Johnson & Johnson

SON REPORTED THAT PATIENT WOKE UP 4/7/21 WITH FLU LIKE SYMPTOMS AND STAYED IN BED ALL DAY. PT DID NOT DRINK ANYTHING OR TAKE INSULIN ON 4/7/21. WHEN DAUGHTER ARRIVED AT PTS HOME THAT EVENING, PT WAS INCOHERENT. SHE CALLED 911 AND PT WAS TRANSPORTED TO THE HOSPITAL WHERE HE PASSED AWAY ON 4/9/21.

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.

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.

IRREGULAR HEART BEAT; STAGE 1 HYPERTENSION/HEADACHE/LIGHTHEADEDNESS; FEELING LITTLE BIT CLOUDY AND CONFUSION; 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 non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies and did not had drug abuse or illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 05-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-MAY-2021, the subject experienced feeling little bit cloudy and confusion. On 06-MAY-2021, the subject experienced irregular heart beat. On 06-MAY-2021, the subject experienced stage 1 hypertension/headache/lightheadedness. Laboratory data included: Blood pressure (NR: not provided) HYPERTENSION. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from irregular heart beat, stage 1 hypertension/headache/lightheadedness, and feeling little bit cloudy and confusion. This report was non-serious.

Patient was giventhe Janseen covid vaccine on 5/5. Apparently the patient 6 days later was reportedly aggitated had hallucinations and trouble breathing. The patient proceeded to lay down to rest. The patient never awoke.

Vaccine expiration date was 5/25/21. Gave expired vaccine. There were no adverse reaction, patient was highly anxious before giving the vaccine. Checked on patient today, no adverse reactions to report.

MASSIVE BLUNT FORCE TRAUMA; CAR ACCIDENT; BLEEDING PROBLEMS; FELT PUNK; POSITIVE COVID TEST/ CONFIRMED COVID-19 INFECTION; This spontaneous report received from a consumer concerned an 77year old male. The patient's weight was 216 pounds, and height was 65 inches. The patient's concurrent conditions included pacemaker, and copd (Chronic obstructive pulmonary disease), and other pre-existing medical conditions included the patient was on respiratory medications and blood thinners. The patient was previously treated with warfarin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry :unknown) dose was not reported, 1 total, administered on 10-MAY-2021 for prophylactic vaccination. The batch number was not provided and has been requested. On an unspecified date in JAN-2021, Laboratory data included: COVID-19 virus test (NR: not provided) positive. The patient felt a little punk from the vaccine initially. On 18-MAY-2021, the patient was in a car accident. He was driving a truck and got T-boned by a car and pushed 40 feet into a ditch. He was hospitalized and had 2 negative rapid tests for COVID. He decompensated and was intubated. Upon intubation, another rapid COVID test was done and was positive. They did an additional test that was also positive. He passed away on 25-MAY-2021. An autopsy was performed on an unspecified date. It was reported that she believed the cause of death to be the massive blunt force trauma and bleeding problems. He tested positive for COVID with a 5 day test in JAN-2021. During that time, he had received the monoclonal infusion. She noted that he did not get ivermectin. He also got a physical examination done. Laboratory data included: COVID-19 virus test (NR: not provided) not reported, and SARS-CoV-2 rapid diagnostic test (NR: not provided) positive, positive. Laboratory data included: SARS-CoV-2 rapid diagnostic test (NR: not provided) negative, negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of massive blunt force trauma and bleeding problems on 25-MAY-2021, and the outcome of positive covid test/ confirmed covid-19 infection, car accident and felt punk was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender's Comments: V0. 20210554454-COVID-19 VACCINE AD26.COV2.S. Massive blunt force trauma, bleeding problems, car accident. This events is considered unassessable. The events have an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.; Reported Cause(s) of Death: MASSIVE BLUNT FORCE TRAUMA; BLEEDING

Patient is an elderly male that stated that he experienced memory loss the evening of his vaccination and that it lasted a few days. He also has depression and he states that since he received the vaccination that his depression has became worse with bouts of crying while speaking. He said he has not sought medical treatment as of today, 6/7/21. A friend of the patient encouraged him to seek medical help earlier, but he was going to see his primary care physician instead. He has an appointment with his physician. Patient stated that he did not have severe or persistent headaches. He also denied having blurred vision. As of today, his memory has improved. He feels his depression has not improved.

Caller stated that close to midnight his heart start beating very fast and he couldn't sleep. The next day his heart rate would speed up throughout the day. A few minor aches and pains around the neck and shoulder and more tired than normal.

Patient developed shortness of breath, chest pain 'fuzzy head,' headache, rhinorrhea, diarrhea, and increased fatigue around 3/28/21 had clinic appointment 3/30/21, diagnosed with pneumonia. XR CHEST 2 VIEWS (PA AND LATERAL), TRANSTHORACIC ECHO (TTE) ADULT NON CONGENITAL, EKG 12-LEAD completed. given cefTRIAXone (ROCEPHIN-Equivalent) injection 1,000mg IM, and doxycycline monohydrate (MONODOX) 100 mg capsule PO. was evaluated in ED 4/5/21 CT Abdomen Pelvis with IV Contrast Final Result 1. Positive for extensive acute bilateral pulmonary emboli at the lung bases as detailed in the body of the report. DX Chest Portable 1 View Final Result Mild left ventricular prominence is noted. Small right pleural effusion is seen. Minimal discoid atelectatic changes in the left perihilar region and left lung base. Elevated right hemidiaphragm suggests eventration. Admitted to Hospital 4/5/21, per admission diagnosis: Acute pulmonary embolism (*) submassive likely secondary to covid 19 Per hospital course notes:Patient presented with acute hypoxic respiratory failure and was show to have submassive PE with severe pulmonary hypertension seen on TTE. He should be on lifelong therapy given 2nd VTE and severity. Iwould consider unprovoked (COVID in 11/20 wouldn't count I wouldn't think). He was started on eliquis 10 mg BID x 7 days than 5 mg bid. Given his severe pulm htn on TTE, left atrial pressure normal. We would have outpatient sleep study as well He will need VQ scan to assure no CTEPH. Will have outpatient follow up. We discontinued his aspirin on discharge as well.

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.

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.

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.

Shortness of breath, tired, elevated blood pressure, no appetite, upset stomach, nausiated, blood blister in groin area. soreness in groin area, overall feel bad.

At first right after vaccine it just felt like an invasion of something, I knew I had something I had that was different. March17, I got sick - I had a bad stomach ache. Friday, I thought the doctors would be gone. March 21st, I went to the clinic and they sent me right to the hospital for a scan and I had emergency surgery to remove my appendix - but it did get put off from when I went in because of all the emergencies in front of me with the ambulances coming in from accidents. He said it had burst by the time the surgeon got to me with the surgery and they gave me antibiotics and he said he poked three holes in my belly. Still recovering - I have follow up tomorrow. I am doing real well. My stomach doesn't hurt and I am not taking pain medication any longer.

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.

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.

The patient presented to Emergency Department with lethargy, confusion, and hypoxia. Upon presentation to the ED, the patient tested positive for COVID-19 (04/29/21). The patient is currently being treated with dexamethasone and remdesivir.

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.

PATIENT STATED THAT 1 WEEK AFTER THE VACCINE HE IS EXPERIENCING SEVERE FATIGUE AND SPENDS MOST OF THE DAY SLEEPING. HE ALSO HAS EXPERIENCED CONFUSION

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.

Cause of death not documented. Significant comorbidities include dementia with neuropsychiatric behaviors including anxiety.

Pt states he has since visited the Dr. with heart palpations' and mummers'. Dr. stated she was going to later on to prescribe medications but no current change. Very agitated and mood swings.

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).

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.

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...

POSSIBLE HALLUCINATION; This spontaneous report received from a consumer concerned an 87 year old male. The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. It was reported that the patient had his Janssen Covid-19 vaccination on 19-MAR-2021 and on 20-MAR-2021, the patient experienced possible hallucination and patient's son will be going to their house to investigate. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from possible hallucination. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210340686-COVID-19 VACCINE AD26.COV2.S-hallucination. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

Patient developed confusion four days after receipt of vaccine. At presentation to the hospital was confused, dehydrated. Neuroimaging negative, LP showed aseptic meningitis with 30 neutrophils, normal protein and glucose. Numerous tests for bacterial and viral pathogens were negative. Patient improved, and was discharged after a three day stay.

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.

SLEPT A LOT; FEELING VERY TIRED; This spontaneous report received from a consumer concerned an 89 year old male. The patient's height and weight were not reported. The patient's past medical history included artificial valve surgery, and pacemaker surgery, and concurrent conditions included non smoker, sepsis, cancer on shin bone and radiation burn and other pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A and expiry: 23/JUN/2023) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. Concomitant medications included amoxicillin for sepsis. On APR-2021, the subject experienced slept a lot. On 13-APR-2021, the subject experienced feeling very tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling very tired on 15-APR-2021 and the outcome of slept a lot was not reported. This report was non-serious.