Johnson & Johnson

Fever: 102.3 last night Aches: all over Headache Fever 101.1 this evening and continued headache and general malaise.

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

"patient is observed in the recovery area pale and diaphorectic. v/s taken hr 71 initially,recheck was 51p. ,o2 sat ra 97%, b/p 100/60, resp 18. comfort provided. 13:00 v/s taken hr 80, resp 18, bp 120/80 o2sat ra 98%. still looking pale. comfort and support is provided. 1315 v/s taken hr 80,resp 20,b/p 130/80 02sat ra 100%. after comfort and support provided pt reports feeling well. 13:30 pt continues to be monitored for possible changes. patient reports feeling well. v/a taken b/p 130/80 resp 20,hr 80,o2 sat ra 100% is oriented, and released accompanied by a family member", RN - support staff

Fever (101 F), muscle ache, slight headache/sinus pressure in front nasal cavity. Woke from sleeping after feeling feverish and achy at 2:30 AM. Ate a small bite and took 1 500mg Tylenol.

3/09/21 - Took 2 regular strength Ibuprofen at 4:00 PM, as a precaution of swelling/inflammation or other adverse effects. At approximately 11:00 PM, severe chills set in. No fever at that time. Took 2 regular strength Tylenol. Started running fever at approximately midnight (approximately 100 F). 3/10/21 - By 1:00 AM, fever had spiked to 101.7F. Chills still ongoing. Headache and joint aches/pains as well. Fever reduced to around 100F by approximately 2:00 AM. Fever completed subsided by 4:00 AM. Took 2 regular strength Ibuprofen around 3:00 AM. Aches /soreness/pain lasted until around noon on 3/10/21. Continued alternating Ibuprofen and Tylenol throughout 3/10/21, stopped at approximately 10:00 PM. Extreme fatigue persisted all day on 3/10/21. 3/11/21 - Upon waking, all adverse effects subsided. Energy levels normal.

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.

Body aches around 6 hours after injection. Headache and fever shortly thereafter. Fever reached 102. Fever resulting in shivering with multiple layers of clothing. These symptoms lasted through the evening. Headache, fatigue and injection site stiffness and pain lasted for multiple days.

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.

Dizziness and light headed, with confusion, fatiuge, with head ache. Very severe just after injection. 3 days post vaccine and still feeling dizziness and headache with mild fatigue. Symptoms are similar to a hang over. The symptoms are slightly better than the day of vaccination but still exsist. Symptoms do seem to come and go and are not constant. Little relief is given by tylenol.

By 10.30pm started to feel fatigue and went to sleep. During night had temperature, chills, body aches, dehydration. In the morning still had 99.5 temperature, body aches and headache. After breakfast took some Tylenol around 10am and symptoms eased and temperature went down to 98.5. After a few hours some body aches and tiredness are still felt but overall feeling better.

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.

12:05 PM - began with severe headache. Did not abate until 2:45 on 3/21/21. Ibuprofen taken to counteract. 3:30 PM mild dizziness. Passed within an hour 4:55 PM Fatigue. Felt extremely tired. Condition persisted and continues to do so as of time of this reporting. 8:15 PM Chills. Passed by 4 AM on 3/21/21

Headache, Myalgia & Fever Narrative: 3/18/21 1500: Myalgia, headache, fever 100.5, fatigue; taking Tylenol. Other Relevant History:

Chills, headache, bodyaches, nausea, and tiredness started overnight on 3/19 and lasted throughout Saturday. Woke up fine on Sunday, March 20th. The injection site was also sore for 2 days after vaccination, but is better now too. I did have Covid-19 in August of 2020.

Headache starting 1 hour after injection, lasting 36 hours. Light fever. Trouble sleeping. Trouble concentrating.

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.

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.

Experienced moderate debilitating flu symptoms day after vaccination and recovered the following day. Over one week later (3/25) developed skin sensitivity on the neck which later spread to back, torso, and legs. Skin sensitivity persists still one week after onset, is a severe chafing feeling when skin comes into contact with clothing. No rash or any visual signs. Along with the skin sensitivity, mild to moderate chills from day to day as well as muscle fatigue and upper/lower back pain. Symptoms varied in severity day to day; used ibuprofen and it seemed to offer limited, temporary relief. Concurrent with second onset of symptoms, noticed gradual abdominal inflammation and developed sensation similar to UTI but urine dip and lab test results were all normal. Doctor concluded immune reaction to vaccine as no other allergies or changes in routine as well as no prior medical history of any of these symptoms. Prescribed daily prednisone for three days to calm immune response; after one day symptoms were greatly improved. Abdominal inflammation has improved and UTI sensation improved. Still experiencing slight chills and skin sensitivity unchanged.

Headache, fever, and chills lasting for about 8 hours. Treated with ibuprofen and rest, symptoms cleared on their own.

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

"Janssen Covid-19 Vaccine EUA" flu like symptoms, body aches, running fever, makes you feel like you been hit by a big truck.

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

Employee did not have immediate post-vaccination reaction within 15-30 minutes. Employee reported that his wife found him wondering in the street at 2 AM on 3/27/21, confused with high fever of 104. Also reported nausea, vomiting, diarrhea, chills, myalgia, fatigue, headaches.

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

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.

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

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.

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

Fever, Chills, Body aches. Worst symptoms resolved in a few days. Still feeling fatigue a week after vaccination. Have moments of light nausea.

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

FEVER; DON'T FEEL GOOD; HEADACHE; DEHYDRATED; FREEZING; 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 type 1 diabetic. The patient was previously treated with for vitamin. 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 31-MAR-2021 for prophylactic vaccination.vaccinated at 11:30 pm in right deltoid. No concomitant medications were reported. On 31-MAR-2021, the subject experienced fever. On 31-MAR-2021, the subject experienced don't feel good. On 31-MAR-2021, the subject experienced headache. On 31-MAR-2021, the subject experienced dehydrated. On 31-MAR-2021, the subject experienced freezing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, don't feel good, headache, dehydrated and freezing was not reported. This report was non-serious.

Approximately 5 minutes after the patient received his vaccination, he rested his head on the wall behind him in the chair he was being observed in and passed out and turned white. His wife began slapping his face and screaming his name and the observer called for me. I arrived within seconds and assisted his wife in moving him from the floor to the chair. Within seconds of getting his head to the ground safely, he came back to and was very sweaty, red in the face. He stayed on the ground laying down, and then sitting for approximately 25 minutes. During that time, he told us that he had previously passed out during 3 procedures done at doctors offices. We got him an ice pack and a orange pop as he was complaining of being hot and having only eaten a granola bar all day. He was able to get up to a chair and sat there for an additional 5 minutes, before he was able to walk out on his own accord. I have spoken with the patient twice since, once last evening and once today and he reports he feels great now besides the expected body aches from the vaccination.

Within 8 hours of the shot, patient developed Chills, severe headache, fever (101-102) and vomited four times between 12am-7am. Note that he has had COVID infection in April 2020

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.

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)

Headache, Fever (slightly over 100), Chills, Body Aches all over, Fatigue (recovered from all so far except the fatigue and body aches all over)

Patient became diaphoretic and light headed. Patient had some apple juice and stated he felt better. VSS HR 56; BP 104/84

severe headache, fever, chills, body aches (including in testicles), severe coughing, nausea, difficulty breathing

Feel headache first days only, but last Sunday I was driving and I need to suddenly stop, because I was so dizzy, lightheaded , after this event this happened again today morning, but not like last Sunday, today was less . I don?t know if this is normal or not .

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

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.

Patient was vaccinated at Pharmacy. Patient had COVID vaccine on 03/29/2021- Janssen vax, was administered at Pharmacy at 11:20 am. He had headache "almost migraine like" and nausea started 03/30/2021 lasted about 24 hrs. He states that he was just calling to report HA since he has heard the news about the Janssen vaccine. I informed him that I would take down this information and that most likely he was having side effects to vaccine which is pretty common for those symptoms. I also informed him of the adverse effects that would require immediate medical attention (severe HA, abd pain, leg pain and SOB). He states that currently he feels fine and does not have any symptoms. I informed him that would document this information for him and if he started with any other symptoms to come into clinic.

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

04/13/2021 - 03:30 PM - chills and feverish 04/13/2021 - later that night - severe chills like cold pulse originating from the toes and fever 04/14/2021 - 12.00 PM - reduced fever, chills reduced, tiredness 04/15/2021 - 1.30 AM to 6.00 AM - Severe chest pain, 04/15/2021 - 8.30 AM reduces pain 04/15/2021 - 11.30 AM self medicate Gas-X capsule 04/15/2021 - 1.30 PM self medicate Gas-X capsule

Rash on both arms, started the next day, still there a week later. no treatment Sore throat, next day still happening. Nausea started next day. went away two days after Fatigue. day after and went away after that.

BACK ACHE; FEVER; HEADACHE; 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, batch number: 201a21a, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced back ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and headache on 10-APR-2021, and had not recovered from back ache. This report was non-serious.

Patient reports he had chills and headaches the day after his vaccine. He is reporting SOB at rest that worsens on exertion since having had his vaccine. Pt also reports back pain and chest pressure since the day he got his vaccine

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.

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.

I got a cough two weeks after my vaccine. It's a dry cough that is constant and hard to control. I tried taking cold and flu medicine before bed so that I could sleep. I developed a cough and I damaged my ribs as a result of the coughing. My ribs on the right side hurt when I cough. I was prescribed a cough suppressant Benzonatate 100. I also got a steroid and the cough has gotten better after six weeks. It is still present but seems to be happening less often.

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.

CHILLS; MUSCLE PAIN/ACHE; FEVER; FATIGUE/ TIREDNESS; HEADACHE; This spontaneous report received from a consumer 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: 203A21A, expiry: 23/JUN/2021) .5 ml, administered on 07-APR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced muscle pain/ache. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced fatigue/ tiredness. On 07-APR-2021, the subject experienced headache. On 08-APR-2021, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, muscle pain/ache, fatigue/ tiredness, and headache on 09-APR-2021, and fever on 08-APR-2021. This report was non-serious. This case, from the same reporter is linked to 20210435796.

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.

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

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

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.

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.

I experienced a severe headache later the same day as my vaccination. I took some extra strength acetaminophen at the regular intervals that day/night, but by the bed time (~9:00PM) I was unable to sleep. I experienced chills/sweating throughout the night as well as body ache and nausea. By morning (5/11/2021, ~9:00AM) I began vomiting and soon could not keep down any liquids. After this continued unabated, I went to the emergency room at ~11:00AM I checked myself in and the nurses triaged me and gave me IV fluids. The wait times that morning at the ER were very long, in excess of 2 hours, and after the first full bag of saline my nausea was gone and I felt amazingly better. Realizing I wasn't going to be seen for several hours and concerned about my own Covid exposure/general risk sitting in the waiting room for most of the day, I decided to leave without being seen. I ate lightly that day and drank lots of Pedialyte. By the next day I was ready to eat normally and went about my day. Later that week I went to see my primary care doctor just to establish that nothing more was going on, as the Johnson and Johnson pause was announced that week.

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

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.

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

Very ill feeling started on the following morning from the vaccination. Joint and muscle ache, chills, headache, stomach ache and fever. The symptoms were severe on the first day, and they were gradually fainting during the next two days. Was unable to work on the next day following the vaccination.

BODY ACHE; CHILLS; HEADACHE; FATIGUE; This spontaneous report received from a patient via a company representative concerned a 40 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: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced body ache, chills, headache, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, headache, body ache and fatigue was not reported. This report was non-serious.

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.

I experienced after the vaccine, I got super sick for one to two weeks as if I had Covid again, had a terrible headache that has not gone away. Also have horrible vertigo, feel like I am spinning all the time and it has not gone away. I also had SOB and my heart was pounding for one week. My PCP told me that I should wait it out that it was probably my body revolving against the vaccine and I was prescribed a medication for my headache and vertigo. My ear were also checked with an ENT and I have no inner ear problems. I can say that my symptoms came from the J&J vaccine.

April 17th, felt chest pain and fatigue and shortness of breath. After about two weeks of it, I went to ER on the 26th. I was diagnosed with blood clot on my heart. I spent a week at the hospital Heparin blood thinners and antibiotics - discharged on May 2, 2021. They sent me home with Warfarin regiment. I am still on that. I still have some days where I'm good but some days, I can barely stand and get out of bed due to short of breath, fatigue but not as much chest pain. I think the blood thinners are working. I just have to take it easy and make sure to have some calm days. It could take weeks to months to have the blood clot totally dissolve from the system.

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.

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

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.

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.

Patient is a COVID-19 vaccine breakthrough case. Patient reported being symptomatic from 4/21/2021 to 4/23/2021 and indicated experiencing the following symptoms: headache, sweats, chills, fatigue, body aches, sore throat, fever (101.0), and nasal congestion.

After 3 weeks, small rashes along the arms, minor coughing, occasional breathlessness, and mild diarrhea began appearing. Currently about 4 days of these symptoms. The week immediately after the injection, only minor itching about the body and nothing else. This might all just be a delayed response, but I'd like to note this occurred.

Patient received Johnson & Johnson vaccine 5/17/21. Around 3 days ago 5/23 developed fever, chills with cough. Seen at Urgent care. Evaluated by Dr.

the patient soon after receiving the vaccine started to sweat profusely and felt extremely light headed. we had him sit for a few minutes and drink some water and took his blood glucose to see if it might by hypoglycemia--results were normal (148)-- the patient started to shiver and experience chills but after about 10 minutes the patient started to feel better and in an additional 10 minutes was back to normal. his issues resolved on their own.

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.

Extremely painful headache still ongoing 6 days later. Difficulty in sleeping. Cough developed and has not resolved

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

INSOMNIA (COULD NOT SLEEP FOR THREE TO FOUR NIGHTS); COUGH; BODY ACHE; SORE THROAT; FEVER; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 40 year old male. The patient's weight was 169 pounds, and height was 66 inches. The patient's concurrent conditions included alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies, no drug abuse or illicit drug usage and no pertinent medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A, expiry: 07-AUG-2021) dose was not reported, administered on 08-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-JUL-2021, the subject experienced injection site pain. On 11-JUL-2021, the subject experienced sore throat. On 11-JUL-2021, the subject experienced cough. On 11-JUL-2021, the subject experienced body ache. On 11-JUL-2021, the subject experienced fever. On 15-JUL-2021, the subject experienced insomnia (could not sleep for three to four nights). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on 09-JUL-2021, and fever on 14-JUL-2021, was recovering from body ache, and insomnia (could not sleep for three to four nights), and had not recovered from cough, and sore throat. This report was non-serious.

Clerk in observation noted pt looked unwell during observation. Per report no fall at time of reaction, pt was seated and did experience LOC.

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.

Constant headache since June 11, 2021. Fluctuating pain throughout head. Headache does not respond to over the counter medications.

Chills, fever over 102.1 for 5 hours, extreme burning sensation in stomach, cramps in stomach for over 24 hours. Extreme fatigue for over 24 hours. Pain, soreness, and raised area at injection site.

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.

Janssen COVID-19 Vaccine EUA Vaccine received around 11:30 am. Started feeling chills around 6 pm; took temperature later and verified fever (101.6).

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.

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.

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.

From about 1am to about 7am I felt like I had the flu or a bad cold. Headache. Feverish (but no fever when measured at 8am). Body aches. I took three ibuprofen at about 4am. Now I feel fine. Maybe just a little tired. But that could be from sleeping poorly last night.

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.

I started a low-grade fever about 7 hours after the injection (99.5-100.0 degrees when I'm normally in the 97s) that lasted for about 24 hours. Also I had headaches and achy muscles for that same 24 hours. Still had some fatigue and achyness after that. All symptoms had dissipated after about 48 hours.

Had Fatigue, chills, & dull headache @ 7:30pm. Went to bed early. Woke up @ 4:20 am for work and had fatigue, headache, and sweats on forehead. Took 2 Ibuprofen and went back to bed. woke up at 9:15 am and still had slight fatigue & headache. Effects seemed manageable, so didn?t go see a doctor. It?s about 11am & I still have a dull headache,.

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

Patient reported known allergy to shellfish. Following injection, patient reported throat felt itchy but had no other symptoms. Pulse ox indicated 98. Patient was given liquid Benadryl 25 cc/10ml. Patient went home and had recovered at time of departure from facility.

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.

Chills, fever began about 8 hours after vaccine shot. Slight headache began about 11 hours after vaccine shot. Acetaminophen taken 15 hours after vaccine shot to aid in sleep. No symptoms starting about 26 hours after vaccine shot.

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

Chills, nausea and headache at 9pm, fever at 10pm peaking at 107.1° at 4am, blood pressure peaking at 216 over 103 at 8am. Fever persisted 41 hours, headache persisted 38 hours, nausea persisted 34 hours.

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

Fever of 102, body chills, nausea, headache, body aches, pain in lower back/kidneys, frequent nighttime urination. Headache and body/ kidney aches persisted until 1pm the following day, chills, fever frequent urination, nausea persisted until 7am the following day.

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.

Headache and shooting kidney pain two hours after injection. By that evening, I had severe chills and shivered all night. The next day, the kidney pain turned into a constant ache. Headache worsened. Severe joint pain. Arm/injection site was horribly sore. By 5:00PM I had a 101.2 fever. That (Thursday/next night) evening, I felt much better. Friday morning, I woke up feeling completely normal with only minor pain at injection site.

Started feeling a little off a few hours after the vaccine but it was manageable. Around 8 hours after the vaccine my symptoms had gotten worse to the point i couldn?t leave the bed. Extreme chills, headache, fatigue and nausea were the primary symptoms. As of this writing, 27 hours after the vaccine my symptoms have significantly reduced but haven?t gone away.

BODY ACHES; FEVER; 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 pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808980 expiry: 20-JUN-2021) dose was not reported, administered on 02-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced body aches. On 02-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body aches, and had not recovered from fever. This report was non-serious.

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.

Patient received vaccine and was instructed to sit for 15 minutes as required for monitoring. About five minutes in, another patient who received the vaccine together with patient told us the patient had fainted. Patient was slumped over to the side when I came to check on patient. I called the patient a few times and patient started to come to. I asked the patient how he was feeling and if he had any difficulty breathing to assess for anaphylactic shock. Patient was breathing normal, but was sweating and a bit confused. Patient reported feeling dizzy. I explained to patient that he fainted for a few minutes and instructed to sit as I did not feel comfortable having patient lay down in the state he was in. Patient was given water and a fan to help cool him down and legs elevated (patient reported feeling much better with the fan blowing on him). Patient sat at the pharmacy for over 30 minutes before heading to the bathroom. At this point, patient were no longer dizzy and I instructed him to get up slowly and assessed that patient was no longer dizzy before letting him go to the bathroom.

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.

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.

BODY ACHES AND CHILLS NIGHT OF VACCINE ADMINISTRATION, THEN STARTED EXPIRIENCING SHARP STOMACH PAINS LOWER ABDOMEN A COUPLE OF WEEKS AFTER VACCINE. DID NOT KNOW WHAT WAS CAUSING IT AND DID NOT THINK IT WOULD BE CAUSED BY THE VACCINE, STILL HAVING STOMACH PAINS.

PATIENT REPORTS COUGHING UP BLOOD CLOTS FOR THE PAST 3 DAYS AND SENT PICTURE OF 1 THAT WAS COUGHED UP

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.

I started get chills and sweating around 6pm when I woke up from a nap. I was still tired so I went back to sleep after a hour or two. I woke up again in a few hours with worse chills, minor headache, and minor joint pain. I took over the counter medication, felt a little better and went back to sleep after a few hours. I woke up around 4am to use the bathroom and still had the worse chills, sweats, minor headache and was very dizzy. I decided to lay down on a rug rather than try to make it back to my bed and laid awake for a few hours again I woke up again in a few hours a little better and repeated everything until Sunday night when all my symptoms were very mild. I eat and drank water regularly and took over the counter acetaminophen a few times.

CHILLS, LOWER BACK PAIN, TIREDNESS AT THE FIRST DAY BUMPS ON MY HEAD AN MY MOUTH, MY GUMS ARE DAMAGED 2 DAYS AFTER.

I received the dose at 5:35am on 3/6/21 went home slept most of the day woke up and felt tired, 8:00pm on 3/6/21 I left for work drove a few miles up the road and fainted and crashed my vehicle.

On March 20th I received the J&J covid-19 vaccine shot. Starting on March 21st I begin to experience symptom such as fever, chills and body aches. That lasted for about 2 weeks. The week of April 5th- I been to experience struggling the ability to breathe. I was having serious pain in my left side of my chest and in the lower left side in my back. It was so severe, I went to the hospital on April 8th and at the hospital the Doctors discovered I had blood clots in my lung. I was in the hospital for 2 days. Iam currently on blood thinners inhaler and and oxygen.

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.

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.

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

Very Extreme headache for about 18 hours starting at 11:30 PM 4/1/21, the same day as recieving the vaccine. Chills, fever, fatigue, and joint soreness all accompanied the severe headache as well.

Fever 100F, chills, body pain from 11pm till 6 pm the next day. Vaccin was administered the same day at 10:30am

Extreme fatigue that just won't stop. Headache and body aches. The fatigue is over whelming to the point it almost caused me to crash my vehicle on the way to work twice. It has caused me to miss work because the tiredness is overwhelming. It just doesn't seem to stop.

On April 2, 2021 around 8:00 p.m. I begin having chills, body aches, fever ,nausea, etc. This continued until Monday April 5, 2021, minus the chills. My urine became very dark brown for a few days, then changed to a light pink color.

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)

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

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.

FEELING BAD; LAZY; SLEEPY; 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 past medical history included rheumatic fever, and concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included patient have 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 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-APR-2021, the subject experienced lazy. On 13-APR-2021, the subject experienced sleepy. On an unspecified date, the subject experienced feeling bad. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lazy, and sleepy, and the outcome of feeling bad was not reported. This report was non-serious.

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.

HEART RATE INCREASED; CHILLS; FEVER; HEADACHE; 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 pre-existing medical conditions included the patient had no known drug or non-drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1502072, and batch number: 1502072 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021 21:05, the subject experienced heart rate increased. On 11-MAR-2021 21:05, the subject experienced chills. On 11-MAR-2021 21:05, the subject experienced fever. On 11-MAR-2021 21:05, the subject experienced headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 106.7 (units unspecified), and Heart rate (NR: not provided) 120 (units unspecified), 65 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart rate increased, and chills on 12-MAR-2021, was recovering from fever, and had not recovered from headache. This report was non-serious.

CHILLS; FEVER (101.2 AND 103.5F); NAUSEA; 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 concurrent conditions included high blood pressure, no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced chills. On 20-MAR-2021, the subject experienced fever (101.2 and 103.5f). On 20-MAR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 101.2 F, 103.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever (101.2 and 103.5f), chills, and nausea. 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.

I was vaccinated with J and J for COVID-19 I developed Pneumonia, Blood Clot on right calf (hospital diagnosis- acute deep vein thrombosis (DVT) of lower extremity), lower back pain

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

Patient reported adverse effect after receiving J&J vaccine on the 4/6/21. Pain inner elbow intermittently. Fever 103.2F on the evening of the date of vaccine, but has not had another fever since. Patient reported headache that comes and go. Pt was scheduled for UC visit

DIAGNOSIS OF BRANCH RETINAL VEIN OCCLUSION VIA BLOOD CLOT; LETHARGIC; CHILLS; MUSCLE ACHE; HEADACHE; This spontaneous report received from a patient concerned a 41 year old male. The patient's weight was 210 pounds, and height was 72 inches. The patient's concurrent conditions included alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on left deltoid on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021,he reported blurred vision in left eye. Then he experienced lethargic, chills, muscle ache, headache. On 14-APR-2021, he experienced diagnosis of branch retinal vein occlusion via blood clot in the eye. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lethargic, chills, and muscle ache, and the outcome of diagnosis of branch retinal vein occlusion via blood clot and headache was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This is a report of a 41 year old male patient, who was noted to have branch retinal vein occlusion via blood clot in the eye 7 days after receiving the covid-19 vaccine ad26.cov.2. Patient is 210 pounds and 72 inches. No pre existing medical conditions. No known allergies. Patient is a non smoker and did not have any drug abuse/illicit drug use. On the day of the vaccination, patient reported blurred vision on the left eye. He also experienced lethargy, chills, muscle ache and headache. Seven (7) days after receiving the vaccine, a blood clot was noted leading to branch retinal vein occlusion. The information provided precludes a meaningful medical assessment. Additional information requested.

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.

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

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."

ABOUT 2 MINUTES AFTER VACCINATION PATIENT SAID HE WAS FEELING WARMTH TO HIS FACE , SWEATY , DIFFICULTY BREATHING STILL ALERT. CALLED 911 AND I TOLD HIM THAT I WAS GOING TO GIVE HIM AN EPIPEN. A FEW MINUTES AFTER THE EPIPEN HE SAID HE WAS FEELING BETTER.

I received the COVID Vaccine at 12:30 PM. My temperature had been increasing all afternoon along with my heart rate. At roughly 8:40 PM, my temperature increased dramatically to approximately 38.9C. This may have happened over a relatively short period of time, since it was 37.9 C at approximately 8:00 PM. My heart rate increased to 150 bpm and I became dizzy. After a minute, my heart rate decreased to roughly 115 bpm. Unsure whether to call EMS or not, I called a friend, who is a Dr. at the local hospital (Dr. is a colleague we do research together.) Dr. was concerned but provided information on what to do and when to call EMS or be driven to the ER. I spent the rest of the evening with a pulse between 105 and 110 and my temperature hovered around 38.9C until at least 12:30 AM. The next day, my heart rate had decreased to roughly 80 bpm and my temperature to approximately 37.8C. I spent most of Tuesday sleeping. Today (Wednesday May 12, 2021) my heart rate is down to roughly 76bpm. My temperature is holding around 37.2C. I have reported this to the CDC through the COVID vaccine reporting app. My resting pulse is usually 62 bpm with a waking pulse of 58-60. My normal temperature is 36.5-36.7C. I have a wellness exam schedule for Monday. Dr. is not my regular GP, but was available at a time when my regular doctor was not available.

Two days after the heart rate went up to 135 and I went to the ER. It was better the next day. By day 13 I started to get intermittent headaches that are very sharp. I am still getting them after three weeks. I have tried muscle relaxants and anti-anxiety medicine but they did not help. At night I am able to sleep but, in the morning, when I get up, I get sharp pains that are like ice picks and last for 3-5 seconds. Some of the headaches are more electric and as the day goes on it gets worse. I have tried taking Magnesium and Vitamin B-Complex and the headaches have changed to where they are starting in the afternoon instead of the morning. The headaches are a seven on a scale of 1-10. Sometimes the headaches come with a low grade fever.

Patient was given the vaccine. After sitting in a chair for a few minutes post vaccination, he said he felt dizzy and then fell over and hit the floor face first but had blacked out and did not remember fainting or passing out. He was bleeding because he had hit his face and his lip was split and his tooth was chipped. He also continued to be very dizzy, was extremely pale, and was sweating profusely. The EMT arrived about 20 minutes later and took him to the emergency room.

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.

The next morning I felt feverish. lethargic, cranky, more so that usual. wanted to lay around and sleep for approximately 24 hours

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.

Strong headache at back of head and body aches from about 10 hours after vaccination until about 28 hours after vaccination. Body ache cleared up and headache lessened but off and on present since (now 17 days). I don't normally get headaches. Head has felt cloudy as well. About 4 days after vaccination I had itchy red bumps on my left arm between elbow and wrist for an hour or two then that cleared up. The next day I had the same itchy red bumps on the right arm, also clearing up on its own after a couple of hours. Day 7 or 8 after vaccination I had the same thing on my left leg between knee and ankle. The next day it was on both legs. Always clearing up within a few hours.

It started with wheezing that ive never had in my life, I started and coughing. I went to see the doctor and they put me on inhalers and other medications.

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.

Body aches, headaches, chills, sleeplessness, tiredness. Treated with Ibuprofen, and rest. Took roughly 24 hours to subside to manageable levels.

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

At approximately 1105, patient was vaccinated and immediately fainted in vaccination chair. Patient slumped over in chair for approximately 15 seconds and vaccinator held patient in chair. Patient was alert and oriented to person, place, time, and situation. At 1120, EMT assessed patient vitals: blood pressure 132/86 mmHg, pulse 94 beats/minute, and respirations 18 breaths/minute. Patient reported a headache and history of fainting when feeling nervous. Patient given water and assisted to cot to lay down. At 1135, patient vitals reassessed: blood pressure 128/56 mmHg, pulse 59 beats/minute, and respirations 13 breaths/minute. Patient reported his headache was "going away". At 1200, patient vitals reassessed: blood pressure 122/76 mmHg, pulse 61 beats/minute, and respirations 12 breaths/minute. Patient stated he felt "good". Lead nurse educated patient on signs/symptoms of when to seek emergency care, to sign up on CDC site, and to follow up with primary care provider. At 1201, patient left facility with steady gait and unlabored respirations.

Pt. didn't feel good after the shot. Pt. got out of his chair and fell to the ground. It looked like he passed out. We got medical attention and called 911. We also gave him water to hydrate himself. He was sweating. He needed time to recover while the fire dept came and help out.

I received the vaccine March 15 and just shy of 2 months later; May 10th, 2021 I woke up at 8am with a severe headache. I had a fever as well as the chills. I was nauseous and dizzy all throughout the day. The same symptoms continued on for 1 week. Then they eased up. I didn't think too much about it, but then the headaches have continued. As well as the nausea and dizziness. The symptoms are erratic. They last for 2 days at a time. Then they disappear for a few days. Then the cycle repeats. This has been on going since May 10th.

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

The first three days were normal expected side effects, such as fatigue, headaches, and so forth. I felt better after two days. Then on the 6th day, I suddenly broke out in hives, starting with a reaction at the injection site on my right deltoid. The hives continued to progress and get worse over the next few days and started welting. My legs and arms were covered in hives. I became dyspneic which was relieved by using albuterol. Hives reduced from antihistamines. For three days the hives would appear systemically with skin sensations of burning and itching.

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.

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.

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

Moderate soreness at site of injection. Headache Mild fever (99-99.6) Body wide muscle ache Skin touch sensitivity Tiredness Treated with 2 tablets of Extra strength Tylenol

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

(Janssen COVID-19 vaccine EUA) Day of vaccine - soreness in shoulder at the site of the injection. Day 2 - continuing soreness of shoulder, along with general aches, chills, and sleepiness. Day 3 - continuing soreness in shoulder, but no aches, chills, or sleepiness. Began feeling nauseous, but still had appetite. Day 4 - continuing soreness in shoulder, as well as nausea, but both are somewhat diminished.

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.

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.

Approximately 10 hours after receiving the injection, I experienced extreme chills, nausea, elevated heart rate. The last time I experienced symptoms like this was on the first day I started chemotherapy and had an allergic reaction to one of the chemo drugs (bleomycin). I had a delayed reaction hours later and went to the ER. It was determined it was an allergy. So I took Claritin D 24 H and saw the symptoms I was experiencing last night dissipate.

12 hours post vaccine injection I had a slight fever. Fever lasted until 20 hours post injection. When measured, my temperature was 100.1. 36 hours post vaccine, I started itching and at 50 hours post vaccine the itching has turned to hives. As of right now, 51.5 hours post vaccine i still have hives.

Patient received Janssen vaccine was told to sit for 15 minutes post observation. He came up shortly after (less than 5 mins post imz) saying he didn't feel well, like he was going to pass out. I immediately came from the pharmacy, my tech sat a chair behind him. I called for optical to call a code white. The patient requested to sit on the ground. At this point, his wife was present. He was sweating. I gave him an ice pack, a water after it was determined he was breathing okay. He was pale, extremely lethargic and sweating. After sitting him on floor I told my tech to call 911. I took his blood pressure, it was 99/73, pulse 75. Very low for him. Hes on blood pressure medicine but been having issues controlling it. He later tells me hes terrified of needles. He also tells his wife he hadn't eaten all day. I stayed with the patient until ems left with him because when standing his heart rate dropped 20 points, after they stuck him again to check his blood sugar. They determined then he should be checked out at the hospital and they took him.

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.

Immediate(3-5 seconds) and rapid injection site swelling and redness, bleeding more than usual from a shot, dizziness, full body sweating, rapid heart rate, hives, as well as general body swelling that caused great difficulty in starting an IV. I did not have any significant issues with breathing. They treated me with a IV fluids, an intramuscular injection and IV injection of Benadryl and a steroid that I cannot recall the name of, I apologize.

got the shot on wed 3-17-21. Got flu like symptoms on Thursday and Friday the following days. On Saturday felt better but developed a rash all over my body. On my arms, back, neck, head, chest, legs, feet, waist. It started on Saturday the 3rd day after the vaccine and currently still have it. It calms down during the day and activates at night just before bed around 8pm.

aches and chills lasting approximately 24 hours; alleviated with Tylenol and Motrin soreness at injection site lasting 5 days to 6 days

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.

High fever with chills. Measured 101.7 F at 12:30 am on 3/25/21 with non touch thermometer. Took 1300 mg of slow release Tylenol at 1:30 am. Fever and chills subsided in couple of hours.

Symptoms onset approx 10 hours after dose. Fever of 100.6*F; mild headache; moderate fatigue; elevated heart rate (90-115bpm at rest). Reports felt like active flu. Symptoms persisted for approx 12 hours.

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.

For the 36 hours after my vaccine, I had commonly listed side effects; chills, aches, and shivers. These subsided, and I developed a cough for the next 3 or 4 days. This developed into more of a chesty feeling and lethargic feeling. On the 8th day after my vaccine, my symptoms were similar to those in Covid positive cases; chest tightness, dry cough, and chills. I went to get tested, and was found to be Covid-19 positive. Since then, I have experienced severe headaches, continued tight chest, cough, chills, and sweats.

Woke up 8 hours after receiving vaccine. Violent chills. Light headed. Nauseous. Fever spiked to 103. Headache. Fever broke after 24 hours. All symptoms vanished after 48.

Fever of 100.3° F on 4/6/2021 at 8:43 a.m. Headache Patient says that his symptoms began 4/5/2021 at about 6:00 p.m.

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.

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.

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.

Headache: Moderate headache 6 hours after injection. Became intense 8 hours after injection and disrupted sleep. Stayed intense for 24 hours after injection before moderating. Headache disappeared after 36 hours. Used Tylenol (acetaminophen) 1000 mg every 6 hours. Fever with chills: 8 hours after injection until 24 hours after injection. Fever between 100 and 101 degrees. Treated with Tylenol. Nausea: Again 8 hours after injection until 18 hours after injection.

CHILLS; FEVER; TIREDNESS; BODY ACHES, ACHES AND PAINS; 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 antibiotics allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced body aches, aches and pains. On 26-MAR-2021, the subject experienced fever. On 26-MAR-2021, the subject experienced tiredness. Laboratory data included: Body temperature (NR: not provided) 99.3 deg. On 04-APR-2021, the subject experienced chills. Laboratory data included: Body temperature (NR: not provided) 99.3 deg. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tiredness on 28-MAR-2021, and had not recovered from fever, body aches, aches and pains, and chills. This report was non-serious.

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.

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)

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.

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.

Upset stomach, mild nausea for about 36hrs, extreme fatigue for about 72hrs- rest and eating start by foods were only treatments (self care)

TIREDNESS; This spontaneous report received from a consumer concerned a 43 year old male. The patient's height, and weight were not reported. The patient's past medical history included high cholesterol, and spinal cord surgery. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 04-APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tiredness. This report was non-serious.

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.

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

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.

Flu like symptoms, joint pain, lungs heavy, pain in lungs, headaches - went to ED and PE was found - admitted to ICU - DC'd 5 days later

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

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.

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 hypertension, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced dizziness. On 11-APR-2021, the subject experienced body aching. On 11-APR-2021, the subject experienced chills. On 11-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced nausea. On 11-APR-2021, the subject experienced pain at injection site. Laboratory data included: Body temperature (NR: not provided) 101.2 F. On 12-APR-2021, Laboratory data included: Body temperature (NR: not provided) 99.9 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and pain at injection site, and had not recovered from dizziness, headache, body aching, chills, and nausea. 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

COVID 19 INFECTION; SINUS HEADACHE; 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 diabetes, seasonal allergies, and high blood pressure, and other pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced covid 19 infection. On 31-MAR-2021, the subject experienced sinus headache. On 04-APR-2021, Laboratory data included: Body temperature (NR: not provided) 99.5 F, and COVID-19 virus test (NR: not provided) Positive. Treatment medications (dates unspecified) included: dextromethorphan hydrobromide/doxylamine succinate/ephedrine sulfate/ethanol/paracetamol, fluticasone propionate, triamcinolone acetonide, and dextromethorphan hydrobromide/ethanol/guaifenesin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sinus headache, and had not recovered from covid 19 infection. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as 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.

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

Severe full body rash roughly 36 hours after vaccination. Took Benadryl 48 hours after rash started which resolved the rash. Minor recurrence of rash in patches across body persisting for the past two weeks. Additional symptoms 12 hours after vaccination: heartburn, fever, chills, headache, tiredness . All resolved within 48 hours of vaccination and haven?t returned.

CHEST IRRITATION; ACHES; CHILLS; NAUSEA; FEVER; This spontaneous report received from a consumer concerned a 42 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced chest irritation, aches, chills, nausea, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, fever, chills, aches and chest irritation was not reported. This report was non-serious.

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

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.

Pt reported a headache since the day after getting the vaccine but did not report until 4.22.21. Pt was seen on unspecified date and found to have elevated blood pressure which was already being monitored. Lisinopril was started per MD. Headache improved and patient was using Ibuprofen and Tylenol which also helped. Headache worsened with vomiting episodes and MD changed med to Excedrin Migraine. Pt was tested for COVID-19 - negative antigen test but positive PCR NP swab. - Pt sent to ER due to continued vomiting/headache. Pt was also COVID-19 positive in October 2020 and had tested negative with nasal swabs (not NP) until completed on unspecified date

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.

5 hours later. Terrible Headache, so bad could not sleep the entire night. Chills, aches, small fever. 10 Days later. Rash and bumps all over both arms, neck and upper back

Brain feels foggy or groggy, as if I am depressed, or really tired, no matter if I get enough sleep or not. Have not been able to attain or maintain an erection in two weeks, my sex drive is 100% dead. I used to have an extremely strong sex drive until 2 weeks ago. Something is very, very wrong with me.

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.

Patient presented to urgent care with symptomatic COVID19. He presented with fever, chills, headaches, body aches, sore throat, and cough. He was given the Casirivimab/imdevimab monoclonal antibody infusion 05/12/2021 which is the day of his positive test.

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.

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.

RAPID HEART BEAT; FEVER; This spontaneous report received from a consumer concerned a 42 year old male. The patient's weight was 270 pounds, and height was 77 inches. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 20621A expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On 26-MAY-2021, the subject experienced rapid heart beat. On 26-MAY-2021, the subject experienced fever. On 27-MAY-2021, treatment medications included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from rapid heart beat, and fever. This report was non-serious.

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.

Presented to ER with subacute malaise and worsening bruising area receiving Johnson & Johnson COVID vaccine 11 days ago, found to have microangiopathic hemolytic anemia and thrombocytopenia, concerning for TTP. He was transferred to Hospital as a direct admit to initiate plasmapheresis. Patient outcome tentative.

Currently presents a bruise with pain when touched in the area where the vaccine was placed. A little headache in the temple area.

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 wasn't feeling well after the shot. He said he had a couple episode where he spaced out. He mentioned afterwards that he doesn't do well with immunization shots. He was sweating and seemed dehydrated. We gave him water and to monitor. Fire dept came and asked if he requires urgent care and he said no. He felt better afterwards.

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.

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.

VOMITING; HURTING ALL OVER; SEVERE HEADACHES; NAUSEA; FEVER; This spontaneous report received from a consumer concerned a 42 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: 1820095, and expiry: 04-JUL-2021) dose was not reported, administered on 08-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUN-2021, the subject experienced vomiting. On 09-JUN-2021, the subject experienced hurting all over. On 09-JUN-2021, the subject experienced severe headaches. On 09-JUN-2021, the subject experienced nausea. On 09-JUN-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headaches, nausea, vomiting, hurting all over, and fever. This report was non-serious. This case, from the same reporter is linked to 20210619423, 20210619407 and 20210619408.

A slightly sharper headache in the early morning around 2:00 A.M. Not unusual for me to wake up early as I am an early riser as is. Took Tylenol Acetaminophen for remedy. Usually I am up early in the morning but was a little more unusually was able to fall back to sleep with some headache awakening before waking up at a (for me) relatively late 6:30 A.M. It's about 6 P.M. 6/19/21, and unlike other headaches that may have been from just maybe not drinking enough water during a work day, I felt a couple little pings of a headache.

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)

Lab specimen collected on 4/28/2021. On 4/30/2021 at 11:50 case manager performed case investigation interview and charted, "Client stated that symptoms (head ache, cough) began 4/25 and continue today."

A month after I received the vaccine, I started having symptoms of forgetfulness, became foggy, had severe exhaustion, intense headaches, loss of appetite, issues with balance, vivid dreams and apparent hallucinations. My PCP had me see a neurologist and a rheumatologist. I had blood work drawn, tested for COVID and x-rays done. I have a CT scan in the next three weeks. We are going to come up with a plan after my CT scan.

Patient appeared to faint, was sweating profusely and generalized feeling of malaise. Patient was giving water and Fire-Rescue called. Fire-rescue examined the patient and cleared him to leave after feeling better

CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; SINUS; SWEATING; This spontaneous report received from a Pfizer on 25-JUN-2021 and concerned a 42 year old male. The patient's weight was 99.79 kilograms, and height was 191 centimeters. The patient's concurrent conditions included non smoker and patient had no medical history. He had no known allergies and no current illness at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070, expiry: UNKNOWN) dose was not reported, 1 total administered on 13-MAR-2021 to right arm at 08:30 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in May 2021, patient underwent blood work a week before he knew he had COVID. On 02-JUN-2021, the patient experienced sinus, fever, body aches, diarrhea, congestion, nausea, headache, mild cough and sweating. On the same day, patient underwent SARS-CoV-2 rapid diagnostic test and the results came out to be positive. On an unspecified date the patient underwent SARS-COV-2 PCR TEST and the results came out to be positive (confirmed covid-19 infection and confirmed clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sinus, and sweating on JUN-2021, was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210701758 -COVID-19 VACCINE AD26.COV2.S-confirmed clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS.

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

Was having normal side effects including headache, fever, muscle aches which started about 6 hours after injections. Roughly 14-16 hours after the injection (8:30-9am) started getting chest pain and slight shortness of breath. Called my PCP and they told me to go to the ER as the chest pain is not normal. At the ER they did an EKG which came back abnormal and I was rushed into a procedure to check my heart including a catheter, ultrasound, and a few more I will provide below. Outcome after all the test was inflammation which I asked if it could have been in other areas of my body but doctor said it was my chest. My C-Reactive Protein level was double the normal level. They put me on 3 medications, Ibuprofen, one for Gout and Prilosec.

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.

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

Janssen COVID-19 Vaccine EUA Nasty chills and fever started 10 to 12 hours after vaccination and continued through the night. By 24 hours after the shot, things improved. 24 to 48 hours better -- no chills/fever-- but still general fatigue. "less than 100%". 48+ still not fully recovered. Arm muscle still sore at injection site. Suspect will be better largely by tomorrow.

- severe chills - lasted about 4 hrs - severe headache - lasted about 24hs - body ache - joint pain - nausea - lasted about 18hrs

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

MDM-43-year-old man presents wit syncope versus near-syncope. Differential diagnosis includes vasovagal reaction versus dehydration versus anxiety versus arrhythmia.

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

Had a sudden onset fever which reached 103 the evening of the injection. There was muscle soreness, fatigue, my pulse was above 80 all night and reached 100 during the peak of the fever. By the next morning, the fever had dropped to 100, fatigue remained and a slight headache appeared. The headache was gone by noon, the fatigue remained all day. The evening after the injection, a slight fever returned and then stopped. Two days after the injection, there were no further averse reactions other than slight soreness in the injection site. I am no longer fatigued and feel fine. Hope this information helps.

8 hours after the vaccination, I experienced fairly severe body aches, chills, muscle aches, fever of 102, and severe headache. After 4 days, I feel much better, but still do not feel 100% normal.

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.

Fever increased to 102 from Friday evening and finally broke Sunday around noon (rotated Tylenol and Ibruprofen). Muscle and joint pain that is still ongoing. Not near as painful as the first 72 hours after vaccine, but still ache all over. Chills Headache - Different than cluster headaches and migraines. Began a few hours after receiving vaccine.

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

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

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.

Started feeling heavy chills, deep dull pain in legs (joints, especially knees) for about 12 hours. Headache. Ran low-grade fever of 100.

Headache, different from what I normally get, feels like a vise on my head around temples. Came on 5 days ago, 3 days after receiving vaccine, comes and goes, does not respond to any type of medication.

Strong increasing fever over a period of several hours beginning around 9 hours after dose. Fatigue, dizziness. Chills.

Chills, slight fever, body aches, headache. Treated with Tylenol. Symptoms began 10.5 hours after injection. Chills, fever, body aches subsided in 12 hours, headache was gone after about 15 hours. No symptoms remain.

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.

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

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

ADDISONIAN CRISIS AND EXTREME FATIGUE; ACHE; CHILLS; HEADACHE; This spontaneous report received from a consumer concerned a 43 year old white male. The patient's height, and weight were not reported. The patient's concurrent conditions included addison disease, hyperpituitarism, hypogonadism, and hypothyroidism. The patient experienced drug allergy when treated with baclofen, and pseudoephedrine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose was not reported, 1 total, administered on 31-MAR-2021 to right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 31-MAR-2021, in the evening the patient began to experience addisonian crisis and extreme fatigue, ache, chills and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 2021, and was recovering from headache, addisonian crisis and extreme fatigue, and ache. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210407359-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Addisonian crisis. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE.

20 mins after shot, I nearly fainted - but subsided within minutes. About 6 hours later, had aches, striking headaches, dizziness throughout the entire evening. subsided by the time we woke up - took tylenol.

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.

4/9/21 Vaccination Center At approximately 1115 while observing people post vaccination I was summoned by companion to assist pt who was ?feeling faint?. On arrival person was conscious and responsive, pale, diaphoretic, with eyes closed, verbalizing he felt like he was going to faint. BP measured at 77/41, HR via O2 Sat device 39-44. Person coached to take deep breaths, able to transfer with assist of one to wheelchair, transported to observation room, self transferred to stretcher and placed in supine position with HOB approximately 20 degrees. BP 91/54, HR 51. Person verbalized immediate relief when positioned on stretcher. Monitored for 20 minutes, BP 133/61, HR 64. Assisted to sitting position on stretcher, tolerated cranberry juice and graham cracker. Self transferred to wheelchair where he was transported to main waiting room, observed for 20 minutes. Person reported return to baseline, ambulated independently out of vaccination center. Person remained conscious throughout.

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.

Chills/Rigors for ~2+ hours starting before bed. ~1:30 am had high fever (102.2) and lack of mental clarity. Took 1g tylenol for fever which broke in the early morning. Also had severe headache during this time. Day 2 after the vaccine, lack of mental clarity and mental "fog" all day.

felt tired and sleepy on the same evening; then went to bed; woke up at night feeling a mild headache; took two pills of Acetaminophen; no fever; a few sneezes

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.

Headache, Fever and chills starting about 7 hours after and lasting for 6 hours. Headache lingered for about 36 hours

MUSCLE ACHE; CHILLS; FATIGUE; 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, batch number: 042A21A, and batch number: 042A21A 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 muscle ache. On 05-APR-2021, the subject experienced chills. On 05-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, muscle ache, and chills. This report was non-serious. This case, from the same reporter is linked to 20210411696.

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.

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

Patient received vaccine on 3/31. Developed significant headache the evening of 4/12. Called hospital telephone nurse advisor, and was directed to come to the ER for further evaluation. The patient was not admitted. No evidence/concern of thrombotic event. Patient does have a history of migraines.

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/

(1) Fever 2 days 100.3 - 101.1 (took tylenol every 6-8 hours). (2) Fatigue (slept most of day after injection). (3) Heart rate elevated (woke up 7hrs after injection with feeling of heart pounding in my chest; heart rate over 90 while trying to sleep; believe reducing fever with tylenol helped settle heart rate). (4) Muscle aches 2 days (previously injured muscles/joints became very sore 1-2 day after injection [left hip, right foot, left quad, lower back] - believe tylenol reduced inflammation) --symptoms ended 3-4 days after injection; slight fatigue remains 7 days later.

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.

Body chills. Joint's ached. Fatigue. All mild. Lasted just the Friday after. No symptoms on Saturday. Just rested all day. and hydrated.

Began to develop extreme exhaustion throughout day following shot. At approximately 5:00pm, began to develop a headache, severe joint pain throughout body. Approximately 2 hours later, began to develop a fever that rose to 102.5. Immediately took Tylenol. Fever last for approximately 24 hours as did joint pain. tiredness and washed out feeling lasted approximately 5 days.

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.

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

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

Vasovagal episode. After receiving dose patient complained of feeling lightheaded, nauseous and was visibly sweating. Vitals were taken 10:10 106/60 97% HR: 52. At 1015 vitals were 118/10, 98% and HR 65. Patient was given wet towels around his neck and on his forehead. brought cot to patient and patient placed in trendelenburg position. pt given water and stated he was no longer lightheaded or nauseous but continued to have HA. Pt at that time was being evaluated by both doctors. Patient then walked to monitor area where was continuously checked on until 1100 when his vitals were rechecked (118/80, 68HR). Pt stated he felt better and was released and recommended not to drive. Pt says his brother would drive him home. - RN

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

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. ,

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.

TENDERNESS IN THE CHEST; LUNG INFLAMMATION; COUGHING; SORENESS; TROUBLE BREATHING; THROAT SWELLING; CHEST TIGHTNESS; GENERAL SWELLING; DETERIORATION; DID NOT FEEL WELL; TIRED/FATIGUE; 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 (suspension for injection, route of admin not reported, batch number: 1805020, and batch number: 1805020 expiry: 25-MAY-2021) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-APR-2021, the subject experienced tired/fatigue. On MAY-2021, the subject experienced deterioration. On MAY-2021, the subject experienced did not feel well. On 07-MAY-2021, the subject experienced soreness. On 07-MAY-2021, the subject experienced trouble breathing. On 07-MAY-2021, the subject experienced throat swelling. On 07-MAY-2021, the subject experienced chest tightness. On 07-MAY-2021, the subject experienced general swelling. On 07-MAY-2021, the subject experienced coughing. On 08-MAY-2021, the subject experienced tenderness in the chest. On 08-MAY-2021, the subject experienced lung inflammation. The action taken with covid-19 vaccine was not applicable. The patient was recovering from tired/fatigue, had not recovered from soreness, trouble breathing, throat swelling, chest tightness, general swelling, lung inflammation, and coughing, and the outcome of tenderness in the chest, did not feel well and deterioration was not reported. This report was non-serious.

Received vaccine on 5-6-21. On 5-8-21, complained of headache, bloating, fever, and constipation. Last seen alive at 9 PM on 5-8. Found dead at home at 7 PM on 5-9.

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.

BLAH; CHILLS; FEVER; HEADACHE; SIDE EFFECTS; 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'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: 7/18O/U/V/8978 expiry: JUN-2021) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, Laboratory data included: Body temperature (NR: not provided) 103 F. On 12-MAY-2021, the subject experienced blah. On 12-MAY-2021, the subject experienced chills. On 12-MAY-2021, the subject experienced fever. On 12-MAY-2021, the subject experienced headache. On 12-MAY-2021, the subject experienced side effects. The action taken with covid-19 vaccine was not applicable. The patient recovered from blah, chills, fever, headache, and side effects on 14-MAY-2021. This report was non-serious.

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

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

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).

Case received vaccine at 10:30AM and at approximately 10 minutes into recovery stated he "feels a little dizzy" Case requested a drink of water. Vital signs stable at temp 97.6 Pulse 88 Respirations 16. Pulse ox 99% BP 128/70. He denied any shortness of breath, chest pain, difficulty swallowing itching or scratchy throat. He was advised to be observed for another 15 minutes and stated he was feeling better and returned to work at 11 AM At approximately 11:50 AM patient returned to clinic with boss stating he vomited in the rest room. Patient taken to recover room cot was placed in supine position on cot vital signs continued to be stable with 97.6 88 16 120/70 He complained of funny feeling in his throat. He was give Benadryl Liquid 50mg PO and continued with stable vital signs 97.6 88 20 120/70. He continued to complain of the funny feeling in his throat he was given Epinephrine IM .5ml, He did appear anxious and tearful after speaking with his friend on the cell phone. Vital signs remained stable of 99% SAO2 Pulse 83 Respirations 22 BP 128/70. Throughout entire event he was able to speak in clear sentences with the interpreter assistance. Patient was advised to go to ED for further evaluation and observation. He consented and 911 was called. EMS arrived at approximately 12:30 PM and report was given to EMT on patient event at clinic along with written information on vaccine and vital signs.

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.

Patient admitted to hospital with a platelet count = 0. Patient presented with fatigue, mouth sores and body rash and extensive bruising. Patient also tested positive for COVID 19.

Patient reported received his Johnson and Johnson COVID 19 vaccine 05/31/2021. Reported stated having generalized joint aches, HA and left axillary swelling. Reported symptoms stated 06/1/2021 at 8pm. patient reported did not take any medications for symptoms.

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.

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.

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

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.

patient was given janssen covid- 19 vaccine at 4.30 pm and 10 min later the patient fell forward from his chair on his face as he felt very dizzy and sweating.. Patient regained consciousness right away and was doing fine after a few min.

Woke up the next morning feeling sore at shot site and as the day progressed my body started to ache all over. For the next 2 days after this, I will alternate between having the chills and having intense sweats. On Friday 06/25/2021, I woke up to my chest hurting , I could not catch my breath, it felt like I had a very heavy weight on my chest . I went to the emergency room which is a part of the Hospital. After the initial tests the physician told me with 99% certainty that I had had a heart attack. Soon after this they rushed me by ambulance from hospital to hospital which is about 20 miles or so. They rushed me in and completed an arteriogram within minutes of arriving at the hospital. They confirmed with this test that is was not a heart attack and after several more test, the doctor that I had developed Myocarditis due to the vaccine shot. The admitted me into the hospital on 06/25/2021 for observation and to run more test until I was stable enough to go home. I stayed in the hospital for 1 evening and was discharged on 06/26/2021 at about 1:00 or 2:00 that afternoon. The doctor prescribed several medications for me to take for my heart for the next foreseeable future. On 06/30/2021 I had a visit to my new cardiologist in which he ran several test and stating that I was looking better, but he had ordered an MRI to take place on 07/06/2021 at Hospital. I have a follow up visit for my cardiologist slated for 07/19/2021 in which I will find out more information.

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.

MYOCARDITIS; SWEATS; CHILLS; ACHY AND SORE ALL OVER; 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 left knee surgery six year ago, and concurrent conditions included penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A and expiry: 24-AUG-2021) dose was not reported, 1 total, administered on 21-JUN-2021 to left arm for prophylactic vaccination. The patient was now on three different medications for cardiac precautions. Next day of vaccination (on 22-JUN-2021), the patient felt achy and sore all over. On 23-JUN-2021, the patient began alternating between chills and sweats then he went to bed and woke up 03:00 and felt like a gorilla was sitting on his chest, chest heaviness and shortness of breath, the patient went to the ER (emergency room) and admitted for cardiac tests, was told he had a heart attack then the patient was transferred by ambulance and admitted to hospital on 25-JUN-2021. There he had an arteriogram, hospital cardiologist told him it was not a heart attack. After additional lab tests he was told that he developed myocarditis as a result of the vaccine. The patient was discharged on 26-JUN-2021. He was hospitalised for a day. The patient had a follow up with cardiologist for first time on 30-JUN-2021, magnetic resonance imaging (MRI) was done on 06-Jul-2021 (results were not provided) and second follow up visit with cardiologist on 19-Jul-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from myocarditis, and the outcome of chills, sweats and achy and sore all over was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210730558-covid-19 vaccine ad26.cov2.s -Myocarditis. 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).

TESTED POSITIVE FOR COVID-19; DIZZINESS; HEADACHE; FATIGUE; This spontaneous report received from a patient via a company representative concerned a 43 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 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-APR-2021, the subject experienced dizziness. On 14-APR-2021, the subject experienced headache. On 14-APR-2021, the subject experienced fatigue. On 22-JUL-2021, the subject experienced tested positive for covid-19. Laboratory data included: COVID-19 rapid POC test (NR: not provided) Positive, Influenza A virus infection (NR: not provided) not reported, and Influenza B virus infection (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, headache, and fatigue on 15-APR-2021, and had not recovered from tested positive for covid-19. This report was non-serious. This report was associated with product quality complaint: 90000186982; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non-serious.

10 minutes after injection, dizzy spell and vasovagal reaction. Diaphoretic, pulse rate 48, BP 107/71.

Chills, Sweats, Bad body aches Saturday night through Sunday Morning- Took Tylenol Tiredness- throughout Sunday Chills- Sunday night- Tylenol Monday felt good- Monday night slight temp 99.5 and shortness of breath Took Tylenol Tuesday Feel fine headache and slight shortness of breath.

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

Within hours I quickly became extremely sore, fatigued, and had difficulty breathing. I was unable to eat until the breathing issues subsided late afternoon Sunday since I felt as though I was choking when I attempted to eat. The fatigue and body pain was pronounced enough for me to have to call off work Monday, but they gradually diminished. I am submitting this on 3/11, and I am still experiencing some body aches though the constant feeling of exhaustion is no longer present.

pt stated that he got flu like symptoms including tight muscles, headache, body aches, chills, he was nauseated. He woke up feeling a little better but still has head ache, body aches and some nausea.

Myalgia, Arthralgia, Fever, Diarrhea, Fatigue Narrative: Reports fever on 3/5 at night into 3/6, diarrhea on 3/7. Myalgias, arthralgias, and fatigue on 3/5, 3/6, and 3/7. All resolved on 3/8.

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

Fever, muscle aches, extreme fatigue, nausea. Used Advil and rest...left work due to symptoms. Symptoms lasted about 36 hours. Resolved.

Headaches, body aches, fever (over 101 degrees), fatigue. Fever lasted one day, headaches and body aches for a couple of days, fatigue for 3 days (and counting)

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

Janssen COVID-19 Vaccine EUA. Just reporting that I experienced side effects of fever, full body ache, and headache. The side effects lasted 18 hours.

Janssen COVID-19 Vaccine EUA - Fever & Insomnia 10 hours after injection. Fever & Lethargy 20+ hours after injection.

Fever of 99.5 from 5-7 hours after injection Fever of 101.1-101.3 from 7 hours after time of injection until 28 hours after time of injection (slowly went down after that time, fever completely gone by 36 hours after time of injection)

Severe Headache, body aches, fever, tiredness starting about 4am 4/3. most symptoms gone by 4pm same day. headache lasted until going to sleep that night about 8pm. Symptom free when i woke up 4/4 at 7am.

Chills, fever 102.7 Fahrenheit, light headed Symptoms started 11-12 hours after receiving vaccine. First measured fever identified at 12 hours mark of 100.9....at 13 hours 101.5 at 14 hours 102.7

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.

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.

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.

Sharp, stabbing, intermittent head pain - 12 of 10 on pain scale, left side of head. Located in same spot each time. Occurring 8-10 an hr.

Patient fainted when standing for count. Fell to the floor, lost consciousness, and hit his head against the wall. Reported overnight he experienced chills and lightheadedness

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

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.

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

SYNCOPE/PASSED OUT FOR A COUPLE OF HOURS; SEVERELY DEHYDRATED; FLU; INJECTION SITE WAS SORE; This spontaneous report received from a pharmacist concerned a 44 year old The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: 06-JUN-2021) dose was not reported, frequency 1 total administered on 02-APR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the patient was severely dehydrated a couple of hours after receiving the vaccine, syncope/passed out for a couple of hours (unsure how long), and injection site was sore. On same day, it felt like the patient had the flu, which was described as chills, fever and the patient's throat being sore at the same time. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from syncope/passed out for a couple of hours, severely dehydrated, injection site was sore, and felt like patient had the flu on 04-APR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;20210411188-covid-19 vaccine ad26.cov2. s-syncope/passed out, severely dehydrated. 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).

Extreme fatigue. Feel better when lying down. Can only be upright and active for about an hour or so before needing to lie down again.

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

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

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

I had difficulty to think all friday afternoon(2 days after injection). After going to bed around 9:30 PM and therefore lying down I suddenly started to cough. It last for about 10 minutes, I could not stop. I also started to sweat. At this time I believed I got COVID-19 at the vaccination site and moved to another room to avoid to expose furthermore my wife. I did not cough anymore since then. Today after reading the news and symptoms of blood clot in the lung, I prefer to report this incident.

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.

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.

I'm feeling totally fine while having a conference call thru TEAMS at my home around 3:30PM on April 12, 2021. Then suddenly I felt a severe headache (as if my head was shot by a gun) at the center of my forehead. This is only the first time I felt that kind of headache. However, it only lasted for about 5-10 secs for that severe pain then after that i just felt dizzy for about 20 mins. Since then, I'm fine now and hoping that I will not feel that same pain again.

Mild fever (99.1-99.5), body aches, chill started about 12 hours after receiving injection. Treated with alternating doses of acetaminophen and ibuprofen. Was tired the next day. The symptoms started to dissipate after 24 hours and were gone after 30 hours.

CHILLS; JOINT PAIN; SENSITIVITY AT THE INJECTION SITE; MUSCLE ACHES; HEADACHE; FEVER UP TO 101 FAHRENHEIT; 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 pernicious anemia, non smoker, and ketosis, 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: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 10:00 for prophylactic vaccination. Concomitant medications included cyanocobalamin for pernicious anemia. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced joint pain. On 08-APR-2021, the subject experienced sensitivity at the injection site. On 08-APR-2021, the subject experienced muscle aches. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced fever up to 101 fahrenheit .Laboratory data included: Body temperature (NR: not provided) 98 F, 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, joint pain, muscle aches, headache, and fever up to 101 fahrenheit ,on 10-APR-2021, and had not recovered from sensitivity at the injection site. This report was non-serious.

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

Received shot at 9:20 am. Came home and went to bed. Woke up at 3pm and felt worn out. Then about 5:30pm I got super uncomfortable and then my skin got hypersensitive. To the point I couldn't even touch it. Then I felt like I had a fever but when I checked I did not. Went to bed at 8pm still with the hypersensitive skin. Could not get comfortable to sleep but when i eventually fell asleep I slept for 10 hours. Thats about 5 more than I normally do. The next day the hypersensitive skin was gone just felt a little wore out.

Pt. is a 44 y.o. male evaluated with a web video visit for evaluation of side effects after undergoing the Janssen Covid-19 vaccine yesterday. He describes having systemic side effects of fever as high as 100.8F, chills, fatigue, body aches, and headache. He underwent the vaccine yesterday at approximately 1045. He relates that he took Excedrin migraine a few hours ago but is not having relief. He would like to know if it okay for him to take any other medications to treat his side effects. He denies any cutaneous, thrombohemolytic, or analphylaxis side effects.

Patient reported to medical clinic 24 hours after COVID 19 injection (03/19/2021) with symptoms of visual hallucinations, myalgia, rigors, headache, nausea, vomiting and dehydration. At the time of arrival to the medical clinic, he had refractory nausea and vomiting after receiving Zofran earlier in the day at another clinical site. Medical treatment consisted of IV Fluid bolus with maintenance fluids, IV Phenergan for the nausea and vomiting, and IV Ketorolac for headache pain. His symptoms resolved and he started to feel better so a clinical decision was made to discharge him home in the care of a close friend. He declined any other treatment modalities or medications at the time of the discharge. The patient returned on 03/28/2021 with a right arm DVT proven on U/S. He was then started on anticoagulation therapy after specialist phone consult and will be closely followed.

Patient reported to medical clinic 24 hours after COVID 19 injection (03/19/2021) with symptoms of visual hallucinations, myalgia, rigors, headache, nausea, vomiting and dehydration. At the time of arrival to the medical clinic, he had refractory nausea and vomiting after receiving Zofran earlier in the day at another clinical site. Medical treatment consisted of IV Fluid bolus with maintenance fluids, IV Phenergan for the nausea and vomiting, and IV Ketorolac for headache pain. His symptoms resolved and he started to feel better so a clinical decision was made to discharge him home in the care of a close friend. He planned to follow-up the next day. The patient returned to medical Clinic on 03/22/2021 with no specific symptoms. Previous symptoms from initial encounter resolved according to medical chart. Patient returned on 03/28/2021 with right upper arm DVT proven on U/S. He was seen at Primary Care Clinic beforehand where diagnosis of DVT was made. He was then started on anticoagulation therapy by MD in clinic after specialist phone consult, and will be closely followed. He was sent to Evacuation to home station due to the complexity of the condition, medications, etc.

The patient claims to have received the J and J vaccine on 3/30. He also claims it was his "second shot". He says he has felt ill since this shot, had an admission to the hospital and discharge for CHF. On 4/15, admitted again with Bilateral pulmonary emboli. He says the only thing he has done differently is vaccine.

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

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

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

My symptoms have gotten worse or the past 2 weeks. I have had a headache every day since I got the vaccine. On 4/19/21 my symptoms worsened. I am currently experiencing chills, fever, fatigue, headache, and body aches.

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).

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

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.

The first couple of days had a fever, light-headed, pulsating feeling through my body, and feeling faint at times. Symptoms go away after the third day. Then nearly two weeks later the feeling of being light-headed, pulsation sensation throughout my body, and feeling faint at times came back. It's been a few days of these symptoms returning and it has me concerned.

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

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

Diarrhea-like soft stool 2.5 hours after inoculation; fatigue and general malaise for more than 36 hours after inoculation; sore left arm for more than 36 hours and soreness at the injection site.

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.

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

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.

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

Sweating, Dizziness BP 106/55, HR 78, RR 13 -- > 104/65,62,24 -- > 121/62, 61. Patient stable and released from the vaccination site

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.

Pt became diaphoretic, looked dazed, confused, and about to faint within 10 seconds of vaccination at 1pm. Pt's BP was 110/50, pulse 50. After 10 mins, pt seem to recovered from his symptoms. Later stated that he's had these vasovagal symptoms in the past with other injections. Said he was ok with the previous flu vaccine and didn't think to mention it to vaccinator. Pt stayed until 1:30pm (30 mins after vaccination) and reported he was ok to drive home. Pharmacy f/u in 2 days on 5/12/21 @ 9;15, who stated he is doing well and recovered from all symptoms.

Starting the evening of the vaccine, about 7 hours after receiving it, began feeling lethargic. Then 2 hours later, had strong chills, which lasted for a couple of hours. In parallel also had a fever (around 101F) and headache. Fever lasted for several hours into the night. Fever subsided in the morning (around 7AM on Saturday, May 8th). Felt lethargic throughout the day, had little appetite and light headache. By Sunday was feeling better. Monday was 100% again.

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

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.

Patient was administered Janssen vaccine and instructed to stay seated for 15 minutes as had no prior reactions to drugs or vaccines previously. About 5 minutes after vaccine patient stood up to report to pharmacy counter that he was feeling very dizzy. He was instructed to sit back down. While turning for seat, patient fell and hit mouth on cabinet that resulted in a cut lip. Patient loss consciousness briefly. He was able to respond to verbal commands to roll onto left side. Blood pressure was check and read 94/59 mmHg. Patient remained in this position until feeling well enough to sit up on floor, per ok from paramedics via phone. Patient was perspiring on forehead. Patient took a few sips of water and reported feeling better. Paramedics repeated blood pressure and took patient to hospital. Patient stated he did not remember falling but remembers instruction to roll to side.

Patient was sitting for 15 minute observation and suddenly passed out for about 10 seconds. He was sweaty and pale and mentioned being light headed.

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

Initial reaction day after vaccination - 4/1/2021 site reaction with swelling, erythema, and warmth; generalized reaction - flu-like symptoms - all resolved within a few days. 6/6/2021 - uncertain if related to vaccine - patient reported chest pain as thought he thought he was having a heart attack. Went to hospital. Dx with pulmonary emboli and DVTs. Transferred from (Name) Hospital to (Name) Hospital to ICU. As of 6/7/2021, patient reports he has been moved from the ICU to a regular room, no on oral anticoagulants. Patient has not yet been discharged at the time of report submission.

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.

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

WOKE UP WITH PAIN AND BODY ACHES IN BACK AND LEFT SIDE AND FEELS LIKE THE PAIN IS ENLARGING; FEELING BAD; FELT FEVERISH; DIZZINESS; 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 heart valve replacement, and concurrent conditions included abstains from alcohol, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient has history of no drug drug abuse or illicit drug usage. the patient was taking blood thinning medications. 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 04-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-JUN-2021, the subject experienced dizziness. On 04-JUN-2021, the subject experienced feeling bad. On 04-JUN-2021, the subject experienced felt feverish. On 05-JUN-2021, the subject experienced woke up with pain and body aches in back and left side and feels like the pain is enlarging. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt feverish, dizziness, and woke up with pain and body aches in back and left side and feels like the pain is enlarging, and the outcome of feeling bad 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

Patient presented with wife 6/18/2021. Patient requested Janssen covid-19 vaccine. The immunization was administered at 6:55pm. After 7 minutes of sitting in waiting room, patient started to complain of dizziness, "spinning in head", heavy breathing, and sweating. Patient was very sweaty, pale, and uneasy. Patient then fell to the ground with wife next to him, and lost consciousness briefly. 911 was immediately contacted. Patient did not hit his head or other body parts. Patient was able to be picked up and brought back into his seat. He did lose consciousness again in his seat very briefly but was able to speak to me and answer questions as I spoke with 911. He was very pale and sweaty, but answered questions to check for mental status. 911 police and ambulance arrived and checked his pulse, blood pressure, and asked several questions to examine his mental status. Patient declined going to hospital. Patient did walk out with wife, more color apparent on face, and able to answer questions. Patient and wife were advised to stay home and relax post-vaccination and call 911 if symptoms arise.

Fainted twice after receiving the vaccine. First time 5 days after receding the vaccine, the second time about 6 weeks later. First time I was dehydrated, and fainted at the gym while exercising. The second time I fainted while walking the dog. Both times I broke out in hives, the second time more severely (all over my body). Both times I fell, hit head head and had to get stitches or staples.

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

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

CHRONIC KIDNEY STONES; FEVER; 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 non alcohol user, and smoker, and the patient does not have any no known allergies. The patient did not have any history of drug abuse or illicit drug use. The patient did not have any no known previous medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203AZ1A expiry: not reported) dose was not reported,1 total, administered on 04-JUN-2021 15:00 to left arm as prophylactic vaccination. No concomitant medications were reported. On 04-JUN-2021,at 9 PM after 6 hours of vaccination ,patient was feeling sick, he got fever and steadily got worse over 3 days. Patient went back to the normal before fever broke .On 5-JUN-2021 afternoon, he experienced the abdominal pain and pain steadily got worse. Patient experienced the pain in lower abdomen ,groin and shooting down his legs. Pain got worse and spread a little further. On 11-JUN-2021,following week patient went to the doctor. Patient reported that he was going to the doctor 6 to 8 times. Patient went to the hospital to get the ultrasound (NR: not provided) on lower abdomen, groin and chest. Ultrasound test results were normal. Patient had done a CAT scan (computerised tomogram) (NR: not provided) and found the Chronic kidney stone. Patient had the chronic kidney stones and was hospitalized. Patient reported that he was not having kidney stones before the vaccination. Patient did not remember when he went to the hospital. Patient told that he was prescribed with steroid. Patient reported that he had done with first round and at the time of reporting he was on the fourth day of second round. Patient told that, steroid not helped to his symptoms. Patient was also prescribed with muscle relaxer and Percocet as per need. Patient took only 3 pills of Percocet since 3 weeks ago because patient not like to take medicine. On 09-JUL-2021 the patient received the call from hospital to request a MRI on him. Patient reported that he was healthy like a horse before and now he felt like he was ready to die. Patient stated that pain had not recovered . Number of days of hospitalization were not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and had not recovered from chronic kidney stones. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210722902-COVID-19 VACCINE AD26.COV2.S-Chronic kidney stones. 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).

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.

Fever of 101°f. Joint pain, Fatigue, Muscle aches. Beginning about 10 hours after vaccination. Lasting about 16 hours. Vomiting and diarrhea with fever of 99°f about 60 hours after vaccination.

Fever and chills started all of the sudden around 5:15 pm on day of vaccination (3/8). Fever and chills have continued through say and evening of 3/9.

Initially Fever, Fatigue, Joint Pain. 2 days later pain in right abdomen, diagnosed with Appendicitis and had emergency appendectomy performed.

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.

At bedtime, felt chills. Overnight developed muscle aches and a headache. On 3/12 9:45am still feeling headache and body aches.

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.

I was pretty lethargic all day , but just before bed around 10 PM (approximately 14 hours after inoculation) I started to experience a fever and body chills.

Severe chills, fever, and whole body muscle ache. Symptoms began approximately 8 hours after injection and continued at a high level for 12 hours (overnight). Muscle aches and skin sensitivity continued into the day following but chills and fever subsided completely.

Symptoms: Nausea, Sharp Headache (Right Side), Body Ache, Fatigue. / Time: Bed Rest (two days), hospital visit on the third day. / Treatment: Bed Rest and Antibiotics.

Fever of 102 degrees, body aches, chills, nausea, vertigo, fatigue - Rest, fluids, Tylenol - Recovering well 2 to 3 days

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.

Rash on left foot, both arms and hands. Slight dizziness at times. Slight Fever has been noticed a few times, then went away. Headaches on the first day after, but not on the second day. Treatment was heat pack for head, ice packs for rashes to decrease swelling. Also took ibuprofen

I felt extreme fatigue- really tired. I first got the fever, then chills, the fever, then chills again. Finally, after the fever and chills, I got a very intense headache for about 18 hours. The fever and chills lasted for about 36 hours.

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

After I had the shot, I did get the chills, fever and achiness. However, it kickstarted a really bad bout of IBS/Diverticulitis that has continued on through today. The doctor has prescribed medication to help, but this is one of the worst bouts I've had.

Chills at 7 hours post vaccine; temp taken at 11 hours was 103; headache and nausea; terrible body aches; Worst symptoms resolved at 17 hours post vaccine; low level fatigue still at 48 hours post vaccine

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.

At 3am I woke up with: Chills Fever Headache Body aches Throughout the day the symptoms persisted and included: Brain fog Dryness / dehydration Dizziness

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.

After roughly 15 hours I woke up with a fever, which followed by severe chills, sweating, and muscle aches. Was not ale to sleep the rest of the night. After around 8 hours the symptoms subsided, but still feel flu-like and have a low fever more than 24 hours after the shot.

PATIENT REPORTED STARTING TO FEEL FAINT AND BLACKED OUT FOR 30-45 SECONDS WITHIN 1-2 MINUTES AFTER RECEIVING VACCINE. HE EXPERIENCED DIAPHORESIS AND FELT HE WAS GOING TO PASS OUT. DENIED SOB, HIVES, SWELLING, STOMACH PAIN. REPORTED HE HAD NO HEALTH CONDITIONS BUT THAT THIS HAD HAPPENED TO HIM BEFORE BUT THIS WAS WORSE - SAID HE HAD NOT EATEN THAT DAY OR DRANK WATER. RPH GAVE PATIENT WATER AND LEMONADE ABOUT 2 MINUTES OR SO INTO REACTION AND PATIENT SAID HE STARTED TO FEEL BETTER AFTERWARD. 911 WAS CALLED AND PARAMEDICS RESPONDED WITH TAKING BLOOD PRESSURE AND BLOOD SUGAR - BP A LITTLE LOWER THAN AVERAGE BUT UNSURE WHAT PT TYPICALLY RAN AT. BLOOD SUGAR NORMAL AFTER DRINKING LEMONADE. PATIENT TAKEN TO ER FOR FURTHER CARE

chills and restlessness sleeping Sunday / Monday night, Tuesday 9A: quick onset of severe flu like symptoms: dizziness, significant fatigue, loss of any concentration, nausea, lack of appetite. Dimished quickly after 400mg advil taken in afternoon. Mostly gone by 4:30P. Wed 4/7 most symptoms gone.

GROGGY; HEADACHE PRETTY MUCH THROUGHOUT THE DAY; SORENESS AT INJECTION SITE; 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: 1808609, expiry: UNKNOWN) dose was not reported, administered on left arm on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced groggy. On 26-MAR-2021, the subject experienced headache pretty much throughout the day. On 26-MAR-2021, the subject experienced soreness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from groggy, headache pretty much throughout the day, and soreness at injection site. This report was non-serious.

Patient became light headed and sweating approximately 10 minutes after injection. No fainting or unconsciousness. Gave water and within 5 minutes symptoms subsided. Patient left the pharmacy 30 minutes after injection and was doing well.

Fever, chills, bad headache. Just rested, symptoms lasted about 24 hours. Was worse than any flu I can remember though.

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

Onset Thursday, 4/08/21 at 03:00 am: Fever, Chills, Severe Body Aches and Joint Pain, Exhaustion. 09:00 am to 1:50 pm: Slept with profuse sweating. Friday 4/09/21 at 12 midnight: Fever with ears red and burning. Applied wet cold towels on body. Vomited once, followed by dry heaves. 10: 00 am Nauseous. Checked temperature with ear thermometer- afebrile. Checked oxygen saturation with pulse oximeter- 96% HR 35. Checked pulse manually with a range of 39-44 and irregular.

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.

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.

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.

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.

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.

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.

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.

I was fine after I got the shot. No pain or anything. The next day I was light headed, had a temperature of 102, and felt total body ache. This feeling was persistent and constant for all of the day after the shot and in the morning two days after the shot. The symptoms then subsided and I was fine for the remainder of the day and have been fine since.

Started with chills and muscle fatigue at 8pm. Once chill subsided felt feverish and could not fall asleep at about 1 am on 4/8. Sweating followed by better rest until waking at 6am for day, but felt fatigued from lack of restful sleep during night. Was able to nap during day (4/8) and felt much better by evening.

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.

States that he got the J&J COVID vaccine Thursday 4/8/21 States that he had immediate muscle pain right away and a cough right away Upper chest is painful and he is having trouble breathing Chest pain has started yesterday- reports the pain has gotten worse States that he exercises every day and ran this AM States that today the chest pain has gotten worse and his breathing has gotten worse as well States that he works around chemicals in a woodworking shop but doesn't think that this is the cause of his chest pain Chest pain is located at the top of his sternum States that he feels queasy and unwell over all Advised that with current symptoms that he needs to be evaluated urgently and advised calling 911 if he did not have someone to bring him in. Patient refuses 911 but agrees to be seen in the ER. Will go to his closest ER now.

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.

Headache. Laid down, took 3 hour nap. Felt a little better after nap. Headache continued next day. Took tylenol. By day 2, felt fine.

5 minutes after receiving the injection, my husband passed out, starting sweating profusely, and was out cold for a minute. EMS were called and he was seen in ER due to low heart rate and sweating to rule out any heart conditions. He had 2 EKGs - one in the ambulance and one in the ER. He also had to have a CT for falling and bumping his head to rule out that injury. The DX was listed as a vagal response, but we are not so sure we agree given that he is 45 years old, has no priory history or anxiety about shots.

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

Chills, fever and head ache onset 4 hours after vaccine. Treated with acetaminophen and All adverse events were resolved next day (8th april) evening 7 pm.

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.

Chills and joint pain in the evenings from day 3 through day 7. Mild to moderate Headaches from day 3 through day 9. Shortness of breath, twice between day 5 and 7. Chest pain on the evening of day 6, lasted 3 to 4 minutes.

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.

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.

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.

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.

COUGH; BACK PAIN; CHILLS/SHIVERS; HEADACHE IN RIGHT TEMPLE, MALICIOUS HEADACHE; FEVER; LIGHT HEADEDNESS, DIZZINESS; VOMITING; 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: 203A21A 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 vomiting. On 12-APR-2021, the subject experienced light headedness, dizziness. On an unspecified date, the subject experienced cough, back pain, chills/shivers, headache in right temple, malicious headache, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 F. Treatment medications (dates unspecified) included: oxycodone hydrochloride/paracetamol, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light headedness, dizziness on 12-APR-2021, had not recovered from headache in right temple, malicious headache, and back pain, and the outcome of vomiting, cough, chills/shivers and fever 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 past medical history included covid-19 test positive. 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 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced unable to go work. Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 06-APR-2021, the subject experienced warm throughout right arm at injection site. On 06-APR-2021, the subject experienced severe headache. On 08-APR-2021, the subject experienced stomach/abdominal pain. On 08-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach/abdominal pain, and warm throughout right arm at injection site on APR-2021, had not recovered from severe headache, and fatigue, and the outcome of unable to go work 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.

FLU-LIKE SYMPTOMS; 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: Unknown) dose was not reported, administered on 10-APR-2021 09:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced flu-like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of flu-like symptoms was not reported. This report was non-serious. This case, from the same reporter is linked to 20210427236.

On March 13, I received the Johnson & Johnson vaccine at the clinic The pharmacist monitored me for symptoms but there were none right away. I did have a fever and some body aches in the two or three days that followed but those were short-lived. While driving on March 16, I started experiencing some irregular breathing and periods of shortness of breath about three hours after leaving home. I stopped at the emergency room at the Health Center where Dr diagnosed me with an acute pulmonary embolism after discovering a small blood clot in one of my lungs. He prescribed me with Eliquis, which I am still taking today. Their phone number is provided if you have questions. I haven't had too many shortness of breath episodes lately but do not know if the blood clot is still there. I am scheduled to see my hematologist on April 27 to get further updates on this. My hematologist Dr is located in clinic number provided While it has not yet been proven that the vaccine caused the blood clot in my lung, I feel the need to report this in the wake of recent news about the Johnson & Johnson vaccine. My hematologist and primary care physician are both aware that I have received the vaccine but I have not received any further communication from them.

Patient was doing paperwork when he experienced the worst headache of his life on 4/17 with associated emesis. Patient found to have a Hunt Hess 3 Fisher Grade 3 Subarachnoid Hemorrhage with hydrocephalus s/p EVD, s/p cerebral angiogram on 4/18 negative for aneurysm/AVM. On the evening of 4/20, patient became acutely hypoxic with wheezing for which he required oxygen via 10L oxymask. During 4/21, his oxygen requirements continued to increase with increased work of breathing requiring high flow nasal cannula (HFNC) at 50L/60% + pulmonary congestion on imaging and he was treated with diuresis. On 4/22, oxygen needs increased requiring 70L/100% with worsening imaging. He was then started on steroids, antibiotics were broadened, epoprostenal started in addition to diuresis. On 4/23, patient reports improved breathing and is on non-rebreather. Antibiotics, steroids, and epoprostenal were discontinued as patient showed improvement of oxygenation without clear signs of infection. Of note, patient reports vaping in the past 2-3 months. Patient has also been intermittently febrile. Wife was concerned that these symptoms were possibly related to him getting the J&J vaccine on 4/11. Patient is currently still in hospital on day 6 of admission at this time.

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.

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

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.

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.

CLOT IN SPLENIC ARTERY; CELIAC ARTERY THROMBOSIS; BODY SWEATING; SHORTNESS OF BREATH; CHILLS; 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: 043A21A) dose was not reported, administered to left arm (left deltoid) around 15:00 to 16:00 on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-APR-2021, after 5 days of vaccination, in the morning, while driving patient had very severe abdominal pain, very hard time breathing, had to get out of the car because of that, patient thought he was going to die, after 5-10 minutes he felt chills and body was sweating. His wife took him to the hospital on same day. At the hospital unspecified tests and CAT scans were done, and found clot in splenic and celiac artery. Patient was hospitalized on 14-APR-2021 for 1 day and was discharged around 3pm the next day on 15-APR-2021. Patient had another visit with a hematologist on 28-APR-2021 in morning, he found nothing wrong with the body. Patient now had to take Eliquis for 6 months. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, body sweating, shortness of breath, on APR-2021, and had not recovered from clot in splenic artery, and celiac artery thrombosis. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20210456348 - Covid-19 vaccine ad26.cov2.s-clot in splenic artery, and celiac artery thrombosis. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

12 hours after vaccine, 100.4 fever, chills, body aches. Fever broke after about 18 hours. General pain on injection arm, continuing through this day. General pain/discomfort in upper left arm and shoulder/back area.

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.

Chest pain/discomfort, Heart Palpitations/Abnormal Heart rhythm, Shortness of breath, Exhaustion, Lightheadedness and dizziness. Symptoms are ongoing and of intermittent intensity. Aspirin daily for chest pain. See below for diagnostic tests ordered.

Started in the middle of night- awoke to my arm I got injected in being completely numb. Moved my arm around, got circulation and feeling back went back to sleep. Then the next day all day my back was sore and all my joints felt sore including my ankles, wrist, neck, knuckles, elbows, knees. Just soreness - NO FLU LIKE SYMPTOMS - but sorness all over. I left message with Doc's office. Next day my joints felt better but I awoke with splitting headache. Took aspire and all improved.

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.

Patient started to experience dizziness, profuse sweating, pale-ashen colored face, and nausea three minutes after the vaccine was administered. Offered to call EMS, but patient declined and remained conscious. Symptoms subsided after approximately 10 minutes. Patient returned home with his girlfriend.

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.

Janssen COVID-19 Vaccine Vaccine Lot Number: 202A21A Pt reported feeling light-headed 1-2mins after shot. unconscious for 15-20 sec. diaphoresis before passing out. 911 called. M410 transported to HEC Pt suffered no trauma or fall. 12 lead ekg performed with sinus brady and 1st degree. no daily meds, nkda. ran 4 miles today; oatmeal/granola, milk protein bar; 13:28 92/43 p 57 ; 105/71 P 42; 112/66 p 49

Patient experienced a vasovagal reaction, loss of consciousness, sweating over the course of several minutes.

MAGNETS ARE STICKING TO HIS LEFT SHOULDER; CHILLS; HEADACHE; MUSCLE ACHES; VERY TIRED; This spontaneous report received from a patient concerned a 45 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 (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. Concomitant medications included vitamins nos, and zinc. On 03-MAY-2021, the subject experienced chills. On 03-MAY-2021, the subject experienced headache. On 03-MAY-2021, the subject experienced muscle aches. On 03-MAY-2021, the subject experienced very tired. On 25-MAY-2021, the subject experienced magnets are sticking to his left shoulder. The action taken with covid-19 vaccine was not applicable. The patient recovered from chills, headache, muscle aches, and very tired on 04-MAY-2021, and had not recovered from magnets are sticking to his left shoulder. This report was non-serious.

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

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

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 received 1 dose of Janssen Covid-19 vaccine in left arm. That evening it was determined that vaccine had been expired after its initial 1 puncture on 6-1-21. After original puncture vial had been stored under refrigeration and a time frame of 28 hours had past . Patient was contacted on 6-3-21 notifying him of the error. Patient stated that he was experiencing "normal" side effects, ie. drowsiness, headache and chills. Patient has previously had Covid-19 in December of last year. Advised patient to consult with MD on whether to re-vaccinate due to no studies available per Janssen's Medical Info center.

Patient was severly dizziness and took it upon himself to lay down on the floor. He was also experiencing nausea, sweating on his head, and fast heartbeat which was conveyed to the EMT. He also requested an ambulance.

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.

BONE PAIN IN RIGHT SOLE OF FEET AND BOTH ARMS, FINGERS AS WELL AS WRISTS ON BOTH HANDS; INTERMITTENT FEVER; 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-smoker, and alcohol user, and other pre-existing medical conditions included no known allergies and no drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, expiry: UNKNOWN) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUN-2021, the subject experienced bone pain in right sole of feet and both arms, fingers as well as wrists on both hands. On 02-JUN-2021, the subject experienced intermittent fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from intermittent fever on 05-JUN-2021, and had not recovered from bone pain in right sole of feet and both arms, fingers as well as wrists on both hands. This report was non-serious.

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.

Patient presented to ED on 6/14/21 with 4 day history of cough, malaise and 1 day history of right flank/pleuritic pain. He was found to have a left leg DVT and bilateral pulmonary emboli. He was started on a heparin drip which he tolerated well. He was transitioned from heparin to Eliquis. He has no family or personal history nor other risk factors for DVT or PE; no long travel, no surgery, no immobilization. Hypercoag workup was initiated. He continued to have right sided pleuritic chest pain which improved during his stay. There was some question of possible community-acquired pneumonia, which he was empirically treated with CTX and azithromycin. He had normal WBC, low procalcitonin, and no fever. Patient was discharged home on 6/15/21 on Eliquis with follow up scheduled with primary care provider.

Stomach pain, extreme diarrhea, nausea. Got so dehydrated they put me an IV fluid at doctor's urgent care walk-in on 6/11/2021. My kidneys were hurting. Ciprofloxacin 500 mg 10 days, 1 tablet by mouth twice a day. Could have been a stomach virus. I still don't feel back to 100%. I still feel a little queasy every now and then. She wanted a stool sample, but I was too dehydrated for that.

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

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.

Severe chills was initial symptom, followed by moderate temperature (99 - 103), general fatigue & body ache, loss of appetite. Symptoms sustained for 48 hours.

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

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

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.

On Tuesday, June 8th, I'm driving a car on the highway and a dizzy spell hits me hard with no warning. I got the car pulled off the side of the road but my world was spinning for 2-3 minutes. It scared me enough to go the ER an hour later where I had blood drawn, EKG, CT scan of brain, overnight monitoring, and an echocardiogram. All were normal, but over the course of the next week, I felt the full force of the following symptoms: lightheadedness to the point of almost fainting, brain fog, nausea, neck tightness, headaches, anxiety, and fatigue. I had so many lightheaded moments where I felt I would pass out. My life was affected because I couldn't do anything without feeling like I would pass out. Driving more than a mile is out of the question. Fortunately, I'm a school teacher and all this started on the 2nd day of summer vacation. I certainly would not be able to teach if school were in session. How bad was my brain fog? I have kids who love to play board games like monopoly. I play 5 or more times a week. My brain fog prevented me from playing monopoly with him. It was too complicated for me to roll the dice, count the dice, move my piece the number of spaces, figure out money amounts, etc. . My family was really worried because they noticed how I couldn't think. I felt like a 90 year old man with dementia. As far as my lightheadedness, I never actually fainted, but there were many times I had the "sense of doom" feeling where I was going to die. I visited the ER again a week later and they did another EKG with normal readings again and ordered a holter monitor to be worn for 24 hours, which came back normal. When I finally got into my primary care physician on June 17th, he suspected something terminal, so he orders a brain MRA the very next day. That came back clean, so he orders me to see a neurologist. Once I received news that the brain MRA was normal, my anxiety went away for the most part--I was not going to die! The neurologist prescribed gabapentin 100 mg daily (which is anti-migraine/anti-seizure meds) and a carotid artery ultrasound, which came back clean. (Notice a pattern?) Because of the neck tightness/pain/uncomfortability, I visited a chiropractor thinking neck alignment was off. Chiro realigned me but I didn't feel any better or worse. I have had 2 visits at the chiropractor, specifically for the neck pain and seeking relief. Today, I am 6 weeks from the June 8th out-of-the-blue dizzy spell that changed my life. If I gave a percentage of how good I am today, I would give a 75%. During all this time, I've never had a fever and my blood pressure has been normal every time it's been taken. According to all these tests, I'm the healthiest man in the world--my heart, brain, bloodwork is all great. My episodes are less and less frequent, and I drove today for about 5 miles! Yay! I feel like there's light at the end of the tunnel. In the last week, I've been playing board games much better with less brain fog, but I have my moments with brain fog and lightheadedness. My neurologist and my primary care physician feel like there is no correlation to the vaccine, but the chiropractor I visited has said that he's treated multiple patients like me who are looking for relief from these symptoms in the past 4 months.

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.

Tested (+) for COVID infection after being fully vaccinated - vaccine failure. Patient presented to Urgent Care with cough, chills & nausea after known COVID-19 exposure. Patient was offered treatment with single dose of Regeneron on 7/19/21, which was accepted and received also on 7/19/21.

Vasovagal Syncope - seated talking immediately after vaccine. Suddenly stopped and fell off chair onto gym floor. Regained consciousness after 30 - 60 seconds and was light headed and was diaphoretic. No SOB, swelling, itching, hives, difficulty speaking or swallowing, hoarse voice, palpitations, CP, headache. AO x 3. No hives or rash. Ambulance called but patient declined export. Driven home by a friend. Advised to call 911 if further symptoms.

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.

Pt stated that he had experience side effect of Janssen Vaccine like Headache, Muscle aches, Fever , Pain

High fever, chills, nausea, fast heart beat started about 14 hours after the injection and lasted about 8 hours. Very achy and fatigued for an additional 6 hours after the most severe symptoms passed.

High fever (+5 deg F) from 4 hours to 17 hours after shot. Diminished to +2 deg F fever from 17 to24 hours after shot. Fever accompanied by sharp headache and fatigue.

Sore and swollen at the shot site. 24 hours after shot I experienced chills, and a bad headache that lasted all day off and on even with use of Motrin. Headache went away but still had chills and a low grade fever next day. Was really tired and fatigued for 48 hours sore hips and aching joints. Now 3 days after just a swollen itchy shot site.

Starting about 13 hours after injection, abdominal pain, cramping, nausea, upset stomach, upper stomach pain. Woke up 31 hours after injection with fever (100 F) and abdominal pain. Abdominal pain continuing throughout day and night since (now 6 days after). Loss of appetite, Continued pain in upper stomach. Just had blood labs taken to check pancreas. Labs not received yet.

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

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.

Beginning around 10:00pm the day of the vaccination, which occurred at 2:00pm, I began to experience chills and went to bed. I woke up several times during the night and felt feverish. I got up once and felt dizzy and had some body aches. At around 7:00 am the following day I took my temperature and it was 99.4 F. I took acetaminophen at 8:00 am. I went back to bed and was still feverish and sweating. I woke up at 10:15 am and felt much better. My fever was gone and I had no more chills or body aches. After that time no other adverse reactions occurred.

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.

Full body joint aches starting approx 10 hours after injection. lasting strongly until 27 hours after injection. Minor joint aches continuing at least 32 hours past injection. Treated with regular doses of acetaminophen or ibuprofen. Severe full body chills, starting approximately 11 hours after injection. Treated with multiple heavy blankets and heating pad while attempting to sleep.

Same day/evening: chills, severe headache, sleeplessness, chest pain Next morning/afternoon: fever, muscle soreness, worn down

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.

nausea and minor body aches develop around 5:00 PM low grade fever develops around 7:00 PM full body aches, fatigue, fever and chills fully developed around 9:00 PM high fever, chills, headache, and full body aches continue overnight fever breaks around 6:00 AM intermittent low grade fever, fatigue, and body aches over course of next day (24+ hours post vaccination) no adverse events (48+ hours post vaccination)

He began getting dizzy immediately after vaccine - pale, sweating, and felt like he was going to vomit. He remained in the IMZ room for observation and applied a cool compress to forehead and back of neck. Coloring came back after about 10-15 minutes and he said he felt better. Also mentioned that this happened to him after he got a TDap vaccine about 15 years ago - he said it is a mental thing with him and does not like to get vaccines.

Patient received J & J vaccine on Saturday April 3rd. On Sunday he developed a fever of 102 fever and chills. On 4/6 he developed vertigo.

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

Immediate dizziness and nauseous. Took 20 minutes to resolve. After 12 hours had extreme fatigue and muscle aches that lasted for 2 days. Could still feel some mild symptoms 4 days after the injection.

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.

I received the vaccine at 10:45AM on 04/08/2021. At around 4:30PM, I began experiencing waves of nausea and lethargy. By 7:00PM, I had a fever of about 101 F. By 8:30PM, my fever was exactly 103.46F. It was then that I took medication to bring the fever down. The fever broke overnight while sleeping. Since then, I continue to experience episodes of annoying brain fog. With hope, this will pass soon.

CHILLS; FEVER; MUSCLE ACHE; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 46 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: 1802068, and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 at Right Arm for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced chills. On 05-APR-2021, the subject experienced fever. On 05-APR-2021, the subject experienced muscle ache. On 05-APR-2021, the subject experienced headache. On 05-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from nausea on 05-APR-2021, was recovering from chills, and had not recovered from fever, muscle ache, and headache. This report was non-serious.

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

3AM woke up with high fever, headache, muscle ache from shoulders up. Treated with Tylenol to reduce fever, symptoms continued through the day. 2PM discovered large patch of hives on back from right shoulder to waist approximately 4 inches wide at the top and narrowing to 1 inch wide at the bottom. Treated with my go-to allergic reaction kit: Xyzal, Benadryl, Prednisone, and Pepcid. Hives started fading after 1 hour and were mostly gone within 3 hours, followed by 12 hours of sleep.

He received vaccine and stood to go to monitoring area, noted by vaccinator to lower self to ground. Complained of dizziness, nausea and diaphoresis. No LOC. Did not eat prior to coming to clinic. Provided with juice and crackers. VS stable throughout, He declined ambulance or call to 911. observed for 30 minutes in medical triage area and then d/c to home via friend Advised patient to follow up with PCP

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.

Heart attack after J&J vaccine - My husband, complained of on and off chest/lung discomfort after two days getting the vaccine. This continued for about 3-3.5 weeks. On the night of Apr 16, he went to bed early not feeling well. Next morning he complained of heaviness in the chest area. We immediately consulted Dr., and mentioned that he got the vaccine. Dr. advised us to immediately go to an Emergency Room. Patient was found to be having a heart attack. His right artery was 100% blocked. The 3 left arteries had no blockage at all. Angioplasty was done and he had a stent placed in right artery. The clot was removed as part of angioplasty. He now needs to be on blood thinners for life.

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

Janssen COVID-19 Vaccine EUA I did not feel well within a minute or so of receiving the shot - not an allergic reaction per se. The nurses took my blood pressure and it was 200+/100+ and HR was 108. They continued to monitor and it slowly went down over the course of the 45 minutes I was there. Upon departure, BP reading was at about 160/90. I monitored that evening and Sunday and was normal most of the time. I did have a similar feeling Sunday afternoon and Monday afternoon, and when I checked my BP it was about 150/90 and HR was elevated (between 100-115bpm). Eventually I felt better, excluding expected side effects I've had - fever, aches, and fatigue. As of Tuesday (today as of writing), I am feeling better than yesterday, less fatigue and no fever thus far. I am hoping no more episodes with the elevated BP and HR occur today or in the near future. I did notify my physician about this and he asked me to monitor my BP for the next week, stay hydrated, and report back if no improvement in BP readings.

Since taking vaccine have had chills, slight fever, headaches, fatigued and tiredness with sore muscles for 13 days since vaccination on 4/1/2021

Severe Nausea, Some Vomit, Stomach Upset, Stomachache, Mild but continuous Dizziness, Severe Fatigue, Muscle Weakness

Headache and high fever next day. Symptoms subsided within 24 hours. Treated with Tylenol. 5 days after, itchy hives all over, treated with Benadryl and cortisone cream. Severe Leg and foot swelling (left leg). Treated with steriod regemin

Date and time adverse event started: 04/11 8-9p.m. (bad headache, flu like symptoms, nausea, chills, lethargy) Adverse events experienced and are they still occurring now: aches and pain subsided , still experiencing dizziness when getting up and working, lightheaded when standing for long periods of time Recommendation: please call your doctor for a check up, I would also recommend you to get tested for COVID just to make sure you don't potentially have it

In the evening of the day I had the Janssen vaccine shot, at around 7:00pm (4/5/2021) I experienced strong chills that immediately became a fever. I took some ibuprofen and went to sleep. When I woke up in the morning the fever was gone and I felt fine.

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

24 hours after the vaccination the patient developed a delayed allergic reaction in the vaccination site (right upper arm). He developed 3 serous filled bulla with the largest measuring 5cm by 2.5cm with surrounding erythema and tenderness to palpation in the area. This was associated with headache, diaphoresis, shortness of breath, substernal chest discomfort, and sensation of throat itching. By 72 hours the bulla had popped and the patient's the only remaining symptom was right upper arm pain.

4/9/21 night, about 12hr post vaccination, developed low fever, slight pain in elbow and knees. Took Ibuprofen, recovered next day. 4/13/21 morning around 10am, 4 days post vaccination, mid-level abdominal pain lasted ~1hr, then turned into low level pain, persisted until 4/13 night. 4/14/21, feel normal. 4/15/21 about 7am, abdominal pain again, and persists. Visited family doctor at 11:00am, doctor checked, no lab work was done. Send home with prescription: Ciprofloxacin HCl 500mg Tablet, was instructed to take 1 tablet twice a day for 7 days. Took first tablet at 3pm. Abdominal pain still persists at night.

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.

Dizziness, fatigue, body aches, light headedness, very high blood pressure, mild abdominal pain. Symptoms started day after and worsened. Required an office visit by 1 week after vaccine

FEVER; MUSCLE ACHES (SHOULDERS UP); HEADACHE; LARGE PATCH OF HIVES (SHOULDERS TO WAIST); This spontaneous report received from a patient concerned a 46 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced muscle aches (shoulders up). On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced large patch of hives (shoulders to waist). Treatment medications (dates unspecified) included: prednisone, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, muscle aches (shoulders up), and headache on APR-2021, and large patch of hives (shoulders to waist) on 11-APR-2021. This report was non-serious.

days after J&J vaccine pt reported chills, headache, body aches and fatigue, BP became elevated just after vaccine but came down with rest and reassurance

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

I have had sparatic stomach pains, fatigue , Severe Headache , Muscle pain, Nausea and Pain in joints. The fatigue, knee pain and chronic headache still remains constistent since vaccination.

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

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.

BODY ACHES; HIGH GRADE FEVER OF 103; This spontaneous report received from a patient concerned a 46 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: 1805018 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced body aches. On 14-MAR-2021, the subject experienced high grade fever of 103. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103. The patient was recovering from body aches, and high grade fever of 103. This report was non-serious.

BODY ACHES; SHOULDER PAIN/FELT SYMPTOMS OF SORE JOINTS; FELT FATIGUE/EXTREMELY TIRED; 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 past medical history included exercise induced asthma, and concurrent conditions included occasional alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies. The patient was previously treated with salbutamol for exercise induced asthma. 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 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced body aches. On 01-APR-2021, the subject experienced shoulder pain/felt symptoms of sore joints. On 01-APR-2021, the subject experienced felt fatigue/extremely tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, shoulder pain/felt symptoms of sore joints, and felt fatigue/extremely tired on 03-APR-2021. This report was non-serious.

Janssen COVID-19 Vaccine EUA: two weeks after vaccination patient reported to an urgent care with right leg swelling and headache. Two days later patient presented an emergency department, diagnosed with left lower extremity deep vein thrombosis (DVT) and bilateral pulmonary emboli (PE). Transferred to current hosptial for management including anticoagulation with a direct thrombin inhibitor, intravenous immune globulin (IVIG), and additional laboratory testing.

SWELLING ON HIS KNEES; JOINT PAIN; HORRIBLE CHILLS; FEVER OF 105.9 F; This spontaneous report received from a patient concerned a 46 year old male. The patient's weight was 135 pounds, and height was 173 centimeters. The patient's past medical history included marijuana use, and concurrent conditions included penicillin allergy, alcohol use, smoker, lactose intolerance, attention deficit hyperactivity disorder, and anxiety. 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 prophylactic vaccination. Concomitant medications included clonazepam for ADHD, and anxiety, and hopantenate calcium for ADHD, and anxiety. On APR-2021, treatment medications included: ibuprofen. On 06-APR-2021, the subject experienced swelling on his knees, joint pain, horrible chills, fever of 105.9 f. Laboratory data included: Body temperature (NR: not provided) 105.9 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from horrible chills on 10-APR-2021, and fever of 105.9 f on 09-APR-2021, and was recovering from joint pain, and swelling on his knees. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious

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

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.

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).

Patient presented with shortness of breath and generalized body aches on 3/26/21. Patient has had symptoms for 3 days, with new diarrhea as well. No nausea vomiting, positive fever and chills, no loss of taste or smell. He has chest pain that is pleuritic in nature, central lower sternal region. Patient admitted to the hospital setting from 3/26/21 and still in CCU as of today (4/30/21).

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

Immediately after patient was given vaccine, the patient passed out for 1-2 minutes, then vomited, became light-headed, and broke out into sweats. After 2 minutes the patient regained consciousness, however, the other symptoms persisted for about 10 minutes.

Severe Muscle Aches began 7-8 hours after the shot Chills began 7-8 hours after the shot Elevated Heart Rate - 100BPM Resting - When i woke up the next morning Symptoms started going away roughly 24 hours after injection.

He got the vaccine, at first for about 6 hours he felt okay, did not feel anything, felt fine. Then that day he started getting a headache, feverish, took Tylenol and felt better. The next day he noticed his heart rate would not go down, it will not go down below 100, will shoot up to 130. He went to the ER and at one point went to 150. They prescribed him some medicine to lower his blood pressure and he has been taking that and it has not been helping. He also went to his doctor and told him that it was probably anxiety, and his heart rate will still not go down. He has not had any other reactions other than this and he's scared.

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.

5/5/2021 Client sent an email and stated that "After 1.5=2 weeks after the J&J, I got a headache and it still hasn?t gone away (at least 3 weeks now). I managed to get a dr appt (sic)last week and he gave me antibiotics (in case it was a sinus infection) and a strong form of aleeve (sic).? 5/7/2021 1030 Tel contact and spoke with client. Client stated that his headache is better but it is still there. He went to clinic (4/23/2021). Covid test was done with Neg result. (4/27/2021) Blood test was done in MD visit. Lab result is normal.

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

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

Patient fainted post vaccination. Patient was seated in our post vaccine area in a chair with arms. Within a few minutes patient collapsed into the floor, was hot/sweating and a little disoriented. Patient regained consciousness, applied wet compress and tested in a seated position with head down. Began feeling better. Patient provided with a bottle of water. Patient remained on our site for another 30 minutes until felt better and stable.

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.

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

PATIENT BECAME DIZZY AND FAINTED FOR A FEW MINUTES. WHEN PATIENT WOKE UP HE WAS PALE AND I CHECKED TO MAKE SURE HE WAS BREATHING. HE SAID HE WAS BREATING FINE BUT WAS VERY DIZZY. HE GOT NAUSEAS WITH SENSATION OF VOMITING.

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.

Patient received their J&J vaccination on 4/7/2021. The patient's wife tested positive on 4/12/2021. The patient tested positive on 4/23/2021. The patient presented to the ER with a severe progressive cough (starting one week prior), worsening shortness of breath, a high fever, chills, myalgias, and malaise. The patient was diagnosed with COVID pneumonia and ARDS with hypoxia and given Lovenox, remdesivir, and dexamethasone, tessalon, and Brovana. The patient was admitted on the 23rd and continued to decline until their eventual passing on 4/28/2021.

COUGH; PERSISTENT RUNNY NOSE; CHILLS; NAUSEA; FATIGUE; This spontaneous report received from a patient concerned a 46 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: Unknown) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced chills. On MAY-2021, the subject experienced nausea. On MAY-2021, the subject experienced fatigue. On 19-MAY-2021, the subject experienced cough. On 19-MAY-2021, the subject experienced persistent runny nose. The action taken with covid-19 vaccine was not applicable. The outcome of the cough, chills, nausea, fatigue and persistent runny nose was not reported. This report was non-serious.

FULL BODY FATIGUE; MILD HEADACHE; This spontaneous report received from a patient concerned a 46 year old male. The patient's weight was 165 pounds, and height was 165 centimeters. The patient's concurrent conditions included alcohol use, smoker, chronic pain, scoliosis of the 4 lower vertebrae, high anxiety, and marijuana addiction. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. Concomitant medications included fentanyl citrate for high anxiety, lorazepam for high anxiety, gabapentin for pain, and scoliosis, and cyanocobalamin for scoliosis, and back ache. On 12-MAR-2021, the subject experienced mild headache. On 13-MAR-2021, the subject experienced full body fatigue. The action taken with covid-19 vaccine was not applicable. The patient recovered from mild headache on 12-MAR-2021, and had not recovered from full body fatigue. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.

Since 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.

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.

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

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

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

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

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.

46 y/o male c/o dizziness following Janseen vaccine. Pt was diaphoretic. No PMHx, No allergies, No meds. Vitals: BP=104/65, HR = 78, RR = 22, Sp02 = 97%. BBG = 114. Pt placed on medic stretcher and monitored for 45 minutes. Pt fully recovered and cleared by medical provider to go home with family. Last vitals: BP= 122/75, HR= 65, RR= 20, Sp02 = 98% RA. Cardiac monitor revealed NSR. Pt denied any symptoms when released.

Had the following events: muscle & joint pain, persistent tiredness for 4 days following the shot. On the 3rd day following the shot I started sneezing regularly and having a stuffy head & runny nose. This lasted about 4 days. After the sneezing started to subside I started experiencing a nasty head cold which then traveled to my chest and lasted for about 5 days. Was coughing all day long. Once those symptoms started to subside, about 2 and a half weeks after the shot, I broke out in a body rash which I'm still dealing with today and seems to be getting a little worse. I'm currently at a dermatologist in the waiting room filling out this report. The rash is very itchy & at times a tad painful.

Shortness of breath chest pain severe headache. Multiple blood clots stent placed in one and taking medication now to help with the other blockages.

4/28/2021- Patient presented to ED for evaluation after a syncopal episode with fall and head injury, severe headache; loss of consciousness; bradycardia with early repolarization without acute ischemia. 6/3/2021- continued confusion, disorientation; Brain MRI shows early chronic infarct 6/14/2021- Patient presented with continued syncopal episodes, significant confusion ongoing for weeks, diagnosed with large left MCA stroke.

My dad died after he had symptoms of sweating without doing anything to increase his heart rate. He had stated his heart had been racing recently. He died suddenly and unexpectedly.

One or two minutes after administration, patient said we was feeling light-headed, and then that he didn't feel well. He was instructed to focus on his breathing. He did this for a moment (maybe a minute) and then his head fell forward and he slumped forward in the chair. He was held stable in the chair by the pharmacist. After a short time (less than a minute) the patient's upper body (bilateral arm and hand) muscles contracted (maybe a seizure?) and then he relaxed and sat up. He was alert, a little disoriented initially and had no recollection of his reaction other than feeling light-headed and unwell. He then became sweaty and felt a little nauseated. The pharmacy called 911 and the patient left with the medics. At that time he was alert and oriented, but still not feeling well.

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.

POSSIBLE OCULAR MYASTHENIA GRAVIS; POSSIBLE FOURTH CRANIAL NERVE PALSY; SINUS INFECTION; ALLERGIC REACTION; SLIGHT DIFFERENCE IN EAR PRESSURES; This spontaneous report received from a patient concerned a 46 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included marginally high blood pressure, and the patient had no allergies to medications, food, or other products. The patient had no other illnesses at the time of vaccination and up to one month prior, and no prior medical history or neurological history in the family. The patient had no adverse event following any previous vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 at 11:00 to left arm for prophylactic vaccination. Concomitant medications included ascorbic acid (Vitamin C), Multivitamins, cod-liver oil, Vitamin D, and lisinopril. On an unspecified date in MAY-2021, the patient had some vision issues/seeing double, but did not think much about it . The patient went to his Primary Care Physician (PCP) for annual physical exam where bloodwork and everything was done and it came back normal except Cholesterol, which was marginally higher. The issue was not causing much discomfort for the patient, and it sort of went away, the best the patient could recall or couldn't recall. On 14-JUN-2021, the patient started having trouble focusing with his eyes again. It was causing him more discomfort than before so he visited his PCP, on 15-JUN-2021.doctor mentioned there was slight difference in ear pressures and maybe it was that. Not totally satisfied with that, the patient visited his Optometrist the next day and he suspected 4th nerve Palsy and asked the patient to make an appointment with the Eye Center with a specialist. The patient went and saw doctor at the eye Centre, On 17-JUN-2021 and he also suspected 4th nerve Palsy. Doctor ordered Magnetic Resonance Imaging (MRI) of the brain and Orbit which the patient completed on 22-JUN-2021 (later to come back normal). As the patient waited for the results that week, his condition was slightly deteriorating whereby he had to close his right eye to walk and go up and down the stairs. Just to rule out any Ear, Nose, And Throat (ENT) issues, the patient went and saw his ENT doctor on 21-JUN-2021. His hearing was normal and he conducted a Computed Tomography (CT) scan of the sinuses and he saw some infection but did not think it was in an area which would have caused any issues with the patient's right eye. The doctor, however, did prescribe antibiotics which the patient had started. The first dose and the patient started having an allergic reaction even though he had taken it before and not had any reaction (the patient had never had any reaction to any medication prior to that in his life). So the doctor changed the antibiotic and the patient started taking the other medication. On 27-JUN-2021, when the patient woke up, he noticed his right eye to be half closed, he thought maybe he had overworked his right eye and it might get better. However, on 28-JUN-2021, when the patient woke up, it had got worse. The patient decided to visit doctor that day itself at the Eye institute. Doctor, after his examination and consulting with another neurologist, said that he suspected Cranial nerve Palsy and possible Myasthenia Gravis. doctor suggested that if the patient wanted answers right away, then check into the Emergency Room (ER). The patient did check himself that same day and the neurologists and the ER doctors immediately admitted him to the hospital and conducted multiple tests. Laboratory data included: Antibody test (NR: not provided) Unknown, Carotid angiogram (Magnetic resonance angiography-MRA) (NR: not provided) Unknown, Chest X-ray (NR: not provided) Unknown, Electromyogram (NR: not provided) Unknown, and Lumbar puncture (NR: not provided) Unknown. The patient was at the hospital till 03-JUL-2021, and released with medications and possible diagnosis of cranial nerve palsy/Ocular Myasthenia Gravis. The patient was hospitalized for 6 days. The patient was waiting for a call back from the neurologists for a follow-up appointment and further treatment, if any. The patient's symptoms of droopy eyes persist on his right eye, and both his eyes cannot focus together. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected fourth cranial nerve palsy/right eye half closed/vision issues, seeing double/closes right eye to walk and go up and down the stairs, possible ocular myasthenia gravis, sinus infection, slight difference in ear pressures, and allergic reaction. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210731014-Covid-19 vaccine ad26.cov2.s -Possible ocular myasthenia gravis, IVth nerve paralysis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

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.

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

Janssen COVID-19 Vaccine EUA (3/6) Fatigue began 4 hours after vaccine. (3/6) Severe headache, severe fatigue, moderate fever, mild aches, mild nausea beginning the next day (3/7) and lasting until (3/8). Mild headache and mild fatigue all day (3/8)

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.

Started feeling feverish at 8:30pm - roughly 10 hours after vaccination. Recorded fever as high as 102.4 at 3:00am. Fever ultimately broke and temp was normal when I woke up this morning. Just tired and head-achy now likely from poor nights sleep. Temps were taken with an oral, digital read thermometer. I will follow up if fever continues.

I had cold chills, fever all night, body aches, that lasted throughout the night. I felt better the next day.

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 ---

Fever and chills 9 hours after Ibuprofen taken within 2hours and fever broke by 2am and was completely fine to work the next morning They requested feedback so this may qualify as anticipated reaction and not adverse but I wanted to give feedback as I know many people will not

Started with sore throat and mild cough. By 11:00 PM I had body aches and chills. I could not sleep at all due to chills and body aches. I then had a horrible headache and a fever of 100.4 at 4:00 AM. I still have a headache and body aches at 10:00 AM the next morning.

Chills/shivering (at normal room temperature), Muscle & Joint aches, headache, soreness at injection site. Symptoms (except soreness at injection site) remained for 12 hours after onset. Soreness at injection site reduced to very mild after 48 hours

total body pruritic started about 6 hours after administration: per pt, started from feet, then spread to legs, lower back, sides, then forearms. he took two Benadryl and it subsided while he slept (so exact duration unknown). he did use a dose of sildenafil the night prior to getting the vaccine.

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.

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.

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.

Runny nose started maybe an hour or so after injection. Felt slight nausea around 6:30PM until I went to bed. Woke up at about 1:30AM with mild nausea. Within about 30 minutes I experienced chills. I hydrated and tried to go back to sleep. In the morning I had a fever of 100.3 degrees. Took 1000 mg of Tylenol and hydrated, another 500 mg 4 hours later. Chills came on and off throughout the day. Added layers of clothing to stop the chills. Ate breakfast and lunch. Drank G2 to hydrate. Temp bounced between 99.6 and 100.8 throughout the day. Experienced heartburn for several hours in the afternoon. Took a nap at 3:30 for 2 hours, ate, rehydrated and removed some layers to clothing and put on a cool towel on my forehead to try to reduce. Took 1000 mg of Tylenol and went to bed. Slept well. All symptoms were gone by morning.

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

soreness at injection site, body aches, fever starting about 8 hours after injection and resolved the following evening, about 30 hours after injection

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.

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

Transferred from Hospital on 4/1/21 for fever and altered mental status, suspecting adverse reaction from Janssen COVID vaccine given 3/30/21, symptom onset 3/31/21 morning. Sepsis with unknown source of infection: This is evidenced by leukopenia, tachycardia and fever. Acute metabolic encephalopathy, likely secondary to possible sepsis versus effects of COVID vaccine. Encephalitis and meningitis ruled out. Acute nontraumatic rhabdomyolysis: evidenced by elevated CK levels 1700 on admission, likely secondary to sepsis. Acute renal failure, hypothyroidism, transaminitis, elevated troponin likely associated with rhabdo. On sepsis protocol (vancomycin, meropenem and acyclovir) Disc

Headache, treated with Tylenol for three days Nausea, treated with uncrystallized candied ginger for three days Muscle aches in calves and thighs, treated with rest and Tylenol for three days Fatigue, treated by take many naps over the course of three days. Fever, treated with Tylenol for 1 day Chills on and off for three days

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

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.

Janssen COVID-19 Vaccine 10 Hours after injection, fatigue started. About 11 hours after, chills and full body pain. Headache. 18 Hours after, less fatigue and soreness. Chills gone. 40 Hours after, all side effects gone.

SHORTNESS OF BREATH; FULL BODY ACHE; JOINTS HURT; SEVERE HEADACHE; NAUSEA; SENSITIVITY TO LIGHT; LETHARGIC; This spontaneous report received from a consumer concerned a 47 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 15:25 for prophylactic vaccination. Concomitant medications included benzylpenicillin for drug used for unknown indication. On APR-2021, the subject experienced lethargic. On 02-APR-2021, the subject experienced sensitivity to light. On 02-APR-2021, the subject experienced nausea. On 02-APR-2021 01:15, the subject experienced shortness of breath. On 02-APR-2021 01:15, the subject experienced full body ache. On 02-APR-2021 01:15, the subject experienced joints hurt. On 02-APR-2021 01:15, the subject experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, full body ache, and severe headache on 03-APR-2021 09:35, had not recovered from lethargic, and the outcome of joints hurt, nausea and sensitivity to light was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.

Fever ranging from 100.4 to 101.2 and lasting from approximately 4 pm on 04/08 until about Noon on 04/09. An accelerated heart rate with occasional minor chest pain was also experienced during this time.

Severe body pain all over body lasting for one day, alternating sweating and chills, weakness in left arm

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.

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

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.

I had chills and body aches and fatigue and short breaths. Then I developed Tinittus in left ear that has continued for 4 weeks and still continues.

On the day after the injection, a severe stiffness in both legs occurred. It was a soreness and stiffness similar to the day after running a marathon race . The soreness and stiffness would not change if I was sitting, walking, standing or kneeling. It was constant discomfort and irritation. It was not painful and therefore I originally did not go to medical. There was no discomfort in my left arm at the injection site. The discomfort increased for the rest of the day. A headache started in mid afternoon and kept increasing throughout the rest of day. I have not had a headache in years. Around 7:00 PM on Thursday, I had to sleep. I was extremely tired. My body had chills and I had to wear a sweatshirt and full set of clothes to bed just to stay warm. That is very unusual. I am usually throwing off covers every night throughout the entire year. I did not eat dinner because there was no appetite. I slept in bed for at least 12 hours. Typical night sleep = 8 hours. The next morning was no issue and therefore I did not go seek medical help because there are supposed to be side effects to vaccines. Now, I am reporting it because headache and the stiff muscles were identified on the news. However, it was around 24-36 hours and not the 6 days on the news.

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.

The morning of 2 April, I woke up with a fever, chills, sweating and an excruciating headache. The symptoms persisted for approximately 10 hours. The following Monday, I woke up with sharp pains across my chest and shortness of breath. I was admitted to the hospital Emergency Room for about 7 hours and subsequently diagnosed with pericarditis. It is unknown if the pericarditis was associated to the vaccine but thought it was a good idea to document here.

Patient said he had 2 severe headaches with each followed by a nosebleed that relieved the headache. Both incidences occured 10 days after the shot. Patient called his doctor and is awaiting further instruction.

102 fever for 48 hours beginning 5 hours after injection. Stiff neck for 3 days beginning 24 hours after injection. Rash on back, chest, and feet with itching and redness beginning 13 days after injection

Started sweating a lot and got very pale soon after injection. Hours after injection got chills, muscles aches, and a bad headache that lasted days. Lot appetite for days. Overall felt like I had the flu.

PAIN; CHILLS; HEADACHE; MUSCLE ACHES; 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 ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1808978 expiry: /2023) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced pain. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced muscle aches. On 08-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.9. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, headache, muscle aches, fever, and pain. This report was non-serious.

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.

Patient received Johnson & Johnson COVID 19 vaccination on 3/31/21. Follow up telephone call made to screen patient for warning signs of blood clots. Patient reports new onset symptoms of severe headache that started occurring on 4/2/21 at 4:pm. Patient was given the recommendation to seek medical attention at the nearest emergency department for medical evaluation for blood clots due to reported symptoms. Patient denies any abdominal pain, leg pain or swelling, or shortness of breath. Patient states he does not plan to be evaluated in emergency department but will make an appointment to be seen by primary care provider. Patient educated and informed that the severe headache symptom is a warning sign of a blood clot and should seek medical evaluation at the nearest emergency department. Patient verbalizes understanding. Patient also given Nurse COVID line number.

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

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%.

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

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

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)

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.

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

Very fatigued and nauseated within hours of injection. Worsened next day and then waned over next couple days leaving only fatigue that still lingers

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

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

CHILLS; FEVER; MILD HEADACHE; BODY ACHES AND PAINS; DIARRHEA; 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 familial tremors, non alcohol user, and smoker, and other pre-existing medical conditions included the patient had no known allergies and did not had drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025, and expiry: UNKNOWN) dose was not reported, administered on 22-MAR-2021 for prophylactic vaccination on left arm. Concomitant medications included propranolol, and venlafaxine hydrochloride. On 22-MAR-2021, the subject experienced diarrhea. On 23-MAR-2021, the subject experienced body aches and pains. On 23-MAR-2021, the subject experienced fever. On 23-MAR-2021, the subject experienced mild headache. On an unspecified date, 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 diarrhea on 22-MAR-2021, and body aches and pains, fever, and mild headache on 23-MAR-2021, and the outcome of chills was not reported. This report was non-serious.

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

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

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

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).

PT HAS A PANIC ATTACK AND FELT DIZZINESS AFTER THE SHOT. HE WAS SWEATING PROFUSELY BUT COGNITIVE. WE LIED PT DOWN FOR ABOUT 5 MINUTES AND HE WAS FINE.

MAXILLARY EMBOLISM; PROFUSE NOSE BLEED; SEEMED TO BE A 3-4 INCH LONG WORM IN THE VEIN OF HIS LEFT OUTER THIGH; FELT LIKE CRAP; This spontaneous report received from a consumer concerned a 47 year old male. The patient's height, and weight were not reported. The patient's past medical history included coronary stent, and concurrent conditions included alcohol use (a beer or two a day after work), and non smoker, and other pre-existing medical conditions included the patient had no known drug 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: 041A21A, expiry: UNKNOWN) dose was not reported, 1total, administered on 05-APR-2021 to left arm for prophylactic vaccination. Concomitant medications included cefalexin for infection, acetylsalicylic acid, atorvastatin calcium, lisinopril, and metoprolol. On 05-APR-2021, within the first hour after vaccination, the patient felt like crap (feeling sick) and took a bath and relaxed after that he felt better. On 14-APR-2021, while he was taking bath he yelled at his wife and also the patient experienced profuse nose bleed which lasted for 20 minutes. These nose bleeds occur at least 4 times daily lasting about 20 minutes each time. On 20-APR-2021, the patient went to emergency room and he had a plug procedure and was discharged. On 25-APR-2021, the patient went to the hospital because his bleeding was ongoing and his Platelet count (NR: not provided) Not reported and treated him with some platelets and cauterization procedure was done. On 26-APR-2021, he was discharged from the hospital. On 27-APR-2021, still his bleeding was ongoing and he was taken back to the hospital. On 28-APR-2021, a surgery for maxillary embolism was performed and he was discharged from the hospital on 01-MAY-2021. This was very stressful for the patient and his entire family. The patient was not prone to nose bleeds and so this has been scary. A week and half after vaccination, there seemed to be a 3-4inch long worm in the vein of his left outer thigh. The patient walked it off and it do go away relatively quickly. The patient's wife was not sure that what will happen next. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from seemed to be a 3-4inch long worm in the vein of his left outer thigh on 14-APR-2021, and felt like crap on 05-APR-2021, had not recovered from profuse nose bleed, and the outcome of maxillary embolism was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210509176-covid-19 vaccine ad26.cov2.s-maxillary embolism, profuse nose bleed. 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). 20210509176- covid-19 vaccine ad26.cov2.s-felt like crap. This event(s) is labeled per RSI and is therefore considered potentially related.

CHILLS; MUSCLE ACHES; NAUSEA; SORENESS AT INJECTION SITE; HEADACHES; 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: 204A21A, 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 chills. On 17-MAY-2021, the subject experienced muscle aches. On 17-MAY-2021, the subject experienced nausea. On 17-MAY-2021, the subject experienced soreness at injection site. On 17-MAY-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and nausea on 17-MAY-2021, was recovering from muscle aches, and soreness at injection site, and had not recovered from headaches. This report was non-serious.