Johnson & Johnson

PATIENT RECEIVED THE VACCINE, AND WILL SITTING IN THE RECOVERY ROOM, FELT HOT, DIZZY AND SWEATY AS WELL AS OBTUNDED. BP 90/42, HR 55 SAT 97 RR12 DIAPHORETIC, AROUSABLE, COHERENT CV PULSE DIFFICULT TO PALPATE, BRADYCARDIC PHYSICAL EXAM OTHERWISE UNREMARKABLE PLACED ON STRETCHER. MENTAL STATUS IMPROVED. VS 115/97, 75, 12, SAT 98 TRASNFERRED TO EMERGENCY ROOM FOR EVALUATION

Patient became hypoxic with chest pain. Wheezing noted throughout lung fields. SPO2 80% on room air. Tachycardic 115 with decreased level of consciousness. Admitted to hospital with diagnosis of COPD exacerbation with Hyperkalemia (6.2). Currently stabilized on O2 at 3l/m

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.

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

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

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

Patient complained of face numbness around jaw area and inside cheeks. States "I feel like I went to the dentist and got a shot of Novocain". Patient notified staff at 1530, 15 minutes after receiving the vaccine. Patient denies difficulty breathing or difficulty swallowing. No rash noted. 30 minutes post vaccine patient states "It is getting better now but I still have some numbness". Patient denied difficulty breathing or difficulty swallowing. No rash noted. No other symptoms reported.

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

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.

Patient is a 60 year old male who has completed a 45-minute observation period with the following signs and symptoms of an adverse reaction: tingling and numbness around lips area, left arm and bilateral lower extremities 30 minutes after Janssen/J&J COVID-19 vaccine# 1 in series administered. Action(s) taken: Vital sign at 1626 blood pressure ; 153/95, heart rate: 70, respiration ; 16, Spo2: 98 % Repeat Vital sign at 1635: blood pressure ;148/101, heart rate:69, respiration ; 16, Spo2: 98 % - Patient denies chest pain ,shortness of breath, nausea vomiting, diarrhea, abdominal pain, difficulty swallow, headache, dizziness, or vision changes. Action(s) taken: Transferred to higher level of care/urgent care, report given to doctor. Doctor states that he is going to prescribed benadryl and will observed for 30 minutes. Patient advised to follow up with Primary Care Physician

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

Too weak to lift himself out of bed into the wheelchair or from wheelchair onto toilet. Fell twice on two consecutive days when trying to get from the bed into his wheelchair. 911 was called each time to help him get off the floor and into his chair.

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

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

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

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

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).

As I am driving home from the vaccine, I got the shot on my left arm so numbness there seemed normal. I also got numbness in my left jaw and left thigh which seemed strange. I thought later maybe this was a mini stroke. It went on for at least 30 minutes.

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.

Patient presented to consultation on 04/14 stating reports of numbness in left big toe and calf over the "past few days." They further clarified it improved throughout the day each day and they noticed an improvement in these symptoms with a "leg cramp PM" OTC product containing Tylenol and Benadryl.

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

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

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

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

THE PATIENT BECAME SEVERLY HOARSEAND HIS VOICE WAS VERY UNCLEAR. HE ALSO WAS UNABLE TO SLEEP SINCE HE WAS VACCINATED. HE WAS NOT MANIC OR AGITATED. HE HAD NO PANIC ATTACKS AND HE HAD NO ANXIETY..

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

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.

HEADACHE; PAIN DURING INJECTION ON RIGHT ARM; PAIN DOWN RIGHT ARM; STOMACH PAIN; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's past medical history included triple bypass, back surgeries, and neck surgery.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and batch number: 1808980) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced stomach pain. On 31-MAR-2021, the subject experienced pain during injection on right arm. On 31-MAR-2021, the subject experienced pain down right arm. On 13-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and had not recovered from pain during injection on right arm, stomach pain, and pain down right arm. This report was non-serious.

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

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

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

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.

I'm reporting just in case others had a mini stroke after receiving this Johnson and Johnson shot, doctors at hospital say they have seen it causing Big strokes but not mini strokes but if J&J shots causes big strokes it can also cause mini strokes I believe, A stroke is a stroke. My husband is a healthy 60 year old with no real heath issues. all his test in hospital showed no reason for his stroke and they did them all...?..but test did show he had a stroke His arm and leg went numb at about 8 pm Friday at home so I took him to hospital and test showed he had a spot on his brain saying it was a stroke, they kept him 2 days running test and they found no reason he had a stroke but he did and I believe it was caused by the COVID-19 vaccine shot from Johnson and Jonson

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

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

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.

60 yo male with BMI 30 and vodka x 2-3 bottles per day. In hospital 4/9-14 for obstructive uropathy of undetermined origin. In hospital on 4/12 and got J & J there. 4/13 with no prior history developed a DVT. D/C'd on 4/14 on Eliquis. Found unresponsive 4/19. At autopsy, found pulmonary thromboemboli

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

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

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

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

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

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

About 5 min after getting immunization the patient started to stand to tell an associate that he was having a reaction. He got light headed and started to pass out. A pharmacy technician was able to get to him in time and guide him to the ground. He was unresponsive for 10-30 seconds. Before we could take further action he regain consciousness. After a couple minutes he wanted to go back to chair. Within a minute he lost color and passed back out. This time he came back sooner and stayed on the ground till EMSA arrived. Only BP we got was several minutes into the event 124/82 HR 54. Paramedics did not transport the pt.

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.

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

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

BAD REACTION; ALLERGIC GROWTH UNDER SKIN, ON HEAD AND FACE, AND IT IS NOW GOING DOWN TORSO; COLD SWEATS; RESPIRATORY ISSUES; LOSS OF TASTE; LOSS OF SMELL; SLEEPING 20 HOURS PER DAY; RED AND ITCHY GROWTH; NO ENERGY; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 21-JUN-2021) dose was not reported, administered on 27-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-APR-2021, the subject experienced bad reaction. On 29-APR-2021, the subject experienced allergic growth under skin, on head and face, and it is now going down torso. On 29-APR-2021, the subject experienced cold sweats. On 29-APR-2021, the subject experienced respiratory issues. On 29-APR-2021, the subject experienced loss of taste. On 29-APR-2021, the subject experienced loss of smell. On 29-APR-2021, the subject experienced sleeping 20 hours per day. On 29-APR-2021, the subject experienced no energy. On 29-APR-2021, the subject experienced red and itchy growth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bad reaction on MAY-2021, and cold sweats, respiratory issues, loss of taste, loss of smell, sleeping 20 hours per day, and no energy on 06-MAY-2021, and had not recovered from allergic growth under skin, on head and face, and it is now going down torso, and red and itchy growth. This report was non-serious.

Started getting symptoms on the right side - both front and back - upper quarter of body and all the way under the ar. Red dots and painful to the touch - with clothes, even when the wind blows. Over time it has gone down. I took the Epsom Salts with the hemp helped a lot. The doctor - said there was nothing he can do. He said the viral medicine can only be taken when the day it starts and not three days later (when I saw him). It's almost gone now.

Numbness in my hands and peripheral neuropathy -- extreme sensitivity to clothing and fabrics, particularly cotton ones. Also: mind fog, but that lasted about three days whereas this lasted two weeks.

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

I have uncomfortable tingling in both of lower legs and both feet. Somethings my feet feel too warm and I have to remove my shoes and socks for relief. This condition has been continuous since June 2021. I received my J&J one dose vaccination on 4-1-2021

On four separate occaisions, for as long as 15 minutes, my left hand became paralyzed. This is the same arm as my shot. The first time I called my PCP and we discussed it and she said if it happens again to let her know. A week later, my hand became paralyzed again. I called my HCP and they told me to go to the nearest emergency room. I explained the relationship between the shot and the paralyzation to the health care company, my PCP, the er attendant, and the nurse practitioner. When I was released after an hour in the ER, they hospital said they had no idea what was happening. I asked if they would report it to the CDC. They said anything flagged as covid related was to be sent to you. I was not reassured that they cared about Covid or vaccine related causes. I have the feeling that they checked me for a stroke and sent me on my merry way. When I arrived at my ultimate trip destination, one of my clients told me she had her non-shot arm paralyze two years ago from the flu vaccine.

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.

RESLTESSNESS IN ALL OVER BODY; TREMORS ALL OVER THE BODY; SHOOTING PAIN IN LEGS; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's past medical history included car accident, surgery for disk infusion c 4 5 6 7, left foot surgery for neurological issue, and right foot surgery for neurological issue, and other pre-existing medical conditions included on an unknown date in feb-2021, after surgery, left arm started to lose muscle tone, muscles started to get smaller and weaker and on left hand he felt tremors and weakness.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816027 expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUN-2021, the subject experienced resltessness in all over body. On 09-JUN-2021, the subject experienced tremors all over the body. On 09-JUN-2021, the subject experienced shooting pain in legs. Laboratory data (dates unspecified) included: Blood test (NR: not provided) No Parkinson, no other disease, and EEG (NR: not provided) No Parkinson, no other disease. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the resltessness in all over body, tremors all over the body and shooting pain in legs was not reported. This report was non-serious.

3 weeks after vaccine, developed bilateral lower extremity pain with right lower extremity swelling. Seen by PCP. No new treatment. Symptoms lasted 3 weeks.

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.

Arm rang of motion very painful . feels like bone is broke. Terrible pain when in normal use reaching or yawning . streching. Horrible pain. Like i have been hit with a baseball bat eminating from injection sight outward to shoulder .

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

61 y.o. right handed male who the Program is consulted for possible stroke. Patient reports that he got his COVID vaccination (Johnson & Johnson) today (3/11/2021) at about 10:30 AM. While waiting after the vaccination, at about 11 AM he became dizzy and felt like he was "loaded" ("stoned from smoking weed") and the started shaking "as though he has a fever but without a fever." and left side sensory loss which is non-disabling. He was taking to a CT scan which was negative for stroke and was discharged home.

I was achy and became weak and dizzy about 1pm. By 2pm , I developed Ortho static hypotension which caused my blood pressure to drop and travel to ER via ambulance .

5 days after receiving vaccine, hives appeared from shoulders, down to legs. Hands were itchy and warm. These symptoms continued off and on for 5 days. Symptoms mostly appeared in the late evening.

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.

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

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.)

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

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

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

HOT FLUSHES IN THE FACE; A LITTLE DIZZINESS; A LITTLE KIDNEY PAIN ON HIS RIGHT SIDE; This spontaneous report received from a consumer concerned a 61 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included back fusion, rheumatoid arthritis, and mild high blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072 and expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 on left arm for prophylactic vaccination. Concomitant medications included etanercept for rheumatoid arthritis. On 06-MAR-2021, the subject experienced hot flushes in the face. On 06-MAR-2021, the subject experienced a little dizziness. On 06-MAR-2021, the subject experienced a little kidney pain on his right side. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hot flushes in the face, and a little dizziness on 06-MAR-2021, and a little kidney pain on his right side on 12-MAR-2021. This report was non-serious.

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.

For the first time ever, I had what I determined (based on internet searching) to be an ocular migraine. My vision was distorted in both eyes, although the distortion was stronger when looking to the left. There was a circular area that was fuzzy and a bit wavy like looking through water. The circular distortion area seemed to be outlined by a ring of brighter light. No flashes or floaters. I did not have a migraine headache then or afterwards; I've never had a migraine headache. I followed the on-line advise and laid down and did try to use my eyes for about an hours. The distortion faded within an hour or two; it has not recurred. I did not connect it to the vaccine as a potential source at that time.

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.

Patient was admitted on 4/9 to hospital with left facial, upper and lower extremity numbness that last 5 min and resolved. In ED had similar symptoms. CT head, MRI brain, MRA head and neck unremarkable. Hgb 6.6 and Plt 13. Transferred to Medical Center on 4/10 for more care. Diagnosed with TIA and possible TTP (ADAMTS13 pending, meets other criteria). Started on high dose methylprednisolone 1000 mg IV x 3 doses on 4/11, plasmapheresis on 4/11, and weekly rituximab on 4/11. Status/outcomes pending

Pt was immunized at 1:30pm on monday 4/12/21, He presented today 4/15/21 and stated he had woke up Tuesday 4/13/21 with a knot on his left leg that was very painful and had difficulty walking

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

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

Guillian-Barre Syndrome and Bell's Palsy - inpatient hospitalization, treated with immunoglobulin infusion, transferred to another Hospital and awaiting further treatment

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

CHILLS; NAUSEA; HOT FLASHES; FEELING HOT AND COLD; This spontaneous report received from a patient concerned a 61 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced hot flashes. On 05-APR-2021, the subject experienced feeling hot and cold. On 05-APR-2021, the subject experienced nausea. On 06-APR-2021, the subject experienced chills. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 98 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hot flashes, chills, nausea, and feeling hot and cold. This report was non-serious. This case, from the same reporter is linked to 20210424684.

The patient states that on March 20 he was vaccinated with the Johnson and Johnson COVID-19 vaccine. He states that over the past several days he has developed erythema of the palms and a change of appearance of the palms that ?looks like they aged 3 years.? He states that he has developed new onset pain of the thigh, which has made ambulation difficult. He states that these symptoms were not present prior to obtaining the vaccine.

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

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

PAINFUL LUMP/HARD WHEN PRESS IT HURTS; SORE ARM; ALLERGIC REACTION IN SOFT TISSUE; 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 past medical history included broken wrist in december and a metal plate was inserted, and concurrent conditions included retired, and seasonal allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced allergic reaction in soft tissue. Treatment medications included: diphenhydramine hydrochloride. On 12-APR-2021, the subject experienced painful lump/hard when press it hurts. On 12-APR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from painful lump/hard when press it hurts, and sore arm, and the outcome of allergic reaction in soft tissue was not reported. This report was non-serious.

PAIN IN BOTH LEGS; This spontaneous report received from a patient concerned a 61 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced pain in both legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in both legs. This report was non-serious.

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

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

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.

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

BUZZING IN HIS EARS; RINGING IN HIS EARS; BAD RASH ALL OVER HIS BODY; BOTTOM OF HIS FEET HURT TO WALK ON; This spontaneous report received from a consumer concerned a 61 year old male. The patient's height, and weight were not reported. The patient's past medical history included stomach disorder. The patient was previously treated with esomeprazole magnesium for stomach disorder. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced buzzing in his ears, ringing in his ears, bad rash all over his body, and bottom of his feet hurt to walk on. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the buzzing in his ears, ringing in his ears, bad rash all over his body and bottom of his feet hurt to walk on was not reported. This report was non-serious. This case, from the same reporter is linked to.

DIFFERNCE OF LOT # TO MANUFACTURER: Told got Janssen but lot # is Moderna. He got his vaccine, had no reaction other than his arm hurting. Then on 4/10/21 in the afternoon he started having ringing in the ears. He said that it is pretty bad, and is on and off and bad when it occurs. He has it more days than not and has never had this condition before. He did a telephone APT and informed him of his issue and is aware. He told him to wait and see if it goes away.

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

Swelling in right leg following workout. Became painful as day went on. Swelling, pain continued. After three days, visited doctor.

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.

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

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

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.

After my vaccine, I experienced redness sensation to my arm. My left arm was swollen and raised bump with a rash. I called my doctor and he thought it was possible cellulitis. He prescribed Prednisone and an antibiotic for seven days. After the seven days my rash was gone but I still had the raised bump. I went to an urgent care facility where they performed an ultrasound of left upper extremity and no blood clot was found. I was told to apply warm compresses to my left arm once a day. To this day I still have an aching sensation to my left arm and is also sore and my left arm is still red but flat in shape.

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

MILD ARM SORENESS THAT GOT SPIKED; 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 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: 203AZIA, expiry: 23/JUN/2021) dose was not reported, administered on 08-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced mild arm soreness that got spiked. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild arm soreness that got spiked on MAY-2021. This report was non-serious. This case, from the same reporter is linked to 20210518415.

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

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

Patient had onset of right calf pain and swelling several hours after receiving vaccine. Was seen on 5/10 and diagnosed with right lower extremity DVT.

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

Patient presented in the office on 5/12 complaining of edema. The edema involves the left lower extremity. Onset was gradual 2 month(s) ago. Onset followed starting a new medication (around J and J vaccine). The symptoms occur intermittently. The patient describes this as unchanged. Symptoms are exacerbated by prolonged standing. Symptoms are relieved by leg elevation. Associated symptoms include calf pain (in upper thigh) and calf swelling, while associated symptoms do not include dyspnea, decreased urinary output, ascites, diarrhea, localized redness, localized warmth or fever. No chest pain

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

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

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.

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

The patient first exhibited diaphoresis, then was thirsty. He was then unresponsive and started seizing, and lost control of his bladder. The seizure lasted approximately 1 minute. Emergency services were contacted, and they assessed the patient after the event. He was released from their care back into the community.

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

DIARRHEA; SORE ARM; This spontaneous report received from a patient concerned a 61 year old male. The patient's weight was 170 pounds, and height was 68 inches. The patient's concurrent conditions included alcohol user, and cigarette smoker, and other pre-existing medical conditions included no known allergies and patient does not abuse drug or have illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 25-JUN-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 25-JUN-2021, the subject experienced sore arm. On 26-JUN-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from diarrhea, and sore arm. This report was non-serious.

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

Right leg feels numb and tingly, feels like it's asleep and he can't wake it up. Went to urgent care and was evaluated and ruled out a blood clot. Was prescribed a short course of "steroids" but it is not better.

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.

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

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.

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

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

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

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

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

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

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

Six days after receiving Janssen vaccine at approximately 4:00 pm, left hand experienced numbness. As the evening wore on, weakness spread through the left side of body and speech began slurring. The next day, after no improvement, went to hospital to find from CT scan that he had suffered a stroke. He had no precursors that would lead to being prone to strokes.

Patient started feeling warm and dizzy around the last few minutes of waiting for the vaccine 15 minute window. About 13 minutes after the vaccine was administered. We provided the patient with water and informed him to sit and wait a few more minutes.

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

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

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

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

Pt feeling weak in observation area while sitting down after vaccine administration. Pt slowly lowered to ground by clinical staff,911 called lost consciousness for less than 2 mins aprox., pt afterwards aaox3, ambulance arrived, transported to ER

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.

Warm feeling followed by fainting and slight convulsions. Nausea, gas, feeling faint, and usability to drive a vehicke for approximately 75 minutes. Slept for several hours, faint feelings subsided after 15 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.

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

Patient experienced nausea. Also her irregular heartbeat kicked in. Patient had shakes for about 15 minutes. Eventually we decided because of heart and weakness to transfer to hospital for follow up. Patient as of 6pm 4/13/2021 is fine.

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

Got heaviness in chest and ring finger turned white and numb around 8:30 a.m. Got heaviness in chest again around 6:00 p.m. and it would not subside so I went to the ER and they gave me 3 nitroglycerin and did several tests to check my heart but could not find anything wrong. I am scheduled for a stress test April 20. The person in the bed next to me had similar symptoms and received he Janssen vaccine the same day I did but about 10 minutes earlier.

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

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

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

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

I received the Janssen vaccine on March 13. By the next weekend, I had what I thought was a spider bite on the inside of my left thigh. That "bite" got worse--bigger, hot to the touch, and then red. On the weekend of the 27-28 of March, it was red, raised and very painful even when not touched. I called my family doctor on Monday morning, the 29th of March, and I was sent to the Emergency Room, where I was diagnosed with a 7cm thrombosis in my left greater saphenous vein, which is treated the same as a DVT. I was treated first with Lovenox injections, then Eliquis 10 mg 2x daily, now 5 mg 2x daily. The blood clot is still painful to the touch.

Patient received the Janssen vaccine on 3/17/21 at 4:42 pm. Beginning at 2:30 am on 3/18/21 the patient began to experience dizziness, vertigo, shaking, tremors, nausea, and vomiting. The shaking and tremors occurs all over but is most significant in the hands and arms leaving the patient unable to do simple daily tasks or return to work. These symptoms began 3/17 and have persisted every day since in varying severity. Sometimes the tremors last for more than 20 minutes straight. The patient was seen in the emergency department on 3/26/21 but the hospital notes are unavailable to the pharmacy at this time. Per patient, he had an MRI and no other tests and was given a prescription for ondansetron for nausea and discharged. The patient believes he was not adequately assessed and is still suffering from symptoms. He has a follow up with a primary physician 5/28/21 which is the soonest he was able to be referred.

The injection site is the left arm. Common pain was felt, however, pain sensation traveled down below the left elbow. Persistent muscle cramping is experienced with the calf muscles of both legs. A routine of stretching and daily mile walk before and after vaccination has not eliminated the pain.

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

Pt here for in office visit converted from virtual. He developed painful rash on Friday late morning 4/9. Bumps on his right side of forehead and pain traveling down front of his right ear and into lower part of his jaw. No tinnitus, hearing issues, pain inside ear. No eye issues such as eye pain, vision issues or blurriness, tingling. He had an eye exam 2 weeks ago. No facial paralysis, tingling or numbness. He has been taking tylenol. No hx of shingles. No hx of vaccine for shingles. Chicken pox as a child. He sees GI for UC. On medication last few years. He last saw his GI last year and is overdue to see him this year. He did get his janssen vaccine 2 weeks ago 3/17.

Patient started with Left lower leg pain and redness on 4.1.21. Went to Emergency dept on 4.4.21 and diagnosis of Left leg cellulitis and prescribed Doxycycline. Patient came to PCP office on 4.6.21 with worsening left lower leg pain and swelling. Order L lower leg doppler. Diagnosis of L lower leg deep vein thrombosis of tibial vein on 4.7.21 and prescribed Apixaban 5mg 2 BID x 7 days on 4.7.21

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

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.

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

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

Left leg pain started about 4/16/21. Reports evaluated by nurse practitioner at the medical office of primary care provider on 4/23/21. Ultrasound ordered a hospital and diagnosed with a blood clot in the left leg on 4/23/2021. Placed on a "blood thinner" to take orally BID for one month then once daily for undetermined duration. States MD is not considering the vaccination as the reason for the blood clot because of the duration of time between when the vaccine was given and the onset of the blood clot. When asked, pt reports a platelet count was done.

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

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

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

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.

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

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

CARDIAC ARREST (SEVER CHEST PAIN); CLOGGED VEIN; LEFT ARM GOES TO SLEEP; This spontaneous report received from a patient concerned a 62 year old white male. The patient's past medical history included blood clot, heart attack, lump in leg, and stents in main arteries, and concurrent conditions included heavy smoker, and heart issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808025, expiry: UNKNOWN) dose was not reported, 1 total administered on 12-MAR-2021 to left arm as prophylactic vaccination. The patient was previously treated with clopidogrel bisulfate for blood clot. On an unspecified date in 2021, Laboratory data included: Echocardiogram (NR: not provided) unknown, and Lab test (full workup)(NR: not provided) unknown. On an unspecified date in Mar-2021, a week later vaccination, the patient experienced that left arm went to sleep which felt worse next day, on 25-APR-2021, patient experienced severe pain in chest, called ambulance and was taken to hospital. On same day patient was hospitalized. Patient went to full cardiac arrest twice same day. It was stated that vein that was 60 percent good earlier was 100 percent clogged (clogged vein) in one month after getting the vaccine. They tried to put stent in, clear vein out, and put piece of metal and expanded it, to make alley way for blood flow. Patient stated that patient would not take Plavix this time. According to patient, stent was reacting with Plavix, and decided to take something different. They did same job twice. It was stated that patient was discharged on 05-May-2021 from hospital. On 12-MAY-2021, patient went to consult the health care professional to make sure everything was okay. The patient gave lot number 1808025, then stated that, patient thinks it is 180, and then either 5 or 8, and next it was either D or 0, and then after the space it is 25. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cardiac arrest (sever chest pain), left arm goes to sleep and clogged vein was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210523134-COVID-19 VACCINE AD26.COV2.S-CARDIAC ARREST (SEVERE CHEST PAIN), CLOGGED VEIN. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE

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.

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

He came into the pharmacy and was complaining that he had gone to the doctor and was told to report to the pharmacy so that they could report the pharmacy. He received his vaccine, and he wrote down to the pharmacy that he had a numb arm, no nerve conduction in the upper arm, he cannot raise his elbow outward, and he's still having bicep movement. He informed the pharmacist that it was not any better, his doctor did not give him anything for it and that it would be better over time.

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

RIGHT HAND CRAMPING AND PULSATING PRETTY GOOD; RIGHT HAND SWOLLEN; UNABLE TO CLOSE HAND COMPLETELY; This spontaneous report received from a patient concerned an adult male. The patient's weight was 240 pounds, and height was 73 inches. The patient's past medical history included ablation, and stents, and concurrent conditions included heart issue, non-alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies and no drug abuse or illicit drug usage.The patient received covid-19 vaccine (suspension for injection, route of admin not reported batch number: 1808986 expiry: 04-JUL-2021) dose was not reported, administered on 24-MAY-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced right hand swollen. On MAY-2021, the subject experienced unable to close hand completely. On 25-MAY-2021, the subject experienced right hand cramping and pulsating pretty good. The action taken with covid-19 vaccine was not applicable. The patient was recovering from right hand cramping and pulsating pretty good, right hand swollen, and unable to close hand completely. This report was non-serious.

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

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.

patient has developed blood clot after getting the J&J shot on 4/6/2021. The patient has had a sore arm since the day he got his vaccine. According to his wife, he started to feel weak on Sunday 5/30/2021. She said his hands were cold that day too, then by Tuesday his fingers turned white, this is when she took him to the hospital and found out about the blood clot. His wife also mentioned that after examination, they found out that he has an extra rib that was pressing on the brachial artery and that might have caused the blood clot. It doesn't seem to be sure that the blood clot was caused by the covid vaccine or not

Patient developed numbness and weakness in left arm, left leg and left side of abdomen. Cervical MRI with and without contrast showed enhancement . Lumbar puncture had high protein levels. Neurology consulted and think process is either cervical myelomalacia or cervical transverse myelitis/vaccine associated inflammation. Patient had never had a problem like this before. He was given high dose Solumedrol X 2 days and sent home on a prednisone taper. His numbness and weakness had improved at time of discharge from the Hospital on May 18, 2021. However, I see he has been readmitted to the Hospital on May 27, 2021 with similar symptoms.

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.

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

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

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

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

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

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

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

Patient developed right sided Bell's Palsy. Prescribed.. valACYclovir 1 g oral tablet, one three times daily, # 21 predniSONE 20 mg oral tablet, 3 tablets once daily for 7 days, # 21 Patient will follow up in clinic in 1 week.

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

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

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.

Patient received vaccine during the morning of 05/20/2021. The vaccine was given by the pharmacy manager. The patient reported no symptoms and waited the required 15 minutes prior to leaving. The patient called the pharmacy on 7/20/2021 complaining of a sore arm. He stated that his arm has been hurting since the vaccine was given and the doctor told him that the pharmacy gave the vaccine wrong. He stated he was not looking for compensation or to get anyone in trouble, but that he wanted to let us know. He stated that his doctor told him that they probably hit the nerve and that there was nothing they could do to help.

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

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

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

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

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

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

I started feeling mildly shaky sometime between 10:16 PM and 10:32 PM. I am a diabetic, so I took a blood glucose reading to determine if my blood glucose levels were low (which can cause mild shakiness). They were not (reading was 172 mg/dL), but by the time I took that reading at 10:32 my shakiness had increased from onset, and I was so shaky at 10:35 PM that I was not sure if I could take my bedtime injection of Levemir safely. I was only able to do so by injecting myself and then letting the insulin rest on the palm of my hand (rather than hold it firmly as I usually do). Although the shakiness began to subside several minutes later, I was unable to fully control my toothbrush in my mouth when brushing my teeth. I then got in bed, and the shakiness was gone by around 11:00 PM (I didn't record the exact time).

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.

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

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

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

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

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

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

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

FEELS LIKE SOAR BURNING SENSATION ON LOWER BACK; RASH ON LOWER BACK SPREADING; 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) dose was not reported, administered on 29-MAR-2021 to Right Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 31-MAR-2021, the subject experienced rash on lower back spreading. On 31-MAR-2021, the subject experienced feels like soar burning sensation on lower back. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on lower back spreading, and feels like soar burning sensation on lower back. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.

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

around 3 AM patient got dizzy and passed out. When I talked to patient at 6:30 AM, he stated to me that he was dizzy and fell during the night, his voice was very slurred and I could hardly understand him, he was also very disoriented. Took him to hospital ER around 7 AM

Left side of face became numb, almost like a Bell's Palsy, or like having a novocaine shot at the dentist's office. I was however able to close my eyes properly, wiggle eyebrows, blink, mouth was not drooped.

Beginning March 14 pain in right thigh and right calf. Went to family doctor March 19th said could be dry skin used skin cream no change. Went to hematologist on 26th blood test for blood clots came back normal. On March 29 had ultrasound on right leg for blood clots came back normal. On April 5 went back to famil doctor with pain still in right leg and thigh awaiting blood test results.

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:

Two days after injection my left arm started to hurt and my arm down to my fingers on the left arm tingle constantly, like it fell asleep. It is April 13 and still have the issue. See a little more tired and irritable too.

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

PATIENT DEVELOPED RIGHT POPLITEAL DVT IN LEG AFTER JANSSEN/JOHNSON AND JOHNSON VACCINATION. PRESENTED TO MEDICAL GROUP 2 WEEKS AFTER VACCINATION WITH A 2 WEEK HISTORY OF LEG PAIN AND WAS DIAGNOSED AT THAT TIME. HE RECEIVED JOHNSON AND JOHNSON VACCINE AT MEDICAL CENTER.

Pain in right leg that lasted for 2 days, that started 2 weeks after injection. Also had 5 minutes of dizziness the morning after the injection. I?m going to report this info to my personal physician today.

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

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.

Client left message on immunization nurses line 04/13/2021 stating he received J&J vaccine on Friday, and is having a severe reaction, can't eat, drink, breathing problems, hasn't been able to pee for 4-5 days, throwing up and severe diarrhea, and he can't stand. I returned his call and he verbalized all issues above and also said his legs, arms and hands were cramping up and having ringing in the ears. I recommended him to go to the ER now, he said he had called his PCP and was told the same thing. He stated he is single and lives alone and does not drive. I told him to call 911 and he verbalized he is too embarrassed to do that and states he will wait for his daughter to call him. I offered to call his daughter for him and he declined. Addendum: Created by RN. 04/16/2021 02:01 PM 04/16/2021 Client called reporting the same symptoms as in 4/13 message -- I told him to go to the ER immediately. He stated he could not drive due to muscle spasms and feet and leg pain. Asked if he would please call 911 and stated that was not necessary. He verbalized he understood my directions and stated he would go to urgent Care. Called Sheriff office to make a well person check.

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.

Patient had severe pain in one leg since 03/14/2021 Went to the emergency room on 03/21/2021 where he was notified that he had a clot in his lung. It caused a bilateral pulmonary embolism.

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

Patient presented to the ER with chest pain, non radiating, heavy weight. Patient was found to have acute DVT.

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

Found seizing approximately 48 hours after vaccine. It was confirmed that he had a stroke on 3/12/21.

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

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.

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

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

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

Within a minute I had a hot flash that started in my calf and went through my body. In less than a minute I was lightheaded and almost passed out (or fell asleep). I beeped my horn and the nurse came right over. They took my blood pressure and it was 150 over 120. (I've never had high blood pressure before. The second reading was 140 over 110. In about 5 minutes my BP was normal 120 over 80.

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

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

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 past medical history included bad back, and concurrent conditions included high blood pressure, high cholesterol, intolerant to statin, non smoker, and non alcohol user, and other pre-existing medical conditions included on medication for high blood pressure and high cholesterol and no known allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAY-2021, the subject experienced burning sensation in both legs and feet. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from burning sensation in both legs and feet. This report was non-serious.

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

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

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

Severe vomiting, severe diarrhea, weakness, spasms in legs. Could barely get out of bed for 36 hours.

PATIENT JUST REPORTS SORE ARM SINCE VACCINATION - HAD FOLLOWED UP WITH PCP WHO ADVISED TO USE AN ICE PACK.

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

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.

Patient started with paresthesia and weakness mid April. He was ultimately diagnosed with Guillain-Barre syndrome via lumbar puncture on May 20th after 3 ED visits and 2 hospitalizations.

RED BLOTCHES, ENTIRE BODY; SORE ARM; This spontaneous report received from a consumer 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: 205A21A expiry: 23-JUN-2021) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-MAY-2021, the subject experienced red blotches, entire body. On 30-MAY-2021, the subject experienced sore arm. Treatment medications (dates unspecified) included: hydrocortisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm, and red blotches, entire body. This report was non-serious.

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

Shortness of breath and chest pains after routine workout at the gym. Got worse thru the day. Went to ER in the evening. Tests for heart attack and blood clots were negative. Sent me home next morning feeling slightly better. Next night (6/2) woke up at 3 am with shooting pains in right leg below knee. Back to ER where they repeated heart tests and did sonogram of leg. All normal. Sent me home again. Symptoms continue to this day with slight improvement. Have follow ups scheduled with Cardio and Pulmonary.

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

Please see ER physician note below. Patient later expired at 1337 on June 12th. One day after receiving the COVID vaccine. ER physician note: Patient presents completely unresponsive, CPR in progress Patient's wife reports that this afternoon, they were lying in bed and he leaned over to her and said "help me". He then became unresponsive. She reports that she believed he may have aspirated because he has an issue with his esophagus where he is unable to adequately swallow food sometimes. The family began CPR at home, and reports that EMS arrived approximately 10 minutes later. Patient arrived here at the ED around 1250. CPR continued. Patient given multiple rounds of epi and bicarb. Patient intubated with an 8 at 21 cm with some cold liquid around the tube. He was intubated at arrival.

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

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.

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

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.

Seven minutes after being injected, pt reported feeling lightheaded and thought he might pass out. Myself and other helped lower patient to the floor. He began to shake for 2-3 seconds. instantly snapped out of it. Applied cold ice packs and gave patient water. elevated pt legs. BP taken. After drinking fluids and rest, pt reported he began to feel better. Kept him for a total of 35 minutes. Initial BP was 90/47 with a HR of 50 At time of discharge pt BP was 113/77 with a HR of 76.

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

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

LEFT ARM SWOLLEN; LEFT ARM HURTS; 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 hypertension, diabetes mellitus, non-smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 1865031 expiry: 20-MAR-2021) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced left arm swollen. On 13-MAR-2021, the subject experienced left arm hurts. 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 left arm swollen, and left arm hurts. This report was non-serious.

Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Patient feels tingling in the right arm, wrist, and fingers, and itchiness on right chest

Patient reports he had a sore arm after receiving the vaccine, and that his arm is still sore (3 months later).

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.

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

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.

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

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

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

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

Patient states he began to feel facial flushing approximately 30 minutes after receiving injection. This was followed by a rash, spreading from torso down. He took 2 Benadryl tablets, fell asleep, and awoke after 2 hours. When he woke the facial flushing and rash was resolved. He also reports that on the morning of the following day, he was drinking coffee and noticed the facial flushing returning, then his arms started breaking out in the rash. He took 1 Benadryl tablet and these symptoms resolved.

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.

Severe COVID-19 infection with ARDS. Requiring mechanical ventilation, paralysis and flolan nebulization.

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

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

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

At 5:05 am on April 11, approx. 37 hours after I received the shot, I awakened to a rapid muscle convulsion in my left shoulder muscle, at the approximate location of the injection. I counted between 2 to 6 contractions per second (yes, it was a very quick twitch that involved my whole upper arm). It went on for at least 10 minutes, then paused for less than a minute and then resumed. This was a pronounced muscle spasm which I cannot remember having before. I have had twitching eyelids or facial muscle that would twitch for a few minutes in the past, but this went on for over 30 minutes, and I am not sure it is done. Also, this was much more intense than the above-referenced twitches. The location and time relative to my shot makes me fairly certain that this is an effect of the vaccine. I have not exercised or done anything to cause this to my knowledge. Of course, this seems like a harmless side effect, but my concern is that my heart muscle reacting to this in a similar fashion could be more serious.

6 hour after shot; Bloating, burping with foul taste, diarrhea, nausea 8 hours after shot; Vomiting, diarrhea, nausea, weakness 8-30 hours; Discomfort, nausea, weakness 36 hour; Feeling fine again. Fyi,

Patient vaccinated on 3/7/21, on 4/2 presented pain in left leg and some redness, on 4/3 some dizziness, lightheadedness, difficulty with vision in right eye, some slurred speech; on 4/5 his health agravated and EMS was called and taken to hospital; spouse informed that patient had a blood clot in stem of brain; on 4/6 patient died. No autopsy performed

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

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

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

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.

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

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.

symptoms of shortness of breath, dizziness and weakness 5-6 days after vaccination. complete heart block

About an hour after I received the vaccination, my left leg fell asleep. That never has happened before. on 4/7/2021, at approximately 1:00 pm, I stood up, got light headed and blacked out for a few seconds. I took my blood pressure and it was in the normal range. I didn't think much of this until the recent reports on the Johnson and Johnson vaccine started circulating. I've had no other issues.

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

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.

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

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

Acute Transverse Myelitis with AIDP in the setting of recent Covid vaccinating and possible bacterial meningitis's. Patient is in the hospital.

developed swelling and pain left arm within 1 week of administration Janssen Covid -19 vaccine IM left arm on 3/27/2021, on 4/16/21 left upper extremity venous sonogram demonstrated left axillary vein thrombosis

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

NEUROENDOCRIME TUMOR; PAIN IN EXTREMITY; This spontaneous report received from a patient concerned a 64 years old male. The patient's weight, height, and medical history were not reported. The patient received Ibrutinib (tablet, oral, batch number: 1140389) 420 mg, every 1 day, from SEP-2020, for chronic lymphocytic leukemia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported), start therapy date were not reported 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced neuroendocrime tumor, and pain in extremity. Laboratory data (dates unspecified) included: PET scan (NR: not provided) which showed Neuro endocrine tumor. Treatment medications (dates unspecified) included: lanreotide to suppress the growth in every 28 days of tumor. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of ibrutinib was not changed. The patient was recovering from pain in extremity, and the outcome of neuroendocrime tumor was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-Covid-19 vaccine ad26.cov2.s-Neuroendocrine tumor. This event is considered unassessable. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

Patient received Janssen vaccine on 4/12 and developed left arm pain a few days later. Presented to the ED with left arm swelling 10 days after vaccination and was found to have a left upper extremity DVT.

4/8/21 pt had brain fog like he was in a haze and felt strange being very relaxed like he had taken a tranquillizer he felt better next day. pt seemed to be fine at this point. 4/22/21 pt seemed to be fine and went to the store where he went shopping. He put shopping bags in car. He was found in his car after and hour and 20 minutes by a couple of bystanders unresponsive. 911 was called and he transported to ER. He was intubated but patient died. Unknown is any test were performed.

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.

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

CEREBRAL VENOUS THROMBOSIS; VISUAL IMPAIRMENT; HYPOAESTHESIA/ NUMBNESS IN ARM; This spontaneous report was received from a health care professional via a Regulatory Authority Vaccine Adverse event Reporting system (VAERS) (VAER reference number 1207958) and concerned a 64 year old male of unspecified race and ethnicity. The patient's height and weight were not reported. The patient's concurrent conditions included pollen allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029 expiry: UNKNOWN) dose was not reported. 1 total, administered on 16-MAR-2021 for prophylactic vaccination on left arm. Concomitant medications included atorvastatin and lisinopril; both for unknown indication. On 07-APR-2021, the patient experienced cerebral venous thrombosis, hypoaesthesia, and visual impairment. The patient had cerebrovascular thrombus with partial loss of sight and numbness of his left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cerebral venous thrombosis, hypoaesthesia, visual impairment. This report was serious (Disability Or Permanent Damage). This case version (1) was created on 30-APR-2021 for the purpose of quality improvement the following corrections were made. The MAC was added for the pharmacovigilance narrative.; Sender's Comments: V1: This spontaneous report was received from a health care professional via VAERS (ID: 1207958) and concerned a 64-year-old male of unspecified race and ethnicity who experienced cerebral venous sinus thrombosis (CVST) 22 days after vaccine. Concurrent conditions included pollen allergy and concomitant medications included atorvastatin and lisinopril. Twenty-two days after vaccine, the patient experienced CVST, hypoaesthesia, and visual impairment. The patient had cerebrovascular thrombus with partial loss of sight and numbness of his left arm. Specific imaging and laboratory results, including platelet count, were not reported. Information is limited in this case, and the occurrence of CVST could represent background incidence of such events in the general population. The platelet count is not reported and thus this case does not meet the Brighton Collaboration (BC) definition for Thrombocytopenia Thrombosis Syndrome (TTS) with BC Level 5 (not a case of TTS.)

Approximately one month after receiving vaccine, he had a left thalamic infact acute (CMS-HCC). The was taken to Hospital immediately and was treated there. Symptoms included right sided paralysis and weakness and slurred speech. Blood pressure was also elevated(184/97). Glucose(286). Hospital stay was three days.

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".

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

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

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

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

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

April 20, 2021. PT needed to use the restroom. We stopped, he walked to the restroom, I went to the gift shop. Upon returning, I saw PT sitting on a bench. He was leaning to his left, could not see out of his left eye, very unstable when sitting. We missed lunch, so we thought it was his sugar dropping. I started to feed him jam and a chocolate bar. After 2 hours, his vision returned & he seemed better. He drove us back to the rental cabin. He rested the next 2 days. Then on Friday, we packed up our vehicle and Pt drove us back home. After arriving home, Pt's condition got worse. We went to the Dr, explained the events of the previous week & she came to the same conclusion, Diabetes spell. His condition continued to worsen, we went back to Dr several times, the ER 2 times and finally we got into see a Neurologist. That appointment, the doctor said he thought stroke. Dr scheduled a MRI for June 1, 2021. Results of that MRI was a definite stroke. Now he has started outpatient rehab with no promise he will ever regain full mobility. He can no longer drive, mow grass, walk without a cane and help, etc. Life has changed dramatically for both of us.

I had no symptoms until the next morning when I woke up with very extreme pain in my left arm with the epicenter of the pain on the back of my left hand between the bones leading to the ring finger and the pinky. Whenever my hand was below my heart, the entire hand was dark purple in color. I had read that severe reactions from the shot generally dissipated in a day so I took some Hydrocodone which I had for migraines, kept my hand elevated, and decided to wait it out. The next day the pain was still extreme so I went to urgent care. Urgent care eventually said I needed to go to the emergency room to have an ultra-sound. I did so. After many hours of waiting, they got me into the ultrasound room where they told me they cannot ultrasound the back of the hand because the vessels are too small and don?t show up. So they ran an ultrasound on the shoulder and front of the arm and found nothing. I?m not surprised as that is not where the pain was coming from. I went home and alternately put my left hand in ice water and hot water periodically, which eventually reduced the pain to a tolerable amount. As of today, all the pain is gone except for the region mentioned in the back of the hand. That still hurts, so I'm answering item 20 with a No.

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

pt. contacted provider on 6/4/21, stating he has pain in his left shoulder. He stated he felt like the vaccination was given to high and he took a picture of where the nurse placed the band-aid. Director verified if band-aid was the actual place of injection the vaccine was given to high and could have caused SIRVA. Pt stated his shoulder was fine after injection and it was over two weeks post injection that he started to feel shoulder pain. On 6/10/21 pt stopped by vaccination clinic and informed staff his pain was worse and was now causing pain down his arm to his wrist. Nurse informed pt to see his physician.

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

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

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

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 developed right lower extremity DVT diagnosed ultrasound 7/20/21. He started with acute pain right leg Saturday 7/17 and woke up on Sunday 7/18/21 with swelling right upper thigh and bruising and swelling of right foot. His swelling and pain increased and was seen urgent care where he was referred to emergency room for evaluation DVT.

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

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.

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.

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

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

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

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

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.

Shopping, climbed a single level stairway, became winded, nauseous, got bad heartburn feeling, felt flush and started getting dizzy. Took Tums, no help went to Emergency Room and was told that there was an enzyme in my blood which showed I had a heart attack

Friday, approximately 5:00 pm, my wife and I were leaving home to drive to grandson's baseball game. Out of the house and on the driveway I became confused, couldn't speak, felt "clammy" and began to perspire, and couldn't drive. My wife was asking me questions and I couldn't answer wedding date, her DOB, etc. The symptoms disappeared after 10-15 minutes but I felt almost the same as the minimal symptoms I had with my Covid positive, January 14. (My Covid experience resembled having a Cold).

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

Pt states that he had some stomach pain as well as slight leg pain. I instructed him to call his doctor and let them know because it might be signs of a clot and out of caution the doctor might want to see him.

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

I started having migraine headaches on 3-19-2021 , this lasted for 3 days. On 3-23 started coughing up blood , that progressively became worse. Went to emergency room and was admitted CAT scan of lungs showed that I had 3 blood clots.

My father had a massive stroke 3 days after taking his shot. He is now currently paralyzed on his right side and not speaking

Patient with PMH of epilepsy, alcohol use disorder, CVA, dementia presented to ED with witnessed seizures while in bed. History of non-compliance, multiple admissions for seizures previously.

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.

FELT LIKE HEAVINESS / WEIGHTS IN OBLIQUES; SORENESS IN ARM; This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced soreness in arm. On 14-APR-2021, the subject experienced felt like heaviness / weights in obliques. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness in arm on 21-MAR-2021, and had not recovered from felt like heaviness / weights in obliques. This report was non-serious.

DIFFICULTY BREATHING; CANNOT FINISH EXERCISES; WEAKNESS; SWEATING; NAUSEA (FELT LIKE VOMITING); FEVER; This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. The patient's past medical history included stage 3 colon cancer, and concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and had no history of drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced sweating. On 10-APR-2021, the subject experienced nausea (felt like vomiting). On 13-APR-2021, the subject experienced difficulty breathing. On 13-APR-2021, the subject experienced cannot finish exercises. On 13-APR-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, difficulty breathing, weakness, sweating, nausea (felt like vomiting), and cannot finish exercises. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.

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

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

HUSBAND BEING IN EMERGENCY RIGHT NOW. 8 DAYS AFTER HAVING A COVID 19 SHOT; FLUSHING; WEAK; FEVER; INJECTION SITE PAIN; FEELING SICK; This spontaneous report received from a consumer via a company representative concerned a 65 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and other pre-existing medical conditions included allergic to other antibiotic((can't remember). The patient experienced drug allergy when treated with clarithromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) negative. On 06-APR-2021, the subject experienced feeling sick. On 06-APR-2021, the subject experienced injection site pain. On 07-APR-2021, the subject experienced weak. On 07-APR-2021, the subject experienced flushing. On 07-APR-2021, the subject experienced fever. On 15-APR-2021, the subject experienced husband being in emergency right now. 8 days after having a covid 19 shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from feeling sick, weak, flushing, and fever, and the outcome of injection site pain and husband being in emergency right now. 8 days after having a covid 19 shot was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.

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

Patient developed ataxic gait determined to be Guillan-Barre syndrome. Was treated with course of IVIg with improvement but not resolution.

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

Pt presented to Doctors office 4/27/21 with left leg pain and cramping. Pt advises this started over the weekend and became worse.

2 weeks ago on April 17th, I woke up feeling very dizzy and nauseous. The room was spinning. My left ear was ringing, My balance was off. Every time I bent over it was worse. I vomited after I ate. Spent the day and the next day in bed. On Monday I called my doctors office and explained how I was feeling and a tele visit was scheduled later in the day. During the tele visit, the doctor diagnosed my symptoms as vertigo. I never had vertigo in the past. She couldn't tell me if it was from the vaccine or not. She did mention she had patients complaining of vertigo after getting the covid vaccine. Medication and exercises were given to me. A few days later, my big toe on my right foot was aching terribly. Each day it seems to be worse and I am at the point where I can barely walk. Today I did some research online and saw that it could be gout. I never had gout n the past. I read vaccines can cause gout. So here I am 2 weeks since my symptoms began and I am still dizzy and have the toe pain. Exercises and medication is not helping.

About 2 minutes after vaccine injection patient became pale, hands became cold and purplish. Patient's head leaned to the left side, started slurring and became unconcious while his eyes were open. I tried to get the patient's attention but saying "hello, are you still with me?" loudly and he did not respond. His eyes were still open at the time. At that point I yelled for help and other colleagues were calling "911" immediately. Based on store protocol and knolwedge of CPR and CDC guidlines, I checked for pulse and respiration - did not have any. I grabbed epinephrine injection 0.3 mg and injected him on left thigh. He immediately gasped for air, then started to faint again. His face color turned pale. At this point he is still sitting upright and EMT has arrived. His blood pressure was lower than normal based on EMT report. I called the patient on 5/12/21 (one day post-event) and patient reported no adverse reaction from vaccine site, he also reported taking 1.5 hours nap. The injection site on epineprhine injection was somewhat painful.

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

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

PATEINT RECEIVED THE VACCINATION ON 5/21/2021 AT 1330 HOURS. BY 5/22/2021 HE HAS REPORTED THAT HE HAS DEVELOPED PERIPHERAL NEUROPATHY IN BOTH OF HIS HANDS THAT HAS PROGRESSIVELY GOTTEN WORSE OVER THE LAST 6 DAYS. TODAY HIS HANDS HURT SO BAD THAT HE CAN HARDLE ZIP UP HIS PANTS AND CANNOT LIFT MOST OPTIONS. ANYTHING THAT PUTS ANY PRESSURE ON HIS FINGERS OR HANDS CAUSES PAIN. AT THIS TIME, I AM GOING TO CONTACT HIS PHYSICIAN TO SEE IF INCREASING HIS GABAPENTIN WILL BE OF ANY BENEFIT AND IN THE MEANTIME WE ARE STARTING SCHEDULED APAP 1000 MG QID AND NAPROXEN 440 PO BID-TID UNTIL A PHYSICIAN CONSULT CAN BE MADE. CONDITION DOES NOT APPEAR TO BE LIFE THREATENING AT THIS TIME, HOWEVER THE PATIENT IS EXTREMELY DISABLED AT THIS POIN AS USE OF EITHER HAND FOR COMPLETION OF DAILY ACTIVITES IS EXTEREMLY LIMITED.

About a week after the shot, I started getting redness, tenderness, discoloration, and swelling of my right arm. The discoloration began to spread and I went to the doctor on the 21st. The doctor said there was inflammation and because it was warm to the touch, was concerned about blood clots. I was sent for an ultrasound and prescribed an anti-inflammatory medication and advised to take aspirin. Everything cleared up about a week later.

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

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

Dont know if related or not-- around vaccine date noticed I was "dribbling" when drinking out of water bottle about 4-20-21-, mentioned to Doctor have been dribbling last week or 2 - look at me- told me right side of mouth not moving- thought I had stroke and told to go to e.r where they confirmed there was a stroke and I also had 30 % blockage in right carotid artery. Could also be related to ADD med( Vyvanse have been taking for last 10 years)- as med causes spike- high blood pressure.

HEARING IS BETTER/MENTAL FOCUS/VISION IS GETTING/BETTER THOUGH PROCESS; POSITIVE CHANGES; FEELING AWAKENED; TREMORS; SHOULDER AND ARM PAIN; This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. The patient's past medical history included shingles, car accident, nerve damage on the entire body, and tremor in the right side of his body. The patient was previously treated with polio vaccine for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown expiry date: UNKNOWN) dose was not reported, administered on 05-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-JUN-2021, the subject experienced tremors. On 05-JUN-2021, the subject experienced shoulder and arm pain. On 07-JUN-2021, the subject experienced hearing is better/mental focus/vision is getting/better though process. On 07-JUN-2021, the subject experienced positive changes. On 07-JUN-2021, the subject experienced feeling awakened. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from shoulder and arm pain, and tremors, and the outcome of hearing is better/mental focus/vision is getting/better though process, positive changes and feeling awakened was not reported. This report was non-serious.

Acute Ischemic Multifocal Posterior Circulation strokes resulting in L sided weakness, L facial droop and dysphagia. Hospital course complicated by respiratory failure. Patient had placement of tracheostomy en g-tube given failure to wean off the ventilator and prolonged dysphagia with poor mental status to aid in swallowing

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.

Numbness and tingling in two fingers of right hand and minor tingling in other areas. I was working on installing flooring and i associated the tingling with the work I was doing and didn't think anything of it as it seems minor but has not gone away since May etc. It doesn't seem to be getting worse but it's constant numbness in the tips of both fingers.

Tingling feeling in hands and feet that started 3 months after vaccine was administered. Tingling has subsided in feet after 2nd week. I now only have slight numbness in both my thumbs.

Patient states that he was at the Janssen COVID-19 Clinic on 3/13/21 hosted by Pharmacy and received his single dose of the vaccine. Two weeks later, he noticed leg pain and numbness in both arms. He went to the hospital and then to see his regular practitioner with no answers. Patient is convinced that these symptoms are due to the vaccine and would like some answers.

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.

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

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

Redness and mild inflammation 3/29-CSPI f/u: Caller states that his arm is still painful and red. He does OT 3 times a week and does arm exercises. ]ADvised: This is a common effect. Put ice packs and exercise your arm (move it around).

ITCHING; BURNING; RASH; This spontaneous report received from a patient concerned a 66 year old male. The patient's weight was 165 kilograms, and height was not reported. The patient's concurrent conditions included hypertension, thyroid, remission from multiple myeloma, and penicillin allergy. 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 23-MAR-2021 for prophylactic vaccination on right arm. No concomitant medications were reported. On MAR-2021, treatment medications included: diphenhydramine hydrochloride. On 25-MAR-2021, the subject experienced itching. On 25-MAR-2021, the subject experienced burning. On 25-MAR-2021, the subject experienced rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash, itching, and burning. This report was non-serious.

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

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

7 days after receiving J&J COVID19 vaccine, patient developed left ear pain, left sided facial numbness/droop, vertigo. Pt was seen in clinic and physician diagnosed pt with Left Bells Palsy. Prescribed 12 day prednisone course. Pt on Day 3 of steroid course today and slowly feeling better.

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

numbness in right foot, pain and numbness in right leg below the knee. Immediately had ultrasound of leg to confirm no blood clots. Then saw neurologist and orthopedic doctors. They suspect common neuropothy. Started taking 30 days of 15mg Miloxacin and started PT. MRIs of back and leg to be done 4/15. Nerve function test to be done on May 20. No change after 4-5 days.

Pain increased in left calf, clot found in left calf at medical center, rushed to different medical center, 6-1/2 hour surgery to remove clot in lower left leg. 100% blocked. Hospital diagnosis found left leg ischemia (199.8). Procedures performed, popliteal artery patch repair, Angiogram, fasciotomy calf.

Numbness on right side of face , numb tongue, water build up in ears, right nostril closed up right side of face sags and eye will not close can?t blink. Diagnosis Bell?s palsy nad viral infection

On 4/16 at around 10:24AM, patient presented to emergency department via EMS status post a witnessed cardiac arrest. After the witnessed cardiac arrest, EMS was called and reported that the patient was unresponsive. Per EMS, patient was immediately intubated and chest compressions started. EMS reports an initial cardiac rhythm of VFib and shocked patient once. Patient was given 3 epinephrine and brought into the ED. After prolonged CPR and resuscitation for more than hour and a half, the patient was made DNR/DNI and was pronounced dead at 11:45AM.

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

Client fell while waiting in line to enter the POD. Client states that he got hot while waiting in line a long time. Client states that he does not think he lost consciousness but may have hit his head. 911 was called, EMS evaluated client and found him medically stable and client declined to go to the hospital. Client received Johnson and Johnson vaccine and left on his own after 30 minutes waiting time after vaccine.

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

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.

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.

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

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

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

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

Patient experienced dizziness about 40 minutes after dose. Then significant arm swelling at injection site, patient described as "a deltoid on top of his deltoid" started by the same evening. Pain subsequently occurred described as severe that radiated into shoulder and all the way down the patient's arm that also felt like burning. The patient is still experiencing this 15 days later, although admitting it is finally starting to improve. Patient admitted to not being able to do much for the first 1-2 weeks and requiring opioid pain medication relieve the pain enough to sleep at all. Patient contacted primary care as well as drug manufacturer, Janssen.

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.

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

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

That day, light headed ness and heart palpitations. Heart palpitations for short time only but felt periodically over the next few days. June 11, lower left led swelled and painful and shortness of breath. June 14, went to ER. They found multiple blood clots in upper thigh, behind knee and lower left leg. They also found approximately 20 clots in the lungs and administered Heparin drip and I was impatient. They put me on Eliquis and released me the next day. Now convalescing at my daughter?s house. Diagnosis. Acute Deep Vein Thromboses and Pulmonary Embolism bilateral.

Patient is a 66 year old male with diabetes and a recent history of stent placement on who received a dose of Johnson & Johnson COVID vaccine today (6/29/21). He also has a history of rash with soma. He was doing okay and talking to the nurse for 10 minutes post vaccine when he became unresponsive mid-sentence. After 1-2 minutes, he started to respond again, and noted that he felt his throat momentarily closed. However, sensation gradually improved. No nausea, vomiting, weakness on one side. After 20 more minutes of waiting, he reports his throat sensation has returned to normal.

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.

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.

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

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.

Patient complaining of shooting , neuropathic type pain from top of head radiating down. Patient complaining of increased saliva production, difficulty swallowing.

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

ON AND OFF SHAKING HANDS; This spontaneous report received from a consumer concerned a 66 year old male. The patient's weight was 208 pounds, and height was 173 centimeters. The patient's past medical history included heart stent placement surgery, and concurrent conditions included high blood pressure, and cholesterol. 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 30-APR-2021 for prophylactic vaccination. Concomitant medications included clopidogrel bisulfate for cholesterol. On 07-MAY-2021, the subject experienced on and off shaking hands. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from on and off shaking hands. This report was non-serious.

sudden flushing of upper body starting around 4PM 3/6/21 - about 50 hrs post-dose - took Benadryl 50mg seemed to diminish some 30-40 minutes later - itch gone, still minor redness on upper chest, shoulders and face

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

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

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

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

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

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

Per history, patient experienced a ground-level fall early 4/16, and was noted to have weakness on his left side. Patient was brought to the ER 4/18 with concern for CVA, found to have acute pulmonary embolism.

DIZZINESS; FEELING HIGH; WEAKNESS; This spontaneous report received from a patient concerned a 67 year old male. The patient's weight was 167 pounds, and height was not reported. The patient's past medical history included blood clots, and concurrent conditions included flu shot and weed smoker. 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 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced dizziness. On 09-APR-2021, the subject experienced feeling high. On 09-APR-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, and weakness, and the outcome of feeling high was not reported. This report was non-serious.

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

Numbness Tremor in hands 1 to 5 times daily contacted PCP spoke with nurse and was told that she hadn't heard of this reaction to the vaccine, and we could come in and talk with the Dr. but no other recommendations.

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

Patient and wife stated that he has had many vasovagal syncope events when he has had vaccines administered, both more recently, and in the past. The patient was seated in a chair with arms. Within a couple of minutes of administering the vaccine, his eyes rolled back in his head, he broke out in a cold sweat, BP was 75/55, pulse 55. He never stopped breathing (was snoring); epinephrine for an anaphylactic reaction was not indicated. I offered to call 911 multiple times but his wife said this was the normal course of his reaction and held an icepack on his neck for the duration. After 5-10 minutes the patient was once again responsive. He sat for an additional 10 minutes and then said he was ready to leave. His wife walked him out of the store.

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

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

Hypoxia readmission 1 hour after discharge from initial admission for seizure, hyperglycemia, and trach procedure

Brief HPI and Hospital Course: 67 year old male with unknown past medical history was brought in by EMS as post-cardiac arrest. Patient was found on unresponsive on sidewalk, possible collapse. ACLS started by EMS, approx 10-15 minutes. Initial rhythm was junctional PEA. Was given 2 epi and intubated by EMS and had ROSC, Initial ROSC rhythm was SVT which slowed to 90s on its own. On arrival to ED, left femoral central line placed. Tox screen was positive for cocaine and ETOH. Was placed on ACS protocol for possible NSTEMI. Tested positive for COVID19 on admission. Patient required pressor support on admission. Hypothermia protocol was initiated. Patient was rewarmed per protocol, normothermic as of 5/5. Brief Narrative of Events leading to Patient's Death: Patient remained normothermic with persistent septic shock, multi organ failure, ARDS secondary to COVID19. Multiple attempts to reach family members made by ICU team and palliative care team daily without answer. Patient made DNR by two-physician consent. Patient's BP low despite maximum levophed support.

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.

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

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

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

patient died. right side of patients face (eye, nose, mouth) were drooped, right hand was drawled up.

I am a retired physician who has done injections in my practice. My injection was in the wrong site, either sub- periosteal or in the shoulder joint. After the initial severe pain, my arm ached for about 5 days but not like a typical vaccination. I was concerned about not having an appropriate immune response because of the lack of vascular in the site of the misplaced vaccine dose. My primary doctor sent me to an immunologist. We waited for over 4 weeks after the vaccination and I had a semi-quantitative spike antibody test at lab which came back as no measurable antibodies. Dr. recommended a second vaccination and I had the Pfizer vaccine (lots EW0170 and EW0183 on 4/18/21 and 5/9/21. I am scheduled to have a follow up spike semi-quantitative antibody test on on 6/22/21. Also of interest is that my wife also got the J&J vaccine and had no spike antibodies over 6 weeks after her vaccine on 2 different occasions.

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.

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

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.

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.

About 24 hours after the vaccine administration, he became unresponsive at the nursing home. He was sent to the hospital where he is now on a heparin drip due to bilateral Pulmonary Embolisms and multiple DVTs.

Patient had received his vaccination and was waiting for 15 minutes. Patient was shopping in pharmacy area and began to feel warm, flush, and light headed. Patient laid himself down and this was noticed by an associate. Code white was announced and 911 called. Pt was responsive and pharmacist applied cold compress to pt. EMS arrived and took over. Pt seemed fine after a few minutes of EMS arriving. Pt did state during the event that this has happened to him before in the past.

Patient was unresponsive initially, slow breathing , pallid color, called 911, patient came too and felt nauseous and needed to use the bathroom, Paramedics check him out and he left with his wife (did not go to the hospital)

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

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

Woke up with swelling in both hands. Right more pronounced. Slight nerve tingling in left hand and wrist. Pronounced tingling in right hand and wrist. Over the next two days the left stayed the same while the right continued to worsen to include pain and tingling from the elbow to the hand particularly in the three central fingers. Hand difficulty holding item in my right hand. I then decided to seek medical attention the next day. The next morning swelling and pain were lessened so I did not contact medical attention. Each day since symptoms have improved except for discomfort in my right middle finger which is noticeable upon touch. Most noticeable when using eating utensils. The right middle finger has remained the same for days.

On March 1st, I had a sonogram of the veins in both of my legs and nothing was found, on March 5th I received the COVID-19 vaccine after standing in line for 2&1/2 hours. By March 8th the swelling and pain in my left leg was so bad I made an appointment with Dr. for March 11th. He ordered another sonogram and found 2 DVTs in my left leg, and prescribed anti-coagulants whyich I am still on. At the time the Doctor said that this was most likly a result of having stood in line for 2&1/2 hours.

SUDDEN ONSET OF SWELLING IN ENTIRE LEFT LOWER EXTREMITY ON APRIL 11, 2021. NO RECENT TRAUMA , CHANGE IN AMBULATORY STATUS OR CHANGE IN HYDRATION OR ORAL INTAKE.

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

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

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

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

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

"Janssen COVID-19 Vaccine EUA" 3/18 twitching of foot...severe leg pain 7:45 PM 3/19 involved in a motor vehicle accident with cardiac arrest and a dissecting aortic aneurysm 12;45 PM

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

Patient's body was found on May 1st. Since the shot , he was complaining of tinnitus, sore legs, dizziness (passed our several times), loss of bowel control, and unable to maintain a stream of thought, which are stroke symptoms. He has had surgery for blood clots in the past. He seemed to get worse in the weeks following the Jansen shot.

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

On 03/14 I woke at 8:15 am and I was having a really bad dizzy spell and I had something like this before it was called bppv ( bengen paroxysmal positional vertigo) but i never had it as intense as it was when i woke up it was beyond anything that i have had in the past and I thought it was that I went on Friday 3/19 to another doctor that specialized in the Epley maneuver and that helped so much but then I had it again on 03/23 and I went back and they did the same thing Epley maneuver 04/02 I went to go see an ent and go to get my ears check she also did Epley maneuver an and nothing happen she turned my head and I had a bad episode of vertigo. and it was worse then it was the first time My blood pressure went up to 190/100 my pulse was at 100 broke out in a cold sweat she called 911 they took me to general hosptial. They did the and nothing came from it. They gave me volume but I only took one pill and it didn't do much for me. They sent me home I called Dr and they person on duty said that they can do a cat scan i said not they told me to go to emergency room right now I had a cat scan nothing came up they put in a ambulance and took me to another hospital so that i could an MRI which 10:30am, everything came back normal from that. So then my regular doctor told me to see my cardiologist to make sure it was not a heart problem last Tuesday i had a nuclear stress and echo cardiogram that came back to show that the dizziness is not from the heart or a blood flow problem

Arm was so sore could not use for about 10 days. Improving but 3 weeks later my bicep is still very sore

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.

Systemic: Numbness on right arm-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: Patient says received Johnson covid shot 4/29/21 on left arm then on 5/25/21 his right arm felt numb.

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

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.

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

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

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.

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

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

Patient. Experienced 2 seizures laying 15 seconds each. Patient has no medical history or taking any medical medications.

3/17 vaccination Later that evening, I got little sleep, tossing and turning. The next day I was achy, arm hurt. That night I noticed loud ringing R ear; screeching noise. As the days went on, it calmed down but there 24 hours a day. I waiting 4-5 days and then saw PCM. No infection, no blockage. Referred to ENT; hearing test. Hearing test came was fine, ears look good. No cure for Tinnitus. I did go buy a white noise machine to help sleeping at night. It is there 24 hours a day.

PT had no reactions post administration. About 36 hours after administration, the patient had a CVA. Pt experienced numbness in his left arm and shortly after proceed to have slurred speech and loss of balance and gait. Patient take to Emergency Room where he received the diagnosis. the patient was hospitalized. After several days, patient was discharge and was recovering.

- 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 March 18, 2021 ( the day following my J&J vaccination ), While on my way back from a 2 mile run , I experienced left-sided listing and lack of control of my left leg and arm. I was dizzy and saw black spots. My wife and son took me to emergency room. My symptoms abated while at the hospital. Hospital staff conducted many tests and I was kept overnight and discharged the next day around 5:00 p.m. with possible TIA as diagnosis.

PATIENT PRESENTED TO CLINIC FOR ANNUAL WELLNESS VISIT ON 4/12/2021 AND RECEIVED THE JANSSEN COVID-19 VACCINE FOLLOWING HIS VISIT. ON 4/14/2021 PATIENT CALLED EMS FOR C/O CHEST TIGHTNESS. DISCOMFORT HAD RESOLVED BY THE TIME EMS ARRIVED. PATIENT WAS TAKEN TO ER FOR FURTHER EVALUATION. PATIENT REMIANED FREE OF CHEST TIGHTNESS/DISCOMFORT THROUGHOUT THE VISIT AND CARDIAC WORK-UP AT THE ER WAS ESSENTIALLY NORMAL. PATIENT WAS DISCHARGED HOME WITH F/U INSTRUCTIONS. ON 4/15/21 RN RECEIVED A CALL FROM THE COUNTY MEDICAL EXAMINER STATING THAT PATIENT WAS FOUND DECEASED IN HIS DRIVEWAY THIS MORNING AT AROUND 09:41 AM. THERE WERE NO SIGNS OF FOUL PLAY AT THE SCENE. PATIENT'S RECENT PHYSICAL AND LAB WORK WITH HIS PROVIDER ON 4/12/2021 SHOWED NO FINDINGS OF CONCERN. PATIENT HAD NO CHRONIC ILLNESSES, WAS ACTIVE, AND OFFERED NO MEDICAL CONCERNS AT HIS VISIT ON 4/12/2021.

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

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

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.

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

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

PARKINSON SYMPTOMS WORSENED; EXCRUCIATINGLY PAINFUL PRESSURE POINT IN THE WRIST/HAND; NUMBNESS LEFT ARM TO A POINT IN WRIST AND FINGERS; SORENESS IN LEFT ARM TO A POINT IN WRIST AND FINGERS; 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 concurrent conditions included parkinson's disease affecting left arm and hand, alcohol use, seasonal sinus problems, and non smoker, and other pre-existing medical conditions included the patient had 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: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the patient experienced parkinson's symptoms worsened, excruciatingly painful pressure point in the wrist/hand, balance loss, numbness left arm to a point in wrist and fingers, muscle tightness in neck, intensified shaking of left arm and soreness in left arm to a point in wrist and fingers. The patient had not visited his physician but consulted a chiropractor. Chiropractor was unable to do anything with his neck to do improve movements. On an unknown date in APR-2021, the patient experienced balance loss over the last 4 to 5 days. On 13-Apr-2021, by the third visit to the chiropractor, the patient had some relief as chiropractor could do some movements. The patient would try to visit the physician next week. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from parkinson's symptoms worsened, excruciatingly painful pressure point in the wrist/hand, numbness left arm to a point in wrist and fingers, and soreness in left arm to a point in wrist and fingers. This report was serious (Other Medically Important Condition, and Disability Or Permanent Damage).; Sender's Comments: V0: 20210428449-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Parkinson symptoms worsened. 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.

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

Slight bruising , swelling, and pain on back of hand of vaccinated arm upon waking up. Patient also reports generalized aches and pains that he did not have prior to vaccination.

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

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

Patient describes frequent bouts of diarrhea with associated weakness and lightheadedness, symptoms started 05/08/21, he had received the Jand J vaccine 05/05/21

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.

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

DIZZINESS; LACK OF ENERGY; This spontaneous report received from a patient 69-year-old male white not Hispanic or white patient. The patient's height, and weight were not reported. The patient's concurrent conditions included abstains from alcohol, nonsmoker, coronary artery disease (takes blood pressure meds, cholesterol meds, and OTC glucosamine/supplements), penicillin allergy, scallops allergy, and contrast media allergy. The patient had no known drug allergies and no drug abuse/illicit drug use. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: 21-JUN-2021) dose 1 total administered on 20-MAY-2021 for prophylactic vaccination. Concomitant medications included glucosamine for coronary artery disease. On 29-MAY-2021, he woke up with dizziness, light-headedness, and low energy. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from dizziness, and lack of energy. 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.

Patient began to experience tingling and numbness in the left arm and 3 left fingers (thumb, pointer and middle fingers) approximately 1 week after receiving the J&J Covid vaccine and has become very concerning as these symptoms continue to persist.

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

Left side of face would go numb from top of head to chin. Left side of face drooping Left eye swollen, watery, blurry Left eye ball quivers when having an attack of the above

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

Muscle cramps in hands and legs, severe pain, unable to walk, unable to move around. Went to doctor. Doctor has scheduled test, but currently no test have been done.

Migraine Auras (lightning bolt). Although I would get 1 or 2 a year, since the vaccine I have had at least 1 every 2 weeks.

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.

Similar pain in opposite (right) arm lasting from day AFTER injection through today (2 days after). Remains at similar intensity, which is decreasing as expected. NOT SEVERE PAIN IN EITHER ARM..

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

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

Patient reported a rash that started on 4/12/2021. Rash is pinpoint, flat, red dots. Rash started on inner thighs and has now spread to navel and chest area. Rash is burning and itching. Patient has reported that he was mowing the lawn on 4/12 and thinks he saw poison ivy. Patient has not tried any treatment for his rash.

I experienced a mini-stroke (TIA) in which my speech was affected and which resulted in me being hospitalized. For about 5 minutes, I was unable to find words and properly communicate. I went to the ER and was admitted and had a battery of tests, kept overnight, and discharged the following day My statin dose was increased, and I was put on a baby aspirin, in addition to Pradaxa blood thinner. i believe that I may have had a vascular thrombi related to the effect of the medicine/spike protein.

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

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

Right lower leg sudden onset severe swelling, pain, redness. Went to urgent care doctor who then performed assessment, blood work and ultrasound. Placed on Xarelto 15mg twice daily for 21 days.

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

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

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.

arm sore for 1 week. still some residual pain. might be coincidence but i have broken out in rash, itch, burning sensation ( fells like sunburn) 4 times since shot. episodes last about an hour.

om 5/8/21 at 9:00 PM, felt light headed, stepped outside for air, returned to closest chair, calling to significant other, I feel dizzy. Sat in chair, staring blankly, not responding to calling, or physical touch. breathing shallow, facial and lip color pale, pasty white gray. weak pulse. 911 called, and responded 8-9 minutes later. By the time they arrived, patient had aroused and aware of his surroundings,. Although color was slow on returning to normal. EMS arrived, BP 120/80. Patient refused to go to ER . On 5/10/21 at 2:00am, patient woke up and had a nosebleed lasting 2 hours, pouring from nose. 911 called and transported to medical center for cauterization, nasal packing and observation. 5/11/21 developed a reddened rash on right hand, lasted 5 days. Nasal packing removed on 5/13/21. No further complaints at this time.

Patient developed a rash and bumps on his arms and reported a burning sensation in his feet. He saw his primary care doctor, and they referred him to dermatology. He will be following up with them in June or July.

RIGHT LEG DEEP VEIN THROMBOSIS; RIGHT ARM PAIN; PULMONARY EMBOLISM; 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, alcohol user, non smoker, tree allergy, onion allergy, topical iodine cleanser allergy, and weeds allergy, and patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070 and expiry: UNKNOWN) dose was not reported, 1 total administered on 19-MAR-2021 on left arm for prophylactic vaccination. Concomitant medications included amlodipine, atorvastatin, cetirizine, fluticasone, levothyroxine and omeprazole used for unknown indication. On 05-APR-2021, the patient experienced chest pain, shortness of breath, extreme shortness on upper back, right arm pain, right rib cage pain. On 19-APR-2011 patient was travelling, took a bus, when patient arrived, symptoms were so severe that patient could not pick up the luggage. Patient arrived around 5:30pm to his destination and was taken to the ER (emergency room). Patient had x-rays and an MRI done, and was admitted to hospital. Patient was discharged on 24-APR-2021 (hospitalized for 5 days) with diagnosis of acute pulmonary embolism, Shortness of breath, right leg deep vein thrombosis, pain in chest, elevated troponins. Patient was prescribed Eliquis during this admission and patient was currently taking it. On 11-JUN-2021 Patient went to the hospital out of town and was admitted. Patient had chest pain and right arm pain, and right side rib pain. Patient was discharged on 12-JUN-2021 and diagnosed with pulmonary embolism. Patient stated that the chest has improved since starting to take Eliquis, but still feels pressure on the right side of rib cage and felt has not fully recovered yet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from right arm pain, and had not recovered from pulmonary embolism, and right leg deep vein thrombosis. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210629366-COVID-19 VACCINE AD26.COV2.S- Pulmonary embolism, right leg deep vein thrombosis, right arm pain. 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. 20210629366-COVID-19 VACCINE AD26.COV2.S- right arm pain. This event is labeled per RSI and is therefore considered potentially related.

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 has noticed a sudden onset of numbness and tingly sensations that began on this right thigh. Over the past week these symptoms have become more spread out.

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

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

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

FELT A LITTLE WEIRD; LITTLE TROUBLE FALLING ASLEEP; FELT SLIGHT WEAK; SORE AT THE SIGHT OF THE NEEDLE STICK; This spontaneous report received from a patient concerned a 71 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: 25-MAY-2021) dose was not reported, administered on 15-MAR-2021 14:00 to right arm for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced felt a little weird. On 15-MAR-2021, the subject experienced little trouble falling asleep. On 15-MAR-2021, the subject experienced felt slight weak. On 15-MAR-2021, the subject experienced sore at the sight of the needle stick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt a little weird, little trouble falling asleep, felt slight weak, and sore at the sight of the needle stick on 16-MAR-2021. This report was non-serious.

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

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

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

On 5/3/2021 was found to be unresponsive with low BP and slow heart rate. 911 was initiated and CPR started. Resident was admitted to Hospital with diagnosis of respiratory failure

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

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

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

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 NOTIFIED PHARMACY OF SORE ARM EVEN AFTER A MONTH OF VACCINATION. PATIENT STATED PAIN IN GETTING BETTER BUT NOT COMPLETELY GONE. NO REDNESS OR RASH IN THE INJECTION SITE.

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.

unilateral Right sided muscular spasms in both upper and lower extremities; onset 1 day after injection

Woke up the morning of 04/22/2021 unable to control the right side of my face. Fearing it was a result of stroke I went to the emergency room at hospital. I was examined by a neurologist who determined that it was Bell?s Polsy. I was admitted overnight for observation and discharged the following day. The symptoms continue to exist today. I?m reporting it now after reading news reports that Johnson and Johnson might cause Bell?s Polsy.

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

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

Patient had a seizure in the middle of the night on Sunday. Wife called 911 and patient was transported to ER where he stayed for observation and then prescribed seizure medication. Patient has no history of seizures.

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.

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.

Per res. being taken to surgery for a perforated diverticulum. ICU, resident had made it through surgery, resident is off the vent, not really responsive at this time and will be keeping a close eye on him.

Patient recived Janssen COVID vaccine at alternate site, came to ED with complaints of pain and rash starting in same arm and spreading. Diagnosed with Shingles

unusual post vaccine discomfort that progressively worsened, a deep ache feeling Given Ultram , Keflex, Medrol dosepak, oxycodone, physical therapy

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

INJECTION SITE PAIN; ARM PAIN; This spontaneous report received from a consumer concerned a 72 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced arm pain. On 11-APR-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site pain, and arm pain. This report was non-serious.

NUMBNESS; TINGLING; This spontaneous report received from a patient concerned a 72 year old male. The patient's weight, height and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A and expiry: 23-JUN-2021) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced numbness. On APR-2021, the subject experienced tingling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the numbness and tingling was not reported. This report was non-serious. This case, from the same reporter is linked to.

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.

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.

feet got sore, became painful icy hot eased pain but it returned pain worsened felt like needle stabbing feet swollen feet

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

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.

I ;began having numbness in my legs, thighs, and everything below my waist. It felt like something had hold of my bones in these areas, and began twisting them. As the pain worsened, it was if someone had taken all the nerves in the lower part of my body and folded them over, in half, and then began twisting them ever so tight

Started shaking inside my body 8 hours after the shot plus a fever of 100. Shaking then turned violent on outside of my body. Took 2 Motrin (225) each. Shaking stopped after 30 minutes, fever disappeared overnight.

Thursday, March 11, 2021 (approximately 8:30 am) Patient experienced blurred vision, unbalance, and slurred speech and had an irregular heartbeat. March 11, 2021 (approximately 11:30 am) Patient was admitted to Hospital administered CT scan, MRI and multiple blood tests. Diagnosis - Ischemic Stroke

My husband is still in hospital trying to recover. He had bad headaches that then led to seizures and confusion ,blood clots, and has been hospitalized since. He's literally fighting for his life and tomorrow Wednesday April 14 th he will be transferred to a rehabilitation center.

Patient presented to the hospital with left leg pain and swelling in the groin region as well as fever. Xrays were performed and blood clotting was diagnosed. Symptoms started around 4/5/2019, but he did not seek immediate treatment until the condition worsened. This is a new diagnosis. Upon discharge he was prescribed both Ciprofloxacin and Eliquis

Patient presented to emergency room 21 days (03/26/2021) following Janssen COVID vaccine with one day history of increased left leg pain and swelling. At that time patient was diagnosed with DVT of left lower extremity. He was started on Xarelto for anticoagulation and has followed up in clinic multiple times.

Received shot in left arm. About one hour after receiving the shot, I started getting very severe pain in my upper right arm that slowly spread to the right side of my neck. My right ear began to feel slightly funny, but no pain. Was going to the hospital but the all the pain went away after about 15 to 20 minutes. No problems after that so I didn't go to the hospital. I did not take any medication.

DIARRHEA; INCREASED PULSE; WEAKNESS; 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 blood in brain, and concurrent conditions included headaches. 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. Concomitant medications included paracetamol for headaches. On 12-APR-2021, the subject experienced increased pulse. On 12-APR-2021, the subject experienced weakness. Laboratory data included: Pulse rate (NR: not provided) 110 (units unspecified). On 14-APR-2021, the subject experienced diarrhea. On 15-APR-2021 05:36, Laboratory data included: Pulse rate (NR: not provided) 87 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from increased pulse, and had not recovered from weakness, and diarrhea. This report was non-serious.

Patient felt L sided weakness and couldn't stand up, had some slurred speech-admitted to PHC 4/26/21 At hospital-EKG- within normal limits, PTT elevated not a TPA candidate, CT of head unremarkable, no acute intercranial findings, unremarkable Circle of Willis and MRI of brain -pending.

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.

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.

SLEEPINESS; SORE ARM; TIREDNESS; This spontaneous report received from a patient concerned a 73 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: 13-JUN-2021) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced sore arm. On 24-MAR-2021, the subject experienced sleepiness. On 24-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, sleepiness, and tiredness on MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210619315, 20210619408 and 20210619407.

On 4/11 i got vaccinted vaccine Johnson & Johnson on Left Arm, on 4/19 I feel my left leg muscle pain from my left sholder to my feetand feel very tied weak body sometime my leg cramp and spasm, until May 18 went to see doctor, did ultra sound and xray on my left leg to to check for blood clut, everything negative, only at my knee have mild osteoarthrosis on 5/26 my left foot swalow and on June 9my right foot start pain cannot step on the floor, then start take 5 advil next day morning right foot pain it no more until now i still have a my muscle pain have to take Advil for pain killer

Father received vaccine on May 13, 2021. Complained of migraine headaches, feeling tired, and generally unwell. Migraines became more persistent. Father died on June 16, 2021 at home. Coughed up blood and vomited around time of death.

73 year old male, vaccinated with the Janssen Covid-19 vaccine at the time of hospital admission (5/31/21) for a type 3 odontoid fracture; C2 vertebral body fracture extending into bilateral transverse foramina and nasal bone fracture from a fall from standing. Admitted to the trauma service for pain control. Noted to be somnolent throughout admission. On 6/2, developed AKI, likely related to dehydration vs. contrast nephropathy. On the early morning of 6/3, found unresponsive. Given naloxone 0.02 mg x 3 with no documented response. Transferred to the ICU, intubated and had PEA arrest on induction for intubation. CPR was initiated and he received epi x 1 with ROSC within 3 minutes. Remained intubated and sedated in the ICU with labile pressures on 2 pressors throughout the day on 6/3. The patient expired following compassionate extubation 6/3 2211.

This spontaneous report received from a physician concerned a 73 year old male. The patient's height, and weight were not reported. The patient's past medical history included anaphylactic shock (black widow bite), and concurrent conditions included allergy to scallops, and allergy to insect bite. The patient had no allergies to medication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported,1 total, administered on 18-MAY-2021 10:00 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 18-MAY-2021, the patient felt some redness, irritation, warmth and soreness at injection site for about an hour afterwards and also experienced a brief fever from 18:00 on the day of vaccination which disappeared by the next morning. The patient also had some intestinal flu symptoms, muscle cramps and triple urinary output for about 72 hours post vaccination and he mentioned that the muscle cramps started around injection site and moved gradually down until it reached his lower extremities. Patient also experienced narcolepsy and said that the episodes would last either 90 minutes or 3 hours and would happen periodically for about 60 hours post vaccination and patient also said narcolepsy episodes would show up without any warning. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from narcolepsy, muscle cramps started around injection site and moved gradually down to lower extremities, intestinal flu symptoms, and triple urinary output on 21-MAY-2021, injection site irritation, injection site warmth, injection site soreness, and injection site redness on 18-MAY-2021, and fever on 19-MAY-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210708286-covid-19 vaccine ad26.cov2.s-narcolepsy. 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).

Two weeks to the day, high fever up to 103.5 for a week; tired slept for about a week, shaky, no appetite. Could barely function.

MACULAR DEGENERATION; CATARACT IN RIGHT EYE; SORENESS LEFT ARM; This spontaneous report received from a patient concerned a 73 year old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, and other pre-existing medical conditions included no drugs abuse, no heart condition, no lung condition and had good vitals. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: 05-AUG-2021) dose was not reported with frequency of 1 total dose administered at left arm on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, since vaccination, patient had experienced soreness in the arm (difficulty to put his left arm behind his back) and his vision began to slowly degrade. On an unspecified date, two weeks ago, his vision became so blurry that he literally couldn't see, patient was very concerned that he might become completely blind. Patient vision was degrading and the blurriness was worsening. Patient still experienced pain in his left arm. On 30-JUN-2021, patient went to the eye doctor, they examined him and concluded to a macular degeneration (prescribed high volume of vitamin C (ascorbic acid) and A (colecalciferol/retinol), caller was unsure if the treatment was helping or not) and to a cataract in his right eye. Physician also said that no corrective lenses were going to fix it and that patient might need Lasix surgery. Severity of eye on a scale of 20 (perfect vision) and 0 (blind) showed before left eye: 19/20 and right eye: 17/20 and now left eye : 4-5-6/20 and right eye : 3/20. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness left arm, macular degeneration/vision became so blurry that he literally couldn't see, and cataract in right eye. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210728718-covid-19 vaccine ad26.cov2.s-Macular degeneration,Cataract right eye.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).

CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; SORE ARM; This spontaneous report received from a consumer concerned a 73 year old male. The patient's height and weight were not reported. The patient's concurrent conditions included diabetes and difficulty hearing. Patient had no known allergies. 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 18-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the patient experienced sore arm. Patient had sore arm for a day. On an unspecified date (two weeks ago), doctor gave patient a blood test to determine if patient had antibodies. Patient had taken an antibody test and it was negative (confirmed immunological vaccine failure). Reporter did not know the type of antibody test that patient received, just knew it was a blood test. Patient had an upcoming appointment with physician in August and would discuss this with him. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 19-MAR-2021, and the outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint 90000186487.; Sender's Comments: V0: 20210739065-Covid-19 vaccine ad26.cov2.s-Confirmed 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

Violent chills 9 hours after injection; very difficult to stand; shaking almost continuous for 60 minutes, followed by fatigue for 10 hours and fever for about 90 minutes. Tried to laugh it off as a natural reaction, but I did not find chills listed as a common side-effect.

vaccine side effect. Patient reports slurred speech, difficulty forming sentences, SOB, R arm tingling x 3 hours. Patient reports symptoms have improved but not resolved. J&J vaccine today at 1045. Denies chest pain, N/V/D, HA, vision changes. Patient is a 74 year old male who presents to ED following a 10 second episode of right arm tingling followed by a 90 minute episode of difficulty finding words. This happened tonight at 8:30pm after dinner when he was with his wife. His symptoms resolved upon arrival at the ED at 10pm. He denies any weakness, no syncope, no chest pain or shortness of breath, no new visual symptoms. He does have a history of CHF, MI in 2013 s/p stend placement, he takes Plavix. He takes a beta blocker for PVC's. He reports he had a J&J COVID shot this morning at 11am and is wondering if his symptoms are a reaction to the vaccine. He is followed closely at Ajou hospital for all his medical care.

3/27-Patient started to experience chills last night, prior to which, the patient put on a sweatshirt. During the night, the patient was experiencing tingling in both hands. Patient's chills resolved at approximately 04:00 today; patient's temperature was 99.3 degrees Fahrenheit at around 09:00-10:00 today. At 13:28 today, the patient's temperature was 98.4 degrees Fahrenheit. Patient was experiencing sluggishness a great deal yesterday, and is now only experiencing a little sleepiness/sluggishness. Patient took Tylenol to help with symptoms.

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.

My father received his shot on March 13, 2021. He drove to move home and on March 28th started having his right arm go numb but did not tell us. He asked to go the ER March 29th at 6:45am saying his chest hurt and was having a hard time breathing, this has happened before since having Covid in September. I called 911 after he became dizzy and could not walk. While at the ER suffered a massive stroke that paralyzed him from his nose down over a course of 3 days. His brain stem was affected and he lost the ability to swallow. After being on a ventilator for 72 hours he was removed from it and died less then 30 mins later from drowning in his own saliva on April 1, 2021.

Patient admitted to hospital due to hyperkalemia; called to come to hospital based on labs from hemodialysis session a day prior- 3/21/21. Patient also complaining of bright red blood with bowel movement and weakness. Patient reports non compliance with medications and diet. Hyperkalemia treated and resolved. Evaluated by cardiology for halter monitor- will follow-up as an outpatient.

I am submitting this report because of symptom onset relative to vaccination date, and because I have not experienced this cluster of symptoms before. My wife and I received the same lot number of the J&J vaccine on Saturday, March 13. We both had slight fatigue that evening and into the following day and she has had no further symptoms. On Tuesday, March 16, I had a mild ache around injection site with no further symptoms until Saturday, March 27 when I experienced a brief episode of lightheadedness. (CONTINUED BELOW)

No pain at injection site nor abnormal symptoms that day (Friday) Next day (Saturday) had general body aches and light chills but no fever and slept all day on the couch On the second day (Sunday) felt ok again except did not sleep well the night before Monday felt agitated and could not sit still: I had to be "doing something" to feel like I wasn't going crazy, slept very poorly that night or the prior night Symptoms described above worsened each day and night up until today. I have slept very little each night and because I have to be "doing something" I am worn out by late in the day. Yesterday (Tuesday 4/20/2021) I felt a little better and slept reasonably well last night. Today I am feeling restless and agitated again but not as severe as it was earlier....

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.

13th of April. I had a blood clot in my hand. My index finger on my left hand was numb and black and blue all around the knuckle area and into my hand area. I went to my primary care - I went to the acute center there. She said the hand was cold and could see the black and blue. They put me on Plavix for 30 days and I haven't had any reoccurrence of that. I think it was the 21st, I couldn't sleep all night, I had a kidney stone - the pain was so bad I got nauseous - around my back and side and in my front. I didn't have a fever. I went to the doctor office and they checked urine - and said there was blood in the urine. I was prescribed - Tamsulosin HCL. They thought I had passed most of it by the time I got there.

Progressively worse headaches culminating in seizure, unconsciousness, and subdural hematoma requiring helicoptering to the ER and brain surgery to drain the hematoma.

After vaccine my toes got extremely sore and it was bad by midnight and felt like I wanted to lose my ten toes, on the scale of 1 - 10 the pain level was a 6 or 7. When I woke up I had a little pain in my right foot and it went away.

Patient states the day following vaccine his " Left breast swelled up, turned purple and black and was very painful" and is now only "the size of a half dollar and stopped hurting 2 days ago". This information was gathered from a Phone encounter. Patient states he did not report this or seek any medical assistance.

WEAKNESS; TIREDNESS; PAIN AT SITE OF INJECTION; 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 the patient had no known drug allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1816027, expiry: 01-JUL-2021) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced pain at site of injection. On 20-MAY-2021, the subject experienced weakness. On 20-MAY-2021, the subject experienced tiredness. The action taken with covid-19 vaccine was not applicable. The patient recovered from pain at site of injection on MAY-2021, had not recovered from weakness, and the outcome of tiredness was not reported. This report was non-serious.

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.

Blood Clot leg/broke off went to lung Blood thinner Very weak tired cough Emergency room 4/72021 hospital two days 372021-3/9/2021

STAY ASLEEP / REST LONGER; INJECTION SITE ARM PAIN; FEELING TIRED; LOSS OF ENERGY; 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 concurrent conditions included high blood pressure, and other pre-existing medical conditions included patient had no known drug allergies. patient was taking multivitamins and multivitamins for the eye. The patient was previously treated with lisinopril for high blood pressure, and amlodipine for high blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 180978 expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-JUL-2021, the subject experienced stay asleep / rest longer. On 15-JUL-2021, the subject experienced injection site arm pain. On 15-JUL-2021, the subject experienced feeling tired. On 15-JUL-2021, the subject experienced loss of energy. Treatment medications (dates unspecified) included: menthol/methyl salicylate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site arm pain on 16-JUL-2021, and the outcome of feeling tired, loss of energy and stay asleep / rest longer was not reported. This report was non-serious.

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

LEFT ARM WAS EXTREMELY SORE. BODY ACHES ALL OVER, LOW GRADE FEVER, NO APPETITE, FATIGUE FOR 24 HOURS,

client complained of hot flash lasting a few seconds after receiving Janssen Covid Vaccine (lot 1808980, Exp 6/20/21). Client informed EMTs at 1335. Vitals: blood pressure 150/90, pulse 71, oxygen 95%. Per client felt hot flash for approximately 10-15 seconds. Client alert and oriented, normal skin color. History of COPD, allergy to penicillin. Client asked to stay for further observation. Vitals 1343: blood pressure 140/80, pulse 69, oxygen 94%. Client denied feeling any symptoms, hot flash resolved. Last set of vitals at 1400: blood pressure 120/80, pulse 70, oxygen 93%. Per client felt fine, no complaints. Client left facility with steady gait.

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).

Extreme vertigo, weakness, unable to walk, extremely unbalanced when attempting to stand up, severe Headaches, blurred vision.. Also with sinus type drainage. Extreme nausea and fatigue. Literally couldnt even hold his head up. All sypmtoms started within 48 hours of injection and came on with a vengance. He was so unsteady and unstable he fell with attempts to get up. Prior to the vaccine he was great! Strong and healthy for all of his underlying medical condtions. Completely Independant, driving , working around the house ect. Unfortunaley this is still going on. He is very weak, and still unsteady when he is up. Nausea continues. He is doing Vestibular therapy for the balance issues. Took a round of seroids.

Patient seen in clinic on 04/07/21 reporting 2 weeks of right leg swelling and calf pain. Vascular ultrasound on 04/07/21 showed blood clots in legs. Lovenox injections started 04/07/21. Warfarin started 04/08/21.

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

It started with a familiar reaction and that was I had tingling and pain in my feet it started with both feet and it was significant, like when the feet goes to sleep and it is coming back and you feel the pins and needles feeling, and it was exactly what I get with CIDP. It moved from both feet up to both hands and I was not really afraid because that is what happens with CIDP when your auto immune system is stimulated. I get numbness on my feet and in my hands. I thought that the vaccine stimulated my immune system. The CIDP has been in remission and maybe the shot has stimulated my nervous system. The other day I noticed that when taking the hot plate from the microwave it was hot but I did not feel it at all. I thought the food has not heated up, when my wife touched the plate she said it was very hot and I did not feel the plate hot at all. I also felt pain in my left foot to a point that I am not ambulatory. The pain is so extreme in my left foot if I try to stand up. I have been in my bed for the last 2 days. I am not sure if it is the CIDP or GOUT that is attacking my foot but it has been triggered by the vaccine. I also have severe pain in my left leg. I called my cardiologist and I have a phone consultation with him today to check for clot formation. The pain has subsided a bit today, but yesterday the pain in my leg was very intense. I also had pain at the injection site and felt a little feverish since yesterday around 3PM and it went to 101F and this morning I am fine again. I did not take anything for it and this morning I woke up and I felt well (in regards to the fever). I did not have fever before then.

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.

3/24/2021 headache, congestion, weakness, loss of balance 5-7-2021 shortness of breath, shaky, weak

Patient received 1 dose of Janssen vaccine at pharmacy on 5/25/21. Patient visited hospital emergency department on 5/28/21 after experiencing new a syncopal episode with abdominal pain and vomiting, then acute left-sided chest and arm pain after with new atrial fibrillation diagnosis which was managed. Patient revisited same ED later on 6/1/21 for significant fatigue/weakness and diagnosed with STEMI.