Johnson & Johnson

3/18/21 ER Triage Nurse Note: "To er via EMS for eval of weakness and dizziness. States he started with sore throat and head congestion last week. Seen PCP Monday 03-15-21. Started amoxil. Took it for 2 days and became dizzy so he quit taking it. Dizziness got worse and came to ER." 3/18/21 ER HPI: 76 y.o. male who presents with c/o weakness cough and fever for the past seven days. Pt report sx are mod better with rest and worse with movement. Transferred to Hospital, dx: pneumonia dt covid-19 virus

Acute metabolic encephalopathy, BPH with urinary obstruction due to blood clot. Patient was vaccinated at a pharmacy with Janssen covid-19 vaccine and experienced headaches and dizziness. Then began to have urinary retention which was believed to be due to a large blood clot requiring 12x 100mL flushes. Patient went to ED at medical center on 3/30/21 and was admitted. He was discharged to nursing home on 4/11/21.

Patient presented to this facility on 5/12/21 as transfer from hospital for treatment of acute hypoxic respiratory failure secondary to COVID pneumonia requiring intensive care unit treatment. Patient did receive a J&J COVID vaccine on 4/7/21. Patient was intubated on arrival. Patient was treated with remdesivir, tocilizumab, steroids, and antibiotics. Patient's ARDS progressed. He developed septic shock, recurrent pneumothoraces, and acute kidney injury on chronic kidney disease. Patient did not improve. Patient was transitioned to comfort care on 5/23/21 and patient expired.

Patient stated he has blood in his urine the evening following vaccination. He went to the doctor and they ran tests and found nothing wrong. About a month later, he reports to us in addition to blood in urine (which resolved in a few days), he now cannot urinate. He went to the doctor again and was given tamsulosin and doxycycline.

76 y.o. male who presents with complaint of right-sided weakness facial droop. Time of onset unknown. Patient has right arm drift, able to raise the right leg against gravity but not against resistance right facial droop. Patient is alert and able to answer questions. Blood pressure is elevated 205/115

Patient came in to the Hospital with blood in the urine since July 3. Patient had been on Kleffx, and then called his own pcp. Pcp adviced he get blood work done at the urgent care. Urgent care was only able to do urine test. Kleffix was discontined and patient was then given Bactrium also Zofran. Patient was complaining of eating very little , denied chest pain, denies SOB. Complained of chills and shaking. No other complaints, Patient did have a chest x-ray. Found on x-ray ground glassin the perfary of right lower lobe. Diagnosis was , acute weakneess, phemonia, hematuria.

Acute respiratory failure- bilateral pulmonary emboli. Acute renal injury. New onset of atrial fibrillation. Patient in ICU intubation occurred on 4.18.2021

Patient caregiver reports that he woke up at 2 a.m. the morning after the vaccine unable to hold his urine which is unusual for him. He also reported extreme acid reflux symptoms whenever he attempted to drink any fluids at that time as well as nausea. This progressed to difficulty breathing at which time the caregiver was alerted and checked his blood pressure. This reading was 88/55 according to the caregiver and the pulse was very high as well but the actual number could not be remembered. The difficulty breathing prompted them to alert emergency medical services where he was picked up and transported to the emergency room via ambulance shortly after for evaluation.

Pt developed L eye vision changes on 3/17/2021 but did not seek medication attention until 3/22 when he saw ophthalmology and was advised to go immediately to ER. After a temporal artery biopsy to r/o temporal arteritis and head/brain imaging studies, he was diagnosed with non-arteritic anterior ischemic optic neuropathy. He was treated and discharged home with close follow up. On 4/5/2021, he developed hematuria and was again hospitalized and found to have an obstructing L ureteral stone. Pt was hospitalized 3 days for first issue, 7 days for second issue.

Initiating on 26 April 2021, the patient experienced gross hematuria. There were no other symptoms associated with the hematuria. On 27 April 2021 with additional hydration the patient experienced decreased hematuria with no other symptoms.

Patient presented to ED on 4/21/21 for weakness that started one week ago. He also complains of decreased appetite and nausea. Patient denies shortness of breath or chest pain. Patient was diagnosed with COVID-19 infection and UTI. COVID was treated steroids and antibiotics, Patient improved and was discharged to ECF for continued convalescence.

Narrative: VETERAN REPORTED THAT HE LOST CONTROL OF BLADDER, HAD SHAKING AND TREMORS IN HANDS LEGS AND BODY. FELT LIKE HE HAD SYNCOPE. LOST ALL STRENGTH. FELL WHEN TRYING TO PICK UP THINGS, COULDN'T GET BACK UP. HAD HA/FATIGUE AND MUSCLE ACHES.TEMPERATURE, GIVEN APAP. DRANK GATORADE. TEMP WAS 101.6, BP 141/68 AT 6AM.

Patient received the vaccine on 4/10/21 and a few days later hit his leg, which subsequently became erythematous and swollen. He went to urgent care on 4/13/21 and received a prescription for doxycycline which he stopped taking prior to resolution of symptoms due to side effects from the medication. He was prescribed clindamycin, but did not start this medication. Patient had outpatient labwork this morning which revealed an elevated SCr, for which he was sent to the ED. The patient was found to have AKI with hyperkalemia, as well as left lower extremity DVT and cellulitis. Patient is being treated with heparin and linezolid, as well as Kayexalate. The patient is being admitted to the hospital for treatment.

URINARY TRACT INFECTION; SPINAL NERVE STIMULATOR IMPLANTATION; POSSIBLE STROKE; ARM TURNING BLACK; LEFT ARM SWOLLEN; EYES NOT FOCUSING; UNABLE TO DO DAILY FUNCTIONS; ISSUES WITH BOWEL MOVEMENT; This spontaneous report received from a consumer concerned an 85 year old,male. The patient's weight was 215 pounds, and height was 71 inches. The patient's concurrent conditions included non-alcohol user, non-smoker, and drug allergy not specified, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: unknown and expiry: unknown) frequency one total, dose was not reported, administered on left arm on 18-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 20-JUN-2021, the patient experienced eyes not focusing, unable to do daily functions and issues with bowel movement, and was hospitalized. On 21-JUN-2021, the patient experienced left arm swollen and arm turning black. On an unspecified date, the subject experienced possible stroke, urinary tract infection and spinal nerve stimulator implantation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from left arm swollen, and arm turning black, had not recovered from eyes not focusing, unable to do daily functions, and issues with bowel movement, and the outcome of urinary tract infection, possible stroke and spinal nerve stimulator implantation was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210740972-Covid-19 Vaccine Ad26.Cov2.S -Possible stroke, Issues with bowel movement, Arm turning black, Urinary tract infection, Spinal nerve stimulator implantation, Left arm swollen, Eyes not focusing, Unable to do daily functions. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

BLOOD CLOTS IN URINE; VISUAL BLOOD CLOTS IN PENILE DISCHARGE; DISCOLOURATION OF URINE; BLOOD DISCHARGE AND CLOTS IN STOOL (CLOTS WOULD FALL OUT WHEN WENT FROM SITTING TO STANDING); This spontaneous report received from a consumer concerned an 86 year old white, not Hispanic or Latino male. 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 administration not reported, batch number: 206A21A, expiry: 23-JUN-2021) frequency one total, dose was not reported, administered on 10-MAY-2021 at 10:00 a.m. in left arm for prophylactic vaccination. No concomitant medications were reported. On 11-MAY-2021, the patient experienced clots in stool which would fall out when patient went from sitting to standing. They are about 3 inches in diameter. He also experienced blood discharge. On 12-MAY-2021, he experienced discoloration of urine with unknown origin. From the night of 13-MAY-2021 to the morning to 14-MAY-2021, he experienced clots in urine and visual of blood clots in penile discharge. The patient was hospitalized on 14-MAY-2021 and the duration of hospitalization was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from discoloration of urine, blood discharge and clots in stool (clots would fall out when went from sitting to standing), blood clots in urine, and visual blood clots in penile discharge. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210529768 -JANSSEN COVID-19 VACCINE Ad26.COV2.S- Blood in stool, Discoloration of urine, Blood clots in urine and Penile bleeding. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

3 days after vaccination, patient was found down in his home. Admitted to ICU from the ER with severe sepsis, bilateral pneumonia, acute kidney injury and rhabdomyolysis. Patient deceased day after hospitalization.