Johnson & Johnson

Fever started 10 hours post injection. Fever was 99.1. Also body aches. Next day was fatigued and had small rash at the base of my neck in front.

Received COVID-19 Vaccine on 03/08/2021. About 7:00 am the next morning began having N/V x4 past 12 hrs, diarrhea x 6, headache and blood in urine. Chronic illness of stage 4 kidney disease with bilateral nephrostomy and acute bloody discharge, ulcerative colitis with colostomy and acute high output, CAD with 7 cardiac stents and 2 CABG. A&Ox4, Malaise, tachycardia and hypotension, afebrile. Patient reports chronic abdominal pain unchanged today. Denies back pain, chest pain, cough, or SHOB. Afebrile. Patient has new diagnosis of UTI. IV fluids administered, IV Zofran, Meropenem, and po Hydrocodone/APAP. Transferred due to creatinine of 4.3, bloody urine, and UTI. T: 98.1 HR 91, R-14 BP 106/71, O2 sat 97%

FELT FINE PRIOR TO GOING TO BED EXCEPT MY SHOULD WAS SLIGHTLY SORE DURING THE DAY BUT GRADUALLY BECAME VERY SORE THROUGH THE NIGHT. AT 1:00AM., I AWOKE WITH A FEVER OF 99.2. AT 3:00 AM, MY TEMPERATURE HAD RISEN TO 100.2. AT 7:30 AM, MY TEMPERATURE HAD SUBSIDED TO 99.2. I TOOK 1 600 MG ACETOMENEPHEN AND 1 IBUPROHEN AS I HAD TO LEAVE MY HOUSE. WHEN I RETURNED HOME AT 1:00 PM, MY TEMPERATURE HAD RETURNED TO 98.6. I FELT DEHYDRATED AND DRANK AT LEAST 32 OUNCES OF WATER DURING THE NIGHT. NORMALLY, I DON'T DRINK ANY WATER AT NIGHT. AT THIS TIME, I.E. 7:33 PM, MY SHOULDER STILL FEELS A BIT SORE.

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

Felt poorly with myalgia, weakness and chills on first day after vaccine that did not resolve. Developed severe shortness of breath and chest pain on day 9 after vaccine and found to be in atrial flutter with rate of 160 on day 10 after vaccine. Has long ho diabetes, but no cardiac history.

fever, chills, myalgias, SOB, increase in baseline cough. Some symptoms improving after 24 hours of onset but SOB and increase in cough still present at 72 hours post-vaccination.

Flu like - low fever, chills, muscle aches, headache (left rear), fatigue,. Lasted about 24 hours from onset.

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

For 24 hours had fatigue, fever, nausea, diarrhea, lost of appetite, soreness in shot arm, and dizziness

Flushed feeling and mild headache. Medical attention not sought. Resolved on own in a couple hours.

THURSDAY MARCH 11TH VACCINE SHOT ADMINISTERED. FRIDAY MARCH 12TH DEVELOPED SWOLLEN RIGHT ANKLE AT WORK AROUND 10:30 AM. SWOLLEN ANKLE MADE MOBILITY DIFFICULT. MARCH 18TH ANKLE STILL SWOLLEN ACCOMPANIED FOR THE FIRST TIME WITH PAINFUL RED RASH AND FEVER. AS A RESULT, UNABLE TO PUT ANY WEIGHT ON RIGHT ANKLE FROM MARCH 18TH TO DAY OF WRITING THIS REPORT, MARCH 22. RIGHT ANKLE IS IN EXTREME PAIN. PATIENT HAS NEVER FELT PAIN SO SEVERE IN HIS LIFE. PATIENT CONTINUES TO FELL UNWELL.

COVID infection post vaccination 1 day following vaccination, patient experienced fatigue, myalgia and low grade fever. RA test positive. That evening, patient with increasing SOB and increasing oxygen requirement and was admitted for hypoxia + LE swelling. Although SNF where vaccination took place denied symptoms at time of vaccination, per H&P, increasing oxygen requirements were noted 3 days prior to vaccination. See H&P below He is currently residing in a rehab facility following a hospitalization detailed below, but essentially he noted some shortness of breath about 4-5 days ago. They checked his oxygen saturation and noted that he was hypoxic, so started him on oxygen (reportedly 4L NC?). He reports a worsened productive cough; sputum is dark but not bloody in color. He has been fatigued and chilled; he thinks he's been intermittently febrile. No nausea, vomiting, or constipation. He endorses twice daily diarrhea, but he associates this with his bowel regimen. He also has a fair amount of lower extremity swelling which is bothersome to him; he says this has been ongoing since his MVA in January.[KE.4] He was recently seen in Nephrology clinic, where he was started on lasix 40mg daily and started on a low sodium diet[KE.3]. He is unsure if the lasix is helping his swelling, but does have robust urine output after he takes it

"Client received Johnson & Johnson vaccine on 3/19/21 and started with symptoms on 3/21/21, he assumed it was a reaction to the vaccine." Client admitted to Hospital on 3/29/2021. Per hospital 3/30/2021: Presented to the ER with SOB and low oxygen saturations that started on 3/30. The patient did not have any complaints of shortness of breath up until that morning. He received the Johnson & Johnson vaccine on 19 March, then developed fevers, fatigue the Wednesday after his vaccine and tested positive for Covid on March 26. Patient does complain of fevers of 103 at home. He resides at home with his wife who is also sick with Covid. He was admitted with Covid pneumonia and new oxygen needs. Tested positive on 3/26.

I had a residual cough when I had the vaccine. Up to a week after vaccine, I had low grade fever and chills; night sweating and coughing seemed to be getting worse and coughing getting more frequent and worse (when it had been dry and occasional). It was ongoing for a week. I called my Doctor during that time and she prescribed me medications including an antibiotic and cold medications for the cough. The medications helped symptoms after I'd been on them awhile . I no longer have the fever and I stopped the night sweating. Cough seems to be improved.

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

Day of vaccine: No symptoms. Next day: Slightly achy, occasional mild nausea, occasional mild light-headedness. Day 2: Headache, muscle aches, bone aches, more prevalent nausea. Feel "feverish", though no elevated temperature present.

I was dizzy, lightheaded, and sweaty. I felt like I was about to pass out. The doctor gave me a cold pack, had me to lay down and checked my vitals--all were normal. I sat there for about 20 minutes until I was feeling better. I still have some soreness and lingering headaches.

Fever chills (felt very cold, shivering). Muscle aches from sole of feet to scalp. Symptoms lasted until 03:00 AM (4 hours duration). Symptoms faded in intensity over next hour until gone.

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

BODY ACHE; DIZZY; CHILLS; HEADACHE; TEMPERATURE GOT AS HIGH AS 101.8; This spontaneous report received from a consumer concerned a 60 year old male. The patient's weight was not reported and height was 170.18 centimeters. The patient's concurrent conditions included alcohol user, non-smoker, and type 2 diabetes mellitus, and other pre-existing medical conditions included the patient had no known allergies to vaccine, drug and food. the patient had no history of drug abuse, no illness at the time of vaccination, no past history of similar events, no adverse event after any previous vaccination, no pre-existing acute illness 30 days prior to vaccination, no history of hospitalization in last 30 days and no family history of any disease (relevant to vaccination) or allergy.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 to the right arm, on 08-MAR-2021 06:07 for prophylactic vaccination. Concomitant medications included empagliflozin for type 2 diabetes mellitus, and metformin for type 2 diabetes mellitus. On 08-MAR-2021, the subject experienced body ache. On 08-MAR-2021, the subject experienced dizzy. On 08-MAR-2021, the subject experienced chills. On 08-MAR-2021, the subject experienced headache. On 08-MAR-2021, the subject experienced temperature got as high as 101.8. Laboratory data included: Body temperature (NR: not provided) 101.8 deg. On 09-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99.5 deg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, chills, headache, and temperature got as high as 101.8 on 09-MAR-2021, and had not recovered from dizzy. This report was non-serious.

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

Patient informed us of previous reaction (fainting) to tetanus vaccine. Covid vaccine was administered and patient remained seated for precaution. Patient fainted and was moved to the floor in a lying position. EMS was called. Pharmacist took patient's blood pressure (148/94). Patient was able to answer questions correctly when asked. EMS arrived and checked patient's vitals. Patient declined EMS transport. Patient left to go home with wife and daughter. Pharmacist called daughter at 6pm to check on patient. Patient had a headache at that time. Will follow up with patient today.

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

Local rash (5-10 cm), pain at injection site x 4 days, Fever and chills x 36 hours, muscle aches x 36 hours, nausea, headache

At 7am Saturday - 1 degree above normal temp, body aches. Saturday evening - 2 degrees above normal temp, continued body aches. Sunday - continued body aches and weakness.

CHEST HEAVINESS; BODY ACHE; FEVER; CHILLS; FATIGUE; This spontaneous report received from a consumer concerned a 60 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic type 2, hypertension, hyperlipidemia, and social alcohol drinker, and other pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 11:00 for prophylactic vaccination on left arm. Concomitant medications included acetylsalicylic acid for drug used for unknown indication, ascorbic acid for drug used for unknown indication, ergocalciferol for drug used for unknown indication, losartan for drug used for unknown indication, atorvastatin, empagliflozin, fish oil, and metformin. On 03-APR-2021, the subject experienced body ache. On 03-APR-2021, the subject experienced fever. On 03-APR-2021, the subject experienced chills. On 03-APR-2021, the subject experienced fatigue. On 04-APR-2021, treatment medications included: paracetamol. On 05-APR-2021, the subject experienced chest heaviness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body ache, chills, and fatigue, and had not recovered from fever, and chest heaviness. This report was non-serious.

Janssen COVID-19 Vaccine EUA. Fever over 103 for several hours, reduced slightly by Tylenol, aches, muscle pain, severe headache. After about 8 hours, fever continually varied between 99 and 101 for 12 hours, continued headache, diminishing muscle pain and aches. Very tired for next 24 hours as headache and fever dissipated.

Patient stated he woke up with red welts on his left arm and experienced numbness/swelling on the left side of his face. The patient compared the numbness to the effects of novocaine at the dentist. The patient also experienced fever, chills and sweating. All of the symptoms resolved within a few hours and the patient was feeling better when we spoke later in the afternoon on 4-8-2021.

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

Effects started approximately 24 hours after injection with a mild headache. Within 2 hours of the onset of the headache queasiness and vomiting occurred.

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

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

Extreme headache / neck pain 2 days following injection. Both have continued since then, but are starting to subside. Suspect fever for days following the onset of symptoms.

After vaccination that night he was nauseated, chills, fever and days followed he had persistent fatigue and pain in both arms. He went into a Hemolytic Elliptocytosis crisis following injection.

Approximately five minutes after vaccination patient began to appear sleepy while in observation area. I walk over to the patient and by the time I got to him the patient was unresponsive. His body was rigid and breaths were erratic. He regained consciousness after about a minute or so and appeared to be alert. EMT's then arrived and took over.

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

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

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

Deceased complained of abdominal pain and was taking aspirin for a headache. He died within less than a day of initial complaints.

Immediately after giving the vaccine, the patient started sweating profusely and stated he had trouble breathing. He proceeded to pass out. The patient woke up within 30 seconds without the administration of an Epipen and was fairly alert. He continued to sweat and when EMS arrived he was reported to have a pulse of 54. BP was not reported

3/31/2021: 6-7 HOURS S/P VACCINATION: HEADACHE, FEVER, COLD CHILLS, SWEATING, AND DRY HEAVES 3/31/2021-4/1/2021: UP AND DOWN ALL NIGHT, DIARRHEA, BODY ACHES, STOMACH ACHE, HEADACHE, DRY HEAVES 4/1/2021-4/4/2021: ABOVE SYMPTOMS CONTINUED . 4/4/2021: STARTED HAVING CHEST PAIN AND WENT TO MEDICAL CENTER - ER . WAS ADMITTED TO HOSPITAL FOR TREATMENT OF A-FIB. 4/8/2021: DEVELOPED A RASH ON BACK.

CHILLS; MILD FEVER; DULL HEADACHE; FATIGUE; This spontaneous report received from a consumer concerned a 60 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid type symptoms. 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 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced mild fever. On 08-APR-2021, the subject experienced dull headache. 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 chills, mild fever, and dull headache on 09-APR-2021, and fatigue on 10-APR-2021. This report was non-serious.

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

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

At noon 8 days after I was vaccinated (Wed 04/14) I suddenly became extremely fatigued. I barely made it out of bed for the next 36 hours. The first afternoon I felt a bit feverish with chills and took a couple Tylenol which removed the feverish feeling but not the fatigue. The second night I had full body trembles on and off for about an hour - not strong enough to disturb my wife who was sleeping in the same bed. I felt much better Friday morning but there is a little lingering fatigue.

On Thursday around noon, pt. had a headache, chest pains, numbness in left arm, the ER checked his heart rate and it was 215, they did blood work which came back normal & took more blood 4 hours later to check for heart damage, They admitted him to the hospital and did an EKG the next day that did not show any negative results (you'd have to get that from the hospital) They completed an Angiogram and found no blockage. Today, April 17th, I believe they did a cat scan of his lungs to check for blood clots and I am not sure of the results.

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

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

HEADACHE; PAIN DURING INJECTION ON RIGHT ARM; PAIN DOWN RIGHT ARM; STOMACH PAIN; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's past medical history included triple bypass, back surgeries, and neck surgery.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and batch number: 1808980) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced stomach pain. On 31-MAR-2021, the subject experienced pain during injection on right arm. On 31-MAR-2021, the subject experienced pain down right arm. 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 headache, and had not recovered from pain during injection on right arm, stomach pain, and pain down right arm. This report was non-serious.

DIZZINESS; SORENESS AT INJECTION SITE; HEADACHE; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient has no known allergies.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: 21-JUN-2021) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced dizziness. On 03-APR-2021, the subject experienced soreness at injection site. On 03-APR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and had not recovered from soreness at injection site, and dizziness. This report was non-serious.

10 days after the shot, my blood pressure rose to 198/112 and my pulse went to 161. and i called 911 and went to hospital. i had a severe headache for 3 days leading up to calling 911. finally on the April 1st, i went to hospital. i had a lump on my right shoulder never there before and i felt like the lump was causing my right side of my face to be numb. The hospital refused to believe me that i had some blood clot, they downplay the incident and instead gave me a brain CT SACN and brain MRA which was negative, they kept me for observation overnight and let me go noon the next day. since i have had follow ups with my regular doctor, a cardiologist and my nephrologist. I know that reaction was due to medication, either way glad i got the shot. BUT Since this time, I am retaining water, i know this because my rings do not fit anymore, rings i had for 20 years, never ever once had a hard time to put on or remove. I know my body, thats not the worse of it. i test my blood pressure every day at requesting of my kidney doctor, since the incudent of my pressure 198/112 my diastolic on average is raised 20 points. I log this daily. here are some examples from before the medication 111/67 , 109/63 , 129/64 , 105/62 120/81. now my pressure is totally different for example, 155/88 150/91 157/90 , 134/88. nothing else changed in my life, I am exactly the same as before only now i have covid shot.. yesterday i saw the 4th doctor since i am shot up and she gave me a new pill olmesartan medoxomil, only on it one day but my diastolic pressure is still much higher than before. i dont want to die, i dont want a stroke, or a heart attach, i have a lot to live for still. nobody is helping me, doctors are just throwing pills at me and not treating root cause which i feel strongly to beleive it is from covid shot.

WEAKNESS; TIREDNESS; FEVER; NAUSEA; HEART RACING; DIZZINESS AND LIGHTHEADEDNESS; This spontaneous report received from a patient. 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 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported On 06-APR-2021, the subject experienced heart racing. On 06-APR-2021, the subject experienced dizziness and lightheadedness. On 06-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced weakness. On 07-APR-2021, the subject experienced tiredness. On 07-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart racing, dizziness and lightheadedness, weakness, tiredness, nausea, and fever on APR-2021. This report was non-serious.

April 7th cold chills lasted 20 min. April 14th a rash on both forearms and both thighs. Also had swelling of feet and hands with ankle and wrist joint soreness. April 16th started taking 4 Benadryl a day. 3 days later rash gone. Swelling and joint pain also gone.

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

Abdominal pain that lasted about an hour. Did not feel well, went to sleep, the pain was gone when I awoke.

COUGHING; SORENESS; THROAT HURTS; WEAKNESS; NOT FEELING WELL; FACE IS SWOLLEN; TIREDNESS; This spontaneous report received from a consumer concerned a 60 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination vaccinated on left deltoid. No concomitant medications were reported. On an unspecified date, the subject experienced coughing, tiredness, soreness, throat hurts, weakness, not feeling well, and face is swollen. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of the coughing, tiredness, soreness, throat hurts, weakness, not feeling well and face is swollen was not reported. This report was non-serious.

MILD FATIGUE; This spontaneous report received from a patient via a company representative concerned a 60 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination.The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 11-MAR-2021, the subject experienced mild fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mild fatigue was not reported. This report was non-serious.

BODY ACHE; CHILLS; DIARRHEA; FEVER; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic obstructive pulmonary disease, and high blood pressure, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, and batch number: 1805018) dose was not reported, once a total administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced body ache. On 11-MAR-2021, the subject experienced chills. On 11-MAR-2021, the subject experienced diarrhea. On 11-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 12-MAR-2021, was recovering from body ache, and had not recovered from fever, and diarrhea. This report was non-serious.

Immediately got hyper dehydrated. Then felt like I was going to passout soon. I ate a banana and drank pint of water. That helped 36 hours later my throught 1/2 of it, got very sore, like pins sticking inti it like a tonselitious maybe. Same time my mid/right side back started to hurt. Thought it might be gastral. Continious to this day and wordened up until today. Maybe Kidneys? or?? I was thinking again was gastral, but now I know it is not. Same pain when pressure put on it by bending, sitting in my truck against seats etc... Now I am worried. NEVEER had something like this other than a Gal Blagger which was removed.

LOSS OF VOICE; CHEST TIGHTNESS; CRAMPS IN THE STOMACH; SORE THROAT; BAD HEADACHE IN THE BACK OF THE NECK; NAUSEA; This spontaneous report received from a patient concerned a 60 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced loss of voice. On 12-APR-2021, the subject experienced chest tightness. On 12-APR-2021, the subject experienced cramps in the stomach. On 12-APR-2021, the subject experienced sore throat. On 12-APR-2021, the subject experienced bad headache in the back of the neck. On 12-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bad headache in the back of the neck, sore throat, nausea, loss of voice, cramps in the stomach, and chest tightness. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.

LETHARGIC; FLUSHED; FEELS WORSE EVERY DAY; WOOZY AND UNSTEADY; A BIT TIGHT IN THE BOTTOM OF HIS CHEST; NO ENERGY; PAIN IN ALL MAJOR MUSCLES, HURTS EVERYWHERE; NAUSEA; LOW GRADE FEVER UNDER 99F; SPLITTING HEADACHE; TIRED; RESTLESS SLEEP; This spontaneous report received from a patient concerned a 60 year old male. The patient's weight was 350 pounds, and height was 75 inches. The patient's concurrent conditions included high blood pressure, chronic lyme disease, seasonal allergies, arthritis, hives allergy, non smoker, and alcohol user. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Concomitant medications included ibuprofen for arthritis, naproxen sodium for arthritis pain, lisinopril for high blood pressure, and fexofenadine hydrochloride for seasonal allergies. On 11-APR-2021, the subject experienced flushed. On 11-APR-2021, the subject experienced feels worse every day. On 11-APR-2021, the subject experienced woozy and unsteady. On 11-APR-2021, the subject experienced a bit tight in the bottom of his chest. On 11-APR-2021, the subject experienced no energy. On 11-APR-2021, the subject experienced pain in all major muscles, hurts everywhere. On 11-APR-2021, the subject experienced nausea. On 11-APR-2021, the subject experienced low grade fever under 99 F. On 11-APR-2021, the subject experienced splitting headache. Treatment medications included: paracetamol. On 12-APR-2021, treatment medications included: acetylsalicylic acid/caffeine/paracetamol/salicylamide. On 13-APR-2021, Laboratory data included: Blood test (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tired, restless sleep, splitting headache, pain in all major muscles, hurts everywhere, no energy, lethargic, nausea, low grade fever under 99 F, flushed, feels worse every day, woozy and unsteady, and a bit tight in the bottom of his chest. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as the case assessed as non-serious

The patient developed thrombotic thrombocytopenic purpura (TTP), a week after the Janssen vaccine (Started having symptoms on March 15, 2021- speech difficulty, petechiae, fatigue, and easy bruising). TTP was confirmed by ADAMTS13 level < 5% and the presence of inhibitor on March 19, 2021. In addition, he had schistocytes, thrombocytopenia, and elevated lactate dehydrogenase. He was treated with PLEX, steroids, and Rituximab. He is currently closely monitored at Clinic.

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

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

Shortness of breath with a crackle sound which became more pronounced when lying down. I sat upright for about 1.5 hrs and respiration returned to a normal rhythm at which time I was comfortable enough to return to bed. I did not seek medical attention but monitored closely during that time and was prepared to go to the ER if necessary. As I write this I am at 22 hrs post vaccination. Respiration is fine, I have some discomfort at the injection site, a slight headache and some aches and pains which is expected.

Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Medium, Systemic: Seizure-Mild, Systemic: Shakiness-Medium, Systemic: Vomiting-Mild

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

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

Moderate headache, joint stiffness, muscle aches and skin sensitivity began 8 hours after injection and lasted 36 hours.

Coughing started right away and has gotten progressively worse. I saw a specialist about three weeks ago and I'm not bad enough to have COPD but close. Treatments with inhalers with steroids and I have been on those for two weeks. I started feeling pain in back of my left leg. I thought it was a blood clot and went to ER but it wasn't a blood clot. No treatment for that. I still feel the pain occasionally at this time. I have been taking Tylenol for it.

Patient had sweating , snoring, dizziness, shaking , throwing up .we called 911, before the paramedic came in, he started to talk and be more aware about everything around. they checked his blood sugar was 152, blood pressure was above the normal. the paramedic kept talking to him and he was responding good. Patient refused to go to the hospital

Presented to emergency department on 5/12/21 with productive cough what onset a week and half prior to presentation. Also had complaints of diarrhea, nausea, dizziness, and shortness of breath when standing. Patient had cardiac stent placed approximately 5 weeks earlier. Was found to be COVID-19 positive and was admitted for further management. He was admitted for 2 days.

SORE ARM; 103 FEVER; NAUSEA; BRUISING ON RIGHT FOREARM; This spontaneous report received from a patient concerned a 60 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203A21A and expiry: UNKNOWN) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced bruising on right forearm. On 04-MAY-2021, the subject experienced sore arm. On 04-MAY-2021, the subject experienced 103 fever. On 04-MAY-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 103 F. The action taken with covid-19 vaccine was not applicable. The patient recovered from sore arm, 103 fever, and nausea on 04-MAY-2021, and had not recovered from bruising on right forearm. This report was non-serious.

LOST ABILITY TO PERSPIRE; ELEVATED INTERNAL BODY TEMPERATURE (INTERNAL BODY TEMPERATURE THROUGH THE ROOF); This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no known drug allergies or illicit use of drugs and usually sweats normally. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced lost ability to perspire. On APR-2021, the subject experienced elevated internal body temperature (internal body temperature through the roof). Laboratory data included: Body temperature (NR: not provided) 98-99 F. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 97.9 F. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from lost ability to perspire, and elevated internal body temperature (internal body temperature through the roof). This report was non-serious.

INJECTION SITE BRUISING; INJECTION SITE KNOTTING; INJECTION SITE SORENESS/PAIN; FEVER; COUGH; INJECTION SITE HEAT; INJECTION SITE RASH; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042a21a, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced injection site heat. On APR-2021, the subject experienced injection site rash. On 02-APR-2021, the subject experienced cough. On 02-APR-2021, the subject experienced fever. On 03-APR-2021, the subject experienced injection site bruising. On 03-APR-2021, the subject experienced injection site knotting. On 03-APR-2021, the subject experienced injection site soreness/pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 05-APR-2021, was recovering from injection site bruising, injection site soreness/pain, injection site knotting, and cough, and the outcome of injection site rash and injection site heat was not reported. This report was non-serious. This case, from the same reporter is linked to 20210544451.

Within 30 minutes after the injection, my face became flush and my heatrate was racing. I went back into the clinic where I received the injection and was checked by EMT's. I was experiencing chest pain and my bloodpressure was extremely high (195/125) An EKG was done which showed irregularities and I was given Baby Asprin and Nitrogylicern. I was then transported by ambulance to Hospital and kept overnight. Several Tests were conducted including EKG's, Ultrasound, Nuclear stress test, and Enzyme Test to determine if I had a heart attack. In the end, all tests were negative and I was released from the hospital the following evening (8:00 pm). I was extremely fatigued and weak for the next two weeks and eventually recovered. The chest pain was determined to be a pulled chest muscle wwas exacerbated by the high blood pressure.

It started with severe fatigue, muscle aches & pain. High blood pressure started about 10 days after getting vaccine and peaked at 185/117. At this point I called my doctor and started blood pressure medication, amlodipine. I then noticed heart rhythm issue and rapid pulse rate and went to cardiologist.

Patient had a stroke on June 4. Developed unusual headache evening of June 3. Went to see doctor on June 4 . Bp remained elevated even after taking bp medicine . Doctors office sent him to ER. First it was said he had a aneurysm in heart which was ruled out . Then it was advised to us he had a brain stem stroke . Patient still in icu. Still in hospital as of today .06/16/2021. Patient will be going to pt therapy snd of therapy . Has dysphagia unable to eat and left side weakness . Peg tube inserted . Want to establish if Johnson and Johnson vaccination was linked to him having stroke . Patient current illness was maintained and under control until this event happened suddenly .

Began feeling like trying to catch a cold. Tired, tight chest, muscles sore. Symptoms continued for a couple weeks then a deep pain in side started. Could not stand the side pain and went to ER. Scan showed enlarged cardiac silhouette. Further tests showed fluid completely surrounding heart with inflammation in duodenum. Was taking into surgery to have fluid from heart sac drained then a drain put in.

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

AE: Dizziness, extreme fatigue, inability to stand or walk immediately after administration of vaccine. Treatment: Vitals taken; stable. Blood glucose taken; not hypoglycemic. Gave Pt water to sip on. Pt assessed by PCP and cleared to go home.

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

BODY ACHES; CHILLS; FEVER/TEMPERATURE DECREASED FROM 102.8 TO 101.5; EYES HURTING; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A24A, expiry: UNKNOWN) dose was not reported, administered on 24-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-JUN-2021, the subject experienced eyes hurting. Laboratory data included: Biopsy prostate (NR: not provided) Not reported. On 25-JUN-2021, the subject experienced body aches. On 25-JUN-2021, the subject experienced chills. On 25-JUN-2021, the subject experienced fever/temperature decreased from 102.8 to 101.5. On 27-JUN-2021, Laboratory data included: Body temperature (NR: not provided) Decreased from 102.8 to 101.5. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever/temperature decreased from 102.8 to 101.5, and had not recovered from eyes hurting, chills, and body aches. This report was non-serious. This case, from the same reporter is linked to 20210661848.

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

07/04/2021 at approx. 3:00 AM I woke up with severe chills . At approx. 6:00 AM I experienced abdominal pain and diarrhea. The diarrhea persisted for approx. 2 hours. I was very weak for the rest of the day . At approx. 7:00pm diarrhea persisted. 07/05/2021 approx. 8:00 PM abdominal pain and diarrhea started again.

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

Hospitalization Case began symptoms on 06/25/2021 consisting of productive cough, diarrhea, syncope, chest pain, and chills - reports pneumonia, diabetes mellitus, cardiovascular disease, and chronic liver disease as pre-existing medical conditions - case was transported to hospital via EMS, admitted 06/25/2021-06/28/2021

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

COVID 19 Death - 7/17/2021 - Admitted to ICU from ED with symptoms of shortness of breath, productive cough, diarrhea, and chills. Started 1 week ago. COVID19 PCR positive while in ED. Diagnosed with COVID19 Pneumonia. Expired later on same day 7/17/2021.

DIARRHEA; SICK; FEVER; COULD NOT BREATH DEEPLY; LOSS OF TASTE; LOSS OF SMELL; SALIVA LIKE FOAM; DRY COUGH WITH NO SECRETIONS; LOSS OF APPETITE; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced loss of appetite. On 27-JUN-2021, the subject experienced loss of taste. On 27-JUN-2021, the subject experienced loss of smell. On 27-JUN-2021, the subject experienced saliva like foam. On 27-JUN-2021, the subject experienced dry cough with no secretions. On 27-JUN-2021, the subject experienced could not breath deeply. On 28-JUN-2021, the subject experienced sick. On 28-JUN-2021, the subject experienced fever. On 29-JUN-2021, the subject experienced diarrhea. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Twice Negative. Treatment medications (dates unspecified) included: dextromethorphan hydrobromide/guaifenesin/paracetamol/pseudoephedrine hydrochloride, and guaifenesin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of taste, loss of smell, saliva like foam, dry cough with no secretions, and fever, and the outcome of sick, could not breath deeply, loss of appetite and diarrhea was not reported. This report was non-serious.

Headache - moderate. Facial numbness - started at the nose, across the bridge of the nose and upper cheeks, then spread to entirety of face. Face is still somewhat numb 55 minutes after symptoms began. Headache also still present.

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

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

About 14 hours after receiving the injection, I started to have some minor chills. After 24 hours of receiving the injection I also developed a fever of 100.4, felt slightly achy, and had a headache. My symptoms lasted for about 36 hours total. I drank a lot of water, had a normal appetite, and took some Tylenol.

Headache, cold chills, body aches, and fever of 100°F. The effects lasted for 10 hours and was back to normal by morning.

Fatigue starting around 12:00pm on 03/09/2021 lasting till I went to sleep about 8:30pm. Then some mild fatigue on the 10th till about 5:00pm.

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

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

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

Approximately beginning 10 hours after injection, I began running a temperature last measured at 99.9. Followed by chills. Bed time and 2 ibuprofen alleviated symptoms. Fatigued and sluggish for next 24 hours.

I felt fine all day and that evening but over night while sleeping l developed severe chills. It resolved over the course of the next day.

Adverse event: Chills (@ 12:45 a.m.) Treatment: took 3 aspirin Time course: lasted 3 hours. Outcome: no current symptoms

fever, chills, localized discomfort, body aches, strong headache - significantly better at 48 hours post dose and resolved by 72 hours post dose - rest/sleep, ibuprofen

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

The patient received the vaccine on 3/16. He developed fever and cough on 3/24 and he tested positive for SARS-CoV2 on 3/25/2021 by PCR of nasal swab.

Developed mile flu like symptoms on Sunday night at 9:30 - chills, muscle aches, fatigue. Spent Monday in med. Feeling normal, if a little weak, on Tuesday morning. (Today.)

Shortly before going to bed I became feverish (102.5 degrees) and had a headache. Was able to sleep, and by morning the fever was down to 100 degrees. I still felt very tired and headachy. I got up and had a small dish of cereal and then slept most of the morning. By the afternoon the fever was gone, however had a headache and fatigue. Took a Tylenol about 4 pm (24 hours after receiving the injection). Headache cleared by the end of the day. Still somewhat fatigued 72 hours after receiving the injection. Stayed hydrated through the whole period.

Got covid shot and then told staff at clinic didn't feel good. Patient was pale and cool and sweaty and so given epi. Medics got there and blood pressure high and heart rate high and patient was non verbal and having intermittent jerking. At time of evaluate patient intially refused to speak to me but then would speak. Having intermittent jerking and when would be touched would jerk violently in arms and legs but this was distractable. States when got shot felt pressure in head which going away

Pain at the injection site, chills, low-grade fever (100.1 was the highest recorded), body aches, extreme fatigue. All symptoms lasted approximately 60-72 hours then felt completely back to normal. Onset of symptoms was 10 hours after receiving the vaccine.

Started with body aches at 5:35PM on 4/1, and slight fever of 99.4F. Both increased into the evening and lasted all night. Highest recorded temp was 100.8F at about 2:30AM on 4/2. By 6AM on 4/2. the fever dropped to 99.4F.

Fever/Chills/Headache/Muscle Aches/Fatigue following day; acid reflux appeared on second day after vaccine and fatigue continued and has continued since vaccination; daily medication doubled for acid reflux but has not gotten it under control; continue to wake up with acid reflux and fatigue daily.

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

HEADACHE; FEVER; BODY ACHE; CHILLS; This spontaneous report received from a patient concerned a 61 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, Expiry) dose was not reported, administered on 25-MAR-2021 at 18:30 to the left arm for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced headache. On 25-MAR-2021, the subject experienced fever. On 25-MAR-2021, the subject experienced body ache. On 25-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient was recovering from headache, fever, body ache, and chills. This report was non-serious. Additional information received from patient on 31-Mar-2021. The following information was updated and incorporated into the case narrative: Due diligence was scheduled. Upon review, the following information was amended: Vaccination site was updated in therapy details and narrative.

Reported by mid Sunday am inability to void or have BM. Stated with temp, chills and feeling clammy that same day. Temp running 101.5. Taking Tylenol. States followed up with PCP on Wednesday 4-7-21 and reported had COVID test done that was negative. Pt's wife called back today and reported still taking Tylenol every 4-6 hours and temps spiking up to 100.9 with clammy skin. Pt reported feeling some better today.

Soon after shot felt sweaty - dizzy - that is all he remembers. States he was very nervous on arrival and does not like needles. Patient observers states they noticed patient coughing and then he passed out.

Got the vaccine ant 8:30 am started getting fever at 4:00 pm same day.fever went to 101.6 at midnight same day Also had body aches

FLU LIKE SYMPTOMS; CHILLS; SHIVERING; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a 61 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 flu like symptoms. On 21-MAR-2021, the subject experienced chills. On 21-MAR-2021, the subject experienced shivering. On 21-MAR-2021, the subject experienced nausea. On 21-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms, chills, shivering, nausea, and headache on 22-MAR-2021. This report was non-serious.

Chronic cough and chest congestion still going on after almost Three weeks. Chest X-ray shows no infections

Severe chills shaking for over 2.5., severe headache fever spiked at 104.2,. Next two days had mild fever 100.1 and tired, aching muscles

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

Headache, body ache, flu like symptoms, shortness of breath All within an hour afterwards and remaining still. Taking aspirin with no relief

patient reports that the day after his vaccine her broke out in hives covering his entire upper body including torso, back both arms, neck and face. hives last for 24 hours required treatment with OTC benadryl l at home. hives went away after 24 hours and have not returned. patient also reports high fever of unknown because they did not have a thermometer for 24 hours

I had no symptoms at all until the next morning when I woke up with a horrible backache. For all that day and the next day I was lethargic, just wanted to sleep, had mild bodyaches, and a very slight headache. not bad at all, especially compared to COVID-19!

Extremely severe headache that lasted 48 hours. Low grade fever and general flu like symptoms. I was tested for Covid and flu. Both tests were negative. The symptoms resolved.

ACHES; CHILLS; TIREDNESS; This spontaneous report received from a patient via a company representative concerned a 61 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced aches. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches, chills, and tiredness on 11-APR-2021. This report was non-serious.

CHILLS; FEVER; This spontaneous report received from a consumer concerned a 61 year old male. The patient's height, and weight were not reported. The patient's past medical history included brain injury, and concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included patient had no known allergies or drug abuse/ illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 201A21A expiry: 23-JUN-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: Body temperature (NR: not provided) 102 F. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and chills. This report was non-serious.

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

Feeling unwell. "Burning" head to toe, shakes, near syncope, sweats, tiredness, dizziness, lightheaded. Onset of symptoms less than 1 hour. Patient denied symptoms of chest pain, (L) arm pain, or SOB. Patient sent by EMS to local emergency department.

BODY ACHES; LIGHT HEADEDNESS; STOMACH ACHE; CHILLS; LOW GRADE FEVER; This spontaneous report received from a consumer concerned a 61 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no medication allergy. 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 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, light headedness, stomach ache, chills, and low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the low grade fever, chills, body aches, light headedness and stomach ache was not reported. This report was non-serious.

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

CHILLS; NAUSEA; HOT FLASHES; FEELING HOT AND COLD; This spontaneous report received from a patient concerned a 61 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported 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 hot flashes. On 05-APR-2021, the subject experienced feeling hot and cold. On 05-APR-2021, the subject experienced nausea. On 06-APR-2021, the subject experienced chills. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 98 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hot flashes, chills, nausea, and feeling hot and cold. This report was non-serious. This case, from the same reporter is linked to 20210424684.

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

CHEST TIGHTNESS; LEG HEAVINESS; LEG TIGHTNESS; TIREDNESS; THROAT CLOSING UP ON HIM; SWEATING; DIZZY; This spontaneous report received from a patient concerned a 61 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high cholesterol, pollen allergy, asthma, chronic obstructive pulmonary disease, colon disorder, non smoker, and non alcoholic, and other pre-existing medical conditions included no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with cefalexin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: 25-MAY-2021) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, Laboratory data included: Blood test (NR: not provided) high cholesterol. On 06-APR-2021, the subject experienced throat closing up on him. On 06-APR-2021, the subject experienced sweating. On 06-APR-2021, the subject experienced dizzy. On 07-APR-2021, the subject experienced tiredness. On 13-APR-2021, the subject experienced chest tightness. On 13-APR-2021, the subject experienced leg heaviness. On 13-APR-2021, the subject experienced leg tightness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, and dizzy on 06-APR-2021, and had not recovered from throat closing up on him, tiredness, chest tightness, leg heaviness, and leg tightness. This report was non-serious.

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

LEG RASH; HEADACHE; This spontaneous report received from a patient concerned a 61 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A27A, and expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. Concomitant medications included isosorbide. On 02-APR-2021, the subject experienced headache. On 14-APR-2021, the subject experienced leg rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and leg rash. This report was non-serious.

the next morning and the following two mornings after the shot I had severe headaches. Theu went away without medication fairly quickly the first two days after I got up.. the third day after about an hour I went out and got some advil to get rid of it. About a week after the shot I started getting a rash under my arms and in the ground area. This got worse every dah and spread to .other parts of the body as time went on. Better today (april.23) but still very uncomfortable.

SWEATY; CHILLS; FATIGUE; This spontaneous report received from a patient concerned a 61 year old male. The patient's weight was 240 pounds, and height was 74 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: 1805029 -last # unclear to caller, and expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 15:30 hours to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced sweaty. On 14-MAR-2021, the subject experienced chills. On 14-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweaty, chills, and fatigue on 14-MAR-2021. This report was non-serious.

TIREDNESS; SEVERE BODY SHAKES WITH TEETH CHATTERING; CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a male. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included alcohol use, and cigarette smoker, and other pre-existing medical conditions included 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, intramuscular, batch number: Unknown, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 17:00, in left arm, for prophylactic vaccination. No concomitant medications were reported. On 10-JAN-2021, Laboratory data included: Blood test (NR: not provided) Normal. On 10-MAR-2021, the subject experienced severe body shakes with teeth chattering. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced headache. On 10-MAR-2021, the subject experienced fever. On 11-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe body shakes with teeth chattering on 11-MAR-2021, was recovering from chills, and headache, and had not recovered from fever, and tiredness. This report was non-serious.; Sender's Comments: V1: Medical assessment comments not required as per the standard procedure as the case is assessed as non serious.

Burning and tingling pain on left side of head and face getting progressively worse. Hurts worse to move facial muscles or touch skin at area. No lesions.

This spontaneous report received from a patient concerned a 61 year old male. The patient's weight was 188 pounds, and height was 174 centimeters. The patient's concurrent conditions included non-alcoholic, and non-smoker, and other pre-existing medical conditions included no allergies, no history of drug abuse, no any other medical history or relevant pre-existing conditions, no any other medication at the time of adverse event started, no past history of similar event, no history of allergy to vaccine, drug, or food, no adverse event after any previous vaccination(s), no pre-existing acute illness 30 days prior to vaccination, no history of hospitalization in last 30 days, with cause, no family history of any disease (relevant to vaccination) or allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 09-MAR-2021 on muscle for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced very sick. On 14-MAR-2021, the subject experienced runny nose. On 14-MAR-2021, the subject experienced sore throat. On 14-MAR-2021, the subject experienced cough. On 14-MAR-2021, the subject experienced weakness. On 14-MAR-2021, the subject experienced mild nausea. On 17-MAR-2021, Laboratory data included: PCR (NR: not provided) Negative, and SARS-CoV-2 test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very sick, runny nose, sore throat, weakness, and mild nausea on 19-MAR-2021, and was recovering from cough. This report was non-serious. Additional information was received from the patient on 22-Mar-2021. The following information was updated and incorporated into the case narrative: Reporter's details (first, middle and last name, address, city, zip code, state and phone number), patient's details (date of birth, gender, disease tab, age at the time vaccination, height and weight), social history, events added (cough), details for all events (outcomes, start and end date), site of vaccination, therapy start date and end date and lab data were added.

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

Persistent headache present daily for the last 18 days. Temporary relief with ibuprofen. Left calf pinpoint cramp, no swelling. Fatigue, low energy.

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

3/18/21 about 6 hours after vaccination- severe muscle cramp Left Leg. Woke about 6am, 3/18/21 with severe headache, muscle aches, temperature 102 degrees Fahrenheit and weakness. I called my physician?s in between help line and left a message.

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

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

Five minutes after receiving the Janssen vaccine, this patient was observed to be diaphoretic sitting in the post vaccination observation area by this nurse. Patient was alert and oriented x 3. Patient reported that he felt nauseous and felt like "passing out". Vital signs were assessed by this nurse and paramedic. Patient's vital signs were normal. Symptoms resolved shortly after vital sign assessment and 5 minutes after first reported. Diaphoresis resolved. Nausea resolved. Patient denied "feeling like passing out". Family escorted and drove patient home after he completed his 30 minute observation. Patient encouraged to call 911 or his PCP if symptoms reoccur.

Saturday evening May 1 I met with nine friends (all vaccinated) and ate a lot of food, drank moderately, and then did not sleep well. Approximately noon the next afternoon (Sunday, May2) while driving I noticed a developing dry-cough, chest congestion, and general fatigue. While camping that night I had some chills, thought I might have a bit of a fever, and had little appetite. I arrived home Tuesday, May 4 coughing a lot and very fatigued. Wednesday morning I went in for a Covid test. My cough and fatigue continued to increase along with muscle pain and headache. Wednesday night my fever topped out near 104. It broke and I felt much better but for the next few days (until around May 11) it fluctuated between normal and around 100-102. The Covid test came back negative but I went back for another just in case. It too came back negative. My temperature has now stabilized, the cough and congestion are mostly gone. I'm still a bit tired but feeling much better. It seemed like a case of Covid without the Covid. I am glad I got vaccinated but that was rough.

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

Chills at 12 hours after shot. Abdominal aches around the rib cage and gut starting 48 hours after shot. Aches were severe for 14 days, moderate for 12 additional days, mild for 10 additional days. Treated abdominal pain with Advil. Shortness of breath after mild exertion - like walking the dogs around the block. Shortness of breath still persists today after 5 weeks. I am concerned the shortness of breath may be due to a PE blood clot.

Within 24 hours pain in left side of left chest, in 48 hours pain on full left side of chest, within 72 hours pain through entire chest. Hospitalized within 72 hours, chest pains, catheterized within 120 hours, had a blood clotting issue, put into medically induced coma for three and a half days, followed by a pulmonary embolism and four (4) clogs, two (2) in either leg, within two weeks. Hospitalized twice, currently on three blood thinners, a beta blocker, pepcid, a statin, and one other. Expected to be on three blood thinners for at least three (3), most likely six (6) months. Start cardiac rehab on 5/19/21. Have chronic cough and chest discomfort. Expected recovery time: six (6) months.

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

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

Patient began sweating and feeling lightheaded shortly after vaccination at approximately 1125. Patient then fainted in his chair and was initially non-responsive to the nurse. At this time I called 911. The nurse administered a single epi pen in patient's quad and he woke up. The nurse then took patient's vitals at 1138: BP - 109/73; P-84; SPO2-99%; T-97.4; R-16. Patient stating he was still feeling dizzy and fatigued. The paramedics arrived and took patient to hospital for continued evaluation. I called patient later in the afternoon and he had already been discharged and was at home resting and feeling better.

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

VOMITING; DIARRHEA; ACHES/ PAINS; FEVER; POUNDING HEADACHE; SWELLING AT INJECTION SITE; This spontaneous report received from a consumer concerned a 61 year old male. The patient's weight was 215 pounds, and height was 74 inches. The patient's concurrent conditions included non-smoker, and other pre-existing medical conditions included no known allergies.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. Concomitant medications included tadalafil for gastric disorder, colestipol, and levothyroxine. On 24-MAY-2021, the subject experienced vomiting. On 24-MAY-2021, the subject experienced diarrhea. On 24-MAY-2021, the subject experienced aches/ pains. On 24-MAY-2021, the subject experienced fever. On 24-MAY-2021, the subject experienced pounding headache. On 24-MAY-2021, the subject experienced swelling at injection site. On 25-MAY-2021, Laboratory data included: Body temperature (NR: not provided) 103 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from fever, vomiting, diarrhea, aches/ pains, pounding headache, and swelling at injection site. This report was non-serious.

Patient received vaccine on Thursday evening. He began to feel very tired Monday and Tuesday. Wednesday he woke up in alot of abdominal pain. We went to healthcare facility at 4:30pm. He was diagnosed with Acute Pancreatitis. He was sent home at 10:30pm We went back to ED at 1:30 am Thursday. He was admitted during the day. In the early morning of Friday May 28th his blood pressure tanked and he became unresponsive. His heart stopped and they did compressions for 8-9 minutes. He was put into ICU. By 3am we were told he may not survive. By 5 am we were told his organs were shutting down. He passed around 7:45am. In researching the vaccine we discovered the SARS virus used in vaccine can attack the pancreas. We believe he died as a result of the reaction to the vaccine and his body and organs could not fight.

Patient experienced soreness at injection site and fatigue for about 12 hours after vaccination. on 05/18/2021 began experiencing pain at top of shoulder, radiating to front of shoulder, up neck and down to fingertips.

PLATELETS WERE REALLY LOW DOWN TO 6; COUGHING SPOTTY BLOOD/COUGHED UP A MOUTH FULL OF BLOOD; SINUS INFECTION; BUNCH OF RED LITTLE DOTS ALL OVER BODY/WORSE ON RIGHT LEG/LIKE HEAT RASH; This spontaneous report received from a patient concerned a 61-year-old white and not Hispanic or Latino 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: 1808982, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAY-2021, the patient experienced bunch of red little dots all over body which was worse on right leg like a heat rash. On 29-MAY-2021, patient thought he had sinus infection and started coughing spotty blood and then coughed up a mouth full of blood on 30-MAY-2021, went to emergency room because he was still coughing out blood. Patient's doctor found that patient's platelets were really low down to 6. Patient's doctor gave him bunch of steroid and platelets. Patient was hospitalized on 30-MAY-2021 and discharged on 01-Jun-2021 and was given a steroid 40 mg a day. The patient recovered from coughing spotty blood/coughed up a mouth full of blood on 01-JUN-2021, and sinus infection, recovered with sequelae from platelets were really low down to 6 on 01-JUN-2021, and was recovering from bunch of red little dots all over body/worse on right leg/like heat rash. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 : 20210616684- JANSSEN COVID-19 VACCINE-Coughing spotty blood , platelet were really low below 6. 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 patient first exhibited diaphoresis, then was thirsty. He was then unresponsive and started seizing, and lost control of his bladder. The seizure lasted approximately 1 minute. Emergency services were contacted, and they assessed the patient after the event. He was released from their care back into the community.

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

Immediate vasovagal syncope at time of injection AEB brief loss of consciousness, diaphoresis, and pallor noted. Lowered pt to floor and elevated BLLE w/ chair. Pt awakened to smelling alcohol pad and verbal cues. calm and cooperative, AOx4. Denies pain, denies SOB. Taken to MedObs via litter where pt was assessed and encouraged to eat snack and drink water as pt reports he has not eaten or had any fluids today. Pt drank 1 bottle of water and declined a snack. Pt VSS though BP elevated and pt encouraged to monitor daily at home and f/u w/ provider. Pt allowed to leave at approx 1405 after 30 minutes, VSS and reported feeling "fine" Not edema, erythema, hives, SOB or any other s/s allergic reaction noted VITALS 1337 sitting HR 86, RR 18, BP 163/98, O2 96%RA 1342 sitting HR 84, RR 16, BP 146/96, O2 96%RA 1347 sitting HR 74, RR 18, BP 161/100, O2 96%RA 1354 sitting HR 76, RR 18, BP 156/94 (manual BP), O2 98%RA 1400 standing HR 80, RR 18, BP 168/98, O2 96%RA

Flu symptoms 12 hours after the vaccination that lasted for another 12 hours. Fatigue the rest of the week. Intermittent fatigue for the next few weeks. On 5-11-2021 another bout of flu like symptoms that lasted 2 days. Started having severe back spasms randomly for the next 2 1/2 weeks. On 5-30-2021 the back spasms became so severe and painful I was rushed to the ER. The first diagnosis I received was a Plural Effusion caused by a bacterial infection that later turned into Pneumonia, requiring a chest tube in my right lung, and a 10 day hospital stay. Before I was hospitalized I had no fever, no cough, no shortness of breath.

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

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

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

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

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

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

apr 24, 21 woke up with swollen face on right side and numb face and fingers and toes. went to dentist 4/27 dr said massive infection, got keflex 500 2 stat, then 1bid , took for 10 days. 4/30/21 full facial paralysis, hands numb, feet numb from arches forward and burning pain in hips and legs and lower back and headache. went to er 5/3/21. they diagnosed w/ lyme disease. started on doxycycline 100mg twice daily for 10 days and asked him to finish keflex too. pt reported zero energy. Went to dr. early 5/7/21 for results from tests run at hospital. Early didn't have results and extended doxycycline to 21 day treatment. (21 day doxycycline and 10 day keflex treatment were both completed) Pt asked early to refer to Dr. pt saw dr 6/1/21. Dr diagnosed w/ guillan barre syndrome. drew labs and did mri and spinal tap. started immunoglobulin tx, plasma transfusions on 6/13/21 for 5 days. had some improvement but currentyl still has partial facial paralysis, hands are tingly but not numb, feet are still numb, pain in hips and legs is gone. after tx, DR said results are not conclusive but there are certain aspects of lyme but he does have gbs. not clear if from shot or tick. tick discovered 4/15. tick was attached.

SHINGLES; FEELING TIRED; This spontaneous report received from a patient concerned a 61 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, and neuropathy, 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: 1808980, expiry: JUN-2021) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAY-2021, the subject experienced shingles. On 14-MAY-2021, the subject experienced feeling tired. Laboratory data (dates unspecified) included: HbA1C (NR: not provided) High. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling tired, and shingles. This report was non-serious.

Sudden onset of severe headache, chest pain, difficulty breathing, fatigue and nausea, ~72 hours post vaccination. After 16 hours of bad symptoms that got worse, I took my husband to the ER, as he was having difficulty breathing and moving. (He is normally very fit, active and healthy). In hospital, they ran a battery of tests and found signs of inflammation in chest and lymph nodes. They gave him fluids, and intravenous pain meds (acetaminophen, Toradol), which helped slightly. Symptoms diminished slowly over next 24 hours, and he was feeling 90% better by Saturday afternoon.

blood pressue 96/42. patient sweating. feeling dizzie like he was about to pass out. provided food/water and constant monitoring until symptoms resolved

Systemic: Fainting / Unresponsive-Medium, Systemic: Fainted but seems responsive-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Patient fainted from sitting after vaccination. No difficulty breathing/swallow, thus gave water and gatorade. He was responsive to my questions. He has history of anxiety to needles and he did not eat lunch before vaccine. He stayed seated for 1 hour to monitor. Then, walked an aisle before driving home. Asked him to eat first before driving home. Called him twice and he is home and feeling okay. Counseled to call pharmacy if any symptoms of allergic reaction to vaccine.

Muscle ache, headache, fatigue -- essentially severe flu-like symptoms beginning at approximately 10 hours after the injection and lasting for 10 hours.

On Monday March 8th I went to the Pharmacy to get the Johnson & Johnson Covid vaccine under the new 1b guidelines. I am a 62 year old white male with type 1 diabetes, insulin dependent for the past 49 years. I filled out the question form I was presented by the staff and then was given a dose of the J&J vaccine. This vaccine was administered at approx. 1:30 p.m. I was asked to wait 15 minutes to see if I had and acute reaction, following none, I was told I could leave. There rest of the day I was fine. I went to bed at 11:00 p.m. and within 15 minutes I was cold, shaking and sick on my stomach. I took my temp and it was 100.2 F My O2 sat was 95% and heart rate was 120 with feelings of palpitations from time to time. I went to the bathroom and stayed there the rest of the night with frequent vomiting and loose stool. Stomach cramps all night long. Several BGL were taken and even with an insulin pump I was not able to lower my 299 level for over the next 24 hours of repeated bolus. I was finally able to stop dry heaves and fall asleep for moments at a time around 5:00 a.m. My temp finally broke around 11:00 a.m. the next day Tuesday. I had a headache this entire time. I called hospital ( Ask a Nurse ) on Tuesday morning around 8:00 a.m.and enquired about side effects for this vaccine and effects on a type 1, they basically told me to go to the ER or Clinic and be seen by a Physician. I choose not to do either, but to monitor myself and see how the rest of the day went. The first time, other than a headache and complete body soreness my vitals and BGL, were WNL, was late Tuesday evening around 7:00 p.m. This was a horrible set of side effects. Onset was within 11 hours from injection. No warning for type 1 people to be careful for the possibilities of increased BGL. Today is Wednesday March 10th, and my vitals have remained WNL, but I still have a mild headache and body soreness, some maybe from the vaccine but I believe mostly from the throwing up. Today is March 11th, my vitals are still WNL and BGL is in target. BGL control is responsive to pump therapy now. The past 2 nights I have awoken in a cold soaking sweat that cannot be tied to a low BGL. My body is somewhat still soreness.

Intense chills began about 9 pm. Lasted till about 10:30 pm. At about 9:30 pm, the aches kicked in in most joints in my body. Back, shoulders, knees, elbows,

6 hours after shot, severe headache and chills. 10 hours after shot vomiting every 1/2 hour for over two hours. 12 hours after shot went to ER . could not hold down fluids. was given IV and anti-nausha medicine. headache lasted two days.

Chills, Fever. Fever started about 10 hours after injection. Highest fever was 101.9 lasting through the night and was back to normal by 0800 next day. Took Tylenol at night...

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

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

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

ive had a sore throat and very hoarse, been checked for strep and it came back negative. its been a week and still not improving.

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

Patient experienced perspiration, dizziness, and fainting with no loss of consciousness. Patient was talking and answering questions appropriately. B/P 120/80, FSBS 131 @ 1:52PM. EMS was notified and Patient was transported to local hospital. I spoke with the patient today and he states he was discharged from hospital and everything was fine. He states he is doing good today.

Fever 101.3 F Headache Stiff Neck Fatigue Started roughly 24 hours after injection and lasted all day. Woke up on 3/27/2021 with none of the above symptoms. On 3/27/2021 and 3/28/21 had 2 bouts of intense sweating during the day.

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

Janssen COVID-19 Vaccine Body ache, fatigue, cold or flu like symptoms. Ate lunch and took 500mg Tylenol and one aspirin and feel better.

I got the shot on a Saturday. On Sunday morning i felt ill, my chest was hurting. By 3:00 pm it started to feel worse. I took my blood pressure at home and it was extremely high. My wife called my Doctor who said go to the E.R. Once there they took my blood pressure and it was over 200. The ER Doctor gave me a nitroGlycerin pill to get the blood pressure down. They did multiple test on my heart. The pain went away once the blood pressure went down. I spent the nite in the hospital and was released after numerous test the next day.

High fever, dizziness, weakness, sore joints, headache, diarrhea. Started approx. 8 hours after injection, worsened over the night, lasted into the next day.

FEVER; BODY ACHES; This spontaneous report received from a consumer concerned a 62 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included latex allergy. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808609,expiry: UNKNOWN) dose was not reported, administered to left deltoid on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-MAR-2021, the subject experienced body aches. On 29-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine was not applicable. The patient recovered from fever on 29-MAR-2021, and had not recovered from body aches. This report was non-serious.

Sore arm. Starting at night, slight fever and headache. Feverand headache persisted through much of the next day (04/07/2021). During the day, temperature checks (with infrared thermometer on forehead) ranged from 99.1 deg F to 100.1 deg F.

Patient fell to right side while sitting in chair hitting back of head on wall and floor. Unresponsive, diaphoretic and pale . Patient was unresponsive for approximately 30 seconds. He said "the last thing I remember is feeling like I needed to take my mask off, then I saw yall standing over me." Pt denied "passing out" in the past. EMS called and the patient was taken out on a stretcher by EMS but refused to be taken to the hospital.

Patient fell to right side while sitting in chair hitting back of head on wall and floor. Unresponsive , diaphoretic and pale. Pt was unresponsive for approximately 30 seconds. He said "the last thing I remember was feeling like I needed to take my mask off, then I saw yall stating over me." Pt denies "passing out" in the past. EMS was called and patient was taken to ambulance on a stretcher. He declined to go to the hospital.

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

ELEVATED BLOOD PRESSURE; RUNNY NOSE; HEADACHE; TIREDNESS; This spontaneous report received from a consumer concerned a 62 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced headache. On 09-MAR-2021, the subject experienced tiredness. On an unspecified date, the subject experienced elevated blood pressure, and runny nose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the elevated blood pressure, runny nose, headache and tiredness was not reported. This report was non-serious.

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

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

After 10 minutes of vaccination, patient was sweating and dizzy. Ambulance team arrived check the vital signs which were stable. Patient was alert and conscious at the movement. He indicated that he wanted water. The ambulance team allowed him to drink about 1 sip (10-15 ml) of water. Then he had tachycardia. Then ambulance took him to the hospital. His wife was with him.

Extremely tired the next day. Some aches the second day (more like having over exerted, not like flue or cold aches).

patient called and notified us that the was having symptoms of headache, fatigued, weakness, and chest heaviness a day after receiving the Janssen COVID immunization. Symptoms present for 4 days. Patient sent to ER for evaluation of chest heaviness on 4/13/2021 when patient called office.

About 10 minutes after getting the shot, while waiting in the Doctor's waiting room, I began to feel dizzy and began sweating. They moved me into an exam room, and which time I passed out. I was awoken by the doctor standing over me, rubbing my chest. I was subsequently transferred to the ER.

24 hours after injection, experienced bad headache ; muscle aches throughout body, mostly back area; overall malaise and spent much of the day resting. Felt better after 48 hours. Felt fine on day 2 and 3 after injection. Next, on fourth day after injection experienced bad headache (current situation). I have not sought medical care as I feel it is not severe enough.

3/25/2021 - 3/31/2021: Mild leg and hip pain 4/01/2021 - 4/07/2021: Severe leg, hips, knees and elbow pain 4/08/2021 - 4/12/2021: Bad headaches, sinus infection, continued joint pain, severe hip pain

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

puffy hands and feet (inflammation) -- shortness of breath (1 night), Headaches (mild), lethargy (2 days)

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

I was fine until the vaccination, 8 days later after running a low fever for the 8 days I got tested positive for COVID-19. I have had severe breathing issues and am still not well. I started 6 days ago and is not gone. The vaccine should be outlawed. I have never in my life been so sick after the vaccine!!!!!

Headache, dizziness starting several hours after vaccine administration and persisting for the past week.

patient stating that he started having runny nose and sneezing on 04/13/21 after receiving vaccine on 04/07/21. Patient is advised to contact his primary care provider and take OTC antihistamine.

WHOLE BODY ACHES; DRY COUGH; FEVER; HEADACHE; NAUSEA; This spontaneous report received from a consumer concerned a 62 year old male. The patient's weight was 205 pounds, and height was 69 inches. The patient's concurrent conditions included elevated cholesterol, arthritis, alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known drug allergies. the patient did not have any history of drug abuse or illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: not reported) dose was not reported, administered on 07-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 nausea. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced whole body aches. On 08-APR-2021, the subject experienced dry cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 08-APR-2021, was recovering from whole body aches, dry cough, and headache, and the outcome of nausea was not reported. This report was non-serious.

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

At night sleep on April 17, I wake up by a sharp pain on top my left head and on and off since then until April 18 morning. And the pain were not severe and keep on and off through out April 18. I felt right armpit and a rounding area bold vessels hurt since April 16.

Fever and chills for the first two days. Then I started having a rash that has not gone away. Have been treating it with cortisone cream and Benadryl pills and cream

BAD TASTE IN MOUTH AND THROAT; STOMACH PAIN; BODY ACHE; FEVER; FATIGUE; HEADACHE; FEELS LIKE KNOT RIGHT BELOW HEART; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection, and concurrent conditions included high blood pressure, and hypothyroidism. The patient experienced drug allergy when treated with morphine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced feels like knot right below heart. Laboratory data included: Body temperature (NR: not provided) 99.9. On 08-APR-2021, the subject experienced body ache. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced fatigue. On 08-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced stomach pain. On 10-APR-2021, the subject experienced bad taste in mouth and throat. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, fever, and fatigue on 09-APR-2021, had not recovered from stomach pain, and bad taste in mouth and throat, and the outcome of headache and feels like knot right below heart was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.

I woke up three days after the shot with a headache. I was running and I got a sharp pain in my hamstring muscle in my right leg. I had to stop running and the leg pain persisted for two days. I went and saw my doctor and my tests were normal. The headache lasted for several days and was dull at first and then concentrated at the back of my head. The leg pain was present for a couple of days. All of the symptoms are gone after two weeks. I still haven't returned to running daily as I normally do.

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

BODY ACHE; SEVERE CHILLS; HEADACHE; YELLOW BLOTCH ON INJECTION SITE, DISCOLORATION; This spontaneous report received from a patient concerned an adult 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 not reported) dose was not reported, administered on 07-MAR-2021 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced yellow blotch on injection site, discoloration. On 08-MAR-2021, the subject experienced body ache. On 08-MAR-2021, the subject experienced severe chills. On 08-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, severe chills, and headache, and had not recovered from yellow blotch on injection site, discoloration. This report was non-serious.

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

PAIN AND BODY ACHES; ABDOMINAL DISCOMFORT; LITTLE SORE ARM; FATIGUE; NAUSEA; This spontaneous report received from a consumer concerned a 62 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced pain and body aches. On 13-MAR-2021, the subject experienced abdominal discomfort. On 13-MAR-2021, the subject experienced little sore arm. On 13-MAR-2021, the subject experienced fatigue. On 13-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little sore arm on 15-MAR-2021, was recovering from pain and body aches, abdominal discomfort, and nausea, and had not recovered from fatigue. This report was non-serious.

BURNING; SLEEPY; THROMBOSIS AND BURNING WENT AWAY; SORE ARM; FELT TIRED; WARM BANDANA LIKE HEADACHE; DIZZINESS; BLEEDING BY ANKLE; This spontaneous report received from a patient concerned a 62 year old white and not Hispanic or Latino male. The patient's height, and weight were not reported. The patient's past medical history included thrombosis, burning on inner thighs and concurrent conditions included thick varicose vein. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 043A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 05-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in APR-2021, the patient experienced bleeding by ankle. On 05-APR-2021, the patient experienced dizziness, sore arm, felt tired and warm bandana like headache. On 05-APR-2021, after getting a shot the patient noticed thrombosis and burning went away. On 06-APR-2021, the patient experienced sleepy. On 16-APR-2021, the patient experienced burning The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning on APR-2021, dizziness, sleepy, felt tired, and warm bandana like headache on 06-APR-2021, and sore arm on 07-APR-2021, and the outcome of bleeding by ankle and thrombosis and burning went away was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0; 20210436178-covid-19 vaccine ad26.cov2. s-Bleeding by ankle. 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 events than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE

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

He received the vaccine, had very painful going in and tingling going down his left arm and to the elbow which was numb, and the left little finger was numb, and a dizzy spell afterward which was typical for him. He then on the 9th day had extreme intercostal pain in the ribs on the right side and his right shoulder extremely painful, low grade fever, chills, fatigue and inability to draw a full breath. He called the doctor and they were on the way to the clinic they told him to go to the ER based on his symptoms. He went to the ER and they admitted him and did blood work, and then did a chest x-ray, then a chest CT scan and it was positive for pulmonary embolism. He was treated with an anti-inflammatory through the IV and a blood thinner to the stomach. He was hospitalized for 1 full day, and discharged home with Eliquis double dose for 14 days and then a single dose until further notice. He is still having fatigue and aches on the right side of his brain and aches in his feet, but is to see a pulmonologist for his lungs, as it will take up to 6 months for it to resolve. He also has damage to the right side of the heart and lung. Is waiting to get a CT of the brain.

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

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

Patient reports that a posterior headache that radiated down into his cervical spine, lasting several hours each day. Not present at night. Getting better with time.

COLD; CHILLS; FATIGUE; SORENESS AT THE SITE OF INJECTION; DIZZINESS; UNABLE TO STAND UP; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's past medical history included sinus infection, and problems in ear, and concurrent conditions included acid reflux, motion sickness, and dizziness.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Concomitant medications included meclozine for motion sickness. On APR-2021, the subject experienced dizziness. On APR-2021, the subject experienced unable to stand up. On APR-2021, the subject experienced fatigue. On APR-2021, the subject experienced soreness at the site of injection. On 10-APR-2021, the subject experienced cold. On 10-APR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizziness, soreness at the site of injection, fatigue, chills, cold and unable to stand up was not reported. This report was non-serious.

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

VACCINE TEMPORARILY WEAKENED IMMUNE SYSTEM; SORENESS IN THROAT; EAR PAIN; HEADACHE, ACHES, FATIGUE; .This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's past medical history included arthritis, bursitis, kidney issues, hernia, angioplasty, and dental implant, and concurrent conditions included microbial or viral present in jaw, and other pre-existing medical conditions included the patient was non alcoholic, non smoker and had no known drug allergies. The patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (form of admin, route of admin were not reported) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced vaccine temporarily weakened immune system, soreness in throat, ear pain, and headache, aches, fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the soreness in throat, vaccine temporarily weakened immune system, ear pain and headache, aches, fatigue was not reported. This report was non-serious.

Severe cough. Doctors ruled it likely a side effect of the Jansen vaccine, and also decided that combined with Meloxicam, a medication that promotes bleeding, led to a torn flank and internal bleeding. Hospitalized for 2 days. Rehab ongoing.

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

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

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

LEFT HAND SORE; LEFT CHEST MUSCLE SORE; SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; HEADACHE; This spontaneous report received from a patient concerned a 62 year old Asian (Not hispanic or latino) male. The patient's height, and weight were not reported. The patient had no history of covid-19 on test. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805029 expiry: unknown) dose was not reported, 1 total administered on 26-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On 09-APR-2021, the patient experienced headache (right side of head, sometimes in left side) but no fever. Six weeks later, his antibody test was performed. On 05-MAY-2021, no antibody (coded as: suspected immunological vaccine failure) found in the test. On 06-MAY-2021, he had left chest muscle sore. He also developed left hand sore. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and left chest muscle sore, had not recovered from suspected immunological vaccine failure, and the outcome of left hand sore was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint:90000178890. The suspected product quality complaint has been confirmed to be void: No based on the PQC evaluation/investigation performed. This case, is linked to 20210516564 (same reporter).; Sender's Comments: V0: 20210516323- Covid-19 vaccine ad26.cov2.s- Suspected immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

I experienced headaches, sinus pressure, chills and fatigue. The chills and fatigue went away in a couple of days. The headaches and sinus pressure are still ongoing. The headaches and sinus pressure aren't as bad or as constant, but still happen.

Pt watching TV, experienced sweating, chills, extreme nausea, and shakiness. Patient went to Emergency dept. BP was 187/71 and all tests were clear. Patient was kept for approx 5 hours and released with no further symptoms.

Right after receiving the vaccination I immediately became drowsy. I became very dizzy could not keep any food down including water. The duration was about 24 hours. I also experienced Vertigo and could not stand up. My head also was spinning like a merry go round.

ITCHY skin Pins and needles in arms and legs I get feeling like I am being pricked with a pin several times a day in various places on my skin, arms, legs, neck, feet tired and fatigued difficulty breathing snoring

The patient received the vaccine, but uses the other pharmacy in town for his medications. The pharmacist called me to relay the info he got from the patient's family. He said that the patient had a headache and body aches on Saturday 05/22/2021 and went to bed but did not wake up the next morning.

TIRED; MUSCLE ACHES; This spontaneous report received from a patient concerned a 62 year old male. The patient's weight was 170 pounds, and height was 68 inches. The patient's past medical history included bladder removal, and polyp removed from colon, and concurrent conditions included alcohol consumer, and non-smoker, and other pre-existing medical conditions included no known allergies and illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAY-2021, the subject experienced tired. On 24-MAY-2021, the subject experienced muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tired, and muscle aches. This report was non-serious.

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

High fever 102degrees 48 hours, Headache 72 hours, Injection site pain120 hours, Muscle aches 120 hours. All started 7 hours after vaccine, except injection site pain started from the time of injection 10 am

CHILLS; LOW ENERGY; MUSCLE ACHES; LOW GRADE FEVER; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included stomach issues, nerve pain, high blood pressure, diabetes pain, non smoker, and non alcohol user, and other pre-existing medical conditions included patient have unspecified allergy. patient did not had any drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 0U1A21A, expiry: UNKNOWN) dose was not reported, administered on 03-JUN-2021 for prophylactic vaccination. Concomitant medications included lisinopril for blood pressure, gabapentin for nerve pain, hydrocodone for pain, menthol/methyl salicylate for pain, pantoprazole for stomach issue, ascorbic acid, ascorbic acid/ergocalciferol/folic acid/nicotinamide/panthenol/retinol/riboflavin/thiamine hydrochloride, potassium, sucralfate, and zinc. On 07-JUN-2021, the subject experienced chills. On 07-JUN-2021, the subject experienced low energy. On 07-JUN-2021, the subject experienced muscle aches. On 07-JUN-2021, the subject experienced low grade fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, low energy, muscle aches, and low grade fever. This report was non-serious.

BRUISING ON BACK OF LEFT KNEE; SEVERE PAIN ON LEFT LEG BEHIND KNEE; HEADACHE; DIZZINESS; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol use, and non 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: 203A21A, expiry: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced dizziness. On 13-APR-2021, the subject experienced headache. On 26-APR-2021, the subject experienced bruising on back of left knee. On 26-APR-2021, the subject experienced severe pain on left leg behind knee. On 10-MAY-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, and headache on 20-APR-2021, and had not recovered from severe pain on left leg behind knee, and bruising on back of left knee. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.

Headache and minor cognitive impairment (10 weeks); eczema on legs (severe; treated with cortisone; lasted 4 weeks)

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

LOOSE BOWEL MOVEMENTS; UPSET STOMACH; ACHY; TIRED; FEVER; NAUSEA; WEAKNESS; This spontaneous report received from a consumer concerned a 62 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 18-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-JUN-2021, the subject experienced loose bowel movements. On 18-JUN-2021, the subject experienced upset stomach. On 18-JUN-2021, the subject experienced achy. On 18-JUN-2021, the subject experienced tired. On 18-JUN-2021, the subject experienced fever. On 18-JUN-2021, the subject experienced nausea. On 18-JUN-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tired, achy, fever, nausea, upset stomach, and weakness, and the outcome of loose bowel movements was not reported. This report was non-serious.

abdominal pain fatigue leg cramps and severe head pain and shortness of breath i now have full blown stage 4 lung cancer that has spead to neck and lymph nodes on left and right sides i was perfectly healthy before the vaccine i blame all of this on the vaccine

BLURRED VISION; NECK PAIN; JAW PAIN; NERVE PAIN; ARM PAIN; SHOULDER PAIN; HEADACHES; This spontaneous report received from a consumer concerned a 62 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 30-APR-2021, the subject experienced blurred vision. On 30-APR-2021, the subject experienced neck pain. On 30-APR-2021, the subject experienced jaw pain. On 30-APR-2021, the subject experienced nerve pain. On 30-APR-2021, the subject experienced arm pain. On 30-APR-2021, the subject experienced shoulder pain. On 30-APR-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm pain, headaches, nerve pain, neck pain, shoulder pain, jaw pain, and blurred vision. This report was non-serious.

Patient had a slight fever from vaccine - Vaccine was placed in freezer upon receipt from manufacturer, then thawed prior to administration

Today 7/8/2021 patient walked into the Pharmacy and reported that he had adverse reaction as result of his Janssens covid-19 vaccination from 4/8/2021. he reported that he had headache for three weeks which went away, then on June 4th 2021 he was coming down a stairway and passed out. He was take to urgent Care and was treated for Hypertension and re-aggravation of concursion according to patient.

severe headaches, nerve pain, shoulder blade pain, muscle aches, "effervescent" sensation in legs, knee pain

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

In May patient noticed progressive painful lower extremity edema (left greater than right). On June 11, patient came to the hospital with sudden onset dyspnea, palpitations, lightheadedness and dizziness while refereeing a basketball game. Ultrasound of lower extremities found non-occlusive thrombus in the left common and profunda femoral veins/occlusive thrombus throughout the left femoral vein/popliteal vein, and tibioperoneal trunk. Patient started on heparin drip and admitted to stepdown unit for concern of submassive PE given elevated BNP, DVTs, and dyspnea, and confirmed via VQ scan. Patient was transitioned to oral anticoagulation (apixaban). Swelling of legs greatly improved, and dyspnea improved though cough persistent by the time of discharge. Of note, patient also has a history of elevated PSA (to 80s), but patient has not seen urology for follow-up for possible malignancy. Patient also found to have UTI (klebsiella) secondary to his chronic urinary retention.

Death - coroner's report received on 7/15/2021. Coroner Dr performed an autopsy and determined the cause of death as brochopneumonia. Heart disease and drug use also contributed to his death. The manner of death is natural.

GOLF SIZE LIGHT PINK MARKING AT THE INJECTION SITE; QUARTER SIZE BRUISING WITH YELLOW SPOT ON THE LEFT ARM, UNDER RIGHT NIPPLE AND BROWN SPOT ON CHEST AND ON LEFT THIGH; CRAMPING OF THE NECK, FINGERS AND TOES; ARM HURT; FLU-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, non-smoker, and poison oak allergy, and other pre-existing medical conditions included no known allergies and no drug abuse or illicit drug usage. patient stated that, he sometimes bruises but it is minor and did not have any medical condition. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: 24-JUL-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 flu-like symptoms. On 08-JUL-2021, the subject experienced arm hurt. On 11-JUL-2021, the subject experienced cramping of the neck, fingers and toes. On 22-JUL-2021, the subject experienced quarter size bruising with yellow spot on the left arm, under right nipple and brown spot on chest and on left thigh. On 26-JUL-2021, the subject experienced golf size light pink marking at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms, and cramping of the neck, fingers and toes on 11-JUL-2021, and arm hurt on 10-JUL-2021, was recovering from golf size light pink marking at the injection site, and had not recovered from quarter size bruising with yellow spot on the left arm, under right nipple and brown spot on chest and on left thigh. This report was non-serious.

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

mid grade fever, headache, fatigue, mild discomfort at injection site. Fever began approximately 8 hours after injection. Headache persisted for approximately 20 hours after injection. ITC Tylenol alleviated most symptoms

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

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

Woke up shaking with chills that lasted for about 1/2 hour. Was uncomfortable the rest of night. Got out of bed at 6 am and had a head ache for most of the next day.

Headaches starting in late afternoon increasing in intensity towards evening. Feeling feverish by 8:00 PM. Took Tylenol and went to sleep. Woke up in the middle of the night with a fever of 100. Took two more Tylenol and slept until 9:00 AM. Felt fine and temperature was back to normal.

Janssen COVID-19 Vaccine EUA. Severe headache 24 hours, chills and shaking 6 hours, fever and sweating 4 hours after chills. Took Tylenol for headache. Laid in bed under covers with space heater going for chills. Laid in bed for fever and sweating.

wife's report "He said he was nauseated all night. at 5am this morning (3/10) he was vomiting and said his stomach felt bloated like it 'needed to pop'. He had a 100.8 temp this am, back pain. he took tylenol at 12:30p and now his temp is at 100."

At 9:15 pm. he took three steps and he started shaking. Got home and went to sleep, woke up every couple hours with a stabbing chest pain, chills and sweating. About 10:30 a.m. the next day, he took 800mg of Ibuprofen and slept for a while and feels better.

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

For the first 24 hours I had no symptoms and no in in the injection site. But a little over 24 hours after dose, I have now developed chills and a fever.

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

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

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

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

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

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

Patient started to complain of not feeling well on 03/18/2021 and went to the ER and was found to be in Complete Heart Block and was transferred to ICU with EP and Cardiology consults pending> He was found to be covid and Flu negative but strep positive.

Chills about 12 hours after the dose. Woke up with slight headache and body ache and it worsened throught the day. I napped for 3 hours and still feel the same. I haven't taken andy additional meds. for symptons yet. Will likely take tylenol.

Hot flashes and excessive sweating, dizziness and nausea, fatigue and achiness. Started at approximately 3:30 am Sunday, March 28th. Symptoms greatly subsided by that evening. Mild nausea Monday morning.

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

pt was at his normal baseline of health the Monday of vaccine. Per sister, he had a fever of 104F, chills and myalgias hte following Saturday. he was not heard from on Sunday therefore on Monday his sister did a forced entry and found him on the ground.

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

sever chills and shakes approximately 10hrs after vaccination lasting 4-6hrs followed by fever with body aches within 24 hrs symptoms subsided by 48 hrs after vaccination 3 200 mg tabs ibuprofen taken

FEVER; This spontaneous report received from a consumer concerned a 63 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808096, expiry: UNKNOWN) dose was not reported, administered to left arm on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021, in evening, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever. This report was non-serious.

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

Every muscle and joint in my body hurt, and I was coughing constantly. It lasted all day, the day after the shot. I slept a lot during the day, it still hurt when I went to bed for the night, and I woke up feeling fine the next day.

Woke up the day after the shot and the sheets were stained and pillow case were stained blue/purple. Continued to sweat blue/purple for about 2 days. Found blue /purple sweat on multi shirts (back, chest and under arm area) and on sheets again the next day. it started with a lot of color and improved over 2 days. Day 3 not blue/purple sweat. Other symptoms: No fever, mild chills, and a bit tired. No change in any products including laundry detergent. Laundry detergent does not have any dyes, phosphates, sulfates, bleach, filler or optical brightners.

Flu Symptoms 13 hours after J&J Vaccine on Wed April 7th @ 10am - Started Vomiting 11pm-1am and then was on the Toilet from 2am - 8am and Dull Headache and Bodyache until Friday April 9th @ 10am. It was like a Colonoscophy Cleanse that started in my upper digerstive and then my lower digestive system. Feel Back to Normal Friday April 9th @ 3pm

After vaccination, pt sitting in observation area. Patient fell to right side out of chair and hit his head on concrete wall while falling. Pt was unresponsive, diaphoretic, and pale after fall. Unresponsive for approximately 30 seconds. ?The last thing the patient remembered was feeling like he needed to take his mask off. Next thing I knew, everyone was standing over me.? Patient denied history of passing out. Patient was transported via stretcher to outside ambulance where he was evaluated. Pt refused to be transported to hospital. Follow up call to patient 4/7/2021 at 6pm ? Pt states bp elevated, but hx of hypertension. Patient calling PCP to discuss medication. Pt adivised if problems arise, call 911 or go to ER.

VOMITING/ THREW UP FOR AT LEAST 6 TIMES; ACHES ALL OVER BODY; FEELING WEAK; FEVER; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included type 2 diabetes mellitus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 10808978, and batch number: 10808978 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 14:00 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced vomiting/ threw up for at least 6 times. On 02-APR-2021, the subject experienced aches all over body. On 02-APR-2021, the subject experienced feeling weak. On 02-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 106 F. On 03-APR-2021, Laboratory data included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting/ threw up for at least 6 times on APR-2021, and had not recovered from fever, aches all over body, and feeling weak. This report was non-serious.

SINUS DISORDER; NASAL SINUS DISCHARGE; FEELING UNWELL; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included there was no reported medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. 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 MAR-2021, the subject experienced sinus disorder. On MAR-2021, the subject experienced nasal sinus discharge. On MAR-2021, the subject experienced feeling unwell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling unwell, sinus disorder and nasal sinus discharge was not reported. This report was non-serious.

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

FATIGUE; BODY ACHES; HEART PALPITATIONS; LOW GRADE; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included g6pd deficiency.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 28-MAR-2021, the subject experienced body aches. On 28-MAR-2021, the subject experienced heart palpitations. On 28-MAR-2021, the subject experienced low grade. On 29-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, heart palpitations, low grade, and fatigue on 2021. This report was non-serious.

Severe head ache began approx. 2- 3 hours after injection. Followed by fever of102 degrees. Day two fever persisted, nauseous, weakness. Spent entire week with high fever, averaging 101-102 degrees. Day 4 severe diarrhea and vomited. Fever finally broke on 4/11. Currently have heavy chest, cough and weakness. Have spent entire week in bed using Tylenol only.

3/19/2021 - Chills, high fever, body aches, shortness of breath, coughing, and headaches. Symptoms have continued to present date ( 4/13/2021). Taking tylenol, and prescribed medicines. 4/9/2021 - Bright red splochy band around right calf, still having fever, body aches, shortness of breath, coughing, and headaches.

started coughing on 03/27/2021 and was taking to hospital on 03/30/2021. There he was treated for blood clots with anticoagulants and a filter placed in the vena cava.

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

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

Janssen COVID-19 Vaccine EUA 6 Hours after injection I became violently ill. Severe Sweats Severe Vomiting Severe Headache Severe Dizziness (could not stand with out falling) Severe Diarrhea

Client presenting for assessment of new onset cough that occurred past 5 days, denies recent illness or known exposure, recently been started on lisinopril. COUGH This is a new problem. Episode onset: 5 days. The problem has been unchanged. The problem occurs constantly. The cough is non-productive. Pertinent negatives include no fever, myalgias, rhinorrhea, sore throat, shortness of breath or wheezing. Nothing aggravates the symptoms. He has tried nothing for the symptoms.

Feeling tired, muscle aches, nausea, vomiting, difficulty breathing, dizziness, weakness, heartburn Medications given: NaCl 0.9 %, ondansetron (ZOFRAN) Rx for ZOFRAN ODT

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

Pt received the J&J vaccine on Monday 4/12 around 10 am. Reports onset of diarrhea mon night, frequent episodes. Then Tuesday 4/13 developed dysuria, fever/chills, headache, nausea, vomiting. Presented to ED 4/14 and admitted to hospital medicine with acute kidney injury.

On Monday 4/12/2021, the patient reported feeling sick and was taken to Medical Center ED but left the ED AMA before being seen by a doctor. He did not have any fever and all other vitals and blood sugar were normal. He then returned to the home facility and did not complain about feeling sick any further. On Tuesday, 4/13/2021, the staff reported that he took his noon medications. The vitals, temperature, and blood sugar was normal as reported by the facility staff. Around 4:10 PM, the patient was found unresponsive without any pulse and some foam around his mouth were reported by the staff. Two rounds of CPR was performed until the arrival of the ambulance. The patient was revived upon the arrival of the ambulance as reported by the facility staff. His O2 saturation was 10% as reported by paramedics/upon admission. He was admitted to the SICU unit at Medical Center and intubated. The hospital was informed that the patient received the Janssen COVID vaccine on the Friday before the event 4/9/2021. Additional notes: The patient is a heavy smoker (4 pack per day). Within two weeks prior to this event, it was reported that the patient missed his Symbicort inhaler for a few days.

FLU-LIKE SYMPTOMS; NOT FEELING WELL; MUSCLE ACHES; FATIGUE; This spontaneous report received from a health care professional concerned a 63 year old male. The patient's height, and weight were not reported. The patient's 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: Unknown) dose was not reported, administered on 07-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 flu-like symptoms. On 13-APR-2021, the subject experienced not feeling well. On 13-APR-2021, the subject experienced muscle aches. On 13-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 flu-like symptoms, muscle aches, not feeling well, and fatigue. This report was non-serious.

I started getting a headache about an hour along with pain in the back of my neck and a mild headache after my shot (maybe an hour or so). Around 1100 hours, about the time I got back from the Facility, I began to feel a tightness in my throat and got a little raspy. When I drank water and ate a little, it hurt similar a hangover as if dehydrated, but went away after a minute or so. About 1400 hours began to develop chills, causing me to get into bed, and then the chills, overall muscular pains, very tired, moderate headache and some nausea ensued as well along with an initial low grade fever. Fever went up to 102.1 degrees and had fever till about 2130 hours and broken only after I took two (1) Tylenols. Still had a very low grade fever till about 2300 hours or so (99-100), but finally went away. I awoke next day (13 APR) about 0800 feeling a bit better, but with a moderate headache and touch of diarrhea. Headache lasted all day. This prompted me to contact my treatment facility and a telecall was conducted giving them my symptoms. They recommended Rizatriptan should my headache continue and Tylenol not enough to relieve. I cannot take any analgesics due to my liver disease and Thrombocytopenia. Finally my headache went away (with a slight hint it might come back), but no more fever, chills etc. On 14 APR, no more headache but still felt a little tired. From 15 APR through today (16 APR), no further symptoms and feel great, but prepared to report anything that may develop laer.

tingling in hands and feet, headache, tired, bilateral bells palsy. Pain in arms and legs and weakness with extreme fatigue. Went to the ER, twice and was admitted. . Diagnosed with guillain-barré syndrome. Still sick.

Monday - extreme tiredness, some chills running nose Tuesday - deep chills temp 95 deg, pulse running 30-40 pts higher, blood pressure ok, visited Dt , said it could be reaction to Janzen shot, said i need to hydrate better, drink lots of Gatorade Friday - Went to Hospital ER, Oxygen level low 90, temp 103.4, high bp - IV'd, Tested positive for Covid -19 gave me 4mg methylprednisolone - 4 days

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

Patient reported on 04/21/21 that he has experienced severe headache for 10 days, increase in blood pressure (189/82, 171/82 vs regular values for him of 150/77), increased blood glucose ( afternoon reading of 289 vs usual 140), abdominal pain, leg pain, all of this for about 10 days. Patient is reporting that he is feeling better and has seen the doctor today.

FEVER; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included aspirin allergy. 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 09-APR-2021 18:00 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021 21:00, the subject experienced fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101.6 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever. This report was non-serious.

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

SPOTS OF IRRITATING IN ARM; FEELING TIRED FOR ABOUT A WEEK FOLLOWING ADMINISTRATION; PHANTOM PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included type 2 diabetes, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: 13/JUN/2021) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced spots of irritating in arm. On 05-APR-2021, the subject experienced feeling tired for about a week following administration. On 05-APR-2021, the subject experienced phantom pain at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling tired for about a week following administration on 12-APR-2021, and had not recovered from phantom pain at injection site, and spots of irritating in arm. This report was non-serious.

Progressive left arm pain and extending to patient's neck and lateral shoulders peaking on 3/21/21. Numbness, tingling, and leg muscle cramps where patient went to urgent care on 3/2/21. Started on a 6 day prednisone course (40 mg daily x 4 days, 20 mg daily x 2 days) but had pain in his lumbar spine, tailbone, and hips. Muscle reflexes +1 in upper and lower extremities. Continued muscle weakness, cramping, and tingling with generalized fatigue seen in neurology clinic on 4/16/21. Admitted to the hospital on 4/21/21 for IVIG treatment and diagnosed with Guillain-Barre Syndrome.

Today it has been 12 days since the patient got vaccinated. Patient called today to report that ever since he got the vaccine he has been with generalized pain all over his body, sick to his stomach, a real bad headache that does not go away and feeling warm to the touch. Patient reported not having any fever. Patient said he was feeling fine before having the vaccine and not having any health issues on the day he received the vaccine. Patient is going to see his primary doctor tomorrow to discuss the situation.

SHAKES; COULD NOT SLEEP; HOT AND COLD CHILLS; COUGHING WAS DRY TODAY BUT PRODUCTIVE YESTERDAY (STUFF WAS COMING OUT); LUNGS WITH BURNING SENSATION LIKE BRONCHITIS; SORE LUNGS; COULD NOT STAND UP; STOMACH ACHE; BURNING ARM FROM SHOT; PAINFUL /SORE ARM; NAUSEA; FEVER; This spontaneous report received from a patient concerned a 63 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported. batch number: 203A21A expiry: 23/JUN/2021) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced shakes. On 06-APR-2021, the subject experienced could not sleep. On 06-APR-2021, the subject experienced hot and cold chills. On 06-APR-2021, the subject experienced coughing was dry today but productive yesterday (stuff was coming out). On 06-APR-2021, the subject experienced lungs with burning sensation like bronchitis. On 06-APR-2021, the subject experienced sore lungs. On 06-APR-2021, the subject experienced could not stand up. On 06-APR-2021, the subject experienced stomach ache. On 06-APR-2021, the subject experienced burning arm from shot. On 06-APR-2021, the subject experienced painful /sore arm. On 06-APR-2021, the subject experienced nausea. On 06-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not sleep on 07-APR-2021, and lungs with burning sensation like bronchitis, stomach ache, and burning arm from shot on 11-APR-2021, was recovering from painful /sore arm, had not recovered from hot and cold chills, shakes, nausea, fever, and coughing was dry today but productive yesterday (stuff was coming out), and the outcome of sore lungs and could not stand up was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.

BODY ACHE; HEADACHE; CHILLS; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included doesn't take any medication, alcoholic, and nonsmoker, and other pre-existing medical conditions included patient had no known allergies. patient was alcoholic consume alcohol occasionally, about once monthly patient was non-smoker.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 001B21A expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 17:00 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, treatment medications included: ibuprofen, and paracetamol. On 14-MAR-2021 23:00, the subject experienced body ache. On 14-MAR-2021 23:00, the subject experienced headache. On 14-MAR-2021 23:00, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on MAR-2021, and was recovering from headache, and body ache. This report was non-serious.

ABDOMINAL PAIN; DIARRHEA; SEVERE CHILLS; FEVER; This spontaneous report received from a patient concerned a 63 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number:1805020 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 103 F. On 20-MAR-2021, the subject experienced abdominal pain. On 20-MAR-2021, the subject experienced diarrhea. On 20-MAR-2021, the subject experienced severe chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 21-MAR-2021, and had not recovered from severe chills, diarrhea, and abdominal pain. This report was non-serious.

FEVER 100.9F; This spontaneous report received from a patient concerned a male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, heart murmur (since child birth), 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: 1805029, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced fever 100.9f. Laboratory data included: Body temperature (NR: not provided) 100.9 F, 98.4 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever 100.9f on 13-MAR-2021. This report was non-serious.

BLOOD PRESSURE INCREASED 147/60; TACHYCARDIA; ACHINESS; FATIGUE; SEVERE LEG PAIN; UNABLE TO WALK LONG DISTANCES; SORENESS IN ARM; This spontaneous report received from a consumer concerned a 63 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total dose administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the patient experienced soreness in arm. On APR-2021, the patient experienced unable to walk long distances. On APR-2021, the patient experienced severe leg pain. On 01-APR-2021, the patient experienced fatigue. On 05-APR-2021, the patient experienced achiness. On an unspecified date, the patient experienced blood pressure increased 147/60, and tachycardia and his EKG came back clear on a suspected heart attack. His blood pressure was normally low. On 19-APR-2021, the patient was hospitalized. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 147/60 mmHg, 110/60 mmHg. Treatment medications (dates unspecified) included: sodium chloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood pressure increased 147/60147/60, had not recovered from soreness in arm, unable to walk long distances, fatigue, achiness, and severe leg pain, and the outcome of tachycardia was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0 20210440548-COVID-19 VACCINE AD26.COV2.S-Blood pressure increased, Tachycardia, Unable to walk long distances and Achiness. This event(s) are considered unassessable. The event(s) 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(s). V0 20210440548-COVID-19 VACCINE AD26.COV2.S-Soreness in arm, Severe leg pain, Fatigue. This event(s) are labeled per RSI and are therefore considered potentially related.

Employee developed a fever and chills on 01-Apr-21 which he managed with Tylenol. Symptoms resolved as per patient who contributed the symptoms as a result of the J&J vaccine. On 10-Apr-21 he developed a cough and requested a day to rest. On 11-Apr-21, he went to Hospital to be evaluated by the physician who ordered some labs which were normal. He was then advised to complete PCR swab and was notified on 12-Apri-21 that his test is positive. As per the protocol, all COVID-19 positive individuals must report to the Health Center within 24 hours of notification and complete 10 days home isolation. During isolation, on 17-Apr-21, patient developed hemoptysis and difficulty breathing a breathing and notified his supervisor who called 112 for an ambulance. He was transferred to Hospital. Evaluated and started treatment for pneumonia and was transferred to Hospital on 18-Apr-21. His condition started declining on 21-Apr-21 as he became hypoxic and tachypneic and was subsequently sedated and intubated. As he became HD unstable, Levophed and Vasopressin were started and reached maxed doses. On 25-Apr-21 Dr. from the hospital called and stated that patient expired at 0830.

Patient received Johnson Johnson COVID vaccination on March 5th (Its not listed as an option for me to choose - Hence Janssen). Two weeks later patient and wife described symptoms of significant abdominal pain and headache, which improved after 24 hours, since then, abdominal pain on and off with worsening, nausea vomiting and diarrhea. Presented to Hospital with sepsis, negative evaluation, possibly GI etiology, given symptoms. MRI of the abdomen shows left portal vein thrombosis/which is an unusual site. Patient has no liver cirrhosis or metastatic cancer. Is being investigated for idiopathic or acquired thrombophilia

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

Emergency room with symptoms of cough, fever, phlegm and sinus congestion since 4/14. He had an outpatient COVID test positive on 4/16. His fevers reoccurred so his PCP obtained a CXR showing atypical pnuemonia, started him on azithromcyin and solumedrol on 4/22. He presents today with worsening shortness of breath, now hypoxic on day 9 of his infection. He got the Johnson & Johnson vaccine on 4/7.

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

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

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

Four days after the vaccine I felt a little chest tightness but the next day it was very scary like a weight on my chest. I also had a cough that was an uncontrollable tickle and then I had trouble catching my breath. I went to the Urgent Care they just thought I had Acid Reflux.. Seven days after my cough was worse and I was very short of breath and I had very bad night sweats. I went to the doctor he gave me Asthma medicine. Two weeks after the vaccine I went back to the Urgent care and they thought Bronchitis. I went back to the ER and I saw a Covid-19 doctor and he thought I had Covid-19 symptoms. He gave me Prednisone and Azithromycin. I took the Prednisone for ten days and I finally started to feel better. I was trying to chew some fresh ginger helped the cough. I have a Heart Echo scheduled next week and I am still a little short of breath. Before the shot I used to walk two or three miles a day and go fishing every day but I can?t do that right now. At least I am back to 80% now which is better.

DIARRHEA; CHILLS; UNBREAKABLE FEVER OF 104F; CARDIOGENIC SHOCK; KIDNEY FAILURE; IMPAIRED LIVER FUNCTION; HIGH BLOOD PRESSURE (200/100); ABNORMAL WHITE BLOOD CELL COUNT (16000); BLISTERS ON CONJUNCTIVA OF BOTH EYES; This spontaneous report received from a physician concerned a 63 year old white male. The patient's weight, height and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) frequency one total, dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The physician reported that one day after receiving vaccine, on 08-MAY-2021, the patient experienced nausea, vomiting, shortness of breath, diarrhea, fever, chills, sweats, and severe chest pain. The patient was admitted to hospital for suspicion of heart attack. He was checked and no blockages were found. Laboratory data included: Scan (NR: not provided) No blockages were found. On 10-MAY-2021, he was transferred to another hospital where he was currently on a ventilator. The doctor reported that he had had fever of 104 f that was unbreakable. His blood pressure was 200/100 mmHg and his pulse oxygen was not good. His white blood cell count was 16000 and he was tested negative for covid-19. The doctor also reported that patient was in cardiogenic shock and was in kidney failure. He reported that the patient's liver function was getting better and patient's face and chest was very red. The patient also had blisters on conjunctiva of both eyes. It was unknown where patient received the vaccine as of this time. No further information was available since doctor had patients to see. Laboratory data included: Blood pressure (NR: not provided) 200/100 mmHg, Covid-19 virus test (NR: not provided) Negative, Body temperature increased (NR: not provided) 104 f, Pulse Oxygen (NR: not provided) Not good, and White blood cell count (NR: not provided) 16000. The patient was admitted to the hospital on 08-MAY-2021 and the duration of hospitalization was 6 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from impaired liver function, had not recovered from blisters on conjunctiva of both eyes, kidney failure, abnormal white blood cell count (16000), high blood pressure (200/100), cardiogenic shock, and unbreakable fever of 104f, and the outcome of diarrhea and chills was not reported. This report was serious (Hospitalization Caused / Prolonged and Life Threatening).; Sender's Comments: V0: 20210525538-covid-19 vaccine ad26.cov2.s-cardiogenic shock, kidney failure, impaired liver function, high blood pressure (200/100), abnormal white blood cell count (16000), blisters on conjunctiva of both eyes, diarrhea, chills, unbreakable fever of 104f. 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 to hospital emergency department on 5/19/2021 with complaints of headache, myalgia, nausea, vomiting with hematemesis and severe abdominal pain (rated 8/10) that began on the 5/16. Patient started on argatroban for treatment of mesenteric vein thrombosis. Treatment course pending.

HEART RATE INCREASED; HEART RATE UNSTABLE; FELT LIKE FIGHTING COLD OR FLU; RESPIRATORY TRACT CONGESTION; VOICE NOT NORMAL; FATIGUED; This spontaneous report received from a patient concerned a 63 year old white (non-Hispanic or Latino) male. The patient's height, and weight were not reported. The patient has not been on any medication and had not seen a doctor for years as he had been feeling really good for years until the last 7-10 days. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, 1 total dose administered on 08-APR-2021 in the late afternoon to left arm for prophylactic vaccination . No concomitant medications were reported. The patient used fitbit and his resting heart rate was high 50s or into 60s beats per minute. On APR-2021, the patient reported that he had been fatigued the first 2 days by following the shot (laid down and watched tv), then went back to normal. Starting one week to 10 days ago, on MAY-2021, his resting heart rate increased to in the 90s beats per minute which could not get below that. On 11-MAY-2021, the patient's heart rate became totally unstable and he had to go to emergency room at 11:00 with heart rate spiking in the 190s beats per minute. His heart rate was in the 180-190s beats per minute, but it was bouncing all over (for example 120, 90, then 190s beats per minute.) Heart rate would bounce around within seconds of each other. He was transferred into hospital and admitted to hospital on 11-MAY-2021 at 22:00 until 12-MAY-2021 at around 17:00. The patient was hospitalized for two days also was put on medications (blood thinner, beta blocker and another medication) while in hospital. It was reported that in hospital they were going to use paddles to shock, but heart rate stabilized on it's on so he was able to be discharged. On 12-MAY-2021, while in hospital heart rate stabilized to around 74 beats per minute. If he moved around at all heart rate went back into the 90s beats per minute. He told that this never happened to him before. On 13-MAY-2021, the patient reported that heart rate high around 80s to 90s beats per minute while resting and over 100 beats per minute when moves around. On MAY-2021, the last 7-10 days he started feeling fatigued, like fighting some kind of cold or flu (but didn't have either) and chest congestion, voice was not normal. He felt like having vaccine response or immune response. This was still going on. Laboratory data included: COVID-19 virus test (NR: not provided) negative (units unspecified), and Heart rate (NR: not provided) 190s beats per minute. Treatment medications (dates unspecified) included: metoprolol tartrate(Lopressor), and apixaban (Eliquis). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart rate increased, felt like fighting cold or flu, respiratory tract congestion and voice not normal, fatigue and heart rate unstable was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210525842-Covid-19 vaccine ad26.cov2.s-Heart rate increased ,heart rate unstable. These events are considered unassessable. The events has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.

Within 24 hrs, onset of truncal itch, hyperesthesia, dysesthesias, bilat trunk, non-dermatomal pattern. Also significant fatigue and hyperhydrosis. This has persisted to this day. Night sweats and itch are worsening.

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

I got the J&J vaccine on 4/6/21. Afterward, I felt fine for about 6 days and then started suffering from head aches, muscle pain, stiffness and nausea. I also suffer from some seasonal allergies so the addition of soar throat a week or so later could have been from that. I had the symptoms for about 4 weeks before they went away.

SLEPT ALOT; NOT FEELING WELL; FATIGUE; BODY TEMPERATURE OF 99.3 DEGREES FAHRENHEIT; LUNGS FELT HARD TO BREATHE; DIARRHEA; BAD BODY ACHES FROM HEAD TO TOE; VOMITING; HEADACHE; NAUSEATED; This spontaneous report received from a health care professional concerned a 63 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included cancer diagnosis: cutaneous lymphoma, and other pre-existing medical conditions included the patient had no respiratory issues, still maintained 92 oxygen saturation, but could not take care of himself and went out of it in 2 weeks. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 203A21A, expiry: 23-JUN-2021) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On DEC-2020, Laboratory data included: Body temperature (NR: not provided) 102 F. On 2021, Laboratory data included: Oxygen saturation (NR: not provided) 92 %. On MAY-2021, the subject experienced vomiting. On MAY-2021, the subject experienced headache. On MAY-2021, the subject experienced nauseated. Laboratory data included: Oxygen saturation (NR: not provided) 93-98 %. On 28-MAY-2021, the subject experienced lungs felt hard to breathe. On 28-MAY-2021, the subject experienced diarrhea. On 28-MAY-2021, the subject experienced bad body aches from head to toe. On 28-MAY-2021, the subject experienced not feeling well. On 28-MAY-2021, the subject experienced fatigue. On 28-MAY-2021, the subject experienced body temperature of 99.3 degrees fahrenheit. Laboratory data included: Body temperature (NR: not provided) 99.3 F. On 29-MAY-2021, the subject experienced slept alot. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient recovered from lungs felt hard to breathe, and diarrhea on 28-MAY-2021, had not recovered from bad body aches from head to toe, fatigue, and body temperature of 99.3 degrees fahrenheit, and the outcome of not feeling well, slept alot, headache, vomiting and nauseated was not reported. This report was non-serious.; Sender's Comments: V0- Medical Assessment Comment not required as per standard operating procedure ,as the case was assessed as non-serious.

The patient had symptoms start 5 minutes after the vaccine was administered. The patient was diaphoretic, his blood pressure dropped 20 systolic, he stated he was weak, he was dry heaving and having difficulty breathing. He was administered an Epi-pen by the nurse. The patient stayed in the office for 45 minutes and was evaluated by the physician. After waiting 45 minutes the patient stated he felt good and wanted to go home.

Sudden and rapid muscle loss. Extremely high CPK (6063) Fatigue Weakness Blood work, Low dose CT, Abdominal Ultrasound, Chest Xray Next appointment is with a Rheumatologist Discontinued Crestor 4/10/2021 No change in two months

SHIVERING; FEVER; TIRED; FELT ACHY; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 202A21A expiry: 23-JUN-2021) dose was not reported, administered on 10-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-JUN-2021, the subject experienced felt achy. On 10-JUN-2021, the subject experienced shivering. On 10-JUN-2021, the subject experienced fever. On 10-JUN-2021, the subject experienced tired. Laboratory data included: Body temperature (NR: not provided) 102.7-102.9 Unit not reported. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from fever, felt achy, tired, and shivering. This report was non-serious.

FATIGUE; LEFT HAND CLENCHED INTO FIST FOR THE PAST TWO MONTHS AND A HALF; PREVIOUS RIGHT SIDED NUMBNESS WAS MORE INTENSE; DECREASED ENERGY; FEELING UNWELL; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included sciatica, numbness of the right side, and environmental allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced left hand clenched into fist for the past two months and a half. On 26-MAR-2021, the subject experienced previous right sided numbness was more intense. On 26-MAR-2021, the subject experienced decreased energy. On 26-MAR-2021, the subject experienced feeling unwell. On an unspecified date, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left hand clenched into fist for the past two months and a half on 15-MAY-2021, had not recovered from decreased energy, feeling unwell, and previous right sided numbness was more intense, and the outcome of fatigue was not reported. This report was non-serious.

On 03/19/2021 I had an headache that lasted a week. On 03/20/2021 I started experiencing IBS which I am still having to this day. On 04/10/2021 I developed neuropathy in my face, hands, and feet.

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

Fever, chills, hives. Fever and chills gone on 7/5/21. The hives are the reason for going to urgent healthcare on 7/5/21 where they prescribed prednisone and famotidine.

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

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

More tired than before and now have a low red blood cell count, as does my sister and niece, all who got the J&J vaccine. My sister got hers at the same place I did about an hour apart, and my niece got hers a couple weeks later. Now we're ALL anemic. I'm also a heart patient, so it's hit me pretty hard, where all I want to do is sleep. Someone called from VAERS and asked about my text report, and I said nothing was wrong. That's how out of it I've been. These vaccines were given WAY too early to know the long term, or even really, the short term effects beyond a few months. I now regret getting it, and would've been fine to just continue to mask up and social distance.

VERY FATIGUE; BURNING NEUROPATHY; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included environmental allergy. The patient was healthy previously. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) 1 total, dose was not reported, administered on left arm on 04-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 04-APR-2021 (two hours after vaccination), the patient's whole body went numb, especially the extremities and it was tingling and numb all over the body. On the same day, the patient experienced burning neuropathy. On 06-APR-2021, two days later, the numbness lessened and his feet were always in burning pain and it inhibited ability to walk and was very fatigued all the time. The patient's muscles in hand were weak and it was hurting to open a jar. Later, the patient was no longer experiencing severe weakness but unable to stand for long periods of time due to pain. He was unable to sit too long because the burning pain radiated to the feet. The patient also felt pain in the back of the legs once sitting. The patient had no breathing problems. It was reported that, the patient spoke to neurologist within two days of experiencing these symptoms and was told to watch it and stay in contact as it might take up to six months for symptoms to resolve. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from very fatigue, and burning neuropathy. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210728778-Covid-19 vaccine ad26.cov2.s- Burning neuropathy. 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.

Eight minutes after receiving the J&J vaccine the patient began sweating profusely, was very hot, had a tingling feeling all over his body and was lightheaded. He was breathing fine and talking the entire time. Used ice packs to cool patient down. Called 911, paramedics took him to the hospital ER where he was discharged to home doing well.

Tightening of chest Difficulty breathing Nausea Pain at injection site for over 7 days Fever Tired needing to rest

Around 11 AM on 3/6/21 I began to feel very tired and lethargic. As I had driven back that morning, I returned home and laid down for a nap. Later in the evening, I was still very tired and lethargic. I had no pain, swelling, or redness around my vaccination site. By Sunday morning, 3/7/21 I was feeling fine and have not experienced any symptoms since.

10 minutes after receiving the vaccine, the patient claimed he was feeling light headed and needed to lay down. After speaking, his eyes then went closed, and he clenched his fists and he started coughing up liquid. He was not responsive. He was moved to the ground and turned on his side. He became alert about 3 minutes after becoming unresponsive. He claimed this happens to him when he is at doctor's offices or receiving vaccines/procedures. He claimed it was "normal." He said he felt fine/normal, and this has happened in the past, though he did not mention this to the pharmacist prior to administration. 911 was called and examined him. He was allowed to go home on his own, did not go to the hospital.

Dull headache. Felt very cold with shivering and very cold feet starting about 28 hours after vaccination. Woke up with cold sweats during the night 36 hours later (very wet tee shirt - changed into dry t-shirts twice during the night). No symptoms upon waking the next morning 42 hours later.

Injection on Mar. 13, around 10:40 am. Slight chills starting around 7 pm, approx 8 hours after injection. Later that night around 10 pm had severe chills, teeth chattering that lasted till approx. 3 am the next morning. Chills so bad I had a hard time walking to the bathroom. Mar. 14, low-grade fever, 99.4, aches, tired, flu-like symptoms all day, took Tylenol. Mar. 15 feeling much better, flu-like symptoms gone, still a little tired, left arm finally sore. Wifes's arm hurt for 2 days.

Patient received vaccine on 3/13, initially had fatigue and myalgia the day after, which resolved, but also on 3/14 began having mild intermittent coughing, nonproductive, occurring every two hours or less. Patient began having some blood in his sputum since this morning at 4AM, and that occurred twice more with intervals of a few hours, both continuously improving and less blood. No other symptoms. No history of TB, no exposure to sick contacts, no recent travel. Unlikely a pulmonary embolus given normal vital signs and no risk factors. Patient was doing outdoor work in his yard for the past few days before the symptom onset and was working on mulch and compost. Although unlikely to have fungal infection currently, may be bacterial pneumonia

The common side effects - chills, achiness and fatigue. No other symptoms, just those. Lasted about 24 hours.

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

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

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

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

Exhaustion, tiredness, fatigue. Blood taken and tested on 3/22. Showed Liver Enzymes very high. Ultrasound taken of Liver, Gallbladder, Pancreas and all looked good. Blood tested again on 3/24 and liver enzymes have come down but still very high levels. Waiting on additional blood work.

I felt like i had to throw up. Took off from work went home I was running fever 101.3 . Took two Tylenol. I felt my joint hurt , my left arm was the sorest from any shot I ever had and is still very sore. I went to bed slept 12 hours. I still feel weak but no fever yet

very bad sore arm at the injection site. sore throat, diarrhea, fatigue, headache, chill (no fever yet)

COVID-19 (+) on 3/22/2021 Presented with hypoxemia, cough, dyspnea on exertion. Per ED report, patient had received the Johnson and Johnson COVID-19 vaccine on 3/6/2021 and started becoming symptomatic on 3/19/2021 with dyspnea, fevers, chills, fatigue and cough. He had reported resolution of his fever/chills, however his dyspnea and cough had progressively worsened. He then presented to the ED (3/25/2021 and discharged on 3/29/2021). In addition to his COVID-PNA, he also had a superimposed Pseudomonas PNA and was discharged on Levaquin and oral steroids (Dexamethasone) for a total of 10-day therapy.

About a week after the vaccination I began to fill chills and joint pain (fingers, elbow and shoulder on my right side). On day 11 my right arm became too painful to use. It felt like severe tennis elbow. I took Tylenol arthritis strength in the morning and the evening and pain subsided after 4 or 5 hour.

Janssen COVID-19 Vaccine EUA , Accelerated Heart Rate of 115 / 120, Acclerated Respirations, Fever with temp of 101.6 lasting for 23 hrs, Extreme body aches, headache, feeling very tired, minor dizziness, minor nausea

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

CHANGE IN VOICE; SWEATING; SORE THROAT; COUGH (THROAT WAS RASKY); TIREDNESS AND FATIGUE; FEVER; This spontaneous report received from a patient concerned a 64 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On 04-APR-2021, the subject experienced tiredness and fatigue. On 04-APR-2021, the subject experienced sweating. On 04-APR-2021, the subject experienced sore throat. On 04-APR-2021, the subject experienced fever. On 04-APR-2021, the subject experienced cough (throat was rasky). On 04-APR-2021, the subject experienced change in voice. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tiredness and fatigue, sweating, sore throat, fever, cough (throat was rasky) and change in voice was not reported. This report was non-serious.

Severe burning chest pains extending to arms and upper body on days 2 and 3. Body aches, low grade fever on days 3 and 4.

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

Several hours after receiving the vaccine I started to feel flu like, tired and achy. In the middle of the night I developed a fever of 101.7, chills, body ache, headache and very fatigued. All of the symptoms lasted for the next few days until Sunday morning (4/11/2021) when I then began to fell better and able to move around. I receive the vaccine in my right arm but my left arm was the one that hurt and had trouble moving for a couple days.

Blood clots in both lungs. Admitted to the hospital with severe pain in chest, trouble breathing, within 5 days of vaccination. Put on blood thinners to help get rid of the clots. Extreme fatigue before admittance to the hospital as well as ongoing extreme fatigue.

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

pt says he had headache, fever, chills, leg pain and SOB. Pt is feeling some better but still has a headache. Pt wants to know if it is safe to take aspirin in case of chance of getting blood clots. Pt will contact his PCP for medical advice.

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

HOSPITAL COURSE: Patient is a 64 y.o. man admitted on 4/8/2021 with hx of HTN, HLD, tobacco use, Hypothyroidism, and OSA who presented with acute right facial droop in setting of 8 days of headaches and paresthesias, found to have acute ischemic stroke. New slurred speech and worsening of facial droop 4/9 AM, but no new findings on repeat MRI. .

TINGLING HAND; SHAKING INSIDE; NO ENERGY; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 64 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, the subject experienced tingling hand. On 08-APR-2021, the subject experienced shaking inside. On 08-APR-2021, the subject experienced no energy. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, tingling hand, fatigue, and no energy, and the outcome of shaking inside was not reported. This report was non-serious.

INSOMNIA; INJECTION SITE REDNESS; FATIGUE; MYALGIA, MUSCLE PAIN; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 64 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced injection site pain. On 29-MAR-2021, the subject experienced fatigue. On 29-MAR-2021, the subject experienced myalgia, muscle pain. On 07-APR-2021, the subject experienced insomnia. On 07-APR-2021, the subject experienced injection site redness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site pain, fatigue, myalgia, muscle pain, insomnia, and injection site redness. This report was non-serious.

Pain in lower left bicep in first week, experiencing fatigue/tiredness. After 10 days I experienced severe pain at the site of injection, very small red spot appeared around injection site. Pain was so severe, I took one capsule hydrocodone 5-325 TB at 2 AM. The medication did not cure the pain, and I slept less than two hours. I called my nurse practitioner's office, and they offered an appoint late in the morning. And I couldn't wait that long so I drove to urgent care. Prompt care examined and saw no swelling, ruling out possible blood clot. Prompt care did not have ultra sound. They told me to use ice, heat, and pain medication. Extreme pain continued for about three more days, pain medication did very little to help. Unable to speak directly to the Nurse Practitioner on the phone, due to my disability and alexia, communicating online is very difficult without an assistant present. The pain slowly subsided over the next week.

MUSCLE SPASMS; UNCONTROLLABLE SHAKING; HOT FLASHES; SWEATY; DISAPPEARANCE OF PREVIOUS TINNITUS; CHILLS; This spontaneous report received from a patient concerned a 64 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included tinnitus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: 21-JUNE-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced muscle spasms. On 10-APR-2021, the subject experienced uncontrollable shaking. On 10-APR-2021, the subject experienced hot flashes. On 10-APR-2021, the subject experienced sweaty. On 10-APR-2021, the subject experienced disappearance of previous tinnitus. On 10-APR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle spasms on 10-APR-2021, and uncontrollable shaking, hot flashes, and sweaty on 11-APR-2021, had not recovered from disappearance of previous tinnitus, and the outcome of chills was not reported. This report was non-serious.

vaccinated on 3/5/2021 with Janssen Covid vaccine. Developed symptoms of covid (runny nose, congestion, cough, shortness of breath) on 4/17/2021 after an exposure to covid.

tested covid-19 positive on 4/3/21 resulting in bilateral pneumonia. patient was discharged home after improvement

PAIN; DRY HEAVING CONTINUOUSLY; BACK DISCOMFORT; DISCOMFORT IN SCAR TISSUE FROM HIS PRIOR SURGERIES; CHILLS; FEVER; NAUSEA; VOMITING; This spontaneous report received from a patient concerned a 64 year old male. The patient's height, and weight were not reported. The patient's past medical history included surgeries. 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 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced vomiting. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced nausea. On an unspecified date, the subject experienced pain, dry heaving continuously, back discomfort, and discomfort in scar tissue from his prior surgeries. Treatment medications (dates unspecified) included: hydrocodone bitartrate/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, and nausea, had not recovered from dry heaving continuously, and the outcome of chills, fever, pain, back discomfort and discomfort in scar tissue from his prior surgeries was not reported. This report was non-serious.; Sender's Comments: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.

MILD HEADACHE FROM SCALE 1-10 SEVERITY 3; This spontaneous report received from a patient concerned a 64 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included sulpha allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 18:30 for prophylactic vaccination at left arm. No concomitant medications were reported. On 20-MAR-2021, the subject experienced mild headache from scale 1-10 severity 3. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from mild headache from scale 1-10 severity 3. This report was non-serious.

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

Pt complained 4 days after vaccination of headaches, abdominal pain, and diarrhea. No reaction at time of vaccination. Dr was notified on 04/12/2021 when pt complained.

BODY PAIN / BODY ACHE; HEADACHE; FEVER; This spontaneous report received from a pharmacist concerned a 64 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, and other pre-existing medical conditions included the patient did not have known allergies .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 05-APR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid. On 06-APR-2021, the subject experienced body pain / body ache. On 06-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced fever. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, body pain / body ache, and fever. This report was non-serious.

PATIENT WAS GIVEN THE JANSSEN COVID VACCINE. ABOUT 5-10 MINS LATER, PATIENT REPORTED HAVING SOME DIZZINESS WITH SOME CHEST PAIN. BENADRYL WAS PROMPTLY GIVEN @1202PM. THEN AT 1209PM, PATIENT BP WAS TAKING, IT WAS HIGH AT 160s/90s. PATIENT STATED THAT HE DOES HAVE HBP IN WHICH HE DOES TAKE MEDICINE FOR. HE ALSO STATED THAT, AT THAT PRESSURE, IT WAS NORMAL FOR HIM. PATIENT WAS MONITORED TILL AROUND 1245PM, HE STATED THAT HE WAS FEELING BETTER AND HIS WIFE HAS TAKEN HIM HOME. A FOLLOW UP PHONE CALL WAS CALLED AROUND 105PM. AT THAT TIME PATIENT WAS A HOME AND SAID THAT HIS SYMPTOMS HAS SUBSIDE BUT JUST FEELS SLEEPNESS FROM THE BENADRYL.

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

PATIENT BECAME FAINT ANDTHEN ADMIN UNRESPONSIVE AFTER RECEIVING VACCINE . STARTED TO SWEAT . EPIPEN WAS ADMINISTERED AND PARIENT SLOWLY RETURNED TO NORMAL. PATIENT STATED THAT THEY HAVE REACTION TO INJECTIONS OR NEEDLES AND IT HAS HAPPENED BEFORE AND CONSIDERS IT PSYCOLOGICAL.

On 4/26/21 The patient presents to our clinic with concerns for back pain, fever, shortness of breath, fatigue and coughing. We performed a covid19 antigen test which resulted positive. Based on this and his history and examination we recommended he go straight to the hospital for further evaluation and treatment. He was admitted to medical center where a PCR was performed and confirmed positive. He was discharged on 4/29. Per his wife, they felt he was discharged too soon and he went to another hospital. He passed away 5/10/2021. This report is being made in regards to the claim by the CDC that "no one that has been infected with covid19 4 weeks after having the janssen vaccine has been hospitalized." This patient was not only hospitalized but passed away.

Patient had chills for 3.5 days, no fever. MIgraine for 11 days. All joints were affected (felt like sticking a knife into them). Severe fatigue. Patient thinks vaccine excaberated his RSD. Pain in right hand and left foot still remains.

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

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

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

Three weeks into the vaccine, I ended up having shortness of breathe when I laid down. It has eased up now a little. I started having an intermittent cough due to the vaccine (felt like my lungs were not feeling great) This occurred during the evening and at night when I would lay down to rest. I had a fairly mild case of COVID-19 (tested at the beginning) and quarantined for three weeks. A month later I took the blood test for antibodies (actually had COVID-19 last June which is nearly a year ago before taking the Janssen vaccine). My blood sugar is off the charts and my blood pressure has elevated since taking the vaccine (reason for awaiting an appointment with my doctor).

I started feeling bad the first night. I woke up with energy @ 1am and then later that day I started feeling extremely drain and exhausted and very tired and weak. I woke up @ 11:30pm and I passed out and hit hit the floor, face first and my wife don't know how long I was passed out up to 30- to 60 mins. I had to put frozen meat on my face. I felt like I was about to pass out again. Felt like my legs was giving out. I do have a spinal disease and it felt worse then that. Then it took my headache away. I felt like a different person.

Patient experienced migraines, fever, abdominal pain, sweating and felt stabbing pains for 7 & 1/2 hours.

TIREDNESS; This spontaneous report received from a patient concerned a 64 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: Unknown) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 20-MAY-2021, the subject experienced tiredness. The action taken with covid-19 vaccine was not applicable. The patient recovered from tiredness. This report was non-serious.

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

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

Heart rate 186, shortness of breath, profuse sweating. Successfully treated with IV adenosine [ADENOCARD]. Diagnosed as SVT (supra ventricular tachycardia), AKI (acute kidney injury), and dehydration.

Woke up extremely cold, but skin hot to touch, body very stiff and headache. these continued for several hours. Also was very tired, so took a long nap. Late afternoon, all but headache was totally gone, headache as gone by the next day.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium

SWEATING; STOMACH ACHE; STING ON THE RIGHT SIDE OF FACE; NAUSEA PREVENTED FROM EATING ANYTHING; NAUSEA; This spontaneous report received from a patient concerned a 64 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included aches every day due to history of arthritis.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821287, expiry: UNKNOWN) dose was not reported, administered on 30-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JUL-2021, the subject experienced sweating. On 01-JUL-2021, the subject experienced stomach ache. On 01-JUL-2021, the subject experienced sting on the right side of face. On 01-JUL-2021, the subject experienced nausea prevented from eating anything. On 01-JUL-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sting on the right side of face on 01-JUL-2021, was recovering from sweating, nausea, and stomach ache, and the outcome of nausea prevented from eating anything was not reported. This report was non-serious.

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

Patient's wife reported today 7/14/21 that patient has experienced weakness in legs and fatigue beginning week or so after vaccine.

Patient admitted to the hospital 7/21/21 through the ED and tested positive for Covid19 via rapid molecular test. Patient states he was vaccinated "months ago" and received one dose. He complained of fever, diarrhea, and fatigue. His Chest XR consistent with patchy airspace opacities. He was found to have orthostatic hypotension and hyponatremia attributed to dehydration.

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

HEAVY FEELING ON HIS BOTH ARMS; CONFIRMED CLINICAL VACCINATION FAILURE; SUSPECTED COVID 19 (TEST UNSPECIFIED); This spontaneous report received from a consumer concerned a 64 year old male. The patient's height, and weight were not reported. The patient's past medical history included heart valve replacement last year, and concurrent conditions included allergic reaction to anesthesia, non-alcohol user, and non-smoker, and other pre-existing medical conditions included patient did not have drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: 21-JUN-2021) dose was not reported, 1 total administered to left arm (deltoid) on 21-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-JUL-2021 (last Sunday) patient started to develop dry cough towards the end of the day. On 19-JUL-2021 (Monday) patient started to experience weakness, heavy feeling on his both arms, fever with a temperature between 99-100 degree Fahrenheit, achiness all over the body, chills, headache and nausea. Patient decided to visit to the hospital. Patient undergone a series of blood test, flu test, pneumonia and Covid-19 test. On 23-JUL-2021, patient clinically tested positive of COVID-19 [Suspected covid-19 (test unspecified) and confirmed clinical vaccination failure]. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid 19 (test unspecified), and heavy feeling on his both arms, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000187127.; Sender's Comments: V0: 20210753055:Covid-19 Vaccine Ad26.Cov2.S: Confirmed Clinical Vaccination Failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

I had all the side effect system, fever, chills, fatigue muscle and joint pain. The joint pain is what I would like to share my concern about. A little more than a year ago (Feb 2020) I have L4/L5 fusion surgery. The surgery was successful and for the last six month had little to no pain (no more than a 1 on the pain scale). Saturday a day after the vaccination my lower back pain was significant (5 to 6 on the pain scale). I am not sure if this was just a coincidence but thought it was worth reporting. Today, Sunday March 7th the pain is much better (about a 2 on the pain scale and I think will completely go away as I move around more and loosen up.

mild fever and headache starting approximately 6 hours after injection. 100.4F by digital no-touch thermometer acquired in ear. Fever gone after 12 hours. Headache gone after 18hours with 400mg Advil taken 18 hours after start of fever.

shivers/chills/fatigue 10-12 hours after vaccine, spent 36 hours in bed with fatigue, headache, muscle aches, nausea, didn't eat or drink anything for past 24 hours, lost 5 lbs in the last 2 days, today I'm partially improved

Roughly 6 hours after the shot I started feeling side effects which included; achy joints, low fever, mild headache, tired and run down like I was getting a cold. The symptoms laster through the night and into this morning when I woke up feeling a bit better. It's been 13 hours since the first side effects and at this point I feel run down but most of the other symptoms have subsided.

Within six hours: fatigue, aches overall of body Six to 24 hours: fatigue, aches overall of the body, especially along the spine, and in joints. 24-48 hours: fatigue, reduced aches overall of the body, but aches in hips and knees remained, especially pronounced on the right side. After 48 hours: some fatigue, much reduced aches overall, some minor aches remain in right leg. At 60 hours: some fatigue, minor achiness. I'd say almost recovered.

Slight fever, chills, shivering, weakness, headache, severe heartburn. Duration from 6:30 in evening to noon the next day. Flu like symptoms without nausea and without tingle in sinuses. More runny nose than usual.

almost 24 hours to the minute after receiving the vaccination i had fever, chills, extreme nausea, headache, muscle pain , weakness. even touching my eyebrows hurt. it lasted 10 hours during which time I did not take any medications, eat or drink anything. I did not seek treatment and by morning I was wiped out but all symptoms had resolved.

Headache, muscle aches, pain at injection site, cough & fever of 100.1 F Was fever free by 10am 3/17/21

Headache, achy and dizzy on evening of March 26 (about 6 hours after). This continued morning of March 27. Then suddenly mid-day (about 24 hours after the vaccine) fever (over 100), chills, shaking, dizzy, nausea set in (could not function) and lasted for 14 hours. March 28, still achy, dizzy and feeling of light headedness and exhaustion.

Patient reported sore arm that lasted almost 3 weeks. Soreness has been improving but still present when he reported. Pt also reported episodes of dizziness and flu like symptoms after the shots. Patient was advised to continue monitoring if symptoms did not improve, pt would call MD.

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

Patient inadvertently received a 1.0 mL dose instead of the prescribed 0.5 mL dose. Patient was originally cleared to leave the office after having no symptoms or complaints for 15 minutes following inject. Once dose error was caught, patient was contacted by clinic physician, MD. Patient notified of error, possible side effects reviewed and advised to go to ER if symptoms develop. Patient had no current symptoms or complaints at that time. Staff followed up with patient several times over the course of the next 24 hours. Was unable to reach patient until 04/09/21 approx. 1030 am. Patient doing OK, tired, but no other symptoms or complaints.

Intense Lymphadenopathy, left neck below the ear, hard, warm, fever, headache, swollen, painful. Am onset impaired neck movement but no challenge to swallowing or breathing.

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

Fever 101.9 degrees, dizziness, Elevated pulse 105 bpm. (Normal pulse rate ranges between 75-78.) Elevated BP 175/100. (Normal BP in the 125/78 range. Nausea. Severe headache. Fever, headache and nausea subsided after 5 days. Heart rate and BP still elevated, Pulse will "race." I contacted my family physician . He suggested I keep close check on BP and go to ER if major symptoms persist after 4 days.

On or around March 19 developed a dry cough with shortness of breath. Was hospitalized on March 23 and diagnosed with interstitial lung disease and is currently on a ventilator. The diagnosis is unknown but suspected amiodorone toxicity or Sjogrens. Both are rare side effects. He is on high dose steroids and antibiotics but no improvement. Has never had lung issues prior to the shot. He has never smoked. Onset of disease was rapid and progressed quickly. Is it possible shot triggered the acute lung disease?

Severe Bloody nose, with quarter size blood clots that took more than 45 minutes to stop. Never had a bloody nose in his life. They told us it was from our dry house, but we had not not had the heat on. It stopped bleeding and we went home. Had bad headache for two days following.

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

johnson and jonson vaccine. He received on 4/1 through the state. that night got chills. ha, n/v. the next day just tired. 2 days later got two pink bumps on his R elbow then enlarged. then developed more on other areas on his body. some have been present in one spot for a week. NO sob or rep sx. no pain. He carries an epipen for insect allergy. on 4/9 he developed sensation of throuat closingand administred an epi pen with relief and went to er. At the er he was given iv prednisone, benedryl and pepcid. He was dischared on a medrol dose pack 7 day. taper (3 days left) and refilled epipen. told to take benedryl. no sob. rash is now stable, no new areas x 2 days, larger areas are much improved..

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

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

FEELING COLD; HIGH FEVER/ SWEATING FEVER; This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. The patient's past medical history included heart murmur, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 201A21A, expiry: 23-JUN-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced feeling cold. On 08-APR-2021, the subject experienced high fever/ sweating fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from high fever/ sweating fever, and the outcome of feeling cold was not reported. This report was non-serious.

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

SKIN FLAKING LIKE DANDRUFF; KNEE PAIN; SLIGHT HEADACHE; This spontaneous report received from a patient concerned a 65 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) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 25-MAR-2021, the subject experienced slight headache. On 01-APR-2021, the subject experienced skin flaking. On 01-APR-2021, the subject experienced knee pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from skin flaking on 02-APR-2021, and slight headache on MAR-2021, and had not recovered from knee pain. This report was non-serious.

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

Janssen COVID 19 vaccine 4/22/21 wife of patient called to report, states husband got up on 4/4/21 with severe migraine, has had them off and on since. He does not have them every day. He has not seen physician regarding the HA and wife states he will not go. I encouraged wife to try and get him to see PCP. She verbalized understanding, stated he does not have HA at this time.

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

DIFFICULTY BREATHING; CANNOT FINISH EXERCISES; WEAKNESS; SWEATING; NAUSEA (FELT LIKE VOMITING); FEVER; This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. The patient's past medical history included stage 3 colon cancer, and concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and had 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: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced sweating. On 10-APR-2021, the subject experienced nausea (felt like vomiting). On 13-APR-2021, the subject experienced difficulty breathing. On 13-APR-2021, the subject experienced cannot finish exercises. On 13-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 fever, difficulty breathing, weakness, sweating, nausea (felt like vomiting), and cannot finish exercises. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.

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

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

HUSBAND BEING IN EMERGENCY RIGHT NOW. 8 DAYS AFTER HAVING A COVID 19 SHOT; FLUSHING; WEAK; FEVER; INJECTION SITE PAIN; FEELING SICK; This spontaneous report received from a consumer via a company representative concerned a 65 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and other pre-existing medical conditions included allergic to other antibiotic((can't remember). The patient experienced drug allergy when treated with clarithromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and 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, Laboratory data included: COVID-19 virus test (NR: not provided) negative. On 06-APR-2021, the subject experienced feeling sick. On 06-APR-2021, the subject experienced injection site pain. On 07-APR-2021, the subject experienced weak. On 07-APR-2021, the subject experienced flushing. On 07-APR-2021, the subject experienced fever. On 15-APR-2021, the subject experienced husband being in emergency right now. 8 days after having a covid 19 shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from feeling sick, weak, flushing, and fever, and the outcome of injection site pain and husband being in emergency right now. 8 days after having a covid 19 shot 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.

Per pt's wife - reported to pharmacy - 2 days after receiving vaccine - pt experienced shortness of breath, coughing, nausea. Patient was not feeling well in general. 2 days after this (so about 5 days after receiving the vaccine) - pt was COVID positive - and is at the moment in the ER.

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

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

HEADACHE; BACK PAIN; RIB PAIN/THE LEFT SIDE OF THE RIBS UNDER THE ARM; SEVERE BODY PAIN; ITCHY RED SPOTS ON LEGS/SPOTS ON BOTH LEGS, UPPER LEG, LOWER PART ANKLE, AND ONE ON THE FEET, SMALL LIKE A DIME; BLOOD SUGAR FASTING RESULTS WAS 450 MG/D; This spontaneous report received from a patient concerned a 65 years male. The patient's weight was 175 pounds, and height was 68 inches. The patient's concurrent conditions included diabetes, and high blood pressure, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 in left deltoid for prophylactic vaccination. No concomitant medications were reported. Patient reported that, received the COVID-19 vaccine on 11-MAR-2021on the left arm. Patient's main reason for calling was the severe body pain on the right back and the left side of the ribs under the arm. Patient was taking Tylenol 500 mg 2 tablets in the morning for the past weeks to ease the pain, which was not normal for him, living on tablet for a couple of week. The pain on the ribs, come on hard, and it might stay like 10-15 mins then it cools off. Patient mentioned that he had headache too and had red spots on his legs that started out to be itchy. Patient had spots on both legs, upper leg 3, lower part ankle 2, and one on the feet, small like a dime. Lastly, patient said that his blood sugar fasting results is 450 mg/dL and that was not normal for him (his normal is 110/180-200mg/dL). However, Patient's blood pressure is under control. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blood sugar fasting results was 450 mg/d, and had not recovered from headache, back pain, itchy red spots on legs/spots on both legs, upper leg, lower part ankle, and one on the feet, small like a dime, rib pain/the left side of the ribs under the arm, and severe body pain. This report was serious (Other Medically Important Condition). .; Sender's Comments: . 20210438296- Covid-19 vaccine ad26.cov2-blood sugar fasting results was 450 mg/d. 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: UNDERLYING DISEASE

Patient began having fever, chills, rash, and vomiting night of the vaccine (03/31). Patients symptoms have continued for almost 4 weeks (03/31-4/26)and have worsened. Unable to keep down any food other than saltine crackers and some ginger ale. Patient now has a cough, shortness of breath, and lower left abdominal pain. Patient has not been able to follow up with primary care doctor or lung specialist. Encouraged the caretaker to take patient to PCP, urgent care, or ER. Symptoms typically resolve within first week (fever, chills, and fatigue). Symptoms, especially, fever persisting with treatment of Tylenol and Motrin should be assessed ASAP. Waiting to hear back from doctor follow up and if there were any underlying causes for symptoms.

He developed a 101F fever the next day after he receive the vaccine on 4-3-21. He took some tylenol and it went down then went back up, then after some rest, the day after, the fever went away.

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

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

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

About a month after i received my shot I had a headache and nausea, stomach ache, headache would not subside. Contacted at the Clinic.

Stoke occurred, including symptoms of: severe headache, shortness of breath, trouble speaking, plus leg pain

DEHYDRATED; URINARY INCONTINENCE; PLEURISY; CHEST PAIN; This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. The patient's past medical history included neck surgery, back surgery, left knee replacement, and covid-19 infection, and concurrent conditions included alcohol consumer, non smoker, and heart patient, and other pre-existing medical conditions included the patient has no known drug allergies and drug illicit use. the patient also had 29 surgeries. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1802068, and expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. Concomitant medications included alprazolam for drug used for unknown indication, apixaban, clopidogrel, lisinopril, metoprolol, ranolazine, rosuvastatin calcium, and . On 31-MAR-2021, the subject experienced pleurisy. On 31-MAR-2021, the subject experienced chest pain. On 01-APR-2021, the subject experienced urinary incontinence. On an unspecified date, the subject experienced dehydrated. Laboratory data (dates unspecified) included: Chest X-ray (NR: not provided) Pleurisy on left lung, and Diagnostic ultrasound (NR: not provided) No abnormal finding. The action taken with covid-19 vaccine was not applicable. The patient recovered from pleurisy, chest pain on APR-2021, and urinary incontinence on 04-MAY-2021, and the outcome of dehydrated was not reported. This report was non-serious.

that night got a 102.7 fever / Trouble breathing / very bad chest pains . My wife called 911 , went to hospital next morning at 6:30 am , came home that afternoon then 8:30 pm that night called 911 again , was in 3 different hospitals for next 19 days . lost 30 pounds in hospitals, been home now

Pain immediately upon injection and continuing for 5 days. Chills and hot flashes beginning 24 hours after injection, continued for several hours. General lethargy for 72 hours.

Janssen Covid-19 vaccine EUA. Approximately 10 hours after the dose I started developing severe chills and sweating. I checked my Temperature and it was 99.7 Degrees F. this has continued all last night and through today up to the time of submission of this report.

On April 7, my husband received the J&J COVID vaccination. On April 17, he started to feel ill and developed severe abdomen and back pain, which were not normal symptoms of his other health conditions. He ate very little on that date (and that was the last food he had). At 3:30 a.m. on Monday, April 19, I took him to the ER because of severe pain. They gave him multiple tests, including CT scan, labs, EKG, ultrasound, and others. He was admitted to the hospital, and multiple other tests were performed during his stay. During his stay, his sodium and other electrolyte levels dropped to dangerously low levels, he experienced major swelling, his pain persisted, his swallowing ability diminished, he didn't eat, and his heart consistently ran at a high rate. He was transferred home (with comfort care/hospice) on Tuesday, April 27, and died on Wednesday, April 28, at about 9:30 p.m.

Day after shot patient was tired, he was not feeling well, & he never fully recovered. He went to work on Monday, May 10th & worked until 6:00pm. Returned home eat a little & went to bed. Tuesday, May 11th he worked at home, Wednesday, May 12th we had coffee, laughed & joked around & he went back to work at home. I went to check on him about five minutes later & he was sitting up sleeping. He would usually wake up & say I took a power nap but he was not breathing. I started mouth 2 mouth but he did not respond. My sister told my nephew to call 911 & they told us to lay him on the floor & start CPR until the paramedics arrived. Once they arrived & took over they tried to get him to breathe & restart his heart. The paramedics worked on him for a long time giving us updates on what they were trying to do. Patient never regained consciousness. They indicated probably a heart attack.

ACHINESS ALL OVER THE BODY LIKE FLU; RUNNY NOSE; NECK PAIN; BACK PAIN; HEADACHE; This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1821288 expiry: UNKNOWN) dose was not reported, administered on 28-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-JUN-2021, the subject experienced achiness all over the body like flu. On 29-JUN-2021, the subject experienced runny nose. On 29-JUN-2021, the subject experienced neck pain. On 29-JUN-2021, the subject experienced back pain. On 29-JUN-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and had not recovered from achiness all over the body like flu, runny nose, neck pain, and back pain. This report was non-serious.

Started experiencing fatigue, muscle weakness. After light cardio exercise, energy depleted and would have to lie down and then would fall asleep. I didn't feel sleepy, just extremely weak. Most pronounced in the arms and legs, but sometimes felt like whole body. Saw doctor on 5/12. Later on 6/5 had a complete CBC, physical workup. Some values were slightly out of range, but nothing significant. Went to urgent care about a week or so later because symptoms seemed to be getting worse. They repeated the complete CBC and also ran a lactic acid test. Again results were insignificant. Echo completed on 7/1 showing only mild diastolic disfunction. I'm afraid to exercise. I wake up in the morning with a mild tingling in hands and legs. As the morning progresses, the tingling, weakness, fatigue get worse. I can have some fairly good days, but most are not good. I have experienced some fatigue in the past, but this time has absolutely been the worse. Even as I am writing this, I feel the tingling, weakness in my hands. Earlier my legs felt achy, Legs feel ok at this time.

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

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

Patient was being monitored for 30 minutes by EMS due to anaphylaxis to Shrimp. About 15 minutes into monitoring, the patient reported to EMS that he was feeling sweaty and had some shortness of breath. EMS reported BP to be 171/89 and pulse of 88. Patient stated that he does take blood pressure medication and reported that BP was elevated for him. EMS contacted ambulance for transport to Emergency room, patient in agreement to transport.

Approximately ten minutes following vaccination patient decided to check his blood pressure at the automated machine because he didn't feel well. Patient passed out sitting at the machine and lost control of his bladder. Patient's eyes were open and he was making snoring noises. Upon checking pulse, it was faint. Patient was breathing. Team moved patient to lying position on the floor. Pulse became more prominent and patient woke up. EMS arrived and took patient to local hospital for precautionary testing. Patient discharge home 2 hours later.

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

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

#1 I had reaction to Moderna first (Jan 22) and 3 MDs told me to get J&J as second A few hours following shot developed dry cough, which persisted 4 days. Within 3 hours developed moderate headache which lasted 4 days. After 7 hours became EXTREMELY cold. Had to stay in bed w 7 blankets for 2 days. By 3 days still chilly but relenting. Mild to sometimes moderate nausea developed first day, lessening over 3 days. Fatigue severe starting 8 hours post vaccine, resolving over 4 days. Tiny bit of injection site pain.

This patient came for his COVID vaccine today. Post vaccine while in the waiting area, patient became pale and diaphoretic. Pt then became unresponsive, laid him to the ground and elevated his legs, pt quickly become responsive with any further intervention. Continued to monitor the patient who left with his wife 30 minutes later with no complaints or deficits.

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

Head ache, fever, body aches, ( shoulders,back,ankles,fingers).Started with head ache, 7:00p.m. then fever, approximately 8:30p.m.then body aches Started about 9:30p.m. Fever ended about 2:00a.m.next day and body aches and head ended about 8:00a.m.

MILD FEVER; This spontaneous report received from a patient concerned a 66 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included familial mediterranean fever. 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 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced mild fever. Laboratory data included: Body temperature (NR: not provided) 99.4-100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mild fever was not reported. This report was non-serious.

Bad headache, Bad spinal pain, chills lasting two days, sore arm for 2 weeks headaches on 6th day aftwer vaccination

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

Brought to the ER as a code blue, 50 minutes down. CBC, CMP, and HIV screen completed. Deceased despite attempts of revival. Wife reports patient reported not feeling well, c/o feeling short of breath, started having foaming at the mouth, loss consciousness. He had pink sputum on arrival.

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

medical history of asthma, obesity, and insulin-dependent type 2 diabetes with insulin pump who was admitted for COVID-19 pneumonia. He had received the JJ vaccine on March 16, but began having chills, cough and malaise on March 30th.

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

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

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

Received Janssen vaccine on 3/4/21. Tested positive for COVID-19 by PCR on 4/21/21. Onset date 4/18/21 w/ cough. Known exposure to COVID-19.

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

STOMACH UPSET; SLIGHT HEADACHE; SLIGHT PAIN; This spontaneous report received from a patient concerned a 66 year old male. The patient's height, and weight were not reported. The patient's past medical history included stomach issue, and concurrent conditions included high blood pressure.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, on left arm administered on 07-MAR-2021 15:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced slight pain. On 08-MAR-2021, the subject experienced slight headache. On 11-MAR-2021, the subject experienced stomach upset. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight headache on 08-MAR-2021, had not recovered from stomach upset, and the outcome of slight pain was not reported. This report was non-serious.

TEMPERATURE (FEVER); ACHING NECK; ACHING BACK; MUSCLE SORENESS ARMS; HEADACHE; This spontaneous report received from a patient concerned a 66 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included atrial fibrillation, and other pre-existing medical conditions included patient had no known allergies and patient reported he had not done any exercise/physical activity or weight lifting the day prior to vaccination or after vaccination. the patient reported no prior history of reaction to vaccination in the past and no previous vaccination in the past 30 days.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: 25-MAY-2021) dose was not reported, administered on 16-MAR-2021 13:30 to Left Arm for prophylactic vaccination. Concomitant medications included apixaban for atrial fibrillation, and dofetilide for atrial fibrillation. On 16-MAR-2021, the subject experienced headache. Treatment medications included: paracetamol. On 16-MAR-2021 21:00, the subject experienced aching neck. On 16-MAR-2021 21:00, the subject experienced aching back. On 16-MAR-2021 21:00, the subject experienced muscle soreness arms. On 17-MAR-2021, the subject experienced temperature (fever). On 17-MAR-2021 05:00, Laboratory data included: Body temperature (NR: not provided) 100.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from temperature (fever) on 17-MAR-2021, and was recovering from aching neck, aching back, muscle soreness arms, and headache. This report was non-serious.

Began to feel chest tightness, breathing a little harder than normal. Started to feel very tired the next day, extreme exhaustion. Had to go to bed. He continued to worsen with the exhaustion daily and now can barely get out of bed, or sit up. Before the vaccine he was not spending time in bed during the day. He now has trouble breathing sitting up.

SHORTNESS OF BREATH; BODY ACHES; DECREASED MOBILITY; EXTREME FATIGUE; PAIN AT INJECTION SITE/LEFT ARM SORE TO TOUCH; This spontaneous report received from a patient concerned a 66 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient allergic to triple antibiotic ointment.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. Concomitant medications included omeprazole for drug used for unknown indication. On 06-APR-2021, the subject experienced pain at injection site/left arm sore to touch. On 07-APR-2021, the subject experienced shortness of breath. On 07-APR-2021, the subject experienced body aches. On 07-APR-2021, the subject experienced decreased mobility. On 07-APR-2021, the subject experienced extreme fatigue. On 17-APR-2021, Laboratory data included: Blood test (NR: not provided) within normal limits, and EKG (NR: not provided) within normal limits. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain at injection site/left arm sore to touch, and had not recovered from shortness of breath, extreme fatigue, body aches, and decreased mobility. This report was non-serious.

The second week after I got the vaccine I started to have a pressure headache on the side of my head and down my neck. My leg was painful by my knee and it lasted a week. I had the headache and the pain at the back of my neck for one week. The pain medication did not help with the pain. The headache was on both sides but much worse on the right. I had a bump on the back of my neck on the right that was painful. I had a rash on my arm around the site of the injection about an inch around which is still visible after three weeks. The rash was a little itchy.

DIARRHEA; LETHARGIC; GENERALISED ACHING; HEADACHE; SWELLING AT INJECTION SITE; REDNESS AT INJECTION SITE; BLOOD CLOT FROM THIGH TO CALF; This spontaneous report received from a consumer concerned a 66 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included paralyzed on left side from a previous injury and not very active. 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 1 total administered on 06-APR-2021 on right arm for prophylactic vaccination. The batch number was not reported and it has been requested. No concomitant medications were reported. On 07-APR-2021, the patient had blow-out diarrhea, lethargic, body aches, headache. On APR-2021, the patient experienced leg pain (started week ago), swelling at injection site and redness at injection site. His left foot was swollen, and called physician to check for blood clot or break. The doctor said that the test showed a blood clot from his thigh all the way down to his calf that was a medical emergency. Reporter thinks there was a possibility that they were already exposed to COVID. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot from thigh to calf, diarrhea, lethargic, generalised aching, headache, swelling at injection site and redness at injection site was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210450241- COVID-19 VACCINE Ad26.COV2. S -Blood clot. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Within within 2-3 hours was dizzy and fatigued, since that day progressive feelings of exhaustion and little balance.

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

Pt experienced sever headache, loss of speech transported to Medical Center. 4/19/21 Reports overnight stay and "blood clots" affecting speech, causing HA. Reports clots seen around his heart on MRI Discharged 4/20/21

ITCHING AT INJECTION SITE; HURTING RIGHT ARM; FATIGUE; SWELLING AT INJECTION SITE; This spontaneous report received from a patient concerned a 66 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 21-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 03-MAY-2021, the subject experienced itching at injection site. On 03-MAY-2021, the subject experienced hurting right arm. On 03-MAY-2021, the subject experienced fatigue. On 03-MAY-2021, the subject experienced swelling at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hurting right arm, fatigue, itching at injection site and swelling at injection site was not reported. This report was non-serious.

Woke up with heart racing/pounding on 04/05/2021, went to ER where blood pressure was 193/110, heart rate 108, given IV meds-metoprolol and discharged with instructions to see PCP and cardiologist. Patient states he saw Dr. who said he "didn't know what to do", sent to cardiologist who put patient back on metoprolol 12.5mg. Patient reports he continues to have extreme fatigue with minimal exertion.

TIRED; ITCHINING ON ARM AND WAISTLINE; RED PATCHES ABOUT THE SIZE OF A GRAPEFRUIT BETWEEN ELBOW AND SHOULDER ON BOTH ARMS AND THREE RED PATCHES ABOUT THE SIZE OF QUARTER; HEADACHE; EXTREME BODY ACHES; This spontaneous report received from a patient concerned a 66 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, kidney stone, gall bladder problem, non-smoker, and no alcohol use, and other pre-existing medical conditions included the patient had no immune disorder, 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 and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAY-2021, the subject experienced itching on arm and waistline. On 11-MAY-2021, the subject experienced red patches about the size of a grapefruit between elbow and shoulder on both arms and three red patches about the size of quarter. On an unspecified date, the subject experienced extreme body aches, headache, and tired. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extreme body aches, and headache, had not recovered from red patches about the size of a grapefruit between elbow and shoulder on both arms and three red patches about the size of quarter, and itching on arm and waistline, and the outcome of tired was not reported. This report was non-serious.

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

HARDLY EATING; SKIN IS PALE; PNEUMONIA; BACK HURTING REAL BAD; LOST 30 LBS; This spontaneous report received from a consumer concerned a 66 year old white, Not Hispanic or Latino male. The patient's height, and weight were not reported. The patient's concurrent conditions included patient might have a touch of emphysema, alcohol use (used to drink beer, about 12 pack once weekly), and non smoker, and other pre-existing medical conditions included patient had no known allergy, the patient had 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: Unknown) dose was not reported, administered, 1 total to right arm on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The patient was diagnosed with pneumonia and had lungs hurting on deep breath on 14-MAR-2021. Lung specialist which patient consulted did not know whether patient had covid-19 or not. The patients's pneumonia had got worse which resulted in weight loss of 30 lbs (pound). The patient had underwent CT (computerized tomography) scan by regular physician to determine pneumonia. The patient was put on prednisone and Doxycycline. The patient had subsequently went to lung specialist and was prescribed with Trelegy and 30 days of generic Augmentin. on 14-MAR-2021 patient had his back hurting very bad, was put on Flexeril for back pain, Flonase, Montelukast 10 mg and Tessalon. Subsequently patient was put on dexamethasone (unsure), 6 mg (milligram) once daily and was feeling better, but condition started going back. On 30-APR-2021, the patient experienced skin as pale. The patient still had shortness of breath, not coughing much at the time of reporting. Laboratory data included: CT scan for diagnosing pneumonia and Weight (NR: not provided) lost 30 lbs.. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from back hurting real bad, and had not recovered from pneumonia, lost 30 lbs (pound), skin is pale, hardly eating. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210518214-COVID-19 VACCINE AD26.COV2.S-Pneumonia. 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 patient got sick and tested positive with COVID19 a month after getting the vaccine. All typical symptoms are present.

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

Vaccine was given on 4/3/21. Pt. presented to this facility with chest pain, pneumonia, hypotension on dehydration on 5/28/21

Received the J&J vaccine on May 11th, on May 17th I began having a migraine headache. On May 19th I began having vertigo symptoms, loss of balance, spinning room if I turned my head and when rolling over in bed. I needed to hold onto a countertop to avoid falling over. The headache subsided after six days, the vertigo (spinning room) continued to June 1st. I am still having balance issues when bending forward. I was seen by a Nurse Practitioner on May 18 at a Clinic. I told the NP I was conerned that I was experiencing headaches and vertigo with one week of receiving the J&J vaccine. I was told to review a video on Eply exercises for the vertigo. I do not know if a report was made by clinic regarding my adverse reactions.

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

Pt w/multiple comorbidities p/w 2-day duration of SOB, coughs and fevers. COVID test was positive despite receiving Janssen vaccine on 3/31/21. Was admitted given his risks for treatment of acute hypoxemic respiratory failure secondary to COVID PNA per CXR. Received dexamethasone with improved O2 sats. Pt did not meet criteria for remdesivir or tocilizumab and was eventually discharged home following home O2 evaluation.

PAROXYSMAL ATRIAL FIBRILLATION; FEELING OR SENSATION OF DRAINAGE IN LEFT NOSTRIL; OCCASIONAL PRESSURE IN BOTH EARS; SLIGHT BURNING SENSATION IN JUST LOWER LIP WITH SMALL, TINY PROTRUSIONS; LOCALIZED BACK PAIN BILATERALLY INFERIOR TO THE POSTERIOR RIB CAGE BUT MOSTLY ON LEFT SIDE; SLIGHTLY HIGH PITCH SOUND IN LEFT EAR; HEADACHE; FATIGUE; SMALL AMOUNT BLOOD IN STOOL; NODULE IN CUBITAL FOSSA AREA ON MEDIAL SIDE OF ARM; SMALL AMOUNTS OF BLOOD IN PHLEGM; IRREGULAR, LESS FREQUENT AND MORE SOLID BOWEL MOVEMENTS; INCREASED URINATION LASTED 2-3 WEEKS; OCCASIONAL LOCALIZED PRESSURE AND HEADACHES IN OCCIPITAL, FRONTAL, AND TEMPORAL AREAS; This spontaneous report received from a patient concerned a 66 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19 (experienced all the typical symptoms, but waited 13 days to get tested) and concurrent conditions included paroxysmal atrial fibrillation (last time he had an episode until after he received the vaccine). He did not have any recent episodes of atrial fibrillation The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 29-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 29-MAR-2021, the patient experienced occasional localized pressure and headaches in occipital, frontal, and temporal areas which were intermittent and pulsating in nature. On APR-2021, the patient experienced small amount of blood in stool and had irregular, less frequent and more solid bowel movements about 2-3 weeks post vaccination. He mentioned around the same time he was urinating more (increased urination lasted 2-3 weeks), and then his bowel movements and urinations became regular again. He also experienced a nodule that appeared in the cubital fossa area on medial side of his arm two weeks after the vaccination and then gradually resolved over 2.5 weeks after it appeared and small amounts of blood in his phlegm which appeared 1.5 weeks post vaccination and he continued to experience this on week 2, week5 post-vaccination and then resolved. On 14-APR-2021, Laboratory data included: Antibody test (NR: not provided) Negative, Complete blood count (NR: not provided) unknown, and Platelet count (NR: not provided) Normal. He reported experiencing 5 episodes of atrial fibrillation within the 7 weeks after vaccination, a diagnosis of paroxysmal atrial fibrillation was confirmed by his cardiologist. He also experienced fatigue about 5-6 weeks after vaccination. He had intermittent waves had fatigue throughout the day which lasts for an hour and then came back later in the day, with no consistency and stated this was still unresolved. (Later on he stated he had no fatigue spells lately and considered this resolved). On an unspecified date, he experienced feeling or sensation of drainage in left nostril, (even though had no excess blood or fluid) which started a few weeks after received the vaccine and then lasted for several months but now resolved and occasional pressure in both ears (opening and closing his mouth did not relieve the pressure) and slight high pitched sound in the his left ear. His ear side effects came and gone and considered them to be resolving but not fully resolved. He noticed a few weeks after vaccination he had slight burning sensation in just his lower lip with small, tiny protrusions (He initially said this was unresolved, but then later said this was resolved). He also experienced localized back pain bilaterally inferior to the posterior rib cage but mostly on the left side. He mentioned he have a checkup next week and will discuss his concerns since this side effect was still unresolved and headache. The patient stated he did not experience any of these side effects before receiving the vaccine. He was generally healthy and tried not to take medication if possible. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from paroxysmal atrial fibrillation, nodule in cubital fossa area on medial side of arm, feeling or sensation of drainage in left nostril, slight burning sensation in just lower lip with small, tiny protrusions, and fatigue, and small amount blood in stool, small amounts of blood in phlegm, irregular, less frequent and more solid bowel movements, and increased urination lasted 2-3 weeks on APR-2021, was recovering from occasional pressure in both ears, and slightly high pitch sound in left ear, and had not recovered from headache, localized back pain bilaterally inferior to the posterior rib cage but mostly on left side, and occasional localized pressure and headaches in occipital, frontal, and temporal areas. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210667239-COVID-19 VACCINE AD26.COV2.S. Paroxysmal atrial fibrillation. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: UNDERLYING DISEASE 20210667239-COVID-19 VACCINE AD26.COV2.S. Small amount blood in stool. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

Headaches and dizziness starting roughly 1 week after vaccination, and continued until eventual hospitalization. Experienced first time ever seizure (tonic-clonic) at midnight, March 29th. 2nd seizure approximately 12 hours later. 3rd seizure on May 2nd, at approx. 5 am. Patient is currently taking 500 mg levetiracetam (Keppra) twice daily. Doctors are still yet to identify the cause of seizures.

COULD NOT MOVE LEGS, ARMS AND UPPER BODY; LOSS OF APPETITE; CHILLS; This spontaneous report received from a consumer concerned a 66 year old male. The patient's height, and weight were not reported. The patient's past medical history included aneurysm in 2012 (rupture killed the nerve with one leg), the aneurysm changed the way he was walking and problems walking and concurrent conditions included ex-alcohol user (Stopped drinking 2 years ago), non-smoker, rheumatoid arthritis, and blood thinner. The patient had no known allergies. The patient had no history of drug abuse or illicit drug use. The patient was previously treated with prednisone. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, 1 total, administered on 03-MAR-2021 in left deltoid for prophylactic vaccination. Concomitant medications included infliximab for rheumatoid arthritis. The last dose of infliximab was in FEB-2021. The patient did not discuss getting the vaccine with rheumatoid arthritis doctor. On 05-MAY-2021, the patient had more limited movement until could not move legs and was not walking good. It went up from legs to arms, upper body (coded as could not move legs, arms and upper body). The patient went to emergency room at hospital and stayed in hospital for 1 week. The patient went to rehabilitation one week after for physical therapy. The patient was about ninety percentage back to where he was before the vaccine. The patient also experienced chills and loss of appetite. The symptoms lasted 3 weeks and went away. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of appetite, and chills, and was recovering from could not move legs, arms and upper body. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210730947-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Could not move legs, arms and upper body. 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, UNDERLYING DISEASE.

Pt called today 7/21/21 around 12:10 pm to inform us that he experience electrical shocks on his arm where he got his vaccine, severe pain on his arm, unable to lift his arm and shoulder, and had phlegm/cough about 3 days after getting the shot. These symptoms continue until now per pt. He said he informed his MD Dr. about it a week ago after he read/heard about the side effects of Janssen vaccine. He was upset at first because he said we didn't inform him about the side effects but I told him as a protocol, we usually inform pts about the side effects before getting the vaccine, provide the EUA fact sheet and advise pt to register on vsafe. The paralysis or nerve side effects were not known yet that time he received the vaccine. Informed pt that we will report this incident to VAERS and for him to also register to vsafe. Advised pt to coordinate with his PCP so they can run necessary test to evaluate his condition.

FELT TIRED FOR 24 HOURS; This spontaneous report received from a patient concerned a 66 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: 18G5031, expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced felt tired for 24 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt tired for 24 hours on 18-MAR-2021. This report was non-serious.

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

About 7 hours after vaccine, I suddenly felt very tired & achy in my shoulders & upper back. These aches eventually spread over my entire body. The tiredness got worse as evening progressed. Finally went to bed, & could not fall asleep for approximately 1 1/2 hrs. During this time, I experienced chills along with the body ache. After 6 hrs of sleep, I woke this AM feeeling achy & exhausted.

Just Sore arm and a bad Headache for 2 days. Sending just for information value on the vaccine. Just took tylenol on next day.

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

Death on 3/23/2021 at 9 AM. Home Health Nurse who gave immunization on 3/19/21 verbalized pt was fine after injection, stayed in home for 1 hour after injection was given. Wife verbalized pt was very tired the following day and through out the weekend. Pt stopped eating one day prior to death. Respirations changed on the morning of 3/23/2021 and wife called EMS, pt died at home.

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

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

Patient reported having 6/10 chest pressure, head pressure, diaphoretic, and heart palpitations Patient had history of heart attack 2 years ago Patient seen by medical team, vitals stable but heart rhythm showed controlled atrial fibrillation per paramedic Patient refused medical transport but son will be driving patient to hospital Patient signed AMA form

Started getting real bad body aches the night of the vaccine. Aching, and Pain in lower back and sick feeling has lasted two weeks now? I dont know for sure if this is vaccine adverse conditon for sure, but all started after getting it? Could vaccine have affected my leukemia???

ITCHING; RASH ALL OVER BODY; CHILLS; HIVE; FATIGUE; This spontaneous report received from a patient concerned a 67 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced itching. On 02-APR-2021, the subject experienced rash all over body. On 02-APR-2021, the subject experienced chills. On 02-APR-2021, the subject experienced hive. On 02-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 itching, hive, rash all over body, fatigue, and chills. This report was non-serious.

The day after vaccination date patient began to have increased SOB and a headache (Pain Score of 6). Spouse checked BP which was WNL for patient. O2 sat was as low as 88% on room air. Patient then applied O2 at 2LPM via nasal cannula. O2 sats have maintained in the low 90's with home intermittent/on demand O2 in place. Has required O2 24/7 since day after vaccination. Headache has remained persistent with a pain score of 6 - unrelieved with routine scheduled pain medication, along with taking PRN Tylenol and Ibuprofen. Patient verbalizes more fatigue than usual for himself. Has had decreased appetite.

In office patient evaluation performed 27 days after patient received J & J covid vaccine at a vaccine site. Symptoms at presentation were: 4 week history of post vaccine fatigue, decreased stamina, exertion related tachycardia, and dyspnea on exertion. Patient is a regular exerciser with a high fitness level. Exam was unrevealing. Lab testing included CBC CMP thyroid profile ESR C-reactive protein Lyme titers and D-dimer. All were normal/negative. The reportable lab findings were: SARS-COV-2 IgM and IgG antibody titers were zero on the initial evaluation. Six days later SARS-COV-2 IgG, IgM, and IgA titers were done at Lab. All titers were zero. So 4 and 5 weeks after receiving the J & J vaccine, this patient had no antibody response. He has no underlying disease process known to me to explain this finding. My concern is possible administration of faulty J & J vaccine which may have been distributed before the manufacturing error was identified.

PT REPORTS ACUTE ONSET OF HEADACHE ON 4/13/2021. SEVERITY OF HEADACHE IS MILD. HA IS INTERMITTENT AND SEEMS TO COME ON AFTER EATING PIZZA

This patient was under hospice care at home with Nursing Service and Hospice. He received the J&J vaccination at noon by local public health nurse on Mon 4/12/21. The patient's wife, reported to hospice team that he had been sleepy during the day and had received a dose of Ativan earlier that morning (PRN medication at 0750). The primary hospice nurse reported wife noted he became more lethargic throughout the day after vaccination with his condition worsening at 1720; at that time his blood sugar levels were noted to be low at "47" but patient was alert enough to drink orange juice, eat ice cream. The patient continued to deteriorate so MD was consulted and he was transported to the ED where he later expired at 1930.

Since March 7 (the day I got the J&J shot coincidentally), I have been experiencing dizziness (lightheadedness), weakness, racing heart from time to time (very badly after I did a work out on the day of the vaccination), tingling in my feet, jitters (like having too much caffeine), fatigue, and being cold (more than usual). Things have gotten progressively worse as I now cannot walk up a flight of stairs without a racing heart and heavy breathing and extreme exhaustion. (FYI, before this I was running 4-5 miles 4-5 times a week). In addition, my doctor tells me that I have no Covid-19 protection based on blood tests.

Starting 4/7/2021, periodic mild headaches in temple area running down to upper back neck area. Does't occur everyday. Prior to this, I have not experienced a single headache in over 30+ years. Have not seek medical attention.

Increasing chest pain and colon discomfort. I went to hospital on Friday April 9th because of this. Troponin levels were normal. Symptoms have been coming and going and are still present. At times I feel like I am going to black out. I feel generally unwell and the chest pain is concerning.

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

TIREDNESS; This spontaneous report received from a consumer concerned a 67 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 07-APR-2021 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tiredness. This report was non-serious.

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

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

FEVER; MILD HEADACHE; BODY ACHES; LOSS OF APPETITE; This spontaneous report received from a patient concerned a 67 year old male. The patient's weight was 150 pounds, and height was 167.6 centimeters. The patient's concurrent conditions included ace inhibitors allergy, heart problems, acid reflux, hypercholesterolemia, sleep problems, high blood pressure, back pain, non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient was no ill at the time of vaccination and had no past history of similar events. the patient had no pre-existing acute illness and no history of hospitalization in last 30 days prior to vaccination. the patient had family history of heart problems and diabetes. the patient had no history of drug abuse. The patient experienced arm soreness when treated with influenza vaccine for prophylactic vaccination, and drug allergy when treated with hydrocodone. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805025 expiry: 25-MAY-2021) dose was not reported, administered on 12-MAR-2021 14:00 for prophylactic vaccination. Concomitant medications included omeprazole for acid reflux, gabapentin for back pain, ergocalciferol for bone health, and to improve immunity, acetylsalicylic acid for heart health, bisoprolol fumarate/hydrochlorothiazide for high blood pressure, pravastatin for hypercholesterolemia, trazodone for sleep problems, and zolpidem for sleep problems. On 13-MAR-2021, the subject experienced body aches. On 13-MAR-2021, the subject experienced loss of appetite. On 13-MAR-2021, the subject experienced mild headache. Laboratory data included: Body temperature (NR: not provided) 100.9 F. Treatment medications included: paracetamol. On 13-MAR-2021 03:00, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.2 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, loss of appetite, fever, and mild headache on MAR-2021. This report was non-serious.

FEVER; INJECTION SITE PAIN; This spontaneous report received from a consumer concerned a 67 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced injection site pain. Laboratory data included: Body temperature (NR: not provided) 100 F, 101.3 F. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101.3 F. 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 fever, and the outcome of injection site pain was not reported. This report was non-serious.

POOR APPETITE; WEAKNESS; FEVER; COUGHING; This spontaneous report received from a consumer concerned a 67 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, Laboratory data included: Body temperature (NR: not provided) 100 F, 97.7 F. On 29-MAR-2021, the subject experienced coughing. On 29-MAR-2021, the subject experienced weakness. On 29-MAR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced poor appetite. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and had not recovered from weakness, coughing, and poor appetite. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.

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

FEVER; CHILLS; SWEATING; SORE ARM; This spontaneous report received from a patient concerned a 67 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 07-APR-2021 14:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, the subject experienced sore arm. On 08-APR-2021, the subject experienced sweating. On 08-APR-2021, the subject experienced chills. Laboratory data included: Body temperature (NR: not provided) 100.7 F. On 08-APR-2021 02:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating on 08-APR-2021, sore arm on APR-2021, chills on 11-APR-2021, and fever on 12-APR-2021. This report was non-serious.

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

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

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

patient stated he received the Johnson and Johnson shot on 5/5/2021, on 5/6/2021 patient stated he is experiencing pain at injection site along with muscle aches and tired

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

Patient developed acute onset bilateral anterior thigh pain that radiated to the lower back and buttocks, as well as in the posterior hamstrings. The pain was 10/10 and started suddenly over 1/2 days, described as sharp and stabbing in nature. He was able to ambulate but had extreme pain with hip flexion. Associated with this had unintentional weight loss of 10 lbs over 3 weeks, loss of appetite, drenching night sweats for 4 days prior to admission. He presented to the ED on 4/16 with negative work up and was discharged. He re-presented on 4/24 with the same symptoms and was admitted until 5/3. His pain was managed with oxycodone and extensive work up was pursued given concern for systemic inflammation with leukocytosis, elevated CRP, ESR, but normal CK. Eventually pursued thigh muscle biopsy which showed ". At last point of contact at 5/7, he described having two more episodes of bilateral thigh pain after discharge that lasted 30 min in the mornings, but had not had any symptoms the day prior to the call.

Received shot at 10:00am on 5/5/2021. On 5/6/2021 Patient began to feel ill with fever, chills and body aches. Spent most of that day in bed. On 5/7/2021 presents to Clinic, fevers, chills and body aches had improved but noticed "rash" - right lower extremity was red, hot to touch, swollen, pain with "tightness" and "burning" sensation at site. Denies itching. Right Lower Extremity well demarcated area of erythema, hot to touch and remarkably TTP, particularly at anterior surface of leg. Erythema extends on anterior surface of leg from ankle up to 8cm inferior to the knee cap ;the erythema on the posterior surface of the leg extends from ankle up to about half way up the calf. Erythema is confluent. Anteromedial surface of the skin has diffuse petechiae. Negative Homan's sign and no calf tenderness, 2+ pitting edema from ankle to midway up the shin.

Intermittent chills lasted 10 days. Intermittent low grade headache lasted 8 days, Severe skin rash / spots ongoing, but slowly going away. Joint pain, Very low energy ongoing.

Had a heart transplant 5 years ago. After vaccination, my calf muscles ached and I had to walk on the balls of my feet. I didn?t feel well and was achy, but all of that resolved after about 4 or 5 days. About 25 days after the vaccine, I woke up and my legs were hurting, swollen and lumpy. I went into the house and elevated my feet. I was sore from my calf to my ankles. I called the doctor and he told me to go the ER. After a 3 hour wait, one of the patients waiting almost threw up me, so I told them I was going home. Later, I went in to see the doctor about what was going on. After rubbing my calf vigorously, some of the lumps started to go away. The only thing my doctors came up with was that I was retaining water. I felt like I had gained some weight. I couldn?t stand long before my legs swelled. They prescribed a strong diuretic called Torsemide and I lost about 10 lbs. I currently wear compression socks every day, which helps with the swelling and my ankles hurt all of the time. I only take the meds as needed because it?s hard on my kidneys, which are already compromised due to my transplant meds.

SLIGHT HEADACHE; This spontaneous report received from a patient concerned a 67 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included donated blood. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced slight headache. The action taken with covid-19 vaccine was not applicable. The outcome of slight headache was not reported. This report was non-serious.

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

Could be coincidence, Bad Cough and congestion 8-10 days after vaccine lasting 5 days, just now getting better

Severe Immune Response. Fever, Rash, Itching, High Heart rate, Weakness, Shortness of breath. Treated at Emergency room May 09, 2021 Follow up office visit with Dr May 10, 2021 May 12, 2021 May 17, 2021 and June 03, 2021

Increased fatigue, lightheadedness, nausea, intermittent left arm pain and underarm pain and swelling. Left sided chest discomfort - pain worse with breathing and coughing non productive cough

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

HEADACHE; DIZZINESS; This spontaneous report received from a patient concerned a 67 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: 103AZ1A expiry: UNKNOWN) dose was not reported, administered on 29-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced dizziness. On an unspecified date, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, and the outcome of headache was not reported. This report was non-serious. This case, from the same reporter is linked to 20210702102 and 20210701921.

Patient stated that he had normal symptom after the vaccine for the first couple days and fatigue for at least five days. On the 16th of march patient felt flutterers in his heart he went to the ER and was there for over 8 hours. They ran test and advised he see a cardiologist. He has been going back and forth to the Dr since March about heart and blood pressure.

Patient stated that he had normal symptoms after the vaccine for the first couple days and fatigue for at least five days. On the 16th of march patient felt flutterers in his heart he went to the ER and was there for over 8 hours. They ran test and advised he see a cardiologist. He has been going back and fourth to the DR. since March about heart and blood pressure.

I have had a severe skin breakout on my right thigh bumps that appeared after a week and are still there. In addition severe pain in my lower back on the left side which was there before the shot. Also, I have been languish and tired since the shot.

PULSE RATE; HEADACHE(COMING AND GOING); NAUSEA; FEVER; This spontaneous report received from a patient concerned a 67 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: 207821A, expiry: UNKNOWN) dose was not reported, administered on 03-JUL-2021 09:30 for prophylactic vaccination. No concomitant medications were reported. On 03-JUL-2021, the subject experienced pulse rate. On 03-JUL-2021, the subject experienced headache (coming and going). On 03-JUL-2021, the subject experienced nausea. On 03-JUL-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 F, Body temperature decrease (NR: not provided) 97.1 F, and Pulse rate (NR: not provided) not reported. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 03-JUL-2021, had not recovered from headache(coming and going), and the outcome of nausea and pulse rate was not reported. This report was non-serious.

LEG GIVING OUT; HEADACHE; FEVER OF 101 F; This spontaneous report received from a patient concerned a 67 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: 07-AUG-2021) dose was not reported, administered on 03-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-JUL-2021, the subject experienced headache. On 03-JUL-2021, the subject experienced fever of 101 f. Laboratory data included: Body temperature (NR: not provided) 101 F. On 12-JUL-2021, the subject experienced leg giving out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from leg giving out, and the outcome of headache and fever of 101 f was not reported. This report was non-serious.

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

Headache, dizziness, vomiting over 3x in a 7 hour time period, pressure in neck up to the back of head, tightness in the back of head, faint feeling.

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

Cough. Body aches Sharp pain shoulders, neck, torax. Could not move his head, could not move his arms. Fever, chills. Short breath Sharp pain right wrisk (fractured long ago and healed) - X-Rays showed arthritis. He did not complain before or it did not bothered before. A sharp pain in a specific point of his head (Right - front - up side). Not being able to laid down. Moving hurts.

Chills, headache, sinus congestion began 7/18/2021 Chest congestion and cough began 7/19/2021 Chest congestion, productive cough with thick mucus and hard white chunks began 7/21/2021 Difficulty breathing , wheezing, and continued cough 7/22/2021 First Emergency Room visit on 7/24/2021 for worsening Congestion, cough, and decreased 02 saturation. Second Emergency Room visit on 7/25/2021 for same complaint Third Emergency Room visit on 7/26/2021 for above complaints and fall from LOC

Fever chills (shivering) started at 11:30 p.m. on May 8, 2021 Temperature was only 99.5 degrees By 1:00 a.m., March 9, fever was 101.5 degrees By 2:30 a.m. May 9, 2021 fever was 102.5 degrees By 4:00 a.m., March 9, 2021fever had reduced to 101.5 degrees By 9:00 a.m., March 9, 2021 fever had reduced to 99.6 degrees

Fever, Aches, Fatigue for a 48 hour period beginning 12 hours after the injection. Highest fever was 102 deg

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

Fever of 100° began @ 10 pm 3/23/21and ended @ 8am on 3/24/21. Minor achy shoulders, back and injection site. Due to MS, fever raises inflammation in quadriceps making walking very difficult. Treated with Tylenol, cool compress and rest. General feeling of fatigue 3/24/2021. All symptoms completely resolved 3/25/2021

I didn't have pain in the arm, after an hour I had a slight headache. The headache lasted about a day. After the 3-4 day I had serve diarrhea and stopped taking my supplements. It stopped for a couple days then came back for a day. I had no headache or pain, just 3 bad episodes of diarrhea. On March 24th I went into the Hospital with severe pain in my lower left back side. I thought I was passing a kidney side, with the pain I was having. When I got there they did a CT scan and blood work and it wasn't kidney stone but I had a blood clot on the lower left side of lung and the right side as well. They immediate put me on blood thinners. I was there for a day and a night. They released and put me on medication. I've had minor pain but nothing like the pain I had before. I have since followed up with a Pomologist and PCP. Pulmonologist said I had blood clots but couldn't give me a cause. My PCP said she thought I had or have Covid. I asked to have my blood drawn and she said it was too late for that because I had taken the vaccine already.

Event: Headache becoming persistent on different areas of the top of the head. Pain is tolerable to the patient although alarming as patient did not have this medical condition before vaccination. Treatment: Self-treatment by patient by taking 240 mg of aspirin which alleviates the pain. Patient avoids fatty and salty food and does more exercise. If condition remains for another week, patient will see his doctor.

Severe chills starting 11 hours after administration. Severe fatigue entire day after administration, milder fatigue for 2 days thereafter. Swelling of injected deltoid muscle noted 3 days after injection, swelling reduced over following 4 days. Bruising 3 to 4 inches in diameter noted 3 inches below injection site (at approximate location of deltoid insertion) developing 5 days after injection and still noticeable 2 weeks after injection. Bruising still noticeable at time this report submitted

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

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

MUSCLE TENSION; HEADACHE; This spontaneous report received from a patient concerned a 68 year old male. The patient's height, and weight were not reported. The patient's past medical history included headache. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982 expiry: 23-JUN-2021) dose was not reported, administered on 05-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced muscle tension. On 05-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, and the outcome of muscle tension was not reported. This report was non-serious.

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

On 3/17/21 started experiencing intense headaches. Just started taking amoxicillin 875mg for previous sinus infection the day before. After a few days called doctor who told me to stop the medication. The headaches got better afterwards.

Severe headache with fatigue started 04/12/2021. 04/14/2021 tightening in chest. went to local urgent care clinic for rapid test and treatment. EKG done also. Showed abnormal.,sent to local ER. Diagnosed with possible STEMI. Ems ride to north cath lab. Heart cath diagnosis of Pericarditis.

The patient called the pharmacy on 4/7/2021 and said that he had vomited and had been experiencing an excruciating headache that he said was worse than any headache he had ever had and was concerned about how he was feeling since he had just had his Covid vaccine on Monday. I told him that headaches were a very common adverse reaction and that many people had experienced headaches after vaccination. I told him that from my experience it usually didn't last more than a day for others and I assured him that it should go away soon. I later talked to him and found out that he had went to the Emergency room that Wednesday evening (4/7/2021) because the headache was so bad. He was seen in the ER, observed overnight, released the next morning, and then had a follow up appointment with his primary care physician on 4/15/2021. He also had a very high blood pressure reading he told me in the Emergency room that evening he was evaluated.

CHILLS; ACHING BODY; This spontaneous report received from a patient concerned a 68 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 07-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-MAR-2021, the subject experienced chills. On 07-MAR-2021, the subject experienced aching body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills and aching body was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.

1 bout of Violent diarrhea that occurred on 4/9/21 or 4/10/21- passed out on the bed after the episode, exhausted. Nausea followed the diarrhea. Comes and goes. Still happening. Experienced heart palpitations at night on 4/12/2021, never experienced before. Got EKG the next day- normal. Back ache began on 4/15/21 to 4/16/21. Not experienced this before. The ache comes and goes. Fatigue and weakness in the whole body. Comes and goes. Better after food.

fever, shortness of breath, shivering, loose stools, loss of appetite, muscle aches, headache, extreme fatigue.

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

ARTHRALGIA; LETHARGIC; This spontaneous report received from a patient concerned a 68 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, expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced arthralgia. On 09-MAR-2021, the subject experienced lethargic. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arthralgia, and lethargic on 10-MAR-2021. This report was non-serious.

severe headache, abdominal pain, or shortness of breath and patient states they were consistent for 2 weeks and now they have passed

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

Flat red rash with bumps started on back day after vaccine. About one week later shoulder and neck pain. A few days after that chills and fatigue and increased neck pain requiring emergency room visit. Had fever, elevated BP and decreased oxygen level with extreme neck pain. Treated and released with medication. Negative CT of head and neck. Next day had extremely swollen uvula and sore throat requiring sleeping elevated to breath. Throat was not examined in ER night before. Unable to get up by himself and slept for 27 hrs except for occasional trip to bathroom. He is recovering now.

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

The following evening after the shot, he had severe pains in his back and shoulders, headache, nausea (vomited). 2 days later, felt severe pain in his stomach, along with pain in his shoulders and back, with a headache, also vomited.

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

Patient developed nasal congestion, cough and fatigue 1 month after receiving COVID vaccine. Patient subsequently tested positive

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

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

VOMITING; NAUSEA; FATIGUE; SURGE OF ENERGY; This spontaneous report received from a patient concerned a 68 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included stage 4 prostate cancer, and sulfonamide allergy. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-MAY-2021, the subject experienced surge of energy. On 16-MAY-2021, the subject experienced vomiting. On 16-MAY-2021, the subject experienced nausea. On 16-MAY-2021, the subject experienced fatigue. The action taken with covid-19 vaccine was not applicable. The patient recovered from surge of energy on 16-MAY-2021, and had not recovered from nausea, vomiting, and fatigue. This report was non-serious.

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

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

DRY HEAVING; NAUSEA; HIGH FEVER; FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 68 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no known allergies and 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: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAY-2021, the subject experienced flu like symptoms. On 19-MAY-2021, the subject experienced high fever. Laboratory data included: Blood glucose (NR: not provided) Not Reported, and Body temperature (NR: not provided) up to 101.9. Treatment medications included: paracetamol. On 20-MAY-2021, the subject experienced dry heaving. On 20-MAY-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) up to 102.9. Treatment medications included: prochlorperazine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from flu like symptoms, dry heaving, and nausea, and had not recovered from high fever. This report was non-serious.

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

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

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

Often starts with headache on top of his head. Extreme Shaking of Body, Stuttering, Muscle Weakness. It was an episode: The longest one was about 2 hours. When episode is complete all symptoms completely stop and has extreme fatigue and headache continues.

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

Patient report tingling in both legs, dehydrated, chills, dark spots all over body w/ burning sensation, and shaking

After about 2 and a half hours, right side neck lymph node swelled up -also pain & tingling in right arm-both lasted 2 days. I got the shot on my right side. Also got a headache & fever the first night,

Patient was exposed to a family member who was COVID-19 positive and tested positive on 7/16. Symptoms start on 7/16 with cough, fever, chills and SOB. Primary care doctor recommended he go to ED and receive casirivimab/imdevimab. Patient received the infusion on 7/21 morning. Then came back to the hospital in the evening due to worsening SOB and was admitted for hypoxia requiring oxygen. Patient was started on remdesivir (7/22) and steroids and lovenox (7/21). No longer febrile starting 7/23. Asymptomatic rash noted on patient's chest on 7/25 and no longer requiring oxygen.

My body started shaking uncontrollably - lasted for about 30 to 45 minutes. Also developed a mild headache with the shaking.

Chills, headache behind eyes, fever, muscle pain/aches; now only bad headache and body aches; time now is 10:05;

6 hours after receiving the vaccine I became achy, with chill s and uncontrollable shaking and freezing cold.

Delayed onset of fever. The day after the vaccination (3/25), I felt feverish. 11 am 101.3 fever 11:24 am took aspirin 3:40 pm 100.5 fever

Janssen COVID-19 Vaccine EUA Headache, muscle aches, very tired Vaccine was given at 10:00 AM; Symptoms started around midnight that night and lasted about 12 to 13 hours. All symptoms began to dissipate between noon and 1:00pm the day after the vaccination.

BODY ACHE; DID NOT SLEEP WELL; CHILLS; FATIGUE; This spontaneous report received from a patient concerned a 69 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on //2021 for prophylactic vaccination. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On //2021, the subject experienced body ache. On //2021, the subject experienced did not sleep well. On //2021, the subject experienced chills. On //2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, did not sleep well, chills, and fatigue on //2021. This report was non-serious.

Onset severe headache that went away, dizziness that diminished when he lay down, two previous nights of stomach cramps

Daughter reported patient was not feeling well. Took blood pressure reading and results were low. Called ambulance to take to hospital. Patient currently in ICU with unknown condition

- The following message was transmitted to my PCP on Sunday, 04/11/2021, about 11 PM. - Hello, yesterday, Saturday, April 10th, 2021, I received the Janssen (O42A21A) single-dose vaccine around 10 AM. About an hour after arriving home, i started having some of the most common symptoms reported, as in the following: Low-grade fever 99.3', Marked fatigue, mild muscle aches, some dizziness and generalized weakness. Took one 800mg Ibuprofen and rested. Last night, at around 10 PM, I had one episode of hematuria with some visible small-to-medium sized red clots, with no pain or discomfort on urination. Today, in the AM, I took another 800m Additional information for Item 18: 800mg Ibuprofen tablet, and by 12 noon, there was less fatigue and weakness, as I moved on in the day, the other symptoms improved or sub-sided, Except, for some, small clots, in a otherwise normal-appearing colored urine, around 1 PM. My B/P was 148/78, pulse 70, which is normal range for me. Additional information for Item 18: On Monday, 04/12/2021, during the day-time, I again experienced severe-to-moderate fatigue, and some dizziness, and then, last night, at around 7 PM, and 10 PM, I had two separate episode's of hematuria with some visible small-to-medium sized, Dark red clots this time, with no pain or discomfort on urination.

I received the shot on Friday and the next day on Saturday I started getting a headache and every day since then I have had a headache that is constant 24 hours a day. It is now 5 days in a row, It just won't go away

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

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

PTS WIFE NSTATES NPT REFUSED TO GO TO HOSPITAL AFTER DEVELOPING CHILLS, LOW BODY TEMP @ 95, VOMITING, FATIGUE, WEAKNESS, AND LOSS OF APPETITE. SHE FED HIM CHICKEN NOODLE SOUP, PENTY OF BLANKETS, AND GATORADE. ITS BEEN 1 WEEK AND HE IS STILL ILL AND STILL REFUSING MEDICAL ATTENTION

PLEASANT MILD DROWSINESS; TINY PAIN AT SITE OF INJECTION; This spontaneous report received from a patient concerned a 69 year old white,non Hispanic or latino male. The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol user, and non smoker, and other pre-existing medical conditions included no known drug allergies reported no drug abuse or illicit drug usage reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and expiry: not reported) dose was not reported, administered on 08-MAR-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the patient experienced pleasant mild drowsiness and tiny pain at site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pleasant mild drowsiness, and tiny pain at site of injection. This report was non-serious.

ITCHY RASH OR ITCHING ON ARM AND THIGHS; RED BLOTCHY HIVES ON THIGHS, BUTTOCKS AND ARMS; SORE ARM; MILD HEADACHE; This spontaneous report received from a patient concerned a 69 year old male. The patient's weight was 185 pounds, and height was 69 inches. The patient's concurrent conditions included copd, emphysema, smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no known drug allergies and no history of hives/rash ad did not have drug abuse history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. Concomitant medications included atorvastatin, levothyroxine sodium, metoprolol, and paroxetine hydrochloride. On 05-MAR-2021, the subject experienced mild headache. On 06-MAR-2021, the subject experienced sore arm. On 13-MAR-2021, the subject experienced itchy rash or itching on arm and thighs. On 13-MAR-2021, the subject experienced red blotchy hives on thighs, buttocks and arms. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from itchy rash or itching on arm and thighs, red blotchy hives on thighs, buttocks and arms, and mild headache on MAR-2021, and sore arm on 07-MAR-2021. This report was non-serious. This case, involving the same patient is linked to 20210330252.

PERSISTED MILD HEADACHE; This spontaneous report received from a patient concerned a 69 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced persisted mild headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from persisted mild headache. This report was non-serious.

Strong headache lasting about 2 weeks, nausea, red raised sores up to half inch diameter clearing some after 12 days on face and scalp

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

FLU LIKE SYMPTOMS; ARM PAIN; TIRED; This spontaneous report received from a patient concerned a 69 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known medical history and no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, the subject experienced tired. On 06-MAR-2021, the subject experienced flu like symptoms. On 06-MAR-2021, the subject experienced arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms on 07-MAR-2021, and tired on 06-MAR-2021, and had not recovered from arm pain. This report was non-serious.

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

COLD SORE ON THE LIP; FEVER WHICH WAS DESCRIBED AS FLU LIKE SYMPTOMS; MUSCLE ACHE; FEELING TIRED; ITCHING; RASH THAT APPEARED ON MIDCHEST AREA BETWEEN THE STOMACH AND THE PECTORALS; RED BLOTCHES; This spontaneous report received from a patient concerned a 69 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: 05-MAY-2021) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On MAR-2021, the subject experienced itching. On MAR-2021, the subject experienced rash that appeared on midchest area between the stomach and the pectorals. On MAR-2021, the subject experienced red blotches. On 05-MAR-2021, the subject experienced fever which was described as flu like symptoms. On 05-MAR-2021, the subject experienced muscle ache. On 05-MAR-2021, the subject experienced feeling tired. On 10-MAR-2021, the subject experienced cold sore on the lip. On 17-MAR-2021, Laboratory data included: Biopsy (NR: not provided) UNKNOWN. Treatment medications (dates unspecified) included: fexofenadine, and triamcinolone acetonide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold sore on the lip on 16-MAR-2021, and fever which was described as flu like symptoms, muscle ache, and feeling tired on 08-MAR-2021, and was recovering from rash that appeared on mid chest area between the stomach and the pectorals, red blotches, and itching. This report was non-serious.

initially had mild headache and diarrhea but this resolved after a few days. Then around 4/25, developed atraumatic bruising and swelling and pain to the left biceps region (opposite side from vaccine). denied current headache/visual symptoms/abdominal pain or other bleeding/bruising.

On March 30th the patient had loss of appetite and headache. On March 31st the patient collapsed and was taken to the ER, the patient's oxygen was low. Patient's blood pressure had dropped and you could not wake him up all afternoon. The Ambulance took him to the hospital on April 1st where he had shortness of breath and blood clots in lungs. On April 1-2 the patient was leaking blood but the hospital staff could not find where so they gave him 3 units of blood. Patient also received 3 antibiotics for a rare pneumonia.

Pt received Covid-19 vaccine on 3/19 then presented to ED with fever and shortness of breath on 3/23 admitted to the hospital found to be COVID 19+ and requiring 2L oxygen via NC. Treated with dexamethasone, remdesivir and empiric antibiotics. Following admission, O2 requirement increased, received tocilizumab then required transfer to the ICU on 3/29. On 3/31 developed right leg ischemia, underwent thrombectomy and heparin infusion then on 4/1 patient intubated due to increased need for respiratory support and had bilateral chest tubes placed, post-intubation course complicated by shock with AKI requiring pressor support, prolonged encephalolpathy. On 4/24 with worsening shock, hypoxemic resp failure, AKI requiring pressors and CRRT with broad spectrum antibiotics and resumption of stress dose steroids, the family was transitioned to comfort measures and passed away on 4/29.

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

Left arm slight soreness > Expected. No fever or raise in heart rate. Mild Fatigue for two days. About 10 days later was doing regular workout running. I have been biking and running and swimming for years on regular basis Very sore hamstring pull and unusual muscle soreness in legs after normal workout that has never happened. Legs took several days to recover which is not normal for me. Seem to be ok now, but strange that I would have that type of soreness. I am retired teacher of exercise physiology who taught college and also worked in cardiac rehab and with back injuries in past , so found this unusual

Day of injection: Slight fatigue, fever and headache began about 6-7 hours after injection. Next day; extreme fatigue, slept three hours in the middle of the day, no fever immediately (slight in the evening) but increased headache, tightness feeling in head all day, joint pain. Next day; fatigue worse, no headache nor fever, joint pain increased. At this point, I considered seeing a doctor but did not. Today; slight headache, no fever, fatigue seems to be getting better.

Injection Site soreness, by bedtime, slight fever, chills (all night), overall aches (like the Flu), terrible headache upon waking. No appetite, symptoms continued for 3 days. Back to somewhat normal on day #4.

I was kinda weak, not feeling real well. I went to see my cardiologist and let him know that I had discovered blood in my stool. They ordered blood work and my hemoglobin and rbc was so low the told me to go straight to the hospital. They gave me 3 units of blood. They did a colonoscopy and endoscopy, and have not determined the cause of the bleeding. I was admitted in the Hospital for 3 days.

I had a mild headache beginning in the forehead shortly after the injection and it increased in intensity radiating to the left temple, along with moderate fatigue. The headache persisted daily and I treated it with Tylenol 625mg every 8 hours. The Tylenol reduced the severity to some degree, but did not reduce the pain measurably. I contacted my PCP and they prescribed Butalacetamin/CF 50-325-40 every 4 hours. As of today I still have the same headache symptoms and have scheduled an in office visit for Tuesday 6/1. I have no other symptoms and honestly would not have associated it with the vaccine had it not occurred immediately following the administration.

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

HEADACHE; This spontaneous report received from a patient concerned a 69 year old male. The patient's weight was 390 pounds, and height was 180.34 centimeters. The patient's concurrent conditions included asthma, diabetes, hypertension, hypothyroid, hyperlipidemia, sleep apnea, arthritis, collapsed spinal disc, lymphedema, allergic to tobacco smoke, and non smoker, and other pre-existing medical conditions included the patient had allergies to non-steroidal anti-inflammatory drugs (nsaids), adverse drug reactions (adrs) to most statins. The patient experienced drug allergy when treated with acetylsalicylic acid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.

HEART INFLAMMATION LEADING TO MILD HEART ATTACK AND PNEUMONIA. 6 DAYS IN HOSPITAL, 3 STENTS IN ARTERIES, 6 WEEKS OF CARDIAC REHAB NEEDED.

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

Wife reports that patient went to see his cardiologist on 6/7/21 for a follow up to the aortic valve replacement on 10/1/20. He received a good report from the cardiologist and was going to be taken off Warfarin the following week. On the way home he complained of a headache and felt like it was sinus headache. When he got home he went to bed as the headache had worsened. His wife assisted him up to the bathroom and back to bed and he went to sleep. She could hear him breathing from the other room. Later in the evening she became aware that she could not hear him breathing and upon checking on him she found him unresponsive, not breathing and he was blue in the face. She call 911 and they attempted to resuscitate him without success. Wife also reported that after the aortic valve replacement in 10/20, her husband went to the hospital with a fever and was diagnosed with covid and sepsis on 12/14/20. He was admitted and started on IV antibiotics and was hospitalized for 5 days. He had home health care coming into his home for 6 weeks of IV antibiotic therapy. He made a good recovery and was followed by an infectious disease doctor who put him on Amoxicillin po tid until the end of May. She states that he was doing very well physically and was playing golf, walking and felt better than he had in a long time.

6.29: Patient recently seen on 6.29.21 at hospital ER and was diagnosed with COVID-19. He was sent home and told to return if symptoms worsened. 7.5.21: patient presents with shortness of breath and cough that have become increasingly worse. Hospitalization due to COVID-19 infection. diagnosed with community acquired pneumonia secondary to COVID-19, acute hypoxic respiratory failure. Patinet has history of receiving the J&J COVID-19 vaccine in April 2021. 7.16: as of the date of this report submission, the patient is still admitted.

At approximately 9:00PM om March 7, 2021 I started to feel very tired and was starting to have trouble breathing. My O2 level was between 89% and 91% and my heart was racing. The oximeter I have showed 98/99 BPM. I also had a temperature of 99.9 degrees. Most of these symptoms started to subside after about 2 hours

fever Advised caller injection site pain, fatigue, headache, muscle aches, chills, joint pain, and fever can occur following COVID-19 vaccination. Swollen lymph nodes and nausea have also been reported, but not as common. Please seek medical attention if experiencing any shortness of breath, throat swelling, weakness, or diffuse body rash.

Patient got up from chair to pick up his phone and collapsed, diaphoretic. There was no loss of consciousness. Initial BP = 80/60 and HR =84. He had no symptoms other than sweating and dizzyness. He stated he felt dizzy after the vaccine but had not eaten since the night before. He also said sometimes gets dizzy after shots. Repeat BP was 110/60 EKG by EMS demonstrated ST wave changes and patient was sent to Medical Center by EMS.

Severe Head ache on the day after, nausea, fever of 100 degrees, felt a lot better on March 13th. Woke up on the 14th with head ache and muscle pain all over especially in my chest area. Treated with Tylenol. During the night on the 15th I had a fever of 102.5 with severe headache and vomited. Tylenol has not worked. Call my PC and let him know my symptoms. It is now late in afternoon on the 15th, still have weakness and headaches and muscle aches. Fever is down to 100.0

Substantial weakness, muscle aches and fatigue, chills, fever, headache, neuropathies, additional digestive problems. Recovered slowly over 5 days.

Patient started to experience dizziness a couple seconds after the shot. Provided patient with water and he waited another 30-45 minutes and he started to experience nausea and chest pain that was rated a 3/10. 911 was called and his blood pressure was measured at 210/110 (previous blood pressure was 190's/110. Nitroglycerin was given but it did not help with his chest pain and he began to have a headache. He was taken to the hospital. He stated that he was not feeling good a couple days before today. He felt better today and received his J&J vaccine. Fired his cardiologist and was looking for a new one.

First 24 hours patient experienced flu like symptoms, and since then for about two weeks patient has been experiencing muscle and joint pain with intermittent flare ups.

PATIENT CALLED ON 04/06/2021 REPORTING FATIGUE THAT EMERGED AFTER A WEEK FOLLOWING HIS COVID 19 VACCINE (JANSSEN). HE STILL FEELS FATIGUE AFTER 3 WEEKS OF HIS IMMUNIZATION

CHILLS; SWEATING; ACHINESS; This spontaneous report received from a patient concerned a 70 year old male. The patient's height, and weight were not reported. The patient's past medical history included alcohol use, and concurrent conditions included asthma, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and patient had no drug abuse or illicit drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) once a total dose was not reported, administered on 16-MAR-2021 16:00 at right deltoid for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included levofloxacin for asthma, and montelukast sodium for asthma. On 16-MAR-2021, the subject experienced chills. On 16-MAR-2021, the subject experienced sweating. On 16-MAR-2021, the subject experienced achiness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, sweating, and achiness. This report was non-serious.

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

Thu 4/1/21: 9:32pm: chills; 10:19pm fever: 101.7; 10:59pm fever: 102.7; (note: no aches with fever but headache worse as fever rose, less as it diminished) Fri 4/2/21: 2:15am fever: 102.8; 12:10pm fever: 100.6; 3:12pm fever 100.6 3am: night sweats Sat 4/3/21: 9am: woke drenched but normal fever. Weak, tired. Strength returning slowly all day. 95% by evening, tho no reserves of strength. Sun thru Wed: night sweats every night so far.

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

HIVES ON EAR AND HEAD; FEVER; This spontaneous report received from a consumer concerned a 70 year old male. The patient's height, and weight were not reported. The patient's past medical history included stroke, and heart problems, and concurrent conditions included penicillin allergy. The patient experienced drug allergy when treated with tramadol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced hives on ear and head. On 26-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hives on ear and head on 28-MAR-2021, and fever on 27-MAR-2021. This report was non-serious.

All symptoms I had when I had Covid in March 2020 returned within 12 hours of receiving this vaccine. Had body aches, severe chills, nausea, and 102.5 fever along with fatigue. Symptoms lasted 36 hours and subsided only to return 12 hours later. with chills and fever of 101.7. Taking Advil and Tylenol alternating every 4 hours.

I felt fatigued for 2 days after the vaccination and then no issues until around day 16. I developed chills, fever, headache, neck aches, malaise and extreme fatigue that lasted 12 days and then resolved for the most part except still experiencing some fatigue. I was concerned because I was expecting side effect shortly after the vaccine however the symptoms were very much delayed. Although I have been very isolated before and after the vaccine I grew concerned I may have been exposed to COVID though highly unlikely and got a PCR covid test which came back negative

VERY MILD SINUS HEADACHE; This spontaneous report received from a patient concerned a 70 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included sinus headache regularly throughout the year. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043421A,expiry: UNKNOWN) dose was not reported, administered to left arm on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced very mild sinus headache. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from very mild sinus headache. This report was non-serious.

Having nausea, vomiting and unable to have bowel movement for 12 days. Symptoms for 12 days so far. having myalgias and fatigue. Excessive coughing

Flank chest pain (pain under right rib cage) and Dyspnea on exertion; woke pt up at 0300 on 4/9/21 Chest pain with deep breathing., fever, and nausea upon presentation to ED Pt denied recent travel or prolonged immobilization Patient diagnosed with bilateral pulmonary embolism per CTA

HEADACHE; LOW GRADE FEVER; MUSCLE ACHES; TIREDNESS; This spontaneous report received from a patient concerned a 70 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, glaucoma, non alcoholic, and non smoker, and other pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced headache. On 13-APR-2021, the subject experienced low grade fever. On 13-APR-2021, the subject experienced muscle aches. On 13-APR-2021, the subject experienced tiredness. Laboratory data (dates unspecified) included: Lab test (NR: not provided) Normal. Treatment medications (dates unspecified) included: acetylsalicylic acid/caffeine/paracetamol/salicylamide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, low grade fever, and tiredness, and had not recovered from muscle aches. This report was non-serious.

HEADACHE; This spontaneous report received from a patient via a company representative concerned a 70 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced headache. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Normal, and Magnetic resonance imaging brain (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.

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

Patient developed cough, fever, shortness of breath on 4/22/21. Tested positive for COVID-19 and was found to have a pulmonary emoblus in the ER on 4/27/21. She is currently admitted at Hospital, under my care. I'm also her primary care physician.

Presented to emergency department at ancillary facility on 3/19/21 with shortness of breath and was admitted at that time. He was transferred to regional medical facility on 3/23/21 for further management due to increasing oxygen requirements and worsening congestion. Patient was discharged on 4/2/21 to rehab facility. Patient presented to emergency department on 4/12/21 from rehab facility for worsening hypoxia and respiratory failure. Chest xray showed new infiltrates and he was started on antibiotics for pneumonia. He was discharged on 4/20/21 to a skilled nursing facility.

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

Four minutes after his vaccination, patient reported feeling "hot", and sweating profusely. Some shortness of breath, and mild chest pain. Patient was responsive, and able to answer questions. By 2:50 PM, pt reported feeling "better" but still "groggy".

BLOOD SUGAR SPIKE; TERRIBLE SICKNESS; TOTAL FATIGUE; This spontaneous report received from a patient concerned a 70 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration 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 terrible sickness. On 01-APR-2021, the subject experienced total fatigue. On 15-APR-2021, the subject experienced blood sugar spike. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from total fatigue on 15-APR-2021, and had not recovered from terrible sickness, and blood sugar spike. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non serious.

PT IS REPORTING EXTREME EXHAUSTION AND VERY PALE TO COLOR 6 DAYS POST VACCINE. PT STATES HE WAS DIAGNOSED WITH COVID IN NOVEMBER 2020, BUT HAD NO SYMPTOMS AND RECEIVED NO TREATMENT FOR COVID.

BLOOD CLOT IN LEG; SWEATING; This spontaneous report received from a consumer concerned a 70 year old male of unspecified ethnicity. 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 APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in 2021, the patient experienced sweating which lasted about one day. It was stated that patient received vaccine around 18-APR-2021. It was also reported that actual date of vaccination may have been prior to 18-APR-2021 but definitely in April. On 17-MAY-2021, patient visited hospital and got diagnosed with blood clot in leg. The patient was on unspecified medications to dissolve clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating on 2021, and had not recovered from blood clot in leg. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20210534558-Covid 19 Vaccine- This case concerns a 70 yr old male. Blood clot in leg, Sweating. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

MUSCLE ACHES; FATIGUE; This spontaneous report received from a patient concerned a 70 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 23-JUN-2021) dose was not reported, administered on 22-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAY-2021, the subject experienced muscle aches. On 23-MAY-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle aches, and fatigue. This report was non-serious.

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

Patient's wife reports 1-1&1/2 weeks after vaccine patient has been experiencing shortness of breath, shoulder pain/movement problems, & tingling in the right hand. He had severe hot sweats that have subsided.

Patient received 5 doses of the Johnson and Johnson vaccine. Patient was observed post shot for extra 30 minutes. No symptoms at time of discharge. Patient was checked on via phone call during the evening on 3/9/2021. Wife stated that he had no adverse symptoms and that he had a good appetite. Patient and wife were reminded that if patient feels bad to call 911. Patient was checked again on 3/10/2021. Pt reports minor headache, shoulder and neck pain. Physician was made aware and Tylenol was prescribed for discomfort.

Vaccination at 0830 am, reactions started at @ 0930 pm while at work, Worked till 0400 am. When I left work my feet felt like they were frostbitten, had chills and temp of 99.9. Went home took 2 Extra Strength Tylenol, went to bed with 100.8 temp. Got up the night of the 16th, chills were gone temp was 101.1. Took more Tylenol drank some fluids tried to eat but couldn't . Went back to bed 3 hrs later temp down to 99.9. got up today at 1130am fill fine ate and drank some, temp now is 99.5 but I fill fine.

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

I developed red rashes on my chest and stomach and a blotchy face. The stomach rashes we?re in some places very itchy. I still have a itchy spot on my stomach. On the morning of March 29, 2021 I could not get warm. I covered myself with blankets and in the evening after not eating anything I went to bed. The next day I was still cold. I didn?t feel better until the next day. I am still blotchy.

Two weeks after the shot, he noticed bloody noses, hematuria, ecchymoses all over his abdomen, bruises on the top of his mouth. Fatigue

CHILLS; NAUSEA; FEVER; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 71 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072 expiry: UNKNOWN) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On 08-MAR-2021, the subject experienced injection site pain. On 20-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.2 F. On 20-MAR-2021 05:00, the subject experienced chills. On 20-MAR-2021 05:00, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on MAR-2021, and had not recovered from chills, fever, and nausea. This report was non-serious.

LOST FEELING IN LEGS; TOOK HIM DOWN; This spontaneous report received from a consumer concerned a 71 year old male. The patient's height, and weight were not reported. The patient's past medical history included prostate cancer, and concurrent conditions included diabetes insulin dependent, and other pre-existing medical conditions included patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. Concomitant medications included insulin for diabetes. On 13-MAR-2021, the subject experienced lost feeling in legs. On 13-MAR-2021, the subject experienced took him down. Laboratory data (dates unspecified) included: Blood sugar abnormal (NR: not provided) 300 (not reported). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lost feeling in legs, and took him down on 13-MAR-2021. This report was non-serious.

10 days after receiving the Janssen vaccine, patient experienced extreme / debilitating fatigue, muscle soreness, stiff joints that lasted 72 hours. At the same time as the fatigue onset, a severe rash with inflamed welts and blood-filled blisters covering torso and abdomen - front and back also appeared. The rash was severe for 3 days and slowly subsided; scars still visible today - red dots.

FEELING WEAK; TIRED; LOSS OF APPETITE; This spontaneous report received from a patient concerned a 71 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: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced loss of appetite. On 03-APR-2021, the subject experienced weak. On 03-APR-2021, the subject experienced tired. On 22-APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. Treatment medications included: Z pack (azithromycin). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tired, weak, and loss of appetite. This report was non-serious.

Exacerbation of facial pain through trigeminal neuralgia attacks. Headache Probably caused by pain and discomfort by speaking, swallowing, chewing, ... Increased Carbamazepine.dose to 900 mg/day (from 200-300 mg before Vaccination) The increased dose still does not prevent pain. Endure discomfort to avoid Limited the Carbamazepine side effects, which includes slowing of brain function including maintaining bodily balance.

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

Patient is a 71 y.o. male with past medical history of a-fib on coumadin, ischemic cardiomyopathy s/p ICD, CAD s/p BM stent 2005, and CKD III who initially presented to urgent care per family recommendations d/t persistent cough, SOB and fatigue. CXR was obtained with findings concerning for viral pneumonia vs CHF, rapid COVID was negative at that time with recommendations to come to ED for further evaluation and treatment. Patient subsequently tested + COVID 19 in ED and was hypoxic with ambulation

One day after vaccination, I developed severe body chills with shivering that lasted about 24 hours. And, my face was flushed and hot. In summary, my body had chills while my face was hot. These side effects ended after one day. However, about a month later, May 9, 2021 the above side effects occured again. Also lasting about one day.

5 minutes after administration of vaccine patient became very hot/body temp very high, sweating, felt like he was going to faint. RPH gave him water, put an ice pack on the back of his neck and sat with him for 15 minutes. His body temp came back to normal after 15 minutes and he left.

10 days after the injection (on 5/16) , husband had headache, lethargy, prolonged diarrhea (48+ hours), fever, chills, neck and body pain that lasted 4-5 days. (Wife with no injection on 5/21 got headache, nausea/bloating feeling and neck ache that lasted 4 days.) Husband resumed outdoor activities on 5/22 but began relapsing on 5/27 with headache, fatigue, neck and body pain that still persists as of date of this report (5/29). Item 21 is PENDING how this continues or hopefully resolves. It is still ongoing but your computer insists I must enter something...and you do not have a box indicating ongoing.

J&J Dose 4/10/21 (042A21A) COVID Positive 5/10/21 5/10/21: This is a 71-year-old male with history of left CVA, right minimal hemiplegia, diabetes mellitus, hypertension, right lower extremity DVT, depression and obesity. The patient is saying he feels excessively weak and fatigued in the last 2 days for which he decided to come to the emergency room. He denies any shortness of breath, wheezing, cough, chest pain. He is a former smoker and does not know any history of COPD. He thinks he is passing urine regularly. He denies any polyuria, nocturia, difficulty passing urine or any history of BPH. His diabetes was poorly controlled for few years and patient does not know how much insulin he is taking at this time. He took covid 19 vacine on April 10. 5/15/21: Patient was admitted on the 10th with complaints of weakness, fatigue going on for at least 2 days. Patient was diagnosed with COVID-19 positivity. Chest x-ray showed bilateral airspace disease. Patient also had acute renal failure. Patient was given supplemental oxygen, started on IV remdesivir, IV dexamethasone, IV ceftriaxone, and IV Zithromax. The patient's oxygen use was attempted to wean down. Patient finished course of IV remdesivir, ceftriaxone, and Zithromax in the hospital. Renal function improved. Losartan was discontinued in the hospital. Home O2 walk was done today. Patient to finish oral dexamethasone. Home Health services were provided. Discharged home today. Advised to remain in isolation.

Right after the vaccine, I experienced no symptoms. I had stomach problems and I felt very woozy and had diarrhea, and I also fainted. I hit my head but not bad at all. I went to the ER. I was dehydrated and they gave me IV. They told me drink liquids and Gatorade. It did help with symptoms. They said that it could have been a virus that was going around or it was food poisoning, one or the other.

Diarrhea started 10:30am 3/7/21 Chills began 12 noon 3/7/21 Took Extra-Strength Tylenol 2 x 500mg at 12:30pm 3/7/21

Patient presents to ED with left hand swelling, fever, and left arm pain on 3/10/21 after receiving his COVID 19 vaccine at Clinic on 3/4/21. I'm unable to determine the route of administration from the immunization documentation. Patient reports that the swelling significantly increased over the past day with increased swelling in his left hand and pain from his left clavicle to his left hand. Patient is febrile upon presentation with a documented temperature of 38.7 and sinus tachycardia. EKG is otherwise unremarkable. Patient has been diagnosed with left arm cellulitis and is being admitted to our hospital. He has been started on vancomycin 800 mg and Zosyn 3.375 g IV.

Head ache and temperature of at least 101.8*. extreme relactation, meditation, deep breathing and soft music.

Site: Pain at Injection Site-Mild, Systemic: Fever-Mild, Systemic: Headache-Severe, Systemic: Tachycardia-Medium, Additional Details: Patient's heart rate is typically in the 80's. After vaccination, night of and morning after, patient's heart rate went up to 113.

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

Severe chilling, body aches. Also headache. Started 6:30 pm day of vaccine. Lasted about 36 hours. Severe chilling lasted about 4 hours.

Pt developed edema and pain to LLE from knee down to ankle on 4/9/21. Describes skin tightness and redness.. No fever, but with chills. Given crutches to avoid weightbearing on left leg. Pt is being worked up for potential blood clot, US Left venous duplex. Pending results for exams, Sent to emergency room on 4/13/21 by reporting nurse.

MUSCLE ACHES IN SHOULDER AND LEGS; TIREDNESS; FELT LIKE VOMITING; BODY ACHES; This spontaneous report received from a patient concerned an elderly male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: 26-MAY-2021) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced body aches. On 06-APR-2021, the subject experienced felt like vomiting. On 06-APR-2021 21:00, the subject experienced tiredness. On 07-APR-2021, the subject experienced muscle aches in shoulder and legs. 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 body aches, and muscle aches in shoulder and legs on 09-APR-2021, tiredness on 07-APR-2021, and felt like vomiting on 06-APR-2021. This report was non-serious.

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

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

72-year-old male history multiple medical problems including coronary artery disease with stents Barrett's esophagus asthma enlarged prostate hypertension presents from the infusion center secondary to being found to have hypotension after receiving his immunoglobulin infusion today for COVID. Patient states he has been feeling ill for the past few days due to COVID he has been eating and drinking much. Patient states that he felt no different during his infusion or after but the blood pressure being low specially felt lightheaded when he stood up he was sent down to the ER for further evaluation. Patient denies any chest pain associated with this no palpitations he is awake alert and not diaphoretic in no significant distress on my evaluation. Patient denies any recent blood in stools. Note is the patient did receive the COVID vaccine Johnson and Johnson approximately 10 days ago. He was diagnosed with COVID infection 4 days after that.

fever, chills, chest pain/dizziness for 4 days starting 48 hours after vaccine - dizziness - SOB since

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

LEGS FEEL LIKE LEAD; PAIN IN THE JOINTS; CHILLS; DIFFICULTY BREATHING; COLD LEGS; LACK OF APPETITE; This spontaneous report received from a patient concerned a 72 year old male. The patient's weight was 170 pounds, and height was 72 inches. The patient's concurrent conditions included allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, expiry: 04-JUL-2021) dose was not reported, administered on 29-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-MAY-2021, the subject experienced difficulty breathing. On 29-MAY-2021, the subject experienced cold legs. On 29-MAY-2021, the subject experienced lack of appetite. On 29-MAY-2021, the subject experienced pain in the joints. On 29-MAY-2021, the subject experienced chills. On an unspecified date, the subject experienced legs feel like lead. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in the joints, cold legs, lack of appetite, difficulty breathing, chills and legs feel like lead 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.

Shortly after vaccine, upper respiratory issue started. Fatigue, falling, soiling bed sheets and pants regularly. Then went to hospital on june 7th with abdominal pain. Low bloid pressure and hight white blood count. Had blood clot. Urinary Infection Possible sepsis. Still in hospital.

On May 20th he came down with a cough and not feeling well. Went to hospital on May 22 and was diagnosed with pneumonia. Gave iv antibiotics and fluids. Sent home. On may 24 went back because he was worse. Temperature and high blood pressure and a headache. They admitted him to the hospital then checked him for covid. He was positive. They gave him a shot on may 24 and May 25th in the stomach for blood clots. On may 25th they sent him home. He started feeling better may 28. Then on June 17th he fell out of his chair complaining of severe dizziness. Called 911 and they transported him to hospital. Did a procedure to see if there were any blood clots. It was determined that he had a blood clot in his artery in the neck. They gave him tPA to break up the clot right away. Then transported him to the hospital to the icu. It was determined that the blood clot caused the stroke. Still having severe dizziness. Released him to rehab on 6/18 @ 4:30 pm

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

TIRED; MUSCLE SORENESS; This spontaneous report received from a consumer concerned a 72 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes. 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 tired. On 09-APR-2021, the subject experienced muscle soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired, and muscle soreness on 11-APR-2021. This report was non-serious.

"Pt c/o flushing/sweating and dizziness 3mins after vaccination. Vitals significant for bradycardia. @13:08 BP 100/58, HR 39, RR 12, SPO2 99% -- > @ 13:12 83/40, 41, 100% -- > @13:22 87/43, 50, 100% -- > @13:23 107/67, 61, 100%. 911 Called at 13:15 and paramedics arrived 13:20. At 15:15 pt elected to leave vaccination site . form signed. Pt driven home. Unknown PMH or current medications."

BLOOD CLOTS IN URINE; BLOOD IN URINE; STABBING BACKPAIN IN THE KIDNEY AREA ON THE RIGHT SIDE; SEVERE HEADACHE; This spontaneous report received from a patient concerned a 72 year old male. The patient's height, and weight were not reported. The patient's past medical history included healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: 09-JUL-2021) dose was not reported, frequency 1 total administered on 05-JUN-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 6-Jun-2021 the patient complaint of a severe headache at 2 am, followed by severe stabbing back pain in the kidney area on the right side and blood in urine. The blood started to clot after an hour. The patient went to the hospital emergency room (ER) twice once at night and the other in the evening. After four days due to persistent clotting, he visited a urologist where a catheter was inserted to help to empty the clots. On 18-Jun-2021, he was admitted to another hospital ER because the bleeding could not be stopped. He was hospitalized for 9 days. In order to stop the bleeding and clotting, a stent was placed in the kidney by a surgeon. On unspecified date in JUN-2021 Laboratory data included: Laboratory test COVID-19 virus test (NR: not provided) negative. The patient was discharged from hospital and came home on 26-Jun-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood clots in urine, and stabbing backpain in the kidney area on the right side on 26-JUN-2021, and was recovering from blood in urine, and severe headache. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210725558-covid-19 vaccine ad26.cov2.s-Blood clots in urine, Blood in Urine ,Stabbing back pain in the kidney area on the right side. 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).