Johnson & Johnson

on 3/24, she had decreased level of alertness, eating less, but continued to drink. On 3/25, appeared a bit better, but still not at baseline. drinking fluids but not eating. she vomited up black material and then passed away on 3/25.

Fatigue, weakness, dizziness, leg pain, head pain. Had a fall on 3/23, not sure if it was due to the vaccine

Pt. felt OK the day of vaccine. The following night she began to feel tired and said she had chills. The next morning she woke up and had shaking chills which were persistent. She called EMS and was brought to the local ED where she continued to feel shaky and weak. She was admitted to hospital to rule out dehydration , suspected UTI, and Reaction to Covid Vaccine. Her vital signs remained stable. She was treated with 3 days of Rocephin. She had initial weakness and shakiness which gradually improved with Physical Therapy. Pt. was discharged on 4/7.

LOW GRADE BLADDER INFECTION; EXTREMELY WARM SENSATION IN CHEST AND BACK; COUGH; SHORT TERM MEMORY LOSS; COULD NOT REMEMBER; NOT WELL; HALLLUCINATIONS; COULD NOT WALK; COULD NOT FEED HERSELF; CONFUSION; PLATELET COUNT DECREASED; UNABLE TO STAND; FALL; DIZZY; FELT TIRED; WEAKNESS; EYES LOOKED PUFFY; ABDOMEN WAS LARGER; BIBASILAR ATELECTASIS; CARDIOMEGALY; SWELLING IN BOTH LEGS INCLUDING ANKLE AND TOES; LEVEL 4 PITTED EDEMA; This spontaneous report received from a consumer concerned a 90 year old female. The patient's weight and height was not reported. The patient's past medical history included Alzheimer's, and dementia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, 1 total, administered on 08-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 patient felt tired. On 12-MAR-2021, the patient had a fall, was dizzy and unable to stand. On 13-MAR-2021, the patient was taken to the emergency room and had a low grade bladder infection and was treated with intravenous (IV) antibiotic (unspecified) from 13-MAR-2021 to 15-MAR-2021 and from 15-MAR-2021 she was switched to oral antibiotic (unspecified) until 23-MAR-2021. The patient was confused and could not walk. It was reported that, the patient was unable to feed herself. On 13-MAR-2021, the patient experienced platelet count decreased. On 13-MAR-2021, the patient's laboratory data included: electrocardiogram (ECG) which could not rule out anterior infarct age undetermined and her platelet count was 136 (unit non specified). On 14-MAR-2021, the patient had hallucinations and her platelet count was 130 (unit non specified). On 15-MAR-2021, her laboratory data included: abdomen computerized tomography (CT) scan which showed bibasilar atelectasis and cardiomegaly, likely cyst vs hemangioma. Unchanged incompletely characterized exophytic lesion in the left kidney significant and possibly represented a hemorrhagic cyst, further evaluation with magnetic resonance imaging (MRI) would need to be performed for definitive characterization. On 17-MAR-2021, the patient's cognition seemed well. On 19-MAR-2021, the patient started showing symptoms of blood clot. On 19-MAR-2021 to 22-MAR-2021, the patient was not well. The patient was wearing slippers because she had level 4 pitted edema and was swollen from her knees down including ankle and toes. It was reported that, her swelling was greater on the left side than the right side and she had this swelling on 23-MAR-2021. Also, the patient's confusion returned. On 29-MAR-2021, the patient had confusion and her ultra sound of left leg was normal. On 01-APR-2021, the patient's laboratory data included: diagnostic ultrasound revealing contralateral femoral vein was widely patent. On 03-APR-2021 and 09-APR-2021, the patient was confused and did not know where she was. On 07-APR-2021, her electrocardiogram did not mention anterior infarct and it was abnormal ECG no significant change found. On 10-APR-2021, the patient could not remember where she was. On an unspecified date, the patient had cough and extremely warm sensation in chest and back. The patient was in rehabilitation center and was set to be discharged 16-APR-2021. On 13-APR-2021, the patient's platelet count was 171 (unit not specified). On 17-MAR-2021, In rehabilitation center the patient was no longer wearing shoes due to swelling of ankle, legs toes and feet. The patient's eyes looked puffy and her abdomen was larger. The patient was treated with Lasix (furosemide) in the rehabilitation center. According to the patient's physician, the patient had no sign of stroke. The patient was propped up on right side while at rehabilitation center so according to her daughter the patient was experiencing weakness. At rehabilitation center an ultrasound was ordered for left leg. The patient's both legs were swollen and one was more swollen than the other. The patient was having an issue with memory and confusion which was unusual as the patient had previously been treated neurologist for Alzheimer's disease and dementia and was highly intelligent. At the time of this report, the patient was being treated for low grade bladder infection. The patient's primary care physician reports that she had no concerns about the vaccine being linked to the patient's fall and hospitalization and reported that there were no blood clots, no stroke, no deep vein thrombosis, and no coagulation abnormalities. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from not well on 22-MAR-2021, was recovering from platelet count decreased, and the outcome of cough, swelling in both legs including ankle and toes, extremely warm sensation in chest and back, confusion, fall, hallucinations, low grade bladder infection, could not feed herself, could not walk, felt tired, dizzy, unable to stand, level 4 pitted edema, could not remember, eyes looked puffy, abdomen was larger, weakness, short term memory loss, bibasilar atelectasis and cardiomegaly was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: v0 This spontaneous report involves a 90-year-old white female patient with the past medical history remarkable for Alzheimer's and dementia who felt tired 3 days after the Janssen COVID-19 Vaccine Ad26.COV2 had administered. The next day the patient had fell, was dizzy and unable to stand. The next, the patient was taken to the emergency room and was diagnosed with a low grade bladder infection. The patient was confused and could not walk and was unable to feed herself. The next day, the patient had hallucinations and her platelet count was 130 (unit non specified), normal range 179-450. While hospitalized, the patient started showing symptoms of blood clot, had pitted edema, could not remember where she was. On an unspecified date, the patient had cough and extremely warm sensation in chest and back. The patient's eyes looked puffy and her abdomen was larger. The patient's primary care physician reports that she had no concerns about the vaccine being linked to the patient's fall and hospitalization and reported that there were no blood clots, no stroke, no deep vein thrombosis, and no coagulation abnormalities. Considering the patient's age, gender – predisposes to urinary tract infections, as well as the underlying Alzheimer's and dementia the causality for the events assessed not related to the vaccine.

Pt began experiencing bilateral leg pain and swelling. Bilateral US today reveals DVT of right calf through mid superficial femoral vein and DVT of left popliteal and left superficial femoral vein. Patient placed on Eliquis.

ACHY; CHILLS; FLU LIKE FEVERISH; MILD/SEVERE HEADACHE; SORE ARM; This spontaneous report received from a patient concerned a 90 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was in excellent health, exercises and eats vegetables.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 05-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, treatment medications included: acetylsalicylic acid, and naproxen sodium. On 05-MAY-2021, the subject experienced sore arm. On 05-MAY-2021, the subject experienced mild/severe headache. On 23-JUN-2021, the subject experienced achy. On 23-JUN-2021, the subject experienced chills. On 23-JUN-2021, the subject experienced flu like feverish. On 27-JUN-2021, Laboratory data included: Lab test (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achy, chills, and flu like feverish, and sore arm on 12-MAY-2021, and had not recovered from mild/severe headache. This report was non-serious.

Patient was in decline in the last month due to increase weakness and increase edema. Daughter visited, found patient unresponsive, taken to hospital - found to be Covid Positive. Patient had had a 15lbs weight loss, had become bed bound, SOB on minimum exertion, incontinent of bowel & bladder. Patient had a pacemaker placed 3 weeks ago. Patient taken to hospice

BURNING ALL OVER THE BODY; FEVER; HEADACHE; NOT BEEN ABLE TO SLEEP; BODY ACHE; This spontaneous report received from a patient. The patient's height, and weight were not reported. The patient's concurrent conditions included high cholesterol, high blood pressure, and sulfonamide allergy, and other pre-existing medical conditions included patient had not pregnant at the time of reporting. The patient experienced drug allergy when treated with codeine. 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 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced not been able to sleep. On 09-APR-2021, the subject experienced body ache. Laboratory data included: Body temperature (NR: not provided) just below 100 F. On 09-APR-2021 12:30, the subject experienced burning all over the body. On 09-APR-2021 12:30, the subject experienced fever. On 09-APR-2021 12:30, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from burning all over the body, and the outcome of fever, headache, not been able to sleep and body ache was not reported. This report was non-serious.

J&J vaccine, extremely dizzy, fainting spells, vertigo started on March 26, 2021. Went to ER after reaction becoming worse on April 8, resulting in falling outside in yard. Dr advised going to ER after visit on April 13. Symptoms were stroke and or blood clots. At hospital they took multiple tests but inconclusive if she had a stroke or blood clots. Took CT scan of brain looking for bleeding on the brain. They have all test results. Today still has vertigo, weakness, and fainting spells.

ALLERGIC REACTION WAS RASH IN BLOTCHES AND HIVES THAT MOVED ALL AROUND THE BODY, SEVERE ITCHING. DIZZINESS, WEAKNESS, TIREDNESS, HOT AND COLD FLASHES ALL CONTINUEING FOR NOW THE 6TH DAY FOLLOWING VACCINE.

Onset of shingles rash and pain on the chin and peri-articula area on the right side also red right eye

Resident c/o L arm pain on 4/7/2021 approx 2300. Resident transferred to ED for evaluation, CT abnormalities, transfer to higher level of care, clot manually removed on 4/8/2021, resident returned to nursing facility on 4/12/2021 without complications

on the third day began to feel headache, body aches, and extreme fatigue. On day 9 I saw that my face was drooping and mouth was crooked, my L eye did not close, L ear pain, L buzzing in ear. I was taken to emergency room and admitted to the hospital on 4/5/21. Was diagnosed with Bell's Palsy. Was discharged back home on 4/8/21

Cardiac arrest at home Patient found down at home by son; son found patient drooling; initially thought she was sleeping but found her with her eyes open sitting in a recliner unresponsive at home. EMS arrived and CPR was initiated; patient was intubated and transferred to local hospital. CPR was performed approximately 10 minutes. Per family, patient was in normal state of health prior to incident

SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; FEELING COLD; FEELING SICK; NO ENERGY; FEELING TIRED; This spontaneous report received from a patient concerned a 92 year old female. The patient's height, and weight were not reported. The patient's past medical history included dropped bladder, and concurrent conditions included non-alcohol user, non-smoker, penicillin allergy, hard time hearing, and hard time understanding. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: 28-JUL-2021) 1 total, dose was not reported, administered on left arm on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. After vaccination, the patient had no side effects. On unspecified date in MAY-2021, the patient was sick and had cold (put a sweater while was 90 F). She felt tired and had no energy. The patient had stated that she was usually energetic. The patient had blood work done on 03-JUN-2021 and chest X-ray on 07-JUN-2021 for which results were not reported. The patient's physician informed that her test results showed that she did not get the COVID-19 vaccine. It was reported that, the patient had covid-19 antibody test which came back negative (suspected immunological vaccine failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected immunological vaccine failure, feeling cold, feeling tired, feeling sick and no energy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210630052-COVID-19 VACCINE AD26.COV2.S-Suspected Immunological Vaccine Failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.

My Mother received the shot at 10:30 am at home. She is on hospice, in a wheelchair. By 11:00 am she started to become unresponsive. By 1:00pm she was unable to blink her eyes, move her mouth, lift any limbs, open her mouth, or swallow water. She was completely helpless and appeared paralyzed. This did not go away until after 5:00 pm when she was able to swallow water fed to her. By 7:00 pm she was responsive, but extremely weak. It took a few days for her to regain her strength. The only reason she was given this shot was that it was required for her upcoming admission into a skilled nursing facility.

Patient became weak within 24 hours and declined daily until she died on 4/5/21. Family wanted no intervention except comfort care given patient's wishes.

POUNDING WHOLE BODY ACHES, SHOOTING IN HER LEGS AND BODY, STABBING PAINS; BONES HURT (KNEES, ARMS); UPPER ARM PAIN; This spontaneous report received from a patient concerned a 93 year old female. 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) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced bones hurt (knees, arms). On APR-2021, the subject experienced upper arm pain. On 13-APR-2021, the subject experienced pounding whole body aches, shooting in her legs and body, stabbing pains. Treatment medications included: paracetamol. On 18-APR-2021, treatment medications included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from upper arm pain on APR-2021, and had not recovered from pounding whole body aches, shooting in her legs and body, stabbing pains, and bones hurt (knees, arms). This report was non-serious. This case, from the same reporter is linked to 20210436303.

Pt had seizure x2 while in clinic during observation period. Son stated that pt does have seizure disorder and anxiety does exacerbate seizures. Pt denies feeling anxious about vaccine. Initially pt was unresponsive to stimulii, but then opened her eyes and was able to follow commands and answer questions. O2 sats during initial seizure was 86% and BP 190's/80's. Pt with tonic clonic movement during initial seizure. Pt then had subsequent seizure but did not lose consciousness during this one but was unable to respond to stimulii or commands. O2 sats low 90's during this event. Pt's son stated that it was not normal for her ot have clusters of seizures like this and so EMS was called.

SEIZURE; This spontaneous report received from a consumer concerned a 94 year old female. The patient's weight was 135 pounds, and height was 60 inches. The patient's past medical history included heart rate, oxalate and polysorbate sensitivity, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular and batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination on the left arm. No concomitant medications were reported. On 23-MAR-2021, the patient experienced seizure, had to be taken by ambulance to hospital and was hospitalized for 5 days. She was in ICU for 3 days. On 26-MAR-2021, Laboratory data included: MRI (NR: not provided) MRI showed no damage Mitral Valve Regurgitation. The Patient was discharged on 27-Mar-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from seizure. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210400319- JANSSEN COVID-19 VACCINE Ad26.COV2. S- Seizure. 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.

RESIDENT COMPAINED OF PAIN TO BILATERAL THIGHS AND LOWER BACK SENT TO ER. NOTIFIED BY ER, PATIENT HAS BLOOD CLOTS IN ABDOMIN

Per Dr. patient has been complaining of arm pain since she has received the vaccine. He said he scheduled for patient to go get an MRI/scan done to see what is going on. Dr. requested that the pharmacy complete a VAERS report for patient.

INJECTION SITE HAS A MASS BRUISE COLOR BLACK AND BLUE WITH RED DOT IN THE MIDDLE; LT ARM IS HEAVY; NO ENERGY; WORN OUT; This spontaneous report received from a patient concerned a 94 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included cancer, asthma, hypertension, arthritis, and carpal tunnel, and other pre-existing medical conditions included the patient had no known allergies and did not had any drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-MAY-2021, the subject experienced injection site has a mass bruise color black and blue with red dot in the middle. On 29-MAY-2021, the subject experienced lt arm is heavy. On 29-MAY-2021, the subject experienced no energy. On 29-MAY-2021, the subject experienced worn out. On 29-MAY-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tired, no energy, lt arm is heavy, and worn out, and the outcome of injection site has a mass bruise color black and blue with red dot in the middle was not reported. This report was non-serious.

About 8 pm the chills started I went to bed , 9:30 my muscles and joints ached. My fever was 99.6, I don't believe I have ever had anything hurt so bad. 10:30 I took an extra strength Tylenol. Back to bed about 12 I did not hurt as bad but still cold. My fever in the morning was 100.2. Took another Tylenol. So tired. Slept for 2 hrs. and felt a little better but my muscles still hurt and still had fever. Monday morning I was a little better and by evening I thought I would live. If it had been a two shot deal. no way would I have gone back for another one.

Developed severe right leg pain within two days after the vaccine. She had confirmed deep venous thrombosis on ultrasound confirmed on 4/23/21 without other known provocation.

only on right side of face- numbness and swelling in the lower part. this happened on 3 separate occasion. 1 day after/ 1 week after/ then maybe 10 or 11 days post vaccine. she feels like it is getting ready to start again today

Patient received her shot and felt very weak within 24 hours. The week of 4/4/2021 began to feel dizzy and stated she felt unwell. Her blood pressure and heart rate were taken and she was having an elevated heart rate. Her normal heart rate is around 50 BPM and her heart rate jumped to over 100 BPM. This continued on and off for a couple of weeks. The week of 4/18/2021, began having shortening of breath. On 4/25/2021, was found in her home unresponsive. Suffered a stroke and was taken to a hospital. She was transferred to a hospice unit on 4/26/2021. She passed away on 4/28/2021

profound exhaustion, unable to stay awake even with stimulation, severe anorexia - unwilling to eat pleural effusion +4 leg edema UTI felt like she was shaking internally (found it painful) felt hot (not common) body aches outcome=death

Patient was a high functioning 97-year-old female with a history of CLL diagnosed 1 year ago on no treatment prior to arrival, chronic stable thrombocytopenia, chronic kidney disease, past history of breast cancer and bladder cancer in remission, transfusion dependent anemia of chronic disease, covid 19 vaccination on 3/5/2021, who presented to the emergency room on 3/25/2021 unresponsive found by the family and emergency services was called. The paramedics found her temperature to be 101.6 and her room air sat was 87%. In the ER CT of the head revealed acute subarachnoid hemorrhage. There was no trauma. CT the abdomen and pelvis showed lymphadenopathy and splenomegaly consistent with her known CLL and new bilateral lung infiltrates. Patient's white blood cell count was 124,000 consistent with her known CLL. Patient prior was high functioning and still drove herself to her doctor's appointments. The day prior she told her son she was feeling slightly nauseous and ill and went to bed early. She was admitted with a subarachnoid hemorrhage which was felt to be spontaneous and not traumatic. She was not on any anticoagulation prior to arrival. She was also admitted with severe sepsis felt possibly due to aspiration pneumonia or pneumonia in general and she did have fever and bilateral infiltrates on imaging. covid 19 and influenza neg. The decision was made to place her on comfort care after discussion with family. She ultimately expired on 3/28 At 14:48 PM in the presence of her family

severe lower extremity weakness. on 4/13/2021 experienced myalgias and generalized weakness/malaise, which have persisted. on 4/21/2021 the patient was able to walk using her walker however extremely slowly. At baseline she is able to walk around the house with a walker relatively briskly. on 4/22/2021 the patient was unable to transfer from a sitting to standing position, and was no longer able to ambulate with her walker.

Approximately 1 week after vaccine, patient began shaking /trembling per caregiver and son. Less shaking 2 days before she died. Following vaccination, appetite decreased and then appetite disappeared 2 days before she passed. History of infection in her foot per caregiver. noted to have a blister on her right toe that became purple/ dark color. MD was notified and was started on an antibiotic. Patient was on palliative care due to advanced age and bedridden status. MD - No autopsy was done.

Received a Janssen vaccination on 4/7/21 from a home visiting nurse from the County Health Department. On approximately 4/13/21, the family noticed slight signs of an issue, with patient slumping towards the right, and showing some signs of weakness on right side of body. Family contacted the PCP, who advised to take her to the ED. Family was hesitant to do that because patient had been bedridden for past few years. She seemed to improve somewhat on 4/15/21. Then the morning of 4/16/21, the family found her on the floor of her bedroom. She appeared to have had a moderate to severe stroke. Right side of body paralyzed, cannot speak. Uncertain whether mental faculties further deteriorated. PCP ordered a hospice facility for care. Stroke likely caused by blood clot but unsure if related to JJ vaccine. She has not been evaluated in person by her health care providers.