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

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.

Acute metabolic encephalopathy, BPH with urinary obstruction due to blood clot. Patient was vaccinated at a pharmacy with Janssen covid-19 vaccine and experienced headaches and dizziness. Then began to have urinary retention which was believed to be due to a large blood clot requiring 12x 100mL flushes. Patient went to ED at medical center on 3/30/21 and was admitted. He was discharged to nursing home on 4/11/21.

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.

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.

DIZZINESS; This spontaneous report received from a patient concerned a 76 year old male. The patient's weight was 120 pounds, and height was 65 inches. The patient's past medical history included heart attack, and concurrent conditions included pollen/seasonal allergy, alcohol use, and non smoker, and other pre-existing medical conditions included the patient did not have history of drug abuse or illicit drug usage. The patient was previously treated with fexofenadine hydrochloride for pollen, seasonal allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021 around 14:00, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from dizziness. This report was non-serious.

With oin 10 hours I began to have extreme chills (no sweating) which lasted 8 hours, dizziness upon rising from bed, and a temperature of 103 degrees F that lasted 9 hours. I did not report these to my doctor, but I did cancel an appointment with a doctor who was going to review CT scan results with me.

Patient left the pharmacy area and when to check out his groceries. While in line, the patient became dizzy and started sweating profusely. The cashier got him a chair so he could sit down. She gave him a cold water and some candy. I came over and asked him about low blood sugar and if he had eaten since I knew he was a diabetic. He sat in the chair for about 20 to 25 minutes. after he drank the water and ate the candy, i did a blood pressure reading, a temperature reading, and a blood glucose reading. The patient was able to leave and drive home after eating the candy and drinking the water.

This is a 76y.o. male significant past medical history of HTN, MI, dyslipidemia, and ESRD on hemodialysis that presented to the hospital with chief complaint of fall. He states he fell out of his recliner chair yesterday and landed on his left side. He admits to striking his head but denies any LOC. He reports he did miss hemodialysis on Monday secondary to episodic diarrhea. He is seen today resting in no acute distress. Endorsing overall he is feeling well. Denies any fever, chills, chest pain, shortness of breath, abdominal pain, nausea, vomiting, diarrhea, or changes in motor strength. In the ED, patient hypertensive, afebrile, stable SPO2 on room air. CT head, C Spine and radiographs negative for acute process. CXR concerning for pneumonia. He was started on antibiotic therapy and admitted to observation for further evaluation and management with nephrology consultation. ROS: Constitutional: Deniesfatigue, fever or chills. Eyes: Denies change in visual acuity, diplopia or pain. HENT: Denies nasal congestion, sore throat or tinnitus. Respiratory: Denies cough,difficulty in breathing or shortness of breath. Cardiovascular: Denies chest pain, palpitations or edema. GI: Denies abdominal pain, nausea, vomiting, constipation or diarrhea. GU: Denies dysuria, urinary frequency or hematuria. Musculoskeletal: Denies back pain, atrophy, spasticity or joint pain. Hematologic: Denies anemia, bleeding or bruising. Integument: Denies rash, lesions, or history of cancer. Neurologic: Denies headache, focal weakness, seizure or stroke. Endocrine: Denies temperature intolerance,polyuria or polydipsia. Lymphatic: Denies tender, abnormal, swollen glands Psychiatric: Denies irritability, depression or anxiety.

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.

According to Patient's son: Patient fell down after reaching home after getting this vaccine. Patient was admitted to ER same evening. According to ER doctor, patient has blood clot in his brain and is in vegetative state.

Dizziness for days after shot leading up to 4/6/21 , on 4/6/21 passed out unconscious in the shower. 911 called takin by ambulance to ER. Admitted for 4 days, all testing was negative.

Began as Dizziness on 3/31, then double vision, vertigo. Adm to The Hospital on 4/1. Diagnosed with TIA. Home next day. Now on hear monitor.

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.

SLIGHT HEADACHE; CHEST PAIN DUE TO DIFFICULTY IN BREATHING; DIFFICULTY BREATHING; SLOW TO MOVE/LACK ENERGY; SORE ON LEFT SHOULDER FELT LIKE HE WAS PUNCHED IN THE SHOULDER; 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 headache. 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 19-APR-2021, the subject experienced chest pain due to difficulty in breathing. On 19-APR-2021, the subject experienced difficulty breathing. On 19-APR-2021, the subject experienced slow to move/lack energy. On 19-APR-2021, the subject experienced sore on left shoulder felt like he was punched in the shoulder. Laboratory data included: Normal pulse rate (NR: not provided) normal at around 60. On an unspecified date, the subject experienced slight headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chest pain due to difficulty in breathing, difficulty breathing, sore on left shoulder felt like he was punched in the shoulder, and slow to move/lack energy, and had not recovered from slight headache. This report was 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.

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.

I was unable to pin down onset of symptoms. Patient was vaccinated on 04/10/2021 and sometime thereafter developed dizziness and double vision. Patient visited his ophthalmologist on 04/22/2021 and was advised to contact his PCP to schedule and MRI to rule out stroke. Patient is insistent that this needs to be reported despite my explanation that his symptoms are probably not vaccine related. I strongly advised patient to see his healthcare provider for further evaluation or go to the ED of local hospital.

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.

abdominal pain, epigastric, non-radiating, sharp, nausea, dizziness, decreased PO intake, sent to emergency center and admitted to hospital.

He got the vaccine, was not able to breath real good and didn't think about it. It got to the point within 2 weeks that he was not able to get up from the chair due to the shortness of breath. By 4/1/21 he was not able to breath very well, but continued to stay home. Then by 4/12/21 he was not able to breath well at all and his wife took him to the ER. In the hospital they did x-rays and found out that his lungs are full of blood clots and both legs have blood clots in them. He was admitted and gave him Heparin drip for the 2 days to get the blood clots dissolved and was also on oxygen for 2 days. He was discharged home yesterday with Xarelto, and was told that he would be on that for the rest of his life, and is on oxygen for sleep and when he's up and around, but if he's resting and feels he's breathing okay he can remove it. They informed him that it would take approximately 2 months for all the blood clots to dissipate, and that he was full of blood clots, and had both legs and both lungs which are quite full.

Systemic: Blood Disorder (diagnosed by MD)-Severe, Systemic: blood clut in the lungs and legs-Severe, Additional Details: Per patient he went to the hospital on 3/17/21 and 3/23/21 and was diagnosed with a blood clut in his lungs as well as his legs. He was treated with Pradaxa but still continues to have difficulty walking and has overal body aches.

Patient states that 4 days after getting the vaccine he had vertigo and light headed-ness. He saw his PCP for follow-up. On Friday, 4/23/21, patient states he woke up with a nose bleed and has had two-three nose bleeds since then.

PATIENT FELT DIZZY AND LOST CONSCIOUSNESS FOR A FEW SECONDS. AT THAT POINT,I ADVISED MY OTHER PHARMACIST TO CONTACT 911. I STAYED WITH THE PATIENT UNTIL EMT ARRIVED AND THEY TOOK OVER.

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.

First night: flu symptoms. Next day: fatigue, drowsy, some flu symptoms. That night: halucinatory dreams, woke up and had difficulty with orientation - room spinning, difficulty walking came back to bed, bed spinning. Got up later room spinning vertically - took several minutes to settle down. This problem has gotten worse as the days go by. This morning, dizziness persists longer than before, feeling of strong nausea, near vomiting, cannot walk in a straight line. Fear of falling. These are symptoms of vertigo I believe. Should I go to a doctor? Feeling that this will get worse. Difficulty concentrating. Quite an unsettling and scary experience.

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

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.

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.

As described by patient's wife, patient has been having intermittent dizziness since receiving his Covid 19 vaccination. Dizzy when his arms are raised above his head and at random times during the day. Patient saw cardiologist and was assured the dizziness was not due to his cardiac condition.

Patient reported an episode of lightheadedness, and loss of balance resulting in a fall with injuries. He required a trip to the ED for stiches and follow-up examination.

Worsening of Parkinson's symptoms, especially difficulty with start-up movement (standing from a sitting position) for approximately 72 hours.

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.

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.

The patient began having flu-like symptoms the following day after the vaccine. Felt achy, fatigue and not wanting to get out of bed even on vacation. That lasted for 2 weeks and still not great even now. The patient's spouse reported trouble walking, stumbling, falling and gait. The patient developed a cough a few weeks ago and is currently being treated with antibiotics called in from the physician. The patient has not see a physician for diagnosis. I encouraged the patient to be evaluated as soon as possible

Ten days later woke up in severe pain in neck and shoulders; spread to other joints over the next few days -- some days so painful can hardly walk (hips, knees, elbow, ankle; most recently big toe...which joints varies from day to day but always in neck, hips and knees). Major fatigue; daytime sleepiness; unexplained and random diarrhea.

Patient would like it on record, patient had the Johnson and Johnson Covid Vaccine on Saturday 4/10, right after taking the vaccine, patient felt a sensation rush to the top of her head and throat, she got dizzy in the top of her head and had a loud noise in her left ear, patient states all symptoms subsided Sunday morning

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.

3-14-21 @ 10PM, slipped to the floor and was unable to get up for 2hr until a family member arrived to help him up. reports he can walk when walking slowly. reports he had a 2ndary fall outside in his driveway on 3-16-21 before going to the doctor. Denies numbness, tingling, paralysis describes What happened as a result of the adverse event? (doctor visit, ED or urgent care visit, hospitalization, life threatening illness, disability/permanent damage, death, none of these): PCP visit, had blood work and urine sample. Is expected to go back Tuesday (3-23-21)

Received Janssen Vaccine on 03/10/2021 IM Left Deltoid. Reported started having "dizzy spells a couple weeks after" receiving his vaccination. Reports then started having "leg heaviness". Was hospitalized with hospital on 04/11/2021 with a blood clot "behind right knee".

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.

LITTLE LIGHTHEADED; This spontaneous report received from a patient via a company representative 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: Unknown) dose was not reported, administered on 27-APR-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 29-APR-2021, the subject experienced little lightheaded. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from little lightheaded. This report was non-serious.

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.

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

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.

Left hand will clinch but cannot open on command. I have to drop my arm to hang and then the hand will open. Hand will not stay open, fingers bend without prompting them to. Grip is strong but fingers will not open. No pain or tingling at this time.

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.

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.

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.

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).

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.

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...

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.

The days after the shot the patient was sleeping 12-14 hours a day which was not normal. On 04/15 pt started to feel dizzy and signs of blurry vision began. They went their general physician ruled out stroke & clot, then recommended they see an eye dr since the vision was the worst symptom. By 04/21/2021 the pt lost 100% of their eye sight. They eye dr after doing a scan discovered the pt had temporal arteritis. They believe the vaccine could had caused the body to lose the fight against the temporal arteritis and pt eyesight was lost.

Rapid decline in ability to perform respiratory gas exchange and build up of carbon dioxide in the blood to life-threatening levels, ultimately leading to death. Rapid decline began about 2 weeks after receiving vaccine. Death would likely have occurred on 5/6/2021 or 5/7/2021 but for hospital intervention via use of a BiPAP machine. Patient had been exhibiting more mild, non-COVID respiratory distress for some time, back to at least late 2020, and likely at even lower levels for several years prior. Signs and symptoms included shallow breathing, extreme fatigue, difficulty or inability to lie down, occasional lightheadedness, etc. Oxygen saturation levels in April, as measured by a pulse oximeter, ranged from about 87%-96%. On May 6, it measured 65% just prior to ER visit.

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.

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

About 8 days after receiving vaccine, recipient suffered a mini stroke. He was hospitalized for several days. He was told he had a clogged artery with 60% blockage. They gave him blood thinner. He recovered and was released from hospital. He moves much slower now and receives physical therapy.