Johnson & Johnson

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.

Shortness of breath leading to primary care physician clinic visit. Continued shortness of breath leading to ED visit. CT angiogram done shows bilateral pulmonary embolism. Patient is currently being treated with Eliquis.

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.

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

91 y.o. female who presents with difficulty breathing onset 1 week ago. States symptoms have worsened the last couple of days and has developed intermittent chest pain, at times on the right lower chest and today on the left upper chest. Patient does have a history of stage III kidney disease, hypertension and was told many years ago that she had congestive heart failure. 3/31/21 admitted observation dx chest pain , sob

SHE WAS PERFECTLY HEALTHY 91 YEAR OLD, ON NO MEDS, RECEIVED HER VACCINE ON TUESDAY AND WAS FINE THAT EVENING. CALLED TO CHECK ON HER WEDNESDAY AT APPROX 9:30 AM, COULD NOT UNDERSTAND WHAT SHE WAS SAYING. CALLED EMS, TRANSPORTED TO EMERGENCY ROOM AND SAID TO HAVE HAD A STROKE.

Pulmonary Embolism RLL Dyspnea and RUQ pain started @ 6 days prior (4/8/2021) to hospital admission on 4/14/2021. Went to hospital secondary to n/v/RUQ pain and was found to have choledocholithiasis. Due to dyspnea, CTA was performed with positive PE. PE was felt to be present on admission. Of note, patient was also found to have a lung mass on the Left upper lobe. Mass has grown from prior CT scans and is considered suspicious. Plan for pulmonology f/u and PET scan is pending.

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.

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.

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

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 04.23.2021, developed leg swelling and was diagnosed with Right lower DVT. Was not admitted to the hospital. Was give RX for Eliquis

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

Doctor ordered vaccine for patient prior to discharge. Vaccine RN went to bedside to provide education with EUA form and VAERS. Pt verbalized understanding, questions answered, sitting up in chair. Administered vaccine per protocol in R deltoid per patient preference at 1429 . Observed pt for 15 min. Patient reported feeling well, and documentation completed. RN left the room at 1448 and then went on to administer another vaccine on the same unit, and previous bedside nurse pulled Vaccine RN aside, and said that the patient became hypotensive at 1450. Per Bedside RN BP was 81/42, HR 84. RN assisted patient back to bed and placed in trendelenberg. Doctor notified. 1457- BP 146/55, HR 75, SaO2 93%. MD ordered 250cc bolus of NS. 1550- BP 138/57, HR 79, SaO2 92% on 2L NC. Patient reported feeling better. Pt was cleared for discharge, and sent home.

Right leg was swollen up and doctor confirmed that she has blood clots. Swelling started two or three weeks after the shot was given.

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

ATRIAL FIBRILLATION; INABILITY TO SWALLOW; BLOOD CLOT IN RIGHT ARM; LOW BLOOD PRESSURE; DEATH 4 DAYS AFTER RECEIVING VACCINE; This spontaneous report received from a vaccine facility via a company representative concerned a 95-year-old female. The patient's height, and weight were not reported. The patient's concurrent conditions included atrial fibrillation. The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. It was reported that on an unspecified date in 2021 the patient received Janssen Covid-19 Vaccine and within 6hrs she had a major atrial fibrillation episode, then several the following day. The next day, she lost her ability to swallow. Two days later she was on oxygen. Three days later she developed a blood clot in her right arm, was still on oxygen and blood pressure was falling. On an unspecified date, the patient died 4 days after receiving vaccine. The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The patient died 4 days after receiving vaccine on an unspecified date, and the outcome of atrial fibrillation, inability to swallow, blood clot in right arm and low blood pressure was not reported. This report was serious (Death, Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210400509: This spontaneous report received from a vaccine facility via a company representative involved a 95-year-old female with the past medical history remarkable for atrial fibrillation who received the Janssen COVID-19 Vaccine for prevention of COVID-19 infection and within 6hrs had a major atrial fibrillation episode. No concomitant medications were reported. The next day, she lost her ability to swallow. Two days later she was on oxygen. Three days later she developed a blood clot in her right arm, was still on oxygen and blood pressure was falling. On an unspecified date, the patient died 4 days after receiving vaccine. No information was provided regarding the cause of death. Considering the patient's past medical history of atrial fibrillation, the causality for the event of atrial fibrillation, as well the consequent events is assessed not related to the Janssen COVID-19 Vaccine.; Reported Cause(s) of Death: DEATH 4 DAYS AFTER RECEIVING VACCINE

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.

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.

Resident developed a femoral, popliteal and posterior tibial DVT. Treated with Xarelto with resolution of symptoms by 6/1/21

Patient taken to local hospital on 05/28/2021 and diagnosed with a DVT left mid and distal femoral vein, left popliteal vein left posterior tibial vein

Respiratory distress, sent resident to Emergency room ; CT scan done showed a small Pulmonary EMbolism.

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.

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

THROWING UP; LOW BLOOD PRESSURE 98/68; This spontaneous report received from a consumer concerned a 97 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: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 21-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-JUN-2021, the subject experienced throwing up. On 21-JUN-2021, the subject experienced low blood pressure 98/68. Laboratory data included: Blood pressure (NR: not provided) low blood pressure 98/68. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from throwing up, and low blood pressure 98/68. This report was non-serious.

Acute occlusive deep vein thrombosis noted in the left proximal and mid femoral and gastrocnemius veins. There is also evidence of acute partially occlusive deep vein thrombosis noted in the left common femoral and distal femoral veins. Patient was initially started on enoxaparin transitioned to apixiban for discharge.

Patient was vaccinated at 2PM (4/12/21) and caregiver said that at 4AM during the night(4/13/21) patient woke up very nauseated. She immediately vomiting and it contained blood. As she vomited more, numerous clots came out which resulted in caregiver calling 911. Patient was admitted immediately to hospital where she remains today (4/14/21). Doctors have performed an endoscopy and other tests to determine the source of the blood clots and treatment options. Caregiver is available if more details are needed.

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.