life, feeling of electric shock on left side of body especially underneath the left feet and left index finger, diminished quality of life, and neurological symptoms. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210738395-Covid-19 vaccine ad26.cov2.s-Platelet count went down to 96. 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

NUMBNESS IN THE LEFT SIDE OF NECK; TINGLING SENSATION IN THE LEFT SIDE OF NECK AND IN FINGERS; SLURRED SPEECH; STRAIN; LOSS OF SENSATION IN LEFT ARM; CRACK JOINT; UNABLE TO TURN ARM AT 360 DEGREE; PAIN GOES TO LEFT SHOULDER; SORENESS AND PAIN IN LEFT ARM; This spontaneous report received from a patient concerned a 49 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 18200095, and expiry: UNKNOWN) dose was not reported, administered on 12-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-JUN-2021, the subject experienced soreness and pain in left arm. On JUL-2021, the subject experienced numbness in the left side of neck. On JUL-2021, the subject experienced tingling sensation in the left side of neck and in fingers. On JUL-2021, the subject experienced slurred speech. On JUL-2021, the subject experienced strain. On JUL-2021, the subject experienced loss of sensation in left arm. On JUL-2021, the subject experienced crack joint. On JUL-2021, the subject experienced unable to turn arm at 360 degree. On JUL-2021, the subject experienced pain goes to left shoulder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness and pain in left arm, numbness in the left side of neck, and slurred speech, and the outcome of tingling sensation in the left side of neck and in fingers, strain, loss of sensation in left arm, crack joint, unable to turn arm at 360 degree and pain goes to left shoulder was not reported. This report was non-serious.

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

LEFT ARM WEAKNESS; PAIN ON LEFT ARM AND FINGERS; CAN'T SLEEP BECAUSE OF PAIN; 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 kidney stone surgery, and concurrent conditions included non-alcohol user, and non-smoker, 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: 205A21A expiry: UNKNOWN) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAY-2021, the subject experienced can't sleep because of pain. On 20-MAY-2021, the subject experienced pain on left arm and fingers. On 15-JUN-2021, the subject experienced left arm weakness. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Not reported. Treatment medications (dates unspecified) included: gabapentin, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left arm weakness, can't sleep because of pain, and pain on left arm and fingers. This report was non-serious. This case, from the same reporter is linked to 20210760712.

Having numbness in right arm from fingertips to shoulder. Also numbness in right ear and cheek. Patient was advised to contact his PCP or go to the ER.

Has not had a SZR since april of last year. He was not feeling well after vaccine, (body aches, subjective fever, tiredness) and wife found him having a seizure while lying in bed.

3/7: No adverse reactions observed 3/8: 12:30 a.m. Awoke vomiting and with fever of 99.8 F 2:30 a.m. Fever of 102 F Multiple measurements prior to 10 a.m. fever of 101.6-102 F 10:00 a.m. Full adult dose Vick NyQuil Severe Cold & Flu. Additional doses as directed. Scheduled rapid Covid-19 test at pharmacy 2:00 p.m. fever of 99.5 F 4:50 p.m. COVID-19 test, no fever 6:00 p.m. Negative test result Remaining evening of 3/8 and until early morning, 3/12, heavy night sweats, clamminess, extreme fatigue

I received the vaccination at 6:50 PM on 13 March 2021. After the vaccination I did not have any symptoms; I was feeling just fine. I went to bed around 10:30 PM and woke up at 4:30 AM with my whole body feeling achy and lethargic; my bones and muscles were achy all that day, my body felt hot but my temperature was normal; I had a headache; I was also very tired; my body felt heavy and my normal resting heart rate is around 50 bpm and my resting heart rate was fluctuating from 72 to 79 bpm all day; all I could do was lay in bed. 14 March 2021 I went to bed around 9:30 PM and woke up around 2:30 AM feeling nauseous and I threw up; I went back to bed and woke up at 7:30 AM and felt much better; still had a headache and feeling achy in my legs and lower back, still tired and I slept from 10:30 AM to 01:45 PM.

Syncope, clammy/sweaty/grey skin, loss of bodily function and non-responsive for 1 minute, with O2 sat dropped to 91% after event. Onset approximately 2 minutes following injection.

Injection site swelling and extreme soreness Fatigue Stomach cramping Nauseous Chills Muscle aches Migrane

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

Immediately on injection felt severe pain in arm - the pain radiated downward but at time of typing this report patient states pain is lightening up and remains only at injection site.

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.

About 10 minutes after injection, got dizzy/clammy. It took about 5-10 minutes after that with EMTs to wait until my blood pressure normalized, and then I was fine. Walked off site. Slowly throughout the day had an increasingly bad headache, which peaked about 10 hours after the injection. Around that same time, bad fatigue started, and then slight chills. The headache at this point was extremely severe for about 10-12 hours. After that (so 20-22 hours after initial injection) the fatigue and chills subsided, but came back occasionally. The headache was less severe at that point, but in total did not go away until an additional 15 hours had passed. My estimate is that took about 36-40 hours to feel 100% normal again.

Felt a slight numbness is throat, possible slight swelling in throat- felt this 20 minutes after shot and it lasted about 30 minutes.... 30 minutes after the shot my face turned red and my ears were very red, almost purple , and hot. This lasted for several hours after... At 11:30pm, almost 7 hours after the shot, I started to feel lousy. I started to get body aches and chills. Within 30 minutes they were fairly intense body aches and chills, shaking. At 1:00am I started to feel nauseas . At 1:30 am I started dry heaving. At approximately 2:30 I threw up twice, and the dry heaving and nausea lasting until 4am , when I took an anti nausea pill. I finally fell asleep at 430am. I woke up at 8am and felt tired, and no longer nauseated.

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.

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.

Vaccination + 3 hrs - Headache, Fatigue Vaccination + 8 hrs - Headache, Severe Fatigue (took over the counter Ibuprofen) Vaccination + 14 hrs - Severe Chills, Headache, Muscle Ache (took over the counter Tylenol) Vaccination + 16 hrs - Cold sweats, Headache, Muscle Ache, Fever = 103 deg F Vaccination + 20 hrs - Headache, Muscle Ache, fever = 101 deg F Vaccination + 24 hrs - Headache, Muscle Ache (took over the counter Ibuprofen)

By midnight my husband had severe chills (he could not get warm no matter how many blankets he covered himself in) - severe headache - lethargic flu like - body aches - he was nervous and checked on me and my mom- as we all got the in home vaccine together . We were both fine but he had side effects on the higher/ more severe end. Lasting about 24 hours where it then began to break into cold clammy sweats (he did use Tylenol starting about 3-4:00pm on the 25th and by the morning of the 26th he felt much better. The Vaccine did not write our lot number on our vaccine cards - I have to call and attempt to find out. I am reporting this in case it is helpful for others. He did not have to be admitted anywhere but he would say that for those first 24 hours he was having side effects more on the severe side.

Nausea for 15 minutes shortly after the vaccine, mild flushing of hands and face shortly after the shot, and fatigue for 24 hours after shot.

Leg pain in left calf for a number of days starting almost a week after getting vaccinated. I thought it might be a blood clot (this was e any news of blood clots was known). I had an ultrasound and it showed nothing. But I thought I?d report it anyway.

Fever (100.5), cold chills, aches, headache, joint pain, fatigue, confusion, sore arm started 24 hours after shot and progressively got worse for two days. Symptoms have got better, but still lingering. A few red scabs appeared on upper arm of arm shot administered to, but not sure if related or not.

Headache, Dizziness, Pain in the arm where the vaccine, these three the first 3 days. Right now arm pain and headache.

Arm hurt badly immediately after shot, around 12:30pm today I started to feel aches, chills and headache, and fever of 101.7 around 7:30pm

Hives (all over body) Spent the day outside on a high-pollen-count day. At 6PM noticed itchy/tingly and upon inspection noticed hives all over body. I have had Hives at least once before while on high-dose (400-600mg) ibuprofin, but never from allergies. Not certain this is related to J&J shot, but doctor said it wouldn't hurt to report. Next day stayed indoors. Hives are less common, but still present.

Pt reports that 23 hrs after receiving the vaccine he experienced " a massive seizure" and was transported by paramedic to the Hospital. A neurologist he saw mentioned that he had seen "other seizures like this ' and they presumed he meant after COVID vaccines

History of Present Illness The patient presents with 50-year-old male with a history of hypertension and diabetes who presents via private vehicle with complaints of atraumatic left calf pain x4 hours. Symptoms started while typing on computer at work sitting in chair. Described as mild soreness to his left medial calf rating behind his knee. No frank tenderness with palpation. No fall, trauma, injury, or overuse syndrome including gym. No swelling, edema, or asymmetry. No associated motor/sensory disturbance able to wiggle and feel all digits with good pulses. No chest pain, shortness breath, palpitation, lightheadedness, or syncope. No spasms, cramps, or charley horses. Patient denies any history or DVT/ PE, hypercoaguable disorder, recent immobilization or surgery, recent long trips or travel, or active malignancy (w/ treatment in last 6 months) but does take prescribed clomiphene for androgen replacement/stimulation. Discomfort scribed as soreness, minimal intensity, 2 out of 10 without provocative or palliative factors.

Diarrhea, mild temperature, sore body initially. 3 days after pain in right leg. It feels like a sharp stabbing pain. Like a charley horse or dehydration. Drank water and Gatorade does not stop pain. Started to take 81 mg aspirin and did not stop pain. Just went to Dr. for blood test on 4/14/21.

Patient felt ok the day of the shot, next day got very sick. Said he felt terrible, felt like the vaccine was going to "do him in." He complained of weakness and shortness of breath. He was dehydrated and worried about his kidney function. Said he had a hard time going to the bathroom with stomach pains. On Mar 31, 2021, said he had fever, but didn't go to doctor. Was taken by ambulance April 3 to ER, admitted that night, transferred to ICU on April 4, on ventilator, proceeded to experience multiple organ failure and died on April 11, 2021

Patient came in to store 4/16 -- he mentioned the day of vaccine that we was uneasy on his feet that evening. ( did not mentione until 4/16.) HE said around 4/11- 4/12 he has cold sweats, dizziness and some coughing started. He said he started to feel better but noticed 4/16 that he was having a little shortness of breath/congestion -- he is taking mucinex to relieve congestion

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.

On the day starting 6pm (injection +8.5 hrs/next day until 2pm: Severe headache, severe nausea/vomiting, dizziness, body ache, chills/hotflashes Two days later, mid afternoon: Nausea Five days later, lunchtime for several hours: severe headache Six days later, lunchtime for several hours: severe headache

LEFT HAND NUMBNESS; TINGLING OF THE TIPS OF THE LEFT HAND FINGERS; SORE RIGHT ARM; 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 acid reflux for more than 10 years, alcohol user 4 times a week, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: 21/JUN/2021) dose was not reported, administered on 09-APR-2021 16:15 for prophylactic vaccination. Concomitant medications included omeprazole for acid reflux. On 09-APR-2021, the subject experienced sore right arm. On 13-APR-2021, the subject experienced left hand numbness. On 13-APR-2021, the subject experienced tingling of the tips of the left hand fingers. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left hand numbness on 13-APR-2021, was recovering from sore right arm, and had not recovered from tingling of the tips of the left hand fingers. This report was non-serious.

A week and a half after taking the Janssen COVID shot I had a knot and pain come up in my lower back. After going to the chiropractor two times the knot and pain ended up in my right leg. I then went to Urgent Care where they diagnosed me with a large blood clot. They sent me to imaging and after scanning the area confirmed that there was a blood clot in my right leg. Urgent Care then set me up with a specialist.

MUSCLE WEAKNESS; NO ENERGY; TIRED; HEADACHE; LIGHT-HEADED; FACIAL SWELLING; 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 covid- 19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 and expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021, the subject experienced facial swelling. On 29-MAR-2021, the subject experienced light-headed. On 29-MAR-2021, the subject experienced headache. On 30-MAR-2021, the subject experienced muscle weakness. On 30-MAR-2021, the subject experienced no energy. On 30-MAR-2021, the subject experienced tired. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from facial swelling on 02-APR-2021, was recovering from muscle weakness, and tired, and had not recovered from light-headed, headache, and no energy. This report was non-serious.

Pt phoned our office on 04/19/21 with complaints of abdominal pain and bilateral leg pain. Pt was instructed to seek immediate health care for evaluation. He refused. Pt was very agitated and concerned about covering costs of medical care despite having health care insurance. Pt again instructed to seek health care and he refused.

Persisted for three days: Arm soreness Headaches Body Aches Tiredness/fatigue These faded and on 4/7/2020, liver began to feel enlarged for two days. This was followed by UTI; pain in kidneys and groin; rigidity, discoloration, and extreme swelling in right testicle; inability to urinate; 100-degree fever. Remains on antibiotic (Keflex 500mg 4/pd) and Flomax. Testicle rigidity & some swelling remain.

On top of flu like symtoms that didn't concern me I started experiencing numbness and tingling on the right side of my face. I also had irregular heart beat for 16-18 hours. I have had neurological issues with 2 other medications in the past which calmed my concerns. I had my arms lock up on me while on Humira and I had the exact facial numbness and tingling with Enbrel. Both of those drugs work through TNF cells. I do not know the mechanism with J&J vaccine but wanted you to know that.

Achy; No appetite; Mild dizziness; Feeling flushed; Soreness at the vaccine site; Fever; MILD JOINT PAIN; Chills; 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 liver disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN expiry: UNKNOWN) 0.5 ml, administered on 05-MAR-2021 10:45 for prophylactic vaccination. The batch number was not provided and has been requested. No concomitant medications were reported. On 05-MAR-2021, the subject experienced mild joint pain. On 05-MAR-2021, the subject experienced chills. On 05-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.4 F. On 05-MAR-2021 11:00, the subject experienced mild dizziness. On 05-MAR-2021 11:00, the subject experienced feeling flushed. On 05-MAR-2021 11:00, the subject experienced soreness at the vaccine site. On 06-MAR-2021, the subject experienced achy. On 06-MAR-2021, the subject experienced no appetite. On 07-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99.6-99.8 (high fever). On 08-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 98.8 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from mild joint pain, and fever, had not recovered from soreness at the vaccine site, and the outcome of mild dizziness, feeling flushed, chills, achy and no appetite was not reported. This report was non-serious.

my right thumb and index finger from the point where i bend it to the top of the thumb and index finger it is completely numb like its dead since three weeks after having vaccine.

PAIN EXTENDING TO THE NECK; FEELING PAIN FROM SHOULDER TO ARM; 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: 202A21A expiry: 23-JUN-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-APR-2021, the subject experienced pain extending to the neck. On 17-APR-2021, the subject experienced feeling pain from shoulder to arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling pain from shoulder to arm, and pain extending to the neck. This report was non-serious.

Soreness & lump in left lower thigh size of tic tac Swollen and sore left foot Diagnosed with ultrasound as superficial blood clot Heat applied and aspirin Still swollen

About a week after receiving vaccine, both my shoulders and both hips started experiencing pain and weakness that is still ongoing, though improving. Until recently, it was difficult to raise my hands over my head, and it would be difficult to stand up from a sitting position. I have regularly exercised and done resistance training for several years. I'm not sure if this is coincidental nor am I concerned, but a pharmacist encouraged me to report it here.

Patient passed out walking down the hall to the bathroom about 5 minutes after receiving the vaccine. When patient regained consciousness, he stated he was having a hot flash and was going to the bathroom to get something to wipe off his face.

BLOOD CLOT IN LEG; SHORTNESS OF BREATH; HEART RATE INCREASED; GANGRENE IN TOE; RIGHT LEG SWOLLEN; RIGHT FOOT SWOLLEN; CHILLS; RUNNY NOSE; FEELING HOT; 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 high blood pressure and diabetes. The patient received COVID-19 vaccine Ad26.CoV2.S (suspension for injection, route of administration not reported, batch number 1802070, expiry date unknown), dose not reported, 1 total administered on 19-APR-2021 for prophylactic vaccination on left arm. Concomitant medications included amlodipine besilate for drug used for unknown indication, empagliflozin for drug used for unknown indication, fenofibrate for drug used for unknown indication, insulin aspart for drug used for unknown indication, insulin glargine for drug used for unknown indication, losartan for drug used for unknown indication, and pioglitazone hydrochloride for drug used for unknown indication. On an unspecified date (reported as 22-MAR-2021; 28 days prior to vaccination), the patient experienced shortness of breath, heart rate increased, runny nose, chills and was hospitalized (date unspecified). He reported that on this past Saturday, 17-APR-2021 (2 days prior to vaccination), he went to the emergency room. He reported that his toenails were coming off, the skin on his toes was coming off, and he had swelling in his right foot and up his leg. He says there was no circulation going to his toe and he was diagnosed with having a blood clot in his right leg. He says he had surgery to open up the arteries in his leg, and also reported gangrene in his toe. The subject was discharged on 21-APR-2021. On 23-APR-2021, the patient experienced feeling hot. He also reported that he may need to have his right pinky (fifth) toe amputated because it has gangrene. He reported that he is going to go back to the hospital, to which he would seek medical attention if he was having issues. Treatment medications (dates unspecified) included paracetamol. When called back due to his vaccination dates being after event start dates, the patient said that his memory is not too good, so he 'had to take his time to remember the correct dates'. The action taken with COVID-19 vaccine Ad26.CoV2.S was not applicable. The patient was recovering from blood clot in leg, and had not recovered from runny nose, shortness of breath, heart rate increased, chills, feeling hot, gangrene in toe, right leg swollen, and right foot swollen. This report was serious (caused hospitalization).; Sender's Comments: V0: This 50-year-old hypertensive and diabetic male patient reported that he was feeling hot and may need to have his fifth toe amputated because it has gangrene 4 days after receiving COVID-19 VACCINE AD26.COV2.S for the prevention of symptomatic SARS-CoV-2 virus infection and 2 days after discharge form the hospital. The patient was hospitalized for shortness of breath, heart rate increased, runny nose, and chills 28 days prior to vaccination. The patient went to the emergency room 2 days prior to vaccination because his toenails/skin on his toes were coming off, swelling in his right foot and up his leg, gangrene in his toe; he reported that there was no circulation going to his toe and was diagnosed with having a blood clot in his right leg; the patient reported he had surgery to "open up" the arteries in his leg. Four days after vaccination, the patient felt hot and reported reported that he may need to have his right pinky (fifth) toe amputated because it has gangrene. The patient is taking paracetamol as treatment. No other details was reported. Based on the lack of temporal association, the causality is considered not related for the events blood clot in leg, shortness of breath, heart rate increased, right leg swelling, right foot swelling, chills, and runny nose. The information available regarding event gangrent of fifth toe and feeling hot 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.

Pt waiting his 15 minutes, cam to the counter asking for a water because patient was filling light headed. Patient fainted, with seconds patient was awake and knew where he was. he was clammy and in the face. Gave patient a water, he immediately felt better.

I experienced pain in my left shoulder after my J&J vaccine, have trouble any pushups. My pain is constant in my left arm above my head. The day I went to the doctor, a guy crashed into me and the pain I experienced was more. I can put my fingers into my shoulder region and it is very painful. I saw a doctor 04-23-2021 ad he advised me if my symptoms persists I should come back for a re-evaluation. I can not put my left arm first, my left arm is unstable. Before the J&J vaccine, I did not have this pain to my left shoulder. I have also taken OTC Tylenol but it does not help with my pain.

Pt developed calf pain ~ 1-2 week after COVID vaccine. Diagnosed with DVT/PE on 5/6 with platelet count decreased from baseline at 92,000.

Pt was admitted to the hospital on 3/31/21 and diagnosed with stroke. Pt states that doctors told him it looked like the stroke may have occurred about one week prior to hospital admission. Pt started experiencing daily headaches after receiving the vaccine, then a couple of days later started experiencing chest tightness, panicky feelings, feeling like he was going to pass out, and some tingling sensation in his hands. Pt states that although he has been released from the hospital, he is still feeling like he is going to pass out multiple times a day and still experiencing tingling in his hands. Pt states that he is still having minor headaches.

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.

DIZZINESS, COLD SWEAT, PALE, DIAPHORETIC, SYNCOPE (LAST 20 SECS), SEEN BY PARAMADICS, VSS, PROVIDED SNACK AND WATER, SX RESOLVED, REFUSED TRANSPORT, AMA SIGNED.

Pt was vaccinated with the Johnson and Johnson Vaccine on 5/3/21. he presented to the emergency room with a stroke on 5/15/2021. 50-year-old male presents emergency department with difficulty finding words and difficulty getting his hands to do what he wants. Last known normal was 1030 the previous night when he went to bed. He has a past medical hx sign for controlled HTN, seasonal allergies and obesity with a bmi of 48. Family members noticed him having difficulty finding words the morning of admission and it got slightly worse throughout the day. According to his wife he was holding the phone and could not dial the right numbers. His hands were working but they could not follow instructions from what his brain wanted to do. On evaluation the patient felt as though he was stuttering and could not get the right words. No numbness or tingling. No weakness on one side or the other. wife and pt reported no prior problems with word finding or memory in the past and other than obesity and controlled HTN he was healthy. He does not smoke. he had no prior hx of atrial fibrillation. telemetry monitoring showed no atrial fibrillation. His LDL was 109, chol 167,trig 119, hdl 34. No prior hx of covid 19 infection. echo with normal EF, no thrombus. He received Physicial therapy and Occupational therapy and speech therapy. He was discharged home on 5/17 on an aspirin. He was called on 5/22 and is still experiencing expressive aphasia and word finding difficulty. He previously worked full time as a machinist and has not been able to go back to work. He is also complaining of fatigue still.

TWO TO THREE DAYS AFTER SHOT 5/2-5/3 PT HAD STIFF/ CRICK IN NECK FELT LIKE IT NEEDED TO VBE CRACKED BUT COULDNT CRACK IT.. ONE WEEK AFTER INJECTION 5/8 PT DEVELOPED BELLS PALSEY ON LEFT SIDE OF FACE PT STILL HAS BELLS PALSELY PT WAS SEEN BY HIS PHYSICIAN AND WAS ADVISED TO REPORT ADVERSE EVENT(S) TO PHARMACY TO REPORT TO VAERS

Fever over 104.8, chills, shakes, headache, muscular aches and pain, fever continues at 20 hours after shot hovering around 101.

Severe headache for 48 hours Mild headache for one week Severe fatigue for 48 hours Fatigue for one week Loss of appetite for 24 hours Night sweats and low grade fever for 72 hours Loss of concentration for one week

He was admitted to Hospital unresponsive as Ventricular Fibrillation cardiac arrest. Found to be COVID-19 positive upon testing on 5/31/2021. No prior positive tests on record.

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.

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.

FATIGUE; BODY ACHES; LOWER BACK PAIN ON LEFT SIDE/BACK PAIN; PAIN IN HIS WHOLE UPPER ARM (SHOULDER TO ELBOW) OF THE INJECTION SITE/LEFT ARM SORENESS; COLD CHILLS; INJECTION SITE PAIN; 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 headaches, blood pressure abnormal, iodine allergy, 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: 207A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. Concomitant medications included losartan for blood pressure abnormal, and verapamil for headaches. On 13-APR-2021, the subject experienced body aches. On 13-APR-2021, the subject experienced lower back pain on left side/back pain. On 13-APR-2021, the subject experienced pain in his whole upper arm (shoulder to elbow) of the injection site/left arm soreness. On 13-APR-2021, the subject experienced cold chills. On 13-APR-2021, the subject experienced injection site pain. On 05-JUN-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and cold chills on 15-APR-2021, lower back pain on left side/back pain, and fatigue on 06-JUN-2021, and injection site pain on APR-2021, and had not recovered from pain in his whole upper arm (shoulder to elbow) of the injection site/left arm soreness. This report was non-serious.

2 days after shot, numbness/weakness in left leg and pins and needles in left hand. Upper arm pain where injection given. Neck pain. Seems to be autoimmune reaction. Hospitalized for 2 nights, seeing neurologist, having physical therapy for leg and neck