Johnson & Johnson

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

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.

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.

Following vaccine and during observation client complained of being "light headed" and "dizzy" for a few minutes. EMS and Dr on site and client reclined briefly in her car seat. Blood pressure was 150/90 pulse 66 02 saturation 95%. Client was alert and oriented and released when she was feeing better. Advised to seek medical attention later if needed. Client stated she has her "life line" and was wearing it around her neck.

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.

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.

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.

Reports of increasing pain in "all muscles and joints", making ambulation increasingly difficult. Has also increased pain medication from tramadol 4 tabs per day to also include hydrocodone-acetaminophen 1.5 tabs per day.

Pt received the vaccine on 3/9/2021 reports to ED on 3/19/2021 s/p fall while transferring from wheelchair no fractures on x-ray, sent home at 2246. started to c/o chest pain and shortness of breath. Went into cardiac arrest at home approximately 4 hours after leaving ER. Pt was pronounced DOA 3/20/201 @ 0343

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 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

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.

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.