Pfizer

Two seizures of Left arm shaking and non-responsiveness with urinary voiding and post-ictal state the day after vaccination

1st dose of vaccine was 1/12/21, Lot number EK9231 2nd dose 2/2/21, Lot number EL8982 Patient was feeling well the day of vaccine and reports no recent illness, no adverse events to first injection in COVID vaccine series. 20 minutes later developed dizziness and nausea. Within hours noticed LUE weakness. Weakness has progressed over last two days to severe left upper extremity and left lower extremity weakness with inability to walk. No sensory deficits. Some urinary retention. Hyperreflexia on examination with upgoing toe on left. Presentation consistent with transverse myelitis. Patient remains hospitalized at this time, starting treatment with IV solumedrol for clinical transverse myelitis. Workup remains in process

About 4-5 hours following injection, started to feel tired and achy. Went home to bed, slept for several hours. Woke up, went to sleep again. Woke in the middle of the night feeling urgent pressure to urinate. Rose to go to bathroom, became dizzy, fell and lost bladder control. Returned to bed with help from spouse. Measured fever of 100.2. Awoke in the morning feeling some better. By mid morning was sitting up in house. Fever and aches were dissipating. By evening felt normal except for fatigue.

Patient was vaccinated tihe Pfizer #1 2/12/21. Started feeling weak 2/13 and presented to ED on 2/14. Was admitted to Hospital. Found to be COVID +, required O2 per NC 2-3 L for approx 24 hours. Was found to have NSTEMI. Was transferred for speciality/cardiology care at General Hospital. Was on heparin gtt. Cardiology-no intervention. Was not treated for COVID and was discharged to home on 2/16. Was unable to care for himself at home and was readmitted with in hours. He has failed discharge twice and is being now discharged to SNF

Patient presented to ED on 3/15/2021 with fatigue, subjective fevers, dry cough, and diarrhea found to have COVID pneumonia. CT PE negative at that time. Hospitalization complicated by RUE superficial cephalic vein thrombus, epistaxis, GIB, gluteal abscess, and AKI. Patient made DNR. Suspected cause of death: ventricular tachycardia secondary to renal failure and metabolic abnormalities in the setting of COVID ARDS.

Could not eat all next day - slept around the clock.; 27 hours later nausea; headache; muscle ache; temperature of 99.5; discolored (orange) urine.; 1st day - sore arm only.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 76-years-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EK 32 48), via an unspecified route of administration, administered in Arm Left on 30Jan2021 at 17:45 as single dose for COVID-19 immunization. Medical history included high blood pressure. No known allergies were reported. Concomitant medications included atorvastatin calcium 40 mg, Metoprolol succinate 25 mg, Colecalciferol (D3) 25. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since vaccination patient was not tested for covid-19. On 30Jan2021, first day after vaccination, the patient had sore arm only. On 31Jan2021 at 10:00 pm, 27 hours later of vaccination, patient experienced nausea, headache, muscle ache, temperature of 99.5 and discoloured (orange) urine. The events were considered nonserious. Patient could not eat all next day and slept around the clock, drank a little bit of bubbly water. After 48 he later patient began to feel a little better and ate some grapes. The patient had not yet recovered from the events.

This is a spontaneous report from a contactable physician. A 76-year-old male patient received BNT162B2 (BNT162B2), dose 1 intramuscular on 25 Feb 2021 (Batch/Lot Number: EN6198) at single dose for COVID-19 immunization administered at clinic. Medical history included hypertension, blood cholesterol increased, myocardial infarction, colon cancer (had surgery for that and also had chemotherapy), coronary artery disease (30% blocked coronary artery), covid-19 from 19May2020 to an unknown date. Concomitant medication(s) included lisinopril for hypertension; amlodipine; rosuvastatin for blood cholesterol increased; evolocumab (REPATHA), subcutaneously at 140 mg (twice a month) for blood cholesterol increased. The patient reported, he was diagnosed positive with COVID-19 on 27May2020 from which he seem to have recovered without any residues of symptoms or side effect. He received first Pfizer COVID vaccination at noon time this past Thursday 25Feb in a vaccination clinic set up, the following day Friday the 26 he woke up the next morning and entire body was so sore from head to toe and could hardly get himself out of bed, but when he got up, he was having difficulty walking, so anyway he stayed in bed all day on 26 and 27. He initially had a slight temperature, some chills, slight cough, runny nose and those symptoms except for the cough seem to have resolved, what hasn't resolved is about every 30 or 40 minutes or so he had been having to urinate ever since 26Feb2021 night, his mouth has been constantly very dry. Still urinating every half hour 45 minutes and ongoing. Mouth has been very dry and had a couple of areas where it seems like maybe he had bit his lip or something, maybe when he was sleeping. It was nothing like that in mouth anymore but the mouth is still constantly so dry like dehydrated and no matter how much of fluid he drank that doesn't seem to help it and what in fact has also caused was on yesterday morning he had been a little constipated on Friday night and then yesterday morning had a severe case of diarrhea. Now he had not had another bowel movement since yesterday morning as no appetite and feeling so lousy, and so tired and fatigued. He had been feeling even much worse since getting the vaccine. He still feels very fatigued, very sore all over, very tired, still have the slight cough and he would say that's about it. Outcome of events for cough, pain and tiredness was not recovered and for the rest of the events it was unknown. No follow-up attempts are possible. No further information is expected.

3/5, admitted 3 days after covid vaccine and died. Patient presented to ED feeling very weak and had fallen and could not get up. He was brought to the emergency room, and a trauma evaluation was negative. He was found to have a severe junctional bradycardia with a heart rate in the 20s and systolic blood pressures in the 60s. In addition, he was found to have a creatinine now of greater than 5 when his previously had been in the low 1s. Patient admitted with junctional bradycardia, acute renal failure, hypotension, cardiogenic shock, and acute hypoxemic respiratory failure with high O2 needs. PMH significant for CAD, pulmonary HTN, aortic stenosis, obstructive lung disease, and chronic hypoxia. This patient has been made DNR/DNI over the weekend which is quite appropriate. Patient was found to be unresponsive with fixed/dilated pupils, absent heart and breath sounds, no respiratory effort, absent pulses, and no response to painful stimuli. Patient was pronounced deceased on 03/10/2021 at 0405.

ED to Hosp-Admission Discharged 4/28/2021 - 5/4/2021 (6 days) CRNP Last attending ? Treatment team COVID-19 virus infection Principal problem HPI: For complete history and physical see the H&P dictated by Dr. on 4/28/2021. This is a 76-year-old male who presented to the emergency department with upper respiratory symptoms for three days. He reports having cough, sneezing, runny nose and poor appetite. His caregiver had Covid recently and he was exposed. He was admitted for further evaluation and treatment. Hospital Course: Patient was admitted inpatient to the medical surgical floor. He was not on telemetry. Patient reports that his caregiver had recently tested positive for Covid and he was exposed. He has been having upper respiratory symptoms including cough, sneezing, and runny nose. His COVID-19 test was positive. He was started on the COVID-19 treatment protocol which included IV remdesivir and IV dexamethasone. He underwent a CT scan of the chest which showed small patchy areas of groundglass infiltrates in the peripheral portions of the left and right upper lobes and also the posterior aspects of the right lung base. These findings are probably due to pneumonia. Hospital course consisted of gentle hydration with IV normal saline. He was also started on antibiotic therapy oral azithromycin and IV Rocephin. He had completed the course of antibiotics while on the unit, therefore, at the time of discharge no antibiotics were prescribed. He initially was hypoxic and started on nasal cannula oxygen to maintain pulse oximetry greater than 92%. Eventually, oxygen was weaned and pulse oximetry on room air has remained in the 95-96% range. He has a history of diabetes mellitus and while on the unit blood glucose levels have fluctuated. His point-of-care glucose have been in the 80-500 range. He has had numerous episodes of hypoglycemia and insulin has been adjusted. The fluctuations of the blood glucose levels may be secondary to IV dexamethasone. At the time of discharge he will continue dexamethasone 6mg daily for the next three days. He was advised to increase insulin 70/25 insulin five units daily for the next thre days. After that time he can return to his normal dose of insulin. He also had been treated with IV remdesivir and had completed the 5-day course. On examination today he has been asymptomatic. He denies any chest pain, dyspnea, abdominal pain, nausea, or vomiting. The initial lab studies showed an elevated creatinine level, although he has a history of chronic kidney disease. At the time of discharge the creatinine level trended downward and he was advised to follow-up with the primary care provider for possible repeat BMP in 1 to 2 weeks. All other lab studies have been within normal limits. The systolic blood pressure has been in the 120-150 range. The most recent systolic blood pressure was 151/66 mmHg with a heart rate of 66 bpm. He denies any lightheadedness or dizziness. He was advised to continue all of his current medications. While on the unit he was in isolation secondary to COVID-19. At the time of discharge he should maintain social distancing/isolation, mask wearing and good handwashing. He will will need to follow-up with the primary care provider. He was also advised if the oxygen level dips below 89% he will need to return to the emergency department. At this time he is resting comfortably, offers no complaints and is stable for discharge. Patient is alert, oriented answering all questions appropriately. He is continent of bowel and bladder. Heis able to make his own decisions. He is able to performhis own ADLs. . At this time he is in agreement with the plan and feels comfortable to be discharged home. Thank you.

Wife stated that Husband passed after receiving dose of Pfizer vaccine, he developed a Guillain-Barre Syndrome after receiving vaccine. Wife stated that he lost ability to walk, ability to speak was severely impacted, had difficulty eating and drinking bc his throat muscles were effected from the syndrome. Then, he couldn't sit up in bed. Then, after was diagnosed that's when his kidneys started to fail and then his heart stopped. DOD: 04/06/2021

developed flu-like symptoms after two weeks. Nausea. Loss of appetite. Wife admitted for renal failure. Patient admitted for acute on chronic heart failure. Now with gouty arthritis. Patient states it?s too much of a coincidence. They will not take another dose.

After the first vaccine he suffered a massive brain bleed. Then in the nursing home he contracted Covid-19 and was in Hospital Heart Transplant unit for 6 days. After 4 or 5 days back in the nursing home he contacted Covid-2 pneumonia. His balance is off he has memory loss and a lot more.

Increased temp of 99.2F oral, extreme fatigue, lethargy, episode of incontinence, hallucinations beginning in the morning and has continued through the day.

Narrative: See "Other Relevant History" in Section 6 above Symptoms: ElevatedLiverEnzymes & death, pneumonia, afib Treatment:

Started getting dark urine and continued getting darker. Went to Hospital emergency dept. and was admitted on 1/31/2021. Tested for Covid negative. Blood test revealed low red blood cells. Urine tests and blood tests were inconclusive on 1/31.

Narrative: See "Other Relevant History" in Section 6 above Other Relevant Hx: 76yo man with a history of for C5 tetraplegia 2/2 cervical stenosis leading to neurogenic bowel/bladder (chronic suprapubic catheter) and chronic respiratory failure with tracheostomy, severe dysphagia s/p G tube placement and multiple aspiration pneumonias, COPD GOLD III, hx MRSA bacteremia (7/2018) and E coli bacteremia (12/2019). Patient transferred from Spinal Cord Injury until to ICU on 1/11/2021 due to worsneing dyspnea, hypoxia (80s) and tachycardia and was found to have acute hypoxic respiratory failure likely 2/2 multifocal pneumonia. CXR findings of "There is interval increase in patchy airspace infiltrates and consolidation in bilateral lungs concerning for pneumonia" Patient was started on vancomycin and pip/tazo on 1/11 and tracheal aspirate cultures were obtained for VAP diagnosis which ultimately grew Serratia liquifaciens and Proteus mirabilis. Infectious Diseases was consulted who recommended a switch to ertapenem therapy for a total 10 day course for VAP. UCx/BCx remained negative. On 1/20, a therapeutic bronchoscopy was completed with cultures growing Stenotrophomonas maltophilia and pan-S Klebsiella pneumoniae. The following day a chest tube was inserted and the course of ertapenem completed but vancomycin was continued. By 1/22, patient developed shock liver with ALT/AST 2135/1579 from normal range the day prior and SCr increased to 1.3 from baseline 0.7/cystatin C of 2.46 up from 1.15. Levofloxacin was added for Stenotrophomonas coverage. By 1/25, patient's clinical status continued to decline and Cardiology was consulted for new onset Afib with RVR. Discussion was documented with patient's family who requested DNR. Patient passed away in the early AM on 1/26. Demise does not appear to be related to COVID-19 vaccination but occurred in recent timeframe. Symptoms: ElevatedLiverEnzymes & death, pneumonia, afib

Thrombocytopenia, SkinRash, Rash & ElevatedBunSCr Narrative: Petichial rash. Patient had IV contrast dye 1/19 no reaction. Patient on Apixiban for a. fib.

Patient was vaccinated at 11:30am. By 7pm he started presenting symptoms of fatigue, chest pain. Patient urinated and defecated in himself. Was not feeling well. Patient died at 10:30pm.

Fall 2/4 hospital admission 2/7/21 with death on 2/8/2021. Patient continued to decline on Bipap he was a DNR/DNI and family decided on comfort measures and he expired 2/8/2021.

dehydrated and then he stayed in the hospital for some time; said patient has Covid; severe reaction to the vaccine/severe allergic reaction to the vaccine; high fever/get real hot/running a 103.1; sweating; UTI; could not breathe and he was struggling to breathe; Moaning; diarrhea; chills; shaking all over; severe headache; started throwing up; he was not feeling well; This is a spontaneous report from a contactable consumer (patient's wife). A 77-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6202 and expiry date: unknown), via an unspecified route of administration on 26Feb2021 16:00 at a single dose for covid-19 immunization. Medical history included asthma and stage 4 kidney disease. The patient's concomitant medications were not reported. On 27Feb2021 (Saturday), patient was not feeling well and on 28Feb2021, he had diarrhea, chills, shaking all over, severe headache and started throwing up. Reporter stated patient had all the symptoms of the reactions and then "you go again to the serious, more dangerous symptoms, he has all of them". Throwing up, fever, chills, diarrhea and then he get real hot and then he started sweating and it was another day on 01Mar2021. On Monday (01Mar2021), reporter called to take patient to the hospital with high fever. The ambulance put him on IV and oxygen right away. They gave him fluids and were monitoring everything because he was dehydrated and then he stayed in the hospital for some time. He had x-rays, they monitored his blood pressure and heart rate, and the doctor was concerned about his heart rate and blood pressure. Doctor decided to check his urine and he did and he had a UTI on 01Mar2021, and so he gave him antibiotics for that (treatment unspecified). Patient seemed to be better after having the fluids and everything so they let him come home. During the night on 01Mar2021, he had another attack and it was the same thing that he had before. The shaking and the chills the fever and throwing up and the doctor said that it was a reaction from having the vaccination and reporter just wanted to report that he did and reported actually thought he was going to die. Reporter tried to call again the ambulance since she thought that he was not going to make it. The doctor put on the report and he did not put on there that he was in there because of suspected of (incomplete sentence) and then told the reporter himself that he had a reaction from the vaccine. The report stated that patient was in for a UT, but the reporter stated that, once does not call an ambulance for a UTI and she (reporter), have UTI's all the time. After the reporter got the patient home, he was even much worse. Patient could not breathe and he was struggling to breathe on 01Mar2021. He was shivering, shaking, having diarrhea, throwing up, soaking wet, and she had to change his clothes twice, and his fever was 103.1 F around 2:00 or 3:00 in the morning of 02Mar2021. The pharmacist gave medicine for vomiting. Reporter called the hospital and the nurses were busy and they could not take it so 24 hour nurse called. She was finally able to get him comfortable enough that she didn't have to call again. She thought she was going lose him. She said she felt twice he was going to die, when she called. At the hospital they told him he was having a severe reaction to the vaccine but also had a UTI and they gave him antibiotics. Patient contacted her nephew who is a medic in the military and RN and he said patient has Covid and thinks reporter has Covid too because the virus was in the vaccine. The nephew explained that patient just could not fight it off and said the vaccine acts like that. It made sense because it is inhibit in it then your body will learn to fight it off, like if you come in contact with it and that makes sense but the woman never explained. The nephew further stated to reported that patient's immune system or whatever was not able to fight it off. So, he said he has to have Covid and when patient heard that after all they had fought to stay away from it and then what were they supposed to do. Patient got the vaccine and ended up with it and that is what reporter have found out and it was very disturbing. Patient was running a 103.1 earlier on the night of 02Mar2021. He was moaning a little bit on Mar2021. Reporter thought patient had severe allergic reaction to the vaccine because he had all the symptoms and stated there was no doubt in her mind (referring to it being an allergic reaction) as it was too soon after the vaccine. Outcome of the event of dehydration was recovering, while for the remaining events was unknown. Reporter was asking if patient should take the second shot.

Evening of injection: confusion, weakness, Night developed more weakness and incontinence, Next day: severe weakness, unable to ambulate, follow directions, mumbling, sleepy, incontinent. Taken to ER - CT of head, EKG, Chest Xray, Labs, UA. Radiologist diagnosis start of Right lower lobe pneumonia. Given IV antibiotic and admitted to hospital. Admission MD thinks no pneumonia with profound weakness. Improved next day and discharged. Same evening as discharge had expressive aphasia. Next day speech normal again and weakness gone. Admitting physician said had another dementia patient with same symptoms and cleared in a couple of days.

Patient received a vaccine at museum sight on 03/23/2021 at 0130 pm according to fiancé. Around 1:30 the next day, his fiance tried to call him and she stated that his voice was garbled, she found him face down with his chin on the table, covered with his own feces and urine. EMS notes that upon their arrival the pt had a right sided facial droop along with some contracture to his left side. Pt was originally awake and confused as he gradually became unresponsive and is only responsive to pain of sternal rub. He has no history of stroke. Pt's BP was noted to be 88/50's en route.

Unknown if pt had s/s at time of vaccination on 1/29/2021 and 2/19/2021. From 3/1/2021-3/6/2021, pt hospitalized w/ covid, resp insufficiency, acute on chronic diastolic HF, dyspnea, ele. D-dimer, acute pulm edema and acute on chronic renal insufficiency. Dcd to home. Six hrs later, readmitted w/ worsening multifocal airspace opacities, enlarged cardiac silhouette, sob, cough. No PE on CXR. Recd O2, cefepime, remdesivir, vanco, Lasix, heparin, rivaroxaban, dexamethasone, tocilizumab. On 3/8/2021, pt had onset R weakness, CT w/ distal R MZ occlusion, Intubated for decline. Not TPA candidate. Per neuro, CVA r/t either a fib hx or hypercoagulability r/t covid. Pt died.

The night after receiving the vaccine he developed hematuria. This continued until his second dose of vaccine. After the second dose of vaccine, the hematuria worsened so much so that he was just leaking blood from the urethra even without urination. With urination he was passing frank blood and clots. He stopped clopidogrel and aspirin and it totally resolved. He underwent cystoscopy and there were no lesions identified. He resumed clopidogrel and aspirin and has not had any more bleeding.

The patient was admitted to hospital from 2/24/2021 until 3/6/2021 for AMS, diagnosed with UTI. He had an MRI on 3/3/2021 that incidentally showed a nonocclusive thrombus in the right dural venous sigmoid sinus, which extends to the right jugular vein. He is being treated with apixaban. It is unclear if this is coincidental or somehow related to the vaccine.

Death Narrative: Patient was admitted to facility from 1/11/2021 to 1/13/2021 for treatment of Covid 19 with symptoms of fatigue and poor oral intake. Admission was uneventful and follow-up notes post discharge from both Cardiology APRN and Primary Care Physician that the Patient was recovering well post admission. Patient received first of Covid Pfizer Vaccine on 4/2/2021 and second dose of Covid Pfizer Vaccine on 4/22/2021. Patient had been observed for 15 minutes after administration of each dose. No reaction was noted during the post vaccination observation period of either dose. Notice of death was received 5 days after second dose of Covid Vaccine from funeral home. There were no reports of an ADR occurring between observation period and death. There were no progress notes in patients chart between second Covid 19 Vaccine note 4/22/201 and death notice 4/27/2021. Cause of death is unknown at this time.

This 77 year old male received the Covid shot on 1/27/21 and went to the ED on 2/1/21 and was admitted on 2/2/21 with the following diagnoses listed below. SIRS (systemic inflammatory response syndrome) Pneumonia, unspecified organism Acute kidney failure, unspecified

From the day following the injection, I felt to be in a mental fog that has very slowly nearly abated. Uncommonly tired, no headache fever, chills, or neurodeficit otherwise. ( I am a retired physician). This lead to change in gait: slow, foot dragging, unstable. Near accident in driving auto. More than 4 time of urinary incontinence ie incontinence when bladder overfilled. Mental clarity lost. speech impaired by word searching. Obvious change in behavior to those around me.

Cardiac arrest at home, EMS performed CPR. Return of spontaneous circulation in the field after 2 rounds of epinephrine, In ED unresponsive, placed on a ventilator, required high doses epi to maintain perfusing blood pressure. Has acute kidney injury with hyperkalemia, shock liver and severe metabolic acidosis with arterial pH 7.04. CT of the head showed early findings of anoxic brain injury. Admitted to ICU and treated with aggressively with vasopressors, bicarbonate drip, heparin drip and empiric broad spectrum antibiotics. Very poor medical and neurologic prognosis, discussed with family and patient was transitioned to comfort care and passed away on 03/21/21 at 1626

A-fib; renal dysfunction; This is a spontaneous report from a contactable physician. A 77-year-old male patient received BNT162B2 (Lot number was not reported), via an unspecified route of administration in Mar2021 (at the age of 77-year-old) as single dose for COVID-19 immunization. The patient medical history was not reported. The patient had no known allergies. Concomitant medications included carbidopa and levodopa. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. In Mar2021, the patient experienced onset of A-fib and resultant renal dysfunction shortly after injection. The adverse events resulted in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient was treated with Cardioversion and medical management for the event A-fib. The outcome of the events was recovered on unspecified date. Information on the lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events of Atrial Fibrillation and Renal Impairment and the suspect vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

77 yo male presented to the ED given unresponsiveness at SNF via EMS, found to be hypoglycemic- intubated/sedated on admission - he was recently admitted, and had prolonged hospital stay (4/30 - 5/10) after orthopedic intervention / ORIF 4/30 Rt hip Fracture- s/p. - Acute hypoxic and hypercarbic respiratory failure, on mechanical ventilation - Bibasilar infiltrates, Lt > Rt, will small bilateral pleural effusions, HCAP - COVID PNA - Small bilateral pleural effusions - Encephalopathy - A-Fib - HFrEF, EF 45%, Mild MR - Acute on CKD - UTI

medical hx for atrial fibrillation, chf, hx of cardiac arrest, CAD, hypertension, prostate cancer, hypothyroidism, presents to ER after an episode of inability to move for over one hour, unable to move extremeties but was able to talk. reported that had a cough on friday but no sob or hypoxia and did not report fever or chills to hospital, although did report those to investigator. Discharged on 6/3/2021. symptoms of fever, chills, runny nose/congestion, sore throat and cough began on 5/25, none of these symptoms present upon hospitalization on 6/1/21.

Pfizer COVID Vaccine EUA Pfizer Vaccine Dose 1 2/5/2021 (lot # not in state registry) Pfizer Vaccine Dose 2 3/6/2021 (lot # not in state registry) COVID Positive 3/27/2021 Hospitalized 3/27-4/2/21 Hospitalized 5/19-5/24/21 6/15/21: Presented to ED. This is a 77 years old gentleman with a history of COPD presents to the emergency department because of shortness of breath and chest pain. Patient states that he was in his usual state of health and suddenly developed shortness of breath and chest tightness. By the time of my evaluation he no longer has chest tightness. He was recently in the hospital and treated with antibiotics for Pseudomonas pneumonia. He is reportedly compliant with his COPD medications at home. He normally wears 2 L nasal cannula at home. Currently he is on the BiPAP and reports feeling better after treatment in the emergency department. He was given IV steroids, bronchodilator therapy. He was also given IV antibiotics given recent history of Pseudomonas pneumonia. Of note patient states that for the past week his bilateral ankle appears to be more swollen and he is on Lasix started by Dr. from pulmonology for this. 6/21/21: This patient with a history of COPD, atrial fibrillation on anticoagulation and chronic dementia, was again admitted 6/16 with increasing shortness of breath and chest pain. It was noted that his COVID 19 test was positive. He was started on IV Remdesivir, but since his COVID 19 test has been positive since March of this year was felt that he did not require additional treatment. We are treating him for an exacerbation of COPD. His chest x-ray was actually normal with COPD but no signs of infiltrate, heart failure or effusions. He is on apixaban for atrial fibrillation and should not have a pulmonary emboli. He was getting IV Lasix, but the BUN and creatinine were rising. We have obtained an echocardiogram to see if there is a degree of systolic heart failure. We will continue the IV antibiotics and steroid therapy. The patient seems comfortable at rest but is on 5 L nasal cannula. The patient reports that he is on 3 L of oxygen at home all the time. I called to talk to the good friend who is listed as the 1st contact and reviewed the situation. He does live by himself but has 24 hour a day care. We discussed that our goal was to get him back down to 2-3 L of oxygen. There seems to be some improvement but if still requires 5-6 L of oxygen, we will ask for a pulmonary consultation. I have talked to the pulmonary team several times unofficially for advice and they seem to have nothing else to offer at this time. Again today the patient seems comfortable and is warning why he can go home.Admitted and treated with bronchodilators, steroids, BiPAP and levaquin. Echocardiogram repeated. By the time of admission, chest pain resolved. Oxygen requirement stay high at 5 liters. Today improved to baseline 2 L. Discharged home.

hypoxemia, urinary retention Narrative: Transferred from facility to ED with 1 day of fevers, hypotension, and c/f new oxygen requirement and admitted to acute care ward on 1/14/21. Tachycardia resolved w/ fluids. Patient was ruled out for PE and infectious workup negative. Fevers, hypoxia resolved overnight. Medicine Team felt symptoms were side effects from COVID vaccine (2nd dose received 1/13). He was treated for possible cellulitis at L shin wound (warm and tender to touch with mild erythema, without fluctuation) with 14-day cephalexin course, however cellulitis not deemed severe and unlikely contributing. Regarding urinary retention, the Discharge Summary stated, "Urinary retention seemed new in the last day. Pt on condom cath during admission, urinating well." Discharged 1/15/21 and returned to facility.

Legs started swelling and shortness of breath Thursday January 21 2021 Was rushed to hospital with kidney failure and fluid build up around lungs and entire body Blood pressure dropped and had multiple organ failure

The next two days following the vaccination, the patient was lethargic and not getting out of bed. His caregiver had to make him eat and bathe. On the third day his care giver had woken him up and found that he had wet himself (this has never happened before). He had altered mental status and was not able to recognize any of his family members. He was taken to the emergency room on 2/6/2021 where he had a seizure and found to have a subarachnoid hemorrhage. He is still hospitalized.

Pt. was hospitalized with acute hypoxic respiratory failure due to severe COVID-19 complicated by acute kidney injury and exacerbation of heart failure on 2/8/2021.

Kidney stones; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine; Batch/Lot number: EL3247), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included nephrolithiasis (before getting the COVID shot). The patient's concomitant medications were not reported. The patient experienced kidney stones on an unspecified date. The patient explained that he was scheduled for the second COVID shot on Wednesday. He noted that he has developed a kidney stone and wanted to know if it was ok to get the second dose. It was confirmed that he was used to the pain and has had a bunch of them in the past; he has a history of kidney stones before getting the COVID shot. He stated that he wanted to go ahead and get the shot, the appointments were so hard to get. Outcome of the event was unknown.

On Eliquis and on and off had bloody urine; This is a spontaneous report from a contactable consumer, based on information received by Pfizer from Bristol-Myers Squibb (manufacturer control number US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-020443), license party for apixaban (ELIQUIS). This spontaneous case was reported by a patient family member or friend and describes the occurrence of haematuria (On Eliquis and on and off had bloody urine) in 78-year-old male patient who received apixaban (Eliquis) for Cerebrovascular accident prophylaxis. Co-Suspect Products included Covid-19 Vaccine for COVID-19 immunization. The patient's past medical history included Prostate cancer (about 10 years ago), Radiation therapy and Capillary fragility. On an unknown date, the patient started Eliquis (unknown route). On 24-Feb-2021, the patient started Covid-19 Vaccine (unknown route). On an unknown date, the patient experienced haematuria (On Eliquis and on and off had bloody urine). The action taken with Eliquis (Unknown) was unknown. At the time of the report, haematuria resolved. Event reoccurred on 24-Feb-2021 For Eliquis (Unknown), the reporter did not provide any causality assessments. The reporter stated that the patient got the Covid vaccine the previous day, he had a history of prostate cancer from about 10 years ago and was treated by radiation, the radiation had caused capillaries in the penis to be fragile and so sometimes when he urinate, he urinate blood or little blood clots, neurologist was aware of it, cardiologist was aware of it but they did not treat it, they just waited for it to resolve itself. He was also on Eliquis for a Atrial fib so the previous day when we came home after he got the vaccine, he was bleeding with the clots and with the bloody urine which he had done in the past. He had a blood urine one hour post vaccination. She was shocked. It would take at least a few hours for the medication to get in the system before having any kind of reaction. It resolved on it's own he did not have a blood urine anymore. The second dose of the vaccine was due on 16-Mar-2021.

About a day after vaccination I began experiencing discomfort & difficulty urinating. This has continued to occur through today (18Mar2021). Symptoms appear to be lessening as time goes by.

The patient presented to the ED with complaints of fatigue. The patient was found to have an NSTEMI and suspected pneumonia on x-ray. The patient was started on a heparin drip, ceftriaxone, and azithromycin. BP was 176/101, pulse 93, O2 sat of 95% and temp 99.3 F. Patient is being admitted to the hospital for continued treatment of NSTEMI.

Multiple pulmonary embolism 100 degree fever Chills incontinence Gout Blood Uric Acid Increase Shortness of breath

2 hrs after injection , felt a URGENT need for Bowel movement, while I was having this bowel movement, I had what I think was a severe Panic attack, felt like I was going to die !!! lasted for 5 or 10 min. After which I felt fine , went to work ,after another 2 hrs I had the same episode ,at work. timing was about the same . went home . Had another aproximently 2 hrs from the last ,was less severe . took a nap , BUT was unable to urinate for 6 hrs . Felt OK ,slepted fine. Felt OK the next couple of days Then had mild case of chills, then mild case of feeling poorly. Very slight fever. AS of today I'm more tired then usual but not debilitating .

Received his vaccine, he had soreness in the arm, but nothing else. On 3/3/21 he went to hospital ER with diagnosis of kidney stones, had a morphine injection, Flomax and a prescription for Oxycontin and Flomax. At that time he was experiencing also in his right eye swelling and it was reddish, and there was an itching around the eye, and there was a couple blotches on top of his head and his cheek, but did not mention it as he was there for kidney stones. On 3/9/2021 he saw a Urologist, Dr. and that morning he passed a kidney stone. The urologist took an x-ray and did not see any more. The eye then became an issue on 3/9/21 and he made an appointment to see the eye Dr., Dr. at Eye institute on 3/11/21 @ 9:00 AM. The doctor diagnosed shingles on the face and right eye, and she put him on 2 medications (Durezol ophthalmic drops). He is still on that medication still 4/16/21. The other medication that they prescribed for him was Valacyclovir which he took 3 times a day, they reduced it from 1000 mg to 500 mg twice a day. The swelling of the eye itself has gone down a little bit. He is still seeing the eye doctor, and has a FU on 5/5/21 as it is getting better but still has symptoms. He did get a single dose Shingrix shot a couple of years ago.

Patient presented to the ER on 3/28/2021 with shortness of breath and lower extremity edema and complaining of lower back pain. O2 sat high 80s on room air. Worsening renal failure since last discharge from hospital on 3/23/2021. Patient was readmitted to hospital from skilled care facility after being discharged 5 days prior with acute on chronic stage IV kidney disease as well as acute on chronic diastolic heart failure and had slowly worsening with renal dysfunction and growing concern for dialysis. Patient had developed a cough, a fever up to 101, and 1 questionable sewed of either hemoptysis or hematemesis since being discharged to skilled nursing facility on 3/23/2021. Patient was transitioned to the hospice team and expired on 4/2/2021.

chills, vomiting,fever,dark urine. Went to clinic and was given rx for nausua after 1st vaccine. After 2nd vaccine went to Doctor and had a series of blood tests and ct scan. Symptoms subsided after a few days, dark urine for a couple of weeks. Tests showed: ast(sgot) 90 , alt (sgpt) 210

1st vaccine: Pain in shoulder neck and head same day. Next day whole body was hurting. After 3 days gout flare-up. NP did labs. Found GFR to be 18.Had been in the 40's prior to vac. 2nd vaccine: worse. Body pain, extreme nausea and vomiting. Dizziness, difficulty walking. Down for 14 days. June 17: Chest pain of # 9and jaw pain. No history of heart problems. To ER with wife. Admitted to hospital. Discharged home 6/19/21. Now sleeping a lot. Trying to resume activity.

Patient received COVID-19 vaccination on 1/14/2021. On 1/17/2021, patient was transferred to Hospital s/p multiple cardiac arrests. Patient was hyperkalemic and in acute renal failure at time of transfer. Hyperkalemia was treated, but the patient suffered PEA vs VFib. At the time of transfer, patient was on vasopressin, norepinephrine, and epinephrine. The patient had an EF of 40-45% and elevated troponins. Patient was made DNR and placed on comfort care. Patient passed away on 1/18/2021. Ultimately we suspect that the patients condition was a direct result of his underlying disease states, but wanted to make sure reporting was made available.

on 1/23, rt became winded and confused, weak and began to require more assistance with ADL's, 1/24/21 acting bizzare, anxious, uncomfortable, increasingly more confused, restless, 1/27 blood noted in urine, SOB and abdominal breathing, was sent to ER - returned with dx of SOB and UTI. 1/29/21 confused and trouble voiding, very restless, 1/30/21 confused and restless, 1/31/21, confused and anxious, 02/02/21, very low heart rate, lethargic, admitted to hospital with cystitis and bradycardia, 2/4/21 returned to facility, 2/11/21 received second dose of Pfazer_ BioNTech vaccine, 2/17/21 very lethargic, bradycardia, 2/21/21 large amount of rectal bleeding, sent to hospital and admitted - remains in the hospital at this time

COUGH, WEAKNESS, INSOMNIA, ACUTE ON CHRONIC CKD, ACUTE ON CHRONIC CHF, EMESIS, DEATH Narrative: 1/12/21-PT REPORTED FEELING TIRED, UNABLE TO SLEEP AND EXPERIENCING DYSPNEA ON EXERTION THAT HE FEELS MAY BE RELATED TO RECENT COVID VACCINE 1/17/21-patient admitted to hospital due to 'severe abdominal pain;' received 1 unit PRBC due to symptomatic anemia and weakness (Hgb 8.4->7.1); dx: acute on chronic CHF exacerbation and difficulty breathing, acute kidney injury-CKD Stage IV; HPI includes chief complaint "weakness/sob since last night, cough x 2 weeks since covid vaccine;" HPI includes "pt states that for 2 weeks he has had SOB, cough, chills, body aches, and weakness, symptoms not improved over the last few days, more weak as of late" 1/28/21-transferred to facility 2/12/21-transferred back to hospital due to SOB, abnormal labs, pleural effusion 2/16/21-episode of coffee ground emesis 2/19/21-EGD showed ulcerative esophagitis and gastritis 2/24/21-transferred to SNF 3/9/21-admitted to hospital d/t multiple episodes of vomiting 3/10/21-pt passed away at hospital Possibility that acute inflammatory process triggered by vaccine resulted in patient's eventual death, but difficult to ascertain due to patient's various comorbidities. Patient never tested positive for COVID. Did not experience immediate ADR following 1st dose of vaccine. Did not received 2nd dose due to illness. Hospitalized multiple times following 1st vaccine dose.

Male patient who to the hospital on 3/15/2021 due to 10 days of shortness of breath on exertion and right-sided chest pain. He went to his PCP for follow-up and had a CT PE study today which was positive for right upper lobe and right lower lobe pulmonary embolism. He notes that he received a 2nd 5 0 COVID-19 vaccination on March 6th and since then has not felt well, feeling short of breath and generally fatigued. He notes that he has not been very active since receiving the vaccine. CT PE study showed an increased RV to LV ratio 1.2. He had no elevation in his troponin or BNP. His echocardiogram showed an EF of 60% and there were no wall motion abnormalities and grade 1 diastolic dysfunction. Patient would prefer Eliquis at this time. He will need a 6 month course of Eliquis. Given the setting of recent COVID vaccination and recent decreased mobility as possible provoking factors, this will be treated as a provoked pulmonary embolus. Per hospital COVID vaccine protocol, patient presentation will be reported to pharmacy for FDA reporting.

Fever and diarrhea following a couple days after the vaccine Being administered. The day prior to hospital emergency admission uncontrollable throwing up extreme side/Stomach/chest pain. Was taken by ambulance to emergency.

Initially was thought to have developed pneumonia but without much in the way of clinical signs - little improvement and moved from local MD to Hospital for further work up. Developed Rapidly Progressive Glomerulonephritis and vasculitis. The subsequent acute kidney failure necessitated renal dialysis - which remains ongoing.

Inpatient Discharge Summary Admission Date: 3/22/2021 Discharge Date: 3/27/2021 Principal Problem: COVID-19 virus infection Hospital Course s a 79 y.o. male who presented to the hospital with a complaint of 1 week of shortness of breath and fever. He was managed for- COVID19 pneumonia with acute hypoxic respiratory failure, POA - CTA negative for PE; there is evidence of COVID19 pneumonia - given a unit of convalescent plasma - Remdesivir daily x 5 days (last day 3/26) -Will be sent on 4 days of Decadron to finish total of 10 days of Decadron. - inflammatory markers have improved - procalcitonin is negative x 2 - Mucinex/is/opep - wean oxygen as able, encourage patient to prone. - patient weaned down to room air. Home oxygen evaluation was done he did not qualify for O2 at home. AKI - Cr 1.36 upon presentation, improved to 1.0. - avoid nephrotoxic agents- d/c mobic. Did get contrast on 3/23 - continue to monitor renal function 5 beat run vtach - Patient does have hx of osa and was using CPAP machine - electrolytes were normal - continue telemetry monitoring - discussed outpatient ECHO Transaminitis - ?secondary to remdesivir vs covid virus Commend to repeat the LFTs in 3 days and follow the results with the PCP.

Patient presented to the ED on 4/22/21 and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnoses were: Severe sepsis (HCC) due to pneumonia causing acute on chronic hypoxic respiratory failure and hypotension that resolved with fluids. He also presented to the ED on 5/13/21 and was subsequently hospitalized for sepsis secondary to UTI.

Temperatures 105; chills; confusion; unsteady walking needing, great assist; Severe pain in back and neck; Severe pain in back and neck; Not eating, taking water OK; Incontinent of urine and stool; Incontinent of urine and stool; This is a spontaneous report from a contactable (patient). A 79-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number was not reported), via an unspecified route of administration, administered in left arm on 04Mar2021 at 10:00 (at the age of 79-years-old), as single dose for COVID-19 immunisation. Medical history included aortic heart valve replaced, mild COPD, edema in legs, irregular heartbeat. Patient had no known allergy. Patient not diagnosed with COVID-19 prior to vaccination. Patient was not received any other vaccine prior four weeks of vaccination. Concomitant medication(s) included MELOXICAM, LASIX and HCTZ. On 04Mar2021 at 14:00 (same day after vaccination), patient experienced temperatures 105, chills, confusion, unsteady walking needing, great assist, severe pain in back and neck, not eating, taking water OK, Incontinent of urine and stool. Patient did not receive any treatment for the events. Since vaccination patient not tested for COVID-19. The patient underwent lab tests and procedures which included Body Temperature: 105 on 04Mar2021. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot been obtained.

79 Male received both doses of Pfizer. Developed symptoms - SOA, decreased activity, generalized weakness, decreased P. O. intake. Tested PCR positive 4/26/2021 & serology 4/29/2021. Hospitalized 4/27/2021. Diagnosis at time of death: Hypoxic ARF requiring MV, COVID-19 PNA, rule out superimposed bacterial PNA, renal failure, oliguric, metabolic acidosis. CWP/COPD exacerbation, CAD, DM present on admission

Roughly 9 hrs after shot malaise. During next 30 hours loss of balance, incontinence, nausea, mild headache. By 40 hours symptoms had diminished and I could eat, although sparingly, again

weakness, fall Narrative: Pt with history of CAD (s/p PCI mid and prox RCA in 2006, on ASA/Plavix; CABG, AVR), afib, GERD, HTN, HLD, hypothyroidism, BPH, diverticulosis, aortic stenosis, small fiber neuropathy (since 2010), lumbar stenosis at S1. Also, pt presented to outside ED on 12/26/20 for increasing falls and weakness over one week and was admitted to outside hospital 12/26/20 for generalized weakness, dehydration, hyponatremia all secondary to covid 10 infection. Hospital course included sepsis due to covid 19, elevated liver enzymes, acute kidney injury. Pt discharged 12/29/2021. After first COVID vaccine 2/12/2021, patient experienced fever x 1 day, weakness, and fall. Presented to outside ED 2/13/21 abd was admitted for critical illness myopathy 2/2 recent COVID infection +/-COVID vaccination. Pt was discharged 2/18/2021.

4/12 Patient was brought by family to ED for excessive fatigue, dry cough and poor PO intake. He was positive for SARS CoV-2 and had some hyponatremia. Date of onset of symptoms: ~Approximately 5 days Date of covid positive test: 4/12/21 Symptoms: dry cough and fatigue Imaging: Chest x-ray?No significant abnormality Oxygen requirements on admission: Room air Current oxygen requirements: Room air Medical therapy: not indicated Of note it has been reported the patient is approximately 2 weeks out from second Covid vaccine injection. His son reports that one day about 2 weeks ago he escaped out of his home into a crowded bar and apparently there were 7 others there who tested positive. . Appreciate Dr's assistance - reswab sent for CT value. CT values were 18.5/19 which are consistent with concern for active disease. He was given monoclonal antibody in-house on the day of discharge

Presented to ER via private vehicle with complaints of general malaise, weakness, "not feeling good" beginning the morning before (04/16/2021), complaints not more specific. Associated symptoms included encephalopathy, lethargy, anorexia, progressively unsteady gait. Wife denied nausea, vomiting, diarrhea, fever, bloody stools, difficulty/painful urination. Diagnosed with thrombotic thrombocytopenic purpura with an initial hemoglobin of 4.8g/dL, hematocrit 14.2%, platelet count 6000uL, PT 12.2sec, INR 1.2, BUN 75mg/dL, creatinine 2.4 mg/dL, total bilirubin 3.3 mg/dL, direct bilirubin 0.60mg/dL, troponin 3.81ng/mL, and ADAMTS13 activity <2.0. He received 2 units PRBC, 2 units platelets, and plasmapheresis was initiated. As of today, he has had 5 consecutive days of plasmapheresis. Repeat laboratory evaluation this morning hemoglobin 8.8, hematocrit 28.4, platelet count 97000, BUN 35, creatinine 1.5, total bilirubin 1.3. Now awake, alert, and oriented. Eating and ambulating with physical therapy

Patient is a 80 y.o. male with significant PMHx of CAD, HTN, HLD, CKD who is admitted to ICU as a transfer from hospital for acute liver failure and cardiac arrest. Pt presented to hospital on 04/28 w/ complaints of nausea and vomiting. He stated that he had recently gotten his COVID vaccine. Pt was found to be in acute liver failure in the ED w/ AST and ALT > 1000. Lactate > 15.0. BMP showed AKI on CKD and BG >500. Pt did have cardiac arrest while undergoing CT Scan and ROSC was achieved after CPR x 20 mins. Pt was hence transferred to the ICU for higher level management and admitted for cardiac arrest and acute liver failure. Upon arrival, Pt was intubated and sedated. He was non-responsive to verbal and physical stimuli. Pt was acidotic. ABG: 6.99 / 28 / 165 / 7. 1 amp of HCO3 was given upon arrival. Pt was started on insulin gtt for DKA and was started on Levophed for low BP. Pt underwent cardiac arrest shortly after arrival to the ICU. CPR was performed for > 20 mins without ROSC. Family arrived at bedside and decision was made to stop CPR at 0205 on 04/29/2021.

headache; minor aches; heart attack; kidneys were compromised; chills; had a cough; muscles were tightening, could hardly walk; lethargic; This is a spontaneous report from a contactable consumer or other non hcp. A 80-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection,Batch/Lot number was not reported), via an unspecified route of administration on 14Jan2021 as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included bypass surgery. The patient's concomitant medications were not reported. On 16Jan2021, the patient experienced headache, minor aches, had a cough, muscles were tightening, could hardly walk, lethargic, chills and heart attack on an unspecified date. Caller states that on 14Jan2021 she and her husband had the 1st Pfizer vaccine dose. 2nd dose was scheduled on 04Feb2021. Caller reporter that 2 days after the 1st dose, her husband's muscles were tightening, could hardly walk, had a cough, was lethargic, had chills and was c/o having reflux in his chest. Caller stated they had appointments that day with their Internist and their Cardiologist. Both HCPs felt all his symptoms were probably from the vaccine. That night she took him to the ER and he had had a heart attack. They did a cardiac Cath and had one of two stents put in. His kidneys were compromised and the HCP couldn't give the amount of dye needed to add another stent. So he still needs another stent. Also the blood count went down. Caller states her husband had cardiac bypass surgery years ago. The caller also mentioned her son is a surgeon and had bad flu like symptoms after second shot and only had a headache and minor aches after the first dose. She was concerned about her husband as he had a heart attack and if he should get the 2nd dose. The patient underwent lab tests and procedures which included blood count: went down. Outcome of the events were unknown. Upon follow-up on 16Apr2021: This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

Arm soreness after each dose was given/ Severe pain in legs; was 187 pounds and now down to 170; fell and busted his spleen; fell and busted his spleen; started peeing; developed blisters in his mouth and on his tongue; developed blisters in his mouth and on his tongue; Vaccination facility staff made a mistake resulted that the patient received the third dose of Covid-19 vaccine; mouth was also full of saliva, started slobbering and couldn't stop; Pain in shoulder/ Severe pain in joints; Severe diarrhea; having problems with words; had some problems with his balance; couldn't hardly walk because of his balance; Has no taste of food; Mouth Burning; break out with bumps around mouth; Scrotum blood blisters; This is a spontaneous report from a contactable consumer (patient). An 80-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration, administered in left arm on 17Apr2021 (Batch/Lot Number: EW0171) as 3rd dose, single for covid-19 immunisation. Ongoing medical history included diagnosed with vertigo 5 years ago but had vertigo long before that, diagnosed with COPD, emphysema, asthma 12 years ago, Congestive heart failure after having a heart attack in Nov2018, stomach problem (had gastric bypass back in the 80's), had Pacemaker in 2020. Patient does take medications, but is unable to provide details. Patient received flu shot in Nov2020. No Prior Vaccinations within 4 weeks. Patient had first dose on 02Feb2021, second dose on 05Mar2021, and Vaccination facility staff made a mistake resulted that the patient received the third dose of Covid-19 vaccine on 17Apr2021. He had gone to Vaccination facility to get a B12 shot and the staff messed up and gave him the Covid-19 vaccine. He states he had arm soreness after each dose was given. On the night of 17Apr2021 after the third dose, pain in his shoulder began, the pain lasted about 3 days and had intensified a little more from the previous dose of the Covid-19 vaccine. When he woke up on 21Apr2021, his mouth was also full of saliva, he started slobbering and couldn't stop. On 22Apr2021 or 23Apr2021, he began experiencing severe diarrhea he began and having problems with words, he knew what he wants to say but it just doesn't come out. About 23Apr2021 or 24Apr2021, he began experiencing problems with his balance. He had vertigo for a long time and has always had some problems with his balance, couldn't hardly walk because of his balance, but the problems with his balance have intensified to where he needs someone to help him stand up now. On 24Apr2021 when he first gets up in the morning, he developed blisters in his mouth and on his tongue. On 27Apr2021 he began having problems with control, and started peeing all over himself, he didn't take his water pill on 27Apr2021 because he was going out and he still peed all over himself, he has been wearing adult diapers so that he doesn't mess himself again. On 04May2021 night, he fell and busted his spleen. And on an unspecified date in Apr2021, has no taste of food, Mouth Burning and break out with bumps around mouth. Scrotum blood blisters. Severe pain in legs and joints. He was 187 pounds and now down to 170. Patient received fourth injection on 21Apr2021 in left arm, but he is unsure if he received a B12 shot or something else. Attempts were made to clarify if the patient received 3 or 4 doses of the Covid-19 vaccine. Patient had blood tests, an EKG, and X-rays with unknown results, his heart looked good. The outcome of events was unknown.

Within one week of vaccine dad lost interest in everything, developed incontinence, became extraordinarily sleepy, stopped gregarious talking and only responded to questions asked, became extremely confused, eventually losing his ability to walk, talk, and swallow. All occurring in short order. ER twice, hospitalized twice, rehabilitation twice. As yet, no formal diagnosis despite three hospitals seeing my father and testing him extensively.

patient began with vomiting and diarrhea the day after administration, leading to bowel and urine incontinence. patient was hospitalized on 01/16/20 with sepsis. no origin discovered yet. still waiting on blood/urine/stool cultures.

EMS brought patient to ED stating patient was bright red and tachypneic with oxygen saturation of 81-82% on RA. Failed on CPAP. Given Benadryl 50mg IVP, Solumedrol 125mg IVP, 0.3mg of IM Epi and a duoneb with no relief. Was RSI'd and intubated and transported to the ED.

fatigue Narrative: Did not feel good, appeared to have symptoms prior to getting vaccine, but had declined ER evaluation prior to vaccine. Pt was light headed, VS stable. Pt reported to have fatigue with exertion. Was sent to MER at 1:30p, routine labs revealed elevation in SCR and admitted for AKI. Pt was determined during admission to be volume depleted exacerbated by diuretics and administered IV fluids. follow-up appointment scheduled for 01/31/2021.

4 days after receiving the shot I lost complete bladder control for 2 days. Two days after that I had diarrhea once a day for two days

Patient is a 81 y.o. gentleman with a history of smoldering multiple myeloma, urinary retention for which he self catheterizes twice daily, as well as recently diagnosed atrial fibrillation that presents complaining of increasing weakness and falls. Patient fell 2/18 pm trying to get out of bed and he took about 20 minutes to get himself to a position where he could pull himself back up. Again 2/19 he was trying to get up and his legs were too weak to carry him and he fell to the ground. He needed assistance to get up and family asked him to come to emergency room for evaluation. He has been feeling poorly for about a month, with poor appetite and has lost about 15 pounds. He is not nauseated or short of breath and has no cough. He was apparently treated for UTI about 4 to 6 weeks ago after a visit to urgent care. He has since been to a different urgent care and was diagnosed with atrial fibrillation which was new in onset and was referred to a cardiologist who is planning to do a stress test in a few weeks. I believe he is on Eliquis now. In ER he was found to have significant pyuria and bacteriuria and was given a dose of Rocephin. Renal function shows worsening from levels in December although it is pretty stable over the past month from looking through other labs.

Day 1-Confusion and weakness Day2-Increase in weakness, inability to swallow, confusion, fatigue Day 3-Weakness, confusion, incontinence, hospitalized for hypoxia, pneumonia Day 20- Deceased

Patient developed a syncopal episode one day following the vaccine. Without warning, he fell to the ground, losing control of bowel and bladder, although no seizure activity noted at the time. He transiently lost consciousness and then woke up confused and combative. Brought to emergency room and admitted with multiple rib fractures. Initial brain imaging was negative but 24 hours later, noted to have small hemorrhagic brain contusion in left frontal/temporal region and a small subdural hematoma. One day later, there was not noted to be any extension of the hemorrhage/hematoma.

This 81 year old white male received the Covid shot on 3/11/21 and went to the ED on 4/2 and was admitted on 4/4 with shortness of breath, pericardial effusion, pulmonary edema, CHF and again to the ED on 4/30 and admitted on 4/30 with abdominal pain, hypoatremia, renal insufficiency and again to the ED on 5/1 with pericardial effusion and died on 5/4/21.

Because I have Stage 4 CKD i get monthly blood tests to check my Creatinine level. My Creatinine level had been hovering around 5. Following my vaccination it spiked to 5.89, which might have required me to start dialysis. However in two subsequent blood tests it has been moving back down toward 5. A chronology of my blood test creatinine and my Covid vaccinations follows: Creatinine EGFR and Vaccine Date Creatinine EGFR 11/30/2020 5.18 10 1/2/2021 4.88 10 2/4/2021 5.01 10 2/5/2021 First Pfizer Vaccination 2/26/2021 Second Pfizer Vaccination 3/4/2021 5.89 8 4/8/2021 5.56 9 4/22/2021 5.14 10

Increased confusion/dizziness today. Increased weakness. Withdrawn affect. Incontinent of urine/stool.

All events took place: Following first dose, minor rash on left arm; following second dose, first developed severe rash on arm and belly, extreme fatigue, severe hiccups and inability to swallow without choking; ultimately developed liver and kidney failure, was diagnosed with DRESS syndrome resulting from reaction to vaccine, was administered high-dose corticosteroids and antibiotics but continued to decline, developed hemorrhage in lungs and died due to multi-organ failure. PDF Continuation field did not permit entering text, see attached Continuation Page.

Patient presented to the ER on 7/7/21 with hematuria and was found to have acute kidney injury. Patient was recently diagnosed with a PE and bilateral DVT 4 weeks PTA and was on Eliquis for these. Patient also has a history of lung cancer and COPD and is chronically on 4L O2 at home. A foley was placed by Urology in the ER and Eliquis was held due hematuria and changed to heparin drip upon admission. In the ER, patient was tested for COVID per policy, and was found to be positive on 7/7/21 despite being fully vaccinated (1/24/21 and 2/14/21). Patient was admitted for further work-up and has not been started on COVID treatment due to patient being asymptomatic for COVID. Pt's chest X-ray was negative for pneumonia.

Patient hospitalized for hematuria, bladder stones on 4/14/2021. Patient presented to the ED and was subsequently hospitalized on 4/19/2021 for urinary retention and hematuria. These visits are within 6 weeks of receiving COVID vaccination.

Patient is a 82 y.o. male presenting with shortness of breath and nausea and vomiting. Patient has a past medical history of bladder cancer, COPD on no home oxygen, hypertension, chronic UTI, BPH, and Pfizer vaccination from COVID-19 on 1/4/21 and 2/5/21. Patient was symptomatic with shortness of breath and nausea and vomiting since 07/13/2021. Patient went to urgent care and tested positive for COVID-19 on 07/19/2021. Patient went to the ER and received a fluid bolus as well as Zofran; the wife states that the Zofran does not help with the nausea and vomiting. At home, patient denies fever, muscle aches, chills, chest pain, abdominal pain. Patient admits chronic cough, chronic headache, and pain with urination, most likely due to BPH. Patient denies known history of sick contacts. COVID-19 pneumonia, tested positive 7/19/21, currently requiring 1-2 L of oxygen, baseline room air

Clammy; feels heated from the waste up; Chills; 98.8 degrees/mostly hot on the inside; kidney trouble; Creatinine high; This is a spontaneous report from a contactable consumer (patient's wife). An 82-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3246), via an unspecified route of administration in left arm on 06Jan2021 12:00 at single dose for COVID-19 immunization. Medical history included gout from Dec2020 and ongoing. Concomitant medication included probenecid tablet from 29Dec2020 and ongoing, allopurinol tablet from 15Dec2020 and ongoing, both for Gout. Prior Vaccinations (within 4 weeks): None. Additional Vaccines Administered on Same Date of the Pfizer Suspect: None. Vaccination Facility Type: Public Health Dept. Vaccine Administered at Military Facility: No. Reported her husband had Gout, and was prescribed 2 pills. She clarified her husband was diagnosed with Gout in Dec2020. She said her husband had a doctor's appointment on 13Dec2020, and on 15Dec2020, he got a prescription for Allopurinol 100mg, once a day. She said the Allopurinol is dispensed in a pharmacy bottle and does not have the NDC, Lot & Expiration Date. She said the word "Accord" appeared after the dose, and may be the name of the Allopurinol manufacturer. She said on 29Dec2020, her husband went to the Emergency Room because he had real bad pain in his legs and feet. She said her husband was prescribed an additional Gout medicine, Probenecid, at that time. She said she doesn't know the Probenecid dose, but he takes it once a day. She didn't have the Probenecid NDC, Lot, and Expiration Date listed on the pharmacy bottle. Her husband received his first dose of the COVID-19 Vaccine on 06Jan2021. And on 07Jan2021, he got chills, felt hot on the inside, and was clammy. He felt heated from the waste up. She said her husband said inside his body feels hot. She said she checked his temperature a while ago, and his temperature was 98.8 degrees. She said her husband said if he could just cool his brain, he could cool himself down. She clarified on 07Jan2021, her husband got chills, felt hot on the inside, and was clammy. She stated her husband is mostly hot on the inside now. Reported her husband had an x-ray of his leg recently, and blood work to check his creatinine. She said her husband's creatinine was high, saying her husband has kidney trouble. No further details provided. Any AE require a visit to: Emergency Room: No, Physician Office: No. The patient underwent lab tests and procedures which included creatinine: high in Jan2021, body temperature: 98.8 in Jan2021, x-ray of his leg: unknown result. Treatment: Declined any. The outcome of the events clammy and felt heated from the waste up was not recovered, for the event chills was recovering, for the other events was unknown.

PATIENT PRESENTED TO EMERGENCY DEPARTMENT WITH SYMPTOMS OF FEVER, CHILLS, AND GENERAL MALAISE TWO DAYS POST VACCINATION. PATIENT HAS HISTORY OF COVID+ IN NOVEMBER 2020. PATIENT WAS NOT GIVEN MEDICAITON AT HOME PRIOR TO ARRIVING TO EMERGENCY DEPARTMENT. PATIENT HAS PRIOR HISTORY OF SHORTNESS OF BREATH AND REQUIRES OXYGEN WHILE HOSPITALIZED BUTH HAS NOT HAD ANY ARTIFICIAL OXYGENATION SINCE. NO COUGH, NO SHORTNESS OF BREATH REPORTED AT EMERGENCY DEPARTMENT. PATIENT ADMITTED FOR FURTHER WORKUP. PATIENT STAYED 1 NIGHT - RECEIVED 2 DOSES OF CEFTRIAXONE IVPB FOR SUSPECTED PYELONEPHRITIS, WHICH WAS EVENTUALLY RULED OUT. PATIENT FOUND TO HAVE AKI. PATIENT DISCHARGED ON 1/28/2021 IN STABLE CONDITION AND RENAL FUNCTION IMPROVI

Acute on chronic respiratory failure with hypoxemia; Acute urinary retention; Arterial leg ulcer; Cardiac rhythm disorder or disturbance or change; Chest discomfort; Chest pain; SOB (shortness of breath)

burning when he urinates; sharp pain where his navel is; pain in his stomach; This is a spontaneous report from a contactable consumer reporting for himself. An 82-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EL1283), via an unspecified route of administration on 14Jan2021 at SINGLE DOSE for COVID-19 immunisation. Medical history included Parkinson's disease from an unknown date. The doctor told him to make an appointment with his Parkinson's doctor and tell him, maybe that has something do with it. There were no concomitant medications. The patient experienced burning when he urinates for 2 weeks, a sharp pain where his navel is, and pain in his stomach on Jan2021. He was wondering if it could be from the shot or if it is something else. He had an appointment with his doctor on Monday and he told him about it. The doctor gave him an antibiotic, Ciprofloxacin 500 mg that made him dizzy, he does not know if he will continue to take it but it helped the burning, the burning was not as bad. It was in a brown clear pharmacy bottle. The burning when he urinated is going away but the pain in his stomach comes and goes and it is right on his navel, it was described as a real hard pain. Patient would come back 03Feb2021 per vaccination card. Outcome of the event burning when he urinates was recovering while unknown for a sharp pain where his navel is, and pain in his stomach. The events were considered non-serious.

Approximately 2 weeks post vaccination developed rapid AF, CHF. Admitted to Medical Center. Discharged home on hospice. Patient died at home on 2/13/2021. Reported to this reporter at second dose clinic on 2/16/21. Other details not known. Unknown if related to vaccine.

Patient developed persistent fevers and weakness and loss of appetite that continued for about 3 weeks after getting the vaccine. There was a delay of about a day from getting the vaccine that he developed symptoms. He came to the hospital at today, 2/23/2021 because of the persistence of his symptoms. Vitals were stable and within normal range, but he had elevated creatinine to 1.66, unknown baseline. Troponin was also elevated to 0.08 without symptoms of ischemic heart disease. EKG was normal.

Pt with no previous history of abdominal aortic aneurysm presented to ER on 02.20.2021 with abdominal pain, weakness and BP of 50/30 via EMS. Abdominal pain started on 02.19.2021 approx 10:00 PM. Pain was described as severe in the left flank, radiating into the lower abdomen and worsened through the night. EMS was called around 11 AM. Pt CT Abd/Pelvis angiography shown Ruptured abdominal aortic aneurysm measuring up to 7.9 cm in diameter and 9.8 cm in length with active extravasation of IV contrast. Large volume of predominantly retroperitoneal hemorrhage. Pt was flown hospital for surgical intervention after being given 2 units of O neg blood with 2 L normal saline.

chills on and off for 2 days, with temperatures of 99-101.5 started on 2/18/2021; cough and exhaustion started on 2/21/2021, urine turned dark, symptoms lasted for 3 to 4 days; cough is ongoing, but it is intermittent and may be due to pollen

Patient presented to the ER on 3/2 for urinary frequency and lower abdominal pain. He was hospitalized at Medical Center- on 3/2/2021 for small bowel obstruction and acute kidney injury. Patient passed on 3/2/2021.

No access to SIH documentation: 4/6/21 Occult blood positive - Cancer Center 4/27/21 Dx Melena, Medical Center, VCE, EDG/upper enteroscopy and colonoscopy discussed / ordered? - wife cancelled? 5/17 ER - Admission: falls, bruising abdomen, pelvic area, right back, buttock - Hospital 5/29/21 ER - Admission: The patient is a 82 y.o. male with a PMH notable for uro lift on 05/26/2021, BPH, CAD, diabetes, atrial fibrillation, hypertension, and CABG who presented on 5/29/2021 for evaluation of catheter problems. Patient presented to our emergency room with complaints of leaking around his catheter. Patient had a uro left done on Wednesday 05/26/2021. Wife and patient stated they went back yesterday due to the catheter was clogging up with clots and they replaced catheter. Patient stated he has been urinating clear but around the catheter and none has been going into his leg bag. Patient wife states that he has not taken his diuretic all day because he was worried about taking it since urine was not going into the Foley catheter bag. Upon arrival to the emergency room patient's temperature 98°, pulse 83, respirations 18, blood pressure 153/77 oxygen saturation 100%. Hemoglobin 8.8, glucose 285, BUN 24, sodium 134, INR 1.3, BNP 1460, urinalysis has culture pending. The emergency room called Dr and he requested that the patient be placed in observation here to assure that anemia is not worsening, CHF improves and patient is able to void on his own without retention. Patient received Lasix 40 mg IV push in the emergency room. Patient was admitted observation status for further treatment and evaluation systolic congestive heart failure, acute post hemorrhagic anemia, anticoagulant induced hematuria. Upon entering the patient's room this morning patient is resting in bed in no acute distress. Patient is alert and oriented x3. Patient states he is voiding without any difficulty from having Foley catheter removed. Patient states he came to the ER because he did not take his diuretics due to he was peeing around the catheter and then of his urine was going in Foley catheter bag. Patient denies any increase in shortness of breath, chest pain or any weight gain. Explained to patient that he is going to be here for the next day receiving IV diuretics to see if we can get swelling decreased on bilateral lower extremities and to continue monitoring his urine for blood and checking his hemoglobin. Rounds made with another Dr.

Urinary tract infection; This is a spontaneous report from a contactable consumer (patient). This 83-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3302, Expiration Date May2021), via an unknown route, on 21Jan2021 at single dose for COVID-19 immunisation. Relevant medical history included urinary tract infection for years. Relevant concomitant medications included apiaxaban (ELIQUIS). On 23Jan2021, the patient developed urinary tract infection (UTI). The patient stated ''I have urinary tract infection for years, so it's not something, it's not unusual". Therapeutic measures taken as result of the event included antibiotics. The patient had not recovered from the events.

Initially presented with weakness/fatigue. He was found to have abnormal liver enzymes with AST/ALT in the 900s, T bili of 10, creatinine of 1.7. CK was elevated >13K. Patient overall worsening and anuric requiring possible hemodialysis for worsening renal function. Overall picture most suggestive of rhabdomyolysis. Unclear etiolgy but can't rule out a vaccine reaction.

Sent to ER 1/14/2021 due to drop in blood pressure with LOC during dialysis. Imaging revealed right lower lobe pneumonia given script for amoxicillin. According to staff patient was on dialysis had pneumonia and was on hospice, dialysis stopped resulting in death.

Pfizer-BioNTech COVID-19 Vaccine EUA Patient presented to the ER on 2/14/21 after experiencing night sweats, fevers, urinary incontinence, flank pain, and generalized fatigue for 5 days. Admitted and treated empirically for sepsis. No source of infection found, fevers continued on IV antibiotics.

Urinary tract infection; high blood pressure; Fall; This is a spontaneous report from a contactable consumer (patient's wife) via the Pfizer sponsored program. An 83-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265, expiration date: 31Mau2021), via an unspecified route of administration on 02Feb2021 13:12 at SINGLE DOSE for Covid-19 immunisation. Medical history included heart surgery (Between 6-9 years before), Congestive heart failure, blood pressure (problems with blood pressure) and fall (history of falls). Concomitant medication included ongoing carvedilol for Congestive heart failure. The reporter stated that her husband has high blood pressure (occurred on an unspecified date) and was having problems falling. He fell the night of 03Feb2021. She called the paramedics to come help get him up. He was taken to the emergency room on the morning of 04Feb2021. He was found to have a urinary tract infection (on 04Feb2021) and was admitted. The patient was hospitalized for the event urinary tract infection on an unspecified date for 2 days. He is now in rehab and will have to learn to walk again. She is calling to ask what needs to be done about her husband getting the second dose. The patient underwent lab tests and procedures which included blood pressure: 150/90, CT scan, labs, urine test and X-rays: unknown, weight: 175-180 lbs on an unspecified date. Outcome of the event urinary tract infection was recovered with sequelae on 06Feb2021. Outcome of the event fall was recovered with sequelae on 03Feb2021 while outcome of the event blood pressure increased was recovering.

Cardiac arrest Narrative: An 82 year old, male, resident of a facility, received his first dose of the Pfizer COVID vaccine on 12/30/20 (time of dose not known). On 12/31/20, patient was reported to be febrile with increased lethargy and UTI was suspected so patient received a dose of ceftriaxone and levofloxacin. Within 30 minutes he became wheezy and short of breath, developed hives and tongue swelling. He required intubation and admission for treatment of acute respiratory failure, acute kidney injury and significant lactic acidosis. Treatment included epinephrine, H1 and H2 blockers, and steroids. He recovered and was extubated on 1/3/21 and discharged back to the facility on 1/6/21. Attending physician noted that antibiotics were most likely contributor to event, but recommended that patient not receive the 2nd COVID vaccine dose. Patient was referred to an allergist to assess this event, with an outpatient visit on 1/14/21. Patient expressed interest in receiving the 2nd dose. Allergist determined that the antibiotics were the cause of anaphylaxis, and recommended skin testing to take place 6 weeks after his reaction. Allergist determined the reaction was not due to the COVID vaccine and advised patient that he could receive the 2nd dose. Patient received the 2nd dose of the Pfizer COVID vaccine on 1/9/21 (time not known). Notes from the facility indicate patient was lethargic and running a fever the morning of 1/20/21. At 1500 on 1/20/21 patient was noted to be lying supine in bed, visiting with aides. At 1508 nurse entered room and noted patient to be lying on floor supine and nurse was unable to get patient to respond to shaking or calling his name. Breathing was noted to be labored, and nurse was unable to detect a pulse. At 1509, 911 was called and CPR initiated. Spontaneous pulse and breathes resumed just before ambulance arrived at 1522. On arrival at the ED patient was responsive and breathing spontaneously, however, hemodynamically unstable. Patient went into cardiac arrest and code blue called at 1535. Received treatment with epinephrine, methylprednisolone, diphenhydramine, amiodarone, atropine. Patient was intubated. EKG obtained and showed acute MI. At 1622 he again went into cardiac arrest and time of death was called.

Shortness of breath sepsis AKI (acute kidney injury) (CMS/HCC) Atrial fibrillation with rapid ventricular response (CMS/HCC) Acute respiratory failure with hypoxia (CMS/HCC) Pneumonia of both lower lobes due to infectious organism

BRIEF OVERVIEW: Primary Care Provider at Discharge: DO Admission Date: 5/5/2021 Discharge Date:5/6/2021 Active Hospital Problems Diagnosis Date Noted POA ? Essential hypertension 05/06/2021 Yes ? Pulmonary embolism on right (HCC) 05/05/2021 Yes ? Right flank pain 05/05/2021 Yes ? Hypokalemia 05/05/2021 Yes ? Uncomplicated alcohol dependence (HCC) 05/05/2021 Yes Resolved Hospital Problems No resolved problems to display. CONSULTS: None INPATIENT PROCEDURES: None DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Patient is a 83 y.o. male with Hx of HTN who presents today with complaint of right sided flank pain, with radiations into the right side of his back and right side of his chest. The pain is worse with movement and deep inspiration. He denies palpitations and shortness of breath. He has no previous HX of VTE. He denies fever, chills, cough, nasal congestion, and sore throat. He denies abdominal pain, N/V, and changes in bowel movements. The patient is a limited historian. He is oriented x4 on admission, but states that he has had difficulty with his memory over the past 2-3 years. He lives alone in an apartment. In the emergency department the patient's vital signs were stable. Labs revealed a potassium of 3.3. AST was 52 and ALT 61. White blood cell count was 11.13. Troponin was negative and BNP was within normal limits. Lactic acid was 1.5. UA showed trace blood. EKG showed normal sinus rhythm with PACs. CTA the thorax abdomen and pelvis showed acute pulmonary emboli involving the segmental subsegmental arteries of the upper and lower lobes. There is no evidence of heart strain. He was admitted for observation due to severe pain, and was given IV fentanyl. Echocardiogram showed: The left ventricular ejection fraction is 67%. No regional wall motion abnormalities noted. The right ventricular size, thickness, and function are normal. The estimated right ventricular systolic pressure is 36 mmHg. The inferior vena cava was not visualized during the exam. There is no comparison study available. He was started on Eliquis 10 mg bid for 7 days, than 5 mg bid for total of 3 months. He should follow up with PCP in 1 week and should check CBC and BMP on 5/10/21. He should also follow up with pulmonologist in 2-3 months. He had Pfizer COVID-19 vaccine on 2/18/21 and 3/18/21. There is remote possibility that this PE could be related to COVID-19 vaccine, so this was reported to Vaccine Adverse Event Reporting System (VAERS). He had mild hypokalemia due to HCTZ, and required K-dur supplement. HCTZ was switched to Maxzide 25/37.5 mg daily. Rechecked K was normal 3.9. BMP should be checked in 1 week. Also he is drinking little bit too much alcohol, 4 alcoholic drinks every night. He was instructed to cut alcohol drinking to </=2 alcoholic drink a day. His daughter was updated over the phone.

Reported by patients granddaughter. Patient received second dose of Pfizer vaccine on 3/5/21. Two days after the second dose, patient began urinating blood. She reports that the color will change from bright ref to brownish red to darker brown. She also shared that patient is on Xarelto. They have been to several doctors and none of them think that the vaccine is the cause, but they wanted to share. He is having some sort of prostate procedure this week, but she is not sure what it is.

83-year-old male with past medical history significant for coronary artery disease with MI, CABG, atrial fibrillation, and COPD, who came to the hospital with shortness of breath. Upon arrival at the ED on June 12, 2021, the patient was in severe respiratory distress with oxygen saturation in around 70s. The patient was intubated for respiratory distress. The patient had recent angiogram with 2 stents placement. The patient was admitted to the ICU with acute hypoxic respiratory failure/ventilator-dependent respiratory failure, pleural effusion, possible pneumonia with sepsis, hypotension, and urinary retention. Critical Care, Cardiology, and Infectious Disease were consulted. Urology was consulted for the patient for urinary retention. The patient went to the OR for urinary retention and urethral stricture. The patient had transurethral incision of the vesical neck contracture. Foley catheter was placed. Infectious Disease was consulted for evaluation of the patient for positive COVID-19 infection. Infectious Disease recommended to continue COVID-19 isolation precautions, anticoagulation and steroids. The patient was seen and examined on June 15. At that time, Neurology was consulted for patient's seizure. Neurology saw the patient and recommended CT of the brain, which showed no acute intracranial process and EEG for further evaluation. Cardiology was consulted for evaluation of the patient for STEMI type 2. The patient had 2D with ejection fraction of 60%. The patient was on aspirin and Plavix. The patient had a recent stent placement. The patient was seen and examined on June 22, 2021. At that time, the patient was successfully extubated to nasal cannula. The patient was improving. The patient had IV antibiotics for suspected pneumococcal bacteremia and hospital-acquired pneumonia. Infectious Disease was following the patient. The patient was seen and examined on June 28. At that time, IR was consulted per Pulmonary request for thoracentesis. IR requested to hold Plavix for the procedure. The patient went to the procedure on June 29. The patient had 300 mL blood-tinged right thoracentesis done. The patient was seen and examined on July 3, 2021. At that time, the patient was lying down in the bed, no acute distress noted. The patient denied any chest pain or shortness of breath. The patient was status post thoracentesis. Infectious Disease was following the patient and IV antibiotics recommended. The patient was status post pneumococcal pneumonia with septicemia, bronchitis. At that time, Infectious Disease was okay to discharge the patient on p.o. antibiotics for 5 more days. The patient was discharged on July 3, 2021, in stable condition to subacute rehab with advice to continue outpatient followup for further medical care. The patient was stable at discharge.

Lethargy/Fatigue, fever/chills, acute chest pain or pressure, Exertional chest gas and pressure occurring in the last week or so Pericardila effusion was present in echo May be alternative cause/etiology for diagnosis--but not identified in report Complex medical history in 83 yr old male including Paroxysmal Atrial Fibrilation, HTN, dilated aorta, s/p prostate cancer, recent hernia surgery (1 week prior) with new signs of inflammation of pericardium after vaccination. Was also treated for possible UTI due to hematuria and fever

increase weakness and fatigue, weakness in extremities, incontinent, jerky arm movements, within first 24 hours, continue to decline sent to hospital returned weaker, within 24 hrs hours BP dropped, low pulse oximeter reading, diaphoretic, lung sounds diminished, loss consciousness and passed away. 01-12-2021

Shortness of Breath, Continuous Coughing with blood tinged spit, Blood Pressure 200/100, Oxygen level 84 began around 5:00 am with paramedics arriving and transporting to the hospital around 7:00 am.

Respiratory distress, Atrial fibrillation, Acute Kidney Injury, COVID 19 positive High flow nasal cannula, BiPAP machine, antibiotics

Patient arrived to ED via EMS after wife called reporting the patient became acutely dizzy, diaphoretic, and short of breath during a bowel movement. Patient was found to have COVID-19 via rapid swab with basilar opacities and effusions noted on X-ray. The patient had an elevated lactate of 3.9 and was in AKI with a serum creatinine of 2.36 (baseline 1.5 on 3/26/21). The patient will be admitted to the hospital. The patient has received azithromycin and ceftriaxone in the ED, as well as a fluid bolus of 500 mL NS. Patient is not hypoxic.

Light headness, Loss of appetite, overall listlessness, slight nausea, fever 101.6, dramatically excessive sweating,dark urine. Spent the next 24 hrs in bed.

Patient is an 84 year old male with a PMH of psoriasis, DM2 on insulin, HTN, HLD, who was admitted on 2/9/2021 with COVID-19 pna, weakness, and AKI. Pneumonia due to COVID-19 likely had concurrent bacterial infection present. Patient received 5 days of IV dexamethasone and ceftriaxone during admission. He was not a candidate for remdesivir. On day of discharge, chest x-ray showed persisting infiltrates and pt was discahrged with additional 5 days of oral dexamethasone. Patient discharged to home on 2/16/2021

Presented to ED following witnessed seizure in setting of COVID+ and BG <50. Given dextrose. COVID treated with dexamethasone and antithrombotic - aspirin 81 mg and intermediate dosing of enoxaparin. Hospital course complicated by UTI. Discharged back.

Urinary tract infection; Has been ill; He has been falling a couple times; Had a fracture at the base of his spine; Has gout in one knee; Couldn't walk; In a lot of pain; his knee swelled up, was very hot,the doctor said it was inflamed; hurt his right knee; he has not been eating; This is a spontaneous report from a contactable consumer. This consumer (patient's wife) reported for an 84-year-old male patient (reporter's husband) who received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EW0158) on 10Apr2021 at right arm for COVID-19 immunization. Relevant medical history included ongoing high cholesterol diagnosed a long time ago when he was very heavy at one point he was quite heavier than he was. Now he was skin and bones, ongoing high blood pressure diagnosed 10 years ago or longer and ongoing diabetes diagnosed 10 years ago, ongoing pacemaker and ongoing irregular heart beat and falls. The patient previously had sore arms at site after receiving the flu shot for immunization. Ongoing concomitant drugs included Carvedilol for high blood pressure, atorvastatin calcium for high cholesterol, amiodarone (this is the medication that would cause an issue with the antibiotic if it was taken orally), acetylsalicylic acid (BABY ASPIRIN) to thin his blood, sitagliptin phosphate (JANUVIA) for diabetes, vitamin D3, cyanocobalamin (B12), ubidecarenone (CO Q10), sertraline (generic of an old drug called Zoloft) as something to calm him down. The patient was scheduled to get the second vaccine on 01May2021, however he was in the hospital and did not have his. They rescheduled the vaccine for this coming Saturday because he was still in the hospital. He was actually getting moved to a rehabilitation facility with intravenous antibiotics for a urinary tract infection and will not be able to get it. The patient was on an IV antibiotic which could not be administered orally do to the fact he has a pacemaker and irregular heart beat. The doctor told her that the oral medication would interrupt the spikes of the pace maker, his heart. The reporter was wondering if her husband can still have the COVID vaccine while taking the antibiotic. She asks will it interfere with that medication. Will he have to start all over again with number one of the vaccine because he missed the vaccine in the allotted time span. The last time the patient was weighed he was 155, but he has not been eating since he has been ill. He had so many problems since he has been ill, he has been falling a couple times. The reporter wanted to protect him from the terrible disease, but didn't want the injection into his body creating anymore problems than he already has. The doctor said that she thought the caller could take the patient out of the rehab facility for the day and get his vaccine and then bring him back. The facility said they would have to do research about that and get back to her. Caller states that her husband kept falling and had a fracture at the base of his spine, in addition to other problems, he has gout in one knee. She states that he would be standing up talking to her and the next thing she knew he was on the floor. She states that he has fell six times in a month. She states that she has become friends with the fire department because they came out so much. The falling occurred before he got the vaccine. She states he was fine when he went for the first vaccine and then the following week it started all over again, he couldn't walk. He had a physical therapist helping him strengthen his walking. She states that her husband says he fell and hurt his right knee while working with the physical therapist and the physical therapist said no, no, no, he didn't fall, he had a strap wrapped around him and the physical therapist caught him before he fell. Caller states that the physical therapist is 30 pounds lighter than her husband and doesn't know if he could of grabbed him before he hit the floor. She states that her husband was in a lot of pain and his knee swelled up, was very hot. She states that the doctor said it was inflamed. She states that she brought him back to hospital because they could not get him up and he could not walk. She couldn't pick him up, her son couldn't pick him up, her daughter couldn't pick him up and her son and daughter together finally got him up but he couldn't walk. She states that she called the emergency medical team. They said he has to go to the hospital and that was the last time he was at home. Has a walker and it takes a little while. She didn't know if he got the gout from that knee, but when they took out his fluid the following day you could of heard him screaming in the next county over. They were suppose to have the results but they didn't, they discharged him from the hospital. She states that he hasn't been able to come up with a breather of fresh air and feeling better. Caller states that he was now taking a gout medication at the hospital and that they told her that her husband had a second fracture to lower spine. The outcome of the events was unknown. Information on the lot/batch number has been requested

Hospital 5/22 thru 5/24/2021 Dx: UTI/ Weakness/ Right Pleural Effusion Covid Positive (5/22/2021) ED to Hosp-Admission Discharged 5/22/2021 - 5/24/2021 (2 days) Treatment team UTI (urinary tract infection) with pyuria Hospital Problem List Generalized weakness Resolved Pleural effusion on right Resolved UTI (urinary tract infection) with pyuria Resolved Lack of appetite Resolved UTI (urinary tract infection) Resolved Constipation Resolved Intractable vomiting with nausea Resolved

84 y/o M PMHx of non-hodgkin's lymphoma, adenocarcinoma of the colon (1996) and type 2 DM, presented ED 4/17 with complaints of weakness x 1 week. He reported some Memory loss but denied fever/chills, coughing, dyspnea or fever. Admitted for UTI. On 4/19 patient developed fever, tested positive COVID, started on decadron and remdesivir, pulmonology consulted. 5/1 increasing O2 requirements, prompting transfer to ICU. Mental status improved. 5/3: Fluctuant FiO2 requirements. Transferred to the floor and back to the ICU for hypoxemia. Intubated 5/7. Pt with worsening AKI, metabolic acidosis and shock in the evening of 5/8. Daughter on 5/9 and pt made a DNR. Worsening shock, metabolic acidosis and MODS. Decision to dc to hospice

N17.9 - Acute kidney failure, unspecified I21.4 - NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC)

1/14/2021-0545, blood noted left and right ear. 0715, vomited x 1. Covid Antigen positive. Acute MD visit-basilar crackles right and coughing. Increased confusion.

DIRECTLY FOLLOWING ADMINISTRATION Involuntary shaking in both arms for 2-3 hrs (severe). Not just trembles Fatigue to near incapacitation (severe) Muscular movement unresponsive Unable to stand, sit up right, raise arms Incontinence Confusion, non-responsive, fog 101.3 F temperature Strained breathing

Resident rec'd COVID vaccine #2 on 02/02/2021 and was hospitalized on 02/03/2021. Diagnosed with UTI & Metabolic Encephalopathy. He was re-admitted to facility on 02/05/2021. On 02/08/2021 resident was found to be unresponsive with small amount of tan emesis in mouth and on bed. CPR initiated and resident was transferred to ER. ER MD notified facility that resident had died.

Extreme exhaustion and weakness. Loss of appetite. Incontinence. Inability to participate in activities of daily living. Possible stroke. Amnesia. Delerium. Visited Dr on March 1st. Bloodwork taken. Bloodwork showed high white blood cell count. On 3/2/21, Doctor advised patient to go to ER but patient refused. Urine sample dropped off on 3/3/21. Urinalysis showed bacteria in urine. Doctor prescribed cephalexin for possible UTI and ordered brain MRI without contrast. Patient is still exhausted and sleeping a great deal. Appetite is improving. Additional information for Item 18: Patient cannot remember any events between February 24-March 9, 2021. MRI done on 3/12/21. Waiting on results of MRI. Switched primary care on 3/12/21.

about 15 hours after dose of vaccine his daughter could hear him carrying on, and was standing but not responding to verbal cues. He was confused, wet himself, and still doesnt remember anything about the event or the ambulance ride. He would not and could not walk, and was sweating, breathing labored, they called 911. went to hospital and was admitted friday morning and was released monday. patient states his body was in pain from head to toe. His daughter stated he received antibiotics and fluids and is not sure what else. Patient is home now and is doing better.

Patient had chills the night after the vaccine and throughout the night pulse ox dropped to 88, given 3L O2. Pt had little sleep and the next day had no appetite pulse ox between 88-90. After dinner had severe chills, no fever ,extreme SOB , pulse ox down to 79, coughing up blood tinged sputum, fluid in lungs, anxious. EMT called sent to hospital confirmed to have had an MI and new onset CHF, enzymes elevated, creat 1.8. Transferred to hospital and was stable. The next day still SOB, enzymes lessening, trying to wean from O2. The nurse attempted to get the pt to the bathroom he became extremely SOB and became unresponsive. They attempted CPR and the pt expired shortly thereafter due to another MI.

This 85 year old white male received the vaccine on 2/19/21 and went to the ED on 4/05 and was admitted with generalized weakness, hyponatremia, fever and elevated bilirubin. On 04/16/21, he went to the ED and was admitted to the hospital on 4/17 with poor appetite and hospital admission dx of ketonuria, leukocytosis, renal insufficiency, elevated troponin, hematuria, generalized weakness and died on 4/19/2021. Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.

This 85 year old white male hospice patient received the Covid shot on 2/16/21 and went to the ED on 2/21/21 and was admitted on 2/22/21 with altered mental status, pneumonia, severe sepsis, bladder cancer, UTI, dementia and died on 4/19/21. Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.

Admit 5/23. Vaccine 1/16, 2/10. H/O CAD, CHF, previous strokes. Presented to ED from NH with AMS, fever. COVID+. CXR shows no infiltrates. No supplemental O2. Also found to have acuta CVA. Palliative care consulted, family agreed to hospice. DC'd to Hospice.

I am the epidemiologist reporting on behalf of patient who tested positive for COVID-19 via PCR on 4/29/21 after the completion of a full Pfizer vaccine series (Dose 1 on 1/24 and Dose 2 on 2/14). The patient later died on 5/04/21. Pre-existing conditions listed as: OTHER CHRONIC DISEASES, IMMUNOCOMPROMISED CONDITION. Comments:05/04/21:Patient was admitted to the hospital on 4/28/2021 for COVID-19 infection, pneumonia, and acute on chronic renal failure. He was transferred to the ICU on 4/29/2021 due to acute hypoxic respiratory failure requiring intubation. Despite maximum therapies, the patient's respiratory status did not improve. He remained mechanically ventilated from 4/29 through 5/4. On 5/4, the patient became hypotensive and bradycardic. The patient died at 10:45.

elderly diabetic man with AFib/RVR who presented with multiorgan failure few hours after receiving his 2nd COVID shot today and ultimately expired. he did well after the 1st COVID shot and subsequently developed this multiorgan failure after the 2nd shot. had his second COVID vaccine shot around 4 pm, went home and collapsed, lay on the floor for a few hours refusing to call paramedics, eventually wife called 911, he arrived to ED and was dead a few hours later. -on arrival the pH was 6.7, agonal breathing, low BP, lactate 18, but no MI, no stroke, no apparent infection/sepsis. important to note that he had a covid vaccine just a few hours from collapsing and dying.

2/27/21 hpi86 y.o. male with a past medical history notable for Dementia, hypertension, hyperlipidemia, recent skin breakdown. The patient presents for evaluation of worsening issues of cellulitis and acute renal failure skilled care facility. Due to patient's dementia other history could not be taking. Patient has had decreased intake. Patient has had some worsening issues with skin breakdown. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed. Patient does show signs of discomfort with his bottom. Patient otherwise appears to be at baseline. Hospital Course: patient was admitted to the hospital for worsening dehydration and finding UTI and pneumonia. The patient is also found have skin breakdown. The patient was placed and patient is started on IV fluids and IV antibiotics and wound care was started on patient. Patient did have some issues with behaviors but this was improved with treatment. 3/20/21 readmission acute renal failure

SHORTNESS OF BREATH Pleural effusion Acute renal failure superimposed on chronic kidney disease, unspecified CKD stage, unspecified acute renal failure type (CMS/HCC) DEATH

This 86 year old male received the Covid shot on 1/20/21 and went to the ED on 1/23/21 and was admitted on 1/23/21 and again went to the ED and admitted on 4/4/21 and again to the ED on 4/26/21 with the diagnoses listed below and died on 5/4/21. D50.0 - Blood loss anemia I21.4 - NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC) N17.9 - AKI (acute kidney injury) (CMS/HCC) S09.90XA - Closed head injury, initial encounter W19.XXXA - Fall, initial encounter S01.01XA - Laceration of scalp, initial encounter S06.5X9A - Subdural hematoma (CMS/HCC) S06.5X9A - Traumatic subdural hematoma (CMS/HCC) Z74.09, Z78.9 - Impaired mobility and ADLs

J18.9 - Left lower lobe pneumonia I48.91 - Atrial fibrillation with RVR (CMS/HCC) N17.9 - Acute kidney injury (CMS/HCC) N30.01 - Acute cystitis with hematuria

Reported due to being transferred to hospital within 3 days of vaccination. Patient sustained a fall and likely this is not related to COVID vaccine as he had no post vaccination symptoms and has a history of falls. He returned after being evaluated and hospitalized for 6 days Dx included urinary tract infection and acute kidney injury. We were instructed to report any hospitalizations within 3 days of vaccine.

Patient was leaving the 15 minute post-vaccine monitoring area approximately 40 minutes after vaccine administration (administration of second dose at 08:42, rapid response called at 09:21). He became pale, lethargic, diaphoretic, incontinent of urine, and collapsed onto his walker. A rapid response was called. Blood pressure on arrival by team was 50's/30's, and fluid resuscitation with 0.9% sodium chloride 500 mL was initiated while in transit to the ED. Approximately 20 minutes later the patient's had stabilized but remained appropriately alert.

Cerebral infarction due to unspecified occlusion or stenosis of other cerebral artery Altered mental status Anemia Renal insufficiency

FALLS, CHEST PAIN, HEMORRAHAGIC CONTUSION, COVID, PNEUMONIA, HYPOXIC RESPIRATORY FAILURE Narrative: 2/22/2021 Patient presented to hospital with multiple complaints. He was reporting falls, chest pain, his wife was diagnosed with Covid. While he was there, he was found to have hemorrhagic contusion in the right frontoparietal region with minimal surrounding edema, Covid, pneumonia, elevated troponin. He was accepted in transfer by trauma surgeon Dr. and arrives with no complaints. 2/26/2021 Patient died after code blue was called Death Diagnosis: s/p fall with head trauma Focal area right intracranial hemorrhage per initial CT - serial CT head showing stability Acute hypoxic respiratory failure secondary to COVID-19 viral illness COVID-19 viral illness Acute chest pain, improved Elevated troponin, suspected type 2 NSTEMI Elevated D-dimer - V/Q scan with intermittent probability PE Acute kidney injury on CKD, improving unlikely that vaccine contributed to patient's death.

3/26/21 Patient presented to the ED w/several days of fever, chills, body aches, SOB, and fatigue. He had a + COVID-19 test several days prior. His RA pulse ox was 83%. He was started on BiPAP, decadron and remdesivir. Acute Hypoxemic Respiratory Failure ARDS secondary to COVID-19 pneumonia Oxygen requirement improving, Antley on 4 L of oxygen Status post 10 days of dexamethasone. Status post remdesivir. Continue incentive spirometer use. Breathing treatment as needed. Ct chest- CT chest images personally reviewed and notable for chronic changes consistent with evolving ILD/fibrosis + areas of consolidation which are consistent with a bacterial pneumonia Agree with pulmonology starting patient on IV Zosyn and IV vancomycin Agree with MRSA PCR from and starting Steroids and plan on a 6 week taper. Repeat OP imaging. Patient desaturates with activity Patient was discharged on 4/21 and was readmitted on 4/22 Patient is a 87 y.o. male patient with a history of hypertension, hyperlipidemia, CLL GERD, vitamin D deficiency, with a history of TIAs who was recently admitted to Hospital with COVID-19 pneumonia requiring remdesivir and steroids. After a protracted hospitalization the patient was deconditioned and on 4/21/2021 the patient was admitted to hospital for aggressive rehabilitation. The patient had been doing well over the past week and was making good progress however today during her visit the Daughter noticed at 11 AM when she came to visit him that he is unable to speak and that his gaze is to the right and there is left facial droop. Nurse confirmed this finding had a stroke alert was called. A CT scan was completed and patient is moved to emergency room department. Upon the virtual neurologist's evaluation, patient is alert and oriented without any aphasia or dysarthria. There is no gaze deviation. Extraocular movements are full. There is no facial weakness. There is no drift in any of the extremities and there is no reported sensory loss and there is no appendicular ataxia. The neurologist reviewed the images of CT head and it showed no acute intracranial abnormality.

Upon leaving the site my husband had great difficulty walking. Upon arrival home he seemed unusually confused and over the course of the next 15 hrs had bouts of incontinence. He was up 6 times during the night (usually only 1-2x) and unable to get himself out of bed without assistance. Walking continued to be very unsteady. I thought perhaps he had a mini-stroke. I relayed this to his PCP but he didn't think it was vaccine related

Pt. tested positive for SARS-CoV-2 on 2/3/2021 and required hospitalization for associated diarrhea and dehydration with mild acute kidney injury. Of note, he has not been hypoxic and has not required supplemental oxygen to maintain his SaO2 as of 2/6/2021.

Patient brought to emergency department at 2210 with concern for stroke d/t left sided weakness. Upon arrival patient appeared to have seizure like activity and was given 2mg of ativan and keppra 1000mg. Patient remained able to converse with providers during episode. Seizure activity/muscle twitching resolved after ativan/keppra administration. At the time of filing this report the patient is being admitted to the hospital.

Patient vaccinated with first dose of Pfizer with subsequent infection and hospitalization due to COVID-19 infection. Initial H&P reads in part as, "Patients symptoms began on or around Thursday 3/11 when he began to feel fatigued. After two days of fatigue, he presented to an urgent care facility on Saturday 3/13. He was noted to have a fever there and was diagnosed with a presumed UTI, though patient reports at bedside that he has not had any dysuria. He was treated with nitrofurantoin and increased his furosemide temporarily per urgent care's recommendations. He then presented to the ER on 3/15 with continued fatigue and a low blood pressure at home. We were unable to clarify the method by which the blood pressure measurement was obtained and/or if it was repeated. Antibiotics were changed to cephalexin at that time despite a relatively clear UA. His daughter brought him back to the ER today (3/18) due to persistent issues with low grade fevers in the 100-100.5 range, significantly worsening fatigue, anorexia, and oxygen levels of 92-93% on nonproductive cough. Does not have a home O2 requirement. In addition, he endorses feeling chilled during the admission evaluation. Denies any chest pain, nausea, vomiting, fevers, diarrhea, constipation. # Fever Progression of symptoms from Saturday 3/13 may constitute original presentation of Covid-19. Presentations on 3/13 and 3/15 with dyspnea and fatigue. Initially thought to be UTI and was treated with nitrofurantoin and cephalexin. UA on 3/15 in ED was negative for leuk esterase and nitrites. Tested positive for covid-19 on 3/18 with lymphopenia, 90-92% on room air. No home O2 req. Given duration of symptoms and worsening fatigue and fevers, will admit for treatment of Covid- 19. Also considered CHF exacerbation, COPD exacerbation as explanations for dyspnea. Possible CHF exacerbation as well given 1+ bilateral pitting edema to mid-shin and JVD to ear lobe. Suspicion for COPD is low given no report of increased sputum production and questionable history in chart to begin with. Would be beneficial to clarify history with collateral history 3/19."

My Father had been in his usual state of health when he received his first Pfizer Covid-19 shot on 1/12/2021 and his second dose on 2/2/2021. He complained of being tired and chills on 1/13/2021 and again on 1/20/2021. He was diagnosed with a UTI and placed on antibiotics on 1/27/2021. After the second covid-19 shot on 2/2/2021 my father had a change in his condition on 2/4/2021. He became very lethargic, more confused and unable to speak and was send to the Hospital. He spent from 2/4/2021 to 2/12/2021 in the hospital being treated for a UTI and also was said to have had a Transient Ischemic Attack. He went to a rehab facility for Physical Therapy from 2/12/2021 to 2/19/2021 after which he returned to the Assisted Living Facility. He had another episode of lethargy/unresponsiveness on 2/26/2021 and was once again sent to the hospital where they did not show any new findings. He spent a few days in the hospital before returning to his facility where he continued to have periodic episodes of increased lethargy/confusion and decreased eating. He was placed on Hospice and passed away on March 29th.

88 y.o. male with medical history of hypertension, dyslipidemia, sinus bradycardia, COPD ,OSA on CPAP night and AFib on Xarelto. Patient presented to the emergency room with a complaint of chest pain and worsening shortness of breath.Initial vitals in the ED showed temperature 36.1° heart rate 83 respiratory rate 20 blood pressure 150/89 SpO2 96%. CBC within normal, PT 18.8 APTT 39 D-dimer 1111, CMP showed bicarb 32 creatinine 1.39 E GFR 45 and lipase 146. Initial troponin is 53 with indeterminate to our delta, will follow-up on 6 hour delta. ProBNP 1663 with no baseline available. Patient tested negative for COVID-19. VBG showed pH 7.33 and pCO2 of 61 no baseline pCO2 available. Chest x-ray as per report no acute abnormality, personal impression increase interstitial reticular opacities suspicion of fluid overload/pulmonary edema. CT PE as per report filling defect left descending pulmonary artery consistent with acute pulmonary embolus. Patient admitted to the ICU for further monitoring and evaluation. Patient started on heparin drip, rivaroxaban factor Xa antibody sent, as per patient he was compliant with Xarelto. Vascular medicine consult done recommended to bridge with warfarin versus start Lovenox. Discussed with the patient, patient prefers warfarin. Patient was started on warfarin INR 2-3. Resumed CPAP for OSA. Venous Doppler lower extremities negative for acute DVT. TTE showed Normal left ventricular chamber size. Estimated LV ejection fraction range 55-60%. No regional wall motion abnormalities. Mildly enlarged right ventricular chamber size and mildly reduced RV systolic function. Estimated RV systolic pressure 46 mm Hg. Moderately enlarged inferior vena cava size with reduced inspiratory collapse (<50%). No hemodynamically significant valvular heart disease. Patient was started on Lasix IV; converted to oral upon discharge. Patient discharged on Lovenox and warfarin. Patient medical condition improved with medical treatment

Went to ER on 4/27 with c/o chest pain (~3 day history), resolved. Returned to ER on 4/30 for chest pain- diagnosed with a small LEFT lower lobe segmental and subsegmental pulmonary embolus on CT 4/30/2021, hospitalized until 5/2/21, discharged on Eliquis, metoprolol, pantoprazole, keflex (for sore throat, negative throat cultures), metoprolol, atorvastatin, amlodipine.

ED to Hosp-Admission Discharged 4/28/2021 - 5/1/2021 (3 days) Last attending ? Treatment team Acute respiratory failure with hypoxia Principal problem Hospital Course Admission HPI: (patient) is an 88 y.o. male come to emergency room for evaluation of cough with thick yellow sputum which is going on since past 2 days. Which is progressively getting worse. Associated with some shortness of breath. On arrival of EMS patient found to have significant hypoxia with 70% at room air. He was placed on nasal cannula. Did bring him to the emergency room. Patient had a dose of Covid vaccine and is due for second dose soon. In emergency room, he was thoroughly evaluated. He found to be septic. He was given dose of IV Levaquin and Covid swab come back positive. Hospitalist service requested to admit the patient. Asking patient, is feeling little better after coming to emergency room. He is having shortness of breath with significant cough with sputum production. He felt wheezy. Denies any fever but had chills. He feels nauseated. Hospital Course: Pt was admitted to the hospital for management of acute hypoxic respiratory failure secondary to COVID-19 virus pneumonia. His breathing improved precipitously. He had resistant hypertension this admission and was started on amlodipine. He did have mild hyponatremia this admission but did not appear to have any volume overload. TSH elevated at 13.8. Will need repeat study. He did also have rising procalcitonin and received few doses of antibiotics. Lipid panel was benign. ED Discharged 5/9/2021 (58 minutes) Hospital ER Treatment team Thrush, oral Clinical impression Sore Throat Chief complaint ED Provider Notes (Physician Assistant) Emergency Medicine Cosigned by: (Doctor) at 5/9/2021 6:45 PM Attestation signed by (Doctor) at 5/9/2021 6:45 PM The patient was seen and treated primarily by the PA-C. I did not independently evaluate the patient. Chief Complaint Patient presents with ? Sore Throat HPI Patient is a very pleasant 88-year-old male with recent COVID-19 infection diagnosed on 4/28/2021 on oxygen 4L NC, who presents to the emergency department complaining of sore throat x 1 day. He states that he started yesterday with a sore throat, painful to swallow, then noticed this morning that he had twice patches on his tongue and mouth. He states he is able to tolerate food and liquid, but that it hurts to do so. He denies any fevers or chills. From a Covid perspective, he states that he would not be here if it were not for the pains and sores in his mouth/throat. He feels that his breathing is stable and he is doing well on 4 L of oxygen nasal cannula as prescribed. He has finished a course of Decadron and states he is currently on no further treatment for COVID-19. ED to Hosp-Admission Discharged 5/10/2021 - 5/13/2021 (3 days) Hospital (Doctor) Last attending ? Treatment team Aspiration pneumonia Principal problem Hospital Course Patient come to the hospital with complaining of abdominal pain and hypoxia and cough. Patient found to have a right middle lobe pneumonia. We are believing that it is aspiration pneumonia which is improving at this time. He had a recent COVID-19 infection which is resolving at this time. During course, GI, pulmonology, urology and oncology consultation obtained. Patient continued to improve clinically. Patient had a urinary retention because of the constipation. He is able to void now. Today morning, I am seeing him. He is feeling better. Is agreed to go home. I discussed with the patient's wife regarding plan. Once he fully recovered from pneumonia he need to have colonoscopy and possible biopsy of colon mass.

Per discharge summary, patient presented to BHL with his wife with increased shortness of breath, diarrhea and hematuria. Found to be COVID +. Patient tested positive for COVID 5/21. He has received both Pfizer vaccinations. Patient was admitted and started on treatment for Covid with remdesivir and steroids. He was continued on his home dialysis schedule. He continued to have intermittent confusion and then for the last 3 to 5 days was very confused and more unresponsive. Reviewed goals of care with wife at length and palliative care was consulted. Decision was made not to pursue feeding tube due to patient having clearly outlined his wishes and his advanced directive. Upon further discussion with family hospice was consulted and patient was transitioned to inpatient hospice

1-12-21 Resident is complaining of heart pain. Resident blood pressure is 228/105. 1-22-21 Dx UTI 1-13-21 His nurse called MD at approximately 0645, reported to him that it was reported to this nurse that resident has not slept in 2 days and night, has an increased blood pressure, reports severe pain in lower back, and appears to be uncomfortable Resident is able to verbalize his pain and where it is at, but is unable to explain the quality of the pain or give a number on the 0/10 pain scale.

Resident was hospitalized for confusion, and hypotension and increased weakness; resident proceeded to have a NSTEMI and died on 5th day in hospital on 1/31/2021.

Bleeding from right kidney; Bleeding from right kidney; Left kidney is shrunken and function at about 10%; Left kidney is shrunken and function at about 10%; This is a spontaneous report from a contactable consumer (patient). An 89-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL8982), via an unspecified route of administration on an unspecified date in Feb2021 (19:00) at single dose (at the age of 89-year-old on Left arm) for COVID-19 immunization. Medical history included arthritic knees and shoulder, prostate cancer, macro degeneration, hearing loss, congestive heart failure, Last right kidney bleed one a year ago (2020 to 2020). The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered:Hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient had no known allergies to medications, food, or other products. Patient had Bleeding from right kidney into nephoscimy bag. No noticeable bold from bladder. Left kidney is shrunken and function at about 10%. All events from 06Feb2021 04:00. No treatment was received in response to the events. The outcome of the events was recovering.

2/17/21 Pt w/fever, SOB and diarrhea. Positive household exposure to COVID. + for SARS-CoV-2. Was given fluids and no hypoxemia. Discharged to home and set up with monoclonal AB infusion 2/18/21 In am pt received bamlanivumab w/o issue 2/18/21 several hours later pt returned to ED w/fever to 103.1, tachypnea and hypoxemia. Pt was started on steroid and he had rapid improvement. He weaned off oxygen on 2/19. He was discharged 2/20.

Chief Complaint Arrived via EMS- per wife pt has been more confused than BL, febrile, incont of bowel and bladder. Denied pain. +cough, SOA. Got first dose of COVID shot wed.. A&Ox1. Has left sided weakness from prior CVA History of Present Illness 89-year-old male who presents to the ER via EMS with confusion. He has also reportedly had a cough and some fever. There has been some report of incontinence of both bowel and bladder. He received his first dose of the Pfizer Covid vaccine on Wednesday, 3/17. He and his wife have returned to the home after wintering in another state. According to his wife, with whom I have spoken this evening, last night he suddenly became confused. The confusion continued throughout the day today, thus prompting the EMS called to the house and the subsequent journey to the ED for further evaluation. In the ER this evening, a battery of testing was completed. A Covid swab is indeed positive. His wife is uncertain of any positive contacts. He had some vascular congestion on chest x-ray. He has a prior history of pleural effusion which is thought to be resolved. He does have a history of lower extremity edema. He had some urinary incontinence and his wife held his Lasix Saturday morning. He was noted to be slightly hypoxic around 88% on room air. He was around 85% or so on room air at home with their home pulse oximeter device. He has been placed on 2 L of nasal cannula.

CHEST PAIN SHORTNESS OF BREATH Shortness of breath Pneumonia Elevated troponin Elevated CK Acute chest pain Elevated lactic acid level Pneumonia of both lungs due to infectious organism, unspecified part of lung Ground glass opacity present on imaging of lung Leukocytosis, unspecified type Hematuria, unspecified type Sepsis

89 yo M presents with complaints of weakness and diarrhea for the last 3 days. He received his COVID-19 Vaccine about 10 days before presenting to hospital. Also complains of decreased appetite and oral intake, but denies any nausea or vomiting. Denies fever, chills, cough, and SOB. Patient tested positive for COVID-19 and was admitted on 01/27/2021 for dehydration, AKI, and pneumonia likely secondary to COVID-19 virus, although he did not exhibit any symptoms of SOB or cough. Patient was treated with IV fluids, Pulmicort, Decadron, Protonix, aspirin, and SQ heparin secondary to renal function. Dehydration and AKI were corrected and the patient was discharged on 01/30/2021 with no complaints of COVID symptoms and an