Pfizer

My son received the vaccine at 12:35pm and he was fine for the reminder of the day and did not have any soreness in his left arm. Around 8:40pm he came to me after using the bathroom and discovered blood in urine. He wiped himself and their was red blood on the toilet paper. He used the bathroom again around 10:00pm and saw red blood in the toilet as well as on the toilet paper when he wiped himself. He also experienced stinging pain when urinating both times.

presented to outside ED with complaints of new onset chest pain that radiated to the back and down his arms with concurrent nausea. Patient was sitting in the living room around 2030-2045 when he developed midsternal and epigastric region pain. Pain radiated to his upper middle back and down both left and right arms. There were no notable exacerbating or relieving factors. Pain was a 4-7 in severity. He was also nauseated. He was given tums by his mother without significant change in symptoms. After 45 minutes they decided to go to the ER. At ER labs were notable for elevated troponin (2-- >15-- >9). EKG with J-point elevation. Non-contrast CT chest/abd/pelvis was unremarkable. He was given ASA 325 and famotidine in the ED. Pain eventually subsided around 2345. He was transferred to another hospital for further evaluation of troponinemia.

Patient had a sore arm but no fever on the day the vaccine was given. The following day (4/29/2021) patient was on a boat, in the sun, not drinking much water and noticed brown discoloration of urine. He drank more fluids and symptoms resolved. Patient received second COVID vaccine on 5/19/2021 and the following day (5/20/2021) he was again on a boat and in the sun all day long and noticed brown discoloration of his urine which resolved with increasing his fluid intake. On 6/2/2021, he noticed brown discoloration again that progressed to bright red blood in urine. Patient was seen in my clinic and labs showed acute kidney injury, hematuria, proteinuria, possible glomerulonephritis and/or acute tubular necrosis. He is being followed closely by Pediatric Nephrology now to monitor symptoms and will repeat labs to see if kidney function, hematuria, proteinuria has resolved. If it has not resolved, then he may need a renal biopsy to confirm diagnosis.

16 year old male with no PMH who presented with chest pain. Initially on 6/10-6/11 had expected myalgias and headaches post vaccination similar to dose #1, but later 6/11 developed chest pain that made it impossible for him to sleep. It was waxing and waning but continued through 6/12 which after discussion with PMD ultimately led to referral into our facility for further evaluation. Received a dose of ibuprofen with marked symptomatic relief. No further medications given during his time, his chest pain had resolved after that ibuprofen dose and was at clinical baseline until discharge on 6/15. Prolonged hospital course was to arrange for cardiac MRI to be done for comparison. Otherwise had serial labs (documented below) which had trended in the right direction.

Presented to urgent care on 5/28 with complaints of sore throat, Headache, body aches and fever for 103, slight cough, denies chest pain or SOB. Had a neg rapid strep. Diagnosed with viral illness 5/30 presented to the ED with chest pain, cough, wheezing and SOB. Also had diarrhea and low abdominal pain. Was hypotensive and bradycardia. Received 2 bolus of Lactated Ringers . EKG with ST segment elevation. Concern for MISC. Transferred to hospital. 5/30 at the hospital he had another bolus of fluid, continued bradycardia admitted to the ICU for potential for hypotension during IVIG for suspected MISC, worsening ST elevation on EKG. TTE unremarkable. Started on IVIG, anakinra, lovenox and solumedrol. Monitored on telemetry. EKGs consistent with myopericarditis. discharged home on prednisone on 6/4 with a long taper, has follow up with rheumatology and cardiology. Stool enterovirus positive culture positive. He had previously been diagnosed with COVID-19 in November 2020

Myocarditis Developed fevers, chest pain and hematuria. Fatigue started the next day, night sweets the night after x 2 days, fever on 6/14, chest pain on 6/15. Troponin elevated, Echo with poor ventricular function, UA with hematuria. Improving on NSAIDs

Urinating blood multiple times. This has occurred over the course of 2 days now and is ongoing, but getting a bit better. Symptoms came 1 day after receiving 2nd dose of Pfizer COVID 19 vaccination. At the advice of the doctor, we went to the Emergency Room as it was Friday night at 9 p.m. A urine test confirmed blood in the urine and the diagnosis was "gross hematuria" and "adverse effect of vaccine, initial encounter"

After my son received his 2nd Dose of the Pfizer on the scheduled date at approx.10:45 am, we went home and were just relaxing and at approx 1:54 pm. My son in a panic yelled for me to come into the bathroom and he showed me his urine and it was bright red with clots (Gross Hematuria). I know the time because as soon as I saw it I took a picture (of which I still have on my phone). I proceeded to access how he was feeling and after he said he felt okay just scared-no pain or anything, I called his Pediatrician whose office instructed me to take him to the ER and that is what I did. He was not rough housing, there was no trauma and again no pain. This has never happened before.

17 y.o. male who presents with chest pain, elevated troponins and diffuse ST elevations concerning for pericarditis vs myocarditis admitted for cardiac monitoring and evaluation. Pt states he has had 1 day of sudden onset L shoulder pain and chest pain. Endorses dyspnea due to pain with deep breaths, denies tachypnea, nausea/vomiting, diaphoresis. Endorses mild chills and aches after COVID vaccine 3 days prior to onset of symptoms, denies any fever, URI symptoms, diarrhea, rash, known COVID contacts. Pain continued to worsen and spread across his chest, causing presentation to ED this afternoon. No history of PE, DVT, long travel, recent surgery, malignancy, alcohol or cocaine use. Significant cardiac history in family: dad with CAD w/LAD blockage, both parents with hypertension. At ED, labs notable for elevated troponin 0.456, repeat 0.67 and diffuse ST elevations on EKG concerning for pericarditis. COVID neg, CXR unremarkable, blood cx drawn, no abx started. Patient was given toradol for pain with minimal improvement. Peds cardiology was consulted and patient was transferred to different ED for further care. At different ED, repeat EKG showed similar diffuse ST elevations in I, II, aVL. Repeat troponins uptrending (4.91), proBNP 562, ESR 43, CRP 18. Mildly tachycardic but otherwise hemodynamically stable. Given tylenol for pain. Cardiology recommended admission for trending troponins, echo and cardiac monitoring. CV: Troponins were trended every 12 hours with a max of 4.91. His last troponin checked on the morning of discharge was 0.41. He had an echo that showed normal cardiac function, an MRI that indicated normal ventricular size and function, with minimal or healing and inflammation or mild myocarditis. During his admission, he had continuous cardiorespiratory monitoring, that did not show any arrhythmias. Resp: On 2L NC for comfort, no respiratory distress or hypoxia. FENGI: Regular diet Neuro: Ibuprofen scheduled and tylenol PRN for pain. He was initially started on ibuprofen 800 mg every 8 hours, but was starting to have pain prior to being due for medicine every 8 hours so his regimen was changed to 600 mg every 6 hours which controlled his pain adequately. ID: Myocarditis panel sent with some results still pending. Thus far, he is CMV negative, EBV IgG was positive but not IgM. RVP was negative. This all occurred in the setting receiving the Covid vaccine 3 days prior to presentation, which has been reported as a rare reaction to the Covid vaccine. At the time of discharge, labs pending results include mycoplasma pneumonia, coxsackie, parvovirus, enterovirus. Etiology of myocarditis remains unclear at this time, could be related to infectious etiology not yet clear to us, vs related to his COVID vaccine prior to admission.

Patient reported they couldnt stand the sight of blood and had fainted during draws before. Father was present in the vaccine office as well. Immediately fooling the administration of the vaccine patients eyes glazed over and he fainted. A few seconds later he began to have a spastic seizure that was short in nature, followed by a voiding of his bladder before he regained consciousness. Patient was given water, glucose tablets, and instructed to lay on the floor of the room with his feet elevated while a member of the staff stayed with him to treat and watch him. Followed up with patient and doctor soon after to learn this was the only time it has happened, patient fully recovered.

Patient evaluated at local hospital for concern for meningitis / encephalitis, transferred to our facility and was able to get studies (detailed below some of which are still pending). Initial symptoms presented with rhinorrhea, then severee headache, neck pain, and fever (tactile). Had sweats and chills. Began to experience diarrhea, dysuria, diffue body aches and myalgias. Severe pain in his neck / posterior occiput. Denied any mental status changes at the time. Studies largely negative for an identifiable bacterial process so presumptive diagnosis is aseptic meningitis. Unclear if from vaccine or other etiologies. Outside hospital had started antibiotics but this was stopped and patient symptomatically recovered with only symptomatic care.

Critical thrombocythemia, causing anemia due to nose bleeding, GI bleeding and metrorrhagia. Elevated WBC. Acute kidney failure. Pancreatitis. Admitted with Dx of Tumor lysis syndrome required blood and platelets transfusion

SARS CoV2 Pfizer vaccine 1 given at CVS in 4/2021. Day of vaccination, pt developed hematuria which self resolved in 2 days. Pt o/w asymptomatic. Dose 2 of pfizer vaccine given at PCP's office. Few days after, pt developed hematuria which progressed until presentation 2 weeks post vaccination. At presentation pt was found to have hematuria, hypoalbuminemia, proteinuria, HTN, and AKI. Dx by biopsy determined IgA nephropathy.

admitted w/ hematuria found to have IgA nephropathy confirmed on kidney biopsy; admitted w/ hematuria found to have IgA nephropathy confirmed on kidney biopsy; This is a spontaneous report from a contactable Physician. A 17-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 17-years-old intramuscular on Apr2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. Medical history was none. The patient received no 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 had not been tested for COVID-19. The patient's concomitant medications were not reported. The patient experienced admitted w/ hematuria found to have IgA nephropathy confirmed on kidney biopsy in Apr2021. History suggestive of symptom correlation with pfizer covid 19 vaccine doses. Pt first noted 1-2d hematuria immediatly after first dose. Sx resumed few days after second dose. The patient was hospitalized for admitted w/ hematuria found to have IgA nephropathy confirmed on kidney biopsy for 5 days. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The outcome was recovering. Information about lot/batch number has been requested.; Sender's Comments: Limited information regarding patient medical history , any concurrent medical conditions ,family history of nephropathy ,clinical course of events and concomitant medications preclude a comprehensive causality assessment of event IgA Nephropathy and Hematuria post- vaccination.

c/o "feeling sick for a week"; treated at clinic Saturday, 6/19, for UTI and prescribed antibiotics; c/o generalized muscle pain/aches since 6/16/2004; positive for diarrhea and fever. Received an EKG, labs, and chest Xray. Diagnosis of Obstructive jaundice and SIRS. Transferred to higher level of care with specialty in house.

Sx. Started with extreme fatigue. At around 16:00. Near 18:00 I had developed a fever, concurrent with aches and chills. Near 22:00 I had developed a headache, one of a dull nature, with Sharp throbs. Between 22:00 and 00:00 01/11/:12 I had developed tinnitus. Near 01:00 01/12/2021 I had developed swelling of the injection sight with contralateral numbness on the left arm and leg. Near 02:00 01/12I had loss sensation In my left arm and developed numbness in the face. From 20:00 01/11 to 22:00 01/12 I had developed episodes of tachycardia with a peak resting heart rate of 143bpm measured via Watch. Between 15:00 01/12 and 22:00 01/12 I had experienced terrible non radiating angina proximal to the sternum. I had developed pain while urinating at around 21:00 01/11 my last urination was at 23:00 01/12, I did not go again until 16:00 01/13. I had experienced lower back concurrent with that. From 22:00 01/11 to 23:00 01/12 I had terrible SOB, and chest pain upon exhalation. Fever and body aches did not subside until through the night of 01/12:13. I had not experienced any symptoms as the night of 01/12. I had developed a rash across my chest near 18:00 01/11 though it has subsided it is still present.

Patient fainted after waiting for 10 minutes. He did not lose consciousness. He responded to RPH commands. He did not have shortness of breath, rash, inflammation. He urinated himself after falling. He remained laying on the ground for 20 minutes, after which he stood up and had recovered from the dizziness/nausea. Patient and parents did not wish for 911 to be called or to go the hospital. They agreed to call 911 if patient has any further symptoms.

the day after getting the shot my son's being very aggressive, throwing things and mood was all over the place. Since getting the shot he has been upset and continuously wetting himself. I had to take him to a crisis center Sunday night because I was unable to calm him down. My son has never had this reaction before after getting shot.

presented to the ER with complaints of abdominal pain. Found to have a ruptured appendix with intra-abdominal abscess, UTI, acute hypoxic respiratory failure related to bilateral aspiration pneumonia, and sepsis. Principal Problem: Perforated appendix POA: Unknown Active Problems: Sepsis (CMS/HCC) (HCC) POA: Yes

Initial presentation Patient was in his usual state of good health until 4/19 when he received his first dose of the Pfizer COVID-19 vaccine. Two hours after the injection he became nauseous and vomited multiple times. Overnight he experienced diffuse myalgia and suprapubic pain. He awoke the next day to a pustular rash on his chin, forehead, chest and back. The patient describes similar previous rashes that have resolved spontaneously. The next day he began to experience gross hematuria and presented to the ED with a temperature of 98.9, blood pressure of 100/69mmHg, heart rate of 110bpm, respiratory rate of 18 breaths per minute and an O2 saturation of 97% on room air. On examination, patient was ill-appearing with diffuse pustules on his face, chest and back, periorbital edema, and leukoplakia of the tongue and buccal mucosa. His abdomen was soft and tender to palpation in the suprapubic area and at both costovertebral angles. Hospital course In the ED the patient was found to have a metabolic acidosis of pH 7.33 with an anion gap of 16, lactate 2.6, neutrophilic leukocytosis (22k), acute renal insufficiency with a BUN of 45 and creatinine 3.81 (baseline is 0.76). The patient?s urine demonstrated packed RBCs and 5-10 WBCs. He was admitted to the medicine service for further management. On the medicine floor he was initially found to have rhabdomyolysis (CK 584), worsening renal failure (Creatinine 8), follicular conjunctivitis by skin biopsy, a low CD3/CD4 count (CD4 91, CD3 47, CD8 258) with normal complement, and bilateral tinnitus. CT A/P without contrast showed increased attenuation of renal pelves and ureters consistent with hemorrhage, but no renal stones or hydronephrosis was seen. The patient was treated with pulse dose 500mg IV Methylprednisilone for 3 days and then transitioned to 60mg Prednisone. The patient?s pustular rash and oral leukoplakia greatly improved while on pulse dose steroids, but his kidney function continued to decline (Creatinine rising from 8 to 11), and the patient?s bilateral tinnitus progressed to bilateral sensorineural deafness over 2 days. Bilateral hearing loss prompted an MRI of the brain which identified several punctate infarcts across multiple vascular territories in bilateral cortices and left cerebellum. The patient?s kidney function has continued to decline, with progressive hyperkalemia and hemodialysis was begun.

worsening renal failure/kidney function continued to decline; gross hematuria; follicular conjunctivitis; a low CD3/CD4 count (CD4 91, CD347, CD8 258); a low CD3/CD4 count (CD4 91, CD347, CD8 258); The patient's unilateral tinnitus progressed to bilateral sensorineural deafness over 2 days; The patient's unilateral tinnitus progressed to bilateral sensorineural deafness over 2 days; pustular rash on his chin forehead, chest and back; nauseous; diffuse myalgia; vomited; suprapubic pain; This is a spontaneous report from a contactable other healthcare professional. A 20-year-old male patient first dose of received bnt162b2 (BNT162B2), intramuscular, administered in left arm on 19Apr2021, at the age of 20-years old, (Lot Number: EW0151) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient has not been diagnosed with COVID-19. It was reported that the patient was in his usual state of good health until 19Apr2021, when he received his first dose of the Pfizer COVID-19 vaccine. Two hours after the injection he became nauseous and vomited multiple times. Overnight he experienced diffuse myalgia and suprapubic pain. On 20Apr2021, he woke up the next day to a pustular rash on his chin, forehead, chest and back. The patient describes similar previous rashes that have resolved spontaneously. On21Apr2021, he began to experience gross hematuria and presented to the Emergency department. On the medicine floor he was initially found to have worsening renal failure, follicular conjunctivitis by skin biopsy, a low CD3/CD4 count (CD4 91, CD3 47, CD8 258) with normal complement, and bilateral tinnitus. The patient's unilateral tinnitus progressed to bilateral sensorineural deafness over 2 days. His kidney function continued to decline and hemodialysis was begun on 27Apr2021. His kidney function continued to decline on hemodialysis, becoming so he was transferred to the MICU for CRRT. The patient was hospitalized for 12 days due to the events, the events were also assessed as life-threathening. The patient been tested for COVID-19 post vaccination with unknown result. The outcome of the events was unknown. Therapeutic measures were taken as a result of the events. Information on Lot/Batch number was available. Additional information has been requested.

Please see housestaff note for full details. In brief, 20-year-old neurologically normal man with history of asthma now presenting with new onset fever, headache and then status epilepticus. On 5/25 the patient received his second dose of COVID vaccine and then started to have intermittent fevers up to 102.5. This was associated with malaise, nausea, fever, headache, myalgias. He came to ED on 5/30 and had IVF, analgesics and a cardiac workup that was unremarkable and was discharged with diagnosis of possible pericarditis/myocarditis. He then had ongoing worsening headaches and increasing fevers and was unable to get out of his bed, and so his wife called 911 and he came to ED on 6/3. There he had vomiting and transaminitis and was diagnosed with gastroenteritis treated with flagyl. Headaches progressed and were associated with dizziness; he had HCT read as unremarkable but then while awaiting MRI had convulsion. He was returned to his room and had two more and thus was intubated, placed on propofol/versed, Keppra, dilantin, and broad-spectrum antibiotics and acyclovir before transfer to UCSF. on 6/5/2021 found to have reduced urine output, and serum creatinine found to be 1.72 and climbed >7 in days later normalized spontaneously with fluid support to 4.26 with continued improvement. LFTs were also found to be elevated. Was acutely encephalopathic. Seizures resolved on Keppra treatment though had acute agitation for several days. Slowly returning to neurologic baseline. with AKI and LFTs slowly normalizing.

Patient was admitted with neurologic complaints (arm numbness and tingling) and chest pain/tightness. Was found to be hypertensive, thrombocytopenic and in AKI. Was evaluated for mutltiple problems but found to have aTTP. Patient received plasma exchange, high-dose steroids, rituximab and caplacizumab. AKI resolved, neurologic complication resolved and thrombocytopenia resolved. Patient was discharge 6.21.21 with prescription for caplacizumab.

20 y/o gentleman developed acute kidney injury and nephrotic syndrome due to biopsy proven minimal change disease following vaccination.

Patient had a seizure about 40 seconds after receiving the COVID19 (Pfizer) vaccine. He urinated, and became cyanotic, not breathing and faint pulse. CPR as initiated and 911 called. Patient regained consciousness after 30 compressions and was taken to the hospital after ambulance arrived.

SARS-CoV-2 / COVID-19 mRNA IM (Pfizer-BioNTech) Date Status Dose VIS Date Route Site Manufacturer Lot# Given By Verified By 3/13/2021 Given 0.3 mL EUA 12/2020 IM RD Pfizer, Inc EN6208 RN --

appendicitis/diagnosis was acute appendicitis with prerenal azotemia; appendicitis/diagnosis was acute appendicitis with prerenal azotemia; This is a spontaneous report from a contactable consumer. A 22-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 11May2021 12:45 (Batch/Lot Number: EW0176) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received the first dose of BNT162B2 on 20Apr2021 for covid-19 immunization (lot_number=ER8735,lot_unknown=False, administration_date=20Apr2021,administration_time=12:30 PM, dose_number=1,vaccine_location=Left arm]. He did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced appendicitis/diagnosis was acute appendicitis with prerenal azotemia on 14May2021 10:00 with outcome of recovering, lower abdominal pain on 14May2021 10:00 with outcome of recovering. The patient was hospitalized for appendicitis/diagnosis was acute appendicitis with prerenal azotemia for 2 days.The patient was hospitalized for lower abdominal pain for 2 days. The patient underwent lab tests and procedures which included computerised tomogram: acute appendicitis on 14May2021, sars-cov-1 test negative: negative on 14May2021 Nasal Swab. Three days after receiving his second dose, he noticed lower abdominal pain, which resulted in visit to his primary care physician, who suspected appendicitis. He was immediately sent to the hospital for a CT scan that Friday night, and had surgery to remove my appendix Saturday morning. Official diagnosis was acute appendicitis with prerenal azotemia. He was discharged Sunday afternoon. Therapeutic measures were taken as a result of all events. The all events were reported as seriousness criteria of life-threatening. Information on lot/batch number was available. Additional information has been requested.

I started having Diarrhea and have to pee a lot more. It started yesterday evening and I noticed all day today that I had to pee more often than normal. I had diarrhea 3 times. (My wife got the same vaccine at the same time and has similar symptoms)

Patient passed out while sitting in a chair during an observation period after the shot. His body started to slightly shake, and he urinated himself. The pt. woke up right after that. He claimed he felt very light headed and like he wanted to vomit. The patient was given water and was observed for 15 more minutes. He claimed he felt better, just slightly light headed. A friend came to pick him up.

24 hrs after vaccination patient developed nausea, vomiting and fatigue. After 1 week went to ER dx with Aki, Since in followup after ER. Diclofenac stopped d/t aki. Had significant weight gain and was admitted over the weekend. Further testing at the hospital with biopsy of kidney revealed minimal change nephropathy

He states he had the first Pfizer COVID-19 vaccine in the series on 4/13/2021. He states that two days later on 4/15/2021 he felt like his feet were heavy. He continues to experience that sensation in his feet, and even feeling like his feet are asleep at nighttime and when he first gets up in the morning. The asleep feeling in the feet gets better when he gets up and moves around but the heavy sensation in the legs does not get better. He states that his mobility is affected though that his legs feel heavy and he is not as easily mobile as he used to be. He feels his balance is off. Patient later reported that he did have and episode of syncope about 5 minutes after he got the vaccine but otherwise was doing okay until 4/15/2021. He presented to the ED with these symptoms on 5/3/2021 at approximately 7:14pm and was admitted to the hospital for evaluation. Patient states that he normally exercises regularly and has been having a great deal of difficulty especially with squatting and now has difficulty walking up stairs, feels very weak and his legs feel heavy. He reports that the numbness and tingling sensation of his feet when sleeping is new and he has never had it in the past. Symptoms get worse with exertion and prolonged activity. Neurologist was consulted and several tests were ordered. Neurology consult noted that patient had a prior COVID 19 infection in November 2020. Per neurologist notes: His symptoms first started about two days after he received Pfizer COVID vaccine on April 13, 2021. He recalled feeling his feet heaviness and it was hard to pick them up. He also had some calf pain. He also had difficulty with doing his stretches and yoga positioning. A week ago, he began to have difficulty with picking up a ball or anything from the ground. He also developed pins and needles at the fingertips at the same time he developed tingling sensation of his feet. He also has lower back pain. He tested positive for SARS-COV-2 antigen on November 12, 2020. He recalled having symptoms lasting for a few days consisting of diaphoresis, cough, and flu-like symptoms. Per neurologist, symptoms seem to resemble acute inflammatory demyelinating polyneuropathy (AIDP). Patient was treated with IVIG for 5 days.

Hematuria (bright red blood), pain while urinating, passage of mucus in urine and possible kidney stone over the course of two days.

Severe nausea, heart palpitations, syncope, shortness of breath and triggered an organ rejection event (I am a kidney transplant patient).

blood in urine, neck stiffness, headache in back of head, stabbing headache, temporal pressure, visual disturbances,

Follow up report: This time that it happened: I had on Saturday morning - urinating pain followed by blood in my urine. That persisted for the next two days. I went to an Urgent Care - this time. They did Urinalysis - confirmed blood in my urine; also leukocytes were high - they gave me course of antibiotics and it resolved that same day but I continued the seven day course of antibiotics - Bactrim. I thought it might be kidney stones but I never saw anything come out and it seemed to resolve pretty quickly. Yet it almost seemed resolved before I really started taking the antibiotics. They also gave me an ultrasound of my kidneys at the Urgent Care.