Pfizer

Same day pt developed burning pain with urination and fever of 101F the same day. Pt came to the hospital, was not determined to have a urinary tract infections. No fevers during time in the hospital.

Received the vaccine & the next day became very weak and ill with throwing up. Her sister came to visit and noticed her right face was drooping & her balance was off so she called ambulance. Subsequently has been hospitalized for a month with a heart failure exacerbation that has led to ICU care, sepsis with Klebsiella pneumonia, acute kidney injury now with long term dialysis, hyponatremia, & elevated liver enzymes

Developed N/V ~2 weeks after 2nd covid vaccine. Presented to PCP, labwork revealed AKI and hyperkalemia. Sent to ED. Admission lab included SCr 8.55 mg/dL and K+ 5.7 mmol/L. Repeat K+ level 7.0 mmol/L (6 hours later). Pt admitted, vascath placed, emergently dialyzed. Further work up revealed positive anti-nuclear antibody, positive anti-nuclear antibody titer, and elevated glomerular basement membrane antibody. High dose steroids (methylprednisone 1g iv qday x 3 days) started for presumed vasculitis. Renal biopsy performed, results c/w severe crescentic acute glomerulonephritis. Treated with rituximab 375mg/m2, subsequently transferred to another facility for plamapheresis.

Patient presented to the emergency room with chief complaint of right side abdominal pain and and nausea. Primary problems were found to be right ureteral stone and urinary tract infection. Patient was admitted on 3/13/21 and while doing rapid COVID-19 testing on 3/13/21, was found to be positive. Patient denies any contact with COVID-19 and presented with no symptoms to suggest COVID-19 illness. Patient denied any fever, headache, loss of senses of taste or smell, muscle aches, fatigue, vomiting, constipation, or diarrhea.

UTI; passing a lot of blood; This is a spontaneous case received from a contactable consumer. A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EJ1688), dose 2 via an unspecified route of administration on 17Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 24Feb2021 at Single dose for COVID-19 immunization. The patient received both doses of the Pfizer-BioNTech COVID-19 Vaccine (first dose last 24Feb2021 and second dose on 17Mar2021). On the 18Mar2021, patient had UTI (Urinary Tract Infection) and was admitted in the emergency Room on the 19Mar2021. She was passing a lot of blood and was put on heavy duty antibiotic (cefuroxamine Possibly cefuroxime). The patient experienced uti on 18Mar2021 and passing a lot of blood on Mar2021. The event was assessed as medically significant. Outcome of the event was unknown. Information about batch/lot number has been requested.

Received dose and tolerated it well. Over last week increasingly SOB, diarrhea and weakness. Of note family contact tested positive for She was admitted to the hospital - c Patient admitted to COVID unit as PUI, tested positive for COVID on 3/7. Required O2 and intubated with ICU admission. She remained intubated for 12 days. Her ICU course was complicated ARDS with severe hypoxemia, A.fib with RVR, mod-severe PFO with R to L shunt, spontaneous intraperitoneal bleed, septic shock, renal failure and ultimately multi-organ failure. Family made decision to transition to comfort measures only. She died shortly after extubation.

Death R41.82 - Altered mental status N39.0 - Urinary tract infection N17.9 - Acute kidney injury (CMS/HCC) A41.9 - Sepsis (CMS/HCC)

she has a little bit of skin that is very dry; Pain under breastbone; Welts; lumps in her skin underneath; Swelling: lips, face swollen, arms, hands, fingers, left foot, left kneecap left thigh, feet swelled up like a balloon; Fingertips felt tingley; rash on her palm, a red circle; hand was hot and itchy; hand was hot and itchy; Tired and exhausted; toes feel puffy; urinary tract infection; not sleeping; Rash, painful; This is a spontaneous report received from a contactable consumer (patient). A 76-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Feb2021 (Lot number: EL9262; Expiration date: 31May2021) on the left arm at 0.3 mL, single for COVID-19 immunization. Medical history included AFib from 2009 and ongoing; allergies to antibiotics and Penicillin; shellfish allergy. No family medical history. Concomitant medications included nitrofurantoin (monohydrate/macrocrystals; Manufacturer: Alvogen Inc) from 17Mar2021 to 24Mar2021 for urinary tract infection; prednisolone from 10Apr2021 to 10Apr2021 for rash; chlorphenamine maleate (ANTIHISTAMIN) from 12Apr2021 for rash; and taking unspecified medications for a long time. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Jan2021 (Lot Number: EN6201; Expiration Date: 30Jun2021) on the left shoulder at 0.3ml single for COVID-19 immunization. Patient previously also had something else 10 years ago that didn't work, it was not a vaccination; took doxycycline hydrochloride (DOXYCILLIN) and amoxicillin that both experienced allergies. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). Stated that she had a urinary tract infection and was put on antibiotics for 7 days. Two days after starting the medication, she came down with a rash. The patient husband, who was a family physician had never seen a rash like that in his 40 years of practice. In the newspaper, there was a woman who got the vaccination, but not sure if it was Pfizer, and had a rash; the article had a picture of the rash the woman had, after the vaccine. Patient stated that her rash looked worse than the woman in the newspaper. The rash happened after the second vaccine, several weeks later, but after the antibiotics. Patient was allergic to a lot of antibiotics. She stated she may have this problem, the rash because she was allergic to a lot of antibiotics. When she got the rash, she went to the Urgent Care and was given a Prednisone shot and Prednisone pills. She got some relief taking the Prednisone. Patient weight as about 5' 4", she gained 8 pounds over the year while being stuck in her house. Patient stated she hasn't seen healthcare provider in a while, but she called him and he gave her the antibiotic prescription. Patient experienced the rash was painful on 17Mar2021 and she could feel when another one would start happening. Patient put ice on it to sop the pain and moved the ice packs around as it was reactive to pressure. Stated if there was anything tight, like underwear, or sitting on the couch, she would get welts and lumps, initially mentioned the top of her head. Reclarified itchy in later part of report. Patient got a prescription for her medication on 17Mar2021 and took it for 7 days, and then the rash happened a couple of days after she stopped the medication. As she had a little bit of skin that was very dry and she can see a line where the rash was. The rash pretty much gone, but not 100 per cent gone. Stated she went to the Urgent Care walk in, when she noticed the rash. Patient had two Covid tests, one was a blood test and one was a nose swab; reported both as negative. Stated she should have gone to the emergency room, but the doctor, in the Urgent are gave her a Prednisone shot. The only reason she didn't go because of the Covid, pandemic, so she went to the Urgent Care. The last medication that she took for the rash was an antihistamine on 12Apr2021, and last Prednisone pill was 10Apr2021; both pills were effective in treating the rash. Patient had a Zoom call with an allergist, and the doctor saw the rash with the help of a flashlight and altered the Prednisone dose. Patient had pain under breastbone that it was really bad and the day before she went, to the Urgent Care on the 28th or 29Mar2021, may in the early afternoon. Stated it was going on the whole time, intermittently, not constant in the last few weeks. She didn't know what was causing it as she had blood work to rule out gallbladder issues and that was not back to rule out a Shellfish allergy. Patient had welts and it all blends in from when she first noticed the rash a couple of days before she went to the Urgent Care. Answered as they were faded out, it was severe, then acute, then extreme for a week or more, and improved with steroids and then faded. Patient had lumps and it started two days before she went to the Urgent Care. Stated when she was sitting on the couch, reclarified, the cords of the pillow put pressure on the areas and it hurt and felt like welts. When she pushed on her skin, here were lumps in her skin underneath, and they hurt and were hot. Described the areas of the lump as buttocks, top of head, legs, arms, groin, underwear line, ear, ear lobe and face. Patient had swelling of lips, and they looked like she had Botox. Also reported additional swelling of arms, hands, fingers, arm from the wrist up to elbow, left foot, left kneecap, left thigh, and her feet swelled up like a balloon. It was better now. Patient had fingertips felt tingley. The palm of hand that patient got rashes in response to pressure and was trying to open a bottle. When she did she got a rash on her palm, a red circle and her hand was hot and itchy. Started as two days before she went to the Urgent Care. Stated she was tired and exhausted from not sleeping and the redness faded away and then it went away a couple of days ago with the help of the steroids. Patient had toes, feel puffy that described as the feeling when she goes to the dentist after she gets Novocain, the feeling. Patient had tired and exhausted. Stated she was tired the first few days until the rash peaked, as she was up all night for two nights icing the rash. Stated she was better but was not doing too much and didn't get out of the house, only when she had to. Lab data included on unspecified dates the blood work for urinary tract infection was negative; negative results for two Covid tests, one was a blood test and one was a nose swab; blood work to rule out gallbladder issues and that was not back to rule out a shellfish allergy. No events required a visit to emergency room or physician office, but patient went to Urgent Care and had a Telehealth appointment. The outcome of events "Rash; Welts; Swelling" was recovering, while of the other events was unknown. No follow-up attempts are needed. No further information is expected.

I63.9 - Cerebral infarction, unspecified N17.9 - Acute kidney failure, unspecified E87.1 - Hypo-osmolality and hyponatremia R56.9 - Unspecified convulsions

Breakout rash around neck, shoulders, chest, arms and tops of legs. None under arms or breasts. Has had rash since 6/7/21. Some raised bumps within rash as well, resembled insect bites. Some of the rash looked like insect bites, other areas skin broken, looks like skin scraped. Skin has peeled off on those areas. Had got bladder infection since then as well. Had blood in urine and received antibiotic (6/9/2021). Since then bladder infection has cleared. But patient has had a cough since then (about 5 days into breaking out). Has also had a slight headache.

she lost her sense of taste.; she had a bad UT infection; This is a spontaneous report from a contactable consumer or other non hcp. A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 23Feb2021 (Batch/Lot Number: Pfizer6203) as 2nd dose, single for covid-19 immunisation. Medical history included blood pressure, diabetes type II from an unknown date. Concomitant medication(s) included ATORVASTATIN; acetylsalicylic acid (BAYER ASPIRIN); CLOPIDOGREL 75mg; ubidecarenone (COQ-10); FLUOXETINE; FISH OIL; GABAPENTIN taken for fibromyalgia,METFORMIN taken for diabetes mellitus; PANTOPRAZOLE; PRAMIPEXOLE taken for restless legs syndrome; VALSARTAN taken for blood pressure abnormal,VITAMIN D3; VITAMIN C [ASCORBIC ACID;BIOFLAVONOIDS NOS;HESPERIDIN;MALPIGHIA GLABRA;ROSA CANINA;RUTOSIDE] taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date in 2021, the patient experienced she lost her sense of taste and she had a bad UT (urinary tract) infection. Caller stated patient received her first Pfizer Covid-19 vaccination bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 03Feb2021 10:30 (Batch/Lot Number: EL9265) as 1st dose, single for covid-19 immunisation. On 04Feb2021 she lost her sense of taste. Caller stated, and still to this day patient didn't have it. Caller stated she received her second Pfizer Covid-19 vaccine on 23Feb2021. Caller asked, she want to know when will she get her taste back. How long would this last. She still can't taste anything. Is that a side effect and for how long. She went to the doctor yesterday. They said she had a bad UT infection. They gave her a shot. Caller doesn't know the name of the shot she was given. Maybe it was an antibiotic. She did ask the doctor about not being able to taste, but the doctor didn't know. She had asked lots of people and doctors, but no one knows. The patient underwent lab tests and procedures which included weight was 175 or 176 lbs on unknown date. Therapeutic measures were taken as a result of she had a bad UT (urinary tract) infection which include antibiotic. The clinical outcome for event she lost her sense of taste was not recovered while outcome for the event she had a bad UT infection was unknown. No follow-up attempts are possible. No further information is expected.

I had my first vaccine on 1/29/2021 without any reaction. I had my second vaccine on 2/22/2021. 12 hours hours later I started having body aches and decreased urine output

Nausea and violent vomiting for 2 hours. Upper back and neck pain for 36 hours. Chills and shaking for 12 hours. Urine is now colorless instead of yellow-orange. I have had no treatment. Urine remains colorless, but other symptoms are almost resolved.

admitted to hospital on 21 Jan 21 with Acute cystitis without hematuria; Cardiovascular disease; Diarrhea; ST segment depression; Syncope, unspecified syncope type Discharged on 26 Jan 21

RECEIVED PFIZER COVID-19 VACCINE 1ST DOSE ON 02/20/21. REPORTED TO ER ON 02/21/21 WITH COMPLAINTS OF ABDOMINAL PAIN AND NAUSEA AND VOMITING. DAIGNOSED WITH EPIGASTRIC ABDOMINAL PAIN, ATYPICAL CHEST PAIN, URINARY TRACT INFECTION WITH OUT HEMATURIA, AND HIATAL HERNIA. DISCHARGED HOME WITH INSTRUCTIONS FOR FOLLOW UP APPOINTMNET WITH PCP, GI, GENERAL SURGERY, AND CARDIOLOGY.

Cardiogenic shock occurred on 2/10/2021, approximately 12 hours after patient received her 12th dose of pemetrexed/pembrolizumab and 4 days after COVID vaccine. Coronary angiography was done on 2/10/2021 and no significant coronary narrowing or blockage were noted. Baseline troponin on 2/10/21 was 0.02 and later on 2/10/21, troponins were 9.99 & 25.27. Creatinine increase from 1.2 to 3.4 within 24hours, and AST/ALT increased from 23 & 31 to 4,220 & 4,786 respectively on 2/11. Patient expired on 02/11/2021.

Admitted to hospital on 1/28/21 from nursing home with altered mental status and UTI. PMH of heart failure, CKD, afib, COPD. discharged on 2/2/21. COVID negative during this admission. Readmitted on 2/28/21 for AMS, family was unable to wake patient up for an hour prior to calling EMS. Upon admission, found COVID positive.

Back pain, bilateral lower extremity neuropathy, paresthesias, lower extremity weakness, urinary retention, orthostatic hypotension

On 3/14/21 @ 2304 : 77-year-old female patient presents emergency room with generalized fatigue body aches dry cough shortness of breath and subjective fevers as aggressive worsening since Friday. Patient received a 2nd dose of the pfizer COVID-19 vaccine on Friday 3/12/21 and states her symptoms worsened since then. Chest x-ray showed patchy bilateral infiltrates with concern for COVID pneumonia, also questionable vascular congestion as patient does have significant history of heart failure with pacemaker. EKG revealed paced rhythm 87 beats per minute. Emergency room patient was placed on BiPAP and responded well, patient was given vancomycin and cefepime for sepsis protocol.

She had been in her usual state of health until tonight. Assisted living facility staff called. He mentioned that the facility staff had earlier noticed that she was dragging her right foot and and has been needing more assistance with activities. The patient was walking and did not feel well. She was lowered to the ground and had a witnessed cardiac arrest. The ambulance was called and she was reportedly found to have pulseless electrical activity. She was given Epinephrine and Amiodarone with return of pulse. The patient was brought to the Emergency Room and was evaluated by ER physician. EKG showed atrial fibrillation, ventricular rate = 66, RBBB with Brugada pattern. She was emergently brought to the Cath Lab. Cardiac catheterization showed normal coronary arteries but EF 35-40%. Repeat EKG showed atrial fibrillation with rapid ventricular response = 110, RBBB. Therapeutic hypothermia was initiated. The patient was admitted to the ICU on mechanical ventilation with TV 350 RR 14 PEEP 5. She is sedated with Propofol and Fentanyl IV. She is on Levophed IV. ABG showed pH = 7.22, pCO2 = 53, pO2 = 66, O2 sat = 88%. Lactate level = 9.5. WBC 8.8, Hgb 13.4, Hct 46, Platelets 138. Na 138, K 3.2, Cl 102, bicarb 20, BUN 16, Crea 1.19, estimated GFR = 44 mL/minute. Magnesium 2.7. Glucose levels have ranged from 273-312. Pro-Calcitonin = 0.26. Albumin 3.7. SGOT 262, SGPT 294. Troponin elevated at 47. Pro-BNP = 600. Urinalysis showed large blood. Chest x-ray showed vague peripheral pneumonitis. Endotracheal tube is in place. COVID-19 test by PCR is negative (2/5/21). COURSE IN HOSPITAL The patient was admitted to the ICU and was followed by Pulmonary/Critical Care. Patient was maintained on mechanical ventilation, sedated with propofol and fentanyl IV. Vasopressors were administered (Levophed IV). She was managed with therapeutic hypothermia. She was followed by Cardiology. Foley catheter was inserted for close input/output monitoring. Neuro checks, vital signs, daily weights, pulse oximetry, cardiac telemetry and fingersticks were monitored. She was given sodium bicarbonate IV due to metabolic acidosis. She was also given insulin IV drip. Potassium chloride IV was administered due to hypokalemia. The patient was given amiodarone IV. Platelet count was noted to be low but stable. Glucose levels were within acceptable range. Metabolic acidosis resolved. Hypokalemia resolved. Hypomagnesemia resolved. There were elevated LFTs which improved. Elevated CPK also improved. She was taken off hypothermia protocol. Sedation was decreased and she was able to open her eyes with verbal stimulus but unable to follow commands. Ammonia level was normal. Neurology evaluated the patient. EEG showed left periodic epileptiform discharges consistent with severe diffuse encephalopathy. Chest x-ray revealed right upper lung and left mid lung increasing opacity for which meropenem IV was started. Levophed was discontinued. Initially she had peripheral cyanosis, but this resolved upon discontinuation of vasopressors. Brain MRI was done demonstrating diffuse bilateral small and moderate-sized ischemic foci throughout the cerebellum and cerebellar region suggestive of embolism. There also was chronic marked atrophy and moderate small-vessel gliosis. CIRCUMSTANCES SURROUNDING DEMISE Based on neurologic evaluation, her prognosis for meaningful neurologic recovery was thought to be extremely poor. The patient was evaluated and followed by Palliative Care. She does not have family members and had designated her neighbor friends as her power of attorney. They have known the patient for a ling time and they know that she does not want to live like this. A decision was therefore made for comfort care measures only. Compassionate extubation was performed on February 12, 2021. The patient passed away on February 12, 2021, at 6:39 p.m.

confused; suspected UTI; This is a spontaneous report from a non contactable consumer. This consumer (daughter) reported for a 77-year-old female patient that A 77 years old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 08Mar2021 at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history included hypertension. Concomitant medications were not reported. On 09Mar2021 at 09:00 patient was taken to ER as was confused and not herself. The patient was being held overnight. The patient was hospitalized and UTI. was suspected. At the time of the reporting the patient was unknown. No follow-up attempts are possible; Information on the batch/lot number could not be obtained. No further information is expected.

3/8/21 ED: c/c of SOB x 2 days. Pt c/o diarrhea. Pt states that she received the 2nd pfizer vaccine 2 days ago. O2 at triage was 96% on RA. She was seen in this facility Saturday 3/6/21 for HA. CTA and labs unremarkable. She reports persistent HA, though improved when compared to Saturday. Reports multiple episodes of NB diarrhea. No other medications or treatments tried. In the ER she was seen to have a significant leukocytosis with wbc in 26, AKi with SCr in 2.7, thombocytopenia. Ordered CT scan which showed congestion and LLL pna and trace effusion. ID, Cardiology and Nephrology consulted. Treated for acute kidney injury with hyposmolar hyponatremia, on tolvactam, Sodium 133, trending up. Treated for sepsis with gram negative bacteremia d/t e.coli, completed ceftriaxone course. Treated for essential hypertension, elevated troponin, BP now controlled. Discharged home on 3/17/21

Legs swelled up really bad ; it left blotches in my leg; Legs swelled up really bad ; it left blotches in my leg; Fever; Bladder infection; UTI; He gave me some medications and it is helping the rash; stomach even swelled up; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on 12Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE (at the age of 77 years old) for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine information included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, for COVID-19 immunization, dose 1 on 17Jan2021 at age of 77 years old. On 23Feb2021, the patient experienced legs swelled up really bad it left blotches in my leg and she went to the doctor, she had fever, bladder infection and Urinary tract infection (UTI). The legs swelled up real bad, her thighs from the waist, she just swelled up everywhere. Her stomach even swelled up but the right leg mostly. She experienced the blotching, it looks like a birth mark on my right leg and the left leg. It is blotchy, looks like a birth mark on the legs. The right one got really big. She did go to doctor and he said it was not a blood clot. He said people are getting swelled up with rash, some people are having rashes and swelling. Treatment included the physician gave her some medications and it is helping the rash and "cephalexin 500 mg, 3 times a day" for the UTI. Outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Non-ST elevation (NSTEMI) myocardial infarction Acute kidney failure, unspecified SHORTNESS OF BREATH CHEST PAIN RESPIRATORY DISTRESS

I had lost control of my bladder not completely but enough/incontinence; After the day and half the covid symptoms came back; This is a spontaneous report from a contactable consumer (the patient). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6201) via an unspecified route of administration on 23Feb2021 at age of 77-year-old at single dose for COVID-19 immunisation. Medical history included COVID-19 from 17Dec2020. The patient had no concomitant medications (reported as "no other products"). The patient had COVID, 17Dec2020 her system started and then about 90 days later she had the Pfizer vaccine and then had Pfizer vaccine again and it was been a while since it is been over two weeks what she had COVID. She had lost control of her bladder, not completely but enough so that she had to change her pajamas bottoms quite often. When she had first Pfizer shot about day and half she had the same problem. The patient's doctor often said that incontinence was not symptom of COVID but it might was. it was just after the shot. The patient had COVID symptoms started in 17Dec2020 and lasted for about 2 or 3 weeks. She had experience of COVID. Her experience of COVID was incontinence not all the time but particularly night and when she have first Pfizer shot about 3 months later after the day and half the COVID symptoms came back including the incontinence. No treatment received for the events. No investigation assessment. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

2/22/2021 - Tested positive for Covid 3/9/2021 - found down at her SNF, taken to ER. complains of lower back pain, left hip pain, bilateral knee pain, low O2 sat Dx: Aspiration pneumonia of both lower lobes (HCC), *Left lower lobe pneumonia, History of COVID-19, Urinary retention, Diarrhea C diff negative. 3/22: placed on palliative care after speaking with family 3/23: Expired

Pfizer COVID Vaccine EUA Pfizer Dose 1 2/6/21 (lot # not listed) Pfizer Dose 2 3/6/21 (lot # not listed) COVID Positive 5/25/21 at PCP office (but negative upon repeat testing 5/25/21) 5/25/21: The patient is a 78-year-old female presents emergency department today after testing positive for COVID-19 at her PCP office, they recommended she present to ED to rule out pulmonary embolism. Patient has a past medical history significant for ESRD on HD Monday Wednesday Friday, hypertension, diabetes mellitus type 2, anemia of CKD, and osteoarthritis. Of note, the patient had her COVID-19 Pfizer vaccination series completed in February of this year. On arrival to the ED, the patient's temperature is 98.4° F, heart rate 68, respiratory rate 26, saturating 90% on room air with blood pressure 163/63. The patient did desaturate to 87% on room air when ambulating in the room. The patient's laboratory studies were significant for HGB 11.3, ESR 44, CRP 1.7, BUN 17, CR 4.80, UA: Proteinuria, trace hematuria, small leukoesterase, many bacteria, 11-30 pyuria, 1-3 RBCs and moderate squamous epithelial cells sent for culture. Blood cultures x2 obtained. Chest x-ray shows no acute cardiopulmonary findings. V/Q scan showed normal exam. EKG showed normal sinus rhythm. The patient was seen emergency department laying in bed. She reports worsening shortness of breath over the weekend and COVID like symptoms for the past week. She reports some dyspnea on exertion. She states she has been weak, fatigued, had some chills, and was seen by her PCP, who tested her for COVID-19 and she tested positive. This COVID-19 test is not and are records. The patient has had some desaturations less than 90% when she falls asleep. She wishes to be a full code. 6/1/21: She is admitted to the hospital, as mentioned above 0 repeat COVID test is negative. V/Q scan is reported as normal. She is started on dexamethasone 6 mg IV daily, along with IV antibiotics ceftriaxone Zithromax and Acapella. Pulse ox is monitored, oxygen is weaned off patient has been stable on room air and has been afebrile. Nephrology consult is requested, patient had hemodialysis as per Nephrology recommendations on Monday, Wednesday and Friday. Her blood pressures were uncontrolled, her home medications Coreg dose was increased to 37.5 mg p.o. b.i.d. and Procardia XL increased to 60 mg p.o. daily and blood pressures have been stable now. Patient did complain of weakness to ambulate, had physical therapy and occupational therapy evaluation. She is being discharged home today in stable condition for skilled nursing. She is off steroids now. Discharge plan is discussed with the patient.

Patient presented to the ED and was subsequently hospitalized on 3/11/2021 for acute cystitis with hematuria and acute kidney injury. Patient presented to the ED and was subsequently hospitalized on 4/19/2021 with generalized weakness and confusion. These visits are within 6 weeks of receiving COVID vaccination.

Apr 28th began noticing right upper abdominal pain, from the sternum area, down and around base of right lower rib cage and toward my back. A tightness feeling going also toward my back. Interfering with breathing because pain increase with deeper breath but did not feel short of breath. Area became tender to touch. Felt like muscle spasms in "bread basket" area. These cont'd off and on - affecting size of meals I would eat - too much increase the discomfort. Self exploring lead me too exercising and deep breathing to advice via website. Provided some relief and improved breathing ability. By May 2th things became more severe- 3 morning episodes of severe gripping pain, sweats, chills ,nausea, vomiting, weakness - Husband took me to Emerg May 4th. Bld in urine. Kidney scan - no stones; Bld work - normal. Agan in Emerg June 29th. No medical reason given for the severe pain. Sent home.

A little sore arm; She then developed pneumonia and a urinary infection; She then developed pneumonia and a urinary infection; This is a spontaneous report from a contactable consumer or other non-health care professional. A 77-year-old female patient received bNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number& Expiry date not reported) via unspecified route of administration in arm on 03Jun2021 (at age of 77-year-old) as dose 1, single for COVID-19 Immunization. Patient medical history includes Memory Loss, Breast Cancer, Allergic to Sulfa Medication, Flexeril, Allergic to Clams and Shellfish, Pneumonia, Urinary infection. Patient concomitant medications were not reported. Caller reporting on behalf of his wife who received her first Covid 19 vaccine on 03Jun2021 and she developed pneumonia and a urinary infection. She was prescribed amoxicillin for her infection. The caller wanted to know how the antibiotic will affect his wife. He reports her second Covid 19 vaccine is past due by 2 weeks. He reports his wife gets pneumonia every year and it is not from the Covid 19 vaccine. She received her first Covid 19 vaccine on 03Jun2021 and was due for the second Covid 19 vaccine on 24Jun2021. This is discrepant from the above information that his wife is past due by 2 weeks but is documented as provided by the caller. She will not be able to get the second Covid 19 vaccine until the first week in Jul2021. She waited because she was prescribed a Z-pack for her pneumonia started on 29Jun2021.She developed a urinary infection, she has a history of getting urinary infections too. The doctor also wanted a chest x-ray to make sure that her pneumonia was gone. The Amoxicillin will double check that his wife has no more pneumonia and will clear up her urinary infection. She was hospitalized in 2019 because of a urinary infection. The doctor prescribed Amoxicillin and she cannot wait any longer to get her second Covid 19 vaccine. She must get her second Covid 19 vaccine before time runs out. He reports none of this has to do with the Covid 19 vaccine. These are problems that his wife has had before.Upon follow up when probing for information regarding the sore arm he and his wife experienced he reports the sore arm was minor, it was just where the injection was in jun2021. His wife had breast cancer and can only get injections in one of her arms. It was a little soreness, nothing, barely noticeable. He and his wife did exactly what the pharmacist said, they took a lot of fluids, drank Gatorade for electrolytes. He reports his wife is sleeping right now because she was at the doctor's office this morning. He reports his wife's doctor is being thorough before his wife gets the second Covid 19 vaccine. He is supposed to call the pharmacy to schedule his wife's second Covid 19 vaccine on 03Jul2021. The pharmacist told him not to cancel his wife original appointment because it would remove her from the system. He's will call on 03Jul2021 and hopefully his wife will be able to get her second dose on 05Jul2021 or 06Jul2021. At that time, she'll almost be off the Amoxicillin. He is asking what the effectiveness rate is of receiving the Covid 19 vaccine while on an antibiotic.The pharmacist told him the effectiveness is diminished for people who have taken an antibiotic. He believes the first Covid 19 vaccine provides 70% effectiveness while the second Covid 19 vaccine provides 95% effectiveness. His sister-in-law has titanium plates in her back and must take an antibiotic for the rest of her life and she received the Covid 19 vaccine. Advised in response to caller to discuss with Health care professional about the final decision about receiving the second dose to discuss the risks and benefits of the administration of the vaccine and the HCP is most familiar with the health history of his wife. Pfizer is unable to make treatment recommendations for individual patients. Patient underwent lab test and procedures include Chest X-ray result was it showed nothing, no pneumonia; SARS-CoV-2 test was negative; Urine analysis result was unknown; all tests done on Jun2021. The outcome of event was unknown. Follow up (29Jun2021): This is a follow up spontaneous report from a Pfizer Sponsored Program. A contactable consumer reported for a 77-year-old female patient (reporter's wife) that: New information include medical history, schedule of second dose, Lab test, event little sore arm, visit of physician office. No further information is provided or obtained.Information on lot/batch number has been requested.

Not sure if it's before or after she got her first dose, she had the COVID 19 Virus; Not sure if it's before or after she got her first dose, she had the COVID 19 Virus; Urinary tract infection; This is a spontaneous report from a Pfizer sponsored program reported by a contactable consumer or other non-health care professional (patient). A 77-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiration date not reported) via an unspecified route of administration in arm left on 26Apr2021 (at the age of 77-year-old) as single dose for COVID-19 immunization and clarithromycin (MACROBID [CLARITHROMYCIN], Capsule Batch/Lot Number and Expiration date was not reported), via an unspecified route of administration from an unspecified date to an unspecified date, at 100 mg for an unspecified indication. Medical history included blood pressure, hypertension, high cholesterol; all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient think about lot number and stated that it must be right here D21, she dont know if that is 1 or L and G, this looks like she don't know if its U9J (D21GU9J). On an unspecified date, she was prescribed by her doctor for, to take an antibiotic because she has UTI (Urinary Tract Infection), so she wants to know if it is okay for her to take it or will it interfere with the antibodies that she has in her body. She said, she got the first dose on 26th of April and she is not yet done with the second dose because she was advised by her doctor that it was okay for her not to take it because she already had a lot of antibodies in her body. She also said that she is not sure if it was before or after she got her first dose, she had the COVID 19 Virus. She took the blood, that was it, that's the blood she had done. When confirmed if the reports, patient stated reports were normal. The patient underwent lab tests and procedures which included antibody test resulted as antibodies and sars-cov-2 antibody test resulted as positive; both on an unspecified date. The seriousness of the events was not reported. The clinical outcome of the events was unknown. Follow-up (05Jul2021): 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 completed. No further information is expected.

After vaccine administration, pt experienced severe diarrhea with incontinence.; After vaccine administration, pt experienced severe diarrhea with incontinence.; This is a spontaneous report from a non-contactable pharmacist. A 78-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EK5730, intramuscular from 16Dec2020 to 16Dec2020 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. After vaccine administration on 16Dec2020, The patient experienced severe diarrhea with incontinence. The outcome of the events was unknown. No follow up attempts are possible. No further information is expected.

Body aches, low gr. temp. aches into her buttocks area down back of post. thighs. She did have Covid infection in Sept 2020. Meds admin - NaCl 0.9% I.V. bolus. 500 ml. Tyl. + Hydrocodone 650/25 - Labs - UA. lactic acid, SARS antigen, BMP, CBC, CXR - revealed pneumonia - F/U with family practice on Monday. In addition to above - numbness from waist down to toes, loss of bowel + bladder. T-102.F. Unable to walk - this lasted for 17 hrs.

Injection time 1302. Symptoms: Lightheaded and flushed. Per pt's daughter, felt symptoms around 1325. Pt. has history of diabetes and also currently taking antibiotics for UTI. BP 110/78. Symptoms improved 1335. Observed pt. until 1355. Pt. is feeling better and in stable condition at the time she left.

AMS-Fever-UTI-myoclonic jerks-unresponsive <6hrs post 1st covid vaccine. AMS-UTI- post 2nd covid vaccine

1/12/21 er HPI: HPI 78 y.o. female who presents with pain swelling and redness left wrist and hand associated with fever according to EMS, but temperature in the ER is 98.4° F. patient was said to have fallen on 1/7/2021. *incidental finding bacterial pne* 1/12/21 admission History: The patient is a 78 y.o. female with a past medical history notable for Dementia, atrial fibrillation, CHF, diabetes, reflux. The patient presents for evaluation of Worsening issues of decline and trouble with breathing. Patient was evaluated the ER and found to have a urinary tract infection in addition to pneumonia. Due to patient's dementia history is difficult to take outside of history of which was taken for patient's nursing staff at skilled care facility. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed

UTI; This is a spontaneous report from a contactable consumer (patient). This 78-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EJ1284; expiration date 30Apr2021) via an unspecified route of administration on 12Jan2021 (at the age of 78-years-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that two weeks ago (as of 26Jan2021) she got her first COVID-19 vaccine shot, and a week from today (as of 26Jan2021), 02Feb2021, she is scheduled for her second COVID-19 vaccine shot. She stated had been prescribed an antibiotic for a urinary tract infection (UTI) and she was to take the antibiotic for 7 days. She clarified that the last day she will take the antibiotic was Tuesday, 02Feb2021. She wanted to know if she had to worry about an interaction between the second COVID-19 vaccine dose and the antibiotic she was prescribed. She clarified further that she was prescribed the generic BACTRIM, "sulfamethoxazole-TMP-DS." The patient also reported that her urinary tract infection had nothing to do with receiving the first dose of the COVID-19 vaccine; she stated she got UTIs all the time. The clinical outcome of UTI was unknown. No follow-up needed. No further information is expected.; Sender's Comments: Based on the current available information, the event Urinary tract infection is most likely related to an intercurrent or underlying condition which is not related to the suspected drug BNT162B2.

RECEIVED FIRST DOSE OF PFIZER COVID 19 VACCINE ON 02/26/21. WENT TO ER ON 02/27/21 COMPLAINING OF HEMATEMESIS AND BLOCK COLORED STOOL. ANTICOAGULATED ON ASPIRIN AND PLAVIX. DIAGNOSED WITH UPPER GI BLEED AND ADMITTED TO HOSPITAL ON 02/27/21.

lost 3 pounds; chills; Sheets were soaking wet, she kept having to urinate; Kept having to urinate; Diarrhea; Getting very hot and cold; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) second dose, lot number: EL9262, via an unspecified route of administration on 07Jan2021 at a single dose in the upper part of left arm for COVID-19 immunization. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EJ1686, expiry Mar2021, on 07Jan2021, she had no reaction or anything. The patient had no medical history. The patient's concomitant medications were not reported. The patient was calling about the second shot, Pfizer asked if there were side effects on the second one, and there were, she can't say what went on yesterday, it was that bad. She was a volunteer at the hospital. She lost 3 pounds in the last few days from this. She was in no condition to talk to anyone yesterday, and in fact, she was getting hot now. Yesterday (26Jan2021) was the worst, she doesn't know how to describe, but her sheets were soaking wet, she kept having to urinate, and she's ashamed, she almost couldn't make it to the bathroom, her aide said to not be ashamed, and she had a lot of diarrhea. It was around 2am she noted her sheets were soaking wet, and it started going away at 5AM. She was still having effects from the shot: she was still getting very hot and cold. Getting very hot and cold started 12:00PM Monday (25Jan2021) night. Getting hot and cold was like the chills. She has 27 chronic illnesses but doesn't think they have anything to do with the shot. She was grateful she got the shot and hopes everyone at Pfizer was able to get the shot. The outcome of the event 'sheets were soaking wet, she kept having to urinate' was recovered on 27Jan2021, diarrhea and getting very hot and cold was recovering, lost 3 pounds and chills was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.

Admitted to the hospital in observation status on 3/8/21 with chief complaint of "I don't feel well, I feel dizzy and I had a rash." Patient treated in urgent care on 2/24/21 for possible UTI and again in urgent care on 3/2/21 for cat bite and given ceftriaxone IM as well as Augmentin. Patient complains of feeling a little dizzy and not quite well, rash was fleeting but she has not been eating or drinking well since vaccination and has been having headaches since that time. She is afebrile and has no respiratory symptoms but positive covid-19 test (and antibodies). Patient did complain of nausea and dehydration. Discharged on 3/9/21.

Swelling on her right ear; Symptoms of the flu/side effects like the flu; Diarrhea/bad diarrhea; Urinating like crazy/had to urinate non-stop; Sick; Swelling on her right eyelid; Pain down her neck; Everything was swollen, her one eyelid and the outside of her ear then down her neck on the right side; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL1283, Expiry date: unknown) via an unspecified route of administration, administered in Right Arm on 19Jan2021 (at the age of 78-years-old) at a single dose for covid-19 immunisation. Medical history included mastectomy (she had a mastectomy before, so she has no lymph nodes, she doesn't let them touch her left arm. She says this was done 26 years ago when she was 52), arthritis (she has bad arthritis in her back), Blood pressure high (she takes a high blood pressure medication), High cholesterol (she takes a high cholesterol medication) and eye surgeries (she has had all kinds of eye surgeries before this). The patient's concomitant medications were not reported. The patient experienced swelling on her right ear, symptoms of the flu/side effects like the flu, diarrhea/bad diarrhea, urinating like crazy/had to urinate non-stop, sick, swelling on her right eyelid, pain down her neck, everything was swollen, her one eyelid and the outside of her ear then down her neck on the right side on an unspecified date in 2021. The patient stated that she had a lot of side effects and she talked to her doctor who said to go ahead and get the second dose. She says she had no fever, but had all the rest of the side effects, such as swelling of her neck, ear, and eye, which all went away fast. She says she was sick almost 4 days, and her doctor said side effects shouldn't last that long, so she called to get advice about whether to get second shot or not. She says her appointment for her second shot is the 09Feb2021, she would like to know if it is safe for her to get. She says her side effects started in the evening, the swelling of her right ear didn't last, it went away. She says during the night she woke up and had to urinate non-stop that started that night a day later. She says that lasted the next day, then the day after, until Saturday she felt better. She says she had all side effects like the flu, then later bad diarrhea too. She says she finally took something for diarrhea (no further information provided about this) and took Tylenol. she doesn't see the expiration on that bottle, she thinks it is good for 2021. She says that she doesn't see too good. She clarifies that they Tylenol she had took before, with no issues, and her not seeing too good had nothing do with the vaccine, she has had all kinds of eye surgeries before this. She says her right ear was swollen, everything was swollen, her one eyelid and the outside of her ear then down her neck on the right side. She says that the pain started about a day later Pfizer COVID-19 vaccine. Caller says that she called her doctor today, that was the first time she did that, she was trying to wait and see, and her doctor said normally side effects don't last that long, so he has her worried. She says if she does not take the vaccine she will not be protected, but if she does, she may have worse side effects. Therapeutic measures were taken as a result of diarrhea/bad diarrhea. The patient recovered from the event swelling on her right ear on an unspecified date in 2021, outcome of the event Urinating like crazy/had to urinate non-stop was recovering, while outcome of other events was unknown.

rise in Cr; Developed decreased PO intake; mild acute kidney injury; pancytopenia; lymphopenia; thrombocytopenia; This is a spontaneous report from a contactable Physician. A 78-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), second dose via an unspecified route of administration, administered in Arm Left on 10Mar2021, single dose for covid-19 immunisation. The patient's medical history was not reported. The patient had unspecified concomitant medications. The patient had the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) for Covid-19 Immunisation. On 13Mar2021, the patient developed decreased PO intake, then mild acute kidney injury with rise in Cr and pancytopenia/lymphopenia/thrombocy topenia. The events caused hospitalization. Treatment for the events were IV fluids, Hematology consult. The outcome of the events was recovered. The patient had negative covid swab test on 12Mar2021.; Sender's Comments: Based on the narrative information provided, a causal association between the reported events and bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product 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 RAs, Ethics Committees, and Investigators, as appropriate.

Pt admitted on 4/5/2021 c/o roughly 4 weeks of just general dyspepsia and feeling like she had acid reflux. She reports that then progressed to some nausea and then vomiting and then some generalized right upper quadrant midepigastric abdominal pain. She also noticed that her skin was becoming yellow. She reports no changes in any of her medications recently she had her second COVID-19 vaccination on 2/14 and blood work on 2/ 8 consisting of liver enzymes/CMP was normal. she arrived severely jaundiced with severe transaminitis, hyperbilirubinemia and acute renal failure. ERCP revealed no gross obstruction and free flowing bile and sphincterotomy was done with no improvement in her blood work. she remains hospitalized and is being transferred for HLOC due to worsening condition REVIEW OF SYSTEMS:

feeling palpitations; blood in her urine; pain in her right kidney; While she was there they took her BP and it was 190/90 and she takes BP pills then last night it was a little high but it came down by itself.; This is a spontaneous report from a contactable consumer or other non hcp. A 78-years-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration on 25Jan2021 as 1st dose, single for COVID-19 immunization. Medical history included anticoagulant therapy (blood thinner) from an unknown date and unknown if ongoing. Concomitant medications included acetylsalicylic acid taken for anticoagulant therapy, start and stop date were not reported. The only medicine that is relevant is the Baby Aspirin, it is 84 mg. She confirms 84 mg baby Aspirin. Her cardiologist gave it to her for a blood thinner. On Jan2021 patient experienced feeling palpitations, blood in her urine, pain in her right kidney and while she was there, they took her BP and it was 190/90 and she takes BP pills then last night it was a little high, but it came down by itself. The patient underwent lab tests and procedures which included blood pressure measurement as 190/90 on Jan2021 she was there they took her BP and it was elevated to 190/90, sars-cov-2 test as unknown results on 28Jan2021 she went to get a COVID test yesterday, urine analysis as blood on Jan2021. Caller is calling about the Pfizer COVID-19 vaccine. She received the first dose 25Jan2021, last Monday and then she began feeling palpitations. She also had blood in her urine and pain in her right kidney. Today her urine was clear but the palpitations are still there and she wanted to call and report and ask does she need to do something about it. Also she went to get a COVID test yesterday. No further information provided. While she was there they took her BP and it was 190/90 and she takes BP pills then last night it was a little high but it came down by itself. No further information provided. She has a flight, should she not fly or is there no problem. She also is set to get the second dose 15Feb2021 and she wants to know what will happen should she not take her baby Aspirin. She takes a Baby Aspiring every 2 days, she took one last night but she does not know if maybe the baby Aspirin is the reason she got the blood in her urine. She wants to know if she should suspend the vaccine or get it. She sees the date she is to get the second vaccine 15Feb2021. She does not see any expiration date. Trying to prevent COVID she is at risk with other issues, she gets pneumonia easy. She has had the vaccine for pneumonia and flu because she is elderly (78) and that is an At risk age. She confirms she wants to know if she should still get the second dose after this experience and also if she does take the second dose should she stop the Baby Aspirin a few days before. The outcome of the events was not recovered for palpitations and recovered for blood in urine, whereas unknown for the other events. Follow-up (29Jan2021): This is a follow-up spontaneous report from a contactable consumer. No new significant information was found. Follow-up attempts are completed. No further information is expected.

I had the vaccine and three hours I was on a walk and I had to turn around half a mile and come back home and I had extreme fatigued for a whole month and my husband would have to wake me up three times a day to feed me, I have severe head aches, my kidney level functioning drop to above 50, then the second month I would sleep 3 3 hour nap for the day, I could not get my stamina back. I went about 2 days later to the doctor. She did some blood tests, I have had 4 of them, and all of them have been fine. Now is month 4 and I am slowly recovering, my heart doctor gave me Colchicine and I have been on that for 5 days. I have to get up 7 times in the night to go to the bathroom for diarrhea. In the 29th of June I will have an ECHO cardiogram.

Death 5/25/2021 Causes of death listed on death certififcate: 1. Acute Hypoxic Respiratory Failure due to Bilateral COVID-19 pneumonia 2. Bilateral Covid-19 Pneumonia 3. Covid-19 disease 4. Acute Renal failure, Metabolic Acidosis, Hyperkalemia, Acute Congestive cardiac failure

Two days following the vaccination, patient (my mom) began to have hallucinations of seeing family members in her home that weren't there, and it was exasperated throughout the week. The first noticeable hallucination was on a Sunday (6/20) and she was sent to the hospital that Thursday evening (6/24). As of today (7/1) she is still in the hospital and experiencing hallucinations. Mom/Patient was recently diagnosed with alzheimers and although there has been confusion over the last few months, the onset and intensity of delusions did not start until the 20th. Patient was initially put on antibiotics thinking hallucinations were caused by a UTI but stopped less than 48 hours later as she did not show bacteria in her urine. Additionally, mom was able to walk with assistance (a cane) prior to hospitalization and now is having trouble with very short distances.

Colon cancer metastatic; Lung disorder; Kidney stones; Kidney cancer; Vomiting; Pain worsened; Back ache; Thyroid nodule; Lung nodule; sciatica; Nauseous; Light-headed; Feelings of weakness; Difficulty in walking; This is a solicited report from a marketing program received from a contactable consumer (patient). A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via intramuscular on 29Mar2021 (Batch/Lot Number: ER8733) at age of 78 years old as single dose for covid-19 immunisation; upadacitinib (RINVOQ), oral from Dec2019 (Batch/Lot number was not reported) and ongoing, at 15 mg, once per day for moderate to severe rheumatoid arthritis. Medical history included non-smoker: secondary tobacco exposure, abstains from alcohol, high blood pressure, glaucoma, rheumatoid arthritis, muscle cramps in legs, cholesterol, acid reflux, and dry eyes. The patient had a relevant medical history of osteoporosis, hiatal hernia, DURICEF allergy manifested by pseudomembranous colitis. The patient had secondary tobacco exposure. She had history of usage of Remicade for unknown indication. Concomitant medications included amlodipine taken for hypertension; vitamin D3 taken for supplementation therapy; ciclosporin (RESTASIS) taken for dry eye and glaucoma; latanoprost taken for eye disorder; folic acid taken for rheumatoid arthritis; methotrexate taken for rheumatoid arthritis; magnesium taken for muscle spasms; fish oil taken for blood cholesterol; omeprazole taken for gastrooesophageal reflux disease; all start and stop date were not reported. Solicited report by a consumer of a female with events of colon cancer metastasize to the liver, kidney cancer that possibly moved onto liver, vomiting, back ache, pain worsened, spot on the lung and kidney stones and non-serious lightheaded, felt weak, could hardly walk, nodule on thyroid and right lung and nauseous with RINVOQ (upadacitinib). On unknown dates, the patient experienced kidney cancer that possibly moved onto liver and nodule on thyroid and right lung. On 29Mar2021, the patient experienced lightheaded, felt weak, could hardly walk and nauseous. On 29Mar2021, the lightheaded, felt weak, could hardly walk and nauseous resolved. In May2021, the patient experienced back ache. On 29May2021, the patient experienced vomiting and pain worsened. On 02Jun2021, the patient experienced kidney stones. On 03Jun2021, the patient experienced colon cancer metastasize to the liver and spot on the lung. On 03Jun2021, the vomiting resolved. On 17Jun2021, the kidney stones resolved. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. On 27May2021, she was sent to the emergency room because of back ache and was given prednisone. In Jun2021, she had a terrible back ache. She thought she had sciatica. In Jun2021, she went to the doctor, physician pressed on her back and she went through the roof. She was vomiting and had pain in her back and her daughter took her to the emergency room and did x-ray and cat scans and she had kidney stones and she was having an ultra sound. Went back to the emergency room from 02Jun2021 until 04Jun2021 because of vomiting and pain. She also had kidney cancer that had possibly moved onto her liver. She had an endoscopy done. The biopsy and other tests to decide what was going to happen. There was a nodule on her thyroid and her right lung. She felt ok and had a little backache at times, but she was taking. She already had the COVID-19 vaccines first dose but was advised not to had the second dose because of the adverse events she experienced after the first dose. It was unknown if she was enrolled in a COVID-19 Vaccine Trial. On 29Mar2021, she received 1st dose COVID-19 Vaccine manufactured by Pfizer, lot number ER8733. The patient was treated with PREDNISONE. Relevant laboratory and other diagnostic tests included: 17Jun2021 abdominal ultrasound: No more kidney stones; Unknown date biopsy: Unknown; Jun2021 CAT scans: Kidney stones; 03Jun2021 chest X-RAY: Spot on the lung; 04Jun2021 colonoscopy: Colon cancer; 03Jun2021 computed tomography scan: Colon cancer metastasize to the liver; 04Jun2021 endoscopy: Hiatal hernia; Jun2021 endoscopy: Unknown; Unknown date lab tests: Unknown; Unknown date ultrasound: Unknown; Jun2021 X-RAY: Kidney stones. The action taken in response to the events for suspect product upadacitinib was dose not changed. The outcome of events colon cancer metastatic, kidney cancer, and lung disorder was not recovered, events vomiting was recovered on 03Jun2021, kidney stones was recovered on 17Jun2021, light-headed, feelings of weakness, difficulty in walking, and nauseous was recovered on 29Mar2021, events back ache, and pain worsened was recovering, of other events was unknown. Causality for RINVOQ(UPADACITINIB): The reporter's causality for the event(s) of colon cancer metastasize to the liver, vomiting, back ache, pain worsened, spot on the lung, kidney stones, lightheaded, felt weak, could hardly walk, nodule on thyroid and right lung unknown onset, nodule on thyroid and right lung unknown onset and nauseous was not provided. The reporter's causality for the event(s) of kidney cancer that possibly moved onto liver with RINVOQ(UPADACITINIB) was no reasonable possibility. (Withheld) opinion is that the events of colon cancer metastasize to the liver, kidney cancer that possibly moved onto liver, spot on the lung, nodule on thyroid and right lung unknown onset and nodule on thyroid and right lung unknown onset are not assessable. (Withheld) opinion is that there is no reasonable possibility that the events of vomiting, back ache, pain worsened, kidney stones, lightheaded, felt weak, could hardly walk and nauseous are related to RINVOQ(UPADACITINIB). The reporter's assessment of the causal relationship of the events with the suspect vaccine was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Considering the close temporal association, a causative role of BNT162B2 vaccine for the reported Light-headed, Feelings of weakness, Difficulty in walking, and Nauseous cannot be excluded. All other events are considered unrelated to BNT162B2 vaccine.

High levels of burning when urinating as well as most of the time. Sense of urgency in needing to pee. Discomfort- feeling like shards of glass between my legs. Sleep at night limited to 1.5 hours before needing to pee. Started 4/17/2021 and continuing up to today (7/13/21)

muscle pains-runs down left leg/thigh, chills, arm pain soreness after vaccination along with itching, frequent urination

urine issues/kept going to the bathroom to urinate; upset stomach; diarrhea; felt like she was going to faint, pass out at any second; dizziness; Had a funny taste in her mouth; felt very weird, strange; This is a spontaneous report from a contactable consumer (patient). This consumer reported same events for two patients (one is patient self). This is the first of two reports. This 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration to right arm on 13Jan2021 15:00 at single dose for COVID-19 immunization. Medical history included allergies to Sulfas, Penicilins, and Avelox, Sulfa or Penicillin allergies since she was a child and had the Avelox allergies about 15-16 years ago. None concomitant medications. Patient did not receive any other vaccines that day or 4 weeks prior. Did get the original Shingles vaccine about 3 years ago and then they came out with the new one and she got the first dose of that and believes she had a reaction to that one, thinks it was a rash. Also had the flu shot and she usually gets sick with it, but didn't with this last one. Thinks her body is just delicate. No vaccines administered on same date. Patient had the Pfizer BioNTech vaccine on 13Jan2021 15:00 and she was fine. She had a reaction the following day (on 14Jan2021). At 11am the next day she got very dizzy and felt like she was going to faint, pass out at any second. Used cold compresses and drank water and took deep breaths, but she didn't pass out. She had a funny taste in her mouth. Then from that time until about 7pm she had urine issues and kept going to the bathroom to urinate and had diarrhea and upset stomach. Patient felt like she was out of her body, felt very weird, strange. Doctor stated she maybe had a reaction to the vaccine and recommended for her to take Tylenol. She didn't take it until right before going to bed. She was able to sleep on 14th night. Woke up the next morning and was fine. She didn't see any of these reactions listed and that happened. Patient explained to a friend of the reactions and the friend mentions that she also had a friend who had the vaccine and had the same exact reactions, everything. Everything improved and stopped the next morning she was fine, on the 15th. No Emergency Room or Physician Office visit. The events outcome was recovered on 15Jan2021. It was just a span of time and she has to assume that it was the vaccine since she has never had that before. Patient does not know if she should blame the vaccine because she also has a lot of allergies to a lot of antibiotics and does not know what caused her reactions.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021065869 Same reporter/ vaccine/ AEs, different patient

Swollen and painful kidneys that started about 36 hours after shot. Very painful for 3 days before getting better but still tender.

Patient was given the vaccine and waited the recommended time (15 minutes) after the administration of the vaccine and did not report any reaction at that time. Approximately six hours after the injection, she suddenly noticed she was having trouble breathing, could not catch her breath, and a call was made to 911. She was transported via ambulance to the hospital, where she remained for a week.

Pt received Pfizer Vaccine on 1/27/2021. Pt was admitted on 2/14/2021 for UTI, abdominal wound drainage (recent hernia repair). Not thought to be related to vaccine. Due to EUA of vaccine, "inpatient hospitalization" requires VAERS reporting.

chills for 2 days, then itchy for several days, then urine burning, then nerve jumping in arms, then clammy all separate in afternoons 2nd shot was 2 weeks ago

Patient had shot Tue. eve.2/9. Woke up Sat AM with sever lower back pain to where she could not stand up without help. Specifically complains of pain in her tail bone, especially when she sits. Went to ER on Sun. AM (2/15) . (diag. Lumbosacral Strain). Saw GP (2/17) ordered PT. Started PT 2/19. 2/23 pain in tailbone gets worse, went to Urgent care, had X-ray of tail bone (OK). Diagnosed with UTI on 3/1, put on Levofixacin 500mg. Received 2nd vaccine 3/3, RT on 3/5 patient walking better. patient on 3/6 complaining of pain getting worse

Uncontrollable shaking, inability to walk, inability to talk, hands hot to the touch, incontinence, inability or desire to eat - all began 4:30pm on the day after first vaccine given (Tuesday 2 Mar 2021) . Patient had to sleep in a reclining chair for 3 nights and was prompted to drink water and was given one Tylenol 650mg. During this time patient needed INCREASED assistance with toileting and could not have a shower with assistance (instead was given a sponge bath). Symptoms lessened over the three days and patient returned to her baseline by Saturday 6 Mar 2021.

Very severe malaise, nausea, lack of appetite, weakness, urinary frequency (every 15 min x 2 days - urine totally colorless though I was not drinkiing anything, yellow tint gradually reappeared over next 3 days), no fever, memory and concentration much worse than usual, could not even think well, joint pain ,prolonged excessive sleepiness (nearly has resolved after 2 weeks)

Patient is a seventy-nine yr/o female who presents with gross Hematuria. She states last night she noted bright red blood in her urine. Today it has been dark brown intermittently. She is chronically anticoagulated on warfarin. Denies any abdominal pain or flank pain. No fevers or chills. Reports urinary frequency and urgency but no dysuria. History of UTI 4 years ago treated with Cipro, but no chronic kidney or bladder problems.

"Pfizer-BioNTech COVID-19 Vaccine EUA" - received first dose 2/25/2021 and second dose 3/18/2021 Patient wint intermittent persistent occipital headache for 2-3 days. Pain was rated 8/10. Also with bilateral lower extremity rash without itchiness persisting for 2 days. no vision change, no photophobia. Denied any fever, chills, SOB, cough, loss of smell or taste, myalgia, nausea, vomiting, diarrhea, weakness or any focal neurological deficit. Admitted for ITP (also with epistaxis and severe low platelets, hyponatremia, acute cystitis without hematuria. No chest pain, no GI bleed.Treatments included 2 units PRBC transfusion (4/6), plateletpheresis (4/6), dexamethasone IV (changed to prednisone oral on 4/7), IVIG infusion from 4/5 to 4/7, and B12 replacement. Discharge home with prednisone oral, folic acid, cyanocobalamin

Patient is a 79 y.o. female with a history of CAD, COPD, chronic CHF, DM2, HTN who presented to hospital 4/14/2021 with chest pain, upper abdominal pain and ongoing melena. 1. Melena: Ongoing for 6 weeks per patient. Underwent colonoscopy 4/7/21 with polypectomy, no inflammation or bleeding. CT A/P 4/14/21 with mild esophagitis, mild colitis, no other acute finding. IV PPI BID. GI followed, pt is s/p EGD 4/15/21 with normal esophagus, large hiatal hernia with multiple Cameron ulcers and erosive gastropathy with no stigmata of recent bleeding. Biopsied. H&H stable at discharge. Avoid NSAIDs. Discharged on PPI 2. Colitis: Mild on CT A/P. Stool PCR discontinued as diarrhea resolved. Patient is s/p cipro/flagyl in ED. Transitioned to Unasyn with end date 4/15/21. 3. Acute Blood Loss Anemia: Baseline Hgb ~ 12-14. Down to 5.8 on admit in setting of GI bleed. Transfused 1 unit pRBC 4/14/21. Trend H/H Q6H. Transfuse for Hgb < 8 given cardiac diease. Iron studies with evidence of iron deficiency. s/p IV iron. H&H stable at discharge 4. AKI: Baseline creat ~ 0.7-0.8. Elevated to 1.35 in the setting of bleeding/anemia. Held ACEi and diuretic. She did receive IV contrast. Colloid resuscitation with blood transfusion. Resolved 5. Chest Pain w/ Elevated Troponin: Troponin T 16 on admit in setting of severe anemia and poor clearance with AKI. ECG non acute on admit. CT PA negative 4/14/21. Suspect demand ischemia. Negative delta troponin. No further workup. 6. Hx COVID 19: Positive testing 12/2020. Repeat testing ordered in ED 4/14/21 and remains positive. She desaturated only after receiving IV fentanyl in ED. Asymptomatic, CT chest 4/14/21 without GGO. Given > 90 day, patient remain in isolation per OhioHealth Policy. 7. CAD: LHC 9/28 with diffuse disease DES to OM1 and BMS to Circ/OM1. Held ASA/Plavix on admit due to GIB, resumed at discharge. Continued home statin, imdur, BB. 8. Chronic HFrEF: due to ischemic cardiomyopathy. LV 45% on LHC. Continued BB, Imdur. ACEi and Maxzide held initially with GIB and hypotension. PCP follow up 9. HTN: Soft BP on 4/15/21. Continued Imdur and BB with hold parameters. Norvasc, Maxzide, and ACEi discontinued at discharge. Follow up with PCP 10. IDDM2: A1c 7.8% on 3/2021. Continued home regimen. 11. Essential tremor: Follows with Dr. (Neurology). Continued home Propranolol. 12. Pulmonary Nodule: Ct chest 4/14/21 with 6mm pulmonary nodule, repeat in 6-12 moths.

This 79 year old female received the Covid shot on 2/18 and went to the ED on 2/26 and was admitted on 2/26 with chest pain and abdominal pain and again to the ED on 3/14 and admitted on 3/14 with hyperkalemia, acute renal injury, chest pain and died on 05/04/21 . 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.

Arrival Date: 2/14/2021 Discharge Date: 2/18/2021 Primary Discharge Diagnosis: Principal Problem: Sepsis (HCC) POA: Yes Active Problems: GERD (gastroesophageal reflux disease) POA: Yes Portal hypertension (HCC) POA: Yes Thrombocytopenia (HCC) POA: Yes Esophageal varices (HCC) POA: Yes Chronic systolic heart failure (HCC) POA: Yes Essential hypertension POA: Yes Hyperlipidemia POA: Yes Operations/Procedures: None Pertinent Diagnostic Studies: Xr Chest 1 View-portable Result Date: 2/15/2021 Portable chest at 0039 hours HISTORY: New left internal jugular catheter. AP sitting portable chest compared to February 14, 2021 and shows introduction of a left internal jugular catheter with the tip doubled back on itself possibly in the distal brachiocephalic vein. No evidence of pneumothorax. There is a coarse appearance to the pulmonary interstitium bilaterally some of which may reflect chronic disease though the possibility of a very small infiltrate at the left base retrocardiac cannot be excluded and has not changed. No significant pleural effusion or definite acute vascular congestion. The heart, mediastinal and hilar structures are not enlarged or changed. Degenerative disease of the spine is noted with a mid thoracic scoliosis convexity to the right. Left internal jugular catheter in place with distal tip curved back on itself possibly in the distal brachiocephalic vein. Chronic interstitial lung disease bilaterally as well as what may be a small focal infiltrate at the left base unchanged. Xr Chest 1 View-portable Result Date: 2/14/2021 PROCEDURE: XR CHEST 1 VIEW-PORTABLE HISTORY: cough COMPARISON: 9/27/2020 Impression: Limited portable view obtained. Heart mediastinum stable There is mild central vascular and interstitial prominence which could reflect developing mild interstitial edema or interstitial pneumonitis. No severe CHF. Some slightly more focal patchy increased interstitial airspace opacity in the left lower lobe retrocardiac region is identified and could represent a developing infectious inflammatory infiltrate. Clinical correlation and follow-up advised Incidental findings: CXR- Chronic interstitial lung disease bilaterally as well as what may be a small focal infiltrate at the left base unchanged. Test Results Pending at Discharge: Pending Labs Order Current Status Microscopic Urinalysis In process Blood Culture Peripheral Preliminary result Blood Culture Peripheral Preliminary result Active Issues Requiring Follow-up: ISSUE- Needs to follow up with PCP Discharge Medications: Discharge Medications New Medications Sig cefpodoxime 200 MG tablet Commonly known as: VANTIN Start taking on: February 19, 2021 Take 1 tablet (200 mg total) by mouth daily. Do not start before February 19, 2021. Quantity: 6 tablet Discharge Disposition: Home Or Self Care Code Status: DNR Details of Hospital Stay History of Present Illness (from the H&P) CHIEF COMPLAINT: Chills fever, nausea, vomiting, diarrhea after receiving Covid vaccine #2 (Pfizer) HPI: This is a 79 y.o. female with a past medical and surgical history as below-most significant for breast cancer that was diagnosed in 2017, portal hypertension secondary to fatty liver in 2019, resultant esophageal varices that bleed presents with the following chronological history: Approximately 9 AM yesterday morning she went to the clinic for her second Covid vaccination. At that time her temperature was 97.3. She felt fine the rest the day. At 1 AM she woke up with shakes. She continued with nausea and that resulted in vomiting and then diarrhea. She also had severe pain in her thighs. This was severe enough that she called the ambulance. Patient also relates later that she had had some burning on urination 2 days prior to the vaccination. She had leftover Macrodantin that she took 9 PM yesterday. Also relates back in December she was seen by Dr for vaginal infection and 2 times a week she has to administer intravaginal antibiotics. She has had multiple GI bleeds secondary to esophageal varices and is followed regularly by Dr who has had to do multiple banding procedures on her. She also relates she has an enlarged spleen and is followed by Dr. In the emergency room she was noted to be febrile and hypotensive. She received a total of 5 L of normal saline in the ER to bring her pressures up with a systolic below 100. She has a very elevated procalcitonin as well as lactic acid. Urine is positive for large amount of blood and small leukocyte esterase Hospital Course 79 y.o. year old female with HTN, infiltrating ductal carcinoma of the right breast stage I status post lumpectomy with positive margins was on anastrozole but taken off secondary to abnormal liver enzyme testing, CLL/thrombocytopenia stage I with no treatment needed, fatty liver complicated by portal hypertension/splenomegaly resulting in bleeding esophageal varices, history of viral cardiomyopathy in 2006, B12 deficiency, history of admission for septic shock, chronic diarhea, presented to the emergency room on 2/14 complaining of fevers, myalgias fatigue nausea and vomiting 24 hours after having a second dose of COVID-19 vaccine. She was admitted for septic work-up and later found to be hypotensive after 7L of fluids and was transferred to the ICU for septic shock, left IJ was placed. Source of infection found to be septic from UTI. Urine culture sterile with less than 1000 colony forming units and blood cultures no growth to date. On the day of discharge. Shock resolved. Her procalcitonin trended down. Wonder whether she had an exaggerated response to the Covid vaccine given that today the urine culture shows no growth. Regarding acute on chronic diarrhea she had unremarkable GI PCR and diarrhea improved after starting Imodium. She is had extensive work-up for this with GI as outpatient and days colonoscopy planned in the near future. CLL with splenomegaly/nodular hyperplasia of the liver with noncirrhotic portal hypertension/neutropenia/thrombocytopenia/hyperbilirubinemia/esophageal varices requiring banding in the past -Was restarted on propanolol and midodrine prior to discharge. -Chronic stable anemia/B12 deficiency-getting supplementation every 3 months Thrombocytopenia -she did have drop in platelet counts during admission while being on pantoprazole and Lovenox and these were discontinued and platelet count stabilized. She can have repeat CBC as outpatient to document improvement in platelet count. She was not noted to have any platelet type bleeding. History of right-sided breast cancer status post lumpectomy was on anastrozole but stopped secondary to liver disease Lab Studies: Lab Results Component Value Date GLUC 86 02/18/2021 CALCIUM 8.4 (L) 02/18/2021 NA 149 (H) 02/18/2021 K 3.8 02/18/2021 CO2 23 02/18/2021 CL 114 (H) 02/18/2021 BUN 18 02/18/2021 CREAT 0.9 02/18/2021 Results from last 7 days Lab Units 02/16/21 0702 MAGNESIUM mg/dL 1.9 Lab Results Component Value Date CALCIUM 8.4 (L) 02/18/2021 PHOS 2.4 (L) 02/17/2021 Results from last 7 days Lab Units 02/18/21 0724 02/14/21 1855 WHITE BLOOD CELL COUNT Thou/uL 4.1 < > 2.9* HEMOGLOBIN g/dL 10.0* < > 8.8* HEMATOCRIT % 30.0* < > 27.7* PLATELET COUNT Thou/uL 33* < > 37* NEUTROS PCT % -- -- 84.7 NEUTROS ABS Thou/uL -- -- 2.40 LYMPHS PCT % -- -- 10.9 LYMPHS ABS Thou/uL -- -- 0.30* MONOS PCT % -- -- 3.1 MONOS ABS Thou/uL -- -- 0.10* EOS PCT % -- -- 0.8 EOS ABS Thou/uL -- -- 0.00 BASOS PCT % -- -- 0.5 BASOS ABS Thou/uL -- -- 0.00 < > = values in this interval not displayed. Lab Results Component Value Date ALT 28 02/18/2021 AST 15 02/18/2021 GGT 22 09/09/2019 ALKPHOS 116 02/18/2021 BILITOT 1.0 02/18/2021 Physical Exam at Discharge Last Vitals: BP 117/70 (BP Location: Left arm, Patient Position: Lying) | Pulse 73 | Temp 98.1 °F (36.7 °C) (Tympanic) | Resp 18 | Ht 1.626 m (5' 4") | Wt 73.2 kg (161 lb 6 oz) | SpO2 94% | BMI 27.70 kg/m² Patient was seen and examined by me on the date of discharge. General Appearance: Alert, Awake, not in acute distress. Cardiovascular: S1-S2 regular, no murmurs present. Respiratory: Bilateral air entry present, no added sounds heard Gastrointestinal: soft, non-tender, non-distended, bowel sounds present. Extremities: B/l LE edema I spoke with the patient regarding the discharge plan. The discharge plan was discussed with the case management and the nursing staff. Patient verbalzied understanding of the discharge and was agreeable for the discharge plan. Called pt;s husband to give update on care plan but got voice mail. Condition on Discharge: Improved

ED Discharged 4/4/2021 (2 hours) Hospital ED MD Last attending ? Treatment team Acute cystitis without hematuria +1 more Clinical impression Sore Throat ? Fever ? Back Pain Chief complaint ED Provider Notes MD (Physician) ? ? Emergency Medicine Expand AllCollapse All HPI Chief Complaint Patient presents with ? Sore Throat ? Fever ? Back Pain 80-year-old female with multiple complaints. Patient states she had her second Covid vaccine yesterday. Since then she is complaining of having generalized weakness, headache, body aches, back pain, cough, nausea, generalized weakness and dizziness. No abdominal pain. She has nausea but no vomiting or diarrhea. No dysuria. Denies any chest pain.

2d dose: Covid19(Pfizer-BioNTech), Lot EL1283given by injection, Left Arm, Feb 3, 2021, 3 PM. Pt walking stamina declined over the next week. Prior to second dose, she could walk about 1.25 miles; afterward her stamina declined to a few blocks distance. On Friday, Feb 12, Pt collapsed after bath. Saturday, Feb 13, 2021, Pt did not get up. Began episodically screaming in pain. Ambulance to Hospital. Admitted and given emergency pericardial window to address pericardial effusion. Pt was discharged Feb 19, 2021, diagnosed with 1:Cardiac tamponade; 2:Hypotension; 3:Sepsis; 4:Acute kidney injury. Slowly Pt recovered some ability to walk but as of June 11, 2021 her distance has not exceeded 0.25 mile.

Emergency hospital visit on 6/22/2021 for high blood sugar and symptomatic. Glucose at bedside point of care was 548 on 6/22/2021 at 2153 and 395 on 6/22/2021 at 2304. During emergency encounter, based on EHR record, sodium chloride 0.9% infusion at 200 mL/hr, Intravenous, CONTINUOUS, Starting on Tue 6/22/21 at 2053 and insulin regular (human) (HumuLIN R) 100 units in sodium chloride 0.9% 100 mL infusion administered at 2153 CDT at 5 Units/hr or 5mL/hr. Impression provided by attending radiology provider, "Mild diffuse interstitial thickening throughout both lungs. Faint interstitial infiltrate at the lung bases, right greater than left. Minimal blunting of the right costophrenic angle. Normal cardiac and mediastinal contours. No pneumothorax. Percutaneous gastrostomy tube in place."

bladder infection; This is a spontaneous report from a Pfizer-sponsored program. A 79-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247), dose 1 via an unspecified route of administration on 14Jan2021 (at the age of 79-years-old) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had her first covid-19 vaccine 2 weeks ago. The patient experienced bladder infection last week (on 2021). She was seen by her doctor last Friday. Her second dose scheduled, and she was inquiring if she should have her second dose of the covid-19 vaccine today on 08Feb2021. Her husband was asking if it ok to take shot with the vaccine with being on an antibiotic. Her husband does not feel the vaccine caused the bladder infection. She was currently taking Unspecified antibiotic the last 2 weeks. The outcome of the event was unknown. Follow-up attempts completed. No further information expected.

Urinary tract infection; This is a spontaneous report received from a contactable consumer (patient). A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection Batch/lot number: EL9266) via an unspecified route of administration in arm left on 15Feb2021 as 1st dose, single and bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection Batch/lot number: EN6206) via an unspecified route of administration in arm left on 08Mar2021 as 2nd dose, single both for COVID-19 immunisation. Medical history included COVID in Dec2020, she did not felt good, but it was not bad, was tired, lost her sense of taste and smell. Concomitant medications were reported as none. Patient got both doses of the Pfizer BioNTech COVID19 vaccine. After each dose, she had a UTI. On 19Feb2021, patient experienced urinary tract infection which was ongoing. Reportedly, she got her first shot on a Monday, and by Saturday she had to go to Urgent Care because she had a Urinary Tract Infection. They gave her medicine, and it cleared it up. Then, she got the second COVID vaccine, and within the same time frame she was back at the Urgent care with another urinary tract infection. She got her second dose on a Monday. On Friday, she had symptoms. On Saturday she went to urgent care and got antibiotics because she had a Urinary Tract Infection and said that her urologist has seen other people have a UTI after the vaccine. Patient wanted to know if it has anything to do with the vaccine. Patient just went to the doctor Tuesday. They are sending of a test. She was going to go back and see the doctor at the end of the Month. She mentioned that she had COVID in December2020 (2 days before Christmas). She didn't feel good, but it was not bad. She was tired and lost her sense of taste and smell. She asked if it is okay to get vaccinated after having covid. On 01Feb2021, they told her she was alright to get it, but she thinks she should have waited later. After the first vaccine, she was prescribed Nitrofurantoin mono MCR, with expiration date 23Mar2022 and after the second vaccine she was prescribed Amoxicillin Clavulanic. She seemed alright again before she got the second dose. She got both doses on a Monday, and by Friday she was having issues, and then she went to Urgent care on Saturday both times. The first medication she was on for the UTI, Nitrofurantoin says not to be vaccinated on that medication. She was off the medication a week or so by the time she got the second vaccine. Patient called her doctor, and she said it was okay for her to go ahead and get the second dose. After the first vaccine she started feeling symptomatic 19Feb2021 and went to urgent care on 20Feb2021. After the second vaccine she started feeling symptomatic 12Mar2021 and went to urgent care the 13Mar2021. The patient underwent lab tests and procedures which included covid-19 resulted as positive on Dec2020. Patient questioned was it okay to get vaccinated after having COVID. The clinical outcome of the event was unknown. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021452640 Same reporter/ drug/ event for different patients

24Hr, 01/09/2021-post vaccine found in room on floor- very shaky and SOB, again later the same day-incontinent urine, confused, pain in extremities with movement, sent out to hospital. returned same evening. 01/12/2021- difficulty communicating, confused- sent out to hospital, returned same day. 01/15/2021- symptoms improved

chest pain, diaphoresis, incontinence, N/V, dizziness; symptoms are no longer occuring after be treated and released from hospital 2/3/21

Patient had her second COVID vaccine on 2/20/21. The next day she developed diffuse body aches. She went on to develop worsening dyspnea and fever to 103°F on February 23. She had a fever again on February 24. The patient also experienced a few episodes of vomiting and diarrhea but no abdominal pain and had pain of the legs, right greater than left. Blotchy red patches of the hands and arms developed. She therefore presented to the ER on 2/25/21. See full history below from infectious disease note on 3/1/21: Patient is an 80 year old female who has a past medical history notable for hypertension, dyslipidemia, and hypothyroidism. The patient was diagnosed with a high-grade lymphoma of the retroperitoneum in 2004 and completed 4 cycles of multi-chemotherapy (Cytoxan, Adriamycin, vincristine, methotrexate, and IT chemotherapy (Magrath-like regimen)). She completed 4 cycles with complete remission on PET scan. The biopsy of a left cervical lymph node in 2007 revealed follicular lymphoma and she completed radiation therapy to the neck with complete remission. A left axillary lymph node biopsy in 2016 revealed grade-3 follicular lymphoma with mixed follicular and diffuse histology. Chemotherapy was pursued. The biopsy of a pelvic lymph node in 2019 was consistent with G1-2 follicular lymphoma.  She completed radiation to the pelvis in May of 2019.  She developed progressive pelvic adenopathy in April of 2020 and received 5 cycles of chemotherapy. Subsequent CT showed improvement in the adenopathy.  Her course was complicated by pulmonary emboli (September 2020).  In November of 2020 she was started on maintenance Rituxan every 2 months.  She received the 2-dose Pfizer COVID vaccine series on 1/29/21 and 2/20/21. With the above background, the patient presented to the emergency room on February 25, 2021 with complaints of diffuse body aches, which had developed that day after receiving her second dose of COVID-19 (SARS-CoV-2) vaccine.  She went on to develop worsening dyspnea and fever to 103°F on February 23.  She had a fever again on February 24. The patient also experienced a few episodes of vomiting and diarrhea but no abdominal pain and had pain of the legs, right greater than left. Blotchy red patches of the hands and arms developed.  She called Oncology on February 20 and it was recommended that she go to the emergency room for evaluation.   She was afebrile on presentation to the emergency room.  She was tachycardic, however, with a pulse rate of 117 bpm.  She was breathing at 48 breaths per minute.  Blood pressure was 105/80 mmHg.  Oxygen saturation by pulse oximetry was 96%. Examination was notable for paraspinous muscle tenderness, tachypnea, mild respiratory distress, and a mildly distended abdomen.  Mild erythematous patches of the feet and forearm were noted, as well as evidence of edema of the right leg from the knee to the lower leg. The peripheral blood leukocyte count measured 0.8x10e3/µL.  ANC was 0.48x10e3/µL.  Platelets measured 96x10e3/µL.  Creatinine was 0.97 mg/dL.  AST was 86 and ALT 20 U/L. The lactic acid level of the venous blood was 3.6 mmol/L. The procalcitonin level of the blood measured 28.37 ng/mL. The C-reactive protein level was 313.7 mg/deciliter. The creatine kinase (CK) level was 4023 U/L.  LDH measured 314 U/L. Troponin was 3.22 ng/mL.  Urinalysis showed 6-10 wbc?s, 0-2 rbc?s/hpf, 3+ blood, negative nitrites, hyaline and granular casts as well as amorphus crystals. A chest radiograph showed possible, but not definite, mild atelectasis or infiltrate at the left lung base.  A radiograph of the right tibia/fibula showed circumferential soft tissue edema seen within the knee and upper to mid aspect of the lower leg.  EKG showed sinus tachycardia but no evidence of arrhythmia or ischemia. Cultures of specimens of the blood were obtained.  The patient was started empirically on vancomycin and cefepime and was admitted.   Faint erythema and ecchymosis of the right leg extending to the dorsal right foot and right wrist erythema were noted following the patient?s admission.  Her condition subsequently destabilized with increased respiratory rate, worsening pain, and hypotension, so she was transferred to the ICU. An abdominopelvic CT on February 25 revealed a small amount of free fluid in the abdomen around the liver, cholelithiasis with no evidence of acute cholecystitis or biliary dilatation, a nonobstructing 5-mm stone of the mid pole of the left kidney, coronary artery calcifications, mild infiltration of the fat in the inferior retroperitoneum and along the right common iliac region with small nodes in this region, similar compared with September 24, 2020, but improved compared with April 30, 2020, and consistent with response of lymphoma to chemotherapy; a myomatous uterus. A CT scan of the right lower extremity showed extensive edema about the subcutaneous tissues of the right lower leg and infiltration of the fat about the muscles of the right lower leg, likely representing cellulitis and fasciitis, and possible myositis. However, there was no air within the subcutaneous tissues or muscles to suggest necrotizing fasciitis and no evidence of abscess.     The patient?s antibiotic treatment was later changed to vancomycin, piperacillin-tazobactam and clindamycin. Cultures of specimens of the blood were later reported as being positive for methicillin-susceptible Staphylococcus aureus on 2/2 sets. Repeat blood cultures (February 26) were positive as well. Her antibiotics were modified to cefazolin monotherapy. Repeat blood cultures on Feb 27 and 28 were negative.   TTE completed 2/27/21 without obvious vegetation.   TODAY (3/1/21): Cultures negative 2/27 and 2/28. Remains on IVIG. Afebrile. She complaints of continued pain in the Right leg and swelling at that left arm. Exam GENERAL: NAD EYES: Sclera and conjunctiva clear NECK: no adenopathy LUNGS: Breath sounds normal and symmetric. No rales or wheezes. HEART: regular rhythm, no murmur appreciated ABDOMEN: Soft without mass, tenderness, organomegaly or hernia. EXTREMITIES: RLE with ecchymosis, slight overlying erythema and anterior blister: blistering more pronounced today. left foot with plantar erythema, some tenderness today. LUE fullness with some heat/tenderness SKIN: No other rashes or other abnormalities are noted. NEUROLOGICAL: alert, appropriate Assessment 1. MSSA septicemia with shock. Positive blood cultures 2/25 and 2/26 thus far. Negative since 2/27. 2. Multifocal cellulitis and interstitial infective myositis of LE- suspect related to above. CT scan was negative for apparent necrotizing infection. 3. Elevated CK due to above- improving 4. Recurrent lymphoma- has been on maintenance rituximab (11/2020). Immunocompromised state. 5. Low immunoglobulins- remains on IVIG 6. Positive urine cultures with Staph aureus- this is typically secondary seeding from bacteremia rather than primary staph uti. CT abd/pelvis negative for nidus of infection along GU track (no renal abscess for example) 7. LUE swelling/tenderness.   Plan 1. Cont Cefazolin without change: goal dosing 8gm/24hr 2. Following repeat blood cultures, negative thus far (tentative D0= 2/27/21) 3. Pending course, anticipate likely TEE--- > presently precluded due to thrombocytopenia 4. Will obtained LUE doppler for completeness given pain/swelling here. Down the line, may need to consider additional imaging (CT?) if concern for abscess, etc). 5. ID will follow along with you. Please call if any questions/concerns. Patient is still admitted, and is in the ICU.

3/3/21 er to hospital admission: 81 y.o. female with a history of Parkinson's in previous stroke. The patient basically is maintained in the nursing home in this state of being bed-bound and nonverbal. She was recently transferred to Rehab after she developed a stage IV sacral ulcer at a previous nursing home. The patient had been seeing wound care and doing very well. Her stage IV sacral ulcer had been healed to a stage II. She had been gaining weight. Unfortunately, at her wound care appointment yesterday the wound had decompensated a little bit and had started to drain some purulent material. It also enlarged in size a little bit. I was called yesterday afternoon and the nursing home reported the patient was not wanting to eat or drink. Lab work showed a sodium of 170 and creatinine consistent with acute kidney injury. She also appeared to have a urinary tract infection. Because of her critical labs she was sent to the nursing home. The patient was evaluated in the nursing home and then admitted to the floor. She was given Zosyn and vancomycin and started on IV fluids. The emergency room physician did counsel the family that the prognosis was very grim. The patient has done reasonably well overnight. She has been grimacing quite a bit and the family has decided they just want her kept comfortable comfort care during admission

Patient presented with back pain for 2 weeks, with fall prior to arrival. Patient had evidence of discitis and UTI on admission. ID felt that the seeding of the discitis was related to cholangitis from recent cholecystectomy. Treated with IV antibiotics with plan for 6 weeks duration and discharged to SNF. Patient had significant pain treated with Percocet and Dilaudid with dramatic but incomplete esolution of pain. Per EAU, hospitalizations are to be reported irrespective of attribution to the vaccine

Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to emergency department with increasing shortness of breath, fever, and cough one day after receiving second vaccine dose. Patient has been experiencing these symptoms for a month prior to arriving at the emrgency department but worsened just prior to arrival. Vital signs: blood pressure 136/75 mmHg, pulse: 96 beats per minute, temperature 36.5 degrees Celsius, respiratory rate 26 breaths per minute, and oxygen saturation 84% on room air (97% on three liters of oxygen via nasal cannula). Physical exam notable for chills, fatigue, fever, cough, dyspnea, nausea, urinary frequency and urgency, headaches, rales, and an irregularly irregular heart rhythm. Patient diagnosed with pneumonia, anemia, gastrointestinal bleeding, and urinary tract infection, administered intravenous fluids and antibiotics, and admitted to another hospital for further care.

Received shot at 2:30 pm. No original pain, redness or swelling to arm. Woke up next morning at 7:30 with urgent need to urinate. developed into urinary tract infection. Was drinking lots of water and cranberry juice for a week. mostly urinating often and lots of urine. Then on March 5, started having pain upon urinating and almost lack of urine . Went to Urgent Care . Lab report showed E Coli . Begin taking Cephalexin 500 . Took this for one week. Seems to have taken care of problem.

patient presented to ED 2/6/2021 with CC of SOB. Patient reported that she started having a cough and runny nose 14 days prior to presentation. Patient was admitted due to further evaluation of respiratory failure. Patient was started on IV decadron due to symptomatology and worsening hypoxia. Infectious disease was consulted for this patient and recommended supportive care and dexamethasone. Patient hospitalized for 10 days due to shortness of breath and oxygen requirements.

2 days after receiving vaccine - pain above kidneys on right side back continuing for 5 days, then next day stabbing pain starting above right kidney in back and shooting up to base of right shoulder, then next day stabbing paid on right side starting at the waist and shooting up ribs, then next day rash appeared on back and right side continuing to front to belly button. Turned out to be severe case of shingles. I had the shingles vaccine several years earlier.

body aches everywhere; severe headache; bones and joints were hurting so bad she couldn't barely walk much; bones and joints were hurting so bad she couldn't barely walk much; bones and joints were hurting so bad she couldn't barely walk much; Nausea; by 10 her mom had hard cramping, that it started at 8:30 with cramping in her abdomen and severe bloating; bloating; could still void but it was pressure tying to go/severe pain and abdominal pain was causing pain to void; couldn't eat or anything; intestinal cramping/severe gut, lower abdominal, intestinal pain; This is a spontaneous report from a contactable consumer via An 80-year-old female patient received the second dose of bnt162b2, via an unspecified route of administration, administered in arm on 04Apr2021 15:00 (Lot number was not reported) as single dose for covid-19 immunisation. Medical history included Ehlers-Danlos syndrome (states she was diagnosed about 40 years ago), Allergies, lung collapses (due to Ehlers-Danlos syndrome), preemie, no fusion in her eyes (States she sees out of one eye most of the time), does not retain sodium and potassium (related to Ehlers-Danlos syndrome), egg allergy. The patient previous received pneumonia and shingles vaccine for immunization and was fine, the first dose of the bnt162b2 via an unspecified route of administration in arm on unspecified date as single dose for covid-19 immunisation and fine. Concomitant medication included potassium as does not retain potassium; spironolactone; a list of medications. Her mom got her 2nd dose on Sunday and is in the process of needing to report that. She ended up with severe gut, lower abdominal, intestinal pain and bloating along with other normal things. States she saw her doctor yesterday and he believes it could be caused by the Propylene Glycol in the vaccine. Her mother received her shot at 3pm on 4Apr2021 and does not know which arm. Her symptoms started around 8:30 with body aches everywhere, a severe headache, her bones and joints were hurting so bad she couldn't barely walk much, she made it to the bathroom and that was it, and nausea. Caller states by 10 her mom had hard cramping, that it started at 8:30 with cramping in her abdomen and severe bloating. States her mom could still void but it was pressure tying to go and caused severe pain and abdominal pain was causing pain to void. Caller provides that her mom continues the same until Tuesday morning and then the intestinal cramping and bloating is still continuing now and it's more primarily her lower left area as of Wednesday. She has a big history of Ehlers-Danlos syndrome and her doctor that she met with yesterday feels this is probably from the propylene glycol component that caused the flare up, as she usually doesn't have this and he is hoping it will calm down in about a week. Her mom also couldn't eat or anything until Tuesday. She was down all of Sunday night and Monday for about 36 hours. Stated the voiding is somewhat better but not much better and the rest of the symptoms are consolidated and persisting. Reporter stated her mom can't go without her medications. Her mom did a virtual doctor visit and will follow up later this week. Her mother got the second dose of the vaccine and had severe intestinal pain, headache, joint pain, nausea, abdominal pain. The outcome of the event Dysuria was recovering, Unable to eat was recovered on 06Apr2021, other events was not recovered. No follow-up attempts are needed. Information about lot/batch number cannot be obtained.

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

admitted with unstable angina, underwent coronary artery bypass, developed acute kidney injury requiring dialysis.

death - Pneumonia due to infectious organism, unspecified laterality, unspecified part of lung - Acute kidney failure, unspecified

Headache; Right arm funny bone nerve pain that would go all the way up and down arm; nerve pain; UTI; she is still dizzy and having bad effects for the UTI; This is a spontaneous report from a contactable consumer (patient). A 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot/NDC number: Unknown; Expiry date: Unknown) via an unspecified route of administration in left arm on an unknown date in 2021 14:00 (at 80-year-old) on left arm as single dose for COVID-19 immunization. The patient's medical history thyroid issues was over 30 years ago, penicillin allergy (since 1964) that gave her hives so bad. loaded with hives and was a pimply mess, ongoing doxycycline allergy that gave her severe diarrhea, sulfonamide allergy, iodine allergy, fever and could not breathe/extreme difficulty breathing. The past drug event included tetracycline, arithromycin, Levaquin, ceftin, Zithromax that caused drug allergy (ongoing). Concomitant medications included levothyroxine (Other products: Yes) taken for thyroid disorder (had it for 30 years or more and had been taking for the same then). The patient previously took doxycycline and experienced diarrhoea, tetracycline and experienced drug hypersensitivity, erythromycin and experienced drug hypersensitivity, levaquin and experienced drug hypersensitivity. It was mentioned that no investigation assessment was done. She came home on an airplane on 03Jan2019, the year COVID started. When she got back, she told her doctor she thought she had gotten Covid, so they tested her, but she was negative. She thought she had it and volunteered for antibodies. She did not get over it until mid Jan2019. They told her she was over it for too long though if she had it. It was mentioned that history of all previous immunization with the Pfizer vaccine, prior vaccinations (within 4 weeks) if applicable, list any other vaccinations within four weeks prior to the first administration were reported as none. Received call from consumer regarding the Pfizer COVID vaccine. She has ongoing symptoms that started after she received the vaccine. She only got the first dose. On an unknown date in 2021, she started having headaches that she never knows when they are going to come on and they are continual. She did not have them before she got the vaccine. She did not remember the start date and said it was right away after the first dose that she received about a month and a half ago. It started right away. She was not getting the second one because the headaches would not go away. They become more continuous and more often. She was hesitant to get the vaccine because she was allergic to just about all antibiotics. She does not have names, lot or expirations for any. She later provided that Penicillin gave her hives so bad. She was loaded with hives and was a pimply mess. She also said that Doxycycline gave her severe diarrhea. She then found her list and also provided allergies to the following: Tetracycline, Arithromycin, Sulfa, Levaquin, Ceftin, Zithromax, and no contrast Iodine. She does not remember the exact reaction. It is either severe hives or severe diarrhea. She does not have the lot or expiration for any of them. No further details provided. She had another issues immediately after the shot. She had funny bone pain in the right arm but she got the shot in the left arm. This pain was described as a nerve pain that would go all the way up and down her right arm. It would come at night after the shot but then it went away. She does not have it right now. Right now she was trying to get rid of a UTI. It was recently within the last 2 weeks ago. She started medication for it and they did not help. She had a call into the doctor and she was still dizzy and had bad effects for the UTI. She took the medication and had to refill it. Medication was Nitrofurantoin Mono Mcr 100 mg. One capsule every 12 hours. It was in a pharmacy vial with unknown lot or expiration. She did a refill and took it twice. She finished them and has none left. Her friends were upset because she would not get second shot and certainly not a third because of these headaches. She felt she may take a chance at getting something worse than these headaches. She does not feel she should get them or anymore. The patient did not require emergency room and physician office visit. She had been to her doctor since and she mentioned the headaches, and all they say was to take Advil. Outcome of the events headache, urinary tract infection and dizzy was not recovered, whereas other events were recovered on an unspecified date in 2021. Description of Product Complaint: Description of complaint: Right now she is trying to get rid of a UTI. It is recently within the last 2 weeks ago. She started medication for it and they did not help. She had a call into the doctor and she is still dizzy and having bad effects for the UTI. She took the medication and had to refill it. Medication is Nitrofurantoin Mono Mcr 100 mg. One capsule every 12 hours. It is in a pharmacy vial with unknown lot or expiration. She did a refill and took it twice. It was mentioned that product strength and count size dispensed: 100mg, 14 count. Information on lot/batch number had been requested.

Resident was fine Day of the vaccine. The pharmacist stayed after for 30 minutes to check the well-being of the residence. Three days later resident was feeling weak wasn?t able to stand so we had to get a chair for her to sit in which was unusual. We did rapid testing and it was the only positive in the facility.

Systemic: Blood Disorder (diagnosed by MD)-Severe, Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: Other- Acute Kidney Injury, Hypoxia; lasted 10 days

PFIZER-BIONTECH COVID-19 VACCINE EUA. Vaccination occurred between 6:30am to 10am. Adverse event noted at 5:30pm included seizure activity followed by lethargy/unresponsiveness lasting a few minutes (approx 15 min unresponsive). VS 138/82, 76,16. Blood sugar 105. O2 sat 98% on room air. MD visited and ordered labs. Subsequently treated for UTI with Rocephin IM x 5days.

My blood/glucose level was abnormally high for two days following the vaccine My diabetes symptoms were more prevalent( thirst, frequent urination, dry mouth, diarrhea)

check her own self with her hand and it was like she put her hand on a stove; Allergic reaction; felt bad after taking the first dose-flu like symptoms /achy like flu symptoms; had high fever/feverish; urine became yellowish-brown; had a little diarrhea symptoms; get sick; vomiting; has a really bitter taste, or no taste in her mouth/ her mouth still has that nasty, old bitter taste that does not go away with brushed teeth; has a really bitter taste, or no taste in her mouth/ her mouth still has that nasty, old bitter taste that does not go away with brushed teeth; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program Pfizer First Connect. An 81-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; manufacturer reported as Pfizer-Wyeth; lot number: EL1283; expiration date: unknown), via an unspecified route of administration left arm on 21Jan2021 12:30 at 0.3 mL, single dose for covid-19 immunization. Medical history included arthritis in back; always had diarrhea because she had cancer and is unable to control her bowels. They tell her she has a lot of fiber in her food; but she can't control it; if she eats vegetables then she knows what's happening; but she always tries to take Imodium A-D before eating vegetables. She mentioned to them if she did not eat vegetables all she could eat is meat and cheese; doctor told her she was borderline diabetic, so she has wanted to keep up with that. The doctor was not worried about it; ongoing acid reflux; pain; and ongoing high blood pressure. Concomitant medication included ongoing omeprazole for acid reflux, ongoing amlodipine for high blood pressure, naproxen for arthritis in back, caffeine, codeine phosphate, paracetamol (ACETAMINOPHEN WITH CODEINE) for pain, loperamide hydrochloride (IMODIUM A-D) for diarrhea. The patient has not received any other vaccinations within four weeks prior to the first administration of the covid-19 vaccine. Vaccinations reported as she has gotten flu shots and pneumonia shot and has never had any adverse events, reactions or problems with those; nothing. The reporter mentioned that she got her first dose of the vaccine in a clinic on 21Jan2021 and aware that the second dose will be on 16Feb2021. The patient reported that she felt bad after taking the first dose-flu like symptoms on 23Jan2021 at 8:00 and had high fever Saturday (23Jan2021), urine became yellowish-brown and wants to know more information. The patient guesses she is having an allergic reaction on 23Jan2021 at 8:00 and asked for further information about the allergic reaction relative to the vaccine. On Saturday (23Jan2021), she was feeling good. She got up, went to store, came back and had little diarrhea symptoms then she began to get sick, feverish. She added that then the vomiting, then achy like flu symptoms. She still feels feverish, she has a really bitter taste, or no taste in her mouth really but it's going away. To her it seems like the worst part is over. She almost called 911 but then did not want to go the hospital because of all the people with COVID in the hospital. The next day on 24Jan2021, when she woke up, she was not as fevered. She can check her own self with her hand and it was like she put her hand on a stove. She went to sleep and the next morning (24Jan2021), she was not as feverish; her mouth still has that nasty, old bitter taste that does not go away with brushed teeth. She feels better today (unspecified date). She mentioned that the second dose is scheduled to be administered 16Feb2021, but she really does not want to go get that if she feels like this. She had blood work for her sugar done on 21Jan2021 because she is borderline diabetic, but results are unknown, have not had any results yet. The outcome of the events was recovering.

chronic muscle tension; Bladder infection; couldnt sleep; shaky; pain; numbness; This is a spontaneous report from a contactable nurse (patient). This 81-years-old female (at the time of vaccination weight; 58.97 kg, height; 160 cm) nurse reported that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL9269) Is COVID19 vaccine a Pfizer product; Yes, COVID19 vaccine manufacturer; unspecified, NDC number, expiry date; unknown via an unspecified route of administration from 02Feb2021 at 04:00 pm to 02Feb2021 at 04:00 pm at single dose (dose number;1) on left arm for covid-19 immunisation. Identification of the country where the drug was obtained: Country of authorization/application. Vaccination Facility Type; Health facility, Vaccine Administered at a Facility; No. Patient's medical history included thyroidectomy had in 1968, blood pressure, neuropathy, back surgery, breast cancer (dates unspecified), family history relevant to AE; none. Past drug event included Aromasin for breast cancer; inflammatory response, historical vaccine included Tetanus Diphtheria; about 4 weeks before, no specific information available. Relevant Tests: Urinalysis on 09Feb2021, diagnosed with bladder infection. Specific values not provided. Concomitant medications included levothyroxine, 88mcg one time a day by mouth for she been taking this since she had thyroidectomy for thyroid, amlodipine, 5mg one time a day from 5 years or so for blood pressure. Caller received the first dose of the Pfizer covid vaccine a week ago. 24 hours after vaccination on 07Feb2021 she could not get comfortable from a lot of pain, which went on for 24-36 hours. She went to urgent care for this and the doctor made her take a urinalysis and diagnosed her with a bladder infection. She was given antibiotics for this and the symptoms have gotten a lot better. She went to the ER on 10Feb2021 and the physician diagnosed her with chronic muscle tension. Caller also added that she had an underlying neuropathy from a back surgery as well as inflammatory response to medication she took for breast cancer 20 years ago. She wanted to check if her side effects may be related to the covid vaccine. Caller needs some information, stated she had the first dose of the Pfizer vaccine a week ago today, 02Feb2021 at the (Name) (Name), states she also has some underlying conditions, like neuropathy and that sort of thing associated with a back surgery she had 3 years ago, states numbness has been increasing over time. Caller states that the first 24 hours after the vaccine were fine, night after 24 hours couldn't sleep, pain, numbness and shaky and just a train wreck on 07Feb2021. Caller states she was so uncomfortable she went to urgent care. Doctor stated the symptoms could be a urinary infection, was diagnosed bladder infection on 09Feb2021 and was prescribed Keflex for treatment. Thinking perhaps it was coincidental, has had an inflammatory response to another medication Aromasin for breast cancer treatment. States this was before, 15 years ago, does not have information to provide, no lot, expiration, or NDC number. States she is just familiar with the inflammatory thing. Caller's question is have we had any reports such as this, any inflammatory responses. The events were not considered serious. Investigation Assessment: No. Did any AE(s) require a visit to: Emergency Room; no, Physician Office; Yes, patient went to Urgent Care. If Yes, which AE(s); pain and numbness. If the patient was hospitalized, how many days was the hospital stay; Not hospitalized. The outcome of events of pain, hypoaesthesia, insomnia and nervousness was recovering while for cystitis was unknown and for muscle tightness was unknown..

ears went dead with no sound to be heard, went to walk felt like could not control body, was swaying all over the place, and really sick. sick to stomach when stroke started happening, weaknesses everywhere could not stand up or get up in bed. Started throwing bike up really bad , dizziness happening, spilled out both ends of body, speech little slurred, stroke was happening. Got to hospital still felt dizzy for at least 3 days, throwing up lasted several hours. Zoned out in hospital for awhile but not while stroke was happening, in intensive care for 2 full days, in hospital for 3 days then transferred to rehab in hospital. Left side was affected both arm and leg and slurry speech. Little weakness in right arm. Home from rehab 2 weeks later. Still having issues with leg.

Office Visit 3/20/2021 Urgent Care PA-C Family Medicine COVID-19 +1 more Dx Fever Reason for Visit Progress Notes PA-C (Physician Assistant) ? ? Family Medicine ? ? Encounter Date: 3/20/2021 ? ? Signed Cosigned by: MD at 3/29/2021 9:22 AM Expand AllCollapse All 1. Viral URI 2. Chest congestion MDM Number of Diagnoses or Management Options Viral URI: new, needed workup Diagnosis management comments: The patient's current medications, allergies, problem list, and family history were reviewed. Please see the physical exam. The patient See HPI and physical exam to review pertinent information regarding visit. Images available were reviewed by me and reviewed with pt/family. Prescription medication recommendations were reviewed in light of the patient's age, past medical history and comorbidities.Plan of care reviewed; patient agrees with plan. See patient discharge instructions for more details. Follow up with PCP if symptoms do not improve or go to ER if symptoms worsen. Patient was seen today for fever. Diagnoses and all orders for this visit: Viral URI Chest congestion - POCT COVID-19 Antigen There are no Patient Instructions on file for this visit. History Chief Complaint Patient presents with ? Fever Fever 101 this morning.chest congstion, body aches, chills since Thursday. HPI Patient is a 81 y.o. female presents complaining of chest congestion, cough, body aches and pain in her chest with breathing for the past 2 or 3 days. She denies any loss of taste/smell, sore throat, shortness of breath, vomiting or diarrhea. ED to Hosp-Admission Discharged 3/22/2021 - 4/18/2021 (27 days) Hospital MD Last attending ? Treatment team Acute hypoxemic respiratory failure due to COVID-19 Principal problem Discharge Summary MD (Physician) ? ? Internal Medicine Discharge Summary Hospitalist Medicine Date: 4/18/2021 Admission Date: 3/22/2021 PCP: CRNP Length of Stay: 27 Days Discharging provider: MD Discharge Date: 4/18/2021 Admission Diagnosis Medical Problems Hospital Problems POA * (Principal) Acute hypoxemic respiratory failure due to COVID-19 Yes Myasthenia gravis without exacerbation Yes Toxic diffuse goiter without crisis Yes Long term current use of anticoagulant therapy Not Applicable Hashimoto's thyroiditis Yes Persistent atrial fibrillation Yes Aspiration into airway Yes COVID-19 Yes Anemia, normocytic normochromic Unknown HPI: 81-year-old female with reported myasthenia gravis diagnosed with myasthenia gravis in 2016 noted 5 weeks after finding to have difficulty swallowing and breathing requiring intubation had Plex during admission she was subsequently placed on CellCept and prednisone for long-term but was subsequently weaned off and now follows with neurology Dr., history of thoracic stenosis neck arthritis, Hashimoto's thyroiditis hyperthyroidism on methimazole, heart failure with LVEF of 45%, and atrial fibrillation on Coumadin and rate control agents following with Cardiology who presented to the Hospital on 03/22/2021 with acute hypoxic respiratory failure. The patient reportedly received her Pfizer first vaccine [per patient's son unclear date-but was reported to be due for her second vaccine at the end of this month] and subsequently was found to have fevers and chills on Saturday for which she went to urgent care and was found to be COVID-19 positive for which she was recommended for Tylenol and supportive care. On 03/22/2021 it was reported that she was found by EMS to have acute hypoxic respiratory failure with oxygen saturation in the 50s unclear for how long this had occurred for for which patient was emergently intubated. There was a concern for possible aspiration as as well given unclear how long she was hypoxic for for which she was started on cefepime and vancomycin protocol. Procalcitonin level was ordered. Hospital Course: Please see in details from H&P initially from critical care since patient was being they are almost 22 days. There is multiple consult including cardiologist palliative care note as well as urologist consult note In briefly this is a very pleasant 81-year-old female she had a history of myasthenia gravis currently treated with Dr. not in medication now for myasthenia gravis chronic atrial fibrillation long-term use of anticoagulation Coumadin history of toxic goiter currently on methimazole she was admitted initially on March 22 because she was having chills fever shortness of breath and EMS found that she is having acute hypoxic respiratory failure oxygen saturation is only 50% and emergently intubated admitted in critical care unit. Patient was intubated on March 22 meanwhile patient has a complicated series whilst she was in ICU. She was treated twice for septic shock she was treated first Covid pneumonia respiratory failure with possible aspiration. She was unable to extubate almost 19 days. Eventually she was extubated on 1 April 9. After that patient initially on BiPAP and then she tolerated nasal cannula successfully currently 3 L of oxygen. Meanwhile because of sepsis aspiration pneumonia COVID-19 pneumonia respiratory failure patient was treated with and also urinary tract infection patient was treated with multiple antibiotic vancomycin and Maxipime. For COVID-19 pneumonia she also was treated for tract residual normal. And also Decadron. Patient was not a candidate for remdesivir at that point. After extubation patient, up very slowly patient was transferred to PCU because of tachycardia and hypotension unable to thread beta-blocker digoxin and Cardizem the medication was adjusted pretty slowly patient was started Lovenox injection for bridging Coumadin Coumadin was initially hold been longtime and then after Lovenox injection and Coumadin was started patient currently INR is 1.9 today. She was Coumadin been longtime because her Chad vascular score was high she also had a history of congestive heart failure in addition of chronic atrial fibrillation heart rate is fluctuated in the range of 80-120. She is currently on digoxin we will continue digoxin she is currently on Toprol which started 50 mg and currently 100 mg Toprol she also have a Cardizem with splitting the medication 120 mg p.o. twice daily. Heart rate is better controlled today blood pressure is low borderline this patient need to be watched even in the nursing home for further evaluation of medication adjustment. She also mentioned that she is having chronic hypokalemia potassium was replaced alert here and so then started potassium 20 M EQ p.o. twice daily may need to further adjustment and follow-up potassium in the nursing she she was tachycardic heart rate in module was started recently as 7 days ago now her heart rate is much better now this patient need to see endocrinologist also to follow-up. Patient was complicated with urinary retention and continue straight cath and finally ended up with Foley's catheter this patient must need to evaluate by urology for further evaluation of chronic urinary retention. Meanwhile patient clinically stable vitals are good she does not have any fever shortness of breath tolerable with 3 L of oxygen now she does not have any chest pain she is not in any myasthenia gravis medication this patient will benefit to see follow-up with pulmonary group for post Covid pneumonia require long-term intubation and also neurology for myasthenia gravis Dr. This patient will benefit to a urologist outpatient and also physician to nursing home need to adjust medication in the setting of hypotension tachycardia we will continue Coumadin current dose 7.5 mg and may need to further adjustment slowly. She is currently on 3 L of oxygen we will continue and titrate down slowly. Discharge disposition is nursing home Condition upon discharge patient is awake alert oriented no chest pain still 3 L of oxygen tolerable.

The patient presents for "body is burning", eyes burning, burning urination, muscle aches, sinus drainage. Describes back pain as 10/10.

Pt with seizure-like activity noted x2 by her husband, with symmetric jerking of legs, loss of responsiveness, loss of bowel/bladder function.

Patient was hospitalized, presenting to the ED with confusion/encephalopathy. She was also found during her hospitalization to have hypoglycemia, CAP, UTI, and liver cirrhosis with elevated LFTs/ammonia. She was given antibiotics and lactulose to manage. Patient recovered and was later discharged

Family call Clinical Lead to car for elderly woman in backseat of car who had become unresponsive. Patient lying on side. Wearing portable NC o2. Unresponsive to verbal/sternal rub. No pulse, No resps. Called AMR to car side who called 911. Transferred patient to a gurney and began CPR as we transferred to AMR rig. EKG - showed PEA - CPR continued - patient intubated by AMR - epi is given. Pt transported by AMR/Fire to hospital. Pt was a full code on Hospice - she passed away 3/11/21 with the following cause of death: 1.Acute-on-chronic hypoxemic/hypercarbic respiratory failure, multifactorial in origin. 2. Possible aspiration pneumonia, present on admission. 3. Bronchiectasis, chronic, secondary to asbestosis. 4. Acute combined metabolic and toxic encephalopathy, present on admission. 5. Out of hospital pulseless electrical activity arrest. 6. Hyperkalemia. 7. Cardiogenic shock. 8. Acute kidney injury. 9. Lactic acidosis. 10. Acute diastolic congestive heart failure. 11. Severe protein-calorie malnutrition.

Patient is an 82-year-old female who came to the emergency department today complaining of shortness of breath. Patient also reports that she has cough, low oxygen and recently received her second Covid shot and when EMS picked her up she was 83% oxygen saturation on room air. Patient has what sounds like pooling secretions in her throat and patient had suctioning done by respiratory which caused her to bleed blood noted in teeth and around mouth. Patient reports that her throat has been hurting her and that is why she has been unable to eat. Patient's daughter is at bedside and is historian for majority of the assessment. Patient's daughter reports she has not been eating or drinking for the last 2 days. Labs in ER showed WBC 11.61, lactate level 3.3, creatinine 2.0, procalcitonin 5.33, magnesium 1.5, BNP 2100, glucose 474. Chest x-ray showed no acute findings.

4/10/21 ER HPI: 82 y.o. female who presents to the Emergency Department by paramedics from a local nursing home. The patient is an 82-year-old female with a known history of end-stage renal disease, diabetes, and coronary artery disease. She presented to the emergency room after being transported from a local nursing home. Apparently, the patient was acting a little bit more confused than normal and she was looking more short of breath than normal. The nursing home nurse stated that her oxygen saturations were in the upper 80s without oxygen and the patient looked visibly more short of breath than normal. Because of this, the nursing home made the decision to send the patient in. When paramedics arrived at the nursing home they placed 2 L of oxygen on her and her oxygen saturations went up into the high 90s. The patient does dialysis on Monday, Wednesday, Friday. She did not miss a dialysis treatment this week. The patient has had her coronavirus (COVID-19) vaccine and several months ago did have coronavirus (COVID-19) at the local nursing home. The patient does have mild dementia and so is somewhat of an unreliable historian. Transferred to pleural effusion

blood in urine abdominal pain R31.9 - Hematuria R31.0 - Gross hematuria N32.89 - Bladder mass R10.2 - Suprapubic pain, acute

Severe nausea; weight loss; stomach pain; bladder infection; This is a spontaneous report from a contactable Nurse (patient). An 82-year-old female patient not pregnant received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 25Mar2021 13:30 (Lot Number: EN6208) as single dose (at the age of 82-years-old) for covid-19 immunisation. Medical history included tachycardia, hypothyroidism and Covid prior vaccination (date unknown). Concomitant medications in two weeks prior to the vaccination included metoprolol succinate (TOPROL), levothyroxine sodium (LEVOXYL). The patient previously took sulfamethoxazole, trimethoprim (BACTRIUM DS) and experienced drug hypersensitivity. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. On 30Mar2021 patient experienced severe nausea, weight loss, stomach pain and bladder infection. Patient had three visits to primary care doctor (dr), one clinic visit for intravenous (iv) fluids, emergency room (ER) Visit and hospital admission. Patient was admitted for three days in response to the events (dates were not provided). Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient underwent laboratory tests and procedures which included sars-cov-2 test (Nasal Swab) negative on 14Apr2021 and sars-cov-2 test (Nasal Swab) negative on 16Apr2021. Patient had not recovered from the events, at the time of the report.; Sender's Comments: Based on the available information it is unlikely that BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) contributed to events occurrence. The reported events more likely represent intercurrent medical conditions unrelated to Covid-19 vaccination. The impact of this report on the benefit/risk profile of the Pfizer product 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.

Lymphedema in her legs/ got lymphedema about 5-6 days after the second Pfizer vaccine; Legs were hurting like the devil; Legs were about six times the size they should be/ she has intense swelling; Peeing too much; Doesn't feel right; she is just so weak; This is a spontaneous report received from a contactable consumer (patient). An 82-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9261; Expiration Date: 31May202, NDC: 59267-1000-2), via an unspecified route of administration, administered on left arm on 06Feb2021 at 12:00 as 2nd dose, single for COVID-19 immunisation. Medical history included ongoing emphysema, ongoing breast cancer from 2007 (she did not take chemo, just radiation) and ongoing follicular lymphoma from 2014 (did not take chemo, just radiation. Cancer was in the bone marrow, said she didn't think that has anything to do with it, has had two operations) and bone marrow cancer. The patient previously took budesonide/ formoterol fumarate (SYMBICORT) she was using SYMBICORT, but her doctor switched it a few months ago, back to ANORO), prochlorperazine maleate (COMPAZINE) she takes a couple of times per month, takes 10mg when she feels nauseated and pseudoephedrine hydrochloride (SUDAFED) she takes when she needs it. Concomitant medications included furosemide (LASIX) at 40 mg, twice a day (one 40mg pill in the morning and one 40mg pill at night) from 1985 to an unspecified date and then increased to 80 mg, twice a day (two pills (80mg total) in the morning and two (80 mg total) at night) from on an unspecified date and ongoing for blood pressure; ongoing simvastatin (ZOCOR) taken for high triglycerides; umeclidinium bromide/ vilanterol trifenatate (ANORO). Patient thought she has been on Lasix since 1985 but can't remember back that far. She was taking Zocor for a long time and stated Anoro Inhaler was a fairly new medication. For Anoro inhaler, patient stated she pulls back the thing and didn't know, maybe it pinches a pill and inhales the white powder. Relevant family medical history included none and both parents were deceased. Patient stated that her oncologist does blood tests once every four months, a test for markers and stuff like that, CBC, metabolic panel and bloodwork every 4 months. The patient previously took first dose of BNT162B2 (Lot number: EL3246, Expiration date: 30Apr2021, NDC: 59267-1000-2) via unspecified route of administration in left arm on 14Jan2021 12:00 pm for COVID-19 immunisation. It was reported that, the patient has very sexy legs, but she doesn't anymore, says she got lymphedema about 5-6 days after the second Pfizer vaccine in Feb2021. She was now going to physical therapy, to bear her out and try to understand what she's saying. Caller states 30% of the people there that have had cancer and had radiation, get the same side effect she has had, some people have it in the arms, she got hers in her leg, says she has intense swelling, called lymphedema, says her legs look like they belong on an elephant. Caller said at the physical therapy place, 30% of people who have come in for help had radiation treatment for some kind of cancer, all have different kinds of cancer, but the swelling, the lymphedema, was the side effect they've all experienced. Caller states that no one has called Pfizer and let Pfizer know, states she won't take the booster, won't have anything to do with this, says it's too scary. Caller states she was an active person, never had a problem with legs swelling or anything like that and now, her look like legs that belong on an elephant. Caller states the correlation seems to be with radiation treatment, because she has bone marrow cancer, and other ladies have breast cancer, states the only thing we all have in common was different treatments but in her own case she had no chemo, but she did have radiation. It seems like with radiation this swelling was an after effect. Caller says it's 2 or 3 things, not just that they had cancer or radiation treatment, says those of us who had radiation also got this swelling. Caller states she never had any trouble with legs or anything, says she was an active person. States some people experienced this four days after the vaccine, says hers started six days after the vaccine, says she woke up one morning, and her legs were huge. States usually legs were smaller in the morning. Caller wonders what were the ingredients that causes swelling. Caller states she doesn't know how to explain it, says like overnight turned a switch on and now her legs were going to be big and fat and ugly. Caller states the reason she's calling was because at physical therapy last Thursday, other people who had the shot had the same side effect, says the only thing the lady said, she wasn't sure if she was a nurse or not, was the relationship was not with the kind of cancer, but the radiation treatment and the shot has been causing this and wasn't surprised. Caller says she was told that about 30% that they're handling now had the Pfizer vaccine. Caller thinks that's all they gave in the state NC, no other vaccine here, says it just seems to be with this. Caller states the lymphedema, hers was in her legs, others have it in their arms, she doesn't know why it's happening. Caller states about six days after the second shot, she can't remember exactly what day, about six to seven days, she woke up one morning, and her legs were hurting like the devil in Feb2021, stated her legs were about six times the size they should be in Feb2021. Caller states usually in the morning, the swelling goes down, but this woke her up out of the blue like zap, says no warning, no nothing, just one day she woke up and that where it was. Caller states her doctor increased Lasix, she used to take one 40mg pill in the morning and one 40mg pill at night, increased it to two pills (80mg total) in the morning and two (80 mg total) at night. Caller states she is now only taking one-and-a-half-pills this morning, because she doesn't feel right and she was peeing too much in Feb2021 and was not feeling right. She doesn't want to get dehydrated. Caller states she has a doctor appointment 10Jun2021 and was going to tell him she was taking less because she was just so weak in Feb2021. Says she was weak because she's taking too much Lasix, states she was taking two 40mg morning and night. Caller states she was just concerned, she has big legs, fat legs, she calls them fat. The patient not visited emergency room. The events result in the patient visited physician office. Patient reported that she has had no shots for four months however she was going to get the high dose flu shot on 01Oct2021. No relevant tests were performed at the time of this report. The outcome of the events lymphedema and Legs were about six times the size they should be was not recovered and outcome for the other events was unknown. No further details provided. Follow-up attempts are needed. Further information requested.

New onset altered mental status after fall. Per son, she was found in bed, unresponsive at around 12:15 AM on 1/10 by her husband. Brought to the emergency room and admitted, Began treatment for UTI w/ CTX. Discharged 1/11/21 with f/u appointments

Lost consciousness, couldn't breathe, Kidney GFR dropped. Fluid in the lungs, Kidney damage. Still in hospital. No diagnosis at this time.

PATIENT WAS ADMITTED TO ER FOR ALTERED MENTAL STATUS / UTI SEPSIS WITH SEPTIC SHOCK / COVID AND COVID PNA PATIENT WAS ADMITTED TO ICU AND DIED . POA WISH TO WITHDRAWL EXTRME MEASURES

Initially, a UTI developed. As the UTI resolved, double pneumonia took hold. At the hospital they then discovered multiple clots in the legs.

Death; Kidney shutdown; This is a spontaneous report from a contactable consumer reporting for the mother. An 83-year-old female patient received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm, on 28Feb2021, as single dose, for COVID-19 immunisation. Medical history included unspecified ailments. Concomitant medications were not reported. The patient experienced kidney shutdown (medically significant) on 02Mar2021 with outcome of unknown and death (death, medically significant) on 14Mar2021. The cause of death was unknown. It was not reported if an autopsy was performed. The information on the lot/batch number has been requested.; Reported Cause(s) of Death: Death

N17.9 - Acute kidney failure, unspecified E83.42 - Hypomagnesemia N18.9 - Chronic kidney disease N17.9 - Acute kidney injury (CMS/HCC) R53.1 - Generalized weakness

lactic acid was high; dementia had suddenly progressed; spot where her lung was starting to collapse; potassium, Vitamin D and Vitamin B12 were low; potassium, Vitamin D and Vitamin B12 were low; potassium, Vitamin D and Vitamin B12 were low; stopped talking; Cellulitis in her arm/ cellulitis was further down her arm, around her wrist hand area (Her wrist was huge, hot, red, and her hand was swollen); it burned when she peed; blood in her urine; wanted to sleep/getting worse with sleeping; was shutting down; she was dehydrated because her urine was dark; urine was dark; began just feeling bad/having like a terrible time/having a hard time/really not feeling good; more confused; lethargic; had trouble her getting up/was having to do everything for her, feed her, bathe her; couldn't walk; lost her appetite; arm was sore; This is a spontaneous report from a contactable consumer (patient's daughter). An 83-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration, administered in the left arm, on 24Feb2021, as single dose, for COVID-19 immunisation. Medical history included mild asthma, dementia (moments like putting things in the wrong place and being forgetful) and was confused. There were no concomitant medications. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) received at age 83 years, on 03Feb2021, for COVID-19 immunisation. On 24Feb2021, after the second vaccinations, the patient's arm was sore. On 06Mar2021, the patient began just feeling bad, was having like a terrible time, having a hard time, was really not feeling good; was more confused; lethargic; had trouble getting her up, was having to do everything for her, feed her, bathe her; couldn't walk and lost her appetite. On 09Mar2021, the patient was shutting down. On the same day at 18:30, the patient had gone in the bathroom and said it burned when she peed. So, the patient was taken to urgent care so it would not get out of hand. At the urgent care, they said she has a UTI, there was blood in her urine so they gave her Cipro but they cultured her urine and it grew no bacteria but there was still blood in her urine and she was getting worse with sleeping and she didn't even get up to eat. The patient was also dehydrated and her urine was dark. The events dehydrated, urine was dark, it burned when she peed, blood in her urine required emergency visit on 16Mar2021. The reporter thought the patient was going to die. On 16Mar2021, in the ER, they did blood work (unknown result), chest xray which showed she had a spot where her lung was starting to collapse (they said it was a tiny place, from not getting up and moving around, they said it would correct itself) and the patient's potassium, Vitamin D and Vitamin B12 were low. They did a CT scan of the head and chest to look for stroke or seizure and there was nothing. They blamed it on her dementia that had suddenly progressed. The patient was hospitalized from 16Mar2021 to 18Mar2021. On 12Mar2021, the patient experienced cellulitis in her arm. The reporter clarified that the cellulitis was further down her arm, around her wrist hand area. Her wrist was huge, hot, red, and her hand was swollen. On 24Mar2021, the patient followed up with the family doctor because the hospital wanted her to follow up with a GYN because they didn't feel it was urinary at all. When the reporter took the patient in to see the doctor, she couldn't walk in, she had to roll her in a wheelchair, she had stopped talking again. On 26Mar2021, the doctor sent the patient to the emergency room (unspecified reason) and they kept her. They said her said lactic acid was high. She was admitted on 26Mar2021 and discharged on 29Mar2021. On 29Mar2021, the patient's potassium was 3.3 and her lactic acid level was back to 2. The patient was recovering from lactic acid was high; potassium, Vitamin D and Vitamin B12 were low; began just feeling bad/having like a terrible time/having a hard time/really not feeling good; more confused; lethargic; had trouble her getting up/was having to do everything for her, feed her, bathe her; couldn't walk; lost her appetite; was shutting down; stopped talking. The patient recovered from cellulitis in her arm/ cellulitis was further down her arm, around her wrist hand area (Her wrist was huge, hot, red, and her hand was swollen) in Mar2021; and arm was sore on 29Mar2021. The outcome of events spot where her lung was starting to collapse, dementia had suddenly progressed; she was dehydrated because her urine was dark; it burned when she peed; blood in her urine; and wanted to sleep/getting worse with sleeping was unknown.

I60.9 - Subarachnoid hemorrhage (CMS/HCC) J18.9 - Pneumonia I63.9 - Acute CVA (cerebrovascular accident) (CMS/HCC) N17.9 - Acute kidney failure, unspecified R29.810 - Facial weakness

gas; balance problems; dizziness; sensitivity to being enclosed inside warm rooms (above 66 degrees); sleeplessness; anxiety; inability to sit still; dehydration; loss of appetite; frequent urination; sensitivity to noise; This is a spontaneous report from a contactable consumer. A 83-years-old non pregnant female pa-tient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EN9263, Expiration date: Unknown), dose 1 via an unspecified route of administration, in right arm on 05Feb2021 at 14:30 (at the age of 83-years-old) as single dose for COVID-19 immun-isation and the patient received second dose of BNT162B2 (Solution for injection, Lot Number: EL6203, Expiration date: Unknown), via an unspecified route of administration, in right arm on 25Feb2021 at 11:15 AM (at the age of 83-years-old) as single dose for COVID-19 immunization. The patient medical history included arthritis and spinal stenosis. The Patient received concomitant medications in two weeks which included phytosterols nos and chondroitin sulfate sodium, glucosa-mine hydrochloride, multi-vitamins. Patient did not receive any other vaccine within four weeks. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. The patient had no known allergies. The patient had experienced gas, balance problems, dizziness, sensitivity to being enclosed inside warm rooms (above 66 degrees), sleeplessness, anxiety, inability to sit still, dehydration, loss of appetite, frequent urination and sensitivity to noise on 06Feb2021 at 19:00. There has not been any pain at the injection site or anywhere else on her body. No treatment received for events. The patient went to physician or other healthcare professional of-fice/clinic visit, Emergency room/department or urgent care due to events. The patient underwent lab tests and procedures which included nasal swab test on 05Feb2021 and 25Feb2021 result was nega-tive. The outcome of all events was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Pt was vaccinated on 3/9/21 and 4/6/21 with Pfizer vaccines. Prior to her recent hospitalization she or the daughter had no knowledge of her severe hiatal hernia but she did admit to early satiety and poor po intake for a few months. Patient is an 84-year-old female with a past medical history significant for hypertension, hyperlipidemia, recurrent urinary tract infections who presented to the emergency room on 6/1/2021 due to some dysuria, frequency, nausea, vomiting and increased confusion. She denied any fever or chills or any abdominal pain but did report some acid reflux symptoms and poor appetite. she was ultimately admitted with a suspected urinary tract infection. She was also profoundly electrolyte depleted with hypokalemia, hypomagnesemia and hyponatremia due to poor p.o. intake. She was started on IV fluids and electrolyte repletion was also started on Rocephin based on her old cultures and subsequently admitted. Patient's urine and blood cultures ultimately produce no growth and a urinary tract infection was ruled out. She was found the day after admission with a large amount of black emesis covering her sheets. When questioned patient reported that she had been vomiting during the night. Stool OB was ultimately positive. Her DVT prophylactic heparin was discontinued. She was started on IV Protonix. CT of the abdomen pelvis was ordered. CT revealed nearly the entire stomach was above the left hemidiaphragm with air-fluid levels but there was no significant distention seen. The case was discussed with our general surgical team and the decision was made to transfer the patient to a higher level of care for a GI/EGD evaluation .She was transferred on 6/3/21. She was ultimately discharged on 6/7/21 home after being found to have a gastric volvulous. On 6/21 she returned for Robotic-assisted laparoscopic repair of a giant hiatal hernia with Bilateral placement of pleural pigtail catheters as both pleural linings were densely adhesed to the hernia sac. The plan was to discharge her home on 6/25/21.

UTI; This is a spontaneous report from a contactable consumer reporting for a parent (mother). A 83-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EL1283; Expiration date was not reported), dose 1 via an unspecified route of administration, administered in right arm on 30Jan2021 10:30 (at the age of 83-years-old) as single dose for COVID-19 immunisation. Medical history included blood cholesterol, blood pressure and thyroid condition. It was reported patient had all the usual suspects, as far as, medical conditions for her age including cholesterol, blood pressure, and thyroid. It was also reported that all three were controlled, and not an issue for patient and no further details provided. Patient had no other history. There were no concomitant medications. History of previous immunization with Pfizer vaccine and additional vaccines administered on same date of the Pfizer Suspect included none. The patient did not receive any other vaccines within 4 weeks prior to the vaccine nor experienced any adverse events due to prior vaccinations. The patient experienced UTI (urinary tract infection) on 16Feb2021. The patient underwent urine analysis which resulted positive for UTI on 15Feb2021, and no more information was available. Therapeutic measures were taken because of the event. Patient's doctor prescribed antibiotics for UTI. Patient was scheduled for second COVID-19 Vaccine injection on Saturday, 20Feb2021 and was really concerned about taking the antibiotics with the COVID-19 Vaccine. Reporter asked if it is safe for patient to take the antibiotic, or should she not take the antibiotic, or should she wait to take the antibiotic until after she has had her second COVID-19 Vaccine dose. Caller reported that patient was prescribed Cefdinir for 5 days and does not know how many milligrams Cefdinir, the patient was prescribed. Caller said he had to go to the pharmacy to pick up the Cefdinir prescription, so did not have the Cefdinir NDC, Lot, and Expiration Date. Reporter confirmed that patient has not started taking the Cefdinir. Caller stated that the patient said she would rather get her second COVID-19 Vaccine dose than take the Cefdinir because the COVID-19 Vaccine is more important to her. Reported stated he spoke with patient's doctor via telephone last night and described patient's symptoms to the doctor. The doctor told to have a urine test done the night before this report. And the next day morning patient's doctor called in an antibiotic prescription for patient to take for a UTI. Doctor told reporter that the patient can take the antibiotic and it would not interfere with her second COVID-19 Vaccine dose. The caller stated while he trusts the patient's doctor, he wanted to know what Pfizer had to say. Patient was diagnosed with a UTI on the morning of 16Feb2021. Patient did not have to go to Emergency Room. Patient visited Physician Office due to the event. Outcome of the event was unknown. Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

I am an 83 year old female who was thought to have Guillain-Barre ca. 40 years ago. I was paralyzed from the waist down, hospitalized, and had a very slow recovery. This paralysis caused clawed toes that were straightened surgically and affected my balance and walking (I use two hiking poles as aids for walking and balance.) Little was known at that time. I received the first Pfizer Covid shot on April 18, 2021. Two days after I had the Covid shot, the nerves in my left leg, below the knee, were sore when pressed and the affected muscles felt numb. This has persisted and at times different nerves in my lower leg are affected. Currently the muscles going down the back of my lower leg and around the ankle are affected. Three nights after the Covid shot, I had severe left kidney pains, became violently sick and the following morning went to my health facility emergency care department. I had no previous kidney problems or signs of a UTI. I had a CT scan of the kidney and was treated for a kidney infection and UTI with antibiotics. I have been to a kidney specialist and urologist with tests continuing. My breathing was erratic for a few days and I felt nauseous for 2 weeks. I have not had the second covid shot.

death NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC) Pulmonary emboli (CMS/HCC) Acute kidney failure, unspecified Thrombocytopenia, unspecified

Patient presented to the ED and was subsequently hospitalized for Acute kidney injury superimposed on CKD within 6 weeks of receiving COVID vaccination.

Patient was brought in by ambulance on 01/28/2021 with complaints of fever, chills, myalgias, shakiness, and severe hypotension. Patient was treated for severe sepsis and acute kidney injury. Patient was given fluid resuscitation, but unresponsive to treatment; NE+ vasopressin, hydrocortisone IV, along with empiric antibiotic regimen were initiated. Patient later on developed pulmonary edema, Non-ST elevation MI with no chest pain and new onset of cardiomyopathy with EF 40-45% and clean coronary arteries shown on cardiac catheterization. Physician suspected cytokine release syndrome related to the COVID vaccine and congestive heart failure. Naranjo scale score of 2 indicates possible ADR. MD indicated vaccine reaction unlikely.

C/O chills, aches (new onset), headache (chronic) 12 days after COVID dose #1. Patient found to be hypotensive and tachycardic in ED, was admitted due to complex medical history. Hypotension, tachycardia, and AKI resolved after 1L LR.

First dose Pfizer given at assisted living on 1/14/21 she was subsequently admitted to hospital and got her second dose but Moderna was given instead of Pfizer on 2/8/21. She had been improving but in the days following the Moderna vaccine she developed fever and then her mental status declined. She was discharged back to assisted living. Suspected UTI, and moderate dementia, placed on hospice (2/12/21). Died on 2/13/21.

2/23 - PT awoke at 0230 w/altered mental status, generalized weakness, severe headache, nausea and fever. T 101.2, PERL, BP 120/82, HR 88 regular, RR 18. Grips/Pushes equal/weak. A&O x2 (A&O x 4 baseline). ABDM soft, non tender. Breath sounds clear bilaterally. 1100 IV NS 1L, 30 mg Toradol IV given. Temp 99.2-102.0 variable throughout the day. Severe HA. Tylenol and Motrin alternated q 4hr. 2/24 Severe Headache, pt reports disturbances in her visual field. A&O x3. weakness/malaise continues. Motrin & Tylenol - LABS 2/25 Severe Headache, with altered visual fields.- CT HEAD 2/26 Same as above. 2/27 Same as above. Urgent Care for Flu & COVID Testing. Both Neg 2/28 Headache managed with Celebrex, 12 hrs relief, then 200mg Motrin 3/1 Same as above. Retinal specialist for consult and Fluorescien Angiography - WNL 3/2-3/5 Headache and visual field changes continue. Pt states "do not feel myself"

About 11 hours later, severe weakness in muscles causing her to fall in her apartment. She was admitted to hospital, and had fever and cough which progressed to pneumonia. Event further weakened already weak kidney function. After a week in hospital was transferred to nursing home long term.

SHORTNESS OF BREATH Bradycardia Hypothermia Cardiomyopathy Elevated troponin Acute renal failure (ARF) Death

3/13/21 Ferrell ER to admission hpi: 84 y.o. female presented to the emergency room with complaints of back pain, nausea, and abdominal pain. Patient approximately 1 week ago was bending over to pick something up and fell to the floor landing on her coccyx, and has had increased low back pain since that time. Patient does have a history of congestive heart failure and atrial fibrillation. Patient states that she had noticed increasing lower extremity edema and mild shortness of breath with exertion. The patient states that her back pain escalated and she was unable to stand or walk on her own. Patient was then brought to the ER for further evaluation per EMS. The patient did have a CT of the abdomen and pelvis which showed no definite acute intra-abdominal/pelvic abnormality, and mild acute during L2 superior endplate compression fracture with approximately 4 mm of displacement into the spinal canal. Patient also had a CT of the lumbar spine without contrast which showed acute appearing mild L2 superior endplate compression fracture with approximately 2 mm of displacement to the spinal canal, and multilevel degenerative disc disease. This morning upon entering the room the patient was standing with assistance of a walker and hospital staff. Patient tolerated fair. Patient does complain of severe pain with standing and movement. Patient does have 3+ pitting edema to bilateral lower extremities. Denies numbness or tingling to lower extremities. Bilateral lower extremity pulses are 1+ 1+, with CMS being less than 3 sec and skin is pink warm and dry. Patient's EKG in the emergency room did show atrial fibrillation with RVR with a rate of 137. Patient was given Cardizem IV in the emergency room, and then was started on Cardizem CD 100 80 mg p.o. daily. Patient's rate is controlled at between 92 and 96 beats per minute and continues to show atrial fibrillation on the telemetry. No shortness of breath is noted at this time. Patient did also have lab work drawn in the emergency room CBC: White count is 9.4, hemoglobin 14.4, hematocrit was 43.7, with a platelet count of 261. Patient's CMP showed a BUN of 21, creatinine 1.2, potassium was normal at 4.6, and her GFR was noted at 41. Patient also had a BMP drawn which was noted at 322. Patient also had a urinalysis performed which shows negative for leukocytes, nitrate negative. Patient was admitted to medical inpatient as it is deemed that she will need longer than a 2 midnight stay for cardiac monitoring and will work with physical therapy and occupational therapy for gait training and strengthening with relation to the compression fracture of her L2 fracture, and pain control.

?Pfizer-BioNTech COVID-19 Vaccine ? Patient hospitalized after fall with UTI, hyponatremia, and C7 cervical fracture several months after receiving vaccine.

Patient received 1st dose Pfizer COVID vaccine on 2/5/2021 and second dose on 2/26/21. She had no adverse reaction to either dose. Around 3/2/2021, she saw her physician complaining of pain in her arm, which was attributed to gout. At the time, she also had a nonproductive cough, generalized weakness and one episode of loose stool. She presented to the emergency room on 3/7/21 with significant hypoxia. She tested positive for COVID 19 by both rapid test and PCR. A quantitative test for COVID antibodies was sent out to a reference lab on 3/7/2021 and resulted on 3/11/2021 as >250 U/mL. Pt. required CPAP, BiPAP, High Flow Oxygen and ultimately intubation. Was not oxygen dependent before hospitalization. Pt. treated with dexamethasone, 2 doses of Remdesivir (then held due to acute kidney injury), tocilizumab X 1 dose, 1 unit COVID-19 convalescent plasma. Pt. expired on 3/19/2021. Sample sent for genome sequencing to check for variants of interest in joint effort between pathology and infectious disease. Report not yet available.

3/25 temp 99.1, change in condition form sent to dr. 3/26 Res continues to be lethargic this AM shift. Res does nothing to participate with cares, transfers or eating. Denies any pain or SOB when asked. Difficult to have res to keep eyes open. Appetite very poor, even with full assist provided- sent to ER- admitted to hospital dx of UTI/hypernatremia 3/29 retn to nursing home and3/30 admit to hospice

Patient awoke on the morning of 4/6/2021 with disorientation, confusion and tremors. She presented to the ED for workup, diagnosed with a UTI and discharged home. The patient presented to the ED again on 4/11/2021 with ongoing altered mental status, tremors and anorexia. Family reports no improvement in patient's symptoms since onset (4/6/21). Patient now having difficulty finding words, shakiness on ambulation, hallucinations and tremors. Denies urinary symptoms, repeat urine culture was benign. Patient remains hospitalized as of this report (4/15/21) with fluctuating symptoms, Serial head CTs and lab studies also benign. Unclear etiology of symptoms.

3/27/2021- @3 AM resident with increase in SOB with unresponsive episodes. Pt states she has history of unresponsive episodes related to cardiac issues, declined hospitalization.

symtptoms started evening of vaccine dose. Felt fine in am. found on floor by family brought to hosp by EMS, seizure disorder; didn't have the strength to get to bed due to fatigue, which is history. Also abd pain and diarrhea and myalgias. Mottled reticular rash diagnosis identified: Abdominal pain; Acidemia; Acute kidney injury; Lactic acidosis; Mottled skin; NSTEMI (non-ST elevated myocardial infarction); Right hip pain; Tachypnea; Weakness

N17.9 - Acute kidney failure, unspecified R65.10 - Systemic inflammatory response syndrome (sirs) of non-infectious origin without acute organ dysfunction

back was itching like the small of her back/back just itched; Arm was just barely sore; This is a spontaneous report from a contactable consumer. A 84-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL926F) via an unspecified route of administration in arm left on 10Feb2021 13:30 as first dose, single for COVID-19 immunization. Medical history includes that she was diagnosed with Lupus in 2004 and fasciitis in her foot in January2021. She had cortisone shot in her foot on 12Jan2021 and 08feb2021 within four weeks prior to vaccination. The patient previously took vitamin d2 + calcium [calcium gluconate; calcium phosphate; ergocalciferol] 50mg once a week, cortisone for fasciitis on Oct2020 patient has taken flu shot and a booster for pneumococcal pneumonia however in past patient took flu shot and had flu. No adverse event prior vaccination. Patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN62W) via an unspecified route of administration in Arm Left on 03Mar2021 13:30 as second dose, single dose for COVID-19 immunization. On 10Feb2021 had first dose in her arm was barely sore. She did not feel sick or anything. About the second night (12Feb2021) after the first dose of the vaccine they were watching TV and she was sitting on the couch and noticed the small of her back was itching. It was just a little bit, and she did not pay attention because now and then she will have a little itch and did not notice it. She is calling back with questions about the same thing. Confirms that there are no new events. Since her first dose of the covid vaccine, on the second day after, that night, before she got in her bath, her back was itching. She did not pay it much attention. After her second dose of the covid vaccine, on the third day, she took her clothes off to take a shower and she had no rash, but she had chill bumps like she was cold. She read all of the information on side effects on the report. She saw where it said she could have chills. She had no problems with the injection or her arm being sore. She had no nausea, or no other symptoms that they talked about. Her skin felt like she had chills bumps from her knees to her shoulders. This has continued since. She does not have a reference number for her first report. She does not know when it went away/ over next day or 2. She told the person when got the shot that she had Lupus and asked if there was any reason, she should not get this. The nurse talked to somebody and came back and said no it would not affect it. It probably has not. She just wonders if there is something in the injection. She feels like that what caused her to itch since she has not changed her medications at all. The only thing which she came off this before she took the injection, was her rheumatologist advised all of her patients to take Vitamin D2 because of Covid. She was on that and was having some problems, the creatinine in her urine had gone up. They took her off it before she had the Covid injection. The patient underwent lab tests and procedures which included blood creatinine increased: increased on, blood calcium: increased. The outcome of the events was unknown. Description of complaint: While reporting an AE for Covid Shot caller mentioned that she has taken Benadryl for itching and it would calm it but she still has itching now. It makes her so sleepy and puts her to sleep. It says Diphenhydramine HCl 25mg. She sees a number where there is a barcode: 30048284, Lot: Not provided, not probed on call. She can't read an expiration date on it. She also has an old bottle. There is a barcode on it too: 312547 17031 4, Lot/Expiry date: Not provided, not probed on call. She also mentioned her doctor sent her some topical cream, but it took 2 tubes of cream to cover the itchy spot. She used some, but it did not help her at all. The topical cream she was given was Triamcinolone Acetonide ointment. It says USP, 0.1 percent. It is 15 grams. NDC: 0168-0006-15. Lots/Expiry: She does not see any other numbers or expiration date. She also mentioned years ago she took the flu vaccine and then a few days later ended up with the flu. She has no NDC, lot, or expiration date for the flu shot she had prior to getting the flu. She also mentioned that She had a cortisone shot in her foot on 12Jan2021. On 08Feb2021 she had another cortisone shot in her foot for continued fasciitis. Cortisone shots: She has no NDC, lot, or expiration date available, they just gave it in the office. No follow-up attempts are needed. No further information is expected.

Feels very sick; She has fever; pain in her kidney and legs; pain in her kidney and legs; This is a spontaneous report from a contactable consumer or other non hcp. An 84-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection) via an unspecified route of administration on an unspecified date (Lot number and expiry date was not reported) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient's concomitant medications were not reported. On an unspecified date, caller withheld, feels very sick after getting the first dose. She wanted to know what to do. She has fever and was experiencing pain in her kidney and legs. She had COVID before but wanted to know if the side effects will go away and how long will it last. Advised to transfer her to PMI but it was closed already. The outcome of all the events was unknown. Information about lot/batch number has been requested.

Death SAH (subarachnoid hemorrhage) Observed seizure-like activity Hypo-osmolality and hyponatremia Acute kidney failure, unspecified Thrombocytopenia, unspecified

Phone visito Visit History for 3/12/2021 Problem List* Health Maintenance* Results/Data* Review Flowsheets* History of Present Illness HPI: 84 yo female pmh: DJD right hip, CAD and chronic anticoagulation was contacted via telephone: states she received her covid 19 vaccine 3 days ago: now having dry (non productive cough)-denied any fever/chills or loss of smell/taste. o Visit History for 3/12/2021 Problem List* Health Maintenance* Results/Data* Review Flowsheets* History of Present Illness HPI: 84 yo female pmh: DJD right hip, CAD and chronic anticoagulation was contacted via telephone: states she received her covid 19 vaccine 3 days ago: now having dry (non productive cough)-denied any fever/chills or loss Issues Addressed/ Plan Diagnosis Plan 1. Viral upper respiratory tract infection (s/p covid 19 vaccine) predniSONE 20 MG Oral tablet albuterol (PROVENTIL HFA) 90 mcg/actuation Inhl inhaler (afebrile) Counseled on supportive measures Has declined covid 19 test Informed: if conditions worsens: present to ED (immediatetly) 3/25 pt's son in the room, updated and answered all questions at this time. 4/2 Pt's husband also inpatient and covid+. Spoke with daughter today and updated r/t quarantine. 2. Nursing Education/Concerns: Care team met with family (husband, son and daughter) on 3/18/21 to discuss care goals/plan of care moving forward. Pt's code status officially updated to DNR only with trial intubation. 3/18/2021 spoke updated pts daughter on phone at 1031. Report given to SNF- they were made aware that she needs the second pfizer vaccine 3. Interdisciplinary involvement Social Work/Case Management: From home with spouse. STR- Referral out. STR reviewing. Will not take patient before her 10 day exposure quarantine is over. 4/9. STR- Bed offer for tomorrow pending insurance auth and negative COVID. sent for auth. Patient aware. Son updated. COVID exposure - exposure to covid positive visitor on 3/26 and 3/29 - discussed with infection control. Will test on 3/31 and if negative will test again on 4/7 (day 9 of quarantine) unless symptoms develop in interm. Acute hypoxic respiratory failure secondary to acute on chronic systolic LV failure requiring prolonged ventilation and SNF placement after discharge. Encephalopathy, dysphagia, anemia, tachy, AKI

7/23/21: came to the ED with generalized weakness and cough with low oxygen levels with hx of COPD. admitted with COVID-19 pneumonia, acute renal failure, hypoxemia Note: patient previously vaccinated with Pfizer COVID-19 vaccine on: 1/26/2021 and 2/23/2021. Lot numbers EL1283 and EL9269 7/27/21: patient still admitted at the time of this report submission.

2/9/2021 Expired at facility. Several weeks prior with several medical and mental health issues as noted prior. 2/4 began with increased lethargy and somnolence. Medications being held per MD. 2/5 CBC WNL, BUN/Cr 38/1.23 GFR 41 2/5 Admitted to Hospice services on 2/5.

hard of hearing; Headache and then I had muscle aches/Achy and headachy; Headache and then I had muscle aches/Achy and headachy; Little bit of discomfort; Kind of stiff; Trouble in seeing; Used to be 5'7" but now I am 5'4"; she noticed bright red bleeding in her urine when she emptied her bladder; I just had a taint little bit till the day when I got it and then the next day I went to the bathroom to empty my bladder again and I had bright red bleeding again with some blood clots in it; Skin dry; slept a lot; she felt tired and so rotten; mild low-grade fever; body aches and pains; This is a spontaneous report from a contactable consumer (patient herself). An 85-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9810) via an unspecified route of administration on 25Feb2021, 11:00 am as a single dose for COVID-19 immunisation. Medical history included hypertension, stroke, heart attack, COVID-19 in Aug2020 (actually had COVID this summer in August, had the mild case), and emergency surgery in Aug2020. Concomitant medications included ajmaline (CARDIA), isosorbide, and levothyroxine sodium (SYNTHROID) taken for cardiac disorder; and losartan. The patient her first dose on 04Feb2021 and experienced headaches, muscle aches and pains, chills, other flu-like symptoms, heart conditions, and sensitivity to eggs. She mentioned that this was normal and nothing unusual. She received her second dose on 25Feb2021 at 11:00 am. She was still kind of stiff but was okay. The next day on 26Feb2021 at 11:00 am, she noticed bright red bleeding in her urine when she emptied her bladder. After a few hours it faded. On the next day on 27Feb2021, she experienced the bright red bleeding in the urine again. The red blood did not hurt and patient was achy and headachy, "you know muscles." So, that kind of happened and it just kind of eased off. She slept a lot because she felt tired and so rotten from Friday, Saturday, Sunday after getting the shot. She also had a mild low-grade fever, headaches, and body aches and pains which she considered normal. Patient was hard of hearing and did not have a bright red bleeding, just had a taint little bit till the day when she got it and then the next day, she went to the bathroom to empty her bladder again and had bright red bleeding again with some blood clots in it. Then she did not really have that much the rest of the day and since then it seems to be clear. She did have a little bit of discomfort and her skin was dry. She have never had that experience before so she was just not sure was that connected with that shot? She wanted to know if there were any other patients that have had that. Patient also stated, "I have a bit trouble in seeing. So, I am going to have my magnifying glass" when asked about the product details. She will be getting her annual check up on 24Mar2021 so she will also check with her doctor. She mentions that she doesn't take that much flu-shots because she is sensitive to eggs. Her urine seems to be clear as of the time of report. She wants to know if the bright red bleeding in the urine has been reported. Patient stated, "I used to be 5'7" but now I am 5'4". I think I am weighing about 158 now. I am sorry like I said because of my hearing and with a language difference a little bit. I was having a trouble hearing you." The patient did not have treatment for the events. Outcome of the events was unknown.

The day after receiving the second dose, pt became so weak that she couldn?t get out of bed. Also complained of chest pain (has CAD with angina).

Bladder infection; Viral infection; This is a spontaneous report from a contactable consumer (patient). This 85-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 20Mar2021 (Batch/Lot Number: ER2613) as a single dose for COVID-19 immunization. Medical history included arthritis and chronic obstructive pulmonary disease (COPD). Concomitant medication included paracetamol (TYLENOL) for arthritis. Patient was alright for a few days after vaccination and then all of a sudden, patient started getting infections on 28Mar2021, 8 days after she had the first vaccine. She got a really bad bladder infection then she went to the doctor and got medication for that. She was with bladder infection then she came down with the viral infection and she was not even been going anywhere because of the virus, she was been staying home, just to the grocery store and clinic to the doctor. Patient got medicines for the bladder infection: antibiotics (sulfamethoxazole) and she was not quite over that and then she got a virus infection. She went back to the clinic but they did not gave her any medication for that. It was just a viral infection, it was not the COVID-19. Outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

S/p pfizer vaccine 4/9/21. S/p fall. She presented last wk to the hospital in cardiogenic shock, anemia, acute RLE DVTs, AKI, and rib fractures. She was found to have a n intramuscular hematoma along her posterior right thigh and with an acute DVT in her leg - see imaging reports below. Her INR was in the 7 range. She was also found to be in cardiogenic shock as mentioned above, requiring pressors. Pressors were eventually weaned off. S/p PRBCs. Imaging studies were obtained. Findings are listed below. Her AKI resolved by day of discharge. Since hospital discharge: The swelling is improving along her right leg. She is not checking her weight on a daily basis. She has access to a scale. She needs a refill on iron and Fosamax. No bleeding. On day of discharge, her hemoglobin was 8.8. Her MCV was elevated at 100. Her platelet count was 132. Her INR was 1.4. Her calcium is mildly low at 8.3. Her coumadin is on hold at this time. 106/56 was her BP today. She's been resting well. She's doing some house chores. She has yet to schedule a follow-up visit with for an INR check and in office checkup apt since hospital discharge. 4/23/21 RLE CT: Postop changes from ACDF for right femoral neck fracture again noted with good alignment. Early healing process of the fracture noted. No acute osseous fracture or hardware fracture. Extensive muscular and subcutaneous edema in right thigh. Two elongated intramuscular hematomas also noted at the medial posterior right thigh as above. 4/23/21 CXR: Patchy bibasilar pleural parenchymal opacities and enlarged cardiac silhouette without interval change. Multiple thoracic compression deformities better characterize on recent CT. Postoperative changes as discussed. Stable hiatal hernia. 4/23/21 RUQ Ultrasound: Mild gallbladder prominence, nonspecific. Findings similar to reference CT. No gallbladder wall thickening. Negative sonographic Murphy sign. Trace ascites. Partially evaluated right pleural effusion. Increased renal echogenicity. Correlate for medical renal disease. -1.1 cm right renal cyst. 4/22/21 PVL Study: Acute non-occlusive deep vein thrombosis in the mid and distal femoral vein within the right lower extremity. Acute non-occlusive deep vein thrombosis in the distal femoral vein within the left lower extremity. 4/21/21 Chest/Abdomen/Pelvis CT: Age-indeterminate T1, T3, T8, and T9 compression deformities. Subacute or chronic right posterior 12th, 11th, and 10th rib fractures. Intramuscular hematoma in the posterior right thigh, partially visualized. Subcutaneous contusion in the right posterior hip region. Small volume of free fluid which appears minimally complex. No convincing solid organ injury, but assessment is limited without administration of intravenous contrast. Mild biliary dilatation of uncertain etiology. Possible 1.8 cm peripherally calcified splenic artery aneurysm. Nonspecific bilateral perinephric stranding. Trace pleural effusions. Moderate sliding-type hiatal hernia. Additional incidentals as above. 4/21/21 C Spine CT: Age-indeterminate T1 compression fracture, new from March 2019. No other acute fracture or subluxation

urinary tract infection; sore arm; limited her ability to do things; angiogram showed mild blockage; progressively been getting weaker/weakness; bones periodically get icy cold; had heavy breathing which was difficult to control even with her focusing on her breathing; This is a spontaneous report from a contactable consumer or other non hcp (patient). An 85-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EN6201; Expiration Date: unknown), dose 2 via an unspecified route of administration, administered in Deltoid Left on 17Feb2021 at 03:00 as dose 2, single for COVID-19 immunisation. Medical history included atrial fibrillation. The patient's concomitant medications were not reported. The patient previously took BNT162B2 for covid-19 immunisation and experienced asthenia on 30Jan2021. Relevant medical history and concurrent conditions included a fib. The patient has allergy to iodine. The patient did not receive prior vaccinations within 4 weeks. The patient did not receive any prior vaccinations within 4 weeks of receiving covid-19 vaccine. The patient has been keeping a daily journal for over 20 years and she noticed a trend of her symptoms after the vaccines. On 29Mar2021, the patient experienced progressively been getting weaker/weakness, a feeling from the top of her head to her knees. In Mar2021, the patient experienced bones periodically get icy cold. On an unknown date, had heavy breathing which was difficult to control even with her focusing on her breathing; on an unspecified date, the patient experienced sore arm, urinary tract infection, limited her ability to do things and on 22Mar2021, the patient experienced angiogram showed mild blockage, so it does not require surgery. The patient knows there have been reports of body aches then you could say sensations numbness, tingling, etcetera. The patient wakes up and is good for about an hour at most and then she gets weakness. The patient went by ambulance to the emergency room on 1Mar2021, due to the weakness and was out on same day. The patient underwent lab test which included, COVID-19 virus test which was negative on 01Mar2021. On 22Mar2021 Angiogram showed mild blockage. On an unknown date, the white blood cell count was normal. Therapeutic measures were taken with a bag of Rocephin. The patient was on a recording monitor and it sends reports to her cardiologist every night and it has not noted an event in over 90 days. The clinical outcome of the events progressively been getting weaker/weakness was not recovered; bones periodically get icy cold, sore arm, angiogram showed mild blockage, had heavy breathing which was difficult to control even with her focusing on her breathing, limited her ability to do things urinary tract infection was unknown. No follow-up attempts needed. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-2021633718 similar report from same reporter

UTI; Rash; This is a spontaneous report from a contactable other hcp. An 85-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, dose 2 via an unspecified route of administration in arm right on 21Apr2021 11:00 (Lot Number: EW0170; Expiration Date: 31Aug2021) as SINGLE DOSE for covid-19 immunisation. Dose 1 via unspecified route of administration in upper right arm on 30Mar2021 11:00 (Lot number ER8737; Expiry date 31Jul2021). Medical history included ongoing arthritis, tibia and leg swollen unknown if ongoing, ongoing atrial fibrillation, spinal deformity, cardiac pacemaker insertion, open heart surgery from 2021 to an unknown date, ongoing pain, bone disorder, muscle disorder, dyspepsia from an unknown date and unknown if ongoing, body height decreased from an unknown date and unknown if ongoing, she has started shrinking but this is clarified as an event to have started prior to vaccine. Concomitant medications included diltiazem (DILTIAZEM) taken for an unspecified indication from Nov2020 and ongoing; furosemide (FUROSEMIDE) taken for an unspecified indication from 2020, tramadol (TRAMADOL) taken for pain from an unspecified date in Jan2021 and ongoing; simvastatin (SIMVASTATIN) taken for cardiac disorder from an unspecified start date and ongoing; losartan (LOSARTAN) taken for an unspecified indication from an unspecified start date and ongoing; potassium chloride (POTASSIUM CHLORIDE) taken for an unspecified indication from an unspecified start date and ongoing; magnesium (MAGNESIUM) taken for bone disorder, muscle disorder from an unspecified start date and ongoing; zolpidem (ZOLPIDEM) taken for sleep disorder from an unspecified start date and ongoing; gabapentin (GABAPENTIN) taken for pain from an unspecified start date and ongoing; Bifidobacterium lactis (PROBIOTIC [BIFIDOBACTERIUM LACTIS]) taken for dyspepsia from an unspecified start date and ongoing; ciprofloxacin (CIPROFLOXACIN) taken for urinary tract infection from May2021 and ongoing. After the second vaccine, on 21Apr2021, she started to break out all down her legs and arms. The event began on 28Apr2021, she elaborated that the rash they come to a head, crust over and then that comes off and sometimes there is a little blood, but they don't hurt. The patient does not see more of them and her daughter looked and did not see more. When asked the height, the patient states she was 5.7 that she has started shrinking but this is clarified as an event to have started prior to vaccine. Patient also experienced UTI (urinary tract infection) on an unspecified date in May2021. The patient elaborated that the spots are the only thing different. Her rash was scattered from her hands to her shoulders on both arms, also on her forehead, left face, near her left eye, and going into her inguinal area and on the insides of her legs and going down to the bottom too. Patient remarked she picks at them, which she knows was not good. This has been the same since the first week it started. Therapeutic measures were taken as a result of UTI on Zolpidem 12.5 mg ER, tablet once at bedtime. The patient has not been able to refill the medication because it was a controlled substance and was only able to get a 30-day supply. The caller does not have access to NDC, lot or expiration. The patient takes Gabapentin 300 mg once a day, 100 mg three times a day, tablet, NDC, lot, number unknown. Outcome of the events was not recovered. Follow-up (28Jun2021): Follow-up attempts completed. No further information expected.

Patient with 3-7 days of weakness. Hospitalized 2/16-2/20 for fever weakness and SOB. Diagnosed with COVID-19 and UTI. Did require O2 per NC briefly. Was treated with IV/PO dexamethasone and IV/PO Cipro Discharged to home

delirious: incapable of sleeping, insomnia and inability to be awake and aware; high, over the top blood pressure; Sweating; on and off chills; she gets warm and cold, hot and cold; concerned about one kidney/ was dehydrated; affecting her kidney; incapable of sleeping, insomnia; she was weak; feeling like she would slip onto the floor; she is still not clear headed; she is woozy, like foggy; she is still not clear headed, she is woozy, like foggy; arm is still sore from second vaccine; This is a spontaneous report from a contactable consumer (patient). An 86-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number EL9262 expiry date 21May2021), via an unspecified route of administration on 12Feb2021 (at the age of 86 years old) at single dose in right arm for COVID-19 immunisation. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number EL8982) on 22Jan2021 at single dose in upper right arm and on 22Jan2021 experienced severe headache and arm hurting. Relevant medical history includes ongoing compromised immune system diagnosed many years ago, and ongoing one kidney functioning. The patient received no concomitant medications. On 13Feb2021 the patient experienced high, over the top blood pressure, delirious incapable of sleeping, insomnia and inability to be awake and aware which both required hospitalization from 13Feb2021 to 14Feb2021. It was also reported they were concerned about one kidney/ was dehydrated in 13Feb2021. On 13Feb2021 unspecified blood labs showed kidney was extremely dehydrated and Chest X-ray was good. Clinical course was reported as follows: she was just released from hospital yesterday, she took the second Pfizer COVID shot, on 12Feb2021, and became so very very ill, she expected some side effects, the first shot wasn't bad, the first all she had was a severe headache and arm hurting, but that was 3 weeks ago, and the second one she can't say how horrible it was: she had to get the paramedics there, she was very very ill. It was the worst night she has had, and she is 86 years old, and has had a multitude of serious issues but that shot was the worst. It was a combination of high blood pressure, over the top, and insomnia like she couldn't budge and open her eyes, she couldn't see anything but squares, it was like a horrible, if there is such a thing as a trip, a horrible trip, something she can't imagine wishing on anyone. The county administered it, she has several doctor, she initially provides her primary care doctor, for consent to contact, but says her nephrologist would be better, as she hasn't seen her primary care doctor in some time. Her primary care doctor doesn't know she had this, another doctor gave her permission, her nephrologist. States they were more concerned in the hospital about her kidney, she has one kidney functioning and, on mistake of the hospital, they didn't connect her to hydration, the night nurse didn't, and she was dehydrated and it was affecting her kidney. Her husband tried to call Saturday, when she had this reaction at like 06:30/07:00, but there was a huge long wait, he was calling to see about side effects, but they were beyond waiting, had to get the paramedics, her blood pressure was 178/113 and heart rate was 103. First shot was 3 weeks back. It looks like she had it on 22Jan2021, the headache and arm hurting started towards the evening, the shot was taken earlier in the day, and they started in the evening, her headache was quite severe, but with Tylenol it went away, the arm is still sore from the second vaccine, but is slightly better. Clarifies she was hospitalized for the blood pressure and delirium, like, it is best explained, like delirious: incapable of sleeping, insomnia and inability to be awake and aware, all she could see was, like if she talked about people who did LSD and trips, it was a bad trip, it was squares, she wanted to open her eyes, but could only see squares. She fell asleep Friday night about 11PM, and felt this at 04:00, and she pulled off her sleep apnea mask, she had to run to the restroom, she was weak, feeling like she would slip onto the floor, and had to get right in bed, and the insomnia continued until about 7AM, that was when she started to be able to focus on like words, she was able to say words in her mind, it was like a bad nightmare. She was admitted to the hospital, she was in the emergency room (ER), the paramedics took her there Saturday, about 07:30, took her to the hospital after immediate heart checking, an intravenous (IV) of some kind, and brought her to the hospital and she was in X-rays and what not, they did procedures in the ER, and they suggested her to be observed overnight, they watched her and things started to become more normal, but she is still not clear headed, she is woozy, like foggy. High, over the top blood pressure outcome: It has been back to a good blood pressure. Insomnia is ok- she slept ok last night. What is left: the night she woke up, so early Sunday morning, in the hospital, she was profusely sweating like someone came to her room and showered her bed with water, her sheets and blankets were soaked and this morning she woke, she got up, was still very woozy, and asked her husband to help get her out of bed, and she changed her nightgown and after an hour she got in the shower, as she was sweating again, not sweating, but occasionally on and off chills, she is taking off her nightshirt and putting on a bed jacket, she gets warm and cold, hot and cold. She had blood labs a chest X-ray, heart monitor the whole time until she was discharged, and everything was good except the kidney was extremely dehydrated. This was all on Saturday as well. On her first visit to get the vaccine, at that time, the facility was a big mall, and they handed her what to look for after the injection, and she didn't notice until this morning, it says if you have an immune system that is compromised, it could affect it, and she has immune system that is compromised diagnosed many years ago. Over the top blood pressure and insomnia had resolved, arm sore was resolving, dehydrated and affecting kidney had not resolved, final outcome of the remaining events was unknown.

This 86 year old female received the Covid shot on 2/07/21 and went to the ED on 2/12/21 and was admitted on 2/13/21 with a cerebrovascualar accident, weakness, encephalopathy and UTI and went to the ED a 2nd time on 2/24/21 and admitted on 2/26/21 with and went to the ED again on 3/22/21 with altered mental status and died in 4/2021. 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.

Presented to emergency department on 5/15/21 with weakness, lethargy, and increased confusion with onset approximately 4 to 5 days ago. She had a positive COVID exposure prior to presentation. Patient was admitted for further management of COVID-19 infection and acute kidney injury. Patient is admitted at time of writing.

The day after the first shot, my mother had bad knee pain in her left knee. It went on for days/week. After the second dose, days out she started feel very tired and bad pain in her feet that went to her hands and she couldn't get out of bed or urinate properly. Her facility doctor gave her Gabepentin for the pain but it did not help. She declined over a week or so and then She was admitted into the hospital for dehydration (March 19, 2021). The put a catheter in her to get urine out and bring her kidney function back to her normal (she does have kidney disease). Gave her more Gabepentin (which does not help pain in feet an hands) and released her to rehab. and she is now on oxygen. Rehab was bad so I got her out and released to her facility so she could receive rehab there. She declined again with the same reaction: extreme fatigue, can't walk and now urinates and defecates in an adult diaper and now breathing is very labored. She was admitted to the hospital and they can't find out why she is in this way. They did blood work, tests, scan and X-rays without any answers. They switched up meds on her and then released her to rehab since she hasn't walked in weeks/month at this point. She is regaining strength but now on oxygen even when sitting. She is 86 and walked with a walker all around her facility and when going to doctor appointments. Now she is in a wheelchair for doctor appointments since she has no strength and needs oxygen to walk. Her facility saw her decline after the second shot and my mom is very vocal and each day told them how she felt awful and it is because of the shot. She still has neuropathy in her feet and hands but it is not as painful as it originally was and it peaked and now just painful about a 5-6 on a scale of 0-10.

very fatigued; pain in her feet moved up to her hands; she couldn't walk; she was bedridden; could not urinate properly, she couldn't void all the way; Incontinent; breathing was labored; she had no strength at all; This is a spontaneous report from a contactable consumer (patient's daughter). An 86-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 86 years old on 17Feb2021 (Lot number EL3302) received in her arm at single dose for COVID-19 immunization. Ongoing medical history included Low functioning kidney for probably 15 years, Platelete condition for probably 20 years, COPD since she was in her 40's, Asthma for over 40 years, Chronic heart failure for 10 or more years, high blood pressure, acid reflux, allergies, retains water, neuropathy in hands and feet, mucous in the lungs, thyroid condition, hypo for more than 20 years, bad lower back and bad left shoulder, nerves, anxiety, to sleep, to calm her nerves, walked with a walker. Concomitant medications included amlodipine ongoing for high blood pressure; ascorbic acid (VITAMIN C) ongoing; acetylsalicylic acid (ASPIRIN) ongoing for heart condition; atorvastatin ongoing; fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) ongoing for asthma, COPD; buspirone ongoing; carvedilol ongoing; clotrimazole; famotidine ongoing for acid reflux; ferrous sulfate from an unspecified date to Apr2021 as Iron supplement; fluticasone propionate ongoing for allergies and asthma; fluticasone, salmeterol ongoing; folic acid ongoing; furosemide ongoing for retains water; gabapentin from Feb2021 and ongoing for neuropathy in hands and feet; guaifenesin ongoing for mucous in the lungs; hydroxyurea ongoing for her bone marrow made too many platelets; levothyroxine sodium ongoing for thyroid condition, hypo; lidocaine hydrochloride (LIDOCAINE) for bad lower back and bad left shoulder; magnesium oxide (MAG-OX) ongoing; montelukast for allergy and asthma; sertraline hydrochloride (ZOLOFT) ongoing; sitagliptin ongoing; temazepam for nerves and anxiety; linagliptin (TRADJENTA) ongoing; trazodone ongoing to sleep, to calm her nerves; valsartan for high blood pressure; vitamin D. Historical Vaccine included first dose of BNT162B2 (Lot number EK4176) on 27Jan2021 received in one of her arms for COVID-19 immunization and experienced severe pain in her left knee. The patient received the second vaccine on 17Feb2021. A week out or so she started having pain in her feet and she was very fatigued 19Mar2021; both still ongoing, both on a week. The patient had had 2 stints at the hospital, and 2 rehabs. Both of these have very slightly improved. The patient went to the hospital due to the pain in her feet that moved up to her hands, she was very fatigued, and she couldn't walk; she was bedridden on 19Mar2021. Weeks after the shot it continued day after day after day up until 19Mar2021 where she was admitted to the hospital. The patient just had her last stint in rehab this past 2 weeks and could get up with physical therapy. Hospitalization was from 19Mar2021 to 27Mar2021. The patient could not urinate properly, she couldn't void all the way and that this occurred some time between after the second vaccine up until 19Mar2021. Those few weeks things progressed. Now she was incontinent and had to wear diapers. She urinates in diapers and defecates in diapers. The incontinence started sometime during 19Mar2021 to 27Mar2021 and it is ongoing, persisting. In the hospital they could not find anything seriously wrong with her. The patient had total fatigue and the caller begged them to give her mother a (vitamin) B12 shot. They gave it to her but there was no improvement with patient's energy. They put a catheter in her to get her kidney function back to her normal level. It was because she was not urinating properly. They ran a bunch of tests and there was not anything wrong with her. They did cardiac tests, lung tests, and XRays. The patient's breathing was labored. Started sometime after the second shot leading up to the hospital and that the patient had to be on oxygen. She said she was still on oxygen and that the labored breathing was ongoing, persisting. Reporter said all of these above listed were from 25Apr2021 to 03May2021. They did more tests but there were no answers and patient was at this point bedridden all this time; she had no strength at all, all the same symptoms were ongoing, there were no diagnoses, they were switching her meds around. The patient was on oxygen 24/7, all day when she was walking, sitting in a room in her wheelchair. The caller said she was hoping patient could get up and walk around but she was still weak. She said with time she hoped she got better on feet, got back to her normal. The outcome of the events were not resolved. Information on the lot/batch number has been requested.

patient is very confused; arm hurting; body pain; fatigue; uncomfortable feeling; fell; sick; fell asleep; unconscious; vomited all over herself; urinary tract infection; 'weakened state'; muscle aches; This is a spontaneous report from a contactable other hcp. A 86-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 15Jun2021 (at the age of 86-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included covid-19 from Jan2021 to Feb2021, callers mother had covid back in Feb2021. The patient's concomitant medications were not reported. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 16Jun2021 11:00 wednesday, the patient was found unconscious in the living room floor by a neighbor, had vomited all over herself, her arm hurting, muscle aches, body pain, very weak, was diagnosed with a UTI and patient was confused on an unspecified date. She has since been discharged home, is in a weakened state and was advised not to get the 2nd shot. Caller concerned that 2 individuals came over to her mothers house to administer the vaccine. Patient was advised no to receive the second dose Pfizer Covid 19 Vaccine by the doctor. Yesterday (16Jun2021), the caller's mother ended up in the emergency room with an adverse reaction: clarified her mother was discharged from the emergency room. The patient arm was still hurting. When asked if the arm hurting is improved, worsened or persisting, the caller replies it is probably about the same. Stated she was informed on Tuesday evening 15Jun2021 that an individual came to her mother's home and administered the first dose Pfizer Covid 19 Vaccine to the patient. The caller said she spoke to her mother at 11:00 on Wednesday 16Jun2021, had an uncomfortable feeling that someone came to her mother's home and administered her mother the first dose Pfizer Covid 19 Vaccine. At this time on 11:00 on Wednesday, 16Jun2021 was when the caller mother told the caller about her symptoms. The caller clarified the mother's symptoms all began less than 24 hours after the mother received the first dose Pfizer Covid 19 Vaccine. Patient has fatigue, body pain is persisting and being very weak is persisting. The caller has reached out to the doctor and had tried to get home healthcare in to help her mother get her strength back up. The caller said when her mother had come to with the neighbor, her mother said she was in the kitchen and fell and crawled into the living room and that was when the patient got sick all over herself. The caller mother just fell asleep and the caller believed her mother was unconscious at that point. Time the Vaccination was given in mid-afternoon. Patient was on the fence about receiving the Pfizer Covid Vaccine. Patient antibodies were probably just as good as the Pfizer Covid 19 Vaccine. Due to the patients age, she was capable of handling any possible side effects from the Pfizer Covid 19 Vaccine. The patient went ahead and set up to receive the Pfizer Covid Vaccine.The patient underwent lab tests and procedures which included blood test: normal, chest x-ray: normal on 16Jun2021. Events resulted in emergency room visit. The seriousness of unconscious was medically significant. The outcome of all events were unknown. Information on Lot/Batch number has been requested.

1 fall after first dose on 1/8/2021 at 1930; no injuries; 4 falls after second dose on 1/14/21 at 1545, 1/15/21 at 1700, 1/21/21/at 1220 and 1/21/21 at 1330 all falls with no injuries. Started Ceftriaxone 1 GM IM daily for 5 dyas on 1/21/21 for UTI: E. Coli

UTI; This is a spontaneous report from a contactable consumer (patient). A 87-year-old female patient received the first dose of bnt162b2 (Lot number: EL3249), via an unspecified route of administration in left arm on 21Jan2021 09:00 at single dose for covid-19 immunization. Medical history included hypertension (HTN), atrial fibrillation, Allergies to Sulfa. Concomitant medication included diltiazem, apixaban (ELIQUIS), metoprolol, budesonide, formoterol fumarate (SYMBICORT). The patient experienced urinary tract infection (UTI) on 24Jan2021 14:00. The patient received the Antibiotics as treatment. The event resulted in Doctor or other healthcare professional office/clinic visit. The patient was no pregnant. The outcome of event was recovered on Jan 2021.

She developed chills, headaches and weakness starting the day after vaccination 1/14. Profound weakness. She was unable to get out of bed. She developed hypoxia 86 to 90%. She was sent to the emergency room, she was noted to have a urinary tract infection.

After only a couple days post-vaccine, patient was unable to sit up, walk or feed herself. Taken to ER via EMS on 2/7/21. Nothing remarkable discovered. Slight dehydration, scant UTI bacteria. She is now in the Hospice contracted bed at the hospital returning to hospice care at home with 24/7 aides to feed and car for her.

Three days after second COVID-19 vaccine, patient became lethargic. Due to advance directive that instructed that no life saving interventions to take place, patient continued to decline and expired on 29 January 2021.

Pt received initial dose on 1/5/21, diagnosed with COVID-19 on 1/8/21, treated with monoclonal antibodies on 1/13/21. Pt experienced CHF exacerbation, anasarca, and renal failure during acute illness. Pt also treated for pneumonia during this time. Pt was considered terminal status on 1/25/21. She received second COVID-19 vaccine on 2/15/21. Pt then experienced increased difficulty eating and taking medications this same day, in addition to hallucinations she was experiencing. Patient subsequently died on 2/16/21.

She developed mild swelling of her lips just after midnight on 3/3/21, which she discovered after waking up to use the restroom. She then went back to sleep. She awoke the next morning (3/3/21) to find her lips, tongue, and back of her throat were swollen so much that she couldn't talk. She came to the ED where she received 125mg Solu-Medrol , Pepcid 20mg, and Benadryl 25mg. The swelling initially improved then worsened again and she was admitted to the hospital for overnight observation. Swelling improved and she was discharged on 3/4/21.

a few hours Pt states after getting shot had very bad diarrhea dehydration & colon infection & UTI went to ER on 2/21/21-

Pfizer-BioNTech COVID-19 Vaccine EUA: two days after vaccination patient reports in clinic visit pain on right side of hand and leg, diarrhea, chills, difficulty urinating, and fever one day after vaccination. By the time of clinic visit symptoms resolved except for diarrhea. No rash or respiratory symptoms reported. Patient able to manage symptoms at home.

A-fib; AKI (acute kidney injury); AMS (altered mental status); Dehydration; Hyperkalemia; Urinary tract infection without hematuria, site unspecified

Patient received the injection on May 2nd. Following the injection, we noticed an increased weakness and general achiness. On the 8th she was so weak that we purchased a gait belt to assist her. We were not super concerned as we were expecting the second shot to cause body aches or flu like symptoms based on what we had heard from others who had received both vaccine shots. She continued to be unsteady and we found that she has a mild UTI which we had begun treating with prescribed antibiotics. Late afternoon on the 11th, mother suffered a major stroke. we did not take her to the hospital because we had already been told that they would not be able to do anything at her age should she suffer a stroke. On the 12th I called the doctors office and asked for them to send Hospice to the house as we could tell that she was dying. Mother died on the 13th. Just a week prior to her death I had spoken with Dr. and we had discussed how that she was declining in health but that she was not even close to needing Hospice, yet she is dead a week later. Less than 2 weeks after getting her second Covid Shot.

After 1st dose of Pfizer: Nausea, and trouble breathing (Oxygen went up and down from 90 to 95) - Took to Dr and advise to watch oxygen levels After 2nd dose of Pfizer: Nausea, Dry heaves, Stomach Pain, Head Aches, Back Pain, Loosing Control of Bladder (Kidney Failure), Trouble Breathing (Oxygen went under 90) - Took to her Dr and she said to take her to the Emergency Room due to her Oxygen going below 90. I took her to Hospital.

ED to Hosp-Admission Discharged 5/19/2021 - 5/24/2021 (5 days) Last attending ? Treatment team Acute respiratory failure with hypoxia DETAILS OF HOSPITAL STAY Presenting Problem/History of Present Illness/Reason for Admission From admission " Patient is a 88 y.o. female who presents to the hospital today withincreasing weakness, falls over the last few days. She has not been eating or drinking well. It appears she recently started a sulfonylurea. EMS arrived blood sugar 58 and upon arrival to the ER blood sugar was 35 and she was lethargic. Given orange juice and a dextrose bolus with improvement of her blood sugar. Room air sat was 88% on room air however she only feels short of breath but she did not wear oxygen at home. Family member has Covid but she does not endorse any contact with them. In ED she was found to be positive for COVID19, with AKI and SIRS and internal medicine was asked to admit the patient." Hospital Course Patient mandatory medical surgical floor. She was found to have acute hypoxic respiratory failure due to COVID-19 pneumonia. She was found to be 88% on room air and was requiring 3 L of nasal cannula oxygen fourth her first 3 days of admission. She received treatment for her viral infection with IV remdesivir as well as IV dexamethasone to complete 5 days. She also was treated with azithromycin and ceftriaxone. However this was later stopped as her procalcitonin level was not negative. Because her urine showed pyuria she was continued on IV ceftriaxone. However her culture only grew 30,000 colonies of E. coli in 50,000 colonies of Streptococcus and get gnosis. She was fully treated for a UTI. She was successfully weaned off of oxygen onto room air on May 23 and remained stable overnight into the day of discharge. She was seen by physical therapy due to her history of ambulatory dysfunction and rehab was recommended for her. However the patient refused she felt that she had enough family support and assistance at home to return home. Home services were also recommended including home physical therapy which the patient also declined. She will need to follow-up with her family doctor in the next 7 days. A referral for pulmonology was also made on the day of discharge for 1-2 days.

5/5/21 Admission to Med Surg: The patient is a 88 y.o. female with a past medical history notable for CHF, diabetes, CAD, hypertension, hyperlipidemia. The patient presents for evaluation of worsening issues with swelling and shortness of breath. Patient was found to be 3-5 lb from baseline weight. Patient shows significant lower extremity edema in addition worsening rales bilaterally. Patient is on the fevers or chills. Patient struggle with fluid balance due to dietary need to restrictions in addition to patient's diabetic diet. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed. Patient's who was agreeable to in-patient diuresis 5/19/21 ER: 88 y.o. female who presents with chest pain. Patient reports that approximately an hour and half ago while at assisted living facility she began having chest pain. Patient describes her chest pain as located across the central part of her chest. She describes it as a pressure. She currently gives it an 8/10. Patient denies any radiation of the pain. Patient does report associated shortness of breath, lightheadedness, dizziness, but denies nausea, vomiting, or diaphoresis. Patient also reports feeling her heart racing in her chest. Patient denies prior history of atrial fibrillation. Bedside monitor shows AFib with RVR. Patient also reports recurrent swelling of the bilateral lower extremities dx: NSTEMI Transferred to a different hospital

urinary tract infection; Thigh pain; hip pain; vomiting; shaky; weakness; Legs collapsed on her; Leg pain; fatigue; Severe headache; This is a spontaneous report from a contactable consumer. A 87-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration, administered in left arm on 05Feb2021 10:00 as a single dose for COVID-19 immunization and received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration, administered in left arm on 15Jan2021 16:00 as a single dose for COVID-19 immunization. Medical history included allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity, Allergies to medications that contain dynacin; Allergic to Gabapentin; and has allergies to all antibiotics that end with 'cycline'. Pertinent Details Include surgical procedures and dates: She was given doxycycline which made her pass out and lose complete control of muscles and everything and put her in the hospital for 3 days. The pharmacy gave her about 5 other medications that end with 'cycline' and she was highly allergic to all of that so when she goes to the doctor she cannot take anything that has that in it. There were no concomitant medications. About a week after her second dose, she started having severe headache, pain in her legs, weakness, and fatigue. At one point, she collapsed because of weakness in her legs. Caller said they have gone to their HCP 6 times: 3 times with their urgent care doctor, 2 times with doctor, and 1 time in the emergency room. She wanted to know what to do with the adverse events. On 04Feb2021 she was diagnosed with a urinary tract infection (UTI) and started on Cephalexin 7 day therapy as antibiotic and Phenazopyridine for pain with the UTI. On 14Feb2021 she saw her primary care doctor for severe headache. She was sent to the emergency room for the severe headache where she had a CAT scan in case she was having a brain bleed or stroke, but everything checked out just fine, they thought they were safe. On 16Feb2021 she was seen and had urine testing that showed the UTI she had had not cleared up, it had worsened. She was prescribed Ciprofloxacin 10 day antibiotic therapy for the UTI but only took Ciprofloxacin for 8.5 days because of all the side effects she was experiencing. On 22Feb2021 she saw her primary care physician for leg pain, weakness, fatigue and the same severe headache that she was seen for on 14Feb2021. On 22Feb2021 she was prescribed Cyclobenzaprine as a muscle relaxer and Tramadol as pain medication. Before she took any of the Cyclobenzaprine or Tramadol on the night of 22Feb2021 her legs collapsed on her. On 24Feb2021 they called the doctor and told them that she had collapsed again and he said to stop the Cyclobenzaprine and changed Tramadol dose to half strength. She started being shaky. On 26Feb2021 they called the doctor back because she had the same symptoms with the addition of vomiting. They said to stop the Tramadol and start taking Tylenol. On 27Feb2021 they went back to the urgent care for the same symptoms as well as leg pain, thigh pain, hip pain, being real shaky and real weak. Each time they were seen by the doctor or at urgent care they drew blood and said everything was ok. On 02Mar2021 they started thinking maybe it's the Pfizer COVID-19 Vaccine. She called to ask if these events are side effects of the Pfizer COVID-19 Vaccine. Her bloodwork was fine, her urine tests since after 16Feb2021 are fine, the CAT scan showed her head is fine; but she still has severe weakness; she was walking with a cane now and before she was very active. The patient was treated with cyclobenzaprine: 5mg strength. Lot/NDC/Expiry: Unknown, product dispensed in pharmacy vial. Pharmacy label use by date is 22Feb2022; Tramadol: 50mg strength. Lot/NDC/Expiry: Unknown, product dispensed in pharmacy vial. Pharmacy label use by date is 22Feb2022. There are only 2 tablets missing from the bottle so caller believes patient took 1 whole tablet once, and then 1/2 tablet 2 different times and started vomiting so Tramadol was stopped; Tylenol 8 Hour Arthritis: 650mg strength. Lot: SBA002, Expiry: Dec2022; UPC: Unknown, there is no UPC or barcode on the bottle she has with her, but there is a little kind of icon with a stamp with some numbers above it; Phenazopyridine: 100mg strength tablets, Ciprofloxacin: 500mg strength, Cephalexin: 500mg strength. Outcome of the events was unknown. Medications that contain dynacin: Lots/NDCs/Expiries: Unknown, they do not have products, this occurred in before patient moved about 1 year ago. Gabapentin: Lot/NDC/Expiry: Unknown, they do not have the product, this occurred before patient moved about 1 year ago. Doxycycline: Lot/NDC/Expiry: Unknown, they do not have the product, this occurred before patient moved about 1 year ago. Antibiotics that end with 'cycline': Lots/NDCs/Expiries: Unknown, they do not have products, this occurred before patient moved to about 1 year ago. Reported patient was diagnosed with a urinary tract infection (UTI) and started on Cephalexin 7 day therapy as antibiotic and Phenazopyridine for pain with the UTI. On 16Feb2021 she was seen and had urine testing that showed the UTI she had had not cleared up, it had worsened. She was prescribed Ciprofloxacin 10 day antibiotic therapy for the UTI but only took Ciprofloxacin for 8.5 days because of all the side effects she was experiencing. Urine tests since after 16Feb2021 are fine. Phenazopyridine: 100mg strength tablets. Lot/Expiry: Unknown, caller does not have the bottle but has the receipt with an NDC# Ciprofloxacin: 500mg strength. Lot/Expiry: Unknown, caller does not have the bottle but has the receipt with an NDC: #.Cephalexin: 500mg strength. Lot/Expiry: Unknown, caller does not have the bottle but has the receipt with an NDC: #. No follow-up attempts are possible. No further information is expected.

On Tuesday, March 9th, a friend of mine went to my mother's home to take her to a scheduled dentist appointment. Upon arrival, she observed that my mother was disoriented and her vision was impaired. Specifically, her right pupil was completely off to the right side, her eye was irritated and slightly swollen. Per recommendation from the primary care office, my mother was taken to the emergency room. She remained hospitalized for two weeks during which time, several labs and x-rays were performed; several ideas surfaced regarding root cause including Miller Fisher Syndrome, mini-stroke, etc. but no final diagnosis was identified.

1/27/2021 developed increased fatigue, required increased assistance with ADLs. Continued with functional decline and overall decline in mentation. Has impacted functional level (requiring increased assistance with feeding, bathing, dressing, toileting) and speech/swallow ability. Decreased ability to respond/converse with staff

Very loose bowels, causing incontinence twice, intermittently from Feb. 8 through today (13th). Also, since Feb. 10, a mild sore throat, hurting only when I swallow. Both of these symptoms are unusual for me. Generally, I feel normal, able to eat, sleep, take walks, etc.

1/29 /21 Increased fatigued, congestion, BP elevated Stat CBC/BMP/CXR. CXR. CXR-CHF with superimposed bilateral infiltrates and bilateral pleural effusions. N.O. Rocephin 1gm IM QD x 7 days. CBC am. Consult with cardiology. 2nd covid vaccine not given. 2/2-2/5 Sent to ER for ongoing significantly elevated BP's. Remains on Rocephin. Hospitalized 3 days for Acute on Chronic Diastolic and Systolic Heart Failure-Diuresed with IV Lasix, Multiple changes in medications by cardiology for poorly controlled HTN. Head CT negative, Covid negative. 2/5 Readmission from Facility-Followed closely by cardiology. Losartan was increased, Hydralazine was increased, Norvasc was increased. Continue Atenolol. Monitoring daily weights and vital signs. Resident with increased lethargy and then behaviors at times, and refusing meds. Oral intake poor. Continued on Coumadin for A-Fib with monitoring of INR. Palliative consult ordered. Continued to be followed by Mental Health and APRN in addition to PCP. 2/6 CBC/BMP/CXR-BUN/Creatinine elevated 44/2.2 and upon readmission to facility. MD changed from Lasix to Demadex. CXR-Continued PNA. Started on Rocephin 1gm IM x 7 days. 2/8 MD visit. Palliative consult ordered 2/11 Critical labs with elevated BUN/Creatine and Na level. MD ofered hospitalization to ADPOA who declined and wanted to pursue Hospice instead. Resident was seen by APRN from Home Health and Hospice Services who discussed plan of care with ADPOA requested comfort care and no further hospitalizations. 2/12 Resident admitted to Hospice Services. Compassionate visit with ADPOA 2/14 resident with further decline, periods of apnea evident, comfort maintained. 2/18 Passed at facility with Hospice services in place and compassionate visits with ADPOA

hospitalized for acute pancreatitis; acute renal failure; fatigue; very poor appetite; abdominal pain; started having confusion; This is a spontaneous report from a contactable physician. A 88-years-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6207), second dose via an unspecified route of administration on 24Mar2021,single dose for covid-19 immunisation. Medical history included chronic kidney disease from an unknown date and unknown if ongoing , atrial fibrillation from an unknown date and unknown if ongoing , pulmonary hypertension, allergies to medications, food, or other products: clindamycin, levofloxacin, sulfa drugs, penicillin from an unknown date and unknown if ongoing. Patient started having fatigue immediately after 2nd dose vaccination. 3 days later (27Mar2021), patient had very poor appetite, abdominal pain and started having confusion. 6 days later (30Mar2021), patient was hospitalized for acute pancreatitis and acute renal failure. Events resulted in going to the emergency room/department or urgent care. Treatment received for the adverse event was IV rehydration, levophed, vasopressin, dobutamine, cefepime and flagyl. The outcome of the events was unknown. No COVID prior vaccination. Patient had COVID test post vaccination (nasal swab) on 31Mar2021 with result of negative. No follow-up attempts are possible.; Sender's Comments: By close temporal relationship, the company cannot completely exclude a contributory role of BNT162b2 in the development of the reported diagnosis of acute pancreatitis and acute renal failure. Medical history including chronic kidney disease in the setting of elderly age, cannot be also excluded as confounding factors. The impacts of this report on the benefit/risk profile of the Pfizer product 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.

ED to Hosp-Admission Discharged 3/28/2021 - 3/30/2021 (2 days) Last attending ? Treatment team Weakness Principal problem Discharge Summary DO (Physician) ? ? Internal Medicine Discharge Summary Hospitalist Medicine Date: 3/30/2021 Admission Date: 3/28/2021 Length of Stay: 2 Days Discharge Date: 3/30/2021 Admission Diagnosis Hospital Problems POA * (Principal) Weakness Yes Hypothyroidism Yes Pure hypercholesterolemia Yes Benign essential hypertension Yes Atrial fibrillation Yes Acute cystitis without hematuria Yes Generalized weakness Yes COVID-19 virus infection Yes Chronic respiratory failure with hypoxia Yes Home Under Care of a company unnamed CODE STATUS: Full Code Active Issues Requiring Follow-up Finish course of antibiotics. Participating remote monitoring. Test Results Pending at Discharge Pending Labs Order Current Status Blood culture Preliminary result Blood culture Preliminary result Hospital Course HPI: Patient is a 89 y.o. female with PMH listed who presents from home with her daughter complaining of about a week of increased weakness/fatigue and cough. The fatigue is their primary concern, as this is so profound she will fall asleep on the toilet or even in the middle of getting dressed. Appetite is decreased, but she denies N/V/D. She feels "chilled", but no known fevers, no rigors/sweats. Cough is occasionally productive of sputum, mostly clear but sometimes with small "chunks"; no hemoptysis. No LE edema. No HA or changes in taste/smell. No known sick contacts, but patient has exposure to multiple daughters who help care for her, and she has been attending church recently. Urine is dark/strong, but she denies dysuria. Pt has received both doses of COVID-19 vaccine, second dose on 3/17/21. Hospital Course: Patient was admitted to medical floor for COVID-19 infection and urinary tract infection. Patient had a very mild course of illness. Decadron was started but patient did not require any remdesivir. Patient has remained at her seen home oxygen requirement. Patient was seen by PT and OT services for generalized weakness. Blood cultures have been negative. Patient is medically stable for discharge home today. She will need another 2 days of antibiotics treatment for urinary tract infection. Since her respiratory status has been very stable, we have chosen to discontinue the use of Decadron upon discharge to avoid any changes in mental status induced by steroids in an elderly patient. Home health services and remote monitoring kit have been ordered at the time of discharge. I have called patient's daughter to provide update that patient is coming home today and answered her questions

poor oral intake and fatigue, found to have acute kidney injury, hematuria and proteinuria. Renal function progressively worsening. kidney biopsy performed on 3/30/21 showed granulomatous ANCA glomerulonephritis+ anti-GBM nephritis

Patient got her vaccine then the next day developed weakness and knee pain. Later the daughter admitted that she had had increased weaknesss and confusion for a few weeks. She was seen in her PCP's office and diagnosed with a UTI and gout. The x-ray of her knee later showed a fracture of her proximal tibia. A few days later she was brought to the emergency department with a wide complex tachycardia and acute coronary syndrome. She had an 11 day stay complicated with congestive heart failure, hypoxia, aspiration pneumonia and metabolic encpehalopathy. Her daughter thinks that this was brought on by the vaccine, and asked us to fill out a vaers.

I63.9 - Cryptogenic stroke (CMS/HCC) I63.9 - Cerebrovascular accident (CVA), unspecified mechanism (CMS/HCC) N17.9 - Acute kidney failure, unspecified

Systemic: Body Aches Generalized-Medium, Systemic: Confusion-Medium, Systemic: Diarrhea-Medium, Systemic: Fever-Medium, Systemic: SLURRED SPEECH, INABILITY TO HOLD SELF UP IN CHAIR, INCONTINENCE-Medium, Additional Details: RN ADVISED PT HAD FEVER OF 101, DIARRHEA, WHOLE-BODY MUSCLE SORENESS, STROKE LIKE SYMPTOMS INCLUDING SLURRED SPEECH, INABILITY TO HOLD SELF UP WHILE SITTING IN A CHAIR, INCONTINENCE, AND CONFUSION ABOUT HER SURROUNDINGS, DATE, TIME, AND SITUATION. ALSO ADVISED THAT PT IS A GREAT HISTORIAN & NORMALLY KNOWS CURRENT DATE, TIME, AND SITUATION. SYMPTOMS LASTED ROUGHLY 72 HOURS, AND PATIENT DID COMPLETELY RETURN TO BASELINE AFTER 72 HOURS HAD PASSED

Patient presented to the ED 2/6/2021 with increasing SOB and found to have abnormal labs as an outpatient. Patient was found to be COVID positive on 2/6/2021 as well. Patient was discharged on 2/9/2021 for acute decompensations diastolic HF. At 2/19/2021 visit with Nephrology, patient found to have hypervolemic hyponatremia, not responding to oral diuretics and decision was made to manage as an inpatient. Patient found to have cardiomegaly, mild pulmonary vascular congestions with small bilateral pleural effusions, EF 59%, severely elevated pulmonary artery systolic pressure, and had a AKI. Patient did not improve with diuretic therapy. Hospice and comfort care measures were pursued and patient expired on 3/1/2021.