Johnson & Johnson

3/18/21 ER Triage Nurse Note: "To er via EMS for eval of weakness and dizziness. States he started with sore throat and head congestion last week. Seen PCP Monday 03-15-21. Started amoxil. Took it for 2 days and became dizzy so he quit taking it. Dizziness got worse and came to ER." 3/18/21 ER HPI: 76 y.o. male who presents with c/o weakness cough and fever for the past seven days. Pt report sx are mod better with rest and worse with movement. Transferred to Hospital, dx: pneumonia dt covid-19 virus

bilateral nocturnal leg cramps, four severe episodes, onset about 8 hrs after getting the vaccine. He says four in one night +- severity unusual for him.

Beginning 4/9/21 (4 days after vaccination) woke up feeling fatigued and with some dizzy spells. Lasted till around noon then felt better. Started again around 4-5 PM. BPs elevated 189/92. Subjective feeling ?weird". Felt disoriented, tired, and dizzy. No fever. No dyspnea,. No headaches. At 7 PM BP was 165/86. 8pm was same. Following day 4/10/21 continued with symptoms of weakness and a little disoriented. Still weak and a little disoriented. Had medium grade headache at night. Next day 4/11/21 had fatigue all day and intermittent disorientation. Continued with medium grade top posterior headache. The headache resolved on its own without medication by later in morning. Blood pressure has been in the 135/73 range. No fever. Subjective improvement from 2 days prior. Next day 4/12/21 had profound fatigue. It began to let up by the evening. Next day 4/13 fatigue was not as severe but still present.

Pt states that about 3 weeks after the vaccine, pt experienced pain in his right calf where he did not feel like he can put any weight on it. Pt states going to the doctor to check on the leg, ran tests, and also did an xray. Pt states the Dr did not find a clot and mentioned that perhaps it was a sprain/strain. The pt did not agree that it was a sprain and wanted the pharmacy to report this adverse event. No other side effects were reported. Recommended that pt goes back to doctor to get leg checked out some more.

Patient reported thinking he had a blood clot in both legs. Patient stated Saturday night he experienced severe leg pain in both of his legs lasting 30 minutes later. Patient stated that he felt as if he had pain in every muscle in both of his legs; patient stated that he could not stand for quite some time once pain began. Patient stated that pain caused him to wake up. Patient stated that he did not have any other problems afterwards.

Patient starting feeling chills on Sunday, patient stayed home then had a seizure 4-12-21. They were admitted to the hospital on the evening/ night of 4-12-21 . Still in hospital as of 4-20-21.

According to the family, he had symptoms of weakness, nausea, headache, difficulty breathing beginning May 15, 2021. They spoke with him on Sunday, May 16, 2021 and he was continuing to have symptoms. On Monday, May 17, he called one of his daughters, but she missed the call. The family tried to call him on May 18- and May 19, but they couldn't reach him. A welfare check was initiated on May 20; however, the police didn't enter the residence. He was found dead in his bed on May 21, 2021, with changes of decomposition.

Client was vaccinated at 14:02 with Janssen vaccine and was then going to be observed for 15 minutes. Client requested to be observed in the lobby waiting area instead of in the exam room. Client walked himself to the chair, sat down and began to type on his phone. About 8 minutes into his observation, client began to fall forward and did not appear as responsive. Staff immediately tended to client and spoke to client requesting a response. Minimal response was given. 911 was called and responded within 2 minutes. Client was clammy, cool to the touch and eyes appeared glossy and dark. Client's blood pressure was 70/50 at 14:12. Med then arrived and BP was 53/35. At 14:20 (first BP taken when med arrived). Client became responsive but blood pressure minimally improved. Client was taken to the hospital and in agreement.

76 y.o. male who presents with complaint of right-sided weakness facial droop. Time of onset unknown. Patient has right arm drift, able to raise the right leg against gravity but not against resistance right facial droop. Patient is alert and able to answer questions. Blood pressure is elevated 205/115

Patient came in to the Hospital with blood in the urine since July 3. Patient had been on Kleffx, and then called his own pcp. Pcp adviced he get blood work done at the urgent care. Urgent care was only able to do urine test. Kleffix was discontined and patient was then given Bactrium also Zofran. Patient was complaining of eating very little , denied chest pain, denies SOB. Complained of chills and shaking. No other complaints, Patient did have a chest x-ray. Found on x-ray ground glassin the perfary of right lower lobe. Diagnosis was , acute weakneess, phemonia, hematuria.

FEELING LIKE SINUS INFECTION; HEADACHE; NIGHT SWEATS; PAIN IN LEFT EYE; BURNINIG IN BOTH EYES; PINK EYE; MUSCLE ACHES; FEVER; 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 glaucoma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 23/JUN/2021) dose was not reported, administered on 07-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced night sweats. On 08-APR-2021, the subject experienced pain in left eye. On 08-APR-2021, the subject experienced burninig in both eyes. On 08-APR-2021, the subject experienced muscle aches. On 08-APR-2021, the subject experienced pink eye. On 09-APR-2021, the subject experienced feeling like sinus infection. On 09-APR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from night sweats on 10-APR-2021, and muscle aches on 09-APR-2021, had not recovered from headache, and feeling like sinus infection, and the outcome of pain in left eye, burninig in both eyes, fever and pink eye was not reported. This report was non-serious.; Sender's Comments: v0- Medical assessment comment is not required as per standard operating procedures, as case is assessed as non-serious.

Symptoms of fever, nausea, and weakness started 3 days following vaccination. Denies any exposure to COVID positive person. Presented to local emergency department on 3/27/21 with nausea, fever, chills, dizziness, and confusion. Due to patient's condition, he was transferred to larger facility for further management. Patient was admitted to hospital and subsequently transferred to ICU on 4/17/21. He was intubated at that time. Patient went into multisystem organ failure and died on 4/18/21.

Three days after vaccination developed symmetric weakness in both legs, myalgia, difficulty walking, dysarthria/dysphagia, along with shortness of breath and right eye drooping. Also recently (4/13/2021) treated with nivolumab/ipilimumab so immune checkpoint inhibitor toxicity is suspected.

bi-lateral leg pain within 1 week of shot. then severe back pain after 2 weeks. difficulty breathing week 3. Admitted to hospital for multiple blood clots in legs & lungs.

Pt developed sudden-onset of severe left-sided chest pain with heavy pressure, shortness of breath and diaphoresis; pt collapsed and had a period of unresponsiveness lasting approximately 10 minutes. EMS was called and noted significant ectopy as well as frequent NSVT on ECG. Pt was transported to the Emergency Department and subsequently admitted for observation.

No appetite for days. The smell of food made patient sick. On week two after vaccine, oxygen stayed at 84%, patient couldn?t stand as he had no energy. Patient began to eat after lots of convincing and seemed to be doing at least 20% by week 3, but oxygen was still in mid 80%. On day 20 after vaccine patient had to be rushed to the ER due to sepsis. All vital organs began to fail and on transport patient suffered a mild heart attack. Patient was a healthy 78 year old male that lived alone and drove and had no major health issues before the date of the vaccine.

BLOOD SUGAR ELEVATED/BLOOD SUGAR READINGS REMAINED FAIRLY HIGH; SORENESS IN HANDS/ SLIGHT SORENESS; This spontaneous report received from a patient concerned a 78 year old male. The patient's height, and weight were not reported. The patient's past medical history included flu shot in fall. 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-MAR-2021 on arm (deltoid) 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 blood sugar elevated/blood sugar readings remained fairly high, and soreness in hands/ slight soreness. Laboratory data (dates unspecified) included: Blood sugar abnormal (NR: not provided) elevated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the soreness in hands/ slight soreness and blood sugar elevated/blood sugar readings remained fairly high was not reported. This report was non-serious.

SORE ARM; This spontaneous report received from a patient concerned a 78 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 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: 1805022 expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-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 sore arm. This report was non-serious.

MILD CRAMPS; SEVERE DIARRHEA; This spontaneous report received from a patient concerned a 78 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 03-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 03-MAY-2021, the subject experienced severe diarrhea. On 04-MAY-2021, the subject experienced mild cramps. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe diarrhea and mild cramps was not reported. This report was non-serious.

Husband began expressing "I'm tired" which was out of the ordinary on May 1, 2021. Again on May 2 and 3. On May 4 he was really weak, moving much more slowly than normal, complaining of sinus headache above left eye, sleeping longer and more than normal, brain fog and confusion, not able to do normal activities. This impairment has continued through May 11 with no improvement from one day to the next. Visited his Dr to get checked on May 11 due to our concern over how long this was lasting. He has had no fever but some chills here and there. Dr checked everything she could think of and requested blood tests which we have not heard about yet. Extreme fatigue was the major symptom. Today, May 12, he feels better, moving around faster and doing some normal activities but still tires easily and must rest.

TENDERNESS; LOSS OF APPETITE; PROFUSE SWEATING; BACK TIGHTENING; MUSCLE SPASM; SWELLING; BACK SORENESS; LACK OF SLEEP; HIP SORENESS; TIREDNESS; NAUSEOUS; FEVER; This spontaneous report received from a patient concerned a 78 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included disabled. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced tenderness. On MAY-2021, the subject experienced loss of appetite. On MAY-2021, the subject experienced profuse sweating. On MAY-2021, the subject experienced back tightening. On MAY-2021, the subject experienced muscle spasm. On MAY-2021, the subject experienced swelling. On MAY-2021, the subject experienced back soreness. On MAY-2021, the subject experienced lack of sleep. On MAY-2021, the subject experienced hip soreness. On MAY-2021, the subject experienced tiredness. On MAY-2021, the subject experienced nauseous. On MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 98.4 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tenderness, loss of appetite, tiredness, profuse sweating, fever, hip soreness, nauseous, back tightening, muscle spasm, swelling, back soreness and lack of sleep was not reported. This report was non-serious.

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.

The patient developed paresthesias and weakness in the legs approximately 2 weeks after the vaccine. After the thorough work-up he was diagnosed with Guillain-Barré syndrome. He was treated with IVIG and has had some improvement.

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.

Patient suffered a tiny brain bleed and subdural hematoma and fell from our boat to the pier on the afternoon of April 17. I drove him to the ER for evaluation where a CT scan revealed the brain bleed. He was subsequently transported to the emergency unit that evening. He was disoriented and suffered a concussion as well. He had daily blood work and was treated with Levetiracetam for 5 days post discharge on 4/22.

Per Regulatory Authority it is to be reported if patient gets COVID if fully vaccinated. Per MD note 1. Acute hypoxemic respiratory failure: This is in a patient with COVID pneumonia. The patient was placed on supplemental oxygen. The plan is for the patient to use supplemental oxygen with oxygen by nasal cannula up to 6 L and if oxygen saturation falls below 90% on 6 L oxygen by nasal cannula, he will be transitioned to high-flow oxygen. However, if he is on maximal support with high-flow oxygen with oxygen saturation falling below 90%, the patient should be placed on BiPAP and transferred to the ICU. The patient is a full code. 2. COVID pneumonia: This in a patient who apparently received his Johnson and Johnson COVID vaccine 3 weeks ago. The patient started on treatment with remdesivir. He will get steroids. He is prescribed Tessalon Perles and Robitussin with codeine as needed for coughing. He may be considered for potentially other treatments in the setting of his COVID pneumonia, especially if his respiratory status deteriorates. We will closely follow up in the COVID unit after admission. 3. Alteration of mental status and encephalopathy: This in a patient who is hypoglycemic. However, part of his encephalopathy related to his COVID infection and volume depletion. He is being volume repleted and treated for his condition. He will have frequent neurologic checks done after admission. 4. Generalized weakness and deconditioning: This is in a volume depleted patient with COVID. His COVID will be appropriately treated and he will be volume repleted. He will need to work with physical and occupational therapy towards the end of the hospitalization. 5. Congestive heart failure, systolic plus diastolic dysfunction: The patient does not have any evidence of acute congestive heart failure at the moment. However, we will take care to prevent volume overload in this patient, who requires volume repletion in the setting of his volume depletion. 6. Volume depletion: The patient will get another liter of IV fluids after admission at 80 mL per hour as tolerated. The goal is to avoid excessive IV fluid administration in this patient with COVID pneumonia.

Vaccine was given on 4/1/21. Symptoms started 4/2/21 in the afternoon. Symptoms were described as teeth/gums hurting. At 12:30 am on 4/3/21 his mouth was very swollen and he couldn't talk. Also he had trouble breathing. He went to the ER and was given IV solu-medrol. Patient was sent home 30-40 minutes later with the instructions to take Benadryl PO. In the morning they purchased some benadryl and gave it PO every 4-6 hours all day Saturday, 4/3/21. On Sunday, 4/4/21 at about 5:30 am his gums and lips were swollen again. He made another trip to the ER and was given solu-medrol IV again and PO methylprednisolone for 5 days. At this visit, they also gave lasix IV due to extra fluid around his heart. He was told by the ER provider that he developed congestive heart failure due to the vaccine. Patient followed up with his primary care provider on 4/8/21 and was told that his symptoms of congestive heart failure had resolved. Patient also reported his symptoms of swollen gums and mouth had resolved at this time.

Patient woke up on 4/8/2021 around 0700 with complaints of double vision. The double vision is ongoing. On 4/9/2021 patient still had double vision and then stroke like symptoms at 0700. Patient had slurred speech and right arm weakness. As of 4/14/21 patient still has double vision but weakness and slurred speech has resolved. Patient is a DNR so he did not seek medical care.

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.

Janssen vaccine received 3/6/2021. Had a fall from sudden onset weakness 3/9/21 broke hip then ORIF and cardiac arrest. Now at skilled nursing facility

INCREASING HEADACHE, AND SHORTNESS OF BREATH. Previously frequent bloody nose on 03/30/21, pt is not currently taking any blood thinners, he recently went to the ER on 03/30/21, after the visit the nose bleeding stopped. Pt's wife C/o of edema of the ankles with SOB. C/o severe migraine headaches and back pain. Norco helps the patient with his migraines and pain w/o SEs. Patient has still has SOB on exertion, but it is stable, pt's wife states that he is getting worse, he will c/o of SOB after walking less than half a block. He continues to use 2 L oxygen nasal cannula supplement and his inhalers and nebulizer treatment up to 4-6x a day. No fever and chills. Pt only has occasional cough. When he uses his inhalers, his cough will subside. PATIENT HAS HX OF THROMBOCYTOPENIA, BUT THROMBOCYTOPENIA HAS GOTTEN WORSE AFTER VACCINE.

Patient with history of myasthenia gravis with multiple prior myasthenic crises requiring IVIG and one requiring intubation experienced myasthenia gravis exacerbation with no apparent trigger that began two weeks after receiving J&J vaccine. Daughters noticed he was having progressive difficulty swallowing, slurred speech, and generalized weakness. O2 sats were also noted to be lower than normal with pulse oximeter at home (92% compared to baseline of 95%). On day of admission patient had a mechanical fall while carrying a tray with his walker. Hypoxic to 88% on arrival. Labs notable for leukocytosis (13.68), hyponatremia to 127 and negative infectious workup. CTH with chronic microvascular changes and global atrophy but negative for acute process. He was admitted and continued on prednisone 5mg daily (outpatient regimen). Patient was started on a three day course of IVIG on 5/3/21 due to concern for myasthenia exacerbation with subsequent improvement.

Swollen right hand and inflamed and painful index tendon sheath. Swollen right foot and painful large toe

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.

Client reports that about a week after he had the Janssen vaccine he had muscle weakness that resulted in a fall. He reports that he was unable to get himself up out off the floor, laying there until the next day delivery came. He reports that the driver called for help and they were able to help him to the couch. He was weak but able to use the walker to get around. reports that he had not slept during that time and reports having some delusions due to lack of sleep. He does report that he has a history of muscle weakness, but never this bad and is now having to use a walker all of the time. He denies going to the ER, hospital or doctor for treatment and that he is slowly recovering but still having to use a walker.

4/15/2021 approximately 1030 am client found to be AMS, non-responsive, aphasic, aphagic, left-sided facial droop, teeth clenched, left eye closes, right eye with deviated gaze. 911 called, client to hospital ER, work up/evaluation, admission for stroke related to blood clots found left frontal and right temporal lobes, per spouse. Client discharged 4 days later to home s/p CVA, bed-bound, remains aphasic, aphagic, non-communicative, no response to verbal stimuli. PLEASE NOTE: hospital admission. Unable to complete section 21. Admit for 4 days.

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.

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.

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.

Client developed mild cough, weakness, and extreme fatigue on 6/25. Tested with PCR on 6/25 and was positive for Covid

PATIENT WAS ADMINISTERED THE JANSSEN COVID VACCINE AT APPROXIMATELY 10:30AM. IMMEDIATELY FOLLOWING REMOVAL OF NEEDLE AFTER INJECTION, THE PATIENT APPEARED TO FAINT FALLING FORWARD IN HIS OWN LAP. AFTER ABOUT 15 TO 30 SECONDS, HE REGAINED CONSCIOUS. WE ASSESSED THE PATIENT TO ASK IF HE HAD EVER EXPERIENCED FAINTING BEFORE OR SPECIFICALLY DURING VACCINATION. HE HAD NO PREVIOUS EPISODES. WE QUICKLY OFFERED THE PATIENT SOME WATER AND CRACKERS WHILE HE REMAINED SEATED. THE PATIENT FELL FORWARD AGAIN AND APPEARED TO BE CONVULSING. ONCE HE STABILIZED, MY PARTNER STEPPED AWAY TO RETRIEVE WATER, AND THE PATIENT ONCE AGAIN FELL FORWARD AND BEGAN CONVULSING. ONCE HE STABILIZED, HE DRANK SOME WATER AND ATE SOME CRACKERS. HE MENTIONED THAT HE FELT EXTREMELY TIRED. WE INSISTED TO CALL THE PARAMEDICS FOR HELP,BUT HE DECLINED SAYING THAT HE WAS OK AND MAYBE THE NEEDLE TRIGGERED THE EVENT. AFTER WE OBSERVED THE PATIENT FOR 30 MINUTES AND HE ASSURED US HE WAS IN STABLE CONDITION, HE LEFT WITH HIS GIRLFRIEND. PATIENT WAS CALLED TWICE AFTER THE EVENT TO FOLLOW-UP BUT WE HAVE NOT HAD SUCCESS IN FOLLOW-UP.

Extreme lower extremity swelling and pain. Evaluated in PCP office on 04/22/21, ultrasound of right LE was negative for blood clot. Patient?s symptoms worsened and PCP referred patient to ER on 04/16/21 and CT of cheat revealed 3 clots in the lungs. Patient was admitted to hospital and stated on heprin therapy. Still currently inpatient awaiting approval to transfer for inpatient rehab due to decreased endurance and bilateral lower extremity pain which is affecting ability to ambulated without assistance.

Patient has been very stable on anticoagulation with warfarin. On same dose since 2016 with only rare very mild excursions in INR. He had appointment for routine INR check which happened to fall 3 days after his vaccine, and INR was found to be 4.1. There were no other identified explanations for the unusually high INR in him. He did not have any symptoms of bleeding or thromboembolism. He did have some arm pain so took a few doses of ibuprofen (which should not cause the increase in INR and he has been using ibuprofen prn the duration of his anticoag therapy) He was asked to hold 2 doses and returned 1 week later, which was 10 days after vaccine. At that time INR came down to 3.0 and CBC was ordered which came back normal for him. He still did not have any symptoms of bleeding or thromboembolism.

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.

June 4, Became largic, could not speak aloud, but understood. could not swallow hardy even water shock head to answer, only last day, very little response Prior to that, was feeding self, carried on good conversation and was enjoyable to visit with

3/5/ 21 Received J & J at facility. 3/7/21 Client had troubles walking and went to Urgent Care. then he went home. He did not have good control (wife described that his legs did not have strength but was able to walk. Symptoms started getting better later that day. 3/15 He got up and he said he was not feeling to good. Chest hurt and shoulder hurt. Wife took him to the ER at Hospital. He was transported to Hospital. 3/16/21 Hospital did a Heart catherization. He had a complete blockage in the widow maker and 2 stents were put in. He had 2 blood clots in the Widow Maker. 3/18/21 He was discharged from the hospital. He is doing ok but he has no energy.

I experienced blood clots, also had bilateral leg pain and lower back pain. I currently in the hospital.

DIZZINESS; COUGH; SNEEZING; SORE THROAT; SOME HOARSEN; This spontaneous report received from a patient 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: 1805018, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2021, the subject experienced sore throat. On 15-MAY-2021, the subject experienced some hoarsen. On an unspecified date, the subject experienced dizziness, cough, and sneezing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore throat, and the outcome of dizziness, cough, sneezing and some hoarsen was not reported. This report was non-serious.

Patient with advanced parkinson's, dysphagia, on G-tube feed received J&J vaccine on 6/9 per wife, developed fatigue/general weakness, developed fever, admitted to hospital for aspiration pneumonia/sepsis/acute respiratory failure.

vomiting, diarrhea, dizziness, unable to stand, weak starting the night of vaccine leading to dehydration did an ECHO next day by Dr and found blockages which were taken care of that day by MD, and then episodes of decreased blood pressure, severe headaches

After vaccination that day, patient was too tired to get out of bed to do his evening walking exercises. On 6/10/2021 3:00 am, patient unable to support himself on the commode and was put back to bed. Next couple of days patient was too weak to get out of bed. 6/14/21 1:00 am, patient became very congested and unable to remove fluid in his lungs, wife called medics and patient was admitted to hospital for 2 days with pneumonia. 6/16/21 7:00 pm, patient discharged from hospital. That night, patient became very congested despite continuous suctioning through the mouth, patient experienced respiratory distress and lungs congested with fluids, 2:30 am medics was called and paramedic performed invasive deep suctioning of lungs via his nose on way to the hospital, upon arrival at hospital they performed another deep suctioning of lungs before sending patient to the ICU. 6/21/21 4:00 pm, patient discharged from hospital in stable condition, doing physical therapy and occupational therapy at home.

Two nights after receiving vaccine patient was unable to sleep for two nights. Then the following week, about 10 days after the vaccine he went to using a walker and then a wheelchair and now has no use of his legs, his core strength is very limited, and one arm is affected. He also cannot sit unassisted.

BRAIN FOG; CAN HARDLY HOLD COFFEE CUP DUE TO SHAKING/ KNEES SHAKY; COULD HARDLY STAND UP; SLEEPING A LOT; LEGS RUBBERY; LEGS TINGLY; LEG GAVE OUT; TIREDNESS AND FATIGUE; WEAKNESS; This spontaneous report received from a patient concerned an 83 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: 1805081, and batch number: 1805081 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced brain fog, can hardly hold coffee cup due to shaking/ knees shaky, could hardly stand up, sleeping a lot, legs rubbery, legs tingly, leg gave out, tiredness and fatigue, and weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the can hardly hold coffee cup due to shaking/ knees shaky, leg gave out, could hardly stand up, weakness, tiredness and fatigue, sleeping a lot, brain fog, legs rubbery and legs tingly was not reported. This report was non-serious.

Intermittent left-sided knee pain radiating down leg, spoke with physician who advised him to go to urgent care however he has not gone yet, took ibuprofen on Saturday which provided relief. Advised to follow up with PCP recs. -KLC Spoke with caller, has not yet seen PCP or gone to urgent care, however still c/o pain in leg radiating from knee to foot. Advised to contact PCP and follow recs -KLC

SHAKES AND CHILLS LIKE THE FLU; UNABLE TO MOVE LEFT SHOULDER AND ARM; LOWER BACK PAIN; STABBING PAIN LIKE IN LEFT SHOULDER AND ARM; This spontaneous report received from a patient concerned an 84 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included sciatica, slight asthma in summertime, and seasonal allergy, and other pre-existing medical conditions included patient is taking vitamins (unspecified).The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch no was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced unable to move left shoulder and arm. On APR-2021, the subject experienced lower back pain. On APR-2021, the subject experienced stabbing pain like in left shoulder and arm. On 07-APR-2021, the subject experienced shakes and chills like the flu. Treatment medications (dates unspecified) included: menthol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shakes and chills like the flu on 08-APR-2021, and unable to move left shoulder and arm, and was recovering from stabbing pain like in left shoulder and arm, and lower back pain. This report was non-serious.

Patient presented to ED on 4/21/21 for weakness that started one week ago. He also complains of decreased appetite and nausea. Patient denies shortness of breath or chest pain. Patient was diagnosed with COVID-19 infection and UTI. COVID was treated steroids and antibiotics, Patient improved and was discharged to ECF for continued convalescence.

Apr 10, 2021 ? Jan and I both received Covid-19 Immunization at The Event Center using Janssen (J&J) 042A21A Apr 11, 2021 ? Awoke with slurred speech. Left side of face a little droopy. Vision partly blocked by what I thought was droopy eyebrow. April 12, 2021 ? Made appt to see Dr. After initial checkout and some discussion she sent me directly to ER. Arrived and was checked in and admitted; IV installed, CT Scan, chest ray, MRI and many other tests were administered. One was X_RAY recording me as I drank barium water. I was diagnosed as having had a Stroke by Drs as well as resident Physician. My dosage of (Imdur) Atorvastatin was increased to 80 MG per day. Other meds remain the same. @ Dr: 226.4#, 95% ox, 56hr, 120/72 bp hospital has complete records.

Narrative: VETERAN REPORTED THAT HE LOST CONTROL OF BLADDER, HAD SHAKING AND TREMORS IN HANDS LEGS AND BODY. FELT LIKE HE HAD SYNCOPE. LOST ALL STRENGTH. FELL WHEN TRYING TO PICK UP THINGS, COULDN'T GET BACK UP. HAD HA/FATIGUE AND MUSCLE ACHES.TEMPERATURE, GIVEN APAP. DRANK GATORADE. TEMP WAS 101.6, BP 141/68 AT 6AM.

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.

7/24/21: past 3-4 days, patient had low energy, decreased appetite, drinking very little, and more confused than his baseline. Patient weak and breathing quickly, so came in to ED. found to be COVID positive. Diagnosed with: COVID-19 pneumonia, acute hypoxic resp failure, shortness of breath, acute encephalopathy. Note: patent previously vaccinated with COVID-19 vaccine in April 2021. 7/27: patient still admitted at the time of this form submission.

Flu like symptoms for 3 days, then continue loss of appetite, weakness, so much so that on April 5, 2021, I was taken to the emergency room for immediate treatment. The hospital then discovered 2 pulmonary embolisms (blood clots), one in each lung and pneumonia. At this time, I was extremely weak and in major physical stress. NOTE: I do not have a history of ever having blood clots.

On 4/9/2021 patient suffered from a Hemorragic Stroke on the left side of the brain making him unable to move his right leg and toes, right arm and hand, slight droop of right lip, and responding mostly in one word answers with delays at times. He was hospitalized in the am hours, sent to ER and then to Neuro ICU for 3.5 days and then moved onto a neuro floor for 1.5 days. On 4/13/2021 he was transported to an acute rehabilitation center to receive OT, PT and Speech Theraphy. On 4/19/2021 patient suffered from Ischemic Stroke on the right side of the brain, he became unresponsive. He was intubated on 4/19/2021, placed into ICU and was removed from intubation, due to poor life outcome from the 2 strokes having affected his body, on 4/21/2021.

Daughter reported that on 4/13/21 pt had increased weakness and difficulty breathing, taken to ER for x-ray of lungs, small amount of fluid noted. On 5/11/21 Pt with weakness, shortness of breath, increased edema in lower extremities, taken to ER, admitted to the Hospital with Pneumonia. Pt now home on Hospice.

hypedrthyroid,treated with methimezole for1 month waiting for time to check resilts on july 24 had monoclonal amtibody infusion 2 days after getting covid-19

Started experiencing numbness in feet, weakness in legs, shortness of breath around 6/22. Fell on 6/24. 7/2 shortness of breath increased and weakness in legs. Had trouble walking from living room to the car. Don't have exact date, but on 7/5, 7/6, or 7/8 had trouble walking from living room to the kitchen due to shortness of breath and weakness in legs. Doctor prescribed rehab and started 7/12.

WORSENED GUILLAIN BARRE SYNDROME; PAIN IN FOREARMS; SWOLLEN LEGS AND FEET; FALLING AND IMBALANCE; This spontaneous report was received from a patient and concerned an 87 year old male. The patient's height and weight were not reported. The patient's concurrent conditions included Guillain Barre syndrome, alcohol intake red wine sometimes, non smoker, and no known allergies. Patient had no 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: 1805020) dose was not reported, administered on 16-MAR-2021 to his right arm for prophylactic vaccination. There were no concomitant medications. On an unspecified date, the patient experienced worsened Guillain Barre syndrome. In APR-2021, the patient was falling and had imbalance. In MAY-2021, the patient experienced swollen legs and feet. In JUN-2021, the patient experienced pain in forearms. Patient uses a walker to walk inside his home: " I have to walk beside the wall, otherwise I will fall on the floor and I have difficulty to getup" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen legs and feet, pain in forearms, worsened guillain barre syndrome, and falling and imbalance. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This spontaneous report received from a consumer concerns an 87-year-old male, with concurrent Guillain Barre syndrome (GBS) who was reported to have "worsened" GBS after an unspecified duration of receiving the Janssen Covid-19 vaccine. The worsening was described as falling and had imbalance; swelling of hands and feet; pain in forearms. No treatment reported; the events have not resolved. The information available precludes a complete and meaningful assessment. Based on the information available, and the clinical picture of concurrent GBS could represent the normal progression of the illness. However, a relationship with Janssen Covid-19 vaccine cannot be ruled out and thus the relationship is considered indeterminate.

resident began to experience stroke like symptoms at approximately 0300, resident noted with slurred speech, left arm and leg flacid, facial drooping to left side of face. B/P 193/116. transferred to ER for evaluation

PATIENT WAS GIVEN JANSSEN COVID 19 VACCINE AT AROUND 12PM WHEN PATIENT WAS ACCOMPANIED BY HIS SON. HE WAS OBSERVED FOR 15 MINUTES AFTER THE VACCINATION AND LEFT PHARMACY WITHOUT ANY PROBLEM. PATIENT'S DAUGHTER CALLED AROUND 6PM AND REPORTED HER FATHER JUST DIED. SHE REPORTED HER FATHER ALL OF SUDDEN WAS SHAKING AND DIED RIGHT AFTER.

Dizziness, loss of use of legs, could not stand. had to be hospitalized for a week and then rehab for 2 weeks.

HEADACHE; ACHY ARM; This spontaneous report received from a patient concerned an 89 year old male. The patient's weight was 73.6 kilograms, and height was not reported. The patient's concurrent conditions included pulmonary hypertension.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included selexipag for drug used for unknown indication, tadalafil non-company for drug used for unknown indication, and macitentan for pulmonary hypertension. On an unspecified date, the subject experienced headache, and achy arm. Laboratory data (dates unspecified) included: Pulmonary hypertension (NR: not provided) ICD-9 and ICD-10. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and achy arm was not reported. This report was non-serious.

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.