Johnson & Johnson

Paient was given vaccination on 3/26/2021 and he said he had fever, nausea and headache which lasted for two days. He took Tylenol OTC.

Pt was seen in the emergency room on 4/1/2021 c/o cough, fever, chills, nausea and poor appetite. He tested positive for Covid 19 and was given ivf in the emergency and sent home for recovery and quarantine.

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.

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.

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.

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.

LOSS OF APETITE; ACHES AROUND SHOULDERS; CHILLS; LEGS DO NOT WANT TO MOVE/SOME WEAKNESS IN THE LEG; TIREDNESS; PALPITATION; This spontaneous report received from a patient concerned a 77 year old male. The patient's weight was 135 pounds, and height was not reported. The patient's past medical history included blood thinner, and hospitalisation, and concurrent conditions included weak heart, alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergy and had no drug abuse or illicit drug use. The patient was previously treated with furosemide for weak heart, atorvastatin calcium for weak heart, and acetylsalicylic acid for weak heart. 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 15-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, Laboratory data included: Oxygen saturation (NR: not provided) 140 (unit was not provided), 68 (unit was not provided). On 15-JUN-2021, the subject experienced palpitation. On 15-JUN-2021, the subject experienced aches around shoulders. On 15-JUN-2021, the subject experienced chills. On 15-JUN-2021, the subject experienced legs do not want to move/some weakness in the leg. On 15-JUN-2021, the subject experienced tiredness. On 16-JUN-2021, the subject experienced loss of apetite. Laboratory data (dates unspecified) included: Palpitation (NR: not provided) 74. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches around shoulders on 17-JUN-2021, and chills on 16-JUN-2021, and was recovering from palpitation, tiredness, loss of apetite, and legs do not want to move/some weakness in the leg. This report was non-serious.

Diarrhea, sometimes uncontrolled, lasting 5 weeks then intermittent for 4-5 weeks. Rx- probiotics and lomotil

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.

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

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.

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.

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.

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

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.

Beginning around 3 AM on 4-11-21 experienced extensive joint pain throughout entire body, and beginning at 10 AM and continuing on, experienced significant nausea.

Bilateral arm swelling: 1. Occlusive thrombus is present within the right cephalic vein extending from the upper arm to the elbow. 2. Nonocclusive thrombus is present within the left basilic vein in the mid and distal arm. also developed acute appendicitis 04/06/2021 and underwent lap appendectomy.

4 days after vaccination, beginning at 3AM on Wed 04-15-21, began uncontrolled and unending concurrent watery diarrhea and vomiting and abdominal pain, and sweating. Taken to hospital by ambulance and admitted for 2 days. I was Administered IV fluids, IV zofran, oral vancoymcin, etc. Upon discharge, I was directed to continue oral Zofran and Vancomycin for 9 more days during which I continued to experience watery diarrhea, nausea, and abdominal cramps.

I received the Johnson and Johnson/Janssen Covid-19 vaccine at the vaccination pod on Thursday, April 8th, 2021 (04-08-2021) at around 12:45 pm. The next morning, Friday, April 9th, 2021 (04-09-2021), I woke up around 9:30 am and felt fine at first. But after taking a drink of water, I felt nauseous. I also had a pressure sensation in the center of my chest below my collarbone. After contacting my doctor's office, my family called 911 at around 11:40 am to have the emergency squad take me to the hospital to be evaluated for a heart attack. At the hospital, I was diagnosed with an acute ST elevation myocardial infarction. I was taken to the catheterization lab for a heart catheterization and a stent was placed in my left anterior descending artery (LAD). I was admitted to the hospital on Friday, April 9th, 2021 (04-09-2021) and discharged from the hospital on Saturday, April 10th, 2021 (04-10-2021).

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

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.

DIARRHEA; This spontaneous report received from a patient concerned a 79 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included celiac disease, atherosclerosis, hypertension, hypercholesterolemia, and iodine allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: 25-MAY-2021) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from diarrhea. This report was non-serious.

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.

He got his vaccine and the next day had extreme fatigue and it did go away after a couple of days. Starting last night he has had diarrhea all night long, nausea and a runny nose that started yesterday. He is very tired, possibly due to the diarrhea. He has not called his doctor or taken anything for it.

The day after the vaccine, he noticed he didn't feel well. Tired, headache, stomach ache, and shortness of breath. This started out mild and as the week went on got worse. Symptoms were leg swelling, shortness of breath, persistent stomach pain, headache, and chestpain. On 6/24 at 3:30 am he went to the ER where they discovered a large (golf ball size) blood clot in his right lung. He also has been diagnosed with pancreatitis. We have talked to five different doctors and multiple other hospital staff who all say it is a direct impact of the covid vaccine.

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

Patient caregiver reports that he woke up at 2 a.m. the morning after the vaccine unable to hold his urine which is unusual for him. He also reported extreme acid reflux symptoms whenever he attempted to drink any fluids at that time as well as nausea. This progressed to difficulty breathing at which time the caregiver was alerted and checked his blood pressure. This reading was 88/55 according to the caregiver and the pulse was very high as well but the actual number could not be remembered. The difficulty breathing prompted them to alert emergency medical services where he was picked up and transported to the emergency room via ambulance shortly after for evaluation.

Pt called Call center on 4/23/21 regarding concerns about his symptoms. Pt complains of vomiting/nausea once a week since 1 and 1/2 month ago after eating and sometimes runny nose. Pt mentioned coming back from a trip out of the country on 3/25/21 and getting Johnson and Johnson vaccine on 4/9/21 and had concerns about the symptoms. Vomiting and nausea started before getting the vaccine and frequency didn't change afterwards. No doctor appt within 24 hrs at the time of call. Advised pt to go to ED.

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.

OCCASIONAL NAUSEA; This spontaneous report received from a patient concerned an 82 year old male. The patient's height, and weight were not reported. The patient's past medical history included atrial fibrillation, and concurrent conditions included irritable bowel syndrome. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-APR-2021, the subject experienced occasional nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from occasional nausea. This report was non-serious.

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

Patient had diarrhea that started about half a day after the vaccine was received (7/22/21). He presented to the emergency department 7/24/21 with chief complaint of diarrhea and bilateral lower extremity weakness.

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

Patient started having abdominal pain on March 26, 14 days after vaccination. Went to ER on March 29 and was admitted. Diagnosed with blood clot in spleen. Discharged from hospital on March 31.

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.

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.

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.

Patient had the vaccine and within 24-48 hours he began to experience pain on his right side-primarily abdomen area. He lives alone and is 86 years old. The pain got worse so he was taken to the hospital. He reports being told that he had a heart attack. He is still in the hospital at this time, but felt that he should report it. He does not know who is doctor is.

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.

BLOOD CLOTS IN URINE; VISUAL BLOOD CLOTS IN PENILE DISCHARGE; DISCOLOURATION OF URINE; BLOOD DISCHARGE AND CLOTS IN STOOL (CLOTS WOULD FALL OUT WHEN WENT FROM SITTING TO STANDING); This spontaneous report received from a consumer concerned an 86 year old white, not Hispanic or Latino male. The patient's weight, height and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 206A21A, expiry: 23-JUN-2021) frequency one total, dose was not reported, administered on 10-MAY-2021 at 10:00 a.m. in left arm for prophylactic vaccination. No concomitant medications were reported. On 11-MAY-2021, the patient experienced clots in stool which would fall out when patient went from sitting to standing. They are about 3 inches in diameter. He also experienced blood discharge. On 12-MAY-2021, he experienced discoloration of urine with unknown origin. From the night of 13-MAY-2021 to the morning to 14-MAY-2021, he experienced clots in urine and visual of blood clots in penile discharge. The patient was hospitalized on 14-MAY-2021 and the duration of hospitalization was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from discoloration of urine, blood discharge and clots in stool (clots would fall out when went from sitting to standing), blood clots in urine, and visual blood clots in penile discharge. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210529768 -JANSSEN COVID-19 VACCINE Ad26.COV2.S- Blood in stool, Discoloration of urine, Blood clots in urine and Penile bleeding. 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).

Vaccine administered 12 APR about 0830 hours and all fine that day. Next day (13 APR) my father awoke feeling tired, somewhat sluggish and experienced a little diarrhea. 14 APR, still a hint of diarrhea but now tired and with pain in the back of his neck and his body ached all over, but pain was mild and these conditions lasted through 15 APR 21. No fever or headache observed. Today he awoke and felt fine, no additional issues to report but will report anything else should it occur.

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.