Johnson & Johnson

on 3/24, she had decreased level of alertness, eating less, but continued to drink. On 3/25, appeared a bit better, but still not at baseline. drinking fluids but not eating. she vomited up black material and then passed away on 3/25.

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

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.

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

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

Patient became weak within 24 hours and declined daily until she died on 4/5/21. Family wanted no intervention except comfort care given patient's wishes.

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

I am the epidemiologist reporting on behalf of patient who tested positive for COVID-19 via PCR on 5/30/21 after the completion of a full Janssen vaccine series (Dose 1 on 5/5/21). The patient later died on 6/03/21. Cause of Death is listed as ?Upper gastrointestinal hemorrhage?. Comments:=======================nnJune 01, 2021 at 3:07 PM by HD nn6/1 3:06 Supervisor Review completed by HD): ICP needednPT resides at ..nPT admitted to hospital- as asymptomatic. No dates were provided. shows specimen collected via hospital on 5/30 and no notes regarding admittance.nClosed as medical barriers.nnn=======================nnJune 01, 2021 at 2:34 PM by CNA, case is hospitalized since 5/30. Head of Nursing sent her to hospital for vomiting and is not currently in the ICU or being treated for any respiratory issues related to COVID,

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

There are two adverse events. First is that the skilled nursing facility (SNF) clinical staff incorrectly listed the patient as unvaccinated when requesting SNF patients be vaccinated by the local health department. The patient was previously vaccinated with Moderna on 1/26 (Lot # 004M20A). This should be listed as a vaccine administration error. Second- Approximately, 1 week after being vaccinated with Janssen on 3/24/2021, the patient tested positive for COVID-19 (4/1/21). At the time, the patient was documented to have an asymptomatic infection, picked up on weekly surveillance testing due to a large outbreak at the nursing facility. I was informed on 6/9/21 that the patient had been referred to hospice on 5/4/21 and died on 5/6/21. The medical records are not yet available (pending from the SNF and hospice agency) but the referral was made due to her COVID illness leading to worsening of her general health status. During this period from 4/1 to 5/4, she remained at the SNF. Notably, she was not hospitalized and did not present to the emergency department for care.

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.

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.

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

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

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

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

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

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.

Approximately 1 week after vaccine, patient began shaking /trembling per caregiver and son. Less shaking 2 days before she died. Following vaccination, appetite decreased and then appetite disappeared 2 days before she passed. History of infection in her foot per caregiver. noted to have a blister on her right toe that became purple/ dark color. MD was notified and was started on an antibiotic. Patient was on palliative care due to advanced age and bedridden status. MD - No autopsy was done.

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.

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.