Johnson & Johnson

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.

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.

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

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

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.