Johnson & Johnson

Per telephone call from spouse, developed blister type lesions to back and shoulder, noticed following day after vaccine administered.

injection site reaction 20 days later. Pain & supposed infection per ER physician. Lack of physical signs of infection, pain really only substantial symptom.

Patient reports a large bruise on his rib cage and right arm which started approx. 1 week after vaccine.

UNABLE TO RISE UP ARM AS NORMAL; LEFT SHOULDER PAIN; INJECTION SITE SORENESS; This spontaneous report received from a patient concerned a 77 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 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAR-2021, the subject experienced unable to rise up arm as normal. On 11-MAR-2021, the subject experienced left shoulder pain. On 11-MAR-2021, the subject experienced injection site soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site soreness, left shoulder pain, and unable to rise up arm as normal. This report was non-serious.

INJECTION SITE PAIN; HEADACHE; TIREDNESS; This spontaneous report received from a patient concerned a 77 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: upadacitinib (oral, batch number: 1138391 expiry: UNKNOWN, form of admin was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported. On 11-MAR-2021, the subject experienced injection site pain. On 11-MAR-2021, the subject experienced headache. 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 injection site pain, headache, and tiredness on 11-MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210425531.

EXTREMELY TIRED; UNABLE TO STAY AWAKE; WOBBLINESS; SHORTNESS OF BREATH; PAIN AT INJECTION SITE; NOSEBLEED; LETHARGIC; This spontaneous report received from a patient concerned a 77 year male. The patient's height, and weight were not reported. The patient's concurrent conditions included Chronic obstructive pulmonary disease (COPD). The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1802070 expiry: Unknown) dose was not reported, 1 total dose, administered on 06-APR-2021 for prophylactic vaccination in left arm. No concomitant medications were reported. On 06-APR-2021 (evening), the patient experienced extremely tired and lethargic. On 07-APR-2021 (the day after), he developed nosebleeds. For a long period of time, he felt extremely tired, and he was unable to stay awake. Later, he developed wobbliness. On 17-APR-2021, he was taken to emergency room (ER) and was admitted to the hospital for couple of days. His all tests and assessments were performed which came out clear. He also experienced shortness of breath, and pain at injection site. On an unspecified date, he experienced shortness of breath, and pain at injection site. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nosebleed, had not recovered from extremely tired, wobbliness, lethargic, and unable to stay awake, and the outcome of shortness of breath and pain at injection site was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: 2021506688-Covid 19 Vaccine-Unable to stay awake, Wobbliness. 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). 2021506688-Covid 19 Vaccine-Extremely tired. This event is labeled per RSI and is therefore considered potentially related.

SINUS INFECTION; RASH STARTED ON LEFT SIDE OF CHEST, UNDER THE ARMS AND BACK; This spontaneous report received from a patient concerned a 77 year old male. The patient's weight was 250 pounds, and height was 69 inches. The patient's past medical history included prostate cancer survivor, and concurrent conditions included high cholesterol, tremor, high blood pressure, catheterized, chronic urinary tract infection, acid reflux, depression, wheezing, chest pain, erectile dysfunction, dizziness, muscle cramps, alcohol user, previous long term smoker, seasonal allergies, environmental allergies, sores on lips, sores on mouth, and seizure, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug usage (recreational drugs) and no hospitalizations in the month before his vaccination. The patient experienced bad dizziness, drug allergy and loss of balance when treated with primidone for control seizures. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. Concomitant medications included omeprazole for acid reflux, mirabegron for bladder, acetylsalicylic acid for chest pain, atorvastatin for cholesterol, potassium for cramps, sertraline for depression, meclozine for dizziness, sildenafil for erectile dysfunction, paracetamol for fever, nifedipine for high blood pressure, methenamine hippurate for prevent urinary tract infection, triamterene for prevent urinary tract infection, nitrofurantoin for prevention of urinary tract infection, lysine for sores on lips, and sores on mouth, clonazepam for tremor, budesonide/formoterol fumarate for wheezing, fluticasone propionate/salmeterol xinafoate for wheezing, tocopheryl acetate, zinc, and . On 12-MAY-2021, the subject experienced rash started on left side of chest, under the arms and back. Laboratory data included: Body temperature (NR: not provided) 96.5 F, and Pulse rate (NR: not provided) 145/50. On 30-MAY-2021, the subject experienced sinus infection. Treatment medications included: dextromethorphan hydrobromide/guaifenesin. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) high, and Cholesterol (NR: not provided) high. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sinus infection, and the outcome of rash started on left side of chest, under the arms and back 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.

This morning, patient experienced dime size rash on chest, no pain, non-pruritic rash Recommended primary provider if symptoms worsen

Patient states on Friday, 4/9, he went to the pharmacy to receive his J&J Covid-19 vaccine. He states on Saturday morning, his R nostril began to bleed, and continued to bleed until Monday. He states on Wednesday, 4/7, he noticed oral sores that at first were not painful, but large. He was worried about it interfering with his shot, but because he had waited so long to get it, he decided to proceed anyway. He denies any fever or chills, no frank diarrhea, but occasional loose stools, without blood seen. He denies HA, vision changes, or focal neuro deficits. On Sunday, 4/11, the patient ended up going to ED to evaluate his epistaxis, the MD attributed it to his elevated BP, the patient reports it being 160s/90s. They gave him new BP medications, which he took, but when he saw the Dr., he instructed the patient not to keep taking his BP meds. When asking the patient if anything correlates with foods he eats, the only thing he can pinpoint it to, would be pico de gallo. He states it has irritated his mouth before. He also reports recently taking his wife's supplement (unknown name) but thinks it is for cholesterol. He took that approximately 1 week ago. No new changes in food habits, mouthwash, or toothpaste. He states once his sores began to get a little painful, he went to buy a special mouthwash for oral sores (unsure name). His only reported allergy is to Lisinopril, which his reaction was a whole body rash. He states they did not pack his nose or do anything for his epistaxis at the ER, but eventually he let the nostril clot with blood. Now he feels fullness in the nare, but does not want to disturb the clot in fear that it will re-bleed. His wife also noticed a petechial rash that began on his BLE, he is unsure when that started. He presented to ED on 4/13, due to his PCP instructing him to be evaluated when he had outpatient labs done and revealed a PLT count of 4,000. In the ED, the patient had normal vital signs. He was transfused one unit of PLTs. He also had a negative head CT. He was also started on decadron 40mg PO daily by heme/onc. Patient tells me today his sores are less painful and feel smaller than usual. Heme/onc also ordered 2 IVIG 1,000 mg/kg/day x2 doses.

Systemic: Allergic: Rash Generalized-Medium, Additional Details: Patient called on 05/27/2021 after receiving covid-19 vaccine on 05/19/2021 to report a rash on lower back and inner thigh. Patient says it is not itchy. Patient noticed it appeared around Monday 05/24/2021.

One month after the vaccine I started to get Hot Flashes followed by pain. The pain lasted for six hours and then went away. The pain is all over my body The process returned after a week or so and it has continued intermittently since then. The cycle is always the same. I get a hot flash and then the pain starts. As time goes on it is happening more often and the pain lasts for longer. I get really hot and sweat for about 15 minutes and then the pain starts. It builds up to being a more severe pain which has been lasting up to 24 hours. It has been getting less often and for slightly shorter periods of pain. Just in the last two weeks I started to get pain at the injection site, and it is starting to affect my whole arm around the area. It is like a muscle pain. I have consulted my doctor and She prescribed Tramadol. It seems to help but over the counter medications don't seem to work.

Symtoms were first noticed on Tuesday June 8th about two oclock in the afternoon when I noticed a slight burning sensation on my right shoulder. I had presumed this to be sunburn. The next day I noticed a few blisters and additional discomfort and subsequently applied OTC lotion. As the days progressed it looked as though it was poison-ivy as opposed to sunburn. Again applied OTC medications to relieve the pain. By Monday, June 14th, the situation had progressed in severity, necessitating a visit to the emergency room. I was examened by DR. who diagnoeded the problem as 'shingles', not poison-ivy. He subsequetly dianosed taking ValACYclovir for seven-days then recommended that I follow-up with a Primary Care Provider in seven-days. The valACHclovir helped stop the spread of the problem, but did't do much to relieve the discomfort. The following Tuesday, June 22nd I met with Dr. of the Health Clinic adjacent to the hospital. After vitals were all taken, we had a question and answer session where it was determined that nothing else could be done for Me except for the shingles to 'run their course'. Retuning home I continued to administer OTC lotions and sprays to help reduce some of the burning sensations experienced around the face, ear, neck, and shoulder which was becoming more severe. After several days of not being able to sleep or get any relief from the 'burning and stinging', I decided it was necessary to get a second opinion. I then notified another hospital, that I would be arriving for an examination that afternoon, July 12th. at approximately 2pm. Upon arrival and completion of completion of all vital signs by medical staff, I was met with a doctor. Upon examination and understanding the symptoms experienced, she prescribed 'Gabapentin' to help reduce the 'burning sensations' and 'Prednisone' to help reduce the 'skin rash and swelling'. Returning home and starting the prescribed meds, I did notice some immediate relief from the Gabapentin, which for the first time in more than a week or so, I was able to get a nights sleep. I didn't notice any changes taking the prednisone and had to presume that it helped stop the spead of the rash from going further. As I prepare this overview, it is now July 18th and once again experiencing severe pain and tighening of muscles around the face, neck and shoulder. Pain feels like 'stinging needles', 'miniture electical shocks' that course thru from above the ear, down thru the face neck and over to the chin-throat' area. Pain lasts but a brief second, but very painfull, making sleep impossible. Touching any area on the right side of my body from the scalp, across the face and neck down to my shoulder, back and collar bone result in extreme 'burning sensations'. I have a 12:45 pm appointmet at the hospital on Tuesday July 20th to meet with Dr. who will become my Primary Care Provider. I can only hope that we're able to come-up with some solution that will easy the severity of the 'stinging sensations and burning' that will allow me to sleep and get beck to resuming nornal activity. Up until this event, I had been an actrive, healthy, 78yo man who had never been sick nor been to a Dr. in over 20 years, which I contribute to the clean, healthy environment here. In summary, it is my firm belief that in view of recent media reports about the Guillian-Barr symtoms which affect the nerves and muscles, it is the result of having received the Johnson&Johnson vaccine that contributed to the onset of my developing shingles. Because I had not had the Shingles vaccine at any time, it might be advisable for those that are beyond a certain age who have not had the shingles vaccine NOT get the Johnson&Johnson vaccine if other alternatives are available.

Urticaria and angioedema with nausea/vomiting 48 hours after vaccination. Symptoms persisted responded to treatment but came back 6 days later and required further treatment with steroids.

Systemic itching and hives; swelling of lips, inside of the mouth and throat. Seen at ED. Treated with IV fluids and steriods. Released to home after several hours. Physician believes it was from the vaccination and ruled out any other cause(s) for the reaction.

4/5/21 vaccinated 4/7/21 numbed face.,right side from nose to ear and from upper lip to top of scalp. painful face and scalp like a severe burn.

Patient had normal discomfort after the shot. helped family moving heavy items that day and next day and was sore afterward. no issues until two days ago when he has started having burning in the area with use of his arm. it is not happening constantly, just seldom with use of his left arm.

pt says he developed the shingles the next day after taking the vax and lost about 70% of his strength. He says he started having pain in his left knee. Has loss of appetite. He went to his PCP on 4/12/2021. His DX was Shingles. He was given antibiotics and pain pills. He back on 4/16/2021 and saw a NP that prescribed Tylenol 3 and gabapentin 100mg, diclofenac and prednisone. He was also given 2 shots and had an XRAY on knee. He has a FU appt on 5/3/21 and has not been the same since taking the vaccine.

ACHE IN LEFT ARM AND PAIN RUNNING DOWN TO LEFT ARM; SORE ARM AT INJECTION SITE; REDUCED SLEEP; This spontaneous report received from a patient via a company representative concerned a 79 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic obstructive pulmonary disease, and penicillin allergy. 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 10-JUN-2021 for prophylactic vaccination. Concomitant medications included bisacodyl, and docusate sodium. On JUL-2021, the subject experienced reduced sleep. On JUL-2021, the subject experienced sore arm at injection site. On 08-JUL-2021, the subject experienced ache in left arm and pain running down to left arm. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ache in left arm and pain running down to left arm, and sore arm at injection site, and the outcome of reduced sleep was not reported. This report was non-serious.

Mild tenderness at the site injection has persisted for five weeks. Not a constant tenderness but related to arm position and any stress applied to it.

LITTLE PAIN IN ARM; RED DOTS ON LEGS LIKE PURPURA; This spontaneous report received from a patient concerned an 80 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included cigarette smoker, and non alcoholic, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. The patient experienced drug allergy when treated with azithromycin, and clindamycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-MAY-2021, the subject experienced red dots on legs like purpura. On an unspecified date, the subject experienced little pain in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little pain in arm, and had not recovered from red dots on legs like purpura. This report was non-serious.

I developed fluid filled blisters which itched to an extreme located on my buttocks, groin, and upper legs. Painful, constant extreme itching disrupting sleeping and sitting . Had an almost three week waiut to get an appointment with my primary physician who then referred me to a skin specialst with another 4 week wait to get my appointment with him. He made a visual diagnosis of Bullous pemphigoid and took two biopsies and a blood draw. I am still waiting for results and have a June 14,, 2021 appointment to remove biopsy stitches and get his report.

patient initially devleoped joint pain, fever, chills, vomiting abd distention on 7/11/21 then on 7/14/21 awoke with diffuse maculopapular rash over entire body and came to ED.

Patient received the 1 dose J&J vaccine on 3/25/2021. Patient reports on 3/27/2021 swelling and pain and redness in LLE. Of note, patient has a hx of PE (1995) and afib, and is not on a blood thinner per cardiologist. Patient presented to ED on 4/8/2021 and u/s r/u DVT. Patient contacted physician's office on 4/19/2021 with continuation of symptoms. Unsure if this is truly an ADE as patient reports the pain/swelling/redness occurred during a walk.

Severe headaches and pain, right foehead, right side of head and neck and right side back of neck. Skin in hair on right side hurts to touch.

1 WEEK AFTER VACCINATION- EXPERIENCED HEAD ACHES , SORE THROAT AND EAR ACHES. AROUND 2 WEEKS- PATIENT. FELT DIZZY AND PASSED OUT. STILL HAS SOME BRUISING IN THE ARM NEAR BICEPS.

HEART ACHE; SORE THROAT; BODY ACHE; SNIFFLES; INJECTION SITE SORENESS; This spontaneous report received from a consumer concerned an 81 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, disabled, emphysema, and seasonal allergy, and other pre-existing medical conditions included unknown. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 23-JUN-2021) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-MAY-2021, the subject experienced injection site soreness. On 08-MAY-2021, the subject experienced sniffles. On 10-MAY-2021, the subject experienced body ache. On 11-MAY-2021, the subject experienced sore throat. On 12-MAY-2021, the subject experienced heart ache. The action taken with covid-19 vaccine was not applicable. The patient was recovering from injection site soreness, and sniffles, and had not recovered from body ache, heart ache, and sore throat. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.

Pt said that he couldn't lift his left arm a few days ago. Today 5/20, he moved his left arm without issue or pain. There are bruising on left bicep area and he claimed the bruising have been getting bigger. He has shown his arm to his PCP staff a few days ago but they did not show any concern.

DULL ACHE TO RIGHT ARM/ PAINFUL TO SLEEP ON THAT SIDE; INJECTION SITE PAIN- RIGHT ARM; This spontaneous report received from a consumer concerned an 81 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic lymphocytic leukemia, and sulfa allergy. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-MAY-2021, the subject experienced injection site pain- right arm. On 17-MAY-2021, the subject experienced dull ache to right arm/ painful to sleep on that side. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine was not applicable. The patient recovered from injection site pain- right arm on 04-MAY-2021, and had not recovered from dull ache to right arm/ painful to sleep on that side. This report was non-serious.

Still having injection site pain as of today goes away after 15 - 20 minutes repeating every 2 - 3 wks since getting vaccine

Pt presented recently to anti-coagulation clinic with supra-therapeutic INR of 4.1. Pt has been on stable dose of warfarin with INRs in range 90% of the time with only small excursions (0.1-0.2) since 2016. He received Johnson and Johnson vaccine on 4/10 at outside facility, brought in his vaccine card. He states only arm pain and no other side effects from vaccine (although well known to providers here to minimize complaints). He took 4 doses of Advil the day after the vaccine (has taken prn Advil for years while on warfarin). 4/13 came in for INR check, INR was 4.1. He is clinically fine, no bleeding. History and exam did not find any other causes for elevated INR in this otherwise very stable patient.

The day after the injection, my lips and tongue became swollen. Saliva dwindled to near-nothing but occasionally dribbles from the left mouth corner . Could not whistle. Could not speak a clear 'esss'. Speech impeded. Mouth and lips 'puffy'. My ability to taste became severely limited. Today, 11 days later these symptoms are reduced to perhaps 30% of the worst values on about the second day after the injection.

RASH ON RIGHT ARM; HIVES ON RIGHT ARM; This spontaneous report received from a consumer concerned an 83 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced rash on right arm, and hives on right arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hives on right arm and rash on right arm was not reported. This report was non-serious.

Swollen shoulder, pain in shoulder in line with the injection site. Tiredness, fever for two nights.

He got his vaccine, he had chills that didn't last too long. Then two days later he could not move his left shoulder, and could not move his arm. If he moves it across his chest feels like somebody is stabbing him. His lower back is also in a lot of pain, the entire back. It now feels like a ball rolling from left to right, and sometimes it is both, and then perhaps one or the other. It has also affected his bowel movements as well, watery bowel movements. He now goes 3-4 times a day. When he relieves himself the pain subsides He still continues to have the pain. He went to his PCP and he gave him OTC medicines that helped some but did not get rid of the pain, especially in his lower back as it felt like somebody was stabbing him, as well as his left arm. His PCP sent him to pain management and that didn't work. He gave him 6 shots into his back, 3 on each side which did not relieve the pain. He went back to that doctor last week, and has a friend who is in charge of an x-ray company and got an x-ray. His lower back didn't show much of anything. He went back to pain management and told him to come back and went last week and told him that it could be arthritis and gave him some exercises, stretches, and he couldn't help him. He gave him some Tylenol with codeine for the pain, but has not taken them all. He is improving with his symptoms very slowly and is now able to move some and do exercises which are helping him. He was almost paralyzed before and now able to move some. He is waiting for the effects to just leave his body.

RED BLOTCHES ITCHING ON CHEST, BLOTCHES ON STOMACH ON THIGHS AND ALL OVER TOPS OF FEET AND BOTH LEGS; SEVERE CHILLS; This spontaneous report received from a patient concerned an 85 year old male. The patient's height, and weight were not reported. The patient's past medical history included heart attacks, and concurrent conditions included penicillin allergy, and tetracycline allergy. The patient experienced drug allergy when treated with amoxicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) once a total dose was not reported, administered on 23-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, Laboratory data included: Body temperature (NR: not provided) Normal. On 23-MAR-2021, the subject experienced severe chills. On 27-MAR-2021, the subject experienced red blotches itching on chest, blotches on stomach on thighs and all over tops of feet and both legs. Treatment medications (dates unspecified) included: cortisone, and paraffin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe chills on 24-MAR-2021, and had not recovered from red blotches itching on chest, blotches on stomach on thighs and all over tops of feet and both legs. This report was non-serious. This case, from the same reporter is linked to 20210355358.

Patient received the vaccine on 4/10/21 and a few days later hit his leg, which subsequently became erythematous and swollen. He went to urgent care on 4/13/21 and received a prescription for doxycycline which he stopped taking prior to resolution of symptoms due to side effects from the medication. He was prescribed clindamycin, but did not start this medication. Patient had outpatient labwork this morning which revealed an elevated SCr, for which he was sent to the ED. The patient was found to have AKI with hyperkalemia, as well as left lower extremity DVT and cellulitis. Patient is being treated with heparin and linezolid, as well as Kayexalate. The patient is being admitted to the hospital for treatment.

LOSS OF CONSCIOUSNESS; RECURRENT EPISODES OF SLURRED SPEECH; FALL; SCRAPPED HEAD; BALANCE PROBLEMS; This spontaneous report received from a consumer concerned an 85 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: 043A21A expiry: unknown) dose was not reported,1 total administered on 02-APR-2021 14:18 to left arm for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, after 18:30 the patient experienced slurred speech while finishing his dinner and it lasted for 30 seconds. The patient still had difficulty responding. On 03-APR-2021, at night the patient experienced loss of consciousness and fell to the ground with a little scrapped head and ten minutes later he was able to get up and felt better. On 04-APR-2021 at 13:15, he was finishing his lunch and had slurred speech again; he had repeated episode within five minutes. The paramedics had been called and checked his vitals (not specified). The patient was taken to emergency room on 04-APR-2021 at 14:30 and taken X-ray and CT (Computed Tomography) scan (unknown). The patient was admitted to hospital on 04-APR-2021 at 22:00 and was kept overnight for observation. The patient had not anything concerning and got discharged on 05-APR-2021 to follow-up with his treating physician. The patient was using cane for balance and was home bound but kept active. The duration of hospitalization was 1 day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of consciousness, and fall on 03-APR-2021, and recurrent episodes of slurred speech on 05-APR-2021, was recovering from balance problems, and the outcome of scrapped head was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210420526-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Loss of consciousness, Recurrent episodes of slurred speech, Fall, Balance problems, Scrapped head. 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).

Day after shot, end of all patient's fingers turned yellow then purple and were numb. Left hand was worse than right (had rec'd injection in left arm). Patient had chills for 2 hours. Purple fingers went away after the second day. Numbness lasted for 3 days then went away. Numbness continues to come back every few days and lasts 1 to 2 hours (worse in thumbs, mostly the left). No purpleness. Patient called his MD the day after the shot. MD told him to soak in a warm bath, which he said did help some.

URINARY TRACT INFECTION; SPINAL NERVE STIMULATOR IMPLANTATION; POSSIBLE STROKE; ARM TURNING BLACK; LEFT ARM SWOLLEN; EYES NOT FOCUSING; UNABLE TO DO DAILY FUNCTIONS; ISSUES WITH BOWEL MOVEMENT; This spontaneous report received from a consumer concerned an 85 year old,male. The patient's weight was 215 pounds, and height was 71 inches. The patient's concurrent conditions included non-alcohol user, non-smoker, and drug allergy not specified, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: unknown and expiry: unknown) frequency one total, dose was not reported, administered on left arm on 18-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 20-JUN-2021, the patient experienced eyes not focusing, unable to do daily functions and issues with bowel movement, and was hospitalized. On 21-JUN-2021, the patient experienced left arm swollen and arm turning black. On an unspecified date, the subject experienced possible stroke, urinary tract infection and spinal nerve stimulator implantation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from left arm swollen, and arm turning black, had not recovered from eyes not focusing, unable to do daily functions, and issues with bowel movement, and the outcome of urinary tract infection, possible stroke and spinal nerve stimulator implantation was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210740972-Covid-19 Vaccine Ad26.Cov2.S -Possible stroke, Issues with bowel movement, Arm turning black, Urinary tract infection, Spinal nerve stimulator implantation, Left arm swollen, Eyes not focusing, Unable to do daily functions. 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).

As soon as I started to inject vaccine into arm patient arm started to swell and get a welt at injection sight. I finished injecting vaccine but by the time I finished the welt was about 1.5 inches in diameter and about a 1/4 inch thick. Notified provider and he looked at it and stated it was a local reaction and stated to patient to watch it and put ice on it when he got home. He also told patient if he had any other side effects to come in to clinic or go to ER.

3/24/2021-He was walking and drove himself to get vaccinated. 3/25/2021-He experienced the usual soreness at the injection site and had some body aches. 3/26/2021-At 5:30 AM, he was in excruciating pain all over his body. He was unable to sit up in bed to get up and walk. After multiple ER and doctor/specialist visits, he is still in pain and currently uses a walker and has a long road ahead to get back the mobility he had on March 24, 2021. After 3/26/21 - New symptoms showed up almost daily. His hands and arms were very sensitive to touch. He writhed in pain when anyone even placed their hand on his arm very gently. He had the sensation of broken glass in his legs one night. Legs started giving out on him...

Onset of extreme fatigue, diarrhea, and then swelling, pain, redness, heat, and hardness of the Left Leg and Ankle. Sharp pain in the leg and ankle developed over the next months with swelling, becoming severe enough to see an Orthopedist on June 15, and then a visit to the primary Dr. on June 22. EKG, Blood including d-dimer, and Chest xray done same day, then a Sonogram done on June 23. No signs of blood clot, but leg issues and diarrhea continue, with skin breakdown occuring at the ankle. Placed on Prednisone 10Mg x 5 days, Lasix 40mg x 30days, Klor-Con MEG 10mg x 30 days, Keflex 500mg x 10 days, Mupirocin 2%.skin cream 3x day. Some improvement of the diarrhea since this time, but leg continues to be swollen, red, painful, and hard.