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.

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.

Patient was in decline in the last month due to increase weakness and increase edema. Daughter visited, found patient unresponsive, taken to hospital - found to be Covid Positive. Patient had had a 15lbs weight loss, had become bed bound, SOB on minimum exertion, incontinent of bowel & bladder. Patient had a pacemaker placed 3 weeks ago. Patient taken to hospice

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.

3 hours after injection patient had tremendous amount of GI GAS, very odd oder (smell). Buildup of gas came suddenly and was unstoppable. Patient feels better after release of gas and cleanup of bowel movement.

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.

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.

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

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.

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,

10 minutes after injection of Janssen vaccine patient became nauseated, HR dropped into the 30's and she vomited. Symptoms lasted 2 minutes and she returned to baseline. No subsequent recurrence of symptoms.

severe diarrhea with abdominal pain that started a few to several hours after vaccination. Symptoms self resolved within 2 days

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

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

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.

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.