Johnson & Johnson

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.

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.

DIZZINESS; WOBBLY; OVERALL FEELING TERRIBLE; FOOT ACHE; This spontaneous report received from a patient concerned a 91 year old female. 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: 203A21A expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAY-2021, the subject experienced dizziness. On 17-MAY-2021, the subject experienced wobbly. On 17-MAY-2021, the subject experienced overall feeling terrible. On 17-MAY-2021, the subject experienced foot ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, foot ache, wobbly, and overall feeling terrible. This report was non-serious. This case, from the same reporter is linked to 20210622893.

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.

On 4/8/21 my mother was confused and non-communicative. She couldn't remember events from earlier in the day. We thought she was dehydrated. On 4/10 she had a second event where she was confused and had a delusion. She was hospitalized that night. She had an mri on her brain and I was informed yesterday that she had a stoke in the last 5 days.

11;45 Mom put her light on had shortness of breathe, needed a Nirtro pill. Didn?t give much relief. Was given Ativan for anxiety & Diltiazm for blood pressure.. not much relief, was given oxygen. Then LASIK for fluid build up. Passed about 6;20 A.M. on the 9th.

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

severe anxiety, fear, restlessness, hyper, agitated, talking gibberish, not coherent, she was inconsolable