Pfizer

Fatigue but only in evening. Able to work. Irregular heart beat (not normal intermittent PVC) that caused chest discomfort. Nothing concerning, just more curious. With second vaccine, developed chills within one hour and went to bed. Upon awakening, had headache, nausea, chills, kidney area pain, chest discomfort from irregular heart beat. This resolved for about 18 hours, then started again and lasted for 1 week. Chest pain became sharp at times spreading to arm with mild shortness of breath. Having had a full heart workup last year, did not pursue tests. wanted to see if would pass on it's own. After one week, only have occasional chest discomfort. Arrhythmia has returned to baseline occasional PVC. No further chills, headache, nausea or other pains.

Sunday after administration, pt stated she started to feel her hear racing when going to bed, woke up with her heart racing in the am. Pt stated to experience tingling and burning in her feet that later traveled to her hands. Pt has a history of PVCs but noted an increase in the PVC frequency. Chest pain that was intermittent but lasted for 4-5 days. Continues to experience twitches and tingling feet to this day.

Since the week after the first Pfizer vaccine, I began struggling with symptoms of diabetes. I experienced extreme thirst, frequent urination and I lost 17 pounds in the 3 weeks following the first dose. I never associated it with the vaccine, initially, because I never heard of any side effects like increased glucose, and my dad and sister have type 2 diabetes, so I was altering my diet, but the symptoms did not subside. I proceeded to get the second vaccine and that?s when I knew something was seriously wrong. That afternoon my blood sugar was 528, my vision was blurred, and I experienced a strange feeling in my heart. I was diagnosed by my GP with diabetes, and put on medication (Metformin and Glipizide). I proceeded to see an endocrinologist, I was put on insulin and after additional blood tests was diagnosed with Latent Autoimmune Diabetes , and Premature Atrial Complexes.

Normal side effects except extreme pain at back and left kidney. Felt like I had been kicked in the kidney by a mule. Lasted Wednesday through Friday. Could not get comfortable.

first dose gave me hot flashes night sweats, put me back into meno pause hasn't stopped, yet second dose gave me frequent urination going on the 6th day, blood in urine

Cold Feet, Nausea, Vomiting, Diarrhea/abdominal cramps. The diarrhea and abdominal cramps/stomachache are still happening as I write this report today April 5, 2021.

Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Medium, Additional Details: Thirty minutes after shot, patient passed out and urinated on herself. Plus, had what she discribed as a seizure.

Pfizer-BioNTech COVID-19 Vaccine EUA: patient with seizure disorder reports seizure one day following vaccination. No loss of conscioussness or speech. Seizure reported as arm weakness, incontinenece, and vomiting. Afterwards rested all day and able to eat and drink. Patient also reports fatigue, myalgias, arthralgias, and nausea. Symptoms improving and no additional seizures documented.

April 1, dark urine April 2, Fatigue, injection site pain dark urine April 3, Extreme fatigue, dark urine Jaundice went to urgent care, they advised i go to ER as they felt i needed an abdominal scan to see why i had so much bilirubin in my urine. Went to Hospital. CBC showed my hemoglobin was 5.9. Went down to 4.9 before first transfusionhad CT SCan and sonogram.. Was admitted and disagnosed with hemolytic Anemia brought on by Covid Vaccine. had 5 blood transfusions over the course of my 8 day hospital stay. As of 5/06/21 My hemogloblin is 10.3 and has been at this level for past three weeks, I am currently under the care of a hemotologist

Patient reports after first dose on 4/8/21 they had red rash on left arm, itchiness at site of injection, then itchiness spread over face and body and lasted for one week. Then on 4/28/21 patient had swelling in their thighs and went to the ER and was diagnosed with Urinary Tract Infection. Patient reports after second dose of pfizer on 5/8/21 getting headache, joint pain, fever, cough, itchiness all over body/face, under right armpit. Symptoms started between 4-7pm on Saturday 5/8/21. Patient reports having fatigue on Sunday 5/9/21 and Monday 5/10/21. Patient self treated at home and took tylenol, ketorolac, and benadryl for symptoms.

A female patient received bnt162b2 (Pfizer- Biontech COVID-19 Vaccine Formulation: Solution for injection), via an unspecified route of administration on 05May2021 16:30 as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included eczema ( I have eczema, its since I was a baby) , food allergy, food allergy, drug hypersensitivity and food allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced i had an uti on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on unspecified date. I have anaphylactic shock. Penicillin - not sure my reaction, I have eczema, its since I was a baby. I was told I was allergic to it, probably itching because of the eczema, I haven't drank orange juice in a long time, it makes me itchy, that's probably what the reaction to penicillin was. The outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

After 1 shot had doctor appt and was notice that my kidneys function has declined slightly, then 7 days after the second shot I notice these blisters on my right lower leg near ankle filled with clear liquid it was a rash of multiple blisters. After about 7days they begin to go down I did not try to pop them I just took pictures each day and now they have went down today is May 19th 2021. and the area has dark scabs that seem to be going away.

incredible chest pressure; shortness of breath; anxiety; chest started hurting; pain across her breasts; concentration levels are off; but being that sick makes her so weary.; She goes to the bathroom 12 times a night to urinate; body aches; feet hurt/top of her feet hurt really super bad/legs hurt; pressing under her arm and she had pain really bad there; pain went around her back /whole back started hurting; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration administered in right arm on 27Apr2021 (Batch/Lot Number: ER8731) as single dose for COVID-19 immunisation. Medical history included ongoing congestive heart failure, diabetes, high cholesterol and high blood pressure. Concomitant medication(s) included aripiprazole (ABILIFY) taken for an unspecified indication, start and stop date were not reported; atorvastatin calcium (ATORVASTATIN CALCIUM) taken for an unspecified indication, start and stop date were not reported, noted as on of the 2 new heart medication; and another unspecified heart medication. No other vaccine within 4 weeks. The patient received the first dose of the COVID-19 vaccine on 27Apr2021, then 2 days later on 29Apr2021 she developed side effects of body aches and couldn't get comfortable sitting, laying down, or standing, and her feet hurt, the top of her feet hurt really super bad and her legs hurt. She stated she was feeling "fair to partly cloudy" and "this is just beyond anything". She stated she literally didn't want to exist anymore the pain was that horrible, that when she was experiencing adverse effects she couldn't get comfortable in any way, nowhere to go, nothing to do, no warm bath, no hot warm or cool compresses, it was just her whole body. She said there was nothing that would help and she just didn't know if she could do that again. She only had relief through paracetamol (TYLENOL) and she took so much that she felt her liver was in jeopardy. She stated it was a really bad experience. The patient was also having incredible chest pressure and shortness of breath, onset date unspecified. She had a diagnosis of heart failure/a history of congestive heart failure, with the body aches she was having, she thought she was going into heart failure. She did call an ambulance twice (maybe 29Apr2021 then 01May2021; she didn't remember exactly which days) and the emergency medical technicians (EMT) took an EKG each time. The first time she called the ambulance the EMT's offered to take her to the hospital. Her EKG did look abnormal but it could have been attributed to her history of heart related issues or anxiety. The second time her chest started hurting it was hard to distinguish between pain and pressure. There was definitely pressure. There was also pain across her breasts (onset date unspecified) and underneath her arm (on 29Apr2021; initially she was pressing under her arm and she had pain really bad there), she was questioning her lymph nodes. Then the pain went around her back and then her whole back started hurting and her whole body was hurting, onset date 29Apr2021. She had never experienced anything like this before, as stated. She also reported that her concentration levels were off (onset date unspecified). She couldn't listen to music or do anything like that. She spoke with her doctor but being that sick made her so weary (onset date unspecified). The patient reported she didn't know if her symptoms were because of the COVID-19 vaccine or because of her new heart medication, but she said it's stupid to think her symptoms could be caused from her new pills. Her doctor wanted blood work on 27Apr2021 primarily because of all the medical diseases she had. She's guessing maybe blood work would give her an indication of why the vaccine made her feel the way it did. She went on 05May2021 to get bloodwork. She went to the bathroom 12 times a night to urinate (onset date unspecified) and she asked her doctor to put her on Lasix so she could just get the urine out. The doctor told her that her heart and her lungs sound good. The patient asked if she should still get the second dose of the vaccine as she was worried that the symptoms could be worse after the second dose. She was supposed to return for her second COVID-19 vaccine on 14May2021, but she was not going (though she knew she needed to get the second dose), she did not want to get it. The events body aches, feet hurting/legs hurting, pain underneath her arm, back pain, were ongoing but lessened in severity. As of the time of reporting, she had started to feel better, these events (body aches, feet hurting/legs hurting, pain underneath her arm, back pain) were resolving. The outcome of the other events was unknown.

2 days after my second Pfizer vaccine I experienced lung pain when breathing, pleurisy, fever, dypsnea, shortness of breath, extreme fatigue.

Sudden and unusual passing of a slight blockage, much blood, and blood clots in urine lasting a few hours one month after the second vaccine. This was in addition to other symptoms following the vaccine, which included struggling with dehydration, especially for 2 weeks following the second vaccine dose, and tingling in feet that started a few days following second dose of vaccine and still comes and goes with varying intensity as of today (6 and half weeks following 2nd dose). The blood in urine was followed up with the following tests, in which results all were negative (no cause of hematuria found): cystoscopy, blood and urine cultures, comprehensive metabolic panel, cat scans of abdomen and pelvis.

Possible anaphylactic shock, acute kidney injury, shock liver, hypotension, rash, thrombocytopenia. Full body rash, abdominal pain, vomiting, diarrhea, RLE pain, fever, dizziness, body aches, headache. Sx onset 06/26/2021 after receiving COVID vaccine #2 the same day. Pt went to medical facility on 06/30/2021 and was sent to ED. Pt admitted to ICU 06/30 - 07/02. Transferred to general medical floor on 07/02/2021.

temporary partial paralysis.; During my hospitalization my creatinine levels elevated and I was diagnosed with Kidney Failure.; During my hospitalization my creatinine levels elevated and I was diagnosed with Kidney Failure.; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received first dose of BNT162B2 (Formulation: Solution for injection; Batch/Lot number: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 02Apr2021 14:30 PM (at the age of 60 years) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Diabetes, High Blood Pressure, Asthma, Lupus, Fibromyalgia, Bipolar, PTSD from an unknown date and unknown if ongoing. Concomitant medications included insulin glargine (LANTUS), insulin lispro (HUMALOG), lisinopril (LISINOPRIL), gabapentin (GABAPENTIN), tizanidine (TIZANIDINE) taken for an unspecified indication, start and stop date were not reported. The patient has allergy to Sulfa, Ibuprofen, Heaprin, Lisinipril. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 14Apr2021 at 01:00AM the consumer stated that she had the Pfizer first vaccine 02Apr after which I was hospitalized for back surgery. During my hospitalization my creatinine levels elevated, and I was diagnosed with Kidney Failure. Which doctors attributed to an allergy to my blood pressure medication Lisinipril. I also experienced temporary partial paralysis. I have taken Lisinipril for 5 years with no side effects. I had previous blood test with normal findings. The adverse event resulted in life threatening illness (immediate risk of death from the event). The outcome of the events was recovering. Information on Lot/Batch number has been requested.

Was unable to walk, pain in uterus, severe pain in lower extremities, constant urination, dehydration.

I was at work yesterday morning and began to feel shaky. Progressed to both hands trembling; legs feeling weak and wobbly. Could not perform my work duties. Progressed to Rigors. Lasted at least 3 hrs in it's severest form. Now, 24 hrs later I still have some hand tremors, and legs are weak. Shoulder, knees, hips achy. I'm very fatigued. Right arm soreness @ injection site. All events were reported. I was sent home from work, had to be driven home. I rested, slept and hydrated the remainder of the day. Did not go to work today.

61 yo F with history of bilateral lung transplant 6/23/17 presented to ED on 2/4/21 with chief complaint of worsening shortness of breath, nausea and diarrhea for past week since receiving since receiving COVID-19 vaccine (Pfizer) on 1/28/21. Upon arrival to triage she was obviously dyspneic with significantly low oxygen saturations. O2 sats on arrival were 65%, improved to mid 90's with O2 6 liters per NC. Admitting diagnosis: hypoxic respiratory failure post COVID vaccine. Lab work shows an elevation of the BUN and creatinine at 31 and 1.71 which is slightly higher than her usual baseline levels. BNP is elevated at 2 448 with a mildly elevated troponin. Procalcitonin is also elevated. Patient's white blood cell count is 11.07. Full viral panel including COVID-19 is not detected. All blood cultures and respiratory cultures were negative. Patient chest x-ray shows numerous bilateral patchy opacities which is significantly different from her previous chest x-ray here. Empiric rejection treatment initiated including high dose methylprednisolone, plasmapheresis, IVIG, Thymoglobulin. She continued to decline and ultimately required intubation, proning and paralyzing on 2/8/2021 and then VV ECMO cannulation on 2/13/2021. EGD done 2/14/2021 as unable to pass the TEE probe during cannulation prior day (unable to complete due to abnormal anatomy). Acute pupil exam change in the early am hours of 2/15/2021 prompted urgent head CT which revealed catastrophic brain bleed. Brainstem reflexes were lost soon after. Despite placing an EVD emergently at bedside, brain stem reflexes were not recovered. GOL engaged and patient not an organ donation candidate. Therefore discussion with sister at bedside resulted in decision for cessation of life support. Patient expired shortly after support withdrawn and pronounced dead on 2/15/2021 at 11:11 AM.

1. Cold chills in store, had to use restroom and urinate immediately. 2. Cold chills at home, started to shiver, jaw rattling, immediately had hot tea and wrapped in blanket. 3. Nosebleed, very unusual for me, 7 am. 4. Nosebleed, severe tinnitus, nausea, had to get out of bed and get to restroom, immediate bowel movement, severe dizziness vertigo getting back to bed. Slight tinnitus day after while writing report. Still have low nausea. 5. Sore arm for 4-5 days.

BP dropped to 70/40; seizures; She did fall into a cabinet; bruised up; inflamed; back was on fire; if she moves her head quickly, she can feel like she will have a headache, hangover; could not walk; Trouble walking; Funny taste in mouth; Pain/ felt achy; tingling sensation from head to her to spine/ hands tingling/ it was also in her abdomen area and in her leg; Back pain; Could hardly move; could not stand up; autoimmune response; delayed allergic reaction; tweaky muscle/ pulled a muscle in her back; pain at the top of her head down to her hip; pain at the top of her head down to her hip; having trouble holding her urine; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID19 VACCINE, Solution for injection, lot number: EL9266), via an unspecified route of administration in the left arm, on 05Mar2021 1:45 PM at a single dose for COVID-19 immunization. The patient did not receive any vaccines within 4 weeks prior to receiving the BNT162B2. Medical history included allergic reaction, autoimmune disease, brain barrier fever, epilepsy, encephalitis and meningitis. She had epilepsy as a child. She gets epilepsy when she gets sick. The last 4 times she got sick she had a seizure. The last seizure was 1 year ago (in 2020). She may have had COVID, but she got really sick and had a seizure. She is not sure if it was COVID or not. If it was the flu, she does not want that again. She had ataxia and ended up in hospital two times but did not stay. Prior to this, she did not go to hospital for 30 years. She was unable to walk, her gait was real bad. The neurological disorder messed her up for a while. Concomitant medications were not reported. It was reported that the patient received the PFIZER-BIONTECH COVID19 VACCINE first dose and experienced autoimmune response. After the vaccine, she had pain and tingling sensation from head to her to spine (05Mar2021), BP dropped to 70/40 (06Mar2021), seizures (06Mar2021), and delayed allergic reaction (Mar2021). She wanted to know if she should take the second dose or not. She also wanted to know if that would be considered the anaphylactic reaction. It was also reported that the patient experienced funny taste in mouth, back pain, hands tingling on 05Mar2021. The patient further explained that when she got the shot, she had a funny taste in her mouth. It started immediately after she got the vaccine and it lasted 30 minutes. She mentioned this to the people at the facility, but they said she was crazy and no one else has mentioned this. She thought they would be interested, but they did not care. About 20 minutes later she had a tingly sensation. It was in the back of her head that developed into a stingy, painful, heat, funny type feeling. It was all the way down to her back. She later further explained the back of her head was tingling (05Mar2021). Like were the cerebellum is to spine. This sensation is still there, but better. After she felt this feeling her back then started hurting. She bent over and her back went out. She felt achy. She already had what she called a tweaky muscle (05Mar2021). She had pulled a muscle in her back, but it was nothing that had caused a problem. After getting the COVID vaccine it triggered an immune response in her body. She started to have pain at the top of her head down to her hip (05Mar2021). She bent over and she could not stand up (05Mar2021). Her husband had to help her put her pants on and sit down due to this. She started to have horrible back pain (05Mar2021). She could hardly move (05Mar2021). She was having trouble walking (05Mar2021). She was having trouble holding her urine (05Mar2021). On Saturday evening (06Mar2021), her blood pressure started dropping and she later had a seizure. After the seizure occurred it seems like everything got better and she did not have any trouble since. It was very scary. She mentioned she was in the bathroom and there was a tub full of water. She had a hard time already getting to the bathroom. She was in a lot of pain. The amount of pain she had she thinks affected her blood pressure. She had pain in the back, middle of her back. It started at her head, back of head, down her spine, came down to her back and hips. She was hurting a lot and having a terribly hard time getting around. She could hardly walk. She was going to the bathroom because she felt like she had to go. Her husband was helping her sit on the toilet. When she stood up it was like her blood pressure dropped, she almost went headfirst in the tub full of water, but her husband caught her, laid her down, and had a seizure. This was a very unnerving feeling. The seizure did not last more than a minute, maybe two at the very most. The seizure occurred probably around 6PM or 7PM. It did not last long at all. She woke up on the floor. She had been sitting and she thought she had fallen off the toilet. However, her husband had to remind her that a few things happened in between. She almost fell in the bathtub and she has glass doors. She mentioned she felt as clarified and confirmed sped up. She did fall into a cabinet and is bruised up from that seizure (06Mar2021). She is sore from the pain from that. Still inflamed (06Mar2021) possibly due to the seizure. Like she has ruminants of what occurred to back of head, cerebellum. Before she had the seizure, her blood pressure had started dropping. It started dropping in the evening around 5PM or 5:30PM. Mentioned she is a little confused about the time onset because she was hurting so much and bad all day. She does not take any pain medication. She has an autoimmune disease and it is difficult for her to take medications. On top of that, if she wanted to take an Aspirin she was told she should not take one. She was informed she was trying to promote an auto-immune response to the vaccine. As the day ran on, she was in a lot of pain. She had been in pain since Friday and was trying to deal with that. The patient further stated her blood pressure is back, no illness. After the seizure her blood pressure went back to normal and at this time it is perfectly fine. The back pain she experienced went from the brain down to her backbone. The pain is gone. It started to go away after the seizure and by Sunday 07Mar2021 it was totally gone. At first it was like she could not walk (05Mar2021). It was like she/her back was on fire (05Mar2021). The patient also mentioned if she moves her head quickly, she can feel like she will have a headache, hangover. She feels it in her back. She feels like she is near recovery, and this is a feeling she does not thing will stay. She further went on to say her hip where she fell is a different story. However, this is associated to a fall and not a vaccine. She was having this problem when she had the vaccine, but the vaccine caused it to be more and extra aggravating. She later added, when she first got home along with head tingling her hands were tingling as well. When her brain and hands were going through this tingling sensation, she started to notice the back trouble and it was also in her abdomen area and in her legs causing trouble walking (05Mar2021). The events did not require a visit to the emergency room or physician office. Outcome of the events trouble walking, could not walk, tingling sensation and hangover was recovering. Outcome of BP dropped to 70/40 was recovered on Mar2021. Outcome of seizures recovered on 06Mar2021. Outcome of funny taste in mouth was recovered on 05Mar2021. Outcome of back pain was recovered on 07Mar2021. Outcome of bruised up was not recovered. Outcome of the remaining events was unknown. The patient provided an unrelated causality between the vaccine and event fall. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the current available information, the event Fall is most likely related to an intercurrent or underlying condition which is not related to the suspected drug.

Irregular heart rhythm, fever of 100.8, chills, headache, high blood pressure 145/94, frequent urination, body aches

Having suffered all the common side effects of this vaccine between date of receiving it, April 7th, 2021, to this time of writing, evening of April 11th, 2021, I began to suffer from bladder pain and burning during urination on the morning of April 11th, 2021. I've had no treatment for this as of the time of reporting . I plan to contact my doctor's office Monday morning, April 12th, 2021.

Strong pains in lower abdomen the following evening, roughly 24 hrs after injection, and considerable blood in urine the following day roughly 8 hrs later. Urine dark pink to red. Bleeding lasted for 3 days after first dose. Bleeding still ongoing currently.

Presented to emergency department with complaints of fatigue, cough, diarrhea, epigastric pain, confusion, and malaise. Patient was admitted for hyperglycemia, suspected UTI and COVID-19 infection. Patient reported symptoms started around the same time of vaccination. Patient is still admitted at time of writing.

1/20/2021 - pt experiencing marked fatigue 01/23/2021 - pt went to ED with fatigue, sweats, cough, and low BP. Admitted with diagnoses of cardiogenic shock, myocarditis, acute renal failure, heart failure, anemia, UTI, oral thrush. Treated with IV fluids, dialysis, temporary pacemaker. 02/06/2021 - discharged to rehab facility 02/17/2021 - discharged home

Caller reported she thinks he said 0.5mL but cannot verify that dose information at time of the call.; Urinary incontinence; This is a spontaneous report from a contactable pharmacist. This 61-year-old female contactable pharmacist(Patient) reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot: EL3302) at single dose for COVID-19 immunisation on 29Mar2021. Relevant history included Urinary incontinence. Relevant concomitant drug included estradiol (ESTRING) for Urinary incontinence, had been a few years already. The patient (pharmacist) said the dose of vaccine was 0.5mL but cannot verify that dose information at the reporting time. This patient stated the last few days the Estring had not been working; she did not know if they didn't put enough estrogen (1 count 2mg strength) in the ring or if the ring ran out of Estrogen, like at the end of the thing, or if the Estring not working was due to a defect. She clarified that the Estring has not been working because she has had 2 episodes of urinary incontinence, urinary incontinence outcome provided as worsened. First episode happened like 09Apr2021, and the second episode happened last night, 13Apr2021. These episodes were upsetting, annoying and embarrassing. This particular vaginal ring involved in this report was inserted intravaginally on 21Jan2021 and was still in place intravaginally. No change performed as of yet, but she was getting a new Estring today and is going to see if that one works. Because of Covid pandemic she had basically been home but she normally visited friends and may stay over and it would have been really embarrassing if she was staying over and had urinary incontinence episodes; she would probably have to wear a diaper if she stayed over which would be really embarrassing. The event was not considered as life-threatening. The urinary incontinence outcome was not resolved (worsened). She was scheduled for her second dose of Pfizer-BioNTech COVID-19 Vaccine on 26Apr2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained

Patient developed paroxysmal atrial fibrillation. Upon date of death- pt husband reported SOB, incontinence, gasping for air, slumped forward and died upon 911 arrival.

Patient became rigid and fell down and could not get up, she can no longer stand unassisted. She has become incontinent and now has to where a diaper, and leans to her right side while sitting and standing. She cannot focus for very long. And she becomes rigid and stiff for periods of time. She is no longer able to bath herself or care fir her basic needs. Even with intense therapy hasn?t reached her baseline.

Nausea, vomiting, diarrhea, abdominal cramping intermittently for nearly 2 weeks before admit to ED. Presents upon admission with acute renal failure, proteinuria, E. Coli UTI, hypocalcemia, hypoalbuminemia, elevated serum osmolality, metabolic acidosis, lymphopenia. Treated with plasmapheresis x 5 sessions + cytotoxic therapy (cyclophosphamide) + hemodialysis 5/28 and 5/29. Outcome pending, patient still receiving treatment inpatient.

Component Results: Component Your Value Standard Range Flag; Troponin T, 2 hr., 5th gen 1923 ng/L<=10 ng/L<=10 ng/L H; Consider acute myocardial injury 2H Delta 862 ng/L ng/Lng/L;2H Delta Interp Changing Evaluate for acute myocardial injury; Troponin T, 6 hr., 5th gen; 2104 ng/L; <=10 ng/L<=10 ng/L H; Consider acute myocardial injury; 6H Delta SEE COMMENT ng/L ng/Lng/L; Test cancelled. Specimen not received within delta timeframe.; 6H Delta Interp SEE COMMENT; Test cancelled. Specimen not received within delta timeframe. General Information-Ordered by, M.D., Ph.D._____________________________________________________ Your Admission - 03/30/21Printer friendly page--New window will open-Admission Summary-Notes-Clinical Notes H&P by M.D., Ph.D. at 3/30/2021 3:55 AM-Status: Signed-CARD 3 Admission Note-SUBJECTIVE- CHIEF COMPLAINT= Chest pain. HISTORY OF PRESENT ILLNESS Patient is a 56 y.o. female who presented to the Emergency Department due to chest pain. She has experienced this pain each evening for the past 3 evenings, and states that it starts in her right arm then migrates through her shoulder and across to her chest. The pain can last for anywhere from 5 minutes to 4 hours. This has come on at rest, but in the setting increased personal life stressors as well as uncontrolled hypertension. She states that she is normally on hydrochlorothiazide for hypertension, but ran out of this medication about a week ago. When she checked her blood pressure at home it was in the 230s/120s, therefore she presented to the emergency department locally. Her medical comorbidities are notable for poorly controlled hypertension, mixed hyperlipidemia that is untreated, current tobacco use (1-2 packs per day for 40 years), and medically complicated obesity. In the emergency department she was found to have mild polycythemia with hemoglobin of 15.2 and leukocytosis of 13.7. INR, D-dimer, and BMP were normal. High sensitivity troponin T was found to be 770 ng/L. ECG showed normal sinus rhythm with T-wave inversion in aVL that was not present on 08/25/2004. Chest x-ray was largely unremarkable. Her chest pain resolved, but given the elevated troponin ECG changes she was treated for NSTEMI with heparin infusion, and loaded with aspirin and clopidogrel and directly admitted to the Hospital Cardiology service. Upon arrival she remained free of chest pain but continued to have significant hypertension. I have reviewed and updated the following: Past Medical History, Family History, Social History, and Allergies. Current Outpatient Medications on File Prior to Encounter: hydrochlorothiazide (HYDRODIURIL) 25 mg tablet, Take 1 tablet (25 mg total) by mouth daily., Past Week at Unknown time; Lorazepam (ATIVAN) 0.5 mg tablet, Take 0.5 mg by mouth daily as needed for anxiety., More than a month at Unknown time. REVIEW OF SYSTEMS Pertinent items are noted in HPI; all other review of systems was negative. OBJECTIVE VITAL SIGNS Temperature: [36.8 °C-36.9 °C] 36.9 °C; Heart Rate: [83-117] 83; Resp Rate: [20-26] 22; Blood Pressure: (164-195)/(81-129) 164/106; SpO2:[92 %-97 %] 95 %;Weight: [104 kg-106 kg] 104 kg; Pulse Rate: [90-109] 94. PHYSICAL EXAM General: Alert, oriented, no acute distress; HEENT: Mucous membranes moist, JVP difficult to assess due to body habitus; CV: Regular rate and rhythm without murmur; Lungs: Clear to auscultation bilaterally; Abdomen: Obese, soft, nontender, nondistended, normoactive bowel sounds; Extremities: No peripheral edema appreciated; Neuro: No focal deficits appreciated. DIAGNOSTICS I have reviewed labs and imaging from the past 24 hours. ASSESSMENT / PLAN Patient is a 56 y.o. female who was directly admitted to the Cardiology Service from Emergency Department due to NSTEMI and poorly controlled hypertension. She also has untreated mixed hyperlipidemia and is a current smoker. We will continue to trend troponins and treat NSTEMI was heparin infusion, aspirin, and clopidogrel. I will start a statin and initiate low-dose lisinopril and carvedilol for blood pressure control with plans to up titrate as tolerated. I will update a lipid panel in checked for diabetes. I will obtain a TTE in the morning and keep her NPO for probable coronary angiogram pending negative COVID swab. #1 Non-ST Elevation Myocardial Infarction; #2 Poorly controlled systemic hypertension; #3 Mixed hyperlipidemia, previously untreated; #4 Medically complicated obesity (BMI 38-trend troponin- loaded with aspirin and clopidogrel- Aspirin 81 mg daily- clopidogrel 75 mg daily- moderate intensity heparin infusion- rosuvastatin 20 mg daily- lisinopril 2.5 mg daily, up titrate as tolerated- carvedilol 6.25 mg twice daily, up titrate as tolerated- holding home hydrochlorothiazide in lieu of lisinopril and carvedilol- lipid panel - hemoglobin A1c- TTE- NPO for probable angiogram (not-ordered)- cardiac rehab consult ordered;#5 Abuse Tobacco Smoking- nicotine patch- nicotine inhaler as needed- nicotine cessation consult; #6 Anxiety She is prescribed lorazepam 0.5 mg which she takes when she has a panic attack which only occurs a couple times per year. For now we will just monitor. Diet: NPO; Tubes/lines: PIV; VTE prophylaxis: heparin infusion; Code status: Full Code; Disposition: anticipate discharge to home when clinically stable. Counseling was provided face-to-face at bedside regarding the plan of care as stated above. I personally spent over half of a total 70 minutes in counseling and coordination of care as documented above. M.B.B.S. at 3/30/2021 10:58 AM Status: Signed. SUBJECTIVE HISTORY OF PRESENT ILLNESS Patient is a very pleasant 56-year-old female who is owner of multiple nursing facilities who presented with chest pain and hypertensive emergency. She ran out of her hydrochlorothiazide last week, was fairly busy managing all her nursing homes with COVID pandemic and vaccination program. She was having intermittent chest pain, chest pressure radiating to the right arm. In this setting she checked her blood pressure, and it was noted to be 240 systolic over 140 diastolic. In this setting was sent to the ER and subsequently sent here. Initial troponin was 770. Subsequently, it went up to 1923. Delta was 862. ECG showed sinus rhythm with clear ST depression in the inferolateral leads. Patient currently is chest pain-free. She was initiated on carvedilol and restarted her home hydrochlorothiazide. Blood pressure is better. She had a good night's sleep. OBJECTIVE PHYSICAL EXAMINATION; Vital Signs: Noted.; General: Alert and oriented x3. Cardiac: S1, S2 normal.; Lungs: Clear.; Abdomen: Soft.; Extremities: No edema of feet.; Vessels: Peripheral pulses well-felt.; DIAGNOSTICS Creatinine is 0.7. Bicarb is 30. ASSESSMENT / PLAN Patient, is a 56-year-old female with obesity, hypertension, smoking, presented with hypertensive emergency. Blood pressure is better controlled now. She did have clear ST-T changes with troponin elevation, and we will treat it as NSTEMI at this point. Certainly, this can be demand ischemia in setting of hypertensive emergency, but she has multiple risk factors which would warrant coronary artery disease evaluation. We will plan for an angiogram today. We will get an echo today. Post that, we will reassess and see how things go. It appears that this was in setting of medication noncompliance. However, if this happens again, we may also look for other secondary causes of hypertension, especially with the fact that her bicarbonate was 30. All her questions were answered. DIAGNOSES: #1 Hypertensive emergency; #2 NSTEMI; #3 Obesity. M.B.B.S. DD: 03/30/2021 08:54:32 CT; DT: 03/30/2021 09:13:15 CT; Job ID: 914158020/mjb. Sedation Note by HCP at 3/30/2021 10:22 AM Status: Signed. INTERVAL HISTORY AND PHYSICAL PRE-PROCEDURE UPDATE H&P reviewed. The patient was examined and there are no significant changes to the H&P. PRE-SEDATION ASSESSMENT Consent Consents Obtained: written. The benefits, risks and alternatives to the procedure and the potential need for sedation or anesthesia as well as the names, roles, and responsibilities of healthcare team members performing significant interventional tasks were discussed with the patient and/or decision maker: yes. Indications / Reason for Visit. Procedure / Reason for Visit: coronary angiogram with possible intervention. Presedation Assessment. The following portions of the patient's history were reviewed and updated as appropriate: allergies, current medications, family history, medical history, social history and problem list: Yes. Review of Symptoms pertinent ROS negative. Physical Exam Mallampati: II - soft palate, uvula, fauces visible. Assessment Plan ASA Physical Status: class 3 - patient with severe systemic disease Sedation Plan: moderate sedation. Patient seen, evaluated, and approved for sedation: yes. Cardiology Fellow 11053 Discharge Instr - Referrals / Follow-Ups by HCP at 3/30/2021 11:18 AM Status: Written Take a copy of this after visit summary to your appointment(s).---------------------------------------------------- Monday, April 5th, 2021:-- 12:30 p.m. -- Hospital follow-up with Dr. primary care provider, at Medical Center------------------------------ --------------------------- You may have outpatient appointments at Clinic that changed during your hospitalization. Refer to your Clinic Patient Visit Guide (PVG) for the most current schedule of appointments and detailed instructions of tests/procedures. Call, if you did not receive an PVG or need to CANCEL any Clinic appointment(s). H&P by HCP at 3/30/2021 12:33 PM; Status: Signed; CARDIOLOGY 3 H&P HISTORY OF PRESENT ILLNESS; Patient is a 56 yo F with history of hypertension, dyslipidemia, smoking history, and obesity who presents with chest pain, found to have NSTEMI. She owns and runs 4 assisted living facilities. In the past three days, she has had chest pain at rest following dinner, while sitting in the living room. It has lasted from minutes to hours and was relieved on its own. Yesterday she was prompted by her husband to present for medical attention. She has smoked 1-2 packs daily for the past 40 years. She is on hydrochlorothiazide 25mg daily for her blood pressure. Blood pressure was 171/129 here in the ED. Troponins rose from 770 to 1061 to 1923. Current Medications: [MAR Hold] acetaminophen tablet 1,000 mg (TYLENOL), Q6H PRN; acetaminophen tablet 1,000 mg (TYLENOL), TID PRN; [START ON 3/31/2021] aspirin chewable tablet 81 mg, Daily; [MAR Hold] aspirin DR tablet 81 mg, Daily; atropine injection 0.5 mg, Q5 Min PRN; bisacodyl suppository 10 mg (DULCOLAX), Daily PRN; [MAR Hold] calcium carbonate chewable tablet 400 mg of calcium (TUMS), Q2H PRN; carvedilol tablet 25 mg (COREG), BID with meals; [MAR Hold] Clopidogrel tablet 75 mg (PLAVIX), Daily; [START ON 3/31/2021] Clopidogrel tablet 75 mg (PLAVIX), Daily; docusate sodium capsule 100 mg (COLACE), BID PRN; fentanyl injection 25 mcg (SUBLIMAZE), Q2 Min PRN; fentanyl injection 25 mcg (SUBLIMAZE), Once PRN; flumazenil injection 0.2 mg (ROMAZICON), Once PRN; heparin (porcine) 1,000 unit/mL injection 3,200 Units, PRN **OR** heparin (porcine) 1,000 unit/mL injection 6,400 Units, PRN; heparin (porcine) 100 Units/mL in NaCl 0.45% 250 mL infusion, Continuous; [MAR Hold] lisinopril tablet 2.5 mg (PRINIVIL,ZESTRIL), Daily; Lorazepam injection 1 mg (ATIVAN), Once PRN; midazolam (PF) injection 0.25 mg (VERSED), Q2 Min PRN; midazolam (PF) injection 0.5 mg (VERSED), Once PRN; midazolam (PF) injection 0.5 mg (VERSED), Q2 Min PRN; midazolam (PF) injection 1 mg (VERSED), Q2 Min PRN; NaCl 0.9 % bolus 250 mL, Once; NaCl 0.9% infusion, Once PRN; naloxone injection 0.2 mg (NARCAN), Once PRN; naloxone injection 0.2 mg (NARCAN), PRN; MAR Hold] nicotine 10 mg inhaler 1 puff (NICOTROL), PRN [MAR Hold] nicotine 21 mg/24 hr. 1 patch (NICODERM CQ), Daily; ondansetron (PF) injection 4 mg (ZOFRAN), Once PRN;[MAR Hold] polyethylene glycol powder packet 1 packet (MIRALAX), Daily PRN; promethazine injection 6.25 mg (PHENERGAN), Q6H PRN; [MAR Hold] rosuvastatin tablet 20 mg (CRESTOR), Daily at bedtime; sodium chloride 0.9 % injection 10 mL, PRN; sodium chloride 0.9 % injection 3 mL, PRN; sodium chloride 0.9 % injection 3 mL, Q12H SCH. OBJECTIVE BP 143/83 | Pulse 71 | Temp 36.6 °C (Oral) | Resp 21 | Ht 165.1 cm | Wt 104 kg | SpO2 94% | BMI 38.19 kg/m². Intake/Output Summary (Last 24 hours) at 3/30/2021 1212. Last data filed at 3/30/2021 1130. Gross per 24 hour Intake 323.71 ml; Output 700 ml; Net-376.29 ml; GEN: Pleasant, no distress CV: Regular, no extra heart sounds, JVP is flat; PULM: Clear bilaterally; EXTR: No edema, strong R radial pulse ; ;EKG: NSR, nonspecific changes. ASSESSMENT / PLAN NSTEMI, s/p PCI to circumflex 3/30/21; Hypertension, uncontrolled; Nicotine dependence; Dyslipidemia; Obesity. She has an NSTEMI with significant elevation in her troponin. We will proceed with coronary angiography for this and anticipate PCI. We will intensify her antihypertensive regimen. Nicotine cessation is critical and we will consult our cessation specialists. We will refer her to cardiac rehab. DAPT for 1 year. Plan:1. Coronary angiography with intervention today; 2. High intensity statin, uptitrate carvedilol, keep lisinopril 2.5mg, restart hctz later this evening.; 3. Nicotine cessation referral. Cardiac rehab referral; 4. F/u TTE. Addendum: Angiography demonstrated her culprit lesion to be in the circumflex for which she received a 2.5 x 16 mm synergy stent. Mild disease elsewhere. She will require DAPT for one year. The patient was seen and discussed with the attending consultant, Dr. and PA. M.D. Cardiology fellow 3/30/2021 Consults by HCP at 3/30/2021 1:51 PM Status: Signed Consult Orders 1. Cardiac Rehabilitation consult (hospital) [2222776702510] ordered by M.D. at 03/30/21 1136; 2. Cardiac Rehabilitation consult (hospital) [2222776391034] ordered by M.D., Ph.D. at 03/30/21 0343 Cardiac Rehabilitation Referral. Reason for Visit: Cardiac Health Clinic consultation for referral to cardiac rehabilitation. Liaison met with the patient/family to discuss cardiac rehabilitation referral. Patient/family was provided with progressive verbal and printed home-going exercise guidelines. Patient/family understands and agrees with the exercise guidelines.1. Participation in a Phase II cardiac rehabilitation program is recommended. Patient was informed about what cardiac rehabilitation has to offer and why it is beneficial. The plan of care for the rehabilitation program consists of risk factor modification, monitored and supervised exercise and assistance in the recovery process with ongoing education and support. Patient is interested in attending a cardiac rehabilitation program.; 2. Eligibility: MI and PCI; 3. Exceptions/exclusions: None;.4. Referral: Patient agreed with referral to a cardiac rehabilitation program. Please see discharge order and/or letter for program details. Clinic Health System Phone:; 5. Appropriate referral information will be sent to the receiving cardiac rehabilitation program as applicable. Patient provided verbal authorization to send relevant materials to the cardiac rehab program. Recommend that the patient check with insurance company to verify coverage of the cost of cardiac rehabilitation program visits. Discharge Summary by PA at 3/31/2021 10:20 AMStatus: Addendium CARDIOLOGY HOSPITAL DISCHARGE SUMMARY DATE OF ADMISSION: 3/30/2021 DATE OF DISCHARGE: 3/31/2021 Discharge Provider: M.B.B.S. Discharge Provider Team: RST CARD 3 PRINCIPAL DIAGNOSIS Non-ST Elevation Myocardial Infarction. DISMISSAL DIAGNOSES #1 Non-ST Elevation Myocardial Infarction; #2 Poorly controlled systemic hypertension; #3 Mixed hyperlipidemia, previously untreated;#4 Medically complicated obesity (BMI 38); #5 Abuse Tobacco Smoking, Nicotine Dependence; #6 Anxiety. RECOMMENDATIONS FOR FOLLOW-UP APPOINTMENTS CBC and Basic metabolic panel; Cardiovascular risk factor modification; Cardiac rehabilitation participation (set up); Nicotine cessation; Blood pressure monitoring and management; Plavix for one year, aspirin lifelong; Assess right radial access site. *Statin Therapy Initiated: *A fasting lipid profile showed: Total Cholesterol 173 mg/dL, Triglycerides 218 mg/dL, HDL 39 mg/dL, LDL 90 mg/dL. *Baseline LDL is [ ] mg/dl. Please titrate to meet goal lipid levels.*Please recheck lipids and ALT/AST in 6 to 8 weeks.*Goal of statin therapy is a LDL less than 70 mg/dl or a 50% reduction in LDL. FOLLOW-UP APPOINTMENTS For appointment details refer to your Patient Appointment Guide. HOSPITAL COURSE Admission Weight: 104 kg; Dismissal Weight: 103 kg; BMI: Body mass index is 37.82 kg/m².Patient is a 56 y.o. female who presented to the Emergency Department due to chest pain. She has experienced this pain each evening for the past 3 evenings, and states that it starts in her right arm then migrates through her shoulder and across to her chest. The pain can last for anywhere from 5 minutes to 4 hours. This has come on at rest, but in the setting increased personal life stressors as well as uncontrolled hypertension. She states that she is normally on hydrochlorothiazide for hypertension, but ran out of this medication about a week ago. When she checked her blood pressure at home it was in the 230s/120s, therefore she presented to the emergency department locally. Her medical comorbidities are notable for poorly controlled hypertension, mixed hyperlipidemia that is untreated, current tobacco use (1-2 packs per day for 40 years), and medically complicated obesity(BMI 38.19 kg/m2). Intravenous heparin was initiated for the heparin nomogram. She was Plavix loaded and received aspirin. Carvedilol, lisinopril and Rosuvastatin were initiated. She proceeded to coronary angiogram with drug-eluting stent to the left distal circumflex artery. Transthoracic echocardiogram demonstrated ejection fraction 63%. Nicotine dependence was consulted and provided cessation information and prescriptions for nicotine replacement therapy. TEST RESULTS PENDING AT DISCHARGE :Pending Labs; None; DISCHARGE DISPOSITION: Home or Self Care [1]; CONDITION ON DISCHARGE: Stable. DIET AT DISCHARGE: Cardiac diet consisting of low sodium (1500 mg to 2000 mg per day), low cholesterol, low fat. No alcohol, (or discuss with physician).PRIMARY PROVIDER Patient Care Team:D.O. as External Primary Care Physician (Family Medicine) Primary Care Providers: Pcp (General); No address on file Primary Care Provider Phone Number: None Primary Care Provider Fax Number: None MARGIN CODE Operative Note Report Case/Log ID: 1507626443 Case Time: 10:44 AM Procedure Information CORONARY ANGIOGRAPHY Laterality N/A; Left Heart Catheterization Laterality N/A; Percutaneous Coronary Angioplasty Laterality N/A; Stent Placement Laterality N/A. Surgeons Surgeon Role M.D. Primary M.D. First Assistant, M.D. First Assistant, Diagnosis. Pre-op diagnosis: Non-ST Elevation Myocardial Infarction , Morbid Obesity Body Mass Index >= 35 with Comorbid Condition. Post-op diagnosis: Non-ST Elevation Myocardial Infarction , Morbid Obesity Body Mass Index >= 35 with Comorbid Condition. Anesthesia Type Moderate sedation (rn). Surgeon Documentation. No notes of this type exist for this encounter. Specimens None. Implants Implant Name LRB; Site No. Used; Manufacturer Mfr No.; Serial No.; Status; Type STNT SYNERGY XD DE 2.50X16 - LOG1507626443 N/A; Coronary Scientific H7493941816250 Implanted Cardiac Stent; Drains None Estimated Blood Loss None. Worsening shortness of breath COVID-19 positive on 06/06, Sxs started on 06/01 HPI: This is a 61 year old female who presents with complain of worsening Shortness of breath, COVID-19 positive PMHx Kidney transplant for glomerulonephritis, 1998, 2nd transplant in 2009 on Cellcept and prednisone and recurrent UTIs since then and since then when she gets UTI, she starts Cipro or Keflex HOCM myectomy 2009. Just saw yesterday. Denied CP/ SOB/ orthopnea/ cough/ leg swelling/ syncope/ PND. stated " no gradients across LVOT. At acceptable risk for planned procedure. Afib in 2009, Legally blind, Gout, Hand amputation 2017 at work , Hip replacement Ventriculostomy - cyst removed 1999] Pt completed COVID vaccination series (Pfizer 2/25/21, 3/18/21) but has been on immunosuppression 2/2 renal tx. Her symptoms have been persistent since 6/1. She states that she has been having fever morning and evening, cough, fatigue. She states that over the past 1-2 days prior to presentation to the ED she has had hypoxia to 85-89% on home pulse ox and intermittent episodes of fever, pt reports worse dyspnea w/ ambulation. Pt called her nephrologist on 06/01 and recommended course of Amoxicillin w/out improved, given worsening and not improving sxs her nephrollogist recommended to presented to the ED, On arrival to the ED she was initially tachypnic with ambulation to the bed, but has since improved. On initial exam she is not in any acute respiratory distress. CXR showed finding of viral PNA, Creatinine 1.17 baseline < 1.0 Sodium 126 This is a 61 year old female who presents with complain of worsening Shortness of breath, COVID-19 positive PMHx Kidney transplant for glomerulonephritis, 1998, 2nd transplant in 2009 on Cellcept and prednisone and recurrent UTIs since then and since then when she gets UTI, she starts Cipro or Keflex HOCM myectomy 2009. Just saw Physician yesterday. Denied CP/ SOB/ orthopnea/ cough/ leg swelling/ syncope/ PND. Physician stated " no gradients across LVOT. At acceptable risk for planned procedure. Afib in 2009, Legally blind, Gout, Hand amputation 2017 at work , Hip replacement Ventriculostomy - cyst removed 1999] Worsening shortness of breath COVID-19 positive on 06/06, Sxs started on 06/01 On arrival to the ED she was initially tachypnic with ambulation to the bed, but has since improved. On initial exam she is not in any acute respiratory distress. CXR showed finding of viral PNA, Creatinine 1.17 baseline < 1.0 Sodium 126 Active Problems: Active respiratory failure dute to COVID-19 Hypoxia Symptomatic 6/1, tested positive for COVID infection 6/6. Currently sat 93-95% on RA; States she sats down to 85% at night. Short of breath on ambulation Xray findings suggestive of atypical viral/Covid 19 pneumonia. Plan: - dexamethasone, remdesivir, mucinex - Oxygen NC to keep SpO2 >94% - IS q1h - ID consult appreciate recommendations - Mucinex,Sch, robitussin PRN and albuterol PRN - Incentive spirometry Kidney replaced by transplant Aki Increased creatinine 1.77 baseline Hyponatremia Hypochloremia - Creatinine 1.17 from 0.95 possible d/t dehydration. - Na 126, Cl 94 Plan: - Normal saline bolus - Hold cellcep - Continue tacrolimus - Prednisone hold, due dexamethasone for tx of COVID infection - Hold lasix, allopurinol, lisinopril - Continue valgancclovir - Avoid Nephrotoxic agent - renally dose meds - Gentle IVF NS 75 ml/hr - Usodium and Uosm Hypertension Hypertrophic obstructive cardiomyopathy (HOCM) (HCC) Atrial fibrillation (HCC) DVT prophylaxis - Normal sinus rhythm on EKG Plan: - Heparin - Continue atorvastatin, ASA, coreg - Monitor for palpitations, dizziness, headache, SOB - Holding Lisinopril and Lasix in setting of Aki - Continue Coreg Gastritis - currently asymptomatic Plan: - Protonix while on Steroids Prediabetes - Hgb A1C 6.1 4/3 Plan: - Low carb diet Legally blind - Patient moves about room without difficulty

About 4:00 pm, pain in my back and then it kept getting worse and worse and I was feeling nausea and was in a lot of pain. Husband came home and took me to urgent care. They gave me a shot there, and it was a pain reliever, which relieved it and I think the kidney stone passed at that time; Toradol injection. After that I had to strain my urine and got some of the stones and took them in the lab to test it.

It did not matter where or how hard the doctor hit here right knee; She has complications with having no taste; She was itching on her right arm, wrists and fingers; She was tomato red from head to toe; Her throat and face was swollen; Her right hand and arm was swollen; She began having vagina spasms. She literally felt like half of a fish was inside of her vagina, and it was flopping around.; Her chest felt heavy; Her right knee had no reflex what so ever.It did not matter where or how hard the doctor hit her right knee, it did not move; The bubble blisters on her wrist; She started getting bubble blisters on her arms, fingers, and over her chest, above her boobs; Her left but cheek, back of leg and knee cap all felt numb, but also felt on fire at the same time. It just really hurt; Excruciating pain in her left butt cheek, back of leg, and knee cap; Her urinary tract started burning. She was peeing, and peeing and peeing. She was using the bathroom a lot; her urinary tract started burning. She was peeing, and peeing and peeing. She was using the bathroom a lot.; This is a spontaneous report from a contactable consumer (patient herself). A 61-year-old female patient (self-reported) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 01Apr2021 13:00 (Batch/Lot Number: ER8737) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included allergy to shellfish and allergy. Concomitant medication included estrogens conjugated (ESTROGENS CONJUGATED) taken for an unspecified indication, start and stop date were not reported. She received the first dose of the covid vaccine on Thursday, 01Apr2021. She felt fine over the weekend. By Monday evening, 05Apr2021, she started not feeling very good. She received her covid vaccine in her right arm. Around 1:00, her left butt cheek was in excruciating pain, then the pain spread to the back of her leg, and to her knee cap. Her left but cheek, back of leg and kneecap all felt numb, but also felt on fire at the same time. It just really hurt. By 4:00PM, she was hurting so bad, and it moved to her vagina and left leg. It did not bother her right leg. It was only bothering her vagina, butt cheek and left leg. About 16:00 to 16:30, her urinary tract started burning. She was peeing. She was using the bathroom a lot. Her husband came home around 5:30PM and co convinced her to take a hot shower. By 8:00PM, she could not take it anymore. She sent her husband to go get her something for a urinary tract infection. Her husband got her some cranberry juice, and over the counter AZO medication for urinary tract infection. Her back of leg was hurting. She had her husband look at it, but nothing showed up. She did not know that you could not see a blood clot visually. She laid on the sofa and fell asleep. About 1:00, she woke up itching. She was itching on her right arm, wrists and fingers (medically significant). She went to the bathroom, and woke her husband up because from head to toe she was tomato red. She took some Benadryl and went back to her bed. She was still in pain in her left leg, butt cheeks and vagina. She began having vagina spasms. She knows that what she is about to say sounds gross, but she does not know how else to describe it. She literally felt like half of a fish was inside of her vagina, and it was flopping around. She stayed awake and was worried. She was thinking about going to the hospital. She called her doctors on call number, and her they told her to go see her doctor first thing the next morning. Her throat and face were swollen also. She was still red all over. She has shellfish allergies. Her chest felt heavy also. Her doctor looked her over and checked for a urinary tract infection. She took AZO over the counter medication, so the urinary tract infection did not show up. Her tests did grow cultures, but no urinary tract infection showed up. While she was at the doctor, the doctor checked her reflexes. Her left knee had a reflex. Her right knee had no reflex whatsoever. It did not matter where or how hard the doctor hit here right knee. She saw a nurse practitioner, not a doctor. The nurse practitioner did not want to give her a steroid shot. The nurse practitioner wanted her to hold on to as much of the covid vaccine as possible. The nurse practitioner told her to take four Benadryl's a day until her symptoms stopped. She got about 16 minutes from her doctor's office, and she started getting bubble blisters on her arms, fingers, and over her chest, above her boobs. The bubble blisters lasted for two days. Now she has red spots where some of them were. She went to the doctor on a Tuesday. The bubble blisters did not alleviate until Saturday or Sunday. She was told not to get the second dose of the covid vaccine. Her symptoms after the first dose were scary. Her doctor said that she did not have an urinary tract infection, but her sample grew cultures. Her doctor told her that her urinary tract burning had nothing to do with covid. She is an esthetician, she does facials. She knows of three or more people that are her age, in their 60s that have not had a urinary tract infection for the past 25 years. Those people all had a urinary tract infection after getting the covid vaccine. No further information provided. Her symptoms began on Monday, 05Apr2021. Over the weekend, her arm was extremely sore. Excruciating pain in her left butt cheek, back of leg, and kneecap: Her left but cheek, back of leg and knee cap all felt numb, but also felt on fire at the same time. Began on 05Apr2021. It began as a tingle. She knew that it was hurting a lot. At first, she could not pinpoint what it was. The pain moved to her vagina and left leg: Clarifies that it moved down her left leg, over her vagina, to her knee cap. It kept going and stopped at her other leg. She takes Estrogen vaginally. She states that Benadryl helped slow down all of that down. 08Apr2021 through 11Apr2021, she was recuperating. She has complications with having no taste: She does not taste metal, or anything. She feels like she is having trouble cooking, but her husband tells her that her cooking has been wonderful. The food she makes tastes horrible to hear. She feels like her sense of taste is getting a little bit better. Her urinary tract started burning. She was peeing and peeing and peeing. She was using the bathroom a lot: Began about 16:30. She did not have an urinary tract infection, but her sample did grow cultures. She was prescribed Amoxicillin on 07Apr2021. Her symptoms had lessened by 07Apr2021. She does not know if she needed the Amoxicillin. 07Apr2021 through 09Apr2021, she felt so much better. She was itching on her right arm, wrists and fingers: Began about 1:00 on 06Apr2021. She took four Benadryl a day. The itching was annoying to her in certain spots. The itching lasted through 13Apr2021 or 14Apr 2021, she is not sure the end date. She was tomato red from head to toe: Began about 1:00AM on 06Apr2021. It went away 08Apr2021 or 09 Apr 2021. The redness went away the same time as the swelling. Her throat and face was swollen: Began about 1:00 on 06Apr2021. It went away 08Apr2021 or 09Apr2021. Her right hand and arm was swollen: Began about 1:00 on Apr 06 2021. It went away 08Apr2021 or 09Apr 2021. She began having vagina spasms. She literally felt like half of a fish was inside of her vagina, and it was flopping around: Her vagina hurt before she went to sleep. But the spasms did not start until the middle of the night. The spasms lasted all day, for a good ten hours. The vagina spasms have not happened again. Her chest felt heavy: Began about 1:00 on 06Apr2021. Her right knee had no reflex whatsoever. It did not matter where or how hard the doctor hit her right knee, it did not move: Began Tuesday, 06Apr2021. Now she thinks that her knee is just fine. It was just weird. She started getting bubble blisters on her arms, fingers, and over her chest, above her boobs: The bubble blisters lasted for two days. Now she has red spots where some of them were. The bubble blisters lasted until the evening of 07Apr2021. Most of the bubble blisters have went away. The bubble blisters on her wrist went away around 08Apr2021. Indication was she has three children. One of her children is an extreme democrat. Her other two children are democrats. Her democrat daughter did not have anything to do with her if she did not get the covid vaccine. At her age, she could not risk it. She has a lot of junk going on. She is allergic to everything. She has five bulging discs. Her two republican daughters did not want her to get the covid vaccine, they wanted her to wait and see how it affected everyone else. Her democrat daughter was losing it. Outcome of the event She has complications with having no taste was recovering. Outcome of the event It did not matter where or how hard the doctor hit here right knee and Her left but cheek, back of leg and kneecap all felt numb, but also felt on fire at the same time. It just really hurt was unknown. Outcome of the events she began having vagina spasms. She literally felt like half of a fish was inside of her vagina, and it was flopping around was recovered on 06APR2021. She started getting bubble blisters on her arms, fingers, and over her chest, above her boobs was recovered on 07Apr2021. Excruciating pain in her left butt cheek, back of leg, kneecap and Her chest felt heavy and The bubble blisters on her wrist was recovered on 08Apr2021. Her urinary tract started burning. She was peeing and peeing and peeing. She was using the bathroom a lot was recovered on 09Apr2021. Outcome of the other events was recovered on unspecified date in APR2021. Information on Lot/Batch number was available. Additional information has been requested.

Approximately 2 days post vaccination individual experienced a sudden onset of headache, felt hot, started sweating then reportedly lost consciousness. During episode bystanders state patients eyes rolled back in her head, she vomited and she urinated on herself. Episode lasted a few seconds and was not followed by a post ictal period. Patient was taken to ER and subsequently admitted for further evaluation.

I had Covid-19 in March 0f 2020. In July 2020 I had Pneumonia. The night that I got the second dose of the vaccine I woke up with a temperature and I had fever, chills and body aches. It lasted for 18 hours and then I was fine. Five months after the second dose of the vaccine I started to have abdominal pain. It was like menstrual cramping. I had a fever, and the pain was severe. I was nauseous and I drove myself to the ER. I was diagnosed with diverticulitis and a urinary tract infection. My colon was so swollen that it displaced my bladder. I was admitted and given IV antibiotics and now I am on oral antibiotics.

Patient was hospitalized with COVID, diagnosed on 7/18/2021; currently in our ICU; AKI, possible bacteremia

Kidney pain; Jaw lymph nodes swelling; Jaw lymph nodes pain; Fatigue; Injection arm pain; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Apr2021 at 10:00 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetic, asthma, high bp (blood pressure high), obese (obesity), arthritis and disc problems. The patient received many unspecified medications within two weeks of vaccination. The patient previously took sulfa (MANUFACTURER UNKNOWN) for unknown indication and experienced drug allergy on unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 12:00 the patient experienced kidney pain, jaw lymph nodes swelling (swollen lymph nodes) and pain (lymph nodes pain), fatigue and injection arm pain (pain in arm). The patient did not receive any treatment for the reported adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events kidney pain, jaw lymph nodes swelling, jaw lymph nodes pain, fatigue and injection arm pain were not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Patient was found in house by EMS with agonal respirations. Patient was intubated on scene and brought to ER. At ER, patient presented with a HR of 55, BP of 80/43, O2 of 99%, and a rectal temperature of 107.3F. Further work-up revealed thrombocytopenia with a platelet count of 63, WBC of 13.7, and an elevated lactate of 2.2. Imaging shows a kidney stone obstruction of the right ureter. Diagnosis of sepsis was made with patient admitted to the hospital. Repeat rectal temp after acetaminophen suppository and external cooling continues to be 107. Care is ongoing at time of this report.

26 hours following vaccination I developed a severe UTI. I have never had a UTI before, and not sure this is connected to the vaccine, but thought I would go ahead and report.

Arm numbness extending to wrist, immediately after injection. 48 hrs. later patient states experienced "upper body" swelling, "heart racing", "throat swelling", "lymph nodes" swelling, "trouble swallowing", "kidney pain"

I thought that I had kidney stone; aches and pain/Pain in my right side was very severe/Body ache; Foggy brain; When I stood up and I had been standing for a minute or two and it wasn't that I got up too fast and then I got very dizzy; almost passed out; can't even focus; I was not feeling well; They did gave me Cyclobenzaprine, Prednisone and Hydrocodone and I took them for two days and then I just stopped because it was just making it worse and then I was foggy and couldn't event get up; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 12Mar2021 (Batch/Lot Number: EN6206) as SINGLE DOSE for COVID-19 immunisation; cyclobenzaprine, prednisone and hydrocodone; all via an unspecified route of administration from an unspecified date (Batch/Lot Number: Unknown) to an unspecified date, at unspecified dose for an unspecified indication. Medical history included COVID-19 from Dec2020 to an unknown date. The patient's concomitant medications were not reported. The patient stated, "First, I had COVID back in early December and then on 12Mar2021, I got my first vaccine and I have lot of aches and pain and very foggy brain. I was just with the 'chiropractor' and he was just with me and I stood up and we were talking and I just got super dizzy and almost passed out, I just don't know. I missed, I can't even focus." When clarified the concern, the patient stated, "When I stood up and I had been standing for a minute or two and it wasn't that I got up too fast and then I got very dizzy and almost passed out, luckily there was a chair to catch me. So, my concern is, do I get the second vaccine if I already had COVID, should I didn't had this first vaccine since I already tested positive? When I had COVID, I was very cloudy in the brain. I don't know if this is a part of side effect, I am trying to find out if I can get the second vaccine." The patient experienced kidney stone. The lab data is clear, upon checking, the blood and urine samples. CAT scan has been done and the report is clear. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

1st reaction - Day 1 As I was walking to my vehicle, after waiting my 15 minutes, I had an awful metallic taste in my mouth. I had to spit out the saliva, which helped, but it still lingered for a few minutes. 2nd reaction -Day 1 After several hours, I experienced swelling in my right arm, and diarrhea. I also had insomnia, and slept very little the night of the shot. Day 2 I had loose stools, slight nauseous feeling most of the day. My body odor smelled like onions. I also had bad muscle aches and fatigue. That night, I had insomnia again and slight chills. Day 3 Still had loose stools, fatigue and muscle aches. The onion smell comes and goes. I experienced excessive urination throughout the day (about once an hour, which is not usual for me). Day 4 Muscle aches and fatigue are gone, Day 5 Excessive urination again. Onion smell comes and goes.

Began feeling unwell, had urinary urgency, and was itching shortly after 2nd dose of Pfizer COVID-19, then found obtunded due to pulmonary embolus resulting in death within 24 hours of receiving 2nd dose

N17.9, N18.9 - Acute kidney injury superimposed on chronic kidney disease (CMS/HCC) E87.5 - Hyperkalemia R06.00 - Dyspnea, unspecified type R53.1 - Weakness R73.9 - Hyperglycemia E11.10 - DKA, type 2, not at goal (CMS/HCC)

She is concerned because she has urinated on herself twice today without the sense of urgency. It happened this am while putting her key in the door to bring groceries in and this afternoon while watching TV on the couch. She has made an appt with her MD on Friday at 11:30am. I told her that we will follow up with her on Friday around 3pm to see how her appt went and to see if she has had more episodes or if it ceased. Doctor's appt 4/16/21 @ 11:30

Patient presented complaining of worsening SOB over the past 3 days. She reports leg swelling, as well. Patient was found to have a heart failure exacerbation and critically high potassium, prompting admission to the hospital. Patient received calcium gluconate, insulin, dextrose, and Kayexalate.

Within 24 hours of vaccine dose, patient had one episode of blood in urine. No further episodes. No other symptoms

My first dose was administered on Mar. 5th, 2021. On March 18th, 2021 I had a spontaneous anaphylactic reaction requiring the use of Benadryl and an inhaler. 40 minutes after second injection (Apr. 2nd, 2021) my face became bright red - which is usually the beginnings of an allergic or non-tolerant reaction to something to which I've come in contact. A Benadryl dose resolved this reaction within 20 minutes. On April 10th I had a spontaneous anaphylactic reaction requiring the use of Benadryl. 12 Days after second dose I noticed my tongue feeling raw and started feeling a UTI beginning. By 14 days after second dose I had approximately 14 pea sized lumps on the back and back sides of my tongue, the gums of my teeth were very swollen and sore. The roots of my teeth ached terribly, chewing was very difficult. My ears were both very itchy deep within. I was seen my my physician on April 20th, 2021 and diagnosed with Candida Overgrowth.

Just wondering if anyone else has reported blood in their urine. About 3 weeks after receiving the first dose I saw blood in my urine for 3 days (April 10, 11, 12). I was going to see a doctor, but the issue disappeared and I had no other symptoms (fever, pain, etc.) that one would associate with a bladder infection or UTI. (BTW, I have never ever had a bladder infection or UTI.) After hearing about some patients developing blood clots after receiving the J&J vaccine, I wondered if the Pfizer vaccine had caused some sort of clot to form in my bladder and then dissolved and was eliminated when I urinated. I am waiting to see if the same thing will happen now that I've received the second shot....

Symptoms: Patient reports balance issues since receiving her COVID vaccine. (received vaccine 4.16.21) She fell the first evening (4.16.21) after losing her balance. She denies significant dizziness, weakness or numbness. She fell again yesterday (4.27.21). (called nurse triage line to report on 4.28.21) She also reports worsening of her urinary incontinence and isn't sure if its related. She reports a headache only because she fell hit her head when she fell. Balance issues-recent fall twice concern seeking medical advice Noticed no balance control Noticed increased of dreams of falling while sleeping first fall on same day of vaccine 7:30pm second fall yesterday -around 10am Symptom duration: couple days Recommended ED or Urgent Care - no follow up or visit by patient at this time of reporting (evening 4.28)

Hives upper torso (within 8 hours of shot) Orange urine and less urination (within 12 hours of shot) Swelling of joints and exhaustion (within 3 hours of shot) Nausea- loss of appetite (within 3 hours of shot)

severe arm pain; Nausea; Dizziness; klebsiella pneumoniae, 50,000 to 100,000 cfu; Headache; Urine retention; blood and blood clots in her urine; blood and blood clots in her urine; tore or messed up a ligament in her hand; This is a spontaneous report received via a Pfizer-sponsored program, from a contactable nurse (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number not reported), via an unspecified route of administration, administered in arm right on 31Mar2021 (at the age of 62-years-old) as 2nd dose, single for COVID-19 immunisation. Medical history included fibromyalgia from 1996 and ongoing, allergies from 1981 and ongoing, hypothyroidism and is pre-diabetic from 2012 and ongoing, Lyme disease from an unknown date and unknown if ongoing, concussion from Sep2019 to an unknown date, post-concussion syndrome from Sep2019 and ongoing , seasonal, food and chemical allergies from an unknown date and unknown if ongoing and had wisdom teeth extracted on an unknown date. The patient's concomitant medications were not reported. The patient previously took nalbuphine hydrochloride (NUBAIN) and experienced anaphylaxis. The patient previously received the first dose of BNT162B2 (Batch/Lot Number: EN6206), administered in right arm on 10Mar2021 for COVID-19 immunisation and experienced Face and ears became very flushed, red, and itchy, Headache, headache was more like a migraine/felt like a migraine, but worse, Post concussion syndrome was retriggered, not eating well and had lost some weight, feeling more worn out, she is allergic to alcohol and thought maybe it was the glycol in the COVID-19 vaccine that caused the reaction, flu like symptoms, achiness all over, pelvic pain and pressure, some burning during urination, did not have the energy level and stamina that she used to, blood in her urine and clots, she was not able to release the urine (urine retention), Nausea and Dizziness. About a week after receiving the second dose of the Covid-19 vaccine on 31Mar2021, she noticed the feeling again of retaining the urine. She was not swollen or anything and immediately went with increased fluids. The urine retention was not as severe at that point. It really showed up and intensified quickly with groin pain, pelvic pain, abdominal pain, and some back pain. She woke up the next morning after being doubled over in pain the night before and there was so much blood in her urine that she couldn't see any urine. Her urine was the darkest burgundy and the color of the darkest wine. She did not have anything in her urine the night before when she was doubled over in pain. She was increasing fluids and even drinking Propel for the electrolytes to make sure she was not making things worse. She woke up around 5 AM and felt so sick to her stomach. She had nausea the night before, but she was really nauseated the morning that she discovered blood in her urine. She woke up with severe nausea last Friday, 30Apr2021. Her doctor performed a urine culture. The urine culture returned positive for Klebsiella Pneumoniae with 50,000 to 100,000 CFU/mL on 30Apr2021. She does not have the urine culture results from her first doctor visit. Her friend is an RN that is administering the Covid-19 vaccine, was talking to company representatives and told the caller that she needed to call company to make a report and see if anyone else has experienced the same adverse events. Urinary retention came back in Apr2021 following her second dose of the Covid-19 vaccine on 31Mar2021. She can really go to the bathroom, but she is still feeling the abdominal and pelvic pressure as well as some burning and pain. Her symptoms are improving but not enough. It feels like she always has a full bladder still. She tore or messed up a ligament in her hand and she has been going to occupational therapy. She can't seem to be able to handle a pain level like she used to. It seems like pain is triggering her feelings of nausea and dizziness. Her body is not doing things well right now. The day before, of, and after getting the Covid-19 vaccine, someone suggested taking electrolytes before the second dose of the Covid-19 vaccine, so she drank Powerade. She was expecting the symptoms following the second dose of the Covid-19 vaccine to be a lot worse and they were a walk in the park in comparison. She had a mild headache the first day, 31Mar2021. She woke up in the morning of 01Apr2021 and her headache was gone. Following the second dose of the Covid-19 vaccine, she had severe arm pain. It felt like she was walking around with someone constantly punching her. She was moving her arm all around trying to get it to stop hurting. She saw blood and blood clots in her urine for over 24 hours. The blood and clots were lessening over the 24-hour time period. She probably saw in a 2-hour period at least 60 clots about the size of a quarter to a half dollar. The pain was excruciating. She was taking Phenazopyridine but is still feeling a sense of urgency, burning, and sometimes pain during urination. Her doctor did give her a prescription for phenazopyridine, but it was cheaper for her to buy over the counter and take the same dosage. She has been taking generic Macrobid, Nitrofurantoin Mono, 100 mg twice daily. It was dispensed in a pharmacy bottle. She is seeing a urogynecologist tomorrow, 06May2021. The patient underwent lab tests and procedures which included culture urine: unknown cfu on 26Mar2021 and culture urine: klebsiella pneumoniae, 50,000 to 100,000 cfu on 30Apr2021. The outcome of the event Headache was recovered on 01Apr2021 while of the rest was unknown. No follow-up attempts are possible. No further information is expected. Information on lot number already obtained.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events. 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.

This is a spontaneous report received from a contactable nurse (patient) via a Pfizer-sponsored program. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6206), via an unspecified route of administration in the right arm, on 10Mar2021, as 1st dose, single, for COVID-19 immunisation. Medical history included ongoing fibromyalgia (diagnosed in 1996), ongoing allergies from 1981, ongoing food allergies and chemical allergies, ongoing allergy to alcohol, ongoing hypothyroidism from 2012, ongoing pre-diabetic from 2012, Lyme disease for 11 years before being correctly diagnosed and treated, concussion in Sep2019, and post concussion syndrome in Sep2019. The patient previously took nalbuphine hydrochloride (NUBAIN) in 1981 and experienced anaphylaxis; and paracetamol (TYLENOL) and was very sensitive, had rash and high blood pressure. Within the first 15 to 20 minutes following the administration of the first dose of the Covid-19 vaccine, on 10Mar2021, the patient's face and ears got very red, flushed, and itchy. The patient reported that she is allergic to alcohol and thought maybe it was the glycol in the COVID-19 vaccine that caused the reaction. She reported that she has had glycol before and has never reacted quite like that. The flushing, redness, and itchiness of her face and ears subsided within an hour and were gone by 4 hours. Her allergist instructed her to take 2 Zyrtec before getting the second dose of the Covid-19 vaccine. After her face and ears became flushed, red, and itchy, she ended up having a really bad headache that continued until the next day. Her headache was severe for about 12 hours and continued for a total of a day and a half. She stated that her headache was more like a migraine during the 12 hours when it was severe. It felt like a migraine, but worse. On 10Mar2021, the patient reported that she experienced flu-like symptoms like being nauseous, had dizziness, achiness all over, and was not feeling well, her post-concussion syndrome was triggered and had more headaches, dizziness, nausea. She reported that things have been going awry in her body since she had the COVID-19 vaccine. She reported that the increase in headaches seemed to have improved, but the nausea and dizziness have in some ways improved and then some days it feels like "here we go again" when it hits. About a week after she received the first dose of the Covid-19 vaccine, in Mar2021, the patient noticed a change in her urination. It wasn't severe or anything at that point, she just felt like she was not able to release the urine (urine retention). She thought to increase her intake to see if it would help her urinate and it didn't seem to help much. She received a prescription on 26Mar2021, and during that week, she noticed that she was having more issues with some burning during urination and was developing pelvic pain and pressure. The patient stated that the scent and color of her urine looked fine. She reported that the frequency started to increase with not much urine coming out. When she finished her antibiotics about 7 days later, the urine retention had really improved and went away at the end of March. In the morning of 26Mar2021, when the patient woke up, she had blood in her urine and clots. The clots were about the size of a pea and a couple were about the size of a dime. The blood and blood clots in her urine were what made her go to the doctor. She reported she has never had blood in her urine that she remembers. She was put on Macrobid for 5 days. She reported that Macrobid wasn't relieving enough of her symptoms and her provider ended up adding a couple more days. The patient reported feeling more worn out in Mar2021, since she received the first dose of the COVID-19 vaccine. This did not improve and some days it was worse. The patient did not have the energy level and stamina that she used to (Mar2021). She reported that whether it's combined with the retriggering of her post-concussion syndrome, it is significant for her life. She was also not eating well and had lost some weight (Mar2021). She reported that her appetite is improving but it is still not normal for her. She mentioned it was harder for her to want to eat something because of feeling nauseated. The patient assessed the events "face and ears became very flushed, red, and itchy", headache, "headache was more like a migraine/felt like a migraine, but worse", "post concussion syndrome was retriggered", "blood in her urine and clots", "not eating well and had lost some weight" and "feeling more worn out" as serious (medically significant). The patient recovered from "face and ears became very flushed, red, and itchy" and "she is allergic to alcohol and thought maybe it was the glycol in the COVID-19 vaccine that caused the reaction" on 10Mar2021; headache, "headache was more like a migraine/felt like a migraine, but worse", "she was not able to release the urine (urine retention)", "blood in her urine and clots", "flu like symptoms", dizziness, "achiness all over", "pelvic pain and pressure", and "some burning during urination" in Mar2021; and was recovering from "not eating well and had lost some weight". The outcome of the remaining events was unknown. The patient assessed the causality of events headache, flu like symptoms, nausea, "face and ears became very flushed, red, and itchy", dizziness, "post concussion syndrome was retriggered", and "not eating well and had lost some weight" as related to BNT162B2.; Sender's Comments: Based on the information in the case report and a plausible temporal association, A possible causal relationship between urinary retention, hemorrhage urinary tract and suspect drug BNT162B2 cannot be 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.

face got hot; she felt the pressure in her head all of sudden like a big air bubble trying to blow up; pressure in both her ears; excruciating pain from the top of her chest down to her right breast; excruciating pain from the top of her chest down to her right breast; excruciating pain that went down from her neck to her right breast; nauseous for a couple days; D-Dimer was also elevated, it was 0.7%; kidney function 62%; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program Covax US Support. A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm at age of 62 years old on 15Apr2021 14:30 (Batch/Lot Number: EW0153; Expiration Date: Jul2021) as single dose for covid-19 immunization. Medical history included ongoing high blood pressure/ hypertension. The patient's concomitant medications were not reported. No additional vaccines administered on same date of the Pfizer suspect, no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. With the first dose patient felt nauseous (2021) for a couple days and she also felt excruciating pain from the top of her chest down to her right breast. She also felt pressure in her head and both of her ears. After receiving first Covid 19 vaccine on 15Apr2021, patient sat for 30 minutes and then she went to the store. Standing in the check out line was when she felt the pressure in her head all of sudden like a big air bubble trying to blow up and in both her ears. She went back to her car and sat there and that was when she felt right where her neck connected to her chest, in the middle, a little bead in the center, excruciating pain that went down from her neck to her right breast. The pain caught her off guard and she thought she should go to the emergency room, but she did not go to the emergency room. She had just received the Covid 19 vaccine and she was told that she can't take any medications or antibiotics after getting the Covid 19 vaccine for so many days. She went home and she prayed. She stayed at her house. She did call the facility where she received her Covid 19 vaccine and she was told that some people did experience a weird pain after receiving the Covid 19 vaccine and then the pain went away. The facility told her it was her immune system reacting to the vaccine. She decided to let it go but she did call her doctor and got an appointment for Tuesday, 20Apr2021. She had blood work done (in 2021) and that turned out ok. Then on Thursday, 22Apr2021, she had to cancel her appointment at her beautician because she had to pick up her grandchild. In her car, her face got hot and she thought did her air condition malfunction. Her air condition was fine. Then it happened again, her face got hot in her car again. She called her doctor and her doctor told her to come in and be seen. She was seen by a nurse practitioner (in 2021) and had an EKG and she did some other blood work. Her Troponin was normal but her kidney function had dropped. Her kidney function was always pretty good even though she has high blood pressure. Her kidney function was always around 92% or 108% but it dropped down to 62%. Her D-Dimer was also elevated, it was 0.7%, she stated normal range is 0-0.5%. She received a call from her doctor's office while she was at work and she was told to go and have a scan done (in 2021). She had a CT scan of her heart and lungs. That was negative. Why was her D-Dimer elevated, she was told it could be inflammation or there are so many things that could cause it. Her D-Dimer was just mildly elevated. Maybe she should have gone to the emergency room after the first Covid 19 vaccine but there was stuff she didn't know and she didn't know what the emergency room staff was going to do and she's just had this Covid 19 vaccine and its kind of like Jeopardy, she just didn't know what to do. Meaning she was afraid to take any medications or receive any treatments because she had just had the Covid 19 vaccine. Treatment information was not reported. Vaccine Administered was not at Military Facility. Physician Office visit requested for the events. No Emergency Room visit. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.

No treatment. Just took tylenol for the headache. The second dose was not as bad as the first dose. Just headache and body ache. I went to the doctor with these bladder infections. My doctor said to do the VAERS report.

Few days after receiving the vaccine around 4/25, my mother complained to me that she was feeling very weak and tired, she was unable to hold anything down. She also had a rash. She became weaker and weaker so suddenly and unable to even drink protein drinks. She finally went to the ER on 5/4 because she could barely walk, unable to eat anything and was short of breath. They diagnosed her with pneumonia and a possible lung mass. She was diagnosed simultaneously 10 days later with small cell lung cancer however she had no symptoms prior. She received first dose chemo on 5/20/21 and had a reaction to the chemo that the doctor stated was very rare. They then had to try a different type of chemo for second dose 2 days later. She progressively got worse suddenly after chemo dose #3 and was in renal failure the day following chemo completion. She died on 5/27/2021. Her primary death diagnosis was sepsis, pneumonia and small cell lung cancer. I am reporting this for my mother because the vaccine has not been tested on cancer or chemo patients. It can and should not be regarded as coincidental. It needs to be tracked in case there are future reports regarding cancer patients.

At 6:00 p.m. on April 23rd I realized my lower back was hurting on the left side. The pain became worse gradually throughout the evening and extended to the front pelvic/ groin area on the left side. Buy the middle of the night, I was able to make it to the bathroom but could not get back to the bedroom alone because of the severity of the pain. I had to call my husband to help me back to bed. The pain was severe the next day and my husband called the doctor on call. She prescribed large doses of tylenol, ibuprofen, and she gave me a muscle relaxant. I took those as prescribed for a week and stopped gradually when I saw blood in my urine. For about 5 days after the onset of pain, I was unable to put my pants on unaided, tie my shoes, or climb into bed. There was also an area on the lower left pelvic area that was numb. The pain and numbness gradually subsided over a number of weeks. At this time, there is still a small amount of pain and numbness in the pelvic area at times, but my back is fine. It felt like the vaccine affected a nerve in my lower spine that went to the pelvic area. This was my second dose of the Pfizer vaccine. When I got that second dose on April 7th, I had poison ivy. I also got a different rash on my left arm on April 14th. The vaccine rash lasted about 2 weeks.

I experienced on or about 05-02-2021; started to smell ammonia and it continued for awhile, it was a constant smell all the time then it would kind go and comes. I got concerned about my kidneys. I had some discomfort very slight in my abdomen area and I also had some headaches. I did not call the doctor right away, waited about two weeks. I did go see my doctor on 05-13-2021. I had full physical exam, blood panel, ordered at CT scan of head, have history of lymphoma, non-Hodskin type, that was in the tonsils and asked that I see a ENT specialists to rule out any problems with my sinuses on 06-08-2021. I saw an ENT, also did a sniff test, and there was no problems, no evidence of growth. I also pretty much aced the sniff test. Then my doctor ordered on 06-24-20201 an U/S of my kidney and bladder and another lab work up. The GFR was 53 in May 2021 then on 06-24-2021 my GFR was 55. I still have the ammonia smell but it is less frequent. I have scheduled a colonoscopy and will see what that turns out and will monitor with my doctor and then if my numbers do not improve then the next step of treatment is to see a nephrologist. I do not know that if what I experience is related to the vaccine. I have never had any trouble with my kidneys in the past.

Patient presented to the office with increased lower extremity weakness, imbalance, frequent falls, and numbness in her legs bilaterally. The patient stated that she started having also urine incontinence in last 24 hours. The patient did receive COVID-19 vaccine, Pfizer in June. Concerned about a CNS process disorder or even transverse myelitis, the patient was admitted directly to the hospital. The patient also had an unclear and puzzling rash on her dorsal aspect of her hands bilaterally and started having seen the rash on her foot. She attributed that recently to a sunburn, however, it has been 2 weeks with no improvement.

At about 45 minutes of having the vaccine I had an instant feeling of lethargicness, muscle weakness, little bit of coughing, just exhausted, I had to go lie down. The first week of May I went to the doctor, they did all kinds of blood work and everything was normal, except one thing, the EGFR level 51 which is incredibly low and dangerous, and 3 years ago my level was 78. I got it retested yesterday and the levels came back to 73-78. The blood work mentioned that race matters with this number. 2 weeks ago when I went back for my results the muscles in my back were hurting so the doctor gave me some mild muscle relaxers. They also did a bilateral kidney ultrasound with doppler. I have never had any sort of knee problems and I had to go to the doctor yesterday because suddenly this past weekend my knee swelled up on the joint and I have not been able to walk. They did some x-rays and blood work and I am going back on Monday to get the results.

Urinary tract infection; Injection site soreness/ Injection site pain; Achy; Headache; Sore on the injection arm; Her arm was stiff feeling; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect. A contactable consumer (patient) reported that a 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EL0140), intramuscular on 18Dec2020 15:00 at single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. The transferring agent stated that she has a caller on the line that received the first dose of the Covid-19 vaccine on 18Dec2020. She is supposed to get the second dose tomorrow 06Jan2021. She developed a urinary tract infection over new years and was put on antibiotics. She wanted to know if she could get the second dose while on antibiotics. The transferring agent stated that the caller reported that she started feeling achy and had a headache, but did not think it was related to the shot. She stated that she had injection site pain and was sore on the injection arm. She had the shot late in the afternoon around 15:00 on 18Dec2020. She said that she was sore later on that evening at the injection site and her arm was stiff feeling the next day, but it was resolved by the day after. She said that the headache came and went. She treated it with Tylenol. She said that she did not feel real good most of the day on Saturday 19Dec2020, but by Sunday she was back to normal again. The outcome of the event Urinary tract infection was unknown while the outcome of the other events was resolved on 20Dec2020.

dysuria, abdominal, pelvic, left flank, upper and lower back pain. bladder spasms, urinary frequency, headache, vision changes, loss of appetite, dysphagia and fatigue

Report from assisted living. starting 2-15-2021 Client was confused. UTI ruled out. She was wandering places she should not. She was in another residents room. She is speaking to staff in another language. VERY confused. Trying to eat her napkin. Unable to dress herself. 2-16-2021 incontinent. not normal for her. unable to stand up. very weak. still very confused. left arm pain. falling asleep mid sentence.

Pt developed a new onset, acute deep vein thrombosis approximately 6-7 days after vaccination in the R lower extremity with extreme pain and inability to bear weight.

3-11-21 pain in groin on right side/leg weakness around 2:00pm better next day just sore arm., Fatigue on 3-12 & 3-13. On 3-14 developed intense pain right side lower back and kidney. 3-16 went to Doctor as felt I had kidney infection but urine checked find, she thought it was muscle spasms. 3-19 broke out with shingles and back to doctor on 3-22 and given Acyclovir and Gabapentin. 3-23 went to ER. In as woke with pain so severe I broke out in sweat and threw up. Gave me Hydrocodone, nurse commented was worse break out she had ever seen. Internal pain is worse than the rash which is naval to spine and 3 to 4 " wide.

patient become diaphoretic and felt like she was going to pass out. pt wheelchaired to bed bp 100/64. pt never lost consciousness. bp came up to 126/74. pt called husband to come in and drank 2 apple juices. EMS requested at 1615. patient then stated she felt woozy and became diaphoretic again. repeat bp 85/56. it later increased to 109/68, sat 97, hr 82. pt also incontinent

dysuria; abdominal pain; pelvic pain; bladder spasms; left flank, low back and upper back pain; left flank, low back and upper back pain; headache; This is a spontaneous report received from a contactable nurse. A 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot number: EL0142) via an unspecified route of administration left arm on 14Jan2021 08:15 at single dose for COVID-19 immunization. Medical history was not provided. Concomitant medications included colecalciferol (VITAMIN D) and vitamin b complex. Patient previously took BNT162B2 (lot number: Eu1685) on 23Dec2020 07:45 to Left arm for COVID-19 immunization. On 26Jan2021 Lab data was reported as PCR test, Nasal Swab and Veritor rapid test results were negative. On 15Jan2021 the patient experienced with dysuria, abdominal pain, pelvic pain, bladder spasms, left flank, low back and upper back pain, headache. Patient received Bactrim, Toradol and Advil as treatment for events. Seriousness was reported as non-serious. Outcome of events was unknown. No follow-up attempts are possible. No further information was provided.

rash that was all over her body; Extremely red sunburn rash- really bad sunburn, most of it on torso, had it on legs/face was so red like the rough sunburn feeling; Eyelids red, itchy, and swollen; Eyelids red, itchy, and swollen; Eyelids red, itchy, and swollen; Felt dizzy and weak/had less energy today; Dizziness and lightheadedness /felt dizzy and weak; Worst and really sharp Charlie horse between ankle and calf- took forever to walk; Extremely dehydrated, kidneys were showing some damage, creatinine level was really off.; Extremely dehydrated, kidneys were showing some damage, creatinine level was really off.; Extremely dehydrated, kidneys were showing some damage, creatinine level was really off.; Anaphylaxis due to vaccination; Vomited; Major diarrhea; She was so cold that her toes were purple; Blood Pressure so low: 58, couldn't find a bottom number at first but then at the hospital it was 58/38; Face was extremely pale; could not function- she was beyond cold; felt like she was in a bad dream and couldn't wake up, couldn't walk. Feeling like she was getting the flu; could not function- she was beyond cold; felt like she was in a bad dream and couldn't wake up, couldn't walk. Feeling like she was getting the flu; could not function- she was beyond cold; felt like she was in a bad dream and couldn't wake up, couldn't walk. Feeling like she was getting the flu; Too cold to function or do anything; Nauseated- almost like morning sickness/Extremely nauseated/queasy feeling; Nauseated- almost like morning sickness; very extremely tired; creatinine /it was still high; sick; body temperature was low; She thought she was going to die because of the purple toes; but it seems like her nose won't stop running ever since she got it, sore from blowing- looks like Rudolph.; but it seems like her nose won't stop running ever since she got it, sore from blowing- looks like Rudolph.; her body catching up on sleep or she's just tired; This is a spontaneous report from a contactable consumer (patient herself). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6206), via an unspecified route of administration, on 11Mar2021 as single dose in left arm for COVID-19 immunisation. Medical history included ongoing High Blood Pressure (It's under control now, fairly healthy; diagnosed probably when she started menopause in early 50s), ongoing Anxiety (Diagnosed probably when she started menopause in early 50s), ongoing Sinus headache (Worst sinuses; Takes Excedrin because Tylenol does not have an effect on her), ongoing smoker (Pack a day, but smoking about only about half of it each time. started when she was a teenager. She was without a cigarette for 3 days in the hospital, but when she came home she had to start again), menopause (in early 50s), shoulder- torn rotator cuff-operated in 2018. Family history included cardiac and heart disease, Parkinson's and Frontal lobe dementia (husband). Concomitant medication included colecalciferol (VITAMIN D3) 1000 IU, once a day, by mouth (Taken these for as long as she can remember, they kept advising it, husband takes it for Parkinson's so she just throws one in for her), calcium ascorbate (VITAMIN C) 1000 IU, once a day, by mouth (Started at least 2 years ago, doesn't drink enough orange juice, doesn't do fruits, doesn't get enough Vitamin C), linum usitatissimum seed oil (FLAXSEED OIL) 1000 IU, once a day, by mouth (Started at least 2 years ago, family history of cardiac and heart disease, takes as preventative) for cardiac and heart disease, takes as preventative, fish oil 1000 IU, once a day, by mouth (Started at least 2 years ago, family history of cardiac and heart disease, takes as preventative) for family history of cardiac and heart disease, takes as preventative, hydrochlorothiazide, lisinopril 20/12.5 mg, once a day, by mouth (She has been taking this medication for years, under control with this medication) for High Blood Pressure, lansoprazole from 2020 30 mg, once a day, by mouth (Started years ago) for Stomach pill for acid reflux, duloxetine hydrochloride 60 mg, once at bedtime, by mouth (Started forever ago) for just being achy and anxiety, lorazepam .05 mg, 1 tablet 3 times a day, takes one tablet a day at bedtime, by mouth for Anxiety (Started this a while back- with the heart disease and everything else, gave this to help with menopause symptoms too), meloxicam 15 mg, at bedtime as needed from 2017 for back issues- really sore at times, takes if really stressed or she overdoes it. Patient previously took Tylenol for sinus headache and does not have an effect on her. After the first dose of the vaccine the patient reported that she was extremely tired on 11Mar2021. She was completely nauseated most of the day on the second day. On Saturday, she was extremely nauseated (12Mar2021) with vomiting and major diarrhea on 13Mar2021. By 4 PM that afternoon (12Mar2021), she could not function because she was so cold; she felt like she was in a really bad dream and couldn't wake up. She called on 13Mar2021, her blood pressure was so low-they got 58 for the top number, they were unable to pull up bottom number at that point. patient reported that when the ambulance arrived, they described her face as extremely pale on 13Mar2021; her major complaint was that she was so cold- she has never been that cold in her life. When she got to the ER- they had to use the old blood pressure cuff to get her blood pressure because it wasn't coming up on the machine- the kind where you pump it up and watch the needle, they said it was 58/38. patient states that they asked her about the rash that was all over her body in 2021; caller reports that she did not have a rash when she called at 4 PM. patient describes the rash as an extremely red sunburn rash- like you got really bad sunburn, most of it was on her torso, she also had it on legs on 13Mar2021. patient mentioned she remembers them taking off sock and her toes were purple on 13Mar2021. She also had a red on her eyelids- she described as itchy and swollen on 13Mar2021. patient mentions that unbelievably as sick as she was in 2021, she could understand everything that they were telling her. Treatment was given as they prescribed her Prednisone and Benadryl; she was also hooked up to an IV, and they were trying to warm up her body because body temperature was low in 2021. Discharge paper reads as anaphylaxis due to vaccination on 13Mar2021. patient states that she came home from hospital on Monday, 15Mar2021. patient reports she started a diet. 2nd day (12Mar2021)- From the time she got up, she was too cold to do anything; she couldn't walk and she was feeling like she was getting the flu. Saturday (13Mar2021)- She woke up and had the worst Charlie horse between ankle and calf- took forever to walk Charlie horse off. Really sharp Charlie horse. Even had less energy today. Really nauseated. patient reports that yesterday and today, she is just tired. She doesn't know if it's just her body catching up on sleep or she's just tired; she will find out today when she goes to doctor. Caller mentions that she is normally more active than she feels right now. patient reports her eyes have been itchy and she has a rash on her eyelids. patient doesn't know if it's from the shot; patient mentions that she decided on 01Mar2021 she would start a diet, get healthy, and see a nutritionist. patient reports that initially she didn't think her symptoms were from the vaccine and thought it was that she wasn't eating enough food on Friday. She got in touch with the dietitian. patient reiterated she did not attribute this to shot right away. patient reports that she was wondering if she had asymptomatic covid, and it would have been within a 3-month period that she reacted to the shot. She was not sick if she did have asymptomatic covid. There still trying to figure out why her body had this reaction. patient states that every now and then she was still cold, but she doesn't know if its her imagination and plus it is cold outside where she is. She is still on the cuff on that one. patient describes the nausea she first felt as almost felt like morning sickness on 12Mar2021-that's why she attributed it to her diet. patient mentions that the day she started feeling better, late Sunday afternoon, she wanted salty foods. Anything salty, chips, she just really wanted salty stuff. She was not normally a salt person, but the saltier it was, the better it was. patient reports that when she was vomiting with diarrhea and laying down, she would be throwing up in a towel because she couldn't make it to the bathroom when she was laying, it would just gush. patient describes it felt like her body was going to be locked into the position it was in, she doesn't know how to describe it. patient states that she had vomit on her clothes when she called. patient reports the nausea stopped late Monday and the queasy feeling went away. patient reports she stopped vomiting when they gave her Zofran- they had to give her a couple because she didn't stop throwing up right away. patient reports she was extremely dehydrated and her kidneys were showing some damage; her creatinine level was really off on 13Mar2021. The diarrhea was gone, but now she has a mixture of soft stools and semi formed. It is trying to improve but hasn't yet. patient states that because of her creatinine level, they did want her to drink and she might have soft stools because she was drinking so much. patient reports she knows when her husband put the shirt on her she did not have the rash, but when the ambulance arrived, they said she had the rash. Upon discharge, they told her not to receive any further covid vaccines- she cannot get her second one which was scheduled for 01Apr2021. She started experiencing the really cold feeling on 12Mar2021 after receiving the vaccine. She went to bed at 7, that's not like her, she was usually up all hours of the night. symptoms she was experiencing were beyond typical. patient reports she also felt dizzy and weak on 13Mar2021. She thought she was going to die because of the purple toes in 2021- she knew that was a sign of her body shutting down and she got the most scared. patient mentions she is experiencing a residual side effect from the covid and influenza tests-both were negative on 13Mar2021, but it seems like her nose won't stop running ever since she got it, sore from blowing- looks like Rudolph in 2021. patient reports she feels human today, but she is still sleepy in 2021. She thinks she would feel a whole lot better if her nose stopped running. The tiredness might be from nose blowing and stuff. patient remembers the nurse was thrilled that her toes weren't purple anymore. It started going away when her blood pressure and everything came back up. patient states that she was so scared that she was dying so she remembers everything that happened. patient remembers she was in the ER still when her blood pressure improved. Treatment for her face was so red like the rough sunburn feeling and putting moisturizer on the dried cheeks. patient reports that she doesn't see any patches of red on her. Part of her has a fear that the stuff is not totally out of her system and it will happen again. patient mentions she has heard comments that this was not a typical reaction from the first one and wants to know if it is typical to be that sick from the first dose. patient reports that now her eyes just feel like she's allergic to something. She doesn't know if the redness is from crying now- it was improving, but was still there. Husband has Parkinson's and Frontal lobe dementia and she is his caregiver, she cannot afford to get Covid, she wants to get back to normal. patient reports that she did not take any of her prescriptions the day of the vaccine, she did not want to get a reaction. patient reports she had her shoulder- torn rotator cuff-operated on in 2018. If nose is really stuffed up or allergies, or Fluticasone nasal spray- she can take it 2 times a day, 2 squirts in each nostril, take it as needed. patient reports that she has the worst sinuses- when it gets too bad, she'll go to the doctor and she'll prescribe Flonase, take Metamucil or whatever she thinks will help with sinuses. she still wants to get the second vaccine. patient reports her creatinine came down well enough that she could come home from the hospital, it was still high on 15Mar2021 so they told her to drink lots of water so she does not get dehydrated. Patient was hospitalized from 13Mar2021 to 15Mar2021 for Anaphylaxis, Tiredness, Nauseated, Morning sickness, Vomited, Activities of daily living impaired, Walking difficulty, Flu like symptoms, Pale, Photosensitive rash, Asthenia, Dizziness, Charley horse, Dehydration, Renal disorder, Creatinine low, Cold, Diarrhea, Purple toes syndrome, Blood pressure low, Redness of eyelid, Eyelids itchy sensation of, Swollen eyelid. For rash also patient was hospitalised. The outcome of Vomited, Pale, Photosensitive rash, Dizziness, Asthenia recovered on 13Mar2021, Nauseated, Morning sickness recovered on 15Mar2021, Activities of daily living impaired, Walking difficulty, Flu like symptoms recovered on 17Mar2021, Diarrhea, Cold, Blood pressure low, Purple toes syndrome, Redness of eyelid, Eyelids itchy sensation of, Swollen eyelid were recovering, Tiredness and Creatinine high were not recovered, while remaining events were unknown. No follow-up attempts are possible. No further information is expected.

approximately 10 days after the first shot i began to have heart palpitations, hot flashes, chills, nausea, headache, dry mouth, fatigue, increased urination. Day 11 was the worst. Day 12 I felt 90% better.

Progressive ascending weakness (R>L) with urinary retention. MRI spine showing T6-conus longitudinally extensive non-enhancing lesions and minimally enhancing 3x 2.3cm L thalamic lesion. Differential diagnosis includes post-infectious vs post-vaccine autoimmune demyelinating process such as ADEM-like picture with transverse myelitis vs paraneoplstic process. Lower suspicion for primary CNS lymphoma. -s/p brain biopsy 4/7/21 -s/p 5 plasma exchanges with two more planned

N17.0 - Acute kidney injury (AKI) with acute tubular necrosis (ATN) W19.XXXA - Fall, initial encounter N39.0 - UTI (urinary tract infection) R73.9 - Hyperglycemia

Thrombocytopenia AKI (acute kidney injury) Neutropenic fever C. difficile colitis Hypotension, unspecified hypotension type Sepsis

She got the vaccine, and had a sore throat initially. She felt in her mouth that it was swollen the first night. Had a slight headache and a slight tiredness. On Tuesday, the next day she felt unwell, but nothing abnormal about that. That evening she had a fever, surprising to her as it was already the 2nd day. The next day from there Wednesday, was weak, a little dizzy. Then on Thursday she started feeling very very dizzy, she felt it coming on and about 10 minutes after she felt that she felt as is she was going to faint, very dizzy feeling. She said it out loud so that somebody could recognize she was having problems. She slumped into the chair with dizziness and not feeling well, a lot of weakness. Since yesterday the sore throat has continued, and has had a cough since the beginning also. She also had on Tuesday some diarrhea, but nothing too serious Since yesterday she is still dizzy, has a canker sore, lips feel a little more puffy, still has headache. She does not feel that she needs to go to the hospital, but still feeling unwell. She also did have the arm pain at the injection site, and felt that she was getting better as her reaction didn't seem so severe and went away quickly. She did not take anything for her symptoms. She also did have burning on urination. She also had chest discomfort/burniness.

1) March 19, 2021: Intestinal discomfort and diarrhea for 2 weeks. Treated with over the counter drugs and food (BRAT diet). Resolved after 2 weeks. 2) April 10, 2021: Urinary Tract Infection, urine lab test, antibiotics, not resolved yet. Still have cramps and will follow-up with my doctor. I have NEVER had a UTI before.

1 shot- fatigue only 2nd shot- hard to tell I was diagnosed with a UTI and told to start on Macrobid that night- I definitely did not feel well for several days but am not sure which was the cause. skin issue started 11 days later ( I did have a massage the day before)

UTI; This is a spontaneous report from a Contactable Consumer (patient, self-reported). A 64-year-old female patient (age at the time of vaccination 63 year) received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL9262 and expiry date: 31May2021), via an unspecified route of administration, in Arm Left, on 25Jan2021, as a single dose for COVID-19 immunization. The patient's medical history included urinary tract infection (UTI) and it was not unusual for her to get UTI, she got them frequently. Concomitant medications were not reported. The patient reported that on 28Jan2021, she woke up with the UTI today. The patient stated that she knew they were not related because she got them periodically and asked what she could do about taking antibiotics, did that effect the efficacy of the product. The patient stated that she was scheduled to have a call with the doctor today, but he was not called yet. Usually, the doctor tells her to go on Macrobid. The patient clarified that she currently did not have an answer from the doctor yet, she was not prescribed anything yet and her UTI felt about the same. The patient's weight was 114 lbs or 115 lbs. The patient declined to provide an address; she did not want anything sent to her in the mail and they could email her. Outcome of the event was not recovered. Follow-up attempts are completed. No further information is expected.

Stomach pain; Kidney pain; Vomiting; Vascular stomach issue; Chills; Mild body aches; This is a spontaneous report received from a contactable consumer. A 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EP7533) via an unspecified route of administration in Left Arm on 30Apr2021 12:00 as 2nd dose, single for COVID-19 immunization. Medical history included cerebellar ataxia and breast cancer from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient was having no allergies. Prior to vaccination the patient was not diagnosed with COVID-19. The reporter also reported that the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EN6206) via an unspecified route of administration in Left Arm on 02Apr2021 01:00 as 1st dose, single for COVID-19 immunization. On 06May2021 the patient experienced stomach pain, kidney pain and vomiting. On an unspecified date Patient also experienced chills, vascular stomach issue and mild body aches in 2021. The seriousness of the stomach pain, kidney pain was reported as serious, which leads to hospitalization for 3 days. The clinical outcome of the events was not recovered. Follow-up pending was reassigned. further information has been requested.

On day 14 post second vaccine, I spiked a 102 degree fever at 2am and experienced excruciating low back pain and body aches. Afraid that I somehow contracted COVID despite taking all precautions, I went to the urgent care center mid-day. Abbott rapid test negative. Chest and abdominal X-rays clear. Blood and protein in urine, so assumptive diagnosis was kidney infection. However, urine was very clear not cloudy and I never had any UTI symptoms. Received injection of rocephin and 7 day course macrobid. No symptoms after 3 days. Lab lost urine so no culture results. Seems very coincidental that occurred at exactly two weeks. Possible nephritis/kidney inflammation caused by immune response? Maybe not, but I thought it important to report in case there are other similar instances.

Pfizer-BioNTech COVID-19 Vaccine EUA: one day after vaccination patient presents for regular dialysis session with diarrhea and cough. Dialysis session not completed, patient transferred to emergency room, found to be hypoxic with rhinovirus, pulmonary edema, and fluid overload. Patient received oxygen, underwent emergent dialysis with symptom improvement, and was discharged to home medically stable.

hypoglycemic shock; positive for covid 19; mobility issues; gets out of breath easily; weak; couldn't remember anything which wasn't normal; WBC was elevated; headaches; went sky high into the 500s and they couldn't control it in the hospital; viral pneumonia; renal failure; Her blood sugar was 28; Covid fog; was not eating or drinking; throw up; This is a spontaneous report from a contactable consumer or other non-health care professional (patient daughter) via Pfizer. A 63-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, solution for injection, Batch/Lot number was not reported and expiry date unknown) via an unspecified route of administration on 25Mar2021 (at the age of 63-year-old) as 1st DOSE, SINGLE for covid-19 immunization. Patient took vaccine as she wanted to fly on an airplane and not worry as heavily. Medical history included ongoing diabetes mellitus, patient had diabetes for at least 5 years, ongoing high blood pressure from an unknown date, reporter think patient high blood pressure was more with her weight because patient was obese. Patient was immunocompromised with her diabetes. Patient had no relevant family medical history. Concomitant medication included ongoing metformin (METFORMIN) taken for diabetes mellitus. Patient has been on it for years. Reporter believed she was on the max dose that she thinks was 2000mg, but could be wrong. Patient was not eating or drinking from 03Apr2021 and did throw up. On 06Apr2021 patient was tested positive for Covid and experienced hypoglycemic shock at 11:00, renal failure and Covid fog. Reportedly, patient also experienced viral pneumonia, mobility issues, gets out of breath easily, weak, her blood sugar was 28, covid fog, couldn't remember anything which wasn't normal, wbc was elevated and headache. The patient was hospitalized for hypoglycemic shock and COVID-19 from 06Apr2021 to 17Apr2021 (11 days), then discharged and was told by her HCP to wait 8-12 weeks before getting second dose of Pfizer covid vaccine. Patient scheduled to receive second vaccine dose 15May2021. Reporter was told that it was a max of 42 days that patient can get the second dose of the vaccine, but that has obviously since passed. They want patient to come in and get a second first shot. When patient was admitted, the doctor thought patient had viral pneumonia already for at least a week, so it would have started about when she got the shot. Patient was better, she was not on oxygen anymore, but she still gets out of breath easily. Patients mobility issues started when she came down with symptoms. Patient had renal failure and was weak. Patient was not eating or drinking. Patient was diabetic and she had hypoglycemic shock which was what put her in the hospital. Reporter thought it was probably a cold or flu or something and Easter happened where she was not hungry and did throw up. Reporter thought it was something she ate that was bad. When she had the hypoglycemic shock reporter could not wake her and patient was in some kind of unresponsive state from 11:00 to about 15:45. Patient blood sugar was 28 when the paramedics arrived. They were able to get her responsive and transferred her to the hospital. They ended up putting her on a dextrose drip because they could not keep her blood sugar up. They put her on steroids and the number went sky high into the 500s and they could not control it in the hospital. There was a lot of stuff that happened. Reporter did not believe that patient has any lasting effects from the hypoglycemic shock. Patient sugar was back to normal and she was on her normal medications. Patient was off insulin which they gave her in the hospital, so that part was okay. Patient was dealing with Covid fog also. Reporter does not know if it has to do with blood sugar or how the virus attacks the body. Patient had multiple MRIs because they were worried, she had a stroke, and she said she could not remember anything which was not normal. Patient not eating and drinking started right before Easter and was much better. Reporter believed that at about 14Apr2021 or so patient started to eat better and have more of an appetite for food. Patient has recovered completely. The reporter did not notice the Covid fog until her mother was in the hospital on 06Apr2021. She does not remember her first week in the hospital, and then even when she was discharged on 17Apr2021 that whole next week she was still very foggy. The reporter would say she was better now. patient talks normally and was back to swearing which is perfectly her. Patient has recovered completely at this point. Patient mobility was better. Patient was not using the walker in the house today, and her balance was better. It was probably due to some of the side effects of the medicines they added like a beta blocker and other things to make sure she was okay. Regarding kidney failure started, reporter stated on 06Apr2021 patient creatinine was 3.99. Patient also had a high D dimer and were worried about her clotting and throwing a PE or something. That was mostly in the first few days around the 6Apr2021, 7Apr2021, 8Apr2021, 9 Apr2021, 10Apr2021 when they were not sure what was going to happen. The following week patient was still at 5 to 6 liters of oxygen, but by Friday night 16Apr2021 she was down to 1 liter of oxygen. Patient did not come home on oxygen. Reporter believed patient kidneys have recovered, but she did not know. The patient underwent lab tests and procedures which included blood creatinine: 1.47 on an unknown date, 0.97 on Sep2020, reporter does not know if it returned to 0.97, but the last number she knows of was 1.47, 3.99 on 06Apr2021, blood creatinine: 1.47 on 17Apr2021. Patient had normal bloodwork in Sep2020 and her creatinine was 0.97. Reporter did not know if it returned to 0.97, but the last number she knows of was 1.47. That would have been when patient was discharged from the hospital. Blood glucose: 500s on an unknown date in Apr2021, blood glucose: 28 on 06Apr2021. On 06Apr2021 patient was tested positive for Covid. On an unknown date patient got CT, high d dimer, CBC, MRI, metabolic function test, white blood cell count, X-ray and Chem 28. Reportedly, bloodwork were done daily in the hospital, and patient has had bloodwork once since she was discharged. WBC was elevated so they did a blood culture to make sure patient did not have an infection. The culture was negative. There were no additional vaccines administered on same date of the Pfizer suspect. There was no prior vaccination within 4 weeks. There were predisposing factors diabetes and immunosuppression. Patient started Tylenol pill on 06Apr2021 after vaccination at an unknown dose. They gave it to her continuously because she had bad headaches. They started her on antivirals and took her off of Remdesivir because of her kidneys. They put her on a different antiviral that the reporter did not remember the name of and a biologic. Home health just discharged patient, and she was still dealing with viral pneumonia and mobility issues. Patient was still on different medicines and she normally was not. The report is related to study or programme. The outcome of the event hypoglycemic shock was recovered on 06Apr2021 and was not eating or drinking was recovered on 14Apr2021, viral pneumonia, mobility issues, was recovering, renal failure, positive for covid 19, gets out of breath easily, weak, her blood sugar was 28, went sky high into the 500s and they couldn't control it in the hospital, covid fog, couldn't remember anything which wasn't normal, wbc was elevated, throw up and headaches was unknown. Follow-up attempts are completed; information about lot/batch number cannot be obtained

I had a urinary tract infection after each dose. I have never had a UTI in my life - until these two.My elderly father also received 2 doses of the Pfizer covid vaccine with me, and he had a urinar; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 63-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9267 and expiration date was not reported) via an unspecified route of administration, administered in arm left on 16Feb2021 12:30 (at the age of 63 years) as a single dose for COVID-19 immunization. Medical history included blood cholesterol increased managed with atorvastatin, drug hypersensitivity from an unknown date and unknown if ongoing along with known allergies that is Penicillin, known allergies that is Soy from an unknown date and unknown if ongoing known. Concomitant medication(s) included atorvastatin (20 mg, 1x/day [daily in evening) taken for Slightly elevated cholesterol, start and stop date were not reported and calcium (ALGAE CALCIUM) taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 post vaccination. Historical vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN5318 and expiration date was not reported), first dose via an unspecified route of administration, administered in arm left on 26Jan2021 12:30 as 1ST DOSE, SINGLE for COVID-19 immunization. On 16Feb2021, the patient experienced at 18:00 had a urinary tract infection after each dose. Patient never had a UTI in her life until these two. Cranberry juice was used to treat the adverse event. Reporter assessed the event as non-serious. The outcome of the event was recovered on unspecified date. No follow-up attempts are possible. No further information is expected.

J18.9 - Pneumonia, unspecified organism N17.9 - Acute kidney failure, unspecified I21.4 - NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC)

Extrême fever and unaware of surroundings for 1 day. Then chemical odd smell of urine and pain /burning upon urination, then urination became very infrequent and so did bowel movements. Extreme abdominal swelling which has continued for over 1 week. Slight dry cough.

Immediately after vaccine, I had arm soreness and as soon as I took Tylenol, it went away. Two or three days later, I had some diarrhea. Right after that, I noticed low pressure symptoms - it was progressive as to when it was happening and now I'm experiencing it every day - 80/50 or there about. If my blood pressure is 80/40 than I don't take my medication and so I'll need to tell my doctor. The first week of June, I had a Urinary Tract infection - I am a diabetic and it doesn't happen. I hadn't had one in a couple of years so I did think it was strange. I was given Ciproflaxin for that. It hung in there a little bet but they kept keep drinking fluids. It just took a little longer to get rid of. But still needing to address the low blood pressure I'm experiencing.

I developed a Urinary Tract Infection approximately 4 days after the vaccine. This was very unusual; I estimate that I haven't had a UTI for about 15 years.

I developed a Urinary Tract Infection approximately 3 days after the vaccine. (This was the 2nd vaccine.) This was very unusual. I estimate that I haven't had a UTI for about 15 years. The exception was that I got one after the 1st vaccine. I reported this separately (see confirmation # 584913.)

Numbness beginning in feet the last week of March/first week of April. Extended to knees by mid May, thigh level by mid June. Now at hip level. Gait unsteady. Bladder urgency. Diagnostic testing in progress.

7/23/21: patient came to ED with increased confusion, shakiness, and generally feeling unwell the past day. husband diagnosed with COVID-19 day prior. Patient tested positive for COVID-19. diagnosed with UTI, shortness of breath/cough/hypoxia. Note: patient previously vaccinated with COVID-19 Pfizer vaccine on: 4/10/2021, 5/2/2021 7/27/21: patient still admitted at the time of this report submission.

I exp headache and diarrhea The next day after I was urinating blood. I went to my PCP I got Culture and given antibiotics.

forceful beat feeling in her chest/she was really uncomfortable in her chest, the force was the most uncomfortable at this point; seemed like UTI symptoms were coming back; felt really wiped out and worn down/tired; anxiety; racing/ pounding in chest; potassium was a little low; elevated blood pressure; arm a little bit sore; 99.1 degrees Fahrenheit fever; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EJ1685), via intramuscular on 28Dec2020 07:15 at single dose on deltoid left for COVID-19 immunisation. Medical history included hepatitis C which cleared in 2016, hysterectomy was done in 2004 or 2005, cyst removed from breast long ago, ongoing arthritis in left knee, urinary tract infection was treated in Nov2020. The patient's concomitant medications were not reported. She received the first vaccine on 28Dec2020. She did fine that day. She came home and laid down and rested. Her temperature went up to 99.1 degrees Fahrenheit but was resolved that same day/night. Early in the morning on 29Dec2020, around 3:30 a.m., she woke up and had a racing/pounding feeling in her chest. She took her blood pressure and it was 158/86, heart rate (HR) was 83. She felt really funny. She hadn't been diagnosed with high blood pressure before, so this was high for her. She took her blood pressure again about an hour later and it was 165/95, HR 73. She took it again about an hour later and her blood pressure read 180/98, HR 77. Her heart rate stayed in the normal range, but the force felt really strong. She did go to the emergency room around 5:00 am on 29Dec2020. She told them what she was experiencing and that she had received the COVID-19 vaccine. About the time she got to the hospital, her blood pressure was starting to come down. An EKG was done and they drew bloodwork. Her potassium came back a little low-they didn't tell her how low or what her level was. She was given 2 potassium tablets which did help. She confirms she doesn't have any NDC, Lot number or expiration date for the potassium she was given. It was given to her at the hospital. She was also given a sheet to monitor her salt intake, which she already does that. She confirmed she was not admitted into the hospital, she was discharged from the Emergency Room. She felt pretty good. She didn't go to work that Wednesday, 30Dec2020, but she went to work on Thursday, 31Dec2020. On 01Jan2021, the same thing happened to her again. She had elevated blood pressure, forceful beat. She went back to the ER early in the morning, around 5:00 am, on 01Jan2021. Her pulse stayed within normal range, but she had such a forceful beat. She informed them that she was really uncomfortable in her chest, the force was the most uncomfortable at this point. They wanted to make sure she wasn't have a stroke or heart attack, so they did their normal procedures to rule this out. They did 2 EKG's, 2 sets of labs, Chest X-ray, CAT scan and everything came back normal. She had a discussion with the physician that saw her about what she was experiencing and the physician was asking her about having anxiety. Caller explains she has never really had problems with anxiety before, but she can't say she hasn't had it. Being around COVID patients and getting the shot, sometimes anxiety can be there. The physician wanted her to try a low dose of Hydrochlorothiazide 12.5mg. She was to only to take a half dose by mouth, if her top number (systolic blood pressure) was between 140-160. Caller clarifies when she means half of a dose, the dose equals 12.5mg. She was instructed to take this 12.5mg dose until she saw her PCP. So, she did this and called her PCP and wasn't able to get an appointment to speak with a provider until the following Wednesday, 06Jan2021. She did a tele visit with her provider and let her know what had happened and that the half of the pill will only bring her top number (systolic blood pressure) to 130's-140's. Caller states she was used to her top number (systolic) being maybe in the 120's, low 130's. Her doctor increased her dose to 25mg. She was prescribed to take 25mg, tablet, by mouth, once a day. She confirmed she still checks her blood pressure before she takes the medicine. Caller verifies she has 2 bottles, one being the 12.5mg dose and the second being the 25mg dose. With the 12.5mg bottle, she sees refills and the date 05Jan2022. Caller clarifies both bottles are dispensed in pharmacy vials with no NDC, Lot number or expiry date. About a month prior to all of this and receiving the COVID-19 vaccine, clarified as Nov2020, she was treated for a UTI. During that time, her blood pressure went up a little and kind of bounced around a little bit, but came back down. Then, she got the COVID-19 shot. She initially felt fine but later on by the time she got a chance to do the tele visit with her PCP, she was telling her about her previous UTI, and the provider put her on Cipro because it seemed like her UTI symptoms were coming back. Caller verifies she doesn't have any NDC, Lot number or expiration for the Cipro. She already took of all of that. She went to the ER for the third time on 08Jan2021 because she again felt the forceful beat feeling in her chest. She explained she felt really wiped out and worn down and she was tired. An EKG was done and they did labs. She confirms she doesn't have any results with her at this time. She was taken off of work for a couple of weeks. She is currently getting in contact with a Cardiologist to make sure everything is alright. The cardiologist wants her to have a stress test. The caller states so this is where she is now. She is taking blood pressure medicine and getting set up to do a stress test. Sore arm outcome: Caller confirms she recovered from the arm soreness within that same day. Her arm didn't stay sore long at all. Racing/pounding in chest: This had improved. It's not like it was. She still has it a little bit of it now, but she is going to see her cardiologist and do a stress test. The blood pressure medicine has helped some. Elevated blood pressure: Today her blood pressure top number got to 161 and she had to take medication but her blood pressure has improved. Outcome of elevated blood pressure, racing/ pounding in chest was resolving; outcome of forceful beat feeling in her chest, UTI, potassium was a little low, felt really wiped out and worn down/tired, anxiety was unknown; outcome of arm a little bit sore, 99.1 degrees Fahrenheit fever was resolved on 28Dec2020.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Patient is a 64 y.o. female admitted for acute DKA, glucose is 771 Severe ketoacidosis, bicarb is only 7 AKI, pseudohyponatremia K 5.3 LFT's ok Got the covid 19 vaccine 2 days ago She has sore throat and chills She did vomit up coffee ground material

The NEXT day: chills, headache, heavy nausea, dry cotton mouth, but couldn't drink. Dizzy. Couldn't barely lift legs to walk. No bladder control. Hard to get to bathroom. Fell twice. Second time hitting head. Then, Difficulty breathing. And heart racing. (Please note: I did actually have Covid last summer from July through August).

Developed burning in L buttock and labia on the evening of the vaccine (3/13). This progressed to shingles with urinary retention by 3/17

Tiredness - couple of days; Headache - day; Chills - day; Fever - few hours; Nausea - few hours; Couldn't pee or have a bowel movement - few hours

At 10 p.m. the evening of the shot i was awoken by a pain i had never had in my lower back, then it spread to my groin area down to my right knee . I began bleeding when I urinated. I have genetic kidney stones, but this pain was different as I had never had the pain radiate down to my knee. I am still passing blood when I urinate and the pain in the low back and knee persists.

I felt very tired and weak; I felt very tired and weak; my heart was skipping really bad I could hear it, could felt it in my chest. Then trembling; heart palpitations and it was skipping and trembling off and on; arm is sore; weird feeling; trembling; trembling, shaking and she thought she was going to have a seizure, she had no control over her muscles; muscles twitching, like if I had no control over the muscles; she had to use the bathroom a couple hours after the shot. She stated she has been drinking a lot; didn't feel good last night; This is a spontaneous report from a contactable consumer (patient). A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 06Apr2021 13:00 (Batch/Lot Number: ER8737) as SINGLE DOSE for covid-19 immunisation, at 64 years old. Medical history included cholesterol (abnormal, takes cholesterol medication 3 times a week as she gets side effects from it), cutaneous lupus (She always has to do bloodwork and goes in every 3 months), heart problem that is not major (she takes 1 medication, patient stated once in a while she sees her cardiologist every 6 months and she did get a halter monitor for 24 hours for a week and they take an average and said it wasn't as bad and knows that is a problem), 2 cervical spine surgeries, arthritis, allergic to contrast dye for CAT scans, allergy to medications (sensitive to medications), shrunk a lot because of issues, and had surgery which shrunk her because of her spine from an unknown date. Concomitant medication included atorvastatin calcium (LIPITOR) taken for blood cholesterol abnormal from 2016 and ongoing; and nadolol (CORGARD) taken for an unspecified indication from 2001 and ongoing. Patient's son got COVID on an unspecified date. Patient previously took generic atorvastatin which made her sick on an unspecified date and LIPITOR and experienced muscle weakness on an unspecified date. No additional vaccines administered on the same date of the Pfizer vaccine. No prior vaccinations. Patient never got a flu shot as she was scared. On 06Apr2021, her arm was sore which is normal. Normal side effects from the arm did not concern her, patient had no fever nothing else. She stated she came home and felt like she had to use the bathroom a couple hours after the shot. She stated she has been drinking a lot and she made sure of that. At 19:00 (also reported as 7-8pm), patient experienced her heart was skipping really bad. Patient could hear it and could felt it in her chest. Patient clarified her heart was not fast, it was more skipping, and she could feel it beating in her throat. She commented has a problem but that has not happened in a long time. Patient then experienced trembling described as lots of body trembling concerned like a seizure. She thought she was going to have a seizure. It was not chills; she had no fever or anything. The trembling came on and off. Her muscles were twitching, like if patient had no control over the muscles. Patient did not feel dizzy, it was a weird feeling. She did not feel good. On 07Apr2021 at 02:00, patient felt very tired and weak, her heart was better. About 02:00 she fell asleep. She woke up at 6:30 and she felt tired but that does not bother her. Her concern was the body trembling. She called her doctor but was not available. She was advised that it does not sound like a symptom of the vaccine. She was worried she needs to go to the cardiologist and see what is happening. She stated if it keeps happening, she will go, and she does not know if this is a side effect other people are reporting. Patient was wondering if this is a reaction as she cannot find it, one says a severe reaction is a fast heartbeat, really fast and skipping and she does not know. She expected anything, tired, headache, muscle aches but these did not happen, but she was expecting them to. Patient is wondering why her heart is doing that is it from the shot or what is going on with her which is weird, and stated the shaking, trembling of her whole body is weird. She mentioned she is sensitive to medication and gets reactions to a lot of medications. She stated this is why she was scared to get the vaccine and what the reaction was with the 1st. Patient stated her heart is a lot better than it was last night, that she feels very tired and feels unwell. She stated she took her temperature (Apr2021) and she had no fever, no nothing a little unwell, a weird feeling. Patient stated she is not trembling anymore and has no heart skipping, that went away about 2am when she fell asleep for a few hours (also reported as went away after about an hour, she had it off and on 3-4 times in an hour). Patient clarified she has not had testing done for the reported symptoms. The patient stated she is concerned and does not know what to do about second dose, which is scheduled for 04May2021. She does not if it was a reaction and stated she is very sensitive to medicine. Events did not require emergency room and physician office visit. Outcome of the event heart was skipping, tremor and palpitations was recovered on 07Apr2021 02:00 while unknown for the other events. Follow-up attempts are completed. No further information is expected. Lot number has been obtained.

I went to bed a healthy person and did not wake up until Sunday Afternoon. I ached everywhere, couldn?t stay awake had fever and a cough that felt like my head was going to blow off if I didn?t hold it. I had a slight UTI Friday which I was going to treat over counter but when I woke up I had a full blown UTI with blood In my urine. Went back to health dept. Tuesday and was given a COVID test which I did. Wednesday I was getting worse and went to walk-in clinic and was given two shorts antibiotics and cough syrup . Sill not well Monday went back to walk in clinic got two more shots and more medicine and cough syrup.

possible kidney stones/has experienced a possible kidney stone or some type of kidney function problem; possible kidney stones/has experienced a possible kidney stone or some type of kidney function problem; she has very frequent urination and would say she urinates 15-20 times per day and in large quantities; she has blood in her urine also; This is a spontaneous report from a contactable consumer. A 64-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EP6955 via an unspecified route of administration, administered in right arm on 29Mar2021 09:48 as single dose for Covid-19 immunisation. Medical history included atrial fibrillation from 2007. Concomitant medications included apixaban (ELIQUIS) taken for atrial fibrillation and levothyroxine. On an unspecified date, over the last few days, the patient has experienced a possible kidney stone or some type of kidney function problem; she stated that she went to the HCP and they wanted to start her on an antibiotic tomorrow or the next day and she has to have kidney function tests and different things like that and she is not really sure and does not think this is related to the Pfizer Covid vaccine but thinks it is a kidney stone. The patient has very frequent urination and would say she urinates 15-20 times per day and in large quantities and it is ongoing and has been pretty much the same as when it began. Stated she has blood in her urine also. The outcome of the event polyuria was not recovered. The outcome of other events was unknown.

4/10/21-Patient presented to an outlying hospital ED w/acute N/V/D and abdominal pain. She was found to have pancreatitis and was found to be SARS-CoV-2 with screening for admission. She had a history of symptomatic COVID with a positive NP swab 1/2/21. Because the patient had no respiratory symptoms she was considered "asymptomatic." She rapidly progressed to having severe necrotizing pancreatitis. She was transferred to tertiary care center where she remains hospitalized. Her hospitalization has been complicated by acute hypoxic and hypercapnic respiratory failure requiring intubation x 24 hours. She had mental status changes and an MRI revealed posterior reversible encephalopathy syndrome, acute kidney injury, splenic vein thrombosis -parital occlusion.

Kidney infection; UTI; tightness around her rib cage; size of her arm at the injection site is down to 2.5 inches by and inch.; allergic reaction; when they injected the vaccine that it burned; lethargic; half a bandage was covered in blood; it felt like three baseballs are sitting on her arm.; The muscles were so tight in her ribcage that she couldn't take a deep breath.; She states that the front of her shoulder, the sides, and the back of her arm was all hard and tense.; teeth chattered after getting the vaccine; Dizziness; difficulty breathing/hard time breathing; headache; fatigue; can still feel where the injection went; feels like an electrical shock; arm pain that radiated under her arm to her rib cage right after the vaccine/arm hurting; nerves were jerking starting at her temple going down throughout her body to her arms and fingers; itching; muscle aches; joint aches; arm pain that radiated under her arm to her rib cage right after the vaccine/arm hurting; arm pain that radiated under her arm to her rib cage; nerves were jerking starting at her temple going down throughout her body to her arms and fingers; hit a nerve upon vaccination; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6206), dose 1 , single dose via an unspecified route of administration in the right arm on 27Mar2021 at 11:00 (at the age of 64 years-old) for COVID-19 vaccination. Medical history included hypertension from an unknown date and unknown if ongoing History: Caller states that she does have health problems but they are not relevant to this event. She takes high blood pressure medication and is diabetic, diabetes mellitus from an unknown date and unknown if ongoing History: She has health problems but they are not relevant to this event. She takes high blood pressure medication and is diabetic. Hostorical vaccine included tired when she gets flu shot and got the thing where she couldn't lift her arm up and it hurt down the ribcage; still hurts in the lower quarter along the back side of the rib cage; still tender and goes to the bottom where the rib cage ends when she got the pneumonia shot . She is not sure if it effects the lungs more. The patient had no family history relevant to the adverse events. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Concomitant medications were not reported. The patient experienced kidney infection, urinary tract infection (UTI), itching all over and that lasted two days and didn't get hives, muscle aches and in the beginning she couldn't get out of bed, fatigue, arm pain that radiated under her arm to her rib cage right after the vaccine/arm hurting, hurts down her arm, nerves were jerking, feels like an electrical shock in her, would feel like her eyebrow or her nose would twitch in the center; it was so bizarre, starting at her temple going down throughout her body to her arms and fingers, it was jerking like lightening fire, the jerking started at the temple on right side and went down the face, it made her knees and ankles jerk, her arm was jerking, she still has some jerking in her left hand so it jerks over to the thumb, she can't control that, the nerves were doing their own thing, her leg and knee would move with out her wanting it to, that the moving is still happening in her shoulder, arms, knees, leg, and foot and joint aches, they hit a nerve upon vaccination and can still feel where the injection went on 27Mar2021, headache and difficulty breathing/hard time breathing and changed her position to sitting up more than laying down on 28Mar2021, dizziness on 29Mar2021, really tired for a good week and a half, size of her arm at the injection site is down to 2.5 inches by and inch, arm felt like it was big in the front, on the side and the back, it felt like three baseballs are sitting on her arm, allergic reaction, it burned when they injected the vaccine, more lethargic than normal on an unknown date. It was also reported that she had difficulty breathing, described as tightness around her rib cage on day 3 and was having a harder time breathing when laying down on day 2.5-3. She states that it still hurts down her arm. It took 4 days for her to be able to lift her arm to her head. She didn't want to lift up because it was still tender around the chest area, especially on right side. it was still tender around the chest area, especially on the right side. The muscles were so tight in her ribcage that she couldn't take a deep breath. On an unknown date, half a bandage was covered in blood and the front of her shoulder, the sides, the back of her arm was all hard and tense and teeth chattered after getting the vaccine. There was no laboratory tests performed. Treatment was received for difficulty breathing/hard time breathing and fatigue. She used her inhaler for her breathing and took ibuprofen (ADVIL, lot: RA467, expiration date: Jul 2022) liquid gel minis at night for her pain. She was prescribed cephalexin. She had an albuterol inhaler on the 28th, 29th, 30th, and 31st, so she took that treatment for 3 days. She was only trying to use one dose of the albuterol inhaler because it can raise the blood pressure, but she also wanted to breathe easier. The muscles were so tight in her ribcage that she couldn't take a deep breath. She still has that in the right lower quarter from her back side ribcage under the arm to the side of the leg. The events did not require emergency room or a physician's office visit. The clinical outcome of Itching was recovered on 29Mar2021 and dizziness was recovered on 30Mar2021, headache recovered around 31Mar2021, unknown for her leg and knee would move with out her wanting it to, felt like three baseballs are sitting on her arm, hit a nerve upon vaccination, half a bandage was covered in blood, kidney infection, urinary tract infection (UTI), fatigue, tightness around her rib cage, size of her arm at the injection site is down to 2.5 inches by and inch, allergic reaction, injected the vaccine that it burned and lethargic and recovering for muscle aches, joint aches, difficulty breathing/hard time breathing, pain in arm, nerves were jerking and feels like an electrical shock, arm pain that radiated under her arm to her rib cage and the front of her shoulder, the sides and the back of her arm was all hard and tense.

feeling so bad; couldn't hold anything down/Vomiting that wouldn't stop/vomiting; Diarrhea; Nauseous; It was just bile coming up; Headache; Was passing clots/were clots/in the vaginal area; Was passing clots/were clots/in the vaginal area/vaginal bleeding; Being dehydrated; couldn't hold her own weight up; stomach pain; So sick; White blood cell count and kidney and liver function were all elevated; White blood cell count and kidney and liver function were all elevated; White blood cell count and kidney and liver function were all elevated; A sharp pain in her side; Stools were dark tarry stringy stuff; Stools were dark tarry stringy stuff; Passing blood in her urine; allergic internal reaction; Weighing 130 pounds but lost about 4 pounds during this illness, so 4 pounds lighter; This is a spontaneous report from a contactable consumer (patient herself). A 64-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, at age 64 years, administered in left arm on 05Apr2021 10:30 (Batch/Lot Number: ER8734) as single dose, for COVID-19 immunization, in order to go back to normal, without a mask so she was told she had to have one. Medical history included hysterectomy, anxiety, disorder in thyroid and cholesterol. Patient had family history of dementia, had to stay home and take care of her mom who is a heart patient and has dementia. Patient had no history of previous immunizations. Patient's concomitant medication includes unspecified medications one is for thyroid, one is for cholesterol and the other 2 are for anxiety. Patient had no prior vaccinations within 4 weeks. No additional vaccines administered on the same date. Patient's symptoms started with a headache the morning after the shot (05Apr2021), was on and off for a couple of days, lasted 3 days or so for a couple days and she took paracetamol (TYLENOL). On 09Apr2021, Friday morning, patient woke up so nauseous she couldn't hold anything down. It was just bile coming up, and she had severe diarrhea and so sick vomiting that wouldn't stop, stomach pain, couldn't hold her own weight up. She got medication at a walk in clinic and that didn't stop it. She started out at acute/urgent care, where she was taken by her daughter on Sunday, 11Apr2021, because she was feeling so bad and was tested for COVID and they said if it does not get better to go to the Emergency Room and she continued having problems. It was not COVID. They said she was dehydrated and send her home to push fluids and drink Pedialyte. Monday or Tuesday (Apr2021) she was in the ER all night (she does not remember the day because all of her days are mixed up). They did CAT scans on her abdomen and ran blood work. They didn't see anything in her abdomen. Her white blood cell count and kidney and liver function were all elevated and they said it was from being dehydrated from diarrhea and vomiting. They gave her fluids and sent her home. Within another 48 hours she still had vomiting and diarrhea, it was a clear bile and a sharp pain in her side. Her stools were dark tarry stringy stuff so she went back to the ER and waited in the lobby for 9 hours. In that 9 hours as she was waiting, she felt like she had to go to the bathroom. She was then wheeled into the bathroom and started passing blood. It wasn't coming from the urethra. It must have come form the vagina, she doesn't have a uterus. There were clots. She started passing blood in her urine but most was in the vaginal area but she has already had a hysterectomy. She was passing clots and her doctor who works in the healthcare field looked at it and said they were clots. Very shortly after, she passed the clot and the pain went away. The pain was passing clots/were clots/in the vaginal area at one point went away but she still have nausea and diarrhea and they gave her more fluids and sent her home. They didn't really want to address the vaginal bleeding. Patient have not been back and was not sure if she is still dehydrated. Patient was still pushing fluids and still not back to normal. Patient's daughter told her that since it was 5 days later it was not a reaction. Patient was thinking maybe it was an allergic internal severe reaction. Patient was weighing 130 pounds but lost about 4 pounds during this illness, so 4 pounds lighter. She stated her daughter-in-law was doing research and found a blog and there are woman the caller's age complaining of these symptoms (unexplained bleeding) after the vaccine. She asked if this was from the vaccine. She stated she was so sick that if there is even a chance then she doesn't want the second dose. She asked if this is a coincidence or has it been reported. She stated she is trying to make a decision on if she should get the second dose because she heard other people have symptoms and take the second shot. The outcome of the events passing clots/were clots/in the vaginal area, headache, a sharp pain in her side, passing blood in her urine, passing clots/were clots/in the vaginal area/vaginal bleeding was recovered on Apr2021, while for the other events, it was unknown.

24 hours post-vaccination, pt developed abdominal pain, dizziness, weakness, frequent diarrhea, myalgias. After 3 days of symptoms, pt was taken to ER by EMS and admitted w diagnosis of colitis, likely ischemic.

Patient stated, "I got really sick after the second shot. My legs were so huge and full of water. Now my kidneys are failing. The vaccine brought on so much water. Now, I have high blood sugar levels and I never had that before."

urinary tract infection; the vaccine stung when it went in and the site was tender; shingles / shingles rash; the vaccine stung when it went in and the site was tender; This is a spontaneous report from a contactable consumer. A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on 23Feb2021 at 12:00 (Batch/Lot number: EL9269) as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history included pain, eye condition, Prediabetes, immunosuppressive - she is also taking immunosuppressive medication that is lowering her immunity: Mycophenolate since Dec2020. She also had a pain in her lower back on about 19Feb2021. Concomitant medications included prednisone (PREDNISONE) taken for eye condition from Aug2020 and ongoing-her immune system is attacking her retina, started a high dose in Aug2020 and has titrated down since then; mycophenolate mofetil (MYCOPHENOLATE) taken for eye condition and immunosuppressive from Dec2020 and ongoing; metformin (METFORMIN) taken for Prediabetes from an unspecified start date and ongoing and been on it about 6 years; and gabapentin for pain. The patient developed shingles on 03Mar2021. She is on prednisone, mycophenalate, and pain medications. She wants to know if it's ok to get the second dose since she is immunosuppressed. The patient was calling about the Covid-19 vaccine and reported that she got the first dose on 23Feb2021 and about 3.5 days later she got a shingles rash. She wanted to know if it is ok to get the second vaccine or if that is contraindicated. The patient said that she is also taking immunosuppressive medication that is lowering her immunity (Mycophenolate) and she has been on it since Dec2020. The patient said that she was on another immunosuppressive medication before this for a month that she had a reaction to. She said that was when she was switched to Mycophenolate. The doctor had her on an antiviral for shingles rash that she started on 03Mar2021. She clarified that it is Valacyclovir HCL 1 pill 3 times a day for 7 days, and she was given pain medicine called Gabapentin 100mg 1 pill 3 times a day by mouth. Her next dose of the Covid-19 Vaccine was scheduled for 16Mar2021. The patient said that the vaccine stung when it went in and the site was tender. Her arm is still a little tender at the site. She said that it seems since she has the shingles stuff it is a little tender. The patient said that she had a pain in her lower back on about 19Feb2021. She went to the doctor on 01Mar2020 because it was not going away. The doctor thought it was a urinary tract infection and gave her an antibiotic that she stopped on 04Mar2021 after being diagnosed with the shingles. The event shingles / shingles rash required a visit to Physician Office; she did a telehealth visit with her doctor for her shingles rash. The event shingles / shingles rash had not resolved while the outcome of the rest of the events was unknown.

Extreme go.lying and nausea, dehydration, couldn't keep down medicines, went into altered state, kidney failure heart and was in Hospital for March 31 - April 7, was not conscious until.April 5th. Some dr blamed it on the morphine but have had past unconscious hospitalization when sudden withdrawal from gabapentin which resulted from vomiting. Have never had problem with heart kidneys or lungs before this. Was given (medication) three times but it didn't bring me back to normal. As for level of morphine sudden stoppage of gabapetin CA affect the levels in blood. I was told not to get the second vaccine but not one dr in hospital seemed to want to report this and I don't think its right. I am going to have bill from being in intensive care and who knows what this will cost me.

mild sepsis; It was normal, except her bladder, because it was so swollen she felt like she couldn't empty it completely; swelling in her brain; thyroid felt swollen; gained 10 pounds overnight of fluid.; lymph nodes got huge; headache; Her tongue feels swollen; Pain in all her organs; Her arm was so sore/ sore left arm; so she had it put in her left hip/ sore left hip. It was sore for about 2 weeks; gained 10 pounds overnight of fluid. Her kidneys, bladder, intestines, stomach and she felt swollen and her liver too; affected her brain and speech/difficulty pronouncing words; Affected her brain and speech; allergic reaction; experienced a personality change; feeling puffy; felt like she had a tourniquet around her neck/Her organs felt swollen; cognitive issues; Throat swelling; pain in the part of her liver; couldn't remember where she put things; muscles did not work right; bladder infection; She was so cranky; Intense stomach ache; This is a spontaneous report received from a contactable consumer (patient reported for herself) from a Pfizer- sponsored program. A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 08Apr2021 at the age of 64 years old (Lot Number: ER8732) as 2nd dose, single for covid-19 immunisation. Medical history included Cancer: Gerson Therapy; Autoimmune disorder; allergies ongoing; Parvovirus B19: exposed to Parvo B virus, it's called the 5th Disease, she had a rare reaction to it and it gave her Rheumatoid Arthritis ongoing, Fibromyalgia ongoing, Multiple Sclerosis ongoing and Behcet's like overnight; allergies to food (she got swelling, intense depression, suicidal tendencies, and a fight or flight response), drugs (Tylenol and Aspirin, basically any pain killer, Percocet and Darvocet), air, dirt, trees, and bugs. It runs in her family; inflammation. Concomitant medications included ongoing fish oil (FISH OIL); ongoing curcuma longa (TURMERIC [CURCUMA LONGA]); several other supplements; ongoing Benadryl for allergies when need. The patient previously received the first dose of BNT162B2 on 19Mar2021 09:00 at the age of 64 years old (lot number: EN6207) in Left arm for Covid-19 immunization and experienced allergic reaction, throat itchy, numbness on her left side/ Legs were like spaghetti and she felt like the scarecrow in Wizard of Oz, lungs itchy and inflamed, coughing, barking asthma cough, Speech slurred, Oxygen level felt like it was in the 80s (80%), muscles not responding, Crooked walk, died 6 times and experienced an out of body experience. Vaccination Facility Type was Hospital. Vaccine was not Administered at any Facility. No History of all previous immunization with the Pfizer vaccine considered as suspect. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. Caller wanted to know about the need for booster dose; Was it going to be like the first or second dose of the vaccine. Caller wanted to know the ingredient of the Pfizer covid vaccine. She said she took both of the doses and had a bad reactions from it. Caller stated she had a lot of issues with the first dose but not as bad as second dose. The second dose almost killed her and affected her brain and speech. She had the Pfizer Covid-19 vaccine, and experienced a bad reaction after both doses. Caller asking what was in the vaccine that could cause her bad reaction. She never had a reaction to any vaccine. She had allergies and autoimmune disorder. Her arm was so sore/ sore left arm the first time. It was difficult to get in and out of car for 3 weeks, but she recovered completely. She helps the handicap people, so she had it put in her left hip/ sore left hip. It was sore for about 2 weeks, but she recovered completely. Caller added she needed to decipher what was written on the vaccination card. She wished they would write better. She used her glasses. Caller took no pharmaceuticals, just Benadryl for allergies when need. The Hospital where she received her vaccine was used and created by another facility, but not a an offsite facility. But for them to use also. Caller added she was cured of everything she had from the Therapy. After the second dose: She started same day as vaccine on 08Apr2021. She did her protocol that time, and as far as breathing and that, it was not like the first dose, but towards the evening she had an auto immune response that lasted for 3 weeks. She felt like she experienced mild sepsis and gained 10 pounds overnight of fluid. Her kidneys, bladder, intestines, stomach and she felt swollen and her liver too. When this happened it started with feeling puffy that evening and lasted for 3 weeks. Caller added if she was exposed to a virus, or had an allergic reaction this happens. Caller added even her lymph nodes got huge and thyroid felt swollen, felt like she had a tourniquet around her neck. That lasted for 3 weeks. It was bad the 1st week. That caused a severe headache that started on the 3rd day and lasted 4 days. It was really bad on the 1st day and she wanted to go to the Emergency Room. She took Benadryl and Ibuprofen, and a Doctor told her she shouldn't take Ibuprofen because of Covid. She was allergic to Tylenol and Aspirin, basically any pain killer, Percocet and Darvocet, Everything except Ibuprofen. Caller did not have the bottle to provide details. She usually put Ibuprofen in her Benadryl bottle for her inflammation. That was the only thing that she took. She took Turmeric and fish oil and several other supplements. Her headache peaked on the 4th day, and she took the Ibuprofen and was better the next day. Throat swelling started on the 5th day and lasted and was still causing her difficulty pronouncing words. Her tongue felt swollen. Her cognitive issues started the 4th day of her headache and was intense. It continued, but was much, much better. She did her normal protocol, and had gotten by, but it was not normal. Her organs felt swollen and the doctor did a test. It was normal, except her bladder, because it was so swollen she felt like she couldn't empty it completely. The muscles did not work right and she got an bladder infection and received antibiotics, about 2 weeks after the injection, because her bladder wasn't working right. Urine test: infection. Intense stomach ache: started at the time her headache stated after 3 days along with the headache and ended with her doing the Therapy. They lasted for 4 weeks. Pain in all her organs: started the 3rd day after the second dose. The pain started, she felt swelling and it lasted for 3 weeks, actually, for 4 weeks, the pain in the part of her liver by her stomach. She experienced a personality change and she wouldn't have the vaccine again. She couldn't remember where she put things, started on the 7th day after her second dose and lasted until the Therapy made her feel better. Finally, after 4 weeks, she recovered completely and was pretty much back normal now. Caller added she was a happy person and was with her Cancer. People asked how she did it. But with this experience she literally wanted to hurt someone or kill herself, and no it was not normal. She was so cranky. She was sure it was the swelling in her brain. With her food allergies she got swelling, intense depression, suicidal tendencies, and a fight or flight response. She wanted to leave her life, it was scary. Caller added she did not feel like this now. For the Vaccine Indication: Caller added that people that need it most, didn't want it. Because of her autoimmune disorder, she was a long huller and she had died 6 times, so she was willing to try it and take it and deal with the side effects. She was hoping it would not cause any. Her boyfriend died at Christmas. After 24 hours he was dead. He had a mild sepsis from a virus. He has Autoimmune disease. If she got Covid, she didn't want to end up like him and see her arms and legs amputated. Caller asked if anyone else had reported symptoms she had experienced. Caller asked to clarify details of her symptoms of suicide and killing and hurting others. Caller denied she was experiencing this at time of call. Therapeutic measures were taken as a result of events headache, Personality change, couldn't remember where she put things, bladder infection. The outcome of the events Pain in arm, Pain in hip, Personality change, couldn't remember where she put things, Stomach ache was recovered on an unspecified date, of cognitive issues was recovering, of the other events was unknown.

I developed rigors with high fever 39.4 C. I was coughing, non-productive cough, pain at the base of my lungs from coughing, running nose, muscle pain, GI problems- vomited once and stool foul smelling, loose. I developed hematuria- visit to Patient first, placed on an antibiotic. Continued with high fever and shivers- went to Emergency Department, admitted. Started on cefuroxime- fever and symptoms subsided. Discharged home. One week at home- getting stronger by day. Back to work January 11, 2021

Starting on 1/17/21 had fever of 101.6, 1/18/21 fever of 101.2, 1/19/21 fever of 102.6. From 1/19-1/23 she had defervesed to normal temp. Afternoon of 1/23/21 temp 101.4, 1/24/21 fever of 103 and 101. On 1/25/21 the nurses called the doctor and said that she was lethargic. Dr. found her to be hypotensive, lethargic, tacchycardic, They sent her to the ER. She also had during that day they found her with neck pain with movement, chills and fever. From 1/25-today she is still admitted to the hospital. They found her to have staph aureus sepsis - source unknown, encephalopathy related to sepsis, they did rule out meningitis, hyponatremia, UTI with E-coli and some staph, urinary retention, rhabdomyalisis with acute kidney injury and dehydration. They are treating her with antibiotics, getting better but still hospitalized.

Vaccine 10 am- fine all day and evening. Awoke at 3:40 am and rolled off of arm where injection given and a wave of pain and nausea and malaise overwhelmed me. I passed completely out still lying in bed (so out that I wet myself in bed) and gradually came to, still feeling horrible. Got up, changed clothes, and major chills when I returned to bed. Around 6am I felt nauseous, got up to vomit, but instead passed completely out on the bathroom floor for about 15 minutes. Remainder of day I felt very stiff, low energy and slightly woozy. By afternoon, energy was returning (I vacuumed the house). Minimal pain in arm this time compared to previous.

2/3 rehab visit: PA - 02/03/2021 12:25 PM CST Formatting of this note might be different from the original. NURSING HOME ACUTE VISIT 6/24/1955 MD SUBJECTIVE: Chief Complaint Patient presents with ? Cough Pt has COVID 19 and she is coughing and congestion. This is an acute visit with pt. Status and changes discussed with staff. Advanced directives on file. Allergies reviewed at NH, though may not be fully updated in electronic record. Problem List reviewed. ROS: Gen: Denies fever CV: Denies chest pain Resp: Denies dyspnea GI: Denies abdominal pain. GU: Denies dysuria. Psych: Denies depression. OBJECTIVE: VITALS: Vitals: 02/03/21 1226 BP: (!) 94/54 Pulse: 79 Resp: 18 Temp: 37 °C (98.6 °F) SpO2: 96% PHYSICAL EXAM: General: Alert, awake, no acute distress Skin: Intact HEENT: Grossly normal Neck: Supple Lungs: Within normal limits/clear CV: RRR Abdomen: Soft, BS active Extr: WNL Neuro: Unchanged and nonfocal ASSESSMENT/PLAN: Reviewed and signed orders. Recheck in 60 days. Patient was seen today for cough. Diagnoses and all orders for this visit: COVID-19 Cough CXR 2 view. Plan to start melatonin, vit D3, zinc. Rehab nurse note: Table of Contents for Miscellaneous Notes Telephone Encounter - RN - 02/09/2021 9:30 AM CST Telephone Encounter - 02/09/2021 9:16 AM CST Telephone Encounter - RN - 02/09/2021 9:30 AM CST Discussed with Dr. and he recommended that patient go to ER for urgent evaluation/treatment with dyspnea and low O2 levels even with supplemental oxygen. Electronically signed by RN at 02/09/2021 9:32 AM CST Back to top of Miscellaneous Notes Telephone Encounter - 02/09/2021 9:16 AM CST Rehab called, they stated PT was having trouble breathing and her O2 was 80 with oxygen. They wanted to know if they should bring her in but PT is Covid positive. Staff recommended that she go to the ER. Electronically signed at 02/09/2021 9:17 AM CST 2/9 ER-> admission note: (6day admission) History The patient is a 65 y.o. female with a past medical history notable for History of anemia, anxiety, cirrhosis, COPD, CHF, diabetes, reflux, hypertension. The patient presents for evaluation of Worsening issues of cellulitis in addition to the patient's history of recent Covid 19 infection. Patient also tested positive for influenza. Patient was started on steroids at skilled care facility. Patient was already on breathing medications. Patient has had issues with CHF and lower extremity swelling. Patient was taking a diuretic for this. Due to patient's cerebral kidney function patient is not a candidate for certain medications or either influenza, Covid 19 and we are limited on antibiotics. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed. 3/1/21 er to admission note: currently inpatient History The patient is a 65 y.o. female presents for evaluation of altered mental status. Notable PMHx: CHF, morbid obesity, diabetes, Patient is 3 weeks out from hospitalization for COVID-19 pneumonia. She has been more confused over the couple of days before admission. Because of altered mental status, patient was transferred to the emergency room. Patient also had some shortness of breath. In the ER, she had a chest x-ray which showed moderate interstitial infiltrate secondary to pulmonary edema or pneumonia. Lab work did show a UTI. BNP was normal at 45. Creatinine was near her baseline at 1.8. She did have elevated alkaline phosphatase at 452. White count was elevated at 14.7. Patient was difficult to arouse in the ER. On my exam, patient is difficult to arouse. After shaking her shoulder and yelling at her, she did open her eyes and say to me "I'm ok" before closing her eyes again. She is satting well on nasal canula oxygen.

received 1st dose 1/15/21, complaints of cough, nausea, diarrhea started 1/20/2021. Presented to the ED on 1/24/2021 with the same symptoms; COVID-19 test came back +. Per ED physician, "On repeat evaluation she is resting comfortably in the room. O2 saturation remains in the low 90s on room air. Vital signs otherwise stable. Her Abbott Covid test was positive. CBC does show leukopenia otherwise unremarkable. BMP shows mildly elevated creatinine, no other significant abnormalities. Chest x-ray unremarkable. Patient was ambulated with pulse oximeter and O2 saturation dropped into the mid 80s. Recommended she be admitted and she agrees. Case discussed with hospitalist who agrees to meet the patient. We will give her Decadron here". Admitted to the RCU where she received ceftriaxone and azithromycin for bacterial pneumonia. Transferred to healthcare facility on 2/1/2021.

On comprehensive blood work drawn 3/25/21 abnormal kidney function values: elevated BUN, elevated creatinine and low eGFR-NAA.

Fever. Chills, hallucinations, renal failure, ischemic colitis, gi bleed, blood clot,, dehydration

kidneys were inflamed; grade IIIa kidney failure; got a flight or fight response; lower lip was full tingling; tongue tip so irritated and a strange feeling that it was a tiny bit edematous; tongue tip so irritated and a strange feeling that it was a tiny bit edematous; mucoid eruption on her lower lip/ mucoid eruptions in her mouth, on her palate and down her throat; rash to her face, neck, chest, back, shoulders and thighs; has bright red palms and sole of her feet are bright red; it looked like Kawasaki disease; voice change; had joint pain in her left arm and could not use her left arm and her whole entire arm and hand; had left clavicle pain under the clavicle; spontaneous cough where her heart races; spontaneous cough where her heart races; felt she couldn't catch her breath; issues in her throat and neck area had something pressing around her throat; she was so tired; chest flutters; tingling in her hands and her entire body from her scalp to her soles was so irritated and prickly; may be body inflammatory response to being vaccinated; This is a spontaneous report from a contactable Nurse (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 07Mar2021 09:40 (Lot Number: EN6199) (at the age of 65 years old) as single dose (dose 1) for COVID-19 immunisation; and methylprednisolone (MEDROL), via an unspecified route of administration from an unspecified date to an unspecified date at short term increase of the Medrol dose (as reported), from unspecified date to an unspecified date at 2 mg (for four years, as reported), then from unspecified date to 10Mar2021 at 6 mg, then from 11Mar2021 to 13Mar2021 at 8 mg, then from 14Mar2021 to unspecified date at 6 mg, for Lupus. Medical history included diagnosed with asthma initially exercised induced and now it is seasonal and was diagnosed years ago (states she has not had to use her Albuterol inhaler that much now because it is seasonal but she is doing more outside and is allergic to outside things so she tends to use the inhaler more if needed), right leg paresthesia (she did have a right leg paresthesia and had that before the vaccine), autoimmune disorder, thyroid disorder and patient stated that she has lost height. Concomitant medications included salbutamol (ALBUTEROL HFA) taken for asthma; levothyroxine sodium (SYNTHROID) taken for thyroid disorder; paracetamol (TYLENOL); and diphenhydramine hydrochloride (BENADRYL). The patient had a history of Lupus and is on maintenance Medrol 2mg for four years and before that she had a short-term increase of the Medrol dose with flares of her Lupus. She had the Pfizer COVID Vaccine 1st dose and then three days later on 10Mar2021 at 16:00, she thought what is going on and had her tongue tip so irritated and a strange feeling that it was a tiny bit edematous, her lower lip was full tingling. She had mucoid eruption on her lower lip and saw then that the next day thought it was swollen but it wasn't swollen. She had eruption on her tongue, had a rash to her face, neck, chest, back, shoulders and thighs. The rash was dispersed and there is a red raised rash with Lupus called Livedo reticularis and that is usually on the thighs but this rash on her was below her thighs and came up and dispersed between all the same rash elsewhere on her body. The healthcare professionals were closed so she took increased Medrol steroids and her Albuterol inhaler and Benadryl; the Benadryl was thrown out and discarded so she has no lot number to provide for it, stated that the Benadryl was the pediatric dye free bubblegum free. The Albuterol Sulfate HFA inhaler is 90mcg per puff and she does two puffs every 6 hours as needed; she had not taken the inhaler but she has trouble with asthma and took the Albuterol inhaler now as preventative and needs to use the inhaler as of yesterday (lot Y23B with expiry date Dec2021). Patient stated that she has the tools of her Albuterol inhaler, the steroid Medrol and the Benadryl and the knowledge so she prevented the symptoms she was reporting from being life threatening but stated the reported events were a little disabling and medically significant.She had joint pain in her left arm and could not use her left arm and her whole entire arm and hand. She had left clavicle pain under the clavicle and knows this did occur in the random trials but for her it went away after two days and is now back regarding the pain. She has bright red palms and sole of her feet are bright red. The next morning on 11Mar2021, her upper lip was tingling and she did go see her healthcare professional in town and sent photos to her Rheumatologist. As time went on she had tingling in her hands and her entire body from her scalp to her soles was so irritated and prickly and her soles and palms were bright red; it looked like Kawasaki disease and she used to take care of children with Kawasaki disease. On Saturday which was the 3rd day she was on the Medrol 8mg and had the fight or flight cardiac symptom and she cut herself down on the Medrol on the next Sunday to 6mg which seemed to make her better. The redness was gone until she had the Pfizer COVID Vaccine 2nd dose yesterday and the healthcare professional initially said after her 1st dose of the vaccine to wait and see her rheumatologist do decided to do the increased Medrol dose of steroids and she stated she has got to get the 2nd dose of the Pfizer COVID Vaccine; the healthcare professional checked her lungs that were clear and her pulse ox was fine and she was not wheezing and she then went on increased steroids from Medrol 6mg to 8mg right away. She did have a right leg paresthesia and had that before the vaccine so she knows what it is like because she has issues with her spine but had not had the paresthesia in a long time. She increased to Medrol 8mg for the three days after the 1st dose of the Pfizer COVID Vaccine and got a flight or fight response. She had to increase the Medrol dose from 6mg and popped it up to 8mg and she had mucoid eruptions in her mouth, on her palate and down her throat and had a voice change. She has a laryngoscopy on Thursday (25Mar2021) with her ENT. She has pediatric doses of everything because she reacts to almost everything. The 2nd dose of the Pfizer COVID Vaccine was administered to her on 29Mar2021 09:45 with lot ER8732. Patient stated that anyone else would have gone to the emergency room but she took care of herself at home and knows the risk factors related to the vaccine. She absolutely felt the reported events were related to the Pfizer COVID Vaccine in terms of causality and she never had these issues before. The rheumatologist had experience with patients with autoimmune diseases and stated people with autoimmune disease have a heightened immune reaction to the vaccine no matter which vaccine they get and are overly active and then a vaccine is thrown in there and we are charting new territory. The next Thursday or Friday over a week now after the Pfizer COVID Vaccine she had a multisystem type of thing and on 18th and 19th of March she started having episodes and was not doing anything but quietly doing something and had chest flutters and spontaneous cough where her heart races and felt she couldn't catch her breath and is now on a 30 day event monitor. She was not sure this is due to the Medrol steroids or the Pfizer COVID Vaccine. She got her thyroid TSH level done because sometimes when the Synthroid dose needs to be lowered because it is too high for your body and you can have atrial flutter which she has had before in the past from her Synthroid dose being too high; states her Synthroid is 50mcg and takes it once per day by mouth and it is in a prescription bottle with no lot, expiry date or NDC. Patient saw her primary care physician again last Tuesday on 23Mar2021 and all the issues in her throat and neck area had something pressing around her throat and thought it was lymph nodes and woke up with a voice change and physician said he would take a look and he said it was not thrush and she would have to be scoped because he couldn't see in her throat. She had a referral for a CBC and Chemistry lab to be done on 25Mar2021 and TSH was in the usual range for her, the results from Thursday (25Mar2021) night had her BUN and creatinine and GSR (Glomerular filtration rate) abnormal. The rheumatologist called her that night and talked to the physician and said he considered this may be body inflammatory response to being vaccinated and could be that her kidneys were inflamed and she does not know as this is all new territory. For the kidney issues, the information was sent off to the rheumatologist who did orders and called the physician back the next day and she told him she thought she needed a nephrology consult and had urine chemistry, a urinalysis and looked for protein and did a blood draw for a chemistry screen with the following results on 25Mar2021: BUN 22.3, grade IIIa kidney failure, creatinine 1.28, eGSR-NAA 42ml/min, normal is over 60 and she usually runs 70 something. She went to the hospital over the years to have her chemistry lab done because she has Lupus and over the last two years she has never been below 60 for the eGSR-NAA. On 26Mar2021, she repeated the blood work and sent everything to her physician and the CMP had her BUN still elevated at 19.5, the creatinine was down to 0.97 and the eGSR-NAA was up to 58mL/min which is still abnormal; the urinalysis was all fine with no white cells and no leukocytes and no protein; the urine chemistry had the creatine of 8.5, the protein in the urine LVL was less than 0.4mg. Her CBC had her lymphs and monos down and she would expect having this response to the vaccine. Both physician called her on the weekend and they were concerned this came out of nowhere and now are monitoring her again in a month; her physician and rheumatologist both were entertaining this could be related to the Pfizer COVID Vaccine. She does not take vaccines because of what they do to the body and did take the flu vaccine in Oct2020. She was covid negative (unspecified date) and stated had to be screened on Friday 26Mar2021 before her laryngoscopy and did the PCR test and only does the PCR. States she was doing research and had conflicting information from her physician and rheumatologist who she first saw her physician, after her 1st dose of the vaccine and the rheumatologist talked about increasing her steroids and she told him she was so tired and how with increased steroids, do steroids impact the effectiveness of the covid vaccine being blunt immune suppressants. Physician said long term chronic steroids have no effect on the effectiveness of the vaccine. She has no had headaches, shaky chills like everybody else has because she is on immune suppressants and has an article that says some evidence for steroids diminishing efficacy in Pfizer COVID Vaccine. No prior vaccinations within 4 weeks. No additional Vaccines administered on same date of the Pfizer suspect. Events required a visit to physician office (No visit to the ER but did see her physician). The last action taken in response to the events for methylprednisolone was unknown. The outcome of the event had left clavicle pain under the clavicle was recovered on 12Mar2021; event has bright red palms and sole of her feet are bright red was recovered in Mar2021; outcome for the other events was unknown.; Sender's Comments: The reported events are assessed as possibly related to the suspect drug BNT162B2 based on strong temporal association, but possible contributory effects from patient's medical history and concomitant medications cannot be completely ruled out. 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.

Sore throat, Fever, unspecified fever cause, Exposure to COVID-19 virus ED to Hosp-Admission Discharged 4/1/2021 - 5/14/2021 (43 days) Hospital MD Last attending o Treatment team COVID-19 Principal problem Discharge Summary MD (Physician) o o Internal Medicine HOSPITAL DISCHARGE SUMMARY HOSPITALIST GROUP . Patient: Date: 5/14/2021 DOB: Admission Date: 4/1/2021 MRN: Length of stay: 43 Days PCP:MD Discharging provider: MD Admission diagnosis: Primary Admission Diagnosis Medical Problems Hospital Problems Hospital Course HPI: Past medical history significant for type 1 diabetes mellitus, essential hypertension, obstructive sleep apnea, peripheral vascular disease status post femoropopliteal bypass 2016, status post multiple toe amputations on left foot, history of right foot osteomyelitis, left foot osteomyelitis in November 2020 who presented to ER on 4/1/2021 with shortness of breath. She was diagnosed with acute hypoxic respiratory insufficiency in the setting of Covid pneumonia with AKI, hyponatremia, troponin elevation, LFT elevation admitted to regular floor on high flow nasal cannula oxygen. Patient was intubated on 4/2/2021 for increased work of breathing and worsening hypoxemia and hypercapnia. Later patient was found to have persistent Candida fungemia. Hospital Course: Persistant Candida fungemia, now improving Blood cultures positive for Candida albicans from 4/12, 4/14 and 4/17/2021. Cardiology was consulted for TEE, done on 04/30 which was negative for vegetations. Ophthalmology was consulted and there was no evidence of fungal endophthalmitis. Blood cultures from 4/23/2021 so far no growth. PICC line has been placed. ID recommendations appreciated. -Currently patient on 6 weeks of IV micafungin, to be continued through 6/7/2021 as per ID recommendations. ID has therapy plan in system Moderate to severe pharyngeal dysphagia Post extubation SLP and modified barium swallow demonstrated aspiration with thin and thickened liquids. S/p PEG tube on 5/7/2021. CT head did not reveal any infarct. Repeat modified barium swallow done today , patient now advanced to level 3 soft diet with thin liquids. -Continue with tube feeds and alter tube feeds based on patient's diet advancement Type I Diabetes mellitus: Labile blood sugars in the setting of changes done to tube feeding. Patient currently on tube feeding and diet has been advanced today. Regimen at the time of discharge Lantus twice daily: With sliding scale insulin and standing dose of short-acting insulin with tube feeds bolus. -Patient will need close monitoring of her blood sugars given changes being done to tube feed and diet advancement, will need titration of insulin based on blood sugars. Lower extremity edema, improved Likely dependent lower extremity edema. Echo April 2021 reviewed: Normal EF, no diastolic dysfunction. -Elevate legs while patient is seated -Ace wraps -Restarted home dose of hydrochlorothiazide Acute on chronic anemia Received 1 unit of blood transfusion during this hospitalization Monitor hemoglobin Vitamin B12 and folate level normal. Hb on last check was 8.0 COVID-19 pneumonia Acute hypoxic and hypercapnic respiratory failure -resolved Status post extubation 04/06/2021 Treated with Remdesivir,convalescent plasma, Decadron as well as Tocilizumab. Treated with IV vancomycin, Levaquin and cefepime in the setting of possible secondary bacterial pneumonia. CT chest ruled out PE but showed extensive infiltrates on admission. Patient is off Covid precautions Currently saturating well on room air and stable from respiratory standpoint. Elevated d dimer, POA : Patient had elevated D-dimer on presentation. Lower extremity ultrasound 4/3/2021 was negative for DVT. CT chest ruled out PE. She was initially placed on intermediate dose of anticoagulation. D-dimer eventually trended down. Currently patient is on subcu heparin for prophylaxis. AKI POA now resolved Creatinine stable. -Continue to monitor renal function, electrolytes and urine output. Hypernatremia : resolved Acute Urinary retention, now resolved. Foley catheter was placed on 4/24 after patient had multiple straight cath done. DC'd Foley catheter on 5/3/2021. Patient is currently voiding without any issues. Chronic medical issues : o Essential Hypertension: On amlodipine, Coreg and hydrochlorothiazide. o Peripheral vascular disease status post femoropopliteal bypass: Restarted home aspirin, statin. _ Admission Current 5/14/2021 - present (6 days) Hospital MD Last attending o Treatment team COVID-19 with multiple comorbidities Principal problem Physical Medicine and Rehabilitation History and Physical Date: 5/14/2021 Admission Date: (Not on file) PCP: MD DOB: Hospitalist: MD Assessments Patient is a 65 y.o. female on hospital day number 0 Active Problems: No Active Hospital Problems: There are no active hospital problems currently on the Problem List. Please update the Hospital Problem List and refresh. IMPRESSION / PLAN: 1. Covid pneumonia/sepsis with hypoxic respiratory failure Received remdesivir, dexamethasone, convalescent plasma Received IL-6 inhibitor Intubation 4/1/2021–extubated, O2 weaned and now tolerating room air CTA chest 4/22/2021–extensive consolidation in both lungs C/W Covid pneumonia, no PE 2. Diabetes mellitus type 1 Lantus scheduled dose twice daily Humalog every 6 hours scheduled and sliding scale Insulin to be adjusted as PEG feedings decrease 3. Diabetic peripheral neuropathy arterial insufficiency Status post femoropopliteal bypass 2016– Status post right common femoral and mid popliteal bypass 9/28/2020 Dr. –no use of synthetic graft Status post remote history of multiple toe amputations left foot osteomyelitis Acute necrotic areas of feet being treated locally 4. Candida albicans fungemia On 6-week course of IV micafungin Weekly CBC, LFT, sed rate, CRP and BMP 5. Essential hypertension On amlodipine, carvedilol, HCTZ, 6. Dysphagia PEG tube placed 5/7/2021–Dr. Cleared for dysphagia level 3 soft diet thin liquids 5/14/2021 Aspiration precautions Speech and Language Pathology 7. Decreased ambulation and functional mobility and functional ability for activities of daily living Physical therapy, Occupational Therapy Plan Patient is admitted for comprehensive inpatient rehabilitation program consisting of physical therapy, Occupational Therapy, speech and language pathology, rehabilitative nursing, psychology, and case management support. Goals will be aligned with patient family goals and directed to improving functional mobility, functional interaction, and activities of daily living to allow the patient to return home safely and continue his rehabilitation as an outpatient or at a home health basis. Estimated length of stay is 16 days. Patient has a good prognosis History of Present Illness Patient is an 65 y.o. female with history of diabetes mellitus type 1 hypertension and sleep apnea who became febrile with shortness of breath over several days. Her PCP, Dr, ordered Covid test which was positive. She presented to Hospital on 4/1/2021 for further work-up. On admission she was found to be in hypoxic respiratory failure requiring high flow oxygen which progressed to requiring a nonrebreather and eventually intubation with ICU care. She received remdesivir, dexamethasone, and convalescent plasma. Patient also received IL-6 inhibitor Tocilizumab recommendation of pulmonary critical care. Procalcitonin level was 35.32. Because of concern of superimposed bacterial pneumonia she was also treated with broad-spectrum antibiotics. Patient had a prolonged complicated acute care hospital course. On 4/12/2021 ENT evaluation showed poor phonatory effort but mobile true vocal cord without lesions. Patient was found to have a fungemia from cultures of 4/12/2021 of C albicans with positive blood cultures with C. albicans on 4/17/2021. Patient was placed on IV micafungin for a total of 6-week course. TEE showed no evidence of acute valve pathology. Ophthalmology was consulted and there was no evidence of fungal endophthalmitis. Repeat blood cultures from 4/23/2021 showed no growth. Patient had PEG tube placed by Dr of GI on 5/7/2021. Repeat modified barium swallow on 5/14/2021 showed improvement of swallowing and the patient was upgraded to a dysphagia level 3 soft diet with double swallows and thin liquids via cup or straw with aspiration precautions. Patient was evaluated by therapies while at Hospital acute care. She requires supervision to rise from sit to stand using a rolling walker and contact-guard ambulate 45 feet using a rolling walker with wheelchair follow and verbal cues for walker management. She continues to have some knee buckling. She needs minimal assistance for bathing and min mod assistance for lower body dressing. She is able to perform toileting with contact-guard. Acute inpatient rehabilitation was recommended. Patient is being transferred to the Hospital for comprehensive inpatient rehabilitation program. Additional information for Item 19: Updated Procedure 04/01/21 1217 Respiratory virus detection panel Collected: 04/01/21 0917 | Final result | Specimen: Swab from Nasopharynx Adenovirus Not Detected Mycoplasma pneumoniae Not Detected Chlamydophila pneumoniae Not Detected Parainfluenza Not Detected COVID-19 SARS-CoV-2 Overall Result DetectedCritical Enterovirus/Rhinovirus Not Detected Coronavirus Not Detected Respiratory Synctial Virus Not Detected Influenza A Not Detected Bordetella pertussis Not Detected Influenza B Not Detected Bordetella parapertussis Not Detected Metapneumovirus Not Detected 03/27/21 1807 COVID-19 (SARS CoV-2,RNA Molecular Amplification) Collected: 03/27/21 0859 | Final result | Specimen: Swab COVID-19 SARS-CoV-2 Overall Result DetectedCritical Labs/Imaging LABORATORY: CBC: Results from last 7 days Lab Units 05/13/21 0557 05/10/21 0614 05/09/21 0724 WBC AUTO K/mcL 5.4 5.0 4.7 HEMOGLOBIN g/dL 8.0* 8.0* 8.5* HEMATOCRIT % 24.7* 25.3* 26.4* PLATELETS K/mcL 201 197 196 NEUTROS PCT AUTO % 67 -- -- LYMPHS PCT AUTO % 21 -- -- MONOS PCT AUTO % 8 -- -- EOS PCT AUTO % 4 -- -- CHEMISTRY: Results from last 7 days Lab Units 05/14/21 0609 05/13/21 0557 05/10/21 0614 SODIUM mmol/L 137 134* 136 POTASSIUM mmol/L 4.2 4.2 3.9 CHLORIDE mmol/L 103 101 104 CO2 mmol/L 28 25 26 BUN mg/dL 23 21 16 CREATININE mg/dL 0.86 0.78 0.82 CALCIUM mg/dL 9.0 8.8 8.6 Results from last 7 days Lab Units 05/14/21 0609 05/13/21 0557 05/10/21 0614 MAGNESIUM mg/dL 2.0 1.9 1.7 COAGULATION: OTHER TESTS: 0 Lab Value Date/Time TROPONINI 0.10 (H) 04/06/2021 0412 TROPONINI 0.17 (H) 04/03/2021 0436 TROPONINI 0.29 (H) 04/02/2021 1655 TROPONINI 0.28 (H) 04/02/2021 1323 TROPONINI 0.29 (H) 04/02/2021 1107 TROPONINI 0.28 (H) 04/02/2021 0546 TROPONINI 0.38 (H) 04/01/2021 1248 TROPONINI 0.15 (H) 04/01/2021 0857 TROPONINI 0.01 11/27/2012 0522 TROPONINI 0.08 (H) 11/26/2012 1104 TROPONINI 0.04 11/26/2012 0626 TROPONINI 0.04 11/25/2012 2304 IMAGING: Gastrostomy tube, place Result Date: 5/7/2021 Gastrostomy tube, place Procedure Note Surgical Pre-Operative Patient Identification Yes, after the patient was placed on the operating room/procedure table, I confirmed the patient's identity. Impression Overall Impression: Normal EGD up to second part of duodenum. 20 French PEG placed without any immediate complications. Recommendation There is no recommended follow-up for this procedure. Okay to use back for medications and water flushes. Start feeding via PEG tomorrow after GI evaluation. Indication Pre-procedure diagnosis: Pharyngeal dysphagia Post-procedure diagnosis: See impression Preprocedure A history and physical has been performed, and patient medication allergies have been reviewed. The patient's tolerance of previous anesthesia has been reviewed. The risks and benefits of the procedure and the sedation options and risks were discussed with the patient. All questions were answered and informed consent obtained. Details of the Procedure The patient underwent monitored anesthesia care, which was administered by an anesthesia professional. The patient's blood pressure, heart rate, level of consciousness, oxygen, respirations, ETCO2 and ECG were monitored throughout the procedure. The scope was introduced through the mouth and advanced to the second part of the duodenum. Retroflexion was performed in the cardia, fundus and incisura. The patient experienced no blood loss. The procedure was not difficult. The patient tolerated the procedure well. There were no apparent complications. See anesthesia record for more information regarding anesthesia administered. Specimens * No specimens in log * Implants No implants documented in log. I attest the accuracy of any implant/graft nursing documentation. Findings The cricopharynx, upper third of the esophagus, middle third of the esophagus, lower third of the esophagus, GE junction, Z-line, cardia, fundus of the stomach, body of the stomach, greater curve of the stomach, lesser curve of the stomach, incisura, antrum, prepyloric region, pylorus, duodenal bulb, 1st part of the duodenum and 2nd part of the duodenum appeared normal. PEG-G tube successfully placed in the body of the stomach using a deformable internal bolster via the pull technique after the site was identified via transillumination, visualized indentation and needle passed through abdominal wall; distance from external bolster to external end of tube: 3 cm; scope reinserted to confirm placement Staff/Assistant(s) Staff Role RN Other CRNA Other Other MD Other Disposition: PACU - hemodynamically stable. Condition: stable Attending Attestation: I performed the entire procedure. CT abdomen pelvis without contrast Result Date: 4/15/2021 PROCEDURE INFORMATION: Exam: CT Abdomen And Pelvis Without Contrast Exam date and time: 4/15/2021 12:00 AM Age: 65 years old Clinical indication: Other: Na; Additional info: Distention, fungemia workup. TECHNIQUE: Imaging protocol: Computed tomography of the abdomen and pelvis without contrast. Radiation optimization: All CT scans at this facility use at least one of these dose optimization techniques: automated exposure control; mA and/or kV adjustment per patient size (includes targeted exams where dose is matched to clinical indication); or iterative reconstruction. COMPARISON: No relevant prior studies available. FINDINGS: Tubes, catheters and devices: Small bowel feeding tube noted. Lungs: Bibasilar patchy nodular airspace disease with ground-glass opacity. Liver: Normal. No mass. Gallbladder and bile ducts: Multiple gallstones. Pancreas: Normal. No ductal dilation. Spleen: Normal. No splenomegaly. Adrenal glands: Normal. No mass. Kidneys and ureters: Bilateral renal vascular calcifications. Stomach and bowel: Visualized bowels demonstrated a generalized constipation. Appendix: Not well seen. Intraperitoneal space: Unremarkable. No free air. No significant fluid collection. Vasculature: Moderate atherosclerotic changes. Lymph nodes: Unremarkable. No enlarged lymph nodes. Urinary bladder: Unremarkable as visualized. Reproductive: Unremarkable as visualized. Bones/joints: Degenerative changes within the lumbar spine. Soft tissues: Unremarkable. IMPRESSION: Bibasilar nodular airspace disease with ground-glass opacity. No other acute inflammatory process or obstructive uropathy within the abdomen and pelvis. THIS DOCUMENT HAS BEEN ELECTRONICALLY SIGNED BY MD X-ray abdomen 1 view Result Date: 5/4/2021 XR ABDOMEN 1 VW PORT IMPRESSION: Weighted enteric tube with the tip in the gastric antrum. Residual oral contrast throughout a nondilated colon. END OF IMPRESSION: INDICATION: ng tube placement ng tube placement. TECHNIQUE: AP supine portable projection of the abdomen was acquired. COMPARISON: AP abdomen on 4/15/2021. FINDINGS: The gas pattern is unremarkable. There is residual oral contrast equally distributed throughout a nondilated colon. There is a new weighted enteric tube with the tip in the gastric antrum. Small right lung base pleural effusion is present. No abnormal mass effect is noted. No significant radiopaque calculus is identified. There are no significant bony findings. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray abdomen 1 view Result Date: 4/15/2021 XR ABDOMEN 1 VW PORT IMPRESSION: Orogastric tube is in the stomach. Nonspecific bowel gas pattern. END OF IMPRESSION: INDICATION: Feeding tube placement. TECHNIQUE: Single view of the abdomen. COMPARISON: Prior examination of April 15, 2020. FINDINGS: Orogastric tube is in the stomach. Nonspecific bowel gas pattern is noted. Osseous skeleton is grossly intact. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. CT head without contrast Result Date: 4/21/2021 CT HEAD WO CONTRAST IMPRESSION: No acute intracranial pathology. Mucoperiosteal thickening in the ethmoid sinuses as well as some opacification of the bilateral mastoid air cells consistent with chronic sinus disease and mastoiditis. END OF IMPRESSION: INDICATION: DYSPHAGIA DYSPHAGIA. TECHNIQUE: Spiral CT scan through the head from the skull base through the vertex was performed with 5 mm axial reconstructions. Images obtained without contrast. CONTRAST: No contrast was administered. COMPARISON: April 13, 2021 FINDINGS: No acute hemorrhage, mass, or mass effect. No abnormal extra-axial fluid collections are identified. There is preservation the gray-white differentiation. No evidence to suggest large vascular distribution infarct. The ventricles, cisterns, and other CSF containing spaces demonstrate normal size, shape, and configuration. The basal cisterns are patent and symmetric. Stable focal area of gliosis in the right frontal white matter. The calvarium is intact. The visualized portions the aerated paranasal sinuses mastoid air cells demonstrate bilateral ethmoid sinus mucoperiosteal thickening. Additionally there is scattered opacification of some mastoid air cells bilaterally. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. Fluoroscopy video swallow with speech therapy Result Date: 4/19/2021 FL VIDEO SWALLOW WITH SPEECH THERAPY MBSS IMPRESSION: Aspiration of thin and nectar thick liquid. Please refer to speech therapy report. END OF IMPRESSION: INDICATION: Dysphagia. Concern for aspiration. Covid 19. SUPERVISION: Procedure was performed by RRA under direct supervision by MD TECHNIQUE: Fluoroscopy assistance was provided to the speech pathology department. Multiple consistencies of barium and food products were administered to the patient. Fluoroscopy of the oral and pharyngeal region was performed. FLUOROSCOPY TIME: 1.1 minutes COMPARISON: Modified barium swallow of 4/12/2021. FINDINGS: Aspiration of thin and nectar thick fluid. Hypopharyngeal residue with all trials provided. Significant dry secretions in the oral cavity and pharynx. Please see speech pathologist's report for further details and recommendations. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. Fluoro NG long tube placement Result Date: 4/30/2021 FL NG LONG TUBE PLACEMENT IMPRESSION: Successful fluoroscopically guided Dobbhoff placement. END OF IMPRESSION: INDICATION: Dobbhoff placement. SUPERVISION: Procedure was performed by staff member under personal supervision by Dr.. TECHNIQUE: Fluoroscopic guidance for nasogastric tube placement. FLUOROSCOPY TIME: 2.2 minutes COMPARISON: None available. FINDINGS: Using fluoroscopic guidance, a nasogastric tube was placed from the left nares into the stomach. Upon placement of the nasogastric tube, 10 cc of Omnipaque contrast material was injected to confirm placement. Opacification within the stomach was visualized confirming appropriate NG tube placement. There were no intraprocedural complications and the procedure was well tolerated by the patient. The patient was discharged from the imaging department in satisfactory condition. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray chest 1 view Result Date: 4/26/2021 XR CHEST 1 VW PORT IMPRESSION: NG tube in the fundus of stomach left upper abdomen. END OF IMPRESSION: INDICATION: SOB evaluate NGT placement following advancement.. TECHNIQUE: AP projection of the chest is acquired. COMPARISON: 4/26/2021 FINDINGS: NG tube in the fundus of stomach left upper abdomen. Stable diffuse patchy infiltrates both lungs in the upper, mid to lower zones and left effusion. No pneumothorax. The heart size is normal. Rib cage is unremarkable. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray chest 1 view - portable Result Date: 4/26/2021 XR CHEST 1 VW PORT IMPRESSION: 1. Interval increase in diffuse airspace opacity and effusions from prior. 2. NG tube tip in the region of the GE junction. Consider further advancement. END OF IMPRESSION: INDICATION: Hypoxia, acute shortness of breath. TECHNIQUE: Portable AP view of the chest is acquired. COMPARISON: 4/22/2021. FINDINGS: Diffuse airspace opacity and effusions appear mildly increased from prior. The NG tube tip is in the region of GE junction. Recommend further advancement. No pneumothorax is identified. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray chest 1 view Result Date: 4/22/2021 XR CHEST 1 VW PORT IMPRESSION: Persistent diffuse patchy infiltrates bilaterally, consistent with Covid infection. END OF IMPRESSION: INDICATION: hypoxia. Covid 19. TECHNIQUE: AP upright projection of the chest is acquired. COMPARISON: Radiographs of 4/18/2021. FINDINGS: The cardiomediastinal silhouette is unchanged. Persistent diffuse patchy infiltrates bilaterally, consistent with Covid infection. No evidence of pleural effusion or pneumothorax. No significant change compared to prior radiographs. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray chest 1 view, Portable Result Date: 4/18/2021 XR CHEST 1 VW PORT IMPRESSION: Enteric tube extends into the stomach. Tip collimated from view. Multifocal airspace disease, increased slightly since 4/13/2021. END OF IMPRESSION: INDICATION: Verify placement of NG tube. TECHNIQUE: AP upright portable projection of the chest is acquired. COMPARISON: 4/13/2021 FINDINGS: An enteric tube extends into the stomach; the tip is collimated from view. The lungs are symmetrically aerated. Multifocal airspace opacities are slightly increased since 4/13/2021. No pneumothorax or pleural effusion. Cardiomediastinal silhouette is stable. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. Transthoracic echo (TTE) limited Result Date: 4/21/2021 FINALIZED REPORT TWO-DIMENSIONAL ECHOCARDIOGRAPHIC FINDINGS LEFT VENTRICLE: Normal size and function RIGHT VENTRICLE: Normal size and function AORTIC VALVE: Trileaflet sclerotic MITRAL VALVE: Mitral annular calcification TRICUSPID VALVE: Normal PULMONIC VALVE: Not well seen LEFT ATRIUM: Normal size RIGHT ATRIUM: Normal size INTERATRIAL SEPTUM: Intact AORTIC ROOT: Normal size PERICARDIUM: No effusion IVC: Normal size and normal collapse AORTIC ARCH: Not well seen COLOR AND SPECTRAL DOPPLER: PA systolic pressure in the range of 30 mmHg FINAL IMPRESSIONS: This is a technically limited study with poor acoustic windows and poor endocardial border definition. Normal LV size with normal wall thickness. No clear-cut regional wall motion abnormalities. EF 55 to 60% Normal RV size and function Aortic sclerosis Mitral annular calcification No vegetations or a source of fungemia noted Transesophageal echo (TEE) Result Date: 4/30/2021 FINALIZED REPORT TWO-DIMENSIONAL ECHOCARDIOGRAPHIC FINDINGS: INTUBATION: Anesthesia airway management provided by the anesthesiologist. I intubated esophagus myself without difficulty LEFT VENTRICLE: LV cavity size mild LVH normal function EF 55-60 RIGHT VENTRICLE: Normal RV size function AORTIC VALVE: Leaflet no vegetation MITRAL VALVE: Appears normal no vegetation TRICUSPID VALVE: Appears normal no vegetation PULMONIC VALVE: Appears normal no vegetation LEFT ATRIUM: Appears normal RIGHT ATRIUM: Appears normal INTERATRIAL SEPTUM: Intact SVC: Appears normal IVC: Appears normal PERICARDIU no effusion LEFT ATRIAL APPENDAGE: Appears normal PULMONARY VEINS: Not well seen AORTIC ROOT: Appears normal ASCENDING THORACIC AORTA: Appears normal AORTIC ARCH: Appears normal DESCENDING AORTA: Appears normal COLOR AND SPECTRAL DOPPLER: No stenotic regurgitant lesions noted FINAL IMPRESSIONS: No vegetations noted Normal LV cavity size wall thickness function EF 55-60 Normal RV size function No valve abnormalities Ultrasound upper extremity venous right Result Date: 4/24/2021 US UPPER EXTREMITY VENOUS RIGHT IMPRESSION: No DVT identified. Superficial thrombosis identified in the cephalic vein. END OF IMPRESSION: INDICATION: Concern for DVT. TECHNIQUE: Real-time two-dimensional ultrasound of the right upper extremity was performed with grayscale, color and duplex Doppler imaging. Compression and augmentation were performed where possible. Permanently recorded images were obtained and stored. FINDINGS: The internal jugular vein, subclavian vein, axillary vein, brachial veins, basilic vein are normal. They demonstrate normal flow and compressibility. There is a thrombus identified in the right cephalic vein at the mid arm through distal forearm. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. CT angiogram chest pulmonary embolism with and without contrast Result Date: 4/22/2021 CTA CHEST PULMONARY EMBOLISM W WO CONTRAST IMPRESSION: No evidence of pulmonary embolus or right heart strain. Extensive parenchymal consolidation in both lungs, left greater than right consistent with severe pneumonia such as Covid 19 pneumonia. Moderate left-sided small to moderate right sided pleural effusions are seen with associated compressive atelectasis. Enlarged main pulmonary artery which can be seen in the setting of chronic pulmonary hypertension. Interval development of large mediastinal adenopathy particularly in the right paratracheal region and subcarinal region. These may be reactive in nature in the setting of as diffuse pneumonia. Enterogastric tube with the tip extending to just within the stomach. END OF IMPRESSION: INDICATION: pneumonia. Assess for pulmonary artery embolism. TECHNIQUE: Enhanced helical CT scan of the chest was performed from the lung apices to below the diaphragm. 2mm axial reconstruction with MPR coronal, oblique and sagittal images were created. 3D shaded surface images also created on a separate workstation and permanently stored. CONTRAST: 100mL of IOHEXOL 350 MG IODINE/ML INTRAVENOUS SOLUTION administered INTRAVENOUS. Quality of contrast opacification was adequate. COMPARISON: July 22, 2013 FINDINGS: Lung windows demonstrate extensive consolidation involving the lungs, left greater than right. There is a moderate left-sided effusion and a small to moderate right sided effusion with associated compressive atelectasis. The trachea and bronchi are grossly unremarkable. No endobronchial lesions are seen. Soft tissue windows demonstrate a grossly unremarkable thoracic inlet. The thyroid is unremarkable. Moderate bilateral axillary lymph nodes are seen with extensive bulky adenopathy in the mediastinum to include the right paratracheal region as well as the subcarinal region and to a lesser extent the hila. The largest lymph nodes are seen in the paratracheal chain demonstrating short axis of approximately 15 mm. Smaller lymph nodes are seen in the aortopulmonary window. These may be reactive in nature. The heart demonstrates a normal configuration. No right heart enlargement is seen. No pericardial effusion is seen. The thoracic aorta and great vessels demonstrate normal branching pattern. Normal course and caliber is seen. The pulmonary arteries demonstrate normal course. There is moderate dilation of the main pulmonary artery up to 3.2 cm. This can be seen in the setting of chronic pulmonary arterial hypertension. No filling defects are seen. Enterogastric tube is seen with the distal tip extending to just within the proximal stomach. The visualized portions of the upper abdomen are grossly unremarkable. The surrounding osseous structures demonstrate mild degenerative changes of the thoracic spine. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient.

Urinary tract infection; Her right arm got real sore, she could not lift her arm; Her right arm got real sore, she could not lift her arm; back hurting/lower part of back on right-hand side; soreness in legs; headache; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 04May2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored-program. A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at 65 years old, dose 1, intramuscular, administered in arm right on 29Mar2021 (Batch/Lot Number: EP7533) (time given: 10:30 or 11:00) as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received the first Pfizer COVID shot and she became sick after receiving it. She was supposed to go back on 19Apr2021 for the second dose but she was still recovering then. Patient was asking if she can she still get the second dose. Her right arm got real sore, she could not lift her arm. Then her back started hurting like it settled in lower part of back on right-hand side, she developed a real bad urinary tract infection (UTI) and soreness in legs, she could not even lay on her left side since she was in such pain. She ended up going to urgent care because she was in such pain with her back and arm. They gave her a steroid shot, antibiotic shot and oral antibiotics to take. Patient also experienced headache. She is feeling a lot better. She recovered completely around 26Apr2021. Did not require a visit to emergency room, required a visit to physician office.

chest pain, fever, chills, nausea, vomiting diarrhea, myalgias and hematuria. BP 170-195/76-89, BMI 30.3 kidney biopsy received on 4/26/21 showed: MPO-ANCA+ anti-GBM associated crescentic GN; also has C3 glomerulopathy

She started having delusions and hallucinations, body tremors like epileptic seizure, she was falling down and using the bathroom on herself, her walk was a shuffled gate, she didn't remember almost 3 months in hospital, coma for 5 days and had a mini stroke. Her psych doctor thought maybe the vaccine could have triggered this type of reaction. She gained consciousness and was sent to a rehab nursing home where she's learning to walk to feed herself and getting stronger now that she's home. There's a long road to recovery.

May 23-June 2Right medial bicep; chronic staight line pain radiates elbow to shoulder, all around deltoids 2 x into Emerge cardiac symptoms Grade 4 at night- Grade 1-2 day & night. All symptoms following appear at random locations,sporadic times 24 hours, intensity always 4+ . Noted in order of cumulative appearance. All are chronic Sharp linear pain in Left Lateral neck stays stationary. L temple 7 behind eyeball. Pains in liver, Spleen, L Kidney. radiating pain along Left & Right lower jaw and upper jaw Left orbital socket lower onto cheekbone. R cheek horizontal between U & L jaw bone. straight line from R base of skull up to level with R ear tip. R lateral calf 'creeping' pain from lateral maleolus to ribs

Injection site pain; urinary tract infection (UTI); This is a spontaneous report from a contactable consumer or other non health care professional. A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6198), dose 1 via an unspecified route of administration, in Left Arm on 23Feb2021 at 15:45 (at the age of 65-years-old) as 1st dose, single for Covid-19 immunisation. The patient medical history included depression, arthritis, post-traumatic stress disorder (PTSD). The patient was diagnosed with all the medical history in her twenties. The patient concomitant medications were not reported. The patient had no other recent vaccinations or started any new medications. On 24Feb2021, the patient had experienced urinary tract infection and injection site pain on an unspecified date. The patient reported that the first symptoms she had only a very small pain where she got the shot. She informed that her main concern is that last night she had a UTI, so she wondered if it could be because of that, clarified to being a side effect. She reported that she got her first dose late in the afternoon, about 03:45PM. She took over the counter AZO yesterday for the UTI since it was horrible yesterday. No further details provided about the AZO. The patient received treatment for the event urinary tract infection. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

I had a UTI; My ears feel hot./she feels her neck and ears feel different; worst last night; she still feels full; my glands when I would swollen would be super sharp. I have swollen lymph nodes; soreness in arm/I had injection pain; soreness in arm/I had injection pain; This is a spontaneous report from a contactable consumer or other non hcp. A 65-years-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6201), via an unspecified route of administration, administered in Arm Left on 08Feb2021 11:00(age at vaccination: 65 years) as 1st dose, single for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. The patient stated that she had her first dose of vaccine at 11 AM yesterday. On 08 Feb2021, the patient experienced soreness in arm. The patient reported that throat doesn't feel sore and her ears feel hot. On 09Feb2021 at noon, the patient experienced her glands was swollen and when she swallows she had a sharp pain on one side, so right way, she ate chicken noodle soup and hot tea, and made it feel a lot better, she had swollen lymph nodes that have been a side effect as she saw it on the list, had a UTI (urinary tract infection) but was felt better and was taking a Macrobid 100mg capsule by mouth twice daily for UTI, so she thought maybe that would help, but her pharmacist said it would not help with swollen glands, but she did not know if it came from a UTI, her ears feel hot/she feels her neck and ears feel different, soreness in arm/I had injection pain, worst last night and she still feels full when she feels her neck and ears feel different. She was a massage therapist, she iced, and rubbed over it and can lift-up, last night it hurt to lift-up, she moved it around, now she can barely feel it, not like last night. It was reported that patient had no longer sharp pain. She had no thermometer, so unknown if she had a temperature, her face feels warm, but she was hot all the the time being 65. Patient was recovering from the events my glands when I would swollen would be super sharp. Patient had not recovered from the event still feels full. The outcome of the events UTI, my ears feel hot/she feels her neck and ears feel different and worst last night was reported as unknown. Follow-up (11May2021): Follow-up attempts completed. No further information expected.

Patient is a 65 yo female from home with a history of complicated ESBL E. Coli urinary tract infection, nephrolithiasis, s/p stone basket removal of stone May 2020. DM, HTN, GERD, osteroarthritis, who presented to the ED complaining of AMS. The night prior to presentation, she went to sleep with a friend staying over, and this morning the friend noted that the patient was not acting appropriately. She then called EMS, and on arrival the patient had a temperature of 101.1F. She needed 2L NC. This patient was recently evaluated in the ED on 6/06, where she was diagnosed with right-sided pyelonephritis. She was sent home on cefpodoxime and Motrin. During this current hospitalization, patient was found to be COVID positive on 6/26/21 with RLL pneumonia and E. Coli ESBL complicated UTI. She did not have a prior diagnosis of COVID. Last COVID PCR test on 6/6/21 was negative.

One week after my first dose, I started to feel sick and had a fever. I also slept for 12 hours, felt very fatigued and lethargic for two days. On 03-27-2021 I went to Urgent Care where they performed lab work and was found I had an UTI. I had not had a UTI for 35 years. I was placed on antibiotics for 10 days which helped fight off my infection.

On 04-21-2021 I woke up with a big lump on my neck, also experienced fever. I am a breast cancer survivor and got concerned. The lump on my neck hurt really bad and my left arm was also hurting and I had a bruise. I called my family doctor where he performed medical imaging and said to me that the lump was on my carotid gland. The lump was the size of a golf ball, which lasted nine days. My family doctor put me on antibiotics for ten days. On 06-17-2021 I again went to see my family doctor because I had recurrence of UTI and was again placed on antibiotics for ten days. I haven not felt great since receiving my vaccine.

dark urine; back pain; fatigue; extreme chills; vomited overnight; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6201) via unspecified route of administration in the left arm on 16Mar2021 at 11:30 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included hiatal hernia, chronic heartburn, hay fever and high blood sugar. The patient had a history of allergy to penicillin and sensitive to aspirin. Concomitant medications included women multi vitamins (MANUFACTURER UNKNOWN), vitamin d (MANUFACTURER UNKNOWN) and omeprazole (MANUFACTURER UNKNOWN) all for unspecified indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN9581), via unspecified route of administration in the left arm on 23Feb2021 at 11:30 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16Mar2021 at 21:30, the patient had experienced extreme chills and vomited once over night and on 17Mar2021, the patient woke up and had 3 or more occasions of dark urine, back pain, more chills and fatigue. Adverse events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if the patient had received any therapeutic measures for the reported events. The clinical outcome of the events extreme chills, vomited overnight, dark urine, back pain and fatigue was resolved on unknown date in Mar2021. No follow-up attempts are needed. No further information expected.

Around 5am on May 1st caller woke up and could not breathe. She took 4 puffs of her inhaler. She advised husband to call 911. Sister came and gave patient another 4 puffs. When EMT arrived patient was unconscious. Patient was told that she lost her bowels urine and was forming at the mouth. Patient was transferred hospital. Patient was sent to ICU. Patient was put on the vent. Patient was in ICU for 40 days. Patient was then sent to a respiration clinic to help wing her off the vent. Patient walked a little. Patient was released on July 20th and sent to a rehabilitation center. Patient also stated that she received fecal tube.

66 you female who presented to to infusion clinic for lung cancer treatment. Pt received apap 650mg po, diphenhydramine 50mg PO at 1000. She also was administered NaCL 0.9% as a carrier for durvalumab as an infusion between 1000-1200. Pt was administered COVID19 vaccine at 1110. At 1120 patient called out stating "I just don't feel right". Pt was diaphoretic/weak/hypotensive. No swelling or respiratory distress noted during the episode. Attending physician and PharmD alerted and were at bedside. Per note, pt has needle phobia. Please refer to relevant history below for information regarding BP. Patient was monitored closely at the infusion clinic. She was able to receive her chemo agent as planned after she felt better from eating. Patient does not wish to get the second dose of covid vaccine.

1/29-Reported increased fatigue, weak and itchy, hands were red and blotchy. MD updated and PRN Benadryl given with good effect. C/O nausea and decreased appetite 1/30 received PRN Zofran with good effect. No further complaints 2/1

Urine had a reddish dye not quite blood and loose bowel movement the next day following the first dose. After eliminating the waste my urine and bowles was back to the normal. It was quite scary.

I received the vaccination at the clinic. About 24 hours after receiving the vaccination, my urine became very dark (amber) and stayed this way for 9 days. I was not dehydrated. Five days after the vaccination, my stool became very pale (clay color) and stayed this way for 6 days. Both conditions resolved on their own. I was very tired for a couple of days after the vaccination, had some soreness in the vaccination site and my appetite was off a little for a few days. These were the only other symptoms.

Within 10-minutes of vaccination, the patient reported dizziness when standing up. EMS evaluated the patient on-site. The patient was hypertensive (159/88) with a FSBG of 89mg/dl. EKG demonstrated NSR, rate 61 bpm, no ST elevation. EMS transported the patient to Medical Center Emergency Department. In the ED, the patient denied vertigo symptoms. Labs were grossly unremarkable, but UA did have leukocyte esterase and bacteria. Physician considered 1g Rocephin for UTI, but did not administer due to hives reaction to amoxicillin. Prescribed the patient 5-days of Macrobid PO BID. Discharge diagnoses were lightheadedness and UTI.

3/30/21: Patient presented and was admitted for abnormal labs, nausea and dry heaving x 1 week. On admission, patient was found to be hypokalemic (K 2.2), creatinine of 4.81. Patient received second dose of COVID vaccine this morning. Patient was tested positive for Covid-19 at this visit. Per the EUA, hospitalizations to be reported irrespective of attribution to vaccine.

four days after second shot, severe stomach pain, fevers, trouble urinating, chest pain, . turned into kidney infection, blood infection and having AFIB, need for pace paker.

N30.01 - Acute cystitis with hematuria R31.9 - Hematuria, unspecified type D68.32 - Hemorrhagic disorder due to extrinsic circulating anticoagulants

This 66 year old female received the Covid shot on 3/26/21 and went to the ED on 4/17/21 and was admitted on 4/17/21 with the following diagnoses listed below. R65.10 - SIRS (systemic inflammatory response syndrome) (CMS/HCC) N17.9 - Acute kidney failure, unspecified R65.10 - Systemic inflammatory response syndrome (sirs) of non-infectious origin without acute organ dysfunction

Tingling sensation on her right arm, lower back pain that she states "is either from the lung or kidney", and neuro symptoms such as "feeling something is wrong". Around this time she was having difficulty urinating. She then contacted her Primary Care Team , who advised her to go to the EC. Pt refused to go to EC at the time, and started hydrating further, with water and coffee. Eventually she was able to start a flow of urine, but it was foamy and white. The next day, she states that she continued to hydrate, and that she was eventually able to maintain a stream of urine. Her other symptoms did persist, as well as a new bout of diarrhea. Pt denied any fever or chills, and denied any anaphylactic symptoms, such as difficulty breathing, rash or swelling. When asked about any wheezing, pt stated she did not really have what she believes is wheezing, but did experience some cough and a slight pain on her back, which she could not differentiate if it radiated from her lung or from her kidney. Pt did state that 2 weeks prior to her first covid vaccine shot, she did have a UTI, that was treated with a 5 day course of Cipro, and 1 dose of Diflucan.

Calcium went up to 10.8; Glucose was 107; phosphorus level is very low, it went up to 3.5; FBF 23 was 899; Parathyroid Hormone went down to 13; Creatinine/ it went down to 0.9 where it belongs.; Sodium: it went up; Creatinine went down to 0.9 where it belongs / shot did something good too; Arm was a little sore just where the shot was; This is a spontaneous report from a contactable consumer. A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8729), via an unspecified route of administration on 06Apr2021 at around 09:15-09:30 (at the age of 66-year-old), as 2nd dose, single in left arm for COVID-19 immunization. The patient's medical history included ongoing Tumour Induced Osteomalacia from Jul2019 and had surgery in Feb2021. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6207), via an unspecified route of administration on 16Mar2021 around 09:15-09:30, as single in left arm for COVID-19 immunization and her arm was just a little sore. Patient did not receive any other vaccinations within 4 weeks prior to COVID vaccine. Concomitant medications included Calcitriol 0.5mcg every morning and every night by mouth and then reduced it to 0.25mcg every morning and every night, taken for calcium. Patient had been going for lab tests every 3 months since Jul2019. On 13Apr2021, after the second dose, the blood work came back all crazy. Patient could not figure out why it went so crazy and the only difference was that she had the vaccine. On 13Apr2021, her tumour marker FBF 23 (Fibroblast growth factor 23) was 899, which was supposed to be under 189, and hers was typically about 365, 348. Patient did not receive FBF 23 test result performed on 10May2021, and she assumed that this would be normal as all other results went back to normal. On 13Apr2021, calcium went up to 10.8, which concerned the doctors, and she went again to physician's office on 10May2021 to repeat the blood work and everything went back to normal: 9.9, it was usually 9.7 or 9.6. Patient's glucose was normally 85, 86. On 13Apr2021, glucose was 107 and on 10May2021, it was back to 96. Patient's phosphorus level was usually very low, but on 13Apr2021, it went up to 3.5, but it was in the normal range. On 13Apr2021, patient's parathyroid hormone went down and then reached back to 24. Creatine level was 1.1 on 13Apr2021, but on 10May2021, it went down to 0.9 where it belongs and the patient stated that the vaccine might have done something good too. On 13Apr2021, sodium went up to 146, but it was not bad. On 10May2021, it decreased to 144. On 06Apr2021, the patient's arm was a little sore just where the shot was taken and confirmed that she got this after both vaccines. It was not a whole sore arm, pain was present only on the vaccination spot and pained only on touching it. The clinical outcome of events fibroblast growth factor 23 increased, arm was a little sore just where the shot was, creatinine went down to 0.9 where it belongs / shot did something good too was unknown and clinical outcome of all other events was recovered.

appear to have a partial blockage of digestive system; It has been 2 complete weeks since she received the vaccine and she is still having some sort of intestinal blockage or obstruction; bruise; serious migraine headache; have degenerative arthritis in her spine; still having tremors at night; muscle spasms cramps; Constipation; pain in kidneys; muscle aches and pains; Chills; pain shooting across back of neck and shoulders; diarrhea; bloated; coated tongue, white film over her tongue; metallic taste; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, #lot: EK9231) intramuscularly administered in Arm Right on 27Jan2021 11:00 (at the age of 66-years-old) as single dose for COVID-19 immunisation. Medical history and concomitant medications included none. The patient previously took amoxicillin pill and experienced adverse reaction. A long time ago she had a reaction to a rhogam shot, she checked the ingredients, and the only similar ingredient is sodium chloride, she does not have lot, NDC, or expiration. She is Rh- blood and rhogam was given to her for blood crossing over. Prior Vaccinations (within 4 weeks), history of all previous immunization with the Pfizer vaccine considered as suspect and additional vaccines administered on same date of the Pfizer Suspect included none. Adverse reactions following prior vaccinations included none that she remembers, then clarifies she had an adverse reaction to an amoxicillin pill, she does not have lot, NDC, Exp or manufacturer. The patient experienced , appear to have a partial blockage of digestive system on an unspecified date, it has been 2 complete weeks since she received the vaccine and she is still having some sort of intestinal blockage or obstruction on an unspecified date, pain shooting across back of neck and shoulders, diarrhea on 27Jan2021, pain in kidneys, muscle aches and pains, chills on 29Jan2021, muscle spasms cramps on 30Jan2021, constipation on 30Jan2021, bloated, coated tongue, white film over her tongue, metallic taste on Jan2021, bruise, serious migraine headache, have degenerative arthritis in her spine, still having tremors at night on an unspecified date, she drank a milk product and had horrible stomach cramps and had a big stomach explosion, appear to have a partial blockage of digestive system, it has been 2 complete weeks since she received the vaccine and she is still having some sort of intestinal blockage or obstruction on an unspecified date. Patient had the Pfizer Covid vaccine on 27Jan2021 and did have some side effects that people are supposed to have on the second dose, but she started having some pretty bad side effects a couple of days after the first dose of the vaccine. Patient clarified she had one bad side effect the night of the vaccine than felt. Then she started having some different side effects. Patient was asking if she should get the second dose. She asked her doctor and her doctor recommended to contact Pfizer. She was asking if other people are having these side effects. Height/Weight was estimated. She saw the nurse practitioner after she had the side effects, no email. Immediately within seconds of the shot, she felt pain shooting across back of her neck and shoulders, it still hurts, it has improved. She asked the facility if it was normal, and they said no. She saw 03Sep2020 printed on the bottom of the card, thinks it is the card creation date and read mls # from the card. She has a bruise where the shot was given, a big round bruise, she thinks that is normal. Later that night after she got the vaccine, she drank a cup of hot chocolate and her stomach started gurgling and she got very bloated. She had severe stomach cramps for two hours which ended up in a big stomach explosion, clarified as diarrhea which recovered completely the same evening. For the next few days, she ate soda crackers, drank tea and stuff and it was fine. She went a couple of days and it was fine. She had a tiny bit of milk with grits, and she is not lactose intolerant, and she started experiencing muscle spasm cramps that started Saturday, reports that they come and go like labor pain. The cramps recovered but her stomach has not recovered. She is still bloated, sometimes the bloating comes down and sometimes it stays, even if she does not eat anything. Constipation started Saturday and is still occurring a week later. She experienced pains in her kidneys, and this is the reason she went to see her doctor. She thought she might have a kidney infection or kidney stones, but she did not have a kidney infection or kidney stones. Her HCP told her it was probably due to muscles. She provides that one of the tests said something irregularity with kidney, but she does not have the test available to provide complete details. States it is still a small pain, but it is not excruciating at this time, the excruciating pain stopped on Monday, but there is still a little bit of pain as of today. She also experienced muscle aches and pain, Chills which she is not sure if there is a relationship with the shot or something else. She did not have a fever. The day after her horrible stomach cramps she noticed she had a coated tongue, white film all over her tongue. She clarifies she is not sure if this started Thursday, Friday, or Saturday. She thinks it started the night after the bad stomachache. The same day she noticed the coated tongue, she noticed she had a metallic taste, then clarifies maybe the metallic taste started the day after the vaccine. The metallic taste comes and goes, reports she has experienced this before. She had a serious migraine headache for several days; she is not sure if this is from the vaccine or from the weather changing. Patient was taking treatment with stool softener hoping her stomach will get better. The doctor did order an X-ray of her neck on Monday and she was found to have degenerative arthritis in her spine. She thinks the vaccine may hit areas she is not well in. Her main concern was her kidney pain. Patient did not visit Emergency Room however visited Physician Office. Patient reported that one of the tests said something irregularity with kidney but did not have the test available to provide complete details, rhesus antigen negative: she is rh- blood on 25Jan202, X-ray found to have degrative arthritis in her spine on 25Jan2021. Other relevant tests included none. Therapeutic measures were taken as a result of bloated (abdominal distension), constipation (constipation), stomach cramps (abdominal pain upper). Upon follow-up on 09Feb2021, patient was asking if this vaccine protective against the new variants or was there a booster that is needed to get. Patient stated that she called 1 week ago to file a report of her symptoms after she received her first vaccine dose. Patient called to report that she is still experiencing significant side effects and asked if this was normal, what to do about it. And asked if this meant that she had Covid prior getting her first dose and why she was still going through this. Caller reported that the first night after getting the vaccine, she drank a milk product and had horrible stomach cramps and had a big stomach explosion for about 2 hours. It also reoccurred on Saturday, she was fine for a couple of days and appear to have a partial blockage of digestive system at the time of this report. It's really backed up. Patient went to her doctor on Monday following the vaccine and at that time her kidneys were in pain, so questioned a kidney infection or kidney stones, so they did a did a kidney test. Patient continued to have bloating, had a migraine headache and was still having tremors at night. Patient reported that her symptoms were still persisting at the time of this report. She did not want to speak with anyone at the time of this report. Patient asked about the timing of the second dose and if she could postpone the second dose to later than 3 weeks. Patient asked if she got the first dose from Pfizer, whether she could get the second dose from Moderna and whether she could mix the two vaccines. And asked how effective the first dose of the vaccine was. Upon additional follow-up on 09Feb201, patient reported that she called about a week ago concerning some side effects from the Pfizer COVID-19 vaccine. The person took down all of her information and went through a report and was going to switch the caller over to a different department and she got all of her information. She was switched over to some people that she was told would be able to answer some questions concerning getting the next shot. She clarifies further, the person just said they were called professionals. What happened was that she gave them her cell phone number, but the switch had gotten turned off and her phone didn't ring. Therefore, she missed the call. When she tried to call back, she gets in this thing where she had to wait 20 minutes and she gets another person who only records side effects. The caller confirmed she was not provided with any type of reference number from any previous call. She clarifies the problem she had since she had the vaccine was that her digestive system and stomach muscles shut down and it has not gotten any better. It's still a problem. She is scheduled to take the second vaccine next Wednesday and she can't in good conscious get the second vaccine if her digestive system is not working. Caller verifies she did report this information that her stomach was upset, however, it was so long ago (last week) when she reported it, she kind of figured her stomach would be operating again. It has been 2 complete weeks since she received the vaccine, and she is still having some sort of intestinal blockage or obstruction. The caller confirms she didn't report in the previous call that this stomach issue is still ongoing and there hasn't been anything she has been able to do to correct it. Patient had questions concerning getting the next shot. Clinical outcome for the events muscle spasms cramps recovered on30Jan2021, diarrhea recovered on unspecified date, pain shooting across back of neck and shoulders, pain in kidneys, muscle aches and pains, chills, coated tongue, white film over her tongue was recovering, appear to have a partial blockage of digestive system, still having some sort of intestinal blockage or obstruction, bloated, constipation, she drank a milk product and had horrible stomach cramps and had a big stomach explosion were not recovered, outcome of events metallic state, bruise, serious migraine headache, degenerative arthritis in her spine, still having tremors at night was unknown at the time of this report. Follow-up attempts have been completed and no further information is expected.

Death I21.4 - Non-ST elevation (NSTEMI) myocardial infarction J18.9 - Pneumonia, unspecified organism N17.9 - Acute kidney failure, unspecified

N17.9 - Acute kidney failure, unspecified E87.1 - Hypo-osmolality and hyponatremia NASAL CONGESTION COUGH VOMITING WEAKNESS - GENERALIZED

severe abdominal pain; clay colored stool; tea colored urine; a intensely burning, exploding headache; productive cough; This is a spontaneous report from a contactable Nurse (Patient). A 66-years-old non pregnant female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EKT231), via an unspecified route of administration, administered in Arm Left on 24Dec2020 14:15 (age at vaccination: 66-year-old) as single dose for covid-19 immunization. (vaccination facility: Hospital). The patient medical history was not reported. Concomitant medication included losartan (LOSARTAN) taken for an unspecified indication, start and stop date were not reported, metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported, dulaglutide (TRULICITY) taken for an unspecified indication, start and stop date were not reported, vitamin d3 (VITAMIN D3) taken for an unspecified indication, start and stop date were not reported. patient did not receive other vaccine in four weeks. Patient also took second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration, administered in Left deltoid on 14Jan2021 as single dose for covid-19 immunization. No covid prior vaccination. No known allergies. It was reported that on 29Dec2020 06:30 PM 5 days after, severe abdominal pain, clay colored stool, tea colored urine and intensely burning, exploding headache, productive cough. patient tested nasal swab positive for covid-19 post vaccination on 29Jan2021. Patient was not received any treatment for events. The patient underwent lab tests and procedures which included sars-cov-2 test: positive (Nasal Swab) on 29Jan2021. Outcome for the event was reported as Resolved with Sequel on unspecified date. Follow-up (11May2021): Follow-up attempts completed. No further information expected.

UTI; Frequent urination; amber to brown urine; tasted bitter; This is a spontaneous report from a non contactable consumer reported similar events for herself, her husband and 2 other people. This report is for reporter self. A 66-Year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration into the left arm on 16Feb2021 12:15 PM (at the age of 66-years-old) as dose 2, single for covid-19 immunization. No medical history and concomitant medications were not reported. It was reported that the patient had no allergies and other medical history. The patient previously took historical vaccine dose 1 on an unspecified date for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On an unspecified date patient experienced feeling like she had UTI(urinary tract infection), frequent urination, amber to brown urine. Everything she put into her mouth tasted bitter for a day. Had shot Sunday and everything still tastes bitter. It's Tuesday. The patient did not received any treatment for adverse events. The clinical outcome of the events were not recovered. No follow-up attempts are Possible. Information on lot/batch cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021225203 same reporter/drug with different patient, similar AE;US-PFIZER INC-2021225201 same reporter/drug with different patient, similar AE;US-PFIZER INC-2021225202 same reporter/drug with different patient, similar AE

Urinary tract infection; Frequent urination; amber to brown urine; Everything I put into my mouth tasted bitter for a day; This is a spontaneous report from a non-contactable consumer (patient). A 66-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry dates were not provided) via an unspecified route of administration in left arm on 16Feb2021 at 12:15 as single dose for COVID-19 Immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines in four weeks of vaccination. The patient had no known allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration on an unspecified date as single dose for COVID-19 Immunization. The patient was not diagnosed with COVID prior vaccination. The patient has not been tested for COVID post vaccination. On an unspecified date, the patient felt like she had UTI, frequent urination, amber to brown urine and everything she put into her mouth tasted bitter for a day. She stated that she had a shot on Sunday and everything still tastes bitter till Tuesday. The patient did not received treatment for the events. The outcome of events was not recovered. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information was expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021225127 same reporter/drug with different patient, similar AE

Muscle weakness, muscle spasms, staggering, was unable to walk, strained abdomen, cold air caused knees and legs to ache, blood in urine, constant urination, no appetite.

The morning after I got the shot (Wed), I had a sinus headache which got worse throughout the day. As the day progressed I had body aches, was exhausted, got congested and coughed from time to time. I worked every day during the week with this. And later that night, I got severe chills for about 4 hours. I lost my appetite and had to urinate frequently. My headache got worse and my arm was red, itchy, painful and hot to the touch. I felt like I had the flu or maybe even Covid. I woke up every 2 hours during the night with the headache and having to urinate. Finally around 3 AM I decided to take 2 Ibuprophen and the headache was gone when I woke up (Thurs) at 5:30 AM. On Thurs, I was still tired at work, arm was sore and no appetite. But no matter how much water I drank, I hardly urinated. I was still very tired but cough & congestion was just about gone. By Friday I felt a lot better. But my arm is still sore today (Sunday.)

Noticed blood in urine about 2 pm on day of injection (Sunday Feb 21, 2021). Also blood in urine at about 5 pm and 9 pm that day. Also the next morning at 7:30 am and 10:15 am but gone by 4 pm when I am writing this up. No pain on urination. Some discomfort inside. Had general and ob/gyn check up already scheduled for tomorrow at 8 am.

3/9/21 PM headache, 3/10/21 AM fever, generalized achiness, 3/11/21 bilateral hand swelling and rash on hands, diffuse itching. 3/14/21AM swelling around eyes. continues itching. continued fever. swelling in hands improved.

Five days after the vaccine she was on the phone, sitting in a chair and she lifted her arm up and it felt heavy and it just dropped. She then started to raise the arm and she was not able to do it. She then suddenly lost sensation in her left arm. She then could not control it, would raise when it wanted to but was not able to feel it or control it. (had the feeling that it was not connected to her body and it was just floating around). Then started having involuntary muscle spasms in her mid torso region. The same thing then happened again and the muscle spasms were more intense and she waited around and lasted for minutes. She never lost consciousness, but then it happened again and was spreading on her left side. It then encompassed from her hip up to her shoulder. The involuntary muscle spasms were moving from the side toward her chest to where she felt it would impact her breathing. She then went to the ER and they started doing testing, and she had more spasms, and then started having double vision. In talking with the doctor about all of this she had a CVA with complex partial epilepsy with recurrent seizures and that the double vision was related to the infarct in her brain and that the stroke triggered the seizure that she had. She did not lose any memory, loss of consciousness, no weakness or loss of sensation. These episodes only lasted minutes and a refractory time of minutes and when she got to the ER she the other episode when they were trying to test her. They were not able to do the EKG or EEG due to the involuntary movements and these resolved. She is now completely recovered other than the fatigue with no residual. She saw a neurologist on 2/24/21 who felt like that she had a stroke and put her on Keppra and is going to FU in 3 months at IU. It was ruled out that there was no relationship of her transplant to this reaction. She is now on Keppra, Atorvastatin for the swelling in her brain, and also put on aspirin 81 mg. Her blood tests that were done were all drawn and were all within normal limits except for kidney function, but is only a minor #'s for her secondary to the transplant. She then had some titers drawn for CMV and that was also negative. Then she had a COVID test that was negative. Then she had spinal tap that came back normal results.

Patient desires reported that received first dosage of Pfizer on 2/8/2021 and with diverticulitis on 2/26/2021. Received second dosage of Pfizer on 3/1/2021 and with UTI on 3/15/2021

I woke up at 1 am and needed to urinate. I did but then immediately felt the urge to go again but I could only go a small amount. This continued on for every 5 to 10 minute until 2am. My urine was tinged pink and then continued to get worse. By 2am, it was the color of tomato juice with several clots. I went the the emergency room and was given 1 liter of IV solution and an IV antibiotic. I was released around 4am and returned home. I was prescribed a 7 day regimen of oral antibiotics. I did not feel any pain, only the discomfort from the urge to urinate which lasted about 18 hours. By 9am, my urine was clear and in normal amounts. I have never had a UTI in my life which is why I am reporting this.

Minimal reaction the first 2 days after receiving the shot. on the 3rd day I became fatigued but noticed some lower abdominal discomfort. 4th day had loose stools and noticed some burning when urinating.. Late in the day had a splitting headache, i never get headaches, took Tylenol and felt better. At 2 am that night woke up with teeth chattering and limbs shaking. Urinated and noticed a pink tinge. My husband took me to the ER ( He had had a similar reaction to his first Pfizer shot) Found to have a fever, increased heart rate and a raging bladder infection (significant amount of blood in urine). Treated with Keflex via IV . Went home with a presciption for Keflex They are running a culture. I HAD COVID IN NOVEMBER AS DID MY HUSBAND IT APPEARS THAT MAYBE ONE DOSE WOULD HAVE BEEN SUFFICIENT FOR US. I HOPE THIS WILL BE EVALUATED AND THE PUBLIC INFORMED OF BEST PRACTICE

Chickenpox ( was not diagnosed in hospital, rash did not appear till later) Went to ER w/Kidney stone pain, set hone same day, returned 3days later, went to ICU with 107temp, diagnosed with Septic Shock,kidney stones, severe kidney infection , acute renal failure, High Troponin 1 levels,

kidney was not functioning properly; GFR was 41 (stage 3)/ low GFR; Stage 3B Kidney disease; 100.2°F fever; whole body was aching; tired; right kidney started aching and then the left kidney; leucocytes in her urine; high creatinine; bladder symptoms; oil bubbles in my pee/bubbles in her pee; I don't at all feel well; I have got lots of fluid in my body around my middle; put on about 5 or 6 pounds; cystitis; This is a spontaneous report from a contactable healthcare professional (patient). A 57-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot no. PEL9261, via an unspecified route of administration on 05Feb2021 as single dose for prevention of COVID 19 virus. No relevant medical history and no concomitant medications. The patient previously took the first dose BNT162B2 for COVID-19 immunisation (lot no. batch/lot number: EL1284). The patient received the first dose of the BNT162B2 on 15Jan2021. She had a reaction to the vaccine, had a mild reaction with first one she felt like if her heart warmed up and a burning sensation in her left side of the neck and face. She received the injection on her left side. She was kept for half an hour and then she had a mild headache and slept. She also had fever, pain at the injection site and felt very tired. She received the second dose of the vaccine 5 weeks ago. Several days after second dose on Saturday mornings, started having 100.2°F fever for two days and her whole body was aching. When the fever disappeared, she was very tired that week. Her right kidney started aching and then the left kidney, there were also bubbles in her pee and it went worse (no blood in the pee). A few weeks ago, she went to the urgent care, because a week before there were leucocytes in her urine and she took antibiotic. On Monday, she saw the urologist and the urologist sent her a CT scan and a blood test. The blood test results were abnormal so she didn't have a CT scan done because it could be dangerous. Her creatinine was high and her GFR was 41 (stage 3), she didn't know her kidney disease stage until they have the results (Monday). She was very healthy, didn't take drugs and there's no history of kidney disease in her family, also she exercised every day. She would like to know if something similar has been reported with the Pfizer-BioNtech Covid-19 vaccine because she's trying to understand these symptoms that came from nowhere. She knew the Covid-19 could cause kidney problems. She would like to know if there's any live virus in the Pfizer-BioNtech Covid-19 vaccine. She was normally completely fit and healthy. She did not have any abnormality whatsoever and no big medical history. She had the 2nd Pfizer job about 4-5 weeks ago and in the last 3 or 4 weeks at least, she has been having aching kidney, kind of oily bubbles in her urine and she went to see a doctor, a specialist to send her for some test. Today, she discovered that she got a high creatinine and low GFR so that meant have got at the moment, the picture was stage 3B Kidney disease. She had no family history of that. She never had any problems before. She just wondered whether there was any other case report like vaccine should be toxic to her kidneys. This was so out of the loose. Just so uncharacteristic. She stated that probably more than that, she thinks it started because she did not realize at first, it just made her feel tired, her kidney was aching because she was working too hard. It has developed over, it was hard to say. She had the second shot and she had fever for two days. She was so tired anyways. So, she was not exactly sure whether it began exactly when she had it but she certainly did not have it before or whether it came on a few days after or a week after, she was not sure but she knew that it has got worse and now, she was in a situation where she had a CT scan today (19Mar2021). So, she went to the doctor probably on Monday or Tuesday to find out exactly what was going on but she had absolutely no history of anything like this. She had no family history. She was completely healthy. She normally exercised, aerobic exercise most days. She was a healthcare professional (nutritionist). This had come as a complete shock to her today. She was phoning because she wanted to know if there were any other case reports. She knew it was very early and there was not much research on the vaccine but she did not know whether anybody else had reported having kidney problem. She knew you can get kidney problem with the actual disease, with the virus rather but she did not know if the vaccine could cause that. She knew it had something to do with the vaccine and obviously, it may be temporary and she can deal with it. She just needed tab a little bit insight of what to do next. She was not on her normal weight because she has put on about 5 or 6 pounds in the last few weeks. So, she thinks she had got so much fluid. She was normally 5 foot 5 (inches) and her weight was normally about 130 pounds. Actually, it was less than that so it was 127 or 128 pounds but at the moment she was 134. She had got lots of fluid in her body around her middle. When she had the second shot, she had the fever for two days on the Saturday and Sunday and got really tired on Monday and Tuesday and she went there and felt a little bit better but she cannot remember when her kidney started aching. She did not know if it was immediately or whether it was the next week. It started gradually and it had got worse in the last couple of weeks. So, the ache had got so much worse and the amount of bubbles in her pee and urinary symptoms had got worse in the last, at least probably 2 to 3 weeks or so. She had nothing at all before the second vaccination. She would say that it was shortly after she carried on feeling tired and then her kidney started aching and then she developed urinary symptoms. So, that was within a week to 2 weeks of having the shot. She definitely noticed that she had the symptoms and it may have been sooner. She was not entirely sure. It may have been the same week. She honestly cannot remember because it began gradually and she started to feel like she was getting cystitis and she did not think anything over it and then it got progressively, her kidney started hurting and she got really tired and then she just started having oily bubbles in my pee. When probed for the LOT# of vaccine, the first one looked like as EL1284, and the second one, it looked like PEL9261. It could be 4916. She had got the card but she did not know exactly. It was terrible writing. She was not sure it was hard to read. The first one was in her left shoulder and the second one was in her right shoulder. She felt it was related. It has taken incident from when she had the vaccine. Well, she was obviously not a 100 percent sure that was why she was phoning to ask if there is any other similar case report. When probed for the treatment, she stated no, not yet. She only found out today that what happened was she went to see a neurologist this week and on Monday and they organized her to have a CT scan today and some blood work and when she got to the CT scan center today and they looked at the blood work and they said that her levels were too abnormal to have the CT scan with the contrast dye. It would be dangerous. So, that was when she found out it was an abnormal result. So, it just happened today. So, she had not even seen the results of the scan yet and had not seen the doctor but she just knew that her blood was abnormal and her kidney was not functioning properly and trying to find out whether it was related to the vaccine because she needed to find out how to manage it going forward. She was hoping if it was due to the vaccine she can, it has been toxic stroke to her kidney and then she can workout how to deal with it hopefully reverse the situation but she had no Idea but she was just trying to get the feeling for what this could be. She did not have the results of the CT scan yet. She only got the results of the blood which said her kidney, when she went to have the scan her doctor asked her to have the scan and then to have a second scan to what they call a contrast dye and the technician said that when he looked at her blood results he said she cannot give her the contrast dye it was too dangerous. She needed to phone the doctor and so he phoned the doctor and the doctor said just do the scan without the contrast dye and they told her what the blood results were. So, she looked online and she can see that it was Stage 3B Kidney disease and she was in the stage of shock and she was feeling before she went to have this test that this was related to the vaccine because it has come since she has had the vaccine, so close to her having it so now she was more convinced and she just wanted to see anybody else has had this. Obviously, the doctor would not know about this because this was so new and so she needed to workout on how to deal with what has happened to her. Her creatinine was 2 and GFR was 41. With second one she had the fever for few days and she felt very tired, and then she developed some bladder symptoms, and she thought maybe she just had something like cystitis, and then she was very tired, her kidney started aching and particularly on the right hand side but on the left as well, it's got worse and worse to point that she got oil bubbles in her pee and she went to see neurologist on Monday, she had the blood test and today she got scan, a CT scan and she meant to have a consult after the scan with the scan but when they saw the blood result, which she has not seen, they said that was so abnormal they could not get her the contrast dye, so they said because of the result, she suddenly got out of nowhere and stage 3B kidney disease, and she had not gotten the result of the scan yet but she has sent in on stay, but she didn't at all feel well, haven't felt well since she had the vaccine she personally felt it had something to do with the vaccine because she did not have any family history of kidney disease or anything related to that and she never had an issue, never even had kidney infection so, she phoned up today to off Pfizer whether there have been any other case reports, because she had to go back and see her Urologist now and he won't know because it's obviously such early days with the vaccine and there not any proper Clinical Trials to, she would think to reflect this. She was concerned about the side effects and she just wanted to know because now, she knew had to deal with it, and she was, obviously that came as big shock to her that she just wanted to, if there have been any, she knew that the Covid virus can cause kidney disease, but I didn't know whether the vaccine has been showing to do that in any other individual. Results of tests and procedures for investigation of the patient on 15Mar2021: blood test, result: creatinine 2 and GFR 41. The outcome of fever and tired was recovering, while outcome of other events was unknown. Information on the lot/batch number has been requested.

Case called to report symptoms he developed after his vaccination. He was vaccinated on 4/30/21 with the Pfizer vaccine. He reported soreness in his arm the first few days. On 5/11/21 he developed extreme fatigue, subjective fever, increased back pain, and urgency to urinate. He has a history of sciatica, back pain, high blood pressure, and high cholesterol. He states he is still experiencing the fatigue, back pain, urinary urgency, and subjective fever. He also states that he has developed neck pain as well. He feels that the vaccination has exacerbated his underlying medical conditions. The case states he has been reporting this symptoms to the V-Safe program but has received no follow up. RN encouraged case to call his physician ASAP to report these symptoms as it could be other issues and he needs to have physician follow up. He states he would call his physician directly. Case asked if he should have the second COVID vaccination. RN encouraged patient to talk to his physician and for them to decide together if he should have the second vaccination.

N17.9 - Acute kidney failure, unspecified E87.1 - Hypo-osmolality and hyponatremia D69.6 - Thrombocytopenia, unspecified

On May 21 woke up to heavy brown discharge. Went to ER on may 23rd . Having Cycles for 3 days . Off for week and return for 3 days . this happens every two weeks . also burning when urinating . Back pain all the time

Patient is a 68yo female with a PMH s/f of osteoarthritis, CHF, TIA with right limb weakness and aphasia and HTN presenting with a 1 week history of bilateral upper and lower extremity pain, stiffness and weakness. Patient states that she received the Pfizer COVID vaccine on 1/14 last week at pharmacy. At the time of inoculation, she did not experience any symptoms and went home after the 15 minute waiting period. The next day, she developed a generalized headache that started in her neck and continued over her head. She states that this continued to get worse throughout the day and on Saturday, she woke up and described a constant, 10/10, dull-aching pain that started at her neck/back of head and extended down to her shoulders to the tips of her fingers. She also stated that she had the same pain starting around her groin extending down to her knees and ankles. Patient initially tried taking Tylenol and ibuprofen to treat the pain, and said that those treatments normally work for her osteoarthritis, but that her pain did not improve afterwards. In addition to the pain, she also states that she developed worsening weakness to the point where she could not walk around her home. She stated that she thought moving around and being active had helped her fight through the pain and tolerate it, but that laying down and resting actually seemed to make it worse. With her symptoms worsening and her inability to walk, she decided to come to the hospital to get further treatment. She denied ever having an adverse reaction to other vaccines she has received previously. She receives the flu vaccine every year, and received measles, polio and other childhood vaccinations that she could not recall. She was diagnosed with polymyalgia rheumatica and started on 20mg prednisone daily. She had a remarkable response to the steroids and her symptoms resolved within 24 hours. She was discharged on her 3rd day of admission. On ROS, she denies fevers, chills, night sweats, SOB, changes to vision, eye pain, cough, chest pain, sputum production, nausea, vomiting, diarrhea, dysuria or hematuria. She affirmed weight loss, headache, neck stiffness, dizziness, lightheadedness, muscle stiffness/pain, reduced ROM, and urinary urgency and incontinence.

Had a floater in Left eye for 4/5 days, started last week for a few. Diarrhea several times since the shot (no big deal although more than normal). This last one is the one I'm concerned about believe I have a UTI infection for the last 5 days, self treating with many products. It's getting a little better ... just concerned. Wondering if I should get an antibody test before the second shot ..... HELP!

Severe migraine headache associated with visual distortion, nausea/vomiting, and prolonged word-finding difficulty lasting at least a few days. No prior history of migraines. TIA work up ongoing.

she is having confusion and dementia,; went into this kind of like dementia-like state where she talked incessantly/ she is having confusion and dementia,; She had days of vomiting and nausea; She had days of vomiting and nausea; She complained of brain fog and couldn't focus on the tv or her programs; kidney functions were not good enough; she has mood swings; she could not remember or know everything from the present; she had a UTI; This is a spontaneous report from a contactable consumer (patient's sister). A 68-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular injection on 20Jan2021 (at the age of 68-year-old) at single dose for COVID-19 immunisation. Medical history included ongoing breast cancer stage IV, patient was in treatment for breast cancer stage IV, she had cancer 13 years prior the report in 2008, and then was found again and diagnosed 3 years prior the report, in Jun2018; chronic obstructive pulmonary disease (COPD), a long time, a lot of her adult life. The patient was on oxygen; she had a lot of fluid built up from the cancer; patient tested positive for COVID in 2020 (Feb2020 or Mar2020, as reported). She and her roommate tested positive and had a cough. They had no fever or other symptoms. Both in the nursing home got over the cough and 21 days later tested negative. Patient tested negative for COVID ever since. The nursing home tested the residents and staff every week. They had tested the patient so much to the point her nose was bloody which the reporter got upset about; hallucinations and paranoid thoughts. Concomitant medications included ongoing perphenazine (TRILAFON) taken for hallucinations and paranoid thoughts; treatment for breast cancer stage IV and oxygen. The patient lived in nursing facility and had received both Pfizer vaccine doses. The patient received the first vaccine for COVID-19 immunisation in Dec2020. She was fine. She got the second one on 20Jan2021. Since patient received the 2nd vaccine dose, in Jan2021, she was having confusion and dementia, which was not an issue before the vaccine doses. The patient was having trouble putting words together. Patient initially had vomiting, nausea and brain fog where she could not concentrate on her TV, in Jan2021. She was hospitalized from 17Feb2021 to 20Feb2021 to have all kinds of tests run and see if her cancer had spread to her brain. Patient had 3 years with stage 4 breast cancer and had fought so hard and was aware of her confusion and it was very upsetting to her. She had days of vomiting and nausea. She complained of brain fog and could not focus on the tv or her programs. Within days, she went into this kind of like dementia-like state where she talked incessantly and could not get a thought completed. Patient would go from one thought to the next. It was very bizarre. She had never had this kind of issues. This went on for so long, they finally put her in the hospital. Patient had stage 4 breast cancer, and the doctors thought maybe her cancer had gone to her brain. The doctor did not think it was related to the COVID-19 vaccine. She was checked for a urinary tract infection (UTI), for brain cancer, for a stoke, for everything. She saw so many doctors. She still had not come out of this a month later. She was currently on psych meds because she had mood swings, since Jan2021. It had been one thing after another. The patient could not tell the time. On some level, patient knew something was wrong. She was in a very confused state. She did not know how to tell anyone what she wanted to tell. It was very distressing to say the least. She had made a little bit of progress. She could tell time with some struggling but she got upset and cried. Patient could only tell that the time was 3, but not 3:15. But, then she cried and got upset. She had been able to tell time a couple of times, but if you asked her what day was it, she had no clue. She had no clue what day it was and would ask "what day is it?" Her moods all over the place. The patient was still very confused. The reporter explained the patient could be 5'3'', she was unsure. The reporter really did not know the patient weight, she was guessing around 270lbs. She had a lot of fluid built up from the cancer, and reporter had not seen her since COVID started. Patient told that her weight was up around 300lbs. The reporter declined to include a healthcare professional for the report, stating she had not spoken to her sister's primary care doctor. She was waiting for her to call back. The patient was sent to the ER and admitted into the hospital on 17Feb2021. She came back from the hospital on 20Feb2021 at 6:30pm. She had a CAT scan, MRI, bloodwork done, in Feb2021. She saw a psychiatrist, neurologist, her oncologist. There was so many doctors seeing her and talking to the reporter. The last doctor the patient saw in the hospital said that she thought the patient was dehydrated from her vomiting episodes, but did not know for sure. In Feb2021, the nursing home did blood tests and a urinalysis to see if she had a UTI. The blood work would have shown if patient was dehydrated and she was not. The head nurse thought it was the vaccine, but she was not sure. Everybody was not sure. No one could tell her anything concrete about patient. She was not normally like this. Patient had recovered completely from the nausea and vomiting. They tried for a while to give her an anti-nausea medicine, but she could not keep anything down. It was given to her orally, she did not know why an injection was not given. This lasted for a few days, clarified as maybe 3 days. The reporter had no name, NDC, lot number or expiry date for the anti-nausea medicine the patient took. She knew it was given to her once and when they tried to give it to her again, patient refused. Reporter had no product information to provide for the first and second doses of the COVID-19 vaccine, did not have the patient vaccine record card. This would be with the nursing facility. She mentioned patient went into the nursing home on Jan2018 and then was diagnosed with breast cancer Jun2018. She did not know if there were any interactions there with the patient having the breast cancer and receiving the COVID-19 vaccine. The reporter had no product information for the first dose. When probed for the date in which the first dose was given, she explained she was sent constant emails which could have provided a date, but she did not know this information offhand. It was approximately a month before the second dose, or it could have been on 27Dec2020, which was a little closer than a month apart. No additional vaccines were administered on the same date of the Pfizer vaccine. The events required a visit to emergency room. Patient had constant testing while in the hospital. In the hospital, in Feb2021, they did MRI and CAT scan to see if the breast cancer had gone to the brain and both were negative. They tested for UTI. They did the first UTI test at nursing home in 2021 and they said she had a UTI and patient was put on an antibiotic. They tested her again for a UTI when she was admitted into the hospital in Feb2021 and they said she did not have a UTI. She did have a buildup of urine in her bladder because her kidney functions were not good enough for the MRI at first, in Feb2021. Her bladder was relieved of the urine build up and her kidney functions improved and she was able to get the MRI. The MRI did not show any cancer in the brain. None of it relieved her symptoms. This was just bizarre. It happened within a week of receiving the vaccine. She could not talk with patient and patient had never been like that. The patient had always been lucid and open and you could talk about anything: the past, the present, she had no problems. She could remember everything crystal clear from the past but she could not remember or know everything from the present. The reporter would ask her what day was it and the patient did not know. The patient would absorb the information she was told but there was like this strange disconnect, almost like a dementia of some form. About concomitant medications, the reporter explained the patient had not started anything new. She had been on the same stuff for many years. She had psych meds that she had been on, but she had been on those for many years. She clarified further that patient had been stable on her psych meds for many years, and the nursing facility had the patient stable for 3 years at the nursing home. At the time of the report, her mood swings were all over the place, she had never had that before. She had hallucinations and paranoid thoughts in the past, but she had never had mood swings like this and never had dementia. She had been on the same medications for a long time, but they were currently trying to play with them and trying to adjust her psych meds. It was apparent it was not working and this was something more organic, something going on in her body. The psych med was perphenazine all of her life. The psych nurse was a new nurse and was not familiar with the patient. The psych nurse informed the reporter she raised the perphenazine to the highest dose she could possible go on and told she could have to try the patient on a mood stabilizer and could have to put her in a psych unit. The reporter would not have any NDC, lot numbers or expiration dates, or anything like that. The reporter had been told an UTI could have caused the patient symptoms. It could have been brain cancer, or this or that. She did not know what was going on. Reporter asked if there had been any reports or had other people called in with these types of reactions or adverse events. The patient had recovered from vomiting and nausea on an unknown date in 2021, had recovered from kidney functions were not good enough and UTI in Feb2021, the outcome of the other events was unknown. Information on the lot/batch number has been requested.

68 yo WF in excellent health with prior history of intermittent benign positional vertigo for seven years and a cerebral concussion two years ago from which she recovered uneventfully in 6 weeks with no residual neurologic or physical issues. Patient received first dose 1/19/2021 with only mild fatigue and arm soreness at injection site. 16 hours after the second dose, Patient developed a dull total cranial headache and fatigue , retiring to bed , taking no medicines. She had taken only her premarin 0.625 mg for the last week. Patient awoke at 4:30 am with severe headache, nausea and vertigo, being unable to stand without assistance. urinary incontinence also occurred, but most likely occurred as she was unable to to get to the bathroom due to vertigo and pronounced vomiting of clear yellow fluid. incontinence never occurred again throughout the illness. examination at this time showed nystagmus on bilateral lateral gaze and vertical nystagmus. no other neurological signs or symptoms were present. On return to bed, Patient continued to have vertigo headache and nausea even supine with eyes closed. Vetigo and standing instability did not respond to epley manuvers. Headache remained mild to moderate, along with persistent vertigo and nystagmus for 4 days, becoming slightly less each day. On the fifth day, Patient was able to ambulate unaided by holding onto walls furniture etc. vomiting did hot reoccur after her initial bout. Headache abated on the fifth day. Patient remained "fuzzy" and imbalanced for the next 14 days with occasional mild posterior cranial headache. Rotary nystagmus abated on the 7th day. Note is made that no abnormalities of the tympanic membranes were noted. no cardiac symptoms or irregularities were noted HR 60 BP 110/70 several attempts at epley manuvers only resulted in symptom worsening. Patient felt well enough to traveled by airplane day 8 post dose, having still some "fuzziness 'and slight imbalance, being unable to walk briskly due to gait instability..symptoms worsened slighty after air flight, and on return to home, slight barotraumatic changes were noted in the tympanic membranes, slight fluid levels and some small streaky membrane hemorrhages noted. her gait became slighty more unstable, but she was able to walk unaided. symptoms improved daily and by day 14 symptoms seemed to be much lessened, no nystagmus being noted. vertigo was present only on rapidly standing , position change and vertical looking up., vertigo abating quickly after each motion at rest. Patient traveled by plane on 3/4/21-3/8/21, vertigo escalateed to mild to moderate..no response to epley manuvers. Vertigo worsened daily and Patient again developed mild gait instability and nystagmus bilaterally and vertically. Ear exam was unchanged. no headache was present during this time. Patient was taken for balance training to a specially trained Physical therapist on 3/10/21 for evaluation , Patient being markedly symptomatic, examination showing both right and left ear abnormaities as well as vertical nystagmus. driving was prohibited. The constellation of symptoms for the even are most consistent with acute vestibular neuronitis or central vertigo.. Neuologic localizing signs suggestive of cerebral thrombosis, etc were not present , so MRI was not performed. Patient had Had a Notmal CT scan with here cerebral concussion two years prior. As the symptoms weer worsening and the result of the balance training session on 3/10/21 resulted on significant worsening on awakening on 3/11/21 with moderate gait instability, bilateral horizontal and vertical nystagmus, Prednisone 40MG po was administered. Approximately 8 hours after the prednisone dose, Patient was able to stand unaided, and vertigo was almost totally cleared. 30mg prdnisone was administered on 3/12/21 with Patient being totally asymptomatic. No nystagmus could be detected and epley manuvers done by the physical therapist resulted in no symptons or evoked nystagmus. Predinsone dose was deescalated by 10 mg daily, Patient remaining totally asymptomatic. today 3/16/21 Patient will take 5mg of prednisone, still assymptomatic, prednisone to be discontinued tomorrow.

Transverse myelitis acute rapid onset 3/22/21 with severe right lateral mid back pain, rapidly progressing lack of bilateral lower extremity sensation and rapidly progressing within hours to complete paralysis with fecal and urinary incontinence

3/26/2021 Note Nursing Assessment: Patient called through Office line Reason for Call WHEEZING Onset: 2 days ago Occurrence: acute Anatomical Location : na Severity: moderate Symptoms: Patient concerned about having asthma exacerbation. Started with cough and wheezing 2 days ago. Cough is productive but has not visualized the sputum. No fever. Having intermittent chest achiness in center of chest also. No known covid exposure. Had 2nd covid vaccine 2 days ago and states that 2-3 hours after the vaccine she began to have a "wheezing attack" and then it has continued since. Currently able to talk in full sentences but wheezing and having some breathing difficulty. Has not used Albuterol since last night. Any treatment So Far: Pulmicort, Spriva, and Albuterol Response: Helps for a little bit 3/26/2021 ED Visit CHIEF COMPLAINT: RESPIRATORY DISTRESS (began yesterday; says had 2nd covid vaccine weds and believes it "sparked my asthma"; hx of asthma/COPD. associated midsternal chest tightness) DIAGNOSIS at time of disposition: 1. COVID-19 ruled out 2. Bilateral pleural effusion 3. Acute cystitis without hematuria EKG NSR Chest x-ray showed no acute abnormalities showed stable mild cardiomegaly. CT results showed new small bilateral pleural effusions, right greater than left. Minimal bibasilar atelectasis mucus plugging. No airspace consolidation or PE noted. Patient reports that she was recently taken off her Lasix secondary to some weight loss and the fact that she had recently had surgery and oral intake was low. At this time, I do feel some of her symptoms may be related to fluid overload. Discharge 3/26/2021 3:59 PM 3/28 ED follow up. Pos urine cx. ABX started 3/29/2021 Called nurse triage. MODERATE difficulty breathing (e.g., speaks in phrases, SOB even at rest, pulse 100-120) of new onset or worse than normal. Told to go to ED. 3/29/2021 ED to hosp admission 28 hours. The encounter with the patient was in whole, or in part, for the following medical condition, which is the primary reason for home health care shortness of breath, anxiety, UTI, recent surgical intervention for bowel obstruction.

68 y.o. female who presents with FEVER, ALTERED MENTAL STATUS, URINARY INCONTINENCE. DAUGHTER STATES INCONITNENCE STARTED Friday 4/9 AND FEVER AND CONFUSION STARTED TODAY WITH SHORTNESS OF BREATH. PT WAS SEEN AND SWABBED FOR COVID AND FLU BUT REFERRED TO ER FOR FURTHER EVAL AND WORKUP. PT IS DIABETIC BUT DAUGHTER REPORTS NOT KNOWING WHERE ACCUCHECKS ARE AS THEY HAVE NO MONITOR AT HOME. Admitted Inpatient 4/13/21

Seizure lasting ~ 2minutes, patient incontinent of urine. Patient transported to ER via ambulance for treatment and observation. Patient post-ictal for several hours prior to discharge.

Patient was admitted due to COVID pneumonia without hypoxia. She has a history of COPD, hypertension, hyperlipidemia, CAD, recent COVID-19 infection diagnosed on 04/16 presented to MMC ED for ongoing episodes of abdominal pain, nausea, diarrhea that has worsened for last couple of days. Patient has had symptoms of generalized fatigue malaise weakness is his since 4/14 and has had been worsened and was seen in ED on 4/21 were symptoms of some COPD exacerbation were for home with COVID-19 and was prescribed antibiotics and steroids which he took at home. Since then, patient has had symptoms of feeling more weakness, abdominal cramping pain radiating down his towards her groin with some burning in a.m. for urination and started noticing diarrhea, 3-4, loose, watery with yellowish output without any blood. Has some nausea but no vomiting, poor appetite and is trying to keep herself hydrated but unable to complete full drinks. Denies fever, and chills. No active cough, slight wheezing at home, but she has used her nebulizer 4 times and had improvements Patient did not qualify for any treatment but her home medications were continued. Patient did not have any shortness of breath, cough fever. Patient also had mild renal failure which resolved. Overall patient did well. Upon discharge examination, she denied any new complaints. Her renal failure resolved. She was recommended to stay 1 more day but she stated that she is feeling fine and want to be discharged. So patient discharged and told to return to emergency center if she gets any fever, increased diarrhea, nausea, vomiting.

3/11 ED Patient admitted for urinary tract infection without hematuria after recurrent falls. She reports that the weakness was actually in all 4 extremities. She did not hit her head or lose consciousness. ED work-up including a CT of the brain was unremarkable. She had a lumbar puncture as well which did not reveal any acute signs of infection or other etiologies. The patient was concerned that this could have been a result of receiving her Covid vaccination. She will be discharged home on cephalosporins. She was encouraged to follow-up with her primary care provider within 1 week and to call neurology office for follow-up particularly if she has any more episodes. She was encouraged to return to the emergency department if she continues to have episodes as well.

loosing urine; mind would 'go off' for a couple of seconds and she would just urinate.; seizure; she would just urinate.; This is a spontaneous report received from a contactable consumer (patient). A 68-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot number and Expiration date were not reported), via an unspecified route of administration, administered in Arm Left on 24Feb2021 10:00 (at age of 68 years old) as single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included omeprazole (PROTONIX). No Prior Vaccinations (within 4 weeks). No AE(s) following prior vaccinations. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot number and Expiration date were not reported), via an unspecified route of administration, administered in Arm Left on 03Feb2021 (at 68 years old) as single dose for COVID-19 immunisation. Caller stated she received Pfizer's COVID vaccine and shortly afterwards (on 24Feb2021), her mind would 'go off' for a couple of seconds and she would just urinate. She stated, "I never had this issue before. It happened one day, then 2 days later, then 2 days later. My mind would just go off for a second and I would just stand there and urinate. And it went on for 10 days every other day. Now it just happened. I just unloaded yesterday (29Apr2021). It all just started happening after the 2nd vaccine. It may be related or may not. The urologist said that's strange and they said there's nothing they can do about it. I will be seeing the neurologist on 07Jun2021." Caller calling about the Pfizer COVID vaccine. She states that 2 days after getting the second shot every now and then her mind would go off, like a mini seizure and then she would loose her urine. She states that she has never had this issue before. It has been going on for almost over a month now, but it has been going down a little less, but it's still happening. She is going to a neurologist, but the neurologist can't see her until June. She is wondering has anyone else had an issue with this? She states she has been to a urologist, but they say they can't do anything for her and that she needs to see a neurologist. She states that it is very strange. She does state that it is becoming less and less, and it is like every 4 days now. She states she did have a 6 day stretch where she didn't have any incidence of the mini seizure or loosing her urine. She states she has never had anything happen to her like this, not even close. It happens out of the blue, and she doesn't even feel the sensation to urinate. She states she could be talking to someone, or in a store talking to someone and her mind goes out for just a second and then she just pees. She states that she is aware of what is going on. Caller states that she doesn't know what a mini seizure is like and does not know how to describe this event. However, it is usually when she is talking to someone, her mind might go off for a second then she just pees. She states it's weird. She states that it is usually when she is out, and that it doesn't happen at home. She states that she doesn't have the sensation of having to go to the bathroom she just goes. She says it's weird, nothing like this has ever happened before. She doesn't have a problem with fizzing out for a couple seconds. Caller states she doesn't want to use mini-seizure because then that marks her of having epilepsy. She also states that her doctor told her not to describe it as a seizure because they are not sure what it is yet. She wants to use the term fizz out for a min. Fizzing out for a minute: She clarified and states that the last two times this happened she did not fizz out, but she still just peed out of nowhere, without even having a sensation of having to pee. The last time she fizzed out was 10Apr2021. She doesn't know what to do and she is hoping that it gets figured out. She went four days without anything happening and then she was waiting in line and it just happened. She states she just urinated but doesn't recall fizzing out. She states it is not every day but every four days now, the urine. She states that it happened after the second vaccine. Dates for loosing urine was 04Mar2021. Physician Office visit for all events (went to the doctor after this happened. She states that the events might of happened before the second vaccine, she is not sure, but she started righting it down shortly after receiving the second vaccine). The outcome of the event loosing urine was not recovered, for other events was unknown. information on the lot/batch number has been requested.

After receiving the vaccine I had soreness in my left arm. I developed a severe urinary tract infection the next day. I had severe heavy bleeding in the urine and severe left sided pain in the back. A week later I started to feel some aching under my left under arm and left breast. I had a mammogram on May 5th and I still had pain under my left breast area. A few weeks after getting the shot, the aching continued until early May. I had a headache the first day.

Low grade fever Tmax 100.7F, fatigue, myalgia, recurrent UTI approximately 1 month after second dose of vaccine and persistent

Felt dizzy; Not been drinking enough water recently; Might be dehydrated; Stated she has been drinking water and her urine went to clear from yellow; Severely obese; This is a spontaneous report from a contactable consumer (patient herself) via a medical information team. A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN5318), via an unspecified route of administration in left arm on 05Feb2021 (Friday) at 09:48 (at the age of 68-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included ongoing blood pressure, dehydration, hospitalization. Mentioned in the past she had a hospitalization for dehydration. Concomitant medication included felodipine, orally from an unspecified date (taking for years) and ongoing at 5 mg once a day (5 mg take once daily by mouth) for blood pressure. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). Patient's medical history (including any illness at time of vaccination) was none. Family medical history was none. It was reported that, patient did not experience any immediate adverse event, however, today (08Feb2021) she felt dizzy, asked if: There are reports of other patients feeling dizzy days after vaccination, dizziness was usually followed by other side effects. Patient acknowledged she has not been drinking enough water recently (08Feb2021), considered the dizziness experienced may be a result of that and probably not an adverse event associated to the COVID-19 vaccine. She didn't have any side effects for three days and then she began to feel dizzy. Adds that it was not too bad as she was able to work but it was persisting. Mentioned she read that dizziness could be a severe side effect and she was asking could it come on three days later. Adds that she might be dehydrated on 08Feb2021 and stated she has been drinking water and her urine went to clear from yellow on 08Feb2021. Mentioned she didn't drink enough water on Saturday or Sunday, so she was trying to make that up today. Also asking would she have other side effects along with the dizziness if this was a side effect. Mentioned in the past she had a hospitalization for dehydration. Asking to have any of you girls heard anything about this. Mentioned that she was severely obese on an unspecified date in 2021. Adds she was scheduled to receive the second dose of the vaccine on 26Feb2021. The adverse events did not require a visit to physician or emergency room. No relevant test. No investigation assessment. The events were considered as non-serious by the consumer. The outcome of the event felt dizzy was not resolved and unknown for the other events. Follow-up attempts completed. No further information expected.

Acute kidney failure, unspecified Proteus (mirabilis) (morganii) as the cause of diseases classified elsewhere

At injection site in right arm, bruising developed, and redness appeared approximately 3 inches below injection site. It was a large red area about size of a small apple. The raised area was red and warm. Fever 102.9 Nausea Dizziness Bladder control dysfunction - once Persistent headache.

extremely nauseated; my eyes kind of crossed; Well after the shot I could barely even walk from the first tent to the second tent; UTI; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on 20Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reported stated she receive the first dose of the COVID-19 vaccine on Wednesday 20Jan2021 and she had a "strange" reaction on 20Jan2021. Specifically, she states, "as soon as she pushed it in, I became extremely nauseated, my eyes kind of crossed and I had to sit in my car for 4 hours afterwards because I couldn't drive. They had 2 tents set up. Tent 2 was for people who had previous reactions or allergies and tent 1 was for people who had no reactions. Well after the shot I could barely even walk from the first tent to the second tent I stayed there for 45 minutes and then I could barely even walk to my car." Caller wants to know if she should get the second dose of the vaccine. She was started on the antibiotic sulfamethoxazole;trimethoprim (BACTRIM) on 22Jan2021 for a UTI which started after receiving first dose of COVID-19 vaccine in Jan2021. She would like to know if it is okay to use this medication since she just received the vaccine. She reported that she submitted her urinalysis the same day that she received the vaccine on 20Jan2021. The patient underwent lab tests and procedures which included urinalysis: with unknown results on 20Jan2021. Therapeutic measures were taken as a result of UTI. The outcome of the events was unknown. Information on the lot/batch number has been requested.

HEADACHE, NAUSEA, JOINT INFLAMMATION, EXCESSIVE NASAL MUCOUS DRAINAGE, DISORIENTATION, DIZZINESS, HYPERSENSITIVITY TO LIGHT AND NOISE, LACK OF URINATION, BOUTS OF DIARREAH, CHILLS WITH SKIN ICE COLD TO TOUCH, FREEZING FEET, UNABLE TO DRINK LIQUIDS; COULD NOT EAT FOR 3 DAYS; NO FEVER

Racing heart for about 8 hours Diarrhea for 3 days Fatigue for 5 days Headache for 5 days Nausea for 3 days Muscle pain for 2 days Joint pain (right knee swollen and painful) for 2 days UTI started 4 days after vaccine

muscle spasms; wasn't feeling well; she stumbled again, and fell against her car; too tired; cry; patient with rheumatoid arthritis received Pfizer Covid-19 Vaccine; patient with rheumatoid arthritis received Pfizer Covid-19 Vaccine; headaches/The headache is above her ear and the pain is "past 10"; She recalled experiencing "swelling around her eyes" and "had some swelling" after the 1st dose of the Pfizer-Biontech COVID19 vaccine/left eye swelling; had some swelling; Dizziness/Lightheadedness; Vomiting; Blurry vision; She said the left arm pain started immediately after receiving the COVID-19; Injection site swelling; she is sweating something fierce under her arms; peeing on herself (running to bathroom more); lady asked her to call her when she got home, and she forgot, saying her mind wasn't there; acid reflux taste in mouth/she tasted the COVID-19 Vaccine shot when it was administered; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982; expiration date: unknown) at the age vaccination of 69-year-old via an unspecified route of administration in the upper left arm on 19Jan2021 08:00 (also reported as 11Dec2020) at a single dose for covid-19 immunization. Medical history included was hit by a truck a GM and the truck busted her legs up, ongoing RSD (Reflex Sympathetic Dystrophy) pain since 1991 and was prescribed with oxycodone/acetaminophen (PERCOCET), rheumatoid arthritis from 1991 to an unknown date, spinal cord implant is in her spine, and goes from her spine to her waist, and from her waist to both legs, and down to her ankles from 1991 to an unknown date and migraine when she was 12 or 13 years old. There were no concomitant medications. She received the vaccine in a hospital. The patient previously had a flu shot for immunization but was allergic to the flu shot. It was reported that a patient with rheumatoid arthritis received Pfizer Covid-19 Vaccine on 19Jan2021 08:00. On 19Jan2021, the patient reported that she said she had a slight headache, left eye swelling, dizziness, vomiting, blurry eyes, sweating up under her arms, and peeing on herself (running to bathroom more) after receiving the COVID-19 Vaccine. It was reported that the patient had injection site swelling on 19Jan2021. She said she has never had any side effects like what she is experiencing now after getting the COVID-19 Vaccine. She reported that her mild headache turned severe over the weekend, and she had to wrap a towel around the back of her head, so she could lay down. She said the headache pain was a sharp pain at the bottom of the back of her head and neck. She clarified she had migraines when she was 12 or 13 years old, but the headache pain she had now is nothing like the migraines she had then. She further clarified that her severe headache feels like a knife in the back of her head and neck. She said the pain is more severe on the right side of her head than the left. She said right now she has pressure in the front of her head with a slight headache. She additionally clarified that the swelling in her left eye comes and goes and is persisting. She said her left eye didn't swell close, but her granddaughter told her it looks like something is wrong with her left eye. She added that she had dizziness this morning when she was going to work. She said she stumbled when she was walking this morning but drove to work anyway. She said when she got to work, she wasn't feeling well on an unspecified date, so she decided to go back home. She said when she was walking to her car, she stumbled again, and fell against her car. She reported when she first got the COVID-19 Vaccine (19Jan2021), she was driving in a bad way. She said after she got her COVID-19 Vaccine, she picked up an elderly lady she sits with, and the elderly lady told her she wasn't normal. She said the elderly lady told her she was too relaxed while she was driving, like she was in a daze. She said the elderly lady said she was scared for her and herself when she was driving. She said the elderly lady asked her to call her when she got home, and she forgot, saying her mind wasn't there. She mentioned that she had to wait 15 minutes after receiving her COVID-19 Vaccine (19Jan2021), and when she was driving home, she had to pull over and get out of her car to vomit. She said she had an acid reflux taste in mouth before she threw up. She said she threw up a little bit last night when she had a severe headache. Clarified her eyes are constantly blurry now. She said she has to put her glasses on to see but has to turn her head sideways in order to see anything past her blurriness. She said her burry eyes are worse at night. She stated that she was sweating something fierce under her arms, she said she has to take 3 showers a day now to get rid of the sweating and smell under her arms. She said she has never sweated like that before. She reported her left arm is sore too. She said the left arm pain started immediately after receiving the COVID-19 Vaccine (19Jan2021). She said she has swelling too, and has been rubbing her left arm with alcohol, but the left arm soreness is still there. She reported that she tasted the COVID-19 Vaccine shot when it was administered. She has blown off calling her doctor when she first experienced her side effects, but then her headache got worse. She said she so spoke to doctor 30 minutes before calling Pfizer. She said she told her doctor if her headache comes back, she is going to the emergency room when she gets off work after tonight. She stated that she has been experiencing headaches/muscle spasms that have been getting worse. She says they last 15-20 minutes and then it stops. The headache is above her ear and the pain is "past 10". Yesterday night (unspecified date), the headache was so severe that she wanted to go to the ER but was too tired. The patient reported that she was taking ibuprofen (ADVIL) for her slight headache. She said she took the Advil for a couple days and nights, and her headache eased up some with the Advil. She reported that 2 days ago she bought aspirin, caffeine, acetaminophen (EXCEDRIN MIGRAINE). She also reported that she started taking Ibuprofen when her headaches became severe. She said the Ibuprofen eased the headache, but the headache comes back. Reported she took pain medicine prescribed from a doctor way back, and the prescription pain medication doesn't ease her headache pain. She clarified that the medication was dispensed in a pharmacy was oxycodone, acetaminophen (PERCOCET). She called her doctor when she returned home from work this morning, and her doctor told her to call Pfizer to report her side effects. She reported when she went to work this morning, she got lightheaded. She took Percocet and other medications, but it hasn't relieved it. She says it's not a migraine. She recalled experiencing "swelling around her eyes" and "had some swelling" after the first dose of the Pfizer-Biontech COVID19 vaccine on 19Jan2021. She reported on 02Feb2021 that she was calling back today to report that her headaches were worse. She said her headaches are not a migraine, but more like a muscle spasm in the right side of her head, above her ear. She said the pain is between her neck and ear on the right side of her head. She said the headache pain feels like it is as big as a golf ball. She said her headache pain is so severe, the headache pain wakes her up in a cry. She said the headache pain lasts 15-20 minutes, and then eases up slightly. She said the headaches have been happening twice at night, and twice during the daytime. She said the headache pain doesn't last long. She mentioned that she has been doing self-remedies. She said she ate a spoonful of mustard to ease the headache, and the spoonful of mustard did ease her headache. The patient inquired if she should get the second COVID-19 Vaccine if she is continuing to experience headaches after receiving the first COVID-19 Vaccine. The outcome of the events headache, eye swelling, blurry vision, frequency urinary were not recovered, as for the events dizziness, vomiting, vaccination site pain and vaccination site swelling were recovering, while the outcome of the other events was unknown.

she got the shot on 1/31/2021. Over the next 3 days she developed poor oral intake and diarrhea every 15 minutes; required hospitalization on 2/3/2021. Was hospitalized at Hospital. Hospital course was complicated by sepsis, pressors, intubation, GI bleed with ruptured rectum requiring surgery (ostomy). anticipated discharge 3/3/2021.

1st shot = only tender at injection site but remains tender. 2nd shot = 1 hr after injection: feelings of fatigue, soreness at injection site with swelling, slight throbbing in back of head/neck, later in PM ate late lunch Big Mac meal around 3:00 but not hungry though had no breakfast, aching in knee and hips began to become constant with movement. Slept a couple of hours and began to feel chilled to bone rest of evening, headache continued, thirst and frequent urination (1 1l2 hr apart), had stopped all medication to allow shot to work. Friday late evening early Saturday Am chill became violent in shakes used blankets/plastic sheets/socks to get warm. Slept in 2 hrs increments all night. Saturday sipped fluids

Approximately 30-40 minutes after vaccine, I experienced blurred vision in my left eye and had left sided tingling and weakness. I have had several episodes of that since, and my vision in that eye continues to be somewhat blurred. I have continued to have swollen lymph nodes in many areas of my body as well as pressure in my head.

My second COVID-19 vaccination injection on Friday morning, 2/19/2021 resulted initially (starting on Saturday, the day following the vaccination} in a sore right wrist and a much more painful right arm that steadily grew in intensity and spread rather rapidly into my upper torso. By the following day (Sunday, 2/21) my breasts became very sensitive and I had severe pains across my back. This may or may not have been the beginning of a banding type MS exacerbation, but by Monday, 2/22, it was clear that I was experiencing a full-blown and seriously disabling exacerbation. Both legs experienced the tingling and numbness I have had in a prior exacerbation, and by the time I was able to talk to Dr. (my neurologist) on Monday afternoon (2/22), the numbness had progressed upward into my lower abdomen and I was no longer able to stand at all. It appears highly likely that the MS attack was triggered by the response of my immune system's reacting to the discomfort and severe body pains that occurred following the vaccination. I told Dr. of the total loss of feeling and use of both legs and was experiencing a increasing numbness from toes up to abdomen. Before ordering the high doses of corticosteroids used to stop my exacerbation, Dr. sent me to the Emergency Room for testing to make sure I did not have an infection that could be covered up by the steroids. When this testing did not show any such infection, the ER administered an IV infusion of 1 gram of solumedrol, followed by gradually decreasing high oral doses of prednisone. As of this date, numbness has started decreasing and some limited utility of right leg has returned. Still i can no longer stand and perform even the minimal movements to-and-from wheelchair to bed or toilet without substantial physical help (not needed before this exacerbation) from my sole caregiver, my husband.

This is a 70 year old female with paroxysmal atrial fibrillation (anticoagualted on Eliquis), obstructive sleep apnea (uses CPAP), mitral valve regurgitation, remote tobacco use, hypertension and dyslipidemia who presents to the ED for worsening dyspnea, cough, subjective fever, chills and body aches that have been ongoing for the past several days. The patient indicates that her dyspnea is exacerbated with exertion but she denies chest pain, pleuritic chest pain, leg swelling or calf pain. She mentions that she has received both of her COVID-19 vaccines (Pfizer); the first immunization was on 02/25 followed by her second immunization which took place eight days ago on 03/18. She is not confident that she has had any contact with a known sick or definitive COVID-positive individual recently. Of note, the last documented incidence of testing for COVID-19 was performed on 10/31/2020 after the patient was seen at a Clinic after a exposure for a COVID-positive individual. Testing at that time had resulted negative. To her knowledge, she states that she had, in fact, tested positive for COVID-19 in late fall of 2020, but she was not hospitalized. Yesterday (3/26/2021), she was evaluated at a Pharmacy where she was testing for COVID-19 which has since resulted positive. The patient denies any other acute symptoms of illness. In the ED, the patient was found to have acute respiratory failure with hypoxemia and pneumonia due to SARS-CoV-2 infection. Review of Systems Constitutional: Positive for chills, fatigue and fever. Negative for activity change. Respiratory: Positive for cough and shortness of breath. Cardiovascular: Negative for chest pain and leg swelling. Gastrointestinal: Negative for abdominal pain, diarrhea, nausea and vomiting. Genitourinary: Negative for dysuria. Musculoskeletal: Positive for arthralgias and myalgias. Negative for gait problem. Neurological: Negative for syncope. All other systems reviewed and are negative. Vitals Blood pressure 159/79, pulse 65, temperature 36.4 °C (97.5 °F), temperature source Oral, resp. rate 18, height 1.6 m (5' 3"), weight 107 kg, SpO2 98 %. Physical Exam Vitals reviewed. Constitutional: General: She is awake. She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is morbidly obese. She is ill-appearing. She is not toxic-appearing. Interventions: Nasal cannula in place. HENT: Head: Normocephalic and atraumatic. Nose: Congestion present. Mouth/Throat: Mouth: Mucous membranes are dry. Pharynx: Oropharynx is clear. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Decreased breath sounds present. Comments: Diminished breath sounds in all lung fields. Occasional cough. Abdominal: General: Bowel sounds are normal. There is no distension. Palpations: Abdomen is soft. Tenderness: There is no abdominal tenderness. Musculoskeletal: General: Normal range of motion. Cervical back: Normal range of motion and neck supple. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Behavior: Behavior is cooperative.

Patient states that she had numbness in both feet and legs. Several days later these symptoms were getting worse and she went into a seizure, lost control of her use of her legs, arms and her bladder. She called 911 and transported to y Hospital ER. She had MRI w/ negative results and was given fluids. She was released to go home. Pt has appt w PCP and will discuss her symptoms w/ them. Pt is still weak, has fatigue but can use her arms and legs. She is not able to do normal activities. She had her 2nd Covid dose on 3/26/21 @ 9:20 am in her right arm.

patient has become extremely fatigued and is experiencing bodyaches for several days. she had the same thing happen to her after the first shot, but this only lasted for 2 days and resolved. this time her symptoms are lasting for 4 days and because they are not resolving, she is in the ED. she is also found to be clinically dehydrated

was given Pfizer-BioNTech COVID-19 in right arm duty 1. within 2 minutes of shot, my throat began closing and lasted 20 minutes 2. next morning I awakened with right hand severely contracted and had a tingling sensation; I forced my hand to open and close to relieve contraction 3. .then all day, I lost control of my bladder and had to use several pads to catch the flowing urine;

N17.9 - Acute kidney failure, unspecified R29.810 - Facial weakness N93.9 - Abnormal uterine and vaginal bleeding, unspecified

Death E87.1 - Chronic hyponatremia N17.9 - AKI (acute kidney injury) (CMS/HCC) J18.9 - Pneumonia of right lower lobe due to infectious organism

Started getting Nauseated at 3:45 and took Promethazine 25mg. Started throwing up at 4:30 PM and continued throughout the night. Called my Primary Care Doctor the next morning and was given Zofran 4mg. It did not help and I continued throwing up after drinking water. I was bombarded with everything stinking. I could not eat and cooking smells were nauseating me. On Saturday, 04/24/2021 I could not even drink water and called EMS. I was hydrated via IV and test were done and I had a mild bladder infection and given IV antibiotic and a 5 day course of Tiadylt ER 300 mg taken twice a day. I continued taking nausea meds which were helping and vomiting ceased but everything still tasted and smelled nasty. (Question

pt admitted to the hospital, COVID + diagnosis after having received COVID vaccine x2 (2/16/2021 & 3/9/2021) Brief exam: Mildly acutely ill appearing Lungs w/ faint insp crackles left base Cv rrr nml s1 and s2 Abd s/nt/nd nml bs Skin - incisions healing well without erythema, edema, exudate Neruo MAE Brief history and medical decision making: 70 yo woman w/ BOLT 6/2020 for COPD and recent laparoscopic hiatal hernia repair with post-op abdominal issues including nausea, diarrhea, dyspepsia, malaise, fatigue. Now with a few days of exertional dyspnea and fevers. Home testing + for COVID. Directed to ED where confirmatory test positive and abdominal CT with patchy ground glass opacities at lung bases compatible with COVID-19 pneumonia. COVID-19 pneumonia with mild symptoms - onset of symptoms unclear - respiratory symptoms and fevers only have been present for the past few days. Her GI complaints may be related to her recent surgery or COVID. Given that she is an immunocompromised patient at high risk of progressing to severe disease and who became infected despite receiving the covid vaccine, She should receive the monoclonal antibody. She does not have severe enough disease at this point for remdesivir or tocilizumab. Rec: Hold mycophenolate Continue other immunosuppressants COVID- mAb infusion

Rash over the entire body; Severe Chills; Body ache; Vomitting; Nausea; Frequent urination; Fatigue; Headache; This is a spontaneous report from a contactable consumer, the patient. A 69-years-old non-pregnant female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: en6199) via an unspecified route of administration in the right arm on 04Mar2021 at 15:00 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included COVID-19 (Lot number: el 9267) (MANUFACTURER UNKNOWN) unspecified route of administration in the right arm on 11Feb2021 for an unknown indication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 15Mar2021, the patient had experienced fatigue, headache. On 16Mar2021 the patient had experienced severe chills, fatigue, headache, body aches, vomiting, nausea, frequent urination. On 17Mar2021, the patient had experienced rash over entire body, fatigue, headache, body aches. The patient did not receive any treatment for the events. The clinical outcome of fatigue, headache, severe chills, fatigue, rash over entire body, body aches, vomiting, nausea and frequent urination were not resolved. No follow-up attempts are needed. No further information is expected.

experienced low blood pressure.; she couldn't breathe.; heart damage; bleeding stomach; kidney failure; was feverish; she experienced an achy body; This is a spontaneous report from a contactable registered nurse (patient) and a contactable consumer (patient's husband) from Pfizer sponsored program. This 69-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of adminsitration on 07Jan2021, at patient age of 69-year-old, as single dose (Lot number EK9231) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Dec2020, at patient age of 69-year-old, as single dose (Lot number EJ1685) for COVID-19 immunization. The patient received the second dose on 07Jan2021. In the late afternoon on 07Jan2021 (after taking second dose), the patient experienced an achy body and was feverish. The symptoms got worse the next few days. After that, she had kidney failure after taking the second dose and experienced low blood pressure. She also mentioned she couldn't breathe. She also had heart damage, and bleeding stomach. She was hospitalized because of this condition. The patient further stated that she was also intubated and on a ventilator. She didn't know how many days, so it kind of affected her all over. The patient's husband stated there were no underlying conditions found with his wife. The patient added she was healthy going into all of this. The patient was on dialysis for a while. The patient's husband clarified it was CRRT, and stated they ran the regular machine once for just under 30 minutes and she couldn't handle it. When they finally ran it again, she was able to go through it. She was on 6 pumps and a whole bunch of other stuff. The outcome of the events was unknown.; Sender's Comments: Based on temporal association, a contributory role of bnt162b2 to the reported events cannot be excluded. The case will be reassessed once more information become available. 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.

Patient presented to the ED with acute cystitis without hematuria and was subsequently hospitalized for hypokalemia within 6 weeks of receiving COVID vaccination.

Pt having signs/sympathy of Pneumonia for 2 weeks, went to urgent care and received antibiotics. Progressively got worse and was admitted to Medical Center July 11, 2021. At that time, the only test result pt grew was in her sputum culture, Photoehabdus Luminescens. Pt received both Covid-19 vaccines in April of 2021, they were both Pfizer. During pts stay the ICU, the pt was going into renal failure and having multiple cardiac arrhythmias, despite multiple IV antibiotics. Pt was transferred to a higher level of care on July 19, 2021

pain in Kidney-liver area; pain in Kidney-liver area and into right shoulder blade; pain in Kidney-liver area; This is a spontaneous report received from a contactable consumer (herself) reported that a 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and lot number: EN5318) via an unspecified route of administration in the right arm on 29Jan2021 17:15 at single dose for COVID-19 immunization. Medical history included Lymes, undiagnosed illness and CK levels doubled into the 550 level in November (unknown year). Concomitant medication was not reported. Patient was not pregnant at the time of vaccination. On 30Jan2021 07:00 patient experienced pain in Kidney-liver area and into right shoulder blade concern as her CK levels just doubled into the 550 level in November (unknown year). No treatment was received for the adverse events. Seriousness was reported as non-serious. Outcome of events was not recovered. No follow-up attempts are possible. No further information was provided.

Hypercalcemia AKI encephalopathy acute vomiting fatigue acute ER 2/15 ICU 2/15 Hospitalized till 2/2021 IVs extensive electrolyte medications

severe back pain; unable to urinate; may have passed a kidney stone; Bladder infection; This is a spontaneous report from a contactable consumer who reported for herself. A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot #: EL3247; expiry date: May2021), via an unspecified route of administration on 26Jan2021 at 12:00 (at the age of 70-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history and concomitant medications were both reported as none. The patient did not receive any other vaccines on the same date as the COVID-19 vaccination or within four weeks prior to the vaccination. On 08Feb2021 the patient experienced bladder infection and may have passed a kidney stone; on unspecified dates the patient experienced severe back pain and unable to urinate. The clinical course was reported as follows: "The patient received the first dose of the COVID-19 vaccine two weeks ago. She reported no side effects from the first dose of the vaccine; however, she was currently on an antibiotic for a bladder infection. She was scheduled to get the second dose on 16Feb2021; however, this weekend she developed a bladder infection and was on an antibiotic. She had symptoms on Sunday, and she saw her doctor on Monday. She also may have passed a kidney stone, but she was not certain. She had severe back pain and was unable to urinate." The patient read to not take any shots while taking the antibiotic. She would be off of the shot (as reported) for four days when she would get the next dose of the vaccine. The patient wanted to know "how many days would she need to be off of the antibiotic before she could get the next dose?" She stated that she would stop taking the antibiotic if she had to. She took one dose of the antibiotic on Monday and two doses today. The patient also inquired whether the side effects were different after the 2nd dose of the vaccine and how long she had to be off her antibiotics before getting her second dose of the COVID vaccine. The patient was taking sulfamethazole-TMP DS as treatment for the bladder infection since 08Feb2021. The patient sought care at the physician's office for the event bladder infection. Relevant tests were reported as none. The clinical outcome of the event bladder infection was recovering/resolving; the clinical outcomes of the events may have passed a kidney stone, severe back pain and unable to urinate were all unknown.

Confusion, Myalgia, Fever, Diarrhea, Nausea Vomiting, ElevatedLiverEnzymes, Jaundice, ElevatedBunSCr, , Continues to feel weak and following up with PCP. Reports had no health issues prior to her second vaccine dose. She reports had fever, joint pain and nausea with first dose. Patient reports receiving her first COVID vaccine 12-23-20 and developed nausea, joint pain and fever. She had her second dose on 01-11-21 and noted nausea,vomiting, weakness, become jaundiced and fevers that required hospitalization and developed autoimmune problems. She reports hepatitis and kidney problems and PCP following.

the day after my first vaccination I woke with bilateral wrist stiffness and pain, bilateral ankle knee and swelling in my ankles. This subsided in a few days. I was holding off on taking my Orencia infusions because I wasn't sure when I would be able to get the vaccine. Orencia dosing is every 4 weeks and I am supposed to take any vaccinations two weeks post infusion. After my second vaccination, I had a full flare. Swollen joints, IBS symptoms, fatigue,fevers, decreased appetite. I went to my rheumatologist and scheduled an infusion as soon as possible. I had to stop taking NSAIDs because my creatinine became abnormal. I had my Orencia 750mg on Februray 1, 2021, but continued to feel ill and started a prednisone

She is legally blind in her good eye; Felt like crap; proverbial headache was reported as worsened/pain and tightness in both jaw lines was reported as worsened; I do have migraine; Hives; this is just a nightmare if this is not a normal problem; Can't think; pain and tightness in both jaw lines; pain and tightness in both jaw lines; thrush; proverbial headache/When I bend over I have a blinding headache; no coordination; Vomiting projectile/Throwing up right away; arm was hurting; swelling in arm; Chills; uncontrollable bladder gushing leaking; shaky arms; unable to eat anything; has been as sick as a dog; non stop coughing; Rib pain; This is a spontaneous report from a contactable consume. A 70-years-old female patient received bnt162b2 (BNT162B2) , via an unspecified route of administration on 2Feb2021 as a single dose, for covid-19 immunisation . Medical history included arthritis from 1992 and ongoing Verbatim: Arthritis , fibromyalgia from 1994 and ongoing Verbatim: Fibromyalgia , gastrooesophageal reflux disease from 1992 and ongoing Verbatim: GERD , lactose intolerance from 1992 and ongoing Verbatim: Lactose intolerance , depression from 1994 to an unknown date Verbatim: Anxiety depression , hypertension from 1992 to an unknown date Verbatim: Blood pressure high , MRSA , water pollution from an unknown date and unknown if ongoing She was unable to drink anything except sips of cold water and eat a few ice chips. She is unable to drink lukewarm water. This was prior to getting the vaccine , surgery from an unknown date and unknown if ongoing She had 22 surgeries in 4 years on her left eye. It started with pressure testing then infections. The patient reported she is legally blind in her good eye, has been as sick as a dog, non stop coughing, , non stop coughing , thrush on 23Feb2021, proverbial headache/when i bend over i have a blinding headache, , no coordination, vomiting projectile/throwing up right away arm was hurting, swelling in arm chills, uncontrollable bladder gushing leaking pain and tightness in both jaw lines unable to eat anything can't think felt like crap. The outcome of the events: Unknown: blindness, thrush, shaky arms, unable to eat anything, Can't think, Felt like crap, I do have migraine; Recovered, vomiting, swelling in arm; Recovoring illness, cough, rib pain, Not recovered headache, no coordination, uncontrollable bladder gushing leaking, pain and tightness in both jaw lines, pain and tightness in both jaw lines; Chills recovered with sequelae.

Urinary tract infection; Arm bothered her with first shot, it was just very sore; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on left arm on 21Jan2021 at single dose as the patient didn't want to get Corona and die. Medical history included compromised immune system, asthma which was diagnosed in the late 80's or early 90's, fibromyalgia from 2000 and ongoing, and being sensitive to Bandaids. Concomitant medication was reported as none. The patient received the first shot 3 weeks ago on 21Jan2021. She mentioned that she was fine and the only thing that bothered her was her arm, but it was fine, like she knew she had a shot. Her arm bothered her with the first shot, it was just very sore on 21Jan2021 and lasted about maybe 24 hours. The patient also experienced urinary tract infection last week (Feb2021) and took CIPRO for 10 days which she was still on. She told her doctor she would get the second shot and said that it was not a problem. The outcome of the event pain in arm was recovered on 22Jan2021 and unknown for urinary tract infection.

I was positive for the virus; UTI; This is a spontaneous report from a Pfizer-sponsored program, . A contactable consumer (patient) reported that a 70-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot: EL8982; expiry: May2021), intramuscular on the left arm on 26Jan2021 (at the age of 70years) at single dose for covid-19 immunization. Medical history included high blood pressure and diabetic. Concomitant medications were unspecified. The patient was hospitalized on 04Feb2021 for a UTI and when she got into the hospital and they did the testing and they found that she was positive for the virus (in Feb2021). The patient was released on 06Feb2021 and she haven't had anything wrong, nothing and doctors were really surprised. When she was in the hospital, it was done on 04Feb2021 to the 06Feb2021, and every day, they took blood work for two days. The patient had her first vaccine on 26Jan2021 and due for her second vaccine tomorrow. She was wondering if she should go and get her next vaccine because she really wanted to, and her quarantine was up to Thursday. The patient was out of quarantine on 16Feb2021. The outcome of the events was unknown.

kidney injury; swelling of her lower extremeties; proteinuria; acute tubular injury; This is a spontaneous report from a non-contactable healthcare professional. A 70-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL8982), intramuscular in the left arm on 28Jan2021 (at the age of 70-year-old) as a single dose for Covid-19 immunization. Medical history was not reported. The patient previously received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL3246), intramuscular in the left arm on 07Jan2021. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications included valaciclovir hydrochloride (VALTREX), atenolol (MANUFACTURER UNKNOWN), zolmitriptan (MANUFACTURER UNKNOWN), alprazolam (XANAX) and multivitamins (unspecified), all from an unknown date for unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Jan2021, 3 days after the second dose, the patient experienced swelling of her lower extremities with proteinuria and acute kidney injury. The patient was hospitalized on 24Feb2021. The patient underwent lab tests and procedures which included creatinine of 0.7 mg/dl in Nov2020, albumin of 4.7 mg/dl in Nov2020, creatinine of 1.02 on 03Feb2021, and on arrival to Hospital on 24Feb2021: creatinine of 2.2 mg/dl, proteinuria of 19.99g, and kidney biopsy which showed minimal change disease and acute tubular injury. Therapeutic measures were taken as a result of the events which included prednisone 70mg daily. The clinical outcome of the events acute kidney injury, peripheral swelling and proteinuria was recovering; renal tubular injury was unknown. No follow-up attempts are possible. No contact Information available.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be completely 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Shortness of breath, severe chest tightness started 5 to 8 minutes after the injection lasted for 5 minutes and were followed by an overwhelming weakness, confusion, later also by abdominal cramps, some urinary urgency- all gradually improved over 30-40 minutes. I felt later agitated, had dry mouth, headache- improved after drinking 8-10 cups of water. I did not seek help. I stayed in the shot area in a large tent.

8 pm - hyper, frequent urination,chills,fever,nausea,weakness , feeling ?faint?. Symptoms lasted 4 days . Then intermittent fever & chills . After 4 days red & swollen @ site of FIRST injection (NOT the 2nd injection !) . Extreme fatigue for a week .

States 1 week before 2nd vaccine she had right axillary lymph node swelling, which has continued to now, 1 week after 2nd vaccine developed shortness of breath, and hematuria. Continues shortness of breath. Hematuria lasted 2 weeks. Seen by PCP on 3/4/21 & in ER on 4/8/21.

slight temperature of 99; kidney function sky rocketed/kidney function: 1.21/kidney function increase; This is a spontaneous report received from a contactable consumer (patient). A 70-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0161), via an unspecified route of administration, on 12Apr2021, as single dose, for COVID-19 immunisation. Medical history included lymphoma (large b cell), chronic obstructive pulmonary disease (COPD), blood pressure high, chronic back pain, and allergy. Concomitant medications included loratadine taken for hypersensitivity; and paracetamol (TYLENOL) taken for an unspecified indication, both start and stop dates were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6206) at age 70 years, via an unspecified route of administration, on 18Mar2021, for COVID-19 immunisation. It was reported that the patient received the second dose of 12Apr2021 and had very minimal reactions (unspecified), she felt fine. On 21Apr2021, the patient underwent blood work and showed that her kidney function sky rocketed or increased. Prior to the vaccine, her kidney function was great. She reported that her kidney function prior to the vaccine was 0.69 and it was 1.21 on 21Apr2021 (a week after the second vaccine). She also reported she had a slight temperature of 99 (unspecified date) and this was nothing bad. The outcome of the event "kidney function sky rocketed/kidney function: 1.21/kidney function increase" was not recovered, while slight temperature was unknown.

Hypo-osmolality and hyponatremia Acute kidney failure, unspecified Systemic inflammatory response syndrome (sirs) of non-infectious origin without acute organ dysfunction

Patient is 70 F with Type 1 von Willebrand's disease, mild hypertension, asthma, mild mitral regurgitation, and diffuse degenerative joint disease. She has been safe at home during the pandemic tested a few times for COVID-19, consistently negative. Approximately 1 month after the second Pfizer vaccine she developed a precipitous onset of severe acute congestive heart failure subsequently diagnosed nonischemic cardiomyopathy/myocarditis. Initially, prior to the diagnosis at the onset of the illness she was treated with 1 week course of high-dose prednisone as if this were asthma because of the primary symptom of shortness of breath. This was of no benefit. Over the ensuing 2 months she has been seen by primary cardio

I had a mild fever, severe cramping, diareeha for 5 days. A little pain in my back....a lot of pain in my tummy. I called my Dr and he told me to "ride it through" I didn't want to get the second vaccine,but he said emphatically to "get the boater". After the booster I had a fever and severe bladder infection. Went to urgent care for antibiotics and after taking the antibiotics I went again to a Urology Dr for a check up. Dr told me "anything is possible with virus and vaccine".

Urinary tract infection; Pain; unable to walk; lack of mobility and that it take 1 and sometimes 2 people to assist her; becoming more depressed and hopeless; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 09Mar2021 (Batch/Lot number was not reported) (at the age of 70-year-old) as dose number unknown, single for covid-19 immunisation; alglucosidase alfa (ALGLUCOSIDASE ALFA), intravenous from 16May2006 (Batch/Lot number was not reported) and ongoing, at 2200 mg every other week, then from 04Jun2021 at unspecified dose for Pompe's disease. Medical history included Pompe's disease. The patient's concomitant medications were not reported. On 19Mar2021, patient was admitted for a urinary tract infection and pain (both assessed as serious due to hospitalization) and the medical team was concerned about her lack of mobility and that it take 1 and sometimes 2 people to assist her (serious: disability) and because of that, the medical team was recommending patient go to a skilled nursing facility. Therapy with alglucosidase alfa was ongoing. On 09Mar2021 the patient received Pfizer biontech covid-19 vaccine, unknown formulation, dose, route and frequency (with an unknown batch number). On 10Mar2021 after a latency of 14 years 9 months 22 days, the patient could not walk for which patient was hospitalized and was sent to a nursing home and was now living in assisted living. The patient will not restart the treatment as she cannot walk and was in assisted living. And patient is increasingly becoming more depressed and hopeless. The action taken in response to the events for alglucosidase alfa was unknown. The outcome of events was unknown. Reporter causality: unassessable for depression and couldnt walk, not reported for rest events. Company causality: not reportable for all the events. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Abdominal pain, chills, n/v, dark urine, elevated LFT's, Bilirubin in urine. Patient currently admitted to hospital

weakness, decreased ADL's requiring assistance, incontinence, decreased appetite, decreased fluid intake, and became bedbound 2 days. On 2/15, resident is improving slowly

Markers for ESR and CR were more than double what they should be; Markers for ESR and CR were more than double what they should be; This is a spontaneous report from a contactable nurse reporting for herself. A 71-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EL9269), via an unspecified route of administration, on 02Feb2021, at single dose, for COVID-19 immunisation and methotrexate sodium (unknown manufacturer) (exp date 12Nov2021) tablet, via an unspecified route of administration, from 2014 and ongoing, at 7 DF weekly (it was 17.5 mg), for rheumatoid arthritis. Medical history included pain and ongoing rheumatoid arthritis. Concomitant medication included folic acid (unknown manufacturer). The patient experienced markers for ESR and CR were more than double what they should be (red blood cell sedimentation rate abnormal) in Feb2021 with outcome of unknown. The patient underwent lab tests and procedures which included blood creatinine: more than double in Feb2021, red blood cell sedimentation rate: abnormal in Feb2021. The action taken in response to the events for methotrexate sodium was unknown.

Emergency Room HPI: The patient is a 71 y.o. female with a PMH notable for COPD, hypertension and anxiety and depression who presented on 2/6/2021 for evaluation of shortness of breath. Patient presented to our emergency room yesterday morning from local nursing facility rehab nursing staff reported that she had had a increased shortness of breath for the last 3 days she has been diagnosed with COVID-19 on 2-2-2021. Patient has also received both COVID-19 vaccines. Patient presented to the emergency room with labored respirations conscious awake and was on a non-rebreather at 15 L. upon arrival to our emergency room patient's temperature 101.6°, pulse 169, respirations 40 to blood pressure 142/91 and oxygen saturation 100% on 15 L non-rebreather. Patient received a chest x-ray that showed chronic emphysema and fibrotic changes in the lung no acute processes identified. Patient's white count 12.8, glucose 197, creatinine 1.2, lactic acid 4.6, cardiac enzymes negative, D-dimer 1180, patient has urine culture pending. Patient has received about 3 L normal saline boluses patient was having hypotension 86/52. Patient also received IV acetaminophen a 1000 mg IV in the emergency room along with Decadron 10 mg IV piggyback. Patient was admitted acute care for the need of IV fluids and IV antibiotics for COVID-19 and sepsis 2/12 admit Brief history and initial physical exam: Patient is a 71 year old long-term resident of Rehab and Healthcare. Unfortunately, she contracted coronavirus (COVID-19) at the nursing home. Her respiratory status started to decompensate and so she was brought into the hospital. Initial workup showed significant bilateral pleural effusions and ground-glass opacity of both lungs. She had a significant supplemental oxygen requirement. She was admitted for further evaluation and treatment. Hospital course: The patient was admitted and started on IV Remdesivir. She was given IV Decadron. She was given immune support vitamins. Despite this, her sepsis worsened. When it became apparent that the patient was not going to recover, her daughter did make her comfort care only and hospice was consulted. The patient was found to be appropriate for general inpatient hospice and was made comfort care. Her requirement for morphine and Ativan did slowly rise. Eventually, the patient did succumb to her respiratory failure. Time of death was called at 10:00 p.m. on February 15, 2021 Discharge Condition: expired. Presume cause of death with cardiopulmonary arrest secondary to acute respiratory failure secondary to coronavirus (COVID-19) pneumonia Disposition: Deceased

8:00 p.m. day of injection - Fever & Severe Chills. Chills eased about 3:00 a.m. 02/10/21 7:00 a.m. 02/10/21 - abdominal muscles and unable to function extremities very weak loss of bladder control improved very, very slowly until 02/11/21 - 3:00p.m. 02/11/21 return to normal 02/11/21. No lasting consequences

3/9/21 ER HPI Patient is a 71 y.o. female who presents with complaint of elevated blood pressure systolic of over 200 since last night. Patient said that she has taken her blood pressure medications without much improvement. The elevated blood pressure is associated with frontal headache. No nausea vomiting, no dizziness, no chest pain, no cough or shortness of breath. No fever or chills

The patient initially presented (3/3/21) with headache, fevers, nausea, vomiting, diarrhea, myalgias, malaise. Patient related she was in her normal state of health and only started to feel poorly after she received her second COVID-19 vaccination three days earlier. She interestingly related that after her first Pfizer COVID-19 vaccination she had significant burning in her stomach that she noted but no other major symptoms and notably did not experience this severe burning in her stomach after the second dose. She denied any chest pain, current dyspnea, productive cough, sore throat, urinary symptoms, sick contacts. She has no history of C. difficile, no recent antibiotics, no recent spoiled foods, no recent travel, no history of radiation. She does have a history of GERD and has had gastritis with mild gastrointestinal bleeding in the past and undergone EGD negative for H. pylori infection. She also has undergone colonoscopies with polyps that have been removed and reported as tubular adenomas. As her hospitalization progressed, she was diagnosed with Severe Sepsis due to E. Coli bacteremia in setting of liver abscess, Cholelithiasis without acute cholecystitis, Atrial Fibrillation with rapid ventricular response, Transaminitis (which resolved). Patient was appropriately treated for these conditions. Also, her known uncontrolled diabetes was treated. Per an Infection Disease note on 3/9/21: The patient has had hx of biliary colic (self diagnosis) now with discovery of non-obstructive cholelithiasis on RUQ US it is plausible that the abscess originated from self limiting cholecystitis/cholangitis which would be consistent with recent abdominal pain exacerbated with oral intake. Difficult to state definitively any relation to COVID-19 vaccination, though may have resulted from associated dehydration. Additional COVID vaccine info (both Pfizer): first dose: 2/7/21 lot# EN 5318 second dose: 2/28/21 lot# EN6202

Experienced chills, fever, fatigue, numbness of hands and legs (right), no appetite, no sense of taste, jittery, weakness, no bowel or bladder control. From 3/3 - 3/19 (16 days). Currently, fingertips are still numb.

It was increasingly difficult to ambulate; nasal congestion; runny nose; very dizzy/The dizziness became worse; clammy; developed symptoms of a urinary infection; This is a spontaneous report from a contactable consumer (patient). A 71-years-old non pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 13Jan2021 09:30 (Batch/Lot Number: EL3248) as [SINGLE DOSE] for covid-19 immunisation; fexofenadine hydrochloride (MUCINEX ALLERGY), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at for nasal congestion, rhinorrhoea; loratadine, pseudoephedrine sulfate (CLARITIN-D), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at for nasal congestion; trimethoprim (TRIMETHOPRIM), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at for urinary tract infection. Medical history included multiple sclerosis from an unknown date and unknown if ongoing. Known allergies: Penicillin, Tetracycline, Topiramate, Iodinated Diagnostic Agents. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks. She had other medications in two weeks. No covid prior vaccination. It was reported that they were not sure that it was due to vaccine received on 13Jan2021. Approximately 2 days following vaccine, 15Jan2021, she experienced nasal congestion & runny nose. She took Mucinex for i dose (she had allergies & have taken it many times with no problems) she became very dizzy & clammy. 2 days later the patient experienced nasal congestion and took Claritin D. The dizziness became worse. She stopped it. She had Multiple Sclerosis. She developed symptoms of a urinary infection that she self medicate with Trimethoprim. The patient became increasingly more dizzy so she called her Dr. She went to office because it was increasingly difficult to ambulate due to dizziness. She ordered lab work & a Covid test (post vaccination SARS-COV-2) on 27Jan2021 that was negative. The dizziness was getting better but still present. The patient was due to have her 2nd vaccine Wednesday 03Feb2021. They just wanted to be sure it is safe to proceed. AE resulted in Doctor or other healthcare professional office/clinic visit. Outcome of the events was recovering.

71- year old woman with past medical significant for hypertension on 10 mg of Lisinopril daily for many years. She had her first dose of Pfizer vaccine two weeks prior to admission (3/11/21). After her vaccination, patient felt unwell and dizzy in the mornings. She felt persistent fatigue and had a decreased appetite. The week prior to admission she noticed a decrease in her urine output. She denied NSAID use. Her primary care physician ordered blood week and her Cr was found to be 16.54 and BUN of 163, phosphate of 17.5. Her last known Cr prior to her admission was 18 months prior and was 1.17. She was asked to present to the emergency room. Renal ultrasound showed no hydronephrosis or stones. Urinalysis showed 1+ protein, spec grav of 1.023 with a urine protein/creatinine ratio of 0.09. Urine sediment was unremarkable. Her temperature was 95.6 and her BP was as low as 75/46 and she was put on a low dose of levo. CRP was 202.3. COVID was negative. CK wnl. ANA + to 1:160 (dsDNA, Smith, RNP, SS-A, SS-B all negative). Blood smear was negative. Cultures were all negative. Echo showed an EF of 68% with trivial pericardial effusion. Patient was oliguric, and then initiated on hemodialysis. Renal biopsy was performed. The biopsy consists of one fragment which is stained with H&E, PAS, Trichrome, Jones Silver, and HPS stains. Review of all stains reveals 12 glomeruli, one of which is globally sclerotic. The architecture of the kidney is well-preserved. There is interstitial fibrosis with proportional atrophy involving 10% of the biopsy tissue. There is a focal interstitial infiltrate consisting of lymphocytes involving <5% of the interstitium. The tubules show diffuse acute tubular injury. Calcium oxalate crystals are present in seven tubular profiles. The glomeruli show expansion of Bowman's capsule. The mesangium shows normal cellularity. The vessels show no abnormalities. IMMUNOFLUORESCENCE MICROSCOPY: Frozen sections are stained for IgA, IgG, IgM, C3, C1q, kappa, lambda, and fibrinogen. All immunofluorescence stains are negative. ELECTRON MICROSCOPY: Specimens are prepared for electron microscopy and semi-thin sections stained with toluidine blue are reviewed prior to thin sectioning for ultrastructural examination. Electron microscopy demonstrates patent capillary loops. The glomerular architecture demonstrates segmental corrugation of basement membranes with increase in lamina rara interna. No subepithelial deposits and no intramembranous deposits are identified. The tubules show dilated mitochondria and injury. There is segmental effacement of foot processes. There are no subendothelial deposits. Mesangial electron dense deposits are not identified. Patient received three dialysis treatments and Creatinine began to improved down to 1.46 within 8 days.

Patient is a 71-year-old female with history of hypertension, hyperlipidemia, and obesity who presents with complaint of acute onset shortness of breath. She reports she was walking around her house earlier when she suddenly became short of breath. She denies any chest pain, numbness or tingling but states that shortness of breath persisted. She denies any tobacco, alcohol or drug use and states she has never had any symptoms similar to this before. Denies any lung disease or heart disease previously. She does have hypertension and hyperlipidemia and is on metoprolol and rosuvastatin respectively which she reports good compliance. Denies family history of MI or strokes. She also denies other symptoms such as nausea, vomiting, abdominal pain, fevers or lower extremity edema. In the ED vitals were found to be within normal limits. EKG was obtained showing diffuse T wave inversions, right bundle branch block, no ST changes, no hypertrophy. Troponin found to be elevated at 0.137, creatinine elevated at 1.3, BUN 26. Chest x-ray was within normal limits. Otherwise lab work was unremarkable. She was given aspirin and Nitropaste Hospital Course: Patient was admitted to the medical floor and remained hemodynamically stable throughout her stay. She actually remained asymptomatic and had no further shortness of breath. She was not hypoxic, at no point required supplemental oxygen. Her troponins however continued to uptrend to 0.389. Cardiology consulted, she was medically optimized with increased statin dose, therapeutic lovenox, and aspirin. Original plan was for cardiac catheterization. However, a d-dimer was ordered which returned elevated to 13.7. CTA was performed which revealed extensive bilateral pulmonary emboli with large clot burden and concern for right heart strain. Echocardiogram showed mildly dilated and hypokinetic RV with mild diastolic dysfunction with impaired relaxation. She was deemed not to be candidate for EKOS. Troponin elevation was felt to be type II NSTEMI 2/2 PE. PE was classified as unprovoked as she has no definite risk factors for this: no prior DVT/PE, no family history of clotting disorder, no evidence of malignancy (UTD with cancer screenings and visits PCP q6m for health maintenance), no cell line abnormalities, no prolonged immobility or long trips or surgeries, no trauma, no hormone or steroid therapies or even antidepressants. She is obese, and has mild CKD. She tested negative for COVID-19 by antigen testing. The only identifiable change in her health habits recently was receiving the first COVID-vaccine dose on 3/18. We discharged her with Eliquis with instructions to taper from 10BID to 5BID after 7 days. As she will be on anticoagulation, the benefit will likely outweigh the risk of receiving the second COVID dose. She will follow up with her PCP and hematology/oncology.

4/14-Resident c/o not feeling well and declined scheduled dialysis. c/o bilateral shoulder pain and fatigue. AP- 44, BP- 80/45, c/o headache, no chest pain and no SOB. Sent to CMC ER- patient deceased on 4/14/2021.

Pt reports she was woken up at 0300 this morning from the side effects, she feel sick, headache, have frequent urination, diarrhea and pain in her stomach and feeling nauseous. ***NOTE*** Recommend pt can take Ibuprofen PRN for her headache, to stay hydrated to prevent dehydration due to her her frequent bouts of urination and diarrhea, rest and consume some food to help with feeling of nausea. Advised pt these ADEs are common within first 3 days and should resolve in 1-2 days of symptoms onset. Recommend if symptoms does not get better to contact MD or seek medical care right away. **Please follow up with pt after 11am** 5/2-Patient feeling better today. No signs and symptoms at this time. Patient has taken 600mg of ibuprofen as directed which helped alleviate symptoms.

Vague arm soreness and itchiness but then 1 week after vaccination with second Pfizer covid vaccine urine turned dark orange, approx 2 weeks after vaccination started noticing jaundice

ED to Hosp-Admission Discharged 3/30/2021 - 4/17/2021 (18 days) Last attending ? Treatment team Acute respiratory failure with hypoxia (CMS/HCC) Principal problem Discharge Summary Inpatient Discharge Summary BRIEF OVERVIEW Admission Date: 3/30/2021 Discharge Date: 04/17/21 Primary Discharge Diagnosis Principal Problem: Acute respiratory failure with hypoxia (CMS/HCC) Active Problems: AKI (acute kidney injury) (CMS/HCC) Type 2 diabetes mellitus with diabetic polyneuropathy, with long-term current use of insulin (CMS/HCC) Mixed hyperlipidemia GERD without esophagitis OSA on CPAP Pure hypercholesterolemia COVID-19 Secondary Discharge Diagnosis Patient Active Problem List Diagnosis Date Noted ? AKI (acute kidney injury) (CMS/HCC) 03/30/2021 Priority: Medium ? Acute respiratory failure with hypoxia (CMS/HCC) 05/31/2019 Priority: Medium ? COVID-19 03/30/2021 Presenting Problem/History of Present Illness/Reason for Admission From admission H&P " a 71 y.o. female with Past medical history metabolic syndrome morbid obesity, HL, DM2 on long term insulin, CKD3 due to DM2, OSA on CPAP presenting with fatigue, poor appetite, nausea, loose stools, cough past 1 week. Significant fatigue so got COVID test today and positive sent to ED as 74% on room air patient placed on high flow o2. Currently reports feeling better on high flow, no chest pain, palpitations, LE swelling or calf tenderness. Confirms DNR/DNI status prior to admit

71 yo F with RA and GERD, received the second Pfizer covid vaccine on 6/15, then was brought by the family on 6/23 with progressively worse symptoms of weakness, nausea and vomiting and fall/near syncope at home. Prior to admission, patient reported dizziness and weakness to the PCP, meclizine prn was prescribed, but this didn't help. On admission patient was found to have NSTEMI and started on Heparin drip, ASA, Plavix, beta-blocker. Was to have a cardiac cath on 6/25 but noted to have change in MS/ acute confusion and right hemiparesis. CT brain followed by MRI brain showed extensive acute infarcts involving the b/l centrum semiovale, corona radiata, b/l cerebellum, b/l basal ganglia and b/l thalamus. On 6/28 labs also show an acute increase in creatinine/AKI and patient had an episode of gross hematuria on 6/29. Heparin drip and Plaxix were d/c'ed , ASA continued. Heme evaluation is requested to comment on possible thrombophilia associated with Pfizer covid vaccine. Exam - somnolent elderly patient in bed, answers some questions (name, place), but confused about time, with flaccid RUE, also some weakness noted in the LLE, normal S1,2 no n/r/g, clear lungs, soft abdomen w/o masses. Imaging reviewed with Neuroradiology suggested a cardioembolic picture. Wonder if she also had embolization to the kidney with AKI and renal infarcts w hematuria? CTA neck does not show significant ats disease to the aortic arch or neck arteries. Renal US with doppler exam was also normal. TEE was done on 7/2 and was a normal study, w/o PFO or intracardiac clot. Patient also had a loop recorder to evaluate for occult arrhythmias. This patient never had thrombocytopenia and/or a TTP-like picture reported with the Astra-Zeneca or Janssen vaccines. Heparin induced platelet Abs were 0.158.

after first vaccine was given 4/08, patient became very weak, tired and slept almost the entire 3 weeks, when it was time to take the second dose, on 4/29 she drove herself to the hospital, got the shot and went home, that evening she becan to feel very weak and fell down, calling an ambulance for help, the following day, she fell down once again, called 911 and got help getting to her feet, she began to realize her body was too weak to carry herself and when she fell the 3rd time called 911 and asked to go to the hospital. arriving she was immediately give blood transfusions, being told her kidneys had somehow gotten much much worse out of no where and they were no longer producing red blood cells properly, within the first week she was in the hospital, she was given 4 total blood transfusions and was told her heart was not functioning properly, There were elevated enzymes. She was beginning to bloat as her kidneys were not working at all anymore, she was no longer urinating. she was scheduled to have a dialysis port put in and she started dialysis. she was given medication and was sent to a rehab facility for a few weeks where she made no progress at all, she was still weak and unable to walk. due to her inability to walk she was sent home from the rehab, our family had to rally around her to help keep her clean, no bed was sent to us, no commode, we had to find money for all of these things, she quickly got bed sores and we tried all we could do to care for her with little help there was home health coming to see her twice a week, and we repeatedly asked if someone could look into the vaccine doing this to her no one cared to hear our suspicions of the vaccine doing this to our mother, she went to the dialysis clinic 3 times a week all the while paying for her own 800 dollar a week gurney transportation due to her inability to walk, on july 15th she finally got to see her dr, upon taking her vital signs they found no pulse, no blood pressure and no pulse ox but the dr did not seem to think this was a good reason to go to the hospital. we asked if the vaccine did this to her, the dr laughed it off, she went back home and was very tired, she went to sleep and the next morning when my father tried to wake her up for dialysis, she would not wake, 911 was called and she was once again rushed to the hospital, where her heart stopped within minutes of arriving.we asked the people in the ER if there was anyway we could talk to someone about the vaccine doing this to her. our mother is dead!! we were advised to call the health department, they told us to call the cdc, and i was directed to the compensation fund

Patient's response to vaccine was VERY similar to her response to the illness. Lack of body strength, stability,(unable to stand by herself, to walk, to follow commands requiring body movement) incontinence, inbility to think clearly, unable to recognize her loved ones, No fever, no vomiting or diarreah, no cough. These symptoms lasted for 24 hours, then went away almost fully and completely. Left arm soreness exists two days after injection.

Both hands & fingers swollen & VERY PAINFUL on 03-05-2021 -- cracked open more on fingers, than hands- but all fingers & both hands feel like SAND PAPER--Had to use Cera/Ve Crm and wear cotton gloves to keep "moisture in"- and I have to wear gloves to wash anything by hand--Have made appt. with dermatologist for 03-11-2021 to check this condition .

Extreme headache, dizzy - can't walk without support. This is 3 days after. Low BP 82/59, low grade fever. Difficulty with urination.

Patient is a 72-year-old female presenting with fever and altered mental status. History is obtained for the patient and her husband. She got her second dose of Pfizer vaccine for Covid on 3/6/21. On 3/7/21, she woke with fever and urinary symptoms. She have an episode of incontinence and urinary frequency and urgency today. She was too weak to get up out of the recliner at home. She did have a fever this morning, which resolved with Tylenol. She also has been confused much lower mentally than normal. She is on 4L chronically for COPD, DM, HTN, HLP, CAD, previous DVT. She has had sepsis previously. She was admitted to the hospital, and received one dose of IV Rocephin, IV fluids, and tylenol.

sore arm, chills, and extreme urge to urinate lasted 1 hr took oxycodone/tylenol. exhausted next 24hr

Pt. became unconscious and lost bladder control-she had shallow, infrequent respirations with an exp. stridor noted-pulse faint and slow. Epinephrine given IM per clinic standing order and pt. became conscious within 15 seconds-could not remember losing consciousness. Taken to the hospital for further evaluation.

UTI symptoms (frequent urge to urinate, burning sensation when passing urine), lightheadedness, heaviness in sternum region, chills, fever (38 C)

Patient in usual state of health, apporx 1.5 days after vaccination, health declined with confusion, inability to speak or find correct words for communication, sitting up on her own, incontinent episode x1, admitted to hospital for fever, vaccine reaction, discharged home

On day of 2nd vaccination, 2/11/21, severe momentary dizziness about an hour after then no reaction until 2/13/21. Approximately, 8P on 2/13/21, found blood in urine that lasted approximately 3 days. Towards the end of the episode, saw very small blood clots. Went to my clinic . Urine sample confirmed blood in urine, CT Scan showed no abnormalities of kidneys, and Cystoscopy with a Urologist showed bladder to be normal. Have no history of kidney stones, kidney disease or cancer. As of today's date, 4/08/21, no further episode. Lab worked showed no abnormalities.

Thumb on left hand turned entirely black, skin died. After seeing Infectious Disease and receiving IV antibiotics with no improvement, Dermatology consult was made. After a biopsy, it was diagnosed as Sweet Syndrome. Ongoing steroid treatment, whirlpool treatment of wound.

Arm on fire burning, fever dizziness nausea tired fever chills sweats pains in muscles bones lymph nodes swollen are dry throat yellow tongue could not urinate then urgency brown urine. Fever started night of shot and still have yellow tongue, sore dry throat swollen lymph nodes, some dizziness and small amount nausea

Presented to the ER on 3/26/21 with complaint of shortness of breath/not being able to take a deep breath. CTA Pulmonary Embolism W IV Contrast at that time revealed an acute PE RIGHT lower lobe without RIGHT heart strain.. Patient was started on heparin drip and transitioned to Eliquis (apixaban). She improved during hospitalization and was discharged on 3/31/21.

pt says about 2 weeks after taking 2nd dose of vax she became extremely weak, was dizzy, had a headache, kidney pain, blurry vision, has fatigue, has brain fog and confusion. She had these symptoms the entire month of march. In April she started getting fever and chills daily that would come and go. On 4/25/21 she was so sick it flared up her IBS. She became shaky and feeling like she was going to pass out, then started vomiting bile and was very constipated. She has become sweaty, with hot flashes and legs were like rubber not being able to hardly stand up. On 4/27/21 she went to clinic to have antibody test which was negative. She feels like her chronic conditions have been heightened or flared up and is scared to take any medicine. At night she has jitters, sweating, shaking and headaches. She has heart palpitations with normal activity. This symptom comes and goes. As of today, 5/5/2021 she still is feeling bad, like she is dying and is becoming depressed due to the ongoing symptoms. She has spoken with her PCP and told she was having adverse effect to taking the vax. She has another appt by phone w/ her PCP tomorrow. She RH negative blood.

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

Death ABDOMINAL PAIN BACK PAIN J18.9, J91.8 - Pleural effusion associated with pulmonary infection E87.1 - Hyponatremia N13.2 - Hydronephrosis with renal and ureteral calculous obstruction C79.9 - Metastatic disease (CMS/HCC)

fast heart beat, 9 days the runs, 1 day total sneezing/headache, 1 day total coughing, 2 weeks nausea, intermittent bruising worse starting May 19, sore left kidney, sore liver area, restless legs syndrome, reverse sleep pattern- awake all night long for 4 or 5 days, extreme weakness, dizziness, eyesight worse, ringing in ears...starting to get better by May 24.

3/9 MHN, admitted day after covid vaccine with weakness/SOB. Patient with history of small cell lung cancer metastatic on chemotherapy, COPD, diabetes, Sjogren's who presents with shortness of breath, confusion, and generalized fatigue as well as fall 1 week ago found to have recurrent pleural effusion, T7 fracture, new metastases, UTI. Shortness of breath: Suspicion is that this is related to malignancy plus effusion. Shortness of breath markedly improved after removal of Transudative fluid, 470cc obtained on thora 3/10 with cytology negative. Encephalopathy: Daughter notes that she has been more confused. The patient is off on her timeline of details. CT shows no evidence of brain metastases nor does recent MRI. Chronic hypoxemic respiratory failure: Patient is on 3 L of oxygen at baseline and she is currently at baseline. Generalized weakness: Her neuro exam is nonfocal aside from her confusion of timeline. CT and MRI have been unremarkable. I discussed her T7 fracture with spine surgery who recommends CT of entire spine which showed additional metastases. Patient has no pain and has declined the need for brace. Metastatic small cell lung cancer: Patient admits that she does not like to talk much about the big picture however her daughter at bedside did speak with me outside the room and understands that she may have a poor prognosis. UTI: With increased frequency/urgency/incontinence. There is trace leuk esterase on UA. She has been on ceftriaxone but urine culture showing 80,000 colonies of Enterococcus. Changed to vancomycin. I discussed with the microbiology lab who stated that sensitivities would not be available until 3/13. Discharged with sensitivities pending initially with plan for amoxicillin but given interaction with methotrexate change to Macrobid. Normocytic anemia: Likely related to malignancy and chemotherapy. No blood loss has been noted. She received 1 unit RBCs prior to discharge.

Diverticulitis; She was not able to get the second dose because she was still home on antibiotics and wasn't well.; UTI; she was still in pain; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in arm right on 10Mar2021 09:30 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. She did not have any other vaccinations the same day as her Pfizer COVID-19 vaccine or in the four weeks prior. The patient received the first dose of the vaccine on 10Mar2021. Her vaccine card was handwritten, she couldn't really read what was handwritten for the LOT, it could be SNG207, but she was not sure she was reading it right, it also could be 7NG207, she couldn't read it. Yesterday (18May2021) she got tested for antibodies and had none. She got both the POC rapid and blood test and both were negative. After the first dose she was hospitalized on 29Mar2021 for diverticulitis (in Mar2021) and was given many different antibiotics. She was discharged she thought on 31Mar2021, she was there maybe two days. She said recovery took a while, they had her on long rounds of antibiotics. She thought though that she went for her Pfizer COVID-19 vaccine injection 10Mar2021, then was seen in PRIVACY on 12Mar2021, and she thought she had a UTI and put her on Cipro then two days later she was still in pain (Mar2021) so they put her on Keflex for a week and she was still in pain so she went to another doctor who put her on Amoxicillin, so she had a lot of antibiotics after getting the shot, then she was in the hospital for diverticulitis. Then she was on metronidazole (FLAGYL) and ciprofloxacin (CIPRO) medications IV while she was in the hospital for diverticulitis, and then she came home on Cipro and Flagyl for four more days, until the night her mouth started to swell so she stopped taking them because she thought she was having a reaction (AER#2021571213). She then took an unknown antibiotic that she only took it for one day before she stopped it, then she got a CAT scan that said she was ok (unknown date). She clarified that for the unknown antibiotic she stopped after she took one pill because she had a reaction and then said she was done. She said all that time she was supposed to get the second dose, while she was in hospital and then was told to wait until she was better. She thought she must have some antibodies, so she got tested and had none. She was checked and tested for some percentage of antibodies since after her first dose it said she should have 70-80% and she was unable to get her second dose. She said that the test said she had no antibodies, it was totally negative, and she would like to know is that normal. She was not able to get the second dose because she was still home on antibiotics and wasn't well. She is unsure if that sickness was from the shot or not and does not know if she should start her first dose over again at this point (she did not ask a question regarding this). Patient underwent Ig/IgM Rapid POC test and SARS-COV2 Ig anti-spike test and both revealed negative result on 18May2021. Outcome of diverticulitis was not recovered, outcome of other events was unknown. Information on the lot/batch number has been requested.

Patient became disoriented with time (Dementia symptoms). Went into kidney failure and was admited into the hospital with mental confusion (dilerium).

after the first shot i was lethargic , tired and bloated . after another week i had pinched nerve in my back with excruciating pain going down my leg and lost muscle strenght with numbness . after 2nd shot > hit me like a large truck .... 4 hours later developed chills , nausea and vomiting , dark urine , no appetite and taste is off , joint and muscle pain .

Patient presented to emergency department on 6/8/2021 with complaints of abdominal pain and confusion. She was found to have a urinary tract infection and admitted for further management. She was found to by positive for COVID-19 during routine screening for hospital admission. She has remained asymptomatic for COVID-19 infection during admission. Patient remains admitted at time of writing.

I am sick; I am having trouble with urinary tract infection; This is a spontaneous report from a contactable consumer or other non hcp. A 72-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration on 23Feb2021 (72-years-old at the time of vaccination), as a SINGLE DOSE for COVID-19 immunization. The patient's medical history included Blood pressure high. The patient's concomitant medication included Thyroid medication. On an unspecified date, the patient experienced I am sick, and I am having trouble with urinary tract infection. Patient stated that she had to cancel her appointment to get her second vaccine because she was sick. She thought, they just going to call her and let her know appointment she had, instead she had not heard from them. She did not have any email address. Patient stated she did not feel sick from that, she was a heart patient but she was having trouble with urinary tract infection and stuff, so she was on antibiotics, so she told them she was sick, they told her to use that and set up another appointment. Patient stated she finally got her antibiotic, and she was feeling better. Patient stated that she would like to connect with the people who know when she was supposed to come back there, she will be there. On an unspecified date, the patient underwent lab tests and procedures which included body height: 5'3 or 5'4, Her height is 5'3 or 5'4 something like that and weight: 163, her weight is 163 something like that. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot been obtained.

I was feeling bad after the vaccine. Weak and no energy after the 2nd vaccine. My blood pressure was dropping. I was hospitalized at a medical center for acute renal failure and hyponatremia (low sodium). Was hospitalized for overnight the Last week of March. Still have a little hard spot on the location of the vaccine that had started. On June13, dizziness, nausea, double vision symptoms. Double vision didn't last long, just a few minutes, and dizziness came and went through the day. I didn't feel good all day. I felt wiped out the next day. I called the doctor on Monday because I was to start cardiac rehab. My regular doctor called me the next day. I take Meclizine. I have been taking that for a few years but I have not taken it the last day or so but I may have taken it the day I was experiencing dizziness.

Pt's , May 27 fell and broke distal fibula , cellulitis then a few weeks later/ after antibiotics (clindamycin) pt had no energy, said dr told her to stop taking due to side effects. One evening had severe pain in foot, that was broken doctor ordered Doppler ultrasound calf muscle DVT. Took Xarelto after 6 days her urine was very dark and pink dr said stop taking Xarelto . due to symptoms. by Friday went to get another ultrasound. blood clot dissolved Vascular surgeon ordered another ultra sound and said that the other ultrasound was inaccurate and she still had it . now waiting on dr to call

about 10 minutes after vaccine patient became unresponsive, could not feel a pulse on her and was not responding to verbal commands per Dr. She became incontinent of urine. Sinus rhythm on monitor, pulse in low 60-70s. BP 170/81 RR 18 oxygen saturation 96%, blood glucose 107. Patient began to feel nausea no vomiting while at clinic, was taken to ER by EMS who were on site at the clinic. She was responsive when she left the clinic A&O x 3.

She was in her usual state of health until January 26 when she received her first dose of the Pfizer COVID-19 vaccine and the second dose on February 18, 2021. Within 4 days of receiving this vaccine she noticed she fell on Monday, February 22 she was able to raise herself up she fell again on Tuesday, February 23 and on Thursday, February 24. By Friday she could not get up and she presented to hospital where she was noted to have lower extremity weakness. An MRI has revealed extensive edema of the whole of the spinal cord extending from the cervical region to the sacral area. She has lost motor function and sensation to the lower extremities as well. She has not had a bowel movement since Thursday, February 24 and she has had to have a Foley catheter placed because of difficulties passing urine.

Symptoms include breaking out in small red spots on shoulders and neck at first. Then eventually spread downward to elbow and bend of arms bilaterally . Now has continued on down clients body. Some are under the skin. A few errupt. They are very sore. If they do errupt they have a small white pustule in the center. The rash has now spread completely down abdomen and covered legs also . There is periods that the itching stops with an antihistamine but it doesnt go away. This started on the 7th and has continued..

nausea, elevated temp, excessive urination, swollen soft tissue (mouth, tongue), painful urination - bladder and kidneys, extreme weakness, no interest in food.

Pathology confirmed: OXALATE NEPHROPATHY. Unclear trigger for abrupt onset of AKI requiring initiation of dialysis in this lady with hyperoxaluria. Her hyperoxaluria is thought due to roux-en-y bypass. But unclear why she abruptly had Cr go from 1.2 mg/dl in Dec 2020 to 11 on 3/10/21 with oliguria. I - her attending hospitalist - am unsure what precipitated the crisis. I've attending renal pathology conference which discussed case. Some nephrologist entertained attributing it to Cdiff colitis, but the existing literature for this is very limited and her infection seems to have followed her AKI, rather than preceded it. Although unlikely, I've considered that patient may have existed with supersaturate hyperoxaluric state that experienced shock to equilibrium after small PEG injection of pfizer vaccine.

Pfizer COVID-19 EUA Vaccine Pt received first COVID vaccine 2/25/21. Tested positive for COVID late February. Reported to ED 3/5/21 with near syncope. Patient was seen emergency department laying in bed. The patient had a noticeable scalp laceration to posterior parietal area. After being symptomatic with COVID-19 for a few days, the patient reports getting up at 5:00 a.m. to use the bathroom, feeling lightheaded, then ended up on the floor, she reports sitting on the floor and then hit her head at some point, but was not entirely sure of this timeline. She states she ended up moving to the living room when she noticed that her head was bleeding a lot and her fiance called 911. She reports a history of syncopal episode in 2001 when she had influenza and apparently the story was much the same as this time, but she actually lost consciousness in 2001. Admitted to observation. 3/7: 73-year-old female recent COVID-19 infection admitted on 03/05/2021 for an episode of syncope probably secondary to bradycardia versus volume depletion. Paramedic on arrival at home reported bradycardia with heart rate in the 30s but has been normal since admission. The CT angiogram of the chest done at the emergency room showed bilateral infiltrates compatible with recent COVID-19 infection. No PE. However patient has no respiratory symptoms and O2 saturation is perfectly normal. Urinalysis was suggestive of infection and subsequent culture was positive for E coli and it is pansensitive. She was admitted to hospital for overnight observation. She was commenced on IV Rocephin and azithromycin. The EP cardiologist was consulted and she recommended and echocardiogram and it revealed mild global hypokinesis with LVEF of 45-50% but patient denied any prior history of cardiac problem. On re-evaluation this morning the vital signs remains normal. Patient has not had any episode of bradycardia since she presented to the emergency room. She will be discharged home follow up with the EP cardiologist for further evaluation. Patient does not need outpatient oral antibiotics as IV Rocephin for 3 days should be adequate for uncomplicated UTI.

increasing body wide weakness 1 day after vaccine, found to be in fulminant renal and hepatic failure with +troponin and rhabdomyolysis with no other preceding symptoms or significant history

The patient is a 73yr old female with multiple comorbidities including but not limiting to ESRD on dialysis, DM, COPD on home oxygen, OSA not compliant with CPAP at home, pulmonary hypertension, tachy-brady syndrome s/p pacemaker in March 2021, with multiple admissions (?6) this year already, admitted with septic shock, NSTEMI on 4/13/2021. She underwent R foot debridement and amputation on 4/16/2021. ID team treated with Vanco/Cefepime. On 4/18 afternoon, she developed PEA and coded for about 25min. Since ROSC, she never regained consciousness. This morning, at the beginning of my shift at 7am, she's on bicarb drip, maxed Levophed 100, Epi 100 drips and full vent. However, she was getting paced and BP stayed in 40s. I discussed with ICU pharmacist and gave her stress dose Solu-cortef. Checked serum cortisol level, turned out to be appropriate later. Lactic acid 22 and bicarb was only 2 despite being on Bicarb drip. I called Shauna/daughter to inform her about guarded prognosis (imminent death) and asked to bring husband to come see her asap. Before family arrived, she developed another PEA and code blue was called. She was given Epi, bicarb pushes and CPR started immediately. Code blue was unsuccessful. At 8:13am, she was pronounced dead. I called daughter again to notify her of patient's death. Family arrived around 10am. I met both daughter and husband at bedside and offered emotional support. Chaplain was consulted. Disposition - critically ill patient with multi-organ failure, septic shock from R foot osteomyelitis, ESRD on dialysis, DM, COPD on home oxygen, OSA not compliant with CPAP at home, pulmonary hypertension, tachy-brady syndrome s/p pacemaker in March 2021 - Patient coded and did not survive

didn't eat or drink much of anything/couldn't eat or drink; She was probably dehydrated; GFR of 52; blood pressure 82/50; skin tenting; dizziness/orthostatic dizziness/dizzy; Nausea vomiting; Nausea vomiting; chills and cold sweats; chills and cold sweats/all sweaty, cold; felt blah; sore arm after 2nd dose; This is a spontaneous report from a contactable nurse reporting for herself. A 73-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EP7533), via an unspecified route of administration, administered in arm left on 07Apr2021 at 13:30 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously received BNT162B2 on 16Mar2021 (at the age of 73-years-old) for COVID-19 immunisation and experienced Sore arm and feeling blah. Clinical course was as follows: She spent 50 years in neurology and neuroscience, she was a crazy RN that did neurology right out of school, she was recommended for that specialty. She is not sure if she had a reaction to the vaccine or if it is just her. Her 2nd dose was last Wednesday, 07Apr2021. She had a sore arm and felt blah. Just like after the 1st shot. On Saturday night (10Apr2021) at 0200, she was awakened with chills, cold sweat, dizziness, nausea and vomiting. She was sick as a dog for 2 days and didn't eat or drink much of anything. She went to the doctor who sent her to an infusion center. She is down to 5' 2" and weighed too much. She has not been able to lose weight for a couple years. She gained 40 pounds when she turned 50 years old. After the shot, she had a sore arm and felt blah like she did after the first dose, but she thought everyone felt that way. She missed a day of gym class because of her really sore arm. This got better like after a flu shot, it was nothing. This time she had a really sore arm and felt blah after the shot but then on Saturday morning this whole thing started happening. She woke up very restless, was all sweaty, cold, dizzy and was too miserable to try and take her blood pressure. Her blood pressure tends to run low. Her symptoms of the sore arm resolved at 06:00 Saturday (08Apr2021). She had nausea and vomiting and couldn't eat or drink. That lasted through Monday morning. She had some back pain with this, but she has back pain normally as she is a little old lady. She had a scheduled Oncology appointment Monday, as did her husband. She experienced orthostatic dizziness. She woke up plain dizzy. Her doctor gave her a liter of fluids and it helped her. This was something that needed to be addressed. It was serious. It was all serious. She had nothing left to vomit. She is an old lady with Breast Cancer. Her creatinine level of 1.10 which dropped her GFR of 52, she calculated the GFR using a computer program. This is what lead to the doctor giving her a liter of fluid. She had an appointment scheduled and her doctor sent her to the infusion centers for a liter of D5NS. She was sent home afterwards and encouraged to drink fluids. She also had a CBC and chemistry panel with her blood work. She was worried because her skin was tenting badly, and she couldn't keep anything down. She was probably dehydrated. Her blood pressure at the doctor's office was 82/50. She didn't care that her skin was tenting. She has been drinking a lot of fluids as advised after her liter of fluids at the infusion center. She is interested in researching the MRNA process because it is used it in other things. The way the vaccine was developed, it should have dissipated after 48 hours. She likes to research everything. She and her husband experienced a year from Hell starting in August of last year. All events are considered serious. The patient underwent lab tests and procedures which included blood creatinine: 1.10 and blood pressure measurement: 82/50 on 12Apr2021, blood test, full blood count and investigation with unknown results and glomerular filtration rate: 52 on an unspecified date. The outcome of the events chills and cold sweat was recovered on 12Apr2021, skin tenting and orthostatic dizziness was recovered on 13Apr2021, vomiting and nausea was recovered on 14Apr2021, pain in arm was recovered on 10Apr2021, feeling abnormal was recovered on an unspecified date, while of the rest was unknown.; Sender's Comments: Based on a temporal association and the known drug safety profile, the reported events are considered possibly related to BNT162B2. 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.

Pfizer COVID-19 Vaccine EUA Pfizer Dose 1 3/18/21 (EN6207) Pfizer Dose 2 4/8/21 (EW0161) COVID Positive 4/23/21 4/22/21: Presnted to ED. The patient presents with Nausea and vomiting. A 73 year old female with a history of UTI and DM was brought to the ED today due to having nausea and vomiting for the past couple of days. She was administered Zofran by EMS; they checked her BS which was 171. The patient states she has been sick since the eighth of this month, and has had diarrhea, dysuria, and arm pain. She reports not taking her insulin since February due to her insurance no longer covering her. . The onset was 3 days ago. The course/duration of symptoms is constant. The character of symptoms is unknown. The degree at present is moderate. The exacerbating factor is none. The relieving factor is none. Risk factors consist of diabetes mellitus. Therapy today: emergency medical services. Associated symptoms: diarrhea. 4/30/21: A 73-year-old female, history of hypertension, diabetes mellitus type 2 with chronic kidney disease, adrenal insufficiency from renal cell carcinoma and adrenalectomy, and nonalcoholic steatohepatitis with portal hypertension, esophageal varices, has had nausea and vomiting for several days. She did receive her second COVID-19 vaccination on April 8, and has had ongoing symptoms since that time, much worse in the 3 days prior to admission. An initial COVID screen was negative, but rechecking the PCR COVID test was positive. Initially, she did not require any oxygen, but did require 2 L nasal cannula at night on the second night, at which time remdesivir and convalescent plasma were administered. She was also given dexamethasone, but had marked rise in her blood sugar to greater than 400. The dexamethasone was tapered and stopped. Glucose regulated with insulin. The patient initially had severe anorexia, poor oral intake, but this slowly improved. CT scan of the abdomen and pelvis has shown the small nodular liver consistent with cirrhosis and portal hypertension. There is some ascites and mild pleural effusions. The patient had been receiving some IV fluids, and we would discontinue the Lasix because of low blood pressure. There was no other obvious explanation for her poor oral intake or abdominal pain. The patient had IV access problems and eventually, despite the PICC line and midlines being attempted, we were unable to complete a successful IV to finish her CAP antibiotics or the remdesivir. The patient seemed to be doing better, oxygen is 98% on room air, blood pressure 98/63 and 116/60. We are holding the Lasix, potassium, and spironolactone. The glucose has been running at 213, 154, and 202. BUN at 35, creatinine 1.4. WBC 11,700 and hemoglobin 11.5. The patient was seen on the day of discharge at 1100 hours, doing quite well, and will be discharged home with her family. We have offered visiting nurses, but she feels that the family is there 24 hours a day. She does not need any visiting nurses. We have made some changes to her medications, and she will need to follow up with her primary doctor in the next week to see whether we need to restart Lasix, potassium, and spironolactone. DISCHARGE MEDICATIONS: Will be hydrocortisone 15 mg a.m., 5 mg evening, venlafaxine 37.5 daily, venlafaxine 150 mg at bedtime, rifaximin 550 mg b.i.d., Bactrim DS 1 daily, multivitamins daily, insulin glargine 35 units at bedtime, atorvastatin 20 mg daily, NovoLog 20 units before meals. Again, we are holding Lasix, potassium, and spironolactone.

This 73 year old female received the Covid shot on 3/2/21 and went to the ED and admitted on 3/25/21 with the following diagnoses listed below. R56.9 - Seizure R56.9 - Unspecified convulsions N17.9 - Acute kidney failure, unspecified

Patient reported feelings of malaise, SOB, and non-specific symptoms on 4/22. Patient sought medical care for symptoms on 05/08/2021. Patient was noted to have multiple large ecchymosis scattered over upper and lower extremities bilaterally; Plt. count came back at 7k, and patient was diagnosed with ITP (no prior history of ITP).

Patient started 18-24 hours with loss of strength- inability to bear weight, and confusion with inability to communicate- both expressive and receptive, moaning and complete loss of awareness. The initial episode lasted approximately 4 hours. These episodes repeated for the next 3 days. She was taken to the Emergency Room by ambulance 3 days after the vaccine and a workup was completed. It was negative at the time of exam. She did have a mild anemia, but CT and laboratory work were otherwise negative. She had recovered strength and her memory. Later that evening she was again unresponsive except to painful stimuli and was like that over night. She was fatigued but was repulsive the next day. She never gained her full strength back. Over the next 4 weeks, she had progressively more of the periods of unresponsiveness and amnesia that stayed progressively longer and recovery was even less in-between the periods of unresponsiveness. She was placed on Hospice Care and succumbed on March 9, 2021, 1 month after her first vaccine.

4/21/21 Pt was reportedly admitted to the Hospital for generalized weakness. Her nephrologist noted worsening renal function and had her admitted for hemodialysis. Of note, she had not been able to keep her appointment for mAB due to weakness. At the outlying hospital she had a palliative consult and started dialysis. First day of RRT was 4/24/21. Approximately one hour after dialysis she developed 10/10 CP and her EKG changed from a partial LBBB to a complete LBBB. She was transferred to a different Hospital for further evaluation. Her BP was fairly labile and troponins were positive. Approx 7 hours after arrival, she became unresponsive. Heart rate was very irregular in what appeared to be a fib. Transcutaneous pacing was initiated. She was given several amps of bicarb and started on a dopamine infusion. Her daughter arrived shortly thereafter and the pt became apneic. She was transitioned to comfort care and death was pronounced at 04:13 on 4/25/21.

Post the Second Dose Following symptoms started to show-up - Tiredness, Confused state of mind, Loss of appetite - Lack of Sleep - Fluid accumulation and swelling in legs, face/eyes - Increased Creatinine, Reduced Hemoglobin, Vitamin and Iron Deficiency

Admit 5/25 for AMS and UTI. Rapid COVID+, 2 subsequent COVID PCRs negative but not ruled out as per documentation. Treated with Zinc and Decadron. Remains admitted at time of review 6/7/21, to be transferred to another hospital.

development of UTI; high Blood pressure/her blood pressure was 200; could hardly walk; dizziness/ light-headedness; legally blind in her left eye; feeling sick; fatigue; she was not able to come to work; Female consumer who had the1st dose of the MODERNA COVID19 vaccine on Feb 18, 2021 and had mistakenly received PFIZER-BIONTECH COVID-19 VACCINE for her 2nd dose on March 18, 2021; This is a spontaneous report from a contactable consumer or other non hcp. A 73-years-old female patient received bnt162b2 (BNT162B2, formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 18Mar2021 (Batch/Lot Number: EN6206) as DOSE 2, SINGLE for covid-19 immunisation; and covid-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), via an unspecified route of administration from 18Feb2021 (Batch/Lot Number: 029M2A) to 18Feb2021, at DOSE 1, SINGLE for covid-19 immunisation, Second dose information from her card: 18Mar2021, Lot: 031A21A and it was given in the left arm. In her medical record it showed the first dose as Moderna with Lot: 024M20A. The second dose as Pfizer with Lot: EN6206. Both doses were given in the afternoon. Patient Age at Time of Vaccination was 73 Years. Medical history included ongoing hypertension High blood pressure for 10 years. The patient's concomitant medications were not reported. The caller explains that when she got the first dose, she got in the withheld by withheld. With the second dose, she had to go to a drive through at the [Redacted]. The caller notes she first had to stop and give the card to a person who documented the lot and product information on the card. Then she pulled up to another spot where the nurse had the shot in hand ready, told her she was giving the Pfizer shot, and put it in her arm. She questioned in her head and thought maybe Pfizer makes the Moderna one too. Then she went to another spot to wait. At that time, she reports she felt kind of bad then but the next night her blood pressure was 200 something over 100 something, caller could not provide the exact number. She states she was hospitalized the next night after getting the Pfizer vaccine; admitted on 19Mar2021 and was there 3 days. Admitting diagnoses was adverse reaction to vaccine. The caller then clarified this all started after the first dose. She was admitted the first time on 27Feb2021. Dizziness was the admitting diagnoses, and she was hospitalized for 2 days. It was also noted she had given a years' worth of medical information to Agency looking for compensation. She on 12Jun2021 she went to urgent care for lightheadedness, fatigue, and unspecified UTI. At that time, she was sent for a chest X-ray which showed an enlarged heart; she did not have this previously. The caller remarks she had been sick since getting the shot. Then she went back on 24Jun2021 and was admitted for 2 days with a diagnosis of dizziness, high blood pressure, and could hardly walk. Her next visit was on 06Jul2021 to urgent care for dizziness and high blood pressure where she was treated and released. Her eyes started bothering her really bad during this time. Caller had never been to an optometrist other than once in her life but went to see one 12Jul2021 and was told she was legally blind in her left eye while the right eye had 20/20 vision. She tried several medications in the hospital and they did tons of test. She could not take the medications and therefore is currently just taking her blood pressure medication. She was on that previously, explaining that she has been dealing with and treated for blood pressure issues for 10 years. She had no product names, NDC, Lot, or Expiry for product tried while hospitalized and that she cannot take. Caller did not provide the name of the blood pressure medication when asked if there were any Concomitant Products that she would like to share or felt was relevant. While in the hospital they did a CAT scan on her brain and it was normal and an EKG and it was normal. She had blood tests but doesn't know those tests or results right now. She turned in information to Agency looking for compensation but they only pay if she was working and at the time she was not due to COVID. Now she cant go to work because she is so sick. She doesn't know what to do. The patient had the 1st dose of the MODERNA COVID19 vaccine on 18Feb2021 and had mistakenly received PFIZER-BIONTECH COVID-19 VACCINE for her 2nd dose on 18Mar2021 and has been in and out of the hospital ever since. She has contacted Moderna and they never got back with her. She also contacted Agency and submitted a request to get some of her money back regarding this but has not heard back about that either. Her card had that both shots are Moderna but her hospital record is different and shows she had Pfizer for the second dose. Caller experienced side effects such as feeling sick, light-headedness, fatigue, dizziness, high Blood pressure, and development of UTI at some point. And because of this she was not able to come to work. She mentioned that it started happening after she got her 1st dose with MODERNA and continues post-vaccination of her 2nd dose for Pfizer. The patient was hospitalized for high blood pressure/her blood pressure was 200, could hardly walk (gait inability) and dizziness/ light-headedness from 24Jun2021 to 26Jun2021. The patient was in emergency room and urgent care. The outcome of the event was high Blood pressure was not recovered and outcome of other event was unknown. Additional information has been requested and will be provided as it becomes available.

Shallow breath with spastic cough On again off again fever and chills Headaches Fatigue, lethargic, not able to do much No appetite Urine strong odor, different color, and frequent Cramping in hands and feey

Rash/welts developed over entire body (face, trunk, arms and legs) within 1 hour of receiving vaccine. Itching started that evening. Next day went to PCP who ordered 3 doses of prednisone 20mg and benadryl 25mg every 6 hours PRN. Day 2, rash/welts increased as well as itching. Evening of day 2, rash to legs progressed to purpura, temp of 102.7, chills and extreme pain to bilateral hips which prompted taking to ED and being admitted to progressive care unit.

Nausea; Dizziness and room spinning; room was spinning; her white blood cell count was elevated; Kidney failure and allergic reaction; Allergic Reaction; still wasn't feeling normal; Could not keep head up and was in bed; breathless; extreme fatigue; exhausted and weak; Heart was banging fiercely; Totally dehydrated; Urinating a great deal more; Chills, shakes and felt terrible; Chills, shakes and felt terrible; sicker every single day/sick/felt terrible; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration on the left arm on 18Jan2021 14:30 at a single dose for prevention for COVID. Medical history included hip replacement on 04Jan2021 and fibromyalgia (When her children were younger, she was told she had Fibromyalgia). Family history includes diabetes (father late onset) and very rare cancer (mother). There were no concomitant medications. It was reported that the patient received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine and got sick the next day (19Jan2021). She also mentioned that she got sicker every single day. Then after 8-9 days, she said she started to feel better, but still wasn't feeling normal. She said she had extreme fatigue, was breathless, and felt exhausted and weak on an unspecified date. She said she was supposed to receive the 2nd dose of the vaccine this Monday (unspecified date), but because of her side effects, she was told that she can come back to receive the 2nd dose after 6 weeks. She wants to know if this is acceptable. The patient reported that on 19Jan2021, she woke up in the middle of the night with chills, shakes, and felt terrible. She cancelled her plans for Tuesday (as reported). On Wednesday, she forced herself to get up and went out for lunch and came home. She could not keep her head up and went back to bed and that lasted several days. It got worse before it got better. She ended up being hospitalized for 4 days (25Jan2021 to 29Jan2021). It appeared to be she was in Kidney Failure and experienced allergic reaction on 25Jan2021 and her white blood cell count was elevated (unspecified date). She went to the ER and they kept her 6-8 hours and discharged her on a Friday and by Monday, she was admitted to the hospital. The first ER visit, she was there for 6-8 hours and they sent her home. They gave her IV fluids and took a lot of tests. The patient's first ER visit was on 22Jan2021, and was kept for 6-8 hours and released. She was given IV fluids and they did a lot of tests. She went to see her doctor and sent her to the emergency room. They took her blood, EKG and everything seemed ok. Creat was 1.0 and by Monday it was 1.6 and then on Friday it was 1.9 (unspecified dates). She was admitted to hospital on Monday and they gave her IV fluids and did kidney test and admitted her as soon as she could get a room. She never had a problem before with her kidneys. They did bacteria test and they were normal. The patient called her doctor on 24Jan2021, because she was nauseous, dizzy, and room was spinning and she felt worse. She went to his office on Monday morning and he put her right in the hospital (unspecified date). She got worse and now it is improved. Heart was banging fiercely on 22Jan2021 20:00. They took an Echocardiogram. She has never had a cardiac problem and could not find anything wrong with her heart. The patient started feeling a bit better. She was sick as can be through Sunday. By Tuesday (unspecified date), she was a little better and today is a little better. She is urinating a great deal more because of fluids, but later said it started the day after she got it. She had to get an aide to take care of her. The patient experienced totally dehydrated on 22Jan2021 14:00 and urinating a great deal more on 19Jan2021 03:00. Therapeutic measures were taken as a result of kidney failure, allergic reaction and white blood cell count was elevated. The outcome of the events sicker every single day/sick, chills, shakes and felt terrible was not recovered; event could not keep head up and was in bed recovered with sequel; events nausea, dizziness and room spinning, heart was banging fiercely, totally dehydrated, urinating a great deal more was recovering; while unknown for the rest of the events.

With first shot, mild itching all over. One Day. With second shot on 2/16- itching, took Benedyl and tylenol. On 21st sore all over, knees, back, shoulders, difficulty rising from seated position. It was as if all my joints were inflamed. Had strange bruise of left thigh, Dificulty walking. Took warm bath, muscle rub, ibuprofin, Pain continued on 10.,muscle spasms. When to ungent Care 2/27. Test Netrophils 61.7,lymphs 30.0, monos 6.0, eos,2.1 baso 0.2, AnC 2.99;Lymphs 1.45, monos 0.29, eos auto 0.10,BASO,001, WBC 4.8, RBC 4.70. HGB 12.7 HCT 39.8, MCV 84.7,MCHC 31.9.RDW<BLOOOD, 14.0,PLT'S AUTO,NA 141, K 4.1,CL 103, CO2 29. CREAT 0.86, GFR 77, BUN 15 , GLUC 112, ESR 23

She received her 2nd vaccine and started feeling very chilled and tired around 6:30 that evening, started shaking and feeling like restlessness. She went to bed and covered up under lots of covers, and just froze. She put on extra clothes, layers of blankets and her legs felt swollen, painful. She kept having to urinate a lot, could not sleep, was awake all night, her arm started hurting as well, could not lay on that side, and then started getting cold/hot flashes. She felt as though her heart was racing, and her brain as well trying to figure out what was happening. Her husband took her temperature in the morning and it was 101.9, which her normal is 97.9. At that point she was exhausted from being up all night, and was frightening and couldn't stop trembling all night long into Saturday. When day broke on Saturday shew as not able to get out of bed for the entire day. She could not eat, had no appetite and drank water day. On Sunday she felt a little better, ate breakfast and the rest of the day went okay other than being exhausted. This morning, 3/22/21, she still feels lofty, is able to function and feels a little removed/foggy feeling. She is still not feeling completely well, but is on her way. Not steady on her feet yet. She took some Bayer aspirin for the symptoms.

Caller is pt's wife, all information was obtained from caller. 74 year old male received 1st dose of Pfizer COVID-19 Vaccine Lot# EL8982 at location on 01/25/2021 @ 10:30. On 01/28/2021 pt started feeling chills, which resolved in 2-3 weeks. Pt started feeling back pain around 02/15/2021, went to Clinic around 02/17/2021 for the pain. The 2nd dose of Pfizer vaccine was due on 02/17/2021, pt had to cancel 2nd dose appointment due to Clinic appointment. Clinic staff told pt back pain was most likely due to a pinched nerve or lower back problems that comes with age. No x-rays or blood work was performed at Clinic. On 02/21/2021 pt stood up and felt even worse lower back pain, couldn't walk, pt went to ER and was admitted for 5 days, discharged 02/26/2021. Blood work was done and showed hyperkalemia, proteinuria, and kidney failure, upon discharge ER staff told pt to follow up with nephrologist. Nephrologist appointment is scheduled for 04/01/2021. Pt takes Morphine sulfate IR 15mg, Atenolol 50 mg, Fenosteride 5 mg, and Terazosin 10 mg. Pt has Myeloma, Hypertension, and Benign Prostatic Hyperplasia. Caller denies pt has any allergies. Pt will receive oncology treatment 03/29/2021, the oncologist alerted the caller the 2nd dose must be administered to the pt before oncologic treatment. Caller asked if the pt should get the second dose due to the kidney failure occurring after the 1st dose was administered. Currently pt is only experiencing lower back pain. Pt was advised that it is unlikely the vaccine caused kidney failure and the pt should get the second dose as soon as possible. SPI was consulted and Dr. was notified.

DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Cardiac arrest (HCC) [I46.9] HOSPITAL COURSE: Patient is a 74 year old female who receives care through healthcare clinic and second healthcare clinic with past medical history of HTN, CKD, cardiomyopathy/congestive heart failure, atrial fibrillation on Pradaxa who presented to the ED 3/16 after suffering an out of hospital cardiac arrest at her dentist's office. Per report, patient had SBP in the 80s on arrival but was asymptomatic. Prior to start of any procedure (no reports of being given sedative medications), she became unresponsive. CPR was initiated and was found to be in asystole. She received 3 rounds of CPR with ROSC. CT head without acute abnormality. Chest XR showing mild vascular congestion and interstitial edema. Initial labs showing AKI, elevated liver enzymes, BNP >29,000, troponin 39, lactic acid of 11, INR of 6.6, PTT 62, APTT 87. UA with protein, nitrite, moderate blood. Urine culture ordered. Blood cultures ordered. In ED, patient was hypotensive requiring addition of vasopressors. Targeted temperature management was started. Ceftriaxone and flagyl started for possible urinary tract infection and aspiration. Patient with profound coagulopathy, INR increasing to 12.0 on arrival to the ICU. Two units FFP and vitamin K were given. Patient with escalating pressor requirements at this time so CT t/a/p was ordered showing multiple bilateral rib fractures, nondisplaced sternal fracture with small anterior mediastinal retrosternal hematoma, small right sided hemothorax, right chest wall hematoma, patchy bilateral airspace disease consistent with atelectasis/infiltrate/aspiration, diffuse GGO consistent with interstitial edema, enlarged pulmonary arteries consistent with pulmonary hypertension, cholelithiasis. FDP elevated and 2 units of cryoprecipitate given 3/16. Hemoglobin decreased to 5.9 3/17 with INR of 5.4. Two additional units of FFP and additional dose of vitamin K ordered. Two units RBCs ordered. CTA thorax and abdomen 3/17 re-confirmed hemothorax and chest wall hematoma but no active bleeding noted. CT bilateral LE showed no evidence of hematoma. Trauma consulted who recommended chest tube placement. Overnight 3/16-3/17, patient also noted to have seizure activity on EEG and patient loaded with Keppra. Head CT 3/17 negative for hemorrhage or other acute processes. Patient remained in status epilepticus 3/17am and additional Keppra load was given and neurology consulted. Received Praxbind for continued bleeding/coagulopathy. 3/17pm went into PEA arrest with 10 minutes of CPR with ROSC. Bronchoscopy following ROSC noted evidence of bleeding from multiple areas, clots removed. MRI brain showing diffuse anoxic brain injury. Propofol stopped 3/19am. After goals of care discussion this morning, all first degree relatives (daughter and son) all in agreement to transition to comfort care measures. I received call from bedside RN that patient had passed away. On exam, no heart or breath sounds appreciated upon auscultation for 2 minutes. No spontaneous movement or chest rise noted. No pulse palpated for two minutes. Pupils fixed and dilated. No response to noxious stimuli. Time of death 1400 3/20/2021.

Two days after receiving vaccine patient and family reports patient developed nausea and headache. symptoms seemed to worsen over time and not improve. was evaluated on 3/3/2021 where patient reported weakness, body aches, slight ear discomfort, slight headache. Seen again on 3/8/2021 by other provider reports symptoms of fatigue, dizziness, weakness, diarrhea, nausea. Admitted on 3/11/2021 for COPD exacerbation, treated and sputum cultures grew pseudomonas readmitted on 3/18/2021 due to recurrence of symptoms, diagnosed with Covid pneumonia, increasing oxygen requirements. complication of subcutaneous emphysema with small bilateral pneumothorax from continuous noninvasive ventilation and eventually with worsening hypoxia on 100% FiO2 was intubated and chest tube placed. 4/4/2021 removal of invasive care, comfort care. patient passed away inpatient Prior to covid vaccine patient did have several co morbidities and then subsequently covid that resulted in her death, family is adamant that her decline in health started after her covid vaccine and requested adverse reaction report.

Patient presented to the hospital for low hemoglobin, hematuria, abdominal pain, and cough. The patient tested positive for COVID-19 upon admission to the hospital on 3/24/2021. CXR showed mild pulmonary vascular congestion. The patient was on 2L/min supplemental oxygen throughout admission.

5/2/21 er hpi: 74 y.o. female who presents to the Emergency Department by EMS. EMS was called to the patient's home at an assisted living facility with a complaint of shortness of breath. When EMS initially arrived the patient was able to talk and tell them that she was feeling poorly and then shortly after this, she started having a lot of trouble breathing and essentially became unresponsive. EMS started bagging the patient and back to her all the way here. When she got here she was obviously in respiratory distress. Once IV access was established, the patient was intubated using RSI. Not much history other than this is available because the patient was unable to speak before she was intubated due to her shortness of breath. transferred to higher level of care 4/30/21 ER HPI: 74 y.o. female who presents with severe lumbar back pain that radiates into her right buttock and right posterior thigh. She rates it a 7 to 8/10. The pain has improved since its onset last evening. She denies any numbness tingling or muscle weakness. She further denies injury or incontinence. Patient does have a history of low back pain though none as severe as this. dc'd home

Patient presented to the ED with LUQ pain and was subsequently admitted for acute kidney injury within 6 weeks of receiving COVID vaccination.

At 11:40am on 1/8/21, resident appeared catatonic and was just staring at the wall. When on unit, observed resident seated in a chair, blankly staring at the wall with no loss of consciousness. Blank stare accompanied with mild jerky movement. Resident was safely assisted to bed. Oxygen at 3lpm was administered. Petit mal- like seizure lasted for 5 minutes. Resident regained prior level of alertness and doesn't recall what had happened. Resident with no known history of seizure disorder.

Dizziness; history included compromised immune status; history included compromised immune status; getting really tired/fatigue; Gets real sweaty; chills; almost passed out at doctor's office; Nausea; Felt cold; Blood in urine; Feeling unwell; Feeling bad; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EJ1686), intramuscular in the left upper arm on 08Jan2021 at 15:45 at 0.3 mL, single for COVID-19 immunization. Medical history included Leighten Plantar Alopecia (hair follicle is an enemy), skin infection (infection in body most of the time, at least on skin), diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities, obesity, autoimmune disorder (diagnosed 8 months ago). She has lost some height, prior to taking the vaccine and she said it was related to age. There were no concomitant medications. The patient experienced feeling unwell on 10Jan2021; blood in urine on 10Jan2021 at 17:00; nausea at 10:00, chills at 11:00, almost passed out at doctor's office at 10:00, felt cold - all on 11Jan2021; getting really tired/fatigue on 14Jan2021 at 09:30; gets really sweaty on 13Jan2021 at 10:00; and dizziness on unknown date. The patient had the first shot on Friday (08Jan2021). On Sunday (10Jan2021), she started feeling bad. She was feeling good about getting it and had no reaction. She has an autoimmune disorder that made her a little afraid to take, but with all the indications, they said it would be much better for her to take it than to get the COVID virus. Sunday (10Jan2021), she does not feel good. So, she started having blood in urine. She thought she had a UTI and had not had one in 20 years. It felt like that is what she had and with the blood in urine. She just took Tylenol and waited until Monday morning because she does not like sitting in doctor's office. They gave her a cup to give sample and said she didn't need to see provider. They will have it checked and in the meantime call in a prescription. It kept getting worse and worse. She was about to passed out in the doctor's office on 11Jan2021, she got nauseous and almost threw up. She got in the car with her husband and he was trying to get her home. She got chills and got so cold and could not warm her body up. Her husband gave her Phenergan and it kind of knocked her out for a while to ease her nausea. She was thinking of going later today (14Jan2021), when she gets enough energy, to get a COVID test. She does not know if it will give false positive or not. She had chills and now she gets sweaty since 13Jan2021. She took her temperature and she did not have one. She just now got up. It is 10:00. She got up this morning (14Jan2021) and was really tired. She was not sweating this morning. Tiredness is kind of new, and when she talked to the nurse, she sort of felt like maybe it was a reaction to the COVID vaccine, but then she talked to her daughter and she said the symptoms she was having are usually symptoms that occur with second dose of the vaccine. It is not uncommon for people to have symptoms she was having. She wanted to know if she should have a COVID test. If she has had just one shot, would the test give a false positive coming from the COVID. They were asking if patient should take the second dose, and should she continue her UTI medication. Doctor's visit to give urine sample on 11Jan2021 (results: negative for UTI). She did not see a doctor though. They sent sample and prescribed a sulfa based medication for a UTI. She did start feeling a little better and stopped having blood in her urine. She plans to continue it because she does not like to stop taking an antibiotic. She did not have any clue that it was not a UTI until the nurse from her provider's office called to tell her results of urine sample was negative. Outcome of event getting really tired/fatigue was not recovered; events almost passed out at doctor's office, blood in urine, chills, and gets really sweaty was recovering; and unknown for other events.

Sudden onset of left arm heaviness and problems working 3rd and 5th digits of left hand. Admitted overnight for suspected TIA. MRI subsequently confirmed acute to subacute right frontoparietal infarct

Patient presented on 1/24 with acute onset weakness and numbness of the left leg so a stroke alert was activated. NIHSS 3. Head Ct and CTA head/neck were unremarkable. Not a candidate for tPA given on Eliquis. Initial exam was notable for weakness and sensory loss in the left leg, but a sensory level was also found to the umbilicus raising concern for a myelitis. Of note, the patient also reported that certain red colored things she looked at appeared black. Labs unrevealing- CBC, CMP unremarkable. ESR, CRP normal. UA and UCx positive for E. Coli UTI, she was treated with ceftriaxone. MRIs were done of her brain, cervical and thoracic spine which were unrevealing. On 1/25, her exam worsened including worsening weakness in the left leg and new numbness and paresthesias in the right leg. Reflexes were preserved. MRI L spine was done which was unrevealing. Lumbar puncture was done which showed 2 nucleated cells and mildly elevated protein at 50, but was otherwise unrevealing. IgG Index normal. No oligoclonal bands. She developed mild hyperreflexia in the left leg and continued to have a sensory level, now at around T5-6. Repeat imaging of her cervical and thoracic spine were completed on 1/28 which showed a contrast enhancing hyperintensity at T5. The patient was diagnosed with myelitis and she was started on IV methylprednisolone x5 days and sent to rehab. Patient is now significantly improved though continues to report some numbness in the left leg.

Patient called stating she received the second Pfizer vaccine on 2/21. That evening, she developed severe generalized weakness. She was unable to walk or stand. She laid on the floor from 2/21 3pm until 2/22 PM. She was incontinent of urine- reports urinating on towels throughout yesterday. She was unable to hold her head up due to weakness. She still feels weak today, but is able to stand and walk with husband's assistance. Also reports generalized muscle soreness and intermittent vertigo. She is drinking fluids well, has eaten a light meal today. Denies fever, shortness of breath, chest pain, palpitations.

Transverse myelitis; bowel and urine issues; bowel and urine issues; she can't walk; numbness from her toes up to her breast on the left side and numbness from her toes to her groin on the right side; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Jan2021 at 13:00 at single dose into right arm for COVID-19 immunisation at the age of 75-year-old. Lot number was EL8982. Medical history was unknown and concomitant medications included blood pressure pills and cholesterol pills and vitamins. On 24Jan2021, the patient experienced transverse myelitis; the patient was hospitalized due to the event (hospitalization dates from 24Jan2021 to 7Feb2021; emergency room since 24Jan20211 noon). Consumer stated that when she was in the hospital, she was on heavy doses of steroids intravenous (IV) for 5 days. Blood work at the hospital was normal. Consumer left the hospital to go to the rehab facility on 30Jan2021, and then consumer left the rehab facility on 07Feb2021. Consumer stated that she could not walk. Consumer had complete numbness from her toes up to her breast on the left side and numbness from her toes to her groin on the right side. Consumer stated that she was still having issues with dragging her left leg, and with rehab, she was finally getting back some feeling, the numbness was still there but she was having bowel and urine issues. Consumer stated that her issues have somewhat improved with the help of rehab. The patient was recovering from the events.

PATIENT AWAKENED DURING NIGHT WITH EXTREME CHILLS, HEADACHE, FATIGUE, FREQUENT DIARRHEA, URINARY FREQUENCY. THIS HAS NOT RESOLVED OR IMPROVED IN 6 DAYS AFTER VACCINATION #2

emergency visit on 4/30 for cystitis, on 5/4 for costochondritis, on 5/13 for nausea vomiting and diarrhea, on 6/13/21 for tophaceous gout flare

Bowel blockage started Saturday 6/12/21 during breakfast. Had stabbling pains in lower abdomen and violent vomiting, especially water. Lost 10 pounds. Went to ER late afternoon 6/13/21. Admitted morning of 6/14/21, discharged Saturday 6/19/21. Had NG tube. Received antibiotics and potassium by IV. Had atrial fibrillation and AKI (acute kidney injury from depletion of electrolytes).