Johnson & Johnson

Patient arrived at observation area after getting vaccine at 5:40 PM. Patient complained of SOB and feeling unwell. V/S taken. Patient feels fine after sitting for 10 minutes.

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

EAR RINGING; FATIGUE; This spontaneous report received from a consumer concerned a 90 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included unspecified medical issues, and fatigued. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported,) dose was not reported, administered on 14-MAR-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 14-MAR-2021, the subject experienced ear ringing. On 14-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, and the outcome of ear ringing was not reported. This report was non-serious.

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.

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.

This patient developed COVID-19 about 3 weeks after being vaccinated. The patient had the Janssen adenovirus COVID-19 vaccine at a local pharmacy. She developed COVID-19 on 6/19/2021 and was diagnosed at the urgent care, placed on Zithromax, medrol dosepak, and albuterol MDI. Also was placed on hydroxychloroquine. She developed hypoxia on the 25th of June, and acute on chronic renal failure, was transferred for higher level of care to medical Center. Discharged eventually and re-presented on 7/1/2021. Was sent home with continued oxygen. Patient was confused and kept taking oxygen off at home and was direct admitted by myself on7/1/2021. I was treating her daughter for the same infection (COVID-19). The patient rebounded, had normal mental status, but continued to have signs and symptoms of a severe COVID-19 pneumonia. On 7/4/2021, the patient had a sudden escalation in oxygen requirement, sudden drop in blood pressure, and she became febrile and hypotension and septic. She did not recover. Eventually family elected to withdraw care and the patient expired. Was on remdesivir,dexamethasone, had a dose of actemra, had vitamin C, Vitamin D, zinc

day following vaccination (vax administered around 1:44pm on 3/9), on 3/10 slight headache in morning, by around 1:30pm severe headache, could hardly open eyes, was very nauseous, severe diarrhea, slept for 16hours. Symptoms continued, less severe but not debilitating on 3/11. Even today (3/16) if bend over get dizzy and head throbs. Doesn't feel very secure if moves quickly -- affected her entire body, slowly improved each day, but not back to normal 7 days later. Wasn't eating much due to nausea in days following. slow improvement but unable to return to normal routine b/c still not feeling well.

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.

DIARRHEA; SLIGHT FEVER; SLEEPING A LOT; SICKNESS; CHILLS; FEELING NOT WELL; NAUSEA; HEADACHE; This spontaneous report received from a consumer concerned a 91 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, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) Negative. On 08-APR-2021, the subject experienced sleeping a lot. On 08-APR-2021, the subject experienced sickness. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced feeling not well. On 08-APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced slight fever. On 13-APR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, headache, chills, feeling not well, diarrhea, slight fever, sleeping a lot and sickness was not reported. This report was non-serious. The suspected product quality complaint has been confirmed to be voided (did not meet pqc criteria) based on the PQC evaluation/investigation performed.

Resident had Johnson Vaccine on 6/25 at approximately 11:30am, had no initial symptoms on the day of vaccination. On 6/26, resident was alert and verbal all day, VS 98.1-93-18-119/77-95% on R/A , respositioned frequently in bed, at 5pm CNA was doing care and alerted nurse of res c/o not feeling well " I feel like im going to die" fingertips purple unable to obtain 02sat, color pale temp 98.3, pulse 110, RR 22, BP 87/53 res stating " please rush me to the hospital" , HCP and MD contacted, transfer orders given, resident left facility via ambulance at 5:20pm. Per hospital on 6/27 at 7:00AM resident in the ICU at this time.

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.

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

11am Resident vaccinated. 2pm Chest congestion, STAT dose of Solumedrol and non rebreather applied. Resident had small amount of emesis and was suctioned. Was being monitored and expired at 2:30 pm

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.

SLEEPY; TIRED; This spontaneous report received from a patient concerned a 94 year old female. The patient's weight was 137 pounds, and height was not reported. The patient's concurrent conditions included atrial fibrillation, oral cancer, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had allergies but can not remember which allergies patient had. 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 admin not reported, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. Concomitant medications included diltiazem for atrial fibrillation, acetylsalicylic acid, biotin, calcium carbonate/magnesium hydroxide/zinc, colecalciferol, glucosamine hydrochloride, glucosamine sulfate, magnesium, and nutrients nos. On 29-MAY-2021, the subject experienced sleepy. On 29-MAY-2021, the subject experienced tired. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Clear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sleepy, and tired. This report was non-serious.

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.

This spontaneous report received from a patient concerned a 95 year old Asian female. The patient's height, and weight were not reported. The patient's concurrent conditions included macular degeneration. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the patient experienced tiredness. On 01-APR-2021, the patient experienced blurry vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blurry vision, and the outcome of tiredness was not reported. This report was non-serious.

SHE STARTED FEELING ILL THE NEXT DAY AND THEN 4 DAYS LATER SHE STARTED GETTING LARGE RED SPOTS WENT TO URGENT CARE AND THEY INFORMED US THAT SHE HAD SHINGLES...AND IT WAS CAUSED BY THE COVID SHOT.

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

HIGH BLOOD PRESSURE; COULDN'T WALK; COULDN'T DO ANYTHING; SO SICK; NOT FEELING WELL; VERTIGO; VOMITING; NAUSEA; This spontaneous report received from a patient concerned a 96 year old female. The patient's weight was 128 pounds, and height was not reported. The patient's concurrent conditions included arthritis, neuropathy, thyroid issue, non smoker, non alcohol user, diabetes, and cannot walk without a walker, and other pre-existing medical conditions included patient had no known allergies. 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 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced vomiting. On MAR-2021, the subject experienced nausea. On 31-MAR-2021, the subject experienced vertigo. On an unspecified date, the subject experienced high blood pressure, couldn't walk, couldn't do anything, so sick, and not feeling well. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 200 over something. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vertigo, high blood pressure, not feeling well, couldn't walk, couldn't do anything, and so sick, and the outcome of nausea and vomiting was not reported. This report was non-serious.

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

resident with acute SOB on 4/13 sent to ED dx with pneumonia. Sent to rehab. Passed away in her sleep on night of 4/20/21

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.

pts granddaughter says she was not feeling well and a couple of weeks after taking the vax and had to call 911 on 4/16/2021. Paramedics took her to Hospital ER, in same city and state as patient, where she was admitted. She called her granddaughter 4/18/2021 and told her she had tested positive for Covid Virus while at the hospital and that she had a blood clot on her lung. She is being treated w/ a blood thinner.