Johnson & Johnson

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.

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

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.

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.

60yr old male (documented allergies: erythromycin (diarrhea) and penicillin (rash)) with unknown PMH presented for COVID-19 vaccine on 4/7/21. Of note, patient reported previously lightheadedness/dizziness after blood draw or injection. Patient declined to be reclined for administration. RN administered JANSSEN COVID19 VACC (LOT # 043A21A, exp 6/21/21) IM in patient's left deltoid at 1425. Shortly after, patient reported feeling lightheaded and requested to be reclined. Patient alert and oriented, other symptoms denied including hives, shortness of breath, or throat swelling. BP 152/76, MAP 102, HR 85, 92% RA (of note, patient hypertensive at baseline). After resting in reclined position for ~5min, patient r BP 152/76, MAP 102, HR 85, 92% RA (of note, patient hypertensive at baseline). After resting in reclined position for ~5min, patient reported feeling better. BP upon sitting was 161/92, MAP 115, HR 85, 97% RA. Patient endorsed being back at baseline. Patient discharged in stable condition with no other issues.

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

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.

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.

Gout-like reaction (self-diagnosed) at joint of large toe of right foot. No previous history of gout. Symptoms include significant swelling and joint pain, redness and warmth at affected area. Condition persisted 3 days; condition has begun to subside (at present date, only minor swelling remains).

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.

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.

Patient began experiencing back pain on March 14 and on or around March 18 he started coughing up blood clots according to a coworker. Patient lived alone and was unable to be reached on Sunday March 21. I went over to his house and found him deceased in his bed. Patient had a trashcan beside his bed and it appeared to have some blood in it. Patient had thick mucus coming out of his mouth and blood coming out of his nose. According to paramedics he had passed a few hours before finding him. Unfortunately Patient has been cremated so there is no way to say that this was related to the Covid 19 shot from Johnson and Johnson, however there are new reports that blood clots have been a side effect. I would like to speak with someone from the Department of Health to discuss this further. I feel this could be related to the vaccination and I would to know how long the Health Department knew about this possible side effect. If patient would have known sooner that the blood clots were a side effect I feel he would have gone to the Emergency Room. Patient had no health insurance and he was trying to prevent getting Covid. This has caused our family so much heartache and we are all very apprehensive about getting the Covid Vaccine ourselves. Please contact me as soon as possible, I am also patient's executor so I am able to speak to you on behalf of patient and our family. Thank you.

4/10/2021 - Arrived in ED with weakness reported in R arm and Bilateral legs, Admitted into facility. 4/11/2021 - Neurology consulted expressed concern for AIDP, various neurological tests performed (MRI Brain, CT head and Lumbar Puncture). CVC placed for plasma exchange treatment 1/5 4/12/2021 - CT no acute abnormality, L.P. high protein. 4/13/2021 - Continued ascending Paresis. Monitored closely for Respiratory distress plasma exchange treatment 2/5 4/14/2021 - Plasmapheresis 3/5 performed. decreasing GCS intubated.

muscle tightness, Onset: 3 weeks ago. The problem has worsened. The frequency of pain is constant. Location of pain is bilateral anterior neck, bilateral lateral neck and right shoulder. Associated symptoms include difficulty sleeping and muscle spasm. Pertinent negatives include numbness. Additional information: Pt here alone. Pt reports that 3-4 weeks ago he awoke with neck, right shoulder and arm pain. States he can't turn his head, raise his right arm due to pain. Taking 800mg of ibuprofen and it is not helping. States "it just dawned on me, I had the J/J vaccine 3days prior" Per pt and it was given in. right arm. Not sleeping well. Feels it is triggering his reflex sympathetic dystrophy.

(First of all, I'm not sure the COVID Vaccine caused this) Approximately 2 1/2 weeks after receiving the J&J single dose vaccine (around 22Jan21) I started to experience light itching on my lower back. Within a few days the itching spread to my entire back. By 30Jan21 i saw my primary care physician and a light rash was presenting on my back and chest. I was prescribed some cetirizine for itching. By Saturday 3Apr i had a full blown body rash on my chest, back, down my arms and down to my thighs. My doctor described it as angry red and indicated it appeared to potentially be some type of allergic reaction to a drug. On this date 13Apr, the rash has subsided but some itching continues. We are in the process o

PAIN ON RIGHT KIDNEY AREA; MUSCLE CRAMPS ON RIGHT FOOT AND LEFT UPPER THIGH; HOT FLASHES; BACK 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 concurrent conditions included penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 201A21A, 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 hot flashes. On 08-APR-2021, the subject experienced back pain. On 09-APR-2021, the subject experienced pain on right kidney area. On 09-APR-2021, the subject experienced muscle cramps on right foot and left upper thigh. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from back pain on 09-APR-2021, and had not recovered from hot flashes, pain on right kidney area, and muscle cramps on right foot and left upper thigh. This report was non-serious.

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.

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.

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.

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

Medical team dispatched to the residence of the the name person on April 10, 2021 at 2327. Pt assessed by medic on scene and determine patient with obvious death. Pt found halfway on the couch and to be pulseless, apneic, and with rigor mortis. Unknown down time and when further assessed, patient death determine by EMS. pt had fixed and dilated pupils, non-responsive to painful stimuli, absent breath sounds, no heart sounds auscultated. Pt was also placed on the monitor and found to be in asystole in 2 contiguous leads. CPR with held and no resuscitative measures performed.

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

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

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.

Patient developed paresthesia/sensory changes and lower back and abdominal pain. Found to have likely Guillain Barre syndrome. No motor involvement and discharged home.

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

Three weeks after the vaccine my ankles were swelled up. I gained 30 pounds over the course of fourteen days. I was having trouble breathing. I was admitted to the hospital and diagnosed with Atrial Fibrillation and Congestive Heart Failure. I also had water in my lungs. I have not had any heart symptoms before that. I tested positive for Covid-19 antibodies in June of 2020. I had multiple tests on every organ. There were no clogged arteries and no heart problems except for AFIB. My blood pressure is fine but I am taking half a blood pressure pill. I am trying to lose weight. I am scheduled to see a cardiologist on 05/25/2021

Patient had SOB, upper chest and back pain, diagnosed with small pulmonary embolism in right upper lung

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

I was having arm , shoulder and stomach pain. I have been suffering with leg pain since the vaccine. I am now going to see a spinal surgeon. I have cyst on my nerves and I also have thyroid issues.

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.

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.

The evening of the vaccine my neck began hurting. When I awoke the following morning I couldn?t move my head. I had to move my head with my hands. The pain was excruciating. This cycle continued for four days. On the fifth day the symptoms began to subside.. After about ten days the symptoms were gone. I did not contact the doctor about it. That was my mistake.

I am experiencing numbness in my left leg and food. When walking my left food feels heavy and I can't control my step, i.e., my foot hit the ground with a thud and I can't control it. It makes waking at a normal pace more difficult and I don't have control nor dexterity that I have in my right leg and foot.

Muscle pain in left arm from shoulder to wrist, mostly in tendons or ligaments. Muscle pain went away to be replaced by constant tingling in left arm (like hitting your funny bone, a constant fiery tingle). Constant tingling is now intermittent flair-ups, sometimes so intense that it interrupts my work and causes a safety issue. Injection site still sore to the touch ( a hard touch or press at injection site). Issue still ongoing 12 weeks after vaccination.

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.

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.

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

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

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.)

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.

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.

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!

Janssen COVID-19 Vaccine EUA. One day after vaccine, patient reports onset right sided weakness (face, upper and lower extremities). Found to have stroke on brain imaging: L inferior M2 branch occlusion.

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).

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.

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.

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

PT STATED HE WENT TO THE CLINIC AND THEN THE ER WITH A BUMP ON THE BACK OF HIS LEG. PT WAS TOLD IT WAS A BLOOD CLOT.

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.

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

Within one day following the vaccine, I experienced 24 hours of the same symptoms I had when I contracted covid-19 in November 2020. Since then I've had muscle and joint pain that is not normal for me. I've also had occasional chills and a general feeling of weakness. This has been for 3 weeks now.

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.

Sore arm - five or ten minutes after the shot - hurt right after but then it kind of subsided. It took a full month for the pain to stop - especially if pressed on. After two weeks, the pain in the arm migrated to the central right back. I could sleep on my right side only. Lasted about two days and then subsided. About a week or so after that, I was getting a throbbing pain on my left calf. That lasted a couple of days where it would intermittently start throbbing. I called the doctor. When I went in the symptoms has subsided but the doctor (on April 13) said to do an ultrasound if it returns. It didn't return so I have not had an ultrasound.

HE CALLED ME ON MAY 6, 2021 REPORTED THAT HE IS HAVING SEVERE NAUSEA, MUSCLE ACHES, THROWING UP. NO DIZZINESS. BECUASE OF MUSCLE ACHES I ASKED HIM TO STOP TAKING ATORVASTATIN NEED TO CONTACT MD ABOUT THE FURTHER CHECKUP AND EVALUATION.

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.

muscle pain in my left leg for the last three days unable to sit or use my leg to stand up pain meds do not work

MINI STROKE IN LEFT ARM, HAS LEFT ARM WITHOUT STRENGTH, NO MUSCLE CONTROL OF 3 LEFT HAND/LEFT SIDE FINGERS. ARM/WRIST JERK UNCONTROLLABLY. DR. VISIT 8 DAYS AFTER STROKE. LAB TESTS DONE. PRESCRIBED atorvastatin 40 MG 1 PILL AT NIGHT. URGENT CARE VISIT 5/18/21 LEFT HAND AND FINGERS UNCONTROLLABLE, HAND HAD SEVERE SWELLING. PREDNISONE PRESCRIBED

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.

Admitted with c/o generalized weakness and significant pain to BLE s/p J and J vaccination. Neurology diagnosed pt with Guillain-Barre syndrome and is s/p IVIG and steroids'. Pt improved with IVIG and steroids'. Of note pt. states he has been to the hospital multiple times with these symptoms and told he had rhabdomyolysis 2/2 statin use therefore it was d/c on prior evaluations and he was d/c home. Further evaluation showed pt has Guillain-Barre syndrome.

dementia like feeling occurred after 2 days , worse after 4 and still has slightly , joint and muscle pain. pt very concerned about this

my immunologist, stated it caused a "flare" of my arthritis. Pharmacy where I received shot did not tell me to pause my meds before or after shot. Caused extreme pain at site and in my entire L. shoulder area. Pain persists to present day. Doctor gave me prednisone im and p.o. as well as gabapentin and flexaril.

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

Arthralgia in both knees. No visible swelling. Symptoms became progressively worse. Pain and difficulty walking peaked 5 days after administration. On the sixth day the symptoms stopped completely. No longer in pain. Walking returned to normal. I participated in the Pfizer m-RNA clinical study. Received my second m-RNA dose in October 2021. After the second m-RNA dose I made a VAERS report of pain in joints. I should not have made the decision to take the booster dose. I made this decision on my own.

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.

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.

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

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.

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

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,

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

Joint muscle pain, twitching of lips on the left side, (minor) My niece had a severe reaction of twitching on both sides of face for 5-6 days, now she has right side drooping

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.

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.

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

I have been experiencing severe pain in my joints, my shoulders and lower back are the worse. It's bad enough I can't sleep very well or even walk right.

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.

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.

Janssen COVID-19 Vaccine Woke middle of the night very cold under heavy covers, Hard to walk the next day, had some of the same symptoms I had when I had covid in November. I can't find the lingering side effect mentioned and why I am sending this: A month later my legs feel like they are in ice water, everything else went away after 3 days. At the touch they feel normal, this is all day everyday.

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

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.

Severe lower bottom left of the abdomen on March 26 at around 7am. Difficulty in walking. Pain around hip and middle and upper back.

Pt reported to Urgent Care with paralysis and numbness on his left side. Left-sided neck pain radiating into the top of the shoulder.

NECK PAIN; 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 myocardial infarction, and concurrent conditions included high cholesterol, high blood pressure, alcohol use every once in a while, and cigarette smoker, and other pre-existing medical conditions included the patient did not have any known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 09:00 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced neck pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from neck pain. This report was non-serious.

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.

DIZZINESS WITH MOVEMENT; MUSCLE ACHES ALL OVER; SLIGHT NAUSEA; 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 asthma, overweight, and dental numbing, and other pre-existing medical conditions included the patient had no known allergies. The patient experienced drug allergy when treated with epinephrine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025, and batch number: 1805025 expiry: UNKNOWN) .5 ml, administered on 08-MAR-2021 09:00 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021 16:00, the subject experienced dizziness with movement. On 08-MAR-2021 16:00, the subject experienced muscle aches all over. On 08-MAR-2021 16:00, the subject experienced slight nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle aches all over, dizziness with movement, and slight nausea. This report was non-serious.

My head felt like it was weightless! It felt two feet above my shoulders! No dizziness but a vacantness feeling. No confusion and no forgetfulness, just a weightless head. Also, beginning the 4th day, my upper teeth feel as though they were heavily flossed the night before...like swollen gums, but tight...in the Maxilla! They don't ache, they feel 'tight'!

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

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.

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

Sharp pain to collar bone, neck and shoulder. Sharp pain shoots down arm to fingers. Hand becomes cold and discolored. No treatment to date except ibuprofen which does not help.

Seven days after the vaccine I got up from dinner and I had sharp pains in both wrists on the inside. I could not rotate my thumbs and I could hear clicking. I called my doctor and she confirmed Dequervains Syndrome. It was bilateral. I don't have any history or other symptoms of Rheumatoid Arthritis. I couldn't pick anything up for ten days and I still have to stretch my wrists to have any strength or motion. I have full motion but I still get pain when I rotate my arm.

Abrupt onset of widespread joint pain, stiffness, significantly limited range of motion within a few days of receiving his covid vaccine -- > PMR like symptoms -- > elevated CRP

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

SEIZURES; PAIN IN JOINTS; VISION BLURRY; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's past medical history included he had been healthy individual all his life. The patient's concurrent conditions included patient was non-alcohol user, and non-smoker. The patient had no history of comorbidities. The patient had no known allergies and drug abuse or illicit drug usage. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: 11-MAY-2021) 1 total dose was administered at left arm on 10-MAY-2021 (reported as Monday) for prophylactic vaccination. No concomitant medications were reported. On 10-MAY-2021, the patient experienced blurry vision (vision blurry) which had happen all of sudden. On 12-MAY-2021, (reported as Wednesday) after taking JNJ vaccine he was taken to the emergency room because he had developed seizures (seizure), the patient experienced pain in joints (pain in the joints) which had happen all of sudden and was hospitalized. The patient was treated with Levetiracetam 500 mg for seizure. He was hospitalized for a day. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from seizures, and had not recovered from pain in joints, and vision blurry. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210529765-COVID-19 VACCINE AD26.COV2.S-Seizures. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). V0: 20210529765-COVID-19 VACCINE AD26.COV2.S-Pain in joints. This event(s) is labeled per RSI and is therefore considered potentially related.

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.

Approximately two weeks (05/12/2021) after receiving the vaccine, I started to experience tightening in my legs all around. It felt like every time I would massage the cramps out of my legs, an hour later the muscle tightness/pain would come back. It was interrupting my sleep. I also experienced knee and hip pain along with the tightness in my legs. I also experienced some brain fog on and off for about 3 weeks. I visited my PCP on 05/19, but by 05/17 my symptoms had improved. On 05/18 my pain/tightness had gone away completely. I had to do vigorous stretches and I took 4 tablets of 200mg per day for a couple days.

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

On 9 April, I suddenly experienced joint and muscular pain, along with inflammation in both shoulders. My right shoulder was in far worse pain, with loss of strength, and range of motion when compared to my left. R Shoulder: 8/10, Left Shoulder 4/10. The pain and inflammation initially set-in at a lesser strength, perhaps 65% compared to the above levels, but increased overnight to the above referenced levels. That pain has lessened over the weeks since, and currently diminishes at a slow pace. Currently the left arm is nearly 100%, with only some inflammation and joint pain left. The right arm is better, but if I do any manual work with it, it becomes inflamed and warm to the touch. Cooling the shoulder works, heat does not. NOTE: in 2015 I fell in an accident and injured my right shoulder. The rotator cuff was torn, and the labrum torn as well, and the pain in the Right Shoulder has echoed that injury (which I had recovered from) greatly. It still feels as if my should was wrenched all over again - and I think that injury may be why the current pain in that shoulder is greater. I have no other explanation for the difference. This isn't easy to figure out - feel free to contact me for more information.

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.

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.

Patient has had intermittent weakness since covid vaccine in April. Admitted on May 11 for weakness, stroke was ruled out. Noted to have bilateral upper and lower extremity paresthesia thought secondary to diabetes. Readmitted on May 17, began to have frequent falls with bilateral lower extremity weakness, when he stood up his legs could not hold him. MRI ruled out ischemic infarction. Diagnosed with Guillain-Barre disease and ambulatory weakness. Followed up with neurologist.

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.

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

About a week and a half after receiving the Janssen Vaccine, severe muscle weakness and joint and bone pain.. This has been going on for over 3 months. My primary doctor prescribed Prednisone for the severe pain and if it was not for this I would be incapacitated. Going to specialist on 7/16/21.

Excruciating Inflammation, blood clots, pains in joints and muscles, and burning nerve sensations in legs/feet and slight numbing in hands.

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

JOINT PAIN IN GREAT TOE AND 2 TOES NEXT OF RIGHT FOOT; NUMBNESS IN GREAT TOE AND 2 TOES NEXT OF RIGHT FOOT; TINGLING IN GREAT TOE AND 2 TOES NEXT OF RIGHT FOOT; This spontaneous report received from a patient concerned a 62 year old male. The patient's weight was 160 pounds, and height was 69 inches. The patient's concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included patient had no known allergies and no drug abuse or illicit drug usage. patient was not taking any daily medications and did not have any medical conditions. 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 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced numbness in great toe and 2 toes next of right foot. On APR-2021, the subject experienced tingling in great toe and 2 toes next of right foot. On an unspecified date, the subject experienced joint pain in great toe and 2 toes next of right foot. Laboratory data (dates unspecified) included: Pain scale (NR: not provided) 5-6/10 pain scale level. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness in great toe and 2 toes next of right foot, tingling in great toe and 2 toes next of right foot, and joint pain in great toe and 2 toes next of right foot. This report was non-serious.

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.

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."

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.

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.

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.

ON 4/17/2021 PT DEVELOPED BACK PAIN SIMILAR TO WHEN HE WAS FIRST DIAGNOSED WITH TRANSVERSE MYELITIS. PT WAS SEEN AT EMERGENCY ROOM. MRI WAS ORDERED AND COMPARED TO PREVIOUS MRI WITH NO SIGNIFICANT CHANGE SHOWN. PT WAS FEELING BETTER ON 4/18/2021 WHEN I CHECKED ON HIM

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

3/19/2021 - 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.

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:

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

Between 3/9 and 3/22 patient experienced unilateral ankle swelling. Dr prescribed furosemide with no effect. Patient did doppler US and other screening for blood clot and did not find a DVT/peripheral clot. Swelling has since decreased. Patient was taking meloxicam for shoulder pain x 1 week around the time of the vaccination.

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.

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

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.

The injection itself was incredibly painful. The nurse giving the injection asked why they were given extra long needles and then asked if I'd like to see it. I said, "Yes." I joked and said it looked like it was more likely for the ass than the arm. She laughed and proceeded to inject me. The injection was the most painful I had ever felt. The next morning, I awoke with pain in my shoulder, neck and back. Though I expected some reaction to the vaccine, I didn't expect the amount of pain and discomfort I experienced. It has continued in large part to the present. I sought medical advice towards the end of the first week. Eventually, I received an MRI which suggested myelitis/discitis. Of course, the MRI was more detailed. I was subsequently hospitalized for four days where I had numerous blood cultures and another MRI (cervical and thoracic w/and without contract). The MRI essentially had the same findings. The doctors are stymied by my history and symptoms. However, given the temporal proximity between the time of the injection and the onset of my pain/symptoms (that has yet to resolve), I think it important to report this matter. I am still is pain and my issues have not resolved.

He got the vaccine, and when they administered it on his left shoulder it started bleeding. The younger girl put a band-aide on it, and walked off and called another girl. The other girl took over the band-aide and it was saturated with blood but stopped bleeding, but area was swollen. They then had him wait 30 minutes, and everything was fine, and instructed to put ice on it which he did. The pain seems to have not gone away yet and it's been over 30 minutes. At night he feels it more as he relaxes, it's the same pain as it was when he got the vaccine and he can also feel a little knot if he rubs it. He called employee health and they offered to do an US and gave him our information to call. This pain goes all the way past his elbow on the left side only. Sometimes he can feel it on his back, but it's mainly on the shoulder area.

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.

SWELLING OF THE HAND; SWELLING OF THE ANKLE; SWELLING OF LEFT TOE; GOUT; 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: 1805022 expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced gout. On 23-MAR-2021, the subject experienced swelling of the hand. On 23-MAR-2021, the subject experienced swelling of the ankle. On 23-MAR-2021, the subject experienced swelling of left toe. Treatment medications (dates unspecified) included: colchicine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling of the hand, swelling of left toe, gout, and swelling of the ankle. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.

SWOLLEN LEFT ANKLE (DOUBLE IN SIZE); 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 diabetic type 1 with insulin pump, 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, route of admin not reported, batch number: Unk) dose was not reported, administered on 09-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: Blood test (NR: not provided) Not reported, and Doppler ultrasound (NR: not provided) Not reported. On MAR-2021, the subject experienced swollen left ankle (double in size). On 15-MAR-2021, treatment medications included: furosemide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen left ankle (double in size). This report was non-serious.

The patient described severe left arm weakness with inability to lift his arm in order to bring a cup to his lips. He has some sort of upper respiratory complaints at after he got the vaccine and received treatment from his PCP.

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.

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.

I didn't have anything for two weeks. But then a lot of pain in arm. from a sound sleep. I took ibuprofen. Over the next few hours, the pain radiated down my left arm. Wave would come and go (of pain). The pain came on to my chest - and I decided to go get check. Had very low energy for about four days - after that. My left arm, I lost the strength in it - I could barely lift 10 lbs over my head. Swimming - I couldn't pull my arm with my elbow high - I could barely skim the top of the water. This is still happening. I had a doctor appt - yesterday but that was for arthritis pain that is in my knees, wrists etc - he gave me arthritis medication and I noticed the positive affects of it already. But it didn't address the arm that I can't pull up over my head. It seems like my immune system is attacking me- a couple of years ago this happened when I had a virus and it took me almost a year to get that muscle to start working again.

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.

Left arm pain and swelling in wrist and fingers. Tendonitis systems in wrist and gout like systems in fingers. Then bursitis systems in left elbow

RIGHT ARM WHICH IS WHERE THE INJECTION WAS RECEIVED IS SORE WHICH STARTED ON 05/20/21 STILL TO THIS DAY 06/07/21. PATIENT HAS FULL RANGE OF MOTION. CAN LIFT ARM A LITTLE MORE THAN HALF WAY TO THE SKY WHEN THE PAIN IS FELT IN THE MUSCLE. AT POINT OF INJECTION THERE IS STILL A SCAB.

High levels of pain and stiffness in joints, tendon anchorages and muscles. Initially concentrated in hips; migrating to shoulders joints, deltoids, trapezoid, front of pelvis, buttocks.

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

8 hours of receiving the vaccine my temperature begin to increase by 8PM it was 99 degrees Fahrenheit my body could not take liquid or food continued diarrhea. The temperature continued all the night and the diarrehea I only took a pair of aspirin the next day the same no thirst or hunger and reluctance with body, muscular and bone pain. Around 4PM all symptoms began to gradually lessen, by night I had thirst and hunger. The next day I was almost normal with only reluctance and heavy legs. This was all I experience after the vaccination.

Swelling and pain in the primary knuckles of my hands--especially the right hand. Unable to make a firm fist with my right hand--weak. Ring finger on the right hand is particularly swollen and inflexible. I don't know what has caused this to occur.

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

Severe random pain in right shoulder radiates down to hand and up into neck. Numbness and tingling in arm down to and including fingers

Severe muscle weakness, joint pain in shoulders hips, groin area. worse in morning , or long seated period. Can't stand up from kneeling position

Pt. states that after receiving the J&J vaccine 04/07/2021, started to experience 04/17/2021 painful leg swelling, groin area, and (previous Hernia) irritant. Primary visit recommended leg elevation and compression socks. Still continuing to swell.

FEELS LIKE SOMEONE PUNCHED IN THE ARM AND IT THROBS AT NIGHT; ARM FEEL WEAK AND LIMITS WHAT CAN DO; ARM HURTS ALMOST CONSTANTLY; PAINFUL SHOT/ARM REALLY HURTS IN THE INJECTION SITE AREA/THE SEVERITY OF THE PAIN FLUCTUATES; 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced painful shot/arm really hurts in the injection site area/the severity of the pain fluctuates. On an unspecified date, the subject experienced feels like someone punched in the arm and it throbs at night, arm feel weak and limits what can do, and arm hurts almost constantly. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from painful shot/arm really hurts in the injection site area/the severity of the pain fluctuates, arm feel weak and limits what can do, arm hurts almost constantly, and feels like someone punched in the arm and it throbs at night. This report was non-serious.

Starting in early June, have severe muscle cramps in both biceps lasting 1 minute. Occurred six different times through now. Also, legs buckled on me, similar to my wife, on Sunday, July 25.

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

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

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

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.

Patient received his J&J vaccine for COVID-19 on 03/10/2021. On 3/17, he was at the grocery store when he felt a sting on his left lateral ankle. When he pulled up his pant leg, he saw the small little red spots that were exquisitely tender. He went immediately to his primary care physician's office, where he was prescribed Bactrim for suspected cellulitis. The rash steadily worsened with extension up his left leg and onto his right leg and blistering of some of the lesions most markedly in his groin. Pain associated with the rash increased and remained most severe on the lateral aspect of the left ankle. He presented back to his primary care physician's office on 3/19, where he was given methylprednisolone 80 milligrams IV, discharged with a prescription for prednisone 60 milligrams daily for the next few days. Pain worsened the morning of 3/20/21 to the point that he was unable to bear much weight on the left leg prompting his presentation to the emergency department.

03/22/2021, severe right back pain. 03/23/2021 visited Urgent Care (severe right back pain). 03/26/2021 visited Emergency Care (severe lower right side pain).

Left side is numb went down the leg and into the knee. this went away after a couple days. BUT Left hand and little finger and next finger are still numb. Tingle like the are asleep. Stiff in movement.

Vaccine was the J & J one shot A few days after getting the shot I started to have pain in my shoulders and hip joints. Feels like arthritis but very painful and seems to get worse every day. Never had arthritis before in these areas so very concerned. It has been over 3 weeks now and pain medicine barely helps.

The patient is a 64 y.o. male who presents to the Emergency Department with a few days of right sided neck pain wrapping around to his right upper back. Patient reports a history of similar pain prior to his cervical laminectomy hardware placement. Patient also reports that his sciatica on the right has been exacerbated recently and he is having BLE numbness. He is ambulatory. Patient was seen in the ED for this complaint on 4/5 and was prescribed ibuprofen and Robaxin. He denies any alleviation with these medications. He denies any recent falls, injuries, or other concerning MOI's. Patient notes that he has been trying to get into his PCP, but they are on vacation. He recently quit smoking.

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; 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.

Stiffness right side of neck, up to base of skull, behind right ear, and into right trapezoid. Comes and goes, but is present most of the time. Not debilitating but painful.

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.

Diagnosed with Bradycardia; Dyspnea; Mobitz Type II A-V Block Low heart rate 30s-40s; Currently monitoring with outcome of pacemaker implant

4/25/2021 - He was apparently well until 2 days prior to admission when he developed spontaneous left calf pain and swelling. He denies any associated trauma, recent travel and immobility. He is not taking any new prescription, including steroids. One day prior to admission, he started experiencing left-sided pleuritic chest pain up to 9/10 in intensity and exertional shortness of breath. He denies any fevers, hemoptysis, sputum production, diaphoresis, nausea, vomiting, abdominal pain, dizziness or lightheadedness. The pain was persistent throughout the day. Today, his chest pain persisted and his shortness of breath had progressed. He also noted left arm swelling with mild discomfort. He felt that his left leg swelling and pain had improved today. Nevertheless, given persistent symptoms, he decided to come to the emergency room for further evaluation management. In the emergency room, his initial blood pressure was 218/104 with mild tachycardia of 99, normal oxygen saturation and no fevers. CBC showed a white count of 12.35, hematocrit of 50.4 and normal platelet count 198. INR was normal at 1.06. BMP showed mild hyperglycemia at 148. Troponin was 5 and BNP was 8. Imaging studies show extensive left upper extremity DVTs that involved the left subclavian vein, left lower extremity DVTs and bilateral lower lobe pulmonary emboli. 4/30/2021 Presumed unprovoked extensive DVT of the left upper extremity and left lower extremity. However, he did recently receive Johnson & Johnson Covid vaccine. Now status post catheter directed thrombolysis to the left upper extremity.

Guillain-Barre Syndrome - mild case. Tingling, numbness up entire legs more prominent in feet. Mild back pain. No weakness. Some numbness and paresthesias hands. Restlessness.

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.

64 yo M with PMHx HTN, HLD, Diverticulitis s/p sigmoid colectomy 6/2020, and Hep C who presented as a transfer from hospital due to acute onset R sided weakness with ICH found on CT scan. History taken from patient bedside. Around 8pm last night 4/27, patient felt acute onset of numbness and weakness to his right lower extremity as he was coming out of the shower. He then tried to sleep and had a restless night. He noticed ataxia with his right leg as he tried to walk around. In the morning, his right upper extremity became numb and weak as well and he decided to go to the ED. Upon arrival, CT Head showed "Acute hematoma of L Lateral thalamus 2 x 2.6cm with surrounding edema and mass effect".

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.

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).

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.

I experienced leg and side cramps that has been very severe. I still have those episodes with a lingering pain afterwards.

Approximately 2 weeks after being vaccinated, I started having joint pain and stiffness throughout my body. It continues to bother me. It is especially noticeable in the morning after rising from bed, or after sitting for a long period of time. After pushing through the pain into normal activities, the pain lessens, but afterwards, the pain returns. I especially notice numbness and stiffness in my calves and feet after waking in the morning. I do not feel pain while not moving. Only when I attempt to move. My range of motion has been decreased because of the pain. I am normally an active person.Taking Ibuprofen seems to relieve the symptoms, but pain returns after the medication wears off.

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.

Patient had Janssen COVID-19 vaccine on 5/8/21. Developed calf tightness, pain, and swelling 5/13/21. Sought medical care 5/20/21. Diagnosed with DVT 5/20/21

Knee pain - left knee. Went to the doctor - it's believed to be a torn Meniscus. I'm going to have an MRI done. MRI scheduled for June 29th, 2021. No treatment. The pain comes and goes - it's not constant. It occasionally is painful enough that I limp.

15 min. after receiving vaccine in left arm, felt tingling in left hand. Two weeks later left arm went completely numb, temporary loss of fine motor control, ok after a couple days. About a week later arm went numb with an icy cold prickly feeling. Lasted about a week, with a little residual numbness still present. About May 1st, also noticed swelling of left ankle. During the month of June had pain behind knee and continual pain and stiffness in left leg. End of June left leg became noticeable swollen. Went to Urgent Care on June 30, 2021. Sent for ultrasound, found four blood clots (DVT's) in left leg (3 upper thigh and one behind left knee). Sent to ER, started on Eliquis, will follow-up with primary care next week. No history of blood clots before, and I am quite active.

2 days after receiving shot i experienced weakness in my left leg, difficulty walking, abnormal movement in my leg like continuous movement in my legs when standing still or setting. These events are still ocurring daily after 3 weeks

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

patient reported having joint pains about 3 or so weeks after the vaccine then was found to have DVT 4 months later.

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.

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.

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

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.

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

On Friday, March 12, 2021, at the pharmacy I had an 8:00 am appointment to receive the Johnson & Johnson?s Janssen COVID-19 Vaccine. I received my vaccine in the left arm but the injection seemed to me (and my wife) to be in an odd location, which was very high up on the shoulder near the shoulder joint. Things seemed fine until Saturday evening when I started to feel some tightness in my left trapezius between my scapula and my occipital bone. By Sunday morning that same area was very tight and painful; what we used call a ?crick.? Sunday afternoon I began to feel some sharp pain in my left shoulder joint. I had very little sleep on Sunday night and by Monday morning I had significant pain in what felt like my humerus. I made an appointment with a chiropractor for Monday afternoon and he suggested the vaccine shot might have started an inflammation that led to the tight trapezius, which in turn was causing the cervical spinal nerves to react, thus causing the pain in my arm. At this point I was in a lot of pain and the pain was moving further down toward my elbow. The chiropractor did his usual things and told me to put ice on it and take OCT Ibuprofen and or Naproxen. I was a bit better on Tuesday and decided to attend a three-day pastors? retreat. By Tuesday afternoon the pain had expanded to just below my elbow. I consulted with a doctor friend and he thought it was likely that I was having a reaction to the vaccine and that it would pass. He as concerned to hear of the odd location of my injection. I had another sleepless night and on Wednesday I noticed that the ends of my left thumb and index finder were numb and by that night the numbness had expanded to include most of my index finder. The other arm and shoulder pain continued but varied in intensity. On Wednesday morning I called my wife and asked her to come get me at the retreat and that afternoon I called my doctor's office office and made an appointment for Thursday morning (3-18-21). I'm feeling the cumulative effects of the pain and fatigue. My overall pain level is a little less but still present, as is the numbness in my index finger and thumb. My doctor suggested the nerve inflammation was a reaction tot he vaccine.

3.13.21 - tight and painful shoulder area, 3.14.21 - pain moved down to elbow, 3.15.20, 3.15.21 numbness in fingers, 3.18.21 pain not as bad still numbness

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

ELBOW PAIN; PAIN IN LEFT ARM FROM SHOULDER TO ELBOW; PAIN IN THE RIGHT ARM; This spontaneous report received from a consumer 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, and batch number: 041A21A expiry: 29-JAN-2023) dose was not reported, administered on 06-APR-2021 at 10:30 to right deltoid for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced elbow pain. On 06-APR-2021, the subject experienced pain in the right arm. On 06-APR-2021 22:00, the subject experienced pain in left arm from shoulder to elbow. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in the right arm, and the outcome of elbow pain and pain in left arm from shoulder to elbow was not reported. This report was non-serious.

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.

PAIN IN BACK; PAIN IN LEFT HIP AND SHOULDER; DRAGGING FOOT; 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, batch number: 1805029, expiry: not reported) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced dragging foot. On 28-MAR-2021, the subject experienced pain in left hip and shoulder. On 28-MAR-2021, the subject experienced pain in back. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in back, and pain in left hip and shoulder, and the outcome of dragging foot was not reported. 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.

Muscle in shoulder is still very painful. Hard to lift arm over my head. Hard to take off a shirt and make certain motions.

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.

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

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

05/03/2021 Paresthesias both feet, weakness lower extremities. Increased heart rate. Shortness of breath when recumbent. Ataxia. 05/07/2021 Paresthesias both hand, fasciulations, tremors 05/21/2021 Evaluation by neurologist, Dr. Diagnosis

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.

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.

Minor muscular pain throughout body most of the day. No treatment. Back to normal 2 days after receiving vaccine.

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.

Extreme pain in spine at sit of surgery with metal titanium implants , pain remains, no treatment available

TORN ROTATOR CUFF; SHOULDER PAIN (FEEL COMING FROM ARMPIT, SHOULDER SOCKET AND SHOULDER NUMBNESS ON SKIN, PAIN GOING ALL THE WAY THROUGH SHOULDER JOINTS, PAIN RADIATING DOWN IN ARM AND IN WRIST AND HAND); BLED MORE THAN USUAL; 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 shoulder injury. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1802070, expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 to right deltoid for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced bled more than usual. On 16-MAR-2021, the subject experienced shoulder pain (feel coming from armpit, shoulder socket and shoulder numbness on skin, pain going all the way through shoulder joints, pain radiating down in arm and in wrist and hand). On an unspecified date, the subject experienced torn rotator cuff. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from shoulder pain (feel coming from armpit, shoulder socket and shoulder numbness on skin, pain going all the way through shoulder joints, pain radiating down in arm and in wrist and hand), and the outcome of torn rotator cuff and bled more than usual was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case assessed as non serious.

Substantial lower back pain making mobility difficult. No prior hx of back issues or injuries. Started 2nd day after vaccination.

Muscle aches and pain in left arm has continued for past month since receiving injection. I do have full function in arm.

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.

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

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

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.

MODERATE CHEST PAIN; MODERATE UPPER ARM PAIN; FELT LIKE PULLED MUSCLE; 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: 1802068, and batch number: 1802068 expiry: 25-MAY-2021) dose was not reported, once a total administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced moderate upper arm pain. On 09-MAR-2021, the subject experienced moderate chest pain. On 09-MAR-2021, the subject experienced felt like pulled muscle. Treatment medications (dates unspecified) included: menthol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from moderate upper arm pain, moderate chest pain, and felt like pulled muscle. 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.

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.

Bilateral lower extremity weakness, bilateral hand paresthesia, areflexia - diagnosed as Guillain Barre Syndrome by neurology team

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).

Very, very Severe pain in right leg upper leg near hip area. - never had this pain before. Nothing has relieved the pain for him. He went to Primary care and urgent. Still having very severe pain in the same leg. waiting to see pain management doctor.

DECREASE MOBILITY IN SHOULDER; UNABLE TO WORK; DEPRESSED; SEVERE SHOULDER PAIN; 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 pre-existing medical conditions included patient was in good health. patient had undergo physical therapy. 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 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced decrease mobility in shoulder. On 2021, the subject experienced unable to work. On 2021, the subject experienced depressed. On 2021, the subject experienced severe shoulder pain. Treatment medications (dates unspecified) included: ibuprofen, paracetamol, cortisone, prednisone, and hydrocodone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe shoulder pain, decrease mobility in shoulder, unable to work and depressed was not reported. This report was non-serious.

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.

My shoulders began hurting. I could not flex my left arm for a couple of days. That was now over 2 months ago, and I still have pain and stiffness, in both shoulders, that I never had before the vaccination.

Moderate to severe radiating right leg pain since late May, 2021, w/ no known cause. Recent swelling and stiffness in right knee. OTC meds for pain and cyclobenzaprine. Physical Therapy.

Pain well after injection of shoulder/arm injection was given in. From shoulder to elbow, rarely to wrist. Not joint pain but feels like muscles/nerve Can not lay on that side, limited comfortable positions. limited motion during the day because of varying amounts of pain.

SWELLING IN BOTH ANKLES; SWELLING IN FEET; 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 bee string allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A2LA, and batch number: 042A2LA expiry: UNKNOWN) dose was not reported, administered on 15-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-JUL-2021, the subject experienced swelling in both ankles. On 15-JUL-2021, the subject experienced swelling in feet. Laboratory data included: Blood pressure (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling in both ankles, and swelling in feet. This report was non-serious.

Two weeks after receiving vaccination, severe dull ache began in right shoulder. Pain is sometimes in shoulder blade, shoulder (deltoid), right upper arm (bicep area). Pain is worse at night, enough to cause sleeplessness and inability to lie on right side. Pain somewhat eased by Tylenol or Tylenol/ Advil. Pain has not subsided or lessened since it began three weeks ago. I am an active healthy male in excellent health otherwise. I exercise regularly, maintain a healthy weight and have no chronic conditions.

(3) syncopal episodes following vaccination, one of which resulted in a fall with direct injury to the base of neck, head, and right flank. Pt reported chest pain prior to syncope.

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.

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!

widespread muscle and joint pain, worse in bilateral posterior knee ligaments and bilateral shoulders and bilateral hands, he states that getting out of chair was difficult, Range of motion slightly restricted due to pain and tight muscles, sensation intact, capillary refill normal in all extremities

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???

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.

ITCHING; PAINFUL; HIVES; RASH; MUSCLE ACHING; 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 high blood pressure, high cholesterol, 3 heart stents, and blood thinners, and concurrent conditions included allergy to x-ray contrast, occasional alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug usage and never had chicken pox or shingles. 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 at 16:30 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced muscle aching. On 07-APR-2021, the subject experienced itching. On 07-APR-2021, the subject experienced painful. On 07-APR-2021, the subject experienced hives. On 07-APR-2021, the subject experienced rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itching, painful, hives, and rash, and the outcome of muscle aching was not reported. This report was non-serious.

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

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 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

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.

Patient received COVID vaccine (Janssen) on Saturday, March 6th at the Fairgrounds, patient called Health Department on 5/12/21 with the following report. Approximately the week of April 6th patient begin experiencing weakness in both thighs. Patient describes the weakness feeling like 'a twisted tendon', reports difficulty standing from a seated position, and reports pain when walking. Patient saw physician, on May 7th who prescribed a muscle relaxer and recommended PT. Advised patient to return if symptoms persist for an ultrasound.

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.

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

Approx. 1 week after vaccine administration, developed severe pain in my right shoulder area. The right arm received the vaccine. No pain prior. All felt well. Went to see primary care doctor who said I have sub-deltoid bursitis possibly from vaccine shot. Gave me an injection of Triamcinolone (steroid) in my right shoulder. This was done on 6/8/21. Today is 6/15/21 and still have pain but not as severe as initially. Still hurts when moving my shoulder or right arm. I can hear snapping noises in shoulder area when I move my arm around. Difficult to sleep due to the pain. Have been doing range of motion exercises. I Notified public health about bad rxn. but no one has yet returned my call

Developed myalgias and joint pains approximately 48 hours after the injection, then improved. Then about a week after the injection, developed severe myalgias and joint pains. Treated with Medrol dose pack (6 days) with improvement. 3 days later developed pleuritic chest pain as well as shortness of breath. Presented 48 hours after this started for medical care and was diagnosed with acute pericarditis. Started on ibuprofen 600 mg TID and colchicine 0.6 mg BID with significant improvement in discomfort. Discharged from the hospital after 48 hours of observation. Did develop paroxysmal SVT which was felt to be 2/2 to the acute pericarditis. Started on metoprolol tartrate 50 mg BID to help with rate control and sent home with zio patch for additional cardiac monitoring.

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.

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.

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.

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.

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.

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.

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.

After receiving the vaccine I returned to work and then went home, ate dinner, showered and bed. The following morning (Easter Sunday) I woke up at approximately 07:00 AM and when I got out of bed my legs (bi-laterally knee pain) were so weak that I almost fell down, I had to hold on to various furniture and walls to get to the bathroom. This weakness and joint pain has been constant and continuous and is still ongoing as of this writing. On 4/8/2021 I called my private physician, and explained what was happening and he prescribed me METHYLPREDNISOLONE 4 MG DOSEPK (medrol). I took the medication as prescribed and had no relief. On 4/14/2021 I went to ER and had X-rays taken of both knees and was sent home with a suggestion to follow-up with my private physician (on vacation until 4/26/2021) whom I have a telemedicine call scheduled with for that same day 4/26/2021. I have scheduled an appointment with an Orthopedic Specialist now on 4/20/2021 @ 3:20 PM for an evaluation.

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.

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

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.

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.

Extreme pain to arm Swollen at vaccine spot Pain radiates to neck and shoulder blade Cannot lay on arm Began 22 days after vaccine

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.

had redness and tightening of the legs, went to ER, found very small blood clot in right calf. Gave rx blood thinner eloquis along with current plavix and asa

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.

diffuse severe myalgias, arthralgias, starting 2 days after vaccine administration, and progressive through current day. Patient evaluated today in clinic, and symptoms are increasing. No fevers, chills, but diffuse muscle tenderness and guarding with range motion shoulders and hips

WEAKNESS; MUSCLE ACHES; SWELLING; ITCHING; RASH ON EXTREMITIES AND BACK ON THE LEFT SIDE; This spontaneous report received from a patient concerned a 68 year old male. The patient's weight was 230 pounds, and height was 70 inches. The patient's concurrent conditions included diabetes mellitus 2, alcohol user, non smoker, gout, stomach ulcers, cholesterol, and blood pressure, and other pre-existing medical conditions included patient does not have known allergies. patient does not have drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prevention of covid-19. Concomitant medications included lisinopril for blood pressure, atorvastatin for cholesterol, glimepiride for diabetes mellitus 2, metformin for diabetes mellitus 2, metformin hydrochloride/sitagliptin phosphate monohydrate for diabetes mellitus 2, febuxostat for gout, and pantoprazole for stomach ulcers. On APR-2021, the subject experienced itching. On APR-2021, the subject experienced rash on extremities and back on the left side. On 29-APR-2021, the subject experienced swelling. On 06-MAY-2021, the subject experienced weakness. On 06-MAY-2021, the subject experienced muscle aches. On 18-MAY-2021, Laboratory data included: Blood test (NR: not provided) Non-reactive for Lyme, and Skin biopsy (NR: not provided) Insect related. Treatment medications (dates unspecified) included: triamcinolone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling on 09-JUN-2021, was recovering from weakness, and muscle aches, had not recovered from rash on extremities and back on the left side, and the outcome of itching was not reported. This report was non-serious.

Muscle pain starting 3 days after injection of vaccine increasing week after week until a pain level of 9 was reached. First left arm then right arm then neck then both upper legs then lower back.

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.

Developed tingling/ache in left leg, calf and knee. Saw chiropractor twice. Weakness is said leg for 2-3 weeks. Has almost subsided as of today. Saw today?s report of new adverse reaction to Jannson Vaccine and felt I needed to report it.

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.

THINNING BLOOD; TACHYPNEA; MUSCLE PAIN; WEAKNESS; This spontaneous report received from a patient concerned a 68 year old male. The patient's weight was 166 pounds, and height was 72 inches. The patient's past medical history included diabetic right foot neuropathy, and concurrent conditions included hypertension, type 2 diabetes mellitus, non smoker, and no alcohol use, and other pre-existing medical conditions included the patient has no known allergies. no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 206A21A, expiry: 07-AUG-2021) dose was not reported, administered on 02-JUL-2021 for prophylactic vaccination. Concomitant medications included insulin detemir for diabetes mellitus, insulin lispro for diabetes mellitus 2, enalapril for hypertension, and hydrochlorothiazide for hypertension. On 02-JUL-2021, the subject experienced thinning blood. On 02-JUL-2021, the subject experienced tachypnea. On 02-JUL-2021, the subject experienced muscle pain. On 02-JUL-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from weakness, muscle pain, and thinning blood, and the outcome of tachypnea was not reported. This report was non-serious.

pain in the deltoid area of injection arm that "felt like needles" soon after getting vaccine; pt thought the pain would go away after some time, and although the pain has gotten better, he still feels discomfort in the arm. Pt is just reporting to pharmacy today because he was expecting the pain to resolve with time.

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

Beginning 24 hrs post injection: every bone and joint in my body began to ache. Then incredibly painful bone pain in the chest - originally thought it was a heart attack. It is random and acute pain in the chest / rib area. It varies in duration and length of time between attacks. The pain is so acute it is hard to manage. Also this appears to have attacked my lungs as I am very short of breath and cannot do any exertion. The body ache, incredible chest bone pain, joint pain and difficulty breathing have continued as I finish day 6 post injection.

pt stated he got vax he started having joint pain in the left knee. On 3/23/2021 he is still having this pain and it has become severe. He is taking Aleve and has not contacted his PCP at this time.

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.

Right knee joint pain and bakers cyst at back of knee one week after vaccination. At about the same date, left shoulder pain.

- 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.

On April 6th at 8:30am, wife noticed her husband had facial drooping and slurring of speech, and left hand weakness. He was taken to Good Hospital.. Upon arrival a CT was performed, in which it was confirmed a right middle cerebral infarction. He was then transfered priority to a Trama Hospital for a thrombectomy by Dr. This was successful in removing the clot. He spent 3 days in ICU and then moved to progressive care. Pt is on his 13 day in the hospital where he is no longer able to care for himself. He now has behavioral disturbances, aggitation, confusion, delium, halluciantions. He is under Psychiatric care, physical, occupational, and speech therapy.

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.

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.

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.

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

In about 2-3 weeks after the vaccine, I had just real achy and soreness all over. And I got very stiff muscles and was hardly mobile - not unlike my usual flares for Rheumatoid Arthritis event. My joints hurt. I hurt all over. I told my doctor I was having an ongoing flare that wouldn't stop. I had suggested that maybe it had something to do with the vaccination as I couldn't pinpoint anything else that would have caused it. He prescribed Prednisone - for seven days - I felt good during that time. As soon as it wore off, it went back to flare. He is treating me again with Prednisone for a whole month to try to calm the inflammation down. It also could mean that one of my meds is no longer working for me. The prednisone seems to be working this time, as well. He took me off my Celebrex, too, for this period of time and so the first few days were kind of rough but the prednisone is starting to build, I think, and I'm feeling better.

DIZZINESS; MUSCLE ACHES; SWELLING IN THE NECK AND SHOULDER AREA; UNUSUAL TASTE IN THE MOUTH; UPSET STOMACH; This spontaneous report received from a patient concerned a 69 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the subject experienced swelling in the neck and shoulder area. On 22-MAR-2021, the subject experienced unusual taste in the mouth. On 22-MAR-2021, the subject experienced upset stomach. On 22-MAR-2021, the subject experienced muscle aches. On 24-MAR-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling in the neck and shoulder area, muscle aches, unusual taste in the mouth, upset stomach, and dizziness. This report was non-serious.

After 3 weeks he came down with gout and knee started hurting. Never had gout or knee problems before taking the vaccine

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.

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.

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.

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

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

Patient brought to Emergency Department due to knee pain after sustaining a fall 2 days prior to arrival- patient tripped over bump on sidewalk. No loss of conciseness. XR showed right patella fracture, received surgical intervention- ORIF.

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.

Arm pain and continued muscle and nerve pain. Waking up at night / taking ibuprofen to get back to sleep. Still persisting a month later

I received covid vacine in left arm, now 2-3 times a day my left hand/wrist is momentarily hard to move (like making a fist) and is painful for 10-15 seconds and then goes back to normal.

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.

BACK PAIN; This spontaneous report received from a patient concerned a 70 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: 205A21A, expiry: 30/JUN/2021) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAY-2021, the subject experienced back pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from back pain. 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.

BACK PAIN IN KIDNEY AREA, BRUISING THAT LOOKS LIKE LIVER SPOTS. REPORTS THAT THIS BEGAN RIGHT AFTER VACCINE.

SWELLING FOREARM; RED AND BLUE ARM; SWELLING ELBOW; ITCHY ARM; INFLAMMATION IN ARM; BRUISED ARM; ARM SWELLING UP AROUND RIGHT SHOULDER WHERE GOT THE SHOT; This spontaneous report received from a consumer 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: 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 APR-2021, the subject experienced swelling forearm. On APR-2021, the subject experienced red and blue arm. On APR-2021, the subject experienced swelling elbow. On APR-2021, the subject experienced itchy arm. On APR-2021, the subject experienced inflammation in arm. On APR-2021, the subject experienced bruised arm. On APR-2021, the subject experienced arm swelling up around right shoulder where got the shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the swelling forearm, red and blue arm, swelling elbow, itchy arm, inflammation in arm, bruised arm and arm swelling up around right shoulder where got the shot was not reported. This report was non-serious.

Patient admitted 4/14/2021 to the ICU from ED. Patient was experiencing hand weakness. Patient given TPA as treatment for a potential stroke. Patient with known stroke on CT imaging, unable to further verify with MRI imaging. Upon further investigation/discussion with the patient, he reports receiving the Johnson & Johnson Vaccine 10 days prior to admission. Patient with known comorbidities which increase his risk of an embolitic stroke however with recent findings from the CDC, unsure if this needs to be further investigated. Patient had 2 head CT scans, showing no intracranial abnormalities and MRI was unable to be completed due to patient's size. Neurology states high probability of stroke within their consult note. Patient's risk factors for stroke include: uncontrolled hyperlipidemia (LDL 132 on Crestor 40 mg daily PTA), hypertension (as high as 182/92 mmHg in ED), physical inactivity (BMI 76 kg/m^2), and male. Low suspicion of CVST based on patient's platelet count of 212 on admission and no abnormality on head CT. MRI would have been beneficial in potentially diagnosing CVST, as well. Our recommendation is to submit this information to the VAERS database as a possible ADR from the vaccine. The patient fits the timing of an ADR, within 6-13 days of vaccine administration, and CDC recommends watching for neurological symptoms based on their most recent press release.

Starting on 04/13/2021 noticed very easy bruising seems to be improving. Starting 04/16/2021 backache right side near kidney area, still on-going. Starting 04/18/2021 sore on tongue and right inside of mouth.

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.

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.

Patient had acute onset of low back pain 1.5 weeks prior to presentation on 6/3/2021. This pain and weakness progressed to complete bilateral lower extremity paralysis with loss of bowel and bladder function on 6/09/2021. Patient was seen emergently and found to have critical, bilateral lower extremity ischemia. imaging showed RIGHT RUNOFF: 1)There is abrupt vessel cut off suggestive of acute thrombotic occlusion of the proximal common femoral artery with propagation into the superficial femoral artery and the popliteal artery. On the delayed imaging, small amount of contrast is seen within the severely stenotic popliteal artery and very small amount of contrast is seen in the peroneal artery extending to the ankle suggesting proximal stenosis and extremely slow flow. LEFT IMPRESSION: 2)Abrupt cut off suggestive of acute thrombotic or embolic occlusion identified at the origin of the LEFT common iliac arteries with propagation throughout the LEFT lower extremity down to the popliteal artery. 3)On the delayed phase imaging, tiny wisp of contrast within the severely stenotic popliteal artery identified suggestive of very slow flow. The peroneal artery is also faintly patent on the delayed phase imaging with flow contrast extending to mid calf level. Due to severity of the ischemic limb, patient was offered bilateral above the knee amputations. He declined and will discharge to hospice on 6/12/2021. He is going to die.

DIPLEGIA; ANAL INCONTINENCE; URINARY INCONTINENCE; ASTHENIA; ILIAC ARTERY EMBOLISM; ILIAC ARTERY OCCLUSION; PERIPHERAL ARTERY OCCLUSION; PERIPHERAL ARTERY STENOSIS; PERIPHERAL ARTERIAL OCCLUSIVE DISEASE; PERIPHERAL ARTERY THROMBOSIS; POOR PERIPHERAL CIRCULATION; ANGIOGRAM PERIPHERAL ABNORMAL; COMPUTERISED TOMOGRAM ABDOMEN; COMPUTERISED TOMOGRAM PELVIS ABNORMAL; BACK PAIN; This spontaneous report received from a health care professional via a Regulatory Authority VAERS (Vaccine Adverse Event Report System) concerned a 71 year old male of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes type II. The patient experienced drug allergy when treated with acetylsalicylic acid (aspirin), and ibuprofen. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, expiry: unknown) dose was not reported, 1 total administered to left arm, on 18-MAR-2021 for prophylactic vaccination. Concomitant medications included ascorbic acid/calcium/minerals NOS/retinol/tocopheryl acetate/vitamin B NOS/vitamins NOS/zinc (centrum silver), fish oil, glipizide and lisinopril, all for unknown indications. Patient had acute onset of low back pain 1.5 weeks prior to presentation on 03-JUN-2021. On 09-JUN-2021, this pain and weakness (asthenia) progressed to complete bilateral lower extremity paralysis (diplegia) with loss of bowel function (anal incontinence) and bladder function (urinary incontinence). He was seen emergently and was found to have critical, bilateral lower extremity ischemia. Computerised Tomogram angiography of the abdomen and pelvis revealed: 1. Right runoff: abrupt vessel cut off suggestive of acute thrombotic occlusion of the proximal common femoral artery with propagation into the superficial femoral artery and the popliteal artery. On the delayed imaging a small amount of contrast was seen within the severely stenotic popliteal artery and very small amount of contrast was seen in the peroneal artery extending to the ankle suggesting proximal stenosis and extremely slow flow. 2. Left impression: abrupt cut off suggestive of acute thrombotic or embolic occlusion identified at the origin of the left common iliac arteries (iliac artery embolism, iliac artery occlusion) with propagation throughout the left lower extremity down to the popliteal artery. 3. On the delayed phase imaging, tiny wisp of contrast within the severely stenotic popliteal artery (peripheral artery stenosis) identified suggestive of very slow flow. The peroneal artery is also faintly patent on the delayed phase imaging with flow contrast extending to mid-calf level. Additional events were reported which occurred on an unspecified date in JUN-2021: peripheral arterial occlusive disease, peripheral artery occlusion, peripheral artery stenosis, peripheral artery thrombosis, poor peripheral circulation. The patient was hospitalized for 6 days. Due to severity of the ischemic limbs, he was offered bilateral above the knee amputations. He declined and would discharge from the hospital to hospice on 12-JUN-2021. Report stated "He is going to die." The patient had also visited Emergency Room (ER) for the events anal incontinence, angiogram peripheral abnormal, asthenia, back pain, Computerised Tomogram abdomen, Computerised Tomogram pelvis abnormal, diplegia, iliac artery embolism, iliac artery occlusion, peripheral arterial occlusive disease, peripheral artery occlusion, peripheral artery stenosis, peripheral artery thrombosis, poor peripheral circulation, and urinary incontinence. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from anal incontinence, angiogram peripheral abnormal, asthenia, back pain, Computerised Tomogram abdomen, Computerised Tomogram pelvis abnormal, diplegia, iliac artery embolism, iliac artery occlusion, peripheral arterial occlusive disease, peripheral artery occlusion, peripheral artery stenosis, peripheral artery thrombosis, poor peripheral circulation, and urinary incontinence. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening). Version created to amend previously reported information on 25/Jun/2021. Upon review, following information was amended: In event tab, for Emergency Room (ER) ticked as 'yes' for all the events and updated same in narrative too.; Sender's Comments: V1 The follow up version updates the following information: In event tab, for Emergency Room (ER) ticked as 'yes' for all the events and updated same in narrative too.The updated information does not change the causality of previously reported events. This case, received from VAERS, concerns a 71 year-old male patient with diabetes, who presented with back pain, weakness, lower extremity paralysis and bowel/bladder incontinence, and was found to have critical lower extremity ischemia, 83 days after receiving the Janssen COVID-19 vaccine. Angiography revealed occlusion of the left iliac and bilateral femoral and popliteal arteries. Events included iliac artery occlusion and embolism, and peripheral artery occlusion, stenosis and thrombosis. No platelet counts were provided. The patient was offered amputations but declined; the events did not resolve and he was discharged to hospice. The vessel stenosis is longstanding in nature and most likely related to his age and diabetes; the embolism/thrombosis may also be related to his chronic condition, and the latency between the events and the vaccine is long. However, a relationship with Janssen Covid-19 vaccine cannot be ruled out and thus the relationship is considered indeterminate.

Patient came in today on 7/14/21 and stated that he has been experiencing symptoms after the vaccination. He had a rash and severe itchiness that has since gone away. He states that he has been having leg cramps and has been experiencing muscle weakness. The muscle weakness has been getting progressively worse. He is also experiencing nerve tingling, all of which he did not attribute to the vaccine until recent news about Guillen Barren Syndrome associated with the Johnson and Johnson Covid 19 vaccine.

MUSCLE WEAKNESS RIGHT LEG; MUSCLE WEAKNESS ARMS; TINGLING ON RIGHT LEG; TINGLING ON BACK; 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 concurrent conditions included guillian barre syndrome, transverse myelitis, non-alcoholic, non-smoker, beesting allergy, and left leg paralysis, and other pre-existing medical conditions included no drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported batch number: 1821288 expiry: 15-SEP-2021) dose was not reported, administered on 02-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-JUL-2021, the subject experienced tingling on right leg. On 04-JUL-2021, the subject experienced tingling on back. On 11-JUL-2021, the subject experienced muscle weakness right leg. On 11-JUL-2021, the subject experienced muscle weakness arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling on right leg, tingling on back, muscle weakness right leg, and muscle weakness arms. This report was non-serious.

LOST ABOUT 10 POUNDS IN LAST 2 WEEKS; RASH EPISODE ON BOTH FEET/EXTREME ITCHING TO THE POINT OF SCRATCHING TILL BLEEDING; WEAKNESS; SKIN FELT LIKE CREPE PAPER; FEET FELT COLD/WET FEELING IN FEET; FEET FELT SWOLLEN; CHARLIE HORSES WHEN KNEES BENT/HANDS CRAMP AND COULD NOT BENT; TINGLING IN THE FEET, SHOOTING SENSATION; SHORTNESS OF BREATH; SHOOTING PAIN WHEN LAY DOWN; 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 concurrent conditions included non-smoker, non alcohol user, and cat allergy, and other pre-existing medical conditions included 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: 1821286, and batch number: 1821286 expiry: UNKNOWN) 0.5 ml, administered on 20-MAY-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid, diphenhydramine hydrochloride, and melatonin. On JUN-2021, the subject experienced shortness of breath. On JUN-2021, the subject experienced shooting pain when lay down. On 20-JUN-2021, the subject experienced tingling in the feet, shooting sensation. On JUL-2021, the subject experienced feet felt cold/wet feeling in feet. On JUL-2021, the subject experienced feet felt swollen. On JUL-2021, the subject experienced charlie horses when knees bent/hands cramp and could not bent. On JUL-2021, the subject experienced skin felt like crepe paper. On JUL-2021, the subject experienced weakness. On 04-JUL-2021, the subject experienced rash episode on both feet/extreme itching to the point of scratching till bleeding. On 07-JUL-2021, the subject experienced lost about 10 pounds in last 2 weeks. Laboratory data included: Weight loss (NR: not provided) 10 pounds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling in the feet, shooting sensation, shooting pain when lay down, shortness of breath, rash episode on both feet/extreme itching to the point of scratching till bleeding, feet felt cold/wet feeling in feet, charlie horses when knees bent/hands cramp and could not bent, lost about 10 pounds in last 2 weeks, feet felt swollen, skin felt like crepe paper, and weakness. This report was non-serious. This report was associated with Product Quality Complaint: 90000186747. The suspected product quality complaint has been confirmed to be voided (did not meet pqc criteria) based on the PQC evaluation/investigation performed.; Sender's Comments: V0; Medical assessment comment not required as per standard procedure as case assessed as non-serious.

Patient called regarding possible reaction to Janseen COVID vaccine on Friday. Patient stated between 2:00 pm and 2:30 pm on Friday he started experiencing joint pain in his left wrist that felt like he "sprained" his wrist. Patient denies any injury. Patient also noted some slight swelling in this area. Patient took Aleve and stated the symptoms went away mid-morning on Saturday. He denies any other symptoms.

Patient developed progressive weakness and was diagnosed with Guillain-Barre Syndrome based on physical exam findings (ascending muscular weakness), lumbar puncture, and MRI findings. Disease course complicated by acute hypoxic respiratory failure which required endotracheal intubation and mechanical ventilation. He was treated with intravenous immunoglobulin x4 days.

PAIN SPREAD THROUGHOUT THE SHOULDER; LEFT ARM PAIN; This spontaneous report received from a patient concerned a 72 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included shoulder hurting, and neck hurting. 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 22-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the subject experienced pain spread throughout the shoulder. On 22-MAR-2021, the subject experienced left arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain spread throughout the shoulder, and left arm pain. This report was non-serious.

SEVERE BACK PAIN ON LOWER LEFT SIDE AND WAS UNABLE TO MOVE OR SIT WITHOUT EXPERIENCING IT; 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 sciatica. 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 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced severe back pain on lower left side and was unable to move or sit without experiencing it. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe back pain on lower left side and was unable to move or sit without experiencing it. 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.

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.

Acute gastro intestinal cramps for 12-18 hours Joint pain in kidney, bank and left hip joints Both reactions were acute on the first day experienced then on more modest basis 2 days later

Presented to ED for paresthesia in bilateral palms and plantar aspect of feet, muscle weakness, fall, numbness in arms starting on 04/21 and went to ED on 04/25/2021 after worsening and losing balance.

SEVERELY DRY SKIN; ACHY BACK; ITCHINESS IN LEGS/ARMS/BUTTOCK/BACK/BELLY/UNDER ARM; This spontaneous report received from a patient concerned a 72 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, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-MAY-2021, the subject experienced severely dry skin. On 22-MAY-2021, the subject experienced achy back. On 22-MAY-2021, the subject experienced itchiness in legs/arms/buttock/back/belly/under arm. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from severely dry skin, achy back, and itchiness in legs/arms/buttock/back/belly/under arm. This report was non-serious.

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.

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.

swelling began in feet and moved up legs to abdomen; 25 lb weight gain in two weeks between routine doctor exam and emergency visit leading to hospital admission for 6 days where an atrial flutter was detected that was not present in May 19th exam. Diuretics in the week since admission have pulled off over 35 lbs and vastly reduced swelling but heart damage remains.

NAUSEA; HEADACHE; GENERAL BODY ACHES; 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 back surgery, and herniated disc, and concurrent conditions included copd. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. Concomitant medications included oxygen for copd. On 02-APR-2021, the subject experienced nausea. On 02-APR-2021, the subject experienced headache. On 02-APR-2021, the subject experienced general body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea, headache, and general body aches on 04-APR-2021. This report was non-serious.

Pain and stiffness across top of shoulders and back of neck, down both arms and into both hands. Treatment was 2 aspirin twice a day and Tramadol once per day.

MILD MUSCULAR PAIN IN CHEST AND BACK AREA AFTER 3 OR 4 DAYS. ACUTE MUSCULAR PAIN THROUGH DAY 10 WHEN CERTAIN MOVEMENTS ARE MADE. I CANNOT ATTRIBUTE PAIN TO ANY ACTIVITY. NO HEADACHE OR ARM PAIN.

PAIN ON KNEES, PAIN ON THE SIDE AND INSIDE OF THE KNEES, MORE PAIN ON LEFT KNEE; This spontaneous report received from a patient concerned a 73 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non drinker, and non-smoker. 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: 1805022, and expiry: UNKNOWN) .5 ml, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced pain on knees, pain on the side and inside of the knees, more pain on left knee. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain on knees, pain on the side and inside of the knees, more pain on left knee. 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.

INCREASED BLOOD PRESSURE; BONE PAIN IN LEFT ARM; DIZZY; This spontaneous report received from a patient concerned a 73-year-old male. The patient's height, and weight were not reported. The patient's past medical history included heart stent for heart attack. The patient was non-alcohol user, and non-smoker. 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, 1 total, administered on 10-MAR-2021 at right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-MAR-2021, the patient experienced significant increase in blood pressure (200/110)/headache and bone pain in left arm (vaccine was administered on right arm). On the same day, he also experienced headache and felt dizzy. Laboratory data included: Blood pressure (NR: not provided) 200/110 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy on 10-MAR-2021, and had not recovered from increased blood pressure, and bone pain in left arm. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210430234-COVID-19 VACCINE AD26.COV2.S- Increased blood pressure. 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.

6 days after injection woke with soreness in all joints, stiffness, fatigue. Now on day 10, the S/S are getting worst. Fingers are swollen,. I can't grasp or pinch things. I must use both hands to hold a glass or cup. Very weak, sleeping 16-18 hours a day. At times I get very chilled and start to shiver. Never have had a fever, loss of taste, or smell. I tested NEG for the virus on day 3 (10 days after receiving the vaccine). Soreness is turned into pain. Feels like full-blown RA and if I was black I would be thinking sickle-cell because of the general pain.

beginning on 05/04/21 developed severe and disabling polymyalgia and poly arthralgia : was seen at urgent care twice and a local er once. we all agree this is likely an autoimmune inflammatory response to the vaccine. the patient has been placed on steroids with good response and pain reduction.

LOST LITTLE BIT WEIGHT; NIGHT SWEATS REALLY BAD; DID NOT HAVE SAME ENERGY (LOW ENERGY EACH DAY); CHILLS; TEMPERATURE WENT UP EVERY NIGHT CLOSE TO 100F (FEVER); FELT LIKE HAD FLU WITHOUT VOMITING; HARD TIME SLEEPING; This spontaneous report received from a patient concerned a 73 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included copd (chronic obstructive pulmonary disease), hypertension, diabetes (undiagnosed), skin issues, and allergic to pneumonia vaccine (bad reaction from second dose).The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 2038218, and expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAY-2021, the subject experienced felt like had flu without vomiting. On 26-MAY-2021, the subject experienced hard time sleeping. On 26-MAY-2021, the subject experienced night sweats really bad. On 26-MAY-2021, the subject experienced did not have same energy (low energy each day). On 26-MAY-2021, the subject experienced chills. On 26-MAY-2021, the subject experienced temperature went up every night close to 100f (fever). Laboratory data included: Body temperature (NR: not provided) 100 F. On 02-JUN-2021, Laboratory data included: Body temperature (NR: not provided) 97.4 F. On an unspecified date, the subject experienced lost little bit weight. The action taken with covid-19 vaccine was not applicable. The patient was recovering from felt like had flu without vomiting, night sweats really bad, hard time sleeping, did not have same energy (low energy each day), lost little bit weight, temperature went up every night close to 100f (fever), and chills. This report was non-serious.

Developed symptoms of COVID on 6/24/21, cough, shortness of breath, sore throat, myalgias, and a fever.

Pt was in his usual state of health. He received the J and J Covid 19 vaccine on 4/29/2021. By Mid May pt c/o sudden decline c/o sudden abdominal pain and poor appetite and lost 9 lbs by the end of may. In June the pain and poor appetite worsened and he saw his primary care provider who recommended an abdominal u/s and then a ct scan which showed liver masses/lung metastasis and lymphadenopathy . She scheduled a PET Scan and biopsy but the cancer progressed so rapidly a full work up including a biopsy and PET scan could not be done and he expired the afternoon of 7/16/21. Comparing the 2 CT scans he had on 6/30/21 and 7/13/21 show that the cancer rapidly progressed from 6.5 x 8.4cm lesion in the right lobe of the liver with no adenopathy seen and pulmonary nodules suggestive of metastatic disease to in 13 days the lesion encompassing the entire R lobe of the liver and then measuring 14 cm with no rapid progression of diffuse adenopathy and possible lymphatic obstruction. He was not a smoker (quit over 30 yrs ago per family and only smoked while in the military) and did not drink alcohol. His family denies any history of toxin exposure and He worked as a prison guard and then as a teacher. He was active prior and actively golfed, worked in the garden and was active in the gun club. He had no hx of hepatitis C. He had a past history of Melanoma s/p local incision 2008 with no history of recurrence. He was compliant with annual dermatology follow ups with no signs or symptoms of recurrence.

Patient was given Janssen vaccine dose when he was returned to pharmacy to get his 2nd Moderna Vaccine after 28 days. pt is not having any Major side effects. He is doing well. Pt had body ache and joint pain for about a day after shot.

MUSCLE PAIN; LEFT ARM PAIN; PAIN TRAVELED TO OTHER PARTS OF BODY; This spontaneous report received from a patient concerned a 74 year old male. The patient's weight was 195 kilograms, and height was 67 inches. The patient's concurrent conditions included no alcohol use, non smoker, hypertension, cholesterol, and myasthenia gravis, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 180518 expiry: 25-MAY-2021) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced pain traveled to other parts of body. On 12-MAR-2021, the subject experienced left arm pain. On 16-MAR-2021, the subject experienced muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle pain, left arm pain, and pain traveled to other parts of body. This report was non-serious.

Patient presented to the clinic today reporting onset of pain to posterior left knee with swelling to left lower leg and ankle on 4/14/21. Patient sent to local hospital for venous ultrasound of left leg which showed thrombus to left distal superficial femoral vein, popliteal vein, and peroneal vein. Patient was then sent over the emergency department where he was evaluated and started on Eliquis.

Headache, muscle aches, diarrhea the following day and one week later. Soreness and discoloration at injection site the following day to date.

PAIN IN LOWER RIB CAGE; BODY ACHE; LOSS OF APPETITE; SLEEP WAS LIMITED; CHILLS; LACK OF ENERGY; HIP MUSCLE PAIN; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 74 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included above average health and no daily medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced pain in lower rib cage, body ache, loss of appetite, sleep was limited, chills, lack of energy, hip muscle pain, headache, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99 and plus. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in lower rib cage, chills, hip muscle pain, and fever, and was recovering from body ache, headache, loss of appetite, lack of energy, and sleep was limited. This report was non-serious.

74 y.o. male presented to the ER with complaints of right elbow pain and swelling. The nursing home did call the office yesterday requesting for x-ray of the right elbow. Bed x-ray did show an impression of: Unremarkable limited view left elbow without evidence definite fracture or dislocation this was read by the radiologist. Patient did have CT scan right elbow today showed an impression of: Diffuse soft tissue edema prominence subcutaneous soft tissue gas along the dorsum forearm proximally, in no acute pathology or CT evidence of acute osteomyelitis, no vascular pathology. It is noted that patient has swelling, redness pain, and erythema to the right elbow. Upon examination the patient does grimace pain movement of the right level. Patient does have a large pocket of fluid noted to the right medial epicondyle region and to the medial right upper forearm. Skin is hot to touch, but patient's pulses were noted at 2+ 2+, and CMS is less than 3 sec. Patient did also have lab work a white blood count noted of 5 point, hemoglobin is 10.4, hematocrit was 31, platelet count is 201. BMP showed a nonfasting glucose of 107, sodium was 135, calcium 8 1, and his GFR is 84. Patient's sed rate is elevated at 45. Patient's lactic acid noted at 0 4. Patient did also have blood culture in the emergency room and that result is pending. Patient's procalcitonin level is noted at less than 0.00. The patient was started on vancomycin 1 g IV piggyback every 12 hr. Patient was admitted to medical inpatient as it deemed that he will need longer than a 2 midnight stay for monitoring and IV piggyback antibiotics.

Patient received vaccine on 5/24/21. He called pharmacy on 6/14 complaining that his arm had been sore for about a week since getting the vaccine. he stated that his arm did not bother him after he got the vaccine but started "aching" on 6/7/21 and has been aching on and off every since. patient states that he does not have problem moving his arm or raising arm above his head, but was concerned that the pain did not start until approximately 2 weeks after receving vaccine. he states that there is no redness or swelling or heat around the injection site, has not developed rash or any other reactions, etc. I told patient to continue taking tylenol since that was helping with his muscle soreness and to contact his doctor if aching sensation continued.

pain in lower back, going down both legs, numbness in both legs, tingling in both legs 6/14 dr. visit, received medication, prednisone, cyclobenzaprine, xray of lower back 6/23 tramadol, tylenol, 6/30 oxycodone-acetaminophen, 7/19 MRI and visit to Dr, 7/23 pre procedure for ekg and bloodwork

"Janssen COVID-19 Vaccine EUA" 4 days after the vaccine was administered, my shoulder (muscle) began hurting slightly at the spot I received the vaccine. This is now the 6th day after I received the injection and each day the discomfort is increasing. Is this increases of discomfort normal 6 days after the vaccine was first received?

Patient receive J&J vaccine on 3/1/21, two weeks following vaccine patient noted bilateral leg weakness, bilateral LE parasthesias, and bilateral hand parasthesias. Patient admitted to Hospital on 4/5 with 2 weeks of symptoms. Evaluted by Neurology and underwent MRI Brain, Cervical, Thoracic and Lumbar spine. Patient underwent Lumbar puncture on 4/7/21. CSF results revealed Protein 46.9, glucose 69, WBC 1, RBC 1. Etiology of symptoms with mild elevated protein were concerning for Guillen Barre Syndrome (GBS).

4/7/21 patient presents to ED with severe left arm pain and neck pain, dopplar shows occlusive thrombus in left cephalic vein 4/9/21 patient goes in to cardiac arrest; found to have an INR>10 and concern for life-threatening bleed that required treatment with KCentra; intubated and sedated; liver shock, heart failure with reduced ejections fraction; troponin elevation 4/13/21: patient extubated; patient's wife informs Dr. that patient was vaccinated on 3/31 with Jansen product after seeing news reports regarding adverse events 4/16/21 patient expected to be moved out of CCU to medical floor

Deep Vein Thrombosis right leg. Five days after being vaccinated I began to notice swelling in my right leg from my knee through my ankle-foot area. There was an associated increase in pain in the knee. I tried to shake it off hoping that the swelling and pain would go away, but I finally relented to the concerns of my family and sought care on the 6th of April at the emergency room because my doctor refused an in-person appointment. The emergency room physician prescribed Eliquis which I have been taking. The swelling seems to have leveled off, but my right leg still appears to be twice the size of my left leg

About 4 weeks from vaccination I started having increased muscle and joint stiffness and soreness. Symptoms have not abated as of this report.

Beginning about 10 days after vaccination, the patient noticed pain in his arm and he started ?not feeling so great.? Over several days, this pain began to radiate and involve muscle and bone aches. He continued to feel ill to what he described as the worst symptoms on Monday, April 26th, which included severe pain, high blood pressure (211/113 documented by the ER), symptoms similar to cardiac event. The patient was seen by Emergency Department who did not find a diagnosis, but gave the patient medication to lower blood pressure and referred further treatment to his Primary Care Provider. Blood pressure mediation was taken to lower his blood pressure and clonidine 0.1mg was prescribed by his PCP because of elevated BP (over 150/90). The patient was also instructed to take Advil for pain and was referred to get an X-ray with follow up in 2 weeks on 5/13.

extreme soreness in muscles head to toe, especially neck, shoulder, arms, hands, legs. One night my neck locked up in pain and I couldn't move, called ambulance which took me to hospital where they put me on cyclobenzaprine muscle relaxer, prednisone and hydrocodon for pain.